[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Page 25359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10763]

[[Page 25359]]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Science Board Advisory Committee; 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 and technical issues, as well 
as emerging issues within the scientific community in industry and 
academia. Additionally, the Science Board provides advice to the Agency 
on keeping pace with technical and scientific evolutions in the fields 
of regulatory science, on formulating an appropriate research agenda, 
and on upgrading its scientific and research facilities to keep pace 
with these changes. It will also provide the means for critical review 
of Agency sponsored intramural and extramural scientific research 
    Date and Time: The meeting will be held on Friday, May 20, 2011, 
from 9 a.m. to 4 p.m.
    Location: Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 1503, Silver Spring, MD 20993-0002. Information regarding 
special accommodations due to a disability, visitor parking, and 
transportation may be accessed at: http://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. For those unable to attend in person, the meeting will also be Web 
cast. The link for the Web cast is available at https://collaboration.fda.gov/scienceboard.
    Contact Person: Martha Monser, Office of the Commissioner, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, 
Silver Spring, MD 20993-0002, 301-796-4627, 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 May 20, 2011, the Science Board will discuss the report 
from the subcommittee's review of the Pharmacovigilance Program at the 
Center for Drug Evaluation and Research. The Science Board will be 
provided with updates on FDA's nanotechnology research program plans 
and on FDA's activities in support of Comparative Effectiveness 
Research. The Science Board will also initiate the charge to the 
subcommittee for a science review of the Center for Devices and 
Radiological Health.
    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: 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 May 
13, 2011. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 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 May 5, 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 May 6, 2011.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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 http://www.fda.gov/AdvisoryCommittees/About AdvisoryCommittees/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: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10763 Filed 5-3-11; 8:45 am]