Interagency Coordinating Committee on the Validation of Alternative Methods Evaluation Report and Recommendations for Identifying Chemical Eye Hazards With Fewer Animals; Availability of Report; Notice of Transmittal to Federal Agencies, 61610-61611 [2012-24868]

Download as PDF 61610 Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Notices AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 3, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–24861 Filed 10–9–12; 8:45 am] BILLING CODE 4160–01–P Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1984. 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Specifically, additional outcome measures that can be utilized by grantees that predominantly provide infrastructure services are being developed for submission to OMB. The estimated response burden is as follows: Form Number of respondents Responses per respondent Total responses Burden hours per response Total burden hours Grant Report ........................................................................ 900 1 900 41 36,900 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: October 3, 2012. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2012–24889 Filed 10–9–12; 8:45 am] rmajette on DSK2TPTVN1PROD with NOTICES BILLING CODE 4165–15–P VerDate Mar<15>2010 15:15 Oct 09, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods Evaluation Report and Recommendations for Identifying Chemical Eye Hazards With Fewer Animals; Availability of Report; Notice of Transmittal to Federal Agencies The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method evaluation report (TMER) that provides recommendations for identifying chemical eye hazards with fewer animals. ICCVAM concludes that using a classification criterion of one or more positive animals in a three-animal test to identify chemicals and products that are eye hazards will maintain hazard classification equivalent to that provided by current testing procedures, while using up to 50% to 83% fewer animals. ICCVAM recommends SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 consideration of this classification criterion together with eye safety testing procedures that use a maximum of three animals per test substance. This recommendation also harmonizes the number of animals used for eye safety testing across U.S. regulatory agencies and international test guidelines. The report and recommendations have been transmitted to Federal agencies for their review and response to ICCVAM. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, NICEATM, National Institute of Environmental Health Sciences (NIEHS), P.O. Box 12233, Mail Stop: K2–16, Research Triangle Park, NC 27709. Phone: 919– 541–2384, Fax: 919–541–0947, Email: niceatm@niehs.nih.gov. Hand Deliver/ Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background: Eye safety testing procedures vary among U.S. agencies. Current testing procedures specified in the U.S. Code of Federal Regulations (16 CFR 1500.42) provide criteria and procedures for identifying eye hazards based on rabbit eye test results (CPSC, E:\FR\FM\10OCN1.SGM 10OCN1 rmajette on DSK2TPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Notices 2010); however, current testing procedures (16 CFR 1500.42) do not provide criteria to classify results obtained from a three-animal test. NICEATM, in collaboration with ICCVAM, conducted an analysis to determine classification criteria based on results from a three-animal test that would maintain hazard classification equivalent to that provided by current testing procedures (16 CFR 1500.42). The process for developing the ICCVAM recommendations began with a critical review of the analysis (Haseman et al., 2011) and existing data by the ICCVAM Interagency Ocular Toxicity Working Group (OTWG). As part of ICCVAM’s ongoing international collaborations, scientists from the European Union Reference Laboratory for Alternatives to Animal Testing and the Japanese Center for the Validation of Alternative Methods served as liaisons to the OTWG. The analysis (Haseman et al., 2011) was provided to the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) at the June 17–18, 2010 meeting (75 FR 26758, May 12, 2010) for comment. The public was also given an opportunity to comment at that meeting. The OTWG then developed draft ICCVAM recommendations regarding classification criteria based on results from a three-animal test that would maintain hazard classification equivalent to that provided by current testing procedures (16 CFR 1500.42). The draft ICCVAM recommendations and supporting analysis (Haseman et al., 2011) were made available on the NICEATM–ICCVAM Web site (https:// iccvam.niehs.nih.gov/methods/ocutox/ reducenum.htm) for comment by the broad stakeholder community (76 FR 50220, August 12, 2011). ICCVAM considered the analysis (Haseman et al., 2011), all public comments, and the SACATM comments in preparing the final ICCVAM test method recommendations. The recommendations are provided in the ICCVAM Test Method Evaluation Report: Identifying Chemical Eye Hazards with Fewer Animals (NIH Publication No. 12–7930), which is available on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov/ methods/ocutox/reducenum-TMER. htm). ICCVAM concludes that using a classification criterion of one or more positive animals in a three-animal test to identify chemicals and products that are eye hazards will maintain hazard classification equivalent to that provided by current testing procedures (16 CFR 1500.42 [CPSC, 2010]), while using up to 50% to 83% fewer animals. ICCVAM, therefore, recommends VerDate Mar<15>2010 15:15 Oct 09, 2012 Jkt 229001 consideration of this classification together with eye safety testing procedures that use a maximum of three animals per test substance. Consistent with ICCVAM’s duty to foster interagency and international harmonization (42 U.S.C. 285l-3), this recommendation harmonizes the number of animals used for eye safety testing across U.S. regulatory agencies and international test guidelines. The ICCVAM TMER includes relevant ocular toxicity regulations and guidelines, applicable Federal Register notices, public comments, and SACATM meeting minutes. Background Information on ICCVAM, NICEATM, and SACATM 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 and integrated testing strategies with regulatory applicability and promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (enhance animal wellbeing and lessen or avoid 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 welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM and ICCVAM can be found on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov). SACATM was established in response to the ICCVAM Authorization Act (Section 285l–3[d]) and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 61611 harmonization of new, revised, and alternative toxicological test methods. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/go/167. References CPSC. 2010. Federal Hazardous Substances Act Regulations. 16 CFR 1500. Available: https://www.gpo.gov/ fdsys/pkg/CFR-2011-title16-vol2/pdf/ CFR-2011-title16-vol2-chapII-subchapC. pdf. Haseman J.K., Allen D.G., Lipscomb E.A., Truax J.F., Stokes WS. 2011. Using fewer animals to identify chemical eye hazards: revised criteria necessary to maintain equivalent hazard classification. Regul Toxicol Pharmacol 61: 98–104. Dated: October 3, 2012. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2012–24868 Filed 10–9–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Minority Health and Health Disparities; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Minority Health and Health Disparities Special Emphasis Panel; NIMHD Social, Behavioral, Health Services, and Policy Research on Minority Health and Health Disparities (R01). Date: November 7–9, 2012. Time: 8 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Maryline Laude-Sharp, Ph.D., Scientific Review Officer, National Institute on Minority Health and Health E:\FR\FM\10OCN1.SGM 10OCN1

