E9-862. 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 time.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

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In the Federal Register of September 19, 2008 (73 FR 54407), FDA published the notice of availability for a draft guidance entitled “Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs” giving interested persons until November 18, 2008, to comment on the draft guidance. FDA received numerous comments on the draft guidance.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 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.