Blood Products Advisory Committee Advisory Committee; Notice of Meeting, 52060-52061 [2017-24408]

Download as PDF 52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 314.50 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR 314.70 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR 201.57 have been approved under OMB control number 0910–0572; the collections of information in 21 CFR 314.420 have been approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: November 2, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6358] Blood Products Advisory Committee Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (the Committee). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues related to blood and products derived from blood. The meeting will be open to the public. DATES: The meeting will be held on November 30, 2017, from 8 a.m. to 5:45 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 p.m. and on December 1, 2017, from 8 a.m. to 3:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993– 0002. 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/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Bldg. 71, Rm. 6132, at 240–402–8054, bryan.emery@ fda.hhs.gov and 240–402–8106, joanne.lipkind@fda.hhs.gov respectively, 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 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. For those unable to attend in person, the meeting will also be available via Webcast. The Webcast will be available at the following link for both days: https://collaboration.fda.gov/ bpac2017. SUPPLEMENTARY INFORMATION: Agenda: On November 30, 2017, the Committee members will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. In the afternoon, the Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices. On December 1, 2017, the committee members will meet in open session to discuss strategies to reduce the risk of transfusiontransmitted Zika virus. In the afternoon, an information session on the Transfusion Transmissible Infections Monitoring System will be presented to PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 the Committee. Finally, the Committee will hear an update presentation on the April 6, 2017, FDA public workshop on emerging tick-borne diseases and blood safety. 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 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 November 22, 2017. Oral presentations from the public will be scheduled between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45 p.m. on November 30, 2017. Oral presentations from the public will also be scheduled between approximately 10:45 a.m. and 11:30 a.m. and 3 p.m. to 3:30 p.m. on December 1, 2017. 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 14, 2017. 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 15, 2017. 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 Bryan Emery or Joanne Lipkind at least 7 days in advance of the meeting. E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/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: November 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24408 Filed 11–8–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings sradovich on DSK3GMQ082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; National Centers for Cryo-Electron Microscopy-B. Date: November 30, 2017. Time: 2:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: William A. Greenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4168, MSC 7806, Bethesda, MD 20892, (301) 435– 1726, greenbergwa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–16– 433: Support of NIGMS Program Project Grants. Date: December 1, 2017. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 Contact Person: Kenneth A. Roebuck, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD 20892, (301) 435– 1166, roebuckk@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Vascular and Hematology AREA Application Review. Date: December 5, 2017. Time: 2:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Natalia Komissarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, MSC 7846, Bethesda, MD 20892, 301–435– 1206, komissar@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–15– 053: Exploratory Grant Award in Basic Cancer Research (R21). Date: December 6, 2017. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, BST IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301–435–2204, girouxcn@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cardiovascular Sciences. Date: December 7, 2017. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Yuanna Cheng, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301) 435– 1195, Chengy5@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Serious Adverse Drug Reaction Review. Date: December 8, 2017. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alexander D. Politis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, (301) 435– 1150, politisa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Emotion, Substance Use and Psychopathology. PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 52061 Date: December 8, 2017. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301–594– 3163, champoum@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Biology. Date: December 8, 2017. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Juraj Bies, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 4158, MSC 7806, Bethesda, MD 20892, 301 435 1256, biesj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 3, 2017. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2017–24372 Filed 11–8–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Cooperative Agreement Applications and Clinical Networks I. Date: November 27, 2017. E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52060-52061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6358]


Blood Products Advisory Committee Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Blood Products Advisory 
Committee (the Committee). The general function of the committee is to 
provide advice and recommendations to the Agency on FDA's regulatory 
issues related to blood and products derived from blood. The meeting 
will be open to the public.

DATES: The meeting will be held on November 30, 2017, from 8 a.m. to 
5:45 p.m. and on December 1, 2017, from 8 a.m. to 3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993-
0002. 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: Bryan Emery or Joanne Lipkind, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Bldg. 71, Rm. 
6132, at 240-402-8054, bryan.emery@fda.hhs.gov and 240-402-8106, 
joanne.lipkind@fda.hhs.gov respectively, 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 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. For those unable to attend in person, the meeting will 
also be available via Webcast. The Webcast will be available at the 
following link for both days: https://collaboration.fda.gov/bpac2017.

SUPPLEMENTARY INFORMATION: 
    Agenda: On November 30, 2017, the Committee members will meet in 
open session to discuss bacterial risk control strategies for blood 
collection establishments and transfusion services to enhance the 
safety and availability of platelets for transfusion. In the afternoon, 
the Committee will be seated as a device classification panel. In open 
session, the panel will discuss the appropriate device classification 
of human leukocyte antigen, human platelet antigen, and human 
neutrophil antigen devices. On December 1, 2017, the committee members 
will meet in open session to discuss strategies to reduce the risk of 
transfusion-transmitted Zika virus. In the afternoon, an information 
session on the Transfusion Transmissible Infections Monitoring System 
will be presented to the Committee. Finally, the Committee will hear an 
update presentation on the April 6, 2017, FDA public workshop on 
emerging tick-borne diseases and blood safety.
    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 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 
November 22, 2017. Oral presentations from the public will be scheduled 
between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45 
p.m. on November 30, 2017. Oral presentations from the public will also 
be scheduled between approximately 10:45 a.m. and 11:30 a.m. and 3 p.m. 
to 3:30 p.m. on December 1, 2017. 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 14, 2017. 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 15, 2017.
    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 Bryan Emery or Joanne Lipkind at least 7 days in advance of the 
meeting.

[[Page 52061]]

    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site 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: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24408 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P

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