Notice2026-18217
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
September 8, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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 73). This data collection allows CDC and APHIS have to collect information on the possession, use, and transfer of select agents and toxins.
Full Text
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<title>Federal Register, Volume 91 Issue 172 (Tuesday, September 8, 2026)</title>
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[Federal Register Volume 91, Number 172 (Tuesday, September 8, 2026)]
[Notices]
[Pages 57150-57153]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18217]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-26-0576; Docket No. CDC-2026-1486]
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information
[[Page 57151]]
collection project titled Possession, Use, and Transfer of Select
Agents and Toxins (42 CFR 73). This data collection allows CDC and
APHIS have to collect information on the possession, use, and transfer
of select agents and toxins.
DATES: CDC must receive written comments on or November 9, 2026.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2026-
1486 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#c9a6a4ab89aaadaae7aea6bf"><span class="__cf_email__" data-cfemail="c6a9aba486a5a2a5e8a1a9b0">[email protected]</span></a>.
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. 2/28/2027)--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 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. Accordingly, CDC and
APHIS have adopted an identical system to collect information for the
possession, use, and transfer of select agents and toxins.
Since the implementation of the select agent and toxin regulations
in 2003 (HHS/CDC, 2003), unless a regulatory exemption or exclusion is
applied, individuals and entities are required to register with HHS or
USDA to possess a select agent or toxin. Possession of regulated
material without proper registration is a regulatory violation that
could result in civil, criminal, and/or administrative penalties. Since
this time, there have been at least 100 instances of reports from
entities that ``discovered'' a select agent or toxin in their
possession that the individual or entity was not registered to possess
as required. Many of the agents and toxins ``discovered'' were from
studies associated with personnel who had left their entity, and the
custodianship of samples was not reassigned. Some of the materials were
labeled with obsolete pathogen names, while other ``discovered''
material were found in laboratories where their active use had ceased,
in some cases, decades prior to the establishment of the select agent
and toxin regulations.
HHS/CDC continues to receive reports from entities who find
themselves in possession of select agents and toxins that they are not
registered to possess. Given these instances, HHS/CDC is proposing to
amend section 73.2 of the regulations to clearly state that any
individual or entity in possession of a select agent or toxin, for
which (1) an exclusion or exemption listed in 42 CFR part 73 does not
apply, and (2) that is not included on a certificate of registration
issued by the HHS Secretary or USDA Administrator for that individual
or entity, must immediately report such possession to either the HHS
Secretary or USDA Administrator. This proposal ensures that all
discoveries of possession of a select agent or toxin is reported using
the proposed new form regardless of if the individual or entity is
registered with the program. As such, registered entities that
knowingly come into possession of a material prior to amending their
registration would report the possession using the proposed form. HHS/
CDC would be interested in comments regarding the proposal to ensure
the reporting of discovered select agents and toxins including if there
is an undue burden being placed on registered entities to report the
discovery as well as amending their registration. To facilitate such
reporting, HHS and USDA proposes, in compliance with the Paperwork
[[Page 57152]]
Reduction Act, a new APHIS/CDC form, Report of Discovery of Select
Agent or Toxin form (42 CFR 73.19(c) (Form 6), to specify the
information that must be submitted regarding the discovery of the
select agent or toxin. Establishing a standard form for reporting will
enable HHS and USDA to better understand the circumstances and assess
regulatory violations related to the possession of ``discovered''
select agents and toxins.
CDC is requesting OMB approval to revise this existing information
collection to continue to collect information under the select agent
regulations through the use of five approved forms and to add a sixth
form:
<bullet> 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.
<bullet> Request to Transfer Select Agents or Toxins (APHIS/CDC
Form 2).
<bullet> Incident Notification and Reporting (Theft, Loss, or
Release) (APHIS/CDC Form 3).
<bullet> Reporting the Identification of a Select Agent or Toxin
(APHIS/CDC Form 4).
<bullet> Request for Exemption of Select Agents and Toxins for an
Investigational Product (APHIS/CDC Form 5).
<bullet> Report of Discovery of Select Agent or Toxin form (42 CFR
73.19(c) (APHIS/CDC Form 6).
In addition to the forms listed above, the following forms will
also be used:
<bullet> 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)).
<bullet> Documentation of self-inspection--Annual inspections that
are conducted by the entity must be documented. (42 CFR 73.9(a)(6)).
<bullet> 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)).
<bullet> Request Regarding a Restricted Experiment--An individual
or entity may request approval to perform a ``restricted experiment''
(42 CFR 73.13).
<bullet> 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)).
<bullet> 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)).
<bullet> Administrative Review--An individual or entity may appeal
a denial, revocation, or suspension of registration. (42 CFR 73.20(a)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> Report of Discovery of Select Agent or Toxin form (42 CFR
73.19(c) (Form 6)--This is a new form that will be completed by
entities whenever there is discovery of a select agent or toxin.
Previously, a discovery of a select agent or toxin had to be reported
using Form 3, which was not specifically created to report discoveries.
The new Form 6 would replace Form 3 in this process.
The total estimated annualized burden for all data collection is
estimated as 8,919 hours. This is an increase of 5,416 burden hours
from the previous approval due to: (1) changes in the number of
respondents; (2) shifts in the average burden per response (measured in
hours) across the various forms; (3) the introduction of Form 6 to
capture discoveries of a select agent or toxin previously reported via
Form 3; and (4) minor corrections to burden estimates in the previously
approved 2023 OMB submission, which had underestimated the average
burden per response as described in Notice of Proposed Rulemaking
published 1/30/2024 <a href="https://www.federalregister.gov/documents/2024/01/30/2024-01513/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agents">https://www.federalregister.gov/documents/2024/01/30/2024-01513/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agents</a>. Information will be
collected through FSAP IT system, fax, email and hard copy mail from
respondents. CDC requests a three-year approval for this information
collection request. There is no cost to the respondents other than
their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Section Form name respondents responses per response burden
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 1,484 1 1 1,484
Identification of a
Select Agent or Toxin.
Sections 5 & 6................. Form 5--Request of 1 1 0.5 1
Exemption.
Section 7...................... Form 1--Application for 3 1 31 93
Registration.
Section 1-7.................... Form 1--Amendment to a 960 1 4 3,840
Certificate of
Registration.
Section 9...................... Documentation of self- 230 1 1 230
inspection.
Section 10..................... Request for Expedited 15 1 0.5 8
Review.
Section 11..................... Security Plan.......... 230 1 1 230
Section 12..................... Biosafety Plan......... 230 1 1 230
Section 13..................... Request Regarding a 2 1 2 4
Restricted Experiment.
Section 14..................... Incident Response Plan. 230 1 1 230
Section 15..................... Training............... 230 1 8 1,840
Section 16..................... Form 2--Request to 231 1 1.5 347
Transfer Select Agents
and Toxins.
Section 17..................... Records................ 230 1 0.5 115
Section 19..................... Form 3--Notification of 262 1 1 262
Theft, Loss, or
Release.
[[Page 57153]]
Section 20..................... Administrative Review.. 1 1 1 1
Section 20..................... Form 6--Report of 20 1 10/60 3
Discovery of Select
Agent or Toxin form 42
CFR 73.19(c).
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Total...................... ....................... ............ .............. ........... 8,919
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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. 2026-18217 Filed 9-4-26; 8:45 am]
BILLING CODE 4163-18-P
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