Title: School Nutrition Dietary Assessment Study-III.

OMB Number: Not yet assigned.

Form Number: N/A.

Expiration Date: N/A.

Type of Request: New Collection of Information.

Abstract: The School Nutrition Dietary Assessment Study-III will collect and analyze data from a nationally representative sample of public schools participating in the National School Lunch Program (NSLP), and students in those schools. Data will be collected so as to provide sufficient information to examine the school environment, food service operating practices, student participation and other characteristics of schools and School Food Authorities (SFAs) in the NSLP and School Breakfast Program (SBP); examine school meal participation, participant/nonparticipant characteristics; determine the nutrient content and types of food offered and served to students; determine student dietary intakes and the impact of USDA meals on meal specific and total intake—at school and over twenty-four hours; and compare findings to previously conducted studies on school meals.

Estimate of Burden: Public reporting burden is estimated to be 60 minutes for SFA directors completing the mail questionnaire and assisting the kitchen managers in the menu survey; 25 minutes for the school principal completing the in-person interview; 20 minutes for the kitchen manager completing the in-person interview, plus 510 minutes for completing the mail menu survey; 125 minutes for elementary students completing the in-person interview alone and with a parent; 90 minutes for middle/high school students completing the in-person interview; 80 minutes for parents of elementary school students completing the in-person interview; and, 20 minutes for parents of middle/high school students completing the telephone interview.

Respondents: SFA directors, school principals and kitchen managers of public schools participating in the NSLP and elementary, middle and high school students attending those schools who may or may not be participants in the NSLP.

Estimated Number of Respondents: One hundred thirty-five SFA directors will complete a mail questionnaire and assist kitchen managers in a mail menu survey; 405 school principals will be interviewed in-person; 405 kitchen managers will be interviewed in-person and will complete a mail menu survey; 700 elementary students will be interviewed in-person initially with a subset of 175 to be interviewed a second time; 1720 middle/high school students will be interviewed in-person initially with a subset of 430 to be interviewed a second time; 700 parents of elementary school students will be interviewed in-person with a subset of 175 to be interviewed a second time; and, 1720 parents of middle/high school students will be interviewed by telephone.

Number of Responses per Respondent: SFA directors, school principals, and kitchen managers will respond one time; 75 percent of the students will respond one time and 25 percent will respond twice; 75 percent of parents of elementary school students will respond one time and 25 percent will respond twice; and, parents of middle/high school students will respond once.

Estimated Time per Response:

Estimated Total Annual Burden on Respondents: 7,930 hours.

Title: Public Attitudes, Beliefs, and Values about National Forest Systems Land Management.

OMB Number: 0596-New.

Expiration Date of Approval: New.

Type of Request: New.

Abstract: As a steward of public lands the USDA Forest Service must use public attitudes, beliefs, and values (ABV) information to inform resource allocation and land management decisions. Several tests will be done at a state level over the next three years. This series of tests will be used to develop a set of questions that will be pre-approved by OMB to facilitate on-time data collection and ease of use by forest level social scientists and contractors.

The need for this information is stated in various legislative acts, regulatory documents, laws and executive orders that define and guide the mission and conduct of the Forest Service, including MUSY, NEPA, RPA, NFMA, HFRA, Environmental Justice Executive Order, Civil Rights Act, and Government Performance and Results Act. The authority, objectives, and responsibilities associated with this guide are outlined in the Forest Service Handbook, Forest Service Strategic Plan.

The information will be collected using a standard multiple response collection instrument. Trained interviewers will ask the questions on the telephone or paper questionnaires will be mailed to respondents. Information collection will be done by contract with a proven data collection manager. Information collected will include attitudes, beliefs, and values ABVs about fire management and associated treatments, vegetation management, recreation demand and recreation use. ABV Information will be collected from a statistically representative random sample of the population to enable contrasts at a local level, State level and national level. This information will be used to inform decisionmakers and as input to the forest planning process. Information will be analyzed by Forest Service subject matter experts and statisticians.

The consequence to Forest Service Planning and Management if the collection is not conducted would be significant. Managers are required to make decisions which consider public opinion. Without the ability to use this standard design which includes statistically valid and documented methods for the collection of ABV information, data collection and the incorporation of that information into decisions may not happen. Managers may be forced to write forest plans and make resource allocation decisions without the benefit of knowing public values and beliefs about the issues and resources under consideration.

Estimate of Annual Burden: 15 minutes.

