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

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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