National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Independent Scientific Peer Review Panel Report: Updated Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments, 26242-26243 [E9-12360]
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<![CDATA[
26242
Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices
of donations of personal property to
public agencies for use in carrying out
such purposes as conservation,
economic development, education,
parks and recreation, public health, and
public safety.
B. Annual Reporting Burden
Respondents: 55.
Responses per Respondent: 4.
Total Responses: 220.
Hours per Response: 1.5.
Total Burden Hours: 330.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 3090–0112,
GSA Form 3040, State Agency Monthly
Donation Report of Surplus Personal
Property, in all correspondence.
Dated: May 20, 2009.
Casey Coleman,
Chief Information Officer.
[FR Doc. E9–12586 Filed 5–29–09; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Independent
Scientific Peer Review Panel Report:
Updated Validation Status of New
Versions and Applications of the
Murine Local Lymph Node Assay: A
Test Method for Assessing the Allergic
Contact Dermatitis Potential of
Chemicals and Products: Notice of
Availability and Request for Public
Comments
AGENCY: National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Request for comments.
SUMMARY: NICEATM, in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM),
convened an independent,
international, scientific peer review
panel (hereafter, Panel) on April 28–29,
2009, to evaluate three non-radioactive
modified versions and new applications
for the Murine Local Lymph Node
Assay (LLNA). The LLNA is an
alternative test method that can be used
to determine the allergic contact
dermatitis potential of chemicals and
products. The Panel report from this
VerDate Nov<24>2008
15:29 May 29, 2009
Jkt 217001
meeting is now available. The report
contains (1) the Panel’s evaluation of the
updated validation status of the
methods and (2) the Panel’s comments
on the updated draft ICCVAM test
method recommendations. NICEATM
invites public comment on the Panel’s
report. The report is available on the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov/docs/
immunotox_docs/
LLNAPRPRept2009.pdf or by contacting
NICEATM at the address given below.
DATES: Written comments on the Panel
report should be received by July 15,
2009.
ADDRESSES: Comments should be
submitted preferably electronically via
the NICEATM–ICCVAM Web site at
https://iccvam.niehs.nih.gov/contact/
FR_pubcomment.htm. Comments can
also be submitted by e-mail to
niceatm@niehs.nih.gov. Written
comments can 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: NIEHS, NICEATM, 530 Davis
Drive, Room 2035, Durham, NC 27713.
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes (telephone) 919–541–
2384, (fax) 919–541–0947 and (e-mail)
niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In January 2007, the Consumer
Product Safety Commission submitted a
nomination to NICEATM and ICCVAM
to assess the validation status of (1) the
use of the LLNA to determine potency
for hazard classification purposes, (2)
LLNA protocols using non-radioactive
procedures, (3) the LLNA limit dose
procedure, and (4) the use of the LLNA
to test mixtures, aqueous solutions, and
metals (i.e., an updated assessment of
the applicability domain of the LLNA).
In June 2007, the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM) endorsed these
activities as high priorities for ICCVAM.
NICEATM, on behalf of ICCVAM, also
sought input from the public on these
activities and requested data from
studies using the LLNA or modified
versions of the LLNA (72 FR 27815).
After considering all comments
received, ICCVAM endorsed carrying
out these activities as high priorities.
ICCVAM also developed draft LLNA
performance standards to facilitate
evaluation of modified LLNA protocols
that are functionally and
mechanistically similar to the
traditional LLNA. These draft LLNA
performance standards were made
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
public and comments were requested in
September 2007 (72 FR 52130).
ICCVAM and NICEATM prepared
draft background review documents
(BRDs) that provided comprehensive
reviews of available data and relevant
information for each of the
modifications and new applications of
the LLNA. ICCVAM also developed
draft test method recommendations
regarding the proposed usefulness and
limitations, standardized protocols, and
future studies. NICEATM announced
availability of the draft BRDs and draft
recommendations for public comment
and the public peer review meeting in
January 2008 (73 FR 1360).
