[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Pages 31071-31072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2452]


Endpoints for Drug Development in Heart Failure; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public workshop entitled ``Endpoints for Drug Development 
in Heart Failure.'' The purpose of this public meeting is to bring the 
stakeholder community together to discuss clinical endpoints for trials 
in heart failure that could be used to support FDA approval of drugs. 
The workshop will focus on endpoints related to symptoms and physical 
function. In addition, there will be discussion of the need to assess 
mortality effects of drugs under development for heart failure.

DATES: The public workshop will be held on Friday, July 26, 2019, from 
9 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), 
Silver Spring, MD 20993. Entrance for the public workshop participants 
(non-FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Meg Pease-Fye, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4115, Silver Spring, MD, 20993-0002, 301-
796-1130, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a public workshop regarding clinical endpoints 
for trials in heart failure that could be used to support FDA approval 
of drugs. FDA is convening this public workshop to discuss the Agency's 
current thinking with expert stakeholders and to consider public 
comments.

II. Topics for Discussion at the Public Workshop

    FDA is interested in soliciting feedback on a number of topics:
    1. Consider and discuss endpoints related to symptoms and physical 
function, e.g., patient-reported outcome instruments, exercise tests, 
data from electronic monitors;
    2. Consider the best ways to count multiple hospitalizations;
    3. Discuss when the nature and clinical importance of a treatment 
effect for a particular endpoint may justify deferral or omission of 
outcomes studies;
    4. In setting an upper bound for a mortality risk to be ruled out, 
discuss how the boundary may be influenced by a drug's demonstrated 
benefits and risks;
    5. Discuss the advantages and disadvantages of all-cause vs. 
cardiovascular-specific endpoints, e.g., hospitalizations and deaths;
    6. Discuss the advantages and disadvantages of adjudicating causes 
of deaths and hospitalizations.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website https://fdaheartfailureendpointsindrugdev.eventbrite.com. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability. Persons 
interested in attending this public workshop must register by July 24, 
2019, at 3 p.m., Eastern Time. Early registration is recommended 
because seating is limited; therefore, FDA may limit the number of 
participants from each organization. Registrants will receive 
confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public meeting/public workshop 
will be provided beginning at 8 a.m. We will let registrants know if 
registration closes before the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Meg Pease-Fye at 301-796-2240 no later than July 1, 2019.
    Requests for Oral Comment: On the day of the meeting, a signup 
sheet will be made available for those who wish to speak during the 
public comment session. We will do our best to accommodate requests to 
make public comments. Individuals and organizations with common 
interests are urged to consolidate or coordinate their

[[Page 31072]]

comments. On the day of the meeting, based on demand, we will determine 
the amount of time allotted to each presenter and the approximate time 
each comment is to begin. Please note this will be oral comment only; 
no slides or other presentation material is permitted. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast via https://collaboration.fda.gov/thf072519/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations .gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov.

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13799 Filed 6-27-19; 8:45 am]
 BILLING CODE 4164-01-P