(1) The State health agency does not submit an application to the Secretary for funding of a State-level program, and

(2) The local health agency's intervention activity application is submitted through, and receives the approval of, the State health agency.

(c) Other public health and education agencies, private and voluntary organizations, and native American tribal councils or federation of natives are encouraged to apply to their respective State-level grantee for funding through the State for intervention activities as defined in § 51g.2.

851g.4 What information must be included in the application for a grant?

(a) A grant application must include a project plan which describes clearly and concisely information on the points below:

(1) Budget information:

(1) Items detailing the State level program.

(ii) Itemized budgets for each individual intervention proposal.

(iii) Allocation of shared personnel costs.

(iv) Narrative description and justification of all budget items.

(2) Background and need:

(i) Political subdivision included in the project.

(ii) Structure of health department. (iii) Current population (age groups). (iv) Ethnic and geographic characteristics.

(v) Morbidity and mortality data or a plan for establishing a system to collect morbidity data if not already established.

(vi) Facilities and resources which are or will be available to implement the program.

(vii) Interrelationship with other Federally assisted programs.

(viii) Additional State and/or community resources which can be mobilized.

(3) Project objectives:

(1) The objectives must be specific, measurable, and realistic.

(ii) The objectives must relate to outcomes which can be described on a community-level or specific target

group level, using the common data items provided.

(iii) Both short-term (1-year budget period) and long-term (project period) objectives must be stated.

(4) Intervention proposals.

(5) A list of intervention proposals (received from other agencies) which were not included in the application and the criteria and rationale for not including them.

(b) In addition to the requirements in §51g.4(a), the State-level proposals must include the following Basic PTOgram Elements which establish the State-level program as the principal organization to coordinate grant program activities:

(1) Updating and maintenance of an inventory of existing Health Education-Risk Reduction activities ongo-1 ing in the State.

(2) Maintenance of working liaisons directed toward developing cooperative strategies with voluntary health agencies, professional organizations, and education groups (examples, State and local boards of education, other State and local agencies, school system, Parent-Teacher Associations, Cooperative Extension Services) which have potential for positively affecting risk reduction activities.

(3) If the State-level grant application contains smoking and alcohol intervention proposals, a detailed plan must be submitted which describes the formal relationship and linkage with the State educational and State alcohol agencies, and a plan to work with these agencies to monitor and provide technical assistance to funded intervention activities.

(4) Development and/or improvement of surveillance systems to identify and record the morbidity and mortality of chronic diseases and their related risk factors. This process should be coordinated with existing data collection systems, where appropriate and available.

(5) Provision of technical and management consultation to communities to establish, maintain, and improve "an organized approach to risk reduction" as defined in §51g.2. Specifically, the State-level program must be capable of:

(1) Assisting community organizations to recognize mutual interests and complementary efforts.

(ii) Identifying resources outside of communities which may assist local efforts.

(iii) Providing assistance to determine the prevalence of risks within the community or specific target populations, develop local objectives and work plans, and select health education/promotion methods.

(6) Stimulating intervention activity proposals to compete for Federal funding which address specific target groups and are supported by specific, measurable objectives.

(7) Documenting efforts to stimulate intervention activity proposals which address highly susceptible populations and minority target populations.

(8) Monitoring intervention activities which receive Federal grant support to assure that activities are adquately carried out.

(c) Intervention activity proposals may be submitted to the State health agency by a wide variety of organizations and agencies. (See §51g.3, "Who Is Eligible To Apply * * *?”)

(1) Intervention activity proposals must include the following:

(1) A description of the need and rationale for carrying out the proposed activities in the selected target population.

(ii) A review of the current or previous Health Education-Risk Reduction efforts within the selected target population.

(iii) A description of existing Health Education-Risk Reduction services, resources, or facilities within the community which may complement the activities proposed for the selected target population.

(iv) A plan to document the prevalence of risk factors using common data items.

(v) A work plan describing the delivery of proposed health education programs and risk reduction services to the selected target population which will result in reducing the identified prevalence of risk factors.

(vi) A plan to periodically monitor and evaluate the implementation and effectiveness of applied methodology.

[45 FR 63486, Sept. 26, 1980, as amended at 46 FR 48593, Oct. 1, 1981]

§51g.5 How will grant applications be evaluated and the grants awarded?

The Secretary may award grants for projects which will best promote the purposes of section 1703(a) of the Act. In making this determination:

(a) Each State-level grant application will be reviewed and judged according to the following criteria:

(1) Is each of the Basic Program Elements likely to be achieved satisfactorily?

