[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