20672 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

Abstract: The results of the HHS Web 

Site Customer Satisfaction Survey will 

be used to ensure that the content on the 

HHS Web sites meets visitor needs and 

expectations. The results will also 

determine if the site is easy to use and 

the content easy to understand. 

ESTIMATED ANNUALIZED BURDEN TABLE

Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

(in hrs.) 

Total burden 

hours 

Survey .............................................................................................................. 48,000 1 12/60 9,600 

Mary Forbes, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2011–8796 Filed 4–12–11; 8:45 am] 

BILLING CODE 4150–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Recommendations on In Vitro Ocular 

Safety Testing Methods and Strategies 

and Routine Use of Topical 

Anesthetics, Systemic Analgesics, and 

Humane Endpoints for Ocular Safety 

Testing 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Notice of availability. 

SUMMARY: U.S. Federal agency responses 

to ICCVAM test method 

recommendations on alternative testing 

methods and strategies proposed to 

further reduce and refine the use of 

animals for assessing the ocular hazard 

potential of chemicals and products are 

now available. ICCVAM recommended a 

pain management procedure that should 

always be used to avoid pain and 

distress when it is determined necessary 

to conduct the rabbit eye test for 

regulatory safety purposes. ICCVAM 

also recommended the Cytosensor 

Microphysiometer (CM) test method as 

a screening test (1) to identify some 

types of substances that will not cause 

sufficient injury to require eye hazard 

labeling and (2) to identify some types 

of substances that may cause permanent 

or severe eye injuries. ICCVAM 

previously forwarded recommendations 

to Federal agencies and made these 

recommendations available to the 

public (75 FR 57027). In accordance 

with the ICCVAM Authorization Act of 

2000 (42 U.S.C. 285l–3), agencies have 

notified ICCVAM in writing of their 

findings and ICCVAM is making these 

responses available to the public. 

Federal agency responses are available 

on the NICEATM–ICCVAM Web site at 

http://iccvam.niehs.nih.gov/methods/ 

ocutox/Transmit-2010.htm. The 

ICCVAM recommendations are 

provided in ICCVAM test method 

evaluation reports that are available on 

the NICEATM–ICCVAM Web site at 

http://iccvam.niehs.nih.gov/methods/ 

ocutox/OcuAnest-TMER.htm, http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

MildMod-TMER.htm, http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

AMCP–TMER.htm, and http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

LVET.htm. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes, Director, NICEATM, 

NIEHS, P.O. Box 12233, Mail Stop: K2– 

16, Research Triangle Park, NC 27709, 

(telephone) 919–541–2384, (fax) 919– 

541–0947, (e-mail) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, NIEHS, Room 2034, 530 

Davis Drive, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Environmental Protection 

Agency (EPA) requested that ICCVAM 

(1) evaluate the current validation status 

of the bovine corneal opacity and 

permeability (BCOP), hen’s egg test– 

chorioallantoic membrane (HET–CAM), 

isolated chicken eye (ICE), and isolated 

rabbit eye (IRE) test methods; (2) 

identify in vivo ocular toxicity reference 

data to support the validation of in vitro 

test methods; (3) explore ways of 

alleviating pain and distress from 

current in vivo ocular safety testing; and 

(4) review the state of the science and 

the availability of in vitro test methods 

for assessing mild or moderate ocular 

irritants. The highest priority activity, 

an evaluation of the BCOP, HET–CAM, 

ICE, and IRE test methods for their 

usefulness and limitations for 

identifying potential ocular corrosives 

and severe irritants, was completed in 

2006 (NIH Publication No. 07–4517). 

Based on this evaluation, U.S. Federal 

agencies subsequently accepted the 

BCOP and ICE test methods for certain 

regulatory testing purposes without the 

need for animal testing. The 

Organisation for Economic Co-operation 

and Development (OECD) subsequently 

adopted the BCOP and ICE test methods 

in 2009 as international OECD Test 

Guidelines 437 and 438, respectively 

(OECD 2009a, OECD 2009b). The 

International Organization for 

Standardization (ISO) adopted the 

BCOP and ICE test methods as ISO 

Standard 10993–10 in 2010 (ISO 2010). 

ICCVAM recently completed 

additional test method evaluations 

relevant to the original EPA nomination 

and a subsequent EPA request that 

ICCVAM evaluate a proposed in vitro 

testing strategy for identifying the ocular 

hazard potential of antimicrobial 

cleaning products. Information is 

provided about ICCVAM’s evaluation 

and the committee’s recommendations 

for the alternative testing methods and 

strategies proposed to further reduce 

and refine the use of animals for 

assessing the ocular hazard potential of 

chemicals and products in four 

ICCVAM Test Method Evaluation 

Reports: (1) 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), (2) 

Current Validation Status of In Vitro 

Test Methods Proposed for Identifying 

Eye Injury Hazard Potential of 

Chemicals and Products (NIH 

Publication No. 10–7553), (3) 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), and (4) 

Recommendation to Discontinue Use of 

the Low Volume Eye Test for Ocular 

Safety Testing (NIH Publication No. 

10–7515). 

Agency Responses to ICCVAM 

Recommendations 

In September 2010, ICCVAM 

forwarded final test method 

recommendations for ocular safety 

testing methods and strategies to U.S. 

Federal agencies for consideration, in 

accordance with the ICCVAM 

Authorization Act of 2000 (42 U.S.C. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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