fda ind application fee waiverfda ind application fee waiver

(4) FDA will withdraw authorization to charge if it determines that charging is interfering with the development of a drug for marketing approval or that the criteria for the authorization are no longer being met. The projected 60 FTE delta for CBER was also assessed in the context of other operational and financial factors that may impact the need and/or feasibility of obtaining the additional resources. If required under 312.55, a copy of the investigator's brochure, containing the following information: (i) A brief description of the drug substance and the formulation, including the structural formula, if known. (i) A person may ship a drug intended solely for tests in vitro or in animals used only for laboratory research purposes if it is labeled as follows: CAUTION: Contains a new drug for investigational use only in laboratory research animals, or for tests in vitro. (3) Clinical hold of an expanded access IND or expanded access protocol. If a check, bank draft, or money order is to be sent by a courier that requests a street address, the courier should deliver your payment to: U.S. Bank, Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (a) General. If you have any questions concerning courier delivery, contact the U.S. Bank at 314-418-4013. There are no fees for filing an IND. (i) Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter. 312.30 - Protocol amendments. After assessing current hiring capacity and existing funded vacancies, CDER adjusted the 175 FTE delta to 78 FTEs. The CDER and CBER CPA amounts were then added together to determine the PDUFA CPA for FY 2022 of $26,503,399, as outlined in table 10. (v) The investigation is conducted in compliance with the requirements of 312.7. Modifications of the experimental design of Phase 1 studies that do not affect critical safety assessments are required to be reported to FDA only in the annual report. hb```_\B ce`a0A The drug is not being developed, for example, because the disease or condition is so rare that the sponsor is unable to recruit patients for a clinical trial. (c) Phase 3. (viii) The Commissioner determines that it would not be in the public interest for the study to be conducted or continued. The forecasted CBER PDUFA workload for FY 2022 was then converted into expected FTE resources and compared to current onboard capacity for PDUFA direct review work, as summarized in table 8. FDA ordinarily intends that clinical holds under paragraphs (b)(4)(ii), (b)(4)(iii) and (b)(4)(v) of this section would only apply to additional enrollment in nonconcurrently controlled trials rather than eliminating continued access to individuals already receiving the investigational drug. The scheduling of an end-of-Phase 2 meeting is not, however, intended to delay the transition of an investigation from Phase 2 to Phase 3. the official SGML-based PDF version on govinfo.gov, those relying on it for Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act. (i) A clinical investigation involving an in vitro diagnostic biological product listed in paragraph (b)(2)(ii) of this section is exempt from the requirements of this part if (a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b) it is shipped in compliance with 312.160. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study. CDER has been performing its mission with a staffing level less than that required of its increasing submission workload. The sponsor ordinarily is not required to resubmit information previously submitted, but may incorporate the information by reference. Note that under PDUFA VI, this amount includes both user fee funds available for obligation $126,873,636 and funds that are considered unavailable due to a lack of appropriations $98,850,995.[4]. These can be useful 28, 2016; 84 FR 6673, Feb. 28, 2019]. ). Records and reports of data and shipments under paragraph (a)(1)(ii) of this section are to be maintained in accordance with 312.57(b). Upon receipt of such notification, the sponsor shall have 30 days to respond as to why the IND should continue to remain active. Prescription Drug User Fee Amendments | FDA PDUFA VI provides for an operating reserve adjustment to allow FDA to increase the fee revenue and fees for any given fiscal year during PDUFA VI to maintain up to 14 weeks of operating reserve of carryover user fees. For complete information about, and access to, our official publications 4, 2002; 74 FR 40899, Aug. 13, 2009]. (1) A sponsor must meet the applicable requirements in paragraph (b) of this section for charging in a clinical trial or paragraph (c) of this section for charging for expanded access to an investigational drug for treatment use under subpart I of this part, except that sponsors need not fulfill the requirements in this section to charge for an approved drug obtained from another entity not affiliated with the sponsor for use as part of the clinical trial evaluation (e.g., in a clinical trial of a new use of the approved drug, for use of the approved drug as an active control). The documents posted on this site are XML renditions of published Federal 312.50 - General responsibilities of sponsors. endstream endobj 460 0 obj <. 312.32 - IND safety reporting. 466 0 obj <>/Filter/FlateDecode/ID[<6AA5AB15C132E34D88F8E2869F3296DA>]/Index[459 22]/Info 458 0 R/Length 55/Prev 107222/Root 460 0 R/Size 481/Type/XRef/W[1 2 1]>>stream 19, 1987, as amended at 64 FR 401, Jan. 5, 1999; 64 FR 56449, Oct. 20, 1999; 73 FR 22815, Apr. Disposition of unused supply of investigational drug. (2) The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, gender, and race; the number whose participation in the study was completed as planned; and the number who dropped out of the study for any reason. 