Form 3458 Notice of Claimed Investigational Exemption

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Center for Veterinary Medicine

Import Data

Notice of Claimed
Investigational Exemption

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Form Approved: OMB No. 0910-0117
Expiration Date: 3/31/05

PAPERWORK REDUCTION ACT STATEMENT: A Federal agency may not conduct or sponsor, and a person is not required to respond to, a collection of information,
unless it displays a current valid OMB control number. The public reporting burden for the collection of information is estimated to vary from 15 minutes to 2 hours, with an
average of 45 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the necessary information, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information to the Food and
Drug Administration, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855.

Submit this notice electronically to:
Food and Drug Administration
Center for Veterinary Medicine, HFV7500 Standish Place
Rockville, Maryland 20855
(E-mail:[email protected])

A1. DATE:
A2. DOCUMENT ID:
A3. STUDY / TRIAL ID:
A4. DRUG SHIPMENT NO:
A5. TYPE OF SHIPMENT:

The sponsor,
, submits a notice of claimed
investigational exemption for the shipment or delivery of a new animal drug under the provisions of 21 CFR
511.1. This information is submitted in electronic form.

Shipment or

I.
1.

Receipt Information:

NAME(S) OF THE DRUG(S)
1a. Established Name(s):

1b. Proprietary Name(s):

2.

PROPOSED USE OF THE DRUG(S):

3.

DATE OF DRUG SHIPMENT (OR RECEIPT):

4.

TOTAL QUANTITY (WT. OR VOL.) AND CONCENTRATION OF DRUG(S) SHIPPED (OR RECEIVED):

5.

TYPE OF STUDY / TRIAL:

6.

INTENDED USE OF STUDY OR TRIAL:

7.

INVESTIGATOR INFORMATION:

PIVOTAL (INTENDED FOR SUPPORT OF NADA or ANADA)
7a. Name:
7c. Address:
7d. Address 2:
7e. City:
7g. Country: USA
7i. Phone Number:
8.

NON-PIVOTAL
7b. FEI #:

7f. State/Prov:
7h. Postal Code:

LOCATION OF STUDY / TRIAL INFORMATION:
8a. Name:
8c. Address:
8d. Address 2:
8e. City:
8g. Country: USA
8i. Phone Number:

FORM FDA 3458 (12/2003)
Version 4.0

8b. FEI #:
8f. State/Prov:
8h. Postal Code:

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9.

STUDY MONITOR INFORMATION:
9a. Name:
9c. Address:
9d. Address 2:
9e. City:
9g. Country: USA
9i. Phone Number:

9b. FEI #:
9f. State/Prov:
9h. Postal Code:

10.

APPROXIMATE DATE OF STUDY/ TRIAL

11.

PROTOCOL PREVIOUSLY SUBMITTED TO CVM:
If Yes,

10a. START:

10b. FINISH:
YES

11a. Date Submitted to CVM:

NO

11b. CVM Submission Identifier:
PRODUCTION CLASS:

12.

SPECIES OF ANIMALS:

13.

SIZE AND TYPE OF ANIMALS:

14.

APPROXIMATE NUMBER OF ANIMALS IN THIS STUDY/ TRIAL:
Total: 0
Treated:
Control:
0

0

NUMBER OF ANIMALS PREVIOUSLY USED:
Total: 0
Treated:
0

0

15.

16.

Control:

MAXIMUM DAILY DOSE:
Duration:

17.

METHOD OF ADMINISTRATION:

18.

CONTRACT RESEARCH ORGANIZATION (CRO) USED:

YES

18a. Name:
18c. Address:
18d. Address 2:
18e. City:
18f. State/Prov:
18g. Country:
18h. Postal Code:
18i. Phone Number:
18j. Description of Obligations Transferred to CRO:

19.

NO
18b. FEI #:

IS THIS ADDITIONAL INFORMATION FOR A NOTICE PREVIOUSLY SUBMITTED TO CVM:
YES
If Yes,

FORM FDA 3458 (12/2003)
Version 4.0

NO
19a. Date Submitted to CVM:

Page 2

19b. CVM Submission Identifier:

II.

Animals Intended For Human Food Purposes:

1.

DATE OF CVM AUTHORIZATION LETTER:

2.

WITHDRAWAL PERIOD:

3.

ACKNOWLEDGMENT: Acknowledgment that the date and place of slaughter will be reported to the FDA and to
the USDA/FSIS Technical Service Center, ATTN: INAD/Residue, Division of Technical Assistance and Correlation, 1299
Farnam Street, Suite 300, Omaha, NE, 68102, at least 10 days prior to shipment for slaughter. Experimentally treated
animals will be identified to the inspector in charge of the slaughtering establishment when presented for antemortem
inspection.

4.

NOTIFICATION WAIVER: A waiver of requirements for notification of the date and place of slaughter after a 30-day
holding and observation period following the required withdrawal period has been granted by FDA.

YES

YES

III.
1.

NO

NO

Investigational New Animal Drug Labeling:
SELECT ONE LABEL
a.

New animal drugs for tests in vitro and in laboratory research:
Caution. Contains a new animal drug for investigational use only in laboratory research animals or for tests in
vitro. Not for use in humans.

b.

New animal drugs for clinical investigation:
Caution. Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in
humans. Edible products of investigational animals are not to be used for food unless authorization has been
granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.

c.

New animal drugs for EXPORT:
Caution. Contains a new animal drug for use only in investigational clinical trials. Not for use in humans. Edible
products from animals used for investigation are not to be used for food in any manner contrary to the requirements
of the country in which the clinical trials are to be conducted.

2.

IF THE DRUG IS INTENDED FOR FOOD-PRODUCING ANIMALS, THE LABEL MUST ALSO BEAR:
No official withdrawal time has been established for this product under the proposed investigational use.

IV.

Comments:
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Insert Comments button below. All comments must be included within a PDF document.

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FORM FDA 3458 (12/2003)
Version 4.0

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V.

Sponsor Information:

1.
2a.
2b.
2c.
2e.

Name:
Address:
Address 2:
City:
Country: USA

3.
4.
5.
6.

Contact Name:
Contact Phone Number:
Contact Fax Number:
Contact E-Mail Address:

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FORM FDA 3458 (12/2003)
Version 4.0

1a. FEI #:
2d. State/Prov:
2f. Postal Code:

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Page 4

3 - Save

4 - Signature

5 - Send to CVM