Form FDA 3728 FDA 3728 AGDUFA Cover Sheet

Form Approved: OMB No. 0910-0632 Expiration Date: 05/31/14 See instructions for OMB Statement.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

ANIMAL GENERIC DRUG
USER FEE COVER SHEET

PAYMENT IDENTIFICATION NUMBER (Write the Payment Identification Number on your check)
A completed cover sheet must accompany each original application subject to fees. If payment is sent by U.S. mail or courier, please include a copy of this
completed form with payment. Payment and mailing instructions can be found at:
http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm

1. SPONSOR NAME AND ADDRESS (Include name, street
address, city, state, country, and post office code)

2. CONTACT NAME
2.1 E-MAIL ADDRESS
2.2. TELEPHONE NUMBER (Include Area Code)

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)

2.3 FACSIMILE (FAX) NUMBER (Include Area Code)

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if you are unsure, please refer to the
application descriptions at the following website:
http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm)
3.1 Application Type
[ ] Original Abbreviated New Animal Drug Application (ANADA) - under provisions of 512(b)(2) of the FFDCA
[ ] Original Abbreviated New Animal Drug Application (ANADA) of certain combination pioneer products approved under provisions
of 512(d)(4) of the FFDCA
4. IS THIS NEW APPLICATION COVERED BY THE FOLLOWING USER FEE WAIVER? IF SO, CHECK THE APPLICABLE
SECTION.*
[ ] The sole purpose of the application is to support conditions of use for minor use or minor species [741(d)]. This waiver request
has been approved and the FDA waiver number is
5. USER FEE PAYMENT AMOUNT FOR THIS APPLICATION
*Note to section 4 above: Unless a waiver or reduction has been previously granted by the Agency for this application,
payment is expected pending the outcome of the waiver or reduction decision.

Public Reporting Burden
Public reporting burden for this collection of information is estimated to average 20 minutes per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection
of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer (HFA-710)
5600 Fishers Lane
Rockville, MD 20857
An agency may not conduct or sponsor a collection of information, and a person is not required to respond to a collection of
information, unless it displays a currently valid OMB control number.
Form FDA 3728 (11/08)