Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

ICR 202007-0910-013

OMB: 0910-0620

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0620 202007-0910-013
Active 201707-0910-005
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Extension without change of a currently approved collection   No
Approved with change 08/25/2020
Retrieve Notice of Action (NOA) 07/24/2020
Changes in responses/burden were re-categorized as "adjustments."
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
213 0 293
5,273 0 4,922
0 0 0

This ICR collects information from respondents who wish to make a drug legally available to veterinarians and animal owners for the treatment of a minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). Respondents to the collection are sponsors of these products. FDA reviews the information collected to identify potential problems concerning the safety and effectiveness of the new animal drug.

US Code: 21 USC 369ccc-2 Name of Law: Minor Use and Minor Species Animal Health Act

Not associated with rulemaking

  85 FR 714 01/07/2020
85 FR 23969 04/30/2020

  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 213 293 0 0 -80 0
Annual Time Burden (Hours) 5,273 4,922 0 0 351 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
Miscellaneous Actions
Our estimated burden for the information collection reflects an overall increase of 401 reporting hours. We attribute this adjustment, generally, to an increase in the number of submissions we received over the last few years. We also reduced our burden hour estimate for drug experience reports and distributor statements under 21 CFR 516.165 from 8 hours per submission to 5 hours per submission based on our experience with this type of reporting.

Jonna Capezzuto 301 796-3794 [email protected]


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.

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