Medical Countermeasure Innovation Act of 2016
Latest action · Mar 14, 2016 Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedSep 17, 2015
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 4
Members who signed on, in the order they did. Signatures ran from Sep 17, 2015 to Mar 15, 2016; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-PA | Robert P. Casey Jr. | Original | Sep 17, 2015 |
| R-GA | Johnny Isakson | Oct 26, 2015 | |
| R-KS | Pat Roberts | Nov 19, 2015 | |
| R-TN | Lamar Alexander | Mar 15, 2016 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Sep 17, 2015Markup Mar 9, 2016Reported Mar 14, 2016 |
Actions 5
Everything that happened, newest first.
- Mar 14, 2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
- Mar 14, 2016Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.
- Mar 9, 2016Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Sep 17, 2015Introduced in Senate
- Sep 17, 2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In the Congressional Record 1
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S1381 | Lamar Alexander R-TN | Mar 9, 2016 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Congressional Budget Office cost estimate
- Aug 9, 2016S. 2055, Medical Countermeasure Innovation Act of 2016As reported by the Senate Committee on Health, Education, Labor, and Pensions on March 14, 2016
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| S. Hrg. 114-326 | S. 2205, S. 2421, S. 2564, AND S. 271746 pages | Indian Affairs Committee | Apr 13, 2016 |
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R44502 | Senate Medical Innovation Bills: Overview and Comparison with the 21st Century Cures Act (H.R. 6) Archived | Report | May 17, 2016 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 34 | 21st Century Cures Act | Related bill | Dec 13, 2016 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to national health security.
- Short Titles as Introduced
- Medical Countermeasure Innovation Act of 2015
- Short Titles as Reported to Senate
- Medical Countermeasure Innovation Act of 2016
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Animal protection and human-animal relationships
- Chemical and biological weapons
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Emergency medical services and trauma care
- Government information and archives
- Health
- Health programs administration and funding
- Immunology and vaccination
- Infectious and parasitic diseases
- Medical research
- Nuclear weapons
- Research administration and funding
- Terrorism
- User charges and fees
Text 2
Each version as it was printed, newest first.
- Mar 14, 2016Reported to Senate
- Sep 17, 2015Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
