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Federal Register Summary for the Week of 16-20 August 2004

AGRICULTURE

Office of the Under Secretary, Research, Education, and Economics; Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture Meeting

AGENCY: Agricultural Research Service, Agriculture.

ACTION: Notice of meeting.

SUMMARY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. App. II, the United States Department of Agriculture announces a meeting of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21).

DATES: September 13-14, 2004, 8:30 a.m. to 5 p.m. on the first day and 8 a.m. to 4 p.m. on the second day. Written requests to make oral presentations at the meeting must be received by the contact person identified herein at least three business days before the meeting.

ADDRESSES: Monticello Ballroom at the Wyndham Washington Hotel, 1400 M Street, NW., Washington, DC 20005. Requests to make oral presentations at the meeting may be sent to the contact person at USDA, Office of the Deputy Secretary, 202 B Jamie L. Whitten Federal Building, 12th and Independence Avenues, SW., Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Michael Schechtman, Designated Federal Official, Office of the Deputy Secretary, USDA, Telephone (202) 720-3817; Fax (202) 690-4265; E-mail mschechtman@ars.usda.gov.

SUPPLEMENTARY INFORMATION: The sixth meeting of the AC21 has been scheduled for September 13-14, 2004. The AC21 consists of 18 members representing the biotechnology industry, the seed industry, international plant genetics research, farmers, food manufacturers, commodity processors and shippers, environmental and consumer groups, and academic researchers. In addition, representatives from the Departments of Commerce, Health and Human Services, and State, and the Environmental Protection Agency, the Council on Environmental Quality, and the Office of the United States Trade Representative serve as "ex officio'' members. The AC21 at this meeting will continue its work to develop a report examining the impacts of agricultural biotechnology on American agriculture and USDA over the next 5 to 10 years, specifically: to review two draft introductory chapters prepared by USDA staff with input from specific AC21 members; to review the progress of two work groups on developing report chapters on potential issues to consider and on preparing for the future and to provide guidance to them in their work. The AC21 will also discuss the progress of a work group drafting a separate report for the committee's consideration on the issue of the proliferation of traceability and mandatory labeling regimes for biotechnology-derived products in other countries, the implications of those regimes, and what industry is doing to attempt to address those requirements for products shipped to those countries.

Background information regarding the work of the AC21 will be available on the USDA Web site at http://www.usda.gov/agencies/biotech/ac21.html. On September 13, 2004, if time permits, reasonable provision will be made for oral presentations of no more than five minutes each in duration.

The meeting will be open to the public, but space is limited. If you would like to attend the meetings, you must register by contacting Ms. Dianne Harmon at (202) 720-4074, by fax at (202) 720-3191 or by E-mail at dharmon@ars.usda.gov at least 5 days prior to the meeting. Please provide your name, title, business affiliation, address, and telephone and fax numbers when you register. If you require a sign language interpreter or other special accommodation due to disability, please indicate those needs at the time of registration.

http://edocket.access.gpo.gov/2004/04-19030.htm

Animal and Plant Health Inspection Service

International Sanitary and Phytosanitary Standard-Setting Activities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice and request for comments.

SUMMARY: In accordance with legislation implementing the results of the Uruguay Round of negotiations under the General Agreement on Tariffs and Trade, we are informing the public of international standard- setting activities of the Office International des Epizooties, the Secretariat of the International Plant Protection Convention, and the North American Plant Protection Organization, and we are soliciting public comment on the standards to be considered.

ADDRESSES: You may submit comments by any of the following methods:

Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-058-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 04-058-1.

E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and ``Docket No. 04-058-1'' on the subject line.

Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site.

Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

Other Information: You may view APHIS documents published in the Federal Register and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For general information on the topics covered in this notice, contact Mr. John Greifer, Director, Trade Support Team, International Services, APHIS, room 1132, South Building, 14th Street and Independence Avenue, SW., Washington, DC 20250; (202) 720-7677. For specific information regarding standard-setting activities of the Office International des Epizooties, contact Dr. Michael David, Chief, Sanitary International Standards Team, VS, APHIS, 4700 River Road Unit 33, Riverdale, MD 20737-1231; (301) 734-8093. For specific information regarding the standard-setting activities of the International Plant Protection Convention or the North American Plant Protection Organization, contact Mr. Narcy Klag, Program Director, Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-8469.

http://edocket.access.gpo.gov/2004/04-19005.htm

COMMERCE

NOAA Five-Year Research Plan Draft and NOAA Twenty-Year Research Vision Draft

AGENCY: National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

ACTION: Notice and Request for Public Comment.

