FDA and NIH Workforce Authorities Modernization Act
Latest action. Placed on Senate legislative calendarThe list of measures reported out of committee and eligible for floor action. Being on the calendar is not a promise of a vote.Read the full definition (opens a new tab) under General Orders. Calendar No. 427.
FDA and NIH Workforce Authorities Modernization Act
(Sec. 2) This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) increase the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Government Accountability Office (GAO) must report on these amendments.
(Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration (FDA) additional hiring authority for scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FDA must report on its need for qualified individuals for such positions and must include a recruitment and retention plan. The GAO must report on the FDA’s ability to hire, train, and retain qualified staff.
(Sec. 4) The FDA must establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community.
(Sec. 5) Scientific meetings directly related to the duties of a Department of Health and Human Services (HHS) professional must not be considered conferences for purposes of certain reporting requirements and restrictions on conference travel. Each division of HHS must report on scientific meeting attendance and related travel spending.
(Sec. 6) The bill revises Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the FDA.
(Sec. 7) The Paperwork Reduction Act does not apply to National Institutes of Health research.
(Sec. 9) For certain indications, the FDA may rely upon a summary of clinical data to approve a supplemental application for a drug.
(Sec. 10) The bill revises provisions regarding: (1) FDA screening of the Adverse Event Reporting System, and (2) evaluation of elements to assure safe use of drugs.
The summary continues for 18 more paragraphs. Read it in full on Congress.gov
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Reported to Senate with amendment(s)" stage on April 18, 2016. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on April 18, 2016: Placed on Senate Legislative Calendar under General Orders. Calendar No. 427.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 114th Congress (2015-16), 329 of the 10,233 bills and joint resolutions introduced became law, about 3.2 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Lamar Alexander (R-TN) introduced it on March 17, 2016, and 1 member has since signed on as a cosponsor.
They are 1 Democrat.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on March 17, 2016, 3829 days ago. The most recent recorded action was 3797 days ago, on April 18, 2016.
Measures do not carry over. Anything the 114th Congress has not finished by January 3, 2017 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers