New Animal Drugs for Investigational Use

OMB 0910-0117

OMB 0910-0117

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.

The latest form for New Animal Drugs for Investigational Use expires 2021-08-31 and can be found here.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2018-07-18
Approved without change
Extension without change of a currently approved collection 2015-07-14
Approved without change
Reinstatement with change of a previously approved collection 2012-07-05
Withdrawn
Reinstatement with change of a previously approved collection 2011-09-26
Approved without change
Extension without change of a currently approved collection 2008-06-27
Approved without change
Extension without change of a currently approved collection 2005-04-28
Approved without change
Extension without change of a currently approved collection 2002-01-25
Approved without change
Reinstatement without change of a previously approved collection 1998-11-18
Approved without change
Revision of a currently approved collection 1994-05-20
Approved without change
Reinstatement with change of a previously approved collection 1991-05-07
Approved without change
Reinstatement with change of a previously approved collection 1987-07-27
Approved without change
Reinstatement with change of a previously approved collection 1983-01-03
Approved with change
No material or nonsubstantive change to a currently approved collection 1981-03-21
Approved with change
No material or nonsubstantive change to a currently approved collection 1981-03-17
Approved without change
New collection (Request for a new OMB Control Number) 1981-01-08
OMB Details

Reporting: NAD for Investigational Use

Federal Enterprise Architecture: Health - Consumer Health and Safety


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