Science Board to the Food and Drug Administration; Notice of Meeting, 51278 [2015-20820]
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51278
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act:
Janssen Biotech, Inc., et. al. v.
Celltrion Healthcare Co., Ltd., et al., 15–
cv–10698 (D. Mass., filed March 6,
2015).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20780 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public, via Webcast.
Name of Committee: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice to
the Commissioner of Food and Drugs
and other appropriate officials on
specific, complex scientific and
technical issues important to the FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
VerDate Sep<11>2014
16:48 Aug 21, 2015
Jkt 235001
intramural and extramural scientific
research programs.
Date and Time: The meeting will be
held on September 15, 2015, from 4
p.m. until 5:30 p.m.
Location: This meeting will take place
via Webcast. To access the link for the
Webcast check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link. Information
regarding special accommodations due
to a disability may be accessed at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Contact Person: Rakesh Raghuwanshi,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, Bldg. 1, Rm. 3309,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The Science Board will be
provided with a report from the Science
Looking Forward subcommittee.
FDA intends to make background
material available to the public no later
than 2 business days before 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 September 8, 2015.
Oral presentations from the public will
be scheduled between approximately
4:30 p.m. and 5:30 p.m. Those
individuals 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
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
requested to make their presentation on
or before September 1, 2015. 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
September 2, 2015.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Rakesh
Raghuwanshi 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/
AdvisoryCommittees/
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: August 18, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20820 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0564]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dietary
Supplement Labeling Requirements
and Recommendations Under the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
SUMMARY:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20820]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Science Board to the Food and Drug Administration; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public, via Webcast.
Name of Committee: Science Board to the Food and Drug
Administration (Science Board).
General Function of the Committee: The Science Board provides
advice to the Commissioner of Food and Drugs and other appropriate
officials on specific, complex scientific and technical issues
important to the FDA and its mission, including emerging issues within
the scientific community. Additionally, the Science Board provides
advice to the Agency on keeping pace with technical and scientific
developments including in regulatory science, input into the Agency's
research agenda, and on upgrading its scientific and research
facilities and training opportunities. It will also provide, where
requested, expert review of Agency sponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be held on September 15, 2015, from
4 p.m. until 5:30 p.m.
Location: This meeting will take place via Webcast. To access the
link for the Webcast check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link. Information regarding special
accommodations due to a disability may be accessed at https://www.fda.gov/AdvisoryCommittees/default.htm.
Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist,
Office of the Commissioner, Food and Drug Administration, Bldg. 1, Rm.
3309, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4769,
rakesh.raghuwanshi@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The Science Board will be provided with a report from the
Science Looking Forward subcommittee.
FDA intends to make background material available to the public no
later than 2 business days before 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
September 8, 2015. Oral presentations from the public will be scheduled
between approximately 4:30 p.m. and 5:30 p.m. Those individuals
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 September 1, 2015.
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 September 2, 2015.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Rakesh Raghuwanshi
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/AdvisoryCommittees/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: August 18, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20820 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P
