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

ICR 201503-0910-011

OMB: 0910-0693

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2015-03-25
Supporting Statement A
2014-07-22
ICR Details
0910-0693 201503-0910-011
Historical Active 201407-0910-012
HHS/FDA CDER
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/18/2015
Retrieve Notice of Action (NOA) 03/26/2015
  Inventory as of this Action Requested Previously Approved
08/31/2017 08/31/2017 08/31/2017
124 0 124
2,004 0 2,004
0 0 0

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.

US Code: 21 USC 379g and 379h Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 12201 03/04/2014
79 FR 41579 07/16/2014
Yes

3
IC Title Form No. Form Name
Reconsideration Requests
Appeal Requests
Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act

  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 124 124 0 0 0 0
Annual Time Burden (Hours) 2,004 2,004 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden has increased from 1,524 to 2,004 as a result of updated data on submission under this information collection request.

$700,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  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.
03/26/2015


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