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Sec. 2052. Compliance activities reports.
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12/13/2018: requires issuance of a Report On Activities To Encourage Compliance describing education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, issuance of a Report on Clinical Trials
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FasterCures will periodically assess this item as appropriate.
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20161213 12/13/2016
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Clinical Trials,
FDA,
NIH,
Reports,
Research
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Sec. 2053. Updates to policies to improve data.
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Updates policies to ensure reporting of data from valid analyses for certain clinical trials. Revised policies go into effect for all grant awards received 1 year after enactment.
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11/28/2017: a Guide Notice (NOT-OD-18-014) was released notifying the research community that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analysis are submitted to Clinicaltrials.gov.
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20171128 11/28/2017
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Clinical Trials,
Data Sharing,
NIH,
Research
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Sec. 2054. Consultation.
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3/13/2017 (90 days): requires HHS to consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.
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6/1/2017: NLM rolled out the first in a series of changes to ClinicalTrials.gov
3/16/2017: in a letter responding to several organizations who expressed interest in ensuring the requirements of this provision be fulfilled, the Director of the NIH highlighted a new partnership between NIH and technical experts at 18F to make enhancements to ClinicalTrials.gov.
2/28/2017: the Secretary of HHS delegated the authority to fulfill the requirements of this Section to the NIH.
2/1/2017: a new beta version of ClinicalTrials.gov was released and is available here."
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20170601 06/01/2017
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Clinical Trials,
Data Sharing,
FDA,
NIH,
ONC,
Research
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Sec. 3023. Protection of human research subjects.
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12/13/2018: requires HHS to submit a report to Congress describing progress being made to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act.
12/13/2019: requires harmonization of these rules is to be completed.
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10/15/2018: FDA released a guidance document entitled "Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations," whose purpose is to clarify the impact and progress of certain provisions of the 2018 Common Rule requirements on FDA-regulated clinical investigations.
2/21/2018: FDA announced it is amending its regulations on acceptance of data from clinical investigations for medical devices. FDA recognized its 21st Century Cures obligation to harmonize the differences between the HHS human subject regulations and FDA's human subject regulations. FDA will be working with others at HHS in carrying out this statutory directive, including with respect to de-identified human specimens.
9/25/2017: FDA issued guidance entitled, "Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs" consistent with the goal of rule harmonization set forth in this section of 21st Century Cures. Further context for this guidance was laid out in the Federal Register Notice.
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20181020 10/20/2018
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Clinical Trials,
FDA,
Health Citizenship,
HHS,
NIH,
Research
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