[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Notices]
[Pages 136-137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0573]


Draft Animal Cloning Risk Assessment; Proposed Risk Management 
Plan; Draft Guidance for Industry; Availability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, and is requesting comment on, a draft risk assessment 
on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed 
this draft 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, and is 
requesting comment on, a proposed risk management plan for animal 
clones and their progeny. The proposed risk management plan takes into 
account the risks identified in the draft risk assessment and sets out 
proposed measures that FDA might use to manage those risks. In 
addition, FDA is announcing availability of draft guidance for industry 
179 for public comment. This draft guidance describes FDA's 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 the draft risk 
assessment document, the proposed risk management plan, and the draft 
guidance for industry by April 3, 2007. FDA will accept comments, data, 
and information after the deadline, but to ensure consideration by the 
agency in any final documents, comments must be received by this date. 
Comments on agency guidance documents are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft risk 
assessment, proposed risk management plan, or the draft guidance for 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 draft risk 
assessment, proposed risk management plan, or draft guidance for 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, 240-453-6842, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2001, FDA's CVM issued an update on livestock cloning 
(available at http://www.fda.gov/cvm/CVM_Updates/clones.htm) and 
indicated its intention to work with stakeholders to assess potential 
risks presented by cloning food-producing animals. It also requested 
that companies voluntarily refrain from introducing animal clones, 
their progeny, or their food products (such as milk or meat) into the 
human or animal food supply, pending completion of the risk assessment 
process. The public participation phase of this process begins with the 
release of draft documents entitled ``Animal Cloning: A Draft Risk 
Assessment,'' ``Animal Cloning: Proposed Risk Management Plan for 
Clones and Their Progeny,'' and ``Draft Guidance for Industry 
179: Use of Edible Products From Animal Clones or Their 
Progeny for Human Food or Animal Feed.''
    Among the goals of our draft risk assessment were the determination 
of whether somatic cell nuclear transfer (SCNT), the process used to 
produce the clones being considered in the risk assessment, poses any 
unique risks to animals involved in cloning relative to other assisted 
reproductive technologies, and whether foods derived from animal clones 
or their progeny pose consumption risks greater than those posed by 
foods derived from their conventional counterparts. It specifically 
does not consider risk issues that may be posed by genetically 
engineered animals.
    The draft risk assessment has been peer reviewed in accordance with 
the Office of Management and Budget's Information Quality Peer Review 
Bulletin. The peer reviewers' comments and the agency's response to 
them are posted on the Internet with the draft risk assessment (see the 
Electronic Access section of this document).
    The proposed risk management plan describes proposed measures that 
the agency might use to address animal health and food consumption 
risks identified in the draft risk assessment that are within the 
agency's purview. It also describes the agency's plans with regard to 
issues that are not within the agency's authority to manage (e.g., 
ethics) regarding animal cloning.
    The draft guidance for industry describes FDA's recommendations 
regarding the introduction of edible products from animal clones and 
their progeny into the food and feed supply. FDA will consider 
information received during the comment period in its preparation of a 
final risk assessment. To that end, FDA requests that any producers or 
breeders of clones who have additional data on the health of the clones 
or their progeny or composition of food products (i.e., meat or milk) 
derived from clones or their progeny share those data with us. 
Additionally, the agency reiterates that the release of these draft 
documents does not affect its request to industry to continue to 
refrain from introducing food products from clones and their progeny 
into the marketplace.

II. Significance of Guidance

    The draft guidance for industry is a level 1 draft guidance that is 
being issued consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). The draft guidance represents the agency's current 
thinking on the topic. The draft 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft risk 
assessment document, the proposed risk management plan, and the draft 
guidance for industry. For convenience in reviewing the comments, FDA 
requests that comments be separately identified as to which document 
they address. 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

[[Page 137]]

document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cvm/cloning.htm. In an effort to better ensure broad 
awareness of this Federal Register notice, FDA will announce it and 
make copies available through the FDA Dockets Listserv (http://www.fda.gov/ohrms/dockets/FDAMAIL/DMBemaillist.htm). To be added to any 
of FDA's free e-mail subscription services go to http://www.fda.gov. 
Click on ``Subscribe to FDA's E-mail Lists,'' then follow the 
instructions provided.

    Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-9927 Filed 12-28-06; 11:00 am]
BILLING CODE 4160-01-S