Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), 35393-35394 [2012-14436]

Download as PDF Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Notices Toyota to retain documents relating to its compliance with the order. For most records, the order requires that the documents be retained for a five-year period. For the third party assessments and supporting documents, Franklin Toyota must retain the documents for a period of three years after the date that each assessment is prepared. Part VI requires dissemination of the order now and in the future to persons with responsibilities relating to the subject matter of the order. Part VII ensures notification to the FTC of changes in corporate status. Part VIII mandates that Franklin Toyota submit a compliance report to the FTC within 90 days, and periodically thereafter as requested. Part IX is a provision ‘‘sunsetting’’ the order after twenty (20) years, with certain exceptions. The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way. By direction of the Commission. Richard C. Donohue, Acting Secretary. 35393 GENERAL SERVICES ADMINISTRATION Dated: Dan Tangherlini, Acting Administrator of General Services. [FMR Bulletin–PBS–2012–03; Docket 2012– 0002; Sequence 11] U.S. GENERAL SERVICES ADMINISTRATION Federal Management Regulation; FMR Bulletin PBS–2012–03; Redesignations of Federal Buildings REDESIGNATIONS OF FEDERAL BUILDINGS Public Buildings Service (PBS), General Services Administration (GSA). SUBJECT: Redesignations of Federal Buildings AGENCY: ACTION: Notice of a bulletin. The attached bulletin announces the designation and redesignation of three Federal buildings. Expiration Date: This bulletin announcement expires October 31, 2012. The building designation and redesignations remains in effect until canceled or superseded by another bulletin. SUMMARY: U.S. General Services Administration, Public Buildings Service (PBS), 1800 F Street NW., Washington, DC 20405, telephone number: (202) 501–1100. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2012–14372 Filed 6–12–12; 8:45 am] BILLING CODE 6750–01–P TO: Heads of Federal Agencies 1. What is the purpose of this bulletin? This bulletin announces the designation and redesignation of three Federal buildings. 2. When does this bulletin expire? This bulletin announcement expires October 31, 2012. The building designation and redesignations remain in effect until canceled or superseded by another bulletin. 3. Designation. The name of the designated property (between the United States Federal Courthouse and the Ed Jones Building located at 109 South Highland Avenue in Jackson, Tennessee) is as follows: M.D. Anderson Plaza Jackson, TN 38301 4. Redesignation. The former and new names of the redesignated buildings are as follows: Former name New name United States Courthouse, 80 Lafayette Street, Jefferson City, MO 65101. United States Courthouse, 222 West 7th Avenue, Anchorage, AL 99501. Christopher S. Bond United States Courthouse, 80 Lafayette Street, Jefferson City, MO 65101. James M. Fitzgerald United States Courthouse, 222 West 7th Avenue, Anchorage, AL 99501. 5. Who should we contact for further information regarding redesignation of these Federal buildings? U.S. General Services Administration, Public Buildings Service (PBS), 1800 F Street, NW., Washington, DC 20405, telephone number: (202) 501–1100. Dated: June 7, 2012 Dan Tangherlini, Acting Administrator of General Services. [FR Doc. 2012–14416 Filed 6–12–12; 8:45 am] BILLING CODE 6820–23–P erowe on DSK2VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Division of the National Toxicology Program (DNTP), National Institute of Environmental Health AGENCY: VerDate Mar<15>2010 14:45 Jun 12, 2012 Jkt 226001 Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Availability of Report. The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of the Biennial Progress Report 2010–2011: Interagency Coordinating Committee on the Validation of Alternative Methods. The report was prepared in accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3). The Biennial Progress Report describes activities and progress by NICEATM and ICCVAM during the period from January 2010 through December 2011. During the past two years, NICEATM, ICCVAM, and ICCVAM member agencies contributed to the national and international endorsement and adoption of 14 new and updated alternative safety testing methods. Since ICCVAM was SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 established, NICEATM, ICCVAM, and the ICCVAM member agencies have contributed to the regulatory acceptance of over 50 alternative methods that can be used to protect the health of people, animals, and the environment while reducing, refining, and replacing animal use. The Biennial Progress Report is available on the NICEATM–ICCVAM Web site at https://iccvam.niehs.nih.gov/ about/ICCVAMrpts.htm. Copies can also be requested from NICEATM (see ‘‘ADDRESSES’’). Requests for copies of the report should be sent by mail, fax, or email to 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, (email) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. ADDRESSES: E:\FR\FM\13JNN1.SGM 13JNN1 35394 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Notices Dr. William S. Stokes, NICEATM Director (phone 919–541–2384 or niceatm@niehs.nih.gov). FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background The ICCVAM Authorization Act of 2000 established ICCVAM as a permanent interagency committee of NIEHS under NICEATM. The