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[Federal Register: December 26, 2007 (Volume 72, Number 246)]
[Notices]               
[Page 73028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de07-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0472]

 
Agency Emergency Processing Under the Office of Management and 
Budget Review; Certification to Accompany Drug, Biological Product, and 
Device Applications or Submissions; 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 December 12, 2007 (72 FR 
70599). The document announced that a proposed collection of 
information had been submitted to the Office of Management and Budget 
(OMB) for emergency processing under the Paperwork Reduction Act of 
1995. The document was published with an error. This document corrects 
that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 
Planning, and Preparedness (HF-27), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 07-6023, appearing on page 70599 
in the Federal Register of Wednesday, December 12, 2007, the following 
correction is made:
    1. On page 70599, in the third column, in the second full 
paragraph, the second sentence is corrected to read ``Specifically, at 
the time of submission of an application under sections 505, 515, or 
520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under 
section 351 of the PHS Act (42 U.S.C. 262), or submission of a report 
under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such 
application or submission must be accompanied by a certification that 
all applicable requirements of section 402(j) of the PHS Act have been 
met.''

    Dated: December 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24914 Filed 12-21-07; 8:45 am]

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