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Bill114th CongressFiled Jul 29, 2015Health
H.R. 3299

Strengthening Public Health Emergency Response Act of 2016

Bill journey · stage 2 of 5

Under committee review

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What it doesSummary reported to house with amendment(s) (Sep 9, 2016)

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.

What just happenedSep 9, 2016

Placed on the Union Calendar, Calendar No. 571.

Who’s behind it

Rep. Brooks, Susan W. [R-IN-5](R-IN)Sponsor
47 cosponsors12 D35 R
Read on Congress.gov
47cosponsors1committees13actions13subjects
  1. Sep 9, 2016CalendarsH12410

    Placed on the Union Calendar, Calendar No. 571.

  2. Sep 9, 2016CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735.

    Energy and Commerce Committee
  3. Sep 9, 2016Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735.

    Energy and Commerce Committee
  4. Jul 13, 2016Committee

    Ordered to be Reported (Amended) by the Yeas and Nays: 36 - 15.

    Energy and Commerce Committee
  5. Jul 13, 2016Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  6. Jul 12, 2016Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  7. Jun 8, 2016Committee

    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

    Health Subcommittee
  8. Jun 8, 2016Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  9. Jun 7, 2016Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  10. Jul 31, 2015Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  11. Jul 29, 2015IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  12. Jul 29, 2015IntroReferralIntro-H

    Introduced in House

  13. Jul 29, 2015IntroReferral1000

    Introduced in House

Reported to House with amendment(s)Sep 9, 201617

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.

Introduced in HouseJul 29, 2015

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.)
Strengthening Public Health Emergency Response Act of 2016 — Informed