Page:United States Statutes at Large Volume 100 Part 5.djvu/309

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PUBLIC LAW 99-000—MMMM. DD, 1986

PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3783

vaccines. If the Secretary determines that any such warning, instruction, or information is inadequate for such purpose in any respect, the Secretary shall at the same time require the manufacturers to revise and reissue such warning, instruction, or information as expeditiously as practical, but not later than 18 months after the effective date of this title. SEC. 315. RECALL AUTHORITY.

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Subsection (d) of section 351 of the Public Health Service Act (42 U.S.C. 262) is amended— Ante, p. 3751. (1) by inserting "(1)" after "(d)", and (2) by adding at the end thereof the following new paragraph: "(2)(A) Upon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this paragraph shall be issued in accordance with section 554 of title 5, United States Code. "(B) Any violation of subparagraph (A) shall subject the violator to Law a civil penalty of up to $100,000 per day of violation. The amount of enforcement and a civil penalty under this subparagraph shall, effective December 1 crime. of each year beginning 1 year after the effective date of this subparagraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest Vio of 1 percent. For purposes of this subparagraph, the term 'base quarter*, as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter.". SEC. 316. STUDY OF IMPACT ON SUPPLY OF VACCINES.

42 USC 300aa-4 note.

On June 30, 1987, and on June 30 of each second year thereafter, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate— (1) an assessment of the impact of the amendments made by this title on the supply of vaccines listed in the Vaccine Injury Table under section 2114 of the Public Health Service Act, and Ante, p. 3764. (2) an assessment of the ability of the administrators of vaccines (including public clinics and private administrators) to provide such vaccines to children. PART B—MISCELLANEOUS SEC. 321. WAIVER OF PAPERWORK REDUCTION.

Chapter 35 of title 44, United States Code, shall not apply to information required for purposes of carrying out this title and implementing the amendments made by this title. SEC. 322. NONSEVERABILITY.

If any provision of this title or the application of any provision of this title to any person or circumstance is held invalid by reason of a violation of the Constitution, the entire title shall be considered invalid.

44 USC 3501 et seq. 42 USC 300aa-l note. 42 USC 300aa-l note.