2012-9325. Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE; Correction
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Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; correction.
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.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, Start Printed Page 2326910903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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).”
Start SignatureDated: 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
Document Information
- Published:
- 04/18/2012
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice; correction.
- Document Number:
- 2012-9325
- Pages:
- 23268-23269 (2 pages)
- Docket Numbers:
- Docket No. FDA-2005-E-0310 (previously FDA Docket No. 2005E-0245)
- PDF File:
- 2012-9325.pdf
- Supporting Documents:
- » Exhibit C - Transmittal Letter [FDA-2005-E-0310-0006]
- » Exhibit B - Maintenance Fee Statement [FDA-2005-E-0310-0006]
- » Exhibit A - Abstract [FDA-2005-E-0310-0006]