[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64083-64085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5157]


2019 Public Meeting on Center for Drug Evaluation and Research 
Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant 
Program; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``2019 Public Meeting 
on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints 
Grant Program.'' The purpose of the public meeting is to help ensure 
that as standard core sets of clinical outcome assessments (COAs) are 
developed as part of the FDA pilot grant program, the identified 
concepts, COAs, and endpoints reflect what is most important to 
patients and relevant to regulatory and potentially other stakeholder 
decision making. To facilitate this, stakeholders including patients, 
care partners, FDA reviewers, drug developers, other government and 
academic researchers, health care providers, health technology 
assessors and health payers are encouraged to attend the meeting.

DATES: The public meeting will be held on December 5, 2019, from 8:30 
a.m. to 12 p.m. Submit either electronic or written comments on this 
public meeting by January 6, 2020. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
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.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before January 6, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of January 6, 2020. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

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

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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

    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-N-5157 for ``2019 Public Meeting on CDER Standard Core Sets: 
Clinical Outcome Assessments and Endpoints Grant Program.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
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/2015-23389.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.

FOR FURTHER INFORMATION CONTACT: Meena Savani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 240-
402-1348, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of our Patient Focused Drug Development efforts, FDA 
developed a pilot grant program to support the development of publicly 
available standard core set(s) of COAs and their related endpoints for 
specific disease indications. On September 11, 2019, the FDA made three 
awards under this grant program in the areas of: (1) Migraine, (2) 
acute pain in infants and young children, and (3) physical function 
across a range of chronic conditions.
    The purpose of this public meeting is to ensure that, as these 
standard core sets of clinical outcome assessments are developed, the 
identified concepts, COAs, and endpoints reflect what is most important 
and relevant to patients and support regulatory and potentially other 
stakeholder decision making.
    COAs are often endpoints in clinical trials used to support drug 
approval and labeling claims or other communications regarding clinical 
benefit. Clinical benefit is defined as a positive clinically 
meaningful effect of an intervention on how an individual feels, 
functions, or survives. FDA uses COAs primarily to determine whether a 
drug has been shown to provide clinical benefit to patients. Severity 
of side effects or treatment burden can also be measured by COAs.
    A standard core set of COAs can include different types of COAs 
such as patient-reported outcome (PRO), clinician-reported outcome 
(ClinRO), observer-reported outcome (ObsRO), and performance outcome 
(PerfO) instruments and their related endpoints. These sets should 
assess a minimum list of impacts that matter most to patients, are 
likely to demonstrate change (including differences in trial arms 
related to disease burden, treatment burden, and if applicable, 
physical function), and should be assessed during a clinical trial. A 
standard core set might be relevant across several disease populations 
or subgroups or be focused on attributes of a specific disease.

II. Topics for Discussion at the Public Meeting

    This meeting will provide an opportunity for grantees funded as 
part of the FDA Standard Core COAs and Endpoints Pilot Grant Program to 
share their development plans for the standard core COA sets and to 
receive feedback from stakeholders. FDA will provide an introduction 
and discuss plans for the pilot grant program including future public 
meetings.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
in person or via webcast must register online at https://standard_core_coa_grant_program.eventbrite.com by December 2, 2019, at 
11:59 p.m. Eastern Time. Registration is free and based on space 
availability, with priority given to early registrants. Early 
registration for in person attendance 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.
    If you need special accommodations due to a disability, please 
contact Meena Savani no later than November 29, 2019.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Webcast information will be provided upon completion 
of registration.
    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

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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 meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program.

    Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25160 Filed 11-19-19; 8:45 am]
 BILLING CODE 4164-01-P