[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33528-33529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14364]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0928]
Recommendations for Preparation and Submission of Animal Food
Additive Petitions; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (GFI) #221 entitled
``Recommendations for Preparation and Submission of Animal Food
Additive Petitions.'' This guidance describes the types of information
that FDA's Center for Veterinary Medicine recommends for inclusion in
food additive petitions submitted for food additives intended for use
in food for animals. It is intended to help the petitioner submit this
information in a consistent and appropriate manner.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Policy and Regulations Staff (HFV-6), 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 on the guidance 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: Center for Veterinary Medicine,
Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-7077; [email protected], in
the subject line please include ATTN: Division of Animal Feeds.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 11, 2013 (78 FR 55727), FDA
published the notice of availability for a draft guidance entitled
``Recommendations for Preparation and Submission of Animal Food
Additive Petitions'' giving interested persons until November 12, 2013,
to comment on the draft guidance. In the Federal Register of December
10, 2013 (78 FR 74154), FDA published a notice reopening the comment
period for the draft guidance giving interested persons until January
9, 2014, to comment on the draft guidance.
FDA received four comments on the draft guidance and considered
those comments as we finalized the guidance. The guidance announced in
this notice finalizes the draft guidance dated September 2013.
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on recommendations for preparation and
submission of animal food additive petitions. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 571.1 and 571.6 have been approved
under OMB control number 0910-0546.
IV. 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.
V. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
[[Page 33529]]
Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14364 Filed 6-11-15; 8:45 am]
BILLING CODE 4164-01-P