Title 45--Public Welfare
SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 74--UNIFORM ADMINISTRATIVE REQUIREMENTS FOR AWARDS AND SUBAWARDS TO INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, OTHER NONPROFIT ORGANIZATIONS, AND COMMERCIAL ORGANIZATIONS; AND CERTAIN GRANTS AND AGREEMENTS WITH STATES, LOCAL GOVERNMENTS AND INDIAN TRIBAL GOVERNMENTS
74.1 Purpose and applicability
74.2 Definitions
74.3 Effect on other issuances
74.4 Deviations
74.5 Subawards
74.10 Purpose
74.11 Pre-award policies
74.12 Forms for applying for HHS financial assistance
74.13 Debarment and suspension
74.14 Special award conditions
74.15 Metric system of measurement
74.16 Resource Conservation and Recovery Act (RCRA, Section 6002 of Pub. L. No. 94-580 (Codified at 42 U.S.C. 6962))
74.17 Certifications and representations
74.20 Purpose of financial and program management.
74.21 Standards for financial management systems.
74.22 Payment.
74.23 Cost sharing or matching.
74.24 Program income.
74.25 Revision of budget and program plans.
74.26 Non-Federal audits.
74.27 Allowable costs.
74.28 Period of availability of funds.
74.30 Purpose of property standards.
74.31 Insurance coverage.
74.32 Real property.
74.33 Federally-owned and exempt property.
74.34 Equipment.
74.35 Supplies.
74.36 Intangible property.
74.37 Property trust relationship.
74.40 Purpose of procurement standards.
74.41 Recipient responsibilities.
74.42 Codes of conduct.
74.43 Competition.
74.44 Procurement procedures.
74.45 Cost and price analysis.
74.46 Procurement records.
74.47 Contract administration.
74.48 Contract provisions.
74.50 Purpose of reports and records.
74.51 Monitoring and reporting program performance.
74.52 Financial reporting.
74.53 Retention and access requirements for records.
74.60 Purpose of termination and enforcement.
74.61 Termination.
74.62 Enforcement.
74.70 Purpose.
74.71 Closeout procedures.
74.72 Subsequent adjustments and continuing responsibilities.
74.73 Collection of amounts due.
74.80 Scope of subpart.
74.81 Prohibition against profit.
74.82 Program income.
74.83 Effect on intangible property.
74.90 Final decisions in disputes.
74.91 Alternative dispute resolution.
Appendix A
Appendix E
45 CFR Part 74 -- Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments

45 CFR 74.1 -- Purpose and applicability

45 CFR 74.1(a) -- Unless inconsistent with statutory requirements, this part establishes uniform administrative requirements governing:

45 CFR 74.1(a)(1) -- Department of Health and Human Services' (HHS) grants and agreements awarded to institutions of higher education, hospitals, other nonprofit organizations and commercial organizations;

45 CFR 74.1(a)(2) -- Subgrants or other subawards awarded by recipients of HHS grants and agreements to institutions of higher education, hospitals, other nonprofit organizations and commercial organizations, including subgrants or other subawards awarded under HHS grants and agreements administered by State, local and Indian Tribal governments; and

45 CFR 74.1(a)(3) -- HHS grants and agreements, and any subawards under such grants and agreements, awarded to carry out the entitlement programs identified at 45 CFR Part 92, Sec. 92.4(a)(3), (a)(7), and (a)(8), except that Secs. 74.12, 74.23, 74.25, and 74.52 of this part do not apply. Under these programs, requests to HHS from Governors or other duly constituted State authorities for waiver of single State agency requirements in accordance with 31 U.S.C. 6501-6508 will be given expeditious handling. Whenever possible, such requests will be granted.

45 CFR 74.1(b) -- Nonprofit organizations that implement HHS programs for the States are also subject to state requirements.

45 CFR 74.1(c) -- HHS shall not impose additional or inconsistent requirements except as provided in Secs. 74.4 and 74.14, or unless specifically required by Federal statute or executive order.

45 CFR 74.2 -- Definitions

45 CFR 74.2(a) -- Accrued expenditures mean the charges incurred by the recipient during a given period requiring the provision of funds for: (1) Goods and other tangible property received; (2) services performed by employees, contractors, subrecipients, and other payees; and, (3) other amounts becoming owed under programs for which no current services or performance is required. Accrued income means the sum of: (1) Earnings during a given period from (i) services performed by the recipient, and (ii) goods and other tangible property delivered to purchasers; and (2) amounts becoming owed to the recipient for which no current services or performance is required by the recipient.

45 CFR 74.2(b) -- Accrued income means the sum of: (1) Earnings during a given period from (i) services performed by the recipient, and (ii) goods and other tangible property delivered to purchasers; and (2) amounts becoming owed to the recipient for which no current services or performance is required by the recipient.

45 CFR 74.2(c) -- Acquisition cost of equipment means the net invoice price of the equipment, including the cost of modifications, attachments, accessories, or auxiliary apparatus necessary to make the property usable for the purpose for which it was acquired. Other charges, such as the cost of installation, transportation, taxes, duty or protective in-transit insurance, shall be included or excluded from the unit acquisition cost in accordance with the recipient's regular accounting practices.

45 CFR 74.2(d) -- Advance means a payment made by Treasury check or other appropriate payment mechanism to a recipient upon its request either before outlays are made by the recipient or through the use of predetermined payment schedules.

45 CFR 74.2(e) -- Award means financial assistance that provides support or stimulation to accomplish a public purpose. Awards include grants and other agreements in the form of money or property in lieu of money, by the Federal Government to an eligible recipient. The term does not include: technical assistance, which provides services instead of money; other assistance in the form of loans, loan guarantees, interest subsidies, or insurance; direct payments of any kind to individuals; and, contracts which are required to be entered into and administered under Federal procurement laws and regulations.

45 CFR 74.2(f) -- Cash contributions mean the recipient's cash outlay, including the outlay of money contributed to the recipient by third parties.

45 CFR 74.2(g) -- Closeout means the process by which the HHS awarding agency determines that all applicable administrative actions and all required work of the award have been completed by the recipient and HHS.

45 CFR 74.2(h) -- Contract means a procurement contract under an award or subaward, and a procurement subcontract under a recipient's or subrecipient's contract.

45 CFR 74.2(i) -- Cost sharing or matching means that portion of project or program costs not borne by the Federal Government.

45 CFR 74.2(j) -- Current accounting period means, with respect to Sec. 74.27(b), the period of time the recipient chooses for purposes of financial statements and audits.

45 CFR 74.2(k) -- Date of completion means the date on which all work under an award is completed or the date on the award document, or any supplement or amendment thereto, on which HHS awarding agency sponsorship ends.

45 CFR 74.2(l) -- Departmental Appeals Board means the independent office established in the Office of the Secretary with delegated authority from the Secretary to review and decide certain disputes between recipients of HHS funds and HHS awarding agencies under 45 CFR part 16 and to perform other review, adjudication and mediation services as assigned.

45 CFR 74.2(m) -- Disallowed costs mean those charges to an award that the HHS awarding agency determines to be unallowable, in accordance with the applicable Federal cost principles or other terms and conditions contained in the award.

45 CFR 74.2(n) -- Discretionary award means an award made by an HHS awarding agency in keeping with specific statutory authority which enables the agency to exercise judgment ("discretion") in selecting the applicant/recipient organization through a competitive award process.

45 CFR 74.2(o) -- Equipment means tangible nonexpendable personal property, including exempt property, charged directly to the award having a useful life of more than one year and an acquisition cost of $5000 or more per unit. However, consistent with recipient policy, lower limits may be established.

45 CFR 74.2(p) -- Excess property means property under the control of any HHS awarding agency that, as determined by the head of the awarding agency or his/her delegate, is no longer required for the agency's needs or the discharge of its responsibilities.

45 CFR 74.2(q) -- Exempt property means tangible personal property acquired in whole or in part with Federal funds, where the HHS awarding agency has statutory authority to vest title in the recipient without further obligation to the Federal Government. An example of exempt property authority is contained in the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6306, for property acquired under an award to conduct basic or applied research by a nonprofit institution of higher education or nonprofit organization whose principal purpose is conducting scientific research.

45 CFR 74.2(r) -- Federal funds authorized mean the total amount of Federal funds obligated by the HHS awarding agency for use by the recipient. This amount may include any authorized carryover of unobligated funds from prior funding periods when permitted by the HHS awarding agency's implementing instructions or authorized by the terms and conditions of the award.

45 CFR 74.2(s) -- Federal share of real property, equipment, or supplies means that percentage of the property's or supplies' acquisition costs and any improvement expenditures paid with Federal funds. This will be the same percentage as the Federal share of the total costs under the award for the funding period in which the property was acquired (excluding the value of third party in-kind contributions).

45 CFR 74.2(t) -- Federally recognized Indian Tribal government means the governing body of any Indian tribe, band, nation, or other organized group or community (including any Native village as defined in section 3 of the Alaska Native Claims Settlement Act certified by the Secretary of the Interior as eligible for the special programs and services provided by him through the Bureau of Indian Affairs.

45 CFR 74.2(u) -- Funding period means the period of time when Federal funding is available for obligation by the recipient.

45 CFR 74.2(v) -- Government means a State or local government or a federally recognized Indian tribal government.

45 CFR 74.2(w) -- HHS means the U.S. Department of Health and Human Services.

45 CFR 74.2(x) -- HHS awarding agency means any organization component of HHS that is authorized to make and administer awards.

45 CFR 74.2(y) -- Intangible property and debt instruments mean, but are not limited to, trademarks, copyrights, patents and patent applications and such property as loans, notes and other debt instruments, lease agreements, stock and other instruments of property ownership, whether considered tangible or intangible.

45 CFR 74.2(z) -- Local government means a local unit of government, including specifically a county, municipality, city, town, township, local public authority, school district, special district, intra-state district, council of governments (whether or not incorporated as a nonprofit corporation under State law), any other regional or interstate entity, or any agency or instrumentality of local government.

45 CFR 74.2(aa) -- Obligations mean the amounts of orders placed, contracts and grants awarded, services received and similar transactions during a given period that require payment by the recipient during the same or a future period.

45 CFR 74.2(ab) -- OGAM means the Office of Grants and Acquisition Management, which is an organizational component within the Office of the Secretary, HHS, and reports to the Assistant Secretary for Management and Budget.

45 CFR 74.2(ac) -- OMB means the U.S. Office of Management and Budget.

45 CFR 74.2(ad) -- Outlays or expenditures mean charges made to the project or program. They may be reported on a cash or accrual basis. For reports prepared on a cash basis, outlays are the sum of cash disbursements for direct charges for goods and services, the amount of indirect expense charged, the value of third party in-kind contributions applied and the amount of cash advances and payments made to subrecipients. For reports prepared on an accrual basis, outlays are the sum of cash disbursements for direct charges for goods and services, the amount of indirect expense incurred, the value of in-kind contributions

45 CFR 74.2(ae) -- Personal property means property of any kind except real property. It may be tangible, having physical existence, or intangible, having no physical existence, such as copyrights, patents, or securities.

45 CFR 74.2(af) -- Prior approval means written approval by an authorized HHS official evidencing prior consent.

45 CFR 74.2(ag) -- Program income means gross income earned by the recipient that is directly generated by a supported activity or earned as a result of the award (see exclusions in Sec. 74.24 (e) and (h)). Program income includes, but is not limited to, income from fees for services performed, the use or rental of real or personal property acquired under federally-funded projects, the sale of commodities or items fabricated under an award, license fees and royalties on patents and copyrights, and interest on loans made with award funds. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in the terms and conditions of the award, program income does not include the receipt of principal on loans, rebates, credits, discounts, etc., or interest earned on any of them. Furthermore, program income does not include taxes, special assessments, levies, and fines raised by governmental recipients.

45 CFR 74.2(ah) -- Project costs means all allowable costs, as set forth in the applicable Federal cost principles (see Sec. 74.27), incurred by a recipient and the value of the contributions made by third parties in accomplishing the objectives of the award during the project period.

45 CFR 74.2(ai) -- Project period means the period established in the award document during which HHS awarding agency sponsorship begins and ends.

45 CFR 74.2(aj) -- Property means, unless otherwise stated, real property, equipment, intangible property and debt instruments.

45 CFR 74.2(ak) -- Real property means land, including land improvements, structures and appurtenances thereto, but excludes movable machinery and equipment.

45 CFR 74.2(al) -- Recipient means an organization receiving financial assistance directly from an HHS awarding agency to carry out a project or program. The term includes public and private institutions of higher education, public and private hospitals, commercial organizations, and other quasi-public and private nonprofit organizations such as, but not limited to, community action agencies, research institutes, educational associations, and health centers. The term may include foreign or international organizations (such as agencies of the United Nations) which are recipients, subrecipients, or contractors or subcontractors of recipients or subrecipients at the discretion of the HHS awarding agency. The term does not include government-owned contractor-operated facilities or research centers providing continued support for mission-oriented, large-scale programs that are government-owned or controlled, or are designated as federally-funded research and development centers. For entitlement programs listed at 45 CFR 92.4(a)(3), (a)(7), and (a)(8) "recipient" means the government to which an HHS awarding agency awards funds and which is accountable for the use of the funds provided. The recipient in this case is the entire legal entity even if only a particular component of the entity is designated in the award document.

45 CFR 74.2(am) -- Research and development means all research activities, both basic and applied, and all development activities that are supported at universities, colleges, hospitals, other nonprofit institutions, and commercial organizations. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function.

45 CFR 74.2(an) -- Small awards means a grant or cooperative agreement not exceeding the simplified acquisition threshold fixed at 41 U.S.C. 403(11) (currently $100,000).

45 CFR 74.2(ao) -- State means any of the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, any territory or possession of the United States, or any agency or instrumentality of a State exclusive of local governments.

45 CFR 74.2(ap) -- Subaward means an award of financial assistance in the form of money, or property in lieu of money, made under an award by a recipient to an eligible subrecipient or by a subrecipient to a lower tier subrecipient. The term includes financial assistance when provided by any legal agreement, even if the agreement is called a contract, but does not include procurement of goods and services nor does it include any form of assistance which is excluded from the definition of "award" in this section.

45 CFR 74.2(aq) -- Subrecipient means the legal entity to which a subaward is made and which is accountable to the recipient for the use of the funds provided. The term may include foreign or international organizations (such as agencies of the United Nations) at the discretion of the HHS awarding agency.

45 CFR 74.2(ar) -- Supplies means all personal property excluding equipment, intangible property, and debt instruments as defined in this section, and inventions of a contractor conceived or first actually reduced to practice in the performance of work under a funding agreement ("subject inventions"), as defined in 37 CFR part 401, "Rights to Inventions Made by Nonprofit Organizations and Business Firms Under Government Grants, Contracts, and Cooperative Agreements."

45 CFR 74.2(as) -- Suspension means an action by the HHS awarding agency that temporarily withdraws the agency's financial assistance sponsorship under an award, pending corrective action by the recipient or pending a decision to terminate the award.

45 CFR 74.2(at) -- Suspension of an award is a separate action from suspension under HHS regulations (45 CFR part 76) implementing E.O.s 12549 and 12689, "Debarment and Suspension."

45 CFR 74.2(au) -- Termination means the cancellation of HHS awarding agency sponsorship, in whole or in part, under an agreement at any time prior to the date of completion. For the entitlement programs listed at 45 CFR 92.4 (a)(3), (a)(7), and (a)(8), "termination" shall have that meaning assigned at 45 CFR 92.3.

45 CFR 74.2(av) -- Third party in-kind contributions means the value of non-cash contributions provided by non-Federal third parties. Third party in-kind contributions may be in the form of real property, equipment, supplies and other expendable property, and the value of goods and services directly benefiting and specifically identifiable to the project or program

45 CFR 74.2(aw) -- Unliquidated obligations, for financial reports prepared on a cash basis, mean the amount of obligations incurred by the recipient that has not been paid. For reports prepared on an accrued expenditure basis, they represent the amount of obligations incurred by the recipient for which an outlay has not been recorded.

45 CFR 74.2(ax) -- Unobligated balance means the portion of the funds authorized by the HHS awarding agency that has not been obligated by the recipient and is determined by deducting the cumulative obligations from the cumulative funds authorized.

45 CFR 74.2(ay) -- Unrecovered indirect cost means the difference between the amount awarded and the amount which could have been awarded under the recipient's approved negotiated indirect cost rate.

45 CFR 74.2(az) -- Working capital advance means a procedure whereby funds are advanced to the recipient to cover its estimated disbursement needs for a given initial period.

45 CFR 74.3 -- Effect on other issuances This part supersedes all administrative requirements of codified program regulations, program manuals, handbooks and other nonregulatory materials which are inconsistent with the requirements of this part, except to the extent they are required by Federal statute, or authorized in accordance with the deviations provision in Sec. 74.4.

45 CFR 74.4 -- Deviations

45 CFR 74.4(a) -- After consultation with OMB, the HHS OGAM may grant exceptions to HHS awarding agencies for classes of awards or recipients subject to the requirements of this part when exceptions are not prohibited by statute. However, in the interest of maximum uniformity, exceptions from the requirements of this part shall be permitted only in unusual circumstances. HHS awarding agencies may apply more restrictive requirements to a class of awards or recipients when approved by the OGAM, after consultation with the OMB. HHS awarding agencies may apply less restrictive requirements without approval by the OGAM when making small awards except for those requirements which are statutory. Exceptions on a case-by-case basis may also be made by HHS awarding agencies without seeking prior approval from the OGAM. OGAM will maintain a record of all requests for exceptions from the provisions of this part that have been approved for classes of awards or recipients.

45 CFR 74.4(b) -- As a matter of Departmental policy, requests for individual case deviations will be considered favorably by HHS and its awarding agencies whenever the deviation will facilitate comprehensive or integrated service delivery, or multiple-source consolidated awards, unless the deviation would impair the integrity of the program.

45 CFR 74.5 -- Subawards

45 CFR 74.5(a) -- Unless inconsistent with statutory requirements, this part (except for Sec. 74.12 and the forms prescribed in Sec. 74.22) shall apply to --

45 CFR 74.5(a)(1) -- Except for subawards under block grants (45 CFR part 96), all subawards received by institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations from any recipient of an HHS award, including any subawards received from States, local governments, and Indian tribal governments covered by 45 CFR part 92; and

45 CFR 74.5(a)(2) -- All subawards received from States by any entity, including a government entity, under the entitlement programs identified at 45 CFR part 92, Sec. 92.4 (a), (a)(7), and (a)(8), except that Secs. 74.12 and 74.25 of this part shall not apply.

45 CFR 74.5(b) -- Except as provided in paragraph (a)(2) of this section, when State, local, and Indian Tribal government recipients of HHS awards make subawards to a government entity, they shall apply the regulations at 45 CFR part 92, "Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments," or State rules, whichever apply, to such awards.

45 CFR 74.10 -- Purpose Sections 74.11 through 74.17 prescribe forms and instructions and other pre-award matters to be used in applying for HHS awards.

45 CFR 74.11 -- Pre-award Policies

45 CFR 74.11(a) -- Use of Grants and Cooperative Agreements, and Contracts. The Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301-08, governs the use of grants, cooperative agreements and contracts. A grant or cooperative agreement shall be used only when the principal purpose of a transaction is to accomplish a public purpose of support or stimulation authorized by Federal statute. The statutory criterion for choosing between grants and cooperative agreements is that for the latter, "substantial involvement is expected between the executive agency and the State, local government, or other recipient when carrying out the activity contemplated in the agreement." Contracts shall be used when the principal purpose is acquisition of property or services for the direct benefit or use of the HHS awarding agency.

45 CFR 74.11(b) -- HHS awarding agencies shall notify the public of funding priorities for discretionary grant programs, unless funding priorities are established by Federal statute.

45 CFR 74.12 -- Forms for applying for HHS financial assistance

45 CFR 74.12(a) -- HHS awarding agencies shall comply with the applicable report clearance requirements of 5 CFR part 1320, "Controlling Paperwork Burdens on the Public," with regard to all forms used in place of or as a supplement to the Standard Form 424 (SF-424) series. However, HHS awarding agencies should use the SF-424 series and its program narrative whenever possible.

45 CFR 74.12(b) -- Applicants shall use the SF-424 series or those forms and instructions prescribed by the HHS awarding agency. Applicants shall submit the original and two copies of any applications unless additional copies are required pursuant to 5 CFR part 1320.

45 CFR 74.12(c) -- For Federal programs covered by E.O. 12372, as amended by E.O. 12416, "Intergovernmental Review of Federal Programs," the applicant shall complete the appropriate sections of the SF-424 (Application for Federal Assistance) indicating whether the application was subject to review by the State Single Point of Contact (SPOC). The name and address of the SPOC for a particular State can be obtained from the HHS awarding agency or the Catalog of Federal Domestic Assistance. The SPOC shall advise the applicant whether the program for which application is made has been selected by that State for review. (See also 45 CFR part 100.)

45 CFR 74.12(d) -- HHS awarding agencies that do not use the SF-424 form will indicate on the application form they prescribe whether the application is subject to review by the State under E.O. 12372.

45 CFR 74.12(e) -- This section does not apply to applications for subawards.

45 CFR 74.13 -- Debarment and suspension Recipients are subject to the nonprocurement debarment and suspension common rule implementing E.O.s 12549 and 12689, "Debarment and Suspension," 45 CFR part 76. This common rule restricts subawards and contracts with certain parties that are debarred, suspended or otherwise excluded from or ineligible for participation in Federal assistance programs or activities.

45 CFR 74.14 -- Special award conditions

45 CFR 74.14(a) -- The HHS awarding agency may impose additional requirements as needed, without regard to Sec. 74.4, above, if an applicant or recipient:

45 CFR 74.14(a)(1) -- Has a history of poor performance;

45 CFR 74.14(a)(2) -- Is not financially stable;

45 CFR 74.14(a)(3) -- Has a management system that does not meet the standards prescribed in this part;

45 CFR 74.14(a)(4) -- Has not conformed to the terms and conditions of a previous award; or

45 CFR 74.14(a)(5) -- Is not otherwise responsible.

45 CFR 74.14(b) -- When it imposes any additional requirements, the HHS awarding agency must notify the recipient in writing as to the following:

45 CFR 74.14(b)(1) -- The nature of the additional requirements;

45 CFR 74.14(b)(2) -- The reason why the additional requirements are being imposed;

45 CFR 74.14(b)(3) -- The nature of the corrective actions needed;

45 CFR 74.14(b)(4) -- The time allowed for completing the corrective actions; and

45 CFR 74.14(b)(5) -- The method for requesting reconsideration of the additional requirements imposed.

45 CFR 74.14(c) -- The HHS awarding agency will promptly remove any additional requirements once the conditions that prompted them have been corrected.

45 CFR 74.15 -- Metric system of measurement The Metric Conversion Act, as amended by the Omnibus Trade and Competitiveness Act, 15 U.S.C. 205, declares that the metric system is the preferred measurement system for U.S. trade and commerce. The Act requires each Federal agency to establish a date or dates in consultation with the Secretary of Commerce, when the metric system of measurement will be used in the agency's procurements, grants, and other business-related activities. Metric implementation may take longer where the use of the system is initially impractical or likely to cause significant inefficiencies in the accomplishment of federally-funded activities. HHS awarding agencies will follow the provisions of E.O. 12770, "Metric Usage in Federal Government Programs."

