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imendations under $852h.7, 52h.9 and Human Services Standards of Conduct 1.10 within their respective agencies. (45 CFR part 73), and Executive Order
11222, as amended. c. 215, 58 Stat. 690, as amended (42 U.S.C. ); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat.
(b) In addition to any restrictions im3 (42 U.S.C. 2891-4))
posed under paragraph (a) of this sec
tion: FR 7862, Feb. 24, 1978, as amended at 45 35328, May 27, 1980; 49 FR 38111, Sept. 27,
(1) No member of a peer review group 4)
may participate in or be present during
any review by said group of a grant ap26.4 Composition of peer review plication, contract project, or contract groups.
proposal in which, to the member's a) To the extent applicable, the se- knowledge, any of the following has a tion and appointment of members of financial interest: (i) The member or er review groups and their terms of his or her spouse, parent, child, or vice will be governed by Chapter 9 of partner, (ii) any organization in which 3 Department of Health and Human the member or his or her spouse, parrvices General Administration Man- ent, child, or partner is serving as an 1.1
officer, director, trustee, partner, or b) Subject to paragraph (a) of this employee, or is otherwise similarly astion, members will be selected based sociated, or (iii) any organization with on their training and experience in which the member or his or her spouse, evant scientific or technical fields, parent, child, or partner is negotiating sing into account, among other fac- or has any arrangement concerning cs:
prospective employment or other simi1) The level of formal scientific or lar association. ohnical education completed or expe- (2) In the event any member of a peer ence acquired by the individual; review group or his or her spouse, par2) The extent to which the individ- ent, child, or partner is currently or
I has engaged in relevant research, expected to be the principal investigae capacities (e.g., principal investiga- tor or member of the staff responsible r, assistant) in which the individual for carrying out any research or devels done so, and the quality of such re- opment activities contemplated as part
of a grant application, contract (3) Recognition as reflected by project, or contract proposal, that vards and other honors received from group is disqualified and the review ientific and professional organiza- will be conducted by another group ons outside the Department of Health with the expertise to do so. If there is hd Human Services; and
no other group with the requisite ex(4) The need for the group to have in- pertise, the review will be conducted by uded within its membership experts an ad hoc group no more than 50 per
om various areas of specialization cent of whose members may be from ithin relevant scientific or technical the disqualified group. The composields.
tion of any such ad hoc group will be (c) Not more than one-fourth of the determined in accordance with lembers of any peer review group to $52h.4(b) and 852h.4(c) of this part and, Chich these regulations are applicable to the extent feasible, $52h.4(a) of this aay be officers or employees of the part. nited States. For purposes of the pre- (3) Where a member of a peer review eding sentence, membership on such group participates in or is present durroups does not make an individual an ing: fficer or employee of the United (i) Development or review of a projtates.
ect approach or request for proposals 52h.5 Conflict of interest.
by said group or
(ii) Review by said group under (a) Members of peer review groups $52h.10(b) or $52h.10(c), i.e. after the isovered by this part are subject to rel- suance of a request for proposals, no vant provisions in title 18 of the Unit- contract may thereafter be awarded as d St Code relating to criminal ac- the result of such development or re
artment of Health and view to said member, his or her spouse,
parent, child, or partner or any organi- has been reviewed by a peer re zation in which the member, his or her group in accordance with the pr spouse, parent, child, or partner was sions of this part and said group serving as officer, director, trustee, made recommendations concerning partner, or employee at the time of scientific merit of such application such development or review or with addition, where under applicable which the member, his or her spouse, an awarding official is required to parent, child, or partner was negotiat- cure the approval or advice of a ing or had any arrangement concerning tional advisory council or board prospective employment at said time. cerning an application, said app
(4) No member of a peer review group tion will not be considered by the co may participate in any review under cil or board unless it has been revise this part of a specific grant application by a peer review group in accorda or contract project for which the mem
with the provisions of this part = ber has had or is expected to have any said group has made recommendat other responsibility or involvement concerning the scientific merit of (whether preaward or postaward) as an
application except where the counc officer or employee of the United board is the peer review group. States.
