83 FR 45642 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 175 (September 10, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 175 (September 10, 2018)
| Page Range | 45642-45643 | |
| FR Document | 2018-19484 |
[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)] [Notices] [Pages 45642-45643] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19484] ----------------------------------------------------------------------- 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
![45642 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices
e. What are the implications of these 2. In designing new policies to will be available at the Duke-Margolis
contracting provisions and their changes prevent or mitigate shortages, how can website following the workshop.
for the probability, severity, and the Federal Government avoid creating Transcripts: Please be advised that as
duration of drug shortages? perverse incentives or negative soon as a transcript of the public
f. How much competition exists cascading effects in the health care meeting is available, it will be accessible
throughout the supply chain? Over the financing and delivery system? For at https://www.regulations.gov. It may
past 15 years, have there been example, how might changes to be viewed at the Dockets Management
challenges to competition and if so, government payment and Staff (see ADDRESSES). A link to the
what factors are responsible for these reimbursement affect the other sectors transcript will also be available on the
challenges? For example, has of the market? internet at https://www.fda.gov/Drugs/
consolidation in different parts of the 3. Are there lessons for the Federal DrugSafety/DrugShortages/default.htm.
supply chain created market barriers to Government, or practices that it can Other Issues for Consideration: A 1-
entry and reduced competition? If so, emulate, from strategies used to prevent hour lunch break is scheduled, but food
what effect has the reduction in or mitigate shortages in other will not be provided. There are multiple
competition had on drug shortages? commodity markets that face shortage restaurants within walking distance of
issues? the Washington Marriott at Metro
C. Identifying Strategies for Preventing Center, 775 12th St. NW, Washington,
or Mitigating Drug Shortages 4. What challenges does the global
nature of drug manufacturing and DC 20005.
1. What policies could the Federal marketing pose for efforts to prevent All event materials will be provided
Government adopt, and what strategies shortages in the U.S. market? to registered attendees via email prior to
could it implement, that would reduce 5. As drug shortages are a national the workshop and will be publicly
the likelihood, severity, and duration of problem, what are the sources of available at the Duke-Margolis Center
shortages? Would additional authorities funding that can be applied to provide for Health Policy website at https://
be necessary or helpful? For example: incentives to remedy the root causes? healthpolicy.duke.edu/events/drug-
a. Establish a list of ‘‘essential shortage-task-force.
medicines’’ for use in preventing and III. Participating in the Public Meeting Dated: September 5, 2018.
mitigating shortages. If such a list were Registration: To register for the public Leslie Kux,
established, what should be the criteria meeting, please visit the following Associate Commissioner for Policy.
for inclusion? And how should such a website: https://healthpolicy.duke.edu/ [FR Doc. 2018–19612 Filed 9–7–18; 8:45 am]
list be maintained and administered? events/drug-shortage-task-force. Please BILLING CODE 4164–01–P
b. Provide financial incentives, such provide complete contact information
as tax credits or revised reimbursement for each attendee, including name, title,
policies: e.g., to allow additional affiliation, address, email, and DEPARTMENT OF HEALTH AND
payments for drugs in or at risk of telephone. Registration is free and based HUMAN SERVICES
shortage or to encourage investment to on space availability, with priority given
expand manufacturing capacity or to to early registrants. Persons interested in National Institutes of Health
modernize aging infrastructure, to attending this public meeting must
enhance process capability and register by Wednesday, November 21, Center for Scientific Review; Notice of
variability control, or to prevent 2018, midnight Eastern Time. There will Closed Meetings
manufacturing problems that affect be no onsite registration. Early Pursuant to section 10(d) of the
product availability; registration is recommended because Federal Advisory Committee Act, as
c. Allow other entities (e.g., contract seating is limited; therefore, FDA may amended, notice is hereby given of the
manufacturers) to fill gaps in supply; limit the number of participants from following meetings.
d. Require risk management plans to each organization. Registrants will The meetings will be closed to the
help manufacturers prepare to respond receive confirmation when they have public in accordance with the
efficiently and effectively to potential been accepted. If you are unable to provisions set forth in sections
shortages; attend the meeting in person, you can 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
e. Require the extension of expiration register to view a live webcast of the as amended. The grant applications and
dates for drugs in shortage or at risk of meeting. The Duke-Margolis Center for the discussions could disclose
shortage, where scientifically justified; Health Policy will post on its website if confidential trade secrets or commercial
f. Revise trade policies and registration closes before the day of the property such as patentable material,
authorities: e.g., to allow federal public meeting. and personal information concerning
purchasers to buy imported drugs or If you need special accommodations individuals associated with the grant
raw materials to prevent or mitigate a due to a disability, please contact Sarah applications, the disclosure of which
shortage; Supsiri at the Duke-Margolis Center for would constitute a clearly unwarranted
g. Heighten scrutiny of proposed Health Policy (phone: 202–791–9561, invasion of personal privacy.
