U.S. Code
- Title 1 General Provisions
- Title 2 The Congress
- Title 3 The President
- Title 4 Flag and Seal, Seat Of Government,and the States
- Title 5 Government Organization and Employees
- Appendix to Title 5
- Title 6 Domestic Security
- Title 7 Agriculture
- Title 8 Aliens and Nationality
- Title 9 Arbitration
- Title 10 Armed Forces
- Appendix to Title 10 (Rules of Court of Appeals for the Armed Forces)
- Title 11 Bankruptcy
- Appendix to Title 11
- Title 12 Banks and Banking
- Title 13 Census
- Title 14 Coast Guard
- Title 15 Commerce and Trade
- Title 16 Conservation
- Title 17 Copyrights
- Title 18 Crimes and Criminal Procedure
- Appendix to Title 18
- Title 19 Customs Duties
- Title 20 Education
- Title 21 Food and Drugs
- Title 22 Foreign Relations and Intercourse
- Title 23 Highways
- Title 24 Hospitals and Asylums
- Title 25 Indians
- Title 26 Internal Revenue Code
- Appendix to Title 26
- Title 27 Intoxicating Liquors
- Title 28 Judiciary and Judicial Procedure
- Appendix to Title 28
- Title 29 Labor
- Title 30 Mineral Lands and Mining
- Title 31 Money and Finance
- Title 32 National Guard
- Title 33 Navigation and Navigable Waters
- Title 34 Navy (repealed)
- Title 35 Patents
- Title 36 Patriotic Societies and Observances
- Title 37 Pay and Allowances Of the Uniformed Services
- Title 38 Veterans' Benefits
- Appendix to Title 38 (Rules of Court of Appeals for Veterans Claims()
- Title 39 Postal Service
- Title 40 Public Buildings, Property, and Works
- Title 41 Public Contracts
- Title 42 The Public Health and Welfare
- Title 43 Public Lands
- Title 44 Public Printing and Documents
- Title 45 Railroads
- Title 46 Shipping
- Appendix to Title 46
- Title 47 Telegraphs, Telephones, and Radiotelegraphs
- Title 48 Territories and Insular Possessions
- Title 49 Transportation
- Title 50 War and National Defense
- Appendix to Title 50
§ 355b. Adverse-event reporting
(a)
Toll-free number in labeling
Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule:
(1)
The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.
(b)
Drugs with pediatric market exclusivity
(1)
In general
During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A [1] of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report of an adverse event regarding the drug that the Secretary of Health and Human Services receives shall be referred to the Office of Pediatric Therapeutics established under section
393a of this title. In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee [2] regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.
(2)
Rule of construction
Paragraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the one-year period described in such paragraph regarding the drug has expired.
[1] So in original. Probably should be preceded by “section”.
[2] So in original. Probably should be “Committee”.
Tips