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Bill114th CongressFiled Sep 17, 2015Health
S. 2055

Medical Countermeasure Innovation Act of 2016

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What it doesSummary reported to senate with amendment(s) (Mar 14, 2016)

Medical Countermeasure Innovation Act of 2016

(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats. HHS must report on funding for procurement of medical countermeasures when available funds are below a specified amount.

(Sec. 3) The Biomedical Advanced Research and Development Authority's (BARDA's) contracting authority for procurement of medical countermeasures under Project BioShield is codified.

(Sec. 4) The Office of the Assistant Secretary for Preparedness and Response must annually publish its budget plan for medical countermeasures.

(Sec. 5) BARDA may enter an agreement with an independent, nongovernmental nonprofit to foster and accelerate the development and innovation of medical countermeasures and related technologies. BARDA must direct and oversee the nonprofit's work and ensure transparency and accountability.

(Sec. 6) BARDA's procurement of medical countermeasures no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.

(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 drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) 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.

(Sec. 8) The Government Accountability Office must report on the effectiveness of this priority review voucher program in providing incentives for the development of material threat medical countermeasures.

What just happenedMar 14, 2016

Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.

Who’s behind it

Sen. Burr, Richard [R-NC](R-NC)Sponsor
4 cosponsors1 D3 R
Read on Congress.gov
4cosponsors1committees6actions1related bills15subjects
  1. Mar 14, 2016Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.

  2. Mar 14, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  3. Mar 14, 2016Committee14000

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  4. Mar 9, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

    Health, Education, Labor, and Pensions Committee
  5. Sep 17, 2015IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  6. Sep 17, 2015IntroReferral10000

    Introduced in Senate

Reported to Senate with amendment(s)Mar 14, 20161

Medical Countermeasure Innovation Act of 2016

(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats. HHS must report on funding for procurement of medical countermeasures when available funds are below a specified amount.

(Sec. 3) The Biomedical Advanced Research and Development Authority's (BARDA's) contracting authority for procurement of medical countermeasures under Project BioShield is codified.

(Sec. 4) The Office of the Assistant Secretary for Preparedness and Response must annually publish its budget plan for medical countermeasures.

(Sec. 5) BARDA may enter an agreement with an independent, nongovernmental nonprofit to foster and accelerate the development and innovation of medical countermeasures and related technologies. BARDA must direct and oversee the nonprofit's work and ensure transparency and accountability.

(Sec. 6) BARDA's procurement of medical countermeasures no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.

(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 drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) 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.

(Sec. 8) The Government Accountability Office must report on the effectiveness of this priority review voucher program in providing incentives for the development of material threat medical countermeasures.

Introduced in SenateSep 17, 2015

Medical Countermeasure Innovation Act of 2015

This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats.

The Biomedical Advanced Research and Development Authority's contracting authority for procurement of medical countermeasures under Project BioShield is codified. Such procurement no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.

The Office of the Assistant Secretary for Preparedness and Response must publish its budget plan for medical countermeasures.

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to explain delays in finalizing guidance regarding development of animal models to support approval of medical countermeasures.

Upon approval, the FDA must award a priority review voucher to the sponsor of a drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have a new medication application 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.
Medical Countermeasure Innovation Act of 2016 — Informed