[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29754-29755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-11-0576]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Daniel Holcomb, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576)--Revision--Office of Public Health Preparedness 
and Response (OPHPR), Division of Select Agents and Toxins, 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. 
There have been no new select agent program forms added to this 
information collection request. The current versions of the standard 
forms have been revised to: (1) Reduce the burden expended by the 
regulated entities and CDC by removing similar questions, (2) enhance 
clarification of the transfer process, (3) determine the level of 
potential exposure, and (4) improve surveillance methods for monitoring 
the reports of select agents and toxins identified by registered 
entities. In addition to the standardized forms listed above, requests 
for expedited reviews, administrative reviews and inspections are also 
submitted to CDC. There is not a standardized form for the request for 
expedited review, administrative review and inspections. Therefore, an 
entity must submit a written request to the Secretary of Health and 
Human Services, by way of the Attorney General for expedited reviews 
(42 CFR 73.10(e)) and exclusions 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)). Inspections take place prior 
to issuance of a certificate of registration to ensure compliance with 
regulation 42 CFR 73.18. Following the inspection an entity may be 
asked to respond to written requests and submits the documentation to 
CDC.
    Entities may also amend their registration (42 CFR, 73.7(h)(1)) if 
any changes occur to the information previously submitted. When 
applying for an amendment to a certificate of registration, an entity 
must obtain and complete the relevant portion of the application 
package.
    The total estimated annualized burden for all data collection is 
8,878 hours. Information will be collected via fax, email and mail from 
respondents of the 320 entities registered with the Select Agent 
Program. There is no cost to the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                   Number of
             CFR                  Form name        Number of     responses per   Average burden    Total burden
                                                  respondents     respondent      per response         hours
----------------------------------------------------------------------------------------------------------------
73.3(d)......................  Application for               5               1               4.5              23
                                Registration.
73.7(h)(1)...................  Amendment to                320               8               1             2,560
                                Registration
                                Application.
73.16........................  Request to                  320               1               1.5             480
                                Transfer
                                Select Agents
                                or Toxins.

[[Page 29755]]

 
73.19(a)(b)..................  Notification of             180               1               1               180
                                Theft, Loss or
                                Release.
73.5 & 73.6(a)(b)............  Report of                   320               9               1             2,880
                                Identification
                                of Select
                                Agent.
73.5 & 73.6(d-e).............  Request of                    3               1               1                 3
                                Exemption.
73.3 & 73.4(e)(1)............  Request for                  71               1               1                71
                                Exclusions/
                                Restricted.
73.10(e).....................  Request for                   1               1               1                 1
                                Expedited
                                Review.
73.20........................  Administrative               30               1               4               120
                                Review.
73.18........................  Inspections....             320               1               8             2,560
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ..............  ..............  ................           8,878
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    Dated: May 17, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-12571 Filed 5-20-11; 8:45 am]
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