New subsection (a)(2)(B). requires the Secretary to carry out coordinated clearinghouse activities on sudden infant death syndrome, including the collection (and dissemination to the public, health and educational institutions, professional organizations, sudden infant death syndrome parent self-help organizations, and other interested parties) of information pertaining to sudden infant death syndrome and related issues such as death investigation systems, personnel training, biomedical research activities, and information on the utilization and availability of treatment or prevention procedures and techniques, such as home monitors.

The clearinghouse function would facilitate the timely dissemination of information to the public, health and welfare professionals, law enforcement officials, and other service personnel who come in contact with the families of SIDS victims.

This provision authorizes the Secretary to enter into contracts to carry out the information and the clearinghouse activities required under subsection (a).

New subsection (b) (1) authorizes the Secretary to make grants to public or nonprofit private entities, and enter into contracts with public or private entities, for projects which include both the collection, analysis, and furnishing of information (derived from post mortem examinations and other means) relating to the causes and other appropriate aspects of sudden infant death syndrome; and the provision of information and counseling to families affected by sudden infant death syndrome.

This provision continues the project grant mechanism in existing law and broadens the scope of information to be collected at the project level to include other appropriate aspects of SIDS in addition to information relating to the causes of SIDS.

New subsection (b) (2) provides that no grant may be made or contract entered into under subsection (b) unless an application therefor has been submitted to and approved by the Secretary; requires applications to be in such form, submitted in such manner, and contain such information as the Secretary prescribes by regulation; and requires each application to:

(A) provide that the project for which assistance under the subsection is sought will be administered by or under the supervision of the applicant;

(B) provide for appropriate community representation (including appropriate involvement of parent self-help groups) in the development and operation of the project;

(C) set forth such fiscal controls and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for Federal funds paid to applicants under subsection (b); and

(D) provide for making reports in such form, frequency, and with information the Secretary reasonably requires, including reports that will assist in carrying out the provisions of subsection (a) (2) of section 1011 relating to periodic reporting and clearinghouse activities.

The provisions of subsection 1011 (b) (2) are essentially identical to existing law except that clause (B) is amended to specify that appropriate community representation shall include appropriate in

volvement of parent self-help groups, and clause (D) is amended to require project reports to include reports that will assist the Secretary in carrying out his periodic reporting and clearinghouse activities required by section 1011 (a) (2).

New subsection (b) (3) provides that payments under grants under subsection (b) may be made in advance or by way of reimbursement, and at such intervals and on such conditions, as the Secretary finds necessary a provision identical to existing law.

New subsection (b)(4) provides that contracts under subsection (b) may be entered into without regard to sections 3648 through 3709 of the revised statutes (31 U.S.C. 529; 41 U.S.C. 5)., which require certain advertising and bid procedures, a provision identical to existing law.

New subsection (b) (5) requires the Secretary to seek to make equitable distribution of funds appropriated under part B among the various regions of the country and to insure that the needs of rural and urban areas are appropriately addressed.

This provision is not intended to change the character of the SIDS program from a project grant program to a formula grant program, but would require the Secretary to consider carefully the needs and problems peculiar to rural and urban areas, such as transportation difficulties, and lack of access to specialized services, among other problems.

New subsection (b)(6) provides for the authorization of appropriations of $7,000,000 for fiscal year 1979, $9,000,000 for fiscal year 1980, $11,000,000 for fiscal year 1981 and for each of the next two fiscal years. This increase in authorizations over the present level of $3.6 million will allow for three years of continued project expansion and improvement and two years of transition to greater reliance on community support. It would also provide adequate funding for the establishment of counseling and information projects in all the States, territories, and possessions of the United States not presently served.

Plans and Reports

Subsection (a) of new section 1012 requires that not later than February 1 of each year after 1978, the Secretary shall submit to the Senate Committee on Human Resources and the House Committee on Interstate and Foreign Commerce a comprehensive report on the administration of part B of title X (including funds and positions allocated for personnel) and the results obtained from activities thereunder, including the extent of allocations made to rural and urban areas. The report submitted on or before February 1, 1979 is also required to set forth a plan to extend counseling and information projects to the fifty States and the District of Columbia by July 1, 1979, and extend counseling and information projects to all possessions and territories of the United States by July 1, 1980.