mergers and acquisitions that increase email: sarah.supsiri@duke.edu) no later Name of Committee: Vascular and
market concentration or the likelihood than November 20, 2018. Hematology Integrated Review Group;
of shortages; Streaming webcast of the public Hypertension and Microcirculation Study
h. Revise payment policies and workshop: This public workshop will be Section.
authorities: e.g., that would be coupled webcast live. Persons interested in Date: October 2–3, 2018.
daltland on DSKBBV9HB2PROD with NOTICES
with a requirement to establish viewing the live webcast may register Time: 8:00 a.m. to 7:00 p.m.
contingency plans for supplying ahead of the event by visiting https:// Agenda: To review and evaluate grant
applications.
medicines that go into shortage; and healthpolicy.duke.edu/events/drug- Place: Embassy Suites at the Chevy Chase
i. Federal investment in production shortage-task-force. The live webcast Pavilion, 4300 Military Road NW,
capacity for essential medicines directly will also be available at the website Washington, DC 20015.
related to national security, emergency above on the day of the event without Contact Person: Ai-Ping Zou, M.D., Ph.D.,
preparedness, and defense. pre-registration. Archived video footage Scientific Review Officer, Center for
VerDate Sep<11>2014 17:54 Sep 07, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1](https://thefederalregister.org/doc/83_FR_45817/page/1.svg)
![Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45643
Scientific Review, National Institutes of Time: 8:00 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND
Health, 6701 Rockledge Drive, Room 4118, Agenda: To review and evaluate grant HUMAN SERVICES
MSC 7814, Bethesda, MD 20892, 301–408– applications.
9497, zouai@mail.nih.gov. Place: Hilton Washington/Rockville, 1750 National Institutes of Health
Name of Committee: Integrative, Rockville Pike, Rockville, MD 20852.
Functional and Cognitive Neuroscience Contact Person: Khalid Masood, Ph.D., National Institute on Aging; Notice of
Integrated Review Group; Mechanisms of Scientific Review Officer, Center for Closed Meeting
Sensory, Perceptual, and Cognitive Processes Scientific Review, National Institutes of
Study Section. Health, 6701 Rockledge Drive, Room 5120, Pursuant to section 10(d) of the
Date: October 4–5, 2018. MSC 7854, Bethesda, MD 20892, 301–435– Federal Advisory Committee Act, as
Time: 8:00 a.m. to 5:00 p.m. 2392, masoodk@csr.nih.gov. amended, notice is hereby given of the
Agenda: To review and evaluate grant Name of Committee: Emerging following meeting.
applications. Technologies and Training Neurosciences The meeting will be closed to the
Place: Melrose Hotel, 2430 Pennsylvania Integrated Review Group; Neuroscience and
Ave. NW, Washington, DC 20037.
public in accordance with the
Ophthalmic Imaging Technologies Study provisions set forth in sections
Contact Person: Kirk Thompson, Ph.D., Section.
Scientific Review Officer, Center for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Date: October 4–5, 2018.
Scientific Review, National Institutes of Time: 8:00 a.m. to 6:00 p.m.
as amended. The grant applications and
Health, 6701 Rockledge Drive, Room 5184, Agenda: To review and evaluate grant the discussions could disclose
MSC 7844, Bethesda, MD 20892, 301–435– applications. confidential trade secrets or commercial
1242, kgt@mail.nih.gov. Place: Renaissance Washington DC property such as patentable material,
Name of Committee: Interdisciplinary Downtown Hotel, 999 9th St. NW, and personal information concerning
Molecular Sciences and Training Integrated Washington, DC 20001. individuals associated with the grant
Review Group; Enabling Bioanalytical and Contact Person: Yvonne Bennett, Ph.D., applications, the disclosure of which
Imaging Technologies Study Section. Scientific Review Officer, Center for
Date: October 4–5, 2018.
would constitute a clearly unwarranted
Scientific Review, National Institutes of invasion of personal privacy.
Time: 8:00 a.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 5199,
Agenda: To review and evaluate grant MSC 7846, Bethesda, MD 20892, 301–379– Name of Committee: National Institute on
applications. 3793, bennetty@csr.nih.gov. Aging Special Emphasis Panel; Developing
Place: Crystal City Marriott, 1999 Jefferson Infrastructure for Interdisciplinary Aging
Davis Highway, Arlington, VA 22202. Name of Committee: Molecular, Cellular
Research.
Contact Person: Kenneth Ryan, Ph.D., and Developmental Neuroscience Integrated
Date: September 24, 2018.
Scientific Review Officer, Center for Review Group; Cellular and Molecular
Time: 10:00 a.m. to 1:00 p.m.
