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Federal Register Summary for the Week of 30 August-3 September 2004

DEFENSE

Office of the Secretary

Strategic Environmental Research and Development Program, Scientific Advisory Board

AGENCY: Department of Defense.

ACTION: Notice.

SUMMARY: In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following Committee meeting.

DATES: October 13, 2004 from 8 a.m. to 5:15 p.m. and October 14, 2004 from 8 a.m. to 4:10 p.m.

ADDRESSES: SERDP Program Office, 901 North Stuart Street, Suite 804, Arlington, VA 22203.

FOR FURTHER INFORMATION CONTACT: Ms. Veronica Rice, SERDP Program Office, 901 North Stuart Street, Suite 303, Arlington, VA or by telephone at (703) 696-2119.

SUPPLEMENTARY INFORMATION:

Matters To Be Considered

Research and Development proposals and continuing projects requesting Strategic Environmental Research and Development Program funds in excess of $1M will be reviewed.
This meeting is open to the public. Any interested person may attend, appear before, or file statements with the Scientific Advisory Board at the time and in the manner permitted by the Board.

http://edocket.access.gpo.gov/2004/04-20113.htm


HEALTH AND HUMAN SERVICES

Office of the Secretary

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. October 19, 2004 at the Marriott Hotel Bethesda at 5151 Pooks Hill Road, Bethesda, Maryland. The meeting will be open to the publc 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. Sarah 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/2004/04-19850.htm


National Institutes of Health

National Library of Medicine; Notice of Meeting

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be open to the public as indicated below, 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 portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual journals.

Name of Committee: Literature Selection Technical Review Committee.
Date: October 28-29, 2004.
Open: October 28, 2004, 9 a.m. to 11 a.m.
Agenda: Administrative reports and program discussions.
Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894.

Closed: October 28, 2004, 11 a.m. to 5 p.m.
Agenda: To review and evaluate journals as potential titles to be indexed by the National Library of Medicine.
Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894.

Closed: October 29, 2004, 8:30 a.m. to 2 p.m.
Agenda: To review and evaluate journals as potential titles to be indexed by the National Library of Medicine.
Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894.
Contact Person: Sheldon Kotzin, MLS, Chief, Bibliographic Services Division, Division of Library Operations, National Library of Medicine, 8600 Rockville Pike, Bldg. 38A/Room 4N419, Bethesda, MD 20894.

Any interested person may file written comments with the Committee by forwarding the statement to the Contact Person listed on this Notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person.

In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and sign in at the security desk upon entering the building.

http://edocket.access.gpo.gov/2004/04-19846.htm


From Concept to Consumer: Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

The Food and Drug Administration (FDA), is announcing a public workshop entitled "From Concept to Consumer: Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies.'' The goal of the public workshop is to provide a forum for stakeholders to discuss opportunities for and potential approaches to the development of innovative scientific knowledge and tools to facilitate the development and availability of new biological products including vaccines, blood and blood products, and cellular, tissue, and gene therapies.

Date and Time: The public workshop will be held on October 7, 2004, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at The Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD.

Contact Person: Melanie Whelan, Center for Biologics Evaluation and Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-3841, FAX: 301-827-3079, e-mail: Whelan@cber.fda.gov.

Registration: Mail, fax, or e-mail the registration information (including name, title, affiliation, address, and telephone and fax numbers) to Melanie Whelan (see Contact Person) by September 30, 2004.

Because seating is limited, we recommend early registration. There is no registration fee for the workshop. If you need special accommodations due to a disability, please contact Melanie Whelan (see Contact Person) at least 7 days in advance.

Comments: Regardless of attendance at the public workshop, interested persons may submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 written or electronic comments by September 23, 2004. Submit electronic comments to http://www/fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION: The goal of this workshop is to provide a public forum for input and discussion concerning opportunities for the enhancement of scientific knowledge and tools for safety, efficacy, and product quality that can be used to more effectively and efficiently develop and evaluate new biological products in the areas described.

