Document ID: FDA-2018-D-2776-0001
Agency: fda
Document Type: Notice
Title: Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop
Report; Availability
Posted Date: 2018-08-23T04:00Z

[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42666-42667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18232]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2776]

Evaluating Inclusion and Exclusion Criteria in Clinical Trials; 
Workshop Report; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency is 
announcing the availability of a summary report of a public workshop 
that was held on April 16, 2018, entitled ``Evaluating Inclusion and 
Exclusion Criteria in Clinical Trials.'' The FDA Reauthorization Act of 
2017 (FDARA) requires that the Agency convene a public workshop to 
discuss clinical trial eligibility criteria to inform a guidance on 
this subject and to publish a report summarizing the topics discussed 
within 90 days of the public workshop. This summary report fulfills 
FDA's mandate under FDARA.

ADDRESSES: For persons without internet access, copies of the summary 
report can be requested from the Division of Drug Information, Food and 
Drug Administration, by mail: 10001 New Hampshire Ave, Silver Spring, 
MD 20993-0002, or toll free telephone: 855-543-3784.

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg 51, Rm. 3326, Silver Spring, MD 20993, 301-796-
2500, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 610 of FDARA requires that FDA convene a public workshop to 
discuss clinical trial eligibility criteria to inform a guidance on 
this subject and to publish a report summarizing the topics discussed 
within 90 days of the public workshop (Pub. L. 115-52). On April 16, 
2018, FDA convened the public workshop required by FDARA entitled 
``Evaluating Inclusion and Exclusion Criteria in Clinical Trials.'' 
This notice announces the availability of the report required by FDARA 
that summarizes the major points explored with stakeholders during the 
public workshop. The report is intended only as a summary of the 
workshop

[[Page 42667]]

discussions and does not provide guidance or reflect FDA's current 
thinking on this subject. The workshop report was posted on FDA's 
website on July 11, 2018.

II. Electronic Access

    Persons may obtain the summary report at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/ucm598050.htm.

    Dated: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18232 Filed 8-22-18; 8:45 am]
 BILLING CODE 4164-01-P