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Texas; Newton Delaware Financial Organizations (FBOs) in Accessing (NIEHS), National Institutes of Health
Corporation, Dover, Delaware; and Grants study will identify perceived or (NIH).
CountyBank, National Association, underlying barriers faith-based ACTION: Request for comments,
Newton, Texas. organizations may face in applying for submission of relevant data, and
In connection with this application, federal discretionary grants, as well as nominations of scientific experts.
CBFH, Inc., Beaumont, Texas, also has identify the strategies and approaches
applied to become a bank holding used by successful applicants. The data SUMMARY: The Interagency Coordinating
company by acquiring 100 percent of gathered will help Health and Human Committee on the Validation of
the voting shares of County Bancshares, Services understand the effectiveness of Alternative Methods (ICCVAM) received
Inc., Newton, Texas, and thereby its past internal efforts to ensure that a nomination from the U.S. Consumer
indirectly acquire voting shares of FBOs had equal access to grants, and Product Safety Commission (CPSC) to
Newton Delaware Financial whether additional steps should be evaluate the validation status of: (1) The
Corporation, Dover, Delaware, and considered. Additionally, this study murine local lymph node assay (LLNA)
CountyBank, National Association, should provide future FBO grant as a stand-alone assay for determining
Newton, Texas. applicants, as well as other nonprofit potency (including severity) for the
Board of Governors of the Federal Reserve organizations, information that could be purpose of hazard classification; (2) the
System, May 11, 2007. used to improve the quality of their ‘‘cut-down’’ or ‘‘limit dose’’ LLNA
Jennifer J. Johnson, grant applications and their capacity to approach; (3) non-radiolabeled LLNA
Secretary of the Board. seek federal funding. methods; (4) the use of the LLNA for
[FR Doc. E7–9441 Filed 5–17–07; 8:45 am]
Frequency: Single time. testing mixtures, aqueous solutions, and
Affected Public: Not-for-profit metals; and (5) the current applicability
BILLING CODE 6210–01–S
institutions. domain (i.e., the types of chemicals and
Annual Number of Respondents: 290. substances for which the LLNA has
Total Annual Responses: 290. been validated). ICCVAM reviewed the
DEPARTMENT OF HEALTH AND nomination, assigned it a high priority,
Average Burden Per Response: 35.2
HUMAN SERVICES and proposed that NICEATM and
minutes.
Office of the Secretary Total Annual Hours: 170. ICCVAM carry out the following
To obtain copies of the supporting activities in its evaluation: (1) Initiate a
[Document Identifier: OS–0990–0000] statement and any related forms for the review of the current literature and
proposed paperwork collections available data, including the preparation
30-Day Notice of a comprehensive background review
referenced above, e-mail your request,
AGENCY: Office of the Secretary, HHS. including your address, phone number, document, and (2) convene a peer
ACTION: Agency information collection OMB number, and OS document review panel to review the various
activities: proposed collection; comment identifier, to proposed LLNA uses and procedures for
request. Sherette.funncoleman@hhs.gov, or call which sufficient data and information
the Reports Clearance Office on (202) are available to adequately assess their
In compliance with the requirement 690–6162. Written comments and validation status. ICCVAM also
of section 3506(c)(2)(A) of the recommendations for the proposed recommends development of
Paperwork Reduction Act of 1995, the information collections must be performance standards for the LLNA. At
Office of the Secretary (OS), Department received within 30 days of this notice this time, NICEATM requests: (1) Public
of Health and Human Services, is directly to the Desk Officer at the comments on the appropriateness and
publishing the following summary of a address below: relative priority of these activities, (2)
proposed collection for public OMB Desk Officer: John Kraemer, nominations of expert scientists to
comment. Interested persons are invited OMB Human Resources and Housing consider as members of a possible peer
to send comments regarding this burden Branch, Attention: (OMB #0990–0000), review panel, and (3) submission of data
estimate or any other aspect of this New Executive Office Building, Room for the LLNA and/or modified versions
collection of information, including any 10235, Washington DC 20503. of the LLNA.
of the following subjects: (1) The Dated: May 10, 2007. DATES: Submit comments, data, and
necessity and utility of the proposed nominations by June 15, 2007. Relevant
Alice Bettencourt,
information collection for the proper data will also be accepted after this date
performance of the agency’s functions; Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer. and considered when feasible.
