Documents

National Environmental Policy Act; Revision of Policies and Procedures

Federal Register · Rule · Jul 29, 1997

The agency received four comments during this extended comment period, three of which addressed categorical exclusions for drug and biologic products. … FDA is in the process of establishing a policy for determining when uses of CFC's currently designated essential will no longer be deemed essential under the Clean Air Act due to the availability of safe

Prescription Drug Product Labeling; Medication Guide Requirements

Federal Register · Rule · Dec 1, 1998

Although the August 24, 1995, proposed rule (60 FR 44182) provided a 90-day comment period under the Paperwork Reduction Act of 1980, and this final rule incorporates the comments received, as required … of the comment period.

Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Final Rule

Federal Register · Rule · Feb 15, 1995

Interested persons were invited to submit comments by March 16, 1978. Reply comments in response to comments filed in the initial comment period could be submitted by April 14, 1978. … One comment contended that products for the treatment of ``water-clogged ears'' are not drugs within the meaning of section 201(g) of the act (21 U.S.C. 321(g)) and, thus, are not the proper subject of

Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Federal Register · Rule · Oct 26, 1999

This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … before January 1, 1958, in conformance with Sec. 201(s) of the act.