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Federal Register Summary for the Week of 20-24 September 2004

AGRICULTURE

Notice of Request for Emergency Approval of an Information Collection

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: New information collection; comment request.

DATES: We will consider all comments that we receive on or before October 3, 2004.

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. 04-048-1 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. 04-048-1.

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. 04-048-1'' 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 information on the national animal identification system, contact Mr. Neil Hammerschmidt, Animal Identification Coordinator, Eradication and Surveillance Team, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737; (301) 734-5571, or Dr. John Wiemers, National Animal Identification Coordinator, Eradication and Surveillance Team, National Center for Animal Health Programs, VS, APHIS, 2100 S. Lake Storey Road, Galesburg, IL 61401; (309) 344-1942. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

SUPPLEMENTARY INFORMATION:
Title: National Animal Identification System.
OMB Number: 0579-XXXX.
Type of Request: Emergency approval of a new information collection.
Abstract: The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) regulates the importation and interstate movement of animals and animal products and conducts various other activities to protect the health of our Nation's livestock and poultry.

Animal disease outbreaks around the globe over the past decade, and the detection of an imported cow infected with bovine spongiform encephalopathy in Washington State in December 2003, have intensified the public interest in developing a national animal identification program for the purpose of protecting animal health.

Fundamental to controlling any disease threat, foreign or domestic, to the Nation's animal resources is to have a system that can identify individual animals or groups, the premises where they are located, and the date of entry to each premises. Further, in order to achieve optimal success in controlling or eradicating an animal health threat, the timely retrieval of this information and implementation of intervention strategies after confirmation of a disease outbreak is necessary.

While there is currently no nationwide animal identification system in the United States for all animals of a given species, some segments of certain species are required to be identified as part of current program disease eradication activities. In addition, some significant regional voluntary identification programs are in place, and others are currently being developed and tested.

A national animal identification system, being implemented by USDA at present on a voluntary basis, is intended to identify all livestock, as well as record their movements over the course of their lifespans.

USDA's goal is to create an effective, uniform, consistent, and efficient national system that, when fully implemented, will allow traces to be completed within 48 hours of detection of a disease, ensuring rapid containment of the disease.

This program will involve a number of information collection and recordkeeping activities including nonproducer participant, individual animal, and animal group identifications; premises identifications; individual transaction records; and group/lot movement records. APHIS has submitted a request to the Office of Management and Budget (OMB) for emergency approval of the information collection activities associated with the national animal identification system.

Please send written comments on the emergency approval request to the following addresses: (1) Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) Docket No. 04-048-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 04-048-1 and send your comments within 10 days of publication of this notice. All comments will become a matter of public record. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who areto respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g., permitting electronic submission of responses.

Estimate of burden; Public reporting burden for this collection of information is estimated to average 0.1911198 hours per response.

Respondents: State animal health authorities; federally recognized tribal governments; wner/operators of feedlots, markets, buying stations, and slaughter plants; producers; and nonproducer participants, such as accredited veterinarians, animal identification (ID) number managers (individuals or firms responsible for assigning animal ID numbers to producers), animal identification ID companies (companies that manufacture animal identification tags, microchips, or other animal ID devices), third party service providers (companies that provide herd management, dairy herd improvement, genetic evaluation, and other services to producers), and diagnostic laboratories and livestock buyers/dealers who submit data to the national database.

Estimated annual number of respondents: 495,055.
Estimated annual number of responses per respondent: 10.0991.
Estimated annual number of responses: 4,999,610.
Estimated total annual burden on respondents: 505,560 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

http://edocket.access.gpo.gov/2004/E4-2344.htm


Notice of Request for Extension of Approval of an Information Collection

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Extension of approval of an information collection; comment request.

DATES: We will consider all comments that we receive on or before November 22, 2004.

ADDRESSES: You may submit comments by any of the following methods: EDOCKET: Go to http://www.epa.gov/feddocket 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 you have entered EDOCKET, click on the "View Open APHIS Dockets'' link to locate this document.
Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-087-1, 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. 04-087-1.
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. 04-087-1'' 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 information on the swine health protection program, contact Dr. John Korslund, Staff Veterinarian (Swine Health), Eradication and Surveillance Team, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale MD 20737; (301) 734-5914. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

SUPPLEMENTARY INFORMATION:
Title: Swine Health Protection.
OMB Number: 0579-0065.
Type of Request: Extension of approval of an information collection.
Abstract: The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is responsible for preventing the spread of contagious, infectious, or communicable diseases of livestock or poultry from one State to another and for eradicating such diseases from the United States when feasible.