45 CFR 74.16 -- Resource Conservation and Recovery Act (RCRA, Section 6002 of Pub L No 94-580 (Codified at 42 USC 6962)) Under the Act, any State agency or agency of a political subdivision of a State which is using appropriated Federal funds must comply with section 6002 of the RCRA. This section requires that preference be given in procurement programs to the purchase of specific products containing recycled materials identified in guidelines developed by the Environmental Protection Agency (EPA) (40 CFR parts 247-254). Accordingly, State and local institutions of higher education, hospitals, and other nonprofit organizations that receive direct HHS awards or other Federal funds shall give preference in their procurement programs funded with Federal funds to the purchase of recycled products pursuant to the EPA guidelines.

45 CFR 74.17 -- Certifications and representations Unless prohibited by statute or codified regulation, each HHS awarding agency is authorized and encouraged to allow recipients to submit certifications and representations required by statute, executive order, or regulation on an annual basis, if the recipients have ongoing and continuing relationships with the HHS awarding agency. Annual certifications and representations shall be signed by the responsible official(s) with the authority to ensure recipients' compliance with the pertinent requirements.

45 CFR 74.20 -- Purpose of financial and program management Sections 74.21 through 74.28 prescribe standards for financial management systems, methods for making payments, and rules for satisfying cost sharing and matching requirements, accounting for program income, budget revision approvals, making audits, determining allowability of cost, and establishing fund availability.

45 CFR 74.21 -- Standards for financial management systems

45 CFR 74.21(a) -- Recipients shall relate financial data to performance data and develop unit cost information whenever practical. For awards that support research, unit cost information is usually not appropriate.

45 CFR 74.21(b) -- Recipients' financial management systems shall provide for the following:

45 CFR 74.21(b)(1) -- Accurate, current and complete disclosure of the financial results of each HHS-sponsored project or program in accordance with the reporting requirements set forth in Sec. 74.52. If the HHS awarding agency requires reporting on an accrual basis from a recipient that maintains its records on other than an accrual basis, the recipient shall not be required to establish an accrual accounting system. These recipients may develop such accrual data for their reports on the basis if an analysis of the documentation on hand.

45 CFR 74.21(b)(2) -- Records that identify adequately the source and application of funds for HHS-sponsored activities. These records shall contain information pertaining to Federal awards, authorizations, obligations, unobligated balances, assets, outlays, income and interest.

45 CFR 74.21(b)(3) -- Effective control over and accountability for all funds, property and other assets. Recipients shall adequately safeguard all such assets and assure they are used solely for authorized purposes.

45 CFR 74.21(b)(4) -- Comparison of outlays with budget amounts for each award. Whenever appropriate, financial information should be related to performance and unit cost data. (Unit cost data are usually not appropriate for awards that support research.)

45 CFR 74.21(b)(5) -- Written procedures to minimize the time elapsing between the transfer of funds to the recipient from the U.S. Treasury and the issuance or redemption of checks, warrants or payments by other means for program purposes by the recipient. To the extent that the provisions of the Cash Management Improvement Act (CMIA) (Pub. L. 101-453) and its implementing regulations, "Rules and Procedures for Funds Transfers," (31 CFR part 205) apply, payment methods of State agencies, instrumentalities, and fiscal agents shall be consistent with CMIA Treasury-State Agreements, or the CMIA default procedures codified at 31 CFR 205.9(f).

45 CFR 74.21(b)(6) -- Written procedures for determining the reasonableness, allocability and allowability of costs in accordance with the provisions of the applicable Federal cost principles and the terms and conditions of the award.

45 CFR 74.21(b)(7) -- Accounting records, including cost accounting records, that are supported by source documentation.

45 CFR 74.21(c) -- Where the Federal Government guarantees or insures the repayment of money borrowed by the recipient, the HHS awarding agency, at its discretion, may require adequate bonding and insurance if the bonding and insurance requirements of the recipient are not deemed adequate to protect the interest of the Federal Government.

45 CFR 74.21(d) -- The HHS awarding agency may require adequate fidelity bond coverage where the recipient lacks sufficient coverage to protect the Federal Government's interest.

45 CFR 74.21(e) -- Where bonds are required in the situations described in Sec. 74.21 (c) and (d), the bonds shall be obtained from companies holding certificates of authority as acceptable sureties, as prescribed in 31 CFR part 223, "Surety Companies Doing Business with the United States."

45 CFR 74.22 -- Payment

45 CFR 74.22(a) -- Unless inconsistent with statutory program purposes, payment methods shall minimize the time elapsing between the transfer of funds from the U.S. Treasury and the issuance or redemption of checks, warrants, or payment by other means by the recipients. Payment methods of State agencies or instrumentalities shall be consistent with Treasury-State CMIA agreements, or the CMIA default procedures codified at 31 CFR 205.9, to the extent that either applies.

45 CFR 74.22(b) --

45 CFR 74.22(b)(1) -- Recipients will be paid in advance, provided they maintain or demonstrate the willingness to maintain:

45 CFR 74.22(b)(1)(i) -- Written procedures that minimize the time elapsing between the transfer of funds and disbursement by the recipient; and

45 CFR 74.22(b)(1)(ii) -- Financial management systems that meet the standards for fund control and accountability as established in Sec. 74.21.

45 CFR 74.22(b)(2) -- Unless inconsistent with statutory program purposes, cash advances to a recipient organization shall be limited to the minimum amounts needed and be timed to be in accordance with the actual, immediate cash requirements of the recipient organization in carrying out the purpose of the approved program or project. The timing and amount of cash advances shall be as close as is administratively feasible to the actual disbursements by the recipient organization for direct program or project costs and the proportionate share of any allowable indirect costs.

45 CFR 74.22(c) -- Whenever possible, advances will be consolidated to cover anticipated cash needs for all awards made by all HHS awarding agencies to the recipient.

45 CFR 74.22(c)(1) -- Advance payment mechanisms include electronic funds transfer, with Treasury checks available on an exception basis.

45 CFR 74.22(c)(2) -- Advance payment mechanisms are subject to 31 CFR part 205.

45 CFR 74.22(c)(3) -- Recipients may submit requests for advances and reimbursements at least monthly when electronic fund transfers are not used.

45 CFR 74.22(d) -- Requests for Treasury check advance payment shall be submitted on PMS-270, "Request for Advance or Reimbursement," or other forms as may be authorized by HHS. This form is not to be used when Treasury check advance payments are made to the recipient automatically through the use of a predetermined payment schedule or if precluded by special HHS-wide instructions for electronic funds transfer.

45 CFR 74.22(e) -- Reimbursement is the preferred method when the requirements in paragraph (b) of this section cannot be met. The HHS awarding agency may also use this method on any construction agreement, or if the major portion of the construction project is accomplished through private market financing or Federal loans, and the HHS assistance constitutes a minor portion of the project.

45 CFR 74.22(e)(1) -- When the reimbursement method is used, HHS will make payment within 30 days after receipt of the billing, unless the billing is improper.

45 CFR 74.22(e)(2) -- Recipients may submit a request for reimbursement at least monthly when electronic funds transfers are not used.

45 CFR 74.22(f) -- If a recipient cannot meet the criteria for advance payments and the HHS awarding agency has determined that reimbursement is not feasible because the recipient lacks sufficient working capital, HHS may provide cash on a working capital advance basis. Under this procedure, HHS advances cash to the recipient to cover its estimated disbursement needs for an initial period generally geared to the recipient's disbursing cycle. Thereafter, HHS reimburses the recipient for its actual cash disbursements. The working capital advance method of payment will not be used for recipients unwilling or unable to provide timely advances to their subrecipient to meet the subrecipient's actual cash disbursements.

45 CFR 74.22(g) -- Unless inconsistent with statutory program purposes, to the extent available, recipients shall disburse funds available from repayments to and interest earned on a revolving fund, program income, rebates, refunds, contract settlements, audit recoveries and interest earned on such funds before requesting additional cash payments.

45 CFR 74.22(h) -- Unless otherwise required by statute, the HHS awarding agency will not withhold payments for proper charges made by recipients at any time during the project period unless paragraph (h) (1) or (2) of this section applies:

45 CFR 74.22(h)(1) -- A recipient has failed to comply with the project objectives, the terms and conditions of the award, or HHS awarding agency reporting requirements.

45 CFR 74.22(h)(2) -- The recipient or subrecipient is delinquent in a debt to the United States. Under such conditions, the HHS awarding agency may, upon reasonable notice, inform the recipient that payments shall not be made for obligations incurred after a specified date until the conditions are corrected or the indebtedness to the Federal Government is liquidated. (See 45 CFR part 30).

45 CFR 74.22(i) -- Standards governing the use of banks and other institutions as depositories of funds advanced under awards are as follows:

45 CFR 74.22(i)(1) -- Except for situations described in paragraph (i)(2) of this section, HHS will not require separate depository accounts for funds provided to a recipient or establish any eligibility requirements for depositories for funds provided to a recipient. However, recipients must be able to account for the receipt, obligation and expenditure of funds.

45 CFR 74.22(i)(2) -- Advances of Federal funds shall be deposited and maintained in insured accounts whenever possible.

45 CFR 74.22(j) -- Consistent with the national goal of expanding the opportunities for women-owned and minority-owned business enterprises, recipients are encouraged to use women-owned and minority-owned banks (a bank which is owned at least 50 percent by women or minority group members).

45 CFR 74.22(k) -- Recipients shall maintain advances of Federal funds in interest bearing accounts, unless one of the following conditions apply:45 CFR 74.22(k)(1) -- The recipient receives less than $120,000 in Federal awards per year.

45 CFR 74.22(k)(2) -- The best reasonably available interest bearing account would not be expected to earn interest in excess of $250 per year on Federal cash balances.

45 CFR 74.22(k)(3) -- The depository would require an average or minimum balance so high that it would not be feasible within the expected Federal and non-Federal cash resources.

45 CFR 74.22(l) -- For those entities where CMIA and its implementing regulations do not apply (see 31 CFR part 205), interest earned on Federal advances deposited in interest bearing accounts shall be remitted annually to the Department of Health and Human Services, Payment Management System, P.O. Box 6021, Rockville, MD 20852. Recipients with Electronic Funds Transfer capability should use an electronic medium such as the FEDWIRE Deposit System. Interest amounts up to $250 per year may be retained by the recipient for administrative expense. State universities and hospitals shall comply with CMIA, as it pertains to interest. If an entity subject to CMIA uses its own funds to pay pre-award costs for discretionary awards without prior written approval from the HHS awarding agency, it waives its right to recover the interest under CMIA. (See Sec. 74.25(d)).

45 CFR 74.22(m) -- PMS-270, Request for Advance or Reimbursement. Recipients shall use the PMS-270 to request advances or reimbursement for all programs when electronic funds transfer or predetermined advance methods are not used. HHS shall not require recipients to submit more than an original and two copies.

45 CFR 74.22(n) -- Recipients and subrecipients are not required to use forms PMS-270 and 272 in connection with subaward payments.

45 CFR 74.23 -- Cost sharing or matching

45 CFR 74.23(a) -- To be accepted, all cost sharing or matching contributions, including cash and third party in-kind, shall meet all of the following criteria:

45 CFR 74.23(a)(1) -- Are verifiable from the recipient's records;

45 CFR 74.23(a)(2) -- Are not included as contributions for any other federally-assisted project or program;

45 CFR 74.23(a)(3) -- Are necessary and reasonable for proper and efficient accomplishment of project or program objectives;

45 CFR 74.23(a)(4) -- Are allowable under the applicable cost principles;

45 CFR 74.23(a)(5) -- Are not paid by the Federal Government under another award, except where authorized by Federal statute to be used for cost sharing or matching;

45 CFR 74.23(a)(6) -- Are provided for in the approved budget; and

45 CFR 74.23(a)(7) -- Conform to other provisions of this part, as applicable.

45 CFR 74.23(b) -- Unrecovered indirect costs may be included as part of cost sharing or matching.

45 CFR 74.23(c) -- Values for recipient contributions of services and property shall be established in accordance with the applicable cost principles. If the HHS awarding agency authorizes recipients to donate buildings or land for construction/facilities acquisition projects or long-term use, the value of the donated property for cost sharing or matching shall be the lesser of:

45 CFR 74.23(c)(1) -- The certified value of the remaining life of the property recorded in the recipient's accounting records at the time of donation; or

45 CFR 74.23(c)(2) -- The current fair market value. However, when there is sufficient justification, the HHS awarding agency may approve the use of the current fair market value of the donated property, even if it exceeds the certified value at the time of donation to the project.

45 CFR 74.23(d) -- Volunteer services furnished by professional and technical personnel, consultants, and other skilled and unskilled labor may be counted as cost sharing or matching if the service is an integral and necessary part of an approved project or program. Rates for volunteer services shall be consistent with those paid for similar work in the recipient's organization. In those instances in which the required skills are not found in the recipient's organization, rates shall be consistent with those paid for similar work in the labor market in which the recipient competes for the kind of services involved. In either case, fringe benefits consistent with those paid that are reasonable, allowable, and allocable may be included in the valuation.

45 CFR 74.23(e) -- When an employer other than the recipient furnishes the services of an employee, these services shall be valued at the employee's regular rate of pay (plus an amount of fringe benefits that are reasonable, allowable, and allocable, but exclusive of overhead costs), provided these services are in the same skill for which the employee is normally paid.

45 CFR 74.23(f) -- Donated supplies may include such items as expendable property, office supplies, laboratory supplies or workshop and classroom supplies. Value assessed to donated supplies included in the cost sharing or matching share shall be reasonable and shall not exceed the fair market value of the property at the time of the donation.

45 CFR 74.23(g) -- The method used for determining cost sharing or matching for donated equipment, buildings and land for which title passes to the recipient may differ according to the purpose of the award, if paragraph (g)(1) or (2) of this section applies:

45 CFR 74.23(g)(1) -- If the purpose of the award is to assist the recipient in the acquisition of equipment, buildings or land, the total value of the donated property may be claimed as cost sharing or matching.

45 CFR 74.23(g)(2) -- If the purpose of the award is to support activities that require the use of equipment, buildings or land, normally only depreciation or use charges for equipment and buildings may be made. However, the full value of equipment or other capital assets and fair rental charges for land may be allowed, provided that the HHS awarding agency has approved the charges.

45 CFR 74.23(h) -- The value of donated property shall be determined in accordance with the usual accounting policies of the recipient, with the following qualifications.

45 CFR 74.23(h)(1) -- The value of donated land and buildings shall not exceed its fair market value at the time of donation to the recipient as established by an independent appraiser (e.g., certified real property appraiser or General Services Administration representative) and certified by a responsible official of the recipient.

45 CFR 74.23(h)(2) -- The value of donated equipment shall not exceed the fair market value of equipment of the same age and condition at the time of donation.

45 CFR 74.23(h)(3) -- The value of donated space shall not exceed the fair rental value of comparable space as established by an independent appraisal of comparable space and facilities in a privately-owned building in the same locality.

45 CFR 74.23(h)(4) -- The value of loaned equipment shall not exceed its fair rental value.

45 CFR 74.23(i) -- The following requirements pertain to the recipient's supporting records for in-kind contributions from third parties.

45 CFR 74.23(i)(1) -- Volunteer services shall be documented and, to the extent feasible, supported by the same methods used by the recipient for its own employees, including time records.

45 CFR 74.23(i)(2) -- The basis for determining the valuation for personal service, material, equipment, buildings and land shall be documented.
payments.

45 CFR 74.24 -- Program income

45 CFR 74.24(a) -- The standards set forth in this section shall be used to account for program income related to projects financed in whole or in part with Federal funds.

45 CFR 74.24(b) -- Except as provided below in paragraph (h) of this section, program income earned during the project period shall be retained by the recipient and, in accordance with the terms and conditions of the award, shall be used in one or more of the following ways:

45 CFR 74.24(b)(1) -- Added to funds committed to the project or program, and used to further eligible project or program objectives;

45 CFR 74.24(b)(2) -- Used to finance the non-Federal share of the project or program; or

45 CFR 74.24(b)(3) -- Deducted from the total project or program allowable cost in determining the net allowable costs on which the Federal share of costs is based.

45 CFR 74.24(c) -- When the HHS awarding agency authorizes the disposition of program income as described in paragraph (b)(1) or (b)(2) of this section, program income in excess of any limits stipulated shall be used in accordance with paragraph (b)(3) of this section.

45 CFR 74.24(d) -- In the event that the HHS awarding agency does not specify in the terms and conditions of the award how program income is to be used, paragraph (b)(3) of this section shall apply automatically to all projects or programs except research. For awards that support performance of research work, paragraph (b)(1) of this section shall apply automatically unless:

45 CFR 74.24(d)(1) -- The HHS awarding agency indicates in the terms and conditions of the award another alternative; or

45 CFR 74.24(d)(2) -- The recipient is subject to special award conditions under Sec. 74.14; or

45 CFR 74.24(d)(3) -- The recipient is a commercial organization (see Sec. 74.82).

45 CFR 74.24(e) -- Unless the terms and conditions of the award provide otherwise, recipients shall have no obligation to the Federal Government regarding program income earned after the end of the project period.

45 CFR 74.24(f) -- Costs incident to the generation of program income may be deducted from gross income to determine program income, provided these costs have not been charged to the award.

45 CFR 74.24(g) -- Proceeds from the sale of property shall be handled in accordance with the requirements of the Property Standards. (See Secs. 74.30 through 74.37, below).

45 CFR 74.24(h) -- The Patent and Trademark Laws Amendments, 35 U.S.C. section 200-212, apply to inventions made under an award for performance of experimental, developmental, or research work. Unless the terms and conditions for the award provide otherwise, recipients shall have no obligation to HHS with respect to program income earned from license fees and royalties for copyrighted material, patents, patent applications, trademarks, and inventions made under an award. However, no scholarship, fellowship, training grant, or other funding agreement made primarily to a recipient for educational purposes will contain any provision giving the Federal agency rights to inventions made by the recipient.

45 CFR 74.25 -- Revision of budget and program plans

45 CFR 74.25(a) -- The basis for determining the valuation for personal service, material, equipment, buildings and land shall be documented.

45 CFR 74.25(b) -- Recipients are required to report deviations from budget and program plans, and request prior approvals for budget and program plan revisions, in accordance with this section. Except as provided at Secs. 74.4, 74.14, and this section, HHS awarding agencies may not impose other prior approval requirements for specific items.

45 CFR 74.25(c) -- For nonconstruction awards, recipients shall obtain prior approvals from the HHS awarding agency for one or more of the following program or budget related reasons.

45 CFR 74.25(c)(1) -- Change in the scope or the objective of the project or program (even if there is no associated budget revision requiring prior written approval).

45 CFR 74.25(c)(2) -- Change in the project director or principal investigator or other key persons specified in the application or award document.

45 CFR 74.25(c)(3) -- The absence for more than three months, or a 25 percent reduction in time devoted to the project, by the approved project director or principal investigator.

45 CFR 74.25(c)(4) -- The need for additional Federal funding.

45 CFR 74.25(c)(5) -- The inclusion, unless waived by the HHS awarding agency, of costs that require prior approval in accordance with OMB Circular A-21, "Cost Principles for Educational Institutions;" OMB Circular A-122, "Cost Principles for Nonprofit Organizations;" or appendix E of this part, "Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals," or 48 CFR part 31, "Contract Cost Principles and Procedures," as applicable.

45 CFR 74.25(c)(6) -- The transfer of funds allotted for training allowances (direct payment to trainees) to other categories of expense.

45 CFR 74.25(c)(7) -- Unless described in the application and funded in the approved award, the subaward, transfer or contracting out of any work under an award. This provision does not apply to the purchase of supplies, material, equipment or general support services.

45 CFR 74.25(c)(8) -- The inclusion of research patient care costs in research awards made for the performance of research work.

45 CFR 74.25(d) -- Except for requirements listed in paragraphs (c)(1) and (c)(4) of this section, the HHS awarding agency is authorized, at its option, to waive cost-related and administrative prior written approvals required by this part and its appendixes. Additional waivers may be granted authorizing recipients to do any one or more of the following:

45 CFR 74.25(d)(1) -- Incur pre-award costs up to 90 calendar days prior to award, or more than 90 calendar days with the prior approval of the HHS awarding agency. However, all pre-award costs are incurred at the recipient's risk: the HHS awarding agency is under no obligation to reimburse such costs if for any reason the applicant does not receive an award or if the award to the recipient is less than anticipated and inadequate to cover such costs.

45 CFR 74.25(d)(2) -- Initiate a one-time extension of the expiration date of the award of up to 12 months unless one or more of the conditions identified at paragraphs (d)(2)(i), (ii), and (iii) of this section apply. For one-time extensions, the recipient must notify the HHS awarding agency in writing, with the supporting reasons and revised expiration date, at least 10 days before the date specified in the award. This one-time extension may not be exercised either by recipients or HHS awarding agencies merely for the purpose of using unobligated balances. Such extensions are not permitted where:

45 CFR 74.25(d)(2)(i) -- The terms and conditions of award prohibit the extension; or

45 CFR 74.25(d)(2)(ii) -- The extension requires additional Federal funds; or

45 CFR 74.25(d)(2)(iii) -- The extension involves any change in the approved objectives or scope of the project.

45 CFR 74.25(d)(3) -- Carry forward unobligated balances to subsequent funding periods.

45 CFR 74.25(d)(4) -- For awards that support performance of research work, unless the HHS awarding agency provides otherwise in the award, or the award is subject to Sec. 74.14 or subpart E of this Part, the prior approval requirements described in paragraphs d) (1)-(3) of this section are automatically waived (i.e., recipients need not obtain such prior approvals). However, extension of award expiration dates must be approved by the HHS awarding agency if one of the conditions in paragraph (d)(2) of this section applies.

45 CFR 74.25(e) -- The HHS awarding agencies may not permit any budget changes in a recipient's award that would cause any Federal appropriation to be used for purposes other then those consistent with the original purpose of the authorization and appropriation under which the award was funded.

45 CFR 74.25(f) -- For construction awards, recipients shall obtain prior written approval promptly from the HHS awarding agency for budget revisions whenever:

45 CFR 74.25(f)(1) -- The revision results from changes in the scope or the objective of the project or program;

45 CFR 74.25(f)(2) -- The need arises for additional Federal funds to complete the project; or

45 CFR 74.25(f)(3) -- A revision is desired which involves specific costs for which prior written approval requirements apply in keeping with the applicable cost principles listed in Sec. 74.27.

45 CFR 74.25(g) -- When an HHS awarding agency makes an award that provides support for both construction and nonconstruction work, it may require the recipient to obtain prior approval before making any fund or budget transfers between the two types of work supported.

45 CFR 74.25(h) -- For both construction and nonconstruction awards, recipients shall notify the HHS awarding agency in writing promptly whenever the amount of Federal authorized funds is expected to exceed the needs of the recipient for the project period by more than $5000 or five percent of the Federal award, whichever is greater. This notification shall not be required if an application for additional funding is submitted for a continuation award.

45 CFR 74.25(i) -- Within 30 calendar days from the date of receipt of the request for budget revisions, HHS awarding agencies shall notify the recipient whether its requested budget revisions have been approved. If the requested revision is still under consideration at the end of 30 calendar days, the HHS awarding agency must inform the recipient in writing of the date when the recipient may expect a decision.

