82 FR 52060 - Blood Products Advisory Committee Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52060-52061 | |
| FR Document | 2017-24408 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52060-52061] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24408] ----------------------------------------------------------------------- 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, [email protected] and 240-402-8106, [email protected] 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
![52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
II. Paperwork Reduction Act of 1995 p.m. and on December 1, 2017, from 8 the Committee. Finally, the Committee
This draft guidance refers to a.m. to 3:30 p.m. will hear an update presentation on the
previously approved collections of ADDRESSES: FDA White Oak Campus, April 6, 2017, FDA public workshop on
information found in FDA regulations. 10903 New Hampshire Ave., Building emerging tick-borne diseases and blood
These collections of information are 31 Conference Center, the Great Room safety.
subject to review by the Office of (Rm. 1503), Silver Spring, MD, 20993– FDA intends to make background
Management and Budget (OMB) under 0002. Answers to commonly asked material available to the public no later
the Paperwork Reduction Act of 1995 questions including information than 2 business days before the meeting.
(44 U.S.C. 3501–3520). The collections regarding special accommodations due If FDA is unable to post the background
of information in 21 CFR 314.50 have to a disability, visitor parking, and material on its Web site prior to the
been approved under OMB control transportation may be accessed at: meeting, the background material will
number 0910–0001; the collections of https://www.fda.gov/Advisory be made publicly available at the
information in 21 CFR 314.70 have been Committees/AboutAdvisoryCommittees/ location of the advisory committee
approved under OMB control number ucm408555.htm. meeting, and the background material
0910–0001; the collections of FOR FURTHER INFORMATION CONTACT: will be posted on FDA’s Web site after
information in 21 CFR 201.57 have been Bryan Emery or Joanne Lipkind, Center the meeting. Background material is
approved under OMB control number for Biologics Evaluation and Research, available at https://www.fda.gov/
0910–0572; the collections of Food and Drug Administration, 10903 AdvisoryCommittees/Calendar/
information in 21 CFR 314.420 have New Hampshire Avenue, Silver Spring, default.htm. Scroll down to the
been approved under OMB control MD 20993–0002, Bldg. 71, Rm. 6132, at appropriate advisory committee meeting
number 0910–0001; and the collections 240–402–8054, bryan.emery@ link.
of information in 21 CFR part 601 have fda.hhs.gov and 240–402–8106, Procedure: Interested persons may
been approved under OMB control joanne.lipkind@fda.hhs.gov present data, information, or views,
number 0910–0338. respectively, or FDA Advisory orally or in writing, on issues pending
Committee Information Line, 1–800– before the committee. Written
III. Electronic Access 741–8138 (301–443–0572 in the submissions may be made to the contact
Persons with access to the internet Washington, DC area). A notice in the person on or before November 22, 2017.
may obtain the draft guidance at either Federal Register about last minute Oral presentations from the public will
https://www.fda.gov/Drugs/Guidance modifications that impact a previously be scheduled between approximately
ComplianceRegulatoryInformation/ announced advisory committee meeting 11:35 a.m. to 12:20 p.m. and 4:15 p.m.
Guidances/default.htm or https:// cannot always be published quickly to 4:45 p.m. on November 30, 2017. Oral
www.fda.gov/BiologicsBloodVaccines/ enough to provide timely notice. presentations from the public will also
GuidanceComplianceRegulatory Therefore, you should always check the be scheduled between approximately
Information/Guidances/default.htm or Agency’s Web site at https:// 10:45 a.m. and 11:30 a.m. and 3 p.m. to
https://www.regulations.gov. www.fda.gov/AdvisoryCommittees/ 3:30 p.m. on December 1, 2017. Those
Dated: November 2, 2017. default.htm and scroll down to the individuals interested in making formal
appropriate advisory committee meeting oral presentations should notify the
Lauren Silvis,
link, or call the advisory committee contact person and submit a brief
Chief of Staff.
information line to learn about possible statement of the general nature of the
[FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] evidence or arguments they wish to
modifications before coming to the
BILLING CODE 4164–01–P meeting. For those unable to attend in present, the names and addresses of
person, the meeting will also be proposed participants, and an
available via Webcast. The Webcast will indication of the approximate time
DEPARTMENT OF HEALTH AND requested to make their presentation on
be available at the following link for
HUMAN SERVICES or before November 14, 2017. Time
both days: https://collaboration.fda.gov/
Food and Drug Administration bpac2017. allotted for each presentation may be
SUPPLEMENTARY INFORMATION: limited. If the number of registrants
[Docket No. FDA–2017–N–6358] Agenda: On November 30, 2017, the requesting to speak is greater than can
Committee members will meet in open be reasonably accommodated during the
Blood Products Advisory Committee scheduled open public hearing session,
session to discuss bacterial risk control
Advisory Committee; Notice of Meeting FDA may conduct a lottery to determine
strategies for blood collection
AGENCY: Food and Drug Administration, establishments and transfusion services the speakers for the scheduled open
HHS. to enhance the safety and availability of public hearing session. The contact
ACTION: Notice. platelets for transfusion. In the person will notify interested persons
afternoon, the Committee will be seated regarding their request to speak by
SUMMARY: The Food and Drug as a device classification panel. In open November 15, 2017.