26, 2009; 74 FR 55771, Oct. 29, 2009; 75 FR 37295, June 29, 2010; 80 FR 18091, Apr. An application that is withdrawn before filing, or refused for filing, counts as one-fourth of an FAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant initially paid one-half of the full application fee amount. (ii) The pertinent criteria in 50.24 of this chapter for such an investigation to begin or continue are not submitted or not satisfied. Direct costs include costs per unit to manufacture the drug (e.g., raw materials, labor, and nonreusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized) or costs to acquire the drug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug. The site is secure. If necessary, sponsors may request a meeting with the appropriate reviewing officials and management representatives in order to seek a resolution. (iv) A brief description of the overall plan for investigating the drug product for the following year. Because the estimated end of year FY 2021 PDUFA operating reserve does not exceed the 14-week operating reserve for FY 2022, FDA will not reduce the FY 2022 PDUFA fee revenue in FY 2022. 19, 1987, as amended at 72 FR 73599, Dec. 28, 2007]. GCP does not require informed consent in life-threatening situations when the IEC reviewing the study finds, before initiation of the study, that informed consent is not feasible and either that the conditions present are consistent with those described in 50.23 or 50.24(a) of this chapter, or that the measures described in the study protocol or elsewhere will protect the rights, safety, and well-being of subjects; and. A summary of previous human experience known to the applicant, if any, with the investigational drug. 1061, Rockville, MD 20852, copies of the information that was disclosed, identified by the IND number. If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 FR 32479, June 16, 1997]. Electronic Code of Federal Regulations (eCFR). (a) Promotion of an investigational new drug. It was viewed 71 times while on Public Inspection. Information about this document as published in the Federal Register. Background and more details are available in the 312.48 - Dispute resolution. Whenever a sponsor intends to conduct a clinical investigation with an exception from informed consent for emergency research as set forth in 50.24 of this chapter, the sponsor shall submit a separate IND for such investigation. The expanded access submission must include information adequate to demonstrate that the criteria in 312.305(a) and paragraph (a) of this section have been met. If the person signing the application does not reside or have a place of business within the United States, the IND is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States. This document provides fee rates for FY 2022 for an application requiring clinical data ($3,117,218), for an application not requiring clinical data ($1,558,609), and for the prescription drug program fee ($369,413). Not for use in humans. The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under part 54 of this chapter. [52 FR 8831, Mar. (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under 50.24 of this chapter. FDA may notify a sponsor of its determination regarding the clinical hold by telephone or other means of rapid communication. Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. (b) The sponsor also shall monitor such investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in 50.24(a) of this chapter or because of other relevant ethical concerns. (3) the consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of the investigational drug, and the IND identifies the consignee and describes what, if any, actions the consignee will take with respect to the investigational drug. Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the fiscal year. page 1 of 5. psc publishing services (301) 443-6740. ef. If you have questions for the Agency that issued the current document please contact the agency directly. 312.56 - Review of ongoing investigations. The sponsor must also submit safety information from the clinical study as prescribed by the postmarketing safety reporting requirements (e.g., 310.305, 314.80, and 600.80 of this chapter). If all obligations governing the conduct of the study have been transferred, a general statement of this transferin lieu of a listing of the specific obligations transferredmay be submitted. 52 FR 8831, Mar. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. In general, protocols for Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies. The 3-year average is 2.7383 percent. (iii) For each nonclinical laboratory study subject to the good laboratory practice regulations under part 58, a statement that the study was conducted in compliance with the good laboratory practice regulations in part 58, or, if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. (viii) A list of the names of the subinvestigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s). (a) FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety. The statute specifies that this 1.4041 percent be multiplied by the proportion of all costs other than PC&B to total costs of the process for the review of human drug applications obligated. 19, 1987, unless otherwise noted. A copy of all labels and labeling to be provided to each investigator. Both the sponsor and FDA may bring consultants to the meeting. (a) A sponsor may request FDA to waive applicable requirement under this part. (iv) Any other information for discussion at the meeting. A sponsor shall also maintain complete and accurate records concerning all other financial interests of investigators subject to part 54 of this chapter. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor. Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 4, 2002]. First published: 31/03/2023 Fees for human pharmacovigilance Pharmacovigilance activities conducted at EU level for human medicines are financed by fees paid by marketing-authorisation holders. hb```j) ,@q1DFnSro4g``\Lpb@dX*AD3tPGVsv10TiV !