83 FR 40774 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 159 (August 16, 2018)

Page Range		40774-40775
FR Document		2018-17617

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 83 Issue 159 (Thursday, August 16, 2018)

[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40774-40775]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 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

40774 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices

Public participants may submit written SUPPLEMENTARY INFORMATION: ORI interest to be developed jointly. The
statements in advance of the scheduled oversees and directs U.S. Public Health expression of interest should be a
meeting. Oral comments will be Service (PHS) research integrity bulleted outline, no more than two
honored in the order they are requested activities on behalf of the Secretary of pages in length, single-spaced, and 11-
and may be limited as time allows. U.S. Department of Health and Human point font. An entity may submit an
Requests to submit a written statement Services (HHS), with the exception of expression of interest individually or
or make oral comments to NACRHHS the regulatory research integrity jointly with other entities describing
should be sent to Steven Hirsch, using activities of the Food and Drug their relative contributions.
the contact information above at least 3 Administration. ORI is a program office Evaluation Criteria: After engaging in
business days prior to the meeting. within the Office of the Assistant exploratory discussions with potential
Individuals who plan to attend and Secretary for Health, Office of the co-sponsors that respond to this notice,
need special assistance or another Secretary, HHS. the following considerations will be
reasonable accommodation should ORI’s Division of Education and used by HHS officials, as appropriate
notify Steven Hirsch at the address and Integrity (DEI) has among its duties the and relevant, to select the co-sponsor(s):
phone number listed above at least 10 responsibility to develop and • Qualifications and capability to fulfill
business days prior to the meeting. implement activities and programs to co-sponsorship responsibilities
teach RCR and train Research Integrity • suitability of the location of the
Amy P. McNulty, Officers (RIOs) as well as others that are
Acting Director, Division of the Executive
proposed event in terms of the overall
involved in research integrity, such as geographical distribution of ORI
Secretariat. Institutional Officials (IOs) and
[FR Doc. 2018–17623 Filed 8–15–18; 8:45 am]
events
institutional counsel. • potential for reaching, generating, and
BILLING CODE 4165–15–P Consistent with ORI’s mission and the engaging adequate number of
applicable statutory authority, 42 U.S.C. attendees from stakeholders
289b, ORI Workshops aim to provide • availability and description of
DEPARTMENT OF HEALTH AND clarification and technical information
HUMAN SERVICES facilities needed to support the
on the HHS regulations for handling workshop
research misconduct allegations and on • availability of administrative support
Office of the Secretary education in RCR to foster integrity in for the logistics of hosting such
Opportunity to Co-Sponsor Office of research. ORI Workshops are workshops
Research Integrity Workshops moderately sized, convening over one to
three days, and typically accepting The selected co-sponsoring
AGENCY: Office of the Secretary, HHS. between 20 and 50 attendees. organization(s) shall furnish the
ACTION: Notice. Co-sponsors will assist with necessary personnel, materials, services,
workshop and agenda development, and facilities to administer its
SUMMARY: The Office of Research coordination, financial management, responsibility for the workshop. These
Integrity (ORI) announces the and meeting logistics in conjunction duties will be outlined in a co-
opportunity for non-federal public and with ORI staff. sponsorship agreement with ORI that
private sector entities to co-sponsor ORI Co-sponsors can charge registration will set forth the details of the co-
conferences or workshops (ORI fees to recover costs associated with the sponsored activity, including the
Workshops). Potential co-sponsors must events; however, co-sponsors may not requirements that any fees collected by
have a demonstrated interest and set registration fees at an amount higher the co-sponsor shall be limited to the
experience in the responsible conduct of than necessary to recover related event amount necessary to cover the co-
research (RCR) or the handling of expenses. Further, co-sponsors are sponsor’s related event expenses. This
research misconduct allegations. solely responsible for collecting and co-sponsorship agreement does not
Potential co-sponsors must be willing to handling any registration fees collected. represent an endorsement by ORI of an
participate substantively in the co- Eligibility for Co-Sponsorship: The co- individual co-sponsor’s policies,
sponsored activity. sponsoring entity must have a positions, or activities. Additionally,
Expressions of interest for co- demonstrated interest and experience in this agreement will not affect any
sponsorships of ORI Workshops are the RCR or the handling of research determination concerning activities by
received throughout the year at the misconduct allegations. The co- the co-sponsors that are regulated by
email address below. ORI co-sponsors a sponsoring entity must participate ORI.
limited number of workshops with other substantively in the co-sponsored Dated: August 9, 2018.
entities each year. Expressions of activity, not just provide funding or Scott J. Moore,
interest are being received for ORI logistical support.
Workshops that will take place in the Each co-sponsorship expression of Deputy Director, Office of Research Integrity.
next fiscal year (October 2018 through interest shall describe: (1) The entity’s [FR Doc. 2018–17615 Filed 8–15–18; 8:45 am]
September 2019) or beyond. interest and goals in promoting research BILLING CODE 4150–31–P
Expressions of interest for co- integrity or the RCR, (2) the entity’s
sponsorships should be sent by email to prior experience and current readiness
AskORI@HHS.GOV with ‘‘Co- to undertake the responsibilities DEPARTMENT OF HEALTH AND
sponsorship for ORI Workshops’’ in the described above, (3) the type of event(s) HUMAN SERVICES
subject field or by mail to ORI at 1101 that the entity is interested in co-
sradovich on DSK3GMQ082PROD with NOTICES

Wootton Parkway, Suite 750, Rockville, Meeting of the Advisory Committee on
sponsoring with ORI, (4) facilities Blood and Tissue Safety and
MD 20852. available for the event(s), and (5) any Availability
FOR FURTHER INFORMATION CONTACT: current constraints with respect to dates
Tracey Randolph, Program Analyst, or facilities. The type of event may be AGENCY: Department of Health and
Office of Research Integrity, 1101 an event from ORI’s regular program of Human Services, Office of the Secretary,
Wootton Parkway, Suite 750, Rockville, recurring events (e.g., RCR Instructor’s Office of the Assistant Secretary for
MD 20852, (240) 453–8200. Workshop) or a special topic of mutual Health.

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Document Created: 2018-08-16 01:02:55
Document Modified: 2018-08-16 01:02:55

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 take place on Thursday, September 13, 2018, from 8:00 a.m.-5:00 p.m. ET.
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]
FR Citation		83 FR 40774