[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44803-44804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Cell-Based Products for Animal 
Use; 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availability of a draft guidance for industry #218 entitled 
``Cell-Based Products for Animal Use.'' This draft guidance describes 
FDA's Center for Veterinary Medicine's (CVM) current thinking on cell-
based products for animal use that meet the definition of a new animal 
drug. This draft guidance is for firms and individuals developing cell-
based products, including animal stem cell-based products (ASCPs).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 30, 2014.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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Lynne Boxer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0611, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#218 entitled ``Cell-Based Products for Animal Use.'' CVM is 
aware that many veterinary therapies may be produced using cell-based 
products. Developers of such products for veterinary use have 
approached CVM for clarification regarding the regulation of these 
products. This draft guidance for industry describes CVM's current 
thinking on cell-based products for animal use that meet the definition 
of a new animal drug.
    Cell-based products meeting the definition of a new animal drug are 
subject to the same statutory and regulatory requirements as other new 
animal drugs. Although this draft guidance relates to other cell-based 
products, this draft guidance focuses on ASCPs meeting the definition 
of a new animal drug.
    This draft guidance addresses the following topics:
     How existing regulations apply to cell-based products for 
veterinary use;
     A common vocabulary for ASCPs;
     A risk-based category structure for ASCPs; and
     Industry interaction with CVM early in product 
development.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR

[[Page 44804]]

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

    Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18134 Filed 7-31-14; 8:45 am]
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