Type of Respondents: Respondents will be a random sample of the population of a State for these tests.

Estimated Annual Number of Respondents: 2000.

Estimated Annual Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 30,000 minutes.

Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request for Office of Management and Budget approval.

Agenda topics include review and approval of project proposals, and an open public forum. The meeting is open to the public.

The meeting is open to the public. Persons who wish to bring matters to the attention of the Committee may file written statements with the Committee staff by August 13, 2004. Public comment will have the opportunity to address the committee at the meeting.

Section 752 of the Export Administration Regulations (EAR) outlines the SCL Procedure which authorizes multiple shipments of items from the U.S. or from approved consignees abroad who are approved in advance by BIS to conduct the following activities: servicing, support services, stocking spare parts, maintenance, capital expansion, manufacturing, support scientific data acquisition, reselling and reexporting in the form received, and other activities as approved on a case-by-case basis. Section 753 of the EAR outlines requirements, procedures, and policies for the Special Intra-company License (SIL), whereby exporters with a proven record of conformance with the EAR can eliminate numerous individual licenses for technology exports, reexports, and in-country transfers within the corporate structure of a company, e.g. , from a U.S. corporation to its wholly-owned subsidiaries, from one wholly-owned subsidiary to another, and from the U.S. corporation to its foreign national employees in the U.S. or abroad.

Submitted on forms.

OMB Number: 0694-0089.

Form Number: BIS-748P and BIS-752P.

Type of Review: Regular submission for extension of a currently approved collection for the purpose of adding additional activities to the collection authority.

Affected Public: Individuals, businesses or other for-profit and not-for-profit institutions.

Estimated Number of Respondents: 176.

Estimated Time Per Response: 5 minutes to 40 hours per response.

Estimated Total Annual Burden Hours: 1,375.

Estimated Total Annual Cost: No start-up or capital expenditures.

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 and/or included in the request for OMB approval of this information collection; they will also become a matter of public record.

Background

The Department's procedures for the conduct of sunset reviews are set forth in 19 CFR 351.218. Guidance on methodological or analytical issues relevant to the Department's conduct of sunset reviews is set forth in the Department's Policy Bulletin 98.3— Policies Regarding the Conduct of Five-Year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders; Policy Bulletin , 63 FR 18871 (April 16, 1998) (“ Sunset Policy Bulletin ”).

In accordance with 19 CFR 351.218(c), we are initiating the second sunset reviews of the following antidumping duty orders:

As a courtesy, we are making information related to sunset proceedings, including copies of the Department's regulations regarding sunset reviews (19 CFR 351.218) and Sunset Policy Bulletin , the Department's schedule of sunset reviews, case history information ( i.e. , previous margins, duty absorption determinations, scope language, import volumes), and service lists available to the public on the Department's sunset Internet Web site at the following address: http://ia.ita.doc.gov/sunset/.

All submissions in these sunset reviews must be filed in accordance with the Department's regulations regarding format, translation, service, and certification of documents. These rules can be found at 19 CFR 351.303. Also, we suggest that parties check the Department's sunset Web site for any updates to the service list before filing any submissions. The Department will make additions to and/or deletions from the service list provided on the sunset Web site based on notifications from parties and participation in these reviews. Specifically, the Department will delete from the service list all parties that do not submit a substantive response to the notice of initiation.

Because deadlines in a sunset review are, in many instances, very short, we urge interested parties to apply for access to proprietary information under administrative protective order (“APO”) immediately following publication in the Federal Register of the notice of initiation of the sunset review. The Department's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306.

Domestic interested parties (defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b) of the Department's regulations) wishing to participate in these sunset reviews must respond not later than 15 days after the date of publication in the Federal Register of the notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with the Department's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, the Department will automatically revoke the orders without further review. See 19 CFR 351.218(d)(1)(iii).

If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that all parties wishing to participate in the sunset review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of the notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that the Department's information requirements are distinct from the International Trade Commission's information requirements. Please consult the Department's regulations for information regarding the Department's conduct of sunset reviews. 1 Please consult the Department's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at the Department.

This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

Please refer to the July 26, 2004 (69 FR 44512) Federal Register notice for additional information. That notice announced the times, dates, and locations of nine scoping hearings; this notice announces the 10th such hearing.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Dawn Aring at the Council (see ADDRESSES ) by August 6, 2004.

