Meeting of the National Advisory Committee on the National Health Service Corps, 1517-1518 [2021-00093]
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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
Application
No.
NDA 016801
Drug name
Active ingredient(s)
NDA 018238
XYLOCAINE PRELidocaine HydroSERVATIVE FREE.
chloride.
MICRO–K ................. Potassium Chloride ..
NDA 019568
DERMATOP .............
Prednicarbate ...........
NDA 020192
LAMISIL ....................
NDA 020482
NDA 020591
PRECOSE ................
TARKA ......................
NDA 020635
LEVAQUIN ...............
Terbinafine Hydrochloride.
Acarbose ..................
Trandolapril;
Verapamil Hydrochloride.
Levofloxacin ..............
NDA 020823
EXELON ...................
Rivastigmine Tartrate
NDA 020920
NATRECOR .............
Nesiritide ...................
NDA 021549
NDA 021590
EMEND .....................
FAZACLO ODT ........
Aprepitant .................
Clozapine ..................
NDA 202535
PREPOPIK ...............
Citric Acid, Magnesium Oxide, and
Sodium Picosulfate.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed are unaffected
by the discontinued marketing of the
products subject to those NDAs and
ANDAs. Additional ANDAs that refer to
these products may also be approved by
the Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
tkelley on DSKBCP9HB2PROD with NOTICES
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Strength(s)
Dosage form/route
Applicant
1%; 2%; 4%; 10%; 20% ............
Injectable; Injection ...
8
milliequivalents (mEq); 10
mEq.
0.10% .........................................
Extended-Release
Capsule; Oral.
Ointment; Topical .....
1% ..............................................
Cream; Topical .........
Fresenius Kabi USA,
LLC.
Nesher Pharmaceuticals LLC.
Valeant Pharmaceuticals.
Novartis.
25 mg; 50 mg; 100 mg ..............
1 mg; 240 mg .............................
Tablet; Oral ...............
Extended-Release
Tablet; Oral.
Bayer Healthcare.
AbbVie Inc.
EQ 500 mg/20 mL; EQ 750 mg/
30 mL.
EQ 1.5 mg Base; EQ 3 mg
Base; EQ 4.5 mg Base; EQ 6
mg Base.
1.5 mg/Vial .................................
Injectable; Injection ...
Janssen Pharmaceuticals, Inc.
Novartis.
40 mg .........................................
12.5 mg; 25 mg; 100 mg; 150
mg; and 200 mg.
12 grams (g)/Packet; 3.5 g/
Packet; 10 mg/Packet.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Committee on the National Health
Service Corps
Capsule; Oral ...........
For Solution; Intravenous.
Capsule; Oral ...........
Orally Disintegrating
Tablet; Oral.
For Solution; Oral .....
Scios Inc.
Merck.
Jazz Pharmaceuticals
PLC.
Ferring Pharmaceuticals Inc.
the meeting will be held, visit the
NACNHSC website 30 business days
before the date of the meeting, where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person NACNHSC meetings
will be held at 5600 Fishers Lane,
Rockville, Maryland 20857. For meeting
information updates, go to the
NACNHSC website meeting page at
https://nhsc.hrsa.gov/nac/
meetings.html.
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Committee on the National
Health Service Corps (NACNHSC) will
hold public meetings for the 2021
calendar year (CY). Information about
NACNHSC, agendas, and materials for
these meetings can be found on the
NACNHSC website at https://
nhsc.hrsa.gov/about/national-advisorycouncil-nhsc/.
DATES: NACNHSC meetings will be held
on
• March 16, 2021, 9:00 a.m.–5:00 p.m.
Eastern Time (ET) and March 17, 2021,
9:00 a.m.–2:00 p.m. ET;
• June 22, 2021, 9:00 a.m.–5:00 p.m.
ET and June 23, 2021, 9:00 a.m.–2:00
p.m. ET;
• November 9, 2021, 9:00 a.m.–5: 00
p.m. ET and November 10, 2021, 9:00
a.m.–2:00 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. For updates on how
Diane Fabiyi-King (DFO), Division of
National Health Service Corps, Bureau
of Health Workforce, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–3609; or
NHSCAdvisoryCouncil@hrsa.gov.
SUPPLEMENTARY INFORMATION:
NACNHSC provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under Subpart II, Part D of Title III of
the Public Health Service Act (42 U.S.C.
254d–254k). NACNHSC designates areas
of the United States with health
professional shortages and assigns
National Health Service Corps clinicians
to improve the delivery of health
services in health professional shortage
areas. Since priorities dictate meeting
times and agenda items, be advised that
start times, end times, and agenda items
are subject to change. For CY 2021
meetings, agenda items may include,
but are not limited to, the identification
of NACNHSC priorities for future
AGENCY:
SUMMARY:
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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
program issues and concerns; propose
policy changes using the varying levels
of expertise represented on the Council
to advise on specific program areas;
updates from clinician workforce
experts; and education and practice
improvement in the training
development of primary care clinicians.
More general items may include:
Presentations and discussions on the
current and emerging needs of health
workforce; public health priorities;
healthcare access and evaluation;
NACNHSC-approved sites; HRSA
priorities and other federal health
workforce and education programs that
impact the NACNHSC.
Refer to the NACNHSC website listed
above for all current and updated
information concerning the CY 2021
NACNHSC meetings, including draft
agendas and meeting materials that will
be posted 30 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
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
or make oral comments to the
NACNHSC should be sent to Diane
Fabiyi-King using the contact
information above at least 5 business
days before the meeting date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Diane
Fabiyi-King using the contact
information listed above at least 10
business days before the meeting(s) they
wish to attend.