The Swine Health Protection Act prohibits the feeding of garbage to swine unless the garbage has been treated to kill disease organisms. Untreated garbage is one of the primary media through which numerous infectious and communicable diseases can be transmitted to swine. Therefore, APHIS' regulations promulgated under the Swine Health Protection Act, which are located at 9 CFR part 166, require that before garbage may be fed to swine, it must be treated at a facility holding a valid permit to treat the garbage and must be treated according to the regulations.

APHIS requires certain information in order to license (issue a permit to) a facility to operate and in order to monitor the facility for compliance with the regulations. This information is collected from applications for a license to operate a garbage treatment facility, records of the destination and date of removal of all food waste or garbage from the treatment facility, and food waste reports. With this information, we are able to carefully monitor garbage treatment facilities to ensure that they are meeting our requirements. The information provided by these information collection activities is critical in preventing the interstate spread of various swine diseases and, therefore, plays a vital role in our swine health protection program.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning this information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g., permitting
electronic submission of responses.
Estimate of burden: The public reporting burden for this collection of information is estimated to average 1.2359271 hours per response.
Respondents: Owners/operators (licensees) of garbage treatment facilities, State animal health authorities, and herd owners.
Estimated annual number of respondents: 347.
Estimated annual number of responses per respondent: 3.481268.
Estimated annual number of responses: 1,208.
Estimated total annual burden on respondents: 1,493 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

http://edocket.access.gpo.gov/2004/E4-2345.htm

ENVIRONMENTAL PROTECTION AGENCY

Environmental Laboratory Advisory Board (ELAB) Meeting Dates, and Agenda

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of teleconference meetings.

SUMMARY: The Environmental Protection Agency's Environmental Laboratory Advisory Board (ELAB), as previously announced, will have teleconference meetings on October 20, 2004 at 1 p.m. e.s.t.; November 17, 2004 at 1 p.m. e.s.t.; December 15, 2004 at 1 p.m. e.s.t.; and January 19, 2005 at 1 p.m. e.s.t. to discuss the ideas and views presented at the previous ELAB meetings, as well as new business. Items to be discussed by ELAB over these coming meetings include: Expanding the number of laboratories seeking NELAC accreditation; homeland security issues affecting the laboratory community; ELAB support to Agency's Forum on Environmental Measurements (FEM); implementing the performance approach; increasing state participation in NELAC; and follow-up on some of ELAB's past recommendations and issues. In addition to these teleconferences, ELAB will be hosting their next face-to-face meeting on February 2, 2005 at the Sheraton Society Hill in Philadelphia, Pennsylvania.
Written comments on laboratory accreditation issues and/or environmental monitoring issues are encouraged and should be sent to Ms. Lara P. Autry, DFO, U.S. EPA (E243-05), 109 T. W. Alexandar Drive, Research Triangle Park, NC 27709, faxed to (919) 541-4261, or e-mailed to autry.lara@epa.gov. Members of the public are invited to listen to the teleconference calls, and time permitting, will be allowed to comment on issues discussed during this and previous ELAB meetings. Those persons interested in attending should call Lara P. Autry at (919) 541-5544 to obtain teleconference information. The number of lines for the teleconferences, however, are limited and will be distributed on a first come, first serve basis. Preference will be given to a group wishing to attend over a request from an individual.

http://edocket.access.gpo.gov/2004/04-21067.htm

Environmental Financial Advisory Board; Notice of Meeting

AGENCY: Environmental Protection Agency.

ACTION: Notice of request for nominations.

SUMMARY: The U.S. Environmental Protection Agency (EPA) invites nominations of qualified candidates to be considered for appointments to fill several vacancies on the Environmental Financial Advisory Board. The Board seeks to maintain diverse representation across sectors and geographic locations. Tribal representatives and non-profit environmental group representatives are encouraged to apply. Nominees who demonstrate expertise in commercial banking, environmental engineering, accounting and/or auditing, and/or financial insurance are also encouraged to apply. In addition to this notice, other sources may be utilized in the solicitation of nominees.

