51a.2 Definitions.

51a.3 Who is eligible to apply for Federal

funding?

51a.4 How is application made for Federal funding?

51a.5 What criteria will DHHS use to decide

which projects to fund?

51a.6 What confidentiality requirements must be met?

51a.7 What other DHHS regulations apply? 51a.8 What other conditions apply to these grants?

AUTHORITY: Sec. 1102 of the Social Security Act, 49 Stat. 647 (42 U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the Social Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A) and 706(a)(3)).

SOURCE: 51 FR 7727, Mar. 5, 1986, unless otherwise noted.

851a.1 To which programs does this regulation apply?

The regulation in this part applies to grants, contracts, and other arrangements under section 502(a) and 502(b)(1)(A) of the Social Security Act, as amended (42 U.S.C. 702(a) and 702(b)(1)(A)), the Maternal and Child Health (MCH) Federal Set-Aside project grant programs. Section 502(a) authorizes funding for special projects of regional and national significance (SPRANS), research and training projects with respect to maternal and child health and children with special health care needs (including early intervention training and services development); genetic disease testing, counseling and information programs; comprehensive hemophilia diagnostic and treatment centers; projects for screening and follow-up of newborns for sickle cell anemia and other genetic disorders; and special maternal and child health improvement projects. Section 502(b)(1)(A) authorizes funding for projects termed community integrated service system (CISS) projects for the development and expansion of: maternal and infant health home visiting; projects to increase the participation of obstetricians and pediatricians in title V and title XIX programs; integrated maternal and child health service systems; maternal and child health centers operating under the direction of not-for-profit hospitals; rural maternal and child health programs; and outpatient and community-based services

programs for children with special health care needs.

[59 FR 36706, July 19, 1994]

§51a.2 Definitions.

Act means the Social Security Act, as amended.

Genetic diseases means inherited disorders caused by the transmission of certain aberrant genes from one generation to another.

Hemophilia means a genetically transmitted bleeding disorder resulting from a deficiency of a plasma clotting factor.

Institution of higher learning means any college or university accredited by a regionalized body or bodies approved for such purpose by the Secretary of Education, and any teaching hospital which has higher learning among its purposes and functions and which has a formal affiliation with an accredited school of medicine and a full-time academic medical staff holding faculty status in such school of medicine.

Secretary means the Secretary of Health and Human Services or his or her designee.

$51a.3 Who is eligible to apply for Federal funding?

(a) With the exception of training and research, as described in paragraph (b) of this section, any public or private entity, including an Indian tribe or tribal organization (as those terms are defined at 25 U.S.C. 450b) is eligible to apply for federal funding under this Part.

(b) Only public or nonprofit private institutions of higher learning may apply for training grants. Only public or nonprofit institutions of higher learning and public or private nonprofit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs may apply for grants contracts or cooperative agreements for research in maternal and child health services or in services for children with special health care needs.

[59 FR 36706, July 19, 1994]

§51a.4 How is application made for Federal funding?

An application for funding under the MCH Federal Set-Aside project grant programs must be submitted to the Secretary at such time and in such manner as the Secretary may prescribe. It must include a budget and narrative plan of the manner in which the project will meet each of the requirements prescribed by the Secretary. The plan must describe the project in sufficient detail to identify clearly the nature, need, and specific objectives of, and methodology for carrying out, the project.

(Approved by the Office of Management and Budget under control number 0915-0050)

[59 FR 36706, July 19, 1994]

§51a.5 What criteria will DHHS use to decide which projects to fund?

(a) The Secretary will determine the allocation of funds available under sections 502(a) and 502(b)(1)(A) of the Act for each of the activities described in §51a.1.

