3.0.0 269 2022-11-01T13:49:26Z 2022-11-01T13:49:26Z House HR 2019-01-08 116 [Congressional Record Volume 165, Number 3 (Tuesday, January 8, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. ESHOO:H.R. 269.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H285]]]> hsju00 Judiciary Committee House Standing Referred to 2019-01-08T17:04:30Z hsvr00 Veterans' Affairs Committee House Standing Referred to 2019-01-08T17:04:25Z hshm00 Homeland Security Committee House Standing Referred to 2019-01-08T17:04:20Z hsif00 Energy and Commerce Committee House Standing Referred to 2019-01-08T17:04:15Z SMASH Act 116 345 HR 2019-01-25 Referred to the Subcommittee on Health. Related bill CRS To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. 116 3443 HR 2019-07-24 Sponsor introductory remarks on measure. (CR E971) Related bill CRS Strengthening the National Disaster Medical System Act of 2019 116 11 S 2019-01-03 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 116 1379 S 2019-06-24 Became Public Law No: 116-22. Related bill CRS Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 116 2740 S 2019-12-14 Referred to the Subcommittee on Health. Related bill CRS 2019-01-10 Senate Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10. Calendars 2019-01-09 Senate Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. Calendars 2019-01-08 19:01:35 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2019-01-08 19:01:34 On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 401 - 17 (Roll no. 13). (text: CR H237-262) Floor H37300 2 House floor actions 13 https://clerk.house.gov/evs/2019/roll013.xml House 116 2019-01-09T00:01:34Z 1 2019-01-08 19:01:34 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 401 - 17 (Roll no. 13).(text: CR H237-262) Floor 8000 9 Library of Congress 13 https://clerk.house.gov/evs/2019/roll013.xml House 116 2019-01-09T00:01:34Z 1 2019-01-08 18:30:52 Considered as unfinished business. (consideration: CR H275-276) Floor H30000 2 House floor actions 2019-01-08 16:36:40 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2019-01-08 16:14:09 DEBATE - The House proceeded with forty minutes of debate on H.R. 269. Floor H8D000 2 House floor actions 2019-01-08 16:14:07 Considered under suspension of the rules. (consideration: CR H237-266) Floor H30000 2 House floor actions 2019-01-08 16:13:50 Mr. Pallone moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2019-01-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-01-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsvr00 Veterans' Affairs Committee 2019-01-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hshm00 Homeland Security Committee 2019-01-08 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-01-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-01-08 Introduced in House IntroReferral 1000 9 Library of Congress E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 N B001284 Rep. Brooks, Susan W. [R-IN-5] Susan Brooks R IN W. 5 2019-01-08 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2019-01-08 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2019-01-08 True D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2019-01-08 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2019-01-08 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2019-01-08 True W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2019-01-08 True Health Administrative law and regulatory procedures Advanced technology and technological innovations Advisory bodies Aging Blood and blood diseases Border security and unlawful immigration Centers for Disease Control and Prevention (CDC) Chemical and biological weapons Child health Child safety and welfare Computer security and identity theft Congressional oversight Consumer affairs Disability and paralysis Disaster relief and insurance Drug safety, medical device, and laboratory regulation Emergency communications systems Emergency medical services and trauma care Emergency planning and evacuation Environmental health First responders and emergency personnel Food and Drug Administration (FDA) General health and health care finance matters Genetics Government employee pay, benefits, personnel management Government information and archives Government liability Hazardous wastes and toxic substances Health facilities and institutions Health information and medical records Health personnel Health programs administration and funding Health promotion and preventive care Health technology, devices, supplies Homeland security Hospital care Immunology and vaccination Infectious and parasitic diseases Infrastructure development Intelligence activities, surveillance, classified information Intergovernmental relations Judicial review and appeals Licensing and registrations Marketing and advertising Medical research Military medicine Minority health Musculoskeletal and skin diseases Natural disasters Performance measurement Prescription drugs Research and development Social work, volunteer service, charitable organizations State and local government operations Technology assessment Terrorism User charges and fees Veterinary medicine and animal diseases Women's health World health Health 00 2019-01-08 Introduced in House 2020-08-20T13:29:09Z Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

This bill (1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs.

Among other programs, the bill reauthorizes through FY2023 and revises

  • the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC),
  • the Hospital Preparedness Program,
  • the CDC situational-awareness and biosurveillance program,
  • the Emergency System for Advance Registration of Volunteer Health Professionals,
  • the National Disaster Medical System,
  • the Volunteer Medical Reserve Corps,
  • the National Advisory Committee on Children and Disasters,
  • the Strategic National Stockpile, and
  • the Biomedical Advanced Research and Development Authority.

In addition, the bill provides statutory authority for existing programs, including the CDC's Children's Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise. The bill also establishes new programs and entities, including a trauma-center grant program to support military trauma teams.

The bill further modifies the approval process for OTC drugs by providing statutory authority for the Food and Drug Administration (FDA) to (1) regulate certain OTC drugs that are marketed without an approved new-drug application, and (2) issue administrative orders specifying the conditions under which an OTC drug may be deemed safe and effective and not subject to approval as a new drug. The FDA must assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.

]]> 53 2019-01-08 Passed House 2020-09-11T18:38:21Z Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

This bill (1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs.

Among other programs, the bill reauthorizes through FY2023 and revises

  • the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC),
  • the Hospital Preparedness Program,
  • the CDC situational-awareness and biosurveillance program,
  • the Emergency System for Advance Registration of Volunteer Health Professionals,
  • the National Disaster Medical System,
  • the Volunteer Medical Reserve Corps,
  • the National Advisory Committee on Children and Disasters,
  • the Strategic National Stockpile, and
  • the Biomedical Advanced Research and Development Authority.

In addition, the bill provides statutory authority for existing programs, including the CDC's Children's Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise. The bill also establishes new programs and entities, including a trauma-center grant program to support military trauma teams.

The bill further modifies the approval process for OTC drugs by providing statutory authority for the Food and Drug Administration (FDA) to (1) regulate certain OTC drugs that are marketed without an approved new-drug application, and (2) issue administrative orders specifying the conditions under which an OTC drug may be deemed safe and effective and not subject to approval as a new drug. The FDA must assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.

]]> Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Display Title Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Short Title(s) as Passed House Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 H House Engrossed in House EH Short Title(s) as Passed House for portions of this bill Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H House Engrossed in House EH Official Title as Introduced To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. Engrossed in House EH Short Titles as Passed House for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 H House Short Titles as Passed House for portions of this bill Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H House Short Titles as Passed House Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 H House Placed on Calendar Senate 2019-01-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr269pcs/xml/BILLS-116hr269pcs.xml Engrossed in House 2019-01-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr269eh/xml/BILLS-116hr269eh.xml 2019-01-10 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10. 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.