30 Day FRN

2Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-FY-2025]

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 November, 4 2024 to obtain comments from the public and affected agencies. CDC received no comments 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 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 - 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 for poliovirus containment standards 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 poliovirus containment 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 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 be discontinued and removed from this ICR.

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.

The ”Appeals and Complaints” form is a new form that will be made available by the U.S. National Authority for Containment of Poliovirus, 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.

There is no cost to respondents other than their time. OMB approval is sought for three years. The annualized estimated time burden for this information collection is 109 hours.

Estimated Annualized Burden Hours

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)
Facility Staff/Leadership	Facility Incident Reporting Form for Poliovirus Release or Potential Exposure	10	1	45/60
Facility Staff/Leadership	Facility Incident Reporting Form for Poliovirus Theft or Loss	10	1	45/60
Facility Staff/Leadership	Personal Protective Equipment Survey for Laboratories	20	1	1.5
Facility Staff/Leadership	GAP Poliovirus Containment Poliovirus-Essential Facility Questionnaire	20	1	1.5
Facility Staff/Leadership	The Poliovirus Containment Sampling Plan and Sanitation Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus-Essential Facility (PEF) in the United States	20	1	1.5
Facility and Staff/Leadership	Appeals and Complaints	10	1	15/60

__________________________________

Jeffrey M. Zirger,

Lead,

Information Collection Review Office,

Office of Public Health Ethics and Regulations,

Office of Science,

Centers for Disease Control and Prevention.

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