[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55457-55459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0576; Docket No. CDC-2023-0061]


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. This data collection allows CDC to continue 
to collect information and ensure compliance under the Select Agent 
regulations.

DATES: CDC must receive written comments on or before October 16, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0061 by either of the following methods:
     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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 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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 
73) (OMB Control No. 0920-0576, Exp. 1/31/2024)--Extension--Office of 
Readiness and Response (ORR), 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

[[Page 55458]]

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 Division of 
Agricultural Select Agents and Toxins (DASAT) to administer the select 
agent regulations in a manner to minimize the administrative burden on 
persons subject to the select agent regulations. 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:
     Application for Registration for Possession. Use, and 
Transfer of Select Agents and Toxins (APHIS/CDC Form 1) with an 
addendum form: Form 1 Sec 6A--Amendment to a Certificate of 
Registration.
     Request to Transfer Select Agents or Toxins (APHIS/CDC 
Form 2).
     Incident Notification and Reporting (Theft, Loss, or 
Release) (APHIS/CDC Form 3).
     Reporting the Identification of a Select Agent or Toxin 
(APHIS/CDC Form 4).
     Request for Exemption of Select Agents and Toxins for an 
Investigational Product (APHIS/CDC Form 5).
    In addition to the forms listed above, the following forms will 
also be used:
     Request for Exclusions--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)).
     Documentation of self-inspection--Annual inspections that 
are conducted by the entity must be documented. (42 CFR 73.9(a)(6)).
     Request for Expedited Review--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)).
     Request Regarding a Restricted Experiment--An individual 
or entity may request approval to perform a ``restricted experiment'' 
(42 CFR 73.13).
     Security Plan--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)).
     Training--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)).
     Administrative Review--An individual or entity may appeal 
a denial, revocation, or suspension of registration. (42 CFR 73.20(a)).
     Biosafety Plan--An individual or entity required to 
register under this part must develop and implement a written biosafety 
plan that is commensurate with the risk of the select agent or toxin, 
given its intended use. The biosafety plan must contain sufficient 
information and documentation to describe the biosafety and containment 
procedures for the select agent or toxin, including any animals 
(including arthropods) or plants intentionally or accidentally exposed 
to or infected with a select agent (42 CFR 73.12(a)).
     Incident Response Plan--An individual or entity required 
to register under this part must develop and implement a written 
incident response plan based upon a site specific risk assessment. The 
incident response plan must be coordinated with any entity-wide plans, 
kept in the workplace, and available to employees for review (42 CFR 
73.14 (a)).
     Records--An individual or entity required to register 
under this part must maintain complete records relating to the 
activities covered by the select agent regulations (42 CFR 73.17 (a)).
    The total estimated annualized burden for all data collection was 
calculated using the 2021 Annual Report of the Federal Select Agent 
Program available at https://www.selectagents.gov/resources/publications/annualreport/2021.htm or FSAP IT system and is estimated 
as 3,539 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 January 2024 through January 
2027. There is no cost to the respondents.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
                    Section                                     Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
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Sections 3 & 4.................................  Request for Exclusions.................               1               1               1               1
Sections 5 & 6.................................  Form 4--Report of Identification of a               917               1               1             917
                                                  Select Agent or Toxin.
Sections 5 & 6.................................  Form 5--Request of Exemption...........               1               1               1               1
Section 7......................................  Form 1--Application for Registration...               5               1               5              25
Section 7......................................  Form 1 Sec 6A--Amendment to a                       144               5               1             720
                                                  Certificate of Registration.
Section 9......................................  Documentation of self-inspection.......             233               1               1             233
Section 10.....................................  Request for Expedited Review...........               1               1           30/60               1
Section 11.....................................  Security Plan..........................             233               1               1             233
Section 12.....................................  Biosafety Plan.........................             233               1               1             233
Section 13.....................................  Request Regarding a Restricted                        3               1               2               6
                                                  Experiment.
Section 14.....................................  Incident Response Plan.................             233               1               1             233
Section 15.....................................  Training...............................             233               1               1             233
Section 16.....................................  Form 2--Request to Transfer Select                  229               1             1.5             380
                                                  Agents and Toxins.
Section 17.....................................  Records................................             233               1           30/60             117

[[Page 55459]]

 
Section 19.....................................  Form 3--Notification of Theft, Loss, or             185               1               1             185
                                                  Release.
Section 20.....................................  Administrative Review..................              22               1               1              22
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    Total......................................  .......................................  ..............  ..............  ..............            3539
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-17483 Filed 8-14-23; 8:45 am]
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