On March 16, 2004, FDA released a report addressing the recent slowdown in innovative medical therapies submitted to FDA for approval entitled ``Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products'' at http://www.fda.gov/oc/initiatives/criticalpath/. That report describes the urgent need to create the scientific and technological "tools'' to modernize the medical product development process--the Critical Path--to make medical product development more predictable and less costly.

The Center for Biologics Evaluation and Research (CBER) is seeking input from government and nongovernment research organizations, medical professional organizations, health care practitioners, patients, disease interest groups, pharmaceutical and biological product manufacturers and their industry organizations, and others with interests in facilitating development of the biological products that CBER regulates. The workshop will cover delineation of opportunities in key technologies and medical science knowledge needed to contribute to science based evaluation of the safety and efficacy of those biological products, and innovative development processes to manufacture them. FDA will discuss and welcomes input concerning all applicable areas of science including, but not limited to, bench laboratory investigations, clinical research and clinical trial design and execution, facility and anufacturing process research, statistical and epidemiological research, and computer science and computer modeling research. The workshop will not cover discussions of biological product discovery and invention or regulatory policies. The workshop will include presentations by FDA speakers and breakout sessions with panels composed of both FDA staff and non-FDA stakeholders, with an opportunity for public questions and comments.

FDA will post the agenda for this public workshop, when finalized on CBER's Web sites at http://www.fda.gov/cber/scireg.htm and http://www.fda.gov/cber/minutes/workshop-min.htm.
Transcripts: Please note that transcripts of the workshop will not be prepared.

http://edocket.access.gpo.gov/2004/04-19778.htm


INTERIOR

National Park Service

Notice of Availability of the Draft United States World Heritage Periodic Report for Public Review

SUMMARY: The National Park Service (NPS) announces the availability of the draft United States World Heritage Periodic Report for public review. The draft Periodic Report was prepared in compliance with US commitments under the World Heritage Convention, an international conservation treaty. The Periodic Report consists of the following three components: Section I, a national overview report on US implementation of the World Heritage Convention in the context of overall cultural and natural resource protection and management in the nation; Section II, individual site reports on the current status of each US World Heritage Site with particular reference to the condition of the outstanding universal value for which the site was inscribed on the World Heritage List; and, a joint US-Canada North American Regional Report outlining the key strengths and issues facing World Heritage in the region.

Periodic reporting provides an opportunity for the United States and Canada to raise international awareness of their World Heritage Sites and to provide for the continued protection of these sites and their outstanding universal value.

DATES: There will be a 60-day public review period for these documents. Comments must be received on or before November 1, 2004.

ADDRESSES: The US World Heritage Periodic Report will be available to the public on the NPS Office of International Affairs Web site at http://www.nps.gov/oia/topics/periodic.htm.

FOR FURTHER INFORMATION CONTACT: Stephen Morris, National Park Service, Office of International Affairs, 1849 C Street, NW., (org. code 0050), Washington, DC 20240; or by calling (202) 354-1800.

SUPPLEMENTARY INFORMATION: Under the World Heritage Convention, both the United States and Canada are required to submit a country-specific periodic report and a joint regional periodic report for North America, by the end of 2004. Periodic reporting provides the World Heritage Committee with an overview of each participating nation's implementation of the World Heritage Convention and a "snapshot'' of current conditions at World Heritage Sites.

In 1998, the World Heritage Committee approved a periodic reporting format and process to provide up-to-date information about the application of the World Heritage Convention and the state of conservation of World Heritage Sites around the world. The Periodic Report for North America (followed by the Periodic Report for Europe) once accepted by the World Heritage Committee, represent the conclusion of the first cycle of periodic reporting by the various regions of the world as defined by the World Heritage Committee.

Each periodic report is comprised of three sections:

In Section I, each country reports on the application of the World Heritage Convention. This includes: Identifying properties of cultural or natural value on their territory; legal measures and efforts to protect, conserve and present cultural and natural heritage; international cooperation and fund-raising; and education, information and awareness-building activities.