(b) Except to the extent others (c) Where permissible under the stat
provided for by law, such recommes utes, standards, and order cited in
tions are advisory only and not bizt paragraph (a) of this section, the Direc
on the awarding official or natioca. tor of the National Institutes of
visory council or board. Health, the Administrator of the Alcohol, Drug Abuse, and Mental Health 862h.8 Grants; review criteria. Administration, the Administrator of
In carrying out its review the Health Resources and Services Ad
$ 52h.7, the peer review group wil: ministration, or their designees may
into account, among other factors waive the requirements in paragraph
(a) The significance and origin (b) of this section if he or she deter
from a scientific or technical D mines that there is no other practical means for securing appropriate expert
point of the goals of the proposed
search; advice on a particular grant application, contract project, or contract pro
(b) The adequacy of the methodois
proposed to carry out the research: posal.
(c) The qualifications and experte (Sec. 215, 58 Stat. 690, as amended (42 U.S.C. of the principal investigator and 216); sec. 475, 88 Stat. 360, 89 Stat. 315, 92 Stat.
posed staff; 3436 (42 U.S.C. 2891-4))
(d) The reasonable availability of: (43 FR 7862, Feb. 24, 1978, as amended at 45 sources necessary to the research; FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, (e) The reasonableness of the 1984)
posed budget and duration in relaps
to the proposed research; and $522.6 Availability of information.
(f) Where an application involves Transcripts, minutes, and other doc- tivities which could have an adverse uments made available to or prepared fect upon humans, animals, or the for or by a peer review group will be vironment, the adequacy of the available for public inspection and posed means for protecting against copying to the extent provided in the minimizing such effects. Freedom of Information Act (5 U.S.C. 552), the Federal Advisory Committee
852h.9 Unsolicited contract proposal Act (5 U.S.C. App. I), the Privacy Act (5
matters to be reviewed. U.S.C. 552a), and implementing Depart- (a) No awarding official will awards ment of Health and Human Services contract based upon an unsolicit regulations (45 CFR parts 5, 5b).
contract proposal covered by this per
unless the proposal has 852h.7 Grants; matters to be reviewed.
by a peer review gro" (a) No awarding official will make a with the provisions grant based upon an application cov- ant to procedures se ered by this part unless the application subpart 3-4.52) and sa.
ommendations concerning the sci- Health Administration, the Adminisific merit of such proposal.
trator of the Health Resources and b) Except to the extent otherwise Service Administration, or their desvided for by law, such recommenda- ignees may identify individual conns are advisory only and not binding tracts or classes of contracts which the awarding official.
may not be awarded unless all perti
nent contract proposals have been re2.10 Contract projects involving viewed by a peer review group in ac
solicited contract proposals; mat- cordance with the provisions of this * ters to be reviewed.
part and that group has made rec2) Subject to paragraph (b) of this ommendations concerning the sci
tion, no awarding official will issue entific merit of the proposals. * request for contract proposals with (d) Except to the extent otherwise pect to a contract project involving
provided for by law, such recommendaicited contract proposals unless the tions are advisory only and not binding Sibject concept has been reviewed by a
on the awarding official. or review group in accordance with
(Sec. 215, Public Health Service Act, 58 Stat. Do provisions of this part and said
690, as amended (42 U.S.C. 216); sec. 475, PubDe pup has made recommendations con
lic Health Service Act, 88 Stat. 360, 89 Stat. ning the scientific merit of said con
351, 92 Stat. 3436 (42 U.S.C. 2891-4); sec. 955(a), jst. Where in the judgment of the Pub. L. 97–35, 95 Stat. 590 (42 U.S.C. 3002–7(e))) - arding official the project approach
[43 FR 7862, Feb. 24, 1978, as amended at 45 :533 been sufficiently well defined by
FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, are the the time the review required by the
1984) sceding sentence is conducted, this rewiew and the resulting recommenda- 8526.11 Contract projects and propos
ons shall include the project ap- als; review criteria.
