Patient Engagement Advisory Committee; Notice of Meeting, 34681-34682 [2017-15657]
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Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
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FOR FURTHER INFORMATION CONTACT:
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Evaluation and Research, Food and
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Hampshire Ave., Bldg. 22, Rm. 5418,
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402–0272.
SUPPLEMENTARY INFORMATION:
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I. Background
U.S.C. 601 (note).
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17:49 Jul 25, 2017
Jkt 241001
meeting will be open to the public. This
meeting will be the inaugural meeting of
a new advisory committee.
DATES: The meeting will be held on
October 11, 2017, from 1 p.m. to 5 p.m.
and October 12, 2017, from 8 a.m. to 5
p.m.
ADDRESSES: Hilton Washington DC
North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2017–15653 Filed 7–25–17; 8:45 am]
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring,
MD 20993–0002, 301–796–8398, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
FDA is announcing the availability of
a guidance for industry entitled
‘‘Consumer Antiseptic Wash Final Rule
Questions and Answers.’’ We are
issuing this guidance in accordance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121, as amended by Pub.
L. 110–28) 1 to assist small businesses in
better understanding and complying
with the consumer antiseptic wash final
rule (September 6, 2016, 81 FR 61106),
which established that certain active
ingredients used in OTC consumer
antiseptic wash products are not
15
GRASE. This guidance explains the
scope of the final rule and identifies
which active ingredients were found not
to be GRASE for use in consumer
antiseptic wash products. This guidance
explains when and how manufacturers
must comply with the final rule. This
guidance also explains the significance
of triclosan and triclocarban under this
final rule. In addition, this guidance
identifies which consumer antiseptic
wash active ingredients were deferred
from the final rule and explains what
the effectiveness and safety criteria are
for these deferred consumer antiseptic
wash active ingredients.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on how small
businesses can better understand and
comply with the consumer antiseptic
wash final rule. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
34681
Patient Engagement Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Patient Engagement
Advisory Committee (PEAC). The
general function of the committee is to
provide advice and recommendations to
the Agency on complex issues relating
to medical devices, the regulation of
devices, and their use by patients. The
SUMMARY:
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Fmt 4703
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Agenda: On October 11 and 12, 2017,
the committee will discuss and make
recommendations on the topic of patient
input into medical device clinical trials.
This meeting will provide the
opportunity to bring patients, patient
organization, FDA, industry, and other
medical and scientific experts together
for a broader discussion on this
important patient-related issue.
This meeting is a key part of FDA’s
goal to help assure the needs and
experiences of patients are included as
part of FDA’s deliberations involving
the regulation of medical devices and
their use by patients. For this meeting,
FDA is seeking input from the PEAC
and the public on topics such as to: (1)
Better understand challenges for
patients in medical device clinical
trials, (2) better understand how patient
input and engagement is being used to
overcome these challenges (potential
solutions), and (3) receive
E:\FR\FM\26JYN1.SGM
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34682
Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
recommendations from the PEAC on top
areas for FDA to consider for action.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 20, 2017.
Oral presentations from the public will
be scheduled between approximately
3:40 p.m. to 4:10 p.m. on October 11,
2017, and approximately 9 a.m. to 9:30
a.m. and 2:30 p.m. to 3 p.m. on October
12, 2017. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before September 12, 2017. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 13, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov, or 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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17:49 Jul 25, 2017
Jkt 241001
public conduct during advisory
committee meetings. Please be advised
that, for the round table portion of the
meeting, FDA will prepare a summary
of discussion instead of detailed
transcripts.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commiissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15657 Filed 7–25–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Training in
Primary Care Medicine and Dentistry
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Advisory Committee on
Training in Primary Care Medicine and
Dentistry (ACTPCMD) has scheduled a
meeting. This meeting will be open to
the public. Information about
ACTPCMD and the agenda for this
meeting can be found on the ACTPCMD
Web site at https://www.hrsa.gov/
advisorycommittees/bhpradvisory/
ACTPCMD.
SUMMARY:
August 16, 2017, 10:00 a.m.–2:30
p.m. ET.