The deadline for receiving nominations is Friday, October 29, 2004. Appointments will be made by the Deputy Administrator of the Environmental Protection Agency and will be announced during January 2005. Nominees' qualifications will be assessed under the mandates of the Federal Advisory Committee Act, which requires Committees to maintain diversity across a broad range of constituencies, sectors, and groups.

Nominations for membership must include a resume describing the professional and educational qualifications of the nominee as well as experience. Contact details should include full name and title, business mailing address, telephone, fax, and e-mail address. A supporting letter of endorsement is encouraged but not required.

ADDRESSES: Submit nomination materials by postal mail, electronic mail or fax to: Vanessa Bowie, Membership Coordinator, Environmental Financial Advisory Board, EPA, Office of the Chief Financial Officer, 1200 Pennsylvania Avenue, NW. (2731R), Washington, DC 20460, e-mail
bowie.vanessa@epa.gov, phone (202) 564-5186, fax (202) 565-2587.

FOR FURTHER INFORMATION CONTACT: Vanessa Bowie at (202) 564-5186.

SUPPLEMENTARY INFORMATION: The Environmental Financial Advisory Board meets two times each calendar year (two days per meeting) at different locations within the continental United States. Board members typically contribute approximately 1-3 hours per month to the Board's work. The Board membership services are voluntary. Travel and per diem expenses are covered by EPA in accordance with Federal Travel Regulations for invitational travelers.
The Board was chartered in 1989 under the Federal Advisory Committee Act to provide advice and recommendations to EPA on the following issues:
(a) Reducing the cost of financing environmental facilities and discouraging polluting behavior;
(b) Creating incentives to increase private investment in the provision of environmental services and removing or reducing constraints on private involvement imposed by current regulations;
(c) Developing new and innovative environmental financing approaches and supporting and encouraging the use of cost-effective existing approaches;
(d) Identifying approaches specifically targeted to small community financing; and
(e) Increasing the capacity issue of state and local governments to carry out their respective environmental programs under current Federal tax laws.
The following criteria will be used to evaluate nominees:
Residence in the continental United States;
Professional knowledge of, and experience with, environmental financing activities;
Senior level-experience that fills a gap in Board representation, or brings a new and relevant dimension to its deliberations;
Demonstrated ability to work in a consensus-building process with a wide range of representatives from diverse constituencies; and
Willingness to serve a term as an actively-contributing member, with possible re-appointment to a second term.

http://edocket.access.gpo.gov/2004/04-21389.htm

National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation

AGENCY: Environmental Protection Agency.

ACTION: Notice of meeting.

SUMMARY: Pursuant to the Federal Advisory Committee Act (Pub. L. 92-463), the U.S. Environmental Protection Agency (EPA) gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC).

The National and Governmental Advisory Committees advise the Administrator of the EPA in his capacity as the U.S. Representative to the Council of the North American Commission for Environmental Cooperation. The Committees are authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC), North American Free Trade Agreement Implementation Act, Pub. L. 103-182 and as directed by Executive Order 12915, entitled "Federal Implementation of the North American Agreement on Environmental Cooperation.'' The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory and economic issues related to implementation and further elaboration of the NAAEC. The National Advisory Committee consists of 12 representatives of environmental groups and non-governmental organizations, business and industry, and educational institutions. The Governmental Advisory Committee consists of 12 representatives from state, local and tribal governments.

The Committees are meeting to review and comment on the 2005 Strategic Operational Plan of the Commission for Environmental Cooperation, and other business.

DATES: The Committees will meet on Thursday, October 14, 2004 from 9 a.m. to 6 p.m., and on Friday, October 15, 2004 from 8:30 a.m. to 3 p.m.

ADDRESSES: The meeting will be held at the Wyndham City Center, 1143 New Hampshire Ave., NW., Washington, DC 20037. The meeting is open to the public, with limited seating on a first-come, first-served basis.

FOR FURTHER INFORMATION CONTACT: Mr. Oscar Carrillo Designated Federal Officer, U.S. EPA, Office of Cooperative Environmental Management, at (202) 233-0072.
Meeting Access: Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Oscar Carrillo at least five business days prior to the meeting so that appropriate arrangements can be made.

http://edocket.access.gpo.gov/2004/04-21187.htm

HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR);
Teleconference

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), NCEH/ATSDR announces the following subcommittee meeting:
Name: Program Peer Review Subcommittee (PPRS).
Time and Date: 12:30 p.m.-3 p.m., October 5, 2004.
Place: The teleconference will originate at the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in Atlanta, Georgia. Please see SUPPLEMENTARY INFORMATION for details on accessing the teleconference.