Section II describes the state of conservation of specific World Heritage Sites located in each country and updates the information that was provided to the World Heritage Committee at the time of inscription. The main objective is to assess whether the World Heritage values, for which the property was inscribed on the World Heritage List, are being maintained over time.
The National Park Service is responsible for developing the United States' country-specific periodic report and Parks Canada is responsible for developing Canada's country-specific periodic report. The United States and Canada worked together to develop the third component, a joint regional report outlining the major strengths and issues facing World Heritage in the region as a whole. Both countries have coordinated consultations with World Heritage Site managers and information sharing with key stakeholders.

The ultimate objective is to produce concise, accurate periodic reports for both the United States and Canada, and a joint regional periodic report for North America that fully address the requirements of the World Heritage convention and focus on the criteria established by the World Heritage Committee.

Public Comment Solicitation: Persons wishing to comment on these documents may do so by mailing written comments to Stephen Morris, National Park Service, Office of International Affairs, 1849 C Street, NW., (org. code 0050), Washington, DC 20240. They also may submit written comment via e-mail to WASO--Office-- of_International_Affairs@nps.gov (include name and return address in the e-mail message).

The NPS practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request we withhold their home address from the record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from the record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.

http://edocket.access.gpo.gov/2004/04-19788.htm


Advisory Committee on Water Information (ACWI)

AGENCY: United States Geological Survey, Interior.

ACTION: Notice of an open meeting of the Advisory Committee on Water Information (ACWI).

SUMMARY: Notice is hereby given of a meeting of the ACWI. This meeting of the ACWI is to discuss broad policy-related topics relating to national water initiatives, and to hear reports from ACWI subgroups.

The proposed agenda will include a series of discussions concerning various U.S. Government policies and programs related to the development and dissemination of water information.

The ACWI has been established under the authority of the Office of Management and Budget Memorandum 92-01 and the Federal Advisory Committee Act. The purpose of the ACWI is to provide a forum for water-information users and professionals to advise the Federal Government of activities and plans that may improve the effectiveness of meeting the Nation's water information needs. More than 30 organizations were invited by the Secretary of the Interior to be representatives on ACWI. These include Federal departments, State, local, and tribal government organizations, industry, academia, agriculture, environmental organizations, professional societies, and volunteer groups.

DATES: The formal meeting will convene at 8:30 a.m., on September 14, 2004, and will adjourn on September 15, 2004, at 4:30 p.m.

ADDRESSES: Days Hotel and Conference Center, 2200 Centreville Road, Herndon, Virginia.

FOR FURTHER INFORMATION CONTACT: Ms. Toni M. Johnson (Executive Secretary), Chief, Water Information Coordination Program, U.S. Geological Survey, 12201 Sunrise Valley Drive, 417 National Center, Reston, VA 20192. Telephone: 703-648-6810; Fax: 703-648-5644.

SUPPLEMENTARY INFORMATION: This meeting is open to the public. Up to a half hour will be set aside for public comment. Persons wishing to make a brief presentation (up to 5 minutes) are asked to provide a written request with a description of the general subject to Ms. Johnson at the above address no later than noon, September 8, 2004. It is requested that 40 copies of a written statement be submitted at the time of the meeting for distribution to members of the ACWI and placement in the official file. Any member of the public may submit written information and (or) comments to Ms. Johnson for distribution at the ACWI Meeting.

http://edocket.access.gpo.gov/2004/04-20007.htm


NATIONAL SCIENCE FOUNDATION

Proposal Review; Notice of Meetings

In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces its intent to hold proposal review meetings throughout the year. The purpose of these meetings is to provide advice and recommendations concerning proposals submitted to the NSF for financial support. The agenda for each of these meetings is to review and evaluate proposals as part of the selection process for awards. The review and evaluation may also include assessment of the progress of awarded proposals. The majority of these meetings will take place at NSF, 4201 Wilson Blvd., Arlington, Virginia 22230.
These meetings will be closed to the public. The proposals being reviewed include information of a proprietary or confidential nature, including technical information; financial data, such as salaries; and personal information concerning individuals associated with the proposals. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act. NSF will continue to review the agenda and merits of each meeting for overall compliance of the Federal Advisory Committee Act.