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[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Notices]
[Pages 61610-61611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24868]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods Evaluation Report and Recommendations for 
Identifying Chemical Eye Hazards With Fewer Animals; Availability of 
Report; Notice of Transmittal to Federal Agencies

SUMMARY: The NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM) announces availability of an 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) test method evaluation report (TMER) that provides 
recommendations for identifying chemical eye hazards with fewer 
animals.
    ICCVAM concludes that using a classification criterion of one or 
more positive animals in a three-animal test to identify chemicals and 
products that are eye hazards will maintain hazard classification 
equivalent to that provided by current testing procedures, while using 
up to 50% to 83% fewer animals. ICCVAM recommends consideration of this 
classification criterion together with eye safety testing procedures 
that use a maximum of three animals per test substance. This 
recommendation also harmonizes the number of animals used for eye 
safety testing across U.S. regulatory agencies and international test 
guidelines.
    The report and recommendations have been transmitted to Federal 
agencies for their review and response to ICCVAM.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, 
NICEATM, National Institute of Environmental Health Sciences (NIEHS), 
P.O. Box 12233, Mail Stop: K2-16, Research Triangle Park, NC 27709. 
Phone: 919-541-2384, Fax: 919-541-0947, Email: niceatm@niehs.nih.gov. 
Hand Deliver/Courier address: NICEATM, NIEHS, Room 2034, 530 Davis 
Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
    Background: Eye safety testing procedures vary among U.S. agencies. 
Current testing procedures specified in the U.S. Code of Federal 
Regulations (16 CFR 1500.42) provide criteria and procedures for 
identifying eye hazards based on rabbit eye test results (CPSC,

[[Page 61611]]