(a) In carrying out its review of a
project concept under $52h.10(a) or acabey be requirements of paragraph (a) of is section for peer review before issu
852h.10(b), the peer review group will
take into account, among other facats a request for contract proposals if
tors: determines that the accomplish
(1) The significance from a scientific Co dwents of essential program objectives ould otherwise be placed in jeopardy
or technical standpoint of the goals of ud any further delay would clearly
the proposed research or development
activity; Loretot be in the best interest of the Govnment. The awarding official shall
(2) The availability of the technology
and other resources necessary to Dle annecify in writing the grounds on which
achieve these goals; com sels determination is based. Under ich circumstances, the awarding offi
(3) The extent to which there are al will not award a contract based on identified, practical uses for the anticiare de request for contract proposals un
pated results of the activity; and
(4) Where the review includes the Jestia 5$ the proposals received in response
the request have been reviewed by a project approach, the adequacy of the meer review group and that group has methodology to be utilized in carrying
nade recommendations concerning the out the activity. cientific merit of the project concept (b) In carrying out its review of unsond of the approaches outlined in the licited contract proposals under $529.9,
roposals. The request for proposals the peer review group will take into acontos vill indicate that the project concept count, among other factors, those crie as not been reviewed by a peer review teria in $52h.8 which are relevant to na roup and that no award will be made the particular proposals.
intil such review is conducted and rec- (c) In carrying out its review of solicmmendations made based on such re- ited contract proposals under $52h.10(c) riew.
the peer review group will evaluate (c) The Director of the National In- each proposal in accordance with the
stitutes of Health, the Administrator altarin set forth in the request for proof the Alcohol, Drug Abuse and Mental Dos
152.12 Applicability of other regalo or (2) beyond the period during rt: tions.
any amount of a direct loan mat The regulations in this part are in under sections 610 or 623 of the Act : addition to, and do not supersede other any amount of a loan with respect a regulations concerning grant applica- which a loan guarantee and intes tions, contract projects, or contract subsidy has been provided under e proposals appearing elsewhere in this tions 823 and 624 of the Act remains title, title 41, or title 45 of the Code of paid. Federal Regulations.
(6) Definitions. As used in this e
tion: PART 53-GRANTS, LOANS AND
(1) The term facility includes bo LOAN GUARANTEES FOR CON- pitals, facilities for long-term en STRUCTION AND MODERNIZA- cilities, and public health centers,
outpatient facilities, rehabilitation to TION OF HOSPITALS AND MEDI
(2) The term applicant means us CAL FACILITIES
plicant for, or recipient of, a grant
loan guarantee or a loan under the Subparts A-K (Reserved
(3) Fiscal year means the fiscal
of the applicant; Subpart 1-Services for Persons Unable to
(4) The term operating costs means Pay; Community Service; Non actual operating costs of the applis discrimination
for a fiscal year as determined in Sec.
cordance with cost determination p 53.111 Services for persons unable to pay. ciples and requirements under 5 53.112 Nondiscrimination.
XVIII of the Social Security Act 53.113 Community service.
U.S.C. 1395): Provided, That such
ating costs" shall be determine
the applicant's entire facility 200 Subpart N-Loan Guarantees and Direct
all patients regardless of the sours Loans
payment for such care: And pro
further, That in determining such 53.154 Waiver of right of recovery.
ating costs there shall be deducted 53.155 Modification of loans.
amount of all actual or estimated 53.156 Fees for modification requests.
imbursements, as applicable, for ** AUTHORITY: Secs. 215, 603, 609, 621, 623, Pub- ices received or to be received purse lic Health Service Act as amended, 58 Stat. to title XVIII and XIX of the Social & 690, 78 Stat. 451 and 456, 84 Stat. 344 and 346
curity Act (42 U.S.C. 1395 and 1936); (42 U.S.C. 216, 291c, 2910, 2913–1 and 2911-3; 31
(5) The term reasonable cost med U.S.C. 9701).
