AUTHORITY: The provisions of this Part 52 issued under secs. 215, 58 Stat. 690, as amended, 301, 81 Stat. 504 (42 U.S.C. 216, 1857g). Secs. 301, 58 Stat. 691, as amended; 303, 70 Stat. 929; 304, 81 Stat. 534; 396, 70 Stat. 1063; 103, 81 Stat. 486; 204, 70 Stat. 998; 42 U.S.C. 241, 242a, 242b, 280b-6, 1857b, 3253; sec. 1205, 87 Stat. 597 (42 U.S.C. 300d-4). Reorganization Plan No. 3 of 1966, 31 FR 8855, 80 Stat. 1610; 3 CFR 1966 Comp.; Reorganization Orders and Delegations of Mar. 13, Apr. 1, 1968 (33 FR 4894, 5426) and Jan. 17, 1969 (34 FR 1279).

SOURCE: The provisions of this Part 52 appear at 28 F.R. 10420, Sept. 26, 1963, unless otherwise noted.

Subpart A Applicability and Definitions § 52.1

Applicability.

The regulations of this part apply to grants for the support of health related research projects as set forth in § 52.10. They do not apply to general research support grants, demonstration grants, or other grants as may be authorized by law, such as grants for the construction of research facilities (see Part 57 of this chapter), for the construction of hospital or other medical facilities (see Part 53 of this chapter), or the award of fellowships (see Part 61 of this chapter), traineeships (see Part 63 of this chapter), or training grants (see Part 64 of this chapter).

[39 FR 24231, July 1, 1974]

§ 52.2 Definitions.

As used in this part:

(a) "Secretary” means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved may be delegated.

(b) "Project period" means the period of time, not exceeding 7 years, which the Secretary finds is reasonably required to initiate and conduct a research project meriting support by means of one or more research project grants within the scope of 52.10, except that such period may be extended by the Secretary beyond 7 years solely to permit continuation or completion of the same approved project by use of funds previously awarded but remaining unencumbered by the grantee at the end of such 7 years. The project period may include the time required for initial staffing and acquisition of facilities and for the preparation and publication of the results of the project. The approval and support of a research project for the maximum project period shall not preclude additional support of that project beyond such period if such support of the continued project is requested, evaluated and approved on the same basis as a new or initial application in accordance with §§ 52.12 and 52.13.

(c) "Principal investigator" means a single individual designated by the grantee in the grant application and approved by the Secretary, who is responsible for the scientific and technical direction of the project.

[28 FR. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968; 35 F.R. 5469, Apr. 2, 1970]

Subpart B-Eligibility, Award and Termination

§ 52.10 Nature and purpose of research project grant.

A research project grant is the award by the Secretary of funds to an institution, organization or other person, hereinafter called the "grantee," to assist in meeting the costs of conducting for the benefit of the public health an identified activity or program, hereinafter termed the "project," that is intended and designed to establish, discover, develop, elucidate or confirm information or the underlying mechanisms relating to:

(a) The cause, diagnosis, treatment, control or prevention of the physical or

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(1) Emergency medical techniques, methods, devices, and delivery as authorized by section 1205 of the Public Health Service Act (42 UB.C. 300d-4). 135 FR 5459, Apr. 2, 1970, as amended at 39 FB 24281, July 1, 1974]

3. Any maróval sapeT, İNCİTunon agency IT THE FL jesti vita, tes fallet willfuly and materaly in the judgmen if the Secretary a congly WILL BEDIETE I Hater requireMENS applicable 2 SUCI DOT EVEČ BIG DSqualfeston a square in seminased

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e wakom the meaNOME OF § 52.10 stal be ebbie for a gas sverd Zingite propers may cœsis of laboresory, chimical population, field statistical basic, appled or obe types of inTESORERODE sudes a experiments, or comomamons there:f, and may either be Timmed to one, or a particular aspect of a problem or subject, or may consist of two or more related problems or subjects for comment or consecutive inTermgation and involving motiple disciplines, facilities and resources.

128 FR. 10420, Sept. 25, 1963, as amended st 38 FR. BEZ, July 8, 1958]

52.12 Application for grant.

Any person desiring a grant award under § 52.11 may fle application therefor with the Secretary on such forms as he may prescribe. Such application shall set forth the nature, duration, purpose, and plan of the research project, the name and qualifications of the principal investigator and the qualifications of the principal staff members to be responsible for the project, the total facilities and resources that will be available, a justification of the amount of grant funds requested, and such other pertinent information as the Secretary may require. The application shall be executed by an individual authorized to act for the institution or other applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of any award, including the regulations of this part.

