National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies Using Standardized Testing Methods, 31582-31583 [E7-10966]

Download as PDF 31582 Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than June 22, 2007. A. Federal Reserve Bank of Atlanta (David Tatum, Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30309: 1. Heys Edward McMath, III, Savannah, Georgia; to retain voting shares of First National Corporation, and thereby indirectly retain voting shares of First National Bank, both of Savannah, Georgia. B. Federal Reserve Bank of St. Louis (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: 1. Wilson–Gardner Family Control Group, Jackson, Mississippi, which consists of Fred Gillaspy Wilson, individually and as trustee of the Gardner Trust, Jackson, Mississippi; Rufus K. Gardner, Winona, Mississippi, and Joseph E. Gardner, Austin, Texas, as trustees of the Gardner Trust; Alice King Harrison, Forrest City, Arkansas; John Frederick Wilson, Jackson, Mississippi; Margaret Gardner Wilson, Ridgeland, Mississippi; Margaret Wilson Ethridge, Madison, Mississippi; Ermis King Wilson, Sterlington, Louisiana; Edna Earl Douglas, Memphis, Tennessee; Alison Wilson Page, Sterlington, Louisiana; and Ermis M. Wilson, Sterlington, Louisiana; to retain control of Commerce Bancorp, Inc., and thereby indirectly retain voting shares of Bank of Commerce, both of Greenwood, Mississippi. Board of Governors of the Federal Reserve System, June 4, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7–11009 Filed 6–6–07; 8:45 am] BILLING CODE 6210–01–S The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 3, 2007. A. Federal Reserve Bank of Richmond (A. Linwood Gill, III, Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528: 1. Bank of America Corporation, Charlotte, North Carolina; to acquire 100 percent of the voting shares of ABN AMRO North America Holding Company, Chicago, Illinois, and thereby indirectly acquire voting shares of LaSalle Bank Corporation, Chicago, Illinois; LaSalle Bank Midwest National Assocation, Troy, Michigan; and LaSalle Bank National Association, Chicago, Illinois. Board of Governors of the Federal Reserve System, June 1, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7–10916 Filed 6–6–07; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM rwilkins on PROD1PC63 with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies DEPARTMENT OF HEALTH AND HUMAN SERVICES The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies Using Standardized Testing Methods VerDate Aug<31>2005 20:59 Jun 06, 2007 Jkt 211001 National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for submission of relevant data. AGENCY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM are collaborating with the European Centre for the Validation of Alternative Methods (ECVAM) to evaluate the validation status of in vitro test methods for assessing the ocular irritation potential of substances. On behalf of the ICCVAM, NICEATM requests data on substances tested for ocular irritancy in humans, rabbits, and/ or in vitro. These data will be used to: (1) Review the state-of-the-science in regard to the availability of accurate and reliable in vitro test methods for assessing the range of potential ocular irritation activity, including whether ocular damage is reversible or not and (2) expand NICEATM’s high-quality ocular toxicity database. In vitro test methods for which data are sought include, but are not limited to: (1) The Bovine Corneal Opacity and Permeability (BCOP) test, (2) the Isolated Rabbit Eye (IRE) test, (3) the Isolated Chicken Eye (ICE) test, and (4) the Hen’s Egg Test—Chorioallantoic Membrane (HET–CAM). DATES: Data should be received by July 23, 2007. Data received after this date will be considered as feasible. ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC–17, Research Triangle Park, NC 27709, (fax) 919–541–0947, (email) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. Responses can be submitted electronically at the ICCVAM– NICEATM Web site: https:// iccvam.niehs.nih.gov/contact/ FR_pubcomment.htm or by e-mail, mail, or fax. