[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78040-78041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

[[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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form Name             respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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