Document ID: FDA-2005-E-0310-0015
Agency: fda
Document Type: Notice
Title: Determinations of Regulatory Review Periods: KEPIVANCE; Correction
Posted Date: 2012-04-18T04:00Z

[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23268-23269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9325]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-E-0310 (previously FDA Docket No. 2005E-0245)]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; KEPIVANCE; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of April 2, 2007 (72 FR 15699). 
The document concerned FDA's determination of the regulatory review 
period for KEPIVANCE. The document cited an incorrect statute under 
which the KEPIVANCE biologics license application was submitted. This 
document corrects the citation.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration,

[[Page 23269]]

10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-
0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: In FR Doc. 2007-15699 on page 15700 in the 
Federal Register of Monday, April 2, 2007, the following correction is 
made:
    1. On page 15700, in the first column, in the first line, ``505(b) 
of the act'' is corrected to read ``351 of the Public Health Service 
Act (42 U.S.C. 262).''

    Dated: February 28, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-9325 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-01-P