Meeting of the Council on Graduate Medical Education, 4078-4079 [2019-02317]
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Federal Register / Vol. 84, No. 31 / Thursday, February 14, 2019 / Notices
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Request for Recognition of a Voluntary
Consensus Standard
OMB Control Number 0910–NEW
The draft guidance for industry
entitled ‘‘CDER’s Program for the
Recognition of Voluntary Consensus
Standards Related to Pharmaceutical
Quality’’ provides guidance to industry
about the procedures the Center for
Drug Evaluation and Research follows
when a request for recognition of a
voluntary consensus standard is
received. The guidance outlines
justifications for why a standard may be
recognized wholly, partly, or not at all.
The guidance also provides that any
interested party may request recognition
of a standard. Specifically, this process
will allow CDER to:
• Receive a candidate consensus
standard, with relevant information
(e.g., the scope of the standard and the
purpose), from internal or external
parties for informal recognition.
• Determine whether to informally
recognize a standard in whole or in part
following an internal scientific
evaluation.
• List the informally recognized
standards in a publicly searchable
database on CDER’s website,
accompanied by an information sheet
describing the scope and the extent of
CDER’s informal recognition of that
standard and any other relevant
information about it.
Request for Recognition of a Voluntary
Consensus Standard
We estimate that FDA will receive
nine requests annually. We estimate that
each request will take less than 1 hour
to prepare.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for recognition of a voluntary consensus standard
9
1
9
1
9
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02326 Filed 2–13–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Council on Graduate
Medical Education
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Council on Graduate
Medical Education (COGME) has
scheduled a public meeting. Information
about COGME and the agenda for this
meeting can be found on the COGME
website at https://www.hrsa.gov/
SUMMARY:
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advisory-committees/graduate-medicaledu/.
DATES: June 5, 2019, 8:30 a.m.–5:00 p.m.
and June 6, 2019, 8:30 a.m.–2:00 p.m.
ET.
This meeting will be held
in-person and through teleconference
and webinar. The address for the
meeting is 5600 Fishers Lane, Rockville,
Maryland 20857.
• Conference call-in number is: 1–
888–455–0640.
• Passcode is: HRSA COUNCIL (voice
response).
• Webinar link is: https://
hrsa.connectsolutions.com/cogme.
FOR FURTHER INFORMATION CONTACT:
Kennita R. Carter, MD, Designated
Federal Official (DFO), Division of
Medicine and Dentistry, Bureau of
Health Workforce, HRSA, 5600 Fishers
Lane, 15N–116, Rockville, Maryland
20857; 301–945–3505; or KCarter@
hrsa.gov.
ADDRESSES:
COGME
makes recommendations to the
Secretary of HHS (Secretary) and
Congress on policy, program
development, and other matters of
significance as specified by section 762
of Title VII of the Public Health Service
(PHS) Act. Issues addressed by COGME
include (1) the nature and financing of
medical education training; (2) the
SUPPLEMENTARY INFORMATION:
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development of performance measures
and longitudinal evaluation methods of
medical education programs; (3) foreign
medical school graduates; (4) the supply
and distribution of the physician
workforce in the United States,
including any projected shortages or
excesses; (5) deficiencies in databases of
the supply and distribution of the
physician workforce and postgraduate
programs for training physicians; and
(6) appropriation levels for certain
programs under Title VII of the PHS
Act. Additionally, COGME encourages
entities providing graduate medical
education to conduct activities to
voluntarily achieve the
recommendations of the council.
COGME submits reports to the Secretary
of HHS, the Senate Committee on
Health, Education, Labor and Pensions,
and the House of Representatives
Committee on Energy and Commerce.
During the June 2019, meeting,
COGME will discuss the topic of rural
health in relation to workforce
development and graduate medical
education financing. Agenda items are
subject to change as priorities dictate.
Refer to the COGME website for any
updated information concerning the
meeting. The meeting agenda will be
available on the COGME website at least
14 calendar days prior to the meeting.
E:\FR\FM\14FEN1.SGM
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Federal Register / Vol. 84, No. 31 / Thursday, February 14, 2019 / Notices
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 provide written statements
or make oral comments to COGME
should be sent to Kennita R. Carter,
DFO, using the contact information
above at least three business days prior
to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Kennita R. Carter, DFO, using the
contact information listed above at least
10 business days prior to the meeting.
Since this meeting occurs in a federal
government building, attendees must go
through a security check to enter the
building. Non-U.S. Citizen attendees
must notify HRSA of their planned
attendance at least 20 business days
prior to the meeting in order to facilitate
their entry into the building. All
attendees are required to present
government-issued identification prior
to entry.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–02317 Filed 2–13–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the 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.
AGENCY:
The Advisory Committee on
Training in Primary Care Medicine and
Dentistry (ACTPCMD) has scheduled
public meetings for the 2019 calendar
year (CY). Information about
ACTPCMD, agendas, and materials for
these meetings can be found on the
ACTPCMD website at https://
www.hrsa.gov/advisory-committees/
primarycare-dentist/.
DATES: June 11, 2019, 8:30 a.m. Eastern
Time (ET)–5:00 p.m. ET; August 8,
2019, 8:30 a.m.–5:00 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or via
Adobe Connect webinar. In-person
ACTPCMD meetings will be held at
SUMMARY:
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5600 Fishers Lane, Rockville, Maryland
20857. Instructions for joining the
meetings either in person or remotely
will be posted on the ACTPCMD
website 30 business days before the date
of the meeting. For meeting information
updates, visit the ACTPCMD website
meeting page at https://www.hrsa.gov/
advisory-committees/primarycaredentist/meetings.html
FOR FURTHER INFORMATION CONTACT:
Kennita Carter, MD, Designated Federal
Official (DFO), Division of Medicine
and Dentistry, Bureau of Health
Workforce (BHW), HRSA, 5600 Fishers
Lane, 15N116, Rockville, Maryland
20857; (301) 945–3505 or
BHWACTPCMD@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ACTPCMD provides advice and
recommendations to the Secretary of
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, as it
existed upon the enactment of Section
749 of the PHS Act in 1998. 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, as well as training
programs in oral health and dentistry.