The Panel met in public session on
March 4–6, 2008, to review these topics,
and their report was made available in
May 2008 (73 FR 29136). The draft
BRDs and draft test method
recommendations, the draft ICCVAM
LLNA test method performance
standards, the Panel’s report, and all
public comments were made available
to SACATM for comment at their
meeting on June 18–19, 2008 (73 FR
25754).
As a result of additional data received
by ICCVAM subsequent to the March
2008 Panel meeting, the draft BRDs for
the following were updated:
• The validation status of three
modified LLNA test method protocols
that do not require the use of radioactive
substances.
• The use of the LLNA for testing
pesticide formulations, other products,
and aqueous solutions.
Second Meeting of the Peer Review
Panel
The Panel met again in public session
on April 28–29, 2009 (74 FR 8974). The
Panel reviewed the revised draft
ICCVAM documents for completeness,
errors, and omissions of any existing
relevant data or information. The Panel
evaluated the information in the revised
draft documents to determine the extent
to which each of the applicable criteria
for validation and acceptance of
toxicological test methods (ICCVAM,
2003) had been appropriately addressed.
The Panel then considered the ICCVAM
draft recommendations for test method
uses and limitations, proposed
standardized protocol, proposed plans
for development of test method
performance standards, and proposed
additional studies, and commented on
the extent that the recommendations
were supported by the information
provided in the draft BRDs.
Availability of the Peer Panel Report
The Panel’s conclusions and
recommendations are detailed in the
E:\FR\FM\01JNN1.SGM
01JNN1
26243
Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices
Independent Scientific Peer Review
Panel Report: Updated Validation
Status of New Versions and
Applications of the Murine Local Lymph
Node Assay: A Test Method for
Assessing the Allergic Contact
Dermatitis Potential of Chemicals and
Products (available at https://
iccvam.niehs.nih.gov/docs/
immunotox_docs/
LLNAPRPRept2009.pdf). The revised
draft documents reviewed by the Panel
and the draft ICCVAM test method
recommendations are available at https://
iccvam.niehs.nih.gov/methods/
immunotox/llna_PeerPanel.htm.
Request for Public Comments
NICEATM invites the submission of
written comments on the Panel’s report.
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).
All comments received will be made
publicly available via the NICEATM–
ICCVAM Web site at https://
iccvam.niehs.nih.gov/methods/
immunotox/llna_PeerPanel.htm. In
addition, there will be an opportunity
for oral public comments on the Panel’s
report during an upcoming meeting of
SACATM scheduled for June 25–26,
2009 (74 FR 19562). Information
concerning the SACATM meeting is
available at https://ntp.niehs.nih.gov/go/
7441. ICCVAM will consider the Panel
report along with SACATM and public
comments when finalizing test method
recommendations. An ICCVAM test
method evaluation report, which will
include the final ICCVAM
recommendations, will be forwarded to
relevant Federal agencies for their
consideration. The evaluation report
will also be available to the public on
the NICEATM–ICCVAM Web site at
https://iccvam.niehs.nih.gov/methods/
immunotox/llna.htm and by request
from NICEATM (see ADDRESSES above).
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use, generate, or disseminate
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, and 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 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 U.S.
Federal agencies. Additional
information about ICCVAM and
NICEATM can be found on their Web
site (https://iccvam.niehs.nih.gov).
SACATM was established January 9,
2002, and is composed of scientists from
the public and private sectors (67 FR
11358). SACATM provides advice to the
Director of the NIEHS, ICCVAM, and
NICEATM regarding the statutorily
mandated duties of ICCVAM and
activities of NICEATM. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/ see ‘‘Advisory Board
& Committees’’ (or directly at https://
ntp.niehs.nih.gov/go/167).
Reference
ICCVAM. 2003. ICCVAM Guidelines for
the Nomination and Submission of New,
Revised, and Alternative Test Methods. NIH
Publication No. 03–4508. Research Triangle
Park, NC: NIEHS. Available at: https://
iccvam.niehs.nih.gov.
Dated: May 19, 2009.
John R. Bucher,
Associate Director, NTP.
[FR Doc. E9–12360 Filed 5–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Survey of NHLBI
Constituents’ Health Information
Needs and Preferred Formats
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Estimated
number of
respondents
Type of respondents
General Public .................................................................................................
Private Companies ..........................................................................................