45 CFR 74.25(j) -- When requesting approval for budget changes, recipients shall make their requests in writing.

45 CFR 74.25(k) -- All approvals granted in keeping with the provisions of this section shall not be valid unless they are in writing, and signed by at least one of the following HHS officials:

45 CFR 74.25(k)(1) -- The Head of the HHS Operating or Staff Division that made the award or subordinate official with proper delegated authority from the Head, including the Head of the Regional Office of the HHS Operating or Staff Division that made the award; or

45 CFR 74.25(k)(2) -- The responsible Grants Officer of the HHS Operating or Staff Division that made the award or an individual duly authorized by the Grants Officer.

45 CFR 74.25(l) -- No other prior approval requirements for specific items may be imposed unless a class deviation has been approved by OMB.

45 CFR 74.26 -- Non-federal audits

45 CFR 74.26(a) -- Recipients and subrecipients that are institutions of higher education or other non-profit organizations (including hospitals) shall be subject to the audit requirements contained in the Single Audit Act Amendments of 1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, "Audits of States, Local Governments, and Non-Profit Organizations."

45 CFR 74.26(b) -- State and local governments shall be subject to the audit requirements contained in the Single Audit Act Amendments of 1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, "Audits of States, Local Governments, and Non-Profit organizations."

45 CFR 74.26(c) -- For-profit hospitals not covered by the audit provisions of revised OMB Circular A-133 shall be subject to the audit requirements of the Federal awarding agencies.

45 CFR 74.26(d) --

45 CFR 74.26(d)(1) -- Recipients and subrecipients that are commercial organizations (including for-profit hospitals) have two options regarding audits:

45 CFR 74.26(d)(1)(i) -- A financial related audit (as defined in the Government Auditing Standards, GPO Stock #020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one HHS program; or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or

45 CFR 74.26(d)(1)(ii) -- An audit that meets the requirements contained in OMB Circular A-133.

45 CFR 74.26(d)(2) -- Commercial organizations that receive annual HHS awards totaling less than OMB Circular A-133's audit requirement threshold are exempt from requirements for a non-Federal audit for that year, but records must be available for review by appropriate officials of Federal agencies.

45 CFR 74.27 -- Allowable costs

45 CFR 74.27(a) -- For each kind of recipient, there is a particular set of Federal principles that applies in determining allowable costs. Allowability of costs shall be determined in accordance with the cost principles applicable to the entity incurring the costs. Thus, allowability of costs incurred by State, local or federally-recognized Indian tribal governments is determined in accordance with the provisions of OMB Circular A-87, "Cost Principles for State and Local Governments." The allowability of costs incurred by nonprofit organizations (except for those listed in Attachment C of Circular A-122) is determined in accordance with the provisions of OMB Circular A-122, "Cost Principles for Nonprofit Organizations" and paragraph (b) of this section. The allowability of costs incurred by institutions of higher education is determined in accordance with the provisions of OMB Circular A-21, "Cost Principles for Educational Institutions." The allowability of costs incurred by hospitals is determined in accordance with the provisions of appendix E of this part, "Principles for Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals." The allowability of costs incurred by commercial organizations and those nonprofit organizations listed in Attachment C to Circular A-122 is determined in accordance with the provisions of the Federal Acquisition Regulation (FAR) at 48 CFR part 31, except that independent research and development costs are unallowable.

45 CFR 74.27(b) -- OMB Circular A-122 does not cover the treatment of bid and proposal costs or independent research and development costs. The following rules apply to these costs for nonprofit organizations subject to that Circular.

45 CFR 74.27(b)(1) -- Bid and proposal costs. Bid and proposal costs are the immediate costs of preparing bids, proposals, and applications for Federal and non-Federal awards, contracts, and other agreements, including the development of scientific, cost, and other data needed to support the bids, proposals, and applications. Bid and proposal costs of the current accounting period are allowable as indirect costs. Bid and proposal costs of past accounting periods are unallowable in the current period. However, if the recipient's established practice is to treat these costs by some other method, they may be accepted if they are found to be reasonable and equitable. Bid and proposal costs do not include independent research and development costs covered by paragraph (b)(2) of this section, or pre-award costs covered by OMB Circular A-122, Attachment B, paragraph 33 and Sec. 74.25(d)(1).

45 CFR 74.27(b)(2) -- Independent Research and Development costs. Independent research and development is research and development which is conducted by an organization, and which is not sponsored by Federal or non-Federal awards, contracts, or other agreements. Independent research and development shall be allocated its proportionate share of indirect costs on the same basis as the allocation of indirect costs to sponsored research and development. The cost of independent research and development, including their proportionate share of indirect costs, are unallowable.

45 CFR 74.28 -- Period of availability of funds Where a funding period is specified, a recipient may charge to the award only allowable costs resulting from obligations incurred during the funding period and any pre-award costs authorized by the HHS awarding agency pursuant to Sec. 74.25(d)(1).

45 CFR 74.30 -- Purpose of property standards Sections 74.31 through 74.37 set forth uniform standards governing management and disposition of property furnished by HHS or whose cost was charged directly to a project supported by an HHS award. The HHS awarding agency may not impose additional requirements, unless specifically required to do so by Federal statute. The recipient may use its own property management standards and procedures provided they meet the provisions of Secs. 74.31 through 74.37.

45 CFR 74.31 -- Insurance coverage Recipients shall, at a minimum, provide the equivalent insurance coverage for real property and equipment acquired with HHS funds as provided to other property owned by the recipient.

45 CFR 74.32 -- Real property

45 CFR 74.32(a) -- Title to real property shall vest in the recipient subject to the condition that the recipient shall use the real property for the authorized purpose of the project as long as it is needed and shall not encumber the property without approval of the HHS awarding agency.

45 CFR 74.32(b) -- The recipient shall obtain written approval from the HHS awarding agency for the use of real property in other federally-sponsored projects when the recipient determines that the property is no longer needed for the purpose of the original project. Use in other projects shall be limited to those under federally-sponsored projects (i.e., awards) or programs that have purposes consistent with those authorized for support by the HHS awarding agency.

45 CFR 74.32(c) -- When the real property is no longer needed as provided in paragraphs (a) and (b) of this section, the recipient shall request disposition instructions from the HHS awarding agency or its successor. The HHS awarding agency must provide one or more of the following disposition instructions:

45 CFR 74.32(c)(1) -- The recipient may be permitted to retain title without further obligation to the Federal Government after it compensates the Federal Government for that percentage of the current fair market value of the property attributable to the Federal share in the project.

45 CFR 74.32(c)(2) -- The recipient may be directed to sell the property under guidelines provided by the HHS awarding agency and pay the Federal Government for that percentage of the current fair market value of the property attributable to the Federal share in the project (after deducting actual and reasonable selling and fix-up expenses, if any, from the sales proceeds). When the recipient is authorized or required to sell the property, proper sales procedures shall be established that provide for competition to the extent practicable and result in the highest possible return.

45 CFR 74.32(c)(3) -- The recipient may be directed to transfer title to the property to the Federal Government or to an eligible third party provided that, in such cases, the recipient shall be entitled to compensation for its attributable percentage of the current fair market value of the property.

45 CFR 74.33 -- Federally-owned and exempt property

45 CFR 74.33(a) --

45 CFR 74.33(a)(1) -- Title of federally-owned property remains vested in the Federal Government. Recipients shall submit annually an inventory listing of federally-owned property in their custody to the HHS awarding agency. Upon completion of the award or when the property is no longer needed, the recipient shall report the property to the HHS awarding agency for further agency utilization.

45 CFR 74.33(a)(2) -- If the HHS awarding agency has no further need for the property, it shall be declared excess and reported to the General Services Administration, unless the HHS awarding agency has statutory authority to dispose of the property by alternative methods (e.g., the authority provided by the Federal Technology Transfer Act, 15 U.S.C. 3710(I), to donate research equipment to educational and nonprofit organizations in accordance with E.O. 12821, "Improving Mathematics and Science Education in Support of the National Education Goals"). Appropriate instructions shall be issued to the recipient by the HHS awarding agency.

45 CFR 74.33(b) -- For research awards to certain types of recipients, 31 U.S.C. 6306 authorizes HHS to vest title to property acquired with Federal funds in the recipient without further obligation to the Federal government and under conditions that HHS considers appropriate. Such property is "exempt property". Exempt property shall not be subject to the requirements of Sec. 74.34, except that it shall be subject to paragraphs (h)(1), (2), and (4) of that section concerning the HHS awarding agency's right to require transfer.

45 CFR 74.34 -- Equipment

45 CFR 74.34(a) -- Title to equipment acquired by a recipient with HHS funds shall vest in the recipient, subject to the conditions of this section.

45 CFR 74.34(b) --

45 CFR 74.34(b)(1) -- The recipient shall not use equipment acquired with HHS funds to provide services to non-Federal organizations for a fee that is less than private companies charge for equivalent services, unless specifically authorized by Federal statute, for so long as the Federal Government retains an interest in the equipment.

45 CFR 74.34(b)(2) -- If the equipment is owned by the Federal Government, use on other activities not sponsored by the Federal Government shall be permissible if authorized by the HHS awarding agency.

45 CFR 74.34(b)(3) -- User charges shall be treated as program income, in keeping with the provisions of Sec. 74.24.

45 CFR 74.34(c) -- The recipient shall use the equipment in the project or program for which it was acquired as long as needed, whether or not the project or program continues to be supported by Federal funds and shall not encumber the property without approval of the HHS awarding agency. When no longer needed for the original project or program, the recipient shall use the equipment in connection with its other federally-sponsored activities, if any, in the following order of priority:

45 CFR 74.34(c)(1) -- Programs, projects, or activities sponsored by the HHS awarding agency;

45 CFR 74.34(c)(2) -- Programs, projects, or activities sponsored by other HHS awarding agencies; then

45 CFR 74.34(c)(3) -- Programs, project, or activities sponsored by other Federal agencies.

45 CFR 74.34(d) -- During the time that equipment is used on the program, project, or activity for which it was acquired, the recipient shall make it available for use on other projects or programs if such other use will not interfere with the work on the program, project, or activity for which the equipment was originally acquired. First preference for such other use shall be given to other programs, projects, or activities sponsored by the HHS awarding agency. Second preference shall be given to programs, projects, or activities sponsored by other HHS awarding agencies. Third preference shall be given to programs, projects, or activities sponsored by other Federal agencies.

45 CFR 74.34(e) -- When acquiring replacement equipment, the recipient may use the equipment to be replaced as trade-in or sell the equipment and use the proceeds to offset the costs of the replacement equipment subject to the approval of the HHS awarding agency.

45 CFR 74.34(f) -- The recipient's property management standards for equipment acquired with Federal funds and federally-owned equipment shall include all of the following:

45 CFR 74.34(f)(1) -- Equipment records shall be maintained accurately and shall include the following information:

45 CFR 74.34(f)(1)(i) -- A description of the equipment;

45 CFR 74.34(f)(1)(ii) -- Manufacturer's serial number, model number, Federal stock number, national stock number, or other identification number;

45 CFR 74.34(f)(1)(iii) -- Source of the equipment, including the award number;

45 CFR 74.34(f)(1)(iv) -- Whether title vests in the recipient or the Federal Government;

45 CFR 74.34(f)(1)(v) -- Acquisition date (or date received, if the equipment was furnished by the Federal Government) and cost;

45 CFR 74.34(f)(1)(vi) -- Information from which one can calculate the percentage of HHS's share in the cost of the equipment (not applicable to equipment furnished by the Federal Government);

45 CFR 74.34(f)(1)(vii) -- Location and condition of the equipment and the date the information was reported;

45 CFR 74.34(f)(1)(viii) -- Unit acquisition cost; and

45 CFR 74.34(f)(1)(ix) -- Ultimate disposition data, including date of disposal and sales price or the method used to determine current fair market value where a recipient compensates the HHS awarding agency for its share.

45 CFR 74.34(f)(2) -- Equipment owned by the Federal Government shall be identified to indicate Federal ownership.

45 CFR 74.34(f)(3) -- The recipient shall take a physical inventory of equipment and the results reconciled with the equipment records at least once every two years. Any differences between quantities determined by the physical inspection and those shown in the accounting records shall be investigated to determine the causes of the difference. The recipient shall, in connection with the inventory, verify the existence, current utilization, and continued need for the equipment.

45 CFR 74.34(f)(4) -- The recipient shall maintain a control system to insure adequate safeguards to prevent loss, damage, or theft of the equipment. Any loss, damage, or theft of equipment shall be investigated and fully documented; if the equipment was owned by the Federal Government, the recipient shall promptly notify the HHS awarding agency.

45 CFR 74.34(f)(5) -- The recipient shall implement adequate maintenance procedures to keep the equipment in good condition.

45 CFR 74.34(f)(6) -- Where the recipient is authorized or required to sell the equipment, proper sales procedures shall be established which provide for competition to the extent practicable and result in the highest possible return.

45 CFR 74.34(g) -- When the recipient no longer needs the equipment, it may use the equipment for other activities in accordance with the following standards. For equipment with a current per unit fair market value of $5000 or more, the recipient may retain the equipment for other uses provided that compensation is made to the original HHS awarding agency or its successor. The amount of compensation shall be computed by applying the percentage of HHS's share in the cost of the original project or program to the current fair market value of the equipment. If the recipient has no need for the equipment, the recipient shall request disposition instructions from the HHS awarding agency; such instructions must be issued to the recipient no later than 120 calendar days after the recipient's request and the following procedures shall govern:

45 CFR 74.34(g)(1) -- If so instructed or if disposition instructions are not issued within 120 calendar days after the recipient's request, the recipient shall sell the equipment and reimburse the HHS awarding agency an amount computed by applying to the sales proceeds the percentage of HHS share in the cost of the original project or program. However, the recipient shall be permitted to deduct and retain from the HHS share $500 or ten percent of the proceeds, whichever is less, for the recipient's selling and handling expenses.

45 CFR 74.34(g)(2) -- If the recipient is instructed to ship the equipment elsewhere, the recipient shall be reimbursed by the HHS awarding agency by an amount which is computed by applying the percentage of the recipient's share in the cost of the original project or program to the current fair market value of the equipment, plus any reasonable shipping or interim storage costs incurred.

45 CFR 74.34(g)(3) -- If the recipient is instructed to otherwise dispose of the equipment, the recipient will be reimbursed by the HHS awarding agency for such costs incurred in its disposition.

45 CFR 74.34(g)(4) -- If the recipient's project or program for which or under which the equipment was acquired is still receiving support from the same HHS program, and if the HHS awarding agency approves, the net amount due may be used for allowable costs of that project or program. Otherwise the net amount must be remitted to the HHS awarding agency by check.

45 CFR 74.34(h) -- The HHS awarding agency reserves the right to order the transfer of title to the Federal Government or to a third party named by the awarding agency when such third party is otherwise eligible under existing statutes. Such transfer shall be subject to the following standards:

45 CFR 74.34(h)(1) -- The equipment shall be appropriately identified in the award or otherwise made known to the recipient in writing.

45 CFR 74.34(h)(2) -- The HHS awarding agency may require submission of a final inventory that lists all equipment acquired with HHS funds and federally-owned equipment.

45 CFR 74.34(h)(3) -- If the HHS awarding agency fails to issue disposition instructions within 120 calendar days after receipt of the inventory, the recipient shall apply the standards of paragraph (g)(1) of this section as appropriate.

45 CFR 74.34(h)(4) -- When the HHS awarding agency exercises its right to order the transfer of title to the Federal Government, the equipment shall be subject to the rules for federally-owned equipment. (See Sec. 74.34(g).

45 CFR 74.35 -- Supplies

45 CFR 74.35(a) -- Title to supplies shall vest in the recipient upon acquisition. If there is a residual inventory of unused supplies exceeding $5000 in total aggregate value upon termination or completion of the project or program and the supplies are not needed for any other federally-sponsored project or program, the recipient shall retain the supplies for use on non-federally sponsored activities or sell them, but shall, in either case, compensate the Federal Government for its share. The amount of compensation shall be computed in the same manner as for equipment. (See Sec. 74.34(g)).

45 CFR 74.35(b) --

45 CFR 74.35(b)(1) -- The recipient shall not use supplies acquired with Federal funds to provide services to non-Federal organizations for a fee that is less than private companies charge for equivalent services, unless specifically authorized by Federal statute as long as the Federal Government retains an interest in the supplies.

45 CFR 74.35(b)(2) -- If the supplies are owned by the Federal Government, use on other activities not sponsored by the Federal Government shall be permissible if authorized by the HHS awarding agency.

45 CFR 74.35(b)(3) -- User charges shall be treated as program income, in keeping with the provisions of Sec. 74.24.
Sec. 74.34(g).

45 CFR 74.36 -- Intangible property

45 CFR 74.36(a) -- The recipient may copyright any work that is subject to copyright and was developed, or for which ownership was purchased, under an award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.

45 CFR 74.36(b) -- Recipients are subject to applicable regulations governing patents and inventions, including government-wide regulations issued by the Department of Commerce at 37 CFR part 401, "Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements."

45 CFR 74.36(c) -- The Federal Government has the right to:

45 CFR 74.36(c)(1) -- Obtain, reproduce, publish or otherwise use the data first produced under an award; and

45 CFR 74.36(c)(2) -- Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.

45 CFR 74.36(d) --

45 CFR 74.36(d)(1) -- In addition, in response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under an award there were used by the Federal Government in developing an agency action that has the force and effect of law, the HHS Awarding Agency shall request, and the recipient shall provide, within a reasonable time, the reserach data so that they can be made available to the public through the procedures established under the FOIA. If the HHS Awarding Agency obtains the research data solely in response to a FOIA request, the agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by the agency, the recipient, and applicable subrecipients. This fee is in addition to any fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).

45 CFR 74.36(d)(2) -- The following definitions apply for purposes of this paragraph (d):

45 CFR 74.36(d)(2)(i) -- Research data is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This "recorded" material excludes physical objects (e.g., laboratory samples). Research data also does not include:

45 CFR 74.36(d)(2)(i)(A) -- Trade secrets, commerical information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and

45 CFR 74.36(d)(2)(i)(B) -- Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.

45 CFR 74.36(d)(2)(ii) -- Published is defined as either when:

45 CFR 74.36(d)(2)(ii)(A) -- Research findings are published in a peer-reviewed scientific or technical journal; or

45 CFR 74.36(d)(2)(ii)(B) -- A Federal agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.

45 CFR 74.36(d)(2)(iii) -- Used by the Federal Government in developing an agency action that has the force and effect of law is defined as when an agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.

45 CFR 74.36(d)(3) -- The requirements set forth in paragraph (d)(1) of this section do not apply to commercial organizations.

45 CFR 74.36(e) -- Title to intangible property and debt instruments purchased or otherwise acquired under an award or subaward vests upon acquisition in the recipient. The recipient shall use that property for the originally--authorized purpose, and the recipient shall not encumber the property without approval of the HHS awarding agency. When no longer needed for the originally authorized purpose, disposition of the intangible property shall occur in accordance with the provisions of Sec. 74.34 (g) and (h).

45 CFR 74.37 -- Property trust relationship Real property, equipment, intangible property and debt instruments that are acquired or improved with Federal funds shall be held in trust by the recipients as trustee for the beneficiaries of the project or program under which the property was acquired or improved, and shall not be encumbered without the approval of the HHS awarding agency. Recipients shall record liens or other appropriate notices of record to indicate that real property has been acquired or constructed or, where applicable, improved with Federal funds, and that use and disposition conditions apply to the property.

45 CFR 74.40 -- Procurement standards Sections 74.41 through 74.48 set forth standards for use by recipients in establishing procedures for the procurement of supplies and other expendable property, equipment, real property and other services with Federal funds. These standards are established to ensure that such materials and services are obtained in an effective manner and in compliance with the provisions of applicable Federal statutes and executive orders. The standards apply where the cost of the procurement is treated as a direct cost of an award.

45 CFR 74.41 -- Recipient responsibilities The standards contained in this section do not relieve the recipients of the contractual responsibilities arising under its contract(s). The recipient is the responsible authority, without recourse to the HHS awarding agency, regarding the settlement and satisfaction of all contractual and administrative issues arising out of procurements entered into in support of an award or other agreement. This includes disputes, claims, protests of award, source evaluation or other matters of a contractual nature. Matters concerning violation of statute are to be referred to such Federal, State or local authority as may have proper jurisdiction.

45 CFR 74.42 -- Codes of conduct The recipient shall maintain written standards of conduct governing the performance of its employees engaged in the award and administration of contracts. No employee, officer, or agent shall participate in the selection, award, or administration of a contract supported by Federal funds if a real or apparent conflict of interest would be involved. Such a conflict would arise when the employee, officer, or agent, or any member of his or her immediate fmily, his or her partner, or an organization which employs or is about to employ any of the parties indicated herein, has a financial or other interest in the firm selected for an award. The officers, employees, and agents of the recipient shall neither solicit nor accept gratuities, favors, or anything of monetary value from contractors, or parties to subagreements. However, recipients may set standards for situations in which the financial interest is not substantial or the gift is an unsolicited item of nominal value. The standards of conduct shall provide for disciplinary actions to be applied for violations of such standards by officers, employers, or agents of the recipients.

45 CFR 74.43 -- Competition All procurement transactions shall be conducted in a manner to provide, to the maximum extent practical, open and free competition. The recipient shall be alert to organizational conflicts of interest as well as noncompetitive practices among contractors that may restrict or eliminate competition or otherwise restrain trade. In order to ensure objective contractor performance and eliminate unfair competitive advantage, contractors that develop or draft grant applications, or contract specifications, requirements, statements of work, invitations for bids and/or requests for proposals shall be excluded from competing for such procurements. Awards shall be made to the bidder or offeror whose bid or offer is responsive to the solicitation and is most advantageous to the recipient, price, quality and other factors considered. Solicitations shall clearly set forth all requirements that the bidder or offeror shall fulfill in order for the bid or offer to be evaluated by the recipient. Any and all bids or offers may be rejected when it is in the recipient's interest to do so.

45 CFR 74.44 -- Procurement procedures

45 CFR 74.44(a) -- All recipients shall establish written procurement procedures. These procedures shall provide for, at a minimum, that:

45 CFR 74.44(a)(1) -- Recipients avoid purchasing unnecessary items;

45 CFR 74.44(a)(2) -- Where appropriate, an analysis is made of lease and purchase alternatives to determine which would be the most economical and practical procurement for the recipient and the Federal Government; and

45 CFR 74.44(a)(3) -- Solicitations for goods and services provide for all of the following:

45 CFR 74.44(a)(3)(i) -- A clear and accurate description of the technical requirements for the material, product or service to be procured. In competitive procurements, such a description shall not contain features which unduly restrict competition.

45 CFR 74.44(a)(3)(ii) -- Requirements which the bidder/offeror must fulfill and all other factors to be used in evaluating bids or proposals.

45 CFR 74.44(a)(3)(iii) -- A description, whenever practicable, of technical requirements in terms of functions to be performed or performance required, including the range of acceptable characteristics or minimum acceptable standards.

45 CFR 74.44(a)(3)(iv) -- The specific features of "brand name or equal" descriptions that bidders are required to meet when such items are included in the solicitation.

45 CFR 74.44(a)(3)(v) -- The acceptance, to the extent practicable and economically feasible, of products and services dimensioned in the metric system of measurement.

45 CFR 74.44(a)(3)(vi) -- Preference, to the extent practicable and economically feasible, for products and services that conserve natural resources and protect the environment and are energy efficient.

