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

ICR 201501-0910-009

OMB: 0910-0566

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2011-09-22
Supporting Statement A
2015-02-18
IC Document Collections
ICR Details
0910-0566 201501-0910-009
Historical Active 201110-0910-005
HHS/FDA CVM
Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM
Revision of a currently approved collection   No
Regular
Approved without change 04/10/2015
Retrieve Notice of Action (NOA) 02/18/2015
  Inventory as of this Action Requested Previously Approved
04/30/2018 36 Months From Approved 04/30/2015
8 0 3
80 0 30
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

  79 FR 65976 11/06/2014
80 FR 4931 01/29/2015
Yes

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 8 3 0 5 0 0
Annual Time Burden (Hours) 80 30 0 50 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Burden increase reflects an increase in number of respondents and annual responses. This is discussed more fully at Q15 of the supporting statement.

$1,008,000
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.
02/18/2015


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