the cost of providing services to a Subparts A-K (Reserved)
cific patient determined in accordant with the cost determination principis
and requirements under title XVIIS Subpart L-Services for Persons
the Social Security Act (42 U.S.C. 15 Unable to Pay; Community and subpart D of the regulations the Service; Nondiscrimination. under (20 CFR part 405,1 part 401
seq.); 853.111 Services for persons unable to
(6) The term uncompensated serpis pay.
means services which are made att (a) Applicability. The provisions of able to persons unable to pay there this section apply to every applicant without charge or at a charge which which heretofore has given or hereafter less than the reasonable cost of such will give an assurance that it will services. The level of such services make available a reasonable volume of measured by the difference between the
lo services to persons unable to pay there
d such persons for such for but shall not apply to an applicant
reasonable on (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 522
Reasonable volume of services to per- shall be deemed in presumptive compli- unable to pay therefot means a ance with its assurance. In the case of E of uncompensated services which a loan guarantee with interest subsidy -2.8 a need for such services in the or a direct loan guarantee be sold by E: served by an applicant and which the Secretary with an interest subsidy,
thin the financial ability of such the amount of Federal assistance shall cant to provide.
include the total amount of the inter2: Assurance. (1) Before an applica- est subsidy which the Secretary is, or
under this part is recommended by will be, obligated to pay over the full te agency to the Secretary for ap- life of the loan, as well as any other 21, the State agency shall obtain payments which the Secretary makes issurance from the applicant that on behalf of the applicant in connec
will be made available in the fa- tion with the loan guarantee or the di137 or portion thereof to be con- rect loan which has been sold.
sted or modernized a reasonable (e) Compliance reports. (1) Each applisme of services to persons unable to cant shall, not later than 120 days after therefor. The requirement of an as- the end of a fiscal year, unless a longer
an applicant shall be period is approved by the State agency s'ed if the applicant demonstrates for good cause shown, file with the
le satisfaction of the State agency, State agency a copy of its annual Czect to subsequent approval by the statement for such year as required by
etary, that such a requirement is section 646 of the Act and $53.128(a), feasible from a financial viewpoint. which shall set forth its operating
Prior to recommending that such costs. irement be waived, the State agen- (2) With respect to each fiscal year hall publish in a newspaper of gen- for which a level of uncompensated
circulation in the area served by services has been established in accordapplicant a notice of the request ance with this section, the annual such waiver and invite public com- statement shall also set forth the t thereon, allowing not less than 30 amount of uncompensated services pro3 therefor. All comments received vided in such year. 1 be available for public inspection, (i) The provision of a level of uncom
shall be considered by the State pensated services in such year which ncy in arriving at its recommenda- equals or exceeds the level established
pursuant to paragraph (h) of this sec13. Notice of the determination on
request for waiver shall be given to tion for such year shall constitute interested persons and to the public compliance with the assurance.
(ii) If the level of services provided SCBpre the approval of the Secretary is ght.
was less than the level of uncompen1) Presumptive compliance guideline. sated services established pursuant to applicant which, for a fiscal year, paragraph (h) of this section, the applibudgets for the support of, and cant shall submit with such statement: kes available on request, uncompen- A justification therefor, showing that ed services at a level not less than the provision of such lower level of un
lesser of 3 percent of operating compensated services was reasonable 3ts or 10 percent of all Federal assist- under the circumstances; and a descripce provided to or on behalf of the ap- tion of the steps it proposes to take to cant under the Act, or (2) certifies assure the availability and utilization at it will not exclude any person of the level of uncompensated services m admission on the ground that to be established for the current fiscal ch person is unable to pay for needed year, which shall include an affirmarvices and that it will make avail- tive action plan, utilizing press rele to each person so admitted serv- leases or other appropriate means as es provided by the facility without the facility may desire to bring to the large or at a charge below reasonable attention of the public the availability ist which does not exceed any such of such uncompensated services and son's ability pay therefor as de- the conditions of eligibility therefor. Fed in adance with criteria (3) Each applicant shall file with its
put to paragraphe annual statement a copy of that por