[Federal Register Volume 63, Number 24 (Thursday, February 5, 1998)]
[Notices]
[Page 5957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2910]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0264]


Agency Information Collection Activities; Announcement of OMB 
Approval

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Medical Devices: Substantial 
Equivalence 510(k) Summaries and 510(k) Statements Premarket 
Notification'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 16, 1997 (62 
FR 38098), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 
section 3507 of the PRA (44 U.S.C. 3507). An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0281. The approval expires on September 30, 2000.

    Dated: January 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-2910 Filed 2-4-98; 8:45 am]
BILLING CODE 4160-01-F