Tropical Disease Priority Review Vouchers

ICR 202203-0910-004

OMB: 0910-0822

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0822 202203-0910-004
Received in OIRA 201906-0910-004
HHS/FDA CDER
Tropical Disease Priority Review Vouchers
Extension without change of a currently approved collection   No
Regular 06/14/2022
  Requested Previously Approved
36 Months From Approved 07/31/2022
14 19
88 122
7,616 9,520

This information collection supports implementation of section 524 of the Federal Food, Drug, and Cosmetic Act. The statute provides FDA with authority for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the Act. We have also developed associated guidance intended to explain to internal and external stakeholders how we implement the provisions of section 524.

US Code: 21 USC 524 Name of Law: FDAAA
   PL: Pub.L. 115 - 52 611 Name of Law: FDARA; Tropical Disease Product Application
  
PL: Pub.L. 115 - 52 611 Name of Law: FDARA: Tropical Disease Product Application

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 68503 12/02/2021
87 FR 35788 06/13/2022
No

  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 14 19 0 0 -5 0
Annual Time Burden (Hours) 88 122 0 0 -34 0
Annual Cost Burden (Dollars) 7,616 9,520 0 0 -1,904 0
No
No
Based on our evaluation of the information collection since the last OMB review and approval, the burden estimate decreased by 34 hours based on receipt of fewer vouchers request and other information collection activities.

$5,520
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 [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.
06/14/2022


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