[Federal Register Volume 63, Number 175 (Thursday, September 10, 1998)]
[Notices]
[Page 48516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24240]



[[Page 48516]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0513]


Agency Information Collection Activities; Announcement of OMB 
Approval; Orphan Drugs--21 CFR Part 316

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Orphan Drugs--21 CFR Part 316'' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 18, 1998 (63 
FR 27299), 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 0910-0167. The approval expires on July 31, 2001.

    Dated: September 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-24240 Filed 9-9-98; 8:45 am]
BILLING CODE 4160-01-F