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes (919– 541–2384 or niceatm@niehs.nih.gov). SUPPLEMENTARY INFORMATION: Background In October 2003, the U.S. Environmental Protection Agency (EPA) submitted to ICCVAM a nomination with several activities related to reducing, replacing, and refining the use of rabbits in the current in vivo eye irritation test method (Federal Register Vol. 69, No. 57, pp 13859–13861, March 24, 2004). In response to this nomination, ICCVAM completed an evaluation of the validation status of the BCOP, ICE, IRE, and HET–CAM test methods for identifying severe (irreversible) ocular irritants/corrosives using the United Nations Globally E:\FR\FM\07JNN1.SGM 07JNN1 Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices rwilkins on PROD1PC63 with NOTICES Harmonized System of Classification and Labeling of Chemicals (GHS), the EPA, and the European Union hazard classification systems. NICEATM and ICCVAM prepared a comprehensive background review document (BRD) on each of the four in vitro test methods. Each BRD included an analysis of test method performance (i.e., reliability and relevance) as compared to the in vivo rabbit eye reference test method, based on all available data. ICCVAM developed recommendations on the usefulness and limitations of these in vitro test methods for identifying ocular corrosives/severe irritants after considering the BRDs, comments received from the public and the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), and comments and recommendations received from an independent expert panel (Federal Register Vol. 70, No. 53, pp 13513– 13514, March 21, 2005 and Vol. 70, No. 211, p 66451, November 2, 2005). ICCVAM is now reviewing the validation status of these and other in vitro test methods for identifying nonsevere ocular irritants (i.e., those that induce reversible ocular damage) and non-irritants. Request for Data As part of the review process, NICEATM requests the submission of data from substances tested for ocular irritancy in humans, rabbits, and/or in vitro. Data received by July 23, 2007 will be compiled and added to the database maintained by NICEATM and utilized where appropriate in the evaluation of in vitro ocular irritation test methods. Data received after this date will also be considered and used where applicable for future evaluation activities. All information submitted in response to this notice will be made publicly available upon request to NICEATM. When submitting substance and protocol information/test data, please reference this Federal Register notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from study notebooks and/or study reports, if available. Raw data and analyses available in electronic format may also be submitted. Each submission for a substance should preferably include the following information, as appropriate: • Common and trade name. • Chemical Abstracts Service Registry Number (CASRN). • Chemical and/or product class. • Commercial source. VerDate Aug<31>2005 20:59 Jun 06, 2007 Jkt 211001 • In vitro test protocol used. • Rabbit eye test protocol used. • Human eye test protocol used. • Individual animal/human or in vitro responses at each observation time (i.e., raw data). • The extent to which the study complied with national/international Good Laboratory Practice (GLP) guidelines. • Date and testing organization. Additional information on the submission of data may be obtained at https://iccvam.niehs.nih.gov/methods/ ocutox/ivocutox.htm. Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3, available at https:// iccvam.niehs.nih.gov/docs/about_docs/ PL106545.pdf) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of federal agencies. Additional information about ICCVAM and NICEATM is available on the following Web site: https://iccvam.niehs.nih.gov. Dated: May 25, 2007. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7–10966 Filed 6–6–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institution for Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board) Correction: This notice was published in the Federal Register on May 22, PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 31583 2007, Volume 72, Number 98, pages 28697–28698. The meeting was originally scheduled to be held at the Westin Westminster Hotel. The Committee will now convene at the Sheraton Denver West Hotel, 360 Union Boulevard, Lakewood, Colorado 80228, Phone 303.987.2000, Fax 303.969.0263. Times and Dates: 9 a.m.–5 p.m., June 11, 2007. 8 a.m.–3 p.m., June 12, 2007. Contact Person for More Information: Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226, Telephone 513.533.6825, Fax 513.533.6826. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 31, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7–10987 Filed 6–6–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D–0466] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 9, 2007. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. All comments should be ADDRESSES: E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31582-31583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10966]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Request for 
Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies 
Using Standardized Testing Methods

