Page:United States Statutes at Large Volume 116 Part 2.djvu/829

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1611 "(3) TERMINATION OF DEBARMENT; JUDICIAL REVIEW; OTHER MATTERS.— Subsections (c)(3), (d), (e), (i), (j), and (1)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph (1) to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively.". SEC. 204. DESIGNATION AND REGULATION OF COMBINATION PROD- UCTS. Section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended— (1) in paragraph (1)— (A) in the first sentence, by striking "shall designate a component of the Food and Drug Administration" and inserting "shall in accordance with this subsection assign an agency center"; and (B) in each of subparagraphs (A) through (C), by striking "the persons charged" and inserting "the agency center charged"; (2) by redesignating paragraph (4) as paragraph (5); (3) by inserting after paragraph (3) the following paragraph: "(4)(A) Not later than 60 days after the date of the enactment Deadline. of this paragraph, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. Additionally, the office shall, in determining whether a product is to be designated a combination product, consult with the component within the Office of the Commissioner of Food and Drugs that is responsible for such determinations. Such office (referred to in this paragraph as the 'Office') shall have appropriate scientific and medical expertise, and shall be headed by a director. "(B) In carrying out this subsection, the Office shall, for each combination product, promptly assign an agency center with primary jurisdiction in accordance with paragraph (1) for the premarket review of such product. "(C)(i) In carrying out this subsection, the Office shall ensure timely and effective premarket reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center. "(ii) In order to ensure the timeliness of the premarket review of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be responsible to the Office with respect to the timeliness of the premarket review. "(D) In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. "(E)(i) Any dispute regarding the timeliness of the premarket review of a combination product may be presented to the Office for resolution, unless the dispute is clearly premature.

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