Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting, 4210-4211 [2018-01643]
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Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
• Progress toward Meeting Legislatively
Mandated Benchmark Requirements
• Update on Rigorous Evaluation
Activities
• Home Visiting Program Continuous
Quality Improvement (CQI) Efforts
• Administration of Home Visiting
Program
• Technical Assistance Needs
The proposed data collection form is
as follows:
ACF is requesting approval to renew
and update the existing Tribal Home
Visiting Guidance for Submitting an
Annual or Final Report to the Secretary
(OMB Control No. 0970–0409) that will
include instructions for grantees to
submit either an annual or final report
on the progress of their program to the
Secretary, depending on the reporting
period.
Respondents: Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program Managers (The information
collection does not include direct
interaction with individuals or families
that receive the services).
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
daltland on DSKBBV9HB2PROD with NOTICES
Annual/Final Report to the Secretary (depending on reporting period) ..................................................................
Estimated Total Annual Burden
Hours: 1,250.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office Planning, Research and
Evaluation, 370 L’Enfant Promenade
SW, Washington, DC 20447, Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of
theagency’s estimate of the burden of
the proposed collection of information;
(c) the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–01705 Filed 1–29–18; 8:45 am]
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18:18 Jan 29, 2018
Jkt 244001
Number of
responses
per
respondent
25
1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0129]
Evaluating Inclusion and Exclusion
Criteria in Clinical Trials; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting
entitled ‘‘Evaluating Inclusion and
Exclusion Criteria in Clinical Trials.’’
Convened by the Duke-Robert J.
Margolis, MD, Center for Health Policy
at Duke University and supported by a
cooperative agreement with FDA, the
purpose of the public meeting is to bring
the stakeholder community together to
discuss a variety of topics related to
eligibility criteria in clinical trials and
their potential impact on patient access
to investigational drugs, and how to
facilitate the enrollment of a diverse
patient population.
DATES: The public meeting will be held
on April 16, 2018, from 8:30 a.m. to 5
p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the National Press Club, 529
14th St. NW, Washington, DC 20045.
For additional travel and hotel
information, please refer to the
following website: https://
healthpolicy.duke.edu/events/
evaluating-inclusion-and-exclusioncriteria-clinical-trials. There will also be
a live webcast for those unable to attend
the meeting in person (see Streaming
Webcast of the Public Meeting).
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Average
burden hours
per response
Total
responses
1
Total annual
burden hours
50
1250
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
This public meeting implements
FDA’s mandate under section 610 of the
FDA Reauthorization Act of 2017 to
convene a public meeting to discuss
clinical trial inclusion and exclusion
criteria that will ultimately inform an
FDA guidance on this subject. Among
other things, the public meeting will
include discussion about various ways
in which participation in clinical trials
can be improved, including through
alternative trial designs and expanded
access trials (see Section II. Topics for
Discussion at the Public Meeting).
Inclusion of relevant subpopulations
in drug development programs helps
ensure that approved products will be
safe and effective for the population
likely to be treated when the drug is
marketed. However, certain eligibility
criteria in clinical trials can exclude
patient subgroups, resulting in the
enrollment of study populations that
may not be fully representative of that
broader patient population. FDA has
and will continue its efforts to
encourage greater diversity in clinical
trial populations. For example, FDA
regulations require marketing
applications to provide analyses of
safety and effectiveness by demographic
and other relevant subgroups (see 21
CFR 314.50(d)(5)(v)). In addition, in
2016, FDA published guidance on the
collection of race and ethnicity data in
clinical trials (available on FDA’s
guidance web page at https://
www.fda.gov/downloads/
E:\FR\FM\30JAN1.SGM
30JAN1
Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
regulatoryinformation/guidances/
ucm126396.pdf).
daltland on DSKBBV9HB2PROD with NOTICES
II. Topics for Discussion at the Public
Meeting
Topics for discussion during this
meeting include:
• The risks and benefits of
participation in clinical trials as well as
potential regulatory, geographical, and
socioeconomic barriers to participation.
• the rationale for eligibility criteria
in clinical trials, as well as the impact
of exclusion criteria on the enrollment
of populations, such as infants,
children, pregnant and lactating women,
elderly, individuals with advanced
disease, and individuals with co-morbid
conditions.
• alternative clinical trial designs that
may increase enrollment of more
diverse patient populations, while
facilitating the collection of data to
establish safety and effectiveness.
• how appropriate patient
populations can benefit from the results
of trials that employ alternative designs.
• how changes to eligibility criteria
may impact the complexity and length
of clinical trials, as well as the strength
of data necessary to demonstrate safety
and effectiveness.