(2) the accuracy of the estimated
[FR Doc. E7–9529 Filed 5–16–07; 8:45 am] ADDRESSES: Dr. William S. Stokes,
burden; (3) ways to enhance the quality,
BILLING CODE 4154–07–P NICEATM Director, NIEHS, P.O. Box
utility, and clarity of the information to
12233, MD EC–17, Research Triangle
be collected; and (4) the use of
Park, NC 27709, (fax) 919–541–0947,
automated collection techniques or
DEPARTMENT OF HEALTH AND (e-mail) niceatm@niehs.nih.gov. Courier
other forms of information technology to
HUMAN SERVICES address: NICEATM, 79 T.W. Alexander
minimize the information collection
Drive, Building 4401, Room 3128,
burden. National Toxicology Program (NTP) Research Triangle Park, NC 27709.
Type of Information Collection Interagency Center for the Evaluation Responses can be submitted
Request: New collection. of Alternative Toxicological Methods electronically at the ICCVAM–
Title of Information Collection: (NICEATM); the Murine Local Lymph NICEATM Web site: http://
Understanding Barriers and Successful
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27816 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Notices
directed to Dr. William S. Stokes (919– nominated activities will move forward will also be included in a database to
541–2384 or niceatm@niehs.nih.gov). will be made subsequent to this review support the investigation of other test
SUPPLEMENTARY INFORMATION: and after consideration of comments by methods for assessing skin sensitization.
the public and the Scientific Advisory When submitting chemical and
Background Committee on Alternative Toxicological protocol information/test data, please
ICCVAM previously evaluated the Methods (SACATM). If a decision is reference this Federal Register notice
validation status of the LLNA as a stand- made to proceed with evaluation of and provide appropriate contact
alone alternative method to the Guinea these test methods, ICCVAM and information (name, affiliation, mailing
Pig Maximization Test (GPMT) and the NICEATM propose convening a peer address, phone, fax, e-mail, and
Buehler Assay (NIH publication No. 99– review panel to review the usefulness sponsoring organization, as applicable).
4494; available at http:// and limitations of each of the LLNA NICEATM prefers data to be
iccvam.niehs.nih.gov/methods/ methods listed above. The panel would submitted as copies of pages from study
immunotox/llna.htm). Based on this also formulate conclusions on the notebooks and/or study reports, if
evaluation, ICCVAM recommended the adequacy of draft ICCVAM performance available. Raw data and analyses
LLNA as a valid substitute for the standards, any proposed future available in electronic format may also
guinea pig methods for most testing validation studies, and draft ICCVAM- be submitted. Each submission for a
situations. The Environmental proposed standardized test method chemical should preferably include the
Protection Agency, Food and Drug protocols. following information, as appropriate:
Administration, and the CPSC • Common and trade name.
Request for Public Comments and
subsequently accepted the method as a • Chemical Abstracts Service Registry
Nominations of Scientific Experts
valid substitute. The OECD also adopted Number (CASRN).
the LLNA as OECD Test Guideline 429. NICEATM requests public comments
• Chemical class.
In January 2007, the CPSC submitted on the appropriateness and relative
priority of the nominated activities. • Product class.
a nomination to NICEATM (http://
NICEATM also requests the • Commercial source.
iccvam.niehs.nih.gov/SuppDocs/
submission.htm) requesting that nominations of scientists with relevant • LLNA protocol used.
ICCVAM assess the validation status of: knowledge and experience to serve on • Individual animal responses.
• The LLNA as a stand-alone test for the panel if a panel meeting occurs. • The extent to which the study
potency determinations (including Areas of relevant expertise include, but complied with national or international
severity) for the purpose of hazard are not limited to: physiology, Good Laboratory Practice (GLP)
classification. pharmacology, immunology, skin guidelines.
• LLNA protocols that do not require sensitization testing in animals, • Date and testing organization.
the use of radioactive materials. development and use of in vitro • Sensitization data from other test
• The LLNA ‘‘cut-down’’ or ‘‘limit methodologies, biostatistics, knowledge methods.
dose’’ procedure. about the use of chemical datasets for Consideration by SACATM
• The ability of the LLNA to test validation of toxicity studies, and
mixtures, aqueous solutions, and hazard classification of chemicals and On June 12, 2007, SACATM will meet
metals. products. Each nomination should at the Marriott Bethesda North Hotel
• The current applicability domain include the person’s name, affiliation, and Conference Center in Bethesda,
(i.e., the types of chemicals and contact information (i.e., mailing Maryland. The agenda includes
substances for which the LLNA has address, e-mail address, telephone and consideration of the nominated LLNA
been determined to be useful). fax numbers), curriculum vitae, and a activities, priorities, and proposed
Since 2003, ICCVAM has routinely brief summary of relevant experience activities http://ntp.niehs.nih.gov/go/
developed performance standards for and qualifications. 7441) and an opportunity for oral public
test methods; however, they were not comments. The SACATM meeting was
developed for the LLNA, which was Request for Data announced in a separate Federal
reviewed in 1999. Accordingly, NICEATM invites the submission of Register notice (Federal Register Vol.
