Notice2023-25082
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
November 14, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 218 (Tuesday, November 14, 2023)</title>
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[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78040-78041]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25082]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-23BJ]
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 ``U.S. National Authority for Containment of
Poliovirus Data Collection Tools'' 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 December 12, 2022 to obtain comments from
the public and affected agencies. CDC received one comment related to
the previous notice. This notice serves to allow an additional 30 days
for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget 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
[[Page 78041]]
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
U.S. National Authority for Containment of Poliovirus Data
Collection Tools--New--Office of Readiness and Response (ORR), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The role of the National Authority for Containment (U.S. NAC) of
Poliovirus is to ensure that the requirements established in the World
Health Organization (WHO) Global Action Plan (GAP) III/IV standard are
effectively implemented and maintained in facilities working with or
storing infectious poliovirus or potentially infectious materials. Risk
assessments following an incident are a critical component for adequate
application of the GAP standard. To support risk assessment activities,
The ``Facility Incident Reporting Form for Poliovirus Release and
Potential Exposure'' and the ``Facility Incident Reporting Form for
Poliovirus Theft or Loss'' forms were created for facilities to capture
and submit incident information to the U.S. NAC. These forms will not
only address the biosafety and biosecurity containment emergency
elements of the GAP standard but will also inform the U.S. NAC risk
assessments and thereby, guide CDC's determination of the emergency
response level and direction.
The information collected in the ``Personal Protective Equipment
Survey for Laboratories'' will assist the Centers for Disease Control
and Prevention (CDC), U.S. NAC and National Institute for Occupational
Safety and Health (NIOSH) with developing guidance and recommendations
for PPE selection and use in support of poliovirus containment, as well
as identify laboratory PPE commonly used to evaluate laboratory PPE
performance characteristics in testing studies.
Information collected in the ``Global Action Plan (GAP) Poliovirus
Containment Poliovirus-Essential Facility Assessment Checklist'' will
aid U.S. facilities in preparing for an audit to obtain a poliovirus
certificate of containment. Data collected from this form will also
collect additional information on poliovirus materials held by a U.S.
facility, their work activities, and facility features.
The ``Poliovirus Containment Sampling Plan and Sanitation
Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus-
Essential Facility (PEF) in the United States'' form will collect
information to assess a poliovirus facility's essential WW system, the
primary safeguards to reduce and control the release of poliovirus from
the facility. In addition, it will verify the safeguards of local WW
utilities that receive WW from the PEF.
OMB approval is sought for three years. The annualized time burden
for this information collection is estimated to be 125 hours. There is
no cost to respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form Name respondents responses per response (in
respondent hours)
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Facility Staff/Leadership.......... Facility Incident Reporting 10 1 45/60
Form for Poliovirus
Release or Potential
Exposure.
Facility Staff/Leadership.......... Facility Incident Reporting 10 1 45/60
Form for Poliovirus Theft
or Loss.
Facility Staff/Leadership.......... Personal Protective 20 1 90/60
Equipment Survey for
Laboratories.
Facility Staff/Leadership.......... GAP Poliovirus Containment 20 1 90/60
Poliovirus-Essential
Facility Questionnaire.
Facility Staff/Leadership.......... GAP Facility Assessment 20 1 1
Checklist.
Facility Staff/Leadership.......... The Poliovirus Containment 20 1 90/60
Sampling Plan and
Sanitation Assessment Form
for Wastewater (WW)
Systems Supporting a
Poliovirus-Essential
Facility (PEF) in the
United States.
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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. 2023-25082 Filed 11-13-23; 8:45 am]
BILLING CODE 4163-18-P
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