Office of the Director; Office of Dietary Supplements: Notice of Opportunity for Public Comment and Public Meeting, 17103-17105 [05-6606]

Download as PDF 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 17104 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices the Director, NIH, in 1995 as a major provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA). A key early activity was the development of a Strategic Plan to define the mission of ODS and to define program goals. It was prepared with considerable input from NIH Institutes and Centers, several Federal agencies, consumers, and other interested parties. The original Strategic Plan guided ODS activities and programs from 1998 to 2003. In 2003, the Office of Dietary Supplements undertook a public process to review its original Strategic Plan and developed a revised Strategic Plan for 2004–2009 entitled, ‘‘Promoting Quality Science in Dietary Supplement Research, Education, and Communication’’. This document was published in January 2004 and is available by e-mail request to ods@nih.gov, and on the ODS Web site at https://ods.od.nih.gov. The revised ODS Strategic Plan for 2004–2009 reviews the programs and activities that were initiated under the original Strategic plan during 1998– 2003 and identified five major program goals related to research, education and communication for 2004–2009: • Expand the evaluation of the role of dietary supplements in disease prevention and in reduction of risk factors associated with disease. • Foster research that evaluates the role of dietary supplements in maintaining and improving optimal physical and mental health and performance. • Stimulate and support research to further understanding of the biochemical and cellular effects of dietary supplements on biological systems and their physiological impact across the life cycle. • Promote and support the development and improvement of methodologies appropriate to the scientific study of dietary supplement ingredients. • Expand and conduct outreach activities that inform and educate the public, health care providers, and scientists about the benefits and risks of dietary supplements. Since its inception in 1995 under DSHEA, the original and revised strategic plans focus on implementation of the ODS Mission: ‘‘to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.’’ VerDate jul<14>2003 15:19 Apr 01, 2005 Jkt 205001 The ODS will hold an open public meeting on May 20, 2005 at the location and time listed below to receive comments and suggestions on additional needs and opportunities related to the 2004–2009 ODS Strategic Plan. Information about the meeting, including a link to the registration form and the tentative agenda, is available on ODS Web site https://ods.od.nih.gov. There is no registration fee. The overall purpose of this public meeting is to provide interested parties a time to identify new opportunities and emerging needs for possible incorporation in the ODS research, education, and communication programs and activities. To address this purpose, guidance is being requested from all persons and organizations in the dietary supplement community. Materials that describe the current ODS programs and activities, information about the public meeting, and a link to the meeting registration form are available on the ODS Web site at https://ods.od.nih.gov. In addition, the materials are available from the Office at the address listed below. On or about April 15, 2005, information and data on ODS programs and activities will be updated and will be available on the ODS Web site and at the address listed below as well as at the public meeting. The open meeting will begin with a brief presentation of the current and emerging programs and activities of the ODS. Several invited speakers representing the broad range of interests in the dietary supplement user community will be asked to comment on emerging needs and opportunities that can enhance the scope and depth of ODS programs. There will be an opportunity for individuals and organizations to provide their views and suggestions on possible additional directions that ODS should consider in its five year Strategic Plan. We will use all information received at the meeting as well as written comments received by 5 p.m. e.s.t., on June 30, 2005 in response to this request in considering modifications to the ODS Strategic Plan for 2004–2009. Comments and suggestions should be forwarded to the address listed below or sent to ODSplan@od.nih.gov. Results of this review will be shared with the ODS Trans-NIH/Agency Working Group, a Federal interagency group convened by ODS to enhance cooperation and communication across Federal departments, agencies, institutes, centers, and offices concerning research, education , and communication about dietary supplements. In addition, results of this review will be posted on the ODS PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Web site and will be available upon request. Meeting Title: Office of Dietary Supplements Public Meeting. Date: May 20, 2005. Time: 9 a.m.