(2) Is there a logical method of operation specified for each proposed activity?

(3) Has the applicant developed adequate plans for involving public, private, and voluntary agencies in health education activities in the project area and have plans been made to effectively use existing community resources?

(4) Are the project objectives specific, measurable, realistic, and related to the national program goals?

(5) Have effective evaluation measures been specified?

(6) With respect to previous grants, have the prior year's accomplishments been satisfactory and on schedule?

(7) Have appropriate data been collected and used for planning purposes? (8) Does the application provide a clear understanding of whom the program will serve and who is responsible for the various activities?

(9) Are budget requests and proposed uses of grant funds reasonable considering the anticipated results?

(10) Have project personnel been recruited and are they well qualified by training and/or experience for the support sought?

(11) Do the proposed activities follow a logical pattern to achieve the stated objectives?

(12) Are the program objectives based upon well-defined problems derived from baseline data and other assessments?

(13) Is the inventory of resources related to the intervention activities in such a way that a clear intent is evi

dent to utilize the resources as much as possible?

(14) Will the evaluation plan adequately measure program accomplishments and identify successes and failures of specific health education methods to redirect future efforts?

(15) Does a viable complementary relationship exist between the Statelevel program and proposed intervention activities?

(b) Each intervention proposal will be judged on its own merits, in competition with all the other intervention proposals submitted to the Secretary. The application will have the best opportunity of success if the need for the activity has been carefully assessed and if the activity can be successfully completed in a reasonable period of time. Proposals will be judged according to the following criteria:

(1) Technical quality.

(2) The extent to which the proposal complements or enhances the efforts of a community which is undertaking “an organized approach to risk reduction,” and the extent to which the proposal addresses highly susceptible populations and minority target populations.

(3) Potential for replication at other sites at reasonable costs.

(4) Conformity and linkage with State-level programs and other appropriate agencies.

(5) Contributions toward new knowledge, techniques, and services.

(6) National or regional application of results.

(7) Applicant participation and plans for other than Federal funding.

(8) Availability and adequacy of re

sources.

(9) Adequacy of the evaluation plan to measure program outcomes, impacts, and processes.

[45 FR 63846, Sept. 26, 1980, as amended at 46 FR 48593, Oct. 1, 1981]

$51g.6 For what period of time will grants be awarded?

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

(b) Generally, the grant will initially be funded for 1 year and subsequent continuation awards will also be for 1 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 levels of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Government.

(c) 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.

(d) The Secretary may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the Secretary's written approval is obtained. A budget period is an interval of time (usually 12 months) into which the project period is divided for funding and reporting purposes.

$51g.7 How may a grantee use grant funds?

Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the applicable regulations in this part, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

$51g.8 Which other HHS regulations apply to these grants?

Several other HHS regulations apply to grants under this part. These include, but are not limited to:

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

42 CFR part 122, subpart E-Health Systems Agency reviews of certain proposed uses of Federal health funds

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

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 of this title

45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

45 CFR part 86-Nondiscrimination on the basis of sex in education programs and activities receiving or benefiting from Federal financial assistance

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance

[49 FR 38110, Sept. 27, 1984]

$51g.9 Which other conditions apply to these grants?

The Secretary may, with respect to any grant award, impose additional conditions at the time of the grant award when the Secretary determines that they are necessary to advance the approved program, the interest of the public health, or the conservation of grant funds.

PART 52-GRANTS FOR RESEARCH PROJECTS

Sec.

52.1 To which programs do these regulations apply?

52.2 Definitions.

52.3 Who is eligible to apply for a grant?

52.4 How to apply for a grant.

52.5 Evaluation and disposition of applica

tions.

52.6 Grant awards.

52.7 Use of funds; changes.

52.8 Other HHS regulations that apply. 52.9 Other conditions.

AUTHORITY: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 U.S.C. 216); sec. 301, 58 Stat. 691, as amended, 60 Stat. 423, 62 Stat. 467, 601, 1017, 70 Stat. 490, 74 Stat. 1053, 85 Stat. 785, 86 Stat. 687, 88 Stat. 346, 360 (42 U.S.C. 241); sec. 303, 70 Stat 929, as amended, 84 Stat. 1241, 88 Stat. 132, 346 (42 U.S.C. 242a); sec. 356, 82 Stat. 1174 (42 U.S.C. 263d); sec. 394, 79 Stat. 1062, as amended, 84 Stat. 63, 64, 66, 67, 87 Stat. 92, 88 Stat. 372 (42 U.S.C. 280b-5); sec. 1004, 89 Stat. 306, 352, as amended, 91 Stat. 389 (42 U.S.C. 300a-2); sec. 1006, 89 Stat.

