[Federal Register Volume 76, Number 201 (Tuesday, October 18, 2011)]
[Notices]
[Pages 64355-64356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26891]
[[Page 64355]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Science Advisory Board to the National Center for Toxicological
Research; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 8, 2011, from
8:15 a.m. to 5:30 p.m. and on November 9, 2011, from 8:30 a.m. to 1
p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Rd., Jefferson,
AR 72079.
Contact Person: Margaret Miller, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD. 20993-
0002, 301-796-8890, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), and follow the
prompts to the desired center or product area. Please call the
Information Line for up-to-date information on this meeting. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On November 8, 2011, the NCTR Director will welcome the
participants and provide a Center-wide update on scientific initiatives
and accomplishments during the past year. The SAB will then briefly
review the subcommittee report on the Division of Neurotoxicology,
which was adopted by the full committee at the last meeting. The
Director of the Division of Neurotoxicology will provide a response to
the report, noting the changes that have been implemented based on the
recommendations in the report.
A representative from FDA's Office of Science will present the
Agency's Regulatory Science Strategic Plan and speak about the Agency's
Medical Countermeasure Initiative.
The Directors for the Division of Microbiology and the Division of
Personalized Nutrition and Medicine will update the SAB on the major
research accomplishments of the past year, the important implications
of their findings for FDA, and the research direction of the division,
including issues requiring input from the Committee. The SAB will then
discuss the research direction and provide advice on the state of the
science, future research directions, and impact of the findings on the
public health.
The Center representatives from the Center for Veterinary Medicine
and the Center for Food Safety and Applied Nutrition will describe
their Center's regulatory mandate, public health mission, and strategic
research needs, and discuss opportunities for collaboration to help
address these needs. This information will be considered by NCTR's SAB
in their recommendations for the future direction of NCTR's research
activities. Next, a member of the SAB will present future research
needs in the area of regulatory science for personalized nutrition.
Following the public session, the SAB will hear a presentation by
the representative from the National Toxicology Program (NTP) on the
current and future research collaborations between the National
Institute of Environmental Health Sciences (NIEHS) and the NCTR. This
presentation will be followed by an update from NCTR's Office of
Science Coordination on the NTP studies being conducted at NCTR and
those studies that will commence during the next year.
Next, the Chair of the Nanotechnology Core Facility Subcommittee
will present an overview of the Nanotechnology Core Facility and
subcommittee report. On August 16-17, 2011, the subcommittee convened
to conduct an indepth review of the NCTR/ORA Nanotechnology Core
Facility. The Nanotechnology Core Facility is jointly sponsored by
FDA's NCTR and Office of Regulatory Affairs, and NIEHS/NTP to support
nanotechnology-related scientific studies through the characterization
and detection of nanomaterials in toxicology studies and to develop
analytical methods to accurately monitor nanotechnology-based FDA-
regulated products. Representatives from FDA's Office of the
Commissioner and product Centers, as well as a representative from the
NTP/NIEHS, participated in the evaluation. The site visit report will
be presented to the full Committee and then open for discussion by all
participants before a vote for adoption by the full SAB. All members of
the NCTR SAB and the Center representatives will have an opportunity to
comment on the Nanotechnology Core Facility Subcommittee report.
Following consideration of the Nanotechnology Core Facility
Subcommittee Review report, a member of the SAB will present a vision
for research needs to advance regulatory science in the area of
pharmaceuticals.
On November 9, 2011, the Center representatives from the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research will describe their Center's regulatory mandate, public
health mission, and strategic research needs; and discuss opportunities
for collaboration to help address these needs. Again, this information
will be considered by NCTR's SAB in their recommendations for the
future direction of NCTR's research activities.
The Directors for the Division of Biochemical Toxicology and the
Division of Systems Biology will update the SAB on the major research
accomplishments of the past year, the important implications of the
findings for FDA, and the research direction of the division, including
issues needing input from the Committee. The SAB will then discuss the
research direction and provide advice on the state of the science,
future research directions, and impact of the findings on the public
health.
NCTR's Center Director will discuss research priorities, alignment
of NCTR with the Agency's regulatory science initiative, and the
strategic focus for future research at NCTR.
The Center representative from the Center for Devices and
Radiological Health and the Center for Tobacco Products will present
their regulatory mandate, public health mission, and strategic research
needs; and discuss opportunities for collaboration to help address
these needs. Again, this information will be considered by NCTR's SAB
in their recommendations for the future direction of NCTR's research
activities.
The Director for the Division of Genetic and Molecular Toxicology
will update the SAB on the major research accomplishments of the past
year, the important implications of the findings for FDA, and the
research direction of the division, including issues needing
[[Page 64356]]
input from the Committee. The SAB will then discuss the research
direction and provide advice on the state of the science, future
research directions, and impact of the findings on the public health.
Following an open discussion of all the information presented, the
open session of the meeting will close so that the SAB members can
discuss personnel issues at NCTR.
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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On November 8, 2011, from 8:15 a.m. to 4:20 p.m., the
meeting is open to the public. 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 October 28, 2011. Oral presentations from the public will be
scheduled between approximately 1 p.m. to 2 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 October 20, 2011.
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 October 21, 2011.
Closed Committee Deliberations: On November 9, 2011, the meeting
will be closed to permit discussion where disclosure would constitute a
clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).
This portion of the meeting will be closed to permit discussion of
information concerning individuals associated with the research
programs at NCTR.
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 Margaret Miller 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 http://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: October 11, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-26891 Filed 10-17-11; 8:45 am]
BILLING CODE 4160-01-P