Charter Renewal for the Council on Graduate Medical Education, 50664-50665 [2018-21864]
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50664
Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
AADPAC@fda.hhs.gov, 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
FDA’s website 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: The committees will discuss
new drug application (NDA) 209774, for
an immediate-release oral tablet
formulation of oxycodone, which is
intended to resist common methods of
physical or chemical manipulation and
to deter intravenous and intranasal
abuse, submitted by SpecGx Inc., for the
management of pain severe enough to
require an opioid analgesic and for
which alternative treatments are
inadequate. The committees will also be
asked to determine whether the
Applicant adequately demonstrated that
the abuse-deterrent properties of the
proposed product are sufficient to
include this information in the product
label, and whether the product should
be approved.
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 website prior to the
meeting, the background material will
be made publicly available at the
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location of the advisory committee
meeting, and the background material
will be posted on FDA’s website 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 committees. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
October 30, 2018, will be provided to
the committees. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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 October 22, 2018. 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
October 23, 2018.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
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 Moon Hee V.
Choi (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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Dated: October 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21810 Filed 10–5–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Council on
Graduate Medical Education
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS is hereby giving notice
that the Council on Graduate Medical
Education (COGME) has been
rechartered. The date the renewed
charter took effect is September 30,
2018.
FOR FURTHER INFORMATION CONTACT:
Kennita R. Carter, MD, Designated
Federal Official, COGME at 301–945–
3505 or email at kcarter@hrsa.gov. A
copy of the current committee
membership, charter, and reports can be
obtained by accessing the website
https://www.hrsa.gov/advisory
committees/bhpradvisory/COGME/
index.html.
SUPPLEMENTARY INFORMATION: COGME
provides advice and recommendations
to the Secretary of the Department of
Health and Human Services (Secretary),
the Senate Committee on Health,
Education, Labor and Pensions, and the
U.S. House of Representatives
Committee on Energy and Commerce on
matters concerning the supply and
distribution of physicians in the United
States, physician workforce trends,
training issues, financing policies and
other matters of significance concerning
graduate medical education, as specified
by section 762 of the Public Health
Service (PHS) Act, as amended.
Additionally, COGME encourages
entities providing graduate medical
education to conduct activities to
voluntarily achieve the
recommendations of the Council;
develops, publishes, and implements
performance measures and longitudinal
evaluations; and recommends
appropriation levels for certain PHS Act
Title VII programs. The charter renewal
for COGME was approved on September
30, 2018, which will also stand as the
filing date. Renewal of the COGME
charter gives authorization for the
Council to operate until September 30,
2020.
SUMMARY:
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Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices
A copy of the COGME charter is
available on the COGME website at:
https://www.hrsa.gov/advisorycommittees/graduate-medical-edu/
index.html. A copy of the charter can
also be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website for the
FACA database is https://
www.facadatabase.gov/.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–21864 Filed 10–5–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Performance Review Board Members
Title 5, U.S.C. Section 4314(c)(4) of
the Civil Service Reform Act of 1978,
Public Law 95–454, requires that the
appointment of Performance Review
Board Members be published in the
Federal Register.
The following persons may be named
to serve on the Performance Review
Boards or Panels, which oversee the
evaluation of performance appraisals of
Senior Executive Service members of
the Department of Health and Human
Services.
Employee
last name
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Barry ..........................
Brady .........................
Brown ........................
Coquis .......................
Fantinato ...................
Fischmann .................
Gentile .......................
Goldhaber .................
Hargan ......................
Haseltine ...................
Kretschmaier .............
Lewis .........................
McDaniel ...................
Novy ..........................
Rowell .......................
Sample ......................
Skeadas ....................
Tobias .......................
Employee
first name
Daniel
William
Mark
Roberto
Jessica
Elizabeth
John
Ben
Eric
Amy
Michon
Lisa
Eileen
Steve
Scott
Allen
Christos
Constance
Dated: October 1, 2018.
Charles H. McEnerney III,
Director, Executive and Scientific Resources
Division.
[FR Doc. 2018–21855 Filed 10–5–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Clinical Care
Commission
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The National Clinical Care
Commission (the Commission) will
conduct its inaugural meeting on
October 31, 2018. The Commission will
evaluate and make recommendations to
the U.S. Department of Health and
Human Services (HHS) Secretary and
Congress regarding improvements to the
coordination and leveraging of federal
programs related to awareness and
clinical care for complex metabolic or
autoimmune diseases that result from
issues related to insulin that represent a
significant disease burden in the United
States, which may include
complications due to such diseases.
DATES: The meeting will take place on
October 31, 2018, from 8:00 a.m. to
approximately 5:00 p.m. Eastern Time
(ET).
ADDRESSES: National Institutes of
Health, Building 35, John Edward Porter
Neuroscience Research Center [PNRC
II], 35 Convent Drive, Bethesda, MD
20892. The meeting will also be held
online via webcast. To register to attend
the meeting, please visit the registration
website at https://
events.kauffmaninc.com/events/
ncccmeetingone/.
