Electronic User Fee Payment Form Requests

Forms and Documents

Document Name	Status
Form Form FDA 3914 User Fee Payment Transfer Request--Form FDA 3914 Form	Modified
Form Form FDA 3913 User Fee Payment Refund Request --Form FDA 3913 Form	Modified
0805_Supporting Statement_2018.docx Supporting Statement A	2018-10-12

IC Document Collections

IC ID	Document Title	Status
218311	User Fee Payment Transfer Request--Form FDA 3914 Form	Modified
218309	User Fee Payment Refund Request --Form FDA 3913 Form	Modified

ICR Details

OMB Control No: 0910-0805	ICR Reference No: 201807-0910-008
Status: Active	Previous ICR Reference No: 201509-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Electronic User Fee Payment Form Requests
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/09/2018
	Date Received in OIRA: 10/12/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved	11/30/2018
Responses	2,528	0	3,400
Time Burden (Hours)	881	0	1,105
Cost Burden (Dollars)	0	0	0

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Abstract: 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customers who wish to electronically submit a user fee refund request for a duplicate payment, overpayment or for a withdrawn application or submission.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.

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Authorizing Statute(s): PL: Pub.L. 105 - 277 title XVII Name of Law: Government Paperwork Elimination Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 22493	05/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 50382	10/05/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 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

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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	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

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: 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.

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Annual Cost to Federal Government: $0

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.     Yes

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? Uncollected

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Common Form ICR:  No

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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: 10/12/2018

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