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   
2041Task Force on research specific to pregnant women and lactating womenOther NIH 

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. 

 
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 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."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 11/17/2017This 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 
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)
CBER4/5/2018 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 12/13/2017

FDA website, "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria" 

druginfo@fda.hhs.gov
3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devicesFR Notice CDER 12/13/2017 Federal Register noticedruginfo@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 10/25/2017Breakthrough Devices Program - Draft Guidance for Industry and Food and Drug Administration Staffdisclaimer iconCDRH-Cures@fda.hhs.gov
3051Breakthrough devicesReport to Congress1/1/2019CDRH  CDRH-Cures@fda.hhs.gov
3052Humanitarian device exemptionDraft Guidance6/13/2018CDRH6/13/2018Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration StaffCDRH-Cures@fda.hhs.gov
3053Recognition of standardsTraining 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.

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 7/11/2017Federal Register noticeCDRH-Cures@fda.hhs.gov
3055Classification panelsFR Notice12/13/2017CDRH 6/23/2017Federal Register noticeCDRH-Cures@fda.hhs.gov
3056Institutional review board flexibility ImmediatelyCDRH12/13/2016 CDRH-Cures@fda.hhs.gov
3057CLIA waiver improvementsDraft Guidance12/13/2017CDRH11/29/2017Select 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 StaffCDRH-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 6/13/2018FDA Report to Congress:  Least Burdensome Training AuditCDRH-Cures@fda.hhs.gov
3058Least burdensome device reviewReport to Congress and Public Report CDRH, CBER 6/13/2018FDA Report to Congress:  Least Burdensome Training AuditCDRH-Cures@fda.hhs.gov
3059Cleaning instructions and validation data requirementFR Notice6/11/2017CDRH 6/9/2017Federal Register noticeCDRH-Cures@fda.hhs.gov
3059Cleaning instructions and validation data requirementFinal Guidance11/7/2017CDRH 10/25/2017Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration StaffCDRH-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 personnelReport to Congress6/13/2018OO/OHR   
3072Hiring authority for scientific, technical and professional personnelGAO Report1/1/2022GAO   
3073Establishment of Food and Drug Administration Intercenter InstitutesOther12/13/2017OMPT 1/19/2017FDA website:  "Oncology Center of Excellence"OMPTFeedback@fda.hhs.gov
3074Scientific engagementPublic Report12/29/2017 (and annually thereafter, not later than 90 days after the end of the FY)FDA 2017 Annual Reports on Conferences 
3075Drug surveillanceGuidelines for Best Practices CDER Postmarket Drug and Biologic Safety Evaluationsdruginfo@fda.hhs.gov
3084Medical countermeasures innovationReport to Congress GAO   
3086Encouraging treatments for agents that present a national security threatProgram OCET 

Federal Register Notice

 

FDA Website: "21st Century Cures Act: MCM-Related Cures Provisions"

AskMCMi@fda.hhs.gov
3086Encouraging treatments for agents that present a national security threatOther OCET FDA issued related draft guidance on January 17, 2018 titled, "Material Threat Medical Countermeasure Priority Review Vouchers."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: 06/13/2018
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