VerDate Nov<24>2008
15:29 May 29, 2009
Jkt 217001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Reduction Act of 1995, the National
Heart, Lung and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on March 19, 2009, pages
11736–11737 and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: Survey of
NHLBI Constituents’ Health Information
Needs and Preferred Formats. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
The purpose of this survey is to obtain
information from NHLBI constituents
(health professionals, patients and their
families, and the general public) for the
purpose of evaluating their health
information and education needs and
format preferences. The Consumer
Services Team (CST) will use the data
collected in this survey to create a 3year Strategic Plan. The findings from
the survey, described in the Strategic
Plan, will be used to develop new
health information materials for NHLBI
constituents and to revise materials
currently in the Institute’s portfolio.
Frequency of Response: Once every 3
years. Affected Public: Individuals. Type
of Respondents: Individuals who have
been consumers of NHLBI information
within the past 3 years. The annual
reporting burden is as follows:
Estimated Number of Respondents:
2,450; Estimated Number of Responses
per Respondent: 1; Average Burden
Hours per Response: 0.2; and Estimated
Total Annual Burden Hours Requested:
162. The annualized cost to respondents
is estimated at: $3,518.62. There are no
Capital Costs, Operating Costs and/or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
1,075
332
E:\FR\FM\01JNN1.SGM
0.33
0.33
01JNN1
Average
burden hours
per response
0.2
0.2
Estimated
total annual
burden hours
requested
71
22
]]>Agencies
[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26242-26243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12360]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Independent
Scientific Peer Review Panel Report: Updated Validation Status of New
Versions and Applications of the Murine Local Lymph Node Assay: A Test
Method for Assessing the Allergic Contact Dermatitis Potential of
Chemicals and Products: Notice of Availability and Request for Public
Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: NICEATM, in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM), convened
an independent, international, scientific peer review panel (hereafter,
Panel) on April 28-29, 2009, to evaluate three non-radioactive modified
versions and new applications for the Murine Local Lymph Node Assay
(LLNA). The LLNA is an alternative test method that can be used to
determine the allergic contact dermatitis potential of chemicals and
products. The Panel report from this meeting is now available. The
report contains (1) the Panel's evaluation of the updated validation
status of the methods and (2) the Panel's comments on the updated draft
ICCVAM test method recommendations. NICEATM invites public comment on
the Panel's report. The report is available on the NICEATM-ICCVAM Web
site at https://iccvam.niehs.nih.gov/docs/immunotox_docs/LLNAPRPRept2009.pdf or by contacting NICEATM at the address given
below.
DATES: Written comments on the Panel report should be received by July
15, 2009.
ADDRESSES: Comments should be submitted preferably electronically via
the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm. Comments can also be submitted by e-mail to
niceatm@niehs.nih.gov. Written comments can 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: NIEHS, NICEATM, 530 Davis Drive, Room 2035, Durham, NC
27713.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes (telephone) 919-
541-2384, (fax) 919-541-0947 and (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In January 2007, the Consumer Product Safety Commission submitted a
nomination to NICEATM and ICCVAM to assess the validation status of (1)
the use of the LLNA to determine potency for hazard classification
purposes, (2) LLNA protocols using non-radioactive procedures, (3) the
LLNA limit dose procedure, and (4) the use of the LLNA to test
mixtures, aqueous solutions, and metals (i.e., an updated assessment of
the applicability domain of the LLNA). In June 2007, the Scientific
Advisory Committee on Alternative Toxicological Methods (SACATM)
endorsed these activities as high priorities for ICCVAM. NICEATM, on
behalf of ICCVAM, also sought input from the public on these activities
and requested data from studies using the LLNA or modified versions of
the LLNA (72 FR 27815). After considering all comments received, ICCVAM
endorsed carrying out these activities as high priorities. ICCVAM also
developed draft LLNA performance standards to facilitate evaluation of
modified LLNA protocols that are functionally and mechanistically
similar to the traditional LLNA. These draft LLNA performance standards
were made public and comments were requested in September 2007 (72 FR
52130).
