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Federal Register Summary for the Week of 23-27 August 2004

AGRICULTURE

Confinement of Genetically Engineered Crops During Field Testing; Workshop

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of meeting.

SUMMARY: This is to notify parties involved in those fields associated with the confinement of genetically engineered crops, as well as other interested persons, that a workshop will be held to review past results and obtain an update on the most recent scientific results relevant to biological dispersal and confinement of genetically engineered crops during field testing. The workshop is being organized by the Animal and Plant Health Inspection Service.

DATES: The workshop will be held September 13 through 15, 2004, from 8:30 a.m. to 5 p.m. each day. The sessions on September 13 and 14, 2004, will include panels of invited scientific experts. The session on September 15, 2004, will be open to the public.

ADDRESSES: The workshop will be held at the USDA Center at Riverside, 4700 River Road, Riverdale, MD.

FOR FURTHER INFORMATION CONTACT: Ms. Robyn Rose, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0489, or e-mail: Robyn.I.Rose@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests," (referred to below as the regulations) regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered "regulated articles."

Field tests of genetically engineered crops planted under an Animal and Plant Health Inspection Service (APHIS) permit as plant-made pharmaceuticals (PMPs) and plant-made industrials (PMIs) are currently being conducted under the regulations. In order to provide a forum for the discussion of past and current information relevant to biological and physical factors that influence the design, implementation, efficacy, and feasibility of measures used to confine transgenic plants and their progeny to the authorized field sites, APHIS is organizing a workshop. This workshop will provide a forum for discussing measures that can be taken to limit gene flow beyond the authorized site, commingling with other crops, and persistence of transgenic plants in the environment following termination of the field trial. The workshop will primarily focus on plants most frequently used as PMPs and PMIs, such as corn, barley, rice, safflower, and tobacco, with three break-out groups that will examine wind pollination of crops using corn as a model, self-pollinated crops using rice as a model, and insect-pollinated crops using safflower as a model.

This workshop is scheduled for September 13 through 15, 2004. The sessions on the first 2 days of the workshop will include panels of invited scientific experts. The third day will be open to the public and the results of the panel discussions will be summarized. Preregistration is required for all those who wish to attend the third day of the workshop. The deadline for preregistration is September 10, 2004. Information regarding the meeting and registration instructions are available on the Internet at http://www.aphis.usda.gov/brs/new_info.html. Questions that will be discussed during the workshop may be viewed on the Internet at http://www.aphis.usda.gov/brs/confine_workshop/confine_questions.pdf.

The third day of the workshop will be open to the public. Persons interested in making an oral presentation during the third day of the workshop related to the topic of the workshop should submit a brief written statement or abstract of the science they wish to present, the name and address of each person who will participate in the presentation, and an estimate of the approximate length of time needed to make the presentation. This information should be submitted to the person listed under FOR FURTHER INFORMATION CONTACT no later than September 6, 2004. The number of oral resentations on the third day of the workshop and the time allocated for each may be limited, depending upon the number of requests. Send all statements or abstracts to the person listed under FOR FURTHER INFORMATION CONTACT. Please state that your statement or abstract refers to Docket No. 04-074-1. If you use e-mail, your comment must be contained in the body of your message or sent as an attachment in WordPerfect or Microsoft Word format. Please include your name and address in your message and "Docket No. 04-074-1" on the subject line.

Following the workshop, a proceedings will be published that will summarize the information gathered during the workshop. The proceedings will outline methods for physical, temporal, spatial, and biological confinement of transgenes incorporated into wind-pollinated, insect-pollinated, and primarily self-pollinating crops along with information regarding their efficacy and feasibility of implementation. The effects of scale and use of models to predict or compare efficacy of options will also be addressed. Information gathered during the workshop will be summarized to illustrate the interaction of available tools for gene confinement to form a comprehensive and flexible approach to field testing. Scientific data and references will be included in a bibliography as part of the proceedings.

Parking and Security Procedures

Please note that a fee of $2.25 is required to enter the parking lot at the USDA Center at Riverside. The machine accepts $1 bills or quarters.

