[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62412-62413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-11-0576]


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 20503 or by fax to (202) 395-
5806. 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) Exp. 12/31/2011--Revision--Office of Public 
Health Preparedness and Response (OPHPR), Division of Select Agents and 
Toxins (DSAT), Centers for Disease Control and Prevention (CDC).

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), 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 is requesting continued OMB approval to collect this 
information through the use of five forms: (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. 
Revision will be made to (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. There will be no 
revisions made to the Application for Registration and Request for 
Exemption The total estimated annualized burden for all data collection 
is 8,878 hours. Information will be collected via fax, e-mail and mail 
from respondents of the 320 entities registered with the Select Agent 
Program. Annualized burden hours were calculated by multiplying the 
average number of hours used to complete the: (1) Application for 
Registration; (2) Request to Transfer Select Agent or Toxin; (3) Report 
of Theft, Loss, or Release of Select Agent or Toxin; (4) Report of 
Identification of Select Agent or Toxin; and (5) Request for Exemption. 
The estimated annualized burden for the 2008 Possession, Use, and 
Transfer of Select Agents and Toxins submission was 9,656.5 hours. The 
2011 estimated annualized burden hours are 8,878. Burden has been 
reduced by 778.5 hours due to the removal of similar questions on the 
Request to Transfer Select Agent or Toxin (Form 2), Report of Theft, 
Loss, or Release of Select Agent or Toxin (Form 3) and the Report of 
Identification of Select Agent or Toxin (Form 4). Therefore respondents 
are not required to answer as many questions as requested in the 
previous data collection tool.
    The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) 
will be used by entities requesting transfer of a select agent or toxin 
to their facility. CDC in conjunction with APHIS has revised the 
Request to Transfer Select Agent or Toxin 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. 
Estimated average time to complete this form is 1 hour, 30 minutes. 
Based on data regarding the transfer requests received since the last 
submission, CDC estimates 1 transfer requests submitted per registered 
entity on an annual basis.
    The Report of Theft, Loss, or Release of Select Agent and Toxin 
form (42 CFR 73.19(a)(b)) must be completed by entities whenever there 
is theft, loss, or release of a select agent or toxin. Estimated 
average time to complete this form is 1 hour. Based on data regarding 
the reports received since the last submission, CDC estimates that 1 
report

[[Page 62413]]

per respondent will be received on an annual basis.
    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. In addition, the form will be used by Federal law 
enforcement agencies to report the seizure and final disposition of 
select agents and toxins. CDC in conjunction with APHIS has revised the 
Report of Identification of Select Agent or Toxin form to ensure 
duplicate reports are not submitted by requesting the entity making the 
final identification report the select agents or toxins identified as 
the result of diagnostic or verification testing. Estimated average 
time to complete this form is 1 hour. Based on data regarding the 
reports received since the last submission, CDC estimates that 9 
reports per respondent will be received on an annual basis.
    There is no cost to the respondents other than their time. The 
total estimated annualized burden hours are 8,878, which is a reduction 
of 778.5 hours from the previously approved ICR.

                                        Estimated Annualized Burden Hours
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                                                                                     Number
                CFR                           Form name             Number of     responses per   Average burden
                                                                   respondents     respondent      per response
----------------------------------------------------------------------------------------------------------------
73.3(d)............................  Application for                          5               1              4.5
                                      Registration.
73.7(h)(1).........................  Amendment to Registration              320               8              1
                                      Application.
73.16..............................  Request to Transfer Select             320               1              1.5
                                      Agents or Toxins.
73.19(a)(b)........................  Notification of Theft,                 180               1              1
                                      Loss or Release.
73.5 & 73.6(a)(b)..................  Report of Identification               320               9              1
                                      of Select Agent.
73.5 & 73.6(d-e)...................  Request of Exemption......               3               1              1
73.3 & 73.4(e)(1)..................  Request for Exclusions/                 71               1              1
                                      Restricted.
73.10(e)...........................  Request for Expedited                    1               1              1
                                      Review.
73.20..............................  Administrative Review.....              30               1              4
73.18..............................  Inspections...............             320               1              8
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    Dated: September 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-26008 Filed 10-6-11; 8:45 am]
BILLING CODE 4163-18-P