by reason of the failure of such agency to make payments of principal and interest on a direct loan to such agency, the Secretary shall take into consideration the extent to which:

(a) The facility with respect to which the loan guarantee or direct loan was made will continue to be devoted by the applicant or other owner to use for the purpose for which it was constructed or another public or nonprofit purpose which will promote the purposes of the Act;

(b) There are reasonable assurances that for the remainder of the repayment period of the loan other public or non-profit facilities not previously utilized for the purpose for which the facility was constructed will be so utilized and are substantially equivalent in nature and extent for such purposes; and

(c) Such recovery would seriously curtail the provision of medical services to persons in need of such services in the area.

[37 FR 182, Jan. 6, 1972]

(a) Fees will be charged for the processing of requests for parity, and for major and minor modifications of the terms of documents evidencing and securing direct and guaranteed loans. In accordance with the requirements of the User Charge Statute, 31 U.S.C. 9701(b), the Secretary determines the amount of the application fee that must be submitted with each type of modification.

(1) As used in this section, a request for parity allows new debt to share lien position (i.e. collateral) with an existing Hill-Burton loan.

(2) As used in this section, a major modification is any modification involving the release of $100,000 or more of collateral; a corporate restructuring that involves a transfer of assets; master indenture requests; modifications to a sinking fund; defeasance requests and requests for additional secured indebtedness; and any, other modification that involves a comparably significant use of Department resources.

(3) As used in this section, a minor modification is any modification involving the release of less than $100,000 of collateral; an easement; and any other modification that involves a comparable use of Department resources.

(b) A request for modification is to be accompanied by a certified check or money order in the amount of the appropriate fee, payable to the U.S. Treasury. The fees for modification requests submitted on or after October 28, 1986 are as follows:

(1) $1,500 for a minor modification, (2) $4,500 for a major modification, and

(3) $5,500 for a request for parity.

(c) A submitter may withdraw its request for modification within 10 business days following its receipt and receive a refund of the fee.

(d) If the Secretary determines that a change in the amount of a fee is appropriate, the Department will issue a notice of proposed rulemaking in the FEDERAL REGISTER to announce the proposed amount.

[51 FR 39376, Oct. 28, 1986]

54a.508-54a.509 [Reserved] 548.510 Additional conditions.

Subparts A-D (Reserved)

Subpart E-Grants for National

Alcohol Research Centers

AUTHORITY: Sec. 504, 90 Stat. 1035 (42 U.S.C.

4588).

SOURCE: 44 FR 17921, Mar. 23, 1979, unless otherwise noted.

§ 54a.501 Applicability.

The regulations in this subpart apply to grants to develop, establish, and support centers for interdisciplinary research relating to alcoholism and other alcohol problems, as authorized by section 504 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act (42 U.S.C. 4588).

§ 54a.502 Definitions.

Terms not defined in this section shall have the same meaning as given them in §54a.102. As used in this subpart:

National Alcohol Research Center or Center means an institution engaged in long-term interdisciplinary research focused on a central theme relating to alcoholism and other alcohol problems.

§ 54a.503 Eligibility.

To be eligible for a grant under this subpart, an applicant must be:

(a) A public (except Federal) or nonprofit private institution which is or is affiliated with an institution (such as a university, medical center or research center) with the resources to sustain a long-term research program; and

(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, the Trust Territory of the Pacific Islands, or the Northern Mariana Islands.

§ 54a.504 Application.

(a) Each institution desiring a grant under this subpart shall submit an application in the form and manner and on or before such dates as the Secretary may from time to time require.1

1 Grant applications, instructions, and program guidelines may be obtained from the

(b) Each private institution which does not already have on file with the National Institute on Alcohol Abuse and Alcoholism evidence of nonprofit status must submit with its application acceptable proof of its status.

(c) In addition to any other pertinent information that the Secretary may require, each application shall set forth in detail:

(1) The personnel facilities, and other resources currently available to the applicant with which to initiate and maintain the proposed Center program;

(2) Any biomedical, behavioral, or social science research related to alcohol problems in which the applicant is currently engaged; the sources of funding for those activities; and the relationship of these activities to the proposed Center program;

(3) The central theme of the proposed interdisciplinary research program;

(4) A detailed 5-year plan for the proposed Center program which identifies the principal areas of proposed research, the relationship of each area of proposed research to the central theme of the proposed Center program, the disciplines to be involved, and plans for coordination among them;

(5) A detailed description of each separate research project for which funds are requested;

(6) The names and qualifications of the Center director and key staff members who would be responsible for conducting proposed activities of the Center;

(7) The opportunities that would be available for training;

(8) The organizational structure of the proposed Center and its relationship to the organizational structure of the applicant;

(9) The proposed project period (not to exceed 5 years); a detailed budget and justification of funds requested for core support as well as for each separate research project (not exceeding $1,000,000 in total in any year); and a list of other anticipated sources of support for all research activities at the applicant institution, both planned and ongoing, relevant to alcoholism and

Director of the National Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, MD 20857.

other alcohol problems (both those to be incorporated into the proposed Center program and those outside the Center);

(10) Proposed methods for monitoring and evaluating individual research activities and the overall Center program;

(11) To the extent not covered in the information submitted under the preceding paragraphs, the manner in which the requirements in § 54a.505 will be satisfied.