45 CFR 74.44(b) -- Positive efforts shall be made by recipients to utilize small businesses, minority-owned firms, and women's business enterprises, whenever possible. Recipients of HHS awards shall take all of the following steps to further this goal.

45 CFR 74.44(b)(1) -- Ensure that small businesses, minority-owned firms, and women's business enterprises are used to the fullest extent practicable.

45 CFR 74.44(b)(2) -- Make information on forthcoming opportunities available and arrange time frames for purchases and contracts to encourage and facilitate participation by small businesses, minority-owned firms, and women's business enterprises.

45 CFR 74.44(b)(3) -- Consider in the contract process whether firms competing for larger contracts intend to subcontract with small businesses, minority-owned firms, and women's business enterprises.

45 CFR 74.44(b)(4) -- Encourage contracting with consortiums of small businesses, minority-owned firms and women's business enterprises when a contract is too large for one of these firms to handle individually.

45 CFR 74.44(b)(5) -- Use the services and assistance, as appropriate, of such organizations as the Small Business Administration and the Department of Commerce's Minority Business Development Agency in the solicitation and utilization of small businesses, minority-owned firms and women's business enterprises.

45 CFR 74.44(c) -- The type of procuring instruments used (e.g., fixed price contracts, cost reimbursable contracts, purchase orders, and incentive contracts) shall be determined by the recipient but shall be appropriate for the particular procurement and for promoting the best interest of the program or project involved. The "cost-plus-a-percentage-of-cost" or "percentage of construction cost" methods of contracting shall not be used.

45 CFR 74.44(d) -- Contracts shall be made only with responsible contractors who possess the potential ability to perform successfully under the terms and conditions of the proposed procurement. Consideration shall be given to such matters as contractor integrity, record of past performance, financial and technical resources or accessibility to other necessary resources. In certain circumstances, contracts with certain parties are restricted by agencies' implementation of E.O.s 12549 and 12689, "Debarment and Suspension." (See 45 CFR part 76.)

45 CFR 74.44(e) -- Recipients shall, on request, make available for the HHS awarding agency, pre-award review, procurement documents such as requests for proposals or invitations for bids, independent cost estimates, etc., when any of the following conditions apply:

45 CFR 74.44(e)(1) -- A recipient's procurement procedures or operation fails to comply with the procurement standards in this Part.

45 CFR 74.44(e)(2) -- The procurement is expected to exceed the simplified acquisition threshold fixed at 41 U.S.C. 403(11) (currently $100,000) and is to be awarded without competition or only one bid or offer is received in response to a solicitation.

45 CFR 74.44(e)(3) -- The procurement, which is expected to exceed the simplified acquisition threshold specifies a "brand name" product.

45 CFR 74.44(e)(4) -- The proposed award over the simplified acquisition threshold is to be awarded to other than the apparent low bidder under a sealed bid procurement.

45 CFR 74.44(e)(5) -- A proposed contract modification changes the scope of a contract or increases the contract amount by more than the amount of the simplified acquisition threshold.

45 CFR 74.45 -- Cost and price analysis Some form of cost or price analysis shall be made and documented in the procurement files in connection with every procurement action. Price analysis may be accomplished in various ways, including the comparison of price quotations submitted, market prices and similar indicia, together with discounts. Cost analysis is the review and evaluation of each element of cost to determine reasonableness, allocability and allowability.

45 CFR 74.46 -- Procurement records Procurement records and files for purchases in excess of the simplified acquisition threshold shall include the following at a minimum: (a) Basis for contractor selection, (b) justification for lack of competition when competitive bids or offers are not obtained, and (c) basis for award cost or price.

45 CFR 74.47 -- Contract administration A system for contract administration shall be maintained to ensure contractor conformance with the terms, conditions and specifications of the contract and to ensure adequate and timely follow up of all purchases. Recipients shall evaluate contractor performance and document, as appropriate, whether contractors have met the terms, conditions and specifications of the contract.

45 CFR 74.48 -- Contract provisions The recipient shall include, in addition to provisions to define a sound and complete agreement, the following provisions in all contracts. The following provisions shall also be applied to subcontracts:

45 CFR 74.48(a) -- Contracts in excess of the simplified acquisition threshold shall contain contractual provisions or conditions that allow for administrative, contractual, or legal remedies in instances in which a contractor violates or breaches the contract terms, and provide for such remedial actions as may be appropriate.

45 CFR 74.48(b) -- All contracts in excess of the simplified acquisition threshold (currently $100,000) shall contain suitable provisions for termination by the recipient, including the manner by which termination shall be effected and the basis for settlement. In addition, such contracts shall describe conditions under which the contract may be terminated for default as well as conditions where the contract may be terminated because of circumstances beyond the control of the contractor.

45 CFR 74.48(c) -- Except as otherwise required by statute, an award that requires the contracting (or subcontracting) for construction or facility improvements shall provide for the recipient to follow its own requirements relating to bid guarantees, performance bonds, and payment bonds unless the construction contract or subcontract exceeds $100,000. For those contracts or subcontracts exceeding $100,000, the HHS awarding agency may accept the bonding policy and requirements of the recipient, provided the HHS awarding agency has made a determination that the Federal Government's interest is adequately protected. If such a determination has not been made, the minimum requirements shall be as follows:

45 CFR 74.48(c)(1) -- A bid guarantee from each bidder equivalent to five percent of the bid price. The "bid guarantee" shall consist of a firm commitment such as a bid bond, certified check, or other negotiable instrument accompanying a bid as assurance that the bidder shall, upon acceptance of his bid, execute such contractual documents as may be required within the time specified.

45 CFR 74.48(c)(2) -- A performance bond on the part of the contractor for 100 percent of the contract price. A "performance bond" is one executed in connection with a contract to secure fulfillment of all the contractor's obligations under such contract.

45 CFR 74.48(c)(3) -- A payment bond on the part of the contractor for 100 percent of the contract price. A "payment bond" is one executed in connection with a contract to assure payment as required by statute of all persons supplying labor and material in the execution of the work provided for in the contract.

45 CFR 74.48(c)(4) -- Where bonds are required in the situations described herein, the bonds shall be obtained from companies holding certificates of authority as acceptable sureties pursuant to 31 CFR part 223, "Surety Companies Doing Business with the United States."

45 CFR 74.48(d) -- All negotiated contracts (except those for less than the simplified acquisition threshold) awarded by recipients shall include a provision to the effect that the recipient, the HHS awarding agency, the U.S. Comptroller General, or any of their duly authorized representatives, shall have access to any books, documents, papers and records of the contractor which are directly pertinent to a specific program for the purpose of making audits, examinations, excerpts and transcriptions.

45 CFR 74.48(e) -- All contracts, including small purchases, awarded by recipients and their contractors shall contain the procurement provisions of appendix A to this part, is applicable.

45 CFR 74.50 -- Reports and records Sections 74.51 through 74.53 set forth the procedures for monitoring and reporting on the recipient's financial and program performance and the necessary standard reporting forms. They also set forth record retention requirements.

45 CFR 74.51 -- Monitoring and reporting program performance

45 CFR 74.51(a) -- Recipients are responsible for managing and monitoring each project, program, subaward, function or activity supported by the award. Recipients shall monitor subawards to ensure that subrecipients have met the audit requirements as set forth in Sec. 74.26.

45 CFR 74.51(b) -- The HHS awarding agency will prescribe the frequency with which the performance reports shall be submitted. Except as provided in paragraph (f) of this section, performance reports will not be required more frequently than quarterly or, less frequently than annually. Annual reports shall be due 90 calendar days after the award year; quarterly or semi-annual reports shall be due 30 days after the reporting period. The HHS awarding agency may require annual reports before the anniversary dates of multiple year awards in lieu of these requirements. The final performance reports are due 90 calendar days after the expiration or termination of the award.

45 CFR 74.51(c) -- If inappropriate, a final technical or performance report will not be required after completion of the project.

45 CFR 74.51(d) -- Performance reports shall generally contain, for each award, brief information on each of the following:

45 CFR 74.51(d)(1) -- A comparison of actual accomplishments with the goals and objectives established for the period, the findings of the investigator, or both. Whenever appropriate and the output of programs or projects can be readily quantified, such quantitative data should be related to cost data for computation of unit costs.

45 CFR 74.51(d)(2) -- Reasons why established goals were not met, if appropriate.

45 CFR 74.51(d)(3) -- Other pertinent information including, when appropriate, analysis and explanation of cost overruns or high unit costs.

45 CFR 74.51(e) -- Recipients shall submit the original and two copies of performance reports.

45 CFR 74.51(f) -- Recipients shall immediately notify the HHS awarding agency of developments that have a significant impact on the award-supported activities. Also, notification shall be given in the case of problems, delays, or adverse conditions which materially impair the ability to meet the objectives of the award. This notification shall include a statement of the action taken or contemplated, and any assistance needed to resolve the situation.

45 CFR 74.51(g) -- HHS may make site visits, as needed.

45 CFR 74.51(h) -- The HHS awarding agency complies with the applicable report clearance requirements of 5 CFR part 1320, "Controlling Paperwork Burdens on the Public," when requesting performance data from recipients

45 CFR 74.52 -- Financial reporting

45 CFR 74.52(a) -- The following forms are used for obtaining financial information from recipients:

45 CFR 74.52(a)(1) -- SF-269 or SF-269A, Financial Status Report.

45 CFR 74.52(a)(1)(i) -- The HHS awarding agency will require recipients to use either the SF-269 (long form) or SF-269A to report the status of funds for all nonconstruction projects or programs. The SF-269 shall always be used if income has been earned. The awarding agency may, however, waive the SF-269 or SF-269A requirement when the PMS-270, Request for Advance or Reimbursement, or PMS-272, Report of Federal Cash Transactions, will provide adequate information to meet its needs, except that a final SF-269 or SF-269A shall be required at the completion of the project when the PMS-270 is used only for advances.

45 CFR 74.52(a)(1)(ii) -- If the HHS awarding agency requires accrual information and the recipient's accounting records are not normally kept on the accrual basis, the recipient shall not be required to convert its accounting system, but shall develop such accrual information through best estimates based on an analysis of the documentation on hand.

45 CFR 74.52(a)(1)(iii) -- The HHS awarding agency will determine the frequency of the Financial Status Report for each project or program, considering the size and complexity of the particular project or program. However, the report will not be required more frequently than quarterly or less frequently than annually except under Sec. 74.14. A final report shall be required at the completion of the agreement.

45 CFR 74.52(a)(1)(iv) -- Recipients shall submit the SF-269 and SF-269A (an original and two copies) no later than 30 days after the end of each specified reporting period for quarterly and semi-annual reports, and 90 calendar days for annual and final reports. Extensions of reporting due dates may be approved by the HHS awarding agency upon request of the recipient.

45 CFR 74.52(a)(2) -- PMS-272, Report of Federal Cash Transactions.

45 CFR 74.52(a)(2)(i) -- When funds are advanced to recipients, the HHS awarding agency requires each recipient to submit the PMS-272 and, when necessary, its continuation sheet, PMS-272A through G. The HHS awarding agency uses this report to monitor cash advanced to recipients and to obtain disbursement information for each agreement with the recipients.

45 CFR 74.52(a)(2)(ii) -- The HHS awarding agency may require forecasts of Federal cash requirements in the "Remarks" section of the report.

45 CFR 74.52(a)(2)(iii) -- Recipients shall submit the original and two copies of the PMS-272 15 calendar days following the end of each quarter. The HHS awarding agency may require a monthly report from those recipients receiving advances totaling $1 million or more per year.

45 CFR 74.52(a)(2)(iv) -- The HHS awarding agency may waive the requirement for submission of the PMS-272 for any one of the following reasons: (A) When monthly advances do not exceed $25,000 per recipient, provided that such advances are monitored through other forms contained in this section; (B) If, in HHS' opinion, the recipient's accounting controls are adequate to minimize excessive Federal advances; or, (C) When the electronic payment mechanisms provide adequate data.

45 CFR 74.52(b) -- When the HHS awarding agency needs additional information or more frequent reports, the following shall be observed.

45 CFR 74.52(b)(1) -- When additional information is needed to comply with legislative requirements, the HHS awarding agency will issue instructions to require recipients to submit that information under the "Remarks" section of the reports.

45 CFR 74.52(b)(2) -- When HHS determines that a recipient's accounting system does not meet the standards in Sec. 74.21, additional pertinent information to further monitor awards may be obtained, without regard to Sec. 74.4, upon written notice to the recipient until such time as the system is brought up to standard. In obtaining this information, the HHS awarding agencies comply with report clearance requirements of 5 CFR part 1320, "Controlling Paperwork Burdens on the Public."

45 CFR 74.52(b)(3) -- The HHS awarding agency may accept the identical information from a recipient in machine readable format or computer printouts or electronic outputs in lieu of prescribed formats.

45 CFR 74.52(b)(4) -- The HHS awarding agency may provide computer or electronic outputs to recipients when such action expedites or contributes to the accuracy of reporting.

45 CFR 74.53 -- Retention and access requirements for records

45 CFR 74.53(a) -- This section sets forth requirements for record retention and access to records for awards to recipients.

45 CFR 74.53(b) -- Financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of three years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report. The only exceptions are the following:

45 CFR 74.53(b)(1) -- If any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.

45 CFR 74.53(b)(2) -- Records for real property and equipment acquired with Federal funds shall be retained for 3 years after final disposition.

45 CFR 74.53(b)(3) -- When records are transferred to or maintained by the HHS awarding agency, the 3-year retention requirement is not applicable to the recipient.

45 CFR 74.53(b)(4) -- Indirect cost rate proposals, cost allocations plans, etc., as specified in Sec. 74.53(g).

45 CFR 74.53(c) -- Copies of original records may be substituted for the original records if authorized by the HHS awarding agency.

45 CFR 74.53(d) -- The HHS awarding agency will request transfer of certain records to its custody from recipients when it determines that the records possess long term retention value. However, in order to avoid duplicate recordkeeping, the HHS awarding agency may make arrangements for recipients to retain any records that are continuously needed for joint use.

45 CFR 74.53(e) -- HHS awarding agencies, the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives, have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to the awards, in order to make audits, examinations, excerpts, transcripts and copies of such documents. This right also includes timely and reasonable access to a recipient's personnel for the purpose of interview and discussion related to such documents. The rights of access in this paragraph are not limited to the required retention period, but shall last as long as records are retained.

45 CFR 74.53(f) -- Unless required by statute, the HHS awarding agency will not place restrictions on recipients that limit public access to the records of recipients that are pertinent to an award, except when the HHS awarding agency can demonstrate that such records shall be kept confidential and would have been exempted from disclosure pursuant to the Freedom of Information Act, 5 U.S.C. 552, if the records had belonged to the HHS awarding agency.

45 CFR 74.53(g) -- Paragraphs (g)(1) and (g)(2) of this section apply to the following types of documents, and their supporting records: Indirect cost rate computations or proposals, cost allocation plans, and any similar accounting computations of the rate at which a particular group of costs is chargeable (such as computer usage chargeback rates or composite fringe benefit rates).

45 CFR 74.53(g)(1) -- If the recipient submits to the Federal Government or the subrecipient submits to the recipient the proposal, plan, or other computation to form the basis for negotiation of the rate, then the 3-year retention period for its supporting records starts on the date of such submission.

45 CFR 74.53(g)(2) -- If the recipient is not required to submit to the Federal Government or the subrecipient is not required to submit to the recipient the proposal, plan, or other computation for negotiation purposes, then the 3-year retention period for the proposal, plan, or other computation and its supporting records starts at the end of the fiscal year (or other accounting period) covered by the proposal, plan, or other computation.

45 CFR 74.60 -- Purpose of termination and enforcement Sections 74.61 and 74.62 set forth uniform suspension, termination and enforcement procedures.

45 CFR 74.61 -- Termination

45 CFR 74.61(a) -- Awards may be terminated in whole or in part only if paragraph (a) (1), (2), or (3) of this section applies.

45 CFR 74.61(a)(1) -- By the HHS awarding agency, if a recipient materially fails to comply with the terms and conditions of an award.

45 CFR 74.61(a)(2) -- By the HHS awarding agency with the consent of the recipient, in which case the two parties shall agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated.

45 CFR 74.61(a)(3) -- By the recipient upon sending to the HHS awarding agency written notification setting forth the reasons for such termination, the effective date, and, in the case of partial termination, the portion to be terminated. However, if the HHS awarding agency determines in the case of partial termination that the reduced or modified portion of the award will not accomplish the purposes for which the award was made, it may terminate the award in its entirety.

45 CFR 74.61(b) -- If costs are allowed under an award, the responsibilities of the recipient referred to in Sec. 74.71(a), including those for property management as applicable, shall be considered in the termination of the award, and provision shall be made for continuing responsibilities of the recipient after termination, as appropriate.

45 CFR 74.62 -- Enforcement

45 CFR 74.62(a) -- If a recipient materially fails to comply with the terms and conditions of an award, whether stated in a Federal statute or regulation, an assurance, an application, or a notice of award, the HHS awarding agency may, in addition to imposing any of the special conditions outlined in Sec. 74.14, take one or more of the following actions, as appropriate in the circumstances:

45 CFR 74.62(a)(1) -- Temporarily withhold cash payments pending correction of the deficiency by the recipient or more severe enforcement action by the HHS awarding agency.

45 CFR 74.62(a)(2) -- Disallow (that is, deny both use of funds and any applicable matching credit for) all or part of the cost of the activity or action not in compliance.

45 CFR 74.62(a)(3) -- Wholly or partly suspend or terminate the current award.

45 CFR 74.62(a)(4) -- Withhold further awards for the project or program.

45 CFR 74.62(a)(5) -- Take any other remedies that may be legally available.

45 CFR 74.62(b) -- In taking an enforcement action, the HHS awarding agency will provide the recipient or subrecipient an opportunity for such hearing, appeal, or other administrative proceeding to which the recipient or subrecipient is entitled under any statute or regulation applicable to the action. (See also 45 CFR parts 16 and 95.)

45 CFR 74.62(c) -- Costs to a recipient resulting from obligations incurred by the recipient during a suspension or after termination of an award are not allowable unless the HHS awarding agency expressly authorizes them in the notice of suspension or termination or subsequently. Other recipient costs during suspension or after termination which are necessary and not reasonably avoidable are allowable if:

45 CFR 74.62(c)(1) -- The costs result from obligations which were properly incurred by the recipient before the effective date of suspension or termination, are not in anticipation of it, and in the case of a termination, are noncancellable; and

45 CFR 74.62(c)(2) -- The costs would be allowable if the award were not suspended or expired normally at the end of the funding period in which the termination takes effect.

45 CFR 74.62(d) -- The enforcement remedies identified in this section, including suspension and termination, do not preclude a recipient from being subject to debarment and suspension under E.O.s 12549 and 12689 and the HHS implementing regulations at Sec. 74.13 of this part and 45 CFR part 76.

45 CFR 74.70 -- Purpose Sections 74.71 through 74.73 contain closeout procedures and other procedures for subsequent disallowances and adjustments.

45 CFR 74.71 -- Closeout procedures

45 CFR 74.71(a) -- Recipients shall submit, within 90 calendar days after the date of completion of the award, all financial, performance, and other reports as required by the terms and conditions of the award. The HHS awarding agency may approve extensions when requested by the recipient.

45 CFR 74.71(b) -- Unless the HHS awarding agency authorizes an extension, a recipient shall liquidate all obligations incurred under the award not later than 90 calendar days after the funding period or the date of completion as specified in the terms and conditions of the award or in agency implementing instructions.

45 CFR 74.71(c) -- HHS will make prompt payments to a recipient for allowable reimbursable costs under the award being closed out.

45 CFR 74.71(d) -- The recipient shall promptly refund any balances of unobligated cash that HHS has advanced or paid and that is not authorized to be retained by the recipient for use in other projects. 45 CFR part 30 governs unreturned amounts that become delinquent debts.

45 CFR 74.71(e) -- When authorized by the terms and conditions of the award, HHS will make a settlement for any upward or downward adjustments to the Federal share of costs after closeout reports are received.

45 CFR 74.71(f) -- The recipient shall account for any real and personal property acquired with HHS funds or received from the Federal Government in accordance with Secs. 74.31 through 74.37.

45 CFR 74.71(g) -- In the event a final audit has not been performed prior to the closeout of an award, HHS retains the right to recover an appropriate amount after fully considering the recommendations on disallowed costs resulting from the final audit.

45 CFR 74.72 -- Subsequent adjustments and continuing responsibilities

45 CFR 74.72(a) -- The closeout of an award does not affect any of the following:

45 CFR 74.72(a)(1) -- The right of the HHS awarding agency to disallow costs and recover funds on the basis of a later audit or other review.

45 CFR 74.72(a)(2) -- The obligation of the recipient to return any funds due as a result of later refunds, corrections, or other transactions.

45 CFR 74.72(a)(3) -- Audit requirements in Sec. 74.26.

45 CFR 74.72(a)(4) -- Property management requirements in Secs. 74.31 through 74.37.

45 CFR 74.72(a)(5) -- Records retention requirements in Sec. 74.53.

45 CFR 74.72(b) -- After closeout of an award, a relationship created under an award may be modified or ended in whole or in part with the consent of the HHS awarding agency and the recipient, provided the responsibilities of the recipient referred to in Sec. 74.72(a), including those for property management as applicable, are considered and provisions made for continuing responsibilities of the recipient, as appropriate.

45 CFR 74.73 -- Collection of amounts due

45 CFR 74.73(a) -- Any funds paid to a recipient in excess of the amount to which the recipient is finally determined to be entitled under the terms and conditions of the award constitute a debt to the Federal Government. If not paid within a reasonable period after the demand for payment, the HHS awarding agency may reduce the debt by paragraph (a) (1), (2), or (3) of this section:

45 CFR 74.73(a)(1) -- Making an administrative offset against other requests for reimbursements.

45 CFR 74.73(a)(2) -- Withholding advance payments otherwise due the recipient.

45 CFR 74.73(a)(3) -- Taking other action permitted by statute.

45 CFR 74.73(b) -- Except as otherwise provided by law, HHS awarding agencies will charge interest on an overdue debt in accordance with 4 CFR ch. II, "Federal Claims Collection Standards." (See 45 CFR part 30.)

45 CFR 74.80 -- Scope of subpart This subpart contains provisions that apply to awards to commercial organizations. These provisions are in addition to other applicable provisions of this part, or they make exceptions from other provisions of this part for awards to commercial organizations.

45 CFR 74.81 -- Prohibition against profit Except for awards under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) programs (15 U.S.C. 638), no HHS funds may be paid as profit to any recipient even if the recipient is a commercial organization. Profit is any amount in excess of allowable direct and indirect costs.

45 CFR 74.82 -- Program income The additional costs alternative described in Sec. 74.24(b)(1) may not be applied to program income earned by a commercial organization except in the SBIR and STTR programs.

45 CFR 74.83 --
Effect on intangible property Data sharing (FOIA) requirements as
set forth in Sec. 74.36(d)(1) do not apply to commercial
organizations.

45 CFR 74.90 --
Final decisions in disputes

45 CFR 74.90(a)
-- HHS attempts to promptly issue final decisions in disputes and in
other matters affecting the interests of recipients. However, final
decisions adverse to the recipient are not issued until it is clear
that the matter cannot be resolved through further exchange of
information and views.

