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Appendix b. (to the Guidelines, DES) FEDERAL REGISTER ANNOUNCEMENT OF 9 JULY, 1966 New Drugs: Reports of Information for Drug Effectiveness The National Academy of Sciences-National Research Council (NAS-NRC) has agreed to assist the Food and Drug Administration in its review of the claims of effectiveness for drugs cleared through the new-drug pro- cedures from 1938 until October 10, 1962. To facilitate this review and a determination of whether there may be ground for invoking section SOS(e) of the Federal Food, Drug, and Cosmetic Act, and to provide each holder of such an approved new-drug application an opportunity to present for the consideration of the reviewing experts the best data available to support the medical claims, this order is entered pursuant to section 505 of the act: 1. Each holder of a new-drug application approved between 1938 and October 10, 1962, shall report the following, in duplicate, preferably on forms which have been devised by the National Academy of Sciences- National Research Council and which are available for the purpose from the Food and Drug Administration or any of its offices: a. New-drug application number, date originally approved, and whether Rx or OTC drug. b. Brand name of drug or preparation. c. Applicant's (firm's) name and address. d. Quantitative formula using established (nonproprietary) name of active ingredients. e. Dosage form and route of administration. Where a new-drug application covers different routes of administration, separate forms should be used. f. Current labels and package inserts (attach 10 copies of each to original of form; 1 copy of each to duplicate). g. List of literature references most pertinent to an evalua- tion of the effectiveness of the drug for the purposes for which it is offered in the label, package insert, or brochure. Approximately 5 to 10 key references, if available (attach 10 copies of the list to original of form and 1 copy to duplicate). h. Unpublished articles or other data pertinent to an evalua- tion of the claims (one copy only; attach to duplicate). 49
2. This report shall be made as promptly as possible and no later than 60 days from the date of this publication in the Federal Register, shall be plainly marked on the outside of the envelope or package "Spe- cial Drug Report," and shall be addressed to the Director, Bureau of Medicine (or Director, Bureau of Veterinary Medicine, in the case of veterinary drugs), Food and Drug Administration, Washington, D.C. 20204. 3. The submission of this special report may be made without prej- udice to any person's contention that he is not required by law to make the report. 4. This order is issued pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act (sec. 505(j), 52 Stat. 1052, as amended, 76 Stat. 782, 21 u.s.c. 355(j)) and under the authority delegated to the Commissioner of Food and Drugs by the Secretary of Health, Education, and Welfare (21 CFR 2.120; 31 F.R. 3008). Dated: July 6, 1966. JAMES L. GODDARD, Commissioner of Food and Drugs. 50