[44 FR 17921, Mar. 23, 1979, as amended at 45 FR 31095, May 12, 1980]

$54a.505 Program requirements.

In order to receive support under this subpart, an applicant must:

(a) Have the experience or capability to conduct, through biomedical, behavioral, social, and related disciplines, long-term research on alcoholism and other alcohol problems and to coordinate that research among such disciplines;

(b) Have available to its staff, facilities, and other resources with which to carry out the objectives of the proposed program;

(c) Have available to it sufficient laboratory facilities and reference services (including reference services that will afford access to scientific alcohol literature);

(d) Have facilities and personnel to provide training in the prevention and treatment of alcoholism and other alcohol problems;

(e) Have the capacity to train predoctoral and postdoctoral students for careers in research on alcoholism and other alcohol problems;

(f) Have the capacity to conduct courses on alcohol problems and research on alcohol problems for undergraduate and graduate students and for medical and osteopathic students and physicians;

(g) Provide assurances that the Center will be an identifable organizational unit of the applicant headed by a Center director resonsible for the Center program;

(h) Provide assurances that any significant changes in the Center's scientific activities or other activities will be made only with the prior approval of the Secretary; and

(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).

§ 54a.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 Cen

ter;

(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 a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of those awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In any case, a grant award shall not exceed $1 million in any fiscal year. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.

(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

(e) An initial 5-year project period may be extended by the Secretary for additional periods not in excess of 5 years each, after review of the operations of the grantee by an appropriate peer review group and with the Council's recommendation for approval, except that if an additional period of support involves only the expenditure of funds previously awarded, peer review and consultation with the Council are not required.

[44 FR 17921, Mar. 23, 1979, as amended at 45 FR 31095, May 12, 1980]

§ 54a.507 Expenditure of grant funds.

(a) Any funds granted under this subpart shall be expended solely for the purpose for which the funds were granted in accordance with the approved application and budget, the regulations on this part, the terms and conditions of the award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74, except that those funds may not be expended for trainee stipends, fees, or other expenses directly relating to training or for the purchase or rental of any land or the rental, purchase, construction, preservation, or repair of any building. For purposes of this paragraph, construction means the construction of new buildings, and the expansion, remodeling, and alteration of existing buildings, including architects' fees,

but not including the cost of acquisition of land or off-site improvements, and equipping new buildings and existing buildings, whether or not expanded, remodeled, or altered.1.

(b) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Secretary, provided a continuation award is made. If at any time during a budget period it becomes apparent to the Secretary that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for the period, the Secretary may adjust the amounts awarded by withdrawing the excess.

[44 FR 17921, Mar. 23, 1979, as amended at 45 FR 31095, May 12, 1980]

Act, as used in this part, means the Federal Mine Safety and Health Act of 1977, as amended (30 U.S.C. 801 et seq.).

Secretary means the Secretary of Health and Human Services and any other officer or empolyee of the Department of Health and Human Services to whom the authority involved has been delegated.

Miner or coal miner means any individual who works or has worked in or around a coal mine or coal preparation facility in the extraction or preparation of coal. The term also includes an individual who works or has worked in I coal mine construction or transportation in or around a coal mine, to the extent that the individual was exposed to coal dust as a result of employment.

55a.102 Who is eligible to apply for a Black Lung clinics grant?

Any State or public or private entity may apply for a grant under this part.

§55a.103 What criteria has HHS established for deciding which grant application to fund?

(a) The Secretary will give preference to a State, which meets the requirements of this part and applies for a grant under this part, over other applicants in that State.

(b) Within the limits of funds available for these purposes the Secretary may award grants to assist in the car

rying out of those programs which will in the Secretary's judgment best promote the purposes of section 427(a) of the Act, taking into account;

(1) The number of miners to be served and their needs; and

(2) The quality and breadth of services to be provided.

§ 55a.104 What confidentiality requirements must be met?

All information as to personal facts and circumstances obtained by the grantee's staff about recipients of services shall be held confidential and shall not be disclosed without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for audits with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.

55a.105 How must grantees carrry out their projects?

Grantees must carry out their projects in accordance with their applications and the provisions of this part. § 55a.106 Provision for waiver by the Secretary.

The Secretary may, for good cause shown, waive provisions of these regulations.

Other regulations which apply to the Black Lung Clinics Program include, but are not limited to, the following:

42 CFR part 50, subpart D-Public Health Service grant appeals procedure;

42 CFR part 50, subpart E-Maximum allowable cost for drugs;

45 CFR part 16-Procedures of the Departmental Grant Appeals Board;

45 CFR part 19-Limitations on payment or reimbursement for drugs;

45 CFR part 74-Administration of grants; 45 CFR part 75-Informal grant appeals procedures;

45 CFR part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of title VI of the Civil Rights Act of 1964;

45 CFR part 81-Practice and procedure for hearings under part 80;