[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76052-76053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-23BJ; Docket No. CDC-2022-0139]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled U.S. National Authority for Containment of Poliovirus (U.S. NAC) 
Data Collection Tools. Data collection will capture information 
relating to a poliovirus containment breach or incident at a U.S. 
facility and will assist the U.S. NAC in the initial stages of the 
investigation into the breach, and ensure that facilities have programs 
in place that align with global poliovirus eradication initiative.

DATES: CDC must receive written comments on or before February 10, 
2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0139 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) 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: [email protected].

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:

[[Page 76053]]

    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

    U.S. National Authority for Containment of Poliovirus Data 
Collection Tools--New--Center for Preparedness and Response (CPR), 
Centers for Disease Control and Prevention (CDC)

Background and Brief Description

    The role of the National Authority for Containment of Poliovirus 
(U.S. NAC) 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'' was 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 CDC, U.S. NAC and National 
Institute for Occupational Safety and Health (NIOSH) with developing 
guidance and recommendations for personal protective equipment (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 the ``Global Action Plan (GAP) Poliovirus 
Containment Poliovirus-Essential Facility Questionnaire'' will 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'' will collect 
information to assess poliovirus essential facility's wastewater 
system, the primary safeguards to reduce and control the release of 
poliovirus from the facility. In addition, it will verify the 
safeguards of local wastewater utilities that receive wastewater from 
the PEF.
    OMB approval is sought for three years. The estimated annualized 
burden for this information collection is 72 hours. There is no cost to 
respondents other than their time.

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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Facility Staff/Leadership.....  Facility                      10               1           45/60               8
                                 Incident
                                 Reporting Form
                                 for Poliovirus
                                 Release or
                                 Potential
                                 Exposure.
Facility Staff/Leadership.....  Facility                      10               1           45/60               8
                                 Incident
                                 Reporting Form
                                 for Poliovirus
                                 Theft or Loss.
Facility Staff/Leadership.....  PPE Survey for                10               1           90/60              15
                                 Laboratories.
Facility Staff/Leadership.....  GAP Poliovirus                10               1           90/60              15
                                 Containment
                                 Poliovirus-
                                 Essential
                                 Facility
                                 Questionnaire.
Facility Staff/Leadership.....  GAP Facility                  10               1               1              10
                                 Assessment
                                 Checklist.
Facility Staff/Leadership.....  The Poliovirus                10               1           90/60              15
                                 Containment
                                 Sampling Plan
                                 and Sanitation
                                 Assessment Form
                                 for Wastewater
                                 (WW) Systems
                                 Supporting a
                                 Poliovirus-
                                 Essential
                                 Facility (PEF)
                                 in the United
                                 States.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              72
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-26890 Filed 12-9-22; 8:45 am]
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