ICCVAM and NICEATM prepared draft background review documents
(BRDs) that provided comprehensive reviews of available data and
relevant information for each of the modifications and new applications
of the LLNA. ICCVAM also developed draft test method recommendations
regarding the proposed usefulness and limitations, standardized
protocols, and future studies. NICEATM announced availability of the
draft BRDs and draft recommendations for public comment and the public
peer review meeting in January 2008 (73 FR 1360).
The Panel met in public session on March 4-6, 2008, to review these
topics, and their report was made available in May 2008 (73 FR 29136).
The draft BRDs and draft test method recommendations, the draft ICCVAM
LLNA test method performance standards, the Panel's report, and all
public comments were made available to SACATM for comment at their
meeting on June 18-19, 2008 (73 FR 25754).
As a result of additional data received by ICCVAM subsequent to the
March 2008 Panel meeting, the draft BRDs for the following were
updated:
The validation status of three modified LLNA test method
protocols that do not require the use of radioactive substances.
The use of the LLNA for testing pesticide formulations,
other products, and aqueous solutions.
Second Meeting of the Peer Review Panel
The Panel met again in public session on April 28-29, 2009 (74 FR
8974). The Panel reviewed the revised draft ICCVAM documents for
completeness, errors, and omissions of any existing relevant data or
information. The Panel evaluated the information in the revised draft
documents to determine the extent to which each of the applicable
criteria for validation and acceptance of toxicological test methods
(ICCVAM, 2003) had been appropriately addressed. The Panel then
considered the ICCVAM draft recommendations for test method uses and
limitations, proposed standardized protocol, proposed plans for
development of test method performance standards, and proposed
additional studies, and commented on the extent that the
recommendations were supported by the information provided in the draft
BRDs.
Availability of the Peer Panel Report
The Panel's conclusions and recommendations are detailed in the
[[Page 26243]]
Independent Scientific Peer Review Panel Report: Updated Validation
Status of New Versions and Applications of the Murine Local Lymph Node
Assay: A Test Method for Assessing the Allergic Contact Dermatitis
Potential of Chemicals and Products (available at https://iccvam.niehs.nih.gov/docs/immunotox_docs/LLNAPRPRept2009.pdf). The
revised draft documents reviewed by the Panel and the draft ICCVAM test
method recommendations are available at https://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm.
Request for Public Comments
NICEATM invites the submission of written comments on the Panel's
report. 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). All comments received will be made
publicly available via the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm. In
addition, there will be an opportunity for oral public comments on the
Panel's report during an upcoming meeting of SACATM scheduled for June
25-26, 2009 (74 FR 19562). Information concerning the SACATM meeting is
available at https://ntp.niehs.nih.gov/go/7441. ICCVAM will consider the
Panel report along with SACATM and public comments when finalizing test
method recommendations. An ICCVAM test method evaluation report, which
will include the final ICCVAM recommendations, will be forwarded to
relevant Federal agencies for their consideration. The evaluation
report will also be available to the public on the NICEATM-ICCVAM Web
site at https://iccvam.niehs.nih.gov/methods/immunotox/llna.htm and by
request from NICEATM (see ADDRESSES above).
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate 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, and 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 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 U.S. Federal agencies.
Additional information about ICCVAM and NICEATM can be found on their
Web site (https://iccvam.niehs.nih.gov).
SACATM was established January 9, 2002, and is composed of
scientists from the public and private sectors (67 FR 11358). SACATM
provides advice to the Director of the NIEHS, ICCVAM, and NICEATM
regarding the statutorily mandated duties of ICCVAM and activities of
NICEATM. Additional information about SACATM, including the charter,
roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/ see ``Advisory Board & Committees'' (or directly at
https://ntp.niehs.nih.gov/go/167).
Reference
ICCVAM. 2003. ICCVAM Guidelines for the Nomination and
Submission of New, Revised, and Alternative Test Methods. NIH
Publication No. 03-4508. Research Triangle Park, NC: NIEHS.
Available at: https://iccvam.niehs.nih.gov.
Dated: May 19, 2009.
John R. Bucher,
Associate Director, NTP.
[FR Doc. E9-12360 Filed 5-29-09; 8:45 am]
BILLING CODE 4140-01-P
