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tion of its adopted budget for the cur- billing must be accompanied by rent fiscal year relating to the support stantially the information require 7 of uncompensated services in such the posted notice under paragraph. year. Sach budget for uncompensated this section; and services sčall be based on the operating (ii) Such determination may be a costs of the applicant for the preceding after the provision of such servică fiscal year and shall give due cog- the case of a change in circumsta: nizance to probable increases in operat- as a result of the illness or injury ing costs. Except in the case of a cer- sioning such services (e.g., the tancation pursuant to paragraph (dx2) tient's financial condition has chan of this section, if the budget statement due to a loss of wages resulting does not conform to the presumptive the illness) or in case of insuran : compliance guideline, the applicant erage or other resources being shall submit with its statement.

than anticipated or the costs of (1) A justification therefor, showing

ices being greater than antics that such lower level of uncompensated

Further, in all cases where such services is reasonable under the cir

mination was not made prior cumstances, and

provision of services, such services. (ii) A plan to increase such uncom

not be included as uncompensated a pensated services to meet the presump

ices if any collection effort has a tive compliance guideline or such other

made other than the rendering : level of uncompensated services as may

permissible in the above exception have been established or as it requests the State agency to establish in ac

Provided, That such a determis

may be made at any time if they cordance with paragraph (h) of this sec

mination was hindered or delar tion.

reason of erroneous or incomp4 (4) The applicant shall also submit

formation furnished by or in De such additional reports related to com

the patient. pliance with its assurance as the State

(2) There shall be excluded frck agency may reasonably require. (5) Pending the establishment of a

computation of uncompensated

ices: level of uncompensated services for any fiscal year pursuant to paragraph

(i) Any amount which the app (h) of this section, the applicant shall,

has received, or is entitled to see in such fiscal year, provide a level of

from a third party insurer or ude services which is the higher of

governmental program; and (1) The level established for the pre

(ii) The reasonable cost of any ceding fiscal year (or if no such level

ices for which payment in whole has been established for such prior

part would be available under a gor year, the level of services provided in

mental program (e.g., Medicare such year) or

Medicaid) in which the applicani. (ii) The level proposed in its adopted though eligible to do so, does not budget for the current fiscal year. ticipate, but only to the extent of

(1) Qualifying services. (1) In determin- otherwise available payment. ing the amount of uncompensated serv- (8) Persons unable to pay for SETE ices provided by an applicant, there (1) The State agency shall set fort shall be included only those services its State plan, subject to approva provided to an individual with respect the Secretary, criteria for identit to whom the applicant has made a persons unable to pay for ser p written determination prior to the pro- which shall include persons who vision of such services that such indi- otherwise self-supporting but udabe" vidual is unable to pay therefor under pay the full charge for needed servas the criteria established pursuant to 42 Such criteria shall be based on the big CFR 53.111(g), except that:

lowing or similar factors: (1) Such determination may be made (i) The health and medical care le after the provision of such services in surance coverage, personal or farm. De the case of services provided on an income, the size of the patient's in the emergency basis: Provided, That when ily, and other financial obligations billing is made for such service, such resources of the patient or the faz com

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-lation to the reasonable cost of ervices;

Generally recognized standards of such as: The State standard for the medi- needy as determined for the pur3 of the Aid for Families with Deent Children program;

The current Social Security Adstration poverty income level;

The current Office of Economic rtunity Income Poverty Guideapplicable in the area; or ) Any other equivalent measures h are found by the Secretary to ide a reasonable basis for deterng an individual's ability to pay nedical and hospital services. # A copy of such criteria shall be ided by the applicant, upon ret, to any patient or former patient he applicant and to any person ing services from the applicant.

The State agency shall provide a en of such criteria to any person reiting it. -) Level of uncompensated services. (1)

State agency shall set forth in its e plan procedures for the deteration for each applicant of the 1 of uncompensated services which

stitutes a reasonable volume of rices to persons unable to pay thereprovided that in no event shall the l of uncompensated services estabced under this section exceed the sumptive compliance guideline. :) The State agency shall for the pose of making such determination, iew, and evaluate the annual stateat, the budget and the related docuats submitted by each applicant suant to paragraph (e) of this secn, by applying the following cri

ia: i) The financial status of the appliit, taking account of income from

sources, and its financial ability to vide uncompensated services; ii) The nature and quantity of servs provided by the applicant; iii) The need within the area served

the applicant for the provision, thout charge or at charge which is $8 than reasonable cost, for services

the nature provided or to be pro» ded by the applicant; and (iv) The extent and nature of joint or operative programs with other facili

ties for the provision of uncompensated services, and the extent and nature of outreach services directed to the needs of underserved areas.

