Announcement of Notice; Proposed Establishment of a Federally Funded Research and Development Center-First Notice, 20673-20674 [2011-8942]
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
285l–3) (75 FR 57027). The ICCVAM
Authorization Act requires member
agencies to review ICCVAM test method
recommendations and notify ICCVAM
in writing of their findings no later than
180 days after receipt of
recommendations. The Act also requires
ICCVAM to make ICCVAM
recommendations and agency responses
available to the public. Agency
responses should include identification
of relevant test methods for which the
ICCVAM test method recommendations
may be added or substituted and
indicate any revisions or planned
revisions to existing guidelines,
guidances, or regulations to be made in
response to these recommendations.
ICCVAM agencies concurred with the
test method recommendations for the in
vitro ocular safety testing methods and
strategies and support the routine use of
topical anesthetics, systemic analgesics,
and humane endpoints for ocular safety
testing. Several agencies also indicated
that they would communicate the
ICCVAM recommendations to
stakeholders and encourage their
appropriate use. Agency responses are
available at https://iccvam.niehs.nih.gov/
methods/ocutox/Transmit-2010.htm.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
with regulatory applicability and
promotes the scientific validation and
regulatory acceptance of toxicological
and safety testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine (decrease or eliminate
pain and distress), or replace animal
use. The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) established
ICCVAM as a permanent interagency
committee of the NIEHS under
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
work collaboratively to evaluate new
and improved test methods and
strategies applicable to the needs of U.S.
Federal agencies. NICEATM and
ICCVAM welcome the public
nomination of new, revised, and
alternative test methods and strategies
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18:37 Apr 12, 2011
Jkt 223001
for validation studies and technical
evaluations. Additional information
about ICCVAM and NICEATM can be
found on the NICEATM–ICCVAM Web
site (https://iccvam.niehs.nih.gov).
References
ICCVAM. 2006. ICCVAM Test Method
Evaluation Report: In Vitro Ocular
Toxicity Test Methods for Identifying
Severe Irritants and Corrosives. NIH
Publication No. 07– 4517. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/ivocutox/ocu_tmer.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Recommendations for
Routine Use of Topical Anesthetics,
Systemic Analgesics, and Humane
Endpoints to Avoid or Minimize Pain
and Distress in Ocular Safety Testing.
NIH Publication No. 10–7514. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/OcuAnest-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Current Validation
Status of In Vitro Test Methods Proposed
for Identifying Eye Injury Hazard
Potential of Chemicals and Products.
NIH Publication No. 10–7553. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/MildMod-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Current Validation
Status of a Proposed In Vitro Testing
Strategy for U.S. Environmental
Protection Agency Ocular Hazard
Classification and Labeling of
Antimicrobial Cleaning Products. NIH
Publication No. 10– 7513. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/AMCP-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Recommendation to
Discontinue Use of The Low Volume Eye
Test for Ocular Safety Testing. NIH
Publication No. 10–7515. Research
Triangle Park, NC: NIEHS. Available:
https://iccvam.niehs.nih.gov/methods/
ocutox/LVET.htm.
ISO. 2010. Biological evaluation of medical
devices—10993 Part 10: Tests for
irritation and skin sensitization.
Available for purchase at: https://
www.iso.org/iso/home.htm.
OECD. 2009a. Test Guideline 437. Bovine
Corneal Opacity and Permeability Test
Method for Identifying Ocular Corrosives
and Severe Irritants, adopted September
2009. In: OECD Guidelines for Testing of
Chemicals. Paris: OECD. Available:
https://www.oecd-ilibrary.org/
environment/test-no-437-bovine-cornealopacity-and-permeability-test-methodfor-identifying-ocular-corrosives-andsevere-irritants_9789264076303-en.
OECD. 2009b. Test Guideline 438. Isolated
Chicken Eye Test Method for Identifying
Ocular Corrosives and Severe Irritants,
adopted September 2009. In: OECD
Guidelines for Testing of Chemicals.
Paris: OECD. Available: https://
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Fmt 4703
Sfmt 4703
20673
www.oecd-ilibrary.org/environment/testno-438-isolated-chicken-eye-testmethod-for-identifying-ocular-corrosivesand-severe-irritants_9789264076310-en.
