[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51445-51446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1727]


Public Meeting on the Center for Drug Evaluation and Research 
Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant 
Program--Summer 2020; 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 virtual public meeting entitled ``Public 
Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and 
Endpoints Grant Program--Summer 2020.'' The purpose of the public 
meeting is to 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, as 
well as 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 Friday, August 28, 2020, from 
8:30 a.m. to 12:30 p.m. Eastern Time. Submit either electronic or 
written comments on this public meeting by Wednesday, October 28, 2020. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this public meeting via an 
online teleconferencing platform.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2020-N-1727. The docket will close on October 
28, 2020. Please note that late, untimely filed comments will not be 
considered. Electronic comments must be submitted on or before 
Wednesday, October 28, 2020. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of Wednesday, October 28, 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 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-2020-N-1727 for ``Public Meeting on CDER Standard Core Sets 
Clinical Outcome Assessments and Endpoints Grant Program--Summer 
2020.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Lyna Merzoug, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-6001, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of our Patient Focused Drug Development (PFDD) efforts, FDA 
developed a pilot grant program to support the development of publicly 
available standard core set(s) of COAs

[[Page 51446]]

and their related endpoints for specific disease indications. On 
September 11, 2019, 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. The 
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 progress on the standard core COA sets and to receive 
feedback from stakeholders.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
via webcast must register online at https://www.eventbrite.com/e/public-meeting-on-cder-standard-core-sets-clinical-outcome-assessments-registration-108754210772 by August 28, 2020, at 12 p.m. Eastern 
Daylight Time. Registration is free and based on availability, with 
priority given to early registrants. FDA may limit the number of 
participants from each organization. Registrants will receive 
confirmation when they have been accepted. Webcast information will be 
provided upon completion of registration. Closed captioning will be 
provided.
    Streaming webcast of the public meeting: This public meeting will 
be streamed via a webcast only. To register for the webcast, please 
visit https://www.eventbrite.com/e/public-meeting-on-cder-standard-core-sets-clinical-outcome-assessments-registration-108754210772. The 
webcast can be accessed via: http://fda.yorkcast.com/webcast/Play/50353b66f81e463ea7c0df6e31e225a11d. Click on the link and hit the 
``play'' button and it will start. The webcast link will be activated 
30 minutes prior to the start of the meeting.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible on the meeting 
website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program-0.

    Dated: August 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18238 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P