On April 8, 2004, notice was published in the Federal Register (69 FR 18549) that a modification of Permit No. 1227, issued May 1, 2000 (65 FR 25312), had been requested by the above-named organization. The requested modification has been granted under the authority of the Endangered Species Act (ESA) of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-226).

The modification authorizes the permit holder to attach satellite transmitters using the harness backpack method allowed in the current permit on up to an additional 40 of the remaining leatherbacks that they are already permitted to capture in the eastern Pacific Ocean nearshore to California and Oregon. Twenty of these animals will also have VHF/TDR (time depth recorder)/sonic tag units attached to them by suction cup. The permit modification also authorizes the permit holder to attach VHF/TDR (time depth recorder)/sonic tag units with suction cups to 20 additional leatherbacks in the Monterey Bay area without having to capture them. The information from the satellite transmitters is part of studies on the migration and habitat use of this species in the Pacific Ocean. The VHF/TDR/sonic tag units will be used to study the fine-scale movements and diving behavior of leatherbacks in the vicinity of Monterey Bay and give important information regarding the foraging ecology of this species off the coast of California.

Issuance of this modification, as required by the ESA was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of the endangered species which is the subject of this permit, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

The Advisory Committees' duties include:

• Review and advise the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on matters relating to policies, goals, performance, budget, and user fees of the USPTO relating to patents and trademarks, respectively; and

• Within 60 days after the end of each fiscal year: (1) Prepare an annual report on matters listed above; (2) transmit a report to the Secretary of Commerce, the President, and the Committees on the Judiciary of the Senate and the House of Representatives; and (3) publish the report in the Official Gazette of the USPTO. Members of the Patent and Trademark Public Advisory Committees are appointed by and serve at the pleasure of the Secretary of Commerce for three (3)-year terms.

The Public Advisory Committees are each composed of nine (9) voting members who are appointed by the Secretary of Commerce (the “Secretary”) and who have ‘substantial backgrounds and achievement in finance, management, labor relations, science, technology, and office automation.” 35 U.S.C. 5(b)(3). The Public Advisory Committee members must be United States citizens and represent the interests of diverse users of the USPTO, both large and small entity applicants in proportion to the number of such applications filed. In the case of the Patent Public Advisory Committee, at least twenty-five (25) percent of the members must represent “small business concerns, independent inventors, and nonprofit organizations,” and at least one member must represent the independent inventor community. 35 U.S.C. 5 (b)(2). Each of the Public Advisory Committees also includes three (3) non-voting members representing each labor organization recognized by the USPTO.

Each newly appointed member of the Patent and Trademark Public Advisory Committees will serve for a term of three years. Members appointed in the current fiscal year shall serve from November 27, 2004, to November 27, 2007. As required by the Act, members of the Patent and Trademark Public Advisory Committees will receive compensation for each day while the member is attending meetings or engaged in the business of that Advisory Committee. The rate of compensation is the daily equivalent of the annual rate of basic pay in effect for level III of the Executive Schedule under section 5314 of title 5, United States Code. While away from home or regular place of business, each member will be allowed travel expenses, including per diem in lieu of subsistence, as authorized by Section 5703 of Title 5, United States Code. The USPTO will provide the necessary administrative support, including technical assistance for the Committees.

Members of each Public Advisory Committee shall be special Government employees within the meaning of Section 202 of Title 18, United States Code. The following additional information includes several, but not all, of the ethics rules that apply to members, and assumes that members are not engaged in Public Advisory Committee business more than sixty days during each calendar year:

• Each member will be required to file a confidential financial disclosure form within thirty (30) days of appointment. 5 CFR 2634.202(c), 2634.204, 2634.903, and 2634.904(b).

• Each member will be subject to many of the public integrity laws, including criminal bars against representing a party, 18 U.S.C. 205(c), in a particular matter that came before the member's committee and that involved at least one specific party. See also 18 U.S.C. 207 for post-membership bars. A member also must not act on a matter in which the member (or any of certain closely related entities) has a financial interest. 18 U.S.C. 208.

• Representation of foreign interests may also raise issues. 35 U.S.C. 5(a)(1) and 18 U.S.C. 219.

Meetings of each Advisory Committee will take place at the call of the Chair to consider an agenda set by the Chair. Meetings may be conducted in person, electronically through the Internet, or by other appropriate means. The meetings of each Advisory Committee will be open to the public except each Advisory Committee may, by majority vote, meet in executive session when considering personnel or other confidential matters. Nominees must also have the ability to participate in Committee business through the Internet.

