80 FR 44130 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 142 (July 24, 2015)

[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44130-44131]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0576]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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, Expiration Date 11/30/2015)--Revision--Office of 
Public Health Preparedness and Response, Centers for Disease Control 
and Prevention (CDC).

[[Page 44131]]

Background and Brief Description

    Subtitle A of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, (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 that 
have the potential to pose a severe threat to public health and safety 
(select agents and toxins). Subtitle B of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (which may be 
cited as the Agricultural Bioterrorism Protection Act of 2002), (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 that have the potential to pose a severe threat to 
animal or plant health, or animal or plant products (select agents and 
toxins). Accordingly, HHS and USDA have promulgated regulations 
requiring individuals or entities that possess, use, or transfer select 
agents and toxins to register with the CDC or the Animal and Plant 
Health Inspection Service (APHIS). See 42 CFR part 73, 7 CFR part 331, 
and 9 CFR part 121 (the select agent regulations). The Federal Select 
Agent Program (FSAP) is the collaboration of the CDC, Division of 
Select Agents and Toxins (DSAT) and the APHIS Agriculture Select Agent 
Services (AgSAS) to administer the select agent regulations in a manner 
to minimize the administrative burden on persons subject to the select 
agent regulations. The FSAP administers the select agent regulations in 
close coordination with the Federal Bureau of Investigation's Criminal 
Justice Information Services (CJIS). Accordingly, CDC and APHIS have 
adopted an identical system to collect information for the possession, 
use, and transfer of select agents and toxins.
    CDC is requesting OMB approval to continue to collect information 
under the select agent regulations for the next three years. 
Information will be collected via fax, email and hard copy mail from 
respondents.
    The revisions to the data collection are primarily changes to the 
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. Changes were made to the following 
forms: Report of Identification of a Select Agent or Toxin, Request for 
Exemption, Application for Registration, Request to Transfer Select 
Agents and Toxins, and Administrative Review.
    There is no cost to respondents other than their time. The total 
estimated annualized burden hours are 8,527.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Regulation sections                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
73.3 & 73.4...........................  Request for Exclusions..               3               1               1
73.5 & 6..............................  Report of Identification             303               3               1
                                         of a Select Agent or
                                         Toxin.
73.5 & 73.6...........................  Request for Exemption...               1               1               1
73.7..................................  Application for                        5               1               5
                                         Registration.
73.7..................................  Amendment to a                       277               7               1
                                         Certificate of
                                         Registration.
73.9..................................  Documentation of self-               277               1               1
                                         inspection.
73.10.................................  Request for Expedited                  1               1           30/60
                                         Review.
73.11.................................  Security Plan...........             277               1               5
73.12.................................  Biosafety Plan..........             277               1               5
73.13.................................  Request Regarding a                   20               2               1
                                         Restricted Experiment.
73.14.................................  Incident Response Plan..             277               1               5
73.15.................................  Training................             277               1               1
73.16.................................  Request to Transfer                  156               2               1
                                         Select Agents and
                                         Toxins.
73.17.................................  Records.................             277               1           30/60
73.19.................................  Notification of                      215               2               1
                                         Potential Theft, Loss,
                                         or Release.
73.20.................................  Administrative Review...               5               4               1
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-18094 Filed 7-23-15; 8:45 am]
 BILLING CODE 4163-18-P