99-33760. Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Changes to an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA)

[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Notices]
[Pages 73055-73056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0529]


Agency Information Collection Activities; Announcement of OMB 
Approval; Guidance for Industry: Changes to an Approved New Drug 
Application (NDA) or Abbreviated New Drug Application (ANDA)

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 ``Guidance for Industry: Changes to 
an ``Approved NDA or ANDA'' 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 November 23, 1999 
(64 FR 65716), the agency announced that the proposed information 
collection had been submitted to OMB for review

[[Page 73056]]

and clearance under the emergency processing provisions of the PRA (44 
U.S.C. 3507(j) and 5 CFR 1320.13). 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 collection of information and has assigned OMB 
control number 0910-0431. The approval expires on May 31, 2000. A copy 
of the supporting statement for this information collection is 
available on the Internet at http://www.fda.gov/ohrms/dockets.

    Dated: December 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-33760 Filed 12-28-99; 8:45 am]
BILLING CODE 4160-01-F