Use of Computer Simulation of the United States Blood Supply in Support of Planning for Emergency Preparedness and Medical Countermeasures; Public Workshop, 31026-31027 [2012-12593]
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srobinson on DSK4SPTVN1PROD with NOTICES
31026
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
Contact Person: Minh Doan, Center for
Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
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FDA is committed to the orderly conduct
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for procedures on public conduct during
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Committee Act (5 U.S.C. app. 2).
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Use of Computer Simulation of the
United States Blood Supply in Support
of Planning for Emergency
Preparedness and Medical
Countermeasures; Public Workshop
[FR Doc. 2012–12588 Filed 5–23–12; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Requirements for Importing Food and
Drug Administration Regulated
Products Into the United States
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: ‘‘Requirements for
Importing Food and Drug
Administration Regulated Products Into
the United States.’’ The topics to be
discussed are FDA regulations with
respect to importing pharmaceutical
products, medical devices, food
products, as well as technology which
applies to brokers and forwarders.
Date and Time: The meeting will be
held on July 18, 2012, from 8:30 a.m. to
5 p.m. in Des Plaines, IL.
Location: The meeting will be held at
the Illinois Department of
Transportation Building, 9511 West
Harrison St., Des Plaines, IL, 60016.
Contact: Lisa Misevicz, Food and
Drug Administration, 550 West Jackson
Blvd., suite 1500, Chicago, IL 60661;
312–596–4217; email:
lisa.misevicz@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) to the contact person by July 2,
2012.
If you need special accommodations
due to a disability, please contact Lisa
Misevicz at least 7 days in advance.
SUMMARY:
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12592 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
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Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Use of Computer Simulation
of the United States Blood Supply in
Support of Planning for Emergency
Preparedness and Medical
Countermeasures.’’ The purpose of this
public workshop is to provide
stakeholders a forum for discussion of
data needs and to obtain feedback on
possible modeling scenarios to explore
emergency supply situations should a
pandemic or epidemic disease or other
events that could adversely impact the
blood supply in the United States occur.
The public workshop will include
presentations and panel discussions
with experts from academia, regulated
industry, government, and other
stakeholders.
Date and Time: The public workshop
will be held on July 24, 2012, from 8:30
a.m. to 5 p.m.
Location: The public workshop will
be held at the Hyatt Regency Bethesda,
One Bethesda Metro Center, 7400
Wisconsin Ave., Bethesda, MD 20814,
301–657–1234.
Contact Person: Mark Walderhaug,
Center for Biologics Evaluation and
Research (HFM–210), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6028, email:
Mark.Walderhaug@fda.hhs.gov.
Registration: Mail or email your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Mark
Walderhaug (see Contact Person) by July
17, 2012. 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 8 a.m.
If you need special accommodations
due to a disability, please contact Mark
Walderhaug (see Contact Person) at least
7 days in advance.
SUPPLEMENTARY INFORMATION: The
public workshop presentations and
panel discussions will: (1) Discuss
E:\FR\FM\24MYN1.SGM
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31027
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
simulation modeling of the U.S. blood
supply, including the possible
application of an FDA computer
simulation model of the U.S. blood
supply in support of emergency
preparedness and planning for potential
disruptions in blood donations; (2)
discuss with the blood community the
utility of simulation methods as a
complementary approach to support
planning for daily inventory needs and
forecasting for future blood donations
and demand; (3) discuss the capabilities
and limitations of the U.S. computer
simulation model, assumptions used in
the model and data gaps for model
validation; (4) describe and prioritize
future model enhancements to extend
the model predictions from red blood
cell units to other blood components,
such as plasma and platelets; and (5)
discuss the level of detail required for
a model to characterize the U.S. blood
supply and to develop possible
scenarios in which shortages may be
addressed through countermeasures
such as the use of local and
interregional transfers of blood and
blood components.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857, approximately 15 working days
after the public workshop at a cost of 10
cents per page. A transcript of the
public workshop will be available on
the Internet at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12593 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSK4SPTVN1PROD with NOTICES
Submission for OMB Review;
Comment Request; Web-Based
Assessment of the Clinical Studies
Support Center (CSSC)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on March 12, 2011, Volume 77
No. 44, pages 14531–14533 and allowed
60-days for public comment. One
comment was received. The purpose of
this notice is to allow an additional 30
days for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
current valid OMB control number.
Proposed Collection: Title: Web-Based
Assessment of the Clinical Studies
Support Center (CSSC). Type of
Information Collection Request: New.
