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Federal Register Summary for the Week of May 10-14 2004

COMMERCE

Technology Administration; National Medal of Technology's Call for Nominations 2005

AGENCY: Technology Administration, Department of Commerce.
ACTION: Announcement: call for nominations for the National Medal of Technology 2005.

SUMMARY: The Department of Commerce's Technology Administration is accepting nominations for its National Medal of Technology (NMT) 2005 program.
Established by Congress in 1980, the President of the United States awards the National Medal of Technology annually to our Nation's leading innovators. If you know of a candidate who has made an outstanding contribution in technology, obtain a nomination form from:
http://www.technology.gov/medal.

DATES: The deadline for submission of an application is July 28, 2004.

ADDRESSES: The NMT Nomination form for the year 2005 can be obtained by visiting the Web site at http://www.technology.gov/medal. Please return the completed application to Mildred Porter, Director of the NMT program, at: .

FOR FURTHER INFORMATION CONTACT: Mildred Porter, Director, at or call 202/482-5572.

http://edocket.access.gpo.gov/2004/04-10711.htm


National Oceanic and Atmospheric Administration; Office of Oceanic and Atmospheric Research (OAR); NOAA Research Review Team Report

AGENCY: Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
ACTION: Notice and request for public comment.

SUMMARY: The Office of Oceanic and Atmospheric Research publishes this notice to announce the availability of the NOAA Research Review Team Draft of the Final Report for public comment. The NOAA Research Report is compiled pursuant to requests from the House and Senate Appropriations Subcommittees in their 2003 reports. The report accompanying the House Commerce, Justice State (CJS) Appropriations Subcommittee requests that NOAA review research in NOAA, and specifically OAR, for the purpose of improving the effectiveness and efficiency of its research enterprise. The report addresses how NOAA should improve the management of research to ensure its maximum efficiency and effectiveness.

DATES: Comments on this draft document must be submitted by June 23, 2004.

ADDRESSES: The NOAA Research Review Team Report will be available on the SAB website at http://www.sab.noaa.gov/reports/RRT_final-draft_052504.pdf on May 25, 2004.

The public is encouraged to submit comments electronically to . For commenters who do not have access to a computer, comments may be submitted in writing to: NOAA Research, Science Advisory Board, (SAB) c/o Ms. M.Whitcomb, Silver Spring Metro Center Bldg 3 Room 11558, 1315 East-West Highway, Silver Spring, Maryland 20910.

FOR FURTHER INFORMATION CONTACT: Ms. M. Whitcomb, Silver Spring Metro Center Bldg 3 Room 11558, 1315 East-West Highway, Silver Spring, Maryland 20910 (phone 301-713-2454 x 173), during normal business hours of 8 a.m. to 5 p.m. Eastern Time, Monday through Friday, or visit the SAB web site at: http://www.sab.noaa.gov/reports/RRT_final-draft_052504.pdf.

SUPPLEMENTARY INFORMATION: The Office of Oceanic and Atmospheric Research (OAR) publishes this notice to announce the availability of the NOAA Research Report for public comment. NOAA Research will post the NOAA Research Draft of the Final Report for public comment on May 25, 2004. NOAA Research is seeking public comment from all interested parties. This final report is being issued for comment only and is not intended for interim use. Suggested changes will be incorporated, where appropriate, in the report being submitted to the Congress.

The NOAA Research Report is compiled pursuant to requests from the House and Senate Appropriations Subcommittees in their 2003 reports. The report accompanying the House Commerce, Justice State (CJS) Appropriations Subcommittee requests that NOAA review research in NOAA, and specifically OAR, for the purpose of improving the effectiveness and efficiency of its research enterprise. The report addresses how NOAA should improve the management of research to ensure its maximum efficiency and effectiveness.

In response to the Congressional report language, NOAA appointed an ``Ad Hoc Review Team,'' (here called the NOAA Research Review Team), under the auspices of the SAB consisting of five members to compile the requested information. The Review team will be disbanded once the review is completed and a final report issued. This panel is tasked with: (1) Conducting a review of OAR for the purpose of improving the effectiveness and efficiency of its research enterprise; (2) Determining if OAR is adequately linked to NOAA's service organizations, [i.e., National Weather Service (NWS), National Environmental Satellite Data, and Information Service (NESDIS), National Marine Fisheries Service (NMFS), and the National Ocean Service (NOS)]; (3) Assessing whether the research programs are relevant to the needs of these organizations. The team's recommendations will assist NOAA in responding to the language in the 2004 House and Senate CJS appropriation reports.

The NOAA Research Review Team is presenting its findings to the SAB in two (2) reports. The first report was posted for public comments in December 2003, and was submitted to NOAA on January 29, 2004. The final report, which incorporates the first draft report, will be posted on the SAB web site at: http://www.sab.noaa.gov/reports/RRT_final-draft_052504.pdf on May 25, 2004 for public comment. Public comments may be submitted from May 25, 2004 to 30 days after May 25, or June 23, 2004.