(3) In accordance with its findings made after such review and evaluation, the State agency shall, within 60 days after receipt of the annual statement and related documents required by paragraph (e) of this section, for each fiscal year of an applicant which begins following the expiration of 90 days after the effective date of this regulation:

(i) Establish a level of uncompensated services for each applicant which may be equal to or less than the presumptive compliance guideline: Provided, That if the State agency determines, in accordance with paragraph (h)(2) of this section, that (a) there is a need in the area served by an applicant for a level of uncompensated services greater than the level proposed in the applicant's budget statement, and (0) the applicant is financially able to provide such greater level of uncompensated services, the State agency shall establish such greater level as the level applicable to the applicant; and

(11) Accept or modify a plan submitted pursuant to paragraph (e) of this section.

(4) The State agency shall notify the applicant in writing of the level of uncompensated services which it has established for the applicant for the fiscal year. At the time of notifying the applicant, the State agency shall also publish as a public notice in a newspaper of general circulation within the community served by the applicant the rate that has been established and a statement that the documents upon which the agency based its determination are available for public inspection at a location and time prescribed. In the case of the establishment by the State agency of a rate which is less than the presumptive compliance guideline, such notice shall also include a statement that persons wishing to object to the rate established may do so by writing to the State agency within 20 days after publication of the notice: Provided, That the applicant may object to any level established which is greater than the level pro

54a.508542.509 (Reserved)

(b) Each private institution of 542.510 Additional conditions.

does not already have on file with a b

National Institute on Alcohol Amate Subparts A-D (Reserved) and Alcoholism evidence of congrato

status must submit with its appin Subpart E-Grants for National tion acceptable proof of its status. Alcohol Research Centers (c) In addition to any other pertinent

information that the Secretary matt AUTHORITY: Sec. 504, 90 Stat. 1035 (42 U.S.C. quire, each application shall set to 4588).

in detail: SOURCE: 44 FR 17921, Mar. 23, 1979, unless (1) The personnel facilities, and a otherwise noted.

resources currently available to the

plicant with which to initiate $34a.501 Applicability,

maintain the proposed Center proge The regulations in this subpart apply (2) Any biomedical, behavioral, zi to grants to develop, establish, and cial science research related to alaus support centers for interdisciplinary problems in which the applicant iss research relating to alcoholism and rently engaged; the sources of food other alcohol problems, as authorized for those activities; and the relatu by section 504 of the Comprehensive Al- ship of these activities to the props cohol Abuse and Alcoholism Preven- Center program; tion, Treatment, and Rehabilitation (3) The central theme of the proper Act (42 U.S.C. 4588).

interdisciplinary research program

(4) A detailed 5-year plan for the 8649.502 Definitions.

posed Center program which ide Terms not defined in this section the principal areas of propose shall have the same meaning as given search, the relationship of each them in $54a.102. As used in this sub- proposed research to the centralt part:

of the proposed Center progras National Alcohol Research Center or disciplines to be involved, and pies Center means an institution engaged in coordination among them; long-term interdisciplinary research (5) A detailed description of each! focused on a central theme relating to arate research project for which 3 alcoholism and other alcohol problems. are requested;

(6) The names and qualification 8649.503 Eligibility.

the Center director and key staff of To be eligible for a grant under this bers who would be responsible for $ subpart, an applicant must be:

ducting proposed activities of the US (a) A public (except Federal) or non- ter; profit private institution which is or is (7) The opportunities that woul. affiliated with an institution (such as a available for training; university, medical center or research (8) The organizational structure center) with the resources to sustain a the proposed Center and its relat long-term research program; and ship to the organizational structur

(b) Located in a State, the District of the applicant; Columbia, Puerto Rico, the Virgin Is- (9) The proposed project period lands, Guam, American Samoa, the to exceed 5 years); a detailed bud Trust Territory of the Pacific Islands, and justification of funds requested or the Northern Mariana Islands.

core support as well as for each 8 54a.504 Application.

rate research project (not exceed (a) Each institution desiring a grant

$1,000,000 in total in any year); and under this subpart shall submit an ap- port for all research activities at * & plication in the form and manner and on or before such dates as the Sec

applicant institution, both planned ac

ongoing, relevant to alcoholism retary may from time to time require.1

Director Grant applications, instructions, and pro

ational Institute on Almaty Abuse


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olism, 5600 Fishers gram guidelines may be obt: from the Rocky


alcohol problems (both those to corporated into the proposed Cenrogram and those outside the Cen

Proposed methods for monitoring evaluating individual research acles and the overall Center pro* 1;

To the extent not covered in the "mation submitted under the pre18 paragraphs, the manner h the requirements in $54a.505 will tisfied.

(i) Establish a Program Advisory Committee, chaired by the Center director, to review and make recommendations to the Center director on the conduct of all activities of the Center. The Committee shall be composed of persons who are not associated with the Center (apart from their membership on the Committee).


17921, Mar. 23, 1979, as amended at 45 095, May 12, 1980)

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scene 506 Program requirements.

order to receive support under this art, an applicant must: Have the experience or capability induct, through biomedical, behav

social, and related disciplines, -term research on alcoholism and

alcohol problems and to coordi

that research among such disnes; ' 1.