Dated: April 1, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–8938 Filed 4–12–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7031–NC]
Announcement of Notice; Proposed
Establishment of a Federally Funded
Research and Development Center—
First Notice
Centers for Medicare &
Medicaid Services (CMS), Department
of Health & Human Services (DHHS).
ACTION: Notice.
AGENCY:
This notice announces our
intention to sponsor Federally Funded
Research and Development Center
(FFRDC) to facilitate the modernization
of business processes and supporting
systems and their operations. This is the
first of three notices which must be
published over a 90-day period in order
to advise the public of the agency’s
intention to sponsor an FFRDC issued
under the authority of 48 CFR 35.017.
DATES: We must receive comments on or
before July 5, 2011.
ADDRESSES: Comments on this notice
must be mailed to the Centers for
Medicare & Medicaid Services, Candice
Savoy, Contracting Officer, 7500
Security Boulevard, Mailstop C2–01–10,
Baltimore, MD 21244 or e-mail at
Candice.Savoy@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Candice Savoy, (410) 786–7494.
SUPPLEMENTARY INFORMATION: The
Centers for Medicare & Medicaid
Services (CMS), an operating division
within the Department of Health and
Human Services (DHHS), intends to
sponsor a studies and analysis, Delivery
System, Simulations, and Cost Modeling
Federally Funded Research and
Development Center (FFRDC) to
facilitate the modernization of business
processes and supporting systems and
their operations. Some of the broad task
areas that will be utilized include
Strategic/Tactical Planning, Conceptual
Planning, Design and Engineering,
Procurement Assistance, Organizational
Planning, Research and Development,
SUMMARY:
E:\FR\FM\13APN1.SGM
13APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
20674
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
Continuous Process Improvement,
IV&V/Compliance, and Security
Planning. Further analysis will consist
of expert advice and guidance in the
areas of program and project
management focused on increasing the
effectiveness and efficiency of strategic
information management, prototyping,
demonstrations, and technical activities.
This FFRDC may also be utilized by
non-sponsors, other than CMS, within
DHHS.
The FFRDC will be established under
the authority of 48 CFR 35.017.
The Contractor will be available to
provide a wide range of support
including, but not limited to:
• Strategic/Tactical Planning,
including assisting with planning for
future CMS program policy, innovation,
development, and support for Medicare
and Medicaid.
• Conceptual Planning, including
operations, analysis, requirements,
procedures, and analytic support.
• Design and Engineering, including
Technical Architecture Direction.
• Procurement Assistance, Review/
Recommendations for Current Contract
Processes to include, Contract Reform,
Technical Guidance, Price and Cost
Estimating, Support and Source
Selection Evaluation Support.
• Organizational Planning, including
Functional and Gap analysis.
• Research and Development,
Assessment of New Technologies and
advice on medical and technical
innovation and health information.
• Continuous Process Improvement,
ILC/current practices review and
recommendations, implementation of
best practices and code reviews.
• IV&V/Compliance, DUA
Surveillance and Web Site Content
Review.
• Security, including Security
Assessments and Security Test and
Evaluations (ST&E). Identify, define,
and resolve problems as an integral part
of the sponsor’s management team.
• Providing independent analysis
about DHHS vulnerabilities and the
effectiveness of systems deployed to
make DHHS more effective in providing
healthcare services and implementation
of new healthcare initiatives;
• Providing intra-departmental and
inter-agency cross-cutting, risk-informed
analysis of alternative resource
approaches;
• Developing and deploying
analytical tools and techniques to
evaluate system alternatives (for
example, policy-operations-technology
tradeoffs, etc.), and life-cycle costs that
have broad application across CMS;
• Developing measurable
performance metrics, models, and
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
simulations for determining progress in
securing DHHS data or other authorized
data sources, (non-DHHS data sources,
such as the census data or DOL data,
VA, DOD, data in developing
performance metrics, and models);
• Providing independent and
objective operational test and evaluation
analysis support;
• Developing recommendations for
guidance on the best practices for
standards, particularly to improve the
inter-operability of DHHS components;
• Assessing technologies and
evaluating technology test-beds for
accurate simulation of operational
conditions and delivery system
innovation models;
• Supporting critical thinking about
the DHHS enterprise, business
intelligence and analytic tools that can
be applied consistently across DHHS
and CMS programs;
• Supporting systems integration,
data management, and data exchange
that contribute to a larger DHHS intra
and inter-agency enterprise as well as
collaboration with State, local Tribal
governments, the business sector (forprofit and not-for-profits), academia and
the public;
• Providing recommendations for
standards for top-level DHHS systems
requirements and performance metrics
best practices for an integrated DHHS
approach to systems solutions and
structured and unstructured data
architecture; and
• Understanding key DHHS
organizations and their specific role and
major acquisition requirements and
support them in the requirements
development phase of the acquisition
lifecycle.
