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:
0910-0718
ICR Reference No:
202408-0910-008
Status:
Active
Previous ICR Reference No:
202112-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Biosimilar 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 without change
Conclusion Date:
07/22/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/31/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
36 Months From Approved
07/31/2025
Responses
419
0
314
Time Burden (Hours)
26,055
0
12,986
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports the Food and Drug Administration’s (FDA, us or we) Biosimilars User Fee Program. Respondents to the collection are applicants or sponsors of biosimilar product marketing applications subject to statutory and regulatory requirements administered by FDA.
Authorizing Statute(s):
US Code:
42 USC 262(k)
Name of Law: Public Health Service Act; Biologics Price Competition and Innovation Act
US Code:
21 USC 379g
Name of Law: 351(k) Applications
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 77531
09/23/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 8753
01/31/2025
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
Applications and infringement notifications
Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey
Form FDA 3792
Biosimilar User Fee Cover Sheet
Formal Meeting Requests; Meeting Packages
Pediatric Study Plan
Requests for discontinuation from BPD program and /or to move products to discontinued section.
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
419
314
0
105
0
0
Annual Time Burden (Hours)
26,055
12,986
0
13,069
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The information collection reflects an increase of 13,069 hours and 105 responses annually. Although part of the increase accounts for burden associated with respondents including the submission of pediatric study plan information, the majority of adjustments correspond with an increase in submissions we are receiving under BsUFA.
Annual Cost to Federal Government:
$1,378,703
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:
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:
01/31/2025
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