Center for Scientific Review; Notice of Closed Meetings, 45642-45643 [2018-19484]
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Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices
e. What are the implications of these
contracting provisions and their changes
for the probability, severity, and
duration of drug shortages?
f. How much competition exists
throughout the supply chain? Over the
past 15 years, have there been
challenges to competition and if so,
what factors are responsible for these
challenges? For example, has
consolidation in different parts of the
supply chain created market barriers to
entry and reduced competition? If so,
what effect has the reduction in
competition had on drug shortages?
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C. Identifying Strategies for Preventing
or Mitigating Drug Shortages
1. What policies could the Federal
Government adopt, and what strategies
could it implement, that would reduce
the likelihood, severity, and duration of
shortages? Would additional authorities
be necessary or helpful? For example:
a. Establish a list of ‘‘essential
medicines’’ for use in preventing and
mitigating shortages. If such a list were
established, what should be the criteria
for inclusion? And how should such a
list be maintained and administered?
b. Provide financial incentives, such
as tax credits or revised reimbursement
policies: e.g., to allow additional
payments for drugs in or at risk of
shortage or to encourage investment to
expand manufacturing capacity or to
modernize aging infrastructure, to
enhance process capability and
variability control, or to prevent
manufacturing problems that affect
product availability;
c. Allow other entities (e.g., contract
manufacturers) to fill gaps in supply;
d. Require risk management plans to
help manufacturers prepare to respond
efficiently and effectively to potential
shortages;
e. Require the extension of expiration
dates for drugs in shortage or at risk of
shortage, where scientifically justified;
f. Revise trade policies and
authorities: e.g., to allow federal
purchasers to buy imported drugs or
raw materials to prevent or mitigate a
shortage;
g. Heighten scrutiny of proposed
mergers and acquisitions that increase
market concentration or the likelihood
of shortages;
h. Revise payment policies and
authorities: e.g., that would be coupled
with a requirement to establish
contingency plans for supplying
medicines that go into shortage; and
i. Federal investment in production
capacity for essential medicines directly
related to national security, emergency
preparedness, and defense.
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2. In designing new policies to
prevent or mitigate shortages, how can
the Federal Government avoid creating
perverse incentives or negative
cascading effects in the health care
financing and delivery system? For
example, how might changes to
government payment and
reimbursement affect the other sectors
of the market?
3. Are there lessons for the Federal
Government, or practices that it can
emulate, from strategies used to prevent
or mitigate shortages in other
commodity markets that face shortage
issues?
4. What challenges does the global
nature of drug manufacturing and
marketing pose for efforts to prevent
shortages in the U.S. market?
5. As drug shortages are a national
problem, what are the sources of
funding that can be applied to provide
incentives to remedy the root causes?
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://healthpolicy.duke.edu/
events/drug-shortage-task-force. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. Registration is free and based
on space availability, with priority given
to early registrants. Persons interested in
attending this public meeting must
register by Wednesday, November 21,
2018, midnight Eastern Time. There will
be no onsite registration. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when they have
been accepted. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. The Duke-Margolis Center for
Health Policy will post on its website if
registration closes before the day of the
public meeting.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy (phone: 202–791–9561,
email: sarah.supsiri@duke.edu) no later
than November 20, 2018.
Streaming webcast of the public
workshop: This public workshop will be
webcast live. Persons interested in
viewing the live webcast may register
ahead of the event by visiting https://
healthpolicy.duke.edu/events/drugshortage-task-force. The live webcast
will also be available at the website
above on the day of the event without
pre-registration. Archived video footage
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will be available at the Duke-Margolis
website following the workshop.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/Drugs/
DrugSafety/DrugShortages/default.htm.
Other Issues for Consideration: A 1hour lunch break is scheduled, but food
will not be provided. There are multiple
restaurants within walking distance of
the Washington Marriott at Metro
Center, 775 12th St. NW, Washington,
DC 20005.
All event materials will be provided
to registered attendees via email prior to
the workshop and will be publicly
available at the Duke-Margolis Center
for Health Policy website at https://
healthpolicy.duke.edu/events/drugshortage-task-force.
Dated: September 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19612 Filed 9–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hypertension and Microcirculation Study
Section.
Date: October 2–3, 2018.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Ai-Ping Zou, M.D., Ph.D.,
Scientific Review Officer, Center for
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Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9497, zouai@mail.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Mechanisms of
Sensory, Perceptual, and Cognitive Processes
Study Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW, Washington, DC 20037.
Contact Person: Kirk Thompson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
MSC 7844, Bethesda, MD 20892, 301–435–
1242, kgt@mail.nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Enabling Bioanalytical and
Imaging Technologies Study Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal City Marriott, 1999 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Kenneth Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3218,
MSC 7717, Bethesda, MD 20892, 301–435–
0229, kenneth.ryan@nih.hhs.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Interventions to Prevent and Treat
Addictions Study Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Palomar Hotel, 2121 P Street NW,
Washington, DC 20037.
