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mendations under $8 52h.7, 529.9 and Human Services Standards of Conduct ..10 within their respective agencies. (45 CFR part 73), and Executive Order c. 215, 58 Stat. 690, as amended (42 U.S.C.
11222, as amended. 6 sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat.
(b) In addition to any restrictions im(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 may participate in or be present during
any review by said group of a grant ap2h.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 r 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 > 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
prospective employment or other simi1) The level of formal scientific or lar association. chnical education completed or expe- (2) In the event any member of a peer ince 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 1 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 arch;
of grant application, contract (3) Recognition reflected by project, or contract proposal, that Tards and other honors received from group is disqualified and the review ientific and professional organiza- will be conducted by another group uns outside the Department of Health with the expertise to do so. If there is d Human Services; and
no other group with the requisite ex4) The need for the group to have in- pertise, the review will be conducted by ided within its membership experts an ad hoc group no more than 50 perom various areas of specialization cent of whose members may be from .thin relevant scientific or technical the disqualified group. The composiolds.
tion of any such ad hoc group will be (c) Not more than one-fourth of the determined in accordance with embers of any peer review group to $52h.4(b) and 852h.4(c) of this part and, hich these regulations are applicable to the extent feasible, $52h.4(a) of this ay be officers or employees of the part. nited States. For purposes of the pre- (3) Where a member of a peer review ding sentence, membership on such group participates in or is present duroups does not make an individual an ing: ficer or employee of the United (i) Development or review of a projates.
ect approach or request for proposals
by said group or 26.5 Conflict of interest.
(ii) Review by said group under a) Members of peer review groups $52h.10(b) or 852h.10(c), i.e. after the isvered by this part are subject to rel- suance of a request for proposals, no ant provisions in title 18 of the Unit- contract may thereafter be awarded as State-ode, 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 r zation in which the member, his or her group in accordance with the i spouse, parent, child, or partner was sions of this part and said groo serving as officer, director, trustee, made recommendations concernin partner, or employee at the time of scientific merit of such applicatio such development or review or with addition, where under applicable which the member, his or her spouse, an awarding official is required 1 parent, child, or partner was negotiat- cure the approval or advice of 1 ing or had any arrangement concerning tional advisory council or board prospective employment at said time. cerning an application, said api
(4) No member of a peer review group tion will not be considered by the may participate in any review under cil or board unless it has been rev! this part of a specific grant application by a peer review group in accor 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 recommenda other responsibility or involvement concerning the scientific merit o (whether preaward or postaward) as an application except where the coun officer or employee of the United board is the peer review group. States.
(b) Except to the extent othe (c) Where permissible under the stat
provided for by law, such recomme utes, standards, and order cited in
tions are advisory only and not bir paragraph (a) of this section, the Direc
on the awarding official or nations tor of the National Institutes of
visory council or board. Health, the Administrator of the Alcohol, Drug Abuse, and Mental Health 352h.8 Grants; review criteria. Administration, the Administrator of
In carrying out its review : the Health Resources and Services Administration, or their designees may
$ 52h.7, the peer review group will
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 su 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 applica
(b) The adequacy of the methodol tion, contract project, or contract proposal.
proposed to carry out the research:
(c) The qualifications and expert (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 1 1984)
posed budget and duration in relsi
to the proposed research; and 852h.6 Availability of information.
