Announcement of Notice; Proposed Establishment of a Federally Funded Research and Development Center-First Notice, 20673-20674 [2011-8942]

Download as PDF 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 VerDate Mar<15>2010 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:// PO 00000 Frm 00051 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]


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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
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