These closed proposal review meetings will not be announced on an individual basis in the Federal Register. NSF intends to publish a notice similar to this on a quarterly basis. For an advance listing of the closed proposal review meetings that include the names of the proposal review panel and the time, date, place, and any information on changes, corrections, or cancellations, please visit the NSF Web site:
http://www.nsf.gov/home/pubinfo/advisory.htm. This information may also be requested by telephoning (703) 292-8182.


National Science Board; Committee on Education and Human Resources; Sunshine Act Meeting

Date and Time: September 14, 4 p.m.-5:30 p.m. (e.d.t.).

Place: The National Science Foundation, Stafford I Building, Room 130, 4201 Wilson Boulevard, Arlington, VA 22230.

Status: This meeting will be open to the public.

Matters to be Considered:

Tuesday, September 14, 2004

Open Session (4 p.m. to 5:30 p.m.): Consideration of the Broadening Participation in Science and Engineering Research and Education draft revisions by the National Science Board Committee on Education and Human Resources.

FOR FURTHER INFORMATION CONTACT: Robert Webber, Senior Policy Analyst, NSB, (703) 292-7000, http://www.nsf.gov/nsb.

http://edocket.access.gpo.gov/2004/04-20115.htm

WHITE HOUSE

OFFICE OF SCIENCE AND TECHNOLOGY POLICY

Workshop on National Nanotechnology Initiative Research Directions Sponsored with the National Science and Technology Council, Subcommittee on Nanoscale Science, Engineering and Technology

ACTION: Notice of open meeting.

SUMMARY: This notice announces a workshop sponsored by the Nanoscale Science, Engineering and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC) and the National Nanotechnology Coordination Office (NNCO) to review the current program of the National Nanotechnology Initiative (NNI) and to make program recommendations for the next five to ten years.

DATES: The Nanoscale Science, Engineering and Technology Subcommittee (NSET) and the National Nanotechnology Coordination Office will hold a two-day workshop on Wednesday, September 8, 2004, 10:30 a.m. to 6 p.m.; and Thursday, September 9, 2004, 8:30 a.m. to 6 p.m.

ADDRESSES: All sessions of the workshop will be held at the National Academy of Sciences Building, 2100 C St., NW., Washington, DC 20418, USA.

For information regarding this Notice, please contact Cate Alexander, National Nanotechnology Coordination Office. Telephone: (703) 292-4399. E-mail: calexand@nnco.nano.gov.

The Nanoscale Science Engineering and Technology (NSET) Subcommittee coordinates planning, budgeting, program implementation and review to ensure a balanced and comprehensive National Nanotechnology Initiative. The NSET Subcommittee is composed of representatives from agencies participating in the NNI.

The purpose of this workshop is to provide feedback to the NSET regarding the current NNI program and to make recommendations to guide the development of a new NNI strategic plan for the next five to ten years. Following presentations on research progress in funded program areas, workshop participants will be asked to review current NNI research areas and to evaluate and make recommendations about the future structure and funding components of the NNI including the grand challenge areas. Background materials on current funding areas can be found in the report National Nanotechnology Initiative; esearch and Development Supporting the Next Industrial Revolution, Supplement to the President's FY2004 Budget, October 2003, which is posted on the Internet at http://www.nano.gov/html/res/fy04-pdf/fy04-main.html.
Public Participation: This meeting is open to the public. Time has been reserved for public comments (restricted to 5 minutes maximum for each participant; written statements may be submitted) at 5 p.m. on September 8, 2004. Registration for the workshop is required. Interested persons can register at https://nnco.nano.gov/public_rd2/index.php.
The NNCO assists the NSET Subcommittee of the Committee on Technology of the NSTC in coordinating the NNI. The NSTC was established under Executive Order 12881.

http://edocket.access.gpo.gov/2004/04-20139.htm

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