83_FR_14928 83 FR 14861 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

83 FR 14861 - 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 83, Issue 67 (April 6, 2018)

Page Range14861-14861
FR Document2018-07105

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. 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 FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board advises the Agency on keeping pace with technical and scientific developments, including in regulatory science; provides input into the Agency's research agenda; and advises 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. The meeting will be open to the public.

Federal Register, Volume 83 Issue 67 (Friday, April 6, 2018) 
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Page 14861]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07105]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1324]


Science Board to the Food and Drug Administration 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 Board to 
the Food and Drug Administration. 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 FDA and 
its mission, including emerging issues within the scientific community. 
Additionally, the Science Board advises the Agency on keeping pace with 
technical and scientific developments, including in regulatory science; 
provides input into the Agency's research agenda; and advises 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. The meeting will be open to the public.

DATES: The meeting will be held on April 23, 2018, from 9 a.m. to 4:30 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503, Section A), 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/scienceboard2018/. 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: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, 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 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: The Science Board will hear a report from the Center for 
Biologics Evaluation and Research Program Review Subcommittee; hear 
about FDA's Patient Affairs Initiative; and discuss how the Agency can 
leverage its existing tools and authorities, and work with 
stakeholders, to better address the complex scientific, public health, 
and technology challenges it faces today.
    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: 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 
April 18, 2018. Oral presentations from the public will be scheduled 
between approximately 3:30 p.m. and 4:30 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 April 13, 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 April 16, 2018.
    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 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: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07105 Filed 4-5-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices 14861 III. Electronic Access webcast. The link for the webcast is presentations from the public will be Persons with access to the internet available at https://collaboration.fda. scheduled between approximately 3:30 may obtain the 2003 GFI entitled gov/scienceboard2018/. Answers to p.m. and 4:30 p.m. Those individuals ‘‘Exposure-Response Relationships— commonly asked questions including interested in making formal oral Study Design, Data Analysis, and information regarding special presentations should notify the contact Regulatory Applications’’ at either accommodations due to a disability, person and submit a brief statement of https://www.fda.gov/downloads/Drugs/ visitor parking, and transportation may the general nature of the evidence or GuidanceCompliance be accessed at: https://www.fda.gov/ arguments they wish to present, the RegulatoryInformation/Guidances/ AdvisoryCommittees/AboutAdvisory names and addresses of proposed UCM072109.pdf or https:// Committees/ucm408555.htm. participants, and an indication of the www.fda.gov/Drugs/ FOR FURTHER INFORMATION CONTACT: approximate time requested to make Guidancecompliance Rakesh Raghuwanshi, Office of the their presentation on or before April 13, RegulatoryInformation/Guidances/ Chief Scientist, Office of the 2018. Time allotted for each default.htm. Commissioner, Food and Drug presentation may be limited. If the Administration, 10903 New Hampshire number of registrants requesting to Dated: April 2, 2018. Ave., Bldg. 1, Rm. 3309, Silver Spring, speak is greater than can be reasonably Leslie Kux, accommodated during the scheduled MD 20993, 301–796–4769, Associate Commissioner for Policy. open public hearing session, FDA may rakesh.raghuwanshi@fda.hhs.gov, or [FR Doc. 2018–07028 Filed 4–5–18; 8:45 am] FDA Advisory Committee Information conduct a lottery to determine the BILLING CODE 4164–01–P Line, 1–800–741–8138 (301–443–0572 speakers for the scheduled open public in the Washington, DC area). A notice in hearing session. The contact person will the Federal Register about last minute notify interested persons regarding their DEPARTMENT OF HEALTH AND modifications that impact a previously request to speak by April 16, 2018. HUMAN SERVICES announced advisory committee meeting Persons attending FDA’s advisory cannot always be published quickly committee meetings are advised that the Food and Drug Administration enough to provide timely notice. Agency is not responsible for providing [Docket No. FDA–2018–N–1324] Therefore, you should always check the access to electrical outlets. Agency’s website at https:// FDA welcomes the attendance of the Science Board to the Food and Drug www.fda.gov/AdvisoryCommittees/ public at its advisory committee Administration Advisory Committee; default.htm and scroll down to the meetings and will make every effort to Notice of Meeting appropriate advisory committee meeting accommodate persons with disabilities. AGENCY: Food and Drug Administration, link, or call the advisory committee If you require accommodations due to a HHS. information line to learn about possible disability, please contact Rakesh ACTION: Notice. modifications before coming to the Raghuwanshi at least 7 days in advance meeting. of the meeting. SUMMARY: The Food and Drug FDA is committed to the orderly SUPPLEMENTARY INFORMATION: Administration (FDA or Agency) Agenda: The Science Board will hear conduct of its advisory committee announces a forthcoming public a report from the Center for Biologics meetings. Please visit our website at advisory committee meeting of the Evaluation and Research Program https://www.fda.gov/Advisory Science Board to the Food and Drug Review Subcommittee; hear about Committees/AboutAdvisoryCommittees/ Administration. The Science Board FDA’s Patient Affairs Initiative; and ucm111462.htm for procedures on provides advice to the Commissioner of discuss how the Agency can leverage its public conduct during advisory Food and Drugs and other appropriate existing tools and authorities, and work committee meetings. officials on specific, complex scientific with stakeholders, to better address the Notice of this meeting is given under and technical issues important to FDA complex scientific, public health, and the Federal Advisory Committee Act (5 and its mission, including emerging technology challenges it faces today. U.S.C. app. 2). issues within the scientific community. FDA intends to make background Dated: April 3, 2018. Additionally, the Science Board advises material available to the public no later Leslie Kux, the Agency on keeping pace with than 2 business days before the meeting. Associate Commissioner for Policy. technical and scientific developments, If FDA is unable to post the background [FR Doc. 2018–07105 Filed 4–5–18; 8:45 am] including in regulatory science; material on its website prior to the provides input into the Agency’s BILLING CODE 4164–01–P meeting, the background material will research agenda; and advises on be made publicly available at the upgrading its scientific and research location of the advisory committee facilities and training opportunities. It DEPARTMENT OF HEALTH AND meeting, and the background material HUMAN SERVICES will also provide, where requested, will be posted on FDA’s website after expert review of Agency sponsored the meeting. Background material is Food and Drug Administration intramural and extramural scientific available at https://www.fda.gov/ research programs. The meeting will be [Docket No. FDA–2011–N–0362] AdvisoryCommittees/Calendar/ open to the public. default.htm. Scroll down to the Agency Information Collection DATES: The meeting will be held on appropriate advisory committee meeting Activities; Submission for Office of daltland on DSKBBV9HB2PROD with NOTICES April 23, 2018, from 9 a.m. to 4:30 p.m. link. Management and Budget Review; ADDRESSES: FDA White Oak Campus, Procedure: Interested persons may Current Good Manufacturing Practice 10903 New Hampshire Ave., Bldg. 31 present data, information, or views, Regulations for Finished Conference Center, the Great Room (Rm. orally or in writing, on issues pending Pharmaceuticals 1503, Section A), Silver Spring, MD before the committee. Written 20993. For those unable to attend in submissions may be made to the contact AGENCY: Food and Drug Administration, person, the meeting will also be person on or before April 18, 2018. Oral HHS. VerDate Sep<11>2014 19:21 Apr 05, 2018 Jkt 244001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1


Document Created: 2018-11-01 09:14:59
Document Modified: 2018-11-01 09:14:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on April 23, 2018, from 9 a.m. to 4:30 p.m.
ContactRakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, 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 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 Citation83 FR 14861 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR