80 FR 48870 - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 157 (August 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 157 (August 14, 2015)
| Page Range | 48870-48871 | |
| FR Document | 2015-20051 |
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)] [Notices] [Pages 48870-48871] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20051] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Science Advisory Board to the National Center for Toxicological Research 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). 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). [[Page 48871]] 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 3, 2015, from 12:30 p.m. to 5 p.m., and November 4, 2015, from 8 a.m. to 5 p.m. Location: NCTR SAB, 3900 NCTR Rd., Conference rm. B-12, Jefferson, AR 72079. 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: Donna Mendrick, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-796-8892; 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: On November 3, 2015, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Biochemistry Subcommittee and the Subcommittee Site Visit Report. Representatives from the Office of the Chief Scientist and Office of Medical Products and Tobacco will discuss research needs and opportunities for collaborations with NCTR. On November 4, 2015, the Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Tobacco Products, Center for Veterinary Medicine, and Office of Regulatory Affairs will each briefly discuss their Center-specific research strategic needs. Following the public session, the SAB will hear an update from each of NCTR's research divisions. Following an open discussion of all the information presented, the open session of the meeting will close so the SAB members can discuss personnel issues at NCTR at the end of each day. 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: On November 3, 2015, from 12:30 p.m. to 5 p.m., and November 4, 2015, from 8 a.m. to 4:15 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 27, 2015. Oral presentations from the public will be scheduled between approximately 11:45 a.m. and 12:45 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 19, 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 speak by October 20, 2015. Closed Committee Deliberations: On November 4, 2015, from 4:15 p.m. to 5 p.m., 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 discussions 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 Donna Mendrick 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: August 10, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-20051 Filed 8-13-15; 8:45 am] BILLING CODE 4164-01-P
![48870 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
Contact Persons: Hilda Scharen, verified the Web site addresses in this devices both present important safety
Center for Devices and Radiological document, but FDA is not responsible and effectiveness questions as well as
Health, Food and Drug Administration, for any subsequent changes to the Web study design and data analysis
10903 New Hampshire Ave., Bldg. 66, sites after this document publishes in challenges.
Rm 3625, Silver Spring, MD 20993, the Federal Register.)
Comments: In order to permit the II. Topics for Discussion at the Public
301–796–6815, Hilda.Scharen@
fda.hhs.gov; or Jay Gupta, Center for widest possible opportunity to obtain Workshop
Devices and Radiological Health, Food public comment, FDA is soliciting The workshop seeks to involve
and Drug Administration, 10903 New either electronic or written comments industry and academia in addressing
Hampshire Ave., Silver Spring, MD on all aspects of the public workshop scientific, clinical, and regulatory
20993, Jay.Gupta@fda.hhs.gov, 301– topics. The deadline for submitting considerations associated with medical
796–2795. comments related to this public devices for assessing and influencing
Registration: Registration is free and workshop is December 5, 2015. cognitive function. By bringing together
available on a first-come, first-served Regardless of attendance at the public relevant stakeholders, which include
basis. Persons interested in attending workshop, interested persons may scientists, patient advocates, clinicians,
this public workshop must register submit either electronic comments researchers, industry representatives,
online by November 6, 2015, at 4 p.m. regarding this document to http:// and regulators, to this workshop, we
Early registration is recommended www.regulations.gov or written hope to facilitate the improvement of
because facilities are limited and, comments to the Division of Dockets this rapidly evolving product area.
therefore, FDA may limit the number of Management (HFA–305), Food and Drug This workshop is aimed to address
participants from each organization. If Administration, 5630 Fishers Lane, rm. scientific, clinical, and regulatory
time and space permits, onsite 1061, Rockville, MD 20852. It is only considerations associated with medical
registration on the day of the public necessary to send one set of comments. devices for assessing and influencing
workshop will be provided beginning at Identify comments with the docket cognitive function; including, but not
7:30 a.m. number found in brackets in the limited to, the following topic areas:
If you need special accommodations heading of this document. In addition, • Considerations for clinical study
due to a disability, please contact Susan when providing comments to the topics trial designs, patient populations, and
Monahan, susan.monahan@fda.hhs.gov as outlined in section II of this patient selection methods;
or 301–796–5661 no later than document, please identify the question • considerations for clinical study
November 5, 2015. you are addressing. Received comments endpoints, e.g., clinically relevant
To register for the public workshop, may be seen in the Division of Dockets outcome measures and related statistical
please visit FDA’s Medical Devices Management between 9 a.m. and 4 p.m., analyses;
Workshops and Conferences calendar at Monday through Friday, and will be • identification of risks and risk
http://www.fda.gov/MedicalDevices/ posted to the docket at http:// mitigation strategies; and
NewsEvents/WorkshopsConferences/ www.regulations.gov. • evaluation of prior studies, current
default.htm. Select this meeting/public Transcripts: Please be advised that as
clinical research, and available
workshop from the posted events list. soon as a transcript is available, it will
scientific and clinical evidence.
