81_FR_73323 81 FR 73118 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

81 FR 73118 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 205 (October 24, 2016)

Page Range73118-73118
FR Document2016-25650

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 81 Issue 205 (Monday, October 24, 2016) 
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Page 73118]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25650]


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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 28, 2016, from 9:30 
a.m.-4:00 p.m. and Tuesday November 29, 2016, from 8:30 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, Mary E. Switzer Building, 330 C Street SW., Suite L100, 
Washington, DC 20024. Phone: (202)-795-7697; Fax: (202)-691-2102; 
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. 
In November 2015, the Committee made recommendations again, reaffirming 
the December 2013 recommendations, highlighting the worsening 
conditions, and suggesting potential initiatives to address the issues 
in the blood system. Past recommendations made by the ACBTSA may be 
viewed at http://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/index.html.
    The Committee will meet on November 28-29, 2016 to hear the 
findings from the HHS sponsored RAND study, ``Toward a Sustainable 
Blood Supply in the United States: An Analysis of the Current System 
and Alternatives for the Future.'' The ACBTSA Subcommittee on Blood 
System Sustainability will present their response to the study, and the 
full Committee will discuss and develop appropriate recommendations for 
HHS consideration. Additional topics that are pertinent to the mission 
of the Committee may be added to the agenda.
    The public will have an opportunity to present their views to the 
Committee during public comment sessions scheduled for both days of the 
meeting. 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 submit 
their name, email, and comment summary prior to close of business on 
November 17, 2016. 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 17, 2016. 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 17, 2016.

    Dated: October 18, 2016.
James J. Berger,
Senior Advisor for Blood and Tissue Policy.
[FR Doc. 2016-25650 Filed 10-21-16; 8:45 am]
 BILLING CODE 4150-41-P

