[OS] Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA-IND) for "Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections.

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920 CDC IRB Authorization Agreement (REVIEW)	Form and Instruction	New	Available
Form 0920 CDC IRB Authorization Agreement (COMPLETE)	Form and Instruction	New	Repair queued
Form 0920 CDC IRB Authorization Agreement (COMPLETE)	Form and Instruction	New	Available
Form 0920 IRB Authorization Agreement (REVIEW)	Form and Instruction	New	Repair queued
Supporting Statement B - TPOXX.docx	Supporting Statement B	Uploaded 2023-02-27	Repair queued
Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022 (2).docx	Supplementary Document	Uploaded 2023-02-27	Repair queued
EA IND_TPOXX_Informed-Consent.pdf	Supplementary Document	Uploaded 2023-02-27	Repair queued
6402_EA IND_TPOXX_Protocol (1).pdf	Supplementary Document	Uploaded 2023-02-27	Repair queued
6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation (1).pdf	Supplementary Document	Uploaded 2023-02-27	Available
Supporting Statement A - TPOXX.docx	Supporting Statement A	Uploaded 2023-02-27	Repair queued
Authorizing Legislations.docx	Supplementary Document	Uploaded 2023-02-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
258781	CDC IRB Authorization Agreement (COMPLETE)	Form and Instruction	New	CDC IRB Authorization Agreement (REVIEW)
258781	CDC IRB Authorization Agreement (COMPLETE)	Form and Instruction	New
258780	IRB Authorization Agreement (REVIEW)	Form and Instruction	New	CDC IRB Authorization Agreement (COMPLETE)
258780	IRB Authorization Agreement (REVIEW)	Form and Instruction	New

ICR Details

OMB Control No: 0920-1404	ICR Reference No: 202302-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22HY
Title: [OS] Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA-IND) for "Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections.
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/25/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved
Responses	5,500	0	0
Time Burden (Hours)	1,333	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information request is essential to CDC’s response to the Monkeypox outbreak consistent with requirements set forth by the Food and Drug Administration (FDA). CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the expanded access investigational new drug (EA-IND). CDC holds an intermediate-size patient population EA-IND (IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs.

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Authorizing Statute(s): US Code: 21 USC 312 Name of Law: INVESTIGATIONAL NEW DRUG APPLICATION
  

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 57872	08/22/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 12362	02/27/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
CDC IRB Authorization Agreement (COMPLETE)	0920	CDC IRB Authorization Agreement (REVIEW)
IRB Authorization Agreement (REVIEW)	0920	CDC IRB Authorization Agreement (COMPLETE)

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	5,500	0	0	5,500	0	0
Annual Time Burden (Hours)	1,333	0	0	1,333	0	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: This is a new information collection that is submitted to create a standard ICR package to follow up on our emergency approval (0920-1366) during the Monkeypox outbreak.

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Annual Cost to Federal Government: $92,500

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: 02/28/2023

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