Act directs ICCVAM to coordinate interagency technical reviews of proposed new, revised, and alternative testing methods, including those that may reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace animal use. ICCVAM prepares test method recommendations based on their scientific validity for regulatory safety testing, and submits these recommendations through the HHS Secretary (or designee) to U.S. Federal Agencies for adoption decisions. A provision of the ICCVAM Authorization Act states that ICCVAM shall prepare ‘‘reports to be made available to the public on its progress under this Act,’’ with the first report to be completed within 12 months of enactment of the Act, and subsequent reports to be made biennially thereafter. The fifth ICCVAM biennial progress report, which summarizes ICCVAM activities and accomplishments for the years 2010 and 2011, is now available. erowe on DSK2VPTVN1PROD with NOTICES Summary of Report Highlights The Biennial Progress Report describes new initiatives and progress by NICEATM and ICCVAM during the period from January 2010 through December 2011. During the past two years, NICEATM, ICCVAM, and ICCVAM member agencies contributed to the national and international endorsement and adoption of 14 new and updated alternative safety testing methods. Since ICCVAM was established, NICEATM, ICCVAM, and the ICCVAM member agencies have contributed to the regulatory acceptance of over 50 alternative methods that can be used to protect and improve the health of people, animals, and the environment while reducing, refining, and replacing animal use. Selected highlights of NICEATM and ICCVAM activities described in the Biennial Progress Report include: • On behalf of NICEATM and ICCVAM, NIEHS signed an amendment to an international cooperation agreement to add the Republic of Korea and its Korean Center for the Validation of Alternative Methods (KoCVAM) to the International Cooperation on VerDate Mar<15>2010 14:45 Jun 12, 2012 Jkt 226001 Alternative Test Methods (ICATM). ICATM was established in 2009 by the United States, the European Union, Japan, and Canada to expedite the worldwide validation and regulatory acceptance of improved alternative test methods. • The Organisation for Economic Cooperation and Development (OECD) adopted an international guidance document prepared by NICEATM and ICCVAM that describes how to use two cytotoxicity assays to reduce animal use for testing required to determine the poisoning potential of chemicals. NICEATM led the international validation studies for the two cytotoxicity assays, which can reduce animal use by up to 50% for each test. • Federal agencies and the OECD adopted several new versions and applications of the murine local lymph node assay (LLNA); an alternative method recommended by ICCVAM to assess whether substances may cause allergic contact dermatitis. The test methods reduce animal use for each test by 20–40% and support expanded use of the LLNA for nearly all testing situations. Two new ‘‘green’’ versions of the LLNA were adopted that do not require radioactive reagents and will allow expanded use of the LLNA in laboratories worldwide. • Federal agencies adopted ICCVAM recommended alternative test methods and procedures that will further reduce, refine, and replace animal use for eye safety testing. These include the routine use of medications to avoid most if not all pain and distress when it is necessary to use animals for required safety testing, and the first in vitro test method that can be used in a ‘‘bottomup’’ approach to identify substances that are not considered eye hazards. • NICEATM, ICCVAM, and their ICATM partners convened the first international workshop on alternative methods for human and veterinary vaccine potency and safety testing. The workshop reviewed the state of the science of alternative methods, and recommended priority research needed to develop improved and more efficient test methods that can also reduce, refine, and replace animal use. A focused workshop on human and veterinary rabies vaccine test methods was held in 2011 and additional focused workshops are planned for 2012 and 2013. • ICCVAM completed international evaluation of an in vitro test method proposed as a screening test to identify substances with potential endocrine activity. The test method uses engineered human cells to identify substances that induce or inhibit PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 activation of the human estrogen receptor. Use of this test method may reduce the number of animals necessary for endocrine disruptor screening. • NICEATM and ICCVAM convened two Best Practices for Regulatory Safety Testing Workshops to promote the use of improved and more efficient test methods that can also reduce, refine, and replace animal use. Participants learned how to select and use approved alternative methods to assess the safety or potential hazards of chemicals and products. 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 (enhance animal wellbeing and lessen 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 and submission of new, revised, and alternative test methods and strategies applicable to the needs of U.S. Federal agencies. Additional information about NICEATM and ICCVAM can be found on the NICEATM–ICCVAM Web site (https:// iccvam.niehs.nih.gov). Dated: June 4, 2012. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2012–14436 Filed 6–12–12; 8:45 am] BILLING CODE 4150–01–P E:\FR\FM\13JNN1.SGM 13JNN1

