Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop, 46928-46929 [2016-17008]
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Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
The President’s Committee
for People with Intellectual Disabilities
(PCPID) will host a webinar/conference
call for its members to discuss the
potential topics of the Committee’s 2017
Report to the President. All the PCPID
meetings, in any format, are open to the
public. This virtual meeting will be
conducted in a discussion format.
DATES: Webinar: Monday, August 22,
2016 from 1:30 p.m. to 3:00 p.m. (EST).
ADDRESSES: Webinar Web page: https://
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SUMMARY:
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REASONABLE ACCOMMODATIONS NEEDS
CONTACT: Dr. MJ Karimi, PCPID Team
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MJ.Karimie@acl.hhs.gov; telephone:
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SUPPLEMENTARY INFORMATION: The
Committee held a conference call on
May 2, 2016 to discuss and finalize the
Committee’s 2016 Report to the
President. The purpose of this virtual
meeting is to provide PCPID members
with an update on submission of the
2016 Report to the President and to
begin exploring the topics for the
Committee’s 2017 report.
Webinar/Conference Call: The
webinar is scheduled for August 22,
2016, 1:30 p.m. to 3:00 p.m. (EST) and
may end early if discussions are
finished.
Instructions to Participate in the
Webinar/Conference Call on Monday,
August 22, 2016:
1. Enter the following WebEx Link:
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Background Information on the
Committee: The PCPID acts in an
advisory capacity to the President and
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Services on a broad range of topics
relating to programs, services and
support for individuals with intellectual
disabilities. The PCPID Executive Order
stipulates that the Committee shall: (1)
provide such advice concerning
intellectual disabilities as the President
or the Secretary of Health and Human
Services may request; and (2) provide
advice to the President concerning the
following for people with intellectual
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disabilities: (A) expansion of
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promotion of homeownership; (C)
assurance of workplace integration; (D)
improvement of transportation options;
(E) expansion of full access to
community living; and (F) increasing
access to assistive and universally
designed technologies.
Dated: July 6, 2016.
Aaron Bishop,
Commissioner, Administration on
Disabilities.
[FR Doc. 2016–16980 Filed 7–18–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Extension With
No Changes of a Currently Approved
Collection; Submission for OMB
Review; Comment Request; State
Program Report
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
that the proposed collection of
information listed below has been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
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DATES: Submit written comments on the
collection of information by August 18,
2016.
ADDRESSES: Submit written comments
on the collection of information to Elena
Fazio at 202–795–7343 or email:
elena.fazio@acl.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Elena Fazio at 202–795–7343 or email:
elena.fazio@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance.
The Older Americans Act (OAA)
requires annual program performance
reports from States, the District of
Columbia, and Territories. In
compliance with this OAA provision,
ACL developed a State Program Report
(SPR) in 1996 as part of its National
Aging Program Information System
(NAPIS). The SPR collects information
about how State Agencies on Aging
expend their OAA funds as well as
funding from other sources for OAA
SUMMARY:
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authorized supportive services. The SPR
also collects information on the
demographic and functional status of
the recipients, and is a key source for
ACL performance measurement. This
collection is an extension with no
changes of the 2013 approved version.
The proposed version will be in effect
for the FY 2017 reporting year and
thereafter. The proposed FY 2017
version may be found on the ACL Web
site link entitled Renewal SPR
Instrument for 2016 Extension With No
Changes available at https://
www.aoa.acl.gov/Program_Results/
OAA_Performance.aspx. ACL estimates
the burden of this collection of
information as follows: 2750 hours
Dated: July 12, 2016.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2016–16978 Filed 7–18–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Pre-Clinical Evaluation of Red Blood
Cells for Transfusion; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Pre-Clinical
Evaluation of Red Blood Cells for
Transfusion.’’ The purpose of the public
workshop is to discuss new
methodologies for pre-clinical
evaluation of the safety and efficacy of
red blood cell transfusion products. The
workshop has been planned in
partnership with the National Heart,
Lung, and Blood Institute; National
Institutes of Health (NIH); the
Department of Defense; and the Office of
the Assistant Secretary for Health,
Department of Health and Human
Services. The workshop will include
presentations and panel discussions by
experts from academic institutions,
industry, and government Agencies.
DATES: The public workshop will be
held on October 6, 2016, from 8 a.m. to
5 p.m. and on October 7 from 9 a.m. to
1 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Ruth Kirschstein
SUMMARY:
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
Auditorium, Natcher Conference Center,
Bldg. 45, National Institutes of Health
Campus, 9000 Rockville Pike, Bethesda,
MD 20892. The entrance for the public
workshop participants (non-NIH
employees) is through the NIH Gateway
Center located adjacent to the Medical
Center Metro, where routine security
check procedures will be performed.
Please visit the following Web site for
NIH campus location, parking, security,
and travel information: https://
www.nih.gov/about/visitor/index.htm.
Please visit the following Web site for
information on the Natcher Conference
Center: https://www.genome.gov/
11007522.
FOR FURTHER INFORMATION CONTACT:
Matthew Morrison, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, rm. 3128,
Silver Spring, MD 20993, 240–402–
8126, Matthew.D.Morrison@fda.hhs.gov.
For questions email:
CBERPublicEvents@fda.hhs.gov (Subject
line: Red Blood Cell (RBC) Workshop).
