[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15887-15888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6170]


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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Plan; Draft Guidance for Industry; Availability; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to May 3, 
2007, the comment period for the notice of availability that appeared 
in the Federal Register of January 3, 2007 (72 FR 136). In the notice, 
FDA requested comments on the draft risk assessment, the proposed risk 
management plan, and the draft guidance for industry on animal cloning. 
The agency is taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit written and electronic comments by May 3, 2007.

ADDRESSES: 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proposed risk management plan, or draft guidance for industry to the 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 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 to evaluate the health 
effects 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 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animal clones and their progeny and a draft guidance for industry 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

[[Page 15888]]

recommendations regarding the use of edible products from animal clones 
and their progeny in human food or in animal feed.
    The agency has received requests for an extension of the comment 
period for the draft risk assessment, proposed risk management plan, 
and draft guidance. These requests conveyed concern that the current 
90-day comment period does not allow sufficient time to develop a 
meaningful or thoughtful response to the cloning documents.
    FDA has considered the requests and is extending the comment period 
for the draft risk assessment, proposed risk management plan, and draft 
guidance until May 3, 2007. The agency believes this extension allows 
adequate time for interested persons to submit comments.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on these documents. 
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.

    Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6170 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S