Upon entering the building, visitors should inform security personnel that they are attending the Crop Field Testing workshop. Identification is required. Security personnel will direct visitors to the sign-in tables located outside of the Conference Center. All participants must sign in upon arrival. Conference badges must be worn throughout the day.

http://edocket.access.gpo.gov/2004/04-19235.htm

EDUCATION

Office of Postsecondary Education, Fund for the Improvement of Postsecondary Education

ACTION: Notice Announcing Technical Assistance Workshops for Fiscal Year (FY) 2005 Comprehensive Program.

SUMMARY: This notice provides information about four workshops to assist individuals interested in learning more about the Fiscal Year (FY) 2005 programs of the Fund for the Improvement of Postsecondary Education (FIPSE). Program staff will present program information and answer questions about FIPSE's programs. The workshops will focus primarily on the Comprehensive Program, which provides grants for innovative reform projects that hold promise as models for the resolution of important issues and problems in postsecondary education. Additional information about FIPSE's programs can be found on the Internet at the following site: http://www.ed.gov/FIPSE.

Although the Department has not yet announced an application deadline date for its FY 2005 FIPSE grant competitions in the Federal Register, the Department is holding these workshops to give potential applicants relevant background information on FIPSE programs for which grant competitions are expected to be held in FY 2005. Specific requirements for grant competitions will be announced in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Levenia Ishmell, U.S. Department of Education, 1990 K Street, NW., room 8031, Washington, DC 20006-8544. Telephone: (202) 502-7668 or by e-mail: levenia.ishmell@ed.gov.

If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the program contact person listed in this section.

SUPPLEMENTARY INFORMATION: The technical assistance workshops will be held as follows:

  1. Atlanta, Georgia: Monday, September 27, 12:30-3:30 p.m. Hilton Garden Inn Atlanta Airport-Millenium Center, 2301 Sullivan Road, College Park, GA 30337. Phone: 404-766-0303.
  2. St. Louis, Missouri: Wednesday, September 29, 12:30-3:30 p.m. Renaissance St. Louis Airport Hotel, 9801 Natural Bridge Road, St. Louis, MO 63134. Phone: 314-429-1100.
  3. Los Angeles, California: Thursday, September 30, 12:30-3:30 p.m. Westin Los Angeles Airport Hotel, 5400 West Century Boulevard, Los Angeles, CA 90045. Phone: 310-216-5858.
  4. Washington, DC: Tuesday, October 5, 10 a.m. -1 p.m. with optional writing clinic 2-4 p.m. Barnard Auditorium, Education Department, 400 Maryland Avenue, SW., Washington, DC 20202.

Space at the workshops is limited. Interested individuals are invited to register at this site: http://www.ed.gov/FIPSE.

Please indicate the location you are requesting. You will receive an e-mail reply confirming the status of your registration along with exact information on workshop locations. All confirmed registrants are asked to bring their printed e-mail confirmation to the workshop.

Assistance to Individuals With Disabilities Attending the Technical Assistance Workshops

The technical assistance workshop sites are accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the workshop (e.g., interpreting service, assistive listening device, or materials in an alternative format) notify the contact person listed under FOR FURTHER INFORMATION CONTACT at least two weeks before the scheduled workshop date. Although we will attempt to meet a request received after this date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Electronic Access to This Document

You may view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/news/fedregister.

To use PDF you must have Adobe Acrobat Reader, which is available free at the site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free at 1-888-293-6498, or in the Washington, DC area at (202) 512-1530.

Note: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO Access at: http://www.gpoaccess.gov/nara/index.html

http://edocket.access.gpo.gov/2004/04-19275.htm

ENERGY

Office of Energy Efficiency and Renewable Energy

Biomass Research and Development Technical Advisory Committee

ACTION: Notice of open meeting.

SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory Committee under the Biomass Research and Development Act of 2000. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that agencies publish these notices in the Federal Register to allow for public participation. This notice announces the meeting of the Biomass Research and Development Technical Advisory Committee.

DATES: September 29, 2004. Time: 8:30 a.m.

ADDRESSES: Hilton Crystal City Hotel at National Airport,2399 Jefferson Davis Highway,Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Don Richardson, Designated Federal Officer for the Committee, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585; (202) 586-7766.

SUPPLEMENTARY INFORMATION: Purpose of Meeting: To provide advice and guidance that promotes research and development leading to the production of biobased industrial products.

