Notice2024-25557
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
November 4, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 213 (Monday, November 4, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal
eRulemaking portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#17787a755774737439707861"><span class="__cf_email__" data-cfemail="4c23212e0c2f282f622b233a">[email protected]</span></a>.
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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