83 FR 54756 - 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 83, Issue 211 (October 31, 2018)

Page Range		54756-54757
FR Document		2018-23742

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the NCTR. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 83 Issue 211 (Wednesday, October 31, 2018)

[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54756-54757]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[[Docket No. FDA-2018-N-3844]


Science Advisory Board to the National Center for Toxicological 
Research Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Science Advisory 
Board (SAB) to the National Center for Toxicological Research (NCTR). 
The general function of the committee is to provide advice and 
recommendations to the Agency on research being conducted at the NCTR. 
At least one portion of the meeting will be closed to the public.

DATES: The meeting will be held on December 4, 2018, from 8:00 a.m. to 
5:45 p.m., and on December 5, 2018, from 8:00 a.m. to 11:30 a.m.

ADDRESSES: Heifer Village, 1 World Avenue, Little Rock, AR 72202. 
Answers to commonly asked questions including information regarding 
special accommodations due to a disability, visitor parking, and 
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for 
Toxicological Research, 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 website at https://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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On December 4, 2018, the SAB Chairperson 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 SAB Subcommittee Site 
Visit report and a response to this review. There will be updates from 
the NCTR research divisions and a public comment session.
    On December 5, 2018, there will be a statement given by the FDA 
Chief Scientist. The Center for Biologics and Evaluation and Research, 
Center for Drug Evaluation and Research, Center for Devices and 
Radiological Health, Center for Food Safety and Applied Nutrition, and 
the Center for Tobacco Products will each briefly discuss their center-
specific research strategic needs and potential areas of collaboration.
    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 website 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 website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On December 4, 2018, from 8:00 a.m. to 5:45 p.m., and 
December 5, 2018, from 8:00 a.m. to 11:30 a.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 November 27, 
2018. Oral presentations

[[Page 54757]]

from the public will be scheduled between approximately 1:15 p.m. and 
2:15 p.m. on December 4, 2018. 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 19, 2018. 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 November 19, 2018.
    Closed Committee Deliberations: On December 4, 2018, from 5:45 p.m. 
to 6:00 p.m., and December 5, 2018, from 11:30 a.m. to 12:00 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 
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 
disabilities. If you require 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 website at https://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 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23742 Filed 10-30-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 211 / Wednesday, October 31, 2018 / Notices 54757

from the public will be scheduled AdvisoryCommittees/ following subjects: (1) The necessity and
between approximately 1:15 p.m. and AboutAdvisoryCommittees/ utility of the proposed information
2:15 p.m. on December 4, 2018. Those ucm111462.htm for procedures on collection for the proper performance of
individuals interested in making formal public conduct during advisory the agency’s functions; (2) the accuracy
oral presentations should notify the committee meetings. of the estimated burden; (3) ways to
contact person and submit a brief Notice of this meeting is given under enhance the quality, utility, and clarity
statement of the general nature of the the Federal Advisory Committee Act (5 of the information to be collected; and
evidence or arguments they wish to U.S.C. app. 2). (4) the use of automated collection
present, the names and addresses of Dated: October 25, 2018. techniques or other forms of information
proposed participants, and an Leslie Kux, technology to minimize the information
indication of the approximate time collection burden.
Associate Commissioner for Policy.
requested to make their presentation on Title of the Collection: The Nation
or before November 19, 2018. Time [FR Doc. 2018–23742 Filed 10–30–18; 8:45 am]
Blood Collection & Utilization Survey
allotted for each presentation may be BILLING CODE 4164–01–P
(NBCUS).
limited. If the number of registrants Type of Collection: Extension on a
requesting to speak is greater than can previously approved collection.
be reasonably accommodated during the DEPARTMENT OF HEALTH AND
scheduled open public hearing session, HUMAN SERVICES OMB No. 0990–0313- Office of the
FDA may conduct a lottery to determine Assistant Secretary for Health—Office of
[Document Identifier: OS–0990–0313]
the speakers for the scheduled open HIV/AIDS and Infectious Disease Policy
public hearing session. The contact Agency Information Collection (OHAIDP).
person will notify interested persons Request: 30-Day Public Comment Abstract: Length of request: 3 years.
regarding their request to speak by Request The Nation Blood Collection &
November 19, 2018. Utilization Survey (NBCUS) is a
Closed Committee Deliberations: On AGENCY: Office of the Secretary, HHS. biennial survey of the blood collection
December 4, 2018, from 5:45 p.m. to ACTION: Notice. and utilization community to produce
6:00 p.m., and December 5, 2018, from reliable and accurate estimates of
SUMMARY: In compliance with the national and regional collections,
11:30 a.m. to 12:00 p.m., the meeting
requirement of the Paperwork utilization and safety of all blood
will be closed to permit discussion
Reduction Act of 1995, the Office of the products. The 2019 NBCUS is funded by
where disclosure would constitute a
Secretary (OS), Department of Health Department of Health and Human
clearly unwarranted invasion of
and Human Services, is publishing the Services (DHHS/OASH) and performed
personal privacy (5 U.S.C. 552b(c)(6)).
following summary of a proposed by the Centers for Disease Control and
This portion of the meeting will be
collection for public comment. Prevention (CDC). In previous years, a
closed to permit discussion of
information concerning individuals DATES: Comments on the ICR must be similar survey was performed under the
associated with the research programs at received on or before November 30, auspices of the National Blood Data
NCTR. 2018. Resource Center (NBDRC), a private
Persons attending FDA’s advisory ADDRESSES: Submit your comments to subsidiary of AABB (formerly known as
committee meetings are advised that the OIRA_submission@omb.eop.gov or via the American Association of Blood
Agency is not responsible for providing facsimile to (202) 395–5806. Banks), with private funding. In 2005,
access to electrical outlets. FOR FURTHER INFORMATION CONTACT: 2007, 2009, and 2011 the survey was
FDA welcomes the attendance of the funded by HHS/OS/OASH and
Sherrette Funn, Sherrette.Funn@hhs.gov
public at its advisory committee performed under contract by AABB. The
or (202) 795–7714. When submitting
meetings and will make every effort to CDC has since performed the 2013,
comments or requesting information,
accommodate persons with disabilities. 2015, and 2017 iterations of the NBCUS.
please include the document identifier
If you require accommodations due to a Type of respondent: U.S. Blood
0990–0313–30D and project title for
disability, please contact Donna Collection Centers (number sampled:
reference.
Mendrick at least 7 days in advance of 70), U.S. Hospital Blood Banks (number
the meeting. SUPPLEMENTARY INFORMATION: Interested
sampled: 2850); frequency: biennial;
FDA is committed to the orderly persons are invited to send comments
and the affected public: private
conduct of its advisory committee regarding this burden estimate or any
businesses.
meetings. Please visit our website at other aspect of this collection of
https://www.fda.gov/ information, including any of the Estimated Annualized Burden Table

Average
Number
Number of burden per Total burden
Type of respondent responses per
respondents response hours
respondent (in hours)

Hospital Blood Banks ...................................................................................... 2850 1 2 5700
Blood Collection Centers ................................................................................. 70 1 2 140

Total .......................................................................................................... 2920 ........................ ........................ 5840
amozie on DSK3GDR082PROD with NOTICES1

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Document Created: 2018-10-31 00:33:29
Document Modified: 2018-10-31 00:33:29

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.
Dates		The meeting will be held on December 4, 2018, from 8:00 a.m. to 5:45 p.m., and on December 5, 2018, from 8:00 a.m. to 11:30 a.m.
Contact		Donna Mendrick, National Center for Toxicological Research, 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 website at https://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.
FR Citation		83 FR 54756

83 FR 54756 - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 211 (October 31, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration