Biosimilar User Fee Program

ICR 202112-0910-007

OMB: 0910-0718

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0718 202112-0910-007
Received in OIRA 201805-0910-004
HHS/FDA CDER
Biosimilar User Fee Program
Revision of a currently approved collection   No
Regular 12/23/2021
  Requested Previously Approved
36 Months From Approved 12/31/2021
314 77
12,986 57
0 0

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 biological product applications.

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
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 51900 09/17/2021
86 FR 72605 12/22/2021
No

  Total Request 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 314 77 0 0 237 0
Annual Time Burden (Hours) 12,986 57 0 0 12,929 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects changes and adjustments resulting from consolidating related activity from OMB control no. 0910-0719 and from and increase in the number of estimated respondents to the collection. The result is an increase of 237 responses and 12,929 hours annually.

$367,500
No
    No
    No
No
No
No
No
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.
12/23/2021


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