SUMMARY: NOAA publishes this notice to announce the availability of the NOAA 5-Year Research Plan Draft and the NOAA 20-Year Research Vision Draft for public comment.

DATES: Comments on these draft documents must be submitted by September 30, 2004.

ADDRESSES: The NOAA 5-Year Research Plan Draft will be available at the following location: ftp://www.oarhq.noaa.gov/review/5 and the NOAA 20-

Year Research Vision Draft will be available at: ftp://www.oarhq.noaa.gov/review/20 .

The public is encouraged to submit comments on the NOAA 5-Year Research Plan Draft electronically to: Review.5Year@noaa.gov. The public is encouraged to submit comments on the NOAA 20-Year Research Vision Draft electronically to: Review.20Year@noaa.gov. For commenters who do not have access to a computer, comments on both documents may be submitted in writing to: NOAA Research, c/o Dr. Terry Schaefer, Silver Spring Metro Center Bldg. 3, Room 11863, 1315 East-West Highway, Silver Spring, Maryland 20910.

FOR FURTHER INFORMATION CONTACT: Dr. Terry Schaefer, Silver Spring Metro Center Bldg. 3, Room 11863, 1315 East-West Highway, Silver Spring, Maryland 20910 (phone (301) 713-2465 ext. 184), during normal business hours of 8 a.m. to 5 p.m. Eastern Time, Monday through Friday, or visit the NOAA Research Council Web site at: http://www.nrc.noaa.gov/Reports.htm.

SUPPLEMENTARY INFORMATION: NOAA is publishing this notice to announce the availability of the NOAA 5-Year Research Plan Draft and the NOAA 20-Year Research Vision Draft for public comment. The NOAA 5-Year Research Plan Draft and the NOAA 20-Year Research Vision Draft will be posted for public comment on August 20, 2004. The NOAA Research Council is seeking public comment from all interested parties. The NOAA 5-Year Research Plan Draft and the NOAA 20-Year Research Vision are being issued for comment only and are not intended for interim use. Suggested changes will be incorporated, where appropriate, in the final version.

The NOAA 5-Year Research Plan and the NOAA 20-Year Research Vision are being developed by the NOAA Research Council in response to a January 2004 recommendation from the NOAA Science Advisory Board that NOAA take immediate steps to promulgate a NOAA-wide research plan that is consistent with NOAA's Strategic Plan.

The NOAA 5-Year Research Plan Draft lays the path for how NOAA's research enterprise will begin to deliver, in the short-term, improvements to existing forecasting tools. This plan explicitly states outcomes for the short term and the milestones by which we intend to measure progress towards achieving those outcomes, framed within a vision of a future NOAA.

In order to address the longer-term research goals of the agency, the Research Council has developed the NOAA 20-Year Research Vision Draft. This high-level document intends to outline some of the potential products and services that NOAA will provide in the future, and will further aid environmental forecasting and management over the next 20 years.

NOAA welcomes all comments on the content of the NOAA 5-Year Research Plan Draft and the NOAA 20-Year Research Vision Draft. We also request comments on any inconsistencies perceived within the documents, and possible omissions of important topics or issues. For any shortcoming noted within the draft documents, please propose specific remedies.

Please adhere to the instructions detailed herein for preparing and submitting your comments. 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, e-mail address(es). Overview comments 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 and print identifying information at the top of all pages.

Public comments may be submitted from August 20, 2004, through September 30, 2004.

http://edocket.access.gpo.gov/2004/04-19219.htm

Visiting Committee on Advanced Technology

AGENCY: National Institute of Standards and Technology, Department of Commerce.

ACTION: Notice of partially closed meeting.

