Blood Products Advisory Committee; Notice of Meeting, 4476-4477 [2019-02507]

Download as PDF 4476 Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0426] General and Plastic Surgery Devices Panel of the Medical Devices 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 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on March 25 and 26, 2019, 8 a.m. to 6 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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. Information about the FDA’s Meeting facility on the White Oak Campus can be found at https://www.fda.gov/ aboutfda/workingatfda/buildingsand facilities/whiteoakcampusinformation/ ucm241740.htm. SUMMARY: khammond on DSKBBV9HB2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993–0002, Patricio.Garcia@ fda.hhs.gov, 301–796–6875, 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. VerDate Sep<11>2014 19:41 Feb 14, 2019 Jkt 247001 Agenda: On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) Breast implant associated anaplastic large cell lymphoma (BIA– ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians. 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 March 4, 2019. Oral presentations from the public will be scheduled on March 25, 2019, between approximately 11 a.m. and 12 noon and 2:30 p.m. to 3:30 p.m. Oral presentations from the public will be scheduled on March 26, 2019, between approximately 10 a.m. and 11 a.m. and 3 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and indicate in which session they would like to present (which day, morning or afternoon session). The notification should include 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 February 27, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 sessions. The contact person will notify interested persons regarding their request to speak by February 28, 2019. 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 AnnMarie Williams, at annmarie.williams@ fda.hhs.gov or 301–796–5966 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: February 11, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–02380 Filed 2–14–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0573] Blood Products 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 (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on regulatory issues related to blood and products derived from blood. Matters considered at the meeting will include testing of the blood supply for Zika virus, topics relevant to blood donation by men who have sex with men, and an overview of research programs in the Laboratory of SUMMARY: E:\FR\FM\15FEN1.SGM 15FEN1 khammond on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices Biochemistry and Vascular Biology. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on March 20, 2019, from 8:30 a.m. to 4:45 p.m., and March 21, 2019, from 8:30 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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 those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/bpac0319. FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993–0002, 240– 402–8006, Prabhakara.Atreya@ fda.hhs.gov; Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD 20993–0002, 240–402–8106, Joanne.Lipkind@ fda.hhs.gov; or the 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. 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/ bpac0319. SUPPLEMENTARY INFORMATION: Agenda: On March 20, 2019, in the morning, BPAC will meet in open session to discuss and make recommendations on strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components. The committee will VerDate Sep<11>2014 19:41 Feb 14, 2019 Jkt 247001 discuss whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of the ZIKV epidemic in the United States and worldwide. In the afternoon, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. On March 21, 2019, the committee will meet in open session to discuss blood donation policies regarding men who have sex with men (MSM). The committee will hear presentations on the current epidemiology of HIV in the United States; global developments in MSM blood donor deferral policies; and data on HIV incidence and prevalence among blood donors from the Transfusion-Transmitted Infection Monitoring System. The committee will discuss a proposed HIV risk questionnaire study. In addition, the committee will discuss a proposal for the use of pathogen reduction technology as an alternative procedure to a time-based deferral for MSM. 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: On March 20, 2019, from 8:30 a.m. to 4 p.m., and on March 21, 2019, from 8:30 a.m. to 5 p.m., the meeting is open to the public. 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 March 13, 2019. On March 20, 2019, oral presentations from the public will be scheduled between approximately 11:10 a.m. to 11:40 a.m. and 3:15 p.m. to 3:45 p.m. On March 21, 2019, oral presentations from the public will be scheduled between approximately 11:25 a.m. and 11:55 a.m. and between 3 p.m. and 4 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 4477 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 March 5, 2019. 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 March 6, 2019. Closed Committee Deliberations: On March 20, 2019, from 4 p.m. to 4:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the investigator’s research will, along with other information, be used in making personnel and staffing decisions regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT) 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: February 11, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–02507 Filed 2–14–19; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4476-4477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]


Blood Products 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 (BPAC). The general function of the committee is to provide 
advice and recommendations to the Agency on regulatory issues related 
to blood and products derived from blood. Matters considered at the 
meeting will include testing of the blood supply for Zika virus, topics 
relevant to blood donation by men who have sex with men, and an 
overview of research programs in the Laboratory of

[[Page 4477]]

Biochemistry and Vascular Biology. At least one portion of the meeting 
will be closed to the public.

DATES: The meeting will be held on March 20, 2019, from 8:30 a.m. to 
4:45 p.m., and March 21, 2019, from 8:30 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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 those unable to attend in person, the meeting will also be 
webcast and will be available at the following link: https://collaboration.fda.gov/bpac0319.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 
240-402-8006, Prabhakara.Atreya@fda.hhs.gov; Joanne Lipkind, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD 20993-0002, 
240-402-8106, Joanne.Lipkind@fda.hhs.gov; or the 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. 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/bpac0319.

SUPPLEMENTARY INFORMATION: 
    Agenda: On March 20, 2019, in the morning, BPAC will meet in open 
session to discuss and make recommendations on strategies to reduce the 
risk of Zika virus (ZIKV) transmission by blood and blood components. 
The committee will discuss whether universal testing of blood donations 
for ZIKV is an appropriate strategy considering the decline of the ZIKV 
epidemic in the United States and worldwide. In the afternoon, the 
committee will meet in open session to hear an overview of the research 
programs in the Laboratory of Biochemistry and Vascular Biology in the 
Division of Blood Components and Devices, Office of Blood Research and 
Review, Center for Biologics Evaluation and Research, FDA.
    On March 21, 2019, the committee will meet in open session to 
discuss blood donation policies regarding men who have sex with men 
(MSM). The committee will hear presentations on the current 
epidemiology of HIV in the United States; global developments in MSM 
blood donor deferral policies; and data on HIV incidence and prevalence 
among blood donors from the Transfusion-Transmitted Infection 
Monitoring System. The committee will discuss a proposed HIV risk 
questionnaire study. In addition, the committee will discuss a proposal 
for the use of pathogen reduction technology as an alternative 
procedure to a time-based deferral for MSM.
    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: On March 20, 2019, from 8:30 a.m. to 4 p.m., and on 
March 21, 2019, from 8:30 a.m. to 5 p.m., the meeting is open to the 
public. 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 March 13, 
2019. On March 20, 2019, oral presentations from the public will be 
scheduled between approximately 11:10 a.m. to 11:40 a.m. and 3:15 p.m. 
to 3:45 p.m. On March 21, 2019, oral presentations from the public will 
be scheduled between approximately 11:25 a.m. and 11:55 a.m. and 
between 3 p.m. and 4 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 March 5, 2019. 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 March 6, 
2019.
    Closed Committee Deliberations: On March 20, 2019, from 4 p.m. to 
4:45 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory 
committee regarding the progress of the investigator's research will, 
along with other information, be used in making personnel and staffing 
decisions regarding individual scientists. We believe that public 
discussion of these recommendations on individual scientists would 
constitute an unwarranted invasion of personal privacy.
    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 Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT) 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: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02507 Filed 2-14-19; 8:45 am]
BILLING CODE 4164-01-P

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