[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
[Notices]
[Pages 54407-54408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry: Regulation of Genetically Engineered 
Animals Containing Heritable rDNA Constructs; 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availability of a draft guidance document (GFI187) entitled 
``Regulation of Genetically Engineered Animals Containing Heritable 
rDNA Constructs.'' This draft guidance is intended to clarify FDA's 
requirements and recommendations for producers and developers of 
genetically engineered (GE) animals and their products. The draft 
guidance describes how the new animal drug provisions of the Federal 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.
    Elsewhere in this same issue of the Federal Register, the Animal 
and Plant Health Inspection Service (APHIS) is soliciting public 
comment on any potential implications of activities such as the 
importation or interstate movement of GE animals on the health of the 
U.S. livestock population under the authority of the Animal Health 
Protection Act (AHPA).

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by November 18, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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    Submit written comments on the draft guidance to the Division of 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 draft 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].

SUPPLEMENTARY INFORMATION:

I. Background

    For the purpose of this guidance, FDA defines ``genetically 
engineered (GE) animals'' as those animals modified by recombinant DNA 
(rDNA) techniques. 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

[[Page 54408]]

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.
    FDA's authority over new animal drugs comes from the Federal Food, 
Drug, and Cosmetic Act. The definition of a drug, in section 201(g) of 
the act (21 U.S.C. 321(g)), includes ``articles intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention of disease in man 
or other animals;'' and ``articles (other than food) intended to affect 
the structure or any function of the body of man or other animals.'' 
The rDNA construct in a GE animal that is intended to affect the 
structure or function of the body of the GE animal, regardless of the 
intended use of products that may be produced by the GE animal, meets 
the act drug definition. The draft guidance describes how the new 
animal drug provisions of the act apply with respect to GE animals, 
including FDA's intent to exercise enforcement discretion regarding 
requirements for certain GE animals.
     FDA is one of several Federal agencies that share regulatory 
oversight of GE organisms. In 1986, the Office of Science and 
Technology Policy (OSTP) under the Executive Office of the President 
published a policy document known as the Coordinated Framework for the 
Regulation of Biotechnology (the Coordinated Framework).\1\ This policy 
document describes the system for coordinating the activities of the 
Federal agencies responsible for regulating all GE organisms.\2\
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    \1\Coordinated Framework for the Regulation of Biotechnology: 
June 26, 1986; 51 FR 23302; http://usbiotechreg.nbii.gov/CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf.
    \2\In addition to discussing the regulatory responsibilities of 
these agencies for GE organisms and other products, the Coordinated 
Framework also discusses the responsibilities of agencies with 
jurisdiction over GE research (the National Institutes of Health, 
the National Science Foundation, the Environmental Protection Agency 
(EPA), and the U.S Department of Agriculture's (USDA's) Agricultural 
Research Service).
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    In addition to FDA's role in oversight of GE animals, APHIS is 
authorized, under the AHPA (7 U.S.C. 8301 et seq.), to protect the 
health of U.S. livestock by preventing the introduction and spread of 
livestock diseases and pests into and within the United States. Based 
on that authority, APHIS may broadly consider the potential effects of 
animals with GE traits on the health of the overall U.S. livestock 
population, while FDA is more focused on the direct effects of genetic 
engineering on individual animals based on its authority under the act. 
Given these complementary authorities, FDA and APHIS have been 
discussing their respective roles in overseeing GE animals for some 
time. In conjunction with FDA's release for public comment of its 
guidance on GE animals, APHIS is soliciting public comment in this same 
issue of the Federal Register on any potential implications of 
activities such as the importation or interstate movement of GE animals 
on the health of the U.S. livestock population.

II. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's 
Good Guidance Practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent 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 
method may be used as long as it satisfies the requirements of 
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 have been approved under OMB Control Nos. 
0910-0032, 0910-0045, 0910-0117, and 0910-0284. FDA seeks public 
comment on the agency's determination that the previously approved 
collections of information referred to previously adequately account 
for the collections of information referenced in this guidance. 
Although the collections of information burden estimates previously 
approved by OMB were derived for new animal drug applications (NADAs) 
in general, FDA believes that such estimates are applicable to NADAs 
for GE animals. In particular, FDA previously determined that preparing 
the paperwork required for an NADA under 21 CFR 514.1 will take 
approximately 212 hours. Over the past 5 fiscal years, FDA has received 
an average of 19 NADAs per year.

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS 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/cvm or http://www.regulations.gov.

    Dated: September 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21917 Filed 9-18-08; 8:45 am]
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