Electronic User Fee Payment Form Requests

ICR 201807-0910-008

OMB: 0910-0805

Federal Form Document

IC Document Collections
ICR Details
0910-0805 201807-0910-008
Active 201509-0910-009
HHS/FDA CDER
Electronic User Fee Payment Form Requests
Extension without change of a currently approved collection   No
Regular
Approved without change 11/09/2018
Retrieve Notice of Action (NOA) 10/12/2018
  Inventory as of this Action Requested Previously Approved
11/30/2021 36 Months From Approved 11/30/2018
2,528 0 3,400
881 0 1,105
0 0 0

This ICR collects information from customers who wish to electronically submit a user fee refund request for a duplicate payment, overpayment or for a withdrawn application or submission. Respondents submit organization, contact and payment information. Food and Drug Administration (FDA) has developed Form 3913 to facilitate its review and processing of user fee payment refunds. The information is used to determine the reason for the refund, the refund amount and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. Additionally, this ICR collects information from customers who wish to electronically submit a request to transfer a user fee payment from one cover sheet or invoice to another cover sheet or invoice. Respondents submit payment and organization information. FDA has developed Form 3914 to facilitate its review and processing of user fee payment transfer requests. The information is used to determine the reason for the transfer, how the transfer should be performed and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed.

PL: Pub.L. 105 - 277 title XVII Name of Law: Government Paperwork Elimination Act
  
None

Not associated with rulemaking

  83 FR 22493 05/15/2018
83 FR 50382 10/05/2018
No

2
IC Title Form No. Form Name
User Fee Payment Refund Request --Form FDA 3913 Form FDA 3913 Refund Request
User Fee Payment Transfer Request--Form FDA 3914 Form FDA 3914 Transfer Request

  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 2,528 3,400 0 0 -872 0
Annual Time Burden (Hours) 881 1,105 0 0 -224 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The estimated annual hourly burden, formerly estimated as 1,105 hours, has decreased by 224 hours to a total estimated annual hourly burden of 881 hours. These are determined by the number of refund/transfer requests received from industry. As the user fee programs mature, processes and procedures utilized by industry also mature, leading to fewer requests for transfers of fees or refunds.

$0
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
10/12/2018


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