[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Rules and Regulations]
[Page 63983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 98N-0439]


Medical Devices: Reports of Corrections and Removals; Delay of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) published in the 
Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. 
The direct final rule notified the public of FDA's intention to amend 
the regulations that govern reports of corrections and removals of 
medical devices to eliminate the requirement for distributors to make 
such reports. This document delays the effective date of the direct 
final rule.

EFFECTIVE DATE: The effective date of the direct final published at 63 
FR 42229 rule is delayed until February 22, 1999.

FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20857, 301-827-2970.

SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct 
final rule for a 75-day period ending October 21, 1998. FDA stated that 
the effective date of the direct final rule would be on December 21, 
1998, 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.
    However, FDA has not yet received approval under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520) of the information 
collection requirements in this rule. Therefore, FDA is revising the 
effective date of this rule to February 22, 1999. By that date, FDA 
expects to have received clearance from the Office of Management and 
Budget (OMB) for the information collection requirements in the rule. 
This document delays the effective date of the direct final rule.
    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 August 7, 1998, final rule. Accordingly, the amendments 
issued thereby are effective February 22, 1999.

    Dated: November 10, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30876 Filed 11-17-98; 8:45 am]
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