50220 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 

There are no significant current 

capital or other non-labor costs 

associated with this Rule. Because the 

Rule has been in effect since 1980, 

members of the industry are familiar 

with its requirements and already have 

in place the equipment for conducting 

tests and storing records. New products 

are introduced infrequently. Because the 

required disclosures are placed on 

packaging or on the product itself, the 

Rule’s additional disclosure 

requirements do not cause industry 

members to incur any significant 

additional non-labor associated costs. 

Willard K. Tom, 

General Counsel. 

[FR Doc. 2011–20372 Filed 8–11–11; 8:45 am] 

BILLING CODE 6750–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Availability of Draft ICCVAM 

Recommendations on Using Fewer 

Animals to Identify Chemical Eye 

Hazards: Revised Criteria Necessary to 

Maintain Equivalent Hazard 

Classification; Request for Comments 

AGENCY: Division of the National 

Toxicology Program (DNTP), National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health, HHS. 

ACTION: Availability of 

Recommendations; Request for 

Comments. 

SUMMARY: The NTP Interagency Center 

for the Evaluation of Alternative 

Toxicological Methods (NICEATM), in 

collaboration with the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM), conducted an analysis to 

determine classification criteria using 

results from 3-animal tests that would 

provide eye hazard classification 

equivalent to testing conducted in 

accordance with current U.S. Federal 

Hazardous Substances Act (FHSA) 

regulations, which require the use of 6 

to 18 animals. The results showed that 

using a classification criterion of at least 

1 positive animal in a 3-animal test to 

identify eye hazards will provide the 

same or greater level of eye hazard 

classification as current FHSA 

requirements, while using 50% to 83% 

fewer animals. ICCVAM developed draft 

recommendations based on the results 

of this analysis. NICEATM invites 

public comments on these draft 

ICCVAM recommendations. 

DATES: Written comments on the draft 

recommendations should be received by 

September 26, 2011. 

ADDRESSES: NICEATM prefers that 

comments be submitted electronically 

via the NICEATM–ICCVAM Web site 

(http://iccvam.niehs.nih.gov/contact/ 

FR_pubcomment.htm) or via e-mail to 

niceatm@niehs.nih.gov. Written 

comments may also be sent by mail or 

fax to Dr. William S. Stokes, Director, 

NICEATM, NIEHS, P.O. Box 12233, 

Mail Stop: K2–16, Research Triangle 

Park, NC 27709; (fax) 919–541–0947. 

Courier address: NICEATM, NIEHS, 

Room 2034, 530 Davis Drive, 

Morrisville, NC 27560. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes: (telephone) 919–541– 

2384, (fax) 919–541–0947, or (e-mail) 

niceatm@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Testing requirements necessary to 

determine the eye hazard potential for 

substances regulated under the FHSA 

(FHSA, 2008) are provided in 16 CFR 

1500.42 (U.S. Consumer Product Safety 

Commission [CPSC], 2010). Current 

FHSA regulations provide procedures to 

determine the eye hazard classification 

and labeling requirements for chemicals 

and products to which consumers may 

be exposed. The current procedure 

requires a minimum of 6 animals per 

test and may require up to 3 sequential 

tests for each substance, thus requiring 

6, 12, or 18 animals to reach a hazard 

classification decision. The requirement 

for second and third sequential tests is 

based on the number of positive 

responses in the previous test. 

In 2002, the Organisation for 

Economic Co-operation and 

Development (OECD) Test Guidelines 

Program adopted U.S. proposed 

revisions to Test Guideline 405: Acute 

Eye Irritation/Corrosion (OECD, 2002) 

that reduce the maximum number of 

required animals per test from 6 to 3. 

The Animal Welfare Act (7 U.S.C. 2131 

et seq) and the Public Health Service 

(PHS) Policy (PHS, 2002) similarly 

require that only the minimum number 

of animals necessary to obtain 

scientifically valid results should be 

used and that a rationale for the 

appropriateness of the number of 

animals used be provided to and 

approved by the Institutional Animal 

Care and Use Committee. In light of this 

policy and regulations, most in vivo 

ocular safety testing is expected to 

adhere to the 3-animal procedure 

described in OECD Test Guideline 405 

(OECD, 2002) and in a test guideline 

issued by the U.S. Environmental 

Protection Agency (EPA, 1998). 

However, current FHSA regulations do 

not provide criteria to classify results 

from a 3-animal test. Therefore, an 

analysis was conducted to determine 

classification criteria based on results 

from a 3-animal test that would provide 

eye hazard classification equivalent to 

procedures in current FHSA regulations 

(Haseman et al., 2011). The results 

showed that using a classification 

criterion of at least 1 positive in a 3- 

animal test to identify eye hazards will 

provide the same or greater level of eye 

hazard classification as current FHSA 

requirements, while using 50% to 83% 

fewer animals. Based on these results, 

ICCVAM developed draft 

recommendations to use this 

classification criterion for ocular safety 

testing procedures that use only a 

maximum of 3 animals per test 

substance. 

Availability of the Documents 

The draft ICCVAM recommendations 

and the supporting publication 

describing the results of the analysis are 

available on the NICEATM–ICCVAM 

Web site (http://iccvam.niehs.nih.gov/ 

methods/ocutox/reducenum.htm), and 

may also be obtained by contacting 

NICEATM (see FOR FURTHER

INFORMATION CONTACT). 

Request for Public Comments 

NICEATM invites the submission of 

written comments on the draft ICCVAM 

recommendations and the extent to 

which the NICEATM analysis supports 

the recommendations by September 26, 

2011. When submitting written 

comments, please refer to this Federal 

Register notice and include appropriate 

contact information (name, affiliation, 

mailing address, phone, fax, e-mail, and 

sponsoring organization, if applicable). 