Status: Open to the public, teleconference access limited only by availability of telephone ports.

Purpose: Under the charge of the Board of Scientific counselors (BSC), NCEH/ATSDR the Program Peer Review Subcommittee establishes and monitors working groups of technical experts that perform program peer reviews of National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry. The Subcommittee, working with the NCEH/ATSDR, Office of Sciences (OS), will establish schedule and process for program peer reviews, nominate working group members, reviews summary reports and recommendations, and report back to the BSC. The OS will establish agency policy for program peer review and directly support each working group by collating program documents, and organizing the working groups review and site visit. Each NCEH/ATSDR program eligible for review will be reviewed every 5 years according to CDC/ATSDR policy.

Matters To Be Discussed: The teleconference agenda will include discussions to develop screening methodology to prioritize program reviews using background information; to establish methodology to perform the NCEH/ATSDR program reviews; to establish workgroups to perform the program reviews; and to establish a schedule for program review.

SUPPLEMENTARY INFORMATION: This conference call is scheduled to begin at 12:30 p.m. eastern standard time. To participate in the teleconference, please dial (877) 315-6535 and enter conference code 383520.

FOR FURTHER INFORMATION CONTACT: Sandra Malcom, Committee Management Specialist, Office of Science, NCEH/ATSDR, M/S E-28, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 404/498-0003.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

http://edocket.access.gpo.gov/2004/04-21168.htm


Secretary's Advisory Committee on Human Research Protections

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

ACTION: Notice of meeting.

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its fourth meeting. The meeting will be open to the public.

DATES: The meeting will be held on Monday, October 4, 2004, from 8:30 a.m. to 5 p.m., and on Tuesday, October 5, 2004, from 8:30 a.m. to 5 p.m.

ADDRESSES: The Raddison Hotel Old Town Alexandria, 900 North Fairfax Street; Alexandria, VA 22314.

FOR FURTHER INFORMATION CONTACT: Bernard Schwetz, D.V.M., Ph.D., Director, Office for Human Research Protections (OHRP), or Catherine Slatinshek, Executive Director, Secretary's Advisory Committee on Human Research Protections; Department of Health and Human Services, 1101 Wootton Parkway, Suite 200; Rockville, MD 20852; (301) 496-7005; fax: (301) 496-0527; email address: sachrp@osophs.dhhs.gov.

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

On October 4, 2004, SACHRP will receive and discuss preliminary reports from its two subcommittees, the Subpart C Working Group (HHS regulations and policies for research involving prisoners) and the Subpart D Working Group (HHS regulations and policies for research involving children). The subcommittees were established by SACHRP at its meeting held on July 22, 2003, to provide assistance in addressing issues related to the specified topics. The Committee also will receive an update from OHRP staff on Subpart B issues.

On October 5, 2004, SACHRP will assemble three panels of experts to discuss the following issues: (1) The application of Subpart A in the current research environment; (2) the relationship between public health surveillance activities and research, the relationship between quality assurance/quality improvement activities, and research as defined in the HHS regulations for the protection of human subjects at 45 CFR 46.102(d); (3) and issues related to central IRBs. Public attendance at the meeting is limited to space available. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact persons. Members of the public will have opportunity to provide comments on both days of 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 SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business on September 29, 2004.
Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm.

http://edocket.access.gpo.gov/2004/04-21072.htm


National Institutes of Health

National Center for Complementary and Alternative Medicine Announcement of Draft 5-Year Strategic Plan

ACTION: Notice.

SUMMARY: The National Center for Complementary and Alternative Medicine (NCCAM) is developing its 5-year strategic plan (2005-2009), and invites the public to provide comments on a draft of this plan. The draft plan will be publicly available through the NCCAM Web site at http://nccam.nih.gov from on or about October 4 through November 15, 2004. The public is invited to provide comments through the mail and via the NCCAM Web site.

Background

The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals.

To date, NCCAM's efforts to rigorously study CAM, to train CAM researchers, to conduct outreach, and to facilitate integration have been guided by NCCAM's current strategic plan, "Expanding Horizons of Healthcare: Five Year Strategic Plan 2001-2005'' located on the NCCAM Web site at http://nccam.nih.gov/about/plans/fiveyear/index.htm. Since its inception, NCCAM has funded over 800 research projects and has over 700 grantee publications.