Administration (FDA) announces a session, the panel will discuss the Persons attending FDA’s advisory
forthcoming public advisory committee appropriate device classification of committee meetings are advised that the
meeting of the Blood Products Advisory human leukocyte antigen, human Agency is not responsible for providing
Committee (the Committee). The general platelet antigen, and human neutrophil access to electrical outlets.
function of the committee is to provide antigen devices. On December 1, 2017, FDA welcomes the attendance of the
sradovich on DSK3GMQ082PROD with NOTICES
advice and recommendations to the the committee members will meet in public at its advisory committee
Agency on FDA’s regulatory issues open session to discuss strategies to meetings and will make every effort to
related to blood and products derived reduce the risk of transfusion- accommodate persons with disabilities.
from blood. The meeting will be open to transmitted Zika virus. In the afternoon, If you require accommodations due to a
the public. an information session on the disability, please contact Bryan Emery
DATES: The meeting will be held on Transfusion Transmissible Infections or Joanne Lipkind at least 7 days in
November 30, 2017, from 8 a.m. to 5:45 Monitoring System will be presented to advance of the meeting.
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![Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52061
FDA is committed to the orderly Contact Person: Kenneth A. Roebuck, Date: December 8, 2017.
conduct of its advisory committee Ph.D., Scientific Review Officer, Center for Time: 1:00 p.m. to 3:00 p.m.
meetings. Please visit our Web site at Scientific Review, National Institutes of Agenda: To review and evaluate grant
Health, 6701 Rockledge Drive, Room 5106, applications.
https://www.fda.gov/Advisory Place: National Institutes of Health, 6701
MSC 7852, Bethesda, MD 20892, (301) 435–
Committees/AboutAdvisoryCommittees/ 1166, roebuckk@csr.nih.gov. Rockledge Drive, Bethesda, MD 20892
ucm111462.htm for procedures on Name of Committee: Center for Scientific (Telephone Conference Call).
public conduct during advisory Review Special Emphasis Panel; Vascular Contact Person: Maribeth Champoux,
committee meetings. and Hematology AREA Application Review. Ph.D., Scientific Review Officer, Center for
Notice of this meeting is given under Date: December 5, 2017. Scientific Review, National Institutes of
the Federal Advisory Committee Act (5 Time: 2:00 p.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 3170,
U.S.C. app. 2). Agenda: To review and evaluate grant MSC 7848, Bethesda, MD 20892, 301–594–
applications. 3163, champoum@csr.nih.gov.
Dated: November 6, 2017.
Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
Anna K. Abram, Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel; Member
Deputy Commissioner for Policy, Planning, (Telephone Conference Call). Conflict: Cancer Biology.
Legislation, and Analysis. Contact Person: Natalia Komissarova, Date: December 8, 2017.
[FR Doc. 2017–24408 Filed 11–8–17; 8:45 am] Ph.D., Scientific Review Officer, Center for Time: 12:00 p.m. to 3:00 p.m.
BILLING CODE 4164–01–P
Scientific Review, National Institutes of Agenda: To review and evaluate grant
Health, 6701 Rockledge Drive, Room 5207, applications.
MSC 7846, Bethesda, MD 20892, 301–435– Place: National Institutes of Health, 6701
1206, komissar@mail.nih.gov. Rockledge Drive, Bethesda, MD 20892
DEPARTMENT OF HEALTH AND (Virtual Meeting).
Name of Committee: Center for Scientific
HUMAN SERVICES Contact Person: Juraj Bies, Ph.D., Scientific
Review Special Emphasis Panel; PAR–15–
053: Exploratory Grant Award in Basic Review Officer, Center for Scientific Review,
National Institutes of Health Cancer Research (R21). National Institutes of Health, 6701 Rockledge
Date: December 6, 2017. Drive, Rm. 4158, MSC 7806, Bethesda, MD
Center for Scientific Review; Notice of Time: 11:00 a.m. to 5:00 p.m. 20892, 301 435 1256, biesj@mail.nih.gov.
