42 CFR 73.8 - Denial, revocation, or suspension of registration.

Code of Federal Regulations - Title 42: Public Health (December 2005)


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TITLE 42 - PUBLIC HEALTH

CHAPTER I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER F - QUARANTINE, INSPECTION, LICENSING

PART 73 - SELECT AGENTS AND TOXINS

73.8 - Denial, revocation, or suspension of registration.

  (a) An application may be denied or a certificate of registration revoked or suspended if: (1) The individual or entity, the Responsible Official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b, (2) The individual or entity, the Responsible Official, or an individual who owns or controls the entity as reasonably suspected by any Federal law enforcement or intelligence agency of: (i) Committing a crime specified in 18 U.S.C. 2332b(g)(5), (ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence, or (iii) Being an agent of a foreign power (as defined in 50 U.S.C. 1801).

  (3) The individual or entity does not meet the requirements of this part, or (4) It is determined that such action is necessary to protect public health and safety.

  (b) Upon revocation or suspension of a certificate of registration, the individual or entity must: (1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order, (2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release, and (3) Comply with all disposition instructions issued by the HHS Secretary for the select agent or toxin covered by the revocation or suspension.

  (c) Denial of an application for registration and revocation of registration may be appealed under 73.20. However, any denial of an application for registration or revocation of a certificate of registration will remain in effect until a final agency decision has been rendered.

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