Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds; Request for Comments, 68461 [2013-27194]

Download as PDF Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1994–D–0007] Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments. The Food and Drug Administration (FDA) is considering revising the guidance entitled ‘‘Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,’’ and is seeking comments on this guidance before revisions are made. DATES: Submit electronic or written comments by January 13, 2014. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments to http://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: Xin Li, Center for Veterinary Medicine (HFV–222), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6863, xin.li@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: TKELleY on DSK3SPTVN1PROD with NOTICES I. Background One of the key objectives of Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds (GFI #80) is to help sponsors design efficacy studies to support the submission of Food Additive Petitions (FAPs) for food additives intended for anti-Salmonella use in food for animals. We would like to revise GFI #80 because science, technology, and FDA policy have changed since this guidance was last revised. GFI #80 currently addresses only chemical food additives intended to maintain feeds or feed ingredients Salmonella-negative. We intend to VerDate Mar<15>2010 19:20 Nov 13, 2013 Jkt 232001 expand the scope of this guidance to address other categories of food additives beyond chemical food additives, and to cover all food for animals, including pet food. Before we revise the content of GFI #80 we intend to consider your answers to the following questions: 1. What intended technical effects can we expect to see in FAPs submitted to FDA for anti-Salmonella use of the food additives in food for animals? 2. How should efficacy studies be designed for the intended technical effects described in your response to question 1? 3. Should experimental lots of animal food used in both laboratory and field studies be Salmonella-negative, but not sterile, prior to inoculation? 4. What inoculation levels of Salmonella are appropriate for experimental lots of animal food used in laboratory and field studies? Please justify your comment with scientific evidence. 5. What methods should be used to inoculate experimental lots of animal food used in laboratory and field studies? 6. What sampling criteria should be used to provide statistical confidence that Salmonella will be captured among samples collected? Please justify your comment with scientific evidence. 7. What methods should be used to enumerate the level(s) of Salmonella in animal food? 8. What are the key elements for designing field studies? 9. What are the difficulties faced by sponsors when designing and conducting field studies? 10. What types of facilities are available to conduct field studies? Electronic versions of GFI #80 are in the docket at http://www.regulations.gov and on FDA’s Web site at http:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments 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, and will be posted to the docket at http:// www.regulations.gov. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 68461 Dated: November 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27194 Filed 11–13–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 04, 2013, 01:00 p.m. to December 04, 2013, 05:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on November 05, 2013, 78 FR 214 Pg. 66371. The meeting will start on December 3, 2013 at 12:00 p.m. and end December 3, 2013 at 5:00 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: November 7, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–27172 Filed 11–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Fellowships and Dissertations. Date: December 6, 2013. Time: 2:00 p.m. to 5:00 p.m. E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Page 68461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27194]



[[Page 68461]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1994-D-0007]


Guidance for Industry: Studies To Evaluate the Utility of Anti-
Salmonella Chemical Food Additives in Feeds; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is considering revising 
the guidance entitled ``Guidance for Industry: Studies to Evaluate the 
Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is 
seeking comments on this guidance before revisions are made.

DATES: Submit electronic or written comments by January 13, 2014.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments to http://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: Xin Li, Center for Veterinary Medicine 
(HFV-222), Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-453-6863, xin.li@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    One of the key objectives of Guidance for Industry: Studies to 
Evaluate the Utility of Anti-Salmonella Chemical Food Additives in 
Feeds (GFI 80) is to help sponsors design efficacy studies to 
support the submission of Food Additive Petitions (FAPs) for food 
additives intended for anti-Salmonella use in food for animals. We 
would like to revise GFI 80 because science, technology, and 
FDA policy have changed since this guidance was last revised.
    GFI 80 currently addresses only chemical food additives 
intended to maintain feeds or feed ingredients Salmonella-negative. We 
intend to expand the scope of this guidance to address other categories 
of food additives beyond chemical food additives, and to cover all food 
for animals, including pet food.
    Before we revise the content of GFI 80 we intend to 
consider your answers to the following questions:
    1. What intended technical effects can we expect to see in FAPs 
submitted to FDA for anti-Salmonella use of the food additives in food 
for animals?
    2. How should efficacy studies be designed for the intended 
technical effects described in your response to question 1?
    3. Should experimental lots of animal food used in both laboratory 
and field studies be Salmonella-negative, but not sterile, prior to 
inoculation?
    4. What inoculation levels of Salmonella are appropriate for 
experimental lots of animal food used in laboratory and field studies? 
Please justify your comment with scientific evidence.
    5. What methods should be used to inoculate experimental lots of 
animal food used in laboratory and field studies?
    6. What sampling criteria should be used to provide statistical 
confidence that Salmonella will be captured among samples collected? 
Please justify your comment with scientific evidence.
    7. What methods should be used to enumerate the level(s) of 
Salmonella in animal food?
    8. What are the key elements for designing field studies?
    9. What are the difficulties faced by sponsors when designing and 
conducting field studies?
    10. What types of facilities are available to conduct field 
studies?
    Electronic versions of GFI 80 are in the docket at http://www.regulations.gov and on FDA's Web site at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27194 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P