[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.16]

[Page 450-451]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73_SELECT AGENTS AND TOXINS--Table of Contents
 
Sec. 73.16  Transfers.

    (a) Except as provided in paragraphs (c) and (d) of this section, a 
select agent or toxin may only be transferred to individuals or entities 
registered to possess, use, or transfer that agent or toxin. A select 
agent or toxin may only be transferred under the conditions of

[[Page 451]]

this section and must be authorized by CDC or APHIS prior to the 
transfer.\4\
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    \4\ This section does not cover transfers within an entity when the 
sender and the recipient are covered by the same certificate of 
registration.
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    (b) A transfer may be authorized if:
    (1) The sender:
    (i) Has at the time of transfer a certificate of registration that 
covers the particular select agent or toxin to be transferred and meets 
all requirements in this part,
    (ii) Meets the exemption requirements for the particular select 
agent or toxin to be transferred, or
    (iii) Is transferring the select agent or toxin from outside the 
United States and meets all import requirements.
    (2) At the time of transfer, the recipient has a certificate of 
registration that includes the particular select agent or toxin to be 
transferred and meets all of the requirements of this part.
    (c) A select agent or toxin that is contained in a specimen for 
proficiency testing may be transferred without prior authorization from 
CDC or APHIS provided that, at least seven calendar days prior to the 
transfer, the sender reports to CDC or APHIS the select agent or toxin 
to be transferred and the name and address of the recipient.
    (d) On a case-by-case basis, the HHS Secretary may authorize a 
transfer of a select agent or toxin, not otherwise eligible for transfer 
under this part under conditions prescribed by the HHS Secretary.
    (e) To obtain authorization for transfer, APHIS/CDC Form 2 must be 
submitted.
    (f) The recipient must submit a completed APHIS/CDC Form 2 within 
two business days of receipt of a select agent or toxin.
    (g) The recipient must immediately notify CDC or APHIS if the select 
agent or toxin has not been received within 48 hours after the expected 
delivery time, or if the package containing select agents or toxins has 
been damaged to the extent that a release of the select agent or toxin 
may have occurred.
    (h) An authorization for a transfer shall be valid only for 30 
calendar days after issuance, except that such an authorization becomes 
immediately null and void if any facts supporting the authorization 
change (e.g., change in the certificate of registration for the sender 
or recipient, change in the application for transfer).
    (i) The sender must comply with all applicable laws concerning 
packaging and shipping.