Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20673 

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 http://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 

for validation studies and technical 

evaluations. Additional information 

about ICCVAM and NICEATM can be 

found on the NICEATM–ICCVAM Web 

site (http://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: 

http://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: 

http://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: 

http://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: 

http://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: 

http://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: http:// 

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: 

http://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: http:// 

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 

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, 

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 

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). 

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 

AGENCY: Administration for Children 

and Families’ Office of Head Start 

(OHS), HHS. 

ACTION: Notice. 

SUMMARY: 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 http:// 

www.headstartresourcecenter.org. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

mstockstill on DSKH9S0YB1PROD with NOTICES