Regulatory Information

21st Century Cures Act Deliverables

Key to Abbreviations

SectionSection TitleStatutory Deliverable TypeStatutory DeadlineResponsible Org.Date CompletedPublic Website NotesFor Further Information
1002FDA innovation projectsPlan6/11/2017OPPLA 6/9/2017Submission to Congress: Food & Drug Administration Work Plan and Proposed Funding Allocations of FDA Innovation Account 
1002FDA innovation projectsReport to Congress10/1/17 and each 10/1 through 2025OB   
2052Compliance activities reportsReport to Congress12/13/2018NIH  gcp.questions@fda.hhs.gov
2052Compliance activities reportsReport to Congress4/18/2019,
4/18/2021,
4/18/2023
NIH  gcp.questions@fda.hhs.gov
2052Compliance activities reportsReport to Congress4/18/2021,
4/18/2023
NIH  gcp.questions@fda.hhs.gov
3001Patient experience dataOtherApproval of any application submitted after 6/12/2017CDER  druginfo@fda.hhs.gov
3002Patient-focused drug development guidancePlan6/11/2017CDER 6/7/2017Plan for Issuance of Patient-Focused Drug Development Guidancedruginfo@fda.hhs.gov
3002Patient-focused drug development guidanceDraft  Guidance6/13/2018CDER  druginfo@fda.hhs.gov
3002Patient-focused drug development guidanceFinal GuidanceJune 2020 CDER  druginfo@fda.hhs.gov
3004Report on patient experience drug developmentPublic ReportJune 1, 2021,
June1, 2026,
June 1, 2031
CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsPlan CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsPublic Report CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsDraft Guidance12/13/2019CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsFinal Guidance CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsFR Notice12/13/2018CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsFR Notice CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsPublic Meeting12/13/2018CDER  druginfo@fda.hhs.gov
3011Qualification of drug development toolsPublic Report12/13/2021CDER  druginfo@fda.hhs.gov
3014GAO study of priority review voucher programsGAO Report1/31/2020GAO   
3016Grants for studying continuous manufacturingGrants FDA   
3021Novel clinical trial designsPublic Meeting6/13/2018CDER  druginfo@fda.hhs.gov
3021Novel clinical trial designsDraft Guidance CDER  druginfo@fda.hhs.gov
3021Novel clinical trial designsFinal Guidance CDER  druginfo@fda.hhs.gov
3022Real world evidencePlan12/13/2018CDER  druginfo@fda.hhs.gov
3022Real world evidenceFramework CDER  druginfo@fda.hhs.gov 
3022Real world evidenceDraft Guidance CDER  druginfo@fda.hhs.gov
3022Real world evidenceRevised Draft or Final Guidance CDER  druginfo@fda.hhs.gov
3023Protection of human research subjectsRegulation or Guidance12/13/2019HHS  gcp.questions@fda.hhs.gov
3023Protection of human research subjectsReport to Congress12/13/2018HHS  gcp.questions@fda.hhs.gov
3024Informed consent waiver or alteration for clinical investigationsOther OGCP  gcp.questions@fda.hhs.gpv
3031Summary level reviewOther CDER  druginfo@fda.hhs.gov
3034Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advance therapiesDraft Guidance12/13/2017CBER  ocod@fda.hhs.gov 
3034Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advance therapiesFinal Guidance CBER  ocod@fda.hhs.gov
3035Report on regenerative advanced therapiesReport to Congress2/28/18
(and before March 1 of each calendar year thereafter)
CBER  ocod@fda.hhs.gov
3036Standards for regenerative medicine and regenerative advanced therapiesPlan12/13/2018CBER  ocod@fda.hhs.gov
3036Standards for regenerative medicine and regenerative advanced therapiesOther CBER  ocod@fda.hhs.gov
3038Combination product innovationFinal Guidance12/13/2020OCP  Combination@fda.hhs.gov
3038Combination product innovationList6/13/2018OCP  Combination@fda.hhs.gov
3038Combination product innovationList OCP  Combination@fda.hhs.gov
3042Limited population pathwayDraft Guidance6/13/2018CDER  druginfo@fda.hhs.gov
3042Limited population pathwayFinal Guidance CDER  druginfo@fda.hhs.gov
