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 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
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 | 90/60 |
Facility Staff/Leadership | GAP Poliovirus Containment Poliovirus-Essential Facility Questionnaire | 20 | 1 | 90/60 |
Facility Staff/Leadership | GAP Facility Assessment Checklist | 20 | 1 | 1 |
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 | 90/60 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2023–25082 Filed 11–13–23; 8:45 am]
BILLING CODE 4163–18–P