This provision will help keep Congress informed as to (1) the advances in SIDS projects' counseling and informational activities; (2) the state of the art with respect to the clinical application of SIDS research activities; and (3) whether or not projects are moving toward finding community support. It will also ensure the development of a plan for expansion of the needed counseling and information services to all the States, territories, and possessions of the United States not presently served.

S.R. 822

New subsection (b)-requires the Secretary to conduct or provide for the conduct of a study on State laws and practices relating to death investigation systems and their impact on sudden and unexplained infant deaths, any appropriate means for improving the quality, frequency, and uniformity of the post mortem examinations performed under such laws, practices, and systems in the case of sudden and unexplained infant deaths; and requires the Secretary not later than December 31, 1979, to report to the Congress the results of such study, including recommendations as to appropriate actions by HEW with respect to post mortem investigations in all cases of sudden and unexplained infant death (including the desirability and feasibility of establishing pilot projects for centralized post mortem and specimen examination systems on a statewide or regional basis). The performance of a post mortem examination (autopsy) is vital in making a diagnosis of sudden infant death syndrome because such a determination is made only after other causes of death have been ruled out. Whether or not such an examination is performed, and whether or not that examination is of high quality is dependent upon the death investigation laws and systems in existence within the State. A comprehensive analysis of these laws and systems and their impact on sudden and unexplained infant death will provide information as to what appropriate action, if any, should be taken by HEW. The committee believes consideration should be given to the feasibility and value of establishing projects for centralized post mortem and specimen examination systems on a statewide or regional basis, and expects consideration by the Department and a report prior to the date on which the entire report is due.

Sudden Infant Death Syndrome Research and Research Reports

Subsection (a) of new section 1013-requires the Secretary, from the sums appropriated to the National Institute of Child Health and Human Development under section 441 of the PHS Act, to assure that there are applied to research of the type described in paragraph (1) (A), (B), and (C) of subsection (b) of section 1013 such amounts each year as will be adequate, given the leads and findings then available from such research, in order to make maximum feasible progress toward identification of infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome. This provision highlights the importance of the SIDS research program and the need for increased support for this rapidly advancing area of investigation over the next several years.

News subsection (b) (1)-requires the Secretary not later than ninety days after the close of fiscal year 1978 and each fiscal year thereafter, to report to the Senate and the House Committees on Appropriations, the Senate Committee on Human Resources and the House Committee on Interstate and Foreign Commerce, the information for such fiscal year on

(A) the (i) number of applications approved by the Secretary in the fiscal year reported on for grants and contracts under the PHS Act for research which relates specifically to SIDS, (ii) total number requested under such applications, (iii) number of such applications for which funds were provided in that fiscal year, and (iv) total amount of such funds;

(B) the (i) number of applications approved by the Secretary in such fiscal year for grants and contracts under the PHS Act for research which relates generally to sudden infant death syndrome, (ii) total amount requested under such applications, (iii) number of such applications for which funds were provided in that fiscal year, and (iv) total amount of such funds; and

(C) the (i) number of applications approved by the Secretary in such fiscal year for grants and contracts under this Act for highrisk pregnancy and high-risk infancy research which relates to sudden infant death syndrome, specifying how these conditions relate to SIDS, (ii) total amount requested under such applications, (iii) number of such applications for which funds were provided in that fiscal year, and (iv) total amount of such funds. Clauses (A) and (B) are identical to the existing law requirements in Public Law 93-270 which last applied to a report due for fiscal year 1976. Clause (C) is new and is an area already being studied by researchers interested in the SIDS phenomenon. The findings from studies in the area of high-risk pregnancy and high-risk infancy are considered to have significant applicability in the eventual solution to the problem of SIDS.