Tentative Agenda: Agenda will include discussions on the following:

The Biomass R&D Technical Advisory Committee will meet to develop the 2004 Recommendations to the Secretaries of Energy and Agriculture. The Biomass R&D Technical Advisory Committee will begin developing its 2005 Work Plan.

Public Participation: In keeping with procedures, members of the public are welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, you should contact Don Richardson at 202-586-7766 or the Biomass Initiative at laura.neal@ee.doe.gov (e-mail). You must make your request for an oral statement at least 5 business days before the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chair of the Committee will make every effort to hear the views of all interested parties. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. The Chair will conduct the meeting to facilitate the orderly conduct of business.

Minutes: The minutes of the meeting will be available for public review and copying within 60 days at the Freedom of Information Public Reading Room; Room 1E-190; Forrestal Building; 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

http://edocket.access.gpo.gov/2004/04-19605.htm

ENVIRONMENTAL PROTECTION AGENCY

Science Advisory Board Staff Office, Environmental Economics Advisory Committee; Notification of Public Advisory Committee Meeting (Teleconference)

ACTION: Notice.

SUMMARY: The Environmental Protection Agency (EPA or Agency), Science Advisory Board (SAB) Staff Office announces a public teleconference for the SAB Environmental Economics Advisory Committee (EEAC) to discuss follow-on matters related to its consultation on the valuation of mortality risk reduction.

DATES: The teleconference will take place on Monday, September 20, 2004, from 1 p.m. to 2:30 p.m. (Eastern Time).

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to obtain the teleconference call-numbers and access codes or who wishes to submit written or brief oral comments (five minutes or less), must contact Dr. Holly Stallworth, Designated Federal Officer (DFO), EPA Science Advisory Board (1400A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone/voice mail: (202) 343-9867.

Requests to provide oral comments must be in writing (e-mail, fax, or mail) and received by Dr. Stallworth no later than five business days prior to the teleconference in order to reserve time on the meeting agenda. It is the policy of the EPA Science Advisory Board Staff Office to accept written public comments of any length, and to accommodate oral public comments whenever possible.

SUPPLEMENTARY INFORMATION: Background: The EEAC, a committee of the EPA Science Advisory Board, is a Federal advisory committee chartered under the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. The EEAC is charged with providing advice, information andrecommendations through the chartered SAB to the Agency on the economic issues associated with various EPA programs.

The EEAC held a public meeting in Washington, DC on May 13, 2004 to provide consultative advice to the EPA National Center for Environmental Economics on the valuation of mortality risk reduction. Background on this review was provided in a Federal Register notice published on April 22, 2004 (Vol. 69, No. 78). Minutes of the May 13, 2004 consultation are available on the SAB Web site. The meeting agenda for the September 20, 2004 teleconference will continue this consultative project with a discussion of four questions related to the valuation of mortality risk reduction. This agenda will be posted on the SAB Web site at: http://www.epa.gov/sab prior to the meeting.

http://edocket.access.gpo.gov/2004/04-19437.htm

Board of Scientific Counselors, Executive Committee Meeting--Fall 04

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-463, the Environmental Protection Agency, Office of Research and Development (ORD), gives notice of an Executive Committee meeting of the Board of Scientific Counselors (BOSC).

DATES: The meeting will be held on Wednesday, September 22, 2004 from 9:30 a.m. to 5:30 p.m. Time has been allotted from 8:30 a.m. to 9:30 a.m. for BOSC members of four subcommittees (Endocrine Disrupting Chemicals (EDCs), Computational Toxicology, Global Change, and Mercury) to meet prior to the Executive Committee meeting. The meeting will continue on Thursday, September 23, 2004 from 8:30 a.m. to 3:15 p.m. All times noted are eastern time. The meeting may adjourn early on Thursday if all business is finished.

ADDRESSES: The meeting will be held at the Washington Plaza Hotel, 10 Thomas Circle NW., Washington, DC 20005.

Document Availability

Any member of the public interested in receiving a draft BOSC agenda or making a presentation at the meeting may contact Ms. Lorelei Kowalski, Designated Federal Officer, via telephone/voice mail at (202) 564-3408, via e-mail at kowalski.lorelei@epa.gov, or by mail at Environmental Protection Agency, Office of Research and Development, Mail Code 8104-R, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.