45 CFR 74.90(b)
-- Under various HHS statutes or regulations, recipients have the
right to appeal from, or to have a hearing on, certain final
decisions by HHS awarding agencies. (See, for example, subpart D of
42 CFR part 50, and 45 CFR part 16). Paragraphs (c) and (d) of this
section set forth the standards HHS expects its member agencies to
meet in issuing a final decision covered by any of the statutes or
regulations.

45 CFR 74.90(c)
-- The decision may be brief but must contain:

45 CFR
74.90(c)(1) -- A complete statement of the background and
basis of the awarding agency's decision, including reference to the
pertinent statutes, regulations, or other governing documents; and

45 CFR
74.90(c)(2) -- Enough information to enable the recipient
to understand the issues and the position of the HHS awarding
agency.

45 CFR 74.90(d)
-- The following or similar language (consistent with the
terminology of the applicable statutes or regulations) should appear
at the end of the decision: "This is the final decision of the
(title of grants officer or other official responsible for the
decision). It shall be the final decision of the Department unless,
within 30 days after receiving this decision, you deliver or mail
(you should use registered or certified mail to establish the date)
a written notice of appeal to (name and address of appropriate
contact, e.g., the office responsible for awarding agency
preliminary appeal process or, where none, the Departmental Appeals
Board, Department of Health and Human Services, Washington, DC
20201). You shall attach to the notice a copy of this decision, note
that you intend an appeal, state the amount in dispute, and briefly
state why you think that this decision is wrong. You will be
notified of further procedures."

45 CFR 74.91 --
Alternative dispute resolution HHS encourages its awarding agencies
and recipients to try to resolve disputes by using alternative
dispute resolution (ADR) techniques. ADR often is effective in
reducing the cost, delay and contentiousness involved in appeals and
other traditional ways of handling disputes. ADR techniques include
mediation, neutral evaluation and other consensual methods.
Information about ADR is available from the HHS Dispute Resolution
Specialist at the Departmental Appeals Board, U.S. Department of
Health and Human Services, Washington, DC 20201.

45 CFR 74,
Appendix A -- Contract Provisions All contracts awarded by
a recipient, including small purchases, shall contain the following
provisions as applicable where the cost of the contract is treated
as a direct cost of an award:

45 CFR 74,
Appendix A(1) -- Equal Employment Opportunity All contracts
shall contain a provision requiring compliance with E.O. 11246,
"Equal Employment Opportunity," as amended by E.O. 11375, "Amending
Executive Order 11246 Relating to Equal Employment Opportunity," and
as supplemented by regulations at 41 CFR part 60, "Office of Federal
Contract Compliance Programs, Equal Employment Opportunity,
Department of Labor."

45 CFR 74,
Appendix A(2) -- Copeland "Anti-Kickback" Act (18 U.S.C.
874 and 40 U.S.C. 276c) All contracts and subgrants in excess of
$2,000 for construction or repair awarded by recipients and
subrecipients shall include a provision for compliance with the
Copeland "Anti-Kickback" Act, 18 U.S.C. 874, as supplemented by
Department of Labor regulations, 29 CFR part 3, "Contractors and
Subcontractors on Public Building or Public Work Financed in Whole
or in Part by Loans or Grants from the United States." The Act
provides that each contractor or subrecipient shall be prohibited
from inducing, by any means, any person employed in the
construction, completion, or repair of public work, to give up any
part of the compensation to which he is otherwise entitled. The
recipient shall report all suspected or reported violations to the
Federal awarding agency.

45 CFR 74,
Appendix A(3) -- Davis-Bacon Act, as amended (40 U.S.C.
276a to a-7) When required by Federal program legislation, all
construction contracts awarded by the recipients and subrecipients
of more than $2000 shall include a provision for compliance with the
Davis-Bacon Act, 40 U.S.C. 276a to a-7, and as supplemented by
Department of Labor regulations, 29 CFR part 5, "Labor Standards
Provisions Applicable to Contracts Governing Federally Financed and
Assisted Construction." Under this Act, contractors shall be
required to pay wages to laborers and mechanics at a rate not less
than the minimum wages specified in a wage determination made by the
Secretary of Labor. In addition, contractors shall be required to
pay wages not less than once a week. The recipient shall place a
copy of the current prevailing wage determination issued by the
Department of Labor in each solicitation and the award of a contract
shall be conditioned upon the acceptance of the wage determination.
The recipient shall report all suspected or reported violations to
the HHS awarding agency.

45 CFR 74,
Appendix A(4) -- Contract Work Hours and Safety Standards
Act (40 U.S.C. 327-333) Where applicable, all contracts awarded by
recipients in excess of $100,000 for construction contracts and for
other contracts that involve the employment of mechanics or laborers
shall include a provision for compliance with sections 102 and 107
of the Contract Work Hours and Safety Standards Act, 40 U.S.C.
327-333, as supplemented by Department of Labor regulations, 29 CFR
part 5. Under section 102 of the Act, each contractor shall be
required to compute the wages of every mechanic and laborer on the
basis of a standard work week of 40 hours. Work in excess of the
standard work week is permissible provided that the worker is
compensated at a rate of not less than 1\1/2\ times the basic rate
of pay for all hours worked in excess of 40 hours in the work week.
Section 107 of the Act is applicable to construction work and
provides that no laborer or mechanic shall be required to work in
surroundings or under working conditions which are unsanitary,
hazardous or dangerous. These requirements do not apply to the
purchases of supplies or materials or articles ordinarily available
on the open market, or contracts for transportation or transmission
of intelligence.

45 CFR 74,
Appendix A(5) -- Rights to Inventions Made Under a Contract
or Agreement Contracts or agreements for the performance of
experimental, developmental, or research work shall provide for the
rights of the Federal Government and the recipient in any resulting
invention in accordance with 37 CFR part 401, "Rights to Inventions
Made by Nonprofit Organizations and Small Business Firms Under
Government Grants, Contracts and Cooperative Agreements," and any
further implementing regulations issued by HHS.

45 CFR 74,
Appendix A(6) -- Clean Air Act (42 U.S.C. 7401 et seq.) and
the Federal Water Pollution Control Act as amended (33 U.S.C. 1251
et seq.) Contracts and subgrants of amounts in excess of $100,000
shall contain a provision that requires the recipient to agree to
comply with all applicable standards, orders or regulations issued
pursuant to the Clean Air Act, 42 U.S.C. 7401 et seq., and the
Federal Water Pollution Control Act, as amended 33 U.S.C. 1251 et
seq. Violations shall be reported to the HHS and the appropriate
Regional Office of the Environmental Protection Agency.

45 CFR 74,
Appendix A(7) -- Byrd Anti-Lobbying Amendment (31 U.S.C.
1352) Contractors who apply or bid for an award of more than
$100,000 shall file the required certification. Each tier certifies
to the tier above that it will not and has not used Federal
appropriated funds to pay any person or organization for influencing
or attempting to influence an officer or employee of any Federal
agency, a member of Congress, officer or employee of Congress, or an
employee of a member of Congress in connection with obtaining any
Federal contract, grant or any other award covered by 31 U.S.C.
1352. Each tier shall also disclose any lobbying with non-Federal
funds that takes place in connection with obtaining any Federal
award. Such disclosures are forwarded from tier to tier up to the
recipient. (See also 45 CFR part 93).

45 CFR 74,
Appendix A(8) -- Debarment and Suspension (E.O.s 12549 and
12689) Certain contracts shall not be made to parties listed on the
nonprocurement portion of the General Services Administration's
"Lists of Parties Excluded from Federal Procurement or
Nonprocurement Programs" in accordance with E.O.s 12549 and 12689,
"Debarment and Suspension." (See 45 CFR part 76.) This list contains
the names of parties debarred, suspended, or otherwise excluded by
agencies, and contractors declared ineligible under statutory
authority other than E.O. 12549. Contractors with awards that exceed
the simplified acquisition threshold shall provide the required
certification regarding their exclusion status and that of their
principals prior to award.
[59 FR 43760, Aug. 25, 1994,
as amended at 61 FR 11747, Mar. 22, 1996; 62 FR 41878, Aug. 4,
1997]

45 CFR 74,
Appendix E -- Principles for Determining Costs Applicable
to Research and Development Under Grants and Contracts With
Hospitals

45 CFR 74,
Appendix E(I) -- Purpose and Scope

45 CFR 74,
Appendix E(I)(A) -- Objectives. This appendix provides
principles for determining the costs applicable to research and
development work performed by hospitals under grants and contracts
with the Department of Health and Human Services. These principles
are confined to the subject of cost determination and make no
attempt to identify the circumstances or dictate the extent of
hospital participation in the financing of a particular research or
development project. The principles are designed to provide
recognition of the full allocated costs of such research work under
generally accepted accounting principles. These principles will be
applicable to both proprietary and non-profit hospitals. No
provision for profit or other increment above cost is provided for
in these principles. However, this is not to be interpreted as
precluding a negotiated fee between contracting parties when a fee
is appropriate.

45 CFR 74,
Appendix E(I)(B) -- Policy guides. The successful
application of these principles requires development of mutual
understanding between representatives of hospitals and of the
Department of Health and Human Services as to their scope,
applicability and interpretation. It is recognized that:

45 CFR 74,
Appendix E(I)(B)(1) -- The arrangements for hospital
participation in the financing of a research and development project
are properly subject to negotiation between the agency and the
hospital concerned in accordance with such Government-wide criteria
as may be applicable.

45 CFR 74,
Appendix E(I)(B)(2) -- Each hospital, possessing its own
unique combination of staff, facilities and experience, should be
encouraged to conduct research in a manner consonant with its own
institutional philosophies and objectives.

45 CFR 74,
Appendix E(I)(B)(3) -- Each hospital in the fulfillment of
its contractual obligations should be expected to employ sound
management practices.

45 CFR 74,
Appendix E(I)(B)(4) -- The application of the principles
established herein shall be in conformance with the generally
accepted accounting practices of hospitals.

45 CFR 74,
Appendix E(I)(B)(5) -- Hospitals receive reimbursements
from the Federal Government for differing types of services under
various programs such as support of Research and Development
(including discrete clinical centers) Health Services Projects,
Medicare, etc. It is essential that consistent procedures for
determining reimbursable costs for similar services be employed
without regard to program differences. Therefore, both the direct
and indirect costs of research programs must be identified as a cost
center(s) for the cost finding and step-down requirements of the
Medicare program, or in its absence the Medicaid program.

45 CFR 74,
Appendix E(I)(C) -- Application. All operating agencies
within the Department of Health and Human Services that sponsor
research and development work in hospitals will apply these
principles and related policy guides in determining the costs
incurred for such work under grants and cost-reimbursement type
contracts and subcontracts. These principles will also be used as a
guide in the pricing of fixed-price contracts and subcontracts.

45 CFR 74,
Appendix E(II) -- Definitions of Terms

45 CFR 74,
Appendix E(II)(A) -- Organized research means all research
activities of a hospital that may be identified whether the support
for such research is from a federal, non-federal or internal
source.

45 CFR 74,
Appendix E(II)(B) -- Departmental research means research
activities that are not separately budgeted and accounted for. Such
work, which includes all research activities not encompassed under
the term organized research, is regarded for purposes of this
document as a part of the patient care activities of the
hospital.

45 CFR 74, Appendix
E(II)(C) -- Research agreement means any valid
arrangement to perform federally-sponsored research or development
including grants, cost- reimbursement type contracts,
cost-reimbursement type subcontracts, and fixed-price contracts and
subcontracts.

45 CFR 74, Appendix
E(II)(D) -- Instruction and training means the formal or informal
programs of educating and training technical and professional health services
personnel, primarily medical and nursing training. This activity, if separately
budgeted or identifiable with specific costs, should be considered as a cost
objective for purposes of indirect cost allocations and the development of
patient care costs.

45 CFR 74, Appendix
E(II)(E) -- Other hospital activities means all organized activities of
a hospital not immediately related to the patient care, research, and
instructional and training functions which produce identifiable revenue from the
performance of these activities. If a non-related activity does not produce
identifiable revenue, it may be necessary to allocate this expense using an
appropriate basis. In such a case, the activity may be included as an allocable
cost (See paragraph III D below.) Also included under this definition is any
category of cost treated as "Unallowable," provided such category of cost
identifies a function or activity to which a portion of the institution's
indirect cost (as defined in paragraph V. A.) are properly allocable.

45 CFR 74, Appendix
E(II)(F) -- Patient care means those departments or cost centers which
render routine or ancillary services to in-patients and/or out-patients. As used
in paragraph IX B.23, it means the cost of these services applicable to patients
involved in research programs.

45 CFR 74, Appendix
E(II)(G) -- Allocation means the process by which the indirect costs
are assigned as between:

45 CFR 74, Appendix
E(II)(G)(1) -- Organized research,

45 CFR 74, Appendix
E(II)(G)(2) -- Patient care including departmental research.

45 CFR 74, Appendix
E(II)(G)(3) -- Instruction and training, and

45 CFR 74, Appendix
E(II)(G)(4) -- Other hospital activities.

45 CFR 74, Appendix
E(II)(H) -- Cost center means an identifiable department or area
(including research) within the hospital which has been assigned an account
number in the hospital accounting system for the purpose of accumulating expense
by department or area.

45 CFR 74, Appendix
E(II)(I) -- Cost finding is the process of recasting the data derived
from the accounts ordinarily kept by a hospital to ascertain costs of the
various types of services rendered. It is the determination of direct costs by
specific identification and the proration of indirect costs by allocation.

45 CFR 74, Appendix
E(II)(J) -- Step down is a cost finding method that recognizes that
services rendered by certain nonrevenue-producing departments or centers are
utilized by certain other nonrevenue producing centers as well as by the
revenue-producing centers. All costs of nonrevenue-producing centers are
allocated to all centers which they serve, regardless of whether or not these
centers produce revenue. Following the apportionment of the cost of the
nonrevenue-producing center, that center will be considered closed and no
further costs are apportioned to that center.

45 CFR 74, Appendix
E(II)(K) -- Scatter bed is a bed assigned to a research patient based
on availability. Research patients occupying these beds are not physically
segregated from nonresearch patients occupying beds. Scatter beds are
geographically dispersed among all the beds available for use in the hospital.
There are no special features attendant to a scatter bed that distinguishes it
from others that could just as well have been occupied.

45 CFR 74, Appendix
E(II)(L) -- Discrete bed is a bed or beds that have been set aside for
occupancy by research patients and are physically segregated from other hospital
beds in an environment that permits an easily ascertainable allocation of costs
associated with the space they occupy and the services they generate.

45 CFR 74, Appendix
E(III) -- Basic Considerations

45 CFR 74, Appendix
E(III)(A) -- Composition of total costs. The cost of a research
agreement is comprised of the allowable direct costs incident to its performance
plus the allocable portion of the allowable indirect costs of the hospital less
applicable credits. (See paragraph III-E.)

45 CFR 74, Appendix
E(III)(B) -- Factors affecting allowability of costs. The tests of
allowability of costs under these principles are:

45 CFR 74, Appendix
E(III)(B)(1) -- They must be reasonable.

45 CFR 74, Appendix
E(III)(B)(2) -- They must be assigned to research agreements under the
standards and methods provided herein.

45 CFR 74, Appendix
E(III)(B)(3) -- They must be accorded consistent treatment through
application of those generally accepted accounting principles appropriate to the
circumstances (See paragraph I-E.5.) and

45 CFR 74, Appendix
E(III)(B)(4) -- They must conform to any limitations or exclusions set
forth in these principles or in the research agreement as to types or amounts of
cost items.

45 CFR 74, Appendix
E(III)(C) -- Reasonable costs. A cost may be considered reasonable if
the nature of the goods or services acquired or applied, and the amount involved
therefor reflect the action that a prudent person would have taken under the
circumstances prevailing at the time the decision to incur the cost was made.
Major considerations involved in the determination of the reasonableness of a
cost are:

45 CFR 74, Appendix
E(III)(C)(1) -- Whether or not the cost is of a type generally
recognized as necessary for the operation of the hospital or the performance of
the research agreement,

45 CFR 74, Appendix
E(III)(C)(2) -- The restraints or requirements imposed by such factors
as arm's length bargaining, federal and state laws and regulations, and research
agreement terms and conditions,

45 CFR 74, Appendix
E(III)(C)(3) -- Whether or not the individuals concerned acted with due
prudence in the circumstances, considering their responsibilities to the
hospital, its patients, its employees, its students, the Government, and the
public at large, and

45 CFR 74, Appendix
E(III)(C)(4) -- The extent to which the actions taken with respect to
the incurrence of the cost are consistent with established hospital policies and
practices applicable to the work of the hospital generally, including Government
research.

45 CFR 74, Appendix
E(III)(D) -- Allocable costs.

45 CFR 74, Appendix
E(III)(D)(1) -- A cost is allocable to a particular cost center (i.e.,
a specific function, project, research agreement, department, or the like) if
the goods or services involved are chargeable or assignable to such cost center
in accordance with relative benefits received or other equitable relationship.
Subject to the foregoing, a cost is allocable to a research agreement if it is
incurred solely to advance the work under the research agreement; or it benefits
both the research agreement and other work of the hospital in proportions that
can be approximated through use of reasonable methods; or it is necessary to the
overall operation of the hospital and, in light of the standards provided in
this chapter, is deemed to be assignable in part to organized research. Where
the purchase of equipment or other capital items are specifically authorized
under a research agreement, the amounts thus authorized for such purchases are
allocable to the research agreement regardless of the use that may subsequently
be made of the equipment or other capital items involved.

45 CFR 74, Appendix
E(III)(D)(2) -- Any costs allocable to a particular research agreement
under the standards provided in these principles may not be shifted to other
research agreements in order to meet deficiencies caused by overruns or other
fund considerations, to avoid restrictions imposed by law or by terms of the
research agreement, or for other reasons of convenience.

45 CFR 74, Appendix
E(III)(E) -- Applicable credits

45 CFR 74, Appendix
E(III)(E)(1) -- The term applicable credits refers to those receipts or
negative expenditure types of transactions which operate to offset or reduce
expense items that are allocable to research agreements as direct or indirect
costs as outlined in paragraph V-A. Typical examples of such transactions are:
purchase discounts, rebates, or allowances; recoveries or indemnities on losses;
sales of scrap or incidental services; tuition; adjustments of overpayments or
erroneous charges; and services rendered to patients admitted to federally
funded clinical research centers, primarily for care though also participating
in research protocols. 2. In some instances, the amounts received from the
Federal Government to finance hospital activities or service operations should
be treated as applicable credits. Specifically, the concept of netting such
credit items against related expenditures should be applied by the hospital in
determining the rates or amounts to be charged to government research for
services rendered whenever the facilities or other resources used in providing
such services have been financed directly, in whole or in part, by federal
funds. Thus, where such items are provided for or benefit a particular hospital
activity, i.e., patient care, research, instruction and training, or other, they
should be treated as an offset to the indirect costs apportioned to that
activity. Where the benefits are common to all hospital activities they should
be treated as a credit to the total indirect cost pool before allocation to the
various cost objectives.

45 CFR 74, Appendix
E(III)(E)(2) -- In some instances, the amounts received from the
Federal Government to finance hospital activities or service operations should
be treated as applicable credits. Specifically, the concept of netting such
credit items against related expenditures should be applied by the hospital in
determining the rates or amounts to be charged to government research for
services rendered whenever the facilities or other resources used in providing
such services have been financed directly, in whole or in part, by federal
funds. Thus, where such items are provided for or benefit a particular hospital
activity, i.e., patient care, research, instruction and training, or other, they
should be treated as an offset to the indirect costs apportioned to that
activity. Where the benefits are common to all hospital activities they should
be treated as a credit to the total indirect cost pool before allocation to the
various cost objectives.

45 CFR 74, Appendix
E(IV) -- Direct Costs

45 CFR 74, Appendix
E(IV)(A) -- General. Direct costs are those that can be identified
specifically with a particular cost center. For this purpose, the term cost
center refers not only to the ultimate centers against which costs are finally
lodged such as research agreements, but also to other established cost centers
such as the individual accounts for recording particular objects or items of
expense, and the separate account groupings designed to record the expenses
incurred by individual organizational units, functions, projects and the like.
In general, the administrative functions and service activities described in
paragraph VI are identifiable as separate cost centers, and the expenses
associated with such centers become eligible in due course for distribution as
indirect costs of research agreements and other ultimate cost centers.

45 CFR 74, Appendix
E(IV)(B) -- Application to research agreements. Identifiable benefit to
the research work rather than the nature of the goods and services involved is
the determining factor in distinguishing direct from indirect costs of research
agreements. Typical of transactions chargeable to a research agreement as direct
costs are the compensation of employees for the time or effort devoted to the
performance of work under the research agreement, including related staff
benefit and pension plan costs to the extent that such items are consistently
accorded to all employees and treated by the hospital as direct rather than
indirect costs (see paragraph V. B4b); the costs of materials consumed or
expended in the performance of such work; and other items of expense incurred
for the research agreement, such as extraordinary utility consumption. The cost
of materials supplied from stock or services rendered by specialized facilities
or other institutional service operations may be included as direct costs of
research agreements provided such items are consistently treated by the
institution as direct rather than indirect costs and are charged under a
recognized method of costing or pricing designed to recover only the actual
direct and indirect costs of such material or service and conforming to
generally accepted cost accounting practices consistently followed by the
institution.

45 CFR 74, Appendix
E(V) -- Indirect Costs

45 CFR 74, Appendix
E(V)(A) -- General. Indirect costs are those that have been incurred
for common or joint objectives, and thus are not readily subject to treatment as
direct costs of research agreements or other ultimate or revenue producing cost
centers. In hospitals such costs normally are classified but not necessarily
restricted to the following functional categories: Depreciation; Administrative
and General (including fringe benefits if not charged directly); Operation of
Plant; Maintenance of Plant; Laundry and Linen Service; Housekeeping; Dietary;
Maintenance of Personnel; and Medical Records and Library.

45 CFR 74, Appendix
E(V)(B) -- Criteria for distribution

45 CFR 74, Appendix
E(V)(B)(1) -- Base period. A base period for distribution of indirect
costs is the period during which such costs are incurred and accumulated for
distribution to work performed within that period. The base period normally
should coincide with the fiscal year established by the hospital, but in any
event the base period should be so selected as to avoid inequities in the
distribution of costs.

45 CFR 74, Appendix
E(V)(B)(2) -- Need for cost groupings. The overall objective of the
allocation process is to distribute the indirect costs described in paragraph VI
to organized research, patient care, instruction and training, and other
hospital activities in reasonable proportions consistent with the nature and
extent of the use of the hospital's resources by research personnel, medical
staff, patients, students, and other personnel or organizations. In order to
achieve this objective with reasonable precision, it may be necessary to provide
for selective distribution by establishing separate groupings of cost within one
or more of the functional categories of indirect costs referred to in paragraph
V-A. In general, the cost groupings established within a functional category
should constitute, in each case, a pool of those items of expense that are
considered to be of like character in terms of their relative contribution to
(or degree of remoteness from) the particular cost centers to which distribution
is appropriate. Each such pool or cost grouping should then be distributed
individually to the related cost centers, using the distribution base or method
most appropriate in the light of the guides set out in B3 below. While this
paragraph places primary emphasis on a step-down method of indirect cost
computation, paragraph VIII provides an alternate method which may be used under
certain conditions.

