Form 3536 Protocol for Non- Clinical Laboratory and Effectiveness

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Protocol for
Non-Clinical Laboratory and
Effectiveness Studies

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

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Form Approved: OMB No. 0910-0524
Expiration Date: 2/28/07

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 5 to 20 minutes, with an
average of 12 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. TYPE OF STUDY:

Pivotal

Non-pivotal

The sponsor,
, submits a protocol for use of an
investigational new animal drug. Protocols for non-clinical laboratory studies (safety studies) are required
under 21 CFR 58.120. Protocols for adequate and well-controlled effectiveness studies are required
under 21 CFR 514.117(b). Sponsors may request that CVM review protocols for safety and effectiveness
studies of new animal drugs. This information is submitted in electronic form.

Requesting Protocol CVM Review:

I.
1.

Yes

No

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

1b. Proprietary Name(s):

2.

PROTOCOL TITLE:
2a. Short Abstract Title:
2b. Full Title:

2c. Version Number (If Applicable):
3.

PROTOCOL PREVIOUSLY SUBMITTED TO CVM:
If Yes,

II.

3a. Date Submitted to CVM:

YES

NO

3b. CVM Submission Identifier:

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.
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III.

Protocol:
Please press the Insert Protocol button to include your Protocol. All Protocols must be included
within a PDF document.
Insert Protocol

FORM FDA 3536 (10/2005)
Version 4.1

Page 1

IV.

Sponsor Information:

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

Name:
Address:
Address 2:
City:
Country:

3.
4.
5.
6.

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

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

USA

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FORM FDA 3536 (10/2005)
Version 4.1

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