Last year the FDA published an updated small business guidance document in early August that included the fee schedule. The owner of a DMF incurs the fee on whichever of the following dates occurs earlier: 1) the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012, or 2) the date the DMF holder requests the initial completeness assessment. FDA’s FY begins on October 1 and ends on September 30, with the year being designated by the calendar year in which it ends (e.g., FY 2020 begins on October 1, 2019, and ends on September 30, 2020). That’s because the agency’s authorizing statute, the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifies certain timeframes for FDA to take action on a submission (e.g., 90 days to make a decision on a 510(k)), but the statute does not specify how often FDA must meet that mark. Subject: US FDA Announces OTC Monograph Drug User Fee Rates, Giving 45 Days For First Facility Payments Add a personalized message to your email. GDUFA reflects input received during an open process that included regular public meetings, posting of meeting minutes, and consideration of comments from a public docket. To make submissions to FDA (e.g., Establishment Registration, Product Listing and Self-ID, etc.) Once the DMF fee becomes due, no generic drug submission submitted referencing the DMF will be received unless the fee is paid and the DMF is deemed available for reference. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process. In August, the FDA publishes the new FDA user fee schedule for the next fiscal year, which begins on October 1. On July 9, 2012, GDUFA was signed into law by the President as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Please refer to the GDUFA Fees table above for the exact fee amounts of each facility fee type. A GDUFA Cover Sheet will be completed online using FDA’s User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher. Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. Examples include an API mixed with an antioxidant for chemical stability when the API is prone to oxidative degradation or an API excipient mixture for physical stability to maintain its amorphous form. Before sharing sensitive information, make sure you're on a federal government site. (4) FDA will notify the ANDA applicant of the facility’s failure to satisfy its user fee obligations. Such facilities are required to pay annual FDF or CMO facility fees. Under GDUFA II, the owner of a facility incurs a fee when both of the following conditions are met on the facility fee due date: A facility does not incur a fee for being referenced only in pending generic drug submissions under GDUFA II. Number (PIN). A facility owner who qualifies as a CMO will owe the CMO facility fee; no other facility fee amount will be assessed. In addition, Budget 2017 provided authorities to the Minister of Health to set fees under the Food and Drugs Act via Ministerial Order and granted an exemption from the Services Fees Act. For detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions. If the same company’s two locations manufacture a U.S. generic product and they are in different geographic locations, each has to pay an annual facility fee. you must first create an account. More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page. 379j-51, 379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA Reauthorization Act of 2017, Pub. PDUFA Application requiring clinic data: $2,875,842: PDUFA Application not requiring clinic … Questions for the Generics Drug User Fee staff? Can an ANDA applicant pay the DMF fee for an API referenced in its submission? IMPORTANT NOTICE REGARDING GENERIC DRUG USER FEE STAFF CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice, electronic mail is the Generic Drug User Fee staff’s preferred method of receiving communication over postal mail. Do DMF holders incur a fee each time their DMF is referenced? This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States. The phrase generic drug submission refers to an ANDA, an amendment to an ANDA, or a Prior Approval Supplement (PAS) to an ANDA. There are several consequences for failure to pay a facility fee: (1) No new ANDA or supplement submitted by the person responsible for paying the fee or that person’s affiliates will be received; Name/address/contact information of applicant/holder/owner, Name/address/contact information of representative/U.S. Yes. Section 740 of the FD&C Act (21 U.S.C. L. 112-144, Title III, FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act, GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99KB), Generic Drug User Fee Rates for Fiscal Year 2021, Generic Drug User Fee Rates for Fiscal Year 2020, Generic Drug User Fee Rates for Fiscal Year 2019, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Revised Draft Guidance for Industry, Information Requests and Discipline Review Letters Under GDUFA, ANDA Submissions - Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, Self-Identification of Generic Drug Facilities, Sites, and Organizations, Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments, Type II Drug Master Files – Available for Reference List, Abbreviated New Drug Application (ANDA) Fees, GDUFA Program Fee Parent Company Details List, Generic Drug Applicant Program Fee Arrears List (PDF), Generic Drug Applicant Program Fee Arrears List (XLS), GDUFA Facilities with Outstanding Fees Not on the Arrears List (PDF), GDUFA Facilities with Outstanding Fees Not on the Arrears List (XLS), Type II Drug Master Files - Available for Reference List, Pay.gov is a web-based payment application that allows electronic payments to be made directly from your bank account. Attention: Government Lockbox 979108 1005 Convention Plaza Payment must be made payable to the Food and Drug Administration and make reference to the User Fee Payment I.D. Upon submission, a User Fee Payment I.D. St. Louis, MO 63101, Note: