21st Century Cures Act Deliverables
| Section | Section Title | Statutory Deliverable Type | Statutory Deadline | Responsible Org. | Date Completed | Public Website Notes | For Further Information |
|---|---|---|---|---|---|---|---|
| 1002 | FDA innovation projects | Plan | 6/11/2017 | OPLIA | 6/9/2017 | Submission to Congress: Food & Drug Administration Work Plan and Proposed Funding Allocations of FDA Innovation Account | |
| 1002 | FDA innovation projects | Report to Congress | 10/1/17 and each 10/1 through 2025 | OB | |||
| 2041 | Task Force on research specific to pregnant women and lactating women | Other | NIH | 9/2018 |
NIH held a two-day meeting of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) on 8/21-22/2017. |
||
| 2052 | Report on activities to encourage compliance | Report to Congress | 12/13/2018 | NIH | 12/13/2018 | gcpquestions@fda.hhs.gov | |
| 2052 | Reports on clinical trials | Report to Congress | 4/18/2019, 4/18/2021, 4/18/2023 |
NIH |
4/18/2019, |
gcpquestions@fda.hhs.gov | |
| 3001 | Patient experience data | Other | Approval of any application submitted after 6/12/2017 | CDER | 8/30/2017 | Incorporated into approval template | druginfo@fda.hhs.gov |
| 3002 | Patient-focused drug development guidance | Plan | 6/11/2017 | CDER | 6/7/2017 | Plan for Issuance of Patient-Focused Drug Development Guidance | druginfo@fda.hhs.gov |
| 3002 | Patient-focused drug development guidance | Draft Guidance | 6/13/2018 | CDER | 6/12/2018 | Patient-Focused Drug Development: Collecting Comprehensive and Representative Input - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders | druginfo@fda.hhs.gov |
| 3002 | Patient-focused drug development guidance | Final Guidance | 6/13/2020 | CDER | druginfo@fda.hhs.gov | ||
| 3004 | Report on patient experience drug development | Public Report | June 1, 2021, June1, 2026, June 1, 2031 |
CDER | druginfo@fda.hhs.gov | ||
| 3011 | Qualification of drug development tools | Plan | CDER | druginfo@fda.hhs.gov | |||
| 3011 | Qualification of drug development tools | Public Report | CDER | 11/13/2018 | Drug Development Tool (DDT) Qualification Programs | druginfo@fda.hhs.gov | |
| 3011 | Qualification of drug development tools | Draft Guidance | 12/13/2019 | CDER | druginfo@fda.hhs.gov | ||
| 3011 | Qualification of drug development tools | Final Guidance | CDER | 11/13/2018 | druginfo@fda.hhs.gov | ||
| 3011 | Qualification of drug development tools | FR Notice | 12/13/2018 | CDER | 11/13/2018 | Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments | druginfo@fda.hhs.gov |
| 3011 | Qualification of drug development tools | FR Notice | CDER | druginfo@fda.hhs.gov | |||
| 3011 | Qualification of drug development tools | Public Meeting | 12/13/2018 | CDER | 12/11/2018 | Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments | druginfo@fda.hhs.gov |
| 3011 | Qualification of drug development tools | Public Report | 12/13/2021 | CDER | druginfo@fda.hhs.gov | ||
| 3014 | GAO study of priority review voucher programs | GAO Report | 1/31/2020 | GAO | 1/31/2020 | Drug Development: FDA’s Priority Review Voucher Programs | |
| 3016 | Grants for studying continuous manufacturing | Grants | FDA | Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01) | |||
| 3021 | Novel clinical trial designs | Public Meeting | 6/13/2018 | CDER | 3/20/2018 | FDA website, "Promoting the Use of Complex Innovative Designs in Clinical Trials" | druginfo@fda.hhs.gov |
| 3021 | Novel clinical trial designs | Draft Guidance | CDER | druginfo@fda.hhs.gov | |||
| 3021 | Novel clinical trial designs | Final Guidance | CDER | druginfo@fda.hhs.gov | |||
| 3022 | Real world evidence | Plan | 12/13/2018 | CDER | 12/6/2018 | Framework for a Real-World Evidence Program; Availability | druginfo@fda.hhs.gov |
| 3022 | Real world evidence | Framework | CDER | 12/6/2018 | Framework for FDA's Real-World Evidence Program | druginfo@fda.hhs.gov | |
| 3022 | Real world evidence | Draft Guidance | 12/13/2021 | CDER | 12/9/2021 | Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products, draft guidance for industry | druginfo@fda.hhs.gov |
| 3022 | Real world evidence | Revised Draft or Final Guidance | 9/8/2023 | CDER | 8/31/2023 | FDA issued final: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products, draft guidance for industry | druginfo@fda.hhs.gov |
| 3023 | Protection of human research subjects | Regulation or Guidance | 12/13/2019 | HHS | gcp.questions@fda.hhs.gov | ||
| 3023 | Protection of human research subjects | Report to Congress | 12/13/2018 | HHS | gcp.questions@fda.hhs.gov | ||
