Notice2023-17483
Proposed Data Collection Submitted for Public Comment and Recommendations
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
August 15, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 156 (Tuesday, August 15, 2023)</title>
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[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55457-55459]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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#7916141b391a1d1a571e160f"><span class="__cf_email__" data-cfemail="cfa0a2ad8facabace1a8a0b9">[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. 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:
<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).
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)).
The total estimated annualized burden for all data collection was
calculated using the 2021 Annual Report of the Federal Select Agent
Program available at <a href="https://www.selectagents.gov/resources/publications/annualreport/2021.htm">https://www.selectagents.gov/resources/publications/annualreport/2021.htm</a> 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
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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]
BILLING CODE 4163-18-P
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