(1) Where an application involves Transcripts, minutes, and other doc- tivities which could have an advers 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 agains 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 propos 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 awa ment of Health and Human Services contract based upon an unsolid regulations (45 CFR parts 5, 5b).
contract proposal covered by this
unless the proposal has br- reyle 852h.7 Grants; matters to be reviewed.
by a peer review grouy cord (a) No awarding official will make a with the provisions of grant based upon an application cov- ant to procedures set ered by this part unless the application subpart 3-4.52) and said
mmendations concerning the sci- Health Administration, the Adminisfic merit of such proposal.
trator of the Health Resources and ) Except to the extent otherwise Service Administration, or their desvided for by law, such recommenda- ignees may identify individual conis are advisory only and not binding tracts or classes of contracts which ihe awarding official.
may not be awarded unless all perti
nent contract proposals have been reb.10 Contract projects involving viewed by a peer review group in acsolicited contract proposals; mat- cordance with the provisions of this ters to be reviewed.
part and that group has made rec.) Subject to paragraph (b) of this ommendations concerning the scibion, no awarding official will issue entific merit of the proposals. equest for contract proposals with (d) Except to the extent otherwise pect to a contract project involving provided for by law, such recommendacited contract proposals unless the tions are advisory only and not binding ject concept has been reviewed by a on the awarding official. r review group in accordance with · provisions of this part and said
(Sec. 215, Public Health Service Act, 58 Stat. up has made recommendations con
690, as amended (42 U.S.C. 216); sec. 475, Pub
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), it. 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 s been sufficiently well defined by
(43 FR 7862, Feb. 24, 1978, as amended at 45 ► time the review required by the
FR 35328, May 27, 1980; 49 FR 38111, Sept. 27,
1984) ceding sentence is conducted, this riew and the resulting recommenda- 852h.11 Contract projects and proposins shall include the project ap- als; review criteria. pach as well. b) The awarding official may waive
(a) In carrying out its review of a = requirements of paragraph (a) of
project concept under $52h.10(a) or is section for peer review before issu
$52h.10(b), the peer review group will 5 a request for contract proposals if
take into account, among other facdetermines that the accomplish
tors: ents of essential program objectives
(1) The significance from a scientific vuld otherwise be placed in jeopardy
or technical standpoint of the goals of d any further delay would clearly
the proposed research or development t be in the best interest of the Gov- activity; ament. The awarding official shall
(2) The availability of the technology ecify in writing the grounds on which
and other resources necessary to is determination is based. Under
achieve these goals; ch circumstances, the awarding offi
(3) The extent to which there are al will not award a contract based on identified, practical uses for the anticie request for contract proposals un- pated results of the activity; and 38 the proposals received in response
(4) Where the review includes the the request have been reviewed by a project approach, the adequacy of the er review group and that group has methodology to be utilized in carrying ade recommendations concerning the out the activity. ientific merit of the project concept (b) In carrying out its review of unsod of the approaches outlined in the licited contract proposals under $52h.9, oposals. The request for proposals the peer review group will take into acll indicate that the project concept count, among other factors, those cris not been reviewed by a peer review teria in $52h.8 which are relevant to oup and that no award will be made the particular proposals. til such review is conducted and rec- (c) In carrying out its review of solicamendations made based on such re- ited contract proposals under $52h.10(c) ew.
the peer review group will evaluate (c) The Director of the National In- each proposal in accordance with the Itutes of Health, the Administontor criteris set forth in the request for prothe Alcohol, Drug Abuse and Mental pasals
4522.12 Applicability of other regalo or (2) beyond the period during ta' tions.
any amount of a direct loan The regulations in this part are in
under sections 610 or 623 of the Act, 1 addition to, and do not supersede other
any amount of a loan with respect to regulations concerning grant applica- which a loan guarantee and inters tions, contract projects, or contract subsidy has been provided under E proposals appearing elsewhere in this
tions 623 and 624 of the Act remains o title, title 41, or title 45 of the Code of paid. Federal Regulations.