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Request for submission of relevant data.

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

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and NICEATM are collaborating with the 
European Centre for the Validation of Alternative Methods (ECVAM) to 
evaluate the validation status of in vitro test methods for assessing 
the ocular irritation potential of substances. On behalf of the ICCVAM, 
NICEATM requests data on substances tested for ocular irritancy in 
humans, rabbits, and/or in vitro. These data will be used to: (1) 
Review the state-of-the-science in regard to the availability of 
accurate and reliable in vitro test methods for assessing the range of 
potential ocular irritation activity, including whether ocular damage 
is reversible or not and (2) expand NICEATM's high-quality ocular 
toxicity database. In vitro test methods for which data are sought 
include, but are not limited to: (1) The Bovine Corneal Opacity and 
Permeability (BCOP) test, (2) the Isolated Rabbit Eye (IRE) test, (3) 
the Isolated Chicken Eye (ICE) test, and (4) the Hen's Egg Test--
Chorioallantoic Membrane (HET-CAM).

DATES: Data should be received by July 23, 2007. Data received after 
this date will be considered as feasible.

ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 
12233, MD EC-17, Research Triangle Park, NC 27709, (fax) 919-541-0947, 
(e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W. 
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 
27709. Responses can be submitted electronically at the ICCVAM-NICEATM 
Web site: https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm or by 
e-mail, mail, or fax.

FOR FURTHER INFORMATION CONTACT: Other correspondence should be 
directed to Dr. William S. Stokes (919-541-2384 or 
niceatm@niehs.nih.gov).

SUPPLEMENTARY INFORMATION:

Background

    In October 2003, the U.S. Environmental Protection Agency (EPA) 
submitted to ICCVAM a nomination with several activities related to 
reducing, replacing, and refining the use of rabbits in the current in 
vivo eye irritation test method (Federal Register Vol. 69, No. 57, pp 
13859-13861, March 24, 2004). In response to this nomination, ICCVAM 
completed an evaluation of the validation status of the BCOP, ICE, IRE, 
and HET-CAM test methods for identifying severe (irreversible) ocular 
irritants/corrosives using the United Nations Globally

[[Page 31583]]

Harmonized System of Classification and Labeling of Chemicals (GHS), 
the EPA, and the European Union hazard classification systems. NICEATM 
and ICCVAM prepared a comprehensive background review document (BRD) on 
each of the four in vitro test methods. Each BRD included an analysis 
of test method performance (i.e., reliability and relevance) as 
compared to the in vivo rabbit eye reference test method, based on all 
available data. ICCVAM developed recommendations on the usefulness and 
limitations of these in vitro test methods for identifying ocular 
corrosives/severe irritants after considering the BRDs, comments 
received from the public and the Scientific Advisory Committee on 
Alternative Toxicological Methods (SACATM), and comments and 
recommendations received from an independent expert panel (Federal 
Register Vol. 70, No. 53, pp 13513-13514, March 21, 2005 and Vol. 70, 
No. 211, p 66451, November 2, 2005).
    ICCVAM is now reviewing the validation status of these and other in 
vitro test methods for identifying nonsevere ocular irritants (i.e., 
those that induce reversible ocular damage) and non-irritants.

Request for Data

    As part of the review process, NICEATM requests the submission of 
data from substances tested for ocular irritancy in humans, rabbits, 
and/or in vitro. Data received by July 23, 2007 will be compiled and 
added to the database maintained by NICEATM and utilized where 
appropriate in the evaluation of in vitro ocular irritation test 
methods. Data received after this date will also be considered and used 
where applicable for future evaluation activities. All information 
submitted in response to this notice will be made publicly available 
upon request to NICEATM.
    When submitting substance and protocol information/test data, 
please reference this Federal Register notice and provide appropriate 
contact information (name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization, as applicable).
    NICEATM prefers data to be submitted as copies of pages from study 
notebooks and/or study reports, if available. Raw data and analyses 
available in electronic format may also be submitted. Each submission 
for a substance should preferably include the following information, as 
appropriate:
     Common and trade name.
     Chemical Abstracts Service Registry Number (CASRN).
     Chemical and/or product class.
     Commercial source.
     In vitro test protocol used.
     Rabbit eye test protocol used.
     Human eye test protocol used.
     Individual animal/human or in vitro responses at each 
observation time (i.e., raw data).
     The extent to which the study complied with national/
international Good Laboratory Practice (GLP) guidelines.
     Date and testing organization.
    Additional information on the submission of data may be obtained at 
https://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 federal regulatory and research agencies that use or generate 
toxicological information. ICCVAM conducts technical evaluations of 
new, revised, and alternative methods with regulatory applicability and 
promotes the scientific validation and regulatory acceptance of 
toxicological test methods that more accurately assess the safety and 
hazards of chemicals and products and that refine, reduce, or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, 
available at https://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) 
established ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers the ICCVAM and provides scientific 
and operational support for ICCVAM-related activities. NICEATM and 
ICCVAM work collaboratively to evaluate new and improved test methods 
applicable to the needs of federal agencies. Additional information 
about ICCVAM and NICEATM is available on the following Web site: http:/
/iccvam.niehs.nih.gov.

    Dated: May 25, 2007.
Samuel H. Wilson,
Deputy Director,National Institute of Environmental Health Sciences and 
National Toxicology Program.
 [FR Doc. E7-10966 Filed 6-6-07; 8:45 am]
BILLING CODE 4140-01-P
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