New Subsection (b)(2)(A) requires that each report submitted under paragraph (1) of subsection (b) shall

(A) contain a summary of the findings of intramural and extramural research supported by NICHD relating to SIDS as described in clauses (A), (B), and (C) of paragraph (1), and the Institute's plan for taking maximum advantage of those research leads and findings;

(B) provide information on activities underway and plans to bring about the appropriate clinical application of current research findings and the cost and implications of those applications; and

(C) provide an estimate of the need for additional funds over each of the next 5 fiscal years for grants and contracts under the PHS Act for research activities described in clauses (A), (B), and (C) of this paragraph.

Significant advances have been made in research since the enactment of Public Law 93-270 in 1974. Within the next few years information gathered from the research carried on through NICHD will be available for clinical application. This subsection is thus intended to provide for careful analysis and appropriate application and dissemination of research findings, and to provide sound data on levels of funding required so that research may be continued at an adequate level.

New subsection (c) requires the Secretary, within five days after the budget is transmitted by the President to the Congress for each fiscal year after fiscal year 1979, to transmit to the Senate and House Committees on Appropriations, the Senate Committee on Human_Resources, and the House Committee on Interstate and Foreign Commerce, an estimate of the amounts requested for the NICHD and any other Institutes of the National Institutes of Health, respectively, for research relating to SIDS as described in paragraph (1)(A), (B), and (C) of this subsection, and a comparison of those amounts with the amounts requested for the preceding fiscal year. This continues

on an annual basis the reporting requirements in existing law (Public Law 93-270) and, in addition, for annual reporting of research activities in the areas of high-risk pregnancy and high-risk infancy related to SIDS.

Section 3

1:

On the effective date of the Committee bill, amends the title of title XI of the Public Health Service Act to read "Genetic Diseases and Hemophilia Programs" and repeals part B of title XI of the PHS Act (the Sudden Infant Death Syndrome Programs) and sections 1, 2, 3, and 4 of Public Law 91-572 (the Family Planning and Population Research Act of 1970), and redesignates Part C of title XI (the Hemophilia Program) as part B.

Section 4

1

Provides that the provisions of the Committee bill shall take effect on October 1, 1978.

AGENCY REPORTS

The committee requested reports from the Department of Health, Education, and Welfare, the General Accounting Office, and the Office of Management and Budget. As of the date of filing of this report, none of these departments had submitted a report to the committee. However, a representative of the Department of Health, Education, and Welfare testified at hearings held on legislation to extend the Family Planning Services and Population Research and the Sudden Infant Death Syndrome legislation. The HEW testimony at these hearings is printed below.

STATEMENT BY JULIUS B. RICHMOND, M.D., ASSISTANT SECRETARY FOR HEALTH DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Mr. Chairman, members of the subcommittee, good morning. I am delighted to appear for the first time before this distinguished subcommittee. Mr. Chairman, I have long heard kudos about your leadership and the breadth of interest exhibited by this subcommittee in all areas relating to family planning and population affairs. It is indeed an honor to be here.

Accompanying me today are: Dr. Joyce Lashof, Deputy Assistant Secretary for Health-Programs and Population Affairs; Mr. Ernest Peterson, Acting Director of the Office of Population Affairs; Dr. Philip Corfman, Director fo the Center for Population Research, National Institute of Child Health and Human Development, National Institutes of Health; Dr. Edward Martin, Director of the Bureau of Community Health Services, Health Services Administration; and Dr. Marion Finkel, Associate Director for New Drug Evaluation, Food and Drug Administration.

I know this subcommittee has expressed concern regarding the position and functions of the Deputy Assistant Secretary for Population Affairs. As you may know, I asked Dr. Joyce Lashof to assume that position as well as that of Deputy Assistant Secretary for Health Programs. She has done an outstanding job in accomplishing all that is involved in both functions.

We felt we needed the time to take a careful and hard look at the role of the Deputy Assistant Secretary for Population Affairs and the functioning of the Office of Population Affairs.