Form FDA 3794 GDUFA Cover Sheet Instructions

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 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:
[email protected]
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.
•

ANDA (Original submission or amendment) - Refer to instructions for item 5.

•

PAS (Original post-approval change requiring prior approval or applicable PAS amendment) - 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.
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PSC Publishing Services (301) 443-6740

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ANDA/PAS INFORMATION cont.
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.

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’).

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FACILITY INFORMATION cont.
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. 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.
24. 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. 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.
27. 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/default.htm.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 30 minutes per response, including the time to
review instructions, search existing data sources, gather and maintain the data needed, and complete and review the
collection of information. Send comments regarding this burden estimate or any other aspect of this information collection,
including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
FORM FDA 3794 SUPPLEMENT (8/13) – FORM INSTRUCTIONS

“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 number.”
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