[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)] [Rules and Regulations] [Page 38026] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-18596] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 [Docket No. 91N-0404] RIN 0910-AA09 Medical Devices; Humanitarian Use Devices; Lift of Stay of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; lift of stay of effective date. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on humanitarian use devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule, and they are now effective. EFFECTIVE DATE: July 16, 1997. 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 published a final rule prescribing the procedures for submitting humanitarian device exemption (HDE) applications, amendments, and supplements; procedures for obtaining an extension of the exemption; and the criteria for FDA review and approval of HDE's. In the final rule (61 FR 33232 at 33243), FDA requested comments on the collection of information requirements contained in the final rule by August 26, 1996. FDA received no comments in response to this request. In the Federal Register of October 29, 1996 (61 FR 55804), 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 also published on October 29, 1996 (61 FR 55741), FDA announced that it was staying the effective date of the information collection requirements pending OMB clearance for 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). On November 25, 1996, OMB sent FDA a notice of action stating that the collection of information requirements are approved for use through November 30, 1999, under OMB control No. 0910-0332. FDA announced OMB approval of the collection of information provisions in the Federal Register of January 22, 1997 (62 FR 3297). 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, the stay for 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 was published in the Federal Register of October 29, 1996 (61 FR 55742) is lifted and these provisions are effective July 16, 1997. Dated: June 17, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-18596 Filed 7-15-97; 8:45 am] BILLING CODE 4160-01-F