[Federal Register Volume 62, Number 247 (Wednesday, December 24, 1997)]
[Rules and Regulations]
[Page 67274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33418]



[[Page 67274]]

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; Stay of 
Effective Date of Information Collection Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Stay of effective date of a final regulation.

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SUMMARY: The Food and Drug Administration (FDA) is staying the 
effective date of the information collection requirements of a final 
rule to implement the provisions of the Safe Medical Devices Act of 
1990 (the SMDA) regarding reports of corrections and removals of 
medical devices. FDA is taking this action because the information 
collection requirements in the final rule have not yet been approved by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (the PRA). In the Federal Register of November 26, 1997, 
FDA announced that it sent the proposed information collection to OMB 
for review and clearance.

DATES: Effective November 17, 1997, sections 806.10 and 806.20, which 
contain information collection requirements published at 62 FR 27183, 
May 19, 1997, are stayed pending OMB clearance of the information 
collection requirements. FDA will announce the effective date of these 
sections in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 19, 1997 (62 
FR 27183), FDA issued a final rule implementing the provisions of the 
SMDA concerning reports of corrections and removals of medical devices. 
The rule was scheduled to become effective on November 17, 1997. In the 
preamble to the final rule, FDA provided for a 60-day comment period on 
the information collection requirements of the rule under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3507), which was enacted after the 
publication of the proposed rule on reports of corrections and removals 
of medical devices.
    In the preamble to the final rule, FDA announced that it would 
review the comments received, make revisions as necessary to the 
information collection requirements, and submit the requirements to OMB 
for approval. FDA received four comments and has reviewed and responded 
to them and has submitted the information collection requirements to 
OMB for approval. A notice published in the Federal Register of 
November 26, 1997 (62 FR 63182), informs the public how to address 
comments on the information collection provisions to OMB.
    The Administrative Procedure Act and FDA regulations provide that 
the agency may issue a regulation without notice and comment procedures 
when the agency for good cause finds that such procedures are 
impracticable, unnecessary, or contrary to the public interest (5 
U.S.C. 553(b)(3)(B); 21 CFR 10.40(e)(1)). FDA finds there is good cause 
for dispensing with notice and comment procedures on this amendment to 
stay the effective date of the information collection requirements of 
the final rule on reports of corrections and removals until such time 
as OMB approves these requirements. Engaging in notice and comment 
rulemaking is unnecessary because the information collection provisions 
cannot become effective until such time as FDA obtains OMB approval of 
them. Moreover, notice and comment rulemaking is impracticable and 
contrary to the public interest in this case. There is not enough time 
to solicit a new round of notice and comment on the issue of 
establishing a delayed effective date for these information collection 
requirements without further delaying the implementation of this 
provision of the SMDA. Dispensing with notice and comment rulemaking 
provides that the information collection requirements of the reports of 
corrections and removals rule will go into effect at the earliest 
possible date after OMB review and clearance. FDA will announce the 
effective date of the information collection requirements of the final 
rule in a future issue of the Federal Register.

List of Subjects in 21 CFR Part 806

    Corrections and removals, Medical devices, Reporting and 
recordkeeping requirements.
    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, Secs. 806.10 and 806.20, published in 
the Federal Register of May 19, 1997 (62 FR 27183), are stayed until 
further notice.

    Dated: December 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33418 Filed 12-23-97; 8:45 am]
BILLING CODE 4160-01-F