[Federal Register Volume 65, Number 192 (Tuesday, October 3, 2000)]
[Notices]
[Page 59005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25283]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1224]


Agency Information Collection Activities; Announcement of OMB 
Approval; Submitting and Reviewing Complete Responses to Clinical 
Holds; Guidance for Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Submitting and Reviewing Complete 
Responses to Clinical Holds; Guidance for Industry'' has been approved 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of April, 13, 2000 
(65 FR 19910), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 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 0910-0445. 
The approval expires on September 12, 2003. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: September 26, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-25283 Filed 10-2-00; 8:45 am]
BILLING CODE 4160-01-F