Closed Meetings Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
Pursuant to section 10(d) of the applications. Program Nos. 93.306, Comparative Medicine;
Place: National Institutes of Health, 6701 93.333, Clinical Research, 93.306, 93.333,
Federal Advisory Committee Act, as
Rockledge Drive, Bethesda, MD 20892 93.337, 93.393–93.396, 93.837–93.844,
amended, notice is hereby given of the (Virtual Meeting). 93.846–93.878, 93.892, 93.893, National
following meetings. Contact Person: Craig Giroux, Ph.D., Institutes of Health, HHS)
The meetings will be closed to the Scientific Review Officer, BST IRG, Center
public in accordance with the for Scientific Review, National Institutes of Dated: November 3, 2017.
provisions set forth in sections Health, 6701 Rockledge Drive, Room 5150, Anna Snouffer,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Bethesda, MD 20892, 301–435–2204, Deputy Director, Office of Federal Advisory
as amended. The grant applications and girouxcn@csr.nih.gov. Committee Policy.
the discussions could disclose Name of Committee: Center for Scientific [FR Doc. 2017–24372 Filed 11–8–17; 8:45 am]
confidential trade secrets or commercial Review Special Emphasis Panel; Member BILLING CODE 4140–01–P
property such as patentable material, Conflict: Cardiovascular Sciences.
and personal information concerning Date: December 7, 2017.
Time: 1:00 p.m. to 2:30 p.m. DEPARTMENT OF HEALTH AND
individuals associated with the grant
Agenda: To review and evaluate grant
applications, the disclosure of which applications.
HUMAN SERVICES
would constitute a clearly unwarranted Place: National Institutes of Health, 6701
invasion of personal privacy. Rockledge Drive, Bethesda, MD 20892
National Institutes of Health
Name of Committee: Center for Scientific (Telephone Conference Call).
Contact Person: Yuanna Cheng, MD, Ph.D.,
National Eye Institute; Notice of Closed
Review Special Emphasis Panel; National Meeting
Centers for Cryo-Electron Microscopy-B. Scientific Review Officer, Center for
Date: November 30, 2017. Scientific Review, National Institutes of Pursuant to section 10(d) of the
Time: 2:00 p.m. to 3:00 p.m. Health, 6701 Rockledge Drive, Room 4138, Federal Advisory Committee Act, as
Agenda: To review and evaluate grant MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
amended, notice is hereby given of the
applications. following meeting.
Place: Hyatt Regency Bethesda, One Name of Committee: Center for Scientific
The meeting will be closed to the
Bethesda Metro Center, 7400 Wisconsin Review Special Emphasis Panel; PAR Panel:
Avenue, Bethesda, MD 20814. Serious Adverse Drug Reaction Review. public in accordance with the
Contact Person: William A. Greenberg, Date: December 8, 2017. provisions set forth in sections
Ph.D., Scientific Review Officer, Center for Time: 10:00 a.m. to 1:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Scientific Review, National Institutes of Agenda: To review and evaluate grant as amended. The grant applications and
Health, 6701 Rockledge Drive, Room 4168, applications. the discussions could disclose
MSC 7806, Bethesda, MD 20892, (301) 435– Place: National Institutes of Health, 6701 confidential trade secrets or commercial
1726, greenbergwa@csr.nih.gov. Rockledge Drive, Bethesda, MD 20892 property such as patentable material,
Name of Committee: Center for Scientific (Virtual Meeting). and personal information concerning
Review Special Emphasis Panel; PAR–16– Contact Person: Alexander D. Politis,
individuals associated with the grant
433: Support of NIGMS Program Project Ph.D., Scientific Review Officer, Center for
sradovich on DSK3GMQ082PROD with NOTICES
Scientific Review, National Institutes of applications, the disclosure of which
Grants. would constitute a clearly unwarranted
Date: December 1, 2017. Health, 6701 Rockledge Drive, Room 3210,
Time: 1:00 p.m. to 5:00 p.m. MSC 7808, Bethesda, MD 20892, (301) 435– invasion of personal privacy.
Agenda: To review and evaluate grant 1150, politisa@csr.nih.gov. Name of Committee: National Eye Institute
applications. Name of Committee: Center for Scientific Special Emphasis Panel; NEI Cooperative
Place: National Institutes of Health, 6701 Review Special Emphasis Panel; Member Agreement Applications and Clinical
Rockledge Drive, Bethesda, MD 20892 Conflict: Emotion, Substance Use and Networks I.
(Virtual Meeting). Psychopathology. Date: November 27, 2017.
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Document Created: 2018-10-25 10:30:30
Document Modified: 2018-10-25 10:30:30
| 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 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. | |
| 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, [email protected] and 240-402-8106, [email protected] 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. | |
| FR Citation | 82 FR 52060 |
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