& `I*q Uk4-X)m M c,8 19, 1987, as amended at 52 FR 23031, June 17, 1987; 63 FR 5252, Feb. 2, 1998; 67 FR 9586, Mar. For questions regarding PDUFA fees, drug development, or any FDA related question, please contactVern Norviel,David Hoffmeister,Georgia Ravitz,James Ravitz, or any member of WSGRs Patents and Innovation Strategies or FDA Regulatory, Healthcare and Consumer Products Compliance practices. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999]. In other cases FDA staff may request that the sponsor submit a summary of their proposed investigation in writing for FDA review before providing advice. The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. (9) Previous human experience with the investigational drug. Because of the geographical revision made by the Bureau of Labor and Statistics, the Washington-Arlington-Alexandria index will be used in calculating the direct cost adjustment inflation factor for FY 2021 and subsequent years. Disqualification of a clinical investigator. PDF How to put together an IND application (ii) A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans. The .gov means its official.Federal government websites often end in .gov or .mil. Any obligation not covered by the written description shall be deemed not to have been transferred. An IND so terminated is subject to reinstatement by the Director on the basis of additional submissions that eliminate such danger. (1) If the drug is the subject of an existing IND, the expanded access submission may be made by the sponsor or by a licensed physician. (1) The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; (2) The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and. If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding. Acting Principal Associate Commissioner for Policy. For example, patients may not be able to participate in the trial because they have a different disease or stage of disease than the one being studied or otherwise do not meet the enrollment criteria, because enrollment in the trial is closed, or because the trial site is not geographically accessible. PDUFA fees are significant. formatting. Instructions for Filling Out Form Fda3971 - Small Business Waiver and For example, the PDUFA fee for an NDA requiring clinical data will be$2,942,965 in 2020. (iii) The addition of a new test or procedure that is intended to improve monitoring for, or reduce the risk of, a side effect or adverse event; or the dropping of a test intended to monitor safety. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. 29, 1990]. instructions for filling out form fda3971 - small business The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. The sponsor or applicant must maintain records supporting such statement, including records of the names and qualifications of IEC members, and make these records available for agency review upon request; (7) A summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion; (8) A description of how informed consent was obtained; (9) A description of what incentives, if any, were provided to subjects to participate in the study; (10) A description of how the sponsor(s) monitored the study and ensured that the study was carried out consistently with the study protocol; and. After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. (b) For each toxicology study that is intended primarily to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review. For applications that are submitted on or after October 1, 2021, the new fee schedule must be used. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis). 312.41 - Comment and advice on an IND. 4, 2002]. Forecast workload volumes: Predictive models estimate the volume of workload for the upcoming fiscal year. 312.47 - Meetings. 262. Payment must be made in U.S. currency by electronic check, check, bank draft, wire transfer, or U.S. postal money order payable to the order of the Food and Drug Administration. A section describing the pharmacological effects and mechanism(s) of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known. This message was posted by a user wishing to remain anonymous None------------------------------------------- Hello, There are no fees associated with an IND. 1. The documentation must be accompanied by a statement that an independent certified public accountant has reviewed and approved the calculations. 1040 et seq., as amended (21 U.S.C. These safeguards further include the review of animal studies prior to initial human testing ( 312.23), and the monitoring of adverse drug experiences through the requirements of IND safety reports ( 312.32), safety update reports during agency review of a marketing application ( 314.50 of this chapter), and postmarketing adverse reaction reporting ( 314.80 of this chapter). If the carryover balance exceeds 14 weeks of operating reserves, FDA is required to decrease fees to provide for not more than 14 weeks of operating reserves of carryover user fees. (2) Relevant followup information to an IND safety report must be submitted as soon as the information is available and must be identified as such, i.e., Followup IND Safety Report.. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. (e) Disclaimer. 61077A, Beltsville, MD 20705-4304, 301-796-3997. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. result, it may not include the most recent changes applied to the CFR. Prior to PDUFA VI, the FAE amount also included supplements; supplements have been removed from the FAE calculation as the supplement fee has been discontinued in PDUFA VI. Register, and does not replace the official print version or the official #_!Cg`\ Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, User Fee Waivers, Reductions, and Refunds for Drug and Biological Products. A subject may be a healthy human or a patient with a disease. In all cases of expanded access, sponsors are responsible for submitting IND safety reports and annual reports (when the IND or protocol continues for 1 year or longer) to FDA as required by 312.32 and 312.33, ensuring that licensed physicians are qualified to administer the investigational drug for the expanded access use, providing licensed physicians with the information needed to minimize the risk and maximize the potential benefits of the investigational drug (the investigator's brochure must be provided if one exists for the drug), maintaining an effective IND for the expanded access use, and maintaining adequate drug disposition records and retaining records in a manner consistent with the requirements of 312.57. (iii) If the drug has been marketed outside the United States, a list of the countries in which the drug has been marketed and a list of the countries in which the drug has been withdrawn from marketing for reasons potentially related to safety or effectiveness. (b) Phase 2. 