National Toxicology Program (NTP); Liaison and Scientific Review Office (LSRO); Announcement of National Toxicology Program (NTP) Workshop on “Animal Models for the NTP Rodent Cancer Bioassay: Strains & Stocks-Should We Switch?”, 17102-17103 [05-6605]

Download as PDF 17102 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Variceal Bleeding. Date: April 19, 2005. Time: 4 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Carol J. Goter-Robinson, PhD, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 748, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 594–7791, goterrobinsonc@extra.niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 24, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–6637 Filed 4–1–05; 8:45 am] and benefits of the standards, both financial impact and quality improvement; (2) the current demand on industry resources to implement the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and other electronic standards, including HIPAA standards; and (3) the most cost-effective and efficient means for industry to implement the Standards. Name of Committee: Commission on Systemic Interoperability. Date: April 22, 2005. Time: 8 a.m. to 4 p.m. Agenda: Healthcare Information Technology Standards. Place: Hubert H. Humphrey Building, Room 800, 200 Independence Avenue, Washington, DC 20201. Contact Person: Ms. Dana Haza, Director, Commission on Systemic Interoperability, National Library of Medicine, National Institutes of Health, Building 38, Room 2N21, Bethesda, MD 20894, 301–594–7520. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The comments should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Dated: March 24, 2005. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–6617 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–M BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Library of Medicine, Notice of Meeting National Institutes of Health Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the fourth meeting of the Commission on Systemic Interoperability. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The mission of the Commission on Systemic Interoperability is to submit a report to the Secretary of Health and Human Services and to Congress on a comprehensive strategy for the adoption and implementation of health care information technology standards that includes a timeline and prioritization for such adoption and implementation. In developing that strategy, the Commission will consider: (1) The costs National Toxicology Program (NTP); Liaison and Scientific Review Office (LSRO); Announcement of National Toxicology Program (NTP) Workshop on ‘‘Animal Models for the NTP Rodent Cancer Bioassay: Strains & Stocks— Should We Switch?’’ VerDate jul<14>2003 20:15 Apr 01, 2005 Jkt 205001 National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Meeting Announcement. AGENCY: SUMMARY: Over the past year, the National Toxicology Program (NTP) has developed and refined a vision for toxicology in the 21st century (‘‘NTP Vision’’) and a roadmap for implementing this vision (‘‘NTP Roadmap’’) that will strategically position the program at the forefront for providing scientific data and the interpretation of those data for public health decision-making (see SUPPLEMENTARY INFORMATION for PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 additional detail). As part of the NTP Roadmap, the program will convene a series of public workshops to review aspects of the existing testing program. The first workshop is scheduled for June 16–17, 2005, at the NIEHS in Research Triangle Park, NC and will focus on evaluating stocks and strains currently used in the NTP rodent cancer bioassay in order to improve the ability of the bioassay to identify substances that may pose a carcinogenic hazard for humans. In particular, the goal of this workshop is to seek scientific input as to whether the NTP should continue to use both the F344 rat and B6C3F1 mouse models, use other strains, and/or use multiple strains as previously suggested (Festing, 1995). Future workshops will address other study design issues such as diet, length of study, and age at exposure. The NTP invites public comments on the appropriateness of the F344N and B6C3F1 models currently used and the submission of historical control data for rodent models that the NTP might consider at the workshop. The program will include plenary sessions as well as three breakout group meetings for indepth discussions of rat models, mouse models, and the multiple strain approach. Following the meeting, the NTP will prepare a workshop report and present its proposed testing strategy to the NTP Board of Scientific Counselors for their consideration and input. Attendance at the meeting is limited only by the space available. Members of the public may register to attend the workshop on a first-come, first-served basis per the procedures outlined below. A copy of the agenda and any additional information on the workshop, including participants and background materials, will be posted on the NTP Web site when available (https://ntp.niehs.nih.gov select ‘‘Meetings and Workshops’’) DATES: The workshop will be held June 16–17, 2005. The meeting will begin at 8:30 a.m. each day and end at 5 p.m. on June 16 and approximately 12 p.m. on June 17. Comments: Written comments and historical control data should be received by May 19, 2005, to enable review by NIEHS/NTP staff and workshop panelists prior to the meeting (see FOR FURTHER INFORMATION CONTACT below). The deadline for registration to present oral comments at the meeting is June 9, 2005. Registration: Individuals who plan to attend are strongly encouraged to register by June 9, 2005, in order to ensure access to the NIEHS campus (see FOR FURTHER INFORMATION CONTACT below). Persons needing special assistance, such as sign language E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices interpretation or other reasonable accommodation, in order to attend are asked to notify the NTP at least 7 business days in advance of the meeting. ADDRESSES: The meeting will be held in the Rodbell Auditorium, Rall Building at the National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. FOR FURTHER