[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21917]
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.
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availability of a draft guidance document (GFI187) entitled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 This draft guidance is intended to clarify FDA's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 The draft
guidance describes how the new animal drug provisions of the Federal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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for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Submit written comments on the draft guidance to the Division of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section for electronic access to the draft guidance document.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].
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
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\
\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
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.
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
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.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21917 Filed 9-18-08; 8:45 am]
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