Records and Reports Concerning Experience with Approved New Animal Drugs

ICR 202001-0910-009

OMB: 0910-0284

Federal Form Document

ICR Details
0910-0284 202001-0910-009
Active 201801-0910-008
HHS/FDA CVM
Records and Reports Concerning Experience with Approved New Animal Drugs
Revision of a currently approved collection   No
Regular
Approved without change 07/29/2020
Retrieve Notice of Action (NOA) 01/16/2020
  Inventory as of this Action Requested Previously Approved
07/31/2023 36 Months From Approved 03/31/2021
10,937 0 12,418
99,882 0 101,363
0 0 0

This information collection supports FDA regulations regarding records and reports concerning experience with approved new animal drugs. Respondents to the collection are animal drug manufacturers with approved new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or conditionally approved new animal drug applications (CNADAs), as well as licensed commercial feed mills and licensed mixer-feeders. The reporting and recordkeeping elements implement public health protection provisions provided for in the Federal Food, Drug and Cosmetic.

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

0910-AH51 Final or interim final rulemaking 85 FR 45505 07/29/2020

  83 FR 6480 02/14/2018
85 FR 45505 07/29/2020
Yes

  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 10,937 12,418 0 0 -1,481 0
Annual Time Burden (Hours) 99,882 101,363 0 0 -1,481 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This rulemaking revises the information collection to require electronic reporting or the granting of a waiver from the requirement. We have updated our mandatory reporting element (IC element 1) to reflect estimates consistent with the final rule, which results in a decrease in both annual responses and burden hours in the amount of 1512. This is because the currently approved estimate was shown to be too high by the FRIA for the final rule. Ultimately, upon approval of the revision, the 270 responses and hours attributable to mandatory electronic reporting will be captured under OMB Control No. 0910-0645, FDA’s Adverse Event Reporting System (which administers our MedWatch Program), however the 1 request for waiver will be retained in this information collection. We have also added a one-time recordkeeping burden in the amount of 30 responses and 30 burden hours to reflect implementation of the new requirements, but we expect this burden to be realized upon the next renewal request for the information collection (currently expires March 31, 2021). Cumulatively, these changes reflect a total decrease of 1481 hours and 1481 responses annually.

$700,000
No
    No
    No
No
No
No
No
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.
01/16/2020


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