National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), 68069-68070 [05-22320]

Download as PDF Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Notices By order of the Board of Governors of the Federal Reserve System, November 2, 2005. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 05–22224 Filed 11–8–05; 8:45 am] BILLING CODE 6210–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Meeting announcement and request for comment. AGENCY: SUMMARY: Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the SACATM on December 12, 2005. The meeting is scheduled from 8:30 a.m. to adjournment (~5 p.m.) and is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. 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.’’ DATES: The SACATM meeting will be held on December 12, 2005. All individuals who plan to attend are encouraged to register online at the NTP Web site by December 5, 2005, at http:/ /ntp.niehs.nih.gov/ select ‘‘Advisory Boards & Committees.’’ In order to facilitate planning for this meeting, persons wishing to make an oral presentation are asked to notify the Executive Secretary for SACTAM via online registration, phone, or e-mail by December 5, 2005, (see ADDRESSES below). Written comments should also be received by December 5, 2005, to VerDate jul<14>2003 16:18 Nov 08, 2005 Jkt 208001 enable review by SACATM and NTP staff prior to the meeting. ADDESSES: The SACATM meeting will be held at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. Public comments and other correspondence should be directed to Dr. Kristina Thayer, Executive Secretary for SACATM (NTP Liaison and Scientific Review Office, NIEHS, P.O. Box 12233, MD A3–01, Research Triangle Park, NC 27709; telephone: 919–541–5021, fax: 919–541–0295; or email: thayer@niehs.nih.gov). Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend, should contact 919–541–2475 voice, 919–541–4644 TTY (text telephone), through the Federal TTY Relay System at 800–877–8339, or by email to niehsoeeo@niehs.nih.gov. Requests should be made at least 7 days in advance of the event. SUPPLEMENTARY INFORMATION: Preliminary Agenda and Availability of Meeting Materials A preliminary agenda is provided below. Additional background material will be posted on the NTP Web site as available at https://ntp.niehs.nih.gov/ see ‘‘Advisory Board & Committees’’ or available upon request (see ADDRESSES above). Following the meeting, summary minutes will be prepared and available at this Web site and upon request. Preliminary Agenda, Scientific Advisory Committee on Alternative Toxicological Methods, December 12, 2005, Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. 8:30 a.m. • Call to Order, Introductions, and Recognition of Retiring Members. • NICEATM and ICCVAM Update. • Overview of the May 2005 Ocular Toxicity Scientific Symposia. Æ Mechanisms of Chemically-Induced Ocular Injury and Recovery. Æ Reducing Pain and Distress in Ocular Safety Testing. • Performance Characteristics of the In Vivo Ocular Irritancy Test. Æ Public Comment. • ICCVAM Evaluation of In Vitro Methods to Identify Ocular Sever Irritants and Corrosives: Report from the Expert Panel (Presentation). Æ Bovine Corneal Opacity and Permeability (BCOP) Assay. Æ Isolated Chicken Eye (ICE) Assay. Æ Isolated Rabbit Eye (IRE) Assay. Æ Hen’s Egg Test—Chorion Allantoic Membrane (HET–CAM) Assay. Æ Reference Chemicals. 12 p.m. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 68069 LUNCH BREAK. 1 p.m. • ICCVAM Evaluation of In Vitro Methods to Identify Ocular Severe Irritants and Corrosives: Report from the Expert Panel Continued. Æ Public Comment. • ICCVAM Nominations. Æ Public Comment. • ICCVAM–NICEATM–ECVAM Workshop on Validation Principles and Approaches for Toxicogenomic-based Method. Æ Public Comment. • ECVAM Update. • SACATM General Discussion. ~5 p.m. ADJOURN. Request for Comments Public input at this meeting is invited and time is set aside for the presentation of public comments. Each organization is allowed one time slot per public comment period. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Registration for oral comments will also be available on-site, although time allowed for presentation by on-site registrants may be less than that for preregistered speakers and will be determined by the number of persons who register at the meeting. Persons registering to make oral comments are asked, if possible, to send a copy of their statement to the Executive Secretary for SACATM (see ADDRESSES above) by December 5, 2005, to enable review by SACATM and NIEHS/NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation. If registering on-site and reading from written text, please bring 40 copies of the statement for distribution and to supplement the record. Written comments received in response to this notice will be posted on the NTP Web site. Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document. Background Information on SACATM The SACATM was established January 9, 2002, to fulfill section 3(d) of Public Law 106–545, the ICCVAM Authorization Act of 2000 [42 U.S.C. 285l–3(d)] and is composed of scientists from the public and private sectors (Federal Register: March 13, 2002: Vol. 67, No. 49, page 11358). The SACATM provides advice to the Director of the NIEHS, ICCVAM, and NICEATM regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Additional information about SACATM, E:\FR\FM\09NON1.SGM pfrm13 PsN: 09NON1 68070 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Notices including the charter, roster, and records of past meetings can be found at https://ntp.niehs.nih.gov/ see ‘‘Advisory Board & Committees.’’ Information about NICEATM and ICCVAM activities can be found at the NICEATM/ICCVAM Web site (https://iccvam.niehs.nih.gov) or by contacting the Director of NICEATM, Dr. William Stokes (telephone: 919–541–2384, or E-mail: niceatm@niehs.nih.gov). contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5019; Facsimile: (301) 402–0220; E-mail: shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of the patent applications. Dated: October 26, 2005. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 05–22320 Filed 11–8–05; 8:45 am] The patent applications intended for licensure disclose and/or cover the following: E– 061–2004/0, ‘‘Mucus Shaving Apparatus for Endotracheal Tubes,’’ and E–061– 2004/1, ‘‘Mucus Shaving Apparatus for Endotracheal Tubes with Bactericidal Properties.’’ This invention is an endotracheal tube cleaning apparatus for insertion into the inside of the endotracheal tube of a patient to shave away mucus deposits. This cleaning apparatus comprises a flexible central tube with an inflatable balloon at its distal end. Affixed to the inflatable balloon are one or more shaving rings, each having a squared leading edge to shave away mucus accumulations implicated in bacterial accumulation. In operation, the un-inflated cleaning apparatus is inserted into the endotracheal tube until its distal end is properly aligned with the distal end of the endotracheal tube. After proper alignment, the balloon is inflated by a suitable inflation device (e.g., a syringe) until the balloon’s shaving rings are pressed against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube and in the process the balloon’s shaving rings shave off the mucus deposits from the inside of the endotracheal tube. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within sixty (60) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Cleaning Mucus From Endotracheal Tubes National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E–061–2004/0, ‘‘Mucus Shaving Apparatus for Endotracheal Tubes’’ (Patent Application Ser. No. 10/773,570 filed February 5, 2004), and E–061–2004/1, ‘‘Mucus Shaving Apparatus for Endotracheal Tubes with Bacteriocidal Properties’’ (International Patent Application PCT/US2005/003395 filed February 5, 2005), to C.R. Bard, Inc., a New Jersey corporation having its headquarters in Murray Hill, New Jersey and a division, Bard Medical Division, having offices in Covington, GA. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in the field of cleaning mucus deposits from endotracheal tubes. Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before January 9, 2006 will be considered. DATES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the ADDRESSES: VerDate jul<14>2003 16:18 Nov 08, 2005 Jkt 208001 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Dated: October 31, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–22319 Filed 11–8–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Open Meeting of the Federal Interagency Committee on Emergency Medical Services (FICEMS) Federal Emergency Management Agency (FEMA), Department of Homeland Security. ACTION: Notice of open meeting. AGENCY: SUMMARY: FEMA announces the following open meeting. Name: Federal Interagency Committee on Emergency Medical Services (FICEMS). Date of Meeting: December 1, 2005. Place: 3rd Floor Conference Center, Potomac Room, Parklawn Building, 5600 Fishers Lane Rockville, Maryland 20857. Times: 10:30 a.m.—Main FICEMS Meeting; 1 p.m.—FICEMS Ambulance Safety Subcommittee. Proposed Agenda: Review and submission for approval of previous FICEMS Committee Meeting Minutes; Ambulance Safety Subcommittee and Counter-terrorism Subcommittee report; Action Items review; presentation of member agency reports; and reports of other interested parties. SUPPLEMENTARY INFORMATION: This meeting will be open to the public with limited seating available on a first-come, first-served basis. See the Response and Security Procedures below. For those driving, parking is $7.00 per day. Response Procedures: Committee Members and members of the general public who plan to attend the meeting should contact Mr. Mike McKay, on or before Tuesday, November 29, 2005, via mail at NATEK Incorporated, 21355 Ridgetop Circle, Suite 200, Dulles, Virginia 20166–8503, or by telephone at (703) 674–0190, or via facsimile at (703) 674–0195, or via e-mail at mmckay@natekinc.com. This is necessary to be able to create and provide a current roster of visitors to HRSA Security per directives. Security Procedures: Increased security controls and surveillance are in effect at the Parklawn Building/HRSA facilities. All visitors must have a valid E:\FR\FM\09NON1.SGM pfrm13 PsN: 09NON1