This address is for courier delivery only. Please inquire about the wire transfer fee and include the additional amount with your user fee payment to ensure that your user fee is fully paid and to avoid making additional payments. Is a facility that manufactures an API excipient mixture or a mixture of two or more APIs used to produce FDFs required to pay an annual FDF facility fee? Reflecting this commitment, the 2017 Budget Implementation Act replaced the User Fees Act with the Service Fees Act. The Pay.gov feature is available on the FDA website after completing the OTC Monograph User Fee Cover Sheet and generating the user fee ID number. BACK. Create a cover sheet by answering a series of questions and making appropriate selections. In most cases the critical question is whether there is a generic drug submission approved on the due date in which the facility is referenced. No. Read the instructions below and then go to Create GDUFA Cover Sheet to fill out the form. If you have questions or documentation for the Generic Drug User Fee staff regarding GDUFA Fee requirements, please send them by electronic mail to. An official website of the United States government, : The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012, or when the DMF holder requests the initial completeness assessment, whichever occurs earlier. FDA’s user fee programs are “pay-for-performance” programs. If you encounter any discrepancies in your portfolio, please update your portfolio in the portal and submit as appropriate. This information is required, and FDA cannot process a refund without it. If you already have an account, enter your Username and Password.. The API information fee must be paid for each description of the manufacture of an API by a particular API facility, provided a DMF or API information fee has not already been paid for the manufacture of the same API by the same facility. Please follow the instructions below for your selected payment option: Payments by mail: The site is secure. To request a refund, fill out Form 3913 and email the form to CDERCollections@fda.hhs.gov. The application or supplement to an application will be deemed incomplete on the date of submission and will not be received. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. On August 18, 2017, the President signed the bill reauthorizing GDUFA through September 30, 2022. Generally, manufacturers of API mixtures are required to pay the annual FDF facility fee. Other sites and organizations must self-identify, but are not required to pay the annual facility user fee. A payment may be submitted by Pay.gov (electronic payment), check, bank draft, U.S. postal money order, or wire transfer. They are only required to self-identify. The payment and a copy of your signed cover sheet must be mailed to one of the addresses shown below: Starting in fiscal year (FY) 2021, FDA will no longer permit the transferring of GDUFA fee payments from a closed-out fiscal year (FY) cover sheet to a different FY cover sheet. US Department of Treasury TREAS NYC 33 Liberty Street New York, NY 10045, US Department of Treasury routing/transit number: 021030004, Beneficiary: Silver Spring, MD 20993-0002. Submission of a dispute of an RTR determination without attempting to remedy the deficiencies (i.e., without resubmitting the ANDA) is not considered a resubmission and is therefore not subject to a new ANDA filing fee. Foreign firms who cannot pay for the device establishment registration fee by credit card, electronic check or a check drawn on a US bank must pay by wire transfer to receive their Payment Confirmation Number (PCN). (total remains 6 ANDAs). On December 29, 2020, the FDA published a long-awaited Federal Register notice announcing the fee rates under the OTC Monograph user fee program for fiscal year 2021. Is a facility owner required to pay a GDUFA fee if the facility is referenced in an approved generic drug submission, but is only manufacturing drugs for the non-US market? Due to processing times, you might encounter data discrepancies that might have an impact on your portfolio. Yes, discontinued ANDAs are still considered approved ANDAs for user fee purposes unless these ANDAs are officially withdrawn. U.S. Department of Treasury | TREAS NYC, Bank Address: 33 Liberty Street | New York, NY 10045, Beneficiary: FDA | 8455 Colesville Road, COLE-14-14253| Silver Spring, MD 20993-0002, Description: Reference the User Fee Payment I.D. P.O. The applicable fee corresponds with the date the FDA received the submission. FDA states … See Section VIII.F. A single payment for multiple submissions of the same ANDA is required. For example, if a company with 5 approved ANDAs is determined to be affiliated with another company with 1 approved ANDA, and the date of affiliation is prior to October 1, 2019, then the company’s tier would be medium tier for FY 2020. The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. For application submissions, it is recommended that you send manual payments to the bank 4-5 business days before the application submission arrives at FDA so that there is no delay in starting the review of your application submission. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. St. Louis, MO 63101. Yes. The site is secure. No. If considered an API/FDF manufacturer or a CMO, a facility owner is required to pay an annual facility fee. Beginning in FY 2021, payment transfer requests for cover sheets from a closed-out FY will not be processed. For example, if a company has 6 approved ANDAs and a withdrawal request is submitted for one ANDA before or on April 1, 2020, then the company’s program fee tier would change from medium tier to small tier for FY 2021. If the DMF fee is not paid within 20 calendar days after notification, the ANDA referencing the DMF will not be received. 