SUMMARY: Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app. 2, notice is hereby given that the Visiting Committee on Advanced Technology, National Institute of Standards and Technology (NIST), will meet Monday, September 13, 2004, from 1 p.m. to 5:30 p.m. and Tuesday, September 14, 2004, from 8 a.m. to 2:15 p.m. The Visiting Committee on Advanced Technology (VCAT) is composed of fifteen members appointed by the Director of NIST; who are eminent in such fields as business, research, new product development, engineering, labor, education, management consulting, environment, and international relations. The purpose of this meeting is to review and make recommendations regarding general policy for the Institute, its organization, its budget, and its programs within the framework of applicable national policies as set forth by the President and the Congress. The agenda will include an update on NIST's activities; a review of NIST's performance evaluation system; an update on NRC's FY04-05 biennial assessment process of NIST laboratories; a VCAT panel discussion on the Management of Organizations with Remote Sites in the U.S.; and the NIST response to VCAT recommendations from the FY 2003 Annual Report. There also will be a presentation on NIST's studies to improve first responder communications and three laboratory tours in the areas of measurement science and biosystems and health. Discussions scheduled to begin at 1 p.m. and to end at 2 p.m., on September 13, and to begin at 11 a.m. and to end at 2:15 p.m. on September 14, 2004, on the NIST budget, planning information and feedback sessions will be closed. Agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site. All visitors to the National Institute of Standards and Technology site will have to pre-register to be admitted. Please submit your name, time of arrival, e-mail address and phone number to Carolyn Peters no later than Thursday, September 9, 2004, and she will provide you with instructions for admittance. Ms. Peter's e-mail address is carolyn.peters@nist.gov and her phone number is 301/975-5607.

DATES: The meeting will convene September 13, 2004, at 1 p.m. and will adjourn at 2:15 p.m. on September 14, 2004.

ADDRESSES: The meeting will be held in the Radio Building, Room 1107 (seating capacity 60, includes 35 participants), at NIST, Boulder, Colorado. Please note admittance instructions under SUMMARY paragraph.

FOR FURTHER INFORMATION CONTACT: Carolyn J. Peters, Visiting Committee on Advanced Technology, National Institute of Standards and Technology, Gaithersburg, Maryland 20899-1000, telephone number (301) 975-5607.

SUPPLEMENTARY INFORMATION: The Assistant Secretary for Administration, with the concurrence of the General Counsel, formally determined on December 24, 2004, that portions of the meeting of the Visiting Committee on Advanced Technology which deal with discussion of sensitive budget and planning information that would cause harm to third parties if publicly shared be closed in accordance with section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. app. 2.

http://edocket.access.gpo.gov/2004/04-18866.htm

Patent and Trademark Office

Disclosure Document Program

ACTION: Proposed collection; comment request.

SUMMARY: The United States Patent and Trademark Office (USPTO), as part of itscontinuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the continuing and proposed information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

DATES: Written comments must be submitted on or before October 18, 2004.

ADDRESSES: You may submit comments by any of the following methods:

E-mail: Susan.Brown@uspto.gov. Include ``0651-0030 comment'' in the subject line of the message.

Fax: 703-308-7407, marked to the attention of Susan Brown.

Mail: Susan K. Brown, Records Officer, Office of the Chief Information Officer, Office of Data Architecture and Services, Data Administration Division, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to the attention of Robert J. Spar, Director, Office of Patent Legal Administration, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 703-308-5107; or by e-mail at bob.spar@uspto.gov.

SUPPLEMENTARY INFORMATION:

I. Abstract

A service provided by the USPTO is the acceptance and preservation for two years of a "disclosure document'' as evidence of the date of conception of an invention. A disclosure document is a paper disclosing an invention, signed by the inventor or inventors, and submitted to the USPTO. The document should contain a clear and complete explanation of the manner and process of making and using the invention in sufficient detail to enable a person having ordinary knowledge in the field of the invention to make and use the invention. The disclosure document request must be accompanied by a separate signed cover letter stating that it is submitted by, or on behalf of, the inventor, and requesting that the material be received into the Disclosure Document Program. These documents will be kept in confidence by the USPTO without publication in accordance with 35 U.S.C. 122(b).

The disclosure document will be preserved by the USPTO for two years after its receipt, and then destroyed unless it is referred to in a separate letter in a related patent application filed within the two year period. The disclosure document is not a patent application, and the date of its receipt in the USPTO will not become the effective filing date of any patent application subsequently filed.

The information supplied to the USPTO by an applicant seeking to prove the date of conception for an invention is used by the USPTO as evidence of the date of conception of an invention.

There is one form associated with this information collection, Form PTO/SB/95, Disclosure Document Deposit Request.

II. Method of Collection

By mail, facsimile, or hand carried to the USPTO when the inventor desires to participate in the Disclosure Document Program.