Submit resumés for nomination for the Patent Public Advisory Committee and the Trademark Public Advisory Committee to: Chief of Staff to the Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office, utilizing the addresses provided above.

Title, Associated Forms, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Appendix F, Material Inspection and Receiving Report; DD Form 250, DD Form 250c, DD Form 250-1; OMB Control Number 0704-0248.

Needs and Uses: Collection of this information is necessary to process the shipping and receipt of materials and payment to contractors under DoD contracts.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Annual Burden Hours: 344,500.

Number of Respondents: 34,180.

Responses Per Respondent: 228.

Annual Responses: 7,800,000.

Average Burden Per Response: Approximately 3 minutes.

Frequency: On occasion.

This information collection includes the requirements of DFARS Appendix F, Material Inspection and Receiving Report; the related clause at DFARS 252.246-7000, Material Inspection and Receiving Report; and DD Forms 250, 250c, and 250-1. The clause at DFARS 252.246-7000 is used in contracts that require separate and distinct deliverables. The clause requires the contractor to prepare and furnish to the Government a material inspection and receiving report (DD Form 250) in a manner and to the extent required by DFARS Appendix F. The information in the report is required for material inspection and acceptance, shipping, and payment. The contractor may submit the information by using the Wide Area WorkFlow-Receipt and Acceptance electronic form.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: New.

Title: Report of the Participation and Performance of Students with Disabilities on State Assessments by Content Area, Grade, and Type of Assessment.

Frequency: Annually.

Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

Responses: 60.

Burden Hours: 3,600.

Abstract: This package provides instructions and a form necessary for States to report the number of children with disabilities served under the Individuals with Disabilities Education Act—Part B (IDEA-B) that participated in regular and alternate assessments and their performance on those assessments. These data will be used for monitoring activities, for planning purposes, for congressional reporting requirements, and for dissemination to individuals and groups.

Requests for copies of the submission for OMB review; comment request may be accessed from http://edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 2558. When you access the information collection, click on “Download Attachments “ to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to the Internet address OCIO_RIMG@ed.gov or faxed to 202-245-6621. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at her e-mail address Sheila.Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g ., new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: New Collection.

Title: Annual Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report (SC).

Frequency: Annually.

Affected Public: Not-for-profit institutions (primary). State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

Responses: 56.

Burden Hours: 896.

Abstract: This reporting instrument and web-based data collection system will provide for the collection of annual reports from the 56 PAAT grantees to the Secretary of Education as required by section 102 of the Assistive Technology Act of 1998. Information collected also will assist Rehabilitation Services Administration (RSA) staff in their management of the PAAT program, and in meeting Government Performance and Results Act (GPRA) reporting requirements. Data will be collected through an Internet form.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 2596. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to the Internet address OCIO_RIMG@ed.gov or faxed to 202-245-6621. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Carey at 202-245-6432. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

The Federal operating permits issued by EPA to the facilities identified above incorporate all applicable air quality requirements and require monitoring to ensure compliance with these requirements. Submittal of periodic reports of all required monitoring, as well as submittal of an annual compliance certification, are also required. The Federal operating permits have a term not to exceed five years, and a timely application for permit renewal must be submitted to EPA prior to permit expiration in order to continue operation of the permitted source.

The provisions of 40 CFR part 71 govern issuance of these permits. EPA published a notice and opportunity to comment in a newspaper of general circulation in the area of the facility for each permit issued. The EPA received public comments on the Transwestern Pipeline Company; El Paso Natural Gas Company; El Paso Field Services; and William Field Services, Los Mestenios Compressor Station permits. In accordance with the requirements of 40 CFR 71.11(j), EPA responded to all comments received on these permits. The EPA received no comments on the permit for William Field Services, Ojito. Pursuant to 40 CFR 71.11(i), EPA provided copies of the final permits to the applicant and each person who submitted written comments on a permit or requested notice of the final permit decision. No one requested review of any of the final permits by the Environmental Appeals Board within 30 days of receipt of the final permits in accordance with 40 CFR 71.11(l). Thus, pursuant to 40 CFR 71.11(i) and (l), the permits became final on the dates indicated in the chart above. A petition to the Environmental Appeals Board under 40 CFR 71.11(l) is, under 42 U.S.C. 307(b), a prerequisite to seeking judicial review of the final agency action. See 40 CFR 71.11(l)(4).

