[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
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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]
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