Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Confirmation of Effective Date

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.

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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