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Notebook

The Notebook: a potpourri of items of interest gathered from FDA news releases, other news sources, and the Federal Register (designated FR, with date of publication). The Federal Register is available in many public libraries.

Oat bran and oatmeal products would be able to carry a heart disease health claim under an FDA proposed rule. FDA has tentatively concluded that diets high in oat bran and oatmeal and low in saturated fat and cholesterol may reduce the risk of coronary heart disease. The public may submit written comments on the proposed rule by April 3 to FDA, Dockets Management Branch, HFA-305, Rockville, MD 20857. (FR Jan. 4)

Biotechnology medication regulations will be overhauled under measures FDA has proposed to reduce costs for manufacturers, increase agency efficiency, and continue to protect the public health. The measures were published last November in the pamphlet "Reinventing the Regulation of Drugs Made from Biotechnology." To date, FDA has published two Federal Register notices: "FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biotechnology Products" (FR July 11) and "Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products" (FR Dec. 8). Those interested may comment on either document at any time. For a free copy of the reinventing report, write to FDA, HFI-40, Rockville, MD 20857; telephone (301) 443-3220.

User fee revenues and rates for fiscal year 1996 were set by FDA under the Prescription Drug User Fee Act. The act authorizes FDA to collect fees on drug and biological product applications, on establishments where the products are made, and on the marketed products. The new fees took effect Oct. 1, 1995. (FR Dec. 1)

A new antibiotic, cefpodoxime proxetil, was recently approved, according to an FDA final rule effective last Dec. 27. In the rule, FDA published standards for the drug and its use both as tablets and as granules for oral suspension. (FR Nov. 27)

The first generic albuterol metered-dose inhaler (MDI) was approved by FDA last Dec. 29. The albuterol MDI is used to prevent bronchospasm in patients with asthma and was found equivalent to the brand-name product. (FDA Talk Paper, Dec. 29)

Cadmium and lead contamination of pottery compliance policy guides have been revised by FDA. For free single copies of "Pottery (Ceramics); Imported and Domestic--Cadmium Contamination" and "Pottery (Ceramics); Imported and Domestic--Lead Contamination," send two self-addressed labels to FDA, Division of Compliance Policy, HFC-230, Rockville, MD 20857. Request Docket No. 95D-0370. (FR Dec. 12)

Animal drug and other veterinary information is now available through FDA's Center for Veterinary Medicine World Wide Web home page. The site includes general center information, some CVM guidelines, and information on center research activities. The Internet address is www.fda.gov/cvm/. (FDA Veterinarian, November-December 1995)

U.S. grade standards and other selected regulations have been lifted for various agricultural products, according to an Agriculture Department final rule effective last Dec. 4. Dairy products, tobacco, wool, mohair, fresh and processed fruits and vegetables, livestock, meats and meat products, eggs, and poultry and rabbit products will now be regulated under voluntary standards set by USDA's Agricultural Marketing Service. (FR Dec. 4)

Dietary fat and cancer will be the topic of the American Institute for Cancer Research's annual conference at Loews L'Enfant Plaza Hotel in Washington, D.C., Aug. 29 and 30. For more information, telephone AICR's research department at (202) 328-7744 or (1-800) 843-8114; e-mail jcohn@capcon.net.

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FDA Consumer magazine (March 1996)