Page:United States Statutes at Large Volume 121.djvu/853

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[121 STAT. 832]
[121 STAT. 832]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 832

PUBLIC LAW 110–85—SEPT. 27, 2007

‘‘(1) EXEMPTION.—A drug designated under section 526 for a rare disease or condition and approved under section 505 or under section 351 of the Public Health Service Act shall be exempt from product and establishment fees under this section, if the drug meets all of the following conditions: ‘‘(A) The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and establishment fees. ‘‘(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue during the previous year. ‘‘(2) EVIDENCE OF QUALIFICATION.—An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.’’. (g) CONFORMING AMENDMENT.—Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting ‘‘(c)(5)’’. (h) TECHNICAL AMENDMENT.— (1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is amended by striking the first sentence and inserting the following: ‘‘Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.’’. (2) EFFECTIVE DATE.—Paragraph (1) shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687).

21 USC 379h note.


Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following: 21 USC 379h–1.

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Effective date.

Deadlines. Federal Register, publication.

VerDate Aug 31 2005

13:52 Jan 23, 2009


‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION ADVERTISEMENT REVIEW FEES.—Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows: ‘‘(1) ADVISORY REVIEW FEE.— ‘‘(A) IN GENERAL.—With respect to a proposed directto-consumer television advertisement (referred to in this section as a ‘DTC advertisement’), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3). ‘‘(B) EXCEPTION FOR REQUIRED SUBMISSIONS.—A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review. ‘‘(C) NOTICE TO SECRETARY OF NUMBER OF ADVERTISEMENTS.—Not later than June 1 of each fiscal

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