The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain National Academies’ studies. (Pound signs [##] between passages denote the deletion of unrelated text.)
S1789 Dodd (D-Conn.) 12/18/01
Enrolled (finally passed both houses)
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children.
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SEC. 12. STUDY CONCERNING RESEARCH INVOLVING CHILDREN.
(a) CONTRACT WITH INSTITUTE OF MEDICINE.-The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for-
(1) the conduct, in accordance with subsection (b), of a review of-
(A) Federal regulations in effect on the date of the enactment of this Act relating to research involving children;
(B) federally prepared or supported reports relating to research involving children; and
(C) federally supported evidence-based research involving children; and
(2) the submission to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, not later than two years after the date of enactment of this Act, of a report concerning the review conducted under paragraph (1) that includes recommendations on best practices relating to research involving children.
(b) AREAS OF REVIEW.-In conducting the review under subsection (a)(1), the Institute of Medicine shall consider the following:
(1) The written and oral process of obtaining and defining "assent", "permission" and "informed consent" with respect to child clinical research participants and the parents, guardians, and the individuals who may serve as the legally authorized representatives of such children (as defined in subpart A of part 46 of title 45, Code of Federal Regulations).
(2) The expectations and comprehension of child research participants and the parents, guardians, or legally authorized
representatives of such children, for the direct benefits and risks of the child´s research involvement, particularly in terms of research versus therapeutic treatment.
(3) The definition of "minimal risk" with respect to a healthy child or a child with an illness.
(4) The appropriateness of the regulations applicable to children of differing ages and maturity levels, including regulations relating to legal status.
(5) Whether payment (financial or otherwise) may be provided to a child or his or her parent, guardian, or legally authorized representative for the participation of the child in research, and if so, the amount and type of payment that may be made.
(6) Compliance with the regulations referred to in subsection (a)(1)(A), the monitoring of such compliance (including the role of institutional review boards), and the enforcement actions taken for violations of such regulations.
(7) The unique roles and responsibilities of institutional review boards in reviewing research involving children, including composition of membership on institutional review boards.
(c) REQUIREMENTS OF EXPERTISE.-The Institute of Medicine shall conduct the review under subsection (a)(1) and make recommendations under subsection (a)(2) in conjunction with experts in pediatric medicine, pediatric
research, and the ethical conduct of research involving children.
SEC. 13. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.
Section 499 of the Public Health Service Act (42 U.S.C. 290b) is amended-
(1) in subsection (b), by inserting "(including collection of funds for pediatric pharmacologic research)" after "mission";
(2) in subsection (c)(1)-
(A) by redesignating subparagraph (C) as subparagraph (D); and
(B) by inserting after subparagraph (B) the following:
"(C) A program to collect funds for pediatric pharmacologic research and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C)).";
(3) in subsection (d)-
(A) in paragraph (1)-
(i) in subparagraph (B)-
(I) in clause (ii), by striking "and" at the end;
(II) in clause (iii), by striking the period and inserting "; and"; and
(III) by adding at the end the following:
"(iv) the Commissioner of Food and Drugs."; and
(ii) by striking subparagraph (C) and inserting the following:
"(C) The ex officio members of the Board under subparagraph (B) shall appoint to the Board individuals from among a list of candidates to be provided by the National Academy of Science. Such appointed members shall include-
"(i) representatives of the general biomedical field;
"(ii) representatives of experts in pediatric medicine and research;
"(iii) representatives of the general biobehavioral field, which may include experts in biomedical ethics; and
"(iv) representatives of the general public, which may include representatives of affected industries."; and
(B) in paragraph (2), by realigning the margin of subparagraph (B) to align with subparagraph (A);
(4) in subsection (k)(9)-
(A) by striking "The Foundation" and inserting the following:
"(A) IN GENERAL.-The Foundation"; and
(B) by adding at the end the following:
"(B) GIFTS, GRANTS, AND OTHER DONATIONS.-
"(i) IN GENERAL.-Gifts, grants, and other donations to the Foundation may be designated for pediatric research and studies on drugs, and funds so designated shall be used solely for grants for research and studies under subsection (c)(1)(C).
"(ii) OTHER GIFTS.-Other gifts, grants, or donations received by the Foundation and not described in clause (i) may also be used to support such pediatric research and studies.
"(iii) REPORT.-The recipient of a grant for research and studies shall agree to provide the Director of the National Institutes of Health and the Commissioner of Food and Drugs, at the conclusion of the research and studies-
"(I) a report describing the results of the research and studies; and
"(II) all data generated in connection with the research and studies.
"(iv) ACTION BY THE COMMISSIONER OF FOOD AND DRUGS.-The Commissioner of Food and Drugs shall take appropriate action in response to a report received under clause (iii) in accordance with paragraphs (7) through (12) of section 409I(c), including negotiating with the holders of approved applications for the drugs studied for any labeling changes that the Commissioner determines to be appropriate and requests the holders to make.
"(C) APPLICABILITY.-Subparagraph (A) does not apply to the program described in subsection (c)(1)(C).";
(5) by redesignating subsections (f) through (m) as subsections (e) through (l), respectively;
(6) in subsection (h)(11) (as so redesignated), by striking "solicit" and inserting "solicit,"; and
(7) in paragraphs (1) and (2) of subsection (j) (as so redesignated), by striking "(including those developed under
subsection (d)(2)(B)(i)(II))" each place it appears.