[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18980-18982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0572; Docket No. CDC-2020-0034]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Possession, Use, and Transfer of 
Select Agents and Toxins (42 CFR part 73). This information collection 
intends to support the Public Health Safety and Bioterrorism 
Preparedness and Response Act of 2002 and ensure select agents or 
toxins are managed appropriately to prevent any threats to human health 
or safety. Data will be used to fulfill the requirements promulgated by 
HHS under this part and also subject to corresponding regulations 
promulgated by USDA.

DATES: CDC must receive written comments on or before June 2, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-20-
0034 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road, 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each

[[Page 18981]]

collection of information they conduct or sponsor. In addition, the PRA 
also requires Federal agencies to provide a 60-day notice in the 
Federal Register concerning each proposed collection of information, 
including each new proposed collection, each proposed extension of 
existing collection of information, and each reinstatement of 
previously approved information collection before submitting the 
collection to the OMB for approval. To comply with this requirement, we 
are publishing this notice of a proposed data collection as described 
below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576)--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 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 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 4465 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
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                                                                                      Average
                                                    Number of       Number of       burden per     Total burden
          Section                 Form name        respondents    responses per    response  (in       hours
                                                                    respondent        hours)
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Sections 3 & 4.............  Request for                      1                1               1               1
                              Exclusions.
Sections 5 & 6.............  Report of                    1,181                1               1           1,181
                              Identification of
                              a Select Agent or
                              Toxin.
Sections 5 & 6.............  Request of                       1                1               1               1
                              Exemption.

[[Page 18982]]

 
Section 7..................  Application for                  3                1               5              15
                              Registration.
Section 7..................  Amendment to a                 253                5               1           1,265
                              Certificate of
                              Registration.
Section 9..................  Documentation of               253                1               1             253
                              self-inspection.
Section 10.................  Request for                      1                1             0.5               1
                              Expedited Review.
Section 11.................  Security Plan.....             253                1               1             253
Section 12.................  Biosafety Plan....             253                1               1             253
Section 13.................  Request Regarding                1                1               2               2
                              a Restricted
                              Experiment.
Section 14.................  Incident Response              253                1               1             253
                              Plan.
Section 15.................  Training..........             253                1               1             252
Section 16.................  Request to                     253                1             1.5             380
                              Transfer Select
                              Agents and Toxins.
Section 17.................  Records...........             253                1             0.5             127
Section 19.................  Notification of                201                1               1             201
                              Theft, Loss, or
                              Release.
Section 20.................  Administrative                  28                1               1              28
                              Review.
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    Total..................  ..................  ..............  ...............  ..............            4465
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-06948 Filed 4-2-20; 8:45 am]
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