Meeting of the Advisory Committee on Blood and Tissue Safety and Availability, 40774-40775 [2018-17617]

Download as PDF 40774 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to NACRHHS should be sent to Steven Hirsch, using the contact information above at least 3 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Steven Hirsch at the address and phone number listed above at least 10 business days prior to the meeting. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018–17623 Filed 8–15–18; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Opportunity to Co-Sponsor Office of Research Integrity Workshops Office of the Secretary, HHS. ACTION: Notice. AGENCY: The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co-sponsor ORI conferences or workshops (ORI Workshops). Potential co-sponsors must have a demonstrated interest and experience in the responsible conduct of research (RCR) or the handling of research misconduct allegations. Potential co-sponsors must be willing to participate substantively in the cosponsored activity. Expressions of interest for cosponsorships of ORI Workshops are received throughout the year at the email address below. ORI co-sponsors a limited number of workshops with other entities each year. Expressions of interest are being received for ORI Workshops that will take place in the next fiscal year (October 2018 through September 2019) or beyond. Expressions of interest for cosponsorships should be sent by email to AskORI@HHS.GOV with ‘‘Cosponsorship for ORI Workshops’’ in the subject field or by mail to ORI at 1101 Wootton Parkway, Suite 750, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tracey Randolph, Program Analyst, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:15 Aug 15, 2018 Jkt 244001 ORI oversees and directs U.S. Public Health Service (PHS) research integrity activities on behalf of the Secretary of U.S. Department of Health and Human Services (HHS), with the exception of the regulatory research integrity activities of the Food and Drug Administration. ORI is a program office within the Office of the Assistant Secretary for Health, Office of the Secretary, HHS. ORI’s Division of Education and Integrity (DEI) has among its duties the responsibility to develop and implement activities and programs to teach RCR and train Research Integrity Officers (RIOs) as well as others that are involved in research integrity, such as Institutional Officials (IOs) and institutional counsel. Consistent with ORI’s mission and the applicable statutory authority, 42 U.S.C. 289b, ORI Workshops aim to provide clarification and technical information on the HHS regulations for handling research misconduct allegations and on education in RCR to foster integrity in research. ORI Workshops are moderately sized, convening over one to three days, and typically accepting between 20 and 50 attendees. Co-sponsors will assist with workshop and agenda development, coordination, financial management, and meeting logistics in conjunction with ORI staff. Co-sponsors can charge registration fees to recover costs associated with the events; however, co-sponsors may not set registration fees at an amount higher than necessary to recover related event expenses. Further, co-sponsors are solely responsible for collecting and handling any registration fees collected. Eligibility for Co-Sponsorship: The cosponsoring entity must have a demonstrated interest and experience in the RCR or the handling of research misconduct allegations. The cosponsoring entity must participate substantively in the co-sponsored activity, not just provide funding or logistical support. Each co-sponsorship expression of interest shall describe: (1) The entity’s interest and goals in promoting research integrity or the RCR, (2) the entity’s prior experience and current readiness to undertake the responsibilities described above, (3) the type of event(s) that the entity is interested in cosponsoring with ORI, (4) facilities available for the event(s), and (5) any current constraints with respect to dates or facilities. The type of event may be an event from ORI’s regular program of recurring events (e.g., RCR Instructor’s Workshop) or a special topic of mutual SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 interest to be developed jointly. The expression of interest should be a bulleted outline, no more than two pages in length, single-spaced, and 11point font. An entity may submit an expression of interest individually or jointly with other entities describing their relative contributions. Evaluation Criteria: After engaging in exploratory discussions with potential co-sponsors that respond to this notice, the following considerations will be used by HHS officials, as appropriate and relevant, to select the co-sponsor(s): • Qualifications and capability to fulfill co-sponsorship responsibilities • suitability of the location of the proposed event in terms of the overall geographical distribution of ORI events • potential for reaching, generating, and engaging adequate number of attendees from stakeholders • availability and description of facilities needed to support the workshop • availability of administrative support for the logistics of hosting such workshops The selected co-sponsoring organization(s) shall furnish the necessary personnel, materials, services, and facilities to administer its responsibility for the workshop. These duties will be outlined in a cosponsorship agreement with ORI that will set forth the details of the cosponsored activity, including the requirements that any fees collected by the co-sponsor shall be limited to the amount necessary to cover the cosponsor’s related event expenses. This co-sponsorship agreement does not represent an endorsement by ORI of an individual co-sponsor’s policies, positions, or activities. Additionally, this agreement will not affect any determination concerning activities by the co-sponsors that are regulated by ORI. Dated: August 9, 2018. Scott J. Moore, Deputy Director, Office of Research Integrity. [FR Doc. 2018–17615 Filed 8–15–18; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. AGENCY: E:\FR\FM\16AUN1.SGM 16AUN1 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices ACTION: Notice. 