Summary: H.R.3299 — 114th Congress (2015-2016)All Information (Except Text)

Bill summaries are authored by CRS.

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Reported to House with amendment(s) (09/09/2016)

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.