[Federal Register Volume 63, Number 73 (Thursday, April 16, 1998)]
[Rules and Regulations]
[Page 18836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 91N-0396]


Medical Devices; Reports of Corrections and Removals; Lift of 
Stay of Effective Date

Agency: Food and Drug Administration, HHS.

Action: Final rule; lift of stay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is lifting a stay of 
the effective date of certain provisions in a final rule on 
establishing procedures for submission of reports of corrections and 
removals of medical devices. The Office of Management and Budget (OMB) 
has approved the collection of information requirements contained in 
the final rule.

EFFECTIVE DATE: May 18, 1998.
FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2970.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 19, 1997 (62 
FR 27183), FDA published a final rule to establish procedures for 
implementing the reports of corrections and removals for medical 
devices by requiring that manufacturers, importers, and distributors 
report promptly to FDA any corrections or removals of a device 
undertaken to reduce a risk to health posed by the device or to remedy 
a violation of the Federal Food, Drug, and Cosmetic Act caused by the 
device which may present a risk to health. In the final rule, FDA 
requested comments by July 18, 1997 (62 FR 27183 at 27190), on the 
collection of information requirements contained in the final rule. FDA 
reviewed and responded to four comments received in response to this 
request. In the Federal Register of November 26, 1997 (62 FR 63182), 
FDA announced that the information collection requirements contained in 
the final rule had been submitted to OMB for approval under the 
Paperwork Reduction Act of 1995 (Pub. L. 104-13). In a separate 
document published on December 24, 1997 (62 FR 67274), FDA announced 
that it was staying the effective date of the information collection 
requirements pending OMB clearance for Secs. 806.10 and 806.20 (21 CFR 
806.10 and 806.20).
    On January 30, 1998, OMB sent FDA a notice stating that the 
collection of information requirements are approved for use through 
January 31, 2001, under OMB control number 0910-0359. FDA announced OMB 
approval of the collection of information provisions in the Federal 
Register of February 17, 1998 (63 FR 7811).
    Therefore, under sections 201-903 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321-393) and under authority delegated to the 
Commissioner of Food and Drugs, the stay for Secs. 806.10 and 806.20 
that was published at 62 FR 67274, December 24, 1997, is lifted and 
these provisions will become effective May 18, 1998.

    Dated: April 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10034 Filed 4-15-98; 8:45 am]
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