80_FR_64629 80 FR 64424 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

80 FR 64424 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 205 (October 23, 2015)

Page Range64424-64425
FR Document2015-26904

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.

Federal Register, Volume 80 Issue 205 (Friday, October 23, 2015) 
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64424-64425]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Blood and Tissue Safety and 
Availability

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Advisory Committee on Blood and Tissue Safety and Availability 
(ACBTSA) will hold a meeting. The meeting will be open to the public.

DATES: The meeting will take place Monday, November 9, 2015, from 8:00 
a.m.-4:30 p.m. and Tuesday, November 10, 2015, from 8:00 a.m.-4:00 p.m.

ADDRESSES: Veterans' Health Administration National Conference Center, 
2011 Crystal Drive, 1st floor Conference Center, Crystal City, VA 
22202.

FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal 
Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852. 
Phone: (240) 453-8803; Fax (240) 453-8456; Email [email protected].

SUPPLEMENTARY INFORMATION: The ACBTSA provides advice to the Secretary 
through the Assistant Secretary for Health. The Committee advises on a 
range of policy issues to include: (1) Identification of public health 
issues through surveillance of blood and tissue safety issues with 
national biovigilance data tools; (2) identification of public health 
issues that affect availability of blood, blood products, and tissues; 
(3) broad public health, ethical and legal issues related to the safety 
of blood, blood products, and tissues; (4) the impact of various 
economic factors (e.g., product cost and supply) on safety and 
availability of blood, blood products, and tissues; (5) risk 
communications related to blood transfusion and tissue transplantation; 
and (6) identification of infectious disease transmission issues for 
blood, organs, blood stem cells and tissues. The Committee has met 
regularly since its establishment in 1997.
    In December 2013, the Committee made recommendations regarding the 
blood system. At that time, the Committee expressed concern about the 
ongoing reductions in blood use, the number of large scale 
consolidations occurring, the cost recovery issues for blood centers, 
and the potential effects on safety and innovation due to instability. 
Past recommendations made by the ACBTSA may be viewed at www.hhs.gov/bloodsafety.
    This meeting will provide a focused examination of the mechanisms 
to fund recently approved blood safety innovations, such as pathogen

[[Page 64425]]

reduction, bacterial testing, and infectious disease testing. It is 
anticipated that the implementation of these blood safety innovations 
will come with significant costs to blood collection centers, and it 
remains unclear how or if the blood industry can afford such 
implementation. Speakers will include a broad range of stakeholders 
including blood banks, physicians, blood purchasers, and organizations 
that reimburse for blood and blood products.
    The public will have an opportunity to present their views to the 
Committee during a public comment session scheduled for November 10, 
2015. Comments will be limited to five minutes per speaker and must be 
pertinent to the discussion. Pre-registration is required for 
participation in the public comment session. Any member of the public 
who would like to participate in this session is required to contact 
the Designated Federal Officer at his/her earliest convenience to 
register for time (limited to 5 minutes); registration must be 
completed prior to close of business on November 2, 2015. If it is not 
possible to provide 30 copies of the material to be distributed at the 
meeting, then individuals are requested to provide a minimum of one (1) 
copy of the document(s) to be distributed prior to the close of 
business on November 2, 2015. It is also requested that any member of 
the public who wishes to provide comments to the Committee utilizing 
electronic data projection submit the necessary material to the 
Designated Federal Officer prior to the close of business on November 
2, 2015.

    Dated: October 16, 2015.
James J. Berger,
Senior Advisor for Blood and Tissue Safety Policy.
[FR Doc. 2015-26904 Filed 10-22-15; 8:45 am]
 BILLING CODE 4150-41-P

