Antimicrobial Animal Drug Distribution Reports and Recordkeeping

ICR 201605-0910-004

OMB: 0910-0659

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-05-11
Supporting Statement A
2016-05-11
ICR Details
0910-0659 201605-0910-004
Historical Active 201304-0910-007
HHS/FDA CVM
Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Revision of a currently approved collection   No
Regular
Approved without change 06/13/2016
Retrieve Notice of Action (NOA) 05/12/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 11/30/2016
565 0 350
9,813 0 9,354
419,709 0 6,975

This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.

PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments
  
PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments

0910-AG45 Final or interim final rulemaking 81 FR 29129 05/11/2016

  80 FR 28863 05/20/2015
81 FR 29129 05/11/2016
No

  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 565 350 177 37 1 0
Annual Time Burden (Hours) 9,813 9,354 787 -330 2 0
Annual Cost Burden (Dollars) 419,709 6,975 0 410,223 2,511 0
Yes
Changing Regulations
Yes
Miscellaneous Actions
Information collection is being revised to reflect current rulemaking.

$355,469
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.
05/12/2016


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