40 CFR 71.11(l)(7) requires notice of any final agency action regarding a Federal operating permit to be published in the Federal Register . This notice satisfies that requirement.

The Good Neighbor Environmental Board meets three times each calendar year; locations include Washington, DC, and various locations along the U.S.-Mexico border. It was created by the Enterprise for the Americas Initiative Act of 1992. An Executive Order delegates implementing authority to the Administrator of EPA. The Board is responsible for providing advice to the U.S. President and Congress on environmental and infrastructure issues and needs within the States contiguous to Mexico in order to improve the quality of life of persons residing on the U.S. side of the border. The statute calls for the Board to have representatives from U.S. Government agencies; the governments of the States of Arizona, California, New Mexico and Texas; and private organizations with expertise on environmental and infrastructure problems along the southwest border. Board members typically contribute 10-15 hours per month to the Board's work. The Board membership position is voluntary; travel expenses are covered.

The following criteria will be used to evaluate nominees:

• Residence in one of the four U.S. border states.

• Professional knowledge of, and experience with, environmental infrastructure activities and policy along the U.S.-Mexico border.

• Senior level-experience that fills a gap in Board representation, or brings a new and relevant dimension to its deliberations.

• Representation of a sector or group that is involved in border region environmental infrastructure.

• Demonstrated ability to work in a consensus-building process with a wide range of representatives from diverse constituencies.

• Willingness to serve a two-year term as an actively-contributing member, with possible re-appointment to a second term.

Nominations for membership must include a resume describing the professional and educational qualifications of the nominee as well as community-based 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.

Entities potentially interested in today's notice are those who want to transfer their vessel for reefing, have the capacity to prepare a vessel for reefing, wish to undertake a vessel-to-reef project, or are responsible for managing an artificial reef. Categories and entities interested in today's notice include.

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be interested in this notice. This table lists the types of entities that EPA is now aware could potentially be interested in this notice. Other types of entities not listed in the table could also be interested.

1. Guidance Document Electronic Access. To obtain a copy of the guidance document entitled “Draft National Guidance: Best Management Practices for Preparing Vessels Intended to Create Artificial Reefs,” please access our Web site at: http://www.epa.gov/owow/oceans/habitat/artificialreefs under “Recent Additions.”

2. Federal Register Docket. EPA has established a public docket for this notice under Docket ID No. OW-2004-0003. The public docket consists of the documents specifically referenced in this notice and other information related to this notice. The public docket does not include information claimed as Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The public docket is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. To view these materials, we encourage you to call ahead to schedule an appointment. Every user is entitled to copy 266 pages per day before incurring a charge. The docket may charge 15 cents a page for each page over the 266-page limit plus an administrative fee of $25.00.

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

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view comments, access the index listing of the contents of the public docket, and access those documents in the public docket that are available electronically. Once in the system, select “Search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute will not be available for public viewing in EPA's electronic public docket. Copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Section I.B.2.

For public commenters, it is important to note that comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comments contain copyrighted material, information claimed as CBI, or other information whose disclosure is restricted by statute. When EPA identifies comments containing copyrighted material, EPA will provide a reference to that material in the version of the comments that is placed in EPA's electronic public docket. The entire comment, including the copyrighted material, will be available in the public docket.

Comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comments. Please ensure that your comments are submitted within the specified time period. Comments received after the close of the stated time period will be marked “Late.” EPA might not be able to consider late submittals. If you wish to submit information claimed as CBI or information that is otherwise protected by statute, please follow the instructions in Section I.D. Do not use EPA Dockets or e-mail to submit information claimed as CBI or information protected by statute.

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

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet Home Page, select “Information Sources,” “Dockets,” and “EPA Dockets.” Once in the system, select “Search,” and then key in Docket ID No. OW-2004-0003. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your information.

ii. E-mail. Comments may be sent by electronic mail (e-mail) to: OW-Docket@epa.gov , Attention Docket ID No. OW-2004-0003. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comments that are placed in the public docket, and made available in EPA's electronic public docket.

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

2. By Mail. Send an original and three copies of all comments, enclosures, or references, to the Water Docket, Environmental Protection Agency, Mailcode MC-4101T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, Attention Docket ID No. OW-2004-0003.

3. By Hand Delivery or Courier. Deliver your comments to: EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC 20004, Attention Docket ID No. OW-2004-0003. Such deliveries are only accepted during the Docket's normal hours of operation as identified in Section I.B.2.

