3.0.0 2245 2022-02-03T05:53:06Z 2022-02-03T05:53:06Z House H HR 2011-06-21 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeGETTE:H.R. 2245.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 of the United StatesConstitution.[Page H4364]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-06-22T19:23:57Z Referred to 2011-06-21T16:00:18Z 2011-06-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-06-21 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-06-21 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-06-21 Introduced in House IntroReferral 1000 9 Library of Congress D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 N R000583 Rep. Rooney, Thomas J. [R-FL-16] Thomas Rooney R FL J. 16 2011-06-21 True C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2011-07-07 False L000111 Rep. Latham, Tom [R-IA-4] TOM LATHAM R IA 4 2011-07-07 False C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2011-07-13 False S000480 Rep. Slaughter, Louise McIntosh [D-NY-28] LOUISE SLAUGHTER D NY M. 28 2011-07-19 False J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 2011-07-19 False E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2011-07-20 False L000287 Rep. Lewis, John [D-GA-5] JOHN LEWIS D GA 5 2011-07-21 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2011-08-05 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2011-09-07 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2011-09-07 False J000288 Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4] Henry Johnson D GA C. "Hank" 4 2011-09-07 False L000480 Rep. Lowey, Nita M. [D-NY-18] NITA LOWEY D NY M. 18 2011-09-07 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2011-09-12 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2011-09-12 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2011-09-14 False N000179 Rep. Napolitano, Grace F. [D-CA-38] GRACE NAPOLITANO D CA F. 38 2011-09-14 False E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2011-09-14 False D000191 Rep. DeFazio, Peter A. [D-OR-4] PETER DEFAZIO D OR A. 4 2011-09-15 False P000597 Rep. Pingree, Chellie [D-ME-1] Chellie Pingree D ME 1 2011-09-15 False T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2011-09-22 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2011-09-22 False M001149 Rep. Michaud, Michael H. [D-ME-2] Michael Michaud D ME H. 2 2011-09-22 False C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 2011-09-22 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2011-09-22 False N000002 Rep. Nadler, Jerrold [D-NY-8] JERROLD NADLER D NY 8 2011-10-03 False L000563 Rep. Lipinski, Daniel [D-IL-3] Daniel Lipinski D IL William 3 2011-10-03 False H000627 Rep. Hinchey, Maurice D. [D-NY-22] MAURICE HINCHEY D NY D. 22 2011-10-03 False R000462 Rep. Rothman, Steven R. [D-NJ-9] STEVEN ROTHMAN D NJ R. 9 2011-10-03 False L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2011-10-03 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2011-10-05 False R000591 Rep. Roby, Martha [R-AL-2] Martha Roby R AL 2 2011-10-05 False P000585 Rep. Platts, Todd Russell [R-PA-19] TODD PLATTS R PA RUSSELL 19 2011-10-05 False R000593 Rep. Ross, Dennis A. [R-FL-12] Dennis Ross R FL A. 12 2011-10-06 False Y000031 Rep. Young, C. W. Bill [R-FL-10] C. W. Young R FL Bill 10 2011-10-06 False W000809 Rep. Womack, Steve [R-AR-3] Steve Womack R AR 3 2011-10-13 False W000807 Rep. West, Allen B. [R-FL-22] Allen West R FL B. 22 2011-10-13 False D000600 Rep. Diaz-Balart, Mario [R-FL-21] Mario Diaz-Balart R FL 21 2011-10-14 False C001083 Rep. Carney, John C., Jr. [D-DE-At Large] John Carney D DE C. 0 2011-10-14 False Y000062 Rep. Yarmuth, John A. [D-KY-3] John Yarmuth D KY A. 3 2011-10-25 False M000087 Rep. Maloney, Carolyn B. [D-NY-14] CAROLYN MALONEY D NY B. 14 2011-10-25 False B000652 Rep. Boswell, Leonard L. [D-IA-3] LEONARD BOSWELL D IA L. 3 2011-10-25 False I000057 Rep. Israel, Steve [D-NY-2] STEVE ISRAEL D NY 2 2011-10-25 False G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2011-10-25 False B001245 Del. Bordallo, Madeleine Z. [D-GU-At Large] Madeleine Bordallo D GU Z. 0 2011-10-25 False K000210 Rep. King, Peter T. [R-NY-3] PETER KING R NY T. 3 2011-10-27 False Y000033 Rep. Young, Don [R-AK-At Large] DON YOUNG R AK E. 0 2011-11-01 False S001168 Rep. Sarbanes, John P. [D-MD-3] John Sarbanes D MD P. 3 2011-11-01 False C001066 Rep. Castor, Kathy [D-FL-11] Kathy Castor D FL 11 2011-11-01 False M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2011-11-01 False V000128 Rep. Van Hollen, Chris [D-MD-8] Chris Van Hollen D MD 8 2011-11-01 False L000551 Rep. Lee, Barbara [D-CA-9] BARBARA LEE D CA 9 2011-11-01 False C001059 Rep. Costa, Jim [D-CA-20] Jim Costa D CA 20 2011-11-04 False H001046 Rep. Heinrich, Martin [D-NM-1] Martin Heinrich D NM T. 1 2011-11-04 False C001047 Rep. Capito, Shelley Moore [R-WV-2] Shelley Capito R WV Moore 2 2011-11-04 False R000170 Rep. Reyes, Silvestre [D-TX-16] SILVESTRE REYES D TX 16 2011-11-15 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2011-12-01 False C000754 Rep. Cooper, Jim [D-TN-5] JAMES COOPER D TN H. 5 2011-12-12 False S001162 Rep. Schwartz, Allyson Y. [D-PA-13] Allyson Schwartz D PA Y. 13 2011-12-12 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2011-12-20 False P000099 Rep. Pastor, Ed [D-AZ-4] ED PASTOR D AZ 4 2011-12-20 False A000362 Rep. Altmire, Jason [D-PA-4] Jason Altmire D PA 4 2012-01-25 False C001036 Rep. Capps, Lois [D-CA-23] LOIS CAPPS D CA 23 2012-02-07 False M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2012-02-15 False H001063 Rep. Hahn, Janice [D-CA-36] Janice Hahn D CA 36 2012-02-17 False F000451 Rep. Fitzpatrick, Michael G. [R-PA-8] Michael Fitzpatrick R PA G. 8 2012-02-27 False B000574 Rep. Blumenauer, Earl [D-OR-3] EARL BLUMENAUER D OR 3 2012-02-27 False C001069 Rep. Courtney, Joe [D-CT-2] Joe Courtney D CT 2 2012-02-27 False C001081 Rep. Critz, Mark S. [D-PA-12] Mark Critz D PA S. 12 2012-02-29 False R000581 Rep. Richardson, Laura [D-CA-37] Laura Richardson D CA 37 2012-02-29 False B001274 Rep. Brooks, Mo [R-AL-5] Mo Brooks R AL 5 2012-03-06 False A000022 Rep. Ackerman, Gary L. [D-NY-5] GARY ACKERMAN D NY L. 5 2012-03-06 False B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 2012-03-07 False B001259 Rep. Braley, Bruce L. [D-IA-1] Bruce Braley D IA L. 1 2012-03-08 False L000397 Rep. Lofgren, Zoe [D-CA-16] ZOE LOFGREN D CA 16 2012-03-26 False T000460 Rep. Thompson, Mike [D-CA-1] MIKE THOMPSON D CA 1 2012-03-26 False D000610 Rep. Deutch, Theodore E. [D-FL-19] Theodore Deutch D FL E. 19 2012-03-26 False S001175 Rep. Speier, Jackie [D-CA-12] Jackie Speier D CA 12 2012-03-26 False D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2012-03-26 False B000208 Rep. Bartlett, Roscoe G. [R-MD-6] ROSCOE BARTLETT R MD G. 6 2012-03-28 False R000409 Rep. Rohrabacher, Dana [R-CA-46] DANA ROHRABACHER R CA 46 2012-03-29 False K000172 Rep. Kildee, Dale E. [D-MI-5] DALE KILDEE D MI E. 5 2012-04-17 False B000013 Rep. Bachus, Spencer [R-AL-6] SPENCER BACHUS R AL 6 2012-04-19 False P000258 Rep. Peterson, Collin C. [D-MN-7] COLLIN PETERSON D MN C. 7 2012-04-25 False B001278 Rep. Bonamici, Suzanne [D-OR-1] Suzanne Bonamici D OR 1 2012-04-26 False D000482 Rep. Doyle, Michael F. [D-PA-14] MIKE DOYLE D PA 14 2012-05-09 False B000490 Rep. Bishop, Sanford D., Jr. [D-GA-2] SANFORD BISHOP D GA D. 2 2012-05-10 False L000560 Rep. Larsen, Rick [D-WA-2] RICK LARSEN D WA 2 2012-05-18 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2012-05-25 False M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2012-05-25 False K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2012-05-30 False K000375 Rep. Keating, William R. [D-MA-10] William Keating D MA R. 10 2012-05-30 False H001055 Rep. Heck, Joseph J. [R-NV-3] Joseph Heck R NV J. 3 2012-05-31 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2012-05-31 False B001257 Rep. Bilirakis, Gus M. [R-FL-9] Gus Bilirakis R FL M. 9 2012-07-23 False B001254 Rep. Boren, Dan [D-OK-2] Dan Boren D OK 2 2012-09-14 False Health Civil actions and liability Congressional oversight Consumer affairs Government information and archives Government studies and investigations Health care coverage and access Manufacturing Prescription drugs Health 00 2011-06-21 Introduced in House 2011-08-31T20:13:31Z Preserving Access to Life-Saving Medications Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer of a prescription drug marketed in interstate commerce to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption in the manufacture of such drug. Requires the notification to be submitted six months prior to the date of a discontinuance or interruption, if possible.

Allows the reduction of the notification period if the manufacturer certifies to the Secretary that good cause exists for the reduction. Authorizes the Secretary to reduce the notification period based on the type of discontinuance or interruption at issue or any other factor.

Treats any information provided to the Secretary under this Act as a trade secret or confidential information.

Establishes civil monetary penalties for violations.

Requires the Secretary to publish on the website of the Food and Drug Administration (FDA) and distribute to the appropriate health care providers and patient organizations information on discontinuances, interruptions, and drug shortages.

Requires the Secretary to notify a manufacturer of: (1) any determination by the Secretary that a drug may be vulnerable to a drug shortage, and (2) the Secretary's duty to collaborate to improve continuity of supply. Prohibits the Secretary from requiring a manufacturer to: (1) manufacture a drug in the event of a discontinuance or interruption, or (2) delay or alter a discontinuance or interruption.

Declares that no provision of federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage.

Requires the Comptroller General to examine issues related to drug shortages.

]]> Preserving Access to Life-Saving Medications Act of 2011 Short Titles as Introduced Preserving Access to Life-Saving Medications Act of 2011 Display Title Preserving Access to Life-Saving Medications Act of 2011 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages. Introduced in House 2011-06-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr2245ih/xml/BILLS-112hr2245ih.xml 2011-06-22 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.