III. Data

OMB Number: 0651-0030.

Form Number(s): PTO/SB/95.

Type of Review: Extension of a currently approved collection.

Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; farms; the Federal government; and State, local or tribal governments.

Estimated Number of Respondents: 22,225 responses.

Estimated Time Per Response: The USPTO estimates that it will take the public approximately 12 minutes, depending upon the complexity of the situation, to gather, prepare, and submit a disclosure document deposit request.

Estimated Total Annual Respondent Burden Hours: 4,445 hours.

Estimated Total Annual Respondent Cost Burden: $1,271,270. The USPTO expects that the information in this collection will be prepared by attorneys. Using the professional hourly rate of $286 per hour for associate attorneys in private firms, the USPTO estimates that the respondent cost burden for submitting the information in this collection will be $1,271,270 per year.

IV. Request for Comments

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they will also become a matter of public record.

http://edocket.access.gpo.gov/2004/04-18929.htm

DEFENSE

Office of the Secretary Board of Visitors Meeting AGENCY: Defense Acquisition University. ACTION: Board of visitors meeting.

SUMMARY: The next meeting of the Defense Acquisition University (DAU) Board of Visitors (BoV) will be held at Defense Acquisition University, Fort Belvoir, VA. The purpose of this meeting is to report back to the BoV on continuing items of interest.

DATES: September 8, 2004 from 0900-1500.

ADDRESSES: Packard Conference Center, Defense Acquisition University, Bldg. 184, Fort Belvoir, VA 22060.

FOR FURTHER INFORMATION CONTACT: Ms. Patricia Cizmadia at 703-805-5134.

SUPPLEMENTARY INFORMATION: The meeting is open to the public; however, because of space limitations, allocation of seating will be made on a first-come, first served basis. Persons desiring to attend the meeting should call Ms. Patricia Cizmadia at 703-805-5134.

http://edocket.access.gpo.gov/2004/04-18874.htm

ENVIRONMENTAL PROTECTION AGENCY

Science Advisory Board Staff Office; Notification of Upcoming Science Advisory Board Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a public face-to-face meeting of the chartered SAB. The Board will discuss science issues facing EPA Regions; review and approve of two SAB Committee draft reports; discuss and approve the FY 2005 SAB plans; and plan for the SAB annual meeting. The SAB Staff Office also announces a public meeting of the SAB's Committee on Valuing the Protection of Ecological Systems and Services (C-VPESS) to focus on regional science issues related to the Committee's charge.

DATES:

September 13-14, 2004. A public meeting of the Board will be held from 9 a.m. to 5:30 p.m (Pacific Time) on September 13, 2004, and from 8:30 a.m. to 4 p.m. (Pacific Time) on September 14, 2004.

September 13-15, 2004. A public meeting of the C-VPESS will be held from 1 p.m. to 3:45 p.m (Pacific Time) on September 13, 2004; from 8 a.m. to 6 p.m. (Pacific Time) on September 14, 2004; and from 8 a.m. to 11:30 a.m. (Pacific Time) on September 15, 2004.

ADDRESSES: The meetings of the Board and the C-VPESS will be held at the U.S. EPA Region 9 Headquarters Office, 75 Hawthorne Street, San Francisco, CA 94105.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to obtain further information regarding the Board may contact Mr. Thomas O. Miller, Designated Federal Officer (DFO), U.S. EPA Science Advisory Board via phone (202-343-9982) or e-mail at miller.tom@epa.gov, or Dr. Anthony Maciorowski, Associate Director for Science, U.S. EPA Science Advisory Board via phone (202-343-9983) or e-mail at maciorowski.anthony@epa.gov.

Members of the public wishing further information regarding the C-VPESS meeting may contact Dr. Angela Nugent, Designated Federal Officer (DFO), via telephone at: (202-343-9981) or e-mail at: nugent.angela@epa.gov.

The SAB Mailing address is: U.S. EPA, Science Advisory Board (1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. General information about the SAB, as well as any updates concerning the meetings announced in this notice, may be found in the SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION: Background on the Board Meeting: At this meeting, the Science Advisory Board will focus on the following: (a) Science programs of EPA Region 9, (b) the FY 2005 SAB plan, (c) the review of two draft SAB Panel reports, and (d) planning for the SAB Annual meeting scheduled for December 1-2, 2004. Any additional items that might be discussed will be reflected in the meeting agenda that will be posted on the SAB website prior to the meeting.

