Extension without change of a currently approved collection
No
Regular
07/08/2021
Requested
Previously Approved
36 Months From Approved
08/31/2021
6,960
6,723
15,554
15,060
0
0
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 number of respondents has increased due to an error in calculating the number of sponsors subject to animal drug user fees in the 2018 renewal. When calculating the number of recordkeepers, we inadvertently used the number of sponsors that paid user fees (i.e., those that did not qualify for user fee waivers) as opposed to the total number of sponsors subject to animal drug user fees. Both fee-paying and non-fee-paying sponsors are respondents with respect to this information collection.
Additional information needed to make a final calculation of the total burden hours (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from our records. There is a small increase in the total burden hours which we attribute to an increase in the number of annual responses and records.
$824,362
No
Yes
No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
0117 Supporting Statement NADs for Investigational Use 2021.docx
Reporting: NAD for Investigational Use