[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-F