[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Pages 2923-2924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-675]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0573]
Animal Cloning Risk Assessment; Risk Management Plan; Guidance
for Industry; 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 risk assessment on animal cloning. FDA's Center for
Veterinary Medicine (CVM) developed this risk assessment to evaluate
the health risks to animals involved in the process of cloning and to
evaluate the food consumption risks that may result from edible
products derived from animal clones or their progeny. FDA is also
announcing the availability of a risk management plan for animal clones
and their progeny. The risk management plan takes into account the
risks identified in the risk assessment and sets out measures that FDA
will use to manage those risks. In addition, FDA is announcing
availability of guidance for industry 179. This guidance describes
FDA's recommendations regarding the use of edible products from animal
clones and their progeny in human food or in animal feed.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the risk
assessment, risk management plan, or the guidance for industry to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send a
self-addressed, adhesive label to assist that office in processing your
request. Submit written comments on the guidance for industry 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.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8245, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 3, 2007 (72 FR 136), FDA
published a notice of availability with a 90-day comment period to
request comments on a draft risk assessment on animal cloning. FDA also
announced the availability for public comment of a proposed risk
management plan for animal clones and their progeny and a draft
guidance for industry describing FDA's recommendations regarding the
use of edible products from animal clones and their progeny in human
food or in animal feed. In response to requests to extend the comment
period on these documents, FDA subsequently published a notice in the
Federal Register (72 FR 15887, April 3, 2007) extending the comment
period for an additional 30 days.
The draft risk assessment evaluated the health effects to animals
involved in the process of cloning and evaluated the food consumption
risks that may result from edible products derived from animal clones
or their progeny. The proposed risk management plan described proposed
measures that the agency might use to address animal health and food
consumption risks identified in the draft risk assessment that were
within the agency's purview. It also described the agency's plans with
regard to issues that were not within the agency's authority to manage
(e.g., ethics) regarding animal cloning. The draft guidance for
industry described FDA's recommendations regarding the introduction of
edible products from animal clones and their progeny into the food and
feed supply.
FDA has completed a thorough analysis of all comments and
additional information received and has updated the documents
appropriately. FDA has concluded that meat and milk from clones of
cattle, swine, and goats, and the offspring of clones from any species
traditionally consumed as food, are as safe to eat as food from
conventionally bred animals. FDA, however, in its guidance for
industry, is recommending that edible products from clones from animals
other than cattle, swine, or goat (e.g., sheep) not be introduced into
the human food supply. Whereas the scientific data supports the safety
of edible products from clones of cattle, swine, or goat, there is
insufficient scientific data to reach this conclusion for edible
products from other types of animals.
II. Significance of Guidance
The guidance for industry is a level 1 guidance that 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. The guidance document does not create or confer any rights for
or on any person and will not operate to bind FDA or the public.
Alternative methods may be used as long as they satisfy the
requirements of the applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
For this level 1 final guidance, FDA concludes that there are no
collection of information requirements under the Paperwork Reduction
Act of 1995.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the guidance
for industry. 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 in January 2008 the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
V. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cvm/cloning.htm.
[[Page 2924]]
Dated: January 3, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-675 Filed 1-15-08; 8:45 am]
BILLING CODE 4160-01-S