Contact Person: Miriam Mintzer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
Bethesda, MD 20892, (301) 523–0646,
mintzermz@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Biology of the
Visual System Study Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Michael H Chaitin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202,
MSC 7850, Bethesda, MD 20892, (301) 435–
0910, chaitinm@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Bioengineering,
Technology and Surgical Sciences Study
Section.
Date: October 4–5, 2018.
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Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Khalid Masood, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5120,
MSC 7854, Bethesda, MD 20892, 301–435–
2392, masoodk@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Neuroscience and
Ophthalmic Imaging Technologies Study
Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington DC
Downtown Hotel, 999 9th St. NW,
Washington, DC 20001.
Contact Person: Yvonne Bennett, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5199,
MSC 7846, Bethesda, MD 20892, 301–379–
3793, bennetty@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Cellular and Molecular
Biology of Glia Study Section.
Date: October 4–5, 2018.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW, Washington, DC 20036.
Contact Person: Linda MacArthur, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
Bethesda, MD 20892, 301–537–9986,
macarthurlh@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group; Cellular and
Molecular Immunology—B Study Section.
Date: October 4–5, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Grand Chicago
Riverfront, 71 E Wacker Dr., Chicago, IL
60601.
Contact Person: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4206,
MSC 7812, Bethesda, MD 20892, 301–435–
1223, haydenb@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 4, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–19484 Filed 9–7–18; 8:45 am]
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45643
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Developing
Infrastructure for Interdisciplinary Aging
Research.
Date: September 24, 2018.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W–200, 7201
Wisconsin Avenue, Bethesda, MD 20892.
Contact Person: Anita H. Undale, Ph.D.,
MD, Scientific Review Branch, National
Institute on Aging, Gateway Building, Suite
2W200, 7201 Wisconsin Avenue, Bethesda,
MD 20892, 240–747–7825, anita.undale@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 4, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–19481 Filed 9–7–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee to
the Deputy Director for Intramural
Research, National Institutes of Health.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
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[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45642-45643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19484]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Vascular and Hematology Integrated Review
Group; Hypertension and Microcirculation Study Section.
Date: October 2-3, 2018.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Ai-Ping Zou, M.D., Ph.D., Scientific Review
Officer, Center for
[[Page 45643]]
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 4118, MSC 7814, Bethesda, MD 20892, 301-408-9497,
[email protected].
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Mechanisms of Sensory,
Perceptual, and Cognitive Processes Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Melrose Hotel, 2430 Pennsylvania Ave. NW, Washington, DC
20037.
Contact Person: Kirk Thompson, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301-435-
1242, [email protected].
Name of Committee: Interdisciplinary Molecular Sciences and
Training Integrated Review Group; Enabling Bioanalytical and Imaging
Technologies Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Crystal City Marriott, 1999 Jefferson Davis Highway,
Arlington, VA 22202.
Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, 301-435-
0229, [email protected].
Name of Committee: Risk, Prevention and Health Behavior
Integrated Review Group; Interventions to Prevent and Treat
Addictions Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Palomar Hotel, 2121 P Street NW, Washington, DC 20037.
Contact Person: Miriam Mintzer, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108, Bethesda, MD 20892, (301)
523-0646, [email protected].
Name of Committee: Cell Biology Integrated Review Group; Biology
of the Visual System Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Michael H Chaitin, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202, MSC 7850, Bethesda, MD
20892, (301) 435-0910, [email protected].
Name of Committee: Surgical Sciences, Biomedical Imaging and
Bioengineering Integrated Review Group; Bioengineering, Technology
and Surgical Sciences Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Khalid Masood, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5120, MSC 7854, Bethesda, MD 20892, 301-435-
2392, [email protected].
Name of Committee: Emerging Technologies and Training
Neurosciences Integrated Review Group; Neuroscience and Ophthalmic
Imaging Technologies Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Washington DC Downtown Hotel, 999 9th St. NW,
Washington, DC 20001.
Contact Person: Yvonne Bennett, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5199, MSC 7846, Bethesda, MD
20892, 301-379-3793, [email protected].
Name of Committee: Molecular, Cellular and Developmental
Neuroscience Integrated Review Group; Cellular and Molecular Biology
of Glia Study Section.
Date: October 4-5, 2018.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: St. Gregory Hotel, 2033 M Street NW, Washington, DC
20036.
Contact Person: Linda MacArthur, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301-
537-9986, [email protected].
Name of Committee: Immunology Integrated Review Group; Cellular
and Molecular Immunology--B Study Section.
Date: October 4-5, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Wyndham Grand Chicago Riverfront, 71 E Wacker Dr.,
Chicago, IL 60601.
Contact Person: Betty Hayden, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-
1223, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: September 4, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-19484 Filed 9-7-18; 8:45 am]
BILLING CODE 4140-01-P