(b) Definitions. As used in this e
tion: PART 53-GRANTS, LOANS AND
(1) The term facility includes by LOAN GUARANTEES FOR CON- pitals, facilities for long-term STRUCTION AND MODERNIZA. outpatient facilities, rehabilitation )
cilities, and public health centers, TION OF HOSPITALS AND MEDI
(2) The term applicant means 117 CAL FACILITIES
plicant for, or recipient of, a grant
loan guarantee or a loan under the 1 Subparts A-K (Reserved
(3) Fiscal year means the fiscal is Subpart 1-Services for Persons Unoble to
of the applicant; Pay; Community Service; Non
(4) The term operating costs means * discrimination
actual operating costs of the applis
for a fiscal year as determined in Sec.
cordance with cost determination 53.111 Services for persons unable to pay. ciples and requirements under 3 53.112 Nondiscrimination.
XVIII of the Social Security Ac 53.113 Community service.
U.S.C. 1395): Provided, That such Subpart M-(Reserved
ating costs" shall be determine
the applicant's entire facility 200 Subpart N-Loon Guarantees and Direct all patients regardless of the soura Loans
payment for such care: And pronk
further, That in determining such 53.154 Waiver of right of recovery.
ating costs there shall be deducted to 53.155 Modification of loans. 53.156 Fees for modification requests.
amount of all actual or estimated
imbursements, as applicable, for se AUTHORITY: Secs. 215, 603, 609, 621, 623, Pub- ices received or to be received purstar lic Health Service Act as amended, 58 Stat.
to title XVIII and XIX of the Socials 690, 78 Stat. 451 and 456, 84 Stat. 344 and 346 (42 U.S.C. 216, 291c, 2011, 2913–1 and 2913–3; 31
curity Act (42 U.S.C. 1395 and 1936); U.S.C. 9701).
(5) The term reasonable cost men
the cost of providing services to a Subparts A-K (Reserved)
cific patient determined in accordant
with the cost determination principle Subpart 1-Services for Persons the Social Security Act (42 U.S.C.EE
and requirements under title XVII Unable to Pay; Community and subpart D of the regulations then Service; Nondiscrimination. under (20 CFR part 405,1 part 401
seq.); $53.111 Services for persons unable to (6) The term uncompensated servi pay.
means services which are made av (a) Applicability. The provisions of able to persons unable to pay 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 our will give an assurance that it will services. The level of such services make available a reasonable volume of measured by the difference between services to persons unable to pay there- amor
red such persons for sad! for but shall not apply to an applicant se
reasonable com (1) for more than 20 years after the 01 completion of construction of any facility with respect to which funds have
IFR part 40 been paid under section 606 of the Act 528
reasonable volume of services to per- shall be deemed in presumptive complienable to pay therefor means a ance with its assurance. In the case of of uncompensated services which a loan guarantee with interest subsidy
a need for such services in the or a direct loan guarantee be sold by served by an applicant and which the Secretary with an interest subsidy, hin the financial ability of such the amount of Federal assistance shall ant to provide.
include the total amount of the interAssurance. (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 1, the State agency shall obtain payments which the Secretary makes surance from the applicant that on behalf of the applicant in connecwill be made available in the fa- tion with the loan guarantee or the di
or portion thereof to be con- rect loan which has been sold. ted or modernized a reasonable (e) Compliance reports. (1) Each appline of services to persons unable to cant shall, not later than 120 days after iherefor. The requirement of an as- the end of a fiscal year, unless a longer ace from an applicant shall be period is approved by the State agency 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 ect 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(q), leasible 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 zuch 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 1. Notice of the determination on pursuant to paragraph (h) of this secrequest for waiver shall be given to tion for such year shall constitute interested persons and to the public compliance with the assurance. ore the approval of the Secretary is (ii) If the level of services provided 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 ied 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 its 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 h person is unable to pay for needed year, which shall include an affirmavices and that it will make avail- tive action plan, utilizing press rele to each person so admitted serv- leases or other appropriate means as is provided by the facility without the facility may desire to bring to the arge or at a charge below reasonable attention of the public the availability st which does not exceed any such of such uncompensated services and rson's ability pay therefor as de- the conditions of eligibility therefor. mined in dance with criteria (3) Each applicant shall file with its ablished put to paragraph, annual statement a copy of that por