[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Rules and Regulations]
[Pages 55741-55742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27738]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. 91N-0404]
Medical Devices; Humanitarian Use Devices; 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 humanitarian use devices (HUD's). 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. Elsewhere
in this issue of the Federal Register, FDA is announcing that it has
sent the proposed information collection to OMB for review and
clearance.
DATES: Sections 814.102, 814.104, 814.106, 814.108, 814.110(a),
814.112(b), 814.116(b), 814.118(d), 814.120(b), 814.124(b), and
814.126(b)(1), which contain information collection requirements,
published at 61 FR 33232, June 26, 1996, 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 June 26, 1996 (61
FR 33232), FDA issued a final rule implementing the provisions of the
SMDA regarding HUD's. The rule is scheduled to become effective on
October 24, 1996. 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 expiration of the comment period on the proposed
rule governing HUD's.
In the preamble to the final rule, FDA announced that it would
review the comments received, make the revisions as necessary to the
information collection requirements, and submit the requirements to OMB
for approval. FDA has not received any comments and has submitted the
information collection requirements to OMB for approval. A notice
published elsewhere in this issue of the Federal Register 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)(8); 21 CFR 10.40(e)(1)). FDA finds that 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 HUD's until such time as OMB approves
these
[[Page 55742]]
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 HUD 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 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under secs. 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. 814.102, 814.104, 814.106,
814.108, 814.110(a), 814.112(b), 814.116(b), 814.118(d), 814.120(b),
814.124(b), and 814.126(b)(1) that were published in the Federal
Register of June 26, 1996 (61 FR 33232), are stayed until further
notice.
Dated: October 24, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-27738 Filed 10-24-96; 3:21 pm]
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