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60748 Federal Register / Vol. 71, No.

199 / Monday, October 16, 2006 / Notices

December 14, 1998 (Volume 63, Number a test method nomination for the for validation studies. A request was
239, page 68782)]. The CERHR is a validation of a cell-based estrogen made for nominations of validation
publicly accessible resource for receptor (ER) transcriptional activation studies for in vitro ER and AR binding
information about adverse reproductive (TA) test method from CertiChem, Inc. and TA test methods based on these
and/or developmental health effects CertiChem, Inc. submitted a background recommendations and for which there
associated with exposure to review document (BRD) containing are standardized test method protocols,
environmental and/or occupational information on historical development pre-validation data, and proposed
exposures. Expert panels conduct of the test method, the rationale for the validation study designs (69 FR 21564).
scientific evaluations of agents selected test method, and supporting materials. ICCVAM subsequently received a
by the CERHR in public forums. In accordance with the ICCVAM nomination from CertiChem, Inc. for the
The CERHR invites the nomination of nomination process, NICEATM validation of a cell-based ER TA method
agents for review or scientists for its conducted a pre-screen evaluation of the that evaluates the estrogenic activity of
expert registry. Information about BRD to determine the extent that it substances by measuring whether and to
CERHR and the nomination process can addressed ICCVAM prioritization what extent a substance induces cell
be obtained from its homepage (http:// criteria, submission guidelines, and proliferation via ER-dependent
cerhr.niehs.nih.gov) or by contacting Dr. recommendations for standardization pathways. In support of this
Shelby (see FOR FURTHER INFORMATION and validation of in vitro endocrine nomination, ICCVAM received a BRD
CONTACT above). The CERHR selects disruptor test methods. NICEATM also containing information on the test
chemicals for evaluation based upon reviewed the performance of the test method’s historical development, its
several factors including production method based on pre-validation data to rationale, its protocol, and other
volume, potential for human exposure determine if it warranted consideration supporting materials. In accordance
from use and occurrence in the for further validation. ICCVAM requests with the ICCVAM nomination process,
environment, extent of public concern, public comments on the pre-screen NICEATM conducted a pre-screen
and extent of data from reproductive evaluation titled, ‘‘Pre-Screen evaluation of the BRD to determine the
and developmental toxicity studies. Evaluation of the CertiChem, Inc. In extent that it addressed ICCVAM
CERHR follows a formal, multi-step Vitro Endocrine Disruptor Assay prioritization criteria, submission
process for review and evaluation of (Robotic MCF–7 Cell Proliferation Assay guidelines, and recommendations for
selected chemicals. The formal of Estrogenic Activity.)’’ The pre-screen standardization and validation of in
evaluation process was published in the evaluation is available with supporting vitro endocrine disruptor test methods.
Federal Register on July 16, 2001 documents at (http:// NICEATM also reviewed the
(Volume 66, Number 136, pages 37047– iccvam.niehs.nih.gov/methods/ performance of the proposed test