Do not submit information that you consider to be CBI electronically to the EPA Docket Center or through EPA's electronic public docket or by e-mail. Send or deliver information identified as CBI only to the following address: U.S. Environmental Protection Agency, Mailcode 4504 T, Preparation of Vessels Intended to be Artificial Reefs, 1301 Constitution Ave, NW., Room 7114, EPA West Building, Washington, DC 20004. You may claim information that you submit to EPA as CBI by marking that information CBI (if you submit CBI on disk or CD-ROM, indicate on the outside of the disk or CD-ROM that it contains information claimed as CBI and then identify electronically within the disk or CD-ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you use a disk or CD-ROM, mark the outside of the disk or CD-ROM clearly to indicate that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult one of the persons identified in the FOR FURTHER INFORMATION CONTACT section.

You may find these suggestions helpful for preparing your comments:

1. Explain your comments as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that supports your comments.

4. Provide specific examples to illustrate your concerns.

5. Offer alternatives.

6. Make sure to submit your comments by the deadline identified.

7. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

Options for managing obsolete and decommissioned military and commercial vessels include re-use of the vessel or parts of the vessel, recycling or scrapping, creating artificial reefs, and disposal on land or at sea. The guidance document made available today addresses one of these management options—artificial reef creation—with the intent of promoting a consistent, national approach.

An interagency workgroup, chaired by EPA, was established to develop national environmentally-based best management practices (BMPs) for the preparation of vessels to be sunk with the intention of creating artificial reefs. The workgroup was comprised of representatives from the EPA, U.S. Coast Guard, U.S. Navy, Maritime Administration (MARAD), U.S. Army Corps of Engineers, National Oceanic and Atmospheric Administration, and the U.S. Fish and Wildlife Service. Workgroup members assisted in the drafting of various sections of the document.

This guidance is required by section 3516 of the National Defense Authorization Act for Fiscal Year 2004 (Act), which amends existing law to require that MARAD and EPA jointly develop guidance recommending environmental BMPs to be used in the preparation of vessels for use as artificial reefs. These BMPs are to serve as national guidance for Federal agencies for the preparation of vessels for use as artificial reefs. The Act provides that the BMPs are to (A) ensure that vessels prepared for use as artificial reefs “will be environmentally sound in their use as artificial reefs,” (B) “promote consistent use of such practices nationwide,” (C) “provide a basis for estimating the costs associated with the preparation of vessels for use as artificial reefs,” and (D) include measures that will “enhance the utility of the Artificial Reefing Program of the Maritime Administration as an option for the disposal of obsolete vessels.”

The guidance identifies materials or categories of materials of concern that may be present aboard vessels, indicates where these materials may be found, and describes their potential adverse impacts if released into the marine environment. The materials of concern include: fuels and oil, asbestos, polychlorinated biphenyls (PCBs), paints, debris ( e.g. , vessel debris, floatables, introduced material), and other materials of environmental concern ( e.g. , mercury, refrigerants). Because the BMPs described in the guidance are directed at the environmental concerns associated with using vessels as artificial reefs, other sources of information should also be used with regard to preparation of the vessel from a diver safety perspective or for any other potential in-water uses ( e.g. , breakwaters or other types of barriers).

For each material or category of material of concern identified above, the guidance provides a general performance clean-up goal and information on methods for attaining those clean-up goals in preparation of the vessel prior to sinking. The guidance also includes a description of each material of concern's shipboard use and where it may be found on a vessel, as well as its expected impacts if released into the marine environment.

The guidance describes guidelines for the preparation of vessels in a manner that are intended to ensure that the marine environment will benefit from their use as an artificial reef. Because strategic siting is an essential component of a successful artificial reef project, the guidance also discusses reef siting.

The General Services Administration will be requesting that the Office of Management and Budget (OMB) review and approve information collection, 3090-0121, concerning industrial funding fee and sales reporting. The information is used primarily by contracting officers to estimate requirements for the subsequent year, evaluate the effectiveness of a schedule, negotiate better prices based on volume and for special reports.

Respondents: 15,710

Responses Per Respondent: 20

Total Responses: 314,200

Hours Per Response: .0833

Total Burden Hours: 26,173

OBTAINING COPIES OF PROPOSALS: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VR), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone (202) 208-7312. Please cite OMB Control No. 3090-0121, Industrial Funding Fee and Sales Reporting, in all correspondence.