NCCAM's new strategic plan will stipulate strategic goals and will outline a research agenda for CAM domains and scientific areas, based on identified needs and opportunities.

The public is invited to review the draft strategic plan and provide comments from October 4 through November 15, 2004. The draft plan may be viewed at http://nccam.nih.gov/. Hard copies of the plan may be obtained by calling 1-888-644-6226 or by e-mailing to info@nccam.nih.gov.

Request for Comments

The public is invited to provide comments on the draft strategic plan for 2005-2009. Comments may be provided through the NCCAM Web site at http://nccam.nih.gov or via U.S. mail to: Strategic Plan Feedback, National Center for Complementary and Alternative Medicine, NIH, 31 Center Drive, MSC 2182, Bethesda, MD 20892-2182.

FOR FURTHER INFORMATION: To request more information, visit the NCCAM Web site at http://nccam.nih.gov, call 1-888-644-6226, or e-mail info@nccam.nih.gov.

Comments Due Date

Comments regarding the draft of NCCAM's strategic plan are best assured of having their full effect if received by November 15, 2004.

http://edocket.access.gpo.gov/2004/04-21427.htm

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing the initiation of a Regulatory Site Visit Training Program. This program is intended to give CBER's regulatory review staff, compliance staff, and other relevant staff an opportunity to visit biologics facilities. The visit is intended to provide first hand experience to CBER staff and to give a better understanding of the biologics industry, including its challenges and its operations. The purpose of this notice is to invite biologics companies interested in participating in this program to contact CBER for more information.

DATES: Submit a written or electronic requests for participation in this program by October 25, 2004.

ADDRESSES: If your biologics facility is interested in offering a site visit or learning more about this training opportunity for CBER staff, you should submit a request to participate in this program to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic requests to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Lonnie Warren-Myers, Division of Manufacturers Assistance and Training, Center for Biologics Evaluation and Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, e-mail: cbertrainingsuggestions@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

CBER regulates biological products including blood and blood products, vaccines, and cellular and gene therapies. CBER is committed to advancing the public health through innovative regulations that elp ensure the safety, effectiveness, and timely delivery to patients of biological products. CBER has initiated various training and development programs to promote high performance of its regulatory review staff, compliance staff, and other relevant CBER staff. CBER seeks to continuously enhance and update eview efficiency and quality as well as the quality of its regulatory efforts and interactions. CBER is initiating the Regulatory Site Visit Training Program to provide CBER staff the opportunity to visit biologics facilities to observe first-hand the industry's biologic development and manufacturing processes and thereby obtain better understanding of the biologics industry and its operations.

Further, this program is intended to improve CBER's understanding of current practices, regulatory impacts and needs, and improve communication between CBER staff and industry. The first phase of the program will focus on blood, plasma, and fractionation industries including transfusion centers, although other industries may be considered including vaccines, cellular and gene therapy, and tissues.

II. The Regulatory Site Visit Training Program

A. Regulatory Site Visits

In this program, over a period of time to be agreed upon with the biologics facility, small groups (five or less) of CBER staff may observe operations of biologics manufacturing, packaging, pathology/toxicology laboratory testing, and regulatory affairs operations. These visits, or any part of the program, are not intended as a mechanism to inspect, assess, judge, or perform a regulatory enforcement function, but are meant to improve mutual understanding and to provide an avenue for open dialog between the biologics industry and CBER.

B. Site Selection

All travel expenses associated with the site visits will be the responsibility of CBER. Therefore, selection of potential biologics facilities will be based on the coordination of CBER's priorities for staff training and the limited available resources for this program.

http://edocket.access.gpo.gov/2004/04-21318.htm


HOMELAND SECURITY

Revised Privacy Impact Assessment and Privacy Policy; US-VISIT Program

AGENCY: Department of Homeland Security.

ACTION: Notice; Privacy Impact Assessment and Privacy Policy.