37048) and is available on the CERHR endocrine.htm). ICCVAM also invites method based on pre-validation data to
Web site under ‘‘About CERHR’’ or in public comments on whether this test determine if it warranted consideration
printed copy from the CERHR. method should be considered for for further validation. The BRD was
additional validation studies. In reviewed for completeness and to
Dated: October 5, 2006.
addition, ICCVAM again invites the identify aspects or omissions that could
Samuel H. Wilson, impede further review. The criteria
nomination of other in vitro ER and
Deputy Director, National Institute of considered in evaluating information
androgen receptor (AR) binding and TA
Environmental Health Sciences and National provided in the BRD are:
Toxicology Program. test methods for which there are
standardized test method protocols, pre- • The extent to which the BRD
[FR Doc. E6–17137 Filed 10–13–06; 8:45 am] addresses ICCVAM prioritization
validation data, and proposed validation
BILLING CODE 4140–01–P
study designs. criteria.
• The extent to which the BRD
DATES: Comments and nominations
provides the information requested in
DEPARTMENT OF HEALTH AND should be received by November 30,
the ICCVAM Guidelines for the
HUMAN SERVICES 2006.
Nomination and Submission of New,
ADDRESSES: Correspondence should be Revised, and Alternative Test Methods
National Institutes of Health sent by mail, fax, or e-mail to Dr. (NIH Pub. No. 03–4508, available at
William S. Stokes, NICEATM Director, http://iccvam.niehs.nih.gov).
National Toxicology Program (NTP),
NIEHS, P.O. Box 12233, MD EC–17, • The extent to which the proposed
NTP Interagency Center for the
Research Triangle Park, NC 27709, test method adheres to the
Evaluation of Alternative Toxicological
(phone) 919–541–2384, (fax) 919–541– recommendations of the ICCVAM
Methods (NICEATM); Notice of
0947, (e-mail) niceatm@niehs.nih.gov. Evaluation of In Vitro Test Methods for
Availability of the NICEATM Pre-Screen
SUPPLEMENTARY INFORMATION: Detecting Potential Endocrine
Evaluation of a Cell Proliferation Assay
Disruptors (NIH Pub. No. 03–4503,
To Detect Estrogenic Activity: Request Background
available at http://iccvam.niehs.nih.gov/
for Comments and Nominations of In May 2003, ICCVAM published the methods/endocrine.htm), especially
Other In Vitro Endocrine Disruptor Test report, ‘‘ICCVAM Evaluation of In Vitro those regarding essential test method
Methods Test Methods for Detecting Potential components and recommended
AGENCY: National Institute of Endocrine Disruptors: Estrogen Receptor validation substances.
Environmental Health Sciences and Androgen Receptor Binding and • The extent to which the proposed
(NIEHS), National Institutes of Health Transcriptional Activation Assays (NIH test method shows adequate
(NIH), HHS. Publication No. 03–4503; available: performance (reliability and accuracy)
ACTION: Report availability and request http://iccvam.niehs.nih.gov/methods/ during pre-validation to warrant
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for comments and nominations. endocrine.htm). The report recommends consideration for validation studies.
minimum procedural standards that Based on the pre-screen evaluation,
SUMMARY: In January 2006, the should be incorporated in standardized ICCVAM made a draft recommendation
Interagency Coordinating Committee on test method protocols and minimum that this test method be considered as a
Alternative Methods (ICCVAM) received lists of chemicals that should be used high priority for validation studies to