NOAA welcomes all comments on the content of the report. We also request comments on any inconsistencies perceived within the report, and possible omissions of important topics or issues. For any shortcoming noted within the draft report, please propose specific remedies.

Please follow these instructions for preparing and submitting a review. Using the format guidance described below will facilitate the processing of reviewer comments and assure that all comments are appropriately considered. Please provide background information about yourself on the first page of your comments: your name(s), organization(s), area(s) of expertise, mailing address(es), telephone and fax numbers, email address(es). Overview comments on the section should follow your background information and should be numbered. Comments that are specific to particular pages, paragraphs or lines of the section should follow any overview comments and should identify the page numbers to which they apply. Please number all pages, (on the upper right hand of each page,) and print identifying information at the top of each page.

http://edocket.access.gpo.gov/2004/04-10935.htm


ENVIRONMENTAL PROTECTION AGENCY



Request for Nominations to the National Advisory Council for Environmental Policy and Technology (NACEPT)

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of request for nominations.

SUMMARY: The U.S. Environmental Protection Agency invites nominations to fill vacancies on its National Advisory Council for Environmental Policy and Technology (NACEPT). The Agency seeks qualified senior-level decision makers from diverse sectors throughout the United States to be considered for appointments. EPA encourages interested applicants to send their resumes and qualifications as soon as possible.

ADDRESSES: Submit nominations to: Ms. Sonia Altieri, Designated Federal Officer, Office of Cooperative Environmental Management, U.S. Environmental Protection Agency (1601E), 1200 Pennsylvania Avenue, NW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Sonia Altieri, Designated Federal Officer for NACEPT, U.S. Environmental Protection Agency (1601E), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone (202) 233-0061, e-mail:

SUPPLEMENTARY INFORMATION: NACEPT is a federal advisory committee under the Federal Advisory Committee Act, PL 92463. The U.S. Environmental Protection Agency established NACEPT in 1988 to provide independent advice to the EPA Administrator on a broad range of environmental policy, technology and management issues. NACEPT consists of a representative cross-section of EPA's partners, stakeholders, and constituents who provide timely advice and recommendations on environmental issues, and serve as a sounding board for new strategies that EPA is developing.

We anticipate the Council addressing issues related to environmental technology, environmental foresight, and collaborative approaches to environmental problems. NACEPT will provide advice in a timely manner and operate as a proactive and strategic body that will alert EPA to potential environmental challenges and issues that could impact the Agency's ability to protect public health and the environment, and options to address them.

Members are appointed by the Administrator of EPA for two year terms with the possibility of reappointment. The Council usually meets 3-4 times annually and the average workload for the members is approximately 10 to 15 hours per month. Members serve on the Council in a voluntary capacity; however, EPA does provide reimbursement for travel expenses associated with official government business.

Maintaining a balance and diversity of expertise, knowledge, and judgement is an important consideration in the selection of members. Potential candidates should possess the following qualifications:

Occupy a senior position within their organization
Broad experience outside of their current position
Experience dealing with public policy issues
Membership in broad-based networks
Extensive experience in the environmental field
Recognized expert in the subject matter to be addressed by NACEPT

EPA is seeking nominees for representation from all sectors, in particular federal, state, local and tribal agencies, academia, industry, environmental justice, and non-governmental organizations. Nominations for membership must include a resume and short biography describing the educational and professional qualifications of the nominee and the nominee's current business address and daytime telephone number.

http://edocket.access.gpo.gov/2004/04-10878.htm


HEALTH AND HUMAN SERVICES

Food and Drug Administration

Revision of the Requirements for Spore-Forming Microorganisms; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.

SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of June 1, 2004, for the direct final rule that appeared in the Federal Register of December 30, 2003 (68 FR 75116). The direct final rule amends the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore-forming microorganisms. This document confirms the effective date of the direct final rule.

DATES: Effective date confirmed: June 1, 2004.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 30, 2003 (68 FR 75116), FDA issued a direct final rule amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore-forming microorganisms. The regulations were amended due to advances in facility, system, and equipment design and in sterilization technologies that allow work with spore-forming microorganisms to be performed in multiproduct manufacturing areas.

FDA solicited comments concerning the direct final rule for a 75-day period ending March 15, 2004. FDA stated that the effective date of the direct final rule would be on June 1, 2004, unless any significant adverse comment was submitted to FDA during the comment period. FDA received only one comment (from private industry) on the direct final rule. The comment requested FDA to revise Sec. 600.11(e)(4) (21 CFR 600.11(e)(4)), and asked whether this rulemaking affects the interpretation of Sec. 600.11(e)(4). That comment is beyond the scope of this rulemaking, which is not intended to affect the requirements for live vaccine processing set forth in Sec. 600.11(e)(4). FDA has determined that the received comment is not a significant adverse comment.

Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, the amendments issued thereby become effective on June 1, 2004.

http://edocket.access.gpo.gov/2004/04-11027.htm

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