[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46587-46588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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published the notice of availability for a draft guidance #220 entitled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until September 10, 2014, to comment on the draft guidance.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received several comments on the draft guidance and those comments were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this notice finalizes the draft guidance dated June 2014.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]
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