Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop, 42716-42717 [2011-18095]
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sroberts on DSK5SPTVN1PROD with NOTICES
42716
Federal Register / Vol. 76, No. 138 / Tuesday, July 19, 2011 / Notices
(BECS) as they relate to inventory
control. The public workshop has been
planned in partnership with the
Department of Health and Human
Services (HHS) Office of the Assistant
Secretary for Health, America’s Blood
Centers, and AABB. This public
workshop will include presentations
and panel discussions by experts
knowledgeable in this field from
government Agencies and industry.
Date and Time: The public workshop
will be held on September 13, 2011,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Universities at Shady
Grove Conference Center, 9630
Gudelsky Dr., Rockville, MD 20850–
5820, 301–738–6000.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Rhonda
Dawson (see Contact Person) by
September 1, 2011. 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
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: QREs refer
to the inadvertent release of blood or
blood components either before
completion of testing and determination
that all other criteria affecting the safety,
purity, or potency of the product have
been met, or despite findings that would
render the blood or blood components
unsuitable for release. Although QREs
that result in the distribution of blood
or blood components are required to be
reported to FDA as biologic product
deviation reports (BPDRs), the amount
of information provided in BPDRs varies
and often represents a summary of
information rather than a detailed
description and analysis of the problem.
Thus, the root causes of QREs are not
known with certainty. Further, the rates
of QREs are also not known with
certainty, and actions necessary to
correct and prevent them are unclear.
There has been a recent focus on
QREs related to the release of units with
incomplete or absent testing for
transfusion-transmitted infectious
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diseases. On June 10 and 11, 2010, the
HHS Advisory Committee on Blood
Safety and Availability (the Committee)
met to discuss the current FDA blood
donor deferral policy on men who have
sex with other men. While the
Committee recommended that the
current deferral policy not be changed at
the present time, it found the current
policy to be suboptimal in permitting
some potentially high risk donations
while preventing some low risk
donations. The Committee made a
number of recommendations and
indicated that HHS should take action
to investigate and reduce the risk of
QREs in blood collection
establishments.
This public workshop will serve as a
forum for discussion of QREs and
provide FDA and industry with
information necessary to reduce the
rates of QREs. The public workshop
presentations and panel discussions
will: (1) Review recent BPDR data to
better determine the root causes for
QREs and identify activities that could
address those causes; (2) evaluate the
use of 510(k) cleared BECS or
implementation of BECS performance
standards in reducing the rate of QREs;
and (3) explore other potential strategies
to address QREs. The public workshop
will conclude with a summary of the
issues discussed.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible on the Internet at: https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–18093 Filed 7–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Effects of Ischemia Reperfusion Injury
on Outcomes in Kidney
Transplantation; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
to discuss the effects of ischemia/
reperfusion injury (IRI) on outcomes in
kidney transplantation. This public
workshop is intended to obtain
information from health care providers,
academia, and industry on various
aspects of the pathophysiology, clinical
management, and outcomes following
IRI. The meeting will include a
discussion of animal models, devices,
and clinical trial design. The input from
this public workshop will help in
developing topics for further discussion
and may serve to inform
recommendations on clinical trial
design for products for the mitigation of
IRI and/or for the prophylaxis and/or
treatment of delayed graft function
(DGF) and related conditions in kidney
transplant recipients.
Date and Time: The public workshop
will be held on September 8, 2011, from
9 a.m. to 6 p.m. and on September 9,
2011, from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Crowne Plaza, 8777
Georgia Ave., Silver Spring, MD 20910,
301–589–0800. Seating is available only
on a first-come-first-served basis.
Contact Persons: Christine Moser or
Ramou Mauer, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6209,
Silver Spring, MD 20993–0002, 301–
796–1300 or 301–796–1600.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come-first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and fax number) to
IRIworkshop@fda.hhs.gov. Persons
without access to the Internet can call
Christine Moser, 301–796–1300, or
Ramou Mauer, 301–796–1600, to
register.
Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Ramou Mauer (see
Contact Persons) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding effects of IRI on outcome in
kidney transplantation and medical
product development for the prevention
and/or treatment of DGF in kidney
transplant recipients. This public
workshop will include scientific
discussion on the following topics:
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42717
Federal Register / Vol. 76, No. 138 / Tuesday, July 19, 2011 / Notices
• Pathophysiology and contributing
factors to IRI,
• Downstream measures of response
to IRI,
• Current management strategies and
outcomes in patients with DGF,
• Animal models in IRI and DGF,
• Device issues related to DGF, and
• Clinical trial issues related to the
recipient in development of medical
products for the management of DGF
and related conditions in kidney
transplantation.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (HFI–35),
Office of Management Programs, Food
and Drug Administration, 5600 Fishers
Lane, Rm. 6–30, Rockville, MD 20857.
