View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0822
ICR Reference No:
202203-0910-004
Status:
Active
Previous ICR Reference No:
201906-0910-004
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/18/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/14/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2025
36 Months From Approved
07/31/2022
Responses
14
0
19
Time Burden (Hours)
88
0
122
Cost Burden (Dollars)
7,616
0
9,520
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
86 FR 68503
12/02/2021
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 35788
06/13/2022
Did the Agency receive public comments on this ICR?
No
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
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
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
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 34 hours based on receipt of fewer vouchers request and other information collection activities.
Annual Cost to Federal Government:
$5,520
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(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:
06/14/2022
An official website of the United States government
The .gov means it's official.
The site is secure.