(b) Within the limit of funds determined by the Secretary to be available for each of the activities described in §51a.1, the Secretary may award Federal funding for projects under this part to applicants which will, in his or her judgment, best promote the purpose of title V of the Social Security Act and address achievement Healthy Children 2000 objectives,1 taking, the following factors into account:

of

(1) The extent to which the project will contribute to the advancement of maternal and child health and/or improvement of the health of children with special health care needs;

1Healthy Children 2000: National Health Promotion and Disease Prevention Objectives Related to Mothers, Infants, Children, Adolescents, and Youth is a special compendium of health status goals and national health objectives affecting mothers, infants, children, adolescents, and youth originally published in Healthy People 2000 in September 1990. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Healthy People 2000 (Summary Report; Stock No. 017-00100473-1) through the Superintendent of Documents, Government Printing Office Washington, DC 20402-9325, (telephone: 202 512–1800).

(2) The extent to which the project is responsive to policy concerns applicable to MCH grants and to program objectives, requirements, priorities and/ or review criteria for specific project categories, as published in program announcements or guidance materials.

(3) The extent to which the estimated cost to the Government of the project is reasonable, considering the anticipated results;

(4) The extent to which the project personnel are well qualified by training and/or experience for their roles in the project and the applicant organization has adequate facilities and personnel; and

(5) The extent to which, insofar as practicable, the proposed activities, if well executed, are capable of attaining project objectives.

(c) For the following types of CISS projects, preference for funding will be given to qualified applicants in areas with a high infant mortality rate (relative to the latest average infant mortality rate in the United States or in the State in which the area is located): (1) Projects for the development and expansion of maternal and infant health home visiting;

(2) Projects to increase the participation of obstetricians and pediatricians in title V and title XIX programs;

(3) Integrated maternal and child health service systems;

(4) Maternal and child health centers operating under the direction of notfor-profit hospitals;

(5) Rural maternal and child health programs; and

(6) Outpatient and community based services for children with special health care needs.

[59 FR 36706, July 19, 1994]

§ 51a.6 What confidentiality requirements must be met?

All information as to personal facts and circumstances obtained by the project's staff about recipients of services shall be held confidential, and shall not be disclosed without the individual's consent except as may be otherwise required by applicable law or as may be necessary to provide for medical audits by the Secretary 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.

§ 51a.7 What other DHHS regulations apply?

(a) Several other DHHS regulations apply to awards under this part. These include, but are not limited to:

42 CFR part 50-Policies of general applicability:

subpart B-Sterilization of persons in federally assisted family planning projects. subpart C-Abortions and related medical services in federally assisted programs of the Public Health Service. subpart E-Maximum allowable cost for drugs.

45 CFR part 76-Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants).

45 CFR part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Service-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.

45 CFR part 93-New restrictions on lobbying.

(b) In addition to the above regulations, the following apply to projects funded through grants:

42 CFR part 50--Policies of general applicability:

subpart D-Public Health Service grant appeals procedure.

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

45 CFR part 74-Administration of grants to nonprofit organizations.

45 CFR part 75-Informal grant appeals procedures.

45 CFR part 92-Administration of grants to State and local governments.

[59 FR 36707, July 19, 1994]

§ 51a.8 What other conditions apply to these grants?

(a) Recipients of project grants will be required to submit such additional information to the Secretary on an annual basis as the Secretary determines, including:

(1) the number of individuals served or trained, as appropriate under the project;

(2) a copy of any evaluation conducted by the recipient; and

(3) a list of Healthy Children 2000 objectives addressed by the project and data on how the project contributed toward meeting the objectives.

(b) The Secretary may at the time of award of project grants under this Part impose additional conditions, including conditions governing the use of information or consent forms, when, in the Secretary's judgment, they are necessary to advance the approved program, the interest of public health, or the conservation of grant funds.

[59 FR 36707, July 19, 1994]

Subpart C [Reserved]

Subpart D-Grants for Venereal Disease Control Programs

51b.401 To which programs does this subpart apply?

51b.402 Definitions.

51b.403 Who is eligible for a grant under this subpart?

51b.404 What are the confidentiality requirements?

51b.405 What information is required in the application?

51b.406 How will grant applications be evaluated and the grants awarded?

51b.407 How can grant funds be used?