Please provide complete contact be accessible at http://
information for each attendee, including www.regulations.gov. It may be viewed Dated: August 10, 2015.
name, title, affiliation, email, and at the Division of Dockets Management Leslie Kux,
telephone number. Those without (see Comments). A transcript will also Associate Commissioner for Policy.
Internet access should contact Susan be available in either hardcopy or on [FR Doc. 2015–19990 Filed 8–13–15; 8:45 am]
Monahan to register (see Contact for CD–ROM, after submission of a BILLING CODE 4164–01–P
special accommodations). Registrants Freedom of Information request. The
will receive confirmation after they have address of the Division of Freedom of
been accepted. You will be notified if Information is available on the Agency’s DEPARTMENT OF HEALTH AND
you are on a waiting list. Web site at http://www.fda.gov. A link HUMAN SERVICES
Streaming Webcast of the Public to the transcripts will also be available
Workshop: This public workshop will approximately 45 days after the public Food and Drug Administration
also be available via Webcast. Persons workshop on the Internet at http://
interested in viewing the Webcast must [Docket No. FDA–2015–N–0001]
www.fda.gov/MedicalDevices/
register online by 4 p.m., November 6, NewsEvents/WorkshopsConferences/ Science Advisory Board to the
2015. Early registration is recommended default.htm. (Select this public National Center for Toxicological
because Webcast connections are workshop from the posted events list). Research Advisory Committee; Notice
limited. Organizations are requested to SUPPLEMENTARY INFORMATION: of Meeting
register all participants, but to view
using one connection per location. I. Background AGENCY: Food and Drug Administration,
Webcast participants will be sent Cognitive assessment medical devices HHS.
technical system requirements after are intended to provide healthcare ACTION: Notice.
registration and will be sent connection professionals with an evaluation of
access information after November 10, cognitive function through non-invasive This notice announces a forthcoming
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2015. If you have never attended a measurements. Non-invasive brain meeting of a public advisory committee
Connect Pro event before, test your stimulation medical devices are of the Food and Drug Administration
connection at https:// intended to improve, affect, or (FDA). At least one portion of the
collaboration.fda.gov/common/help/en/ otherwise modify the cognitive function meeting will be closed to the public.
support/meeting_test.htm. To get a of a normal individual (i.e., has no Name of Committee: Science
quick overview of the Connect Pro cognitive impairment) by means of non- Advisory Board (SAB) to the National
program, visit http://www.adobe.com/ invasive electrical or electromagnetic Center for Toxicological Research
go/connectpro_overview. (FDA has stimulation to the head. These medical (NCTR).
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![Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48871
General Function of the Committee: Following an open discussion of all FDA welcomes the attendance of the
To provide advice and the information presented, the open public at its advisory committee
recommendations to the Agency on session of the meeting will close so the meetings and will make every effort to
FDA’s regulatory issues. SAB members can discuss personnel accommodate persons with physical
Date and Time: The meeting will be issues at NCTR at the end of each day. disabilities or special needs. If you
held on November 3, 2015, from 12:30 FDA intends to make background require special accommodations due to
p.m. to 5 p.m., and November 4, 2015, material available to the public no later a disability, please contact Donna
from 8 a.m. to 5 p.m. than 2 business days before the meeting. Mendrick at least 7 days in advance of
Location: NCTR SAB, 3900 NCTR Rd., If FDA is unable to post the background the meeting.
Conference rm. B–12, Jefferson, AR material on its Web site prior to the FDA is committed to the orderly
72079. Answers to commonly asked meeting, the background material will conduct of its advisory committee
questions including information be made publicly available at the meetings. Please visit our Web site at
regarding special accommodations due location of the advisory committee http://www.fda.gov/
to a disability, visitor parking, and meeting, and the background material AdvisoryCommittees/
transportation may be accessed at: will be posted on FDA’s Web site after AboutAdvisoryCommittees/
http://www.fda.gov/ the meeting. Background material is ucm111462.htm for procedures on
AdvisoryCommittees/ available at http://www.fda.gov/ public conduct during advisory
AboutAdvisoryCommittees/ AdvisoryCommittees/Calendar/ committee meetings.
ucm408555.htm. default.htm. Scroll down to the Notice of this meeting is given under
Contact Person: Donna Mendrick, appropriate advisory committee meeting the Federal Advisory Committee Act (5
Food and Drug Administration, 10903 link. U.S.C. app. 2).
