Skip to main content
S. 2055 114th Congress Senate

Medical Countermeasure Innovation Act of 2016

Official title: A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to national health security.

Introduced: September 17, 2015 See on congress.gov
Health Animal protection and human-animal relationshipsChemical and biological weaponsCongressional oversightDrug safety, medical device, and laboratory regulation
More subjectsShow fewer subjects
Drug therapyEmergency medical services and trauma careGovernment information and archivesHealth programs administration and fundingImmunology and vaccinationInfectious and parasitic diseasesMedical researchNuclear weaponsResearch administration and fundingTerrorismUser charges and fees
Sign in to write a letter Sign in to watch
This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 14, 2016
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Mar 14, 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.
Mar 9, 2016
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Sep 17, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 17, 2015
Introduced in Senate
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action March 14, 2016

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

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 1
  • HR 34 21st Century Cures Act
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). S. 2055: Medical Countermeasure Innovation Act of 2016. 114th Congress. Open America. https://openamerica.io/bill/114-S-2055/
MLA
"S. 2055: Medical Countermeasure Innovation Act of 2016." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-S-2055/.
Bluebook (legal)
S. 2055, 114th Cong. (2026), https://openamerica.io/bill/114-S-2055/.
Markdown link
[S. 2055: Medical Countermeasure Innovation Act of 2016](https://openamerica.io/bill/114-S-2055/)
Report a problem