80 FR 67766 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 212 (November 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 212 (November 3, 2015)
| Page Range | 67766-67766 | |
| FR Document | 2015-27957 |
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)] [Notices] [Page 67766] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27957] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Science Board to the Food and Drug Administration 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 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 November 18, 2015, from 9 a.m. until 4 p.m. Location: Food and Drug Administration, White Oak 31, Rm. 1503, Section A, 10903 New Hampshire Ave., 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/scienceboard1115/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, White Oak Bldg. 1 Rm. 3309, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4769, [email protected], 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 http://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 updates from the Center for Food Safety and Applied Nutrition, Centers for Excellence in Regulatory Science and Innovation, Evaluation Subcommittee and the ORA Food Emergency Response Network Evaluation Subcommittee. The Board will hear about the scope of FDA's involvement in precision medicine, as well as an overview of specific health informatics initiatives including precision FDA, Open FDA, and Chillax. The Board will also hear about FDA's laboratory safety initiative. A recipient of one of the FY 2014 Scientific Achievement Awards (selected by the Board) will provide an overview of the activities for which the award was 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 http://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 November 11, 2015. Oral presentations from the public will be scheduled between approximately 3 and 4 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 November 11, 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 November 13, 2015. 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 disabilities. If you require 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 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 28, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-27957 Filed 11-2-15; 8:45 am] BILLING CODE 4164-01-P
![67766 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices
indication of the approximate time Ave., Silver Spring, MD 20993. For available at http://www.fda.gov/
requested to make their presentation. those unable to attend in person, the AdvisoryCommittees/Calendar/
The agenda for the public webinar will meeting will also be webcast. The link default.htm. Scroll down to the
be made available on the Internet at for the webcast is available at https:// appropriate advisory committee meeting
http://www.fda.gov/Drugs/NewsEvents/ collaboration.fda.gov/science link.
ucm466461.htm. board1115/. Answers to commonly
asked questions including information Procedure: Interested persons may
III. Transcripts regarding special accommodations due present data, information, or views,
Please be advised that as soon as a to a disability, visitor parking, and orally or in writing, on issues pending
webinar transcript is available, FDA will transportation may be accessed at: before the committee. Written
post it at http://www.fda.gov/Drugs/ http://www.fda.gov/Advisory submissions may be made to the contact
NewsEvents/ucm466461.htm. Committees/AboutAdvisoryCommittees/ person on or before November 11, 2015.
ucm408555.htm. Oral presentations from the public will
Dated: October 29, 2015.
Contact Person: Rakesh Raghuwanshi, be scheduled between approximately 3
Leslie Kux,
Office of the Chief Scientist, Office of and 4 p.m. Those individuals interested
Associate Commissioner for Policy. the Commissioner, Food and Drug in making formal oral presentations
[FR Doc. 2015–27953 Filed 11–2–15; 8:45 am] Administration, White Oak Bldg. 1 Rm. should notify the contact person and
BILLING CODE 4164–01–P 3309, 10903 New Hampshire Ave., submit a brief statement of the general
Silver Spring, MD 20993, 301–796– nature of the evidence or arguments
4769, rakesh.raghuwanshi@fda.hhs.gov, they wish to present, the names and
DEPARTMENT OF HEALTH AND or FDA Advisory Committee
HUMAN SERVICES addresses of proposed participants, and
Information Line, 1–800–741–8138 an indication of the approximate time
(301–443–0572 in the Washington, DC requested to make their presentation on
Food and Drug Administration
area). A notice in the Federal Register or before November 11, 2015. Time
[Docket No. FDA–2015–N–0001] about last minute modifications that allotted for each presentation may be
impact a previously announced
limited. If the number of registrants
Science Board to the Food and Drug advisory committee meeting cannot
Administration Advisory Committee; requesting to speak is greater than can
always be published quickly enough to
Notice of Meeting be reasonably accommodated during the
provide timely notice. Therefore, you
should always check the Agency’s Web scheduled open public hearing session,
AGENCY: Food and Drug Administration, site at http://www.fda.gov/Advisory FDA may conduct a lottery to determine
HHS. Committees/default.htm and scroll the speakers for the scheduled open
ACTION: Notice. down to the appropriate advisory public hearing session. The contact
committee meeting link, or call the person will notify interested persons
This notice announces a forthcoming advisory committee information line to regarding their request to November 13,
meeting of a public advisory committee learn about possible modifications 2015.
of the Food and Drug Administration before coming to the meeting. Persons attending FDA’s advisory
(FDA). The meeting will be open to the Agenda: The Science Board will be committee meetings are advised that the
public. provided with updates from the Center Agency is not responsible for providing
Name of Committee: Science Board to for Food Safety and Applied Nutrition,
the Food and Drug Administration access to electrical outlets.
Centers for Excellence in Regulatory
(Science Board). Science and Innovation, Evaluation FDA welcomes the attendance of the
General Function of the Committee: Subcommittee and the ORA Food public at its advisory committee
The Science Board provides advice to Emergency Response Network meetings and will make every effort to
the Commissioner of Food and Drugs Evaluation Subcommittee. The Board accommodate persons with disabilities.
and other appropriate officials on will hear about the scope of FDA’s If you require accommodations due to a
specific, complex scientific and involvement in precision medicine, as disability, please contact Rakesh
technical issues important to the FDA well as an overview of specific health Raghuwanshi at least 7 days in advance
and its mission, including emerging informatics initiatives including of the meeting.
issues within the scientific community. precision FDA, Open FDA, and Chillax. FDA is committed to the orderly
Additionally, the Science Board The Board will also hear about FDA’s conduct of its advisory committee
provides advice to the Agency on laboratory safety initiative. A recipient
meetings. Please visit our Web site at
keeping pace with technical and of one of the FY 2014 Scientific
scientific developments including in http://www.fda.gov/Advisory
Achievement Awards (selected by the
regulatory science, input into the Committees/AboutAdvisoryCommittees/
Board) will provide an overview of the
Agency’s research agenda and on ucm111462.htm for procedures on
activities for which the award was
upgrading its scientific and research given. public conduct during advisory
facilities and training opportunities. It FDA intends to make background committee meetings.
will also provide, where requested, material available to the public no later Notice of this meeting is given under
expert review of Agency sponsored than 2 business days before the meeting. the Federal Advisory Committee Act (5
intramural and extramural scientific If FDA is unable to post the background
mstockstill on DSK4VPTVN1PROD with NOTICES
U.S.C. app. 2).
research programs. material on its Web site prior to the Dated: October 28, 2015.
Date and Time: The meeting will be meeting, the background material will
held on November 18, 2015, from 9 a.m. be made publicly available at the Jill Hartzler Warner,
until 4 p.m. location of the advisory committee Associate Commissioner for Special Medical
Location: Food and Drug meeting, and the background material Programs.
Administration, White Oak 31, Rm. will be posted on FDA’s Web site after [FR Doc. 2015–27957 Filed 11–2–15; 8:45 am]
1503, Section A, 10903 New Hampshire the meeting. Background material is BILLING CODE 4164–01–P
VerDate Sep<11>2014 19:22 Nov 02, 2015 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1](https://thefederalregister.org/doc/80_FR_67978/page/1.svg)
Document Created: 2018-03-01 11:32:39
Document Modified: 2018-03-01 11:32:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 80 FR 67766 |
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