[CPR] U.S. National Authority for Containment of Poliovirus Data Collection Tools

Forms and Documents

Document Name	Status
Form 0920- Att 6_ Global Action Plan (GAP) Poliovirus Containment Poliovirus-Essential Facility Questionnaire Form and Instruction	New
Form 0920- Att 5_ Global Action Plan (GAP) Poliovirus Containment Poliovirus- Essential Facility Assessment Checklist Form and Instruction	New
Form 0920- Att 4_ Facility Incident Reporting Form FOR POLIOVIRUS THEFT or LOSS Form and Instruction	New
Form 0920 Att 8- Poliovirus Containment Sampling Points and Sanitation Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus- Essential Facility (PEF) in the United States Form and Instruction	New
Form 0920- Att 7 _Personal Protective Equipment Survey for Laboratories Form and Instruction	New
Form 0920- Att 3_ Facility Incident Reporting Form FOR POLIOVIRUS RELEASE or POTENTIAL EXPOSURE Form and Instruction	New
Att 9 -Non-research determination.pdf Supplementary Document	2023-11-03
Att1b-OSH Act of 1977_29 USC 669 Section 20(a)(1)).pdf Supplementary Document	2023-11-03
Att1a - Federal Information Policy, 44 USC Sect. 3501.pdf Supplementary Document	2023-11-03
Att1 - Public Health Service Act, Section 2102_42 U.S.C. 300a-2.pdf Supplementary Document	2023-11-03
ORR-NAC-SSB.docx Supporting Statement B	2023-11-03
ORR-NAC-SSA.docx Supporting Statement A	2023-11-03

IC Document Collections

IC ID	Document Title	Status
263225	Att 6_ Global Action Plan (GAP) Poliovirus Containment Poliovirus-Essential Facility Questionnaire Form and Instruction	New
263224	Att 5_ Global Action Plan (GAP) Poliovirus Containment Poliovirus- Essential Facility Assessment Checklist Form and Instruction	New
263223	Att 4_ Facility Incident Reporting Form FOR POLIOVIRUS THEFT or LOSS Form and Instruction	New
263170	Att 8- Poliovirus Containment Sampling Points and Sanitation Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus- Essential Facility (PEF) in the United States Form and Instruction	New
263163	Att 7 _Personal Protective Equipment Survey for Laboratories Form and Instruction	New
263162	Att 3_ Facility Incident Reporting Form FOR POLIOVIRUS RELEASE or POTENTIAL EXPOSURE Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202311-0920-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-23BJ
Title: [CPR] U.S. National Authority for Containment of Poliovirus Data Collection Tools
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/14/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	100	0
Time Burden (Hours)	126	0
Cost Burden (Dollars)	0	0

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Abstract: In 2018, HHS designated the Centers for Disease Control and Prevention (CDC) as the National Authority for Containment of Poliovirus (U.S. NAC) for the United States. The U.S. NAC is located in the Center for Preparedness and Response (CPR). The role of the U.S. NAC is to ensure that the requirements established in the World Health Organization (WHO) Global Action Plan (GAP) III and IV standards are effectively implemented and maintained in poliovirus- essential facilities. Part of this standard includes emergency planning, the implementation of surveillance following an incident, and the reporting of facility-associated poliovirus events to the U.S. NAC. Risk assessments following an incident are a critical component for adequate application of the GAPIII/GAPIV standard and efficient emergency response. The goal of the project is to collect data in the event of a poliovirus breach of containment - as well as to understand the biosafety practices of facilities working on poliovirus and mitigations strategies in place to reduce risks. These goals are in line with World Health Organization's Global Action Plan (GAP) for Poliovirus containment efforts. This information will assist with meeting the goals of the Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) and prevents the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.

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Authorizing Statute(s): US Code: 44 USC 3501 Name of Law: Federal Information Policy
   US Code: 29 USC 669 20(a)(1) Name of Law: OSH Act of 1977
   US Code: 42 USC 300a-2 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 76052	12/12/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78041	11/14/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Att 3_ Facility Incident Reporting Form FOR POLIOVIRUS RELEASE or POTENTIAL EXPOSURE	0920-	Facility Incident Reporting Form FOR POLIOVIRUS RELEASE or POTENTIAL EXPOSURE
Att 4_ Facility Incident Reporting Form FOR POLIOVIRUS THEFT or LOSS	0920-	Facility Incident Reporting Form FOR POLIOVIRUS RELEASE or POTENTIAL EXPOSURE
Att 5_ Global Action Plan (GAP) Poliovirus Containment Poliovirus- Essential Facility Assessment Checklist	0920-	Global Action Plan (GAP) Poliovirus Containment Poliovirus- Essential Facility Assessment Checklist
Att 6_ Global Action Plan (GAP) Poliovirus Containment Poliovirus-Essential Facility Questionnaire	0920-	Global Action Plan (GAP) Poliovirus Containment Poliovirus-Essential Facility Questionnaire
Att 7 _Personal Protective Equipment Survey for Laboratories	0920-	Personal Protective Equipment Survey for Laboratories
Att 8- Poliovirus Containment Sampling Points and Sanitation Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus- Essential Facility (PEF) in the United States	0920	Poliovirus Containment Sampling Points and Sanitation Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus- Essential Facility (PEF) in the United States

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	100	0	0	80	20	0
Annual Time Burden (Hours)	126	0	0	96	30	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New collection (Request for a new OMB Control Number).

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Annual Cost to Federal Government: $7,681

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/14/2023

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