Form FDA 3794 FDA 3794 Generic Drug User Fee Cover Sheet

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Form Approved: OMB No. 0910-0727; Expiration Date: 12/31/2015. See Paperwork Reduction Act Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

GENERIC DRUG USER FEE COVER SHEET
Complete Form FDA 3794 for each 1) Abbreviated new drug application (ANDA) or applicable amendment;
2) Prior approval supplement (PAS) or applicable amendment; 3) Type II active pharmaceutical ingredient (API) drug master file
(DMF) prior to initial reference by a generic drug submission; 4) Annual registration fee for a facility producing generic drugs [API
or finished dosage form (FDF)]; and 5) One-time backlog fee for certain ANDAs submitted prior to October 1, 2012. For further
guidance in completing this form, refer to the instructions. For fee schedule and payment instructions, refer to
http://www.fda.gov/gdufa. If payment is sent by U.S. mail or courier, please include a completed copy of Form FDA 3794 with
payment.
1. APPLICANT'S / HOLDER’S / OWNER’S NAME AND ADDRESS:
SONOTECH INC
774 MARINE DRIVE
BELLINGHAM WA 98225
United States
2. NAME, TITLE, TELEPHONE NUMBER, AND E-MAIL ADDRESS OF
APPLICANT’S / HOLDER’S / OWNER’S REPRESENTATIVE OR U.S. AGENT:
Kim Karakorn
Title
703-9292929
kimberly.karakorn@fda.hhs.gov

4. SELECT THE GENERIC DRUG USER FEE TYPE:
[X] ANDA (Original submission or amendment)
[ ] PAS (Original submission or amendment)
[ ] Type II API Drug Master File
[ ] Facility
[ ] Backlog

3. FISCAL YEAR TO WHICH THIS PAYMENT APPLIES:
2015

ANDA/PAS INFORMATION
5. APPLICATION NUMBER FOR ANDA: 123456
6. PROVIDE ESTABLISHED NAME OF PRODUCT: test
7. TYPE OF SUBMISSION
[X] Original or Resubmission after RTR [ ] Other
8. DOES THE ANDA / PAS CONTAIN API MANUFACTURING INFORMATION OTHER THAN BY REFERENCE TO A DMF?
[ ] YES [X] NO
9. PROVIDE THE QUANTITY OF API(s) INCLUDED IN THE APPLICABLE ANDA OR PAS SUBMISSION: 0
10. NAME OF DRUG SUBSTANCE FOR EACH API:
11. IDENTIFY ALL FACILITIES THAT MANUFACTURE THE APIs BY PROVIDING EACH FACILITY'S NAME, ADDRESS, FDA
ESTABLISHMENT IDENTIFIER (FEI) number AND FACILITY DUNS NUMBER:
12. IDENTIFY THE APIs THAT ARE MANUFACTURED BY EACH FACILITY:
13. HAS THE FEE REQUIRED BY SECTION 744B(a)(3)(F) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT ALREADY BEEN PAID
FOR ANY OF THE API / FACILITY COMBINATION(s)?
[ ] YES [X] NO
14. FOR EACH API / FACILITY COMBINATION, PROVIDE USER FEE PAYMENT I.D. NUMBER(s) IN WHICH THE SECTION 744B(a)(3)(F)
FEE WAS PAID:
15. IS THIS ANDA/PAS APPLICATION FOR A PET DRUG?
[ ] YES [X] NO

USER FEE PAYMENT INFORMATION
26. USER FEE PAYMENT I.D. NUMBER (PIN): GD8009114
27. USER FEE PAYMENT AMOUNT FOR THIS SUBMISSION: $58,730.00
CERTIFICATION STATEMENT:

As the responsible official or designee of the company named above, I hereby certify to the United States Food and Drug
Administration that the information provided on this cover sheet is accurate and complete, to the best of my knowledge.
Making or submitting false statements on any documents submitted to FDA may constitute violations of the United States Code
Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years imprisonment.
SIGNATURE OF AUTHORIZED REPRESENTATIVE