45 CFR 74, Appendix
E(V)(B)(3) -- Selection of distribution method. Actual conditions must
be taken into account in selecting the method or base to be used in distributing
to related cost centers the expenses assembled under each of the individual cost
groups established as indicated under B2 above. Where a distribution can be made
by assignment of a cost grouping directly to the area benefited, the
distribution should be made in that manner. Care should be given, however, to
eliminate similar or duplicative costs from any other distribution made to this
area. Where the expenses under a cost grouping are more general in nature, the
distribution to related cost centers should be made through use of a selected
base which will produce results which are equitable to both the Government and
the hospital. In general, any cost element or cost-related factor associated
with the hospital's work is potentially adaptable for use as a distribution base
provided:

45 CFR 74, Appendix
E(V)(B)(3)(a) -- It can readily be expressed in terms of dollars or
other quantitative measure (total direct expenditures, direct salaries, manhours
applied, square feet utilized, hours of usage, number of documents processed,
population served, and the like); and

45 CFR 74, Appendix
E(V)(B)(3)(b) -- It is common to the related cost centers during the
base period. The essential consideration in selection of the distribution base
in each instance is that it be the one best suited for assigning the pool of
costs to related cost centers in accord with the relative benefits derived; the
traceable cause and effect relationship; or logic and reason, where neither
benefit nor cause and effect relationship is determinable.

45 CFR 74, Appendix
E(V)(B)(4) -- General consideration on cost groupings. The extent to
which separate cost groupings and selective distribution would be appropriate at
a hospital is a matter of judgment to be determined on a case-by-case basis.
Typical situations which may warrant the establishment of two or more separate
cost groups (based on account classification or analysis) within a functional
category include but are not limited to the following:

45 CFR 74, Appendix
E(V)(B)(4)(a) -- Where certain items or categories of expense relate
solely to one of the major divisions of the hospital (patient care, sponsored
research, instruction and training, or other hospital activities) or to any two
but not all, such expenses should be set aside as a separate cost grouping for
direct assignment or selective distribution in accordance with the guides
provided in B2 and B3 above.

45 CFR 74, Appendix
E(V)(B)(4)(b) -- Where any types of expense ordinary treated as
indirect cost as outlined in paragraph V-A are charged to research agreements as
direct costs, the similar type expenses applicable to other activities of the
institution must through separate cost grouping be excluded from the indirect
costs allocable to research agreements.

45 CFR 74, Appendix
E(V)(B)(4)(c) -- Where it is determined that certain expenses are for
the support of a service unit or facility whose output is susceptible of
measurement on a workload or other quantitative basis, such expenses should be
set aside as a separate cost grouping for distribution on such basis to
organized research and other hospital activities.

45 CFR 74, Appendix
E(V)(B)(4)(d) -- Where organized activities (including identifiable
segments of organized research as well as the activities cited in paragraph
II-E) provide their own purchasing, personnel administration, building
maintenance, or housekeeping or similar service, the distribution of such
elements of indirect cost to such activities should be accomplished through cost
grouping which includes only that portion of central indirect costs (such as for
overall management) which are properly allocable to such activities.

45 CFR 74, Appendix
E(V)(B)(4)(e) -- Where the hospital elects to treat as indirect charges
the costs of pension plans and other staff benefits, such costs should be set
aside as a separate cost grouping for selective distribution to related cost
centers, including organized research.

45 CFR 74, Appendix
E(V)(B)(4)(f) -- Where the hospital is affiliated with a medical school
or some other institution which performs organized research on the hospital's
premises, every effort should be made to establish separate cost groupings in
the Administrative and General or other applicable category which will
reasonably reflect the use of services and facilities by such research. (See
also paragraph VII-A.3)

45 CFR 74, Appendix
E(V)(B)(5) -- Materiality. Where it is determined that the use of
separate cost groupings and selective distribution are necessary to produce
equitable results, the number of such separate cost groupings within a
functional category should be held within practical limits, after taking into
consideration the materiality of the amounts involved and the degree of
precision attainable through less selective methods of distribution.

45 CFR 74, Appendix
E(V)(C) -- Administration of limitations on allowances for indirect
costs.

45 CFR 74, Appendix
E(V)(C)(1) -- Research grants may be subject to laws and/or
administrative regulations that limit the allowance for indirect costs under
each such grant to a stated percentage of the direct costs allowed. Agencies
that sponsor such grants will establish procedures which will assure that:

45 CFR 74, Appendix
E(V)(C)(1)(a) -- The terms and amount authorized in each case conform
with the provisions of paragraphs III, V and IX of these principles as they
apply to matters involving the consistent treatment and allowability of
individual items of cost; and

45 CFR 74, Appendix
E(V)(C)(1)(b) -- The amount actually allowed for indirect costs under
each such research grant does not exceed the maximum allowable under the
limitation or the amount otherwise allowable under these principles, whichever
is the smaller.

45 CFR 74, Appendix
E(V)(C)(2) -- Where the actual allowance for indirect costs on any
research grant must be restricted to the smaller of the two alternative amounts
referred to in C1 above, such alternative amounts should be determined in
accordance with the following guides:

45 CFR 74, Appendix
E(V)(C)(2)(a) -- The maximum allowable under the limitation should be
established by applying the stated percentage to a direct cost base which shall
include all items of expenditure authorized by the sponsoring agency for
inclusion as part of the total cost for the direct benefit of the work under the
grant; and

45 CFR 74, Appendix
E(V)(C)(2)(b) -- The amount otherwise allowable under these principles
should be established by applying the current institutional indirect cost rate
to those elements of direct cost which were included in the base on which the
rate was computed.

45 CFR 74, Appendix
E(V)(C)(3) -- When the maximum amount allowable under a statutory
limitation or the terms of a research agreement is less than the amount
otherwise allocable as indirect costs under these principles, the amount not
recoverable as indirect costs under the research agreement involved may not be
shifted to other research agreements.

45 CFR 74, Appendix
E(VI) -- Identification and Assignment of Indirect Costs

45 CFR 74, Appendix
E(VI)(A) -- Depreciation or use charge.

45 CFR 74, Appendix
E(VI)(A)(1) -- The expenses under this heading should include
depreciation (as defined in paragraph IX-B.9a) on buildings, fixed equipment,
and movable equipment, except to the extent purchased through federal funds.
Where adequate records for the recording of depreciation are not available, a
use charge may be substituted for depreciation (See paragraph IX-B.)

45 CFR 74, Appendix
E(VI)(A)(2) -- The expenses included in this category should be
allocated to applicable cost centers in a manner consistent with the guides set
forth in paragraph V-B, on a basis that gives primary emphasis to (a) space
utilization with respect to depreciation on buildings and fixed equipment; and
(b) specific identification of assets and their use with respect to movable
equipment as it relates to patient care, organized research, instruction and
training, and other hospital activities. Where such records are not sufficient
for the purpose of the foregoing, reasonable estimates will suffice as a means
for effecting distribution of the amounts involved.

45 CFR 74, Appendix
E(VI)(B) -- Administration and general expenses

45 CFR 74, Appendix
E(VI)(B)(1) -- The expenses under this heading are those that have been
incurred for the administrative offices of the hospital including accounting,
personnel, purchasing, information centers, telephone expense, and the like
which do not relate solely to any major division of the institution, i.e.,
solely to patient care, organized research, instruction and training, or other
hospital activities.

45 CFR 74, Appendix
E(VI)(B)(2) -- The expenses included in this category may be allocated
on the basis of total expenditures exclusive of capital expenditures, or
salaries and wages in situations where the results of the distribution made on
this basis are deemed to be equitable both to the Government and the hospital;
otherwise the distribution of Administration and General expenses should be made
through use of selected bases, applied to separate cost groupings established
within this category of expenses in accordance with the guides set out in
paragraph V-B.

45 CFR 74, Appendix
E(VI)(C) -- Operation of plant

45 CFR 74, Appendix
E(VI)(C)(1) -- The expenses under this heading are those that have been
incurred by a central service organization or at the departmental level for the
administration, supervision, and provision of utilities (exclusive of telephone
expense) and protective services to the physical plant. They include expenses
incurred for such items as power plant operations, general utility costs,
elevator operations, protection services, and general parking lots.

45 CFF 74, Appendix
E(VI)(C)(2) -- The expenses included in this category should be
allocated to applicable cost centers in a manner consistent with the guides
provided in paragraph V-B, on a basis that gives primary emphasis to space
utilization. The allocations should be developed as follows:

45 CFF 74, Appendix
E(VI)(C)(2)(a) -- Where actual space and related cost records are
available or can readily be developed and maintained without significant change
in the accounting practices, the amount distributed should be based on such
records;

45 CFF 74, Appendix
E(VI)(C)(2)(b) -- Where the space and related cost records maintained
are not sufficient for purposes of the foregoing, a reasonable estimate of the
proportion of total space assigned to the various costs centers normally will
suffice as a means for effecting distribution of the amounts involved; or

45 CFF 74, Appendix
E(VI)(C)(2)(c) -- Where it can be demonstrated that an area or volume
or space basis of allocation is impractical or inequitable, other bases may be
used provided consideration is given to the use of facilities by research
personnel and others, including patients.

45 CFR 74, Appendix
E(VI)(D) -- Maintenance of plant.

45 CFR 74, Appendix
E(VI)(D)(1) -- The expenses under this heading should include:

45 CFR 74, Appendix
E(VI)(D)(1)(a) -- All salaries and wages pertaining to ordinary repair
and maintenance work performed by employees on the payroll of the hospital;

45 CFR 74, Appendix
E(VI)(D)(1)(b) -- All supplies and parts used in the ordinary repairing
and maintaining of buildings and general equipment; and

45 CFR 74, Appendix
E(VI)(D)(1)(c) -- Amounts paid to outside concerns for the ordinary
repairing and maintaining of buildings and general equipment.

45 CFR 74, Appendix
E(VI)(D)(2) -- The expenses included in this category should be
allocated to applicable cost centers in a manner consistent with the guides
provided in paragraph V-B. on a basis that gives primary emphasis to space
utilization. The allocations and apportionments should be developed as
follows:

45 CFR 74, Appendix
E(VI)(D)(2)(a) -- Where actual space and related cost records are
available and can readily be developed and maintained without significant change
in the accounting practices, the amount distributed should be based on such
records;

45 CFR 74, Appendix
E(VI)(D)(2)(b) -- Where the space and related cost records maintained
are not sufficient for purposes of the foregoing, a reasonable estimate of the
proportion of total space assigned to the various cost centers normally will
suffice as a means for effecting distribution of the amounts involved; or

45 CFR 74, Appendix
E(VI)(D)(2)(c) -- Where it can be demonstrated that an area or volume
of space basis of allocation is impractical or inequitable, other basis may be
used provided consideration is given to the use of facilities by research
personnel and others, including patients.

45 CFR 74, Appendix
E(VI)(E) -- Laundry and linen.

45 CFR 74, Appendix
E(VI)(E)(1) -- The expenses under this heading should include:

45 CFR 74, Appendix
E(VI)(E)(1)(a) -- Salaries and wages of laundry department employees,
seamstresses, clean linen handlers, linen delivery men, etc.;

45 CFR 74, Appendix
E(VI)(E)(1)(b) -- Supplies used in connection with the laundry
operation and all linens purchased; and

45 CFR 74, Appendix
E(VI)(E)(1)(c) -- Amounts paid to outside concerns for purchased
laundry and/or linen service.

45 CFR 74, Appendix
E(VI)(E)(2) -- The expense included in this category should be
allocated to related cost centers in a manner consistent with the guides
provided in paragraph V-B. on a basis that gives primary emphasis to actual
pounds of linen used. The allocations should be developed as follows:

45 CFR 74, Appendix
E(VI)(E)(2)(a) -- Where actual poundage and related cost records are
available or can readily be developed and maintained without significant change
in the accounting practices, the amount distributed should be based on such
records;

45 CFR 74, Appendix
E(VI)(E)(2)(b) -- Where it can be demonstrated that a poundage basis of
allocation is impractical or inequitable other bases may be used provided
consideration is given to the use of linen by research personnel and others,
including patients.

45 CFR 74, Appendix
E(VI)(F) -- Housekeeping.

45 CFR 74, Appendix
E(VI)(F)(1) -- The expenses under this heading should include:

45 CFR 74, Appendix
E(VI)(F)(1)(a) -- All salaries and wages of the department head,
foreman, maids, porters, janitors, wall washers, and other housekeeping
employees;

45 CFR 74, Appendix
E(VI)(F)(1)(b) -- All supplies used in carrying out the housekeeping
functions; and

45 CFR 74, Appendix
E(VI)(F)(1)(c) -- Amounts paid to outside concerns for purchased
services such as window washing, insect extermination, etc.

45 CFR 74, Appendix
E(VI)(F)(2) -- The expenses included in this category should be
allocated to related cost centers in a manner consistent with the guides
provided in paragraph V-B. on a basis that gives primary emphasis to space
actually serviced by the housekeeping department. The allocations and
apportionments should be developed as follows:

45 CFR 74, Appendix
E(VI)(F)(2)(a) -- Where actual space serviced and related cost records
are available or can readily be developed and maintained without significant
change in the accounting practices, the amount distributed should be based on
such records;

45 CFR 74, Appendix
E(VI)(F)(2)(b) -- Where the space serviced and related cost records
maintained are not sufficient for purposes of the foregoing, a reasonable
estimate of the proportion of total space assigned to the various cost centers
normally will suffice as a means for effecting distribution of the amounts of
housekeeping expenses involved; or

45 CFR 74,
Appendix E(VI)(F)(2)(c) -- Where it can be demonstrated
that the space serviced basis of allocation is impractical or
inequitable, other bases may be used provided consideration is given
to the use of housekeeping services by research personnel and
others, including patients.

45 CFR 74,
Appendix E(VI)(G) -- Dietary

45 CFR 74,
Appendix E(VI)(G)(1) -- These expenses, as used herein,
shall mean only the subsidy provided by the hospital to its
employees including research personnel through its cafeteria
operation. The hospital must be able to demonstrate through the use
of proper cost accounting techniques that the cafeteria operates at
a loss to the benefit of employees.

45 CFR 74,
Appendix E(VI)(G)(2) -- The reasonable operating loss of a
subsidized cafeteria operation should be allocated to related cost
centers in a manner consistent with the guides provided in paragraph
V-B. on a basis that gives primary emphasis to number of
employees.

45 CFR 74,
Appendix E(VI)(H) -- Maintenance (housing) of personnel.

45 CFR 74,
Appendix E(VI)(H)(1) -- The expenses under this heading
should include:

45 CFR 74,
Appendix E(VI)(H)(1)(a) -- The salaries and wages of
matrons, clerks, and other employees engaged in work in nurses'
residences and other employees' quarters;

45 CFR 74,
Appendix E(VI)(H)(1)(b) -- All supplies used in connection
with the operation of such dormitories; and

45 CFR 74,
Appendix E(VI)(H)(1)(c) -- Payments to outside agencies for
the rental of houses, apartments, or rooms used by hospital
personnel.

45 CFR 74,
Appendix E(VI)(H)(2) -- The expenses included in this
category should be allocated to related cost centers in a manner
consistent with the guides provided in paragraph V-B. on a basis
that gives primary emphasis to employee utilization of housing
facilities. The allocation should be developed as follows:

45 CFR 74,
Appendix E(VI)(H)(2)(a) -- Appropriate credit should be
given for all payments received from employees or otherwise to
reduce the expense to be allocated;

45 CFR 74,
Appendix E(VI)(H)(2)(b) -- A net cost per housed employee
may then be computed; and

45 CFR 74,
Appendix E(VI)(H)(2)(c) -- Allocation should be made on a
departmental basis based on the number of housed employees in each
respective department.

45 CFR 74,
Appendix E(VI)(I) -- Medical records and library

45 CFR 74,
Appendix E(VI)(I)(1) -- The expenses under this heading
should include:

45 CFR 74,
Appendix E(VI)(I)(1)(a) -- The salaries and wages of the
records librarian, medical librarian, clerks, stenographers, etc.;
and

45 CFR 74,
Appendix E(VI)(I)(1)(b) -- All supplies such as medical
record forms, chart covers, filing supplies, stationery, medical
library books, periodicals, etc.

45 CFR 74,
Appendix E(VI)(I)(2) -- The expenses included in this
category should be allocated to related cost centers in a manner
consistent with the guides provided in paragraph V-B. on a basis
that gives primary emphasis to a special time survey of medical
records personnel. If this appears to be impractical or inequitable,
other bases may be used provided consideration is given to the use
of these facilities by research personnel and others, including
patients.

45 CFR 74,
Appendix E(VII) --Determination and Application of Indirect
Cost Rate or Rates

45 CFR 74,
Appendix E(VII)(A) --Indirect cost pools.

45 CFR 74,
Appendix E(VII)(A)(1) -- Subject to (2) below, indirect
costs allocated to organized research should be treated as a common
pool, and the costs in such common pool should be distributed to
individual research agreements benefiting therefrom on a single rate
basis.

45 CFR 74,
Appendix E(VII)(A)(2) -- In some instances a single rate
basis for use on all government research at a hospital may not be
appropriate since it would not take into account those different
environmental factors which may affect substantially the indirect
costs applicable to a particular segment of government research at
the institution. For this purpose, a particular segment of
government research may be that performed under a single research
agreement or it may consist of research under a group of research
agreements performed in a common environment. The environmental
factors are not limited to the physical location of the work. Other
important factors are the level of the administrative support
required, the nature of the facilities or other resources employed,
the scientific disciplines or technical skills involved, the
organizational arrangements used, or any combination thereof. Where
a particular segment of government research is performed within an
environment which appears to generate a significantly different
level of indirect costs, provision should be made for a separate
indirect cost pool applicable to such work. An example of this
differential may be in the development of a separate indirect cost
pool for a clinical research center grant. The separate indirect
cost pool should be developed during the course of the regular
distribution process, and the separate indirect cost rate resulting
therefrom should be utilized provided it is determined that:

45 CFR 74,
Appendix E(VII)(A)(2)(a) -- Such indirect cost rate differs
significantly from that which would have obtained under (1) above;
and

45 CFR 74,
Appendix E(VII)(A)(2)(b) -- The volume of research work to
which such rate would apply is material in relation to other
government research at the institution.

45
CFR 74, Appendix E(VII)(A)(3) -- It is a common practice
for grants or contracts awarded to other institutions, typically
University Schools of Medicine, to be performed on hospital
premises. In these cases the hospital should develop a separate
indirect cost pool applicable to the work under such grants or
contracts. This pool should be developed by a selective distribution
of only those indirect cost categories which benefit the work
performed by the other institution, within the practical limits
dictated by available data and the materiality of the amounts
involved. Hospital costs determined to be allocable to grants or
contracts awarded to another institution may not be recovered as a
cost of grants or contracts awarded directly to the hospital.

45 CFR 74,
Appendix E(VII)(B) -- The distribution base. Preferably,
indirect costs allocated to organized research should be distributed
to applicable research agreements on the basis of direct salaries
and wages. However, where the use of salaries and wages results in
an inequitable allocation of costs to the research agreements, total
direct costs or a variation thereof, may be used in lieu of salaries
and wages. Regardless of the base used, an indirect cost rate should
be determined for each of the separate indirect cost pools developed
pursuant to paragraph VII-A. The rate in each case should be stated
as the percentage which the amount of the particular indirect cost
pool is of the total direct salaries and wages (or other base
selected) for all research agreements identified with such a
pool.

45 CFR 74,
Appendix E(VII)(C) -- Negotiated lump sum for overhead. A
negotiated fixed amount in lieu of indirect costs may be appropriate
for self-contained or off- campus research activities where the
benefits derived from a hospital's indirect services cannot be
readily determined. Such amount negotiated in lieu of indirect costs
will be treated as an offset to the appropriate indirect cost pool
after allocation to patient care, organized research, instruction
and training, and other hospital activities. The base on which such
remaining expenses are allocated should be appropriately
adjusted.

45 CFR 74,
Appendix E(VII)(D) -- Predetermined overhead rates. The
utilization of predetermined fixed overhead rates may offer
potential advantages in the administration of research agreements by
facilitating the preparation of research budgets and permitting more
expeditious close out of the agreements when the work is completed.
Therefore, to the extent allowed by law, consideration may be given
to the negotiation of predetermined fixed rates in those situations
where the cost experience and other pertinent factors available are
deemed sufficient to enable the Government and the hospital to reach
a reasonable conclusion as to the probable level of the indirect
cost rate for the ensuing accounting period.

45 CFR 74,
Appendix E(VIII) -- Simplified Method for Small
Institutions

45 CFR 74,
Appendix E(VIII)(A) -- General.

45 CFR 74,
Appendix E(VIII)(A)(1) -- Where the total direct cost of
all government- sponsored research and development work at a
hospital in a year is minimal, the use of the abbreviated procedure
described in paragraph VIII-B below may be acceptable in the
determination of allowable indirect costs. This method may also be
used to initially determine a provisional indirect cost rate for
hospitals that have not previously established a rate. Under this
abbreviated procedure, data taken directly from the institution's
most recent annual financial report and immediately available
supporting information will be utilized as a basis for determining
the indirect cost rate applicable to research agreements at the
institution.

45 CFR 74,
Appendix E(VIII)(A)(2) -- The rigid formula approach
provided under the abbreviated procedure has limitations which may
preclude its use at some hospitals either because the minimum data
required for this purpose are not readily available or because the
application of the abbreviated procedure to the available data
produces results which appear inequitable to the Government or the
hospital. In any such case, indirect costs should be determined
through use of the regular procedure rather than the abbreviated
procedure.

45 CFR 74,
Appendix E(VIII)(A)(3) -- In certain instances where the
total direct cost of all government-sponsored research and
development work at the hospital is more than minimal, the
abbreviated procedure may be used if prior permission is obtained.
This alternative will be granted only in those cases where it can be
demonstrated that the step-down technique cannot be followed.

45 CFR 74,
Appendix E(VIII)(B) -- Abbreviated procedure.

45 CFR 74,
Appendix E(VIII)(B)(1) -- Total expenditures as taken from
the most recent annual financial report will be adjusted by
eliminating from further consideration expenditures for capital
items as defined in paragraph IX-B.4 and unallowable costs as
defined under various headings in paragraph IX and paragraph
III-E.

45 CFR 74,
Appendix E(VIII)(B)(2) -- Total expenditures as adjusted
under the foregoing will then be distributed among (a) expenditures
applicable to administrative and general overhead functions, (b)
expenditures applicable to all other overhead functions, and (c)
expenditures for all other purposes. The first group shall include
amounts associated with the functional categories, Administration
and General, and Dietary, as defined in paragraph VI. The second
group shall include Depreciation, Operation of Plant, Maintenance of
Plant, and Housekeeping. The third group-- expenditures for all
other purposes--shall include the amounts applicable to all other
activities, namely, patient care, organized research, instruction
and training, and other hospital activities as defined under
paragraph II-E. For the purposes of this section, the functional
categories of Laundry and Linen, Maintenance of Personnel, and
Medical Records and Library as defined in paragraph VI shall be
considered as expenditures for all other purposes.

45 CFR 74,
Appendix E(VIII)(B)(3) -- The expenditures distributed to
the first two groups in paragraph VIII-B.2 should then be adjusted
by those receipts or negative expenditure types of transactions
which tend to reduce expense items allocable to research agreements
as indirect costs. Examples of such receipts or negative
expenditures are itemized in paragraph III-E.1.