Agencies

[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35393-35394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Biennial Progress Report of the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM)

AGENCY: Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health (NIH).

ACTION: Availability of Report.

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

SUMMARY: The NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM) announces the availability of the 
Biennial Progress Report 2010-2011: Interagency Coordinating Committee 
on the Validation of Alternative Methods. The report was prepared in 
accordance with requirements of the ICCVAM Authorization Act of 2000 
(42 U.S.C. 285l-3).
    The Biennial Progress Report describes activities and progress by 
NICEATM and ICCVAM during the period from January 2010 through December 
2011. During the past two years, NICEATM, ICCVAM, and ICCVAM member 
agencies contributed to the national and international endorsement and 
adoption of 14 new and updated alternative safety testing methods. 
Since ICCVAM was established, NICEATM, ICCVAM, and the ICCVAM member 
agencies have contributed to the regulatory acceptance of over 50 
alternative methods that can be used to protect the health of people, 
animals, and the environment while reducing, refining, and replacing 
animal use.
    The Biennial Progress Report is available on the NICEATM-ICCVAM Web 
site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can 
also be requested from NICEATM (see ``ADDRESSES'').

ADDRESSES: Requests for copies of the report should be sent by mail, 
fax, or email to 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, (email) 
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 
Davis Drive, Morrisville, NC 27560.

[[Page 35394]]


FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, NICEATM 
Director (phone 919-541-2384 or niceatm@niehs.nih.gov).

SUPPLEMENTARY INFORMATION: 

Background

    The ICCVAM Authorization Act of 2000 established ICCVAM as a 
permanent interagency committee of NIEHS under NICEATM. The Act directs 
ICCVAM to coordinate interagency technical reviews of proposed new, 
revised, and alternative testing methods, including those that may 
reduce, refine (enhance animal well-being and lessen or avoid pain and 
distress), and replace animal use. ICCVAM prepares test method 
recommendations based on their scientific validity for regulatory 
safety testing, and submits these recommendations through the HHS 
Secretary (or designee) to U.S. Federal Agencies for adoption 
decisions.
    A provision of the ICCVAM Authorization Act states that ICCVAM 
shall prepare ``reports to be made available to the public on its 
progress under this Act,'' with the first report to be completed within 
12 months of enactment of the Act, and subsequent reports to be made 
biennially thereafter. The fifth ICCVAM biennial progress report, which 
summarizes ICCVAM activities and accomplishments for the years 2010 and 
2011, is now available.

Summary of Report Highlights

    The Biennial Progress Report describes new initiatives and progress 
by NICEATM and ICCVAM during the period from January 2010 through 
December 2011. During the past two years, NICEATM, ICCVAM, and ICCVAM 
member agencies contributed to the national and international 
endorsement and adoption of 14 new and updated alternative safety 
testing methods. Since ICCVAM was established, NICEATM, ICCVAM, and the 
ICCVAM member agencies have contributed to the regulatory acceptance of 
over 50 alternative methods that can be used to protect and improve the 
health of people, animals, and the environment while reducing, 
refining, and replacing animal use.
    Selected highlights of NICEATM and ICCVAM activities described in 
the Biennial Progress Report include:
     On behalf of NICEATM and ICCVAM, NIEHS signed an amendment 
to an international cooperation agreement to add the Republic of Korea 
and its Korean Center for the Validation of Alternative Methods 
(KoCVAM) to the International Cooperation on Alternative Test Methods 
(ICATM). ICATM was established in 2009 by the United States, the 
European Union, Japan, and Canada to expedite the worldwide validation 
and regulatory acceptance of improved alternative test methods.
     The Organisation for Economic Co-operation and Development 
(OECD) adopted an international guidance document prepared by NICEATM 
and ICCVAM that describes how to use two cytotoxicity assays to reduce 
animal use for testing required to determine the poisoning potential of 
chemicals. NICEATM led the international validation studies for the two 
cytotoxicity assays, which can reduce animal use by up to 50% for each 
test.
     Federal agencies and the OECD adopted several new versions 
and applications of the murine local lymph node assay (LLNA); an 
alternative method recommended by ICCVAM to assess whether substances 
may cause allergic contact dermatitis. The test methods reduce animal 
use for each test by 20-40% and support expanded use of the LLNA for 
nearly all testing situations. Two new ``green'' versions of the LLNA 
were adopted that do not require radioactive reagents and will allow 
expanded use of the LLNA in laboratories worldwide.
     Federal agencies adopted ICCVAM recommended alternative 
test methods and procedures that will further reduce, refine, and 
replace animal use for eye safety testing. These include the routine 
use of medications to avoid most if not all pain and distress when it 
is necessary to use animals for required safety testing, and the first 
in vitro test method that can be used in a ``bottom-up'' approach to 
identify substances that are not considered eye hazards.
     NICEATM, ICCVAM, and their ICATM partners convened the 
first international workshop on alternative methods for human and 
veterinary vaccine potency and safety testing. The workshop reviewed 
the state of the science of alternative methods, and recommended 
priority research needed to develop improved and more efficient test 
methods that can also reduce, refine, and replace animal use. A focused 
workshop on human and veterinary rabies vaccine test methods was held 
in 2011 and additional focused workshops are planned for 2012 and 2013.
     ICCVAM completed international evaluation of an in vitro 
test method proposed as a screening test to identify substances with 
potential endocrine activity. The test method uses engineered human 
cells to identify substances that induce or inhibit activation of the 
human estrogen receptor. Use of this test method may reduce the number 
of animals necessary for endocrine disruptor screening.
     NICEATM and ICCVAM convened two Best Practices for 
Regulatory Safety Testing Workshops to promote the use of improved and 
more efficient test methods that can also reduce, refine, and replace 
animal use. Participants learned how to select and use approved 
alternative methods to assess the safety or potential hazards of 
chemicals and products.

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 (enhance 
animal well-being and lessen 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 and submission of new, 
revised, and alternative test methods and strategies applicable to the 
needs of U.S. Federal agencies. Additional information about NICEATM 
and ICCVAM can be found on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov).

    Dated: June 4, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-14436 Filed 6-12-12; 8:45 am]
BILLING CODE 4150-01-P
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