Tropical Disease Priority Review Vouchers

Forms and Documents

Document Name	Status
0822 Tropical Disease Vouchers SSA 2025 EXT.docx Supporting Statement A	2025-07-30

IC Document Collections

IC ID	Document Title	Status
236382	Attestation regarding clinical investigation reports	Modified
219018	Acknowledgeing the Receipt of a Transferred Voucher Other-Guidance	Modified
219017	Letters Indicating the Transfer of a Voucher Letter Other-Guidance	Modified
219016	Notifications of Intent to Use a Voucher Other-Guidance	Unchanged
219015	Priority Review Voucher Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0822	ICR Reference No: 202501-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202203-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Tropical Disease Priority Review Vouchers
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2025
Responses	6	14
Time Burden (Hours)	42	88
Cost Burden (Dollars)	1,904	7,616

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Abstract: 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.

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

Citations for New Statutory Requirements: PL: Pub.L. 115 - 52 611 Name of Law: FDARA: Tropical Disease Product Application

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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:
	90 FR 18680	05/01/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 35684	07/29/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Acknowledgeing the Receipt of a Transferred Voucher
Attestation regarding clinical investigation reports
Letters Indicating the Transfer of a Voucher Letter
Notifications of Intent to Use a Voucher
Priority Review Voucher

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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	6	14	0	0	-8	0
Annual Time Burden (Hours)	42	88	0	0	-46	0
Annual Cost Burden (Dollars)	1,904	7,616	0	-5,712	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: Based on our evaluation of the information collection since the last OMB review and approval, the burden estimate decreased by 46 hours based on receipt of fewer vouchers request and other information collection activities.

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Annual Cost to Federal Government: $2,220

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: 07/30/2025

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