(a) EPA Regional Science Issues--The SAB will receive briefings from, and discuss scientific issues, with Regional senior leadership and scientists. These are designed to (1) inform the SAB about regional science issues and concerns; (2) identify opportunities for future SAB and Regional office interactions on topics of interest; and (3) provide the regions with insights into the overall SAB role in advising the Agency on the technical underpinnings of the Agency's science and environmental decisions.

(b) SAB FY 2005 Plan--The Board will finalize its operational plans for FY 2005. This will include discussions of projects nominated by Agency offices and regions, projects nominated by SAB and its Committees, and its continuing information gathering activities in support of the SAB review of EPA's science budget.

(c) Review of SAB Committee Draft Reports: The Board will review two draft SAB reports. Reports to be considered include: (1) The SAB's draft report Review of EPA's Draft Report on the Environment 2003, and (2) SAB's draft report Report of the U.S. EPA Science Advisory Board's 3MRA Panel on the Multimedia, Multipathway, and Multireceptor Risk Assessment (3MRA) Modeling System. Information on these reviews, and drafts of each report, can be found on the SAB Web site at: http: // http://www.epa.gov/sab/drrep.htm.

(d) Planning for the SAB Annual Meeting: The Board will discuss its plans for its Annual Meeting of the SAB which is scheduled to be held in Washington, DC on December 1-2, 2004.

Background on the C-VPESS Meeting: Background on the Committee and its charge was provided in 68 FR 11082 (March 7, 2003). The purpose of the meeting is for the Committee to focus on regional science needs, work-products, and activities by holding panel discussions, briefings, and break-out groups. The SAB will receive briefings on issues related to the value of protecting ecological systems and services in Region 9 and discuss scientific issues, with Regional senior leadership and scientists.

All of these activities are related to the Committee's overall charge, to assess Agency needs and the state of the art and science of valuing protection of ecological systems and services, and then to identify key areas for improving knowledge, methodologies, practice, and research.

Availability of Review Material for the Meetings: Agendas and documents that are the subject of these meetings are available from the SAB Staff Office Web site http://www.epa.gov/sab/.

Procedures for Providing Public Comment: It is the policy of the EPA Science Advisory Board (SAB) Staff Office to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA SAB Staff Office expects that public statements presented at Board meetings will not be repetitive of previously submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face-to-face meeting will be limited to a total time of ten minutes (unless otherwise indicated). For conference call meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than fifteen minutes total. Interested parties should contact the Designated Federal Official (DFO) in writing via e-mail at least one week prior to the meeting in order to be placed on the public speaker list for the meeting. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the participants and public at the meeting. Written Comments: Although written comments are accepted until the date of the meeting (unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the committee for their consideration. Comments should be supplied to the appropriate DFO at the address/contact information above in the following formats: one hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat, WordPerfect, Word, or Rich Text files (in IBM-PC/Windows 95/98 format). Those providing written comments and who attend the meeting are also asked to bring 35 copies of their comments for public distribution.

Meeting Accommodations: Individuals requiring special accommodation to access these meetings, should contact the relevant DFO at least five business days prior to the meeting so that appropriate arrangements can be made.

http://edocket.access.gpo.gov/2004/04-18960.htm

HEALTH AND HUMAN SERVICES

Guidance for Industry on Independent Consultants for Biotechnology Clinical Trial Protocols; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols,'' dated August 2004. The guidance document provides guidance to sponsors of clinical trials for certain products on when and how to request from FDA the engagement of an independent consultant to participate in the review of protocols for clinical studies intended to serve as the primary basis of claims of efficacy. This guidance document finalizes the draft guidance of the same title dated May 2003.