• The FFRDC shall function so
effectively as to act as an agent for the
sponsor in the design and pursuit of
mission goals.
• The FFRDC shall provide rapid
responsiveness to changing
requirements for personnel in all
aspects of strategic, technical and
program management.
• The FFRDC shall recognize
Government objectives as its own
objectives, partnering with the sponsor
in pursuit of excellence in public
service.
• The FFRDC shall allow for nonsponsor, other than CMS, work for
operating Divisions within DHHS.
We are publishing this notice in
accordance with 48 CFR 5.205(b) of the
Federal Acquisition Regulations (FAR),
to enable interested members of the
public to provide comments on this
proposed action. This is the first of three
notices issued under the authority of 48
CFR 5.205(b).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
The Request for Proposal (RFP) will
be posted on FedBizOpps in the
Summer of 2011. Alternatively, a copy
can be received by contacting the person
listed in the FOR FURTHER INFORMATION
CONTACT section above.
Dated: April 7, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–8942 Filed 4–12–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Tribal Consultation Meetings
Administration for Children
and Families’ Office of Head Start
(OHS), HHS.
ACTION: Notice.
AGENCY:
Pursuant to the Improving
Head Start for School Readiness Act of
2007, Public Law 110–134, notice is
hereby given of one-day Tribal
Consultation Sessions to be held
between the Department of Health and
Human Services, Administration for
Children and Families, Office of Head
Start leadership and the leadership of
Tribal Governments operating Head
Start (including Early Head Start)
programs. The purpose of these
Consultation Sessions is to discuss ways
to better meet the needs of American
Indian and Alaska Native children and
their families, taking into consideration
funding allocations, distribution
formulas, and other issues affecting the
delivery of Head Start services in their
geographic locations [42 U.S.C. 9835,
Section 640(l)(4)].
DATES AND LOCATIONS: Office of Head
Start Tribal Consultation Sessions will
be held as follows:
Friday, April 29, 2011—Albuquerque,
New Mexico—Indian Pueblo Cultural
Center, 2401 12th Street, NW.,
Albuquerque NM 87104.
Thursday, May 19, 2011—Marksville,
Louisiana—Paragon Casino Resort,
6773 East Tunica Drive, Marksville,
LA 71351.
FOR FURTHER INFORMATION CONTACT:
Camille Loya, Tribal Policy Lead, e-mail
Camille.Loya@acf.hhs.gov or phone
(202) 401–5964. Additional information
and online meeting registration is
available at https://
www.headstartresourcecenter.org.
SUMMARY:
The
Department of Health and Human
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13APN1.SGM
13APN1
Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20673-20674]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8942]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-7031-NC]
Announcement of Notice; Proposed Establishment of a Federally
Funded Research and Development Center--First Notice
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health & Human Services (DHHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our intention to sponsor Federally
Funded Research and Development Center (FFRDC) to facilitate the
modernization of business processes and supporting systems and their
operations. This is the first of three notices which must be published
over a 90-day period in order to advise the public of the agency's
intention to sponsor an FFRDC issued under the authority of 48 CFR
35.017.
DATES: We must receive comments on or before July 5, 2011.
ADDRESSES: Comments on this notice must be mailed to the Centers for
Medicare & Medicaid Services, Candice Savoy, Contracting Officer, 7500
Security Boulevard, Mailstop C2-01-10, Baltimore, MD 21244 or e-mail at
Candice.Savoy@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Candice Savoy, (410) 786-7494.
