3.0.0 3737 2022-02-03T05:53:15Z 2022-02-03T05:53:15Z House H HR 2011-12-20 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. STEARNS:H.R. 3737.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1.[Page H10015]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-12-23T19:04:19Z Referred to 2011-12-20T14:00:36Z 2011-12-23 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-12-20 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-12-20 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-12-20 Introduced in House IntroReferral 1000 9 Library of Congress S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 N T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2011-12-20 True B001271 Rep. Benishek, Dan [R-MI-1] Dan Benishek R MI 1 2012-01-25 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2012-02-09 False R000462 Rep. Rothman, Steven R. [D-NJ-9] STEVEN ROTHMAN D NJ R. 9 2012-02-28 False A000210 Rep. Andrews, Robert E. [D-NJ-1] ROBERT ANDREWS D NJ E. 1 2012-02-28 False V000081 Rep. Velazquez, Nydia M. [D-NY-12] NYDIA VELAZQUEZ D NY M. 12 2012-02-28 False B000208 Rep. Bartlett, Roscoe G. [R-MD-6] ROSCOE BARTLETT R MD G. 6 2012-02-28 False R000587 Rep. Ribble, Reid J. [R-WI-8] Reid Ribble R WI J. 8 2012-03-06 False L000554 Rep. LoBiondo, Frank A. [R-NJ-2] FRANK LOBIONDO R NJ A. 2 2012-03-29 False D000191 Rep. DeFazio, Peter A. [D-OR-4] PETER DEFAZIO D OR A. 4 2012-04-16 False H001052 Rep. Harris, Andy [R-MD-1] Andy Harris R MD 1 2012-04-16 False M001181 Rep. Meehan, Patrick [R-PA-7] Patrick Meehan R PA 7 2012-04-26 False B001269 Rep. Barletta, Lou [R-PA-11] Lou Barletta R PA 11 2012-05-29 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) Health 00 2011-12-20 Introduced in House 2012-03-05T22:10:54Z Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available.

Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.

]]> ULTRA Short Titles as Introduced Unlocking Lifesaving Treatments for Rare-Diseases Act Short Titles as Introduced ULTRA Display Title ULTRA Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to fast track approval of certain orphan drugs. Introduced in House 2011-12-20T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3737ih/xml/BILLS-112hr3737ih.xml 2011-12-23 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.