New Animal Drugs for Investigational Use

ICR 201806-0910-009

OMB: 0910-0117

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0117 201806-0910-009
Active 201507-0910-004
New Animal Drugs for Investigational Use
Extension without change of a currently approved collection   No
Approved without change 08/17/2018
Retrieve Notice of Action (NOA) 07/18/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved 08/31/2018
6,723 0 6,226
15,060 0 13,805
0 0 607,376

This information collection request supports FDA's regulations regarding new animal drugs for investigational uses. Respondents to this collection of information are persons who use new animal drugs for investigational purposes, such as drug industry firms, academic institutions, and the government. Investigators may include individuals from these entities, as well as research firms and members of the medical professions. Our regulations require that certain information be submitted to us in a “Notice of Claimed Investigational Exemption for a New Animal Drug” (NCIE) to qualify for the exemption and to control shipment of the new animal drug and prevent potential abuse. Our regulations also require recordkeeping. We use the reported information to determine that investigational animal drugs are distributed only to qualified investigators, adequate drug accountability records are maintained, and edible food products from treated food-producing animals are safe for human consumption. We also use the information collected to monitor the validity of the studies submitted to us to support new animal drug approval.

US Code: 21 USC 512j Name of Law: null

Not associated with rulemaking

  83 FR 7735 02/22/2018
83 FR 32877 07/16/2018

  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 6,723 6,226 0 0 497 0
Annual Time Burden (Hours) 15,060 13,805 0 0 1,255 0
Annual Cost Burden (Dollars) 0 607,376 0 0 -607,376 0

Amber Sanford 301 796-8867 [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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