Document ID: FDA-2014-D-0634-0011
Agency: fda
Document Type: Notice
Title: Cell-Based Products for Animal Use; Guidance for Industry; Availability
Posted Date: 2015-06-12T04:00Z

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Page 33522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0634]

Cell-Based Products for Animal Use; 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 a guidance for industry #218 (GFI #218) entitled 
``Cell-Based Products for Animal Use.'' FDA is aware that many 
potential veterinary therapies may be produced using cell-based 
products. GFI #218 describes FDA's Center for Veterinary Medicine's 
current thinking on cell-based products for animal use that meet the 
definition of a new animal drug. This guidance is for persons 
developing, manufacturing, or marketing cell-based products, including 
``animal stem cell-based products''.

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: Lynne Boxer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0611, lynne.boxer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 1, 2014 (79 FR 44803), FDA 
published the notice of availability for a draft guidance for industry 
#218 entitled ``Cell-Based Products for Animal Use'' giving interested 
persons until September 30, 2014, to comment on the draft guidance. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. Editorial changes were made 
to improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated August 1, 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 FDA on Cell-Based Products for Animal Use. 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 part 514 and 21 CFR 511.1 have 
been approved under OMB control numbers 0910-0032 and 0910-0117, 
respectively.

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: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14360 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P