Sec. 3. Transparency
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Not later than 6 months after enactment and every 6 months thereafter, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives containing the information described in subsection (c). In this section the term generic fast track review means review under paragraph
(11)of section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ), as added by section 2 of this Act. The report described in subsection
(a)shall include the following information: The number of applications in the most recent 6-month period that are subject to generic fast track review, and which of those applications— are for a drug where the reference drug has not been the reference drug for any other application that is approved under subsection
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); are for a drug where the reference drug has been the reference drug for not more than one other application that is approved under subsection
(j)of such section; and are for a drug that is on the drug shortage list established under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ). The average and median time before an applicant receives an approval decision for an application subject to generic fast track review. The number of applications subject to generic fast track review that were approved. At the time such report is submitted, the number of applications subject to fast track review— that have been withdrawn by the applicant; that have been granted tentative approval; with respect to which the Food and Drug Administration has requested additional information from the sponsor of the application; that are awaiting review by the Food and Drug Administration after additional information has been supplied, as described in subparagraph (C); and with respect to which the Food and Drug Administration has recorded reception of the application but has yet to contact the sponsor regarding the status of the application. A prediction of how long the Food and Drug Administration will take to respond to such applications that are awaiting review with either an approval or a rejection, and how many of such applications are expected to be withdrawn by the applicant. The average review time for such applications that are receiving generic fast track review versus the standard review period. The information described in paragraphs
(1)through
(6)with respect to applications for drugs under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) that are subject to another form of priority review or fast-track review. An annual accounting of how the Food and Drug Administration has spent the fees it has received under part 7 of subchapter C of chapter VII of such Act ( 21 U.S.C. 379f et seq. ) to include the proportion of such fees that such Administration has spent on personnel costs.
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