National Institute on Aging; Notice of Closed Meeting, 7352-7353 [2016-02708]
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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices
to lead to an adverse effect on the safety
or effectiveness of the drug or category
of drugs, taking into account the risks
and benefits to patients, or the drug is
compounded in accordance with all
applicable conditions identified on the
list as conditions that are necessary to
prevent the drug or category of drugs
from presenting such demonstrable
difficulties (see section 503B(a)(6)(A)
and (B) of the FD&C Act).
FDA will discuss with the committee
drugs proposed for inclusion on the
section 503A bulk drug substances list
and on the demonstrably difficult to
compound list under sections 503A and
503B of the FD&C Act.
Agenda: On March 8, 2016, the
committee will discuss six bulk drug
substances nominated for inclusion on
the section 503A bulk drug substances
list. FDA will discuss the following
nominated bulk drug substances:
Quinacrine hydrochloride, boswellia,
aloe vera 200:1 freeze dried, D-ribose,
chondroitin sulfate, and acetyl-Lcarnitine. The nominators of these
substances will be invited to make a
short presentation supporting the
nomination.
On March 9, 2016, the committee will
discuss two categories of drug products
nominated for the list of drug products
that present demonstrable difficulties
for compounding. These categories of
drug products are metered dose inhalers
and dry powder inhalers. The
nominators who nominated the category
of drugs or specific drug products in the
category will be invited to make a short
presentation supporting the nomination.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 1, 2016. Oral
presentations from the public will be
scheduled between approximately 11
a.m. to 11:15 a.m. and 3:15 p.m. to 3:30
p.m. on March 8, 2016, and between
approximately 11:30 a.m. to 12 noon on
March 9, 2016. Those individuals
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interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before February
24, 2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 25, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Cindy Hong at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–02786 Filed 2–8–16; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
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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 of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Career Award and
Conference Grant Review (2016/05).
Date: March 18, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Mark Martin, Ph.D.,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 920, Bethesda, MD 20892,
(240) 447–2148, mark.martin@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; P41 BTRC review
(2016/05).
Date: March 23–25, 2016.
Time: 6:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Boston Beacon Hill, 5
Blossom Street, Boston, MA 02114.
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Bethesda, MD 20892, (301)
451–4794, dennis.hlasta@nih.gov.
Dated: February 4, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02709 Filed 2–10–16; 8:45 am]
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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 (5 U.S.C. App.), 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.
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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices
Name of Committee: National Institute on
Aging Special Emphasis Panel Age-Related
Hearing Loss.
Date: March 9, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kimberly Firth, Ph.D.,
National Institutes of Health, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7702, firthkm@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: February 5, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02708 Filed 2–10–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Kidney Interagency
Coordinating Committee Meeting
The Kidney Interagency
Coordinating Committee (KICC) will
hold a meeting on March 11, 2016, on
the programmatic implications of the
United States Renal Data System
(USRDS) to federal agencies. The
meeting is open to the public.
DATES: The meeting will be held on
March 11, 2016, 9 a.m. to 12 p.m.
Individuals wanting to present oral
comments must notify the contact
person at least 10 days before the
meeting date.
ADDRESSES: The meeting will be held in
the Natcher Conference Center on the
NIH Campus at 9000 Rockville Pike,
Bethesda, MD 20894.
FOR FURTHER INFORMATION CONTACT: For
further information concerning this
meeting, contact Dr. Andrew S. Narva,
Executive Secretary of the Kidney
Interagency Coordinating Committee,
National Institute of Diabetes and
Digestive and Kidney Diseases, 31
Center Drive, Building 31A, Room
9A27, MSC 2560, Bethesda, MD 20892–
2560, telephone: 301–594–8864; FAX:
301–480–0243; email: healthinfo@
niddk.nih.gov.
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SUMMARY:
The KICC,
chaired by the National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), comprises members
SUPPLEMENTARY INFORMATION:
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of the Department of Health and Human
Services and other federal agencies that
support kidney-related activities,
facilitates cooperation, communication,
and collaboration on kidney disease
among government entities. KICC
meetings, held twice a year, provide an
opportunity for Committee members to
learn about and discuss current and
future kidney programs in KICC member
organizations and to identify
opportunities for collaboration. The
March 11, 2016 KICC meeting will focus
on the programmatic implications of the
USRDS for government agencies.
Any member of the public interested
in presenting oral comments to the
Committee should notify the contact
person listed on this notice at least 10
days in advance of the meeting.
Interested individuals and
representatives or organizations should
submit a letter of intent, a brief
description of the organization
represented, and a written copy of their
oral presentation in advance of the
meeting. Only one representative of an
organization will be allowed to present;
oral comments and presentations will be
limited to a maximum of 5 minutes.
Printed and electronic copies are
requested for the record. In addition,
any interested person may file written
comments with the Committee by
forwarding their statement to the
contact person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Because of time constraints for the
meeting, oral comments will be allowed
on a first-come, first-serve basis.
Members of the public who would
like to receive email notification about
future KICC meetings should send a
request to healthinfo@niddk.nih.gov.
Dated: February 2, 2016.
Camille M. Hoover,
Executive Officer, National Institute of
Diabetes and Digestive and Kidney Diseases,
National Institutes of Health.
[FR Doc. 2016–02809 Filed 2–10–16; 8:45 am]
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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 (5 U.S.C. App.), notice is
hereby given of the following meetings.
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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: Oncology 1-Basic
Translational Integrated Review Group;
Cancer Molecular Pathobiology Study
Section.
Date: February 25–26, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Fairmont Hotel San Francisco, 950
Mason Street, San Francisco, CA 94108.
Contact Person: Manzoor Zarger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892, (301) 435–
2477, zargerma@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Genetics.
Date: March 2, 2016.
Time: 4:00 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Dominique Lorang-Leins,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7766, Bethesda, MD 20892,
301.326.9721, Lorangd@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology.
Date: March 3–4, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–13–
231: Phenotyping Embryonic Lethal
Knockout Mice.
Date: March 4, 2016.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
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Agencies
[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7352-7353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02708]
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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 (5 U.S.C. App.), 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.
[[Page 7353]]
Name of Committee: National Institute on Aging Special Emphasis
Panel Age-Related Hearing Loss.
Date: March 9, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, Suite
2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Kimberly Firth, Ph.D., National Institutes of
Health, National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702,
firthkm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: February 5, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-02708 Filed 2-10-16; 8:45 am]
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