• opportunities for using data from
expanded access trials.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://healthpolicy.duke.edu/
events/evaluating-inclusion-andexclusion-criteria-clinical-trials. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. Registration is free and based
on space availability, with priority given
to early registrants. Persons interested in
attending this public meeting must
register by April 12, 2018, midnight
Eastern Time. There will be no onsite
registration. 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. Duke-Margolis will post on its
website if registration closes before the
day of the public meeting.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy, 202–791–9561,
sarah.supsiri@duke.edu, no later than
April 12, 2018.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast; archived video footage will
be available at the Duke-Margolis
VerDate Sep<11>2014
18:18 Jan 29, 2018
Jkt 244001
website (https://healthpolicy.duke.edu/
events/evaluating-inclusion-andexclusion-criteria-clinical-trials)
following the meeting. Organizations are
requested to register all participants, but
to view using one connection per
location whenever possible. Webcast
participants will be sent technical
system requirements in advance of the
event. Prior to joining the streaming
webcast of the public workshop, we
recommend that you review these
technical system requirements in
advance.
Transcripts: Please be advised that
transcripts will not be available.
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.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and
publicly available at the Duke-Margolis
website: https://healthpolicy.duke.edu/
events/evaluating-inclusion-andexclusion-criteria-clinical-trials.
Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01643 Filed 1–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–2082]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Cardiomems HF Monitoring
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CARDIOMEMS HF MONITORING
SYSTEM and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
SUMMARY:
PO 00000
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4211
redetermination by April 2, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
July 30, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: 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 April 2, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 2, 2018. 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
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4210-4211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0129]
Evaluating Inclusion and Exclusion Criteria in Clinical Trials;
Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Evaluating Inclusion and
Exclusion Criteria in Clinical Trials.'' Convened by the Duke-Robert J.
Margolis, MD, Center for Health Policy at Duke University and supported
by a cooperative agreement with FDA, the purpose of the public meeting
is to bring the stakeholder community together to discuss a variety of
topics related to eligibility criteria in clinical trials and their
potential impact on patient access to investigational drugs, and how to
facilitate the enrollment of a diverse patient population.
DATES: The public meeting will be held on April 16, 2018, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held at the National Press Club,
529 14th St. NW, Washington, DC 20045. For additional travel and hotel
information, please refer to the following website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials. There will also be a live webcast for those
unable to attend the meeting in person (see Streaming Webcast of the
Public Meeting).
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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting implements FDA's mandate under section 610 of
the FDA Reauthorization Act of 2017 to convene a public meeting to
discuss clinical trial inclusion and exclusion criteria that will
ultimately inform an FDA guidance on this subject. Among other things,
the public meeting will include discussion about various ways in which
participation in clinical trials can be improved, including through
alternative trial designs and expanded access trials (see Section II.
Topics for Discussion at the Public Meeting).
Inclusion of relevant subpopulations in drug development programs
helps ensure that approved products will be safe and effective for the
population likely to be treated when the drug is marketed. However,
certain eligibility criteria in clinical trials can exclude patient
subgroups, resulting in the enrollment of study populations that may
not be fully representative of that broader patient population. FDA has
and will continue its efforts to encourage greater diversity in
clinical trial populations. For example, FDA regulations require
marketing applications to provide analyses of safety and effectiveness
by demographic and other relevant subgroups (see 21 CFR
314.50(d)(5)(v)). In addition, in 2016, FDA published guidance on the
collection of race and ethnicity data in clinical trials (available on
FDA's guidance web page at https://www.fda.gov/downloads/
[[Page 4211]]
regulatoryinformation/guidances/ucm126396.pdf).
II. Topics for Discussion at the Public Meeting
Topics for discussion during this meeting include:
The risks and benefits of participation in clinical trials
as well as potential regulatory, geographical, and socioeconomic
barriers to participation.
the rationale for eligibility criteria in clinical trials,
as well as the impact of exclusion criteria on the enrollment of
populations, such as infants, children, pregnant and lactating women,
elderly, individuals with advanced disease, and individuals with co-
morbid conditions.
alternative clinical trial designs that may increase
enrollment of more diverse patient populations, while facilitating the
collection of data to establish safety and effectiveness.
how appropriate patient populations can benefit from the
results of trials that employ alternative designs.
how changes to eligibility criteria may impact the
complexity and length of clinical trials, as well as the strength of
data necessary to demonstrate safety and effectiveness.
opportunities for using data from expanded access trials.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Registration is free and
based on space availability, with priority given to early registrants.
Persons interested in attending this public meeting must register by
April 12, 2018, midnight Eastern Time. There will be no onsite
registration. 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. Duke-Margolis will post on its website if registration closes
before the day of the public meeting.
If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy,
202-791-9561, [email protected], no later than April 12, 2018.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast; archived video footage will be available at the Duke-
Margolis website (https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials) following the
meeting. Organizations are requested to register all participants, but
to view using one connection per location whenever possible. Webcast
participants will be sent technical system requirements in advance of
the event. Prior to joining the streaming webcast of the public
workshop, we recommend that you review these technical system
requirements in advance.
Transcripts: Please be advised that transcripts will not be
available.
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.
Meeting Materials: All event materials will be provided to
registered attendees via email prior to the workshop and publicly
available at the Duke-Margolis website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials.
Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01643 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P
