Guidance for Industry on Tropical Disease Priority Review Vouchers

ICR 201906-0910-004

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 201906-0910-004
Active 201511-0910-002
HHS/FDA CDER
Guidance for Industry on Tropical Disease Priority Review Vouchers
Revision of a currently approved collection   No
Regular
Approved without change 07/08/2019
Retrieve Notice of Action (NOA) 06/26/2019
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 08/31/2019
19 0 14
122 0 112
9,520 0 0

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

  83 FR 55720 11/07/2018
84 FR 15619 04/16/2019
No

  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
No
No
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.

$7,616
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
06/26/2019


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