Endpoints for Drug Development in Heart Failure; Public Workshop, 31071-31072 [2019-13799]

Download as PDF Federal Register / Vol. 84, No. 125 / Friday, June 28, 2019 / Notices American Pathologists; National Association of Medical Examiners; MD Anderson Cancer Center); • Kimberley Hanson, MD, MHS, FIDSA (Infectious Diseases Society of America); • Michele M. Schoonmaker, Ph.D. (Advanced Medical Technology Association); Terms have expired (or will expire during Calendar Year (CY) 2019) for the following CDLT Panel members (parenthetical denotes nomination source(s)): • Geoffrey Baird, M.D., Ph.D. (Seattle Children’s Hospital); • Raju Kucherlapati, Ph.D. (Coalition of 21st Century Medicine); • Bryan A. Loy, M.D., M.B.A. (Humana, Inc.); • Gail Marcus, Ph.D., M.B.A., M.S.E. (Self-Nomination); • Carl Morrison, M.D., D.V.M. (The United States Congress; Roswell Park Cancer Center); • Rebecca Sutphen, M.D. (SelfNomination; Informed Medical Decisions); III. Copies of the Charter The Secretary’s Charter for the Medicare Advisory Panel on CDLTs is available on the CMS website at https:// cms.gov/Regulations-and-Guidance/ Guidance/FACA/AdvisoryPanelon ClinicalDiagnosticLaboratoryTests.html. Also, copies of the charter can be obtained by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice. IV. Collection of Information Requirements khammond on DSKBBV9HB2PROD with NOTICES This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) is not required. Dated: June 11, 2019. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2019–13900 Filed 6–27–19; 8:45 am] BILLING CODE 4120–01–P VerDate Sep<11>2014 17:41 Jun 27, 2019 Jkt 247001 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. 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. SUMMARY: 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, Meg.PeaseFye@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: 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. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 31071 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://fdaheartfailureendpoints indrugdev.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 E:\FR\FM\28JNN1.SGM 28JNN1 31072 Federal Register / Vol. 84, No. 125 / Friday, June 28, 2019 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2019–D–2314] Treatment for Heart Failure: Endpoints for Drug Development; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Treatment for Heart Failure: Endpoints for Drug Development.’’ This draft guidance clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:41 Jun 27, 2019 Jkt 247001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Food and Drug Administration AGENCY: approving drugs to treat heart failure. It also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure. DATES: Submit either electronic or written comments on the draft guidance by August 27, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–2314 for ‘‘Treatment for Heart Failure: Endpoints for Drug Development.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

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