379j-12(d))… If a generic drug submission includes API information other than by reference to a DMF, is the applicant required to pay an additional fee? If FDA refuses to receive an ANDA, is there any provision for a partial refund of the application fee? The FY2020 user fees apply to medical device submissions received by the FDA on or after October 1, 2019. If two companies are affiliated, does the parent company have to pay the program fee or can the affiliate pay the fee? 8455 Colesville Road, COLE-14-14253 It is only applicable to a PAS or an amendment that is adding API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA. What is the penalty for failure to pay a facility fee? In some circumstances, ANDA applicants choose to serially submit complete ANDAs in anticipation of a patent being listed for a reference listed drug (RLD) that is protected by new chemical entity (NCE) exclusivity and has no other patents listed. An additional API information fee must be paid for each description, contained in a particular application, of the manufacture of an API by one facility. Please note that you are responsible for paying all wire transfer fees. Before sharing sensitive information, make sure you're on a federal government site. Applicants who choose to serially submit complete ANDAs in anticipation of a patent being listed for a RLD that is protected by NCE exclusivity and has no other patents listed should refrain from remitting their application filing fee until such time as the applicant is instructed by OGD that it has a valid application. However, separate buildings within close proximity are considered to be at one geographic location or address if: 1.      the activities in them are closely related to the same business enterprise; 2.      they are under the supervision of the same local management; and, 3.      they are capable of being inspected by FDA during a single inspection. St. Louis, MO 63197-9000. To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov. (3) the facility will be placed on a publicly available arrears list if the fee is not fully paid within 20 days of the due date; and  Therefore, the total amount of the API information fees for a particular application is a function of the number of APIs referenced in the application and the number of facilities in which those APIs are manufactured. Here are the step by step instructions for FDA fee payment. Products misbranded because of failure to pay facility fees are subject to being denied entry into the United States. U.S.Bank Yes, companies are entitled to a 75% refund of the application fee if the application is withdrawn prior to being received. Packagers are considered to be manufacturers, regardless of whether that packaging is done pursuant to a contract or by the applicant itself. Food and Drug Administration These include facilities manufacturing API and/or FDF contained in human generic drugs. If a facility receives product prior to the point in the manufacturing process in which the drug is first packaged in a container/closure system specified in the “How Supplied” section of an approved ANDA and it packages that product into such a container/closure system for the first time, the facility is a packager for the purposes of GDUFA. On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. FDA Include the Tax ID number (required for all domestic companies) or DUNS number (required for all foreign companies), and the address where the refund should be sent. Whom does FDA consider as a packager for purposes of GDUFA? What are the fee facility fee types under GDUFA II? The chief topic of discussion, according to … Note: Financial institutions may charge a wire transfer fee. Some FDF facilities may be qualified as Contract Manufacturing Organizations (CMOs). Posted 21 August 2017 ... FDA's ability to collect set amounts of money that the biopharmaceutical and medical device industries will pay each of the next five years for consistent reviews of medical products based on timelines agreed to by industry and FDA. 1005 Convention Plaza Specifically, each person who owns a Type II API DMF (DMF holder) that is referenced on or after October 1, 2012, in a generic drug submission, by any initial letter of authorization, shall be subject to a DMF fee. An ANDA filing fee is incurred upon submission. Please note that consolidation of FEI numbers is not an appropriate mechanism to address a non-compliant facility. Each person who owns a facility that is identified in at least one generic drug submission that is approved to produce one or more FDFs incurs the FDF facility fee. Contact your financial institution and provide the following information: Bank Name | Telegraphic Name: Do DMF holders need to wait for a new ANDA applicant to request a letter of authorization before the DMF is assessed to be available for reference? Are the references to fees for each API facility in the above example different from the annual fee that each API facility must pay (discussed below)? When should the application filing fee for a serially submitted ANDA be paid? Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date. Please note: This is different than the address for payments of application and annual report fees and is to be used only for payment of annual establishment registration fees. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/ pay (Note: Only full payments are accepted. Each company and its affiliates will be assessed an annual program fee depending on the number of approved ANDAs in their portfolio. For example, if a facility receives bulk drugs and packages them into the containers in which they are marketed, that facility is a packager. Additionally, goal dates will not apply to applications that have already been received but list facilities for which facility fees are owed. Number (PIN), which begins with the letters “GD”, is generated. However, GDUFA provides one exception, for fee-paying purposes only, to the definition of in-process mixtures as FDF. GDUFA aims to put FDA’s generic drug program on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs. L. 115-52), authorize the collection of fees for biosimilar biological products. When is the deadline for making changes to the approved ANDA list? P.O. the facility is referenced in an approved generic drug submission; and, the facility is engaged in manufacturing or processing an API or FDF. A company can create a program fee cover sheet via the User Fee System and then pay via check, wire transfer, or pay.gov. The facility will cease to incur additional fees if it is no longer identified in any generic drug submission or has stopped manufacturing all APIs and FDFs (including both generic and non-generic APIs and FDFs) by the date that the fee is due. Under section 744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due when the sponsor submits an investigational new drug (IND) application that FDA determines is intended to support a biosimilar biological product application or within 5 calendar days a… These are the same criteria used to evaluate whether separate FDA Facility Establishment Identifiers (FEIs) are necessary for multiple facilities (see final guidance for industry Self-Identification of Generic Drug Facilities, Sites, and Organizations). Submissions will be for the upcoming Fiscal Years 2020-2022. The GDUFA Cover Sheet is required for each of the following human generic drug user fees: Note: A cover sheet in not required for all ANDA amendments and PAS. If an ANDA is withdrawn before the filing fee is paid, will the obligation to pay the fee remain? Number (PIN). You must include your PIN (Payment Identification Number) with your wire transfer. An annual CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA, where the facility is not identified in an approved ANDA held by the owner of that facility or its affiliates. FDA allows on-line payment by credit card and ACH (Automated Clearing House) electronic checks. Small: 5 or fewer approved ANDAs. The PIN must be referenced in your payment submission. Send. (2) Any ANDA submitted by the applicant or its affiliates will not be received. Agreed upon recommendations were sent to Congress, and Congress held hearings on GDUFA that included testimony from FDA, the generic drug industry, and other interested parties. The applicant owes and API information fee for the following: Fee = (additional API Delta + manufacture of API Gamma at Facility 2) x DMF fee Amount, = (1 API + 1 extra facility) x DMF Fee Amount. These include facilities that solely manufacture positron emission tomography (PET) drugs, facilities that are only referenced in applications submitted by State and/or Federal Government entities for drugs that are not distributed commercially, or sites and organizations that only perform testing, repackaging, or relabeling operations. Only DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. An applicant (XYZ Corp.) submits an ANDA that, rather than referencing a DMF, describes the manufacture of three APIs at one or more facilities. Device Registration and Listing, Recalls, Market Withdrawals and Safety Alerts, Important Reminders about Registration and Listing, FDA Onsite Registration and Listing Verifications, Frequently Asked Questions about the New Device Registration and Listing Requirements, Device Advice: Comprehensive Regulatory Assistance, Electronic Payments (such as credit cards or ACH electronic, Mailing in a Paper check drawn on a U.S. bank in U.S. currency, Check made payable to Food and Drug Administration (must be in U.S. dollars and drawn on a U.S. Bank), Write the FDA post office box number ( PO Box 70961) on the check, Write the Payment Identification Number (PIN) on your check, Include a copy of your order with your check. Note: A signed copy of a completed GDUFA Cover Sheet must be included in the following submissions to the FDA: ANDA (placed in the first volume with Form FDA 356h) and Type II API DMF submission. No. For example, if a company has 6 approved ANDAs and requests a consolidation of 2 ANDAs into 1, but the Office of Generic Drugs does not grant the consolidation request until after October 1, 2020, then the company’s tier would remain medium tier for FY 2021. Register your organization by providing information about your organization. Please note the following instructions: When your payment has been received and processed you will be notified by email. According to 21 U.S.C. Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. 2.1 General Contact Information For questions regarding your invoice payment or your account balance, contact Accounts Receivable by phone at 613-957-1052 or 1-800-815-0506; by fax at 613-957-3495; or by email at AR-CR@hc-sc.gc.ca . A drug master file fee shall be due on the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file or the date the drug master file holder requests the initial completeness assessment, whichever occurs earlier. 379j-12(a)). To determine the fee amount, there are three tiers of the program fee: Large: 20 or more approved ANDAs; For FY 2019 through FY 2022, an ANDA shall be deemed not to be approved if the applicant has submitted a request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year. Click here if you have paid the annual registration user fee and have your PIN & PCN. If a facility is identified in an approved generic drug submission on the due date, and that reference to the facility or the drug submission is later withdrawn, the fee will not be refunded. Both years’ fees would be due before Feb. 11 to avoid sanctions and interest. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Every ANDA specifies the forms in which the approved drug product may be distributed in the “How Supplied” section. For technical assistance with the User Fee System or GDUFA Cover Sheet, please contact the User Fee Helpdesk at 301-796-7200 or userfees@fda.gov.