64424 Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices range of professional disciplines and Respectful consideration of opposing SUMMARY: As stipulated by the Federal educational levels. views and active participation by Advisory Committee Act, the U.S. DATES: The meeting will take place citizens in public exchange of ideas Department of Health and Human November 17, 2015, from 9 a.m. to enhances overall public understanding Services is hereby giving notice that the approximately 5 p.m. of the issues at hand and conclusions Advisory Committee on Blood and ADDRESSES: Hilton Arlington Hotel, 950 reached by the Commission. The Tissue Safety and Availability Commission is particularly interested in (ACBTSA) will hold a meeting. The North Stafford Street, Arlington, VA receiving comments and questions meeting will be open to the public. 22203. during the meeting that are responsive DATES: The meeting will take place FOR FURTHER INFORMATION CONTACT: Lisa to specific sessions. Written comments Monday, November 9, 2015, from 8:00 M. Lee, Executive Director, Presidential will be accepted at the registration desk a.m.–4:30 p.m. and Tuesday, November Commission for the Study of Bioethical and comment forms will be provided to 10, 2015, from 8:00 a.m.–4:00 p.m. Issues, 1425 New York Avenue NW., members of the public in order to write ADDRESSES: Veterans’ Health Suite C–100, Washington, DC 20005. down questions and comments for the Administration National Conference Telephone: 202–233–3960. Email: Commission as they arise. To Center, 2011 Crystal Drive, 1st floor Lisa.Lee@bioethics.gov. Additional accommodate as many individuals as Conference Center, Crystal City, VA information may be obtained at possible, the time for each question or 22202. www.bioethics.gov. comment may be limited. If the number FOR FURTHER INFORMATION CONTACT: Mr. SUPPLEMENTARY INFORMATION: Pursuant of individuals wishing to pose a James Berger, Designated Federal Officer to the Federal Advisory Committee Act question or make a comment is greater for the ACBTSA, Senior Advisor for of 1972, Public Law 92–463, 5 U.S.C. than can reasonably be accommodated Blood and Tissue Policy, Office of the app. 2, notice is hereby given for the during the scheduled meeting, the Assistant Secretary for Health, twenty-third meeting of the Commission may make a random Department of Health and Human Commission. The meeting will be open selection. Services, 1101 Wootton Parkway, Suite to the public with attendance limited to Written comments will also be 250, Rockville, MD 20852. Phone: (240) space available. The meeting will also accepted in advance of the meeting and 453–8803; Fax (240) 453–8456; Email be webcast at www.bioethics.gov. are especially welcome. Please address ACBTSA@hhs.gov. Under authority of Executive Order written comments by email to info@ SUPPLEMENTARY INFORMATION: The 13521, dated November 24, 2009, the bioethics.gov, or by mail to the ACBTSA provides advice to the President established the Commission. following address: Public Commentary, Secretary through the Assistant The Commission is an expert panel of Presidential Commission for the Study Secretary for Health. The Committee not more than 13 members who are of Bioethical Issues, 1425 New York advises on a range of policy issues to drawn from the fields of bioethics, Avenue NW., Suite C–100, Washington, include: (1) Identification of public science, medicine, technology, DC 20005. Comments will be publicly health issues through surveillance of engineering, law, philosophy, theology, available, including any personally blood and tissue safety issues with or other areas of the humanities or identifiable or confidential business national biovigilance data tools; (2) social sciences. The Commission information that they contain. Trade identification of public health issues advises the President on bioethical secrets should not be submitted. that affect availability of blood, blood issues arising from advances in Anyone planning to attend the products, and tissues; (3) broad public biomedicine and related areas of science meeting who needs special assistance, health, ethical and legal issues related to and technology. The Commission seeks such as sign language interpretation or the safety of blood, blood products, and to identify and promote policies and other reasonable accommodations, tissues; (4) the impact of various practices that ensure scientific research, should notify Esther Yoo by telephone economic factors (e.g., product cost and health care delivery, and technological at (202) 233–3960, or email at supply) on safety and availability of innovation are conducted in a socially Esther.Yoo@bioethics.gov in advance of blood, blood products, and tissues; (5) and ethically responsible manner. the meeting. The Commission will make risk communications related to blood The main agenda items for the every effort to accommodate persons transfusion and tissue transplantation; Commission’s twenty-third meeting are who need special assistance. and (6) identification of infectious to continue discussing the role of Dated: October 9, 2015. disease transmission issues for blood, deliberation and deliberative methods to Lisa M. Lee, organs, blood stem cells and tissues. engage the public in bioethics, and how Executive Director, Presidential Commission The Committee has met regularly since to integrate pubic dialogue into the for the Study of Bioethical Issues. its establishment in 1997. bioethics conversation; bioethics [FR Doc. 2015–26905 Filed 10–22–15; 8:45 am] In December 2013, the Committee education as a forum for fostering BILLING CODE 4154–06–P made recommendations regarding the deliberative skills, and preparing blood system. At that time, the students to participate in public Committee expressed concern about the dialogue in bioethics; goals and DEPARTMENT OF HEALTH AND ongoing reductions in blood use, the methods of bioethics education; and HUMAN SERVICES number of large scale consolidations integrating bioethics education across a occurring, the cost recovery issues for range of professional disciplines and Meeting of the Advisory Committee on blood centers, and the potential effects Blood and Tissue Safety and mstockstill on DSK4VPTVN1PROD with NOTICES educational levels. The draft meeting on safety and innovation due to agenda and other information about the Availability instability. Past recommendations made Commission, including information AGENCY: Office of the Assistant by the ACBTSA may be viewed at about access to the webcast, will be Secretary for Health, Office of the www.hhs.gov/bloodsafety. available at www.bioethics.gov. Secretary, Department of Health and This meeting will provide a focused The Commission welcomes input Human Services. examination of the mechanisms to fund from anyone wishing to provide public recently approved blood safety ACTION: Notice. comment on any issue before it. innovations, such as pathogen VerDate Sep<11>2014 18:05 Oct 22, 2015 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1

Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64425 reduction, bacterial testing, and confidential trade secrets or commercial Drive, Room 5210, MSC 7846, Bethesda, MD infectious disease testing. It is property such as patentable material, 20892, (301) 435–1246, anticipated that the implementation of and personal information concerning edwardss@csr.nih.gov. these blood safety innovations will individuals associated with the grant Name of Committee: Center for Scientific come with significant costs to blood applications, the disclosure of which Review Special Emphasis Panel; Small collection centers, and it remains would constitute a clearly unwarranted Business: Psycho/Neuropathology, Lifespan unclear how or if the blood industry can Development, and STEM Education. invasion of personal privacy. Date: November 16–17, 2015. afford such implementation. Speakers Name of Committee: National Eye Institute Time: 8:00 a.m. to 5:00 p.m. will include a broad range of Special Emphasis Panel NEI Clinical and Agenda: To review and evaluate grant stakeholders including blood banks, Epidemiological Applications: Uveitis, applications. physicians, blood purchasers, and Cornea and Refractive Error. Place: Hilton Long Beach and Executive organizations that reimburse for blood Date: November 10, 2015. Center, 701 West Ocean Boulevard, Long and blood products. Time: 8:00 a.m. to 5:00 p.m. Beach, CA 90831. The public will have an opportunity Agenda: To review and evaluate grant Contact Person: John H Newman, Ph.D., to present their views to the Committee applications. Scientific Review Officer, Center for Place: Hilton Garden Inn Bethesda, 7301 Scientific Review, National Institutes of during a public comment session Waverly Street, Bethesda, MD 20814. scheduled for November 10, 2015. Health, 6701 Rockledge Drive, Room 3222, Contact Person: JEANETTE M HOSSEINI, MSC 7808, Bethesda, MD 20892, (301) 435– Comments will be limited to five Ph.D. Scientific Review Officer, 5635 Fishers 0628, newmanjh@csr.nih.gov. minutes per speaker and must be Lane, Suite 1300, Bethesda, MD 20892, 301– pertinent to the discussion. Pre- 451–2020, jeanetteh@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: registration is required for participation (Catalogue of Federal Domestic Assistance Basic Research on HIV Persistence. in the public comment session. Any Program Nos. 93.867, Vision Research, Date: November 18, 2015. member of the public who would like to National Institutes of Health, HHS) Time: 8:00 a.m. to 6:00 p.m. participate in this session is required to Dated: October 19, 2015. Agenda: To review and evaluate grant contact the Designated Federal Officer at Natasha Copeland, applications. his/her earliest convenience to register Place: The Fairmont Washington, DC, 2401 Program Analyst, Office of Federal Advisory M Street NW., Washington, DC 20037. for time (limited to 5 minutes); Committee Policy. registration must be completed prior to Contact Person: Kenneth A. Roebuck, [FR Doc. 2015–26926 Filed 10–22–15; 8:45 am] Ph.D., Scientific Review Officer, Center for close of business on November 2, 2015. If it is not possible to provide 30 copies BILLING CODE 4140–01–P Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, of the material to be distributed at the MSC 7852, Bethesda, MD 20892, (301) 435– meeting, then individuals are requested DEPARTMENT OF HEALTH AND 1166, roebuckk@csr.nih.gov. to provide a minimum of one (1) copy HUMAN SERVICES Name of Committee: Center for Scientific of the document(s) to be distributed Review Special Emphasis Panel; Small prior to the close of business on National Institutes of Health Business: Cell and Molecular Biology. November 2, 2015. It is also requested Date: November 18–19, 2015. that any member of the public who Center for Scientific