Meeting of the Council on Graduate Medical Education, 55577-55578 [2019-22649]
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Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices
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INFORMATION section for electronic
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FOR FURTHER INFORMATION CONTACT:
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
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SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Prescription Drug User Fee Act
Waivers, Reductions, and Refunds for
Drug and Biological Products.’’ This
guidance provides recommendations to
applicants regarding requests for
waivers, reductions, or refunds of user
fees assessed under sections 735 and
736 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
379g and 379h). This guidance describes
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the types of waivers, reductions, and
refunds permitted under the user fee
provisions of the FD&C Act and the
procedures for submitting requests for
waivers, reductions, refunds, as well as
requests for reconsiderations or appeals.
The guidance also provides additional
clarification on certain issues such as
user fee exemptions for orphan drugs
and FDA’s current thinking on
considerations relevant to eligibility for
user fee waivers, reductions, and
refunds under the applicable statutory
provisions.
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 ‘‘Prescription Drug
User Fee Act Waivers, Reductions, and
Refunds for Drug and Biological
Products.’’ 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information of
this guidance has been approved under
OMB control number 0910–0693. The
collection of information associated
with Form FDA 3397 has been approved
under OMB control number 0910–0297.
The collections of information
associated with new drug applications
or biologics license applications have
been approved under OMB control
numbers 0910–0001 and 0910–0338,
respectively. See section X of the
guidance document.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, or https://
www.regulations.gov.
Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22690 Filed 10–16–19; 8:45 am]
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55577
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Council on Graduate
Medical Education
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Council on
Graduate Medical Education (COGME or
Council) will hold public meetings for
the 2020 calendar year (CY).
Information about COGME, agendas,
and materials for these meetings can be
found on the COGME website at https://
www.hrsa.gov/advisory-committees/
graduate-medical-edu/.
DATES: April 28–29, 2020, 8:30 a.m.–
5:00 p.m. Eastern Time (ET) and 8:30
a.m.–2:00 p.m. ET; July 17, 2020, 10:00
a.m.–5:00 p.m. ET; December 8–9, 2020,
8:30 a.m.–5:00 p.m. ET and 8:30 a.m.–
2:00 p.m.
ADDRESSES: The meetings scheduled on
April 28–29, 2020, and December 8–9,
2020, will be held in-person at 5600
Fishers Lane, Room 5E29, Rockville,
Maryland 20857. The meeting
scheduled on July 17, 2020, will be held
by teleconference/Adobe Connect
webinar. Instructions for joining the
meetings either in person or remotely
will be posted on the COGME website
30 business days before the date of the
meeting. For meeting information
updates, go to the COGME website
meeting page at https://www.hrsa.gov/
advisory-committees/graduate-medicaledu/meetings/.
FOR FURTHER INFORMATION CONTACT:
Kennita Carter, MD, Senior Advisor and
Designated Federal Official (DFO),
Division of Medicine and Dentistry,
Bureau of Health Workforce (BHW),
HRSA, 5600 Fishers Lane, 15N116,
Rockville, Maryland 20857; 301–945–
9505; or BHWCOGME@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 the supply and distribution of
the physician workforce in the United
States, including any projected
shortages or excesses; foreign medical
school graduates; the nature and
financing of undergraduate and graduate
SUMMARY:
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55578
Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices
medical education; appropriation levels
for certain programs under Title VII of
the PHS Act and deficiencies in
databases of the supply and distribution
of the physician workforce and
postgraduate programs for training
physicians. 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. Additionally, COGME
encourages entities providing graduate
medical education to conduct activities
to voluntarily achieve the
recommendations of the Council.
Agenda items are subject to change as
priorities dictate. During the CY 2020
COGME meetings, COGME will discuss
topics surrounding the rural health
workforce. Refer to the COGME website
listed above for all current and updated
information concerning the CY 2020
COGME meetings, including draft
agendas and meeting materials that will
be posted before the meeting. An agenda
will be posted on the website at least 14
calendar days before the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meetings. 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 the COGME
should be sent to Kennita Carter using
the contact information above at least 5
business days before the meeting dates.
Individuals who need special
assistance or another reasonable
accommodation should notify Dr.
Kennita Carter using the contact
information listed above at least 10
business days before the meeting they
wish to attend. Since all in person
meetings 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–22649 Filed 10–16–19; 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 and Primary Care Medicine
and Dentistry
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Training and Primary
Care Medicine and Dentistry
(ACTPCMD) will hold public meetings
for the 2020 calendar year (CY).
