82 FR 36144 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 148 (August 3, 2017)

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36144-36146]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16333]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0576]


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

[[Page 36145]]

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 (42 CFR 
part 73)--Revision--Centers for Disease Control and Prevention (CDC)/
Division of Select Agents and Toxins (DSAT) and United States 
Department of Agriculture (USDA) Animal and Plant Health Inspection 
Service (APHIS)/Agriculture Select Agent Services (AgSAS).

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 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). The HHS Secretary delegated the 
responsibility for promulgating and implementing select agent 
regulations found at 42 CFR part 73 to CDC Division of Select Agents 
and Toxins (DSAT). The United States Department of Agriculture (USDA) 
Animal and Plant Health Inspection Service (APHIS)/Agriculture Select 
Agent Services (AgSAS) was delegated responsibility by USDA for select 
agent regulations (7 CFR part 331, and 9 CFR part 121). The Federal 
Select Agent Program (FSAP) is the collaboration of the DSAT and AgSAS 
to administer the select agent regulations in a manner to minimize the 
administrative burden on persons subject to the select agent 
regulations. 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 revise the collected information 
under the select agent regulations through the use of the APHIS/CDC 
Form 3 (Incident Notification and Reporting (Theft/Loss/Release)). The 
form (42 CFR 73.19(a),(b)) must be completed by an individual or an 
entity whenever the individual or entity experiences a theft, loss, or 
release of a select agent or toxin. CDC is proposing to revise the form 
to further clarify what needs to be reported as a ``release'' and 
``loss'' and additional fields to assist with categorizing the type of 
release (e.g., spill within secondary containment, occupational 
exposure, possible breach of facility containment, etc.), type of 
exposure, and the understanding of safety and security risk levels 
relative to human illness. Guidance documents were also added to assist 
with the following forms: Application for Registration (APHIS/CDC Form 
1), Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2), 
Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4), 
Request of Exemption of Select Agents and Request for Exclusions Toxins 
for an Investigational Product (APHIS/CDC Form 5), Request for 
Expedited Review, Security Plan, Security Plan, Biosafety Plan, Request 
Regarding a Restricted Experiment, Incident Response Plan, Training, 
and Records.
    Annualized burden hours and cost were calculated based on data 
obtained from 2016 Annual Report of the Federal Select Agent Program 
for submissions to FSAP for 2016. CDC requests a three year approval 
for this Revision. The estimated annualized Burden has been reduced to 
8,408 hours due to the decrease in the number of Respondents. There is 
no cost to Respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
            Section                         Form name                Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
73.7...........................  Application for Registration                  1               1               4
                                  (APHIS/CDC Form 1).
73.7...........................  Amendment to a Certificate of               238               7               1
                                  Registration.
73.7...........................  Application for Registration                  1               1               1
                                  (APHIS/CDC Form 1) Guidance.
73.16..........................  Request to Transfer Select                  188               1               1
                                  Agents and Toxins (APHIS/CDC
                                  Form 2).
73.16..........................  Request to Transfer Select                  188               1           30/60
                                  Agents and Toxins (APHIS/CDC
                                  Form 2) Guidance.
73.19..........................  Report of Theft, Loss, or                   205               1           90/60
                                  Release of Select Agent or
                                  Toxin (APHIS/CDC Form 3).
73.19..........................  Report of Theft, Loss, or                   205               1           30/60
                                  Release of Select Agent or
                                  Toxin (APHIS/CDC Form 3)
                                  Guidance.
73.5 & 6.......................  Report of Identification of a             1,030               1           30/60
                                  Select Agent or Toxin from a
                                  Clinical/Diagnostic Specimen
                                  (APHIS/CDC Form 4A).
73.5 & 6.......................  Report of Identification of a                10               1           30/60
                                  Select Agent or Toxin from a
                                  Proficiency Test (APHIS/CDC
                                  Form 4B).

[[Page 36146]]

 
73.5 & 6.......................  Federal Law Enforcement                       1               1           30/60
                                  Reporting Seizure of Select
                                  Agent or Toxin (APHIS/CDC Form
                                  4C).
73.5 & 6.......................  Report of Identification of a             1,030               1           30/60
                                  Select Agent or Toxin (APHIS/
                                  CDC Form 4) Guidance.
73.5 & 73.6....................  Request of Exemption of Select                1               1           30/60
                                  Agents and Toxins for an
                                  Investigational Product (APHIS/
                                  CDC Form 5).
73.5 & 73.6....................  Request of Exemption of Select                1               1           30/60
                                  Agents and Toxins for an
                                  Investigational Product (APHIS/
                                  CDC Form 5) Guidance.
73.3 & 73.4....................  Request for Exclusions.........               3               1           30/60
73.3 & 73.4....................  Request for Exclusions Guidance               3               1           30/60
73.9...........................  Documentation of Self-                      238               1               1
                                  inspection.
73.1...........................  Request for Expedited Review...               1               1           15/60
73.1...........................  Request for Expedited Review                  1               1           15/60
                                  Guidance.
73.11..........................  Security Plan..................             238               1               5
73.11..........................  Security Plan Guidance.........             238               1           30/60
73.11..........................  Security Plan Template.........             238               1           30/60
73.12..........................  Biosafety Plan.................             238               1               5
73.12..........................  Biosafety Plan Guidance........             238               1           30/60
73.12..........................  Biosafety Plan Template........             238               1           30/60
73.13..........................  Request Regarding a Restricted                1               1           30/60
                                  Experiment.
73.13..........................  Request Regarding a Restricted                1               1           30/60
                                  Experiment Guidance.
73.14..........................  Incident Response Plan.........             238               1               5
73.14..........................  Incident Response Plan Guidance             238               1           30/60
73.14..........................  Incident Response Plan Template             238               1           30/60
73.15..........................  Training.......................             238               1           30/60
73.15..........................  Training Guidance..............             238               1           30/60
73.17..........................  Records........................             238               1           30/60
73.17..........................  Guidance on the Inventory of                238               1           30/60
                                  Select Agents.
73.20..........................  Administrative Review..........               1               1               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. 2017-16333 Filed 8-2-17; 8:45 am]
BILLING CODE 4163-18-P