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

Document Name	Status
IRB Authorization Agreement (COMPLETION) Form and Instruction	New
IRB Authorization Agreement (REVIEW) Form and Instruction	New
Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022.docx Supplementary Document	2022-08-03
Supporting Statement A_MPX_IRB Emergency ICR_03AUG2022 FINAL.docx Supporting Statement A	2022-08-03
6402_EA IND_TPOXX_Attachment-1-Informed-Consent.pdf Supplementary Document	2022-08-03
6402_EA IND_TPOXX_Protocol.pdf Supplementary Document	2022-08-03
6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation.pdf Supplementary Document	2022-08-03
Supporting Statement B_MPX_IRB Emergency ICR 28JUL2022.docx Supporting Statement B	2022-07-28

IC Document Collections

IC ID	Document Title	Status
255040	IRB Authorization Agreement (COMPLETION) Form and Instruction	New
255039	IRB Authorization Agreement (REVIEW) Form and Instruction	New

ICR Details

OMB Control No: 0920-1366	ICR Reference No: 202207-0920-012
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22HY
Title: 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: Emergency	Approval Requested By: 08/03/2022
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/03/2022
	Date Received in OIRA: 08/03/2022
Terms of Clearance: OMB is approving this Emergency ICR with the understanding that within 6 months from the approval date, CDC will complete a 60d and 30d public comment request to support the approval of the ICR ahead of the expiration date. In this subsequent ICR package, CDC should include a discussion on the potential cost burdens as they relate to issues of equitable access to the tecovirimat (TPOXX) treatment for patients with monkeypox.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	6 Months From Approved
Responses	55,000	0	0
Time Burden (Hours)	13,333	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information is essential to CDC’s Monkeypox emergency response 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.

Emergency Justfication: monkeypox continues to spread rapidly in the United States and around the world, and the exponential increase in demand for access to tecovirmat under CDC’s EA-IND. In the United States, as of July 27, 2022, there have been over 4,600 cases in 47 states and Puerto Rico, and more than 90 facilities have elected to rely on the CDC IRB. In order to facilitate access to tecovirmat to ease the suffering of those with monkeypox, CDC must fully execute written agreements with these institutions in a systematic way for recordkeeping as required by FDA.

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Authorizing Statute(s): None

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

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
IRB Authorization Agreement (COMPLETION)	NA	IRB Authorization Agreement
IRB Authorization Agreement (REVIEW)	NA	IRB Authorization Agreement

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ICR Summary 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	55,000	0	0	55,000	0	0
Annual Time Burden (Hours)	13,333	0	0	13,333	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: Submission or "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" is a New Emergency ICR.

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Annual Cost to Federal Government: $92,500

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 08/03/2022

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