[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]
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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.
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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