–4 p.m. Place: Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Kenneth D. Fisher, Ph.D., Office of Dietary Supplements, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892–7517, Phone: (301) 435–2920, Fax: (301) 480–1845, e-mail: ODSplan@od.nih.gov. Public Participation The meeting is open to the public with attendance limited by the availability of space on a first come, first served basis. Interested persons and organizations that wish to present oral comments should indicate this when registering on the ODS Web site or at https://www.scgcorp.com/odspublicmtg, no later than May 6, 2005. Oral comments will be limited to three minutes; however, submission of additional documentation is encouraged. Individuals who register to speak will be assigned in the order in which they registered. Due to time constraints, only one representative from each organization will be allotted time for oral presentation. We may limit the number of speakers and the time allotted depending on the number of registrants. All requests to register should include the name, address, telephone number, and business or professional affiliation of the interested party. If time permits, we will allow any person attending the meeting who has not registered to speak in advance of the meeting to make a brief oral statement during the time set aside for public comments and at the chairperson’s discretion. We encourage individuals unable to attend the meeting and all interested parties to send written comments to the Office of Dietary Supplements by mail, fax, or electronically. If possible, comments that are mailed or faxed should also be forwarded electronically. Persons needing special assistance, such as sign language interpretation or other special accommodations at the meeting should indicate this when registering or contact the Office of Dietary Supplements at the address or telephone number listed no later than April 29, 2005. E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices Dated: March 23, 2005. Paul M. Coates, Director, Office of Dietary Supplements, Office of the Director, National Institutes of Health. [FR Doc. 05–6606 Filed 4–1–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Submission for OMB Review; Comment Request Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, U.S. Department of Homeland Security. ACTION: Notice and request for comments. AGENCY: SUMMARY: The Federal Emergency Management Agency (FEMA) has submitted the following information collection to the Office of Management and Budget (OMB) for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The submission describes the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and includes the actual data collection instruments FEMA will use. Title: Implementation of Coastal Barrier Resources Act. OMB Number: 1660–0010. Abstract: When an application for flood insurance is submitted for buildings located in Coastal Barrier Resources (CBRS) communities, one of the following types of documentation must be submitted as evidence of eligibility: —Certification from a community official stating the building is not located in a designated CBRS area. —A legally valid building permit or certification from a community official stating that the building’s start of construction date precede the date that the community was identified in the system. Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions; Farms; Federal Government; and State, Local or Tribal Government. Number of Respondents: 60. Estimated Time per Respondent: 1.5 hours. VerDate jul<14>2003 15:19 Apr 01, 2005 Jkt 205001 Estimated Total Annual Burden Hours: 90 hours. Frequency of Response: Once. Comments: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs at OMB, Attention: Desk Officer for the Department of Homeland Security/FEMA, Docket Library, Room 10102, 725 17th Street, NW., Washington, DC 20503, or facsimile number (202) 395–7285. Comments must be submitted on or before 30 days from the date of this notice is published in the Federal Register. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection should be made to Muriel B. Anderson, Section Chief, Records Management, FEMA at 500 C Street, SW., Room 316, Washington, DC 20472, facsimile number (202) 646–3347, or e-mail address FEMA-InformationCollections@dhs.gov. Dated: March 18, 2005. George S. Trotter, Acting Branch Chief, Information Resources Management Branch, Information Technology Services Division. [FR Doc. 05–6544 Filed 4–1–05; 8:45 am] BILLING CODE 9110–11–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA–1584–DR] Alaska; Major Disaster and Related Determinations Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security. ACTION: Notice. AGENCY: This is a notice of the Presidential declaration of a major disaster for the State of Alaska (FEMA– 1584–DR), dated March 14, 2005, and related determinations. EFFECTIVE DATE: March 14, 2005. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646–2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated March 14, 2005, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 17105 U.S.C. 5121–5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Alaska, resulting from a severe winter storm on January 7–12, 2005, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121– 5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Alaska. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance in the designated areas; Hazard Mitigation throughout the State; and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible cost. If Other Needs Assistance under Section 408 of the Stafford Act is later warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, William Lokey, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Alaska to have been affected adversely by this declared major disaster: North Slope Borough for Public Assistance. All boroughs and Regional Education Attendance Areas in the State of Alaska are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program—Other Needs; 97.036, Public E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17103-17105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6606]


