Strengthening Public Health Emergency Response Act of 2016

Bill: 114-hr-3299
Sponsor: Rep. Brooks, Susan W. [R-IN-5]
Introduced: 2015-07-29 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2015-07-29
text: 

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.)
action_date: 2016-09-09
text: 

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.


Legislative actions:
action_date: 2016-09-09
text: Placed on the Union Calendar, Calendar No. 571.
action_date: 2016-09-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735.
action_date: 2016-09-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-735.
action_date: 2016-07-13
text: Ordered to be Reported (Amended) by the Yeas and Nays: 36 - 15.
action_date: 2016-07-13
text: Committee Consideration and Mark-up Session Held.
action_date: 2016-07-12
text: Committee Consideration and Mark-up Session Held.
action_date: 2016-06-08
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2016-06-08
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2016-06-07
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2015-07-31
text: Referred to the Subcommittee on Health.
action_date: 2015-07-29
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-07-29
text: Introduced in House
action_date: 2015-07-29
text: Introduced in House