DATES: Submit written or electronic comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; or the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling the CBER voice information system at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Susan S. Johnson, Center for Drug Evaluation and Research, Office of New Drugs (HFD-20), 5515 Security Lane, suite 7215, Rockville, MD 20852, 301-594-3937.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled "Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols'' dated August 2004. On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (PDUFA III). A letter from the Secretary of Health and Human Services (June 4, 2002), to Congress concerning PDUFA III included an addendum containing the performance goals and programs to which FDA committed as a means of facilitating the development and review of products subject to PDUFA III. One commitment was for FDA to establish a program to allow sponsors of clinical trials for certain products to request that FDA engage an independent consultant to participate in the review of protocols for clinical studies that are intended to serve as the primary basis of claims of efficacy. This guidance document is intended to explain when and how a sponsor may take advantage of this program. This guidance document finalizes the draft guidance document of the same title dated May 2003 (68 FR 24486, May 7, 2003). The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/ohrms/dockets/default.htm, or http://www.fda.gov/cder/guidance/index.htm.

http://edocket.access.gpo.gov/2004/04-18974.htm

Public Health Service

National Toxicology Program; Announcement of and Request for Public Comment on Substances Nominated to the National Toxicology Program (NTP) for Toxicological Studies and Study Recommendations Made by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC)

SUMMARY: The National Toxicology Program (NTP) continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from Federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. Evaluation by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) is the initial external review step in the NTP's formal selection process for NTP study nominations. On June 24, 2004, the ICCEC met to review 10 new nominations and make study recommendations. This announcement (1) provides brief background information regarding the substances nominated to the NTP for study, (2) presents the ICCEC's study recommendations from its June 24, 2004 meeting, (3) solicits public comment on the nominations and study recommendations, and (4) requests the submission of additional relevant information for consideration by the NTP in its continued evaluation of these nominations. An electronic copy of this announcement, Internet links to electronic versions of supporting documents for each nomination, and further information on the NTP and the NTP Chemical Nomination and Selection Process can be accessed through the NTP Web site: http://ntp-server.niehs.nih.gov.

Review of Study Nominations

Evaluation by the ICCEC is the initial external step in the NTP's formal selection process for NTP study nominations. At its meeting on June 24, 2004, the ICCEC reviewed 10 new nominations for NTP studies. For 7 of these nominations, the ICCEC recommended one or more types of toxicological studies, and for 3 nominations, the ICCEC deferred making specific study recommendations pending review of additional information. The nominated substances with Chemical Abstract Service (CAS) Registry numbers, nomination source, nomination rationale, and specific study recommendations are given in the accompanying tables.

The ICCEC is composed of representatives from the U.S. Consumer Product Safety Commission, U.S. Department of Defense, U.S. Environmental Protection Agency (U.S. EPA), U.S. Food and Drug Administration's National Center for Toxicological Research, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, National Institutes of Health's (NIH) National Cancer Institute, NIH's National Institute of Environmental Health Sciences (NIEHS), National Institute for Occupational Safety and Health, NIH's National Library of Medicine, and the Occupational Safety and Health Administration. The ICCEC meets once or twice annually to evaluate groups of new study nominations and to make recommendations with respect to both specific types of studies and testing priorities.

Request for Public Comment

Interested parties are invited to submit written comments or supplementary information on the nominated substances and study recommendations that appear in the accompanying tables. The NTP welcomes toxicology and carcinogenesis study information from completed, ongoing, or anticipated studies, as well as information on current U.S. production levels, use or consumption patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is also interested in identifying appropriate new animal and non-animal models for mechanistic-based research, and as such, solicits comments regarding the use of specific in vivo and in vitro experimental models to address scientific questions relevant to the nominated substances or issues under consideration. All information received will be considered by the NTP in its continued review of these nominations. Comments or information should be sent to Dr. Scott Masten (contact information below) by October 19, 2004. Persons responding to this request should include their name, affiliation, mailing address, phone, fax, e-mail address and sponsoring organization (if any) with the submission. Written submissions will be made available electronically on the NTP Web site as they are received.

Send comments or information to Dr. Scott A. Masten, Office of Chemical Nomination and Selection, NIEHS/NTP, P.O. Box 12233, MD A3-07, Research Triangle Park, North Carolina 27709; telephone: (919) 541-5710; FAX: (919) 541-3647; e-mail: masten@niehs.nih.gov.

Background

The NTP actively seeks to identify and select for study chemicals and other agents for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal open nomination and selection process. Substances considered appropriate for study generally fall into two broad yet overlapping categories: (1) Substances judged to have high concern as a possible public health hazard based on the extent of human exposure and/or suspicion of toxicity and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g. by facilitating cross-species extrapolation or evaluating dose-response relationships. Input is also solicited regarding the nomination of studies that permit the testing of hypotheses to enhance the predictive ability of future NTP studies, address mechanisms of toxicity, or fill significant gaps in the knowledge of the toxicity of classes of chemical, biological, or physical substances. Substances may be studied to evaluate a variety of health-related effects, including but not limited to reproductive and developmental toxicity, genotoxicity, immunotoxicity, neurotoxicity, metabolism and pharmacokinetics, and carcinogenicity. In reviewing and selecting nominated substances, the NTP also considers legislative mandates that require responsible private sector commercial organizations to evaluate their products for health and environmental effects. The possible human health consequences of anticipated or known human exposure, however, remain the over-riding factor in the NTP's decision to study a particular substance.