FOR FURTHER INFORMATION CONTACT:
Clydette Powell, Designated Federal
Official, National Clinical Care
Commission, U.S. Department of Health
and Human Services, Office of the
Assistant Secretary for Health, Office of
Disease Prevention and Health
Promotion, 1101 Wootton Parkway,
Suite LL–100, Rockville, MD 20852.
Email: OHQ@hhs.gov. Additional
information may be obtained at https://
health.gov/hcq/national-clinical-carecommission.asp.
SUPPLEMENTARY INFORMATION: The
National Clinical Care Commission Act
(Pub. L. 115–80) requires the HHS
Secretary to establish the National
Clinical Care Commission. The
Commission will consist of
representatives of specific federal
agencies and non-federal individuals
and entities who represent diverse
disciplines and views. The Commission
will evaluate and make
recommendations to the HHS Secretary
SUMMARY:
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and Congress regarding improvements
to the coordination and leveraging of
federal programs related to awareness
and clinical care for complex metabolic
or autoimmune diseases that result from
issues related to insulin that represent a
significant disease burden in the United
States, which may include
complications due to such diseases.
This inaugural meeting of the
Commission will consist of swearing-in
non-federal Commission members, an
overview of various federal interagency
efforts surrounding diabetes programs,
the establishment of the Commission
subcommittee structure, and setting
future agenda topics. The names and
biographies of the Commission members
and final meeting agenda will be
available prior to the meeting at https://
health.gov/hcq/national-clinical-carecommission.asp.
Public Participation at Meeting: The
Commission invites public comment on
issues related to the Commission’s
charge either in-person at the meeting or
in writing. In-person attendees who
plan to provide oral comments at the
Commission meeting during a
designated time must submit their
comments to OHQ@hhs.gov on or before
October 24, 2018 and must check-in onsite. To accommodate as many
individuals as possible, the time for
each comment will be limited to three
minutes. If more requests are received
than can be accommodated, speakers
will be randomly selected. The nature of
the comments will not be considered in
making this selection. Written
comments are welcome throughout the
entire development process of the
Commission and may be emailed to
OHQ@hhs.gov, or by mail to the
following address: Public Commentary,
National Clinical Care Commission,
1101 Wootton Parkway, Suite LL–100,
Rockville, MD 20852. Written comments
should not exceed three pages in length.
To attend the Commission meeting,
individuals must pre-register at the
registration website at https://
events.kauffmaninc.com/events/
ncccmeetingone/. In-person and live
videocast attendance options are
available. In-person attendance at the
meeting is limited to space available. Inperson registrations will be accepted
until maximum capacity is reached and
must be completed by October 25, 2018.
On the day of the meeting, seating will
be provided first to persons who have
pre-registered. Those who have not preregistered will be accommodate on a
first come, first served basis if
additional seats are still available 10
minutes before the meeting start.
Individuals who need special
assistance, such as sign language
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Agencies
[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50664-50665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21864]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Charter Renewal for the Council on Graduate Medical Education
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HHS is hereby giving notice that the Council on Graduate
Medical Education (COGME) has been rechartered. The date the renewed
charter took effect is September 30, 2018.
FOR FURTHER INFORMATION CONTACT: Kennita R. Carter, MD, Designated
Federal Official, COGME at 301-945-3505 or email at [email protected]. A
copy of the current committee membership, charter, and reports can be
obtained by accessing the website https://www.hrsa.gov/advisorycommittees/bhpradvisory/COGME/.
SUPPLEMENTARY INFORMATION: COGME provides advice and recommendations to
the Secretary of the Department of Health and Human Services
(Secretary), the Senate Committee on Health, Education, Labor and
Pensions, and the U.S. House of Representatives Committee on Energy and
Commerce on matters concerning the supply and distribution of
physicians in the United States, physician workforce trends, training
issues, financing policies and other matters of significance concerning
graduate medical education, as specified by section 762 of the Public
Health Service (PHS) Act, as amended. Additionally, COGME encourages
entities providing graduate medical education to conduct activities to
voluntarily achieve the recommendations of the Council; develops,
publishes, and implements performance measures and longitudinal
evaluations; and recommends appropriation levels for certain PHS Act
Title VII programs. The charter renewal for COGME was approved on
September 30, 2018, which will also stand as the filing date. Renewal
of the COGME charter gives authorization for the Council to operate
until September 30, 2020.
[[Page 50665]]
A copy of the COGME charter is available on the COGME website at:
https://www.hrsa.gov/advisory-committees/graduate-medical-edu/. A copy of the charter can also be obtained by accessing the
FACA database that is maintained by the Committee Management
Secretariat under the General Services Administration. The website for
the FACA database is https://www.facadatabase.gov/.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-21864 Filed 10-5-18; 8:45 am]
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