In general, each individual making an oral presentation will be limited to a total of three minutes. Requests for the draft agenda or for making oral presentations at the meeting will be accepted up to 1 business day before the meeting date. The draft agenda can also be viewed through EDOCKET, as provided in Unit I.A. of the SUPPLEMENTARY INFORMATION section.

Submitting Comments

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I.B. of the SUPPLEMENTARY INFORMATION section. Written comments will be accepted up to 1 business day before the meeting date.

FOR FURTHER INFORMATION CONTACT: Ms. Lorelei Kowalski, Designated Federal Officer, via telephone/voice mail at (202) 564-3408, via e-mail at kowalski.lorelei@epa.gov, or by mail at Environmental Protection Agency, Office of Research and Development, Mail Code 8104-R, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION:

I. General Information

Proposed agenda items for the meeting include, but are not limited to: Briefings on ORD's nanotechnology program and EMAP; discussion of BOSC review of ORD research programs; update on review committees for mercury, computational toxicology, endocrine disruptors, and global change; discussion of a proposal to hold a risk assessment workshop in 2005, ORD's Biotechnology Research Strategy and Coastal Health report, and interagency relationships; update on EPA's Science Advisory Board activities; discussion of the BOSC's FY05 work agenda; and future issues and plans (including the Communications and Nomination Subcommittees). The meeting is open to the public.

Information on Services for the Handicapped: Individuals requiring special accommodations at this meeting should contact Lorelei Kowalski, Designated Federal Officer, at (202) 564-3408, at least five business days prior to the meeting so that appropriate arrangements can be made to facilitate their participation.

A. How Can I Get Copies of Related Information?

  1. Docket

    EPA has established an official public docket for this action under Docket ID No. ORD-2004-0014. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Documents in the official public docket are listed in the index in EPA's electronic public docket and comment system, EDOCKET. Documents may be available either electronically or in hard copy. Electronic documents may be viewed through EDOCKET. Hard copy of the draft agenda may be viewed at the Board of Scientific Counselors, Executive Committee Meeting-Fall-04 Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket is (202) 566-1752.

  2. Electronic Access

    You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/.

    An electronic version of the public docket is available through EDOCKET. You may use EDOCKET at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select "search," then key in the appropriate docket identification number. For public commenters, it is important to note that EPA's policy is that public comments, hether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

    Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket.

B. How and To Whom do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period.

  1. Electronically

    If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    i. EDOCKET. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EDOCKET at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet Home Page, http://www.epa.gov, select "Information Sources," "Dockets," and "EDOCKET." Once in the system, select "search," and then key in Docket ID No. ORD-2004-0014. The system is an anonymous access system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

    ii. E-mail. Comments may be sent by electronic mail (e-mail) to ORD.Docket@epa.gov, Attention: Docket ID No. ORD-2004-0014. In contrast to EPA's electronic public docket, EPA's e-mail system is not an anonymous access system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.B.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.2. By Mail

    Send your comments to: U.S. Environmental Protection Agency, ORD Docket, EPA Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention: Docket ID No. ORD-2004-0014.

  2. By Hand Delivery or Courier

    Deliver your comments to: EPA Docket Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC, Attention: Docket ID No. ORD-2004-0014. (Note: this is not a mailing address.) Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.A.1.

http://edocket.access.gpo.gov/2004/04-19612.htm

HEALTH AND HUMAN SERVICES

Public Meeting of the President's Council on Bioethics on September 9-10, 2004

AGENCY: The President's Council on Bioethics, HHS.

ACTION: Notice.

SUMMARY: The President's Council on Bioethics (Leon R. Kass, M.D., chairman) will hold its eighteenth meeting, at which, among other things, it will continue its discussion of the ethical implications of developments in neuroscience. It will also continue discussing ethical issues relating to the treatment of the aged and end-of-life care. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: cloning, stem cell research, embryo research, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), and Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004).

DATES: The meeting will take place Thursday, September 9, 2004, from 9 a.m. to 4:30 p.m. ET; and Friday, September 10, 2004, from 8:30 a.m. to 12:30 p.m. ET.

ADDRESSES: Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202.

Agenda: The meeting agenda will be posted at http://www.bioethics.gov.

