Improving Regulatory Transparency for New Medical Therapies Act
Latest action. Placed on the Union Calendar, Calendar No. 451.
Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General.
Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest.
Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Reported to House amended, Part II" stage on September 19, 2014. 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 September 19, 2014: Placed on the Union Calendar, Calendar No. 451.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the House
- Passage by the Senate
- 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 113th Congress (2013-14), 296 of the 9,091 bills and joint resolutions introduced became law, about 3.3 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?
JOSEPH PITTS (R-PA) introduced it on March 26, 2014, and 15 members have since signed on as cosponsors.
They come from both major parties: 6 Democrats, 9 Republicans.
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 26, 2014, 4551 days ago. The most recent recorded action was 4374 days ago, on September 19, 2014.
Measures do not carry over. Anything the 113th Congress has not finished by January 3, 2015 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
- HouseIn committee, no floor vote yet
- SenateAwaits House passage
- PresidentAwaits both chambers