H.R. 3299, Strengthening Public Health Emergency Response Act of 2016

3.0.0 3299 2023-01-11T13:30:22Z 2023-01-11T13:30:22Z House HR 2015-07-29 114 [Congressional Record Volume 161, Number 121 (Wednesday, July 29, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mrs. BROOKS of Indiana:H.R. 3299.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3[Page H5771]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2016-06-08T13:37:07Z Markup by 2016-06-08T13:36:36Z Referred to 2015-07-31T20:53:29Z Reported by 2016-09-09T16:54:01Z Markup by 2016-07-13T13:23:00Z Referred to 2015-07-29T14:09:05Z H. Rept. 114-735 2016-09-09 Placed on the Union Calendar, Calendar No. 571. Calendars H12410 2 House floor actions U00571 2016-09-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2016-09-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2016-07-13 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by the Yeas and Nays: 36 - 15. Committee 2016-07-13 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2016-07-12 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2016-06-08 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . Committee 2016-06-08 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2016-06-07 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2015-07-31 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-07-29 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-07-29 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-07-29 Introduced in House IntroReferral 1000 9 Library of Congress B001284 Rep. Brooks, Susan W. [R-IN-5] Susan Brooks R IN W. 5 N E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2015-07-29 True F000461 Rep. Flores, Bill [R-TX-17] Bill Flores R TX 17 2015-09-18 False E000291 Rep. Ellmers, Renee L. [R-NC-2] Renee Ellmers R NC L. 2 2015-09-28 False B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2015-09-28 False M001190 Rep. Mullin, Markwayne [R-OK-2] Markwayne Mullin R OK 2 2015-09-28 False H001048 Rep. Hunter, Duncan D. [R-CA-50] Duncan Hunter R CA D. 50 2015-10-08 False W000820 Rep. Walters, Mimi [R-CA-45] Mimi Walters R CA 45 2015-10-21 False B001293 Rep. Bishop, Mike [R-MI-8] Mike Bishop R MI 8 2015-10-21 False L000576 Rep. Long, Billy [R-MO-7] Billy Long R MO 7 2015-11-05 False N000181 Rep. Nunes, Devin [R-CA-22] Devin Nunes R CA 22 2015-11-05 False T000463 Rep. Turner, Michael R. [R-OH-10] Michael Turner R OH R. 10 2015-11-17 False B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2015-12-11 False K000387 Rep. Knight, Stephen [R-CA-25] Stephen Knight R CA 25 2015-12-17 False C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2015-12-17 False B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2015-12-18 False G000559 Rep. Garamendi, John [D-CA-3] John Garamendi D CA 3 2015-12-18 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2015-12-18 False S001193 Rep. Swalwell, Eric [D-CA-15] Eric Swalwell D CA 15 2015-12-18 False C001092 Rep. Collins, Chris [R-NY-27] Chris Collins R NY 27 2016-01-06 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2016-01-06 False C001105 Rep. Comstock, Barbara [R-VA-10] Barbara Comstock R VA 10 2016-01-07 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2016-01-13 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2016-02-02 False K000378 Rep. Kinzinger, Adam [R-IL-16] Adam Kinzinger R IL 16 2016-02-02 False S001192 Rep. Stewart, Chris [R-UT-2] Chris Stewart R UT 2 2016-02-09 False V000130 Rep. Vargas, Juan [D-CA-51] Juan Vargas D CA 51 2016-02-09 False B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 2016-02-09 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2016-02-11 False C001096 Rep. Cramer, Kevin [R-ND-At Large] Kevin Cramer R ND 0 2016-02-12 False H001067 Rep. Hudson, Richard [R-NC-8] Richard Hudson R NC 8 2016-02-23 False J000295 Rep. Joyce, David P. [R-OH-14] David Joyce R OH P. 14 2016-02-25 False J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2016-02-25 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2016-02-25 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2016-03-03 False O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2016-03-03 False S001157 Rep. Scott, David [D-GA-13] David Scott D GA 13 2016-03-03 False C001097 Rep. Cárdenas, Tony [D-CA-29] Tony Cárdenas D CA 29 2016-03-22 False W000804 Rep. Wittman, Robert J. [R-VA-1] Robert Wittman R VA J. 1 2016-04-27 False D000612 Rep. Denham, Jeff [R-CA-10] Jeff Denham R CA 10 2016-04-27 False M001189 Rep. Messer, Luke [R-IN-6] Luke Messer R IN 6 2016-05-11 False R000576 Rep. Ruppersberger, C. A. Dutch [D-MD-2] C. A. Ruppersberger D MD Dutch 2 2016-05-11 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2016-05-16 False S001175 Rep. Speier, Jackie [D-CA-14] Jackie Speier D CA 14 2016-05-16 False S000364 Rep. Shimkus, John [R-IL-15] JOHN SHIMKUS R IL M. 15 2016-05-24 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2016-06-07 False D000619 Rep. Davis, Rodney [R-IL-13] Rodney Davis R IL 13 2016-06-14 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-9] WILLIAM PASCRELL D NJ J. 9 2016-06-15 False 2016-09-07T20:28:06Z H.R. 3299, Strengthening Public Health Emergency Response Act of 2016 https://www.cbo.gov/publication/51975 As ordered reported by the House Committee on Energy and Commerce on July 13, 2016 Health Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Health programs administration and funding Health technology, devices, supplies Hospital care Immunology and vaccination Infectious and parasitic diseases Medical research Public contracts and procurement Research administration and funding Research and development Health