The review and selection of substances nominated for study is a multi-step process. A broad range of concerns are addressed during this process through the participation of representatives from the NIEHS, Federal agencies represented on the ICCEC, the NTP Board of Scientific Counselors--an external scientific advisory body, the NTP Executive Committee--the NTP Federal interagency policy body, and the public. This process is described in further detail in a March 2, 2000 Federal Register announcement (Volume 65, Number 42, pages 11329-11331). This multi-step evaluative process provides the NTP with direction and guidance to ensure that its testing program addresses toxicological concerns relative to all areas of public health, and furthermore, that there is balance among the types of substances selected for study (e.g., industrial chemicals, consumer products, therapeutic agents). As such, it should be recognized that at any given time, the new study nominations under consideration do not necessarily reflect the overall balance of substances historically or currently being evaluated by the NTP in its toxicology testing program. For further information on NTP toxicology studies (previous or in progress) visit the NTP Web site at http://ntp-server.niehs.nih.gov.

http://edocket.access.gpo.gov/2004/04-19136.htm

HOMELAND SECURITY

Directorate of Science and Technology; Notice of Meeting of Homeland Security Science and Technology Advisory Committee

AGENCY: Office of the Under Secretary for Science and Technology, DHS.

ACTION: Notice.

SUMMARY: The Homeland Security Science and Technology Advisory Committee (HSSTAC) will meet in closed session at the Lawrence Livermore National Laboratory, Livermore, CA, on August 31-September 1, 2004.

DATES: The meeting dates are August 31, 2004 and September 1, 2004.

ADDRESSES: The meeting location is Lawrence Livermore National Laboratory, 7000 East Avenue, Livermore, CA 94550-9234.

FOR FURTHER INFORMATION CONTACT: Brenda Leckey, Homeland Security Science and Technology Advisory Committee, Department of Homeland Security, Directorate of Science and Technology, Washington, DC 20528; telephone 202-254-5721; e-mail HSSTAC@dhs.gov.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Pub. L. 92-463, as amended (5 U.S.C. App.2). The HSSTAC will meet for purposes of receiving briefings and examining initiatives and activities at various national laboratories. HSSTAC will be obtaining perspectives from these Homeland Security Research and Development (R&D) performers of what they do, what needs to be done, and any special insights they have as to how the Department of Homeland Security Science & Technology Directorate could better access, utilize and/or develop R&D capabilities. HSSTAC will also be receiving briefings and reviewing subcommittee progress reports and determining future actions. In accordance with section 10(d) of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. 2), the Under Secretary for Science and Technology has determined that this HSSTAC meeting will concern classified and sensitive matters to homeland security within the meaning of 5 U.S.C. 552b(c)(1)(a) and (c)(9)(B) and that, accordingly, the meeting will be closed to the public.

http://edocket.access.gpo.gov/2004/04-18817.htm

INTERIOR

Geological Survey

Request for Public Comments on Extension of Existing Information Collection Submitted to OMB for Review Under the Paperwork Reduction Act

A proposal extending information collection described below has been submitted to the Office of Management and Budget for approval under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Copies of the proposed collection of information may be obtained by contacting the Bureau's clearance officer at the phone number listed below. OMB has up to 60 days to approve or disapprove the information collection but may respond after 30 days; therefore, public comments should be submitted to OMB within 30 days in order to assure their maximum consideration. Address your comments and suggestions on the proposal by fax (202) 395-6566 or E-mail (oira_docket@omb.eop.gov) to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Interior Department. Send copies of your comments to the USGS Clearance Officer, U.S. Geological Survey, 807 National Center, 12201 Sunrise Valley Drive, Reston, Virginia, 20192, or E-mail jcordyac@usgs.gov.

