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mendations under §§ 52h.7, 52h.9 and 1.10 within their respective agencies.

c. 215, 58 Stat. 690, as amended (42 U.S.C. ); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat. 3 (42 U.S.C. 2891-4))

FR 7862, Feb. 24, 1978, as amended at 45 35328, May 27, 1980; 49 FR 38111, Sept. 27, 4]

2h.4 Composition of peer review groups.

a) To the extent applicable, the seEftion and appointment of members of yer review groups and their terms of

vice will be governed by Chapter 9 of ce Department of Health and Human rvices General Administration Man1.1

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b) Subject to paragraph (a) of this tion, members will be selected based on their training and experience in evant scientific or technical fields, king into account, among other facrs:

(1) The level of formal scientific or chnical education completed or expeence acquired by the individual;

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(2) The extent to which the individ1 has engaged in relevant research, e capacities (e.g., principal investigar, assistant) in which the individual s done so, and the quality of such rearch;

(3) Recognition as reflected by vards and other honors received from ientific and professional organizareons outside the Department of Health Ad Human Services; and

(4) The need for the group to have inuded within its membership experts om various areas of specialization cithin relevant scientific or technical elds.

(c) Not more than one-fourth of the embers of any peer review group to hich these regulations are applicable hay be officers or employees of the nited States. For purposes of the preeding sentence, membership on such roups does not make an individual an fficer or employee of the United tates.

52h.5 Conflict of interest.

(a) Members of peer review groups overed by this part are subject to relvivant provisions in title 18 of the Unitid de, relating to criminal acstment of Health and

Human Services Standards of Conduct (45 CFR part 73), and Executive Order 11222, as amended.

(b) In addition to any restrictions imposed under paragraph (a) of this section:

(1) No member of a peer review group may participate in or be present during any review by said group of a grant application, contract project, or contract proposal in which, to the member's knowledge, any of the following has a financial interest: (i) The member or his or her spouse, parent, child, or partner, (ii) any organization in which the member or his or her spouse, parent, child, or partner is serving as an officer, director, trustee, partner, or employee, or is otherwise similarly associated, or (iii) any organization with which the member or his or her spouse, parent, child, or partner is negotiating or has any arrangement concerning prospective employment or other similar association.

(2) In the event any member of a peer review group or his or her spouse, parent, child, or partner is currently or expected to be the principal investigator or member of the staff responsible for carrying out any research or development activities contemplated as part of a grant application, contract project, or contract proposal, that group is disqualified and the review will be conducted by another group with the expertise to do so. If there is no other group with the requisite expertise, the review will be conducted by an ad hoc group no more than 50 percent of whose members may be from the disqualified group. The composition of any such ad hoc group will be determined in accordance with § 52h.4(b) and §52h.4(c) of this part and, to the extent feasible, §52h.4(a) of this part.

(3) Where a member of a peer review group participates in or is present during:

(i) Development or review of a project approach or request for proposals by said group or

(ii) Review by said group under § 52h.10(b) or §52h.10(c), i.e. after the issuance of a request for proposals, no contract may thereafter be awarded as the result of such development or review to said member, his or her spouse,

parent, child, or partner or any organization in which the member, his or her spouse, parent, child, or partner was serving as officer, director, trustee, partner, or employee at the time of such development or review or with which the member, his or her spouse, parent, child, or partner was negotiating or had any arrangement concerning prospective employment at said time. (4) No member of a peer review group may participate in any review under this part of a specific grant application or contract project for which the member has had or is expected to have any other responsibility or involvement (whether preaward or postaward) as an officer or employee of the United States.

(c) Where permissible under the statutes, standards, and order cited in paragraph (a) of this section, the Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Administrator of the Health Resources and Services Administration, or their designees may waive the requirements in paragraph (b) of this section if he or she determines that there is no other practical means for securing appropriate expert advice on a particular grant application, contract project, or contract proposal.

(Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 315, 92 Stat. 3436 (42 U.S.C. 2891-4))

[43 FR 7862, Feb. 24, 1978, as amended at 45 FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, 1984]

§ 52h.6 Availability of information.

Transcripts, minutes, and other documents made available to or prepared for or by a peer review group will be available for public inspection and copying to the extent provided in the Freedom of Information Act (5 U.S.C. 552), the Federal Advisory Committee Act (5 U.S.C. App. I), the Privacy Act (5 U.S.C. 552a), and implementing Department of Health and Human Services regulations (45 CFR parts 5, 5b).

$52h.7 Grants; matters to be reviewed.

