Free Notice of Claimed Investigational Exception - Federal

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

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Notice of Claimed Investigational Exemption

Form Approved: OMB No. 0910-0117 Expiration Date: 08/31/2011

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 Department of Health and Human Services, Food and Drug Administration, Office of Chief Information Officer (HFA-250), 5600 Fishers Lane, Rockville, MD 20857

Food and Drug Administration Center for Veterinary Medicine, HFV7500 Standish Place Rockville, Maryland 20855

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

The applicant, , 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.

I.
1.

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


Receipt Information:

1b. Trade Name(s):

2. 3. 4. 5. 6. 7.

PROPOSED USE OF THE DRUG(S): DATE OF DRUG SHIPMENT (OR RECEIPT): TOTAL QUANTITY (WT. OR VOL.) AND CONCENTRATION OF DRUG(S) SHIPPED (OR RECEIVED): TYPE OF STUDY / TRIAL: INTENDED USE OF STUDY OR TRIAL:
PIVOTAL (INTENDED FOR SUPPORT OF NADA or ANADA)
NVESTIGATOR INFORMATION: I NON-PIVOTAL

7a. Name: 7b: Address: 7c: Address 2: 7d: City: 7f. Country:
USA

7e. State/Prov: 7g. Postal Code:

7h. Phone Number:


8. LOCATION OF STUDY / TRIAL INFORMATION:

8a. Name: 8b. Address: 8c. Address 2: 8d. City: 8f. Country:
USA

8e. State/Prov: 8g. Postal Code:

8h. Phone Number:




FORM FDA 3458 (10/2008) Version 5.2

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9. STUDY MONITOR INFORMATION
9a. Name:
9b. Address:
9c. Address 2:
9d. City:
9f. Country:
USA

9e. State/Prov: 9g. Postal Code:

9h. Phone Number: 10. APPROXIMATE DATE OF STUDY/TRIAL 10a. START: YES NO
10b. FINISH:

11. PROTOCOL PREVIOUSLY SUBMITTED TO CVM: IF Yes, 11a. Date Submitted to CVM:


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:
0

Control:

0

15. NUMBER OF ANIMALS PREVIOUSLY USED:
Total:
0 16. MAXIMUM DAILY DOSE:
Duration:
17. METHOD OF ADMINISTRATION : 18. CONTRACT RESEARCH ORGANIZATION (CRO) USED: 18a. Name:
18b. Address:
18c. Address 2:
18d. City:
18f. Country:
18h. Phone Number:
18i. Descripton of Obligations Transferred to CRO:
18e. State/Prov:
18g. Postal Code:
YES NO Treated:
0

Control:

0

19.

IS THIS ADDITIONAL INFORMATION FOR A NOTICE PREVIOUSLY SUBMITTED TO CVM: YES If Yes, NO
19a. Date Submitted to CVM:
19b. CVM Submission Identifier:

FORM FDA 3458 (10/2008) Version 5.2

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II.
1. 2. 3.

Animals Intended For Human Food Purposes:
DATE OF CVM AUTHORIZATION LETTER: W ITHDRAWAL PERIOD: ACKNOWLEDGMENT: Acknowledgment that the date and place of slaughter will be reported to the FDA and to the Residue Staff, USDA/FSIS, Ste 300, Landmark Ctr, 1299 Farnam St, 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. YES NO

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 NO

III.
1.

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:
If you have additional comments that you would like to include in this submission please press the Insert Comments button below. All comments must be included within a PDF document.

Insert Comments

FORM FDA 3458 (10/2008) Version 5.2

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V.
1. 2a. 2b. 2c. 2e. 3. 4. 5. 6.

Applicant Information:
Name: Address: Address 2: City: Country: USA Contact Name: Contact Phone Number: Contact Fax Number: Contact E-Mail Address:

2d. State/Prov: 2f. Postal Code:

1 - Validate

2 - Save

3 - Signature

FORM FDA 3458 (10/2008) Version 5.2

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