Section 740 of the act (21 U.S.C. 379j-12) establishes four different kinds of user fees: (1) Fees for certain types of animal drug applications and supplements, (2) annual fees for certain animal drug products, (3) annual fees for certain establishments where such products are made, and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions. (See 21 U.S.C. 379j-12(a).) When certain conditions are met, FDA will waive or reduce fees (21 U.S.C. 379j-12(d)).

For FY 2004 through FY 2008, the act establishes aggregate yearly base revenue amounts for each of these fee categories. Base revenue amounts established for years after FY 2004 are subject to adjustment for inflation and workload. Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the revenue for each fee category will approximate the level established in the statute, after the level has been adjusted for inflation and workload.

ADUFA specifies that the aggregate revenue amount for FY 2005 for each of the four animal drug user fee categories is $2,000,000, before any adjustments for inflation or workload are made. (See 21 U.S.C. 379j-12(b)(1)-(b)(4).)

ADUFA provides that fee revenue amounts for each FY after 2004 shall be adjusted for inflation. (See 21 U.S.C. 379j-12(c)(1).) The adjustment must reflect the greater of: (1) The total percentage change that occurred in the consumer price index (CPI) for all urban consumers (all items; U.S. city average) during the 12-month period ending June 30 preceding the FY for which fees are being set or (2) the total percentage pay change for the previous FY for Federal employees stationed in Washington, DC. ADUFA provides for this annual adjustment to be cumulative and compounded annually after FY 2004. (See 21 U.S.C. 379j-12(c)(1).)

The inflation adjustment for FY 2005 is 4.42 percent. This is the greater of the CPI increase during the 12-month period ending June 30, 2004 (3.27 percent) or the increase in pay for FY 2004 for Federal employees stationed in Washington, DC (4.42 percent). No compounding is applied to this amount because there was no inflation increase applied in FY 2004.

The inflation-adjusted revenue amount for each category of fees for FY 2005 is the statutory fee amount ($2,000,000) increased by 4.42 percent, the inflation adjuster for FY 2005. The inflation-adjusted revenue amount is $2,088,400 for each category of fee, for a total inflation-adjusted fee revenue amount of $8,353,600 for all four categories of fees in FY 2005.

For each FY beginning in FY 2005, ADUFA provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect changes in review workload (21 U.S.C. 379j-12(c)(2)).

FDA calculated the average number of each of the five types of applications and submissions specified in the workload adjustment provision (animal drug applications, supplemental animal drug applications for which data with respect to safety or efficacy are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions) received over the 3-year period that ended on September 30, 2002, (the base years). The agency also calculated the average number of each of these types of applications and submissions over the most recent 3-year period that ended May 31, 2004.

The results of these calculations are presented in the first two columns of table 1 of this document. Column 3 reflects the percent change in workload over the two 3-year periods. Column 4 shows the weighting factor for each type of application, reflecting how much of the total FDA animal drug review workload was accounted for by each type of application or submission in the table during the most recent 3 years. Column 5 of table 1 of this document is the weighted percent change in each category of workload and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right in table 1 of this document, the sum of the values in column 5 is added, reflecting a total change in workload of -4 percent for FY 2005. This is the workload adjuster for FY 2005.

ADUFA specifies that the workload adjuster may not result in fees that are less than the inflation-adjusted revenue amount (21 U.S.C. 379j-12(c)(2)(B)). For this reason, the workload adjustment will not be applied in FY 2005, and the inflation-adjusted revenue amount for each category of fees for FY 2005 ($2,088,400) becomes the revenue target for fees in FY 2005, for a total inflation-adjusted fee revenue target in FY 2005 of $8,353,600 for fees from all four categories.

The terms “animal drug applications” and “supplemental animal drug applications” are defined in section 739 of the act (21 U.S.C. 379j-11(1).

FDA is requesting nominations for voting and nonvoting members on the Pediatric Advisory Committee.

The committee advises the Commissioner of Food and Drugs on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which the Food and Drug Administration has regulatory responsibility. The Committee will also advise and make recommendations to the Secretary of Health and Human Services pursuant to 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services.

1. Research and Clinical Scientists : Persons nominated for membership shall have scientific expertise in one or more of the following disciplines: Pediatric research, pediatric sub-specialties, pediatric therapeutics, statistics, and/or biomedical ethics.

2. Consumer Member : Persons nominated for membership on the committee as a consumer member shall have the following: (1) Ties to a consumer and/or community-based organization, (2) ability to analyze technical data, (