Science Board to the Food and Drug Administration; Notice of Meeting, 51278 [2015-20820]

Download as PDF 51278 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices a patent infringement described in section 351(l)(6) of the PHS Act, the applicant is required, under section 351(l)(6)(C) of the PHS Act, to provide the FDA with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register. FDA has received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: Janssen Biotech, Inc., et. al. v. Celltrion Healthcare Co., Ltd., et al., 15– cv–10698 (D. Mass., filed March 6, 2015). FDA has only a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act, and does not perform a substantive review of the complaint. Dated: August 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–20780 Filed 8–21–15; 8:45 am] BILLING CODE 4164–01–P 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. tkelley on DSK3SPTVN1PROD with NOTICES 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, 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 VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 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, rakesh.raghuwanshi@fda.hhs.gov, 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 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0564] Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the SUMMARY: E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
rakesh.raghuwanshi@fda.hhs.gov, 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