NICEATM will post all comments on 

the NICEATM–ICCVAM Web site 

(http://ntp-apps.niehs.nih.gov/ 

iccvampb/searchPubCom.cfm) 

identified by the individual’s name and 

affiliation or sponsoring organization (if 

applicable). ICCVAM will consider all 

public comments and comments made 

by the Scientific Advisory Committee 

on Alternative Toxicological Methods 

(SACATM) at the June 17–18, 2010 

meeting (75 FR 26757) when finalizing 

its recommendations. Final ICCVAM 

recommendations will be forwarded to 

relevant Federal agencies for their 

consideration. These recommendations 

will also be available to the public on 

the NICEATM–ICCVAM Web site 

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

ocutox/reducenum.htm). 

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Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 50221 

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 

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 

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 (http:// 

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 http://ntp.niehs.nih.gov/go/167. 

References 

AWA. 2010. Animal Welfare Act. 7 U.S.C. 

2131 et seq. Public Law 89–544. Available: 

http://www.aphis.usda.gov/ 

animal_welfare/downloads/awa/awa.pdf. 

CPSC. 2010. Hazardous Substances and 

Articles; Administration and Enforcement 

Regulations. 16 CFR part 1500. Available: 

http://www.gpo.gov/fdsys/pkg/CFR-2010- 

title16-vol2/xml/CFR-2010-title16-vol2- 

part1500.xml. 

EPA. 1998. Health Effects Test Guideline, 

OPPTS 870.2400 Acute Eye Irritation. 

Washington, DC: U.S. Environmental 

Protection Agency. Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/ 

EPA/EPA_870_2400.pdf. 

FHSA. 2008. 15 U.S.C. 1261–1278. Public 

Law 86–613. Available: http:// 

www.cpsc.gov/businfo/fhsa.pdf. 

Haseman JK, Allen DG, Lipscomb EA, Truax 

JF, Stokes WS. 2011. Using fewer animals 

to identify chemical eye hazards: Revised 

criteria necessary to maintain equivalent 

hazard classification [published online 

ahead of print]. Regul Toxicol Pharmacol. 

Available: http://dx.doi.org/10.1016/ 

j.yrtph.2011.06.006. 

OECD. 2002. Test No. 405: Acute Eye 

Irritation/Corrosion. In: OECD Guidelines 

for the Testing of Chemicals, Section 4: 

Health Effects. Paris:OECD Publishing. 

Available: http://www.oecd-ilibrary.org/ 

content/book/9789264070646-en. 

PHS. 2002. Public Health Service Policy on 

Humane Care and Use of Laboratory 

Animals. Bethesda, MD: Office of 

Laboratory Animal Welfare, National 

Institutes of Health. Available: http:// 

grants.nih.gov/grants/olaw/references/ 

phspol.htm. 

Dated: August 3, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–20537 Filed 8–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

International Workshop on Alternative 

Methods for Human and Veterinary 

Rabies Vaccine Testing: State of the 

Science and Planning the Way Forward 

AGENCY: Division of the National 

Toxicology Program (DNTP), National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health (NIH), HHS. 

ACTION: Announcement of a Workshop; 

Call for Abstract Submissions. 

SUMMARY: The NTP Interagency Center 

for the Evaluation of Alternative 

Toxicological Methods (NICEATM) 

announces an ‘‘International Workshop 

on Alternative Methods for Human and 

Veterinary Rabies Vaccine Testing: State 

of the Science and Planning The Way 

Forward.’’ This workshop will bring 

together scientists from government, 

industry, and academia to review the 

current state of the science and 

validation status of methods and 

approaches that may reduce, refine, or 

replace animal use in human and 

veterinary rabies vaccine potency 

testing, and to develop an 

implementation strategy to achieve 

global acceptance and use of these 

alternatives. Attendance is open to the 

public at no charge and limited only by 

the available space. Abstracts for 

scientific posters for display at the 

workshop are also invited (see 

SUPPLEMENTARY INFORMATION). 

DATES: The workshop is scheduled for 

October 11–13, 2011. Sessions will 

begin at 8:30 a.m. each day and end at 

approximately 6 p.m. on October 11 and 

12 and at 12 p.m. on October 13. The 

deadline for registration is September 

30, 2011. Due to U.S. Department of 

Agriculture (USDA) security 

requirements, onsite registration at the 

workshop will not be available. The 

deadline for submission of poster 

abstracts is September 16, 2011. 

ADDRESSES: The workshop will be held 

at the Center for Veterinary Biologics at 

the USDA National Centers for Animal 

Health, 1920 Dayton Avenue, Ames, 

Iowa 50010. Individuals with 

disabilities who need accommodation to 

participate in this event should contact 

Ms. Debbie McCarley at voice 

telephone: 919–541–2384 or e-mail: 

mccarley@niehs.nih.gov. TTY users 

should contact the Federal TTY Relay 

Service at 800–877–8339. Requests 

should be made at least 5 business days 

in advance of the event. 

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 

Rabies is one of the oldest known 

zoonotic diseases and is responsible for 

at least 55,000 human deaths worldwide 

each year (World Health Organization 

[WHO], 2010). Rabies vaccines serve a 

vital role in preventing further deaths 

and controlling the disease in certain 

animal populations. An estimated 15 

million people receive post-exposure 

vaccine prophylaxis each year due to 

actual or suspected exposures to the 

rabies virus. In the United States and 

other developed countries, rabies 

vaccines have effectively eliminated 

domestic rabies virus strains. Prior to 

the release of each production lot of 

vaccine, regulatory authorities require 

demonstration of potency and safety. 

Potency and safety testing of rabies 

vaccines requires large numbers of 

laboratory animals and involves 

significant pain and distress. New 

mstockstill on DSK4VPTVN1PROD with NOTICES