Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction, 73028 [E7-24914]

Download as PDF 73028 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for ACF. 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 18, 2007. Brendan Kelly, Reports Clearance Officer. [FR Doc. 07–6158 Filed 12–21–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: December 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–24914 Filed 12–21–07; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration BILLING CODE 4184–01–M [Docket No. 2007C–0474] DEPARTMENT OF HEALTH AND HUMAN SERVICES DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction Food and Drug Administration AGENCY: [Docket No. 2007N–0472] HHS. Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction ACTION: AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice; correction. 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 VerDate Aug<31>2005 18:50 Dec 21, 2007 Jkt 214001 Food and Drug Administration, Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Planning, and Preparedness, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7010. In FR Doc. E7–23473, appearing on page 68166 in the Federal Register of Tuesday, December 4, 2007, the following correction is made: 1. On page 68166, in the third column, in the heading of the document, ‘‘[Docket No. 2007N–0453]’’ is corrected to read ‘‘[Docket No. 2007C–0474]’’. SUPPLEMENTARY INFORMATION: Dated: December 17, 2007. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E7–24911 Filed 12–21–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Trial Design for CommunityAcquired Pneumonia; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for communityacquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of communityacquired pneumonia, effect of antimicrobial treatment for communityacquired pneumonia, endpoints for trials of community-acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301–589– 0800. Seating is limited and available only on a first-come, first-served basis. Contact Person: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Office of Antimicrobial Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993–0002, 301–796–0767, or 301–796–0849. Registration: There is no registration fee for the public workshop. Space is limited; therefore, interested parties are encouraged to register early. Seating will be available on a first-come, firstserved basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to CAPwkshp@fda.hhs.gov by January 9, 2008. Persons without access to the Internet can call 301–796–1300 to register. Persons needing a sign language interpreter or other special E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Page 73028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24914]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.