[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
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Number of
CFR Form name Number of responses per Average burden Total burden
respondents respondent per response hours
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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
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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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