| 3024 | Informed consent waiver or alteration for clinical investigations | Other | OGCP | FDA issued related guidance on July 25, 2017 titled, "IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects." FDA issued a proposed rule on November 15, 2018 titled "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations." |
gcp.questions@fda.hhs.gpv | ||
| 3031 | Summary level review | Other | CDER | druginfo@fda.hhs.gov | |||
| 3034 | Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advance therapies | Draft Guidance | 12/13/2017 | CBER | 11/17/2017 | This draft guidance, and other guidance documents that are part of the comprehensive policy framework for the regulation of regenerative medicine products, can be accessed here. | ocod@fda.hhs.gov |
| 3034 | Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advance therapies | Final Guidance | 2/15/2019 | CBER | 2/15/2019 | FDA issued a final guidance in February 2019: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies | ocod@fda.hhs.gov |
| 3035 | Report on regenerative advanced therapies | Report to Congress | 2/28/18 (and before March 1 of each calendar year thereafter) |
CBER | 8/16/2019 | ocod@fda.hhs.gov | |
| 3036 | Standards for regenerative medicine and regenerative advanced therapies | Plan | 12/13/2018 | CBER | September 2017 | Contract to Standards Coordination Body to facilitate the development of regenerative medicine standards awarded Sept. 2017 NOTES: -FDA firewall prevents display of the Feb 2018 “Regenerative Medicine Standards Landscape” report posted on the Standards Coordinating Body website (found on Standards Coordinating Body, Current Projects) |
ocod@fda.hhs.gov |
| 3036 | Standards for regenerative medicine and regenerative advanced therapies | Other | CBER | ocod@fda.hhs.gov | |||
| 3038 | Combination product innovation | Final Guidance | 12/13/2020 | OCP | Combination@fda.hhs.gov | ||
| 3038 | Combination product innovation | List | 6/13/2018 | OCP | 6/13/2018 | Federal Register notice | Combination@fda.hhs.gov |
| 3038 | Combination product innovation | List | OCP | Combination@fda.hhs.gov | |||
| 3042 | Limited population pathway | Draft Guidance | 6/13/2018 | CDER | 6/13/2018 | Limited Population Pathway for Antibacterial and Antifungal Drugs - Guidance for Industry | druginfo@fda.hhs.gov |
| 3042 | Limited population pathway | Final Guidance | CDER | druginfo@fda.hhs.gov | |||
| 3042 | Limited population pathway | Report to Congress | 12/13/2018 (and biennially thereafter) | CDER | druginfo@fda.hhs.gov | ||
| 3042 | Limited population pathway | GAO Report | 12/31/2021 | GAO | druginfo@fda.hhs.gov | ||
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | Website | 12/13/2017 | CDER | 12/13/2017 |
FDA website, "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria" |
druginfo@fda.hhs.gov |
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | FR Notice | CDER | 12/13/2017 | Federal Register notice | druginfo@fda.hhs.gov | |
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | Other | CDER | druginfo@fda.hhs.gov | |||
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | FR Notice | CDER | druginfo@fda.hhs.gov | |||
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | Website | CDER | ||||
| 3044 | Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices | Report to Congress | 12/13/2018 | CDER | druginfo@fda.hhs.gov | ||
| 3051 | Breakthrough devices | Draft Guidance | 12/13/2017 | CDRH | 10/25/2017 | Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff | DICE@fda.hhs.gov |
| 3051 | Breakthrough devices | Report to Congress | 1/1/2019 | CDRH | 2/11/2019 | Report to Congress: Breakthrough Devices Program | DICE@fda.hhs.gov |
| 3052 | Humanitarian device exemption | Draft Guidance | 6/13/2018 | CDRH | 6/13/2018 | Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff | DICE@fda.hhs.gov |
| 3053 | Recognition of standards | Training | CDRH | 9/22/2017 |
Provided training to FDA employees who review premarket submissions for devices on use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement. |
DICE@fda.hhs.gov | |
| 3053 | Recognition of standards | Other | CDRH | DICE@fda.hhs.gov | |||
| 3054 | Certain class I and class II devices | FR Notice | 4/12/2017 | CDRH | 4/12/2017 | Federal Register notice | DICE@fda.hhs.gov |
| 3054 | Certain class I and class II devices | FR Notice | 3/13/2017 | CDRH | 3/13/2017 | Federal Register notice | DICE@fda.hhs.gov |
| 3054 | Certain class I and class II devices | FR Notice | 7/11/2017 | CDRH | 7/11/2017 | Federal Register notice | DICE@fda.hhs.gov |