INFORMATION CONTACT: Public comments, data submission and any other correspondence should be submitted to Dr. Angela King-Herbert (NIEHS, P.O. Box 12233, MD B3–06, Research Triangle Park, NC 27709; telephone: 919–541–3464, fax 919–541– 7666; or e-mail: kingher1@niehs.nih.gov). SUPPLEMENTARY INFORMATION: Background on the NTP Vision and Roadmap to Achieve the Vision The NTP was established in 1978 to coordinate toxicological testing programs within the Department of Health and Human Services, develop and validate improved testing methods, develop approaches and generate data to strengthen scientific knowledge about potentially hazardous substances and communicate with stakeholders. In its more than 25 years of existence, NTP has become a world leader in providing scientific information that improves our nation’s ability to evaluate potential human health effects from chemical and physical exposures. The NTP maintains a number of complex, interrelated research and testing programs that provide unique and critical information needed by health regulatory and research agencies to protect public health. The last decade of the 20th century and the turn of the 21st century have produced dramatic technological advances in molecular biology and computer science. The NTP is ready to evaluate its key activities and, in a focused and concerted effort, determine how best to incorporate these new scientific technologies into its research and testing strategies and broaden scientific knowledge on the linkage between mechanism and disease. In August 2003, the NTP defined its vision for the 21st century and undertook a yearlong process to refine that vision and develop a roadmap for its implementation. The NTP Vision is to support the evolution of toxicology from a predominately observational science at the level of disease-specific models to a predominately predictive science focused upon a broad inclusion of target-specific, mechanism-based, VerDate jul<14>2003 15:19 Apr 01, 2005 Jkt 205001 biological observations. The NTP roadmap for implementation of the vision will strategically position the program at the forefront for providing scientific data and the interpretation of those data for public health decisionmaking. The NTP Roadmap was developed with input from numerous groups including its federal partners, its advisory committees, and the public. In carrying out the NTP Roadmap, the program plans to formally review the designs of NTP assays to determine whether protocol changes are needed. Additional information about the NTP Vision and Roadmap is available on its Web site (https://ntp.niehs.nih.gov/ntp select ‘‘NTP Vision and Roadmap’’). The NTP periodically conducts reviews of animal models used in the NTP cancer bioassay including recent evaluations on the use of fish and transgenic mouse models as alternative approaches (Board of Scientific Counselors, 2004; NTP Board of Scientific Counselors Technical Reports Review Subcommittee, 2003; Scientific Advisory Committee on Alternative Toxicological Methods, 2004). However, the last formal review of the NTP rodent bioassay occurred in August 1984 (Report of the Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation of the NTP Board of Scientific Counselors, August 17, 1984). Although the NTP has expanded the breadth of its evaluation of individual agents and the number of endpoints critically assessed in the bioassay, the rodent cancer bioassay study design has been minimally modified over the past 30 years. For this reason, the program intends to convene a series of workshops to evaluate the rodent cancer bioassay, beginning with choice of species and strain. Future workshops will address other study design issues, such as diet, study length, and age at exposure. The ultimate goal of any change to the NTP cancer bioassay is to improve the identification of carcinogenic potential (i.e., hazard identification) and/or improve our ability to predict cancer in humans. Request for Comments Public input at this meeting is invited and time is set aside for the presentation of public comments on any agenda topic. Each organization is allowed one time slot per agenda topic. 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 then that for pre-registered speakers and will be determined by the number of persons PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 17103 who register at 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 (https://ntp.niehs.nih.gov select ‘‘Meetings and Workshops’’). Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document. Individuals wishing to submit historical control data are encouraged to contact Dr. Angela KingHerbert prior to submission (see FOR FURTHER INFORMATION CONTACT above). References Festing, MF. (1995). Use of a multistrain assay could improve the NTP carcinogenesis bioassay. Environ Health Perspect. 1995 Jan;103(1):44–52. Available: https://ehp.niehs.nih.gov/. Meeting Minutes of the NTP Board of Scientific Counselors (BSC)—June 29, 2004. Available: https://ntpserver.niehs.nih.gov/ntpweb/ index.cfm?objectid=720164F2-BDB7CEBA-F5C6A2E21851F0C4. Meeting Minutes of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee)—May 22, 2003. Available: https://ntpserver.niehs.nih.gov/ntpweb/ index.cfm?objectid=9404F3B3-F1F6– 975E–70F0DB8B0FDF8F86. Meeting Minutes of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)— March 10–11, 2004. Available: https:// ntp-server.niehs.nih.gov/ntpweb/ index.cfm?objectid=AF6CC417-F1F6– 975E–75B5F3FF7DF1CDDC. Dated: March 22, 2005. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 05–6605 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director; Office of Dietary Supplements: Notice of Opportunity for Public Comment and Public Meeting Background The Office Dietary Supplements (ODS) was established in the Office of E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17102-17103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6605]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); Liaison and Scientific Review 
Office (LSRO); Announcement of National Toxicology Program (NTP) 
Workshop on ``Animal Models for the NTP Rodent Cancer Bioassay: Strains 
& Stocks--Should We Switch?''