Agencies

[Federal Register Volume 70, Number 216 (Wednesday, November 9, 2005)]
[Notices]
[Pages 68069-68070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Liaison and Scientific Review 
Office; Meeting of the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM)

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

ACTION: Meeting announcement and request for comment.

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

SUMMARY: Pursuant to section 10(a) of the Federal Advisory Committee 
Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a 
meeting of the SACATM on December 12, 2005. The meeting is scheduled 
from 8:30 a.m. to adjournment (~5 p.m.) and is open to the public with 
attendance limited only by the space available. SACATM advises the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM), the NTP Interagency Center for the Evaluation of 
Alternative Toxicological Methods (NICEATM), and the Director of the 
NIEHS regarding statutorily mandated duties of ICCVAM and activities of 
NICEATM. SACATM provides advice on priorities and activities related to 
the development, validation, scientific review, regulatory acceptance, 
implementation, and national and international harmonization of new, 
revised, and alternative toxicological test methods. 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.''

DATES: The SACATM meeting will be held on December 12, 2005. All 
individuals who plan to attend are encouraged to register online at the 
NTP Web site by December 5, 2005, at https://ntp.niehs.nih.gov/ select 
``Advisory Boards & Committees.'' In order to facilitate planning for 
this meeting, persons wishing to make an oral presentation are asked to 
notify the Executive Secretary for SACTAM via online registration, 
phone, or e-mail by December 5, 2005, (see ADDRESSES below). Written 
comments should also be received by December 5, 2005, to enable review 
by SACATM and NTP staff prior to the meeting.

ADDESSES: The SACATM meeting will be held at the Hilton Alexandria Old 
Town, 1767 King Street, Alexandria, VA 22314. Public comments and other 
correspondence should be directed to Dr. Kristina Thayer, Executive 
Secretary for SACATM (NTP Liaison and Scientific Review Office, NIEHS, 
P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: 
919-541-5021, fax: 919-541-0295; or e-mail: thayer@niehs.nih.gov). 
Persons needing special assistance, such as sign language 
interpretation or other reasonable accommodation in order to attend, 
should contact 919-541-2475 voice, 919-541-4644 TTY (text telephone), 
through the Federal TTY Relay System at 800-877-8339, or by e-mail to 
niehsoeeo@niehs.nih.gov. Requests should be made at least 7 days in 
advance of the event.

