115 STAT. 1416 PUBLIC LAW 107-109^JAN. 4, 2002 or other aspect is protected by patent or by exclusivity under clause (iii) or (iv) of section 505{j)(5)(D). "(2) LABELING.— Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(D), the Secretary may require that the labeling of a drug approved under section 505(j) that omits a pediatric indication or other aspect of labeling as described in paragraph (1) include— "(A) a statement that, because of marketing exclusivity for a manufacturer— "(i) the drug is not labeled for pediatric use; or "(ii) in the case of a drug for which there is an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and "(B) a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary. " (3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER PROVISIONS. —This subsection does not affect— "(A) the availability or scope of exclusivity under this section; "(B) the availability or scope of exclusivity under section 505 for pediatric formulations; "(C) the question of the eligibility for approval of any application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(D); or "(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505.". 21 USC 355a (b) EFFECTIVE DATE. —The amendment made by subsection (a) iiote. takes effect on the date of enactment of this Act, including with respect to applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j*)) that are approved or pending on that date. 42 USC 289 note. 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:
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