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  1. 21st Century Cures Act

21st Century Cures Act Deliverables

Key to Abbreviations

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 Compliance activities reports Report to Congress 12/13/2018 NIH 12/13/2018   gcp.questions@fda.hhs.gov
2052 Compliance activities reports Report to Congress 4/18/2019,
4/18/2021,
4/18/2023
NIH     gcp.questions@fda.hhs.gov
2052 Compliance activities reports Report to Congress 4/18/2021,
4/18/2023
NIH     gcp.questions@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3002 Patient-focused drug development guidance Draft  Guidance 6/13/2018 CDER  6/12/2018 Patient-Focused Drug Development:  Collecting Comprehensive and Representative Input - Guidance for Industry, Food and Drug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3011 Qualification of drug development tools Draft Guidance 12/13/2019 CDER     druginfo@fda.hhs.gov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     druginfo@fda.hhs.gov
3022 Real world evidence Revised Draft or Final Guidance   CDER     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   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     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

Federal Register Notice

 

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)

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