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 on Thursday, September 13, 2018, from 8:00 a.m.–5:00 p.m. ET. ADDRESSES: Crystal City Marriott at Reagan National Airport, 1999 Jefferson Davis Highway, Arlington, 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: ACBTSA@ hhs.gov. SUMMARY: 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. The Committee will meet on September 13, 2018 to receive presentations on material pertinent to exploring the topic of ‘‘Defining a tolerable risk for infectious diseases from a patient’s perspective.’’ Historical aspects of combating infectious disease risks in the blood supply, ongoing national and global efforts towards mitigating those risks, and emerging considerations shall be presented to the Committee. The full Committee will receive an interim report from the ACBTSA Blood Sustainability subcommittee and additional topics that are pertinent to sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:15 Aug 15, 2018 Jkt 244001 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 session scheduled for 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 September 7, 2018. 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 September 7, 2018. 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 September 7, 2018. Dated: August 9, 2018. James J. Berger, Senior Advisor for Blood and Tissue Policy. [FR Doc. 2018–17617 Filed 8–15–18; 8:45 am] BILLING CODE 4150–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting. DATES: The meeting will be held on September 12 and 13, 2018. The meeting times and agenda will be posted on the NVAC website at https:// www.hhs.gov/nvpo/nvac/meetings/ index.html as soon as they become available. SUMMARY: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Room 800, 200 Independence Avenue SW, Washington, ADDRESSES: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 40775 DC 20201. The meeting can also be accessed through a live webcast on both days of the meeting. For more information, visit https://www.hhs.gov/ nvpo/nvac/meetings/. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in a public comment session. Individuals who wish to attend the meeting and/or participate in a public comment session should register at https://www.hhs.gov/nvpo/nvac/ meetings/. Participants may also register by emailing nvpo@hhs.gov or by calling (202) 690–5566 and providing their name, organization, and email address. FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal Officer, National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690–5566; email: nvac@ hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. 300aa–1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program’s responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. During the September 2018 NVAC meeting, sessions will consist of presentations on valuing vaccines, including presentations on the role of vaccines in combatting antibiotic resistance; vaccine innovation, including presentations on financing, new technologies, and development of new vaccines; lessons from the field, with focus on Ebola and the new Shingles vaccine; and a session on HPV vaccination for cancer prevention. Please note that agenda items will be related to the charge of the Committee and are subject to change as priorities dictate. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website: https:// www.hhs.gov/nvpo/nvac/. Public attendance at the meeting is limited to the available space. Individuals who plan to attend in person and need special assistance, such as sign language interpretation or other reasonable accommodations, E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40774-40775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

[[Page 40775]]


ACTION: Notice.

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

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 on Thursday, September 13, 2018, 
from 8:00 a.m.-5:00 p.m. ET.

ADDRESSES: Crystal City Marriott at Reagan National Airport, 1999 
Jefferson Davis Highway, Arlington, 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. The Committee will meet on 
September 13, 2018 to receive presentations on material pertinent to 
exploring the topic of ``Defining a tolerable risk for infectious 
diseases from a patient's perspective.'' Historical aspects of 
combating infectious disease risks in the blood supply, ongoing 
national and global efforts towards mitigating those risks, and 
emerging considerations shall be presented to the Committee. The full 
Committee will receive an interim report from the ACBTSA Blood 
Sustainability subcommittee and 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 session scheduled for 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 
September 7, 2018. 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 September 7, 2018. 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 September 7, 2018.

    Dated: August 9, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy.
[FR Doc. 2018-17617 Filed 8-15-18; 8:45 am]
 BILLING CODE 4150-41-P

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