45 CFR 74,
Appendix E(VIII)(B)(4) -- In applying the procedures in
paragraphs VIII-B.1 and B.2, the cost of unallowable activities such
as Gift Shop, Investment Property Management, Fund Raising, and
Public Relations, when they benefit from the hospital's indirect
cost services, should be treated as expenditures for all other
purposes. Such activities are presumed to benefit from the
hospital's indirect cost services when they include salaries of
personnel working in the hospital. When they do not include such
salaries, they should be eliminated from the indirect cost rate
computation.

45 CFR 74,
Appendix E(VIII)(B)(5) -- The indirect cost rate will then
be computed in two stages. The first stage requires the computation
of an Administrative and General rate component. This is done by
applying a ratio of research direct costs over total direct costs to
the Administrative and General pool developed under paragraphs
VIII-B.2 and B.3 above. The resultant amount--that which is
allocable to research--is divided by the direct research cost base.
The second stage requires the computation of an All Other Indirect
Cost rate component. This is done by applying a ratio of research
direct space over total direct space to All Other Indirect Cost pool
developed under paragraphs VIII-B.2 and B.3 above.
The total of the two rate
components will be the institution's indirect cost rate. For the
purposes of this section, the research direct cost or space and
total direct cost or space will be that cost or space identified
with the functional categories classified under Expenditures for all
other purposes under paragraph VIII-B.2.

45 CFR 74,
Appendix E(IX) -- General Standards for Selected Items of
Cost

45 CFR 74,
Appendix E(IX)(A) -- General. This section provides
standards to be applied in establishing the allowability of certain
items involved in determining cost. These standards should apply
irrespective of whether a particular item of cost is properly
treated as direct cost or indirect cost. Failure to mention a
particular item of cost in the standards is not intended to imply
that it is either allowable or unallowable; rather, determination as
to allowability in each case should be based on the treatment or
standards provided for similar or related items of cost. In case of
discrepancy between the provisions of a specific research agreement
and the applicable standards provided, the provisions of the
research agreement should govern. However, in some cases advance
understandings should be reached on particular cost items in order
that the full costs of research be supported. The extent of
allowability of the selected items of cost covered in this section
has been stated to apply broadly to many accounting systems in
varying environmental situations. Thus, as to any given research
agreement, the reasonableness and allocability of certain items of
costs may be difficult to determine, particularly in connection with
hospitals which have medical school or other affiliations. In order
to avoid possible subsequent disallowance or dispute based on
unreasonableness or nonallocability, it is important that
prospective recipients of federal funds particularly those whose
work is predominantly or substantially with the Government, seek
agreement with the Government in advance of the incurrence of
special or unusual costs in categories where reasonableness or
allocability are difficult to determine. Such agreement may also be
initiated by the Government. Any such agreement should be
incorporated in the research agreement itself. However, the absence
of such an advance agreement on any element of cost will not in
itself serve to make that element either allowable or unallowable.
Examples of costs on which advance agreements may be particularly
important are:

45 CFR 74,
Appendix E(IX)(A)(1) -- Facilities costs, such as;

45 CFR 74,
Appendix E(IX)(A)(1)(a-g) --
- Depreciation
- Rental
- Use charges for fully depreciated assets
- Idle facilities and idle capacity
- Plant reconversion
- Extraordinary or deferred maintenance and repair
- Acquisition of automatic data processing equipment.

45 CFR 74,
Appendix E(IX)(A)(2) -- Preaward costs

45 CFR 74,
Appendix E(IX)(A)(3) -- Non-hospital professional
activities

45 CFR 74,
Appendix E(IX)(A)(4) -- Self-insurance

45 CFR 74,
Appendix E(IX)(A)(5) -- Support services charged directly
(computer services, printing and duplicating services, etc.)

45 CFR 74,
Appendix E(IX)(A)(6) -- Employee compensation, travel, and
other personnel costs, including;

45 CFR 74,
Appendix E(IX)(A)(6)(a-d) --
- Compensation for personal service, including wages and salaries, bonuses and incentives, premium payments, pay for time not worked, and supplementary compensation and benefits, such as pension and retirement, group insurance, severance pay plans, and other forms of compensation
- Morale, health, welfare, and food service and dormitory costs
- Training and education costs
- Relocation costs, including special or mass personnel movement

45 CFR 74,
Appendix E(IX)(B) -- Selected items
45
CFR 74, Appendix E(IX)(B)(1) -- Advertising costs. The term
advertising costs means the costs of advertising media and corollary
administrative costs. Advertising media include magazines,
newspapers, radio and television programs, direct mail, exhibits,
and the like. The only advertising costs allowable are those which
are solely for;

45 CFR 74,
Appendix E(IX)(B)(1)(a-c) --
- The recruitment of persons required for the performance by the institution of obligations arising under the research agreement, when considered in conjunction with all other recruitment costs as set forth in paragraph IX-B.34.
- The procurement of scarce items for the performance of the research agreement; or
- The disposal of scrap or surplus materials acquired in the performance of the research agreement.
Costs of this nature, if incurred for more than
one research agreement or for both research agreement work and other
work of the institution, are allowable to the extent that the
principles in paragraphs IV and V are observed.

45 CFR 74,
Appendix E(IX)(B)(2) -- Bad debts. Losses arising from
uncollectible accounts and other claims and related collection and
legal costs are unallowable except that a bad debt may be included
as a direct cost of the research agreement to the extent that it is
caused by a research patient and approved by the awarding agency.
This inclusion is only intended to cover the situation of the
patient admitted for research purposes who subsequently or in
conjunction with the research receives clinical care for which a
charge is made to the patient. If, after exhausting all means of
collecting these charges, a bad debt results, it may be considered
an appropriate charge to the research agreement.

45 CFR 74,
Appendix E(IX)(B)(3) -- Bonding costs.

45 CFR 74,
Appendix E(IX)(B)(3)(a) -- Bonding costs arise when the
Government requires assurance against financial loss to itself or
others by reason of the act or default of the hospital. They arise
also in instances where the hospital requires similar assurance.
Included are such types as
bid, performance, payment, advance payment, infringement, and
fidelity bonds.

45 CFR 74,
Appendix E(IX)(B)(3)(b) -- Costs of bonding required
pursuant to the terms of the research agreement are allowable.

45 CFR 74,
Appendix E(IX)(B)(3)(c) -- Costs of bonding required by the
hospital in the general conduct of its business are allowable to the
extent that such bonding is in accordance with sound business
practice and the rates and premiums are reasonable under the
circumstances.

45 CFR 74,
Appendix E(IX)(B)(4) -- Capital expenditures. The costs of
equipment, buildings, and repairs which materially increase the
value or useful life of buildings or equipment should be capitalized
and are unallowable except as provided for in the research
agreement.

45 CFR 74,
Appendix E(IX)(B)(5) -- Civil defense costs. Civil defense
costs are those incurred in planning for, and the protection of life
and property against the possible effects of enemy attack.
Reasonable costs of civil defense measures (including costs in
excess of normal plant protection costs, first-aid training and
supplies, fire-fighting training, posting of additional exit notices
and directions, and other approved civil defense measures)
undertaken on the institution's premises pursuant to suggestions or
requirements of civil defense authorities are allowable when
distributed to all activities of the institution. Capital
expenditures for civil defense purposes will not be allowed, but a
use allowance or depreciation may be permitted in accordance with
provisions set forth elsewhere. Costs of local civil defense
projects not on the institution's premises are unallowable.

45 CFR 74,
Appendix E(IX)(B)(6) -- Communication costs. Costs incurred
for telephone services, local and long distance telephone calls,
telegrams, radiograms, postage, and the like are allowable.

45 CFR 74,
Appendix E(IX)(B)(7) -- Compensation for personal services

45 CFR 74,
Appendix E(IX)(B)(7)(a) -- General. Compensation for
personal services covers all remuneration paid currently or accrued
to employees of the hospital for services rendered during the period
of performance under government research agreements. Such
remuneration includes salaries, wages, staff benefits (see paragraph
IX-B.10), and pension plan costs (see paragraph IX-B.25). The costs
of such remuneration are allowable to the extent that the total
compensation to individual employees is reasonable for the services
rendered and conforms to the established policy of the institution
consistently applied, and provided that the charges for work
performed directly on government research agreements and for other
work allocable as indirect costs to sponsored research are
determined and supported as hereinafter provided. For non-profit,
non-proprietary institutions, where federally supported programs
constitute less than a preponderance of the activity at the
institution the primary test of reasonableness will be to require
that the institution's compensation policies be applied consistently
both to federally-sponsored and non-sponsored activities alike.
However, where special circumstances so dictate a contractual clause
may be utilized which calls for application of the test of
comparability in determining the reasonableness of compensation.

45 CFR 74,
Appendix E(IX)(B)(7)(b) -- Payroll distribution. Amounts
charged to organized research for personal services, regardless of
whether treated as direct costs or allocated as indirect costs, will
be based on hospital payrolls which have been approved and
documented in accordance with generally accepted hospital practices.
In order to develop necessary direct and indirect allocations of
cost, supplementary data on time or effort as provided in paragraph
(c) below, normally need be required only for individuals whose
compensation is properly chargeable to two or more research
agreements or to two or more of the following broad functional
categories:
- Patient care;
- organized research;
- instruction and training;
- indirect activities as defined in
paragraph V-A; or
- other hospital activities as defined in
paragraph II-E.

45 CFR 74,
Appendix E(IX)(B)(7)(c) -- Reporting time or effort.
Charges for salaries and wages of individuals other than members of
the professional staff will be supported by daily time and
attendance and payroll distribution records. For members of the
professional staff, current and reasonable estimates of the
percentage distribution of their total effort may be used as support
in the absence of actual time records. The term professional staff
for purposes of this section includes physicians, research
associates, and other personnel performing work at responsible
levels of activities. These personnel normally fulfill duties, the
competent performance of which usually requires persons possessing
degrees from accredited institutions of higher learning and/or state
licensure. In order to qualify as current and reasonable, estimates
must be made no later than one month (though not necessarily a
calendar month) after the month in which the services were
performed.

45 CFR 74,
Appendix E(IX)(B)(7)(d) -- Preparation of estimates of
effort. Where required under paragraph (c) above, estimates of
effort spent by a member of the professional staff on each research
agreement should be prepared by the individual who performed the
services or by a responsible individual such as a department head or
supervisor having first-hand knowledge of the services performed on
each research agreement. Estimates must show the allocation of
effort between organized research and all other hospital activities
in terms of the percentage of total effort devoted to each of the
broad functional categories referred to in (b) above. The estimate
of effort spent on a research agreement may include a reasonable
amount of time spent in activities contributing and intimately
related to work under the agreement, such as preparing and
delivering special lectures about specific aspects of the ongoing
research, writing research reports and articles, participating in
appropriate research seminars, consulting with colleagues with
respect to related research, and attending appropriate scientific
meetings and conferences. The term "all other hospital activities"
would include departmental research, administration, committee work,
and public services undertaken on behalf of the hospital.

45 CFR 74,
Appendix E(IX)(B)(7)(e) -- Application of budget estimates.
Estimates determined before the performance of services, such as
budget estimates on a monthly, quarterly, or yearly basis do not
qualify as estimates of effort spent.

45 CFR 74,
Appendix E(IX)(B)(7)(f) -- Non-hospital professional
activities. A hospital must not alter or waive hospital-wide
policies and practices dealing with the permissible extent of
professional services over and above those traditionally performed
without extra hospital compensation, unless such arrangements are
specifically authorized by the sponsoring agency. Where
hospital-wide policies do not adequately define the permissible
extent of consultantships or other non-hospital activities
undertaken for extra pay, the Government may require that the effort
of professional staff working under research agreements be allocated
as between (1) hospital activities, and (2) non-hospital
professional activities. If the sponsoring agency should consider
the extent of non-hospital professional effort excessive,
appropriate arrangements governing compensation will be negotiated
on a case by case basis.

45 CFR 74,
Appendix E(IX)(B)(7)(g) --Salary rates for part-time
appointments. Charges for work performed on government research by
staff members having only part-time appointments will be determined
at a rate not in excess of that for which he is regularly paid for
his part-time staff assignment.

45 CFR 74,
Appendix E(IX)(B)(8) -- Contingency provisions.
Contributions to a contingency reserve or any similar provisions
made for events the occurrence of which cannot be foretold with
certainty as to time, intensity, or with an assurance of their
happening, are unallowable.

45 CFR 74,
Appendix E(IX)(B)(9) -- Depreciation and use allowances.

45 CFR 74,
Appendix E(IX)(B)(9)(a) -- Hospitals may be compensated for
the use of buildings, capital improvements and usable equipment on
hand through depreciation or use allowances. Depreciation is a
charge to current operations which distributes the cost of a
tangible capital asset, less estimated residual value, over the
estimated useful life of the asset in a systematic and logical
manner. It does not involve a process of valuation. Useful life has
reference to the prospective period of economic usefulness in the
particular hospital's operations as distinguished from physical
life. Use allowances are the means of allowing compensation when
depreciation or other equivalent costs are not considered.

45 CFR 74,
Appendix E(IX)(B)(9)(b) -- Due consideration will be given
to government-furnished research facilities utilized by the
institution when computing use allowances and/or depreciation if the
government-furnished research facilities are material in amount.
Computation of the use allowance and/or depreciation will exclude
both the cost or any portion of the cost of grounds, buildings and
equipment borne by or donated by the Federal Government,
irrespective of where title was originally vested or where it
presently resides, and secondly, the cost of grounds. Capital
expenditures for land improvements (paved areas, fences, streets,
sidewalks, utility conduits, and similar improvements not already
included in the cost of buildings) are allowable provided the
systematic amortization of such capital expenditures has been
provided in the institution's books of accounts, based on reasonable
determinations of the probable useful lives of the individual items
involved, and the share allocated to organized research is developed
from the amount thus amortized for the base period involved.

45 CFR 74,
Appendix E(IX)(B)(9)(c) -- Normal depreciation on a
hospital's plant, equipment, and other capital facilities, except as
excluded by (d) below, is an allowable element of research cost
provided that the amount thereof is computed:

45 CFR 74,
Appendix E(IX)(B)(9)(c)(1) -- Upon the property cost basis
used by the hospital for Federal Income Tax purposes (See section
167 of the Internal Revenue Code of 1954); or

45 CFR 74,
Appendix E(IX)(B)(9)(c)(2) -- In the case of non-profit or
tax exempt organizations, upon a property cost basis which could
have been used by the hospital for Federal Income Tax purposes, had
such hospital been subject to the payment of income tax; and in
either case

45 CFR 74,
Appendix E(IX)(B)(9)(c)(3) -- By the consistent application
to the assets concerned of any generally accepted accounting method,
and subject to the limitations of the Internal Revenue Code of 1954
as amended, including--
- The straight line
method;
- The declining balance
method, using a rate not exceeding twice the rate which would have
been used had the annual allowance been computed under the method
described in (i) above;
- The sum of the
years-digits method; and
- Any other consistent
method productive of an annual allowance which, when added to all
allowances for the period commencing with the use of the property
and including the current year, does not during the first two-thirds
of the useful life of the property exceed the total of such
allowances which would have been used had such allowances been
computed under the method described in (ii) above.

45 CFR 74,
Appendix E(IX)(B)(9)(d) -- Where the depreciation method is
followed, adequate property records must be maintained. The period
of useful service (service life) established in each case for usable
capital assets must be determined on a realistic basis which takes
into consideration such factors as type of construction, nature of
the equipment used, technological developments in the particular
research area, and the renewal and replacement policies followed for
the individual items or classes of assets involved. Where the
depreciation method is introduced for application to assets acquired
in prior years, the annual charges therefrom must not exceed the
amounts that would have resulted had the depreciation method been in
effect from the date of acquisition of such assets.

45 CFR 74,
Appendix E(IX)(B)(9)(e) -- Depreciation on idle or excess
facilities shall not be allowed except on such facilities as are
reasonably necessary for standby purposes.

45 CFR 74,
Appendix E(IX)(B)(9)(f) -- Where an institution elects to
go on a depreciation basis for a particular class of assets, no
depreciation, rental or use charge may be allowed on any such assets
that would be viewed as fully depreciated; provided, however, that
reasonable use charges may be negotiated for any such assets if
warranted after taking into consideration the cost of the facility
or item involved, the estimated useful life remaining at time of
negotiation, the actual replacement policy followed in the light of
service lives used for calculating depreciation, the effect of any
increased maintenance charges or decreased efficiency due to age,
and any other factors pertinent to the utilization of the facility
or item for the purpose contemplated.

45 CFR 74,
Appendix E(IX)(B)(9)(g) -- Hospitals which choose a
depreciation allowance for assets purchased prior to 1966 based on a
percentage of operating costs in lieu of normal depreciation for
purposes of reimbursement under Pub. L. 89-97 (Medicare) shall
utilize that method for determining depreciation applicable to
organized research.
The operating costs to be used
are the lower of the hospital's 1965 operating costs or the
hospital's current year's allowable costs. The percent to be applied
is 5 percent starting with the year 1966-67, with such percentage
being uniformity reduced by one-half percent each succeeding year.
The allowance based on operating costs is in addition to regular
depreciation on assets acquired after 1965. However, the combined
amount of such allowance on pre-1966 assets and the allowance for
actual depreciation on assets acquired after 1965 may not exceed 6
percent of the hospital's allowable cost for the current year. After
total depreciation has been computed, allocation methods are used to
determine the share attributable to organized research.
For purposes of this section,
Operating Costs means the total costs incurred by the hospital in
operating the institution, and includes patient care, research, and
other activities. Allowable Costs means operating costs less
unallowable costs as defined in these principles; by the application
of allocation methods to the total amount of such allowable costs,
the share attributable to Federally-sponsored research is
determined.
A hospital which elects to use
this procedure under Pub. L. 89-97 and subsequently changes to an
actual depreciation basis on pre-1966 assets in accordance with the
option afforded under the Medicare program shall simultaneously
change to an actual depreciation basis for organized research.
Where the hospital desires to
change to actual depreciation but either has no historical cost
records or has incomplete records, the determination of historical
cost could be made through appropriate means involving expert
consultation with the determination being subject to review and
approval by the Department of Health and Human Services.

45 CFR 74,
Appendix E(IX)(B)(9)(h) -- Where the use allowance method
is followed, the use allowance for buildings and improvements will
be computed at an annual rate not exceeding two percent of
acquisition cost. The use allowance for equipment will be computed
at an annual rate not exceeding six and two- thirds percent of
acquisition cost of usable equipment in those cases where the
institution maintains current records with respect to such equipment
on hand. Where the institution's records reflect only the cost
(actual or estimated) of the original complement of equipment, the
use allowance will be computed at an annual rate not exceeding ten
percent of such cost. Original complement for this purpose means the
complement of equipment initially placed in buildings to perform the
functions currently being performed in such buildings; however,
where a permanent change in the function of a building takes place,
a redetermination of the original complement of equipment may be
made at that time to establish a new original complement. In those
cases where no equipment records are maintained, the institution
will justify a reasonable estimate of the acquisition cost of usable
equipment which may be used to compute the use allowance at an
annual rate not exceeding six and two-thirds percent of such
estimate.

45 CFR 74,
Appendix E(IX)(B)(9)(i) -- Depreciation and/or use charges
should usually be allocated to research and other activities as an
indirect cost.

45 CFR 74,
Appendix E(IX)(B)(10) -- Employee morale, health, and
welfare costs and credits. The costs of house publications, health
or first-aid benefits, recreational activities, employees'
counseling services, and other expenses incurred in accordance with
the hospital's established practice or custom for the improvement of
working conditions, employer-employee relations, employee morale,
and employee performance, are allowable. Such costs will be
equitably apportioned to all activities of the hospital. Income
generated from any of these activities will be credited to the cost
thereof unless such income has been irrevocably set over to employee
welfare organizations.

45 CFR 74,
Appendix E(IX)(B)(11) -- Entertainment costs. Except as
pertains to 10 above, costs incurred for amusement, social
activities, entertainment, and any items relating thereto, such as
meals, lodging, rentals, transportation, and gratuities are
unallowable.

45 CFR 74,
Appendix E(IX)(B)(12) -- Equipment and other facilities.
The cost of equipment or other facilities are allowable on a direct
charge basis where such purchases are approved by the sponsoring
agency concerned or provided for by the terms of the research
agreement.

45 CFR 74,
Appendix E(IX)(B)(13) -- Fines and penalties. Costs
resulting from violations of, or failure of the institution to
comply with federal, state and local laws and regulations are
unallowable except when incurred as a result of compliance with
specific provisions of the research agreement, or instructions in
writing from the awarding agency.

45 CFR 74,
Appendix E(IX)(B)(14) -- Insurance and indemnification.

45 CFR 74,
Appendix E(IX)(B)(14)(a) -- Costs of insurance required or
approved and maintained pursuant to the research agreement are
allowable.

45 CFR 74,
Appendix E(IX)(B)(14)(b) -- Costs of other insurance
maintained by the hospital in connection with the general conduct of
its activities are allowable subject to the following limitations:
- Types and extent and cost of coverage must be in accordance with
sound institutional practice;
- costs of insurance or of any
contributions to any reserve covering the risk of loss of or damage
to government owned property are unallowable except to the extent
that the Government has specifically required or approved such
costs; and
- costs of insurance on the lives of officers or
trustees are unallowable except where such insurance is part of an
employee plan which is not unduly restricted.

45 CFR 74,
Appendix E(IX)(B)(14)(c) -- Contributions to a reserve for
an approved self-insurance program are allowable to the extent that
the types of coverage, extent of coverage, and the rates and
premiums would have been allowed had insurance been purchased to
cover the risks. Such contributions are subject to prior approval of
the Government.

45 CFR 74,
Appendix E(IX)(B)(14)(d) -- Actual losses which could have
been covered by permissible insurance (through an approved
self-insurance program or otherwise) are unallowable unless
expressly provided for in the research agreement, except that costs
incurred because of losses not covered under nominal deductible
insurance coverage provided in keeping with sound management
practice as well as minor losses not covered by insurance such as
spoilage, breakage and disappearance of small hand tools which occur
in the ordinary course of operations are allowable.

45 CFR 74,
Appendix E(IX)(B)(15) -- Interest, fund raising and
investment management costs.

45 CFR 74,
Appendix E(IX)(B)(15)(a-d) --
- Costs incurred for interest on
borrowed capital or temporary use of endowment funds, however
represented, are unallowable.
- Costs of organized fund
raising, including financial campaigns, endowment drives,
solicitation of gifts and bequests, and similar expenses incurred
solely to raise capital or obtain contributions are not
allowable.
- Costs of investment counsel
and staff and similar expenses incurred solely to enhance income
from investments are not allowable.
- Costs related to the
physical custody and control of monies and securities are allowable.

45 CFR 74,
Appendix E(IX)(B)(16) -- Labor relations costs. Costs
incurred in maintaining satisfactory relations between the hospital
and its employees, including costs of labor management committees,
employees' publications, and other related activities are allowable.

45 CFR 74,
Appendix E(IX)(B)(17) -- Losses on research agreements or
contracts. Any excess of costs over income under any agreement or
contract of any nature is unallowable. This includes, but is not
limited to, the hospital's contributed portion by reason of
cost-sharing agreements, under- recoveries through negotiation of
flat amounts for overhead, or legal or administrative limitations.

