3.0.0 3211 2023-01-11T13:22:05Z 2023-01-11T13:22:05Z House H HR 2011-10-14 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BASS of New Hampshire:H.R. 3211.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the Constitution.[Page H6977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-10-18T13:48:55Z Referred to 2011-10-14T13:02:40Z 2011-10-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-10-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-10-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-10-14 Introduced in House IntroReferral 1000 9 Library of Congress B000220 Rep. Bass, Charles F. [R-NH-2] CHARLES BASS R NH F. 2 N R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2011-10-14 True L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2011-10-14 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-14 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2011-10-14 True P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2011-10-14 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-10-14 True S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2011-10-14 True C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2011-10-27 False K000363 Rep. Kline, John [R-MN-2] John Kline R MN 2 2011-11-16 False S001179 Rep. Schock, Aaron [R-IL-18] Aaron Schock R IL 18 2012-01-18 False M001181 Rep. Meehan, Patrick [R-PA-7] Patrick Meehan R PA 7 2012-01-24 False Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health technology, devices, supplies Health

00 2011-10-14 Introduced in House 2012-02-13T23:12:55Z Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

]]>

Display Title Official Title as Introduced Introduced in House IH Short Titles as Introduced Introduced in House 2011-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3211ih/xml/BILLS-112hr3211ih.xml 2011-10-18 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.