SUPPLEMENTARY INFORMATION: The
purpose of the public workshop is to
discuss new methodologies for preclinical evaluation of the safety and
efficacy of red blood cell transfusion
products including potential
identification of biomarkers measurable
during red cell storage that could
predict the in vivo functionality of
transfused red blood cells. The first day
of the workshop will include
presentations and panel discussions on
the following topics: (1) Overview of red
blood cells for transfusion; (2) methods
for determining the suitability of red
blood cells for transfusion; (3) new
methods for detecting red blood cell
processing and storage legions; and (4)
the use of animal models of oxygen
delivery as markers of red blood cell
safety and efficacy in the acute bleeding
and trauma resuscitation settings.
The second day of the workshop will
include presentations and panel
discussions on the potential
mechanisms of red blood cell
transfusion-associated toxicity and a
summary of all workshop panel
discussions, identified gaps, and future
directions.
Registration: Please visit the following
Web site to register for the workshop by
September 23, 2016: https://
www.eventbrite.com/e/pre-clinicalevaluation-of-red-blood-cells-fortransfusion-registration-25813463765.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
VerDate Sep<11>2014
19:39 Jul 18, 2016
Jkt 238001
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Matthew Morrison (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Transcripts: Please be advised that as
soon as possible after a transcript of this
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
ucm507890.htm.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17008 Filed 7–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1895]
Prescription Drug User Fee Act; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting to discuss
proposed recommendations for the
reauthorization of the Prescription Drug
User Fee Act (PDUFA) for fiscal years
(FYs) 2018 through 2022. PDUFA
authorizes FDA to collect fees and use
them for the process for the review of
human drug applications. The current
legislative authority for PDUFA expires
in September 2017. At that time, new
legislation will be required for FDA to
continue collecting prescription drug
user fees in future fiscal years.
Following discussions with the
regulated industry and periodic
consultations with public stakeholders,
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) directs FDA to
publish the recommendations for the
reauthorized program in the Federal
Register, hold a meeting at which the
public may present its views on such
recommendations, and provide for a
period of 30 days for the public to
provide written comments on such
recommendations. FDA will then
consider such public views and
comments and revise such
recommendations as necessary.
DATES: The public meeting will be held
on August 15, 2016, from 9 a.m. to 2
SUMMARY:
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46929
p.m. Please register for the meeting by
August 8, 2016, at https://
pdufareauthorization.eventbrite.com.
Submit electronic or written comments
to the public docket by August 22, 2016.
ADDRESSES: The meeting and workshop
will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave.,
Bldg. 31 Conference Center, the Great
Room (Rm. 1503, Section A), Silver
Spring, MD 20993–0002. Participants
must enter through Building 1 and
undergo security screening. For more
information on parking and security
procedures, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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solely responsible for ensuring that your
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manner detailed (see ‘‘Written/Paper
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Submit written/paper submissions as
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and Drug Administration, 5630 Fishers
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• For written/paper comments
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Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
E:\FR\FM\19JYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46928-46929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pre-Clinical Evaluation of Red Blood Cells for Transfusion;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for
Transfusion.'' The purpose of the public workshop is to discuss new
methodologies for pre-clinical evaluation of the safety and efficacy of
red blood cell transfusion products. The workshop has been planned in
partnership with the National Heart, Lung, and Blood Institute;
National Institutes of Health (NIH); the Department of Defense; and the
Office of the Assistant Secretary for Health, Department of Health and
Human Services. The workshop will include presentations and panel
discussions by experts from academic institutions, industry, and
government Agencies.
DATES: The public workshop will be held on October 6, 2016, from 8 a.m.
to 5 p.m. and on October 7 from 9 a.m. to 1 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public workshop will be held at the Ruth Kirschstein
[[Page 46929]]
Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of
Health Campus, 9000 Rockville Pike, Bethesda, MD 20892. The entrance
for the public workshop participants (non-NIH employees) is through the
NIH Gateway Center located adjacent to the Medical Center Metro, where
routine security check procedures will be performed. Please visit the
following Web site for NIH campus location, parking, security, and
travel information: https://www.nih.gov/about/visitor/index.htm. Please
visit the following Web site for information on the Natcher Conference
Center: https://www.genome.gov/11007522.
FOR FURTHER INFORMATION CONTACT: Matthew Morrison, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993, 240-402-
8126, Matthew.D.Morrison@fda.hhs.gov. For questions email:
CBERPublicEvents@fda.hhs.gov (Subject line: Red Blood Cell (RBC)
Workshop).
SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to
discuss new methodologies for pre-clinical evaluation of the safety and
efficacy of red blood cell transfusion products including potential
identification of biomarkers measurable during red cell storage that
could predict the in vivo functionality of transfused red blood cells.
The first day of the workshop will include presentations and panel
discussions on the following topics: (1) Overview of red blood cells
for transfusion; (2) methods for determining the suitability of red
blood cells for transfusion; (3) new methods for detecting red blood
cell processing and storage legions; and (4) the use of animal models
of oxygen delivery as markers of red blood cell safety and efficacy in
the acute bleeding and trauma resuscitation settings.
The second day of the workshop will include presentations and panel
discussions on the potential mechanisms of red blood cell transfusion-
associated toxicity and a summary of all workshop panel discussions,
identified gaps, and future directions.
Registration: Please visit the following Web site to register for
the workshop by September 23, 2016: https://www.eventbrite.com/e/pre-clinical-evaluation-of-red-blood-cells-for-transfusion-registration-25813463765. There is no registration fee for the public workshop.
Early registration is recommended because seating is limited.
Registration on the day of the public workshop will be provided on a
space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Matthew Morrison (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
Transcripts: Please be advised that as soon as possible after a
transcript of this public workshop is available, it will be accessible
at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17008 Filed 7-18-16; 8:45 am]
BILLING CODE 4164-01-P