| 3055 | Classification panels | FR Notice | 12/13/2017 | CDRH | 6/23/2017 | Federal Register notice | DICE@fda.hhs.gov |
| 3056 | Institutional review board flexibility | Immediately | CDRH | 12/13/2016 | DICE@fda.hhs.gov | ||
| 3057 | CLIA waiver improvements | Draft Guidance | 12/13/2017 | CDRH | 11/29/2017 | Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Wavier Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff | DICE@fda.hhs.gov |
| 3057 | CLIA waiver improvements | Final Guidance | CDRH | 2/26/2020 | Final guidance: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices | DICE@fda.hhs.gov | |
| 3058 | Least burdensome device review | Training | CDRH | 3/1/2018 | DICE@fda.hhs.gov | ||
| 3058 | Least burdensome device review | Self-assessment | CDRH | DICE@fda.hhs.gov | |||
| 3058 | Least burdensome device review | Other | 6/13/2018 | CDRH, CBER | 6/13/2018 | FDA Report to Congress: Least Burdensome Training Audit | DICE@fda.hhs.gov |
| 3058 | Least burdensome device review | Report to Congress and Public Report | 7/13/2018 | CDRH, CBER | 6/13/2018 | FDA Report to Congress: Least Burdensome Training Audit | DICE@fda.hhs.gov |
| 3059 | Cleaning instructions and validation data requirement | FR Notice | 6/11/2017 | CDRH | 6/9/2017 | Federal Register notice | DICE@fda.hhs.gov |
| 3059 | Cleaning instructions and validation data requirement | Final Guidance | 11/7/2017 | CDRH | 10/25/2017 | Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff | DICE@fda.hhs.gov |
| 3059 | Clarifying medical software regulation | No Type | CDRH | 9/27/2019 | Guidance document was issued to explain changes to Existing medical software policies: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act | ||
| 3060 | Clarifying medical software regulation | Public Report | 12/13/2018 (and biennially thereafter) | CDRH | 12/2018 | Report on Non-Device Software Functions: Impact to Health and Best Practices - December 2018 | DICE@fda.hhs.gov |
| 3060 | Clarifying medical software regulation | Final Guidance | Immediately | CDRH | 12/30/2016 | FDA communicated its interpretation of this policy through final guidance titled "Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types" | DICE@fda.hhs.gov |
| 3071 | Silvio E. Conte Senior Biomedical Research and Biomedical Product Assessment Service | GAO Report | 12/13/2020 | GAO | |||
| 3072 | Hiring authority for scientific, technical and professional personnel | Report to Congress | 6/13/2018 | OO/OHR | 6/2018 | FDA 21st Century Cures Workforce Planning Report to Congress | |
| 3072 | Hiring authority for scientific, technical and professional personnel | GAO Report | 1/1/2022 | GAO | |||
| 3073 | Establishment of Food and Drug Administration Intercenter Institutes | Other | 12/13/2017 | OCPP | 1/19/2017 | FDA website: "Oncology Center of Excellence" | OMPTFeedback@fda.hhs.gov |
| 3074 | Scientific engagement | Public Report | 12/29/2017 (and annually thereafter, not later than 90 days after the end of the FY) | FDA | 12/30/2019 | 2017 Annual Reports on Conferences 2018 Annual Reports on Conferences 2019 Annual Reports on Conferences |
|
| 3075 | Drug surveillance | Guidelines for Best Practices | CDER | Postmarket Drug and Biologic Safety Evaluations | druginfo@fda.hhs.gov | ||
| 3084 | Medical countermeasures innovation | Report to Congress | 12/13/2020 | GAO | |||
| 3086 | Encouraging treatments for agents that present a national security threat | Priority Review | 10/1/2017 | OCET | 10/19/2018 |
FDA Website: "21st Century Cures Act: MCM-Related Cures Provisions" |
AskMCMi@fda.hhs.gov |
| 3086 | Encouraging treatments for agents that present a national security threat | User Fee | OCET | 1/19/2018 | FDA issued related draft guidance on January 17, 2018 titled, "Material Threat Medical Countermeasure Priority Review Vouchers." First Medical Countermeasure Priority Review Voucher issued July 13, 2018. | AskMCMi@fda.hhs.gov |
Key to Abbreviations in Chart
OPLIA – Office of Policy, Legislation, and International Affairs (FDA)
OB – Office of Budget (FDA)
NIH – National Institutes of Health
CDER – Center for Drug Evaluation and Research (FDA)
GAO – Government Accountability Office
FDA – U.S. Food and Drug Administration
HHS – U.S. Department of Health and Human Services
OGCP – Office of Good Clinical Practice (FDA)
CBER – Center for Biologics Evaluation and Research (FDA)
OCP – Office of Combination Products (FDA)
CDRH – Center for Devices and Radiological Health (FDA)
OO/OHR – Office of Operations, Office of Human Resources (FDA)
OCPP – Office of Clinical Policy and Programs (FDA)
OCET – Office of Counterterrorism and Emerging Threats (FDA)