Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM

ICR 201110-0910-005

OMB: 0910-0566

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2011-09-22
Supporting Statement A
2011-10-11
IC Document Collections
ICR Details
0910-0566 201110-0910-005
Historical Active 200806-0910-007
HHS/FDA
Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 02/06/2012
Retrieve Notice of Action (NOA) 10/13/2011
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved
3 0 0
30 0 0
0 0 0

This guidance document describes the CVM policy for resolution of disputes relating to scientific controversies. A scientific controversy involves issues that arise within the context of the Center's regulation of a specific product and are related to matters of technical expertise that require some specialize education, training or experience to be understood and resolved. The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions relating to regulated products for animals.

US Code: 21 USC 572 Name of Law: null
  
None

Not associated with rulemaking

  76 FR 41264 07/13/2011
76 FR 62812 10/11/2011
No

1
IC Title Form No. Form Name
Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM

  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 3 0 0 0 -5 8
Annual Time Burden (Hours) 30 0 0 0 -50 80
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$920,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 [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.
10/13/2011


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