2010); however, current testing procedures (16 CFR 1500.42) do not 
provide criteria to classify results obtained from a three-animal test. 
NICEATM, in collaboration with ICCVAM, conducted an analysis to 
determine classification criteria based on results from a three-animal 
test that would maintain hazard classification equivalent to that 
provided by current testing procedures (16 CFR 1500.42).
    The process for developing the ICCVAM recommendations began with a 
critical review of the analysis (Haseman et al., 2011) and existing 
data by the ICCVAM Interagency Ocular Toxicity Working Group (OTWG). As 
part of ICCVAM's ongoing international collaborations, scientists from 
the European Union Reference Laboratory for Alternatives to Animal 
Testing and the Japanese Center for the Validation of Alternative 
Methods served as liaisons to the OTWG. The analysis (Haseman et al., 
2011) was provided to the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM) at the June 17-18, 2010 meeting (75 FR 
26758, May 12, 2010) for comment. The public was also given an 
opportunity to comment at that meeting. The OTWG then developed draft 
ICCVAM recommendations regarding classification criteria based on 
results from a three-animal test that would maintain hazard 
classification equivalent to that provided by current testing 
procedures (16 CFR 1500.42). The draft ICCVAM recommendations and 
supporting analysis (Haseman et al., 2011) were made available on the 
NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/ocutox/reducenum.htm) for comment by the broad stakeholder community (76 FR 
50220, August 12, 2011).
    ICCVAM considered the analysis (Haseman et al., 2011), all public 
comments, and the SACATM comments in preparing the final ICCVAM test 
method recommendations. The recommendations are provided in the ICCVAM 
Test Method Evaluation Report: Identifying Chemical Eye Hazards with 
Fewer Animals (NIH Publication No. 12-7930), which is available on the 
NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/ocutox/reducenum-TMER.htm). ICCVAM concludes that using a classification 
criterion of one or more positive animals in a three-animal test to 
identify chemicals and products that are eye hazards will maintain 
hazard classification equivalent to that provided by current testing 
procedures (16 CFR 1500.42 [CPSC, 2010]), while using up to 50% to 83% 
fewer animals. ICCVAM, therefore, recommends consideration of this 
classification together with eye safety testing procedures that use a 
maximum of three animals per test substance. Consistent with ICCVAM's 
duty to foster interagency and international harmonization (42 U.S.C. 
285l-3), this recommendation harmonizes the number of animals used for 
eye safety testing across U.S. regulatory agencies and international 
test guidelines. The ICCVAM TMER includes relevant ocular toxicity 
regulations and guidelines, applicable Federal Register notices, public 
comments, and SACATM meeting minutes.

Background Information on ICCVAM, NICEATM, and SACATM

    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 and integrated testing strategies with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of testing methods that more accurately assess 
the safety and hazards of chemicals and products and that reduce, 
refine (enhance animal well-being and lessen or avoid 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 welcome the public 
nomination of new, revised, and alternative test methods and strategies 
for validation studies and technical evaluations. Additional 
information about NICEATM and ICCVAM can be found on the NICEATM-ICCVAM 
Web site (https://iccvam.niehs.nih.gov).
    SACATM was established in response to the ICCVAM Authorization Act 
(Section 285l-3[d]) and is composed of scientists from the public and 
private sectors. SACATM advises ICCVAM, NICEATM, and the Director of 
the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and 
activities of NICEATM. SACATM provides advice on priorities and 
activities related to the development, validation, scientific review, 
regulatory acceptance, implementation, and national and international 
harmonization of new, revised, and alternative toxicological test 
methods. Additional information about SACATM, including the charter, 
roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/go/167.

References

    CPSC. 2010. Federal Hazardous Substances Act Regulations. 16 CFR 
1500. Available: https://www.gpo.gov/fdsys/pkg/CFR-2011-title16-vol2/pdf/CFR-2011-title16-vol2-chapII-subchapC.pdf.
    Haseman J.K., Allen D.G., Lipscomb E.A., Truax J.F., Stokes WS. 
2011. Using fewer animals to identify chemical eye hazards: revised 
criteria necessary to maintain equivalent hazard classification. Regul 
Toxicol Pharmacol 61: 98-104.

    Dated: October 3, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-24868 Filed 10-9-12; 8:45 am]
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