Need and Use of Information Collection:
Over the past decade Data Safety
Monitoring Boards (DSMBs),
Observational Safety Monitoring Boards
(OSMBs), and Protocol Review
Committees (PRCs) have become an
important quality standard in clinical
trials and research involving human
subjects. The National Heart, Lung, and
Blood Institute (NHLBI) alone currently
has approximately 60 active review
Committees. These include DSMBs,
OSMBs, and PRCs which are
independent groups convened to review
study protocols developed under NHLBI
funded Clinical Trial Networks. These
committees are composed of members
with expertise in biostatistics, clinical
trials, bioethics, and other specific
scientific and research areas. The
NHLBI is charged with ensuring the
highest quality of each Institute-funded
clinical research project and compliance
with Department of Health and Human
Services (DHHS)/National Institutes of
Health (NIH)/NHLBI regulations
regarding human subject protections
and safety monitoring. To carry out this
responsibility, the NHLBI program staff
instituted a new methodology for
supporting the administration of
NHLBI-appointed Committees in 2009.
The new methodology included the
establishment of the Clinical Studies
Support Center (CSSC) under the
Number of
respondents
Type of respondents
direction of Westat, Inc. The CSSC is a
pilot program to support the operations
of NHLBI’s DSMBs, Observational
OSMBs, and PRCs for the Division of
Blood Diseases and Resources. Utilizing
Executive Secretaries to support each
NHLBI safety monitoring board, the
CSSC is responsible for documenting
standardized operating procedures
related to the administration of
monitoring committees and the support
center in a CSSC Manual of Operations
and Procedures (MOP); coordinating
meeting space and logistics for inperson meetings, Web conferences, and
teleconferences; managing distribution
of adverse event notifications to DSMB
chairs and members, new protocols, and
proposed amendments; and providing
Executive Secretaries who provide
scientific and administrative support to
document board recommendations
related to the safety and efficacy of trial
interventions and the quality and
completeness of clinical research study
data. To move forward with full
knowledge of current Committee
operations and to monitor the effect of
newly established procedures, Westat is
required, as part of this contract, to
conduct an assessment of the efficiency
and effectiveness of NHLBI CSSC
committee operations. As part of this
assessment, the NHLBI requires
feedback and advice regarding the
support provided by the CSSC for
monitoring board operations. To this
end, a Web-based questionnaire will be
administered to Chairs and members of
monitoring boards to learn about their
opinions about specific CSSC activities
and their satisfaction with the
performance of CSSC staff.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Monitoring board
members. The annual reporting burden
is a follows: Estimated Number of
Respondents: 90; Estimated Number of
Responses per Respondent: 1; Average
Burden of Hours per Response: 0.33 and
Estimated Total Annual Burden Hours
Requested: 30.36. The annualized cost
to respondents is estimated at: $ 3.036
(based on $100 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Frequency of
responses
Average time
per response
Annual hour
burden
Table A.12.1. ESTIMATES OF HOUR BURDEN
D/OSMB Chairs ...........................................................................................
D/OSMB Members .......................................................................................
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]]>Agencies
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31026-31027]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Use of Computer Simulation of the United States Blood Supply in
Support of Planning for Emergency Preparedness and Medical
Countermeasures; 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: ``Use of Computer Simulation of the United States
Blood Supply in Support of Planning for Emergency Preparedness and
Medical Countermeasures.'' The purpose of this public workshop is to
provide stakeholders a forum for discussion of data needs and to obtain
feedback on possible modeling scenarios to explore emergency supply
situations should a pandemic or epidemic disease or other events that
could adversely impact the blood supply in the United States occur.
The public workshop will include presentations and panel
discussions with experts from academia, regulated industry, government,
and other stakeholders.
Date and Time: The public workshop will be held on July 24, 2012,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Hyatt Regency
Bethesda, One Bethesda Metro Center, 7400 Wisconsin Ave., Bethesda, MD
20814, 301-657-1234.
Contact Person: Mark Walderhaug, Center for Biologics Evaluation
and Research (HFM-210), Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6028, email:
Mark.Walderhaug@fda.hhs.gov.
Registration: Mail or email your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to Mark Walderhaug (see Contact Person) by July 17, 2012. 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 8 a.m.
If you need special accommodations due to a disability, please
contact Mark Walderhaug (see Contact Person) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: The public workshop presentations and panel
discussions will: (1) Discuss
[[Page 31027]]
simulation modeling of the U.S. blood supply, including the possible
application of an FDA computer simulation model of the U.S. blood
supply in support of emergency preparedness and planning for potential
disruptions in blood donations; (2) discuss with the blood community
the utility of simulation methods as a complementary approach to
support planning for daily inventory needs and forecasting for future
blood donations and demand; (3) discuss the capabilities and
limitations of the U.S. computer simulation model, assumptions used in
the model and data gaps for model validation; (4) describe and
prioritize future model enhancements to extend the model predictions
from red blood cell units to other blood components, such as plasma and
platelets; and (5) discuss the level of detail required for a model to
characterize the U.S. blood supply and to develop possible scenarios in
which shortages may be addressed through countermeasures such as the
use of local and interregional transfers of blood and blood components.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857, approximately 15 working days after the public workshop at a
cost of 10 cents per page. A transcript of the public workshop will be
available on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12593 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P
