Science Board to the Food and Drug Administration; Notice of Meeting, 51031-51032 [2012-20782]
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Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
The proposal also offered Dr. Shrum
an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. The
proposal was received on May 11, 2012.
Dr. Shrum failed to respond and has,
therefore, waived his opportunity for a
hearing and has waived any contentions
concerning his debarment (21 CFR part
12).
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(B) of the
FD&C Act, under authority delegated to
him (Staff Manual Guide 1410.35), finds
that Kelly Dean Shrum has been
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
As a result of the foregoing finding,
Dr. Shrum is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES) (see section 306(c)(1)(B) and
(c)(2)(A)(ii) of the FD&C Act and section
201(dd) of the FD&C Act (21 U.S.C.
321(dd))). Any person with an approved
or pending drug product application
who knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Dr. Shrum in any
capacity during Dr. Shrum’s debarment,
will be subject to civil money penalties
(section 307(a)(6) of the Act (21 U.S.C.
335b(a)(6))). If Dr. Shrum provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act. In addition, FDA will not
accept or review any abbreviated new
drug applications from Dr. Shrum
during his period of debarment (section
306(c)(1)(B) of the FD&C Act.
Any application by Dr. Shrum for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2012–N–0246 and sent to the
Division of Dockets Management (see
ADDRESSES). All such submissions are to
be filed in four copies. The public
availability of information in these
submissions is governed by 21 CFR
10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
[Docket No: FDA–2012–N–0001]
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Dated: August 8, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–20784 Filed 8–22–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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.
Name of Committee: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice
primarily 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; and 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.
DATES: Date and Time: The meeting will
be held on Wednesday, October 3, 2012,
from approximately 8:30 a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm 1503), Silver Spring, MD 20993. For
those unable to attend in person, the
meeting will also be webcast. The link
for the webcast is available at https://
collaboration.fda.gov/scienceboard/.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm, under
the heading ‘‘Resources for You,’’ click
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
51031
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Martha Monser,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4286, Silver Spring,
MD 20993, 301–796–4627, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. 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/Calendar/
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
presented with a draft charge to
establish a new subcommittee to
evaluate the Agency’s continuing work
to address the challenges identified in
the Board’s 2007 ‘‘Science and Mission
at Risk’’ Report. The Science Board will
be provided with updates from the
Center for Devices and Radiological
Health Research Review subcommittee
and the Global Health subcommittee.
The Science Board will also hear
progress updates on nanotechnology
and the ongoing activities in the priority
areas outlined in the Strategic Plan for
Regulatory Science. Overviews of
genomics activities at the National
Center for Toxological Research and the
Center for Biologics Evaluation and
Research will be presented. Finally, the
recipients of the FY2012 Scientific
Achievement awards (selected by the
Science Board) will provide overviews
of the activities for which the awards
were given.
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
E:\FR\FM\23AUN1.SGM
23AUN1
51032
Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
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 Wednesday,
September 26, 2012. Oral presentations
from the public will be scheduled
between approximately 1 p.m. and 1:30
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 Tuesday, September 18, 2012.
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
Wednesday, September 19, 2012.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Martha
Monser 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 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–20782 Filed 8–22–12; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 Cancer
Institute Special Emphasis Panel, NCI
Program Project Meeting II.
Date: October 3–4, 2012,
Time: 3:00 p.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications,
Place: National Institutes of Health
Neuroscience Center 6001 Executive
Boulevard Room A1/A2 Rockville, MD
20852.
Contact Person: Shakeel Ahmad, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH
6116 Executive Boulevard, Room 8139
Bethesda, MD 20892–8328, (301) 594–0114,
ahmads@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NCI
Program Project Meeting III.
Date: October 10–11, 2012.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center 5701 Marinelli Road
Bethesda, MD 20852.
Contact Person: Jeannette F. Korczak,
Ph.D., Scientific Review Officer Research
Programs Review Branch Division Of
Extramural Activities National Cancer
Institute, NIH 6116 Executive Blvd., Room
8115 Bethesda, MD 20892 301–496–9767,
korczakj@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NCI
Program Project Meeting IV.
Date: October 15–16, 2012.
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: Caterina Bianco, MD,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Cancer
Institute, NIH 6116 Executive Blvd., Ste.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
8134 Bethesda, MD 20892–8328, 301–496–
7011, biancoc@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NCI
Program Project Meeting V.
Date: October 18, 2012
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Cancer Institute, 6116 Executive
Boulevard, DEA Conference Room 8018,
Rockville, MD 20852.
Contact Person: Virginia P. Wray, Ph.D.,
Deputy Chief, Research Programs Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH 6116
Executive Blvd., Room 8125, Bethesda, MD
20892,–8328, 301–496–9236,
wrayv@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS).
Dated: August 17, 2012.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–20690 Filed 8–22–12; 8:45 am]
BILLING CODE 4140–01–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 (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: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Cancer and Lipids.
E:\FR\FM\23AUN1.SGM
23AUN1
Agencies
[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51031-51032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No: FDA-2012-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.
Name of Committee: Science Board to the Food and Drug
Administration (Science Board).
General Function of the Committee: The Science Board provides
advice primarily 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; and 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.
DATES: Date and Time: The meeting will be held on Wednesday, October 3,
2012, from approximately 8:30 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm 1503), Silver Spring, MD
20993. For those unable to attend in person, the meeting will also be
webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard/. Information regarding special
accommodations due to a disability, visitor parking, and transportation
may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm,
under the heading ``Resources for You,'' click on ``Public Meetings at
the FDA White Oak Campus.'' Please note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Martha Monser, Office of the Chief Scientist,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-
4627, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), to find out further information
regarding FDA advisory committee information. 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/Calendar/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 presented with a draft charge to
establish a new subcommittee to evaluate the Agency's continuing work
to address the challenges identified in the Board's 2007 ``Science and
Mission at Risk'' Report. The Science Board will be provided with
updates from the Center for Devices and Radiological Health Research
Review subcommittee and the Global Health subcommittee. The Science
Board will also hear progress updates on nanotechnology and the ongoing
activities in the priority areas outlined in the Strategic Plan for
Regulatory Science. Overviews of genomics activities at the National
Center for Toxological Research and the Center for Biologics Evaluation
and Research will be presented. Finally, the recipients of the FY2012
Scientific Achievement awards (selected by the Science Board) will
provide overviews of the activities for which the awards were given.
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
[[Page 51032]]
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
Wednesday, September 26, 2012. Oral presentations from the public will
be scheduled between approximately 1 p.m. and 1:30 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
Tuesday, September 18, 2012. 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
Wednesday, September 19, 2012.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Martha Monser 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 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-20782 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P