Guidance for Industry on Tropical Disease Priority Review Vouchers

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

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

ICR Details

OMB Control No: 0910-0822	ICR Reference No: 201906-0910-004
Status: Active	Previous ICR Reference No: 201511-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Tropical Disease Priority Review Vouchers
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/08/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	08/31/2019
Responses	19	0	14
Time Burden (Hours)	122	0	112
Cost Burden (Dollars)	9,520	0	0

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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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 55720	11/07/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 15619	04/16/2019
Did the Agency receive public comments on this ICR? No

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

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

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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	19	14	5	0	0	0
Annual Time Burden (Hours)	122	112	10	0	0	0
Annual Cost Burden (Dollars)	9,520	0	0	0	9,520	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: The information collection reflects program changes and adjustments. As discussed more fully in our supporting statement at question 1, FDARA revised eligibility requirements for the PRVs covered by the information collection. This results in an increase of 5 responses and 10 burden hours annually. We have also uploaded cost information that, although previously reported, had not been disclosed at omb.report.

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Annual Cost to Federal Government: $7,616

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? Uncollected

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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: 06/26/2019

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