[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Pages 3057-3058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-862]



Food and Drug Administration

[Docket No. FDA-2008-D-0394]

Guidance for Industry on Regulation of Genetically Engineered 
Animals Containing Heritable recombinant DNA Constructs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or the agency) is 
announcing the availability of a guidance for industry 187 
entitled ``Regulation of Genetically Engineered Animals Containing 
Heritable recombinant DNA Constructs.'' This guidance is intended to 
clarify FDA's requirements and recommendations for producers and 
developers of genetically engineered (GE) animals and their products. 
The guidance describes how the new animal drug provisions of the 
Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE 
animals, including FDA's intent to exercise enforcement discretion 
regarding requirements for certain GE animals.

DATES: Submit written or electronic comments on agency guidances at any 

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. Submit written comments on the guidance to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8247, e-mail: [email protected].


I. Background

    In the Federal Register of September 19, 2008 (73 FR 54407), FDA 
published the notice of availability for a draft guidance entitled 
``Regulation of Genetically Engineered Animals Containing Heritable 
rDNA Constructs'' giving interested persons until November 18, 2008, to 
comment on the draft guidance. FDA received numerous comments on the 
draft guidance. FDA reviewed and considered all comments and, in 
response, made several changes. In response to requests for greater 
transparency, the agency clarified its intent to hold public advisory 
committee meetings for GE animal-related approvals and its intent to 
post statements of intent to exercise enforcement discretion over 
certain GE animals. In response to other comments, FDA clarified the 
scope of new animal drug application (NADA) approvals for GE animals 
and clarified its intent to work with other agencies should it receive 
a request for investigation or approval of a new animal drug in a GE 
wildlife animal ultimately intended for release into the wild.
    The guidance announced in this notice finalizes the draft guidance 
dated September 19, 2008.
    For the purpose of this guidance, FDA defines ``genetically 
engineered (GE) animals'' as those animals modified by recombinant DNA 
(rDNA) techniques, including progeny that contain the modification. The 
term GE animal can refer to both animals with heritable rDNA constructs 
and animals with non-heritable rDNA constructs (e.g., those 
modifications intended to be used as gene therapy). Although much of 
this guidance will be relevant to non-heritable rDNA constructs, and 
FDA intends to regulate non-heritable constructs in much the same way 
as described in this guidance for heritable constructs, this guidance 
only pertains to GE animals containing heritable rDNA constructs. We 
may issue a separate guidance on the regulation of GE animals bearing 
non-heritable constructs to discuss when those constructs would be 
under FDA jurisdiction and the kinds of information that would be 
relevant for FDA's review. In this guidance, we will use the term ``GE 
animal'' to refer to GE animals with heritable rDNA constructs. For 
ease of reference, we sometimes refer to regulation of the article (the 
rDNA construct) in such GE animals as regulation of the GE animal.
    The Center for Veterinary Medicine (``CVM'', ``we'', ``us'', 
``our'') has been working on applications submitted by developers of GE 
animals under the New Animal Drug provisions of the act (21 U.S.C. 321 
et seq.). This guidance is intended to clarify these requirements and 
our recommendations for producers and developers (``sponsors,'' 
``you'') of GE animals and their products. CVM will work closely with 
the other Centers at FDA that regulate pharmaceuticals or other medical 
products derived from biopharm animals to ensure that our oversight is 
complementary and not unnecessarily duplicative. Developers of GE 
animals should contact CVM early in the development of their GE animal; 
developers whose animals are already well under development also should 
contact CVM. We intend to issue additional guidance to describe more 
fully how various components of the New Animal Drug provisions of the 
act apply to biopharm animals and how CVM will implement them, the 
division of responsibilities between CVM and the other Centers 
regarding biopharm animals and products derived from them, and, more 
generally, how CVM and the other Centers will work interactively to 
regulate biopharm animals and their products. Developers of GE animals 
should come to CVM early in the process.

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 agency's current thinking on the 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 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 have been approved under OMB Control Nos. 
0910-0032, 0910-0045, 0910-0117, and 0910-0284.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any

[[Page 3058]]

mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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. Submit electronic comments to http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: January 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-862 Filed 1-15-09; 8:45 am]