) Have available to its staff, facili

and other resources with which to odry out the objectives of the proid program;

Have available to it sufficient labory facilities and reference sery(including reference services that afford access to scientific alcohol rature);

) Have facilities and personnel to Liride training in the prevention and

tment of alcoholism and other alol problems; ) Have the capacity to train loctoral and postdoctoral students careers in research on alcoholism

other alcohol problems; ) Have the capacity to conduct rses on alcohol probleins and re'ch on alcohol problems for underluate and graduate students and for ical and osteopathic students and icians; Provide assurances that the Cenvill be an identifable organiza1 unit of the applicant headed by ater director resonsible for the r program; Provide assurances that any sigat changes in the Center's sci

activities or other activities ? made only with the prior apof the Secretary; and

864a.506 Grant awards.

(a) Within the limits of funds available, the Secretary, after taking into account the comments of an appropriate peer review group, may award grants to applicants with proposed programs which have been recommended for approval by the council and will in his judgment best promote the purposes of section 504 of the Act, taking into consideration among other pertinent factors:

(1) The scientific and technical merit of the proposed program and its individual components;

(2) The qualifications and experience of the Center director and other key personnel;

(3) The extent to which the various components of the proposed research program would be coordinated into an interdisciplinary effort within the Center;

(4) The administrative and managerial capability of the applicant;

(5) The reasonableness of the proposed budget in relation to the proposed program;

(6) The adequacy of proposed methods for monitoring and evaluating the overall Center program and its components including proposed mechanisms for review of the Center's program by its Program Advisory Committee;

(7) The potential of the proposed Center to become a significant regional and national research resource; and

(8) The degree to which the application adequately provides for the requirements of $ 54a.505.

(b) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will not exceed 5 years.

(c) Generally the grant will initially be for one year and subsequent continuation awards will also be for one

year at a time. A grantee must submit but not including the cost of 55 a separate application to have the sup tion of land or off-site impropers port continued for each subsequent and equipping new buildings and a 55 year. Decisions regarding continuation ing buildings, whether or not eppan

55 awards and the funding level of those remodeled, or altered... awards will be made after consider- (b) Any balance of federally oup ation of such factors as the grantee's grant funds remaining unobligaz progress and management practices,

the grantee at the end of a bades and the availability of funds. In any riod may be carried forward to the case, a grant award shall not exceed $1

budget period, for use as prescribe million in any fiscal year. In all cases,

the Secretary, provided a contina, continuation awards require a deter- award is made. If at any time du mination by HHS that continued fund

budget period it becomes appares ing is in the best interest of the gov

the Secretary that the amount ! ernment.

eral funds awarded and available ? (d) Neither the approval of any appli

grantee for that period, includis cation nor the award of any grant commits or obligates the United States in

unobligated balance carried for

from prior periods, exceeds the any way to make any additional, sup

ee's needs for the period, the secrets plemental, continuation, or other

may adjust the amounts awarde award with respect to any approved ap withdrawing the excess. plication or portion of an approved application.

(44 FR 17921, Mar. 23, 1979, as ametėsi (e) An initial 5-year project period

FR 31095, May 12, 1980) may be extended by the Secretary for additional periods not in excess of 5

88642.508_542.509 (Reserved] years each, after review of the oper

$64a.510 Additional conditions ations of the grantee by an appropriate peer review group and with the Coun

The Secretary may with res cil's recommendation for approval, ex- any grant award impose ade cept that if an additional period of sup

conditions prior to or at the port involves only the expenditure of

any award when in his judgmedia funds previously awarded, peer review

conditions are necessary to as and consultation with the Council are protect advancement of the app not required.

program, the interest of public is

or the conservation of grant fund (44 FR 17921, Mar. 23, 1979, as amended at 45 FR 31095, May 12, 1980)

PART 550-PROGRAM GRAN $ 54a.507 Expenditure of grant funds. FOR BLACK LUNG CLINIC

(a) Any funds granted under this subpart shall be expended solely for the

Subpart A-General Provision purpose for which the funds were

Sec. granted in accordance with the ap

558.101 Definitions. proved application and budget, the reg- 562.102 Who is eligible to apply for si ulations on this part, the terms and Lung clinics grant? conditions of the award, and the appli- 55a.103 What criteria has HHS estabil cable cost principles prescribed by sub- for deciding which grant applicată part Q of 45 CFR part 74, except that

fund? those funds may not be expended for

55a.104 What confidentiality requires trainee stipends, fees, or other ex

must be met? penses directly relating to training or for the purchase or rental of any land

1 Section 504(b) of the Act provides the or the rental, purchase, construction,

the purposes of that paragraph the preservation, or repair of any building.

"construction" shall have the meaning For purposes of this paragraph, con

to it by section 702(2) of the Public Bed

Service Act (42 U.S.C. 292a). The above struction means the construction of

nition incorporates the language of te new buildings, and the expansion, re- 702(2) in effect on July 26, 1976, the este modeling, and alteration of existing the enact of section 504 by Pub. b buildings, including architects' fees, 371.

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