S.Amdt. 3307

SA 3307. Mr. MANCHIN submitted an amendment intended to be proposed by him to the bill H.R. 4660, making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2015, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

Sec.___. Of the funds made available under title VI of division C the heading “salaries and expenses” under the heading “food and drug administration” under the heading “department of health and human services”, $20,000,000 shall not be available for obligation until the Commissioner of Food and Drugs: (1) finalizes the draft guidance entitled “Guidance for Industry: Abuse-Deterrent Opioids--Evaluation and Labeling”, issued in January 2013; (2) provides to Congress a report detailing the methodology used by the Food and Drug Administration for postmarket tracking of Zohydro and findings as of the date of enactment of this Act; and (3) produces documents responsive to Senator Manchin's letter to the Commissioner of Food and Drugs dated October 9, 2013, relating to conferences of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks: Provided, That if the Food and Drug Administration fails to meet such conditions by June 30, 2015, such funds shall be made available for obligation to the Food and Drug Administration's Office of Criminal Investigation for the purpose of assisting Federal, State, and local agencies to combat the diversion and illegal sales of controlled substances.