
[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.

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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