[35 F.R. 5469, Apr. 2, 1970]

§ 52.13 Evaluation and disposition of applications.

(a) Evaluation. All applications filed in accordance with § 52.12 shall be evalu

ated by the Secretary through such officers and employees and such experts or consultants engaged for this purpose as he determines are specially qualified in the areas of research involved in the project, including review by an appropriate National Advisory Council or other body as may be required by law. The Secretary's evaluation shall take into account among other pertinent factors the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, and the adequacy of the applicant's resources available for the project and the amount of grant funds necessary for completion, and in the case of applications for support of research in emergency medical services, special consideration shall be given to applications for grants for research relating to the delivery of emergency medical services in rural areas.

(b) Disposition. On the basis of his evaluation of an application pursuant to paragraph (a) of this section and subject to such approvals, recommendations or consultations by the appropriate National Advisory Council or other body as may be required by law, the Secretary shall (1) approve, (2) defer because of either lack of funds or a need for further evaluation, or (3) disapprove support of the proposed project in whole or in part. With respect to approved projects, the Secretary shall determine the project period during which the project may be supported. Any deferral or disapproval of an application shall not preclude its reconsideration or a reapplication.

[28 FR. 10420, Sept. 26, 1963, as amended at 33 FR 9821, July 9, 1968; 39 FR 24231, July 1, 1974]

§ 52.14 Grant awards.

(a) General. Within the limits of funds available for such purpose, the Secretary shall award a grant to those applicants whose approved projects will in his judgment best promote the purposes of § 52.10. The date specified by the Secretary as the beginning of the project period shall be no later than 9 months following the date of any initial or new award statement unless the Secretary finds that because of the nature of a project or the grantee's particular circumstances earlier assurance of grant support is required to initiate the project. All

66-019-76- -15

grant awards shall be in writing, shall set forth the amount of funds granted, which may include an estimated provisional amount for indirect costs or for designated direct costs (such as hospital per diem rates or fringe benefit rates) subject to adjustment as set forth below, and shall constitute for such amounts the encumbrance of Federal funds available for such purpose on the date of the award. Within the limits of available funds, provisional amounts shall be subject to upward as well as downward adjustment to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary. All amounts awarded, whether provisional or otherwise, remain subject to accountability as provided under Subpart E of this part.

(b) Determination of award amount. The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or a designated portion of direct project costs (as set forth in §§ 52.31 and 52.33) for either the project period or for such lesser period as he may designate in making the award, plus an additional amount, if any, for overhead or indirect costs (as set forth in § 52.32). Neither the approval of any project nor a grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation or other award with respect to any approved project or portion thereof, but this provision shall not preclude the Secretary from making upward adjustments to actual costs as to amounts awarded on a provisional basis as provided in paragraph (a) of this section. (c) Multiple, concurrent, initial awards. Whenever a research project involves a number of different but related problems, activities or disciplines so as to require evaluation by different groups, or whenever support for a project could be more effectively administered by separate handling of separate aspects of the project, the Secretary may evaluate and approve two or more concurrent applications each dealing with one or more specified aspects of the project, and he may make two or more concurrent grant awards with respect to such a project.

(d) Supplemental and continuation awards. The Secretary may from time to time within the project period make additional grant awards with respect to any approved project continued without change except as provided in

(e) "Home health agency" means an entity which has a provider agreement with the Secretary pursuant to 20 CFR Part 405, Subpart F.

(f) "Home health services" are those items and services listed in Section 1861 (m) of the Social Security Act (42 U.S.C. 1395x(m)) provided by a home health agency.

(g) "Home health organization" means an agency or organization which intends to become a home health agency but which does not, at the time of application for a grant under this part, have a provider agreement with the Secretary.

(h) "Nonprofit" as applied to a private entity means an entity exempt from Federal income taxation under Section 501 of the Internal Revenue Code of 1954.

(i) "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved has been delegated.

(j) "State" means the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.

(k) "State agency" means the agency of a State which has an agreement with the Secretary under Section 1864(a) of the Social Security Act to certify agencies as home health agencies as defined in section 1861 (o) of that Act.

§ 51e.103 Eligibility.

(a) Eligible applicants. Any public or nonprofit private entity is eligible to apply for a grant under this subpart.

(b) Eligible projects. Grants to eligible applicants may be made by the Secretary for projects to meet the initial costs, including costs of compensating professional and paraprofessional personnel, of:

(1) Establishing and operating a home health agency which will provide home health services; or

(2) Expanding the home health services available through a home health agency by:

(i) Adding new home health services not previously provided by such agency; and/or

(ii) Enlarging the catchment area of the agency; and/or

(iii) Increasing the number of persons served within the present catchment area of the agency.