If a meeting is held in-person, it will
occur in a federal government building
and attendees must go through a
security check to enter. Non-U.S.
Citizen attendees must notify HRSA of
their planned attendance at an in-person
meeting 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.
tkelley on DSKBCP9HB2PROD with NOTICES
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–00093 Filed 1–7–21; 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 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 2021 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: COGME meetings will be held on
• April 14, 2021, 8:30 a.m.–5:00 p.m.
Eastern Time (ET) and April 15, 2021,
8:30 a.m.–2:00 p.m. ET;
• August 19, 2021, 10:00 a.m.–5:00
p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. For updates on how
the meeting will be held, visit the
COGME website 30 business days before
the date of the meeting where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person meetings will be held
at 5600 Fishers Lane, Rockville,
Maryland 20857. For meeting
information updates, go to the COGME
website meeting page at https://
www.hrsa.gov/advisory-committees/
graduate-medical-edu/meetings/
index.html.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Shane Rogers, Designated Federal
Official, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N142, Rockville, Maryland 20857;
301–443–5260; or SRogers@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
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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. Since
priorities dictate meeting times, be
advised that start times, end times, and
agenda items are subject to change. For
CY 2021 meetings, agenda items may
include, but are not limited to,
discussion on topics surrounding rural
health workforce and training. Refer to
the COGME website listed above for all
current and updated information
concerning the CY 2021 COGME
meetings, including draft agendas and
meeting materials that will be posted 30
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
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
or make oral comments to COGME
should be sent to Shane Rogers using
the contact information above at least 5
business days before the meeting
date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Shane
Rogers using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend.
If a meeting is held in-person, it will
occur in a federal government building
and attendees must go through a
security check to enter. Non-U.S. citizen
attendees must notify HRSA of their
planned attendance at an in-person
meeting 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. 2021–00058 Filed 1–7–21; 8:45 am]
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Agencies
[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1517-1518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00093]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the National Advisory Committee on the National Health
Service Corps
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 National Advisory Committee on the National
Health Service Corps (NACNHSC) will hold public meetings for the 2021
calendar year (CY). Information about NACNHSC, agendas, and materials
for these meetings can be found on the NACNHSC website at https://nhsc.hrsa.gov/about/national-advisory-council-nhsc/.
DATES: NACNHSC meetings will be held on
March 16, 2021, 9:00 a.m.-5:00 p.m. Eastern Time (ET) and
March 17, 2021, 9:00 a.m.-2:00 p.m. ET;
June 22, 2021, 9:00 a.m.-5:00 p.m. ET and June 23, 2021,
9:00 a.m.-2:00 p.m. ET;
November 9, 2021, 9:00 a.m.-5: 00 p.m. ET and November 10,
2021, 9:00 a.m.-2:00 p.m. ET.
ADDRESSES: Meetings may be held in-person, by teleconference, and/or
Adobe Connect webinar. For updates on how the meeting will be held,
visit the NACNHSC website 30 business days before the date of the
meeting, where instructions for joining meetings either in-person or
remotely will also be posted. In-person NACNHSC meetings will be held
at 5600 Fishers Lane, Rockville, Maryland 20857. For meeting
information updates, go to the NACNHSC website meeting page at https://nhsc.hrsa.gov/nac/meetings.html.
FOR FURTHER INFORMATION CONTACT: Diane Fabiyi-King (DFO), Division of
National Health Service Corps, Bureau of Health Workforce, HRSA, 5600
Fishers Lane, Rockville, Maryland 20857; 301-443-3609; or
[email protected].
SUPPLEMENTARY INFORMATION: NACNHSC provides advice and recommendations
to the Secretary of HHS (Secretary) on policy, program development, and
other matters of significance concerning the activities under Subpart
II, Part D of Title III of the Public Health Service Act (42 U.S.C.
254d-254k). NACNHSC designates areas of the United States with health
professional shortages and assigns National Health Service Corps
clinicians to improve the delivery of health services in health
professional shortage areas. Since priorities dictate meeting times and
agenda items, be advised that start times, end times, and agenda items
are subject to change. For CY 2021 meetings, agenda items may include,
but are not limited to, the identification of NACNHSC priorities for
future
[[Page 1518]]
program issues and concerns; propose policy changes using the varying
levels of expertise represented on the Council to advise on specific
program areas; updates from clinician workforce experts; and education
and practice improvement in the training development of primary care
clinicians. More general items may include: Presentations and
discussions on the current and emerging needs of health workforce;
public health priorities; healthcare access and evaluation; NACNHSC-
approved sites; HRSA priorities and other federal health workforce and
education programs that impact the NACNHSC.
Refer to the NACNHSC website listed above for all current and
updated information concerning the CY 2021 NACNHSC meetings, including
draft agendas and meeting materials that will be posted 30 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 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 or make oral comments to the NACNHSC should
be sent to Diane Fabiyi-King using the contact information above at
least 5 business days before the meeting date(s).
Individuals who need special assistance or another reasonable
accommodation should notify Diane Fabiyi-King using the contact
information listed above at least 10 business days before the
meeting(s) they wish to attend.
If a meeting is held in-person, it will occur in a federal
government building and attendees must go through a security check to
enter. Non-U.S. Citizen attendees must notify HRSA of their planned
attendance at an in-person meeting 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. 2021-00093 Filed 1-7-21; 8:45 am]
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