Medical devices: Corrections and removal reports,

[Federal Register: November 18, 1998 (Volume 63, Number 222)]

[Rules and Regulations]

[Page 63983]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr18no98-8]

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.

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 filedin 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. 98-30876Filed11-17-98; 8:45 am]

BILLING CODE 4160-01-F