PRINTED NAME AND TITLE

DATE

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Instructions for completing Form FDA 3794 (GENERIC DRUG USER FEE COVER SHEET)
Form FDA 3794 is to be completed on-line at https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp for each 1) Abbreviated new
drug application (ANDA) or applicable amendment; 2) Prior approval supplement (PAS) or applicable amendment; 3) Type II active
pharmaceutical ingredient (API) drug master file (DMF) prior to initial reference by a generic drug submission submitted to the
Agency on or after October 1, 2012, unless specifically exempted below; 4) Annual registration fee for a facility producing generic
drugs (API, finished dosage form (FDF), or both); and 5) One-time backlog fee. A copy of the completed form FDA 3794 must be
included in the first volume with Form 356(h) for an ANDA or PAS submission, or with the cover letter for the DMF submission to
the FDA to which it applies. If you need assistance in completing the form, call 301-796-7200 or email: userfees@fda.gov.
NO.
GENERAL INFORMATION
1. APPLICANT, HOLDER OR OWNER: This is the legal person or entity that owns or controls the subject of the submission (i.e.,
the application, the DMF, or the facility). This field is intended to reflect the name and address of record for the applicant, holder
or owner. Note that it is not intended to reflect the physical location of a facility, unless the applicant, holder or owner is physically
located in that facility.
2. REPRESENTATIVE OR U.S. AGENT: This provides the FDA with a person that is authorized to respond to questions on this
user fee cover sheet. If this is a foreign applicant, holder or owner, the contact person must be a U.S. agent. This field is intended
to reflect the name, title, telephone number, and e-mail address of the representative or U.S. agent.
3. FISCAL YEAR: Indicate the U.S. government's fiscal year (October 1 - September 30) to which this payment applies. Note that
each fiscal year starts on October 1 of the previous calendar year (i.e., October 1, 2012 is the beginning of Fiscal Year 2013).
4. GENERIC DRUG USER FEE TYPE: Check the box to indicate the type of generic drug user fee this cover sheet references.
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ANDA ( Original submission or amendment) - Refer to instructions for item 5.
PAS (Original CMC post-approval change requiring prior approval) - Refer to instructions for
item 5.
TYPE II API DRUG MASTER FILE - Refer to instructions for item 16.
FACILITY - Refer to instructions for item 19.
BACKLOG - There is a one-time fee for certain ANDAs that are pending at the FDA and have not
received a tentative approval as of October 1, 2012. Refer to instructions for item 23.

ANDA/PAS INFORMATION
5. APPLICATION NUMBER FOR ANDA: Please provide the six-digit application number for the ANDA. If the application number
has fewer than six digits, please include one or more leading zeroes until the number has six digits. Further information is
available at:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htm .
6. ESTABLISHMENT NAME OF PRODUCT: The name of the product as referenced by the application will be a validation check if
and when questions arise about application of payments or for other purposes.
7. AMENDING ANDA OR PAS: Indicate whether you are amending an ANDA or PAS that has been submitted to the FDA but on
which a final official action has not yet been taken.
8. API MANUFACTURING INFORMATION INCLUDED: Some ANDA or PAS submissions contain API manufacturing information
that does not reference a Type II API Drug Master File. GDUFA requires that such applications pay the Section 744B(a)(3)(F) fee
which relates to API and facility combinations. For more information see Section 744B(a)(3)(F) of the Federal Food, Drug, and
Cosmetic Act.
9. PROVIDE THE QUANTITY OF APIs INCLUDED IN THE APPLICABLE ANDA OR PAS SUBMISSION: Enter the quantity of
APIs contained in the applicable ANDA / PAS submission upon which the ANDA / PAS relies and which are not also contained in
Type II API Drug Master Files. For original ANDA submissions, this would include all APIs stated in the submission that are
manufactured by the applicant. For ANDA amendments, original PAS submissions, and PAS amendments, this would include
only the change and/or addition to APIs manufactured by the applicant that are stated in the applicable submission and would
exclude the APIs previously stated in a prior ANDA/PAS submission. See Section 744B(a)(3)(F) of the Federal Food, Drug, and
Cosmetic Act.
10. NAME OF DRUG SUBSTANCE FOR EACH API: For each API mentioned in question 9, provide the name of the drug
substance.
11. FOR EACH FACILITY, PROVIDE ADDRESS, FDA ESTABLISHMENT IDENTIFIER (FEI) AND FACILITY DUNS: Indicate the
official or internal name of the facility and the facility's physical address. The FDA Establishment Identifier (FEI) number is a
unique identifier issued by the FDA's Office of Regulatory Affairs. More information is available at
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.htm (note that this directive uses the term CFN,
which is a precursor to the FEI). If you have questions about obtaining an FDA Establishment Identifier (FEI) number, or if you
have submitted your electronic registration and have questions on the status of your submission, please contact the SPL
Coordinator at SPL@fda.hhs.gov or see Points of Contact for Drug Registration and Listing. The DUNS Number is issued by the
Dun & Bradstreet corporation and is widely used for firm identification; see http://www.dnb.com/get-a-duns-number.html for more
information. Please be sure to use the DUNS Number associated with the physical location of the facility (also known as the
'establishment DUNS' as distinguished from the 'registrant DUNS').
12. IDENTIFY THE APIs THAT ARE MANUFACTURED BY EACH FACILITY: For each facility, identify which of the APIs
mentioned in question 10 are manufactured at that facility.
13. HAS FEE REQUIRED BY SECTION 744B(a)(3)(F) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT ALREADY BEEN
PAID: Indicate whether the Section 744B(a)(3)(F) fee has already been paid for any of the API / facility combination(s) through a
previously submitted cover sheet or Form FDA 3794. For applications including API manufacturing information other than by
reference to a DMF, GDUFA requires that such applications pay the Section 744B(a)(3)(F) fee which relates to API and facility
combinations. For more information see Section 744B(a)(3)(F) of the Federal Food, Drug, and Cosmetic Act.
14. FOR EACH API / FACILITY COMBINATION, PROVIDE USER FEE PAYMENT I.D. NUMBER IN WHICH THE SECTION 744B

