Free Protocol for Non-Clinical Laboratory and Effectiveness Studies - Federal

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

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Protocol for Non-Clinical Laboratory and Effectiveness Studies

Form Approved: OMB No. 0910-0524 Expiration Date: 04/30/2010

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.

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

A1. DATE: A2. DOCUMENT ID: A3. STUDY / TRIAL ID: A4. TYPE OF STUDY:

Pivotal

Non-pivotal

The applicant, , 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). Applicants may request that CVM review protocols for safety and effectiveness studies of new animal drugs. This information is submitted in electronic form.

I.
1.

Requesting Protocol CVM Review:
NAME(S) OF THE DRUG(S): 1a. Established Name(s):

Yes

No

1b.

Trade 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, 3a. Date Submitted to CVM: YES NO

3b. CVM Submission Identifier:

II.

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

III.

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

FORM 3536 (10/2008) Version 5.2

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

Applicant Information:
Name: Address: Address 2: City: Country:

USA

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

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

1 - Validate

2 - Save

3 - Signature

FORM 3536 (10/2008) Version 5.2

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