308 (42 U.S.C. 300a-4); sec. 501, 90 Stat. 1038 (42 U.S.C. 4585); sec. 1205, 87 Stat. 597 (42 U.S.C. 300d-4); sec. 410, 68 Stat. 84, as amended, 90 Stat. 247, 90 Stat. 1040 (21 U.S.C. 1177); sec. 309(b), 92 Stat. 3447 (42 U.S.C. 242n); sec. 955(a), Pub. L. 97-35, 95 Stat. 589 (42 U.S.C. 300z-7(a)(1)).

$52.1 To which programs do these regulations apply?

(a) The regulations of this part apply to grants for the support of health-related research projects in programs relating to:

(1) The cause, diagnosis, treatment, control, or prevention of the physical or mental diseases, injuries, or impairments to human life, as authorized by sections 301, 303, and related provisions of the Act (42 U.S.C. 241, 242a);

(2) Electronic product radiation control programs designed to protect the public, and safety from electronic product radiation, as authorized by section 356 of the Act (42 U.S.C. 263d);

(3) Medical library science and related activities, and for the development or dissemination of new knowledge, techniques, systems, and equipment for processing, storing, retrieving, and distributing information pertaining to health sciences, as authorized by section 394 of the Act (42 U.S.C. 280b-5);

(4) Emergency medical techniques, methods, devices, and delivery, as authorized by section 1205 of the Act (42 U.S.C. 300d-4);

(5) The behavioral and biomedical etiology, treatment, mental and physical health consequences, and social and economic consequences, of alcohol abuse and alcoholism, as authorized by section 501 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4585);

(6) The improvement of drug maintenance techniques or programs, as authorized by section 410 of the Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1177);

(7) Research in the biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population, as authorized under section 1004 of the Act; and

(8) Health care technology assessments, including studies of the safety, efficacy, effectiveness, and cost effec

tiveness of particular technologies, their social, ethical, and economic impacts, as well as studies of methods of dissemination of information about technologies, and factors affecting the use of technologies as authorized by section 309(b) of the Act (42 U.S.C. 242n).

(9) Research on the causes, consequences and approaches to coping with adolescent sexual relations, contraceptive use, pregnancy and parenthood authorized by section 2008 of the Act.

(b) These regulations do not apply to general research support grants, 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), training grants (see part 64 of this chapter), or to the support of research training under the National Research Service Awards program (see part 66 of this chapter).

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980, as amended at 46 FR 4919, Jan. 19, 1981; 47 FR 50261, Nov. 5, 1982]

§ 52.2 Definitions.

As used in this part:

(a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved may be delegated.

(b) 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.

(c) Act means the Public Health Service Act (42 U.S.C. 201 et seq.).

(d) Department means the Department of Health and Human Services.

(e) Grantee means the institution, organization, individual or other person designated in the grant award document as the responsible legal entity to whom a grant is awarded under this part.

(f) Research project grant means the award by the Secretary of funds to a grantee to assist in meeting the costs

of conducting for the benefit of the public health an identified project which is intended and designed to establish, discover, develop, elucidate or confirm information or the underlying mechanisms relating to a program set forth in §52.1.

(g) Project means the particular activity within the scope of one or more of the programs set forth in §52.1 which is supported by a grant award under this part.

[45 FR 12240, Feb. 25, 1980]

§ 52.3 Who is eligible to apply for a grant?

(a) Persons eligible. Any individual, corporation, public or private institution or agency, or other legal entity shall be eligible for a grant award except:

(1) An individual or entity which is otherwise ineligible for an award under applicable law or regulation, and

(2) Federal agencies or institutions unless specifically authorized by law to receive the grant.

(3) Any individual, corporation, institution, agency or other entity that, having previously received a grant award, has failed willfully and materially in the judgment of the Secretary to comply with accounting or other requirements applicable to that prior award. Ineligibility for a grant award under this paragraph continues until terminated in the public interest by the Secretary.

(b) Permissible activities within projects. Any project found by the Secretary to be a research project within the meaning of §52.1 shall be eligible for a grant award. Eligible projects may consist of laboratory, clinical, population, field, statistical, basic, applied or other types of investigations, studies or experiments, or combinations thereof, and may either be limited to one, or a particular aspect of a problem or subject, or may consist of two or more related problems or subjects for concurrent or consecutive investigation and involving multiple disciplines, facilities and resources.

[45 FR 12240, Feb. 25, 1980, as amended at 46 FR 58675, Dec. 3, 1981]