SUPPLEMENTARY INFORMATION: The Centers for Medicare & Medicaid Services
(CMS), an operating division within the Department of Health and Human
Services (DHHS), intends to sponsor a studies and analysis, Delivery
System, Simulations, and Cost Modeling Federally Funded Research and
Development Center (FFRDC) to facilitate the modernization of business
processes and supporting systems and their operations. Some of the
broad task areas that will be utilized include Strategic/Tactical
Planning, Conceptual Planning, Design and Engineering, Procurement
Assistance, Organizational Planning, Research and Development,
[[Page 20674]]
Continuous Process Improvement, IV&V/Compliance, and Security Planning.
Further analysis will consist of expert advice and guidance in the
areas of program and project management focused on increasing the
effectiveness and efficiency of strategic information management,
prototyping, demonstrations, and technical activities. This FFRDC may
also be utilized by non-sponsors, other than CMS, within DHHS.
The FFRDC will be established under the authority of 48 CFR 35.017.
The Contractor will be available to provide a wide range of support
including, but not limited to:
Strategic/Tactical Planning, including assisting with
planning for future CMS program policy, innovation, development, and
support for Medicare and Medicaid.
Conceptual Planning, including operations, analysis,
requirements, procedures, and analytic support.
Design and Engineering, including Technical Architecture
Direction.
Procurement Assistance, Review/Recommendations for Current
Contract Processes to include, Contract Reform, Technical Guidance,
Price and Cost Estimating, Support and Source Selection Evaluation
Support.
Organizational Planning, including Functional and Gap
analysis.
Research and Development, Assessment of New Technologies
and advice on medical and technical innovation and health information.
Continuous Process Improvement, ILC/current practices
review and recommendations, implementation of best practices and code
reviews.
IV&V/Compliance, DUA Surveillance and Web Site Content
Review.
Security, including Security Assessments and Security Test
and Evaluations (ST&E). Identify, define, and resolve problems as an
integral part of the sponsor's management team.
Providing independent analysis about DHHS vulnerabilities
and the effectiveness of systems deployed to make DHHS more effective
in providing healthcare services and implementation of new healthcare
initiatives;
Providing intra-departmental and inter-agency cross-
cutting, risk-informed analysis of alternative resource approaches;
Developing and deploying analytical tools and techniques
to evaluate system alternatives (for example, policy-operations-
technology tradeoffs, etc.), and life-cycle costs that have broad
application across CMS;
Developing measurable performance metrics, models, and
simulations for determining progress in securing DHHS data or other
authorized data sources, (non-DHHS data sources, such as the census
data or DOL data, VA, DOD, data in developing performance metrics, and
models);
Providing independent and objective operational test and
evaluation analysis support;
Developing recommendations for guidance on the best
practices for standards, particularly to improve the inter-operability
of DHHS components;
Assessing technologies and evaluating technology test-beds
for accurate simulation of operational conditions and delivery system
innovation models;
Supporting critical thinking about the DHHS enterprise,
business intelligence and analytic tools that can be applied
consistently across DHHS and CMS programs;
Supporting systems integration, data management, and data
exchange that contribute to a larger DHHS intra and inter-agency
enterprise as well as collaboration with State, local Tribal
governments, the business sector (for-profit and not-for-profits),
academia and the public;
Providing recommendations for standards for top-level DHHS
systems requirements and performance metrics best practices for an
integrated DHHS approach to systems solutions and structured and
unstructured data architecture; and
Understanding key DHHS organizations and their specific
role and major acquisition requirements and support them in the
requirements development phase of the acquisition lifecycle.
The FFRDC shall function so effectively as to act as an
agent for the sponsor in the design and pursuit of mission goals.
The FFRDC shall provide rapid responsiveness to changing
requirements for personnel in all aspects of strategic, technical and
program management.
The FFRDC shall recognize Government objectives as its own
objectives, partnering with the sponsor in pursuit of excellence in
public service.
The FFRDC shall allow for non-sponsor, other than CMS,
work for operating Divisions within DHHS.
We are publishing this notice in accordance with 48 CFR 5.205(b) of
the Federal Acquisition Regulations (FAR), to enable interested members
of the public to provide comments on this proposed action. This is the
first of three notices issued under the authority of 48 CFR 5.205(b).
The Request for Proposal (RFP) will be posted on FedBizOpps in the
Summer of 2011. Alternatively, a copy can be received by contacting the
person listed in the FOR FURTHER INFORMATION CONTACT section above.
Dated: April 7, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-8942 Filed 4-12-11; 8:45 am]
BILLING CODE 4120-01-P