[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]
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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
