Document ID: FDA-2008-N-0033-0001
Agency: fda
Document Type: Notice
Title: Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability
Posted Date: 2008-01-16T05:00Z

[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]               
[Page 2923-2924]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-61]                         

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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: clones@cvm.fda.gov.

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