National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings, 7352 [2016-02709]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
7352
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
VerDate Sep<11>2014
16:52 Feb 10, 2016
Jkt 238001
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]
BILLING CODE 4164–01–P
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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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]
BILLING CODE 4140–01–P
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.
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Page 7352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02709]
-----------------------------------------------------------------------
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 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]
BILLING CODE 4140-01-P
