42 CFR 73.13 - Restricted experiments.

§ 73.13 Restricted experiments.

(a) An individual or entity may not conduct, or possess products resulting from, the following experiments unless approved by and conducted in accordance with the conditions prescribed by the HHS Secretary:

(1) Experiments that involve the deliberate transfer of, or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture.

(2) Experiments involving the deliberate formation of synthetic or recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] <100

(b) The HHS Secretary may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part.

(c) To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued.

[ 70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61114, Oct. 5, 2012; 79 FR 26862, May 12, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 42 published on 19-Apr-2017 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 73 after this date.

  • 2017-04-12; vol. 82 # 69 - Wednesday, April 12, 2017
    1. 82 FR 17569 - Possession, Use, and Transfer of Select Agents and Toxins—Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC)
      Interim rule; adoption as final and response to public comments.
      Effective April 12, 2017.
      42 CFR Part 73