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

ACTION: Meeting Announcement.

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

SUMMARY: Over the past year, the National Toxicology Program (NTP) has 
developed and refined a vision for toxicology in the 21st century 
(``NTP Vision'') and a roadmap for implementing this vision (``NTP 
Roadmap'') that will strategically position the program at the 
forefront for providing scientific data and the interpretation of those 
data for public health decision-making (see SUPPLEMENTARY INFORMATION 
for additional detail). As part of the NTP Roadmap, the program will 
convene a series of public workshops to review aspects of the existing 
testing program. The first workshop is scheduled for June 16-17, 2005, 
at the NIEHS in Research Triangle Park, NC and will focus on evaluating 
stocks and strains currently used in the NTP rodent cancer bioassay in 
order to improve the ability of the bioassay to identify substances 
that may pose a carcinogenic hazard for humans. In particular, the goal 
of this workshop is to seek scientific input as to whether the NTP 
should continue to use both the F344 rat and B6C3F1 mouse models, use 
other strains, and/or use multiple strains as previously suggested 
(Festing, 1995). Future workshops will address other study design 
issues such as diet, length of study, and age at exposure. The NTP 
invites public comments on the appropriateness of the F344N and B6C3F1 
models currently used and the submission of historical control data for 
rodent models that the NTP might consider at the workshop. The program 
will include plenary sessions as well as three breakout group meetings 
for in-depth discussions of rat models, mouse models, and the multiple 
strain approach. Following the meeting, the NTP will prepare a workshop 
report and present its proposed testing strategy to the NTP Board of 
Scientific Counselors for their consideration and input.
    Attendance at the meeting is limited only by the space available. 
Members of the public may register to attend the workshop on a first-
come, first-served basis per the procedures outlined below. A copy of 
the agenda and any additional information on the workshop, including 
participants and background materials, will be posted on the NTP Web 
site when available (https://ntp.niehs.nih.gov select ``Meetings and 
Workshops'')

DATES: The workshop will be held June 16-17, 2005. The meeting will 
begin at 8:30 a.m. each day and end at 5 p.m. on June 16 and 
approximately 12 p.m. on June 17.
    Comments: Written comments and historical control data should be 
received by May 19, 2005, to enable review by NIEHS/NTP staff and 
workshop panelists prior to the meeting (see FOR FURTHER INFORMATION 
CONTACT below). The deadline for registration to present oral comments 
at the meeting is June 9, 2005.
    Registration: Individuals who plan to attend are strongly 
encouraged to register by June 9, 2005, in order to ensure access to 
the NIEHS campus (see FOR FURTHER INFORMATION CONTACT below). Persons 
needing special assistance, such as sign language

[[Page 17103]]

interpretation or other reasonable accommodation, in order to attend 
are asked to notify the NTP at least 7 business days in advance of the 
meeting.

ADDRESSES: The meeting will be held in the Rodbell Auditorium, Rall 
Building at the National Institute of Environmental Health Sciences, 
111 T.W. Alexander Drive, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Public comments, data submission and 
any other correspondence should be submitted to Dr. Angela King-Herbert 
(NIEHS, P.O. Box 12233, MD B3-06, Research Triangle Park, NC 27709; 
telephone: 919-541-3464, fax 919-541-7666; or e-mail: 
kingher1@niehs.nih.gov).

