Meeting of the Advisory Committee on Blood and Tissue Safety and Availability, 8731-8732 [2019-04408]
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8731
Federal Register / Vol. 84, No. 47 / Monday, March 11, 2019 / Notices
week prior to the meeting at: https://
www.hhs.gov/ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
comments should be sent in by
midnight April 2, 2019, and should be
limited to no more than one page. All
public comments received prior to April
2, 2019, will be provided to Advisory
Council members and will be
acknowledged during the public
teleconference.
Dated: February 26, 2019.
Jomana F. Musmar,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Committee Manager.
[FR Doc. 2019–04404 Filed 3–8–19; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier 4040–0002]
Agency Information Collection
Request. 60-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 10, 2019.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0002–60D
and project title for reference., to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
SUMMARY:
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: The SF–424
Mandatory Form.
Type of Collection: Reinstatement
without change.
OMB No. 4040–0002.
Abstract: The SF–424 Mandatory
Form provides the Federal grant-making
agencies an alternative to the Standard
Form 424 data set and form. Agencies
may use the SF–424 Mandatory Form
for grant programs not required to
collect all the data that is required on
the SF–424 core data set and form.
Type of respondent: The SF–424
Mandatory form is used by
organizations to apply for Federal
financial assistance in the form of
grants. These forms are submitted to the
Federal grant-making agencies for
evaluation and review.
ANNUALIZED BURDEN HOUR TABLE
SF–424 Mandatory ...........................
Grant applicants ...............................
5761
1
1
5761
Total ...........................................
...........................................................
5761
1
1
5761
Tissue Safety and Availability
(ACBTSA) will hold a meeting. The
meeting will be open to the public.
BILLING CODE 4151–AE–P
The meeting will take place
Monday, April 15, 2019, from 8:00 a.m.–
4:30 p.m. and Tuesday, April 16, 2019,
from 8:30 a.m.–4:00 p.m.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
DATES:
[FR Doc. 2019–04288 Filed 3–8–19; 8:45 am]
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.
ACTION: Notice.
AGENCY:
amozie on DSK9F9SC42PROD with NOTICES
Average
burden per
response
Respondents
(if necessary)
Dated: March 5, 2019.
Terry Clark,
Assistant Information Collection Clearance
Officer.
Number of
respondents
Number of
responses per
respondents
Forms
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
SUMMARY:
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18:41 Mar 08, 2019
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U.S. Department of Health &
Human Services, Hubert H. Humphrey
Building, (Conference Room 800), 200
Independence Ave. SW, Washington,
DC 20201.
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.
FOR FURTHER INFORMATION CONTACT:
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Total
burden hours
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 survey and 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.
SUPPLEMENTARY INFORMATION:
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8732
Federal Register / Vol. 84, No. 47 / Monday, March 11, 2019 / Notices
In 2013, updates were made to the
original 1994 Public Health Service
Guidelines on Reducing HIV, HBV, and
HCV through Organ Transplantation
(‘‘PHS Guidelines’’). Public and privatesector stakeholders in organ
transplantation are now seeking to
explore potential important updates to
the PHS Guidelines in order to maintain
accordance with current health sector
circumstances.
The Committee will meet on April
15–16, 2019 to receive presentations
from various public and private sector
stakeholders and to listen to public
comments regarding the PHS
Guidelines. The Committee will explore
important questions to consider as the
PHS Guidelines are examined for any
such necessary updates. Finally, the
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 the second day of the
meeting. Comments will be limited to
five minutes per speaker and must be
pertinent to the discussion. Preregistration 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
April 8, 2019. 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 April 8, 2019.
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 April 8, 2019.
Dated: February 26, 2019.
James J. Berger,
Senior Advisor for Blood and Tissue Policy.
[FR Doc. 2019–04408 Filed 3–8–19; 8:45 am]
amozie on DSK9F9SC42PROD with NOTICES
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Department of
AGENCY:
VerDate Sep<11>2014
18:41 Mar 08, 2019
Jkt 247001
Health and Human Services, Office of
the Secretary.
ACTION: Notice.
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP and the full
meeting agenda will be posted on the
SACHRP website at: https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Wednesday, March 27, 2019, from 8:30
a.m. until 4:00 p.m., and Thursday,
March 28, 2019, from 8:30 a.m. until
3:00 p.m.
ADDRESSES: 6700B Rockledge Drive,
Bethesda, MD 20817.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will open to the
public at 8:30 a.m., on Wednesday,
March 27, 2019, followed by opening
remarks from Dr. Jerry Menikoff,
Director of OHRP and Dr. Stephen
Rosenfeld, SACHRP Chair.
The SAS subcommittee will present
their revised recommendation on
Subject Payment: Ethical and Regulatory
SUMMARY:
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Considerations. This will be followed by
a discussion of implementation issues
experienced to date regarding the newly
effective revised Common Rule. The
afternoon will conclude with a
discussion of questions newly posed to
SACHRP regarding Deceased Donor
Intervention Research (DDIR), with a
particular focus on recipient informed
consent. There will be a panel
presentations from leading experts in
the field of DDIR, followed by SACHRP
discussion. The meeting is scheduled to
end at approximately 4:00 p.m.
The meeting will begin at 8:30 a.m. on
Thursday, March 28th. The SAS
subcommittee will present and discuss
draft recommendations regarding
charging subjects to participate in
clinical trials. Additional time is
reserved for emerging topics and
continuing the previous day’s
discussions. The meeting will adjourn at
approximately 3:00 p.m.
Time will be allotted for public
comment on both days. On-site
registration is required for participation
in the live public comment session.
Note that public comment must be
relevant to topics currently being
addressed by SACHRP. Individuals
submitting written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting.
Dated: February 26, 2019.
Julia G. Gorey, J.D.,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2019–04406 Filed 3–8–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
E:\FR\FM\11MRN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8731-8732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04408]
-----------------------------------------------------------------------
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.
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 Monday, April 15, 2019, from 8:00
a.m.-4:30 p.m. and Tuesday, April 16, 2019, from 8:30 a.m.-4:00 p.m.
ADDRESSES: U.S. Department of Health & Human Services, Hubert H.
Humphrey Building, (Conference Room 800), 200 Independence Ave. SW,
Washington, DC 20201.
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.
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 survey and 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.
[[Page 8732]]
In 2013, updates were made to the original 1994 Public Health
Service Guidelines on Reducing HIV, HBV, and HCV through Organ
Transplantation (``PHS Guidelines''). Public and private-sector
stakeholders in organ transplantation are now seeking to explore
potential important updates to the PHS Guidelines in order to maintain
accordance with current health sector circumstances.
The Committee will meet on April 15-16, 2019 to receive
presentations from various public and private sector stakeholders and
to listen to public comments regarding the PHS Guidelines. The
Committee will explore important questions to consider as the PHS
Guidelines are examined for any such necessary updates. Finally, the
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 the second day
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 April 8, 2019. 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 April 8, 2019. 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 April 8, 2019.
Dated: February 26, 2019.
James J. Berger,
Senior Advisor for Blood and Tissue Policy.
[FR Doc. 2019-04408 Filed 3-8-19; 8:45 am]
BILLING CODE 4150-41-P
