Department of Health and Human Services March 19, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reissuing a final rule restricting the sale, distribution, and use of cigarettes and smokeless tobacco. As required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), FDA is issuing a final rule that is identical to the provisions of the final rule on cigarettes and smokeless tobacco published by FDA in 1996, with certain required exceptions. The rule prohibits the sale of cigarettes and smokeless tobacco to individuals under the age of 18 and imposes specific marketing, labeling, and advertising requirements. Elsewhere in this issue of the Federal Register, FDA is issuing an advance notice of proposed rulemaking to obtain information related to the regulation of outdoor advertising of cigarettes and smokeless tobacco.

The Food and Drug Administration (FDA) has determined that HALFLYTELY AND BISACODYL TABLETS BOWEL PREP KIT (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 milligrams (mg) (20-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 mg.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.