(a) No awarding official will make a grant based upon an application covered by this part unless the application

has been reviewed by a peer rea group in accordance with the p sions of this part and said group i made recommendations concerning scientific merit of such application! addition, where under applicable an awarding official is required to cure the approval or advice of a >> tional advisory council or board c cerning an application, said applie tion will not be considered by the com cil or board unless it has been review by a peer review group in accordan with the provisions of this part said group has made recommendatim concerning the scientific merit of application except where the count: board is the peer review group.

(b) Except to the extent other provided for by law, such recommend tions are advisory only and not bindi on the awarding official or national visory council or board.

§ 52h.8 Grants; review criteria.

In carrying out its review § 52h.7, the peer review group will ▸ into account, among other factors

(a) The significance and origin from a scientific or technical s point of the goals of the proposed? search;

(b) The adequacy of the methodolo proposed to carry out the research:

(c) The qualifications and experienc of the principal investigator and ♫ posed staff;

(d) The reasonable availability of > sources necessary to the research; (e) The reasonableness of the F posed budget and duration in relat to the proposed research; and

(f) Where an application involves tivities which could have an adverse fect upon humans, animals, or the vironment, the adequacy of the posed means for protecting against minimizing such effects.

§ 52h.9 Unsolicited contract proposals matters to be reviewed.

(a) No awarding official will award contract based upon an unsolicite contract proposal covered by this par unless the proposal has by a peer review grou with the provisions o ant to procedures se subpart 3-4.52) and sai

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ommendations concerning the sciific merit of such proposal.

b) Except to the extent otherwise vided for by law, such recommendans are advisory only and not binding the awarding official.

h.10 Contract projects involving solicited contract proposals; matters to be reviewed.

a) Subject to paragraph (b) of this stion, no awarding official will issue request for contract proposals with pect to a contract project involving icited contract proposals unless the ject concept has been reviewed by a or review group in accordance with

provisions of this part and said up has made recommendations conning the scientific merit of said cont. Where in the judgment of the arding official the project approach 3 been sufficiently well defined by time the review required by the eceding sentence is conducted, this view and the resulting recommendaons shall include the project apoach as well.

b) The awarding official may waive e requirements of paragraph (a) of is section for peer review before issug a request for contract proposals if determines that the accomplishents of essential program objectives ould otherwise be placed in jeopardy ld any further delay would clearly ot be in the best interest of the Govnment. The awarding official shall Decify in writing the grounds on which is determination is based. Under ich circumstances, the awarding offial will not award a contract based on le request for contract proposals uness the proposals received in response

the request have been reviewed by a eer review group and that group has nade recommendations concerning the cientific merit of the project concept nd of the approaches outlined in the roposals. The request for proposals ill indicate that the project concept as not been reviewed by a peer review Toup and that no award will be made ntil such review is conducted and recommendations made based on such re

Health Administration, the Administrator of the Health Resources and Service Administration, or their designees may identify individual contracts or classes of contracts which may not be awarded unless all pertinent contract proposals have been reviewed by a peer review group in accordance with the provisions of this part and that group has made recommendations concerning the scientific merit of the proposals.

(d) Except to the extent otherwise provided for by law, such recommendations are advisory only and not binding on the awarding official.

(Sec. 215, Public Health Service Act, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, Public Health Service Act, 88 Stat. 360, 89 Stat. 351, 92 Stat. 3436 (42 U.S.C. 2891-4); sec. 955(a), Pub. L. 97-35, 95 Stat. 590 (42 U.S.C. 300z-7(e))) [43 FR 7862, Feb. 24, 1978, as amended at 45 FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, 1984]

$52h.11 Contract projects and proposals; review criteria.

(a) In carrying out its review of a project concept under §52h.10(a) or § 52h.10(b), the peer review group will take into account, among other factors:

(1) The significance from a scientific or technical standpoint of the goals of the proposed research or development activity;

(2) The availability of the technology and other resources necessary to achieve these goals;

(3) The extent to which there are identified, practical uses for the anticipated results of the activity; and

(4) Where the review includes the project approach, the adequacy of the methodology to be utilized in carrying out the activity.

(b) In carrying out its review of unsolicited contract proposals under §52h.9, the peer review group will take into account, among other factors, those criteria in §52h.8 which are relevant to the particular proposals.

(c) In carrying out its review of solicited contract proposals under § 52h.10(c) the peer review group will evaluate each proposal in accordance with the criteria set forth in the request for proposals

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$52h.12

$52b.12 Applicability of other regulations.

The regulations in this part are in addition to, and do not supersede other regulations concerning grant applications, contract projects, or contract proposals appearing elsewhere in this title, title 41, or title 45 of the Code of Federal Regulations.

42 CFR Ch. I (10-1-95 Edi

or (2) beyond the period during whi any amount of a direct loan ma under sections 610 or 623 of the Act r any amount of a loan with respect t which a loan guarantee and intes subsidy has been provided under tions 623 and 624 of the Act remains u paid.

