3.0.0 4156 2019-11-15T21:18:14Z 2019-11-15T21:18:14Z House H HR 2012-03-07 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MARKEY:H.R. 4156.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8.[Page H1273]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-03-09T18:33:29Z Referred to 2012-03-07T15:01:25Z ExPERT Act 112 2281 S 2012-03-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2012-03-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-03-07 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-03-07 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-03-07 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N M001179 Rep. Marino, Tom [R-PA-10] Tom Marino R PA 10 2012-03-07 True S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 2012-03-07 True B000013 Rep. Bachus, Spencer [R-AL-6] SPENCER BACHUS R AL 6 2012-03-28 False P000099 Rep. Pastor, Ed [D-AZ-4] ED PASTOR D AZ 4 2012-03-28 False M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2012-03-28 False D000604 Rep. Dent, Charles W. [R-PA-15] Charles Dent R PA W. 15 2012-03-28 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2012-03-28 False M001134 Rep. Myrick, Sue Wilkins [R-NC-9] SUE MYRICK R NC WILKINS 9 2012-03-28 False F000456 Rep. Fleming, John [R-LA-4] John Fleming R LA 4 2012-03-28 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2012-05-08 False K000210 Rep. King, Peter T. [R-NY-3] PETER KING R NY T. 3 2012-05-08 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2012-05-08 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2012-05-08 False M001182 Rep. Mulvaney, Mick [R-SC-5] Mick Mulvaney R SC 5 2012-05-08 False T000469 Rep. Tonko, Paul [D-NY-21] Paul Tonko D NY 21 2012-05-08 False C000556 Rep. Coble, Howard [R-NC-6] HOWARD COBLE R NC 6 2012-05-08 False W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2012-05-08 False D000482 Rep. Doyle, Michael F. [D-PA-14] MIKE DOYLE D PA 14 2012-05-08 False W000672 Rep. Wolf, Frank R. [R-VA-10] FRANK WOLF R VA R. 10 2012-05-10 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2012-06-21 False L000397 Rep. Lofgren, Zoe [D-CA-16] ZOE LOFGREN D CA 16 2012-06-21 False C001066 Rep. Castor, Kathy [D-FL-11] Kathy Castor D FL 11 2012-11-29 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Genetics Medical research Public-private cooperation Health 00 2012-03-07 Introduced in House 2012-06-25T19:37:29Z Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.

Requires, under such program, each review division within the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include: (1) rare diseases; (2) the severity of rare diseases; (3) the unmet medical need associated with rare diseases; (4) the willingness and ability of individuals with a rare disease to participate in clinical trials; (5) an assessment of the benefits and risks, including side effects, of current and investigational therapies; (6) the design of clinical trials for rare disease populations and subpopulations; and (7) demographics and the clinical description of patient populations. Allows external experts to request the opportunity to meet with a review division regarding any such topic. Authorizes the Secretary to determine the timing of each consultation, which may occur prior to, or following, the filing of an investigational new drug application, a new drug application, or a biologies license application.

Requires the experts consulted to be considered special government employees.

]]> EXPERRT Act of 2012 Short Titles as Introduced EXPERRT Act of 2012 Short Titles as Introduced Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 Display Title EXPERRT Act of 2012 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases. Introduced in House 2012-03-07T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr4156ih/xml/BILLS-112hr4156ih.xml 2012-03-09 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.