The annual report is submitted to the
Secretary, Chairman, and ranking
members of the Senate Committee on
Health, Education, Labor and Pensions,
and the House of Representatives
Committee on Energy and Commerce.
ACTPCMD 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 ACTPCMD’s CY 2019
meetings, the committee will discuss
matters concerning policy, program
development, and other matters of
significance concerning medicine and
dentistry activities. Refer to the
ACTPCMD website listed above for all
current and updated information
concerning CY 2019 ACTPCMD
meetings, including draft agendas and
meeting materials that will be posted at
least 10 business days before the start of
each meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting(s). Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
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4079
or make oral comments to the
ACTPCMD should be sent to Kennita
Carter using the contact information
above at least five business days before
the meeting date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Kennita
Carter using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend. Since all in-person meetings will
occur in a federal government building,
attendees must go through a security
check to enter the building. Non-U.S.
Citizen attendees must notify HRSA of
their planned attendance at least 20
business days prior to the meeting in
order to facilitate their entry into the
building. All attendees are required to
present government-issued
identification prior to entry.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–02318 Filed 2–13–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Advisory Committee on
Heritable Disorders in Newborns and
Children (ACHDNC) has scheduled a
public meeting. Information about the
ACHDNC and the agenda for this
meeting can be found on the ACHDNC
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: April 23, 2019, 9:00 a.m. to 5:00
p.m. Eastern Time (ET) and April 24,
2019, from 9:00 a.m. to 3:00 p.m. ET.
ADDRESSES: This meeting will be held
in-person and will be webcast. The
address for the meeting is 5600 Fishers
Lane, Rockville, Maryland 20857. While
this meeting is open to the public,
advance registration is required. Please
visit the ACHDNC website for
information on registration: https://
www.hrsa.gov/advisory-committees/
heritable-disorders/. The
deadline for online registration is 12:00
p.m. ET on April 19, 2019. Instructions
on how to access the meeting via
SUMMARY:
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Agencies
[Federal Register Volume 84, Number 31 (Thursday, February 14, 2019)]
[Notices]
[Pages 4078-4079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02317]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Council on Graduate Medical Education
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Council on Graduate Medical Education (COGME) has
scheduled a public meeting. Information about COGME and the agenda for
this meeting can be found on the COGME website at https://www.hrsa.gov/advisory-committees/graduate-medical-edu/.
DATES: June 5, 2019, 8:30 a.m.-5:00 p.m. and June 6, 2019, 8:30 a.m.-
2:00 p.m. ET.
ADDRESSES: This meeting will be held in-person and through
teleconference and webinar. The address for the meeting is 5600 Fishers
Lane, Rockville, Maryland 20857.
Conference call-in number is: 1-888-455-0640.
Passcode is: HRSA COUNCIL (voice response).
Webinar link is: https://hrsa.connectsolutions.com/cogme.
FOR FURTHER INFORMATION CONTACT: Kennita R. Carter, MD, Designated
Federal Official (DFO), Division of Medicine and Dentistry, Bureau of
Health Workforce, HRSA, 5600 Fishers Lane, 15N-116, Rockville, Maryland
20857; 301-945-3505; or KCarter@hrsa.gov.
SUPPLEMENTARY INFORMATION: COGME makes recommendations to the Secretary
of HHS (Secretary) and Congress on policy, program development, and
other matters of significance as specified by section 762 of Title VII
of the Public Health Service (PHS) Act. Issues addressed by COGME
include (1) the nature and financing of medical education training; (2)
the development of performance measures and longitudinal evaluation
methods of medical education programs; (3) foreign medical school
graduates; (4) the supply and distribution of the physician workforce
in the United States, including any projected shortages or excesses;
(5) deficiencies in databases of the supply and distribution of the
physician workforce and postgraduate programs for training physicians;
and (6) appropriation levels for certain programs under Title VII of
the PHS Act. Additionally, COGME encourages entities providing graduate
medical education to conduct activities to voluntarily achieve the
recommendations of the council. COGME submits reports to the Secretary
of HHS, the Senate Committee on Health, Education, Labor and Pensions,
and the House of Representatives Committee on Energy and Commerce.
During the June 2019, meeting, COGME will discuss the topic of
rural health in relation to workforce development and graduate medical
education financing. Agenda items are subject to change as priorities
dictate. Refer to the COGME website for any updated information
concerning the meeting. The meeting agenda will be available on the
COGME website at least 14 calendar days prior to the meeting.
[[Page 4079]]
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
provide written statements or make oral comments to COGME should be
sent to Kennita R. Carter, DFO, using the contact information above at
least three business days prior to the meeting.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify Kennita R. Carter, DFO,
using the contact information listed above at least 10 business days
prior to the meeting. Since this meeting occurs in a federal government
building, attendees must go through a security check to enter the
building. Non-U.S. Citizen attendees must notify HRSA of their planned
attendance at least 20 business days prior to the meeting in order to
facilitate their entry into the building. All attendees are required to
present government-issued identification prior to entry.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-02317 Filed 2-13-19; 8:45 am]
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