Biosimilar User Fee Cover Sheet - Form FDA 3792

ICR 201801-0910-002

OMB: 0910-0718

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2018-01-03
Supporting Statement A
2015-06-22
IC Document Collections
IC ID
Document
Title
Status
202806 Modified
ICR Details
0910-0718 201801-0910-002
Historical Active 201708-0910-005
HHS/FDA CDER
Biosimilar User Fee Cover Sheet - Form FDA 3792
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/31/2018
Retrieve Notice of Action (NOA) 01/04/2018
  Inventory as of this Action Requested Previously Approved
12/31/2018 12/31/2018 12/31/2018
35 0 20
60 0 10
0 0 0

Form FDA 3792, the Biosimilars User Fee Cover Sheet, requests the minimum necessary information to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of biosimilar biological product INDs, applications, and supplements, and to account for and track user fees associated with BPD meetings, biosimilar biological product INDs, applications, and supplements.

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et. seq. Name of Law: Federal Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 4272 01/27/2015
80 FR 31603 06/03/2015
No

1
IC Title Form No. Form Name
Form FDA 3792 Form FDA 3792 Biosimilar User Fee Cover Sheet

  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 35 20 0 15 0 0
Annual Time Burden (Hours) 60 10 0 50 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Program office wants to ask additional questions of respondents.

$920
No
    No
    No
No
No
No
Uncollected
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.
01/04/2018


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