Page:United States Statutes at Large Volume 117.djvu/1959

 117 STAT. 1940

Certification.

Deadline. Certification.

VerDate 11-MAY-2000

10:15 Aug 27, 2004

PUBLIC LAW 108–155—DEC. 3, 2003

‘‘(bb) the Secretary does not receive a response as specified under section 409I(c)(2) of that Act; and ‘‘(iii)(I) the Secretary certifies under subparagraph (B) that there are insufficient funds under sections 409I and 499 of the Public Health Service Act (42 U.S.C. 284m, 290b) to conduct the study; or ‘‘(II) the Secretary publishes in the Federal Register a certification that certifies that— ‘‘(aa) no contract or grant has been awarded under section 409I or 499 of the Public Health Service Act (42 U.S.C. 284m, 290b); and ‘‘(bb) not less than 270 days have passed since the date of a certification under subparagraph (B) that there are sufficient funds to conduct the study. ‘‘(B) NO AGREEMENT TO REQUEST.—Not later than 60 days after determining that no holder will agree to the written request (including a determination that the Secretary has not received a response specified under section 505A(d) of this Act or section 409I of the Public Health Service Act (42 U.S.C. 284m), the Secretary shall certify whether the Secretary has sufficient funds to conduct the study under section 409I or 499 of the Public Health Service Act (42 U.S.C. 284m, 290b), taking into account the prioritization under section 409I. ‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B)(i) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be considered to represent a meaningful therapeutic benefit over existing therapies if the Secretary estimates that— ‘‘(1) if approved, the drug or biological product would represent a significant improvement in the treatment, diagnosis, or prevention of a disease, compared with marketed products adequately labeled for that use in the relevant pediatric population; or ‘‘(2) the drug or biological product is in a class of products or for an indication for which there is a need for additional options. ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit an assessment described in subsection (a)(2), or a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b)— ‘‘(1) the drug or biological product that is the subject of the assessment or request may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303); but ‘‘(2) the failure to submit the assessment or request shall not be the basis for a proceeding— ‘‘(A) to withdraw approval for a drug under section 505(e); or ‘‘(B) to revoke the license for a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262).

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