45 CFR 74,
Appendix E(IX)(B)(18) -- Maintenance and repair costs.

45 CFR 74,
Appendix E(IX)(B)(18)(a) -- Costs necessary for the upkeep
of property (including government property unless otherwise provided
for), which neither add to the permanent value of the property nor
appreciably prolong its intended life, but keep it in an efficient
operating condition, are to be treated as follows:

45 CFR
74, Appendix E(IX)(B)(18)(a)(1-2) --
- Normal maintenance and repair costs are allowable;
- Extraordinary maintenance and repair costs are allowable, provided they are allocated to the periods to which applicable for purposes of determining research costs.

45 CFR 74,
Appendix E(IX)(B)(18)(b) -- Expenditures for plant and
equipment, including rehabilitation thereof, which according to
generally accepted accounting principles as applied under the
hospital's established policy, should be capitalized and subjected
to depreciation, are allowable only on a depreciation basis.

45 CFR 74,
Appendix E(IX)(B)(19) -- Material costs. Costs incurred for
purchased materials, supplies and fabricated parts directly or
indirectly related to the research agreement, are allowable.
Purchases made specifically for the research agreement should be
charged thereto at their actual prices after deducting all cash
discounts, trade discounts, rebates, and allowances received by the
institution. Withdrawals from general stores or stockrooms should be
charged at their cost under any recognized method of pricing stores
withdrawals conforming to sound accounting practices consistently
followed by the hospital. Incoming transportation charges are a
proper part of material cost. Direct material cost should include
only the materials and supplies actually used for the performance of
the research agreement, and due credit should be given for any
excess materials retained or returned to vendors. Due credit should
be given for all proceeds or value received for any scrap resulting
from work under the research agreement. Where government donated or
furnished material is used in performing the research agreement,
such material will be used without charge.

45 CFR 74,
Appendix E(IX)(B)(20) -- Memberships, subscriptions and
professional activity costs.

45 CFR 74,
Appendix E(IX)(B)(20)(a-c) --
- Costs of the hospital's membership in civic, business, technical and professional organizations are allowable.
- Costs of the hospital's subscriptions to civic, business, professional and technical periodicals are allowable.
- Costs of meetings and conferences, when the primary purpose is the dissemination of technical information, are allowable. This includes costs of meals, transportation, rental of facilities, and other items incidental to such meetings or conferences.

45 CFR 74,
Appendix E(IX)(B)(21) -- Organization costs. Expenditures
such as incorporation fees, attorneys' fees, accountants' fees,
brokers' fees, fees to promoters and organizers in connection with
(a) organization or reorganization of a hospital, or (b) raising
capital, are unallowable.

45 CFR 74,
Appendix E(IX)(B)(22) -- Other business expenses. Included
in this item are such recurring expenses as registry and transfer
charges resulting from changes in ownership of securities issued by
the hospital, cost of shareholders meetings preparation and
publication of reports to shareholders, preparation and submission
of required reports and forms to taxing and other regulatory bodies,
and incidental costs of directors and committee meetings. The above
and similar costs are allowable when allocated on an equitable
basis.

45 CFR 74,
Appendix E(IX)(B)(23) -- Patient care. The cost of routine
and ancillary or special services to research patients is an
allowable direct cost of research agreements.

45 CFR 74,
Appendix E(IX)(B)(23)(a) -- Routine services shall include
the costs of the regular room, dietary and nursing services, minor
medical and surgical supplies and the use of equipment and
facilities for which a separate charge is not customarily made.

45 CFR 74,
Appendix E(IX)(B)(23)(b) -- Ancillary or special services
are the services for which charges are customarily made in addition
to routine services, such as operating rooms, anesthesia,
laboratory, BMR-EKG, etc.

45 CFR 74,
Appendix E(IX)(B)(23)(c) -- Patient care, whether expressed
as a rate or an amount, shall be computed in a manner consistent
with the procedures used to determine reimbursable costs under Pub.
L. 89-97 (Medicare Program) as defined under the "Principles Of
Reimbursement For Provider Costs" published by the Social Security
Administration of the Department of Health and Human Services. The
allowability of specific categories of cost shall be in accordance
with those principles rather than the principles for research
contained herein. In the absence of participation in the Medicare
program by a hospital, all references to the Medicare program in
these principles shall be construed as meaning the Medicaid program.

45 CFR
74, Appendix E(IX)(B)(23)(c)(i-iii) --
- Once costs have been recognized as allowable, the indirect costs or general service center's cost shall be allocated (stepped-down) to special service centers, and all patient and nonpatient costs centers based upon actual services received or benefiting these centers.
- After allocation, routine and ancillary costs shall be apportioned to scatter-bed research patients on the same basis as is used to apportion costs to Medicare patients, i.e. using either the departmental method or the combination method, as those methods are defined by the Social Security Administration; except that final settlement shall be on a grant-by-grant basis. However, to the extent that the Social Security Administration has recognized any other method of cost apportionment, that method generally shall also be recognized as applicable to the determination of research patient care costs.
- A cost center must be established on Medicare reimbursement forms for each discrete-bed unit grant award received by a hospital. Routine costs should be stepped-down to this line item(s) in the normal course of stepping-down costs under Medicare/Medicaid requirements. However, in stepping-down routine costs, consideration must be given to preventing a step-down of those costs to discrete-bed unit line items that have already been paid for directly by the grant, such as bedside nursing costs. Ancillary costs allocable to research discrete-bed units shall be determined and proposed in accordance with Section 23.c.ii.

45 CFR 74,
Appendix E(IX)(B)(23)(d) -- Where federally sponsored
research programs provide specifically for the direct reimbursement
of nursing, dietary, and other services, appropriate adjustment must
be made to patient care costs to preclude duplication and/or
misallocation of costs.

45 CFR 74,
Appendix E(IX)(B)(24) -- Patent costs. Costs of preparing
disclosures, reports and other documents required by the research
agreement and of searching the art to the extent necessary to make
such invention disclosures are allowable. In accordance with the
clauses of the research agreement relating to patents, costs of
preparing documents and any other patent costs, in connection with
the filing of a patent application where title is conveyed to the
Government, are allowable. (See also paragraph IX-B.36.)

45 CFR 74,
Appendix E(IX)(B)(25) -- Pension plan costs. Costs of the
hospital's pension plan which are incurred in accordance with the
established policies of the institution are allowable, provided such
policies meet the test of reasonableness and thmethods of cost
allocation are not discriminatory, and provided appropriate
adjustments are made for credits or gains arising out of normal and
abnormal employee turnover or any other contingencies that can
result in forfeitures by employees which inure to the benefit of the
hospital.

45 CFR 74,
Appendix E(IX)(B)(26) -- Plan security costs. Necessary
expenses incurred to comply with government security requirements
including wages, uniforms and equipment of personnel engaged in
plant protection are allowable.

45 CFR 74,
Appendix E(IX)(B)(27) -- Preresearch agreement costs. Costs
incurred prior to the effective date of the research agreement,
whether or not they would have been allowable thereunder if incurred
after such date, are unallowable unless specifically set forth and
identified in the research agreement.

45 CFR 74,
Appendix E(IX)(B)(28) -- Professional services costs.

45 CFR 74,
Appendix E(IX)(B)(28)(a) -- Costs of professional services
rendered by the members of a particular profession who are not
employees of the hospital are allowable subject to (b) and (c) below
when reasonable in relation to the services rendered and when not
contingent upon recovery of the costs from the Government. Retainer
fees to be allowable must be reasonably supported by evidence of
services rendered.

45 CFR 74,
Appendix E(IX)(B)(28)(b) -- Factors to be considered in
determining the allowability of costs in a particular case include
- the past pattern of such costs, particularly in the years prior
to the award of government research agreements on the institution's
total activity;
- the nature and scope of managerial services
expected of the institution's own organizations; and
- whether the
proportion of government work to the hospital's total activity is
such as to influence the institution in favor of incurring the cost,
particularly where the services rendered are not of a continuing
nature and have little relationship to work under government
research agreements.

45 CFR 74,
Appendix E(IX)(B)(28)(c) -- Costs of legal, accounting and
consulting services, and related costs incurred in connection with
organization and reorganization or the prosecution of claims against
the Government are unallowable. Costs of legal, accounting and
consulting services, and related costs incurred in connection with
patent infringement litigation are unallowable unless otherwise
provided for in the research agreement.

45 CFR 74,
Appendix E(IX)(B)(29) -- Profits and losses on disposition
of plant equipment, or other assets. Profits or losses of any nature
arising from the sale or exchange of plant, equipment, or other
capital assets, including sales or exchange of either short- or
long-term investments, shall be excluded in computing research
agreement costs.

45 CFR 74,
Appendix E(IX)(B)(30) -- Proposal costs. Proposal costs are
the costs of preparing bids or proposals on potential government and
non-government research agreements or projects, including the
development of technical data and cost data necessary to support the
institution's bids or proposals. Proposal costs of the current
accounting period of both successful and unsuccessful bids and
proposals normally should be treated as indirect costs and allocated
currently to all activities of the institution, and no proposal
costs of past accounting periods will be allocable in the current
period to the government research agreement. However, the
institution's established practices may be to treat proposal costs
by some other recognized method. Regardless of the methods used, the
results obtained may be accepted only if found to be reasonable and
equitable.

45 CFR 74,
Appendix E(IX)(B)(31) -- Public information services costs.
Costs of news releases pertaining to specific research or scientific
accomplishment are unallowable unless specifically authorized by the
sponsoring agency.

45 CFR 74,
Appendix E(IX)(B)(32) -- Rearrangement and alteration
costs. Costs incurred for ordinary or normal rearrangement and
alteration of facilities are allowable. Special rearrangement and
alteration costs incurred specifically for a project are allowable
only as a direct charge when such work has been approved in advance
by the sponsoring agency concerned.

45 CFR 74,
Appendix E(IX)(B)(33) -- Reconversion costs. Costs incurred
in the restoration or rehabilitation of the institution's facilities
to approximately the same condition existing immediately prior to
commencement of government research agreement work, fair wear and
tear excepted, are allowable.

45 CFR 74,
Appendix E(IX)(B)(34) -- Recruiting costs.

45 CFR 74,
Appendix E(IX)(B)(34)(a) -- Subject to (b), (c), and (d)
below, and provided that the size of the staff recruited and
maintained is in keeping with workload requirements, costs of "help
wanted" advertising, operating costs of an employment office
necessary to secure and maintain an adequate staff, costs of
operating an aptitude and educational testing program, travel costs
of employees while engaged in recruiting personnel, travel costs of
applicants for interviews for prospective employment, and relocation
costs incurred incident to recruitment of new employees are
allowable to the extent that such costs are incurred pursuant to a
well managed recruitment program. Where an institution uses
employment agencies, costs not in excess of standard commercial
rates for such services are allowable.

45 CFR 74,
Appendix E(IX)(B)(34)(b) -- In publications, costs of help
wanted advertising that includes color, includes advertising
material for other than recruitment purposes, or is excessive in
size (taking into consideration recruitment purposes for which
intended and normal institutional practices in this respect) are
unallowable.

45 CFR 74,
Appendix E(IX)(B)(34)(c) -- Costs of help wanted
advertising, special emoluments; fringe benefits, and salary
allowances incurred to attract professional personnel from other
institutions that do not meet the test of reasonableness or do not
conform with the established practices of the institution are
unallowable.

45 CFR 74,
Appendix E(IX)(B)(34)(d) -- Where relocation costs incurred
incident to recruitment of a new employee have been allowed either
as an allocable direct or indirect cost, and the newly hired
employee resigns for reasons within his control within twelve months
after hire, the institution will be required to refund or credit
such relocations costs as were charged to the Government.

45 CFR 74,
Appendix E(IX)(B)(35) -- Rental costs (including sale and
lease-back of facilities).

45 CFR 74,
Appendix E(IX)(B)(35)(a) -- Rental costs of land, building,
and equipment and other personal property are allowable if the rates
are reasonable in light of such factors as rental costs of
comparable facilities and market conditions in the area, the type,
life expectancy, condition, and value of the facilities leased,
options available, and other provisions of the rental agreement.
Application of these factors, in situations where rentals are
extensively used, may involve among other considerations comparison
of rental costs with the amount which the hospital would have
received had it owned the facilities.

45 CFR 74,
Appendix E(IX)(B)(35)(b) -- Charges in the nature of rent
between organizations having a legal or other affiliation or
arrangement such as hospitals, medical schools, foundations, etc.,
are allowable to the extent such charges do not exceed the normal
costs of ownership such as depreciation, taxes, insurance, and
maintenance, provided that no part of such costs shall duplicate any
other allowed costs.

45 CFR 74,
Appendix E(IX)(B)(35)(c) -- Unless otherwise specifically
provided in the agreement, rental costs specified in sale and
lease-back agreements incurred by hospitals through selling plant
facilities to investment organizations such as insurance companies
or to private investors, and concurrently leasing back the same
facilities are allowable only to the extent that such rentals do not
exceed the amount which the hospital would have received had it
retained legal title to the facilities.

45 CFR
Appendix E(IX)(B)(36) -- Royalties and other costs for use
of patents. Royalties on a patent or amortization of the cost of
acquiring a patent or invention or rights thereto necessary for the
proper performance of the research agreement and applicable to tasks
or processes thereunder are allowable unless the Government has a
license or the right to free use of the patent, the patent has been
adjudicated to be invalid, or has been administratively determined
to be invalid, the patent is considered to be unenforceable, or the
patent has expired.

45 CFR
Appendix E(IX)(B)(37) -- Severance pay.

45 CFR
Appendix E(IX)(B)(37)(a) -- Severance pay is compensation
in addition to regular salaries and wages which is paid by a
hospital to employees whose services are being terminated. Costs of
severance pay are allowable only to the extent that such payments
are required by law, by employer-employee agreement, by established
policy that constitutes in effect an implied agreement on the
institution's part, or by circumstances of the particular
employment.

45 CFR
Appendix E(IX)(B)(37)(b) -- Severance payments that are due
to normal, recurring turnover, and which otherwise meet the
conditions of (a) above may be allowed provided the actual costs of
such severance payments are regarded as expenses applicable to the
current fiscal year and are equitably distributed among the
institution's activities during that period.

45 CFR
Appendix E(IX)(B)(37)(c) -- Severance payments that are due
to abnormal or mass terminations are of such conjectural nature that
allowability must be determined on a case-by-case basis. However,
the Government recognizes its obligation to participate to the
extent of its fair share in any specific payment.

45 CFR
Appendix E(IX)(B)(38) -- Specialized service facilities
operated by a hospital.

45 CFR
Appendix E(IX)(B)(38)(a) -- The costs of institutional
services involving the use of highly complex and specialized
facilities such as electronic computers and reactors are allowable
provided the charges therefor meet the conditions of (b) or c)
below, and otherwise take into account any items of income or
federal financing that qualify as applicable credits under paragraph
III-E.

45 CFR
Appendix E(IX)(B)(38)(b) -- The costs of such hospital
services normally will be charged directly to applicable research
agreements based on actual usage or occupancy of the facilities at
rates that (1) are designed to recover only actual costs of
providing such services, and (2) are applied on a nondiscriminatory
basis as between organized research and other work of the hospital
including commercial or accommodation sales and usage by the
hospital for internal purposes. This would include use of such
facilities as radiology, laboratories, maintenance men used for a
special purpose, medical art, photography, etc.

45 CFR
Appendix E(IX)(B)(38)(c) -- In the absence of an acceptable
arrangement for direct costing as provided in (b) above, the costs
incurred for such institutional services may be assigned to research
agreements as indirect costs, provided the methods used achieve
substantially the same results. Such arrangements should be worked
out in coordination with all government users of the facilities in
order to assure equitable distribution of the indirect costs.

45 CFR
Appendix E(IX)(B)(39) -- Special administrative costs.
Costs incurred for general public relations activities, catalogs,
alumni activities, and similar services are unallowable.

45 CFR
Appendix E(IX)(B)(40) -- Staff and/or employee
benefits.

45 CFR
Appendix E(IX)(B)(40)(a) -- Staff and/or employee benefits
in the form of regular compensation paid to employees during periods
of authorized absences from the job such as for annual leave, sick
leave, military leave and the like are allowable provided such costs
are absorbed by all hospital activities including organized research
in proportion to the relative amount of time or effort actually
devoted to each.

45 CFR
Appendix E(IX)(B)(40)(b) -- Staff benefits in the form of
employer contributions or expenses for Social Security taxes,
employee insurance, Workmen's Compensation insurance, the Pension
Plan (see paragraph IX-B.25), hospital costs or remission of
hospital charges to the extent of costs for individual employees or
their families, and the like are allowable provided such benefits
are granted in accordance with established hospital policies, and
provided such contributions and other expenses whether treated as
indirect costs or an increment of direct labor costs are distributed
to particular research agreements and other activities in a manner
consistent with the pattern of benefits accruing to the individuals
or groups of employees whose salaries and wages are chargeable to
such research agreements and other activities.

45 CFR
Appendix E(IX)(B)(41) -- Taxes.

45 CFR
Appendix E(IX)(B)(41)(a) -- In general, taxes which the
hospital is required to pay and which are paid or accrued in
accordance with generally accepted accounting principles, and
payments made to local governments in lieu of taxes which are
commensurate with the local government services received are
allowable except for
- taxes from which exemptions are available
to the hospital directly or which are available to the hospital
based on an exemption afforded the Government and in the latter case
when the sponsoring agency makes available the necessary exemption
certificates,
- special assessments on land which represent
capital improvements, and
- Federal Income Taxes.

45 CFR 74,
Appendix E(IX)(B)(41)(b) -- Any refund of taxes, interest,
or penalties, and any payment to the hospital of interest thereon
attributable to taxes, interest or penalties, which were allowed as
research agreement costs will be credited or paid to the Government
in the manner directed by the Government provided any interest
actually paid or credited to a hospital incident to a refund of tax,
interest, and penalty will be paid or credited to the Government
only to the extent that such interest accrued over the period during
which the hospital had been reimbursed by the Government for the
taxes, interest, and penalties.

45 CFR 74,
Appendix E(IX)(B)(42) -- Transportation costs. Costs
incurred for inbound freight, express, cartage, postage and other
transportation services relating either to goods purchased, in
process, or delivered are allowable. When such costs can readily be
identified with the items involved, they may be charged directly as
transportation costs or added to the cost of such items. Where
identification with the material received cannot readily be made,
inbound transportation costs may be charged to the appropriate
indirect cost accounts if the institution follows a consistent
equitable procedure in this respect. Outbound freight, if
reimbursable under the terms of the research agreement, should be
treated as a direct cost.

45 CFR 74,
Appendix E(IX)(B)(43) -- Travel costs.

45 CFR 74,
Appendix E(IX)(B)(43)(a) -- Travel costs are the expenses
for transportation, lodging, subsistence, and related items incurred
by employees who are in travel status on official business of the
hospital. Such costs may be charged on an actual basis, on a per
diem or mileage basis in lieu of actual costs incurred, or on a
combination of the two provided the method used is applied to an
entire trip and not to selected days of the trip, and results in
charges consistent with those normally allowed by the institution in
its regular operations.

45 CFR 74,
Appendix E(IX)(B)(43)(b) -- Travel costs are allowable
subject to (c) and (d) below when they are directly attributable to
specific work under a research agreement or when they are incurred
in the normal course of administration of the hospital or a
department or research program thereof.

45 CFR 74,
Appendix E(IX)(B)(43)(c) -- The difference in cost between
first class air accommodations and less than first class air
accommodations is unallowable except when less than first class air
accommodations are not reasonably available to meet necessary
mission requirements such as where less than first class
accommodations would
- require circuitous routing,
- require
travel during unreasonable hours,
- greatly increase the duration
of the flight,
- result in additional costs which would offset the
transportation savings, or
- offer accommodations which are not
reasonably adequate for the medical needs of the traveler.

45 CFR 74,
Appendix E(IX)(B)(43)(d) -- Costs of personnel movements of
a special or mass nature are allowable only when authorized or
approved in writing by the sponsoring agency or its authorized
representative.

45 CFR 74,
Appendix E(IX)(B)(44) -- Termination costs applicable to
contracts.

45 CFR 74,
Appendix E(IX)(B)(44)(a) -- Contract terminations generally
give rise to the incurrence of costs or to the need for special
treatment of costs which would not have arisen had the contract not
been terminated. Items peculiar to termination are set forth below.
They are to be used in conjunction with all other provisions of
these principles in the case of contract termination.

45 CFR 74,
Appendix E(IX)(B)(44)(b) -- The cost of common items of
material reasonably usable on the hospital's other work will not be
allowable unless the hospital submits evidence that it could not
retain such items at cost without sustaining a loss. In deciding
whether such items are reasonably usable on other work of the
institution, consideration should be given to the hospital's plans
for current scheduled work or activities including other research
agreements. Contemporaneous purchases of common items by the
hospital will be regarded as evidence that such items are reasonably
usable on the hospital's other work. Any acceptance of common items
as allowable to the terminated portion of the contract should be
limited to the extent that the quantities of such items on hand, in
transit, and on order are in excess of the reasonable quantitative
requirement of other work.

45 CFR 74,
Appendix E(IX)(B)(44)(c) -- If in a particular case,
despite all reasonable efforts by the hospital, certain costs cannot
be discontinued immediately after the effective date of termination,
such costs are generally allowable within the limitations set forth
in these principles, except that any such costs continuing after
termination due to the negligent or willful failure of the hospital
to discontinue such costs will be considered unacceptable.

45 CFR 74,
Appendix E(IX)(B)(44)(d) -- Loss of useful value of special
tooling and special machinery and equipment is generally allowable,
provided
- such special tooling, machinery or equipment is not
reasonably capable of use in the other work of the hospital;
- the
interest of the Government is protected by transfer of title or by
other means deemed appropriate by the contracting officer; and
- the loss of useful value as to any one terminated contract is
limited to that portion of the acquisition cost which bears the same
ratio to the total acquisition cost as the terminated portion of the
contract bears to the entire terminated contract and other
government contracts for which the special tooling, special
machinery or equipment was acquired.

45 CFR 74,
Appendix E(IX)(B)(44)(e) -- Rental costs under unexpired
leases are generally allowable where clearly shown to have been
reasonably necessary for the performance of the terminated contract,
less the residual value of such leases, if
- the amount of such rental claimed does not exceed the reasonable use value of the property leased for the period of the contract and such further period as may be reasonable; and
- the hospital makes all reasonable efforts to terminate, assign, settle, or otherwise reduce the cost of such lease. There also may be included the cost of alterations of such leased property, provided such alterations were necessary for the performance of the contract and of reasonable restoration required by the provisions of the lease.

45 CFR 74,
Appendix E(IX)(B)(44)(f) -- Settlement expenses including
the following are generally allowable:
- Accounting, legal,
clerical, and similar costs reasonably necessary for the preparation
and presentation to contracting officers of settlement claims and
supporting data with respect to the terminated portion of the
contract and the termination and settlement of subcontracts; and
- reasonable costs for the storage, transportation, protection, and
disposition of property provided by the Government or acquired or
produced by the institution for the contract.

45 CFR 74,
Appendix E(IX)(B)(44)(g) -- Subcontractor claims including
the allocable portion of claims which are common to the contract and
to other work of the contractor are generally allowable.

45 CFR 74,
Appendix E(IX)(B)(45) -- Voluntary services. The value of
voluntary services provided by sisters or other members of religious
orders is allowable provided that amounts do not exceed that paid
other employees for similar work. Such amounts must be identifiable
in the records of the hospital as a legal obligation of the
hospital. This may be reflected by an agreement between the
religious order and the hospital supported by evidence of payments
to the order.

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