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[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87581-87582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25557]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-25-1424; Docket No. CDC-2024-0087]

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 continuing 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 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. National Authority for Containment of Poliovirus (U.S. 
NAC) in the initial stages of the investigation into the breach, and 
also gather information regarding personal protective equipment and 
practices used for work and/or storage of infectious materials or 
potentially infectious at laboratory facilities.

DATES: CDC must receive written comments on or before January 3, 2025.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0087 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:
    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 (OMB Control No. 0920-1424, Exp. 12/31/2026)--
Revision--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 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

[[Page 87582]]

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 
(PPE) Survey for Laboratories will assist the CDC, U.S. NAC and 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 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 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.
    The Appeals and Complaints form is a new form that will be made 
available by the U.S. NAC of Poliovirus and will allow facilities or 
persons to appeal or forward complaints based on services provided. 
This form can be used to appeal or initiate complaints with regards to 
specific survey outreach that had been conducted or decisions rendered 
by the audit team after an audit.
    OMB approval is sought for three years. The annualized estimated 
time burden for this information collection is 129 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     Total
       Type of respondents               Form name         respondents   responses per    response    burden (in
                                                                          respondent     (in hours)     hours)
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Facility Staff/Leadership.......  Facility Incident                 10               1        45/60            8
                                   Reporting Form for
                                   Poliovirus Release or
                                   Potential Exposure.
Facility Staff/Leadership.......  Facility Incident                 10               1        45/60            8
                                   Reporting Form for
                                   Poliovirus Theft or
                                   Loss.
Facility Staff/Leadership.......  Personal Protective               20               1          1.5           30
                                   Equipment Survey for
                                   Laboratories.
Facility Staff/Leadership.......  GAP Poliovirus                    20               1          1.5           30
                                   Containment Poliovirus-
                                   Essential Facility
                                   Questionnaire.
Facility Staff/Leadership.......  GAP Facility Assessment           20               1            1           20
                                   Checklist.
Facility Staff/Leadership.......  The Poliovirus                    20               1          1.5           30
                                   Containment Sampling
                                   Plan and Sanitation
                                   Assessment Form for
                                   Wastewater (WW)
                                   Systems Supporting a
                                   Poliovirus-Essential
                                   Facility (PEF) in the
                                   United States.
Facility Staff/Leadership.......  U.S. National Authority           10               1        15/60            3
                                   of Containment of
                                   Poliovirus ``Appeals
                                   and Complaints Form''.
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    Total.......................  .......................  ...........  ..............  ...........          129
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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. 2024-25557 Filed 11-1-24; 8:45 am]
BILLING CODE 4163-18-P
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