Formal Dispute Resolutions; Appeals Above the Division Level

ICR 201902-0910-004

OMB: 0910-0430

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-02-22
ICR Details
0910-0430 201902-0910-004
Active 201510-0910-005
HHS/FDA CDER
Formal Dispute Resolutions; Appeals Above the Division Level
Revision of a currently approved collection   No
Regular
Approved without change 03/28/2019
Retrieve Notice of Action (NOA) 02/27/2019
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved 03/31/2019
18 0 32
144 0 256
0 0 0

This information collection approval request supports FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  83 FR 42127 08/20/2018
84 FR 6004 02/25/2019
No

2
IC Title Form No. Form Name
CDER - Requests for Formal Dispute Resolution
CBER - Requests for Formal Dispute Resolution

  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 18 32 0 0 -14 0
Annual Time Burden (Hours) 144 256 0 0 -112 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects both changes and adjustment. We have decreased our burden estimate by 14 responses and 112 hours based on the number of dispute requests received since last OMB review.

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
02/27/2019


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