00 2015-07-29 Introduced in House 2016-06-21T19:06:13Z Strengthening Public Health Emergency Response Act of 2015

This bill amends the Public Health Service Act to require the program to enhance community and hospital preparedness for public health emergencies to use at least 97% of its funding for awards.

The Government Accountability Office must report on programs for public health emergency preparedness.

The Department of Health and Human Services (HHS) must ensure procedures are in place to coordinate the ongoing stockpiling of countermeasures (certain medical supplies) by the Biomedical Advanced Research and Development Authority (BARDA) and Centers for Disease Control and Prevention.

Procurement of countermeasures using the Biodefense Countermeasures appropriations account no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security (DHS).

BARDA is given direct contracting authority.

The annual countermeasures plan developed by the Office of the Assistant Secretary for Preparedness and Response must report on the amount of time between a BARDA request and the award of a contract.

This bill amends the Federal Food, Drug, and Cosmetic Act to add diseases and other agents that are determined to be a material threat by DHS to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a listed disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.)]]>

17 2016-09-09 Reported to House with amendment(s) 2017-05-15T20:48:17Z Strengthening Public Health Emergency Response Act of 2016

(Sec. 2) This bill requires the Government Accountability Office (GAO) to report on programs for public health emergency preparedness.

(Sec. 3) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure procedures are in place to coordinate the ongoing stockpiling of countermeasures (certain medical supplies) by the Biomedical Advanced Research and Development Authority (BARDA) and Centers for Disease Control and Prevention.

(Sec. 4) Procurement of countermeasures using the Biodefense Countermeasures appropriations account no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.

(Sec. 5) BARDA is given direct contracting authority.

(Sec. 6) The annual countermeasures plan developed by the Office of the Assistant Secretary for Preparedness and Response must report on the amount of time between a BARDA request and the award of a contract.

(Sec. 7) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award, upon approval, a priority review voucher to the sponsor of a new drug or biological product that can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have an application for a new medication acted upon by the FDA within six months.

The sponsor of a medication that is subject to a voucher must pay a user fee based on the FDA's cost for the priority review process.

The FDA must publish a notice each time it issues a voucher or a voucher is used.

The GAO must report on the effectiveness of this priority review voucher program in providing incentives for the development of material threat medical countermeasures.

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Strengthening Public Health Emergency Response Act of 2016 Display Title Strengthening Public Health Emergency Response Act of 2016 Official Title as Introduced To amend the Public Health Service Act to ensure preparedness for chemical, radiological, biological, and nuclear threats, and for other purposes. Introduced in House IH Short Titles as Introduced Strengthening Public Health Emergency Response Act of 2015 Short Titles as Reported to House Strengthening Public Health Emergency Response Act of 2016 H House Reported in House 2016-09-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr3299rh/xml/BILLS-114hr3299rh.xml Introduced in House 2015-07-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr3299ih/xml/BILLS-114hr3299ih.xml 2016-09-09 Placed on the Union Calendar, Calendar No. 571. 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.