3.0.0 4274 2019-11-15T21:18:14Z 2019-11-15T21:18:14Z House H HR 2012-03-28 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ROGERS of Michigan:H.R. 4274.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 of the Constitution, whichstates: ``The Congress shall have Power To regulate Commercewith foreign Nations, and among the several States, and withthe Indian tribes''Article I, Section 8, Clause 18 of the Constitution, whichstates ``To make all Laws which shall be necessary and properfor carrying into Execution the foregoing Powers, and allother Powers vested by this Constitution in the Government ofthe United States or in any Department or Officer thereof.''[Page H1740]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-03-30T18:19:41Z Referred to 2012-03-28T14:00:37Z Food and Drug Administration Reform Act of 2012 112 5651 HR 2012-06-04 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420. Related bill CRS 2012-03-30 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-03-28 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-03-28 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-03-28 Introduced in House IntroReferral 1000 9 Library of Congress R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 N E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2012-03-28 True M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2012-03-28 True Health Administrative law and regulatory procedures Advisory bodies Cancer Child health Congressional oversight Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Intellectual property Medical research Prescription drugs Health 00 2012-03-28 Introduced in House 2012-06-13T17:01:07Z BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA).

Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity.

Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change.

Requires a product sponsor to submit an Initial Pediatric Plan as part of the drug application process and sets forth the process for such submission.

Authorizes the Secretary of Health and Human Services (HHS) to: (1) grant a deferral extension, and sets forth the conditions for such deferral; and (2) issue a non-compliance letter to a product sponsor failing to meet post-marketing requirements, and requires the product sponsor to respond in writing.

Authorizes the Pediatric Review Committee to review deferral extensions.

Requires the Office of Pediatric Therapeutics to include a neonatologist and pediatric epidemiologist.

Reauthorizes the Pediatric Advisory Committee and the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.

]]> BPCA and PREA Reauthorization Act of 2012 Short Titles as Introduced BPCA and PREA Reauthorization Act of 2012 Display Title BPCA and PREA Reauthorization Act of 2012 Official Title as Introduced To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. Introduced in House 2012-03-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr4274ih/xml/BILLS-112hr4274ih.xml 2012-03-30 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.