ICCVAM proposes to now develop data from standard LLNA testing (i.e., 72, No. 83, pp. 23831–32, May 1, 2007).
performance standards for the LLNA. OECD TG 429) with mixtures, aqueous
Performance standards communicate solutions, and/or metals, as well as Background Information on ICCVAM
the basis by which new proprietary and corresponding data from human and and NICEATM
nonproprietary test methods have been other animal studies. In addition, ICCVAM is an interagency committee
determined to have sufficient relevance NICEATM invites the submission of composed of representatives from 15
and reliability for specific testing data supporting the use of (1) the LLNA federal regulatory and research agencies
purposes. Performance standards based as a stand-alone test for determining that use or generate toxicological
on test methods accepted by regulatory potency (including severity) for the information. ICCVAM conducts
agencies can be used to evaluate the purpose of hazard classification, (2) the technical evaluations of new, revised,
reliability and relevance of other test LLNA ‘‘cut-down’’ or ‘‘limit dose’’ and alternative methods with regulatory
methods that are based on similar procedure, and (3) LLNA protocols that applicability and promotes the scientific
scientific principles and measure or do not require the use of radioactivity. validation and regulatory acceptance of
predict the same biological or toxic Although data can be accepted at any toxicological test methods that more
effect. On January 24, 2007, ICCVAM time, data submitted by June 15, 2007, accurately assess the safety and hazards
unanimously endorsed with a high will be considered during the ICCVAM of chemicals and products and that
priority: (1) Developing performance evaluation process. Submitted data will refine, reduce, or replace animal use.
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standards for the LLNA and (2) be used to further evaluate the The ICCVAM Authorization Act of 2000
initiating a review of the available data usefulness and limitations of the LLNA (42 U.S.C. 285l–3, available at http://
and information associated with the and may be incorporated into future iccvam.niehs.nih.gov/about/
CPSC nominated activities. A NICEATM and ICCVAM reports and PL106545.htm) establishes ICCVAM as a
determination of which (if any) of the publications as appropriate. The data permanent interagency committee of the
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Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Notices 27817
NIEHS under NICEATM. NICEATM authority to sign Federal Register notices Dated: May 10, 2007.
administers ICCVAM and provides pertaining to announcements of meetings and Elaine L. Baker,
scientific and operational support for other committee management activities, for
both CDC and the Agency for Toxic Acting Director, Management Analysis and
ICCVAM-related activities. NICEATM Substances and Disease Registry. Services Office, Centers for Disease Control
and ICCVAM work collaboratively to and Prevention.
evaluate new and improved test Dated: May 10, 2007.
[FR Doc. E7–9479 Filed 5–16–07; 8:45 am]
methods applicable to the needs of Elaine L. Baker,
BILLING CODE 4163–18–P
federal agencies. Additional information Acting Director, Management Analysis and
about ICCVAM and NICEATM is Services Office, Centers for Disease Control
available on the following Web site: and Prevention.
[FR Doc. E7–9498 Filed 5–16–07; 8:45 am]
DEPARTMENT OF HEALTH AND
http://iccvam.niehs.nih.gov. HUMAN SERVICES
BILLING CODE 4163–18–P
Dated: May 8, 2007.
David A. Schwartz, National Institutes of Health
Director, National Institute of Environmental DEPARTMENT OF HEALTH AND
Health Sciences and National Toxicology Proposed Collection; Comment
HUMAN SERVICES
Program. Request; Physicians’ Experience of
[FR Doc. E7–9544 Filed 5–16–07; 8:45 am] Centers for Disease Control and Ethical Dilemmas and Resource
BILLING CODE 4140–01–P Prevention Allocation
For Further Information Contact: Trudy authority to sign Federal Register notices Frequency of Response: Once.
Messmer, Ph.D., Designated Federal Official, pertaining to announcements of meetings and Affected Public: Individuals or
1600 Clifton Road, Mailstop C–19, Atlanta, other committee management activities, for households; Businesses or other for-
GA 30333, telephone (404) 639–3770. both the Centers for Disease Control and
The Director, Management Analysis and Prevention and the Agency for Toxic
profit; Not-for-profit institutions.
Services Office, has been delegated the Substances and Disease Registry. Type of Respondents: Physicians.
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