§ 51e.104 Applications.

(a) All applications. An approvable application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe and shall contain the following:

(1) A full and adequate description of the intended project and of the manner in which the applicant intends to conduct the project and carry out the requirements of this subpart;

(2) A budget and justification of the amount of grant funds requested;

(3) A description of the applicant's organizational structure, ongoing activities, and any home health and/or other health services currently being delivered, including a statement indicating any accreditation or certification for such services;

(4) The following information with respect to the current and/or proposed catchment area of the applicant:

(i) The precise boundaries of the catchment area, and the average travel time from the applicant entity or its satellites to the furthermost point within the catchment area;

(ii) Demographic data relating to the catchment area, including the total population of the area, the number and percentage of persons aged 65 years old and older, and number and percentage of recipients under Title XIX of the Social Security Act; and

(iii) A description of the health care resources of the catchment area in ratio to the population, and the accessibility in terms of size and geographic factors, including the number of:

(A) Home health agencies, the range of their services, and the number of persons presently served by such agencies,

(B) Hospitals (size, location, and type), (C) Skilled nursing and intermediate care facilities,

(D) Outpatient rehabilitation facilities,

(E) Physicians (both doctors of medicine and doctors of osteopathy), by specialty,

(F) Homemaker service agencies and number of persons presently served thereby, and

(G) Day care centers for the elderly; (5) A report of utilization patterns of health care resources in the catchment area (or proposed catchment area, if applicable). Such report shall include:

(i) Bed occupancy rates and average length of stays in hospitals, skilled nursing and intermediate care facilities,

(ii) Hospital bed days used per thousand population,

(iii) Hospital bed days used per thousand population aged 65 years old and older, and

(iv) Number of persons served (including the average number of visits per patient) by existing home health agencies in the area (for each of the 3 calendar years preceding the calendar year in which the application is submitted or such lesser period as such home health agencies have been in operation);

(6) Based on the accumulated data required by paragraphs (a) (4) and (5) of this section, a projection of the number of persons who will use the home health services to be provided by the applicant, including quarterly projections of users who are aged 65 years old and older, and users who are medically indigent, as determined under § 51e.108;

(7) Evidence (such as copies of letters or minutes of meetings) that health care providers, local or county medical societies, and other community organizations in the proposed catchment area (such as senior citizens organizations) will actively participate in the promotion and utilization of the home health services to be offered by the applicant;

(8) A description of the referral mechanisms which are in place, or are planned, for referral of patients to the applicant from hospitals, skilled nursing and intermediate care facilities, and other appropriate institutional or ambulatory health care providers in its existing and/or proposed catchment area, as applicable;

(9) A description of the applicant's plan to market the home health services to be offered, including such information as plans to acquaint physicians, hospital and skilled nursing home administrators, other health care providers, and potential users with the services to be offered, and copies of any informational or promotional material in use or proposed to be used;

(10) A description of the proposed staffing pattern, based upon the projection of the number of users developed under subparagraph (6) of this paragraph, which the applicant will employ to carry out the project, and a time-phased plan for hiring staff to meet the requirements of this subpart;

(11) A plan providing for the continuation of home health services after financial assistance under this subpart is no longer available;

(12) A statement indicating how and the extent to which the project plans to meet each of the applicable requirements in § 51e.106, including a description of the methodology which the applicant will use to compile the data required under § 51e.106 (a) (6);

(13) Evidence that the requirements of Part I of Office of Management and Budget Circular No. A-95 have been satisfied; and

(14) The signature of the individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the Act, the applicable regulations of this part, and any additional conditions of the grant award.

(b) Applications submitted by home health organizations. In addition to the requirements of paragraph (a) of this section, an application for a grant for a project described in § 51e.103(b) (1) shall contain the following:

(1) A copy of the S.S.A. Form #1515 (which may be obtained from the Bureau of Health Insurance, Social Security Administration) which the applicant has submitted to the appropriate State agency as evidence of its intent to become certified, and

(2) A detailed plan indicating how the applicant entity plans to meet the conditions of participation necessary to obtain certification by such State agency in accordance with 20 CFR Part 405, Subpart S.

(c) Applications submitted by home health agencies. In addition to the requirements of paragraph (a) of this section, an application for a grant for a project described in § 51e.103 (b) (2) shall contain the following:

(1) A description of the home health services currently being provided by the applicant agency and the manner in which they are provided;

(2) The number of the current provider agreement between the agency and the Secretary;

(3) The number of referrals to the agency from each of the types of referral sources set forth in paragraph (a) (8) of this section for the three calendar years preceding the calendar year in which the application is submitted (or such lesser