[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)] [Rules and Regulations] [Page 1762] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-565] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 807 [Docket No. 98N-0520] Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; confirmation of effective date. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) published in the Federal Register of September 29, 1998 (63 FR 51825), a direct final rule and a correction document published in the Federal Register of November 27, 1998 (63 FR 65554). The direct final rule amends certain regulations that govern establishment registration and device listing by domestic distributors. This document confirms the effective date of the direct final rule. EFFECTIVE DATE: The effective date of the direct final rule published at 63 FR 51825 is confirmed as February 11, 1999. FOR FURTHER INFORMATION CONTACT: Walter W. Morgenstern, Center for Devices and Radiological Health (HFZ-305), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20857, 301-594-4699. SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending on December 14, 1998. FDA stated that the effective date of the direct final rule would be on February 11, 1999, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comment. The direct final rule contained no information collection. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3502) was not required. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, notice is given that no objections or requests for a hearing were filed in response to the September 29, 1998, final rule. Accordingly, the amendments issued thereby are effective on February 11, 1999. Dated: January 4, 1999. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 99-565 Filed 1-11-99; 8:45 am] BILLING CODE 4160-01-F