3042Limited population pathwayReport to Congress12/13/2018 (and biennially thereafter)CDER  druginfo@fda.hhs.gov
3042Limited population pathwayGAO Report12/31/2021GAO  druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesOther12/13/2017CDER  druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesFR Notice CDER  druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesOther CDER  druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesFR Notice CDER  druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesReport to Congress12/13/2018CDER  druginfo@fda.hhs.gov
3051Breakthrough devicesDraft Guidance12/13/2017CDRH  CDRH-Cures@fda.hhs.gov
3051Breakthrough devicesReport to Congress1/1/2019CDRH  CDRH-Cures@fda.hhs.gov
3052Humanitarian device exemptionDraft Guidance6/13/2018CDRH  CDRH-Cures@fda.hhs.gov
3053Recognition of standardsTraining CDRH  CDRH-Cures@fda.hhs.gov
3053Recognition of standardsOther CDRH  CDRH-Cures@fda.hhs.gov
3054Certain class I and class II devicesFR Notice4/12/2017CDRH4/12/2017Federal Register noticeCDRH-Cures@fda.hhs.gov
3054Certain class I and class II devicesFR Notice3/13/2017CDRH3/13/2017Federal Register noticeCDRH-Cures@fda.hhs.gov
3054Certain class I and class II devicesFR Notice7/11/2017CDRH 7/11/2017 Federal Register noticeCDRH-Cures@fda.hhs.gov
3055Classification panelsFR Notice12/13/2017CDRH 6/23/2017 Federal Register noticeCDRH-Cures@fda.hhs.gov
3056Institutional review board flexibility ImmediatelyCDRH12/13/2016 CDRH-Cures@fda.hhs.gov
3057CLIA waiver improvementsDraft Guidance12/13/2017CDRH  CDRH-Cures@fda.hhs.gov
3057CLIA waiver improvementsFinal Guidance CDRH  CDRH-Cures@fda.hhs.gov
3058Least burdensome device reviewTraining CDRH  CDRH-Cures@fda.hhs.gov
3058Least burdensome device reviewSelf-assessment CDRH  CDRH-Cures@fda.hhs.gov
3058Least burdensome device reviewOther6/13/2018CDRH, CBER  CDRH-Cures@fda.hhs.gov
3058Least burdensome device reviewReport to Congress and Public Report CDRH, CBER  CDRH-Cures@fda.hhs.gov
3059Cleaning instructions and validation data requirementFR Notice6/11/2017CDRH 6/9/2017 Federal Register noticeCDRH-Cures@fda.hhs.gov
3059Cleaning instructions and validation data requirementFinal Guidance11/7/2017CDRH  CDRH-Cures@fda.hhs.gov
3060Clarifying medical software regulationPublic Report12/13/2018 (and biennially thereafter)CDRH  CDRH-Cures@fda.hhs.gov
3060Clarifying medical software regulationFinal GuidanceImmediatelyCDRH12/30/2016FDA communicated its interpretation of this policy through final guidance titled "Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types"CDRH-Cures@fda.hhs.gov
3071Silvio E. Conte Senior Biomedical Research and Biomedical Product Assessment ServiceGAO Report12/13/2020GAO   
3072Hiring authority for scientific, technical and professional personnel.Report to Congress6/13/2018OO/OHR   
3072Hiring authority for scientific, technical and professional personnel.GAO Report1/1/2022GAO   
3073Establishment of Food and Drug Administration  Intercenter InstitutesOther12/13/2017OMPT  OMPTFeedback@fda.hhs.gov
3073Establishment of Food and Drug Administration  Intercenter InstitutesFR Notice OMPT  OMPTFeedback@fda.hhs.gov
3074Scientific engagementPublic Report12/29/2017 (and annually thereafter, not later than 90 days after the end of the FY)FDA   
3075Drug surveillanceGuidelines CDER  druinfo@fda.hhs.gov
3075Drug surveillanceBest Practices CDER  druinfo@fda.hhs.gov
3084Medical countermeasures innovationReport to Congress GAO   
3086Encouraging treatments for agents that present a national security threatProgram OCET  AskMCMi@fda.hhs.gov
3086Encouraging treatments for agents that present a national security threatOther OCET  AskMCMi@fda.hhs.gov

Key to Abbreviations in Chart

OPPLA – Office of Policy, Planning, and Legislation (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)
OMPT – Office of Medical Products and Tobacco (FDA)
OCET – Office of Counterterrorism and Emerging Threats (FDA)

Page Last Updated: 07/18/2017
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