73118 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices technology to minimize the information risk communications related to blood Dated: October 18, 2016. collection burden. transfusion and tissue transplantation; James J. Berger, and (6) identification of infectious Senior Advisor for Blood and Tissue Policy. Amy McNulty, disease transmission issues for blood, [FR Doc. 2016–25650 Filed 10–21–16; 8:45 am] Deputy Director, Division of the Executive organs, blood stem cells and tissues. Secretariat. BILLING CODE 4150–41–P The Committee has met regularly since [FR Doc. 2016–25618 Filed 10–21–16; 8:45 am] its establishment in 1997. BILLING CODE 4165–15–P In December 2013, the Committee DEPARTMENT OF HEALTH AND made recommendations regarding the HUMAN SERVICES blood system. At that time, the DEPARTMENT OF HEALTH AND Committee expressed concern about the National Institutes of Health HUMAN SERVICES ongoing reductions in blood use, the number of large scale consolidations Center for Scientific Review; Notice of Meeting of the Advisory Committee on occurring, the cost recovery issues for Closed Meetings Blood and Tissue Safety and Availability blood centers, and the potential effects Pursuant to section 10(d) of the on safety and innovation due to AGENCY: Office of the Assistant Federal Advisory Committee Act, as instability. In November 2015, the Secretary for Health, Office of the amended (5 U.S.C. App.), notice is Committee made recommendations Secretary, Department of Health and hereby given of the following meetings. again, reaffirming the December 2013 The meetings will be closed to the Human Services. recommendations, highlighting the public in accordance with the ACTION: Notice. worsening conditions, and suggesting provisions set forth in sections potential initiatives to address the SUMMARY: As stipulated by the Federal 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., issues in the blood system. Past Advisory Committee Act, the U.S. as amended. The grant applications and recommendations made by the ACBTSA Department of Health and Human the discussions could disclose may be viewed at http://www.hhs.gov/ Services is hereby giving notice that the confidential trade secrets or commercial ohaidp/initiatives/blood-tissue-safety/ Advisory Committee on Blood and property such as patentable material, advisory-committee/index.html. Tissue Safety and Availability The Committee will meet on and personal information concerning (ACBTSA) will hold a meeting. The November 28–29, 2016 to hear the individuals associated with the grant meeting will be open to the public. findings from the HHS sponsored RAND applications, the disclosure of which DATES: The meeting will take place study, ‘‘Toward a Sustainable Blood would constitute a clearly unwarranted Monday November 28, 2016, from 9:30 Supply in the United States: An invasion of personal privacy. a.m.–4:00 p.m. and Tuesday November Analysis of the Current System and Name of Committee: Center for Scientific 29, 2016, from 8:30 a.m.–4:00 p.m. Alternatives for the Future.’’ The Review Special Emphasis Panel; Member ADDRESSES: Veterans’ Health ACBTSA Subcommittee on Blood Conflict: Health Services Organization and Administration National Conference System Sustainability will present their Delivery. response to the study, and the full Date: November 3, 2016. Center, 2011 Crystal Drive, 1st floor Time: 2:00 p.m. to 5:00 p.m. Conference Center, Crystal City, VA Committee will discuss and develop Agenda: To review and evaluate grant 22202. appropriate recommendations for HHS applications. FOR FURTHER INFORMATION CONTACT: Mr. consideration. Additional topics that are Place: National Institutes of Health, 6701 James Berger, Designated Federal Officer pertinent to the mission of the Rockledge Drive, Bethesda, MD 20892, for the ACBTSA, Senior Advisor for Committee may be added to the agenda. (Telephone Conference Call). The public will have an opportunity Contact Person: Peter J Kozel, Ph.D., Blood and Tissue Policy, Office of the to present their views to the Committee Scientific Review Officer, Center for Assistant Secretary for Health, Scientific Review, National Institutes of during public comment sessions Department of Health and Human Health, 6701 Rockledge Drive, Room 3139, scheduled for both days of the meeting. Services, Mary E. Switzer Building, 330 Comments will be limited to five Bethesda, MD 20892, 301–435–1116, kozelp@ C Street SW., Suite L100, Washington, minutes per speaker and must be mail.nih.gov. DC 20024. Phone: (202)-795–7697; Fax: pertinent to the discussion. Pre- This notice is being published less than 15 (202)-691–2102; Email: ACBTSA@ registration is required for participation days prior to the meeting due to the timing hhs.gov. limitations imposed by the review and in the public comment session. Any funding cycle. SUPPLEMENTARY INFORMATION: The member of the public who would like to ACBTSA provides advice to the Name of Committee: Center for Scientific participate in this session is required to Review Special Emphasis Panel; PAR 14– Secretary through the Assistant submit their name, email, and comment 260: Health Promotion and Disease Secretary for Health. The Committee summary prior to close of business on Prevention among Native American advises on a range of policy issues to November 17, 2016. If it is not possible Populations. include: (1) Identification of public to provide 30 copies of the material to Date: November 4, 2016. health issues through surveillance of be distributed at the meeting, then Time: 8:00 a.m. to 5:00 p.m. blood and tissue safety issues with individuals are requested to provide a Agenda: To review and evaluate grant national biovigilance data tools; (2) minimum of one (1) copy of the applications. identification of public health issues document(s) to be distributed prior to Place: National Institutes of Health, 6701 that affect availability of blood, blood the close of business on November 17, Rockledge Drive, Bethesda, MD 20892. sradovich on DSK3GMQ082PROD with NOTICES Contact Person: Martha L Hare, RN, Ph.D., products, and tissues; (3) broad public 2016. It is also requested that any Scientific Review Officer, Center for health, ethical, and legal issues related member of the public who wishes to Scientific Review, National Institutes of to the safety of blood, blood products, provide comments to the Committee Health, 6701 Rockledge Drive, Room 3154, and tissues; (4) the impact of various utilizing electronic data projection MSC 7770, Bethesda, MD 20892, (301) 451– economic factors (e.g., product cost and submit the necessary material to the 8504, harem@mail.nih.gov. supply) on safety and availability of Designated Federal Officer prior to the This notice is being published less than 15 blood, blood products, and tissues; (5) close of business on November 17, 2016. days prior to the meeting due to the timing VerDate Sep<11>2014 17:42 Oct 21, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\24OCN1.SGM 24OCN1


Document Created: 2016-10-21 23:45:48
Document Modified: 2016-10-21 23:45:48
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 28, 2016, from 9:30 a.m.-4:00 p.m. and Tuesday November 29, 2016, from 8:30 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, Mary E. Switzer Building, 330 C Street SW., Suite L100, Washington, DC 20024. Phone: (202)-795-7697; Fax: (202)-691-2102; Email: [email protected]
FR Citation81 FR 73118 
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