To amend the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Better Pharmaceuticals and Devices for Children Act of 2012''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents for this Act is as follows:
Sec. 1. Short title. Sec. 2. Table of contents; references in Act. Sec. 3. Permanence. Sec. 4. Written requests. Sec. 5. Communication with Pediatric Review Committee. Sec. 6. Access to data. Sec. 7. Ensuring the completion of pediatric studies. Sec. 8. Pediatric study plans. Sec. 9. Reauthorizations. Sec. 10. Report. Sec. 11. Technical amendments. (b) References in Act.--Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 3. PERMANENCE.
(a) Pediatric Studies of Drugs.--Subsection (q) of section 505A (21 U.S.C. 355a) is amended-- (1) in paragraph (1), by striking ``on or before October 1, 2012,''; and (2) in paragraph (2), by striking ``on or before October 1, 2012,''. (b) Research Into Pediatric Uses for Drugs and Biological Products.--Section 505B (21 U.S.C. 355c) is amended-- (1) by striking subsection (m); and (2) by redesignating subsection (n) as subsection (m).
SEC. 4. WRITTEN REQUESTS.
(a) Federal Food, Drug, and Cosmetic Act.--Subsection...