Notice2024-00651
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 16, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 10 (Tuesday, January 16, 2024)</title>
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[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2615-2616]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="https://www.selectagents.gov/resources/publications/annualreport/2021.htm">https://www.selectagents.gov/resources/publications/annualreport/2021.htm</a>. 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
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Number of Average burden
Section Form name Number of responses per per response
respondents respondent (in hours)
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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
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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. 2024-00651 Filed 1-12-24; 8:45 am]
BILLING CODE 4163-18-P
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