[Federal Register Volume 76, Number 201 (Tuesday, October 18, 2011)]
[Notices]
[Pages 64355-64356]
From the Federal Register Online via the Government Printing 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

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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