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

ICR 201706-0910-016

OMB: 0910-0693

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0693 201706-0910-016
Historical Active 201503-0910-011
HHS/FDA CDER
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Extension without change of a currently approved collection   No
Regular
Approved without change 10/25/2017
Retrieve Notice of Action (NOA) 08/17/2017
  Inventory as of this Action Requested Previously Approved
10/31/2020 36 Months From Approved 10/31/2017
183 0 124
2,630 0 2,004
0 0 0

The information collection supports agency guidance. The guidance provides recommendations for applicants planning to request waivers or reductions in user fees under the Prescription Drug User Fee Act, 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 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 23581 05/23/2017
82 FR 36795 08/07/2017
No

1
IC Title Form No. Form Name
Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products Form FDA 3971
Reconsideration Requests
Appeal Requests

  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 183 124 0 0 59 0
Annual Time Burden (Hours) 2,630 2,004 0 0 626 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects agency adjustments as explained at Q15 of the supporting statement.

$700,000
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.
08/17/2017


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