Information about ACTPCMD, agendas,
and materials for these meetings can be
found on the ACTPCMD website at
https://www.hrsa.gov/advisorycommittees/primarycare-dentist/
index.html.
DATES: January 8–9, 2020, 8:30 a.m.–
5:00 p.m. Eastern Time (ET) and 8:30
a.m.–2:00 p.m. ET; and August 4, 2020,
10:00 a.m.–5:00 p.m. ET.
ADDRESSES: The meeting scheduled on
January 8–9, 2020, will be held inperson at 5600 Fishers Lane, Room
5E29, Rockville, Maryland 20857. The
meeting scheduled on August 4, 2020,
will be held by teleconference/Adobe
Connect webinar. 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, go to the
ACTPCMD website meeting page at
https://www.hrsa.gov/advisorycommittees/primarycare-dentist/
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;
301–945–9505; 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
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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 as well as the 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 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 2020
meetings, the committee will discuss
matters concerning policy, program
development, and other matters of
significance concerning medicine and
dentistry activities. Agenda items are
subject to change as priorities dictate.
Refer to the ACTPCMD website listed
above for all current and updated
information concerning the CY 2020
meetings, including draft agendas and
meeting materials that will be posted
before the meeting. An agenda will be
posted on the website at least 14
calendar days before each meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meetings. 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 the
ACTPCMD should be sent to Kennita
Carter using the contact information
above at least 5 business days before the
meeting dates.
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 they wish to attend.
Since all in-person meetings 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–22650 Filed 10–16–19; 8:45 am]
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Agencies
[Federal Register Volume 84, Number 201 (Thursday, October 17, 2019)]
[Notices]
[Pages 55577-55578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Council on Graduate Medical Education
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Council on Graduate Medical Education (COGME
or Council) will hold public meetings for the 2020 calendar year (CY).
Information about COGME, agendas, and materials for these meetings can
be found on the COGME website at https://www.hrsa.gov/advisory-committees/graduate-medical-edu/.
DATES: April 28-29, 2020, 8:30 a.m.-5:00 p.m. Eastern Time (ET) and
8:30 a.m.-2:00 p.m. ET; July 17, 2020, 10:00 a.m.-5:00 p.m. ET;
December 8-9, 2020, 8:30 a.m.-5:00 p.m. ET and 8:30 a.m.-2:00 p.m.
ADDRESSES: The meetings scheduled on April 28-29, 2020, and December 8-
9, 2020, will be held in-person at 5600 Fishers Lane, Room 5E29,
Rockville, Maryland 20857. The meeting scheduled on July 17, 2020, will
be held by teleconference/Adobe Connect webinar. Instructions for
joining the meetings either in person or remotely will be posted on the
COGME website 30 business days before the date of the meeting. For
meeting information updates, go to the COGME website meeting page at
https://www.hrsa.gov/advisory-committees/graduate-medical-edu/meetings/.
FOR FURTHER INFORMATION CONTACT: Kennita Carter, MD, Senior Advisor and
Designated Federal Official (DFO), Division of Medicine and Dentistry,
Bureau of Health Workforce (BHW), HRSA, 5600 Fishers Lane, 15N116,
Rockville, Maryland 20857; 301-945-9505; or [email protected].
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 the supply and distribution of the physician workforce in the
United States, including any projected shortages or excesses; foreign
medical school graduates; the nature and financing of undergraduate and
graduate
[[Page 55578]]
medical education; appropriation levels for certain programs under
Title VII of the PHS Act and deficiencies in databases of the supply
and distribution of the physician workforce and postgraduate programs
for training physicians. 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.
Additionally, COGME encourages entities providing graduate medical
education to conduct activities to voluntarily achieve the
recommendations of the Council.
Agenda items are subject to change as priorities dictate. During
the CY 2020 COGME meetings, COGME will discuss topics surrounding the
rural health workforce. Refer to the COGME website listed above for all
current and updated information concerning the CY 2020 COGME meetings,
including draft agendas and meeting materials that will be posted
before the meeting. An agenda will be posted on the website at least 14
calendar days before the meeting.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meetings. 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 the COGME should be
sent to Kennita Carter using the contact information above at least 5
business days before the meeting dates.
Individuals who need special assistance or another reasonable
accommodation should notify Dr. Kennita Carter using the contact
information listed above at least 10 business days before the meeting
they wish to attend. Since all in person meetings 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-22649 Filed 10-16-19; 8:45 am]
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