As required by OMB regulations at 5 CFR 1320.8(d)(1), the USGS solicits specific public comments as to:

  1. Whether the collection of information is necessary for the proper performance of the functions on the bureaus, including whether the information will have practical utility;

  2. The accuracy of the bureau's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

  3. The quality, utility, and clarity of the information to be collected; and

  4. How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.

Title: North American Reporting Center for Amphibian Malformations.

OMB Approval No.: 1028-0056.

Summary: The collection of information referred herein applies to a World Wide Web site that permits individuals who observed malformed amphibians or who inspect substantial numbers of normal or malformed amphibians to report those observations and related information. The Web site is termed the North American Reporting Center for Amphibian Malformations. Information is used by scientists and federal, state, and local agencies to identify areas where malformed amphibians occur and the rates of occurrence.

Estimated Completion Time: 20 minutes.

Estimated Annual Number of Respondents; 450.

Frequency: Once.

Estimated Annual Burden Hours: 150 hours.

Affected Public: Primarily U.S. and Canadian residents.

FOR FURTHER INFORMATION CONTACT: To obtain copies of the survey, contact the Bureau clearance officer, U.S. Geological Survey, 807 National Center, 12201 Sunrise Valley Drive, Reston, Virginia, 20192, telephone (703) 648-7313, or go to the Web site http://frogweb.nbii.gov/narcam/.

http://edocket.access.gpo.gov/2004/04-18589.htm

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

NASA Advisory Council, Earth System Science and Applications Advisory Committee; Meeting

AGENCY: National Aeronautics and Space Administration (NASA).

ACTION: Notice of meeting.

SUMMARY: In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the NASA Advisory Council, Earth System Science and Applications Advisory Committee (ESSAAC).

DATES: Thursday, September 9, 2004, 8:30 a.m. to 5:30 p.m. and Friday, September 10, 2004, 8:30 a.m. to 4 p.m.

ADDRESSES: Holiday Inn, Discovery II Room, 500 C Street SW., Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Mr. Gregory J. Williams, National Aeronautics and Space Administration, Washington, DC 20546, 202/358-0241.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public up to the seating capacity of the room. The agenda for the meeting is as follows:

--Welcome/Opening Remarks --NASA Overview --Science Mission Directorate Overview --Exploration Vision Discussion --Research Strategy, Including Computational Modeling Priorities --Information Technology Investment Review --Data & Information Management Plan Progress --Education Program Status --Committee Deliberations

It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of key participants. Visitors will be requested to sign a visitor's register.

http://edocket.access.gpo.gov/2004/04-18824.htm

Notice of Information Collection

AGENCY: National Aeronautics and Space Administration (NASA).

ACTION: Notice of information collection.

The National Aeronautics and Space Administration (NASA) is requesting Office of Management and Budget approval for a new information collection which will be used to evaluate the need for NASA to establish a central repository of reusable components for earth science data systems. The NASA Earth Science Data Systems Working Group, who will be collecting the information, needs to better understand the community's needs with respect to such a repository before it can be built.

DATES: All comments should be submitted within 60 calendar days from the date of this publication.

ADDRESSES: All comments should be addressed to Ms. Kathleen Shaeffer, Code V, National Aeronautics and Space Administration, Washington, DC 20546-0001.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Ms. Kathleen Shaeffer, Acting NASA Reports Officer, NASA Headquarters, 300 E Street, SW., Code V, Washington, DC 20546, (202) 358-1230, kshaeff1@hq.nasa.gov.

http://edocket.access.gpo.gov/2004/04-19043.htm

Notice of Information Collection

AGENCY: National Aeronautics and Space Administration (NASA).

ACTION: Notice of information collection.

The National Aeronautics and Space Administration (NASA) is requesting Office of Management and Budget approval for a new information collection which will be used by NASA for the purpose of evaluating and selecting applicants for the NASA Science and Technology Scholarship Program (STSP.) The NASA STSP's establishment was authorized by the NASA Workforce Flexibility Act of 2004.

DATES: All comments should be submitted within 60 calendar days from the date of this publication.

ADDRESSES: All comments should be addressed to Ms. Kathleen Shaeffer, Code V, National Aeronautics and Space Administration, Washington, DC 20546-0001.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Ms. Kathleen Shaeffer, Acting NASA Reports Officer, NASA Headquarters, 300 E Street, SW., Code V, Washington, DC 20546, (202) 358-1230, kshaeff1@hq.nasa.gov.

http://edocket.access.gpo.gov/2004/04-19044.htm

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