Procedure: On November 3, 2015,
New Hampshire Ave., Bldg. 32, Rm. Dated: August 10, 2015.
from 12:30 p.m. to 5 p.m., and
2208, Silver Spring, MD 20993–0002, Jill Hartzler Warner,
November 4, 2015, from 8 a.m. to 4:15
301–796–8892; or FDA Advisory Associate Commissioner for Special Medical
p.m., the meeting is open to the public.
Committee Information Line, 1–800– Programs.
Interested persons may present data,
741–8138 (301–443–0572 in the
information, or views, orally or in [FR Doc. 2015–20051 Filed 8–13–15; 8:45 am]
Washington, DC area). A notice in the
writing, on issues pending before the BILLING CODE 4164–01–P
Federal Register about last minute
committee. Written submissions may be
modifications that impact a previously made to the contact person on or before
announced advisory committee meeting October 27, 2015. Oral presentations DEPARTMENT OF HEALTH AND
cannot always be published quickly from the public will be scheduled HUMAN SERVICES
enough to provide timely notice. between approximately 11:45 a.m. and
Therefore, you should always check the 12:45 p.m. Those individuals interested Food and Drug Administration
Agency’s Web site at http:// in making formal oral presentations [Docket No. FDA–2004–N–0451; formerly
www.fda.gov/AdvisoryCommittees/ should notify the contact person and Docket No. 2004N–0226]
default.htm and scroll down to the submit a brief statement of the general
appropriate advisory committee meeting nature of the evidence or arguments Food and Drug Administration
link, or call the advisory committee they wish to present, the names and Modernization Act of 1997:
information line to learn about possible addresses of proposed participants, and Modifications to the List of Recognized
modifications before coming to the an indication of the approximate time Standards, Recognition List Number:
meeting. requested to make their presentation on 040
Agenda: On November 3, 2015, the or before October 19, 2015. Time
SAB Chair will welcome the AGENCY: Food and Drug Administration,
allotted for each presentation may be
participants, and the NCTR Director will HHS.
limited. If the number of registrants
provide a Center-wide update on requesting to speak is greater than can ACTION: Notice.
scientific initiatives and be reasonably accommodated during the
accomplishments during the past year. SUMMARY: The Food and Drug
scheduled open public hearing session, Administration (FDA) is announcing a
The SAB will be presented with an FDA may conduct a lottery to determine
overview of the Division of publication containing modifications
the speakers for the scheduled open
Biochemistry Subcommittee and the the Agency is making to the list of
public hearing session. The contact
Subcommittee Site Visit Report. standards FDA recognizes for use in
person will notify interested persons
Representatives from the Office of the premarket reviews (FDA Recognized
regarding their request to speak by
Chief Scientist and Office of Medical Consensus Standards). This publication,
October 20, 2015.
Products and Tobacco will discuss entitled ‘‘Modifications to the List of
Closed Committee Deliberations: On
research needs and opportunities for Recognized Standards, Recognition List
November 4, 2015, from 4:15 p.m. to 5
collaborations with NCTR. Number: 040’’ (Recognition List
p.m., the meeting will be closed to
On November 4, 2015, the Center for Number: 040), will assist manufacturers
permit discussion where disclosure
Drug Evaluation and Research, Center who elect to declare conformity with
would constitute a clearly unwarranted
for Devices and Radiological Health, consensus standards to meet certain
invasion of personal privacy (5 U.S.C.
Center for Biologics Evaluation and requirements for medical devices.
552b(c)(6)). This portion of the meeting
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Research, Center for Tobacco Products, will be closed to permit discussions of DATES: Submit electronic or written
Center for Veterinary Medicine, and information concerning individuals comments concerning this document at
Office of Regulatory Affairs will each associated with the research programs at any time. See section VII for the
briefly discuss their Center-specific NCTR. effective date of the recognition of
research strategic needs. Following the Persons attending FDA’s advisory standards announced in this document.
public session, the SAB will hear an committee meetings are advised that the ADDRESSES: An electronic copy of
update from each of NCTR’s research Agency is not responsible for providing Recognition List Number: 040 is
divisions. access to electrical outlets. available on the Internet at http://
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Document Created: 2018-02-23 10:59:25
Document Modified: 2018-02-23 10:59:25
| 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 48870 |
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