80 FR 46587 - Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 150 (August 5, 2015)

The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #220 entitled ``Use of Nanomaterials in Food for Animals.'' The 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 the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46587-46588]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of guidance for industry #220 entitled ``Use of 
Nanomaterials in Food for Animals.'' The 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 the safety or regulatory status of food for animals containing 
nanomaterials or otherwise involving the application of nanotechnology.

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: 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

    In the Federal Register of June 27, 2014 (79 FR 36530), FDA 
published the notice of availability for a draft guidance #220 entitled 
``Use of Nanomaterials in Food for Animals'' giving interested persons 
until September 10, 2014, to comment on the draft guidance. FDA 
received several comments on the draft guidance and those comments were

[[Page 46588]]

considered as the guidance was finalized. The guidance announced in 
this notice finalizes the draft guidance dated June 2014.

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 the Food and Drug Administration (FDA or 
Agency) on the use of nanomaterials in food for animals. 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 21 CFR 571.6 have been 
approved under 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.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19179 Filed 8-4-15; 8:45 am]
 BILLING CODE 4164-01-P