SUPPLEMENTARY INFORMATION:

Background on the NTP Vision and Roadmap to Achieve the Vision

    The NTP was established in 1978 to coordinate toxicological testing 
programs within the Department of Health and Human Services, develop 
and validate improved testing methods, develop approaches and generate 
data to strengthen scientific knowledge about potentially hazardous 
substances and communicate with stakeholders. In its more than 25 years 
of existence, NTP has become a world leader in providing scientific 
information that improves our nation's ability to evaluate potential 
human health effects from chemical and physical exposures. The NTP 
maintains a number of complex, interrelated research and testing 
programs that provide unique and critical information needed by health 
regulatory and research agencies to protect public health.
    The last decade of the 20th century and the turn of the 21st 
century have produced dramatic technological advances in molecular 
biology and computer science. The NTP is ready to evaluate its key 
activities and, in a focused and concerted effort, determine how best 
to incorporate these new scientific technologies into its research and 
testing strategies and broaden scientific knowledge on the linkage 
between mechanism and disease. In August 2003, the NTP defined its 
vision for the 21st century and undertook a yearlong process to refine 
that vision and develop a roadmap for its implementation. The NTP 
Vision is to support the evolution of toxicology from a predominately 
observational science at the level of disease-specific models to a 
predominately predictive science focused upon a broad inclusion of 
target-specific, mechanism-based, biological observations. The NTP 
roadmap for implementation of the vision will strategically position 
the program at the forefront for providing scientific data and the 
interpretation of those data for public health decision-making. The NTP 
Roadmap was developed with input from numerous groups including its 
federal partners, its advisory committees, and the public. In carrying 
out the NTP Roadmap, the program plans to formally review the designs 
of NTP assays to determine whether protocol changes are needed. 
Additional information about the NTP Vision and Roadmap is available on 
its Web site (https://ntp.niehs.nih.gov/ntp select ``NTP Vision and 
Roadmap'').
    The NTP periodically conducts reviews of animal models used in the 
NTP cancer bioassay including recent evaluations on the use of fish and 
transgenic mouse models as alternative approaches (Board of Scientific 
Counselors, 2004; NTP Board of Scientific Counselors Technical Reports 
Review Subcommittee, 2003; Scientific Advisory Committee on Alternative 
Toxicological Methods, 2004). However, the last formal review of the 
NTP rodent bioassay occurred in August 1984 (Report of the Ad Hoc Panel 
on Chemical Carcinogenesis Testing and Evaluation of the NTP Board of 
Scientific Counselors, August 17, 1984). Although the NTP has expanded 
the breadth of its evaluation of individual agents and the number of 
endpoints critically assessed in the bioassay, the rodent cancer 
bioassay study design has been minimally modified over the past 30 
years. For this reason, the program intends to convene a series of 
workshops to evaluate the rodent cancer bioassay, beginning with choice 
of species and strain. Future workshops will address other study design 
issues, such as diet, study length, and age at exposure. The ultimate 
goal of any change to the NTP cancer bioassay is to improve the 
identification of carcinogenic potential (i.e., hazard identification) 
and/or improve our ability to predict cancer in humans.

Request for Comments

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments on any agenda topic. Each 
organization is allowed one time slot per agenda topic. 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 then that for pre-registered speakers and will 
be determined by the number of persons who register at 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 (https://ntp.niehs.nih.gov select ``Meetings and 
Workshops'').
    Persons submitting written comments should include their name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization (if any) with the document. Individuals wishing to submit 
historical control data are encouraged to contact Dr. Angela King-
Herbert prior to submission (see FOR FURTHER INFORMATION CONTACT 
above).

References

    Festing, MF. (1995). Use of a multistrain assay could improve the 
NTP carcinogenesis bioassay. Environ Health Perspect. 1995 
Jan;103(1):44-52. Available: https://ehp.niehs.nih.gov/.
    Meeting Minutes of the NTP Board of Scientific Counselors (BSC)--
June 29, 2004. Available: https://ntp-server.niehs.nih.gov/ntpweb/
index.cfm?objectid=720164F2-BDB7-CEBA-F5C6A2E21851F0C4.
    Meeting Minutes of the NTP Board of Scientific Counselors Technical 
Reports Review Subcommittee (TRR Subcommittee)--May 22, 2003. 
Available: https://ntp-server.niehs.nih.gov/ntpweb/
index.cfm?objectid=9404F3B3-F1F6-975E-70F0DB8B0FDF8F86.
    Meeting Minutes of the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM)--March 10-11, 2004. Available: https://
ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=AF6CC417-F1F6-975E-
75B5F3FF7DF1CDDC.

    Dated: March 22, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-6605 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-P

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