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.

ICR 202207-0920-012

OMB: 0920-1366

Federal Form Document

ICR Details
0920-1366 202207-0920-012
Active
HHS/CDC 0920-22HY
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.
New collection (Request for a new OMB Control Number)   No
Emergency 08/03/2022
Approved without change 08/03/2022
Retrieve Notice of Action (NOA) 08/03/2022
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
02/28/2023 6 Months From Approved
55,000 0 0
13,333 0 0
0 0 0

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.
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.

None
None

Not associated with rulemaking

No

2
IC Title Form No. Form Name
IRB Authorization Agreement (COMPLETION) NA IRB Authorization Agreement
IRB Authorization Agreement (REVIEW) NA IRB Authorization Agreement

  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
Yes
Miscellaneous Actions
No
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.

$92,500
No
    No
    No
No
No
No
No
Jeffrey Zirger 404 639-7118 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/03/2022


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