80_FR_51441 80 FR 51278 - Science Board to the Food and Drug Administration; Notice of Meeting

80 FR 51278 - Science Board to the Food and Drug Administration; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 163 (August 24, 2015)

Page Range51278-51278
FR Document2015-20820

Federal Register, Volume 80 Issue 163 (Monday, August 24, 2015) 
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51278]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Science Board to the Food and Drug Administration; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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, via Webcast.
    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 September 15, 2015, from 
4 p.m. until 5:30 p.m.
    Location: This meeting will take place via Webcast. To access the 
link for the Webcast check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link. Information regarding special 
accommodations due to a disability may be accessed at http://www.fda.gov/AdvisoryCommittees/default.htm.
    Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, 
Office of the Commissioner, Food and Drug Administration, 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 a report from the 
Science Looking Forward subcommittee.
    FDA intends to make background material available to the public no 
later than 2 business days before 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 
September 8, 2015. Oral presentations from the public will be scheduled 
between approximately 4:30 p.m. and 5:30 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 September 1, 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 September 2, 2015.
    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 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: August 18, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20820 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P

51278 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices a patent infringement described in intramural and extramural scientific requested to make their presentation on section 351(l)(6) of the PHS Act, the research programs. or before September 1, 2015. Time applicant is required, under section Date and Time: The meeting will be allotted for each presentation may be 351(l)(6)(C) of the PHS Act, to provide held on September 15, 2015, from 4 limited. If the number of registrants the FDA with notice and a copy of the p.m. until 5:30 p.m. requesting to speak is greater than can complaint within 30 days of service. Location: This meeting will take place be reasonably accommodated during the FDA is required to publish notice of a via Webcast. To access the link for the scheduled open public hearing session, complaint received under section Webcast check the Agency’s Web site at FDA may conduct a lottery to determine 351(l)(6)(C) of the PHS Act in the http://www.fda.gov/ the speakers for the scheduled open Federal Register. AdvisoryCommittees/default.htm and public hearing session. The contact FDA has received notice of the scroll down to the appropriate advisory person will notify interested persons following complaint under section committee meeting link. Information regarding their request to speak by 351(l)(6)(C) of the PHS Act: regarding special accommodations due September 2, 2015. Janssen Biotech, Inc., et. al. v. to a disability may be accessed at FDA welcomes the attendance of the Celltrion Healthcare Co., Ltd., et al., 15– http://www.fda.gov/ public at its advisory committee cv–10698 (D. Mass., filed March 6, AdvisoryCommittees/default.htm. meetings and will make every effort to 2015). Contact Person: Rakesh Raghuwanshi, accommodate persons with physical FDA has only a ministerial role in Office of the Chief Scientist, Office of disabilities or special needs. If you publishing notice of a complaint the Commissioner, Food and Drug require special accommodations due to received under section 351(l)(6)(C) of Administration, Bldg. 1, Rm. 3309, a disability, please contact Rakesh the PHS Act, and does not perform a 10903 New Hampshire Ave., Silver Raghuwanshi at least 7 days in advance substantive review of the complaint. Spring, MD 20993, 301–796–4769, of the meeting. rakesh.raghuwanshi@fda.hhs.gov, or FDA is committed to the orderly Dated: August 17, 2015. FDA Advisory Committee Information conduct of its advisory committee Leslie Kux, Line, 1–800–741–8138 (301–443–0572 meetings. Please visit our Web site at Associate Commissioner for Policy. in the Washington, DC area). A notice in http://www.fda.gov/ [FR Doc. 2015–20780 Filed 8–21–15; 8:45 am] the Federal Register about last minute AdvisoryCommittees/ BILLING CODE 4164–01–P modifications that impact a previously AboutAdvisoryCommittees/ announced advisory committee meeting ucm111462.htm for procedures on cannot always be published quickly public conduct during advisory DEPARTMENT OF HEALTH AND enough to provide timely notice. committee meetings. HUMAN SERVICES Therefore, you should always check the Notice of this meeting is given under Agency’s Web site at http:// the Federal Advisory Committee Act (5 Food and Drug Administration www.fda.gov/AdvisoryCommittees/ U.S.C. app. 2). [Docket No. FDA–2015–N–0001] default.htm and scroll down to the Dated: August 18, 2015. appropriate advisory committee meeting Jill Hartzler Warner, Science Board to the Food and Drug link, or call the advisory committee information line to learn about possible Associate Commissioner for Special Medical Administration; Notice of Meeting Programs. modifications before coming to the AGENCY: Food and Drug Administration, [FR Doc. 2015–20820 Filed 8–21–15; 8:45 am] meeting. HHS. Agenda: The Science Board will be BILLING CODE 4164–01–P ACTION: Notice. provided with a report from the Science Looking Forward subcommittee. This notice announces a forthcoming FDA intends to make background DEPARTMENT OF HEALTH AND meeting of a public advisory committee material available to the public no later HUMAN SERVICES of the Food and Drug Administration than 2 business days before the meeting. Food and Drug Administration (FDA). The meeting will be open to the Background material is available at public, via Webcast. http://www.fda.gov/ [Docket No. FDA–2012–N–0564] Name of Committee: Science Board to AdvisoryCommittees/Calendar/ the Food and Drug Administration default.htm. Scroll down to the Agency Information Collection (Science Board). appropriate advisory committee meeting Activities; Proposed Collection; General Function of the Committee: link. Comment Request; Dietary The Science Board provides advice to Procedure: Interested persons may Supplement Labeling Requirements the Commissioner of Food and Drugs present data, information, or views, and Recommendations Under the and other appropriate officials on orally or in writing, on issues pending Dietary Supplement and specific, complex scientific and before the committee. Written Nonprescription Drug Consumer technical issues important to the FDA submissions may be made to the contact Protection Act and its mission, including emerging person on or before September 8, 2015. AGENCY: Food and Drug Administration, issues within the scientific community. Oral presentations from the public will HHS. Additionally, the Science Board be scheduled between approximately ACTION: Notice. provides advice to the Agency on 4:30 p.m. and 5:30 p.m. Those keeping pace with technical and individuals interested in making formal SUMMARY: The Food and Drug tkelley on DSK3SPTVN1PROD with NOTICES scientific developments including in oral presentations should notify the Administration (FDA or we) is regulatory science, input into the contact person and submit a brief announcing an opportunity for public Agency’s research agenda, and on statement of the general nature of the comment on the proposed collection of upgrading its scientific and research evidence or arguments they wish to certain information by the Agency. facilities and training opportunities. It present, the names and addresses of Under the Paperwork Reduction Act of will also provide, where requested, proposed participants, and an 1995 (the PRA), Federal Agencies are expert review of Agency sponsored indication of the approximate time required to publish notice in the VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1


Document Created: 2015-12-15 10:55:18
Document Modified: 2015-12-15 10:55:18
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.
FR Citation80 FR 51278 
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