Documents

Food Labeling: Health Claims; Oats and Coronary Heart Disease

Federal Register · Rule · Jan 23, 1997

Body weights were maintained at a constant level throughout the treatment period. … period.

Over-The-Counter Human Drugs; Proposed Labeling Requirements

Federal Register · Proposed Rule · Feb 27, 1997

During the comment period the agency intends to conduct research on the revised format compared to existing labeling. … FDA intends to include dietary information on the various formats that will be tested during the comment period.

Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

Federal Register · Proposed Rule · Aug 15, 1997

FDA notes that the Federal Food, Drug, and Cosmetic Act (the act) authorizes FDA, under certain circumstances, to grant periods of exclusive marketing to manufacturers who obtain approval of labeling supplements … Over this 5-year period, only two were for products sponsored by small businesses as defined by the Small Business Administration.

Medicare Program; ``Without Fault'' and Waiver of Recovery from an Individual as it Applies to Medicare Overpayment Liability

Federal Register · Proposed Rule · Mar 25, 1998

Under section 1886(d) of the Act, effective with hospital cost reporting periods beginning on or after October 1, 1983, we established a system of payment for acute inpatient hospital stays under Medicare … However, section 1886(g)(1) of the Act now requires that capital- related costs be paid under the prospective payment system effective with cost reporting periods beginning after September 30, 1991, for