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

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

[[Page 17104]]

the Director, NIH, in 1995 as a major provision of the Dietary 
Supplement Health and Education Act of 1994 (DSHEA). A key early 
activity was the development of a Strategic Plan to define the mission 
of ODS and to define program goals. It was prepared with considerable 
input from NIH Institutes and Centers, several Federal agencies, 
consumers, and other interested parties. The original Strategic Plan 
guided ODS activities and programs from 1998 to 2003.
    In 2003, the Office of Dietary Supplements undertook a public 
process to review its original Strategic Plan and developed a revised 
Strategic Plan for 2004-2009 entitled, ``Promoting Quality Science in 
Dietary Supplement Research, Education, and Communication''. This 
document was published in January 2004 and is available by e-mail 
request to ods@nih.gov, and on the ODS Web site at https://
ods.od.nih.gov.
    The revised ODS Strategic Plan for 2004-2009 reviews the programs 
and activities that were initiated under the original Strategic plan 
during 1998-2003 and identified five major program goals related to 
research, education and communication for 2004-2009:
     Expand the evaluation of the role of dietary supplements 
in disease prevention and in reduction of risk factors associated with 
disease.
     Foster research that evaluates the role of dietary 
supplements in maintaining and improving optimal physical and mental 
health and performance.
     Stimulate and support research to further understanding of 
the biochemical and cellular effects of dietary supplements on 
biological systems and their physiological impact across the life 
cycle.
     Promote and support the development and improvement of 
methodologies appropriate to the scientific study of dietary supplement 
ingredients.
     Expand and conduct outreach activities that inform and 
educate the public, health care providers, and scientists about the 
benefits and risks of dietary supplements.
    Since its inception in 1995 under DSHEA, the original and revised 
strategic plans focus on implementation of the ODS Mission: ``to 
strengthen knowledge and understanding of dietary supplements by 
evaluating scientific information, stimulating and supporting research, 
disseminating research results, and educating the public to foster an 
enhanced quality of life and health for the U.S. population.''
    The ODS will hold an open public meeting on May 20, 2005 at the 
location and time listed below to receive comments and suggestions on 
additional needs and opportunities related to the 2004-2009 ODS 
Strategic Plan. Information about the meeting, including a link to the 
registration form and the tentative agenda, is available on ODS Web 
site https://ods.od.nih.gov. There is no registration fee. The overall 
purpose of this public meeting is to provide interested parties a time 
to identify new opportunities and emerging needs for possible 
incorporation in the ODS research, education, and communication 
programs and activities. To address this purpose, guidance is being 
requested from all persons and organizations in the dietary supplement 
community.
    Materials that describe the current ODS programs and activities, 
information about the public meeting, and a link to the meeting 
registration form are available on the ODS Web site at https://
ods.od.nih.gov. In addition, the materials are available from the 
Office at the address listed below. On or about April 15, 2005, 
information and data on ODS programs and activities will be updated and 
will be available on the ODS Web site and at the address listed below 
as well as at the public meeting.
    The open meeting will begin with a brief presentation of the 
current and emerging programs and activities of the ODS. Several 
invited speakers representing the broad range of interests in the 
dietary supplement user community will be asked to comment on emerging 
needs and opportunities that can enhance the scope and depth of ODS 
programs. There will be an opportunity for individuals and 
organizations to provide their views and suggestions on possible 
additional directions that ODS should consider in its five year 
Strategic Plan.
    We will use all information received at the meeting as well as 
written comments received by 5 p.m. e.s.t., on June 30, 2005 in 
response to this request in considering modifications to the ODS 
Strategic Plan for 2004-2009. Comments and suggestions should be 
forwarded to the address listed below or sent to ODSplan@od.nih.gov. 
Results of this review will be shared with the ODS Trans-NIH/Agency 
Working Group, a Federal interagency group convened by ODS to enhance 
cooperation and communication across Federal departments, agencies, 
institutes, centers, and offices concerning research, education , and 
communication about dietary supplements. In addition, results of this 
review will be posted on the ODS Web site and will be available upon 
request.
    Meeting Title: Office of Dietary Supplements Public Meeting.
    Date: May 20, 2005.
    Time: 9 a.m.-4 p.m.
    Place: Marriott Bethesda North Hotel and Conference Center, 5701 
Marinelli Road, North Bethesda, MD 20852.
    Contact Person: Kenneth D. Fisher, Ph.D., Office of Dietary 
Supplements, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892-
7517, Phone: (301) 435-2920, Fax: (301) 480-1845, e-mail: 
ODSplan@od.nih.gov.

Public Participation

    The meeting is open to the public with attendance limited by the 
availability of space on a first come, first served basis. Interested 
persons and organizations that wish to present oral comments should 
indicate this when registering on the ODS Web site or at https://
www.scgcorp.com/odspublicmtg, no later than May 6, 2005.
    Oral comments will be limited to three minutes; however, submission 
of additional documentation is encouraged. Individuals who register to 
speak will be assigned in the order in which they registered. Due to 
time constraints, only one representative from each organization will 
be allotted time for oral presentation. We may limit the number of 
speakers and the time allotted depending on the number of registrants. 
All requests to register should include the name, address, telephone 
number, and business or professional affiliation of the interested 
party. If time permits, we will allow any person attending the meeting 
who has not registered to speak in advance of the meeting to make a 
brief oral statement during the time set aside for public comments and 
at the chairperson's discretion.
    We encourage individuals unable to attend the meeting and all 
interested parties to send written comments to the Office of Dietary 
Supplements by mail, fax, or electronically. If possible, comments that 
are mailed or faxed should also be forwarded electronically.
    Persons needing special assistance, such as sign language 
interpretation or other special accommodations at the meeting should 
indicate this when registering or contact the Office of Dietary 
Supplements at the address or telephone number listed no later than 
April 29, 2005.


[[Page 17105]]


    Dated: March 23, 2005.
Paul M. Coates,
Director, Office of Dietary Supplements, Office of the Director, 
National Institutes of Health.
[FR Doc. 05-6606 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.