[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Notices]
[Pages 39702-39704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-08-0576]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576)--Revision--Division of Select Agents and Toxins 
(DSAT), Coordinating Office for Terrorism Preparedness and Emergency 
Response (COTPER), Centers for Disease Control and Prevention (CDC). 
The revisions to the data collection are primarily changes to the 
guidance documents and forms to clarify instructions, correct editorial 
errors from previous submission, and reformat the structure of the 
forms based on the day-to-day processing of these forms. This request 
is for approval for three years.

Background and Brief Description

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 
262a), requires the United States Department of Health and Human 
Services (HHS) to regulate the possession, use, and transfer of 
biological agents or toxins (i.e., select agents and toxins) that could 
pose a severe threat to public health and safety. The Agricultural 
Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 
(7 U.S.C. 8401),

[[Page 39703]]

requires the United States Department of Agriculture (USDA) to regulate 
the possession, use, and transfer of biological agents or toxins (i.e., 
select agents and toxins) that could pose a severe threat to animal or 
plant health, or animal or plant products. In accordance with these 
Acts, HHS and USDA promulgated regulations requiring entities to 
register with the CDC or the Animal and Plant Health Inspection Service 
(APHIS) if they possess, use, or transfer a select agent or toxin (42 
CFR part 73, 7 CFR part 331, and 9 CFR part 121). CDC and APHIS 
coordinate regulatory activities for those agents that would be 
regulated by both agencies (``overlap'' select agents). CDC and APHIS 
adopted an identical system to collect information for the possession, 
use, and transfer of select agents and toxins.
    CDC is requesting continued OMB approval to collect this 
information through the use of five forms. The forms are: (1) 
Application for Registration, (2) Request to Transfer Select Agent or 
Toxin, (3) Report of Theft, Loss, or Release of Select Agent and Toxin, 
(4) Report of Identification of Select Agent or Toxin, and (5) Request 
for Exemption. The Application for Registration (42 CFR, 73.7(d)) will 
be used by entities to register with CDC. Entities may amend their 
registration (42 CFR, 73.7(h)1)) if any changes occur.
    The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) 
will be used to request transfer of a select agent or toxin to their 
facility. CDC, with APHIS, has revised the form by requiring the 
recipient to submit the initial request, be notified by the sender of 
the expected shipment date, and verify if the shipment did not occur.
    The Report of Theft, Loss, or Release of Select Agent and Toxin 
form (42 CFR 73.19(a)(b)) must be completed by entities if there is 
theft, loss, or release of a select agent or toxin. The Report of 
Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and 
73.6(a)(b)) will be used by clinical and diagnostic laboratories to 
notify CDC that select agents or toxins identified as the result of 
diagnostic or proficiency testing have been disposed of in a proper 
manner. The form will be used by Federal law enforcement agencies to 
report the seizure and final disposition of select agents and toxins. 
CDC has revised the Report of Identification of Select Agent or Toxin 
form to ensure duplicate reports are not submitted by requesting the 
entity that makes the final identification report the select agents or 
toxins identified as the result of diagnostic or verification testing.
    The Request for Exemption form (42 CFR 73.5(d)(e) and 73.6(d)(e)) 
will be used by entities that use an investigational product that are, 
bear, or contain select agents or toxins or in cases of public health 
emergency. An entity may apply to HHS for an exclusion of an attenuated 
strain of a select agent or toxin that does not pose a severe threat to 
public health and safety (42 CFR 73.3(e)(1) and 73.4(e)(1)).
    This regulation outlines situations in which an entity must notify 
or may make a request of HHS in writing. An entity may apply to the HHS 
Secretary for an expedited review of an individual by the Attorney 
General (42 CFR 73.10(e)). CDC has not developed standardized forms for 
these situations. The entity should provide the information in the 
appropriate section of the regulation.
    As part of the requirements of the Responsible Official, the 
Responsible Official is required to conduct regular inspections (at 
least annually) of the laboratory where select agents or toxins are 
stored. Results of these self-inspections must be documented (42 CFR 
73.9(a)(5)).
    As part of the training requirements of this regulation, the entity 
is required to record the identity of the individual trained, the date 
of training, and the means used to verify that the employee understood 
the training (42 CFR 73.15(c)).
    An individual or entity may request administrative review of a 
decision denying or revoking certification of registration or an 
individual may appeal a denial of access approval (42 CFR 73.20). An 
entity must implement a system to ensure certain records and databases 
are accurate and that the authenticity of records may be verified (42 
CFR 73.17(b).
    Prior to issuance of a certificate of registration, CDC inspects 
entities to ensure compliance with this regulation (42 CFR 73.18).
    The estimated annual burden is 9,657 hours.

                                        Estimated Annualized Burden Hours
 
----------------------------------------------------------------------------------------------------------------
                                                                                                  Average burden
             CFR reference                   Data collection         Number of     Responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
73.7(d)...............................  Registration Application               5               1             4.5
73.7(h)(1)............................  Amendment to                         264               5               1
                                         Registration
                                         Application.
73.19(a)(b)...........................  Notification of Theft,                60               1               1
                                         Loss, or Release form.
73.5 & 73.6(d-e)/73.3 & 73.4(e)(1)....  Request for Exemption/                 5               1               1
                                         Exclusion.
73.16.................................  Request to Transfer                  264               4             1.5
                                         Select Agent or Toxin.
73.5 & 73.6(a)(b).....................  Report of Identification             264              10               1
                                         of Select Agent or
                                         Toxin form.
73.10(e)..............................  Request expedited review              10               1           30/60
73.9(a)(5)............................  Documentation of self-               264               1               1
                                         inspection.
73.15(c)..............................  Documentation of                     264               1               2
                                         training.
73.20.................................  Administrative Review...              15               1               4
73.17.................................  Ensure secure                        264               1               4
                                         recordkeeping system.
73.18.................................  Inspections.............             264               1               8
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[[Page 39704]]

    Dated: July 2, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
 [FR Doc. E8-15749 Filed 7-9-08; 8:45 am]
BILLING CODE 4163-18-P