Notice2022-26890
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 12, 2022
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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 237 (Monday, December 12, 2022)</title>
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[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76052-76053]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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#a1ceccc3e1c2c5c28fc6ced7"><span class="__cf_email__" data-cfemail="d4bbb9b694b7b0b7fab3bba2">[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:
[[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.
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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]
BILLING CODE 4163-18-P
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