Form FDA 3794 FDA 3794 Generic Drug User Fee Cover Sheet

Form Approved: OMB No. Pending from OMB; Expiration Date: Pending from OMB; 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 on page 3. 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:

4. SELECT THE GENERIC DRUG USER FEE TYPE:
[ ] ANDA (Original submission or amendment) (go to question 5)

2. NAME, TITLE, TELEPHONE NUMBER, AND E-MAIL ADDRESS OF
APPLICANT’S / HOLDER’S / OWNER’S REPRESENTATIVE OR U.S. AGENT:

[ ] PAS (Original submission or amendment) (go to question 5)

[ ] Type II API Drug Master File (go to question 16)

[ ] Facility (go to question 19)
3. FISCAL YEAR TO WHICH THIS PAYMENT APPLIES:
[ ] Backlog (go to question 23)

ANDA/PAS INFORMATION
5. APPLICATION NUMBER FOR ANDA: (go to question 6)
6. PROVIDE ESTABLISHED NAME OF PRODUCT: (go to question 7)

7. ARE YOU AMENDING AN ANDA OR A PAS?
[ ] YES

[ ] NO (go to question 8)

8. DOES THE ANDA / PAS CONTAIN API MANUFACTURING INFORMATION OTHER THAN BY REFERENCE TO A DMF?
[ ] YES

[ ] NO (if ‘yes’, go to question 9; if ‘no’, go to question 15)

9. PROVIDE THE QUANTITY OF API(s) INCLUDED IN THE APPLICABLE ANDA OR PAS SUBMISSION: (go to question 10)

10. NAME OF DRUG SUBSTANCE FOR EACH API: (go to question 11)

11. IDENTIFY ALL FACILITIES THAT MANUFACTURE THE APIs BY PROVIDING EACH FACILITY’S NAME, ADDRESS, FEI AND FACILITY DUNS
NUMBER: (go to question 12)

12. IDENTIFY THE APIs THAT ARE MANUFACTURED BY EACH FACILITY: (go to question 13)

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

[ ] NO (if ‘yes’, go to question 14; if ‘no’, go to question 15)

Form FDA 3794 (10/11/2012)

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Form Approved: OMB No. Pending from OMB; Expiration Date: Pending from OMB; See Paperwork Reduction Act Statement below.
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:
(go to question 15)

15. IS THIS ANDA/PAS APPLICATION FOR A PET DRUG?
[ ] YES

[ ] NO (go to question 26)
DRUG MASTER FILE INFORMATION

16. PROVIDE TYPE II API DRUG MASTER FILE NUMBER: (go to question 17)
17. NAME OF DRUG SUBSTANCE: (go to question 18)
18. IS THIS DMF RELATED ONLY TO A PET DRUG?
[ ] YES

[ ] NO (go to question 26)
FACILITY INFORMATION

19. IS THIS FACILITY LOCATED IN THE UNITED STATES, ITS TERRITORIES OR POSSESSIONS?
[ ] YES

[ ] NO (go to question 20)

20. PROVIDE FACILITY’S NAME, ADDRESS, FEI AND FACILITY DUNS NUMBER : (go to question 21)

21. INDICATE WHAT THE FACILITY PRODUCES FOR ONLY HUMAN GENERIC DRUGS: (CHECK ALL APPLICABLE)
[ ] API

ARE ALL APIs PRODUCED AT THIS FACILITY FOR PET DRUGS ONLY?

[ ] YES

[ ] NO

[ ] FDF

ARE ALL FDFs PRODUCED AT THIS FACILITY FOR PET DRUGS ONLY?

[ ] YES

[ ] NO

(go to question 22)

22. DOES THIS FACILITY ALSO PRODUCE HUMAN DRUGS OTHER THAN HUMAN GENERIC DRUGS?
[ ] YES

[ ] NO (go to question 26)
BACKLOG INFORMATION

23. APPLICATION NUMBER OF BACKLOG APPLICATION: (go to question 24)
24. PROVIDE ESTABLISHED NAME OF PRODUCT: (go to question 25)
25. IS THIS APPLICATION FOR A PET DRUG?
[ ] YES

[ ] NO (go to question 26)
USER FEE PAYMENT INFORMATION

26. USER FEE PAYMENT I.D. NUMBER (PIN):
27. USER FEE PAYMENT AMOUNT FOR THIS SUBMISSION:
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

Form FDA 3794 (10/11/2012)

PRINTED NAME AND TITLE

DATE

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Form Approved: OMB No. Pending from OMB; Expiration Date: Pending from OMB; See Paperwork Reduction Act Statement below.

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 the cover page (Form 356(h)) of the ANDA, PAS, or DMF submission to the FDA to which it applies.
If you need assistance in completing the form, call 301-796-7200 or email: [email protected].
NO.
1.

2.

3.

GENERAL INFORMATION
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.
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.
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.
•

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. 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.
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 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 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 [email protected] 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
https://smallbusiness.dnb.com/establish-your-business/12334338-1.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(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.
15. 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.

Form FDA 3794 (10/11/2012)

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Form Approved: OMB No. Pending from OMB; Expiration Date: Pending from OMB; See Paperwork Reduction Act Statement below.
DRUG MASTER FILE INFORMATION
16. 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 [email protected].
17.

NAME OF DRUG SUBSTANCE: Provide the name of the substance covered by the Type II API DMF.

18. 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
19.

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.

20. PROVIDE FACILITY NAME, ADDRESS, FEI 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 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 [email protected] 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
https://smallbusiness.dnb.com/establish-your-business/12334338-1.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’).
21. 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.
22. PRODUCE OTHER THAN HUMAN GENERIC DRUGS: Indicate if this facility also produces human drugs other than human generic drugs.
BACKLOG INFORMATION
23.

24.

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.

25. 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
26.
27.

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 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 estimated to
average 30 minutes per response, including the 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 the address to the right:

Department of Health and Human Services
Food and Drug Administration
Office of Information Management (HFA-710)
Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
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 (10/11/2012)

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