[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Page 36530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15030]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1009]


Draft Guidance for Industry on Use of Nanomaterials in Food for 
Animals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GFI 220) 
entitled ``Use of Nanomaterials in Food for Animals.'' The draft 
guidance describes FDA's current thinking regarding the use of 
nanomaterials or the application of nanotechnology in food for animals. 
It is intended to assist industry and other stakeholders in identifying 
potential issues related to safety or regulatory status of food for 
animals containing nanomaterials or otherwise involving the application 
of nanotechnology.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 10, 2014.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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6856, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(GFI 220) entitled ``Use of Nanomaterials in Food for 
Animals.'' This draft guidance applies to food ingredients that are 
intended for use in food for animals and either: (1) Consist entirely 
of nanomaterials, (2) contain nanomaterials as a component, or (3) 
otherwise involve the application of nanotechnology.
    This guidance is not applicable to other products regulated by FDA, 
including food substances intended for use in food for humans. This 
guidance also does not apply to food contact substances or color 
additives intended for use in food for animals or food for humans.
    Medicated feed contains new animal drugs approved for use in or on 
animal food. This guidance does not apply to a nanomaterial form of a 
new animal drug or drug component (e.g., drug carrier) in medicated 
feed. However, it does apply to nanomaterial animal food ingredients in 
medicated feed.
    This guidance is not intended to bring into question the regulatory 
status of animal food ingredients that naturally exist in the nanoscale 
range or that contain incidental amounts of particles in the nanoscale 
range, and that have already been determined to be generally recognized 
as safe or approved in response to a food additive petition.
    A notice announcing the availability of another draft guidance (GFI 
221) entitled ``Recommendations for Preparation and Submission 
of Animal Food Additive Petitions'' was published in the Federal 
Register on September 11, 2013 (78 FR 55727). GFI 221, when 
finalized, would provide information regarding the submission of food 
additive petitions (FAPs) for animal food additives. This draft 
guidance (GFI 220) would provide additional information that 
would be useful when submitting FAPs for nanomaterial animal food 
additives and would supplement the information provided in GFI 
221.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft 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; the collections of information in 
21 CFR 70.25, 71.1, 170.35, 171.1, 21 CFR parts 172, 173, 179, and 180, 
and in Form FDA 3503, have been approved under OMB control number 0910-
0016.

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 draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15030 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P