DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 315 and 601

The Food and Drug Administration (FDA) is reopening until February 12, 1999, the comment period for the draft guidance for industry entitled ‘‘Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics’’ that appeared in the Federal Register of October 14, 1998 (63 FR 55067). FDA is taking this action in response to a request for an extension. DATES: Written comments on the draft guidance may be submitted by February 12, 1999. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Drug Information Branch (HFD–210), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852– 1448, FAX 888–CBERFAX or 301–827– 3844. Send two self-addressed adhesive labels to assist the office in processing your request. Submit written comments to the Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Requests and comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Robert K. Leedham, Center for Drug Evaluation and Research (HFD– 160), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 7510, or George Q. Mills, Center for Biologics Evaluation and Research (HFM– 573), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–5097.