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

ICR 202101-0910-010

OMB: 0910-0566

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2021-02-23
Supporting Statement A
2021-02-23
IC Document Collections
ICR Details
0910-0566 202101-0910-010
Received in OIRA 201802-0910-004
HHS/FDA CVM
Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM
Extension without change of a currently approved collection   No
Regular 02/23/2021
  Requested Previously Approved
36 Months From Approved 03/31/2021
4 4
40 40
0 0

This information collection supports agency guidance and applicable regulations. The guidance describes policy for resolution of disputes relating to scientific controversies within the Center for Veterinary Medicine at FDA. 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 360bbb-1 Name of Law: FFDCA; Dispute Resolution
  
None

Not associated with rulemaking

  85 FR 50827 08/18/2020
86 FR 10581 02/22/2021
No

1
IC Title Form No. Form Name
Request for Review of a Scientific Dispute

  Total Request 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 4 4 0 0 0 0
Annual Time Burden (Hours) 40 40 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,141,608
No
    Yes
    No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
02/23/2021


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