Page:United States Statutes at Large Volume 116 Part 2.djvu/830

 116 STAT. 1612 PUBLIC LAW 107-250—OCT. 26, 2002 Federal Register, publication. Notice. Deadline. Reports. 21 USC 360e note. Deadline. "(ii) During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The Commissioner of Food and Drugs shall consult with the Director of the Of^ce in resolving the substantive dispute. "(F) The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the Secretary shall consult with stakeholders and the directors of the agency centers. After such consultation, the Secretary shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the Secretary from following each agreement, guidance, or practice until continued, modified, revised, or eliminated. "(G) Not later than one year after the date of the enactment of this paragraph and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions— "(i) describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions; "(ii) identifying the number of premarket reviews of such products that involved a consulting agency center; and "(iii) describing improvements in the consistency of postmarket regulation of combination products. "(H) Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center."; and (4) in paragraph (5) (as redesignated by paragraph (2) of this section)— (A) by redesignating subparagraphs (A) and (B) as subparagraphs (B) and (C), respectively; and (B) by inserting before subparagraph (B) the following subparagraph: "(A) The term 'agency center' means a center or alternative organizational component of the Food and Drug Administration.". SEC. 205. REPORT ON CERTAIN DEVICES. Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall report to the appropriate committees of Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health. Such report shall include information on the times required to log in and review original submissions and supplements, times required to review manufacturers' replies to submissions, and times to approve or clear such devices. Such report shall contain the Secretary's recommendations on any measures needed to improve performance including, but not limited to, the allocation of additional resources.

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