Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 7-22-14.doc Supporting Statement A	2014-07-22

IC Document Collections

IC ID	Document Title	Status
198752	Appeal Requests Other-Guidance	Modified
198751	Reconsideration Requests Other-Guidance	Modified
198750	Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0693	ICR Reference No: 201407-0910-012
Status: Historical Active	Previous ICR Reference No: 201108-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/21/2014
	Date Received in OIRA: 07/25/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	124	0	94
Time Burden (Hours)	2,004	0	1,524
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance provides recommendations for applicants planning to request waivers or reductions in user fees, and describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers or reductions.

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Authorizing Statute(s): US Code: 21 USC 379g and 379h Name of Law: FD&C 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:
	79 FR 12201	03/04/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 41579	07/16/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act
Reconsideration Requests
Appeal Requests

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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	124	94	0	0	30	0
Annual Time Burden (Hours)	2,004	1,524	0	0	480	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: No

Burden Reduction Due to:

Short Statement: The burden has increased from 1,524 to 2,004 as a result of updated data on submission under this information collection request.

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Annual Cost to Federal Government: $700,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 07/25/2014

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