Page:United States Statutes at Large Volume 121.djvu/971

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[121 STAT. 950]
[121 STAT. 950]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 950

21 USC 352 note. Deadline.

Reports.

21 USC 355 note.

PUBLIC LAW 110–85—SEPT. 27, 2007

drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800FDA-1088.’,’’ after ‘‘section 701(a),’’. (b) STUDY.— (1) IN GENERAL.—In the case of direct-to-consumer television advertisements, the Secretary of Health and Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the Federal Food, Drug, and Cosmetic Act (as added by section 917), shall, not later than 6 months after the date of the enactment of this Act, conduct a study to determine if the statement in section 502(n) of such Act (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is appropriate for inclusion in such television advertisements. (2) CONTENT.—As part of the study under paragraph (1), such Secretary shall consider whether the information in the statement described in paragraph (1) would detract from the presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion of such statement is appropriate in direct-to-consumer television advertisements, such Secretary shall issue regulations requiring the implementation of such statement in direct-toconsumer television advertisements, including determining a reasonable length of time for displaying the statement in such advertisements. The Secretary shall report to the appropriate committees of Congress the findings of such study and any plans to issue regulations under this paragraph. SEC. 907. NO EFFECT ON VETERINARY MEDICINE.

This subtitle, and the amendments made by this subtitle, shall have no effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act by, or on the lawful written or oral order of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such Act. SEC. 908. AUTHORIZATION OF APPROPRIATIONS.

(a) IN GENERAL.—For carrying out this subtitle and the amendments made by this subtitle, there is authorized to be appropriated $25,000,000 for each of fiscal years 2008 through 2012. (b) RELATION TO OTHER FUNDING.—The authorization of appropriations under subsection (a) is in addition to any other funds available for carrying out this subtitle and the amendments made by this subtitle. 21 USC 331 note.

SEC. 909. EFFECTIVE DATE AND APPLICABILITY.

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(a) EFFECTIVE DATE.—This subtitle takes effect 180 days after the date of the enactment of this Act. (b) DRUGS DEEMED TO HAVE RISK EVALUATION AND MITIGATION STRATEGIES.— (1) IN GENERAL.—A drug that was approved before the effective date of this Act is, in accordance with paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (as added by section 901) (referred to in this section as the ‘‘Act’’) if there are in effect on the effective date of this Act elements to assure safe use— (A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or

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