Public Comments: The Council encourages public input, either in person or in writing. At this meeting, interested members of the public may address the Council, beginning at 11:30 a.m., on Friday, September 10. Comments are limited to no more than five minutes per speaker or organization. As a courtesy, please inform Ms. Diane Gianelli, Director of Communications, in advance of your intention to make a public statement, and give your name and affiliation. To submit a written statement, mail or e-mail it to Ms. Gianelli at one of the addresses given below.

FOR FURTHER INFORMATION CONTACT: Ms. Diane Gianelli, Director of Communications, The President's Council on Bioethics, Suite 700, 1801 Pennsylvania Avenue, Washington, DC 20006. Telephone: (202) 296-4669. E-mail: info@bioethics.gov. Web site: http://www.bioethics.gov.

http://edocket.access.gpo.gov/2004/04-19286.htm

National Institutes of Health

Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society

Pursuant to Public Law 92-463, notice is hereby given of the fifth meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 8:30 a.m. to 5 p.m. on October 18, 2004 and 8:30 a.m. to 3 p.m. on October 19, 2004 at the Marriott Hotel Bethesda at 5151 Pooks Hill Road, Bethesda, Maryland. The meeting will be open to the public with attendance limited to space available. The meeting will be webcast. The first half of the first day will be devoted to a session to receive testimony from individuals who have been affected by genetic discrimination in health insurance and employment. The second half of the first day will include presentations related to and discussion of a revised draft report on coverage and reimbursement for genetic technologies and services and the development of recommendations on the issues identified in the report. Discussion of the draft coverage and reimbursement report will continue throughout the first half of the second day. The second day will end with a status report on the National Academy of Sciences' study of genomics and patents and discussions of future plans for Committee action on the issues of pharmacogenomics and large population studies. Time will be provided each day for public comments.

Under authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic technologies and, as warranted, to provide advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the webcast, will be available at the following Web site: http://www4.od.nih.gov/oba/sacghs.htm.

The Committee would welcome hearing from anyone wishing to provide public comment on any issue related to genetics, health and society. In addition, the Committee is specifically seeking written public comment from individuals who have experienced genetic discrimination in health insurance or in employment, who fear genetic discrimination, or who have paid out of pocket for services to keep genetic information out of medical records. Individuals who would like to provide public comment or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the SACGHS Executive Secretary, Ms. Sara Carr, by telephone at 301-496-9838 or E-mail at sc112c@nih.gov. The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892.

http://edocket.access.gpo.gov/2004/04-19545.htm

Meeting of the National Vaccine Advisory Committee

AGENCY: Department of Health and Human Services, Office of the Secretary.

ACTION: Notice.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.

DATES: The meeting will be held on October 5, 2004, from 9 a.m. to 3:30 p.m., and on October 6, 2004, from 9 a.m. to 3:30 p.m.

ADDRESSES: Department of Health and Human Services; Hubert H. Humphrey Building, Room 800; 200 Independence Avenue, SW., Washington, DC 20201.

FOR FURTHER INFORMATION, CONTACT: Ms. Emma English, Program Analyst, National Vaccine Program Office, Department of Health and Human Services, Room 725H Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; (202) 690-5566, nvac@osophs.dhhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public Service Act (42 U.S.C. 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program (NVP) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Secretary designated the ssistant Secretary for Health to serve as the Director, NVPO. The National Vaccine Advisory Committee (NVAC) was established to provide advice and make recommendations to the Director, NVPO, on matters related to the program's responsibilities.

Topics to be discussed at the meeting include: Pandemic Influenza and the Pandemic Influenza Response and Preparedness Plan and the NVAC Influenza Working Group's assessment of domestic influenza issues/needs. Updates will be given on the NVAC Working Group on Public Participation, the NVAC Working Group on Vaccine Financing, the NVAC Vaccine Safety and Communications Subcommittee, the NVAC Futures Vaccines Subcommittee, and the NVAC Immunization Coverage Subcommittee. A tentative agenda will be made available on or about September 21 for review on the NVAC Web site: http://www.hhs.gov/nvpo/nvac.

Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the Humphrey Building. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed material distributed to NVAC members should submit materials to the Executive Secretary, NVAC, through the contact person listed above prior to close of business September 29, 2004. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvac@osophs.dhhs.gov

http://edocket.access.gpo.gov/2004/04-19601.htm

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