SUMMARY: The Department of Homeland Security (Department) intends to modify the United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT) to expand coverage to include Visa Waiver Program entrants into this entry and exit system and to include the 50 busiest land ports of entry, and to modify the business process by which the Department shares information with other Federal law enforcement agencies. Accordingly, the original privacy impact assessment (PIA) for US-VISIT, which was published in the Federal Register on January 16, 2004, has been amended to reflect these changes in accordance with the E-Government Act of 2002, and is being made available to the public by this notice and in conjunction with the Interim Final Rule of August 31, 2004, United States Visitor and Immigrant Status Indicator Technology Program (``US-VISIT'') Authority to Collect Biometric Data From Additional Travelers and Expansion to the 50 Most Highly Trafficked Land Border Ports of Entry, published at 69 FR 53318.

ADDRESSES: Written comments about this revised PIA for the US-VISIT Program, Increment 2, may be submitted to the DHS Privacy Office, Attn: US-VISIT PIA, Increment 2, U.S. Department of Homeland Security, Washington, DC 20528, fax (202) 298-5201, or e-mail at privacy@dhs.gov. If submitting comments by e-mail, please include the words "US-VISIT PIA'' in the subject line.

Additional comments may be made through the e-docketing system by referencing docket number [DHS-2004-0005] at http://docket.epa.gov/edkfed/index.jsp.

FOR FURTHER INFORMATION CONTACT: Steve Yonkers, Privacy Officer, US-VISIT, Border and Transportation Security, U.S. Department of Homeland Security, Washington, DC 20528, telephone (202) 298-5200, fax (202) 298-5201, e-mail usvisitprivacy@dhs.gov.

http://edocket.access.gpo.gov/2004/04-21280.htm

WHITE HOUSE

OFFICE OF SCIENCE AND TECHNOLOGY POLICY

Meeting of the President's Council of Advisors On Science and Technology

ACTION: Notice of public meeting.

SUMMARY: This notice sets forth the schedule and summary agenda for a meeting of the President's Council of Advisors on Science and Technology (PCAST) and describes the functions of the Council. Notice of this meeting is required under the Federal Advisory Committee Act.

Dates and Place: October 5, 2004, Washington, DC. The meeting will be held in the Horizon Ballroom of the Ronald Reagan Building at the International Trade Center, 1300 Pennsylvania Avenue, NW., Washington, DC 20001.

Type of Meeting: Open. Further details on the agenda will be posted on the PCAST Web site at: http://www.ostp.gov/PCAST/pcast.html.

Proposed Schedule and Agenda: The President's Council of Advisors on Science and Technology is scheduled to meet in open session on Tuesday October 5, 2004, at approximately 8:30 a.m. The PCAST will hold a Workshop on Transatlantic Research and Development Cooperation. The workshop will examine the many formal and informal mechanisms that exist to facilitate the advancement of science through joint research with foreign colleagues throughout Europe. The purpose of this workshop is to identify contemporary issues related to transatlantic cooperation at the individual, academic, corporate and national levels. PCAST will use the proceedings of this workshop to identify topics that merit further examination by the Council. Several members of the European Union Research Advisory Board are expected to join PCAST during the session. The workshop will end at approximately 5 p.m.
Additional information on the workshop will be posted at the PCAST Web site at: http://www.ostp.gov/PCAST/pcast.html.

Public Comments: There will be time allocated for attendees to join in the discussion of the above agenda items. Public comment time is designed for substantive and relevant commentary, not for business marketing purposes. Written comments are also welcome at any time prior to or following the meeting. Please notify Stan Sokul, PCAST Executive Director, at (202) 456-6070, or fax your comments to (202) 456-6021.

FOR FURTHER INFORMATION CONTACT: For additional information regarding time, place and agenda, please call Stan Sokul at (202) 456-6070, prior to 3 p.m. on Friday, October 1, 2004. Information will also be available at the PCAST Web site at: http://www.ostp.gov/PCAST/pcast.html. Please note that public seating for this meeting is limited and is available on a first-come, first-served basis.

SUPPLEMENTARY INFORMATION: The President's Council of Advisors on Science and Technology was established by Executive Order 13226, on September 30, 2001. The purpose of PCAST is to advise the President on matters of science and technology policy and to assist the President's National Science and Technology Council in securing private sector participation in its activities. The Council members are distinguished individuals appointed by the President from non-Federal sectors. The PCAST is co-chaired by Dr. John H. Marburger, III, the Director of the Office of Science and Technology Policy, and by E. Floyd Kvamme, a Partner at Kleiner Perkins Caufield & Byers.

http://edocket.access.gpo.gov/2004/04-21418.htm

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