[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44130-44131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18094]
-----------------------------------------------------------------------
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