Transcripts will also be available on
the Internet at https://www.fda.gov/
Drugs/NewsEvents/ucm206132.htm
approximately 45 days after the
workshop.
Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–18095 Filed 7–18–11; 8:45 am]
BILLING CODE 4160–01–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Correction
In notice document 2011–16127
appearing on page 37821 in the issue of
Tuesday, June 28, 2011, make the
following correction:
In the table on page 37821, in column
one, row three, ‘‘4353’’should read
‘‘2353.’’ A corrected table should appear
as set forth below.
The annual estimate of burden is as
follows:
Number of
responses/
respondent
Number of
respondents
Respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Average hours
per response
Total burden
hours
Survey respondents .........................................................................................
Screened households ......................................................................................
2000
2353
1
1
.166
.016
332
38
Total ..........................................................................................................
2353
........................
........................
370
[FR Doc. C1–2011–16127 Filed 7–18–11; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
sroberts on DSK5SPTVN1PROD with NOTICES
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
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17:20 Jul 18, 2011
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Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Maternal and Child
Health Services Title V Block Grant
Program Guidance and Forms for the
Title V Application/Annual Report
(OMB No. 0915–0172)—[Revision]
The Health Resources and Services
Administration (HRSA) proposes to
revise the Maternal and Child Health
Services Title V Block Grant Program—
Guidance and Forms for the
Application/Annual Report. The
guidance is used annually by the 50
states and 9 jurisdictions in making
application for Block Grants under Title
V of the Social Security Act and in
preparing the required annual report.
The proposed revisions follow and
build on extensive consultation received
from a workgroup convened to provide
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Frm 00044
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Sfmt 4703
suggestions to improve the guidance
and forms.
The changes in this edition of the
Maternal and Child Health Services
Title V Block Grant Program Guidance
and Forms for the Title V Application/
Annual Report include the following
proposed revisions: (1) The
requirements for reporting on the health
status indicators and health systems
capacity indicators were rewritten to
reduce the reporting burden to the
states; (2) instructions for completing
Form 7, Number of Individuals Served,
have been clarified to assist states in
more accurately estimating the number
of individuals who receive Title V
services; (3) a resource tool has been
added to assist states in assessing the
level of family participation in Children
with Special Health Care Needs
Programs (Form 13); and (4) the detail
sheets for the performance measures,
outcome measures, health systems
capacity indicators and health status
indicators have been updated with
corresponding Healthy People 2020
Objectives. In addition, efficiencies
through use of the electronic application
are identified for states to reduce their
efforts in completing the application.
The estimated average annual burden
is as follows:
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]]>Agencies
[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42716-42717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Effects of Ischemia Reperfusion Injury on Outcomes in Kidney
Transplantation; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop to discuss the effects of ischemia/reperfusion injury (IRI) on
outcomes in kidney transplantation. This public workshop is intended to
obtain information from health care providers, academia, and industry
on various aspects of the pathophysiology, clinical management, and
outcomes following IRI. The meeting will include a discussion of animal
models, devices, and clinical trial design. The input from this public
workshop will help in developing topics for further discussion and may
serve to inform recommendations on clinical trial design for products
for the mitigation of IRI and/or for the prophylaxis and/or treatment
of delayed graft function (DGF) and related conditions in kidney
transplant recipients.
Date and Time: The public workshop will be held on September 8,
2011, from 9 a.m. to 6 p.m. and on September 9, 2011, from 8 a.m. to 3
p.m.
Location: The public workshop will be held at the Crowne Plaza,
8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800. Seating is
available only on a first-come-first-served basis.
Contact Persons: Christine Moser or Ramou Mauer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6209, Silver Spring, MD 20993-0002, 301-
796-1300 or 301-796-1600.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited. Seating will be available on a first-come-first-served basis.
To register electronically, e-mail registration information (including
name, title, firm name, address, telephone, and fax number) to
IRIworkshop@fda.hhs.gov. Persons without access to the Internet can
call Christine Moser, 301-796-1300, or Ramou Mauer, 301-796-1600, to
register.
Persons needing a sign language interpreter or other special
accommodations should notify Christine Moser or Ramou Mauer (see
Contact Persons) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding effects of IRI on outcome in kidney transplantation and
medical product development for the prevention and/or treatment of DGF
in kidney transplant recipients. This public workshop will include
scientific discussion on the following topics:
[[Page 42717]]
Pathophysiology and contributing factors to IRI,
Downstream measures of response to IRI,
Current management strategies and outcomes in patients
with DGF,
Animal models in IRI and DGF,
Device issues related to DGF, and
Clinical trial issues related to the recipient in
development of medical products for the management of DGF and related
conditions in kidney transplantation.
The Agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, Rm. 6-30, Rockville, MD 20857.
Transcripts will also be available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm206132.htm approximately 45 days after
the workshop.
Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-18095 Filed 7-18-11; 8:45 am]
BILLING CODE 4160-01-P
