View Information Collection Request (ICR) Package
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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:
201906-0910-004
Status:
Historical 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
Retrieve Notice of Action (NOA)
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
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:
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
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
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 www.reginfo.gov.
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
Agency Contact:
Domini Bean 301 796-5733 domini.bean@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:
06/26/2019
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