Scientific Review, National Institutes of Biology of Glia Study Section.
Agenda: To review and evaluate grant
Health, 6701 Rockledge Drive, Room 3218, Date: October 4–5, 2018.
applications.
MSC 7717, Bethesda, MD 20892, 301–435– Time: 8:00 a.m. to 4:00 p.m.
Place: National Institute on Aging,
0229, kenneth.ryan@nih.hhs.gov. Agenda: To review and evaluate grant
Gateway Building, Suite 2W–200, 7201
applications. Wisconsin Avenue, Bethesda, MD 20892.
Name of Committee: Risk, Prevention and
Place: St. Gregory Hotel, 2033 M Street Contact Person: Anita H. Undale, Ph.D.,
Health Behavior Integrated Review Group;
NW, Washington, DC 20036. MD, Scientific Review Branch, National
Interventions to Prevent and Treat
Contact Person: Linda MacArthur, Ph.D., Institute on Aging, Gateway Building, Suite
Addictions Study Section.
Scientific Review Officer, Center for 2W200, 7201 Wisconsin Avenue, Bethesda,
Date: October 4–5, 2018.
Scientific Review, National Institutes of MD 20892, 240–747–7825, anita.undale@
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 4187, nih.gov.
applications. Bethesda, MD 20892, 301–537–9986,
macarthurlh@csr.nih.gov. (Catalogue of Federal Domestic Assistance
Place: Palomar Hotel, 2121 P Street NW, Program Nos. 93.866, Aging Research,
Washington, DC 20037. Name of Committee: Immunology National Institutes of Health, HHS)
Contact Person: Miriam Mintzer, Ph.D., Integrated Review Group; Cellular and
Scientific Review Officer, Center for Molecular Immunology—B Study Section. Dated: September 4, 2018.
Scientific Review, National Institutes of Date: October 4–5, 2018. Melanie J. Pantoja,
Health, 6701 Rockledge Drive, Room 3108, Time: 8:30 a.m. to 5:00 p.m. Program Analyst, Office of Federal Advisory
Bethesda, MD 20892, (301) 523–0646, Agenda: To review and evaluate grant Committee Policy.
mintzermz@csr.nih.gov. applications. [FR Doc. 2018–19481 Filed 9–7–18; 8:45 am]
Name of Committee: Cell Biology Place: Wyndham Grand Chicago
BILLING CODE 4140–01–P
Integrated Review Group; Biology of the Riverfront, 71 E Wacker Dr., Chicago, IL
Visual System Study Section. 60601.
Date: October 4–5, 2018. Contact Person: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for DEPARTMENT OF HEALTH AND
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant Scientific Review, National Institutes of HUMAN SERVICES
applications. Health, 6701 Rockledge Drive, Room 4206,
Place: Hyatt Regency Bethesda, One MSC 7812, Bethesda, MD 20892, 301–435– National Institutes of Health
Bethesda Metro Center, 7400 Wisconsin 1223, haydenb@csr.nih.gov.
Avenue, Bethesda, MD 20814. (Catalogue of Federal Domestic Assistance Office of the Director, National
Contact Person: Michael H Chaitin, Ph.D., Program Nos. 93.306, Comparative Medicine; Institutes of Health; Notice of Meeting
Scientific Review Officer, Center for 93.333, Clinical Research, 93.306, 93.333,
Pursuant to section 10(a) of the
Scientific Review, National Institutes of 93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National Federal Advisory Committee Act, as
Health, 6701 Rockledge Drive, Room 5202,
Institutes of Health, HHS) amended, notice is hereby given of a
daltland on DSKBBV9HB2PROD with NOTICES
MSC 7850, Bethesda, MD 20892, (301) 435–
0910, chaitinm@csr.nih.gov. meeting of the Advisory Committee to
Dated: September 4, 2018.
Name of Committee: Surgical Sciences,
the Deputy Director for Intramural
Melanie J. Pantoja, Research, National Institutes of Health.
Biomedical Imaging and Bioengineering
Program Analyst, Office of Federal Advisory The meeting will be open to the
Integrated Review Group; Bioengineering,
Committee Policy. public, with attendance limited to space
Technology and Surgical Sciences Study
Section. [FR Doc. 2018–19484 Filed 9–7–18; 8:45 am] available. Individuals who plan to
Date: October 4–5, 2018. BILLING CODE 4140–01–P attend and need special assistance, such
VerDate Sep<11>2014 17:54 Sep 07, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1](https://thefederalregister.org/doc/83_FR_45817/page/2.svg)
Document Created: 2018-09-08 00:43:19
Document Modified: 2018-09-08 00:43:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | October 2-3, 2018. | |
| FR Citation | 83 FR 45642 |
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