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:
0910-0297
ICR Reference No:
202407-0910-006
Status:
Active
Previous ICR Reference No:
202202-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Prescription Drug User Fee Program
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
01/14/2026
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/18/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2029
36 Months From Approved
01/31/2026
Responses
408
0
411
Time Burden (Hours)
3,829
0
3,626
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from certain drug and biologic manufacturers who are subject to Prescription Drug User fees. These fees are related to the submission of certain new drug and biologics license applications as well as for certain approved annual program fees. In addition, the ICR collects information relating to the submission of requests for waivers, exemptions, reductions, or for refunds of these user fees. Manufacturers submit information in accordance with established statutory authorities. Form FDA 3397, Prescription Drug User Fee Cover Sheet, and Form FDA 3971, Small Business Waivers and Refund Requests, were developed to assist respondents with submission of required information.
Authorizing Statute(s):
US Code:
21 USC 379
Name of Law: Federal Food Drug and Cosmetic Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 90705
11/18/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 18673
05/01/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Appeal requests
Other waivers, reductions, refunds, exemptions under secs. 735 & 736
Prescription Drug User Fee Cover Sheet
Form FDA 3397
Prescription Drug User Fee Cover Sheet
Reconsideration requests
Small business waiver requests
FDA 3971
Small Business Waiver and Refund Request
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
408
411
0
0
-3
0
Annual Time Burden (Hours)
3,829
3,626
0
0
203
0
Annual Cost Burden (Dollars)
0
0
0
0
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:
There is decrease of 3 responses and an increase of 203 burden hours annually. Because we are including the recently reauthorized PDUFA commitment goals letter, we have characterized our submission as a revision.
Annual Cost to Federal Government:
$4,707,766
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:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.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:
06/18/2025
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