Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# 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,                         *Dianne.Paraoan@fda.hhs.gov.*

# 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                           ( print 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