ADDRESSES: This meeting will be held
by webinar and teleconference. The
address for the meeting is 5600 Fishers
Lane, Rockville, Maryland 20857.
• The webinar link: https://
hrsa.connectsolutions.com/actpcmd.
• The conference call-in number:
1–888–946–3804. Passcode: 3214611.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding ACTPCMD should contact
Kennita R. Carter, MD, Designated
Federal Officer (DFO), Division of
Medicine and Dentistry, Bureau of
Health Workforce, HRSA, in one of
three ways: (1) Send a request to the
following address: Kennita R. Carter,
MD, DFO, Division of Medicine and
Dentistry, HRSA, 5600 Fishers Lane,
15N–116, Rockville, Maryland 20857;
(2) call 301–945–3505; or (3) send an
email to KCarter@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ACTPCMD provides advice and
recommendations to the Secretary of
DATES:
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HHS (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under section 747 of Title VII of the
Public Health Service (PHS) Act,
including dentistry activities.
ACTPCMD prepares an annual report
describing the activities of the
Committee, including findings and
recommendations made by the
Committee concerning the activities
under section 747, including dentistry
activities. The annual report is
submitted to the Secretary and ranking
members of the Senate Committee on
Health, Education, Labor and Pensions,
and the House of Representatives
Committee on Energy and Commerce.
The Committee also develops,
publishes, and implements performance
measures and guidelines for
longitudinal evaluations of programs
authorized under Title VII, Part C, of the
PHS Act, and recommends
appropriation levels for programs under
this Part.
During the August 16, 2017, meeting,
ACTPCMD will discuss issues related to
the Committee reports under
development. Agenda items are subject
to change as priorities dictate.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACTPCMD
should be sent to Kennita R. Carter, MD,
DFO, using the contact information
above at least 3 business days prior to
the meeting.
Individuals who need special
assistance or another reasonable
accommodation should notify Dr.
Kennita R. Carter at the address and
phone number listed above at least 10
days prior to the meeting.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2017–15665 Filed 7–25–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
Department of Health and
Human Services (HHS).
AGENCY:
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Agencies
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34681-34682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Patient Engagement Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Patient Engagement Advisory
Committee (PEAC). The general function of the committee is to provide
advice and recommendations to the Agency on complex issues relating to
medical devices, the regulation of devices, and their use by patients.
The meeting will be open to the public. This meeting will be the
inaugural meeting of a new advisory committee.
DATES: The meeting will be held on October 11, 2017, from 1 p.m. to 5
p.m. and October 12, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620
Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is
301-977-8900. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002, 301-
796-8398, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On October 11 and 12, 2017, the committee will discuss and
make recommendations on the topic of patient input into medical device
clinical trials. This meeting will provide the opportunity to bring
patients, patient organization, FDA, industry, and other medical and
scientific experts together for a broader discussion on this important
patient-related issue.
This meeting is a key part of FDA's goal to help assure the needs
and experiences of patients are included as part of FDA's deliberations
involving the regulation of medical devices and their use by patients.
For this meeting, FDA is seeking input from the PEAC and the public on
topics such as to: (1) Better understand challenges for patients in
medical device clinical trials, (2) better understand how patient input
and engagement is being used to overcome these challenges (potential
solutions), and (3) receive
[[Page 34682]]
recommendations from the PEAC on top areas for FDA to consider for
action.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 20, 2017. Oral presentations from the public will be
scheduled between approximately 3:40 p.m. to 4:10 p.m. on October 11,
2017, and approximately 9 a.m. to 9:30 a.m. and 2:30 p.m. to 3 p.m. on
October 12, 2017. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before September 12, 2017. Time allotted for each presentation
may be limited. If the number of registrants requesting to speak is
greater than can be reasonably accommodated during the scheduled open
public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by September 13, 2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at Annmarie.Williams@fda.hhs.gov, or 301-796-
5966 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings. Please be advised
that, for the round table portion of the meeting, FDA will prepare a
summary of discussion instead of detailed transcripts.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commiissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15657 Filed 7-25-17; 8:45 am]
BILLING CODE 4164-01-P