FDA Documents on Cloning Available

FDA documents on cloning are now available.

You can view the Animal Cloning Risk Assessment.

The Risk Management Plan for Animals and Their Progeny.

The Guidance for Industry on Cloning

For questions regarding this guidance, contact Larisa Rudenko, Center for Veterinary Medicine (HFV- 100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8245. E-mail: clones@cvm.fda.gov

Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. All written comments should be identified with Docket No. 2003N-0573.

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2 Responses to FDA Documents on Cloning Available

  1. Slobah says:

    I don’t believe this is open for comments, as it is a final ruling. The docket information was for the draft, release in late 2006.

  2. Mark Senak says:

    Actually here is the test of the FDA notice published yesterday:
    Guideline No. 179
    Guidance for Industry Use of Animal Clones and Clone Progeny for Human Food and Animal Feed
    U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
    FOOD AND DRUG ADMINISTRATION
    CENTER FOR VETERINARY MEDICINE
    Comments and suggestions regarding this guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. All written comments should be identified with Docket No. 2003N-0573.
    For questions regarding this guidance, contact Larisa Rudenko, Center for Veterinary Medicine (HFV- 100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8245. E-mail: clones@cvm.fda.gov
    Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/cvm/cloning.htm
    U.S. Department of Health and Human Services
    Food and Drug Administration
    Center for Veterinary Medicine
    January 15, 2008