[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Rules and Regulations]
[Page 1762]
From the Federal Register Online via the Government Printing 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