(b) Definitions. As used in this tion:

(1) The term facility includes pitals, facilities for long-term ca outpatient facilities, rehabilitation

PART 53-GRANTS, LOANS AND
LOAN GUARANTEES FOR CON-
STRUCTION AND MODERNIZA-
TION OF HOSPITALS AND MEDI-cilities, and public health centers,
CAL FACILITIES

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Subpart L-Services for Persons Unable to Pay; Community Service; Nondiscrimination.

§ 53.111 Services for persons unable to pay.

(a) Applicability. The provisions of this section apply to every applicant which heretofore has given or hereafter will give an assurance that it will make available a reasonable volume of services to persons unable to pay therefor but shall not apply to an applicant (1) for more than 20 years after the completion of construction of any facility with respect to which funds have been paid under section 606 of the Act

(2) The term applicant means an § plicant for, or recipient of, a grant loan guarantee or a loan under the (3) Fiscal year means the fiscal y of the applicant;

(4) The term operating costs means t actual operating costs of the applic for a fiscal year as determined in cordance with cost determination ciples and requirements under XVIII of the Social Security Ad U.S.C. 1395): Provided, That such ating costs" shall be determine the applicant's entire facility and all patients regardless of the sour payment for such care: And prost further, That in determining such p ating costs there shall be deducted t amount of all actual or estimated imbursements, as applicable, for ser ices received or to be received pursu to title XVIII and XIX of the Social & curity Act (42 U.S.C. 1395 and 1936);

(5) The term reasonable cost me the cost of providing services to a cific patient determined in accordan with the cost determination principle and requirements under title XVII the Social Security Act (42 U.S.C. I and subpart D of the regulations the under (20 CFR part 405,1 part 401 seq.);

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(6) The term uncompensated servi means services which are made av able to persons unable to pay there without charge or at a charge which less than the reasonable cost of su services. The level of such services measured by the difference between the red such persons for such reasonable cost 4.

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Reasonable volume of services to perunable to pay therefor means a of uncompensated services which s a need for such services in the served by an applicant and which thin the financial ability of such cant to provide.

Assurance. (1) Before an applicaunder this part is recommended by ate agency to the Secretary for apal, the State agency shall obtain ssurance from the applicant that LED will be made available in the fa127 or portion thereof to be coneted or modernized a reasonable me of services to persons unable to therefor. The requirement of an asence from an applicant shall be ed if the applicant demonstrates le satisfaction of the State agency, ect to subsequent approval by the etary, that such a requirement is feasible from a financial viewpoint. * Prior to recommending that such irement be waived, the State agenhall publish in a newspaper of gencirculation in the area served by applicant a notice of the request such waiver and invite public comt thereon, allowing not less than 30 3 therefor. All comments received be available for public inspection, shall be considered by the State acy in arriving at its recommenda1. Notice of the determination on request for waiver shall be given to interested persons and to the public re the approval of the Secretary is ght.

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shall be deemed in presumptive compliance with its assurance. In the case of a loan guarantee with interest subsidy or a direct loan guarantee be sold by the Secretary with an interest subsidy, the amount of Federal assistance shall include the total amount of the interest subsidy which the Secretary is, or will be, obligated to pay over the full life of the loan, as well as any other payments which the Secretary makes on behalf of the applicant in connection with the loan guarantee or the direct loan which has been sold.

(e) Compliance reports. (1) Each applicant shall, not later than 120 days after the end of a fiscal year, unless a longer period is approved by the State agency for good cause shown, file with the State agency a copy of its annual statement for such year as required by section 646 of the Act and §53.128(q), which shall set forth its operating costs.

(2) With respect to each fiscal year for which a level of uncompensated services has been established in accordance with this section, the annual statement shall also set forth the amount of uncompensated services provided in such year.

(i) The provision of a level of uncompensated services in such year which equals or exceeds the level established pursuant to paragraph (h) of this section for such year shall constitute compliance with the assurance.

(ii) If the level of services provided was less than the level of uncompensated services established pursuant to paragraph (h) of this section, the applicant shall submit with such statement: A justification therefor, showing that the provision of such lower level of un

1) Presumptive compliance guideline. applicant which, for a fiscal year, budgets for the support of, and kes available on request, uncompened services at a level not less than lesser of 3 percent of operating compensated services was reasonable

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under the circumstances; and a description of the steps it proposes to take to assure the availability and utilization of the level of uncompensated services to be established for the current fiscal year, which shall include an affirmative action plan, utilizing press re

le to each person so admitted serv- leases or other appropriate means as

the facility may desire to bring to the attention of the public the availability of such uncompensated services and the conditions of eligibility therefor.

(3) Each applicant shall file with its annual statement a copy of that por

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