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Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices 60749

evaluate its usefulness and limitations NICEATM can be found at the following et seq.), an agency may not conduct or
for detecting substances with in vitro Web site: http://iccvam.niehs.nih.gov. sponsor, and a person is not required to
estrogenic agonist and antagonist Dated: October 5, 2006. respond to, a collection of information
activity, and that standardization of an Samuel H. Wilson,
unless it displays a valid OMB control
anti-estrogenic protocol be developed number. Therefore, in preparation for
Deputy Director, National Institute of
prior to starting the main validation OMB review and approval of the
Environmental Health Sciences and National
effort. ICCVAM will finalize its Toxicology Program. following information collection, TSA is
recommendations on the priority for soliciting comments to—
[FR Doc. E6–17134 Filed 10–13–06; 8:45 am]
future validation of this test method (1) Evaluate whether the proposed
BILLING CODE 4140–01–P
after considering comments received information requirement is necessary for
from the public and the Scientific the proper performance of the functions
Advisory Committee on Alternative of the agency, including whether the
Toxicological Methods (SACATM) at DEPARTMENT OF HOMELAND information will have practical utility;
their November 30, 2006 meeting. SECURITY (2) Evaluate the accuracy of the
ICCVAM also takes this opportunity agency’s estimate of the burden;
Transportation Security Administration (3) Enhance the quality, utility, and
to again invite the nomination of other
clarity of the information to be
in vitro ER and AR binding and TA test New Agency Information Collection collected; and
methods for which there are Activity Under OMB Review: National (4) Minimize the burden of the
standardized test method protocols, pre- Explosives Detection Canine Team collection of information on those who
validation data, and proposed validation Program (NEDCTP), Training Course are to respond, including using
study designs (see also 69 FR 21564). Feedback Forms appropriate automated, electronic,
When submitting written comments mechanical, or other technological
AGENCY: Transportation Security
and nominations please refer to this collection techniques or other forms of
Administration, DHS.
Federal Register notice and include information technology.
appropriate contact information (name, ACTION: Notice.
affiliation, mailing address, phone, fax, Information Collection Requirement
SUMMARY: This notice announces that
e-mail and sponsoring organization, if the Transportation Security Title: National Explosives Detection
applicable). All comments received by Administration (TSA) has forwarded the Canine Team Program (NEDCTP),
the deadline listed above will be placed new Information Collection Request Training Course Feedback Forms.
on the ICCVAM/NICEATM Web site and (ICR) abstracted below to the Office of Type of Request: New collection.
made available to ICCVAM. In addition, OMB Control Number: Not yet
Management and Budget (OMB) for
there will be an opportunity for oral assigned.
review and approval under the
public comments on the draft ICCVAM Form(s): Training Course Feedback
Paperwork Reduction Act. The ICR
pre-screen evaluation during a meeting Forms.
describes the nature of the information Affected Public: Canine course
of the SACATM scheduled for collection and its expected burden. TSA
November 30, 2006. Details of the participants.
published a Federal Register notice, Abstract: The National Explosives
SACATM meeting are published as a with a 60-day comment period soliciting
separate Federal Register notice (see Detection Canine Team Program
comments, of the following collection of (NEDCTP) is a component of TSA’s
http://ntp.niehs.nih.gov/go/frn for the information on August 9, 2006, 71 FR
Federal Register notice citation). Office of Law Enforcement/Federal Air
45573. Marshal Service and is a cooperative
Background Information on ICCVAM DATES: Send your comments by partnership with participating airports
and NICEATM November 15, 2006. A comment to OMB and mass transit systems. TSA provides
ICCVAM is an interagency committee is most effective if OMB receives it and trains the canines, and provides in-
composed of representatives from 15 within 30 days of publication. depth training for the handlers. TSA
Federal regulatory and research agencies ADDRESSES: Interested persons are also partially reimburses the
that use or generate toxicological invited to submit written comments on participating agency for costs associated
information. ICCVAM conducts the proposed information collection to with the teams, such as salaries,
technical evaluations of new, revised, the Office of Information and Regulatory overtime, canine food, and veterinary
and alternative methods with regulatory Affairs, Office of Management and care. Following training, TSA requests
applicability and promotes the scientific Budget. Comments should be addressed that handlers and supervisors complete
validation and regulatory acceptance of to Nathan Lesser, Desk Officer, TSA’s Training Course Feedback Form.
toxicological test methods that more Department of Homeland Security/TSA, TSA will use the feedback results to
accurately assess the safety and hazards and sent via electronic mail to continuously evaluate the quality of
of chemicals and products and that oira_submission@omb.eop.gov or faxed training, improve the course curriculum
refine, reduce, or replace animal use. to (202) 395–6974. and course of instruction, as well as
The ICCVAM Authorization Act of 2000 FOR FURTHER INFORMATION CONTACT: obtain new ideas, best practices, and
(42 U.S.C. 285) established ICCVAM as Katrina Kletzly, Attorney-Advisor, insight on the overall canine training
a permanent interagency committee of Office of the Chief Counsel, TSA–2, program.
the NIEHS under the NICEATM. Transportation Security Administration, Number of Respondents: 150.
Estimated Annual Burden Hours: An
NICEATM administers the ICCVAM and 601 South 12th Street, Arlington, VA
estimated 150 hours annually.
provides scientific and operational 22202–4220; telephone (571) 227–1995;
support for ICCVAM-related activities. facsimile (571) 227–1381. Issued in Arlington, Virginia, on October
jlentini on PROD1PC65 with NOTICES

NICEATM and ICCVAM work 10, 2006.


SUPPLEMENTARY INFORMATION:
collaboratively to evaluate new and Lisa S. Dean,
improved test methods applicable to the Comments Invited Privacy Officer.
needs of Federal agencies. Additional In accordance with the Paperwork [FR Doc. E6–17132 Filed 10–13–06; 8:45 am]
information about ICCVAM and Reduction Act of 1995 (44 U.S.C. 3501 BILLING CODE 9110–05–P

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