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15.

16.

17.
18.

19.

20.

21.

22.

23.

24.
25.

26.

27.

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(a)(3)(F) FEE WAS PAID: Provide the User Fee Payment I.D. Number given at the completion of the cover sheet in which the
fee required by Section 744B(a)(3)(F) of the Federal Food, Drug, and Cosmetic Act was paid. This will prevent double payments.
PET DRUG: Positron Emission Tomography (PET) drugs are exempt from paying any generic drug user fees. If this application
deals only with PET drugs under an ANDA, the fee does not apply. This will be reflected in field 27 "User Fee Payment Amount
for This Submission" upon checkout.
DRUG MASTER FILE INFORMATION
TYPE II API DRUG MASTER FILE NUMBER: This applies to a Type II API drug master file (DMF) where the owner intends to
authorize the FDA to reference the information to support approval of a generic drug submission without the application holder
having to disclose the information to the generic drug submission applicant. Please provide the number of the applicable Type II
API DMF, which should be available from the DMF holder. See:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073164.htm
for further information or contact the FDA at dmfquestion@fda.hhs.gov.
NAME OF DRUG SUBSTANCE: Provide the name of the substance covered by the Type II API DMF.
PET DRUG: Positron Emission Tomography (PET) drugs are exempt from paying any generic drug user fees. If this Type II API
DMF relates only to a PET drug, the fee does not apply. This will be reflected in field 27 "User Fee Payment Amount for This
Submission" upon checkout.
FACILITY INFORMATION
U.S. FACILITY: Please indicate if the facility for which this fee is being paid is located in the United States, its territories or
possessions. This information is required to determine the correct fee due, which will be reflected in field 27 "User Fee Payment
Amount for This Submission" upon checkout.
PROVIDE FACILITY NAME, ADDRESS, FDA ESTABLISHMENT IDENTIFIER (FEI) NUMBER AND FACILITY DUNS
NUMBER: Indicate the official or internal name of the facility and the facility's physical address. The FDA Establishment Identifier
(FEI) is a unique identifier issued by FDA's Office of Regulatory Affairs. More information is available at
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.htm (note that this directive uses the term CFN,
which is a precursor to the FEI). If you have questions about obtaining an FDA Establishment Identifier (FEI) number, or if you
have submitted your electronic registration and have questions on the status of your submission, please contact the SPL
Coordinator at SPL@fda.hhs.gov or see Points of Contact for Drug Registration and Listing . The DUNS Number is issued by the
Dun & Bradstreet corporation and is widely used for firm identification; see http://www.dnb.com/get-a-duns-number.htm for more
information. Please be sure to use the DUNS Number associated with the physical location of the facility (also known as the
'establishment DUNS' as distinguished from the 'registrant DUNS').
TYPE OF FACILITY: A facility is a business or other entity under one management either direct or indirect and at one
geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage
form. This term does not include a business or other entity whose only manufacturing or processing activities are one or more of
the following: repackaging, relabeling, or testing. Separate buildings within close proximity are considered to be at one
geographic location or address if the activities in them are closely related to the same business enterprise, are under the
supervision of the same local management, and can be inspected by the FDA during a single inspection. Further information is
available at http://www.fda.gov/edrls. Indicate whether the facility for which this fee is being paid is engaged in manufacturing one
or more APIs, one or more FDFs, or at least one of each. If the API facility produces ONLY Positron Emission Tomography
(PET) drugs, user is exempt from paying any API user fees, but may require FDF fees if applicable. If the FDF facility produces