24, 2005, as amended at 74 FR 13113, Mar. contact the publishing agency. (b) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (3) If the sponsor responds but FDA does not accept the explanation or correction submitted, FDA shall inform the sponsor in writing of the reason for the nonacceptance and provide the sponsor with an opportunity for a regulatory hearing before FDA under part 16 on the question of whether the IND should be terminated. 312.70 - Disqualification of a clinical investigator. (viii) A description of clinical procedures, laboratory tests, or other monitoring necessary to evaluate the effects of the drug and minimize its risks. The drug is being studied in a clinical trial, but patients requesting the drug for expanded access use are unable to participate in the trial. Pressing enter in the search box (e) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to withdraw approval of the product in accordance with the applicable provisions of the relevant statutes. From the passage concerning PDUFA, user fees have played an important role in expediting the drug approval process. If the investigator's participation in the investigation is ended, the sponsor shall require that the investigator dispose of or return the investigational drug in accordance with the requirements of 312.59 and shall notify FDA. (1) Treatment is generally limited to a single course of therapy for a specified duration unless FDA expressly authorizes multiple courses or chronic therapy. Table 11 shows the calculation of the inflation and capacity planning adjusted amount for FY 2022. If you work for a Federal agency, use this drafting FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds, Special Purpose Acquisition Companies (SPACs), Committee on Foreign Investment in the U.S. (CFIUS), FDA Regulatory, Healthcare, and Consumer Products, Antitrust Compliance and Business Strategy, Third-Party Merger and Non-Merger Antitrust Representation, Foreign Ownership, Control, or Influence (FOCI), Artificial Intelligence and Machine Learning, payment online using an electronic check (ACH), 75 percent of the PDUFA fee must be refunded. 2017-05-11 18:38 FDA IND Investigational New Drug ApplicationIND FDA FDA IND FDA IND FDA IND IND FDA IND FDA IND The sponsor is responsible for monitoring the treatment protocol to ensure that licensed physicians comply with the protocol and the regulations applicable to investigators. (e) When submitted. The sponsor shall submit an original and two copies of all submissions to the IND file, including the original submission and all amendments and reports. All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. In addition, the capacity planning adjustment has now demonstrated a sustained gap in the number of CDER staff needed to deliver on the expected forecasted workload. (xi) The sponsor fails to delay a proposed investigation under the IND or to suspend an ongoing investigation that has been placed on clinical hold under 312.42(b)(4). (c) Safeguards. (i) A protocol change under paragraph (b)(1) of this section may be made provided two conditions are met: (a) The sponsor has submitted the change to FDA for its review; and. The primary purpose of this kind of exchange is to uncover any major unresolved problems, to identify those studies that the sponsor is relying on as adequate and well-controlled to establish the drug's effectiveness, to identify the status of ongoing or needed studies adequate to assess pediatric safety and effectiveness, to acquaint FDA reviewers with the general information to be submitted in the marketing application (including technical information), to discuss appropriate methods for statistical analysis of the data, and to discuss the best approach to the presentation and formatting of data in the marketing application. FDA regulations 21 CFR 312 (drugs) and 601 (biologics) contain procedures and requirements governing the use of investigational new drugs and biologics. No PDUFA Fee Payment upon NDA Resubmission. Investigational New Drug (IND) Application | FDA (1) Emergency expanded access use may be requested by telephone, facsimile, or other means of electronic communications. Amendments, reports, and other correspondence relating to matters covered by the IND should be sent to the appropriate center at the address indicated in this section and marked to the attention of the responsible division. 351, 352, 353, 355, 371; 42 U.S.C. The data are published by the Bureau of Labor Statistics and can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0. The FY 2022 CPA of $26,503,399 is then added on line 4, resulting in the inflation and capacity planning adjusted amount of $1,148,753,349 shown on line 5.Start Printed Page 45736, Table 11PDUFA Inflation and Capacity Planning Adjusted Amount for FY 2022, Summary Calculation. CFR - Code of Federal Regulations Title 21 - Food and Drug Administration Protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals. FDA may place an ongoing expanded access IND or expanded access protocol on clinical hold if it is determined that the pertinent criteria in subpart I of this part for permitting the expanded access are no longer satisfied.