PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 863
device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.
(a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— (1) in paragraph (21), by striking ‘‘and’’ after the semicolon at the end; (2) in paragraph (22), by striking the period at the end and inserting ‘‘; and’’; and (3) by inserting after paragraph (22) the following: ‘‘(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.’’. (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.— (1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Director of the National Institutes of Health, and the Director of the Agency for Healthcare Research and Quality, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a plan for expanding pediatric medical device research and development. In developing such plan, the Secretary of Health and Human Services shall consult with individuals and organizations with appropriate expertise in pediatric medical devices. (2) CONTENTS.—The plan under paragraph (1) shall include— (A) the current status of federally funded pediatric medical device research; (B) any gaps in such research, which may include a survey of pediatric medical providers regarding unmet pediatric medical device needs, as needed; and (C) a research agenda for improving pediatric medical device development and Food and Drug Administration clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and effectiveness of pediatric medical devices.
Deadline.
VerDate Aug 31 2005
42 USC 282 note.
(a) IN GENERAL.— (1) REQUEST FOR PROPOSALS.—Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development. (2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section. (b) APPLICATION.—A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require. dkrause on GSDDPC44 with PUBLAW
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY.
Deadline.
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