[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43844-43845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-0576]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Possession, Use, and Transfer of Select 
Agents and Toxins to the Office of Management and Budget (OMB) for 
review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
April 3, 2020 to obtain comments from the public and affected agencies. 
CDC received one comment related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576, Exp. 10/31/2020)--Revision--Center for 
Preparedness and Response (CPR), Centers for Disease Control and 
Prevention (CDC).

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

[[Page 43845]]

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 agents 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 through the use of five forms: (1) 
Application for Registration for Possession. Use, and Transfer of 
Select Agents and Toxins (APHIS/CDC Form 1); (2) Request to Transfer 
Select Agents or Toxins (APHIS/CDC Form 2); (3) Incident Notification 
and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3); (4) 
Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form 
(4); and (5) Request for Exemption of Select Agents and Toxins for an 
Investigational Product (APHIS/CDC Form 5).
    An entity may amend its registration (42 CFR 73.7(h)(1)) if any 
changes occur to the information previously submitted to CDC. When 
applying for an amendment to a certificate of registration, an entity 
would complete the relevant portion of the application package (APHIS/
CDC Form 1).
    Besides the forms listed above, there is no standard form for the 
following information:
    1. An individual or entity may request an exclusion from the 
requirements of the select agent regulations of an attenuated strain of 
a select agent or a select toxin modified to be less potent or toxic. 
(42 CFR 73.3(e) and 73.4(e)).
    2. Annual inspections that are conducted by the entity must be 
documented. (42 CFR 73.9(a)(6)).
    3. An individual's security risk assessment may be expedited upon 
written request by a Responsible Official and a showing of good cause. 
(42 CFR 73.10(f)).
    4. An individual or entity may request approval to perform a 
``restricted experiment'' (42 CFR 73.13).
    5. An individual or entity must develop and implement a written 
security plan, biosafety plan, and incident response plan (42 CFR 
73.11(a), 42 CFR 73.12(a), and 42 CFR 73.14(a)).
    6. The Responsible Official at the entity must ensure a record of 
the training for each individual with access to select agents and 
toxins and each escorted individual is maintained (42 CFR 73.15(d)).
    7. An individual or entity may appeal a denial, revocation, or 
suspension of registration. (42 CFR 73.20(a)).
    8. An individual may appeal a denial, limitation, or revocation of 
access approval. (42 CFR 73.20(b)).
    The total estimated annualized burden for all data collection was 
calculated using the 2018 Annual Report of the Federal Select Agent 
Program available at https://www.selectagents.gov/annualreport2018.html 
or FSAP IT system and is estimated as 4467 hours. Information will be 
collected through FSAP IT system, fax, email and hard copy mail from 
respondents. Upon OMB approval, CDC will begin use of the revised forms 
in October 2020 through October 2023. There is no cost to the 
respondents.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
                Section                         Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Sections 3 & 4........................  Request for Exclusions..               1               1               1
Sections 5 & 6........................  Report of Identification           1,181               1               1
                                         of a Select Agent or
                                         Toxin.
Sections 5 & 6........................  Request of Exemption....               1               1               1
Section 7.............................  Application for                        3               1               5
                                         Registration.
Section 7.............................  Amendment to a                       253               5               1
                                         Certificate of
                                         Registration.
Section 9.............................  Documentation of self-               253               1               1
                                         inspection.
Section 10............................  Request for Expedited                  1               1             0.5
                                         Review.
Section 11............................  Security Plan...........             253               1               1
Section 12............................  Biosafety Plan..........             253               1               1
Section 13............................  Request Regarding a                    1               1               2
                                         Restricted Experiment.
Section 14............................  Incident Response Plan..             253               1               1
Section 15............................  Training................             253               1               1
Section 16............................  Request to Transfer                  253               1             1.5
                                         Select Agents and
                                         Toxins.
Section 17............................  Records.................             253               1             0.5
Section 19............................  Notification of Theft,               201               1               1
                                         Loss, or Release.
Section 20............................  Administrative Review...              28               1               1
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-15655 Filed 7-17-20; 8:45 am]
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