[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2615-2616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00651]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-0576]


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 (42 CFR part 73)'' 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 August 15, 2023, to obtain comments from 
the public and affected agencies. CDC did not receive any comments 
related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    The CDC will accept all comments for this proposed information 
collection project. The OMB 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. 1/31/2024)--Revision--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 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

[[Page 2616]]

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 Centers for Disease Control and 
Prevention (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 Regulatory Science and 
Compliance (DRSC) 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. 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 (Section 7(h)(1)) if any 
changes occur to the information previously submitted to FSAP. 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. 
(Section 3(e) and 4(e)).
    2. Annual inspections that are conducted by the entity must be 
documented. (Section 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. 
(Section 10(f)).
    4. An individual or entity may request approval to perform a 
``restricted experiment'' (Section 13).
    5. An individual or entity must develop and implement a written 
security plan, biosafety plan, and incident response plan (Sections 
11(a), 12(a), and 14(a)).
    6. The Responsible Official must ensure a record of the training 
for each individual with access to select agents and toxins and each 
escorted individual is maintained (Section 15(d)).
    7. An individual or entity may appeal a denial, revocation, or 
suspension of registration. (Section 20(a)).
    8. An individual may appeal a denial, limitation, or revocation of 
access approval. (Section 20(b)).
    The currently approved annualized burden is 4467. CDC requests OMB 
approval for an estimated 3504 annual burden hours. The total estimated 
annualized burden for all data collection was calculated using the 2021 
Annual Report of the FSAP available at https://www.selectagents.gov/resources/publications/annualreport/2021.htm. Burden has been reduced 
due to a decrease in the number of respondents. Information will be 
collected through the FSAP IT system, 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 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)
----------------------------------------------------------------------------------------------------------------
Sections 3 & 4.....................  Request for Exclusions.....               1               1               1
Sections 5 & 6.....................  Form 4--Report of                       917               1               1
                                      Identification of a Select
                                      Agent or Toxin.
Sections 5 & 6.....................  Form 5--Request of                        1               1               1
                                      Exemption.
Section 7..........................  Form 1--Application for                   5               1               5
                                      Registration.
Section 7..........................  Form 1 Sec 6A--Amendment to             144               5               1
                                      a Certificate of
                                      Registration.
Section 9..........................  Documentation of self-                  233               1               1
                                      inspection.
Section 10.........................  Request for Expedited                     1               1           30/60
                                      Review.
Section 11.........................  Security Plan..............             233               1               1
Section 12.........................  Biosafety Plan.............             233               1               1
Section 13.........................  Request Regarding a                       3               1               2
                                      Restricted Experiment.
Section 14.........................  Incident Response Plan.....             233               1               1
Section 15.........................  Training...................             233               1               1
Section 16.........................  Form 2--Request to Transfer             229               1             1.5
                                      Select Agents and Toxins.
Section 17.........................  Records....................             233               1           30/60
Section 19.........................  Form 3--Notification of                 185               1               1
                                      Theft, Loss, or Release.
Section 20.........................  Administrative Review......              22               1               1
----------------------------------------------------------------------------------------------------------------


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. 2024-00651 Filed 1-12-24; 8:45 am]
BILLING CODE 4163-18-P