Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Extension of Comment Period, 57180 [E9-26637]

Download as PDF 57180 Federal Register / Vol. 74, No. 212 / Wednesday, November 4, 2009 / Notices comment period for the draft guidance until January 4, 2010. The agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying finalization of this level 1 guidance. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 30, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–26636 Filed 11–2–09; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0348] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment mstockstill on DSKH9S0YB1PROD with NOTICES period. SUMMARY: The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens’’ that appeared in the Federal Register of August 3, 2009 (74 FR 38439), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written or electronic comments by January 4, 2010. ADDRESSES: Submit electronic comments to https://www. regulations.gov. Submit written comments to the Division of Dockets VerDate Nov<24>2008 16:29 Nov 03, 2009 Jkt 220001 Management (HFA–305), Food and Drug Administration, 5630 Fishers lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amy Green, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 301– 436–2025. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 3, 2009 (74 FR 38439), as corrected on August 21, 2009 (74 FR 42311), FDA published a notice of availability with a 90-day comment period to request comments on the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens’’ (the draft guidance). Comments on the draft guidance will inform FDA’s current thinking for finalization of this Level 1 guidance consistent with FDA’s good guidance practices. The agency has received requests for an extension of the comment period for the draft guidance. FDA has considered the requests and is extending the comment period for the draft guidance until January 4, 2010. The agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying finalization of this Level 1 guidance. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 30, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–26637 Filed 11–2–09; 11:15 am] BILLING CODE 4160–01–S PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Live-Attenuated Tularemia Vaccine Description of Invention: The invention provides compositions and methods of use for a modified strain of Francisella tularensis, the causative agent of tularemia, a category A biodefense agent (NIAID classification). Currently, no vaccines are available, and the only approved therapeutics for tularemia are antibiotics that are only effective if delivered early in the infection. The subject invention defines and characterizes mutations in Francisella tularensis that result in attenuated bacteria capable of inducing strong protective immune responses. Thus, these stable mutant strains could be used as efficient live vaccines against tularemia. Applications: Live-attenuated vaccines against Francisella tularensis. Advantages: • Live-attenuated bacteria can be easily produced through recombinant technologies • Live-attenuated vaccines do no require adjuvants • Immune response to live-attenuated vaccines lasts for years and does not require booster Development Status: In vitro and in vivo data available. E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 74, Number 212 (Wednesday, November 4, 2009)]
[Notices]
[Page 57180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0348]


Draft Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards of Leafy Greens; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to January 
4, 2010, the comment period for the draft guidance entitled ``Guidance 
for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy 
Greens'' that appeared in the Federal Register of August 3, 2009 (74 FR 
38439), as corrected on August 21, 2009 (74 FR 42311). In the notice of 
availability, FDA requested comments by November 2, 2009. The agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES:  Submit written or electronic comments by January 4, 2010.

ADDRESSES:  Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Green, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740 301-436-2025.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 3, 2009 (74 FR 38439), as 
corrected on August 21, 2009 (74 FR 42311), FDA published a notice of 
availability with a 90-day comment period to request comments on the 
draft guidance entitled ``Guidance for Industry: Guide to Minimize 
Microbial Food Safety Hazards of Leafy Greens'' (the draft guidance). 
Comments on the draft guidance will inform FDA's current thinking for 
finalization of this Level 1 guidance consistent with FDA's good 
guidance practices.
    The agency has received requests for an extension of the comment 
period for the draft guidance. FDA has considered the requests and is 
extending the comment period for the draft guidance until January 4, 
2010. The agency believes that this extension allows adequate time for 
interested persons to submit comments without significantly delaying 
finalization of this Level 1 guidance.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26637 Filed 11-2-09; 11:15 am]
BILLING CODE 4160-01-S
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