Subpart E [Reserved]

Subpart F-Grants for Research, Demonstrations, and Public Information and Education for the Prevention and Control of Venereal Disease

51b.601 To which programs does this subpart apply?

51b.602 Who is eligible for a grant under this subpart?

51b.603 What are the confidentiality requirements?

51b.604 What information is required in the application?

51b.605 How will grant applications be evaluated and the grants awarded?

51b.606 How can grant funds be used?

AUTHORITY: Secs. 317 and 318, Public Health Service Act, 92 Stat. 3574 and 3582 (42 U.S.C. 247b, 247c); sec. 1743 Pub. L. 97-35, 95 Stat. 763 (31 U.S.C. 1243 note).

Subpart A-General Provisions

SOURCE: 48 FR 4473, Feb. 1, 1983, unless otherwise noted.

851b.101 To which programs do these regulations apply?

The regulations in this part apply to grants for preventive health service programs authorized under section 317 (42 U.S.C. 247b) and for venereal disease prevention and control programs authorized under section 318 (42 U.S.C. 247c) of the Act.

851b.102 Definitions.

As used in these regulations:

Act means the Public Health Service Act, as amended.

Secretary means the Secretary of Health and Human Services (HHS) or any other officer or employee of that

Department to whom the authority involved has been delegated.

State means one of the 50 States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

851b.103 What are the general application requirements?

(a) The project application shall contain a full description of the program objectives, plans, and activities. With respect to programs authorized by section 317 of the Act only, the application shall also provide, as the Secretary may require:

(1) The amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program.

(2) A description of the services provided by the applicant for this accounting period covered under paragraph (a)(1) of this section.

(3) The amount of Federal funds needed by the applicant to continue providing these services.

(4) A description of any proposed changes in the provision of the services, reasons and priorities, and the amount of Federal funds needed by the applicant to make the changes.

(b) The application shall contain evidence satisfactory to the Secretary that it has been submitted, as appropriate, for action to the planning agency designated by the Secretary under title XV of the Act (42 CFR parts 122 and 123). These grants are subject to the intergovernmental review of Federal programs of Executive Order 12372.

(c) The application shall contain assurances that no one will be denied services because of inability to pay, and that the services are provided in a manner which preserves human dignity and maximizes acceptance.

$51b.104 Can personnel, supplies, and related items be provided in lieu of cash?

The Secretary may reduce a grant by the amount of the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished a grant recipient when furnished at the request of the recipient.

The Secretary also may reduce a grant by the amount of the pay, allowances, travel expenses, and any other costs in connection with the detail of any officer or employee of the Government to the recipient when the detail is at the request of the recipient. The amount the grant is reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment or in detailing personnel and shall be deemed to have been paid to the recipient.

851b.105 Which other HHS Regula

tions 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

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

45 CFR part 46-Protection of human subjects

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

45 CFR part 76-Debarment and suspension from eligibility for financial assistance 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 38109, Sept. 27, 1984]

§ 51b.106 What other conditions apply to these grants?

(a) 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 usually be for 2 to 5 years.

(b) For budgetary and funding purposes, the project period is generally divided into 12-month intervals called budget periods. A grantee must submit

a separate application to have the support continued for each subsequent budget period after the initial award. Decisions regarding continuation awards and the funding level of such 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 HHS 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) Any funds granted pursuant to this subpart shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

(e) The Secretary may, at the time of award, impose additional conditions, including conditions governing the use of information or consent forms, when, in the Secretary's judgment, they are necessary to advance the approved program, the interest of the public health, or the conservation of grant funds.

§ 51b.107 Is participation in preventive health service programs required by these regulations?

Nothing in these regulations shall be construed to require any State or political subdivision to have a preventive health service program which would require any person who objects to treatment to be treated under the program.

Subpart B-Grants for Childhood Immunization Programs

SOURCE: 44 FR 40501, July 11, 1979, unless otherwise noted.

§ 51b.201 To which programs does this subpart apply?

The regulations in this subpart apply to the award of grants under section