Review; Notice of Time: 8:00 a.m. to 5:00 p.m. wishes to provide comments to the Closed Meetings Agenda: To review and evaluate grant Committee utilizing electronic data applications. Pursuant to section 10(d) of the Place: Renaissance Arlington Capital View, projection submit the necessary material Federal Advisory Committee Act, as 2800 South Potomac Ave, Arlington, VA. to the Designated Federal Officer prior amended (5 U.S.C. App.), notice is Contact Person: Maria DeBernardi, Ph.D., to the close of business on November 2, hereby given of the following meetings. Scientific Review Officer, Center for 2015. The meetings will be closed to the Scientific Review, National Institutes of Dated: October 16, 2015. public in accordance with the Health, 6701 Rockledge Drive, Room 6158, James J. Berger, provisions set forth in sections MSC 7892, Bethesda, MD 20892, 301–435– Senior Advisor for Blood and Tissue Safety 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 1355, debernardima@csr.nih.gov. Policy. as amended. The grant applications and Name of Committee: Center for Scientific [FR Doc. 2015–26904 Filed 10–22–15; 8:45 am] the discussions could disclose Review Special Emphasis Panel; Small BILLING CODE 4150–41–P confidential trade secrets or commercial Business: Dermatology, Rheumatology and Inflammation. property such as patentable material, Date: November 18, 2015. and personal information concerning Time: 9:00 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND individuals associated with the grant Agenda: To review and evaluate grant HUMAN SERVICES applications, the disclosure of which applications. would constitute a clearly unwarranted Place: National Institutes of Health, 6701 National Institutes of Health invasion of personal privacy. Rockledge Drive, Bethesda, MD 20892. Name of Committee: Center for Scientific Contact Person: Yanming Bi, Ph.D., National Eye Institute; Notice of Closed Scientific Review Officer, Center for Meeting. Review Special Emphasis Panel; Member Conflict: Addictions, Depression, Bipolar Scientific Review, National Institutes of Pursuant to section 10(d) of the Disorder, Schizophrenia. Health, 6701 Rockledge Drive, Room 4214, Date: November 10, 2015. MSC 7814, Bethesda, MD 20892, 301–451– Federal Advisory Committee Act, as Time: 11:00 a.m. to 4:00 p.m. 0996, ybi@csr.nih.gov. mstockstill on DSK4VPTVN1PROD with NOTICES amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant Name of Committee: Center for Scientific hereby given of the following meeting. applications. Review Special Emphasis Panel; The meeting will be closed to the Place: National Institutes of Health, 6701 Fellowships: Learning, Memory, Language, public in accordance with the Rockledge Drive, Bethesda, MD 20892 Communication and Related Neurosciences. provisions set forth in sections (Virtual Meeting). Date: November 18, 2015. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: Samuel C. Edwards, Ph.D., Time: 10:00 a.m. to 5:00 p.m. as amended. The grant applications and IRG CHIEF, Center for Scientific Review, Agenda: To review and evaluate grant the discussions could disclose National Institutes of Health, 6701 Rockledge applications. VerDate Sep<11>2014 18:05 Oct 22, 2015 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1


Document Created: 2015-12-14 15:31:46
Document Modified: 2015-12-14 15:31:46
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.
DatesThe meeting will take place Monday, November 9, 2015, from 8:00 a.m.-4:30 p.m. and Tuesday, November 10, 2015, from 8:00 a.m.-4:00 p.m.
ContactMr. James Berger, Designated Federal Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852. Phone: (240) 453-8803; Fax (240) 453-8456; Email [email protected]
FR Citation80 FR 64424 
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