SUPPLEMENTARY INFORMATION:

Preliminary Agenda and Availability of Meeting Materials

    A preliminary agenda is provided below. Additional background 
material will be posted on the NTP Web site as available at https://
ntp.niehs.nih.gov/ see ``Advisory Board & Committees'' or available 
upon request (see ADDRESSES above). Following the meeting, summary 
minutes will be prepared and available at this Web site and upon 
request.
    Preliminary Agenda, Scientific Advisory Committee on Alternative 
Toxicological Methods, December 12, 2005, Hilton Alexandria Old Town, 
1767 King Street, Alexandria, VA 22314.
    8:30 a.m.
     Call to Order, Introductions, and Recognition of Retiring 
Members.
     NICEATM and ICCVAM Update.
     Overview of the May 2005 Ocular Toxicity Scientific 
Symposia.
    [cir] Mechanisms of Chemically-Induced Ocular Injury and Recovery.
    [cir] Reducing Pain and Distress in Ocular Safety Testing.
     Performance Characteristics of the In Vivo Ocular 
Irritancy Test.
    [cir] Public Comment.
     ICCVAM Evaluation of In Vitro Methods to Identify Ocular 
Sever Irritants and Corrosives: Report from the Expert Panel 
(Presentation).
    [cir] Bovine Corneal Opacity and Permeability (BCOP) Assay.
    [cir] Isolated Chicken Eye (ICE) Assay.
    [cir] Isolated Rabbit Eye (IRE) Assay.
    [cir] Hen's Egg Test--Chorion Allantoic Membrane (HET-CAM) Assay.
    [cir] Reference Chemicals.
    12 p.m.
    LUNCH BREAK.
    1 p.m.
     ICCVAM Evaluation of In Vitro Methods to Identify Ocular 
Severe Irritants and Corrosives: Report from the Expert Panel 
Continued.
    [cir] Public Comment.
     ICCVAM Nominations.
    [cir] Public Comment.
     ICCVAM-NICEATM-ECVAM Workshop on Validation Principles and 
Approaches for Toxicogenomic-based Method.
    [cir] Public Comment.
     ECVAM Update.
     SACATM General Discussion.
    ~5 p.m.
    ADJOURN.

Request for Comments

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments. Each organization is allowed one 
time slot per public comment period. At least 7 minutes will be 
allotted to each speaker, and if time permits, may be extended to 10 
minutes. Registration for oral comments will also be available on-site, 
although time allowed for presentation by on-site registrants may be 
less than that for pre-registered speakers and will be determined by 
the number of persons who register at the meeting.
    Persons registering to make oral comments are asked, if possible, 
to send a copy of their statement to the Executive Secretary for SACATM 
(see ADDRESSES above) by December 5, 2005, to enable review by SACATM 
and NIEHS/NTP staff prior to the meeting. Written statements can 
supplement and may expand the oral presentation. If registering on-site 
and reading from written text, please bring 40 copies of the statement 
for distribution and to supplement the record. Written comments 
received in response to this notice will be posted on the NTP Web site. 
Persons submitting written comments should include their name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization (if any) with the document.

Background Information on SACATM

    The SACATM was established January 9, 2002, to fulfill section 3(d) 
of Public Law 106-545, the ICCVAM Authorization Act of 2000 [42 U.S.C. 
285l-3(d)] and is composed of scientists from the public and private 
sectors (Federal Register: March 13, 2002: Vol. 67, No. 49, page 
11358). The SACATM provides advice to the Director of the NIEHS, 
ICCVAM, and NICEATM regarding statutorily mandated duties of ICCVAM and 
activities of NICEATM. Additional information about SACATM,

[[Page 68070]]

including the charter, roster, and records of past meetings can be 
found at https://ntp.niehs.nih.gov/ see ``Advisory Board & Committees.'' 
Information about NICEATM and ICCVAM activities can be found at the 
NICEATM/ICCVAM Web site (https://iccvam.niehs.nih.gov) or by contacting 
the Director of NICEATM, Dr. William Stokes (telephone: 919-541-2384, 
or E-mail: niceatm@niehs.nih.gov).

    Dated: October 26, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-22320 Filed 11-8-05; 8:45 am]
BILLING CODE 4140-01-P

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