ONLY PET drugs, user is exempt from paying any FDF user fees, but may require API fees if applicable. Check all that are
applicable.
PRODUCE OTHER THAN HUMAN GENERIC DRUGS: Indicate if this facility also produces human drugs other than human
generic drugs.
BACKLOG INFORMATION
APPLICATION NUMBER OF BACKLOG APPLICATION: There is a one-time fee for certain ANDAs pending as of October 1,
2012. Please provide the six-digit number of the ANDA for which this backlog fee is being paid. If the application number has
fewer than six digits, please include one or more leading zeroes until the number has six digits.
ESTABLISHED NAME OF PRODUCT: The name of the product as referenced by the application will be a validation check if and
when questions arise about application of payments or for other purposes.
PET DRUG: Positron Emission Tomography (PET) drugs are exempt from paying any generic drug user fees. If this application
relates to a PET drug under an ANDA, the fee does not apply. This will be reflected in field 27 "User Fee Payment Amount for
This Submission" upon checkout.
USER FEE PAYMENT INFORMATION
USER FEE PAYMENT I.D. NUMBER (PIN): This number is automatically generated by the User Fee System. When submitting
your payment, please include the PIN on your check, bank draft, or postal money order or reference the PIN on your wire transfer
payment.
USER FEE PAYMENT AMOUNT FOR THIS SUBMISSION: This amount is automatically calculated by the User Fee System
based on the information provided in the cover sheet. If you are remitting this payment by wire transfer, please be sure to include
any additional charges imposed by your financial institution (e.g., wire transfer fee).

Privacy Act Notice:
This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. 552a. The collection of this information is authorized by 21
U.S.C. 744B. FDA will use the information to assess, collect and process user fee payments, and facilitate debt collection under
the Debt Collection Improvement Act. FDA may disclose information to courts and the Department of Justice in the context of
litigation and requests for legal advice; to other Federal agencies in response to subpoenas issued by such agencies; to HHS and
FDA employees and contractors to perform user fee services; to the National Archives and Records Administration and General
Services Administration for records management inspections; to the Department of Homeland Security and other Federal
agencies and contractors in order to detect or respond to system breaches; to banks in order to process payment made by credit
card; to Dun and Bradstreet to validate submitter contact information, and to other entities as permitted under the Debt Collection
Improvement Act. Furnishing the requested information is mandatory. Failure to supply the information could prevent FDA from

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processing user fee payments. Additional details regarding FDA's use of information is available online:
http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/.
This section applies only to the requirements for the Paperwork Reduction Act of 1995
Public reporting burden for this collection of information is
Department of Health and Human Services
estimated to average 30 minutes per response, including the Food and Drug Administration
time for reviewing instructions, searching existing data
Office of Information Management (HFA-710)
sources, gathering and maintaining the data needed, and
Paperwork Reduction Act (PRA) Staff
completing and reviewing the collection of information. Send 8455 Colesville Road, COLE-14-14253
comments regarding this burden estimate or any other aspect Silver Spring, MD 20993-0002
of this collection of information, including suggestions for
reducing this burden, to the address to the right:
DO NOT SEND YOUR COMPLETED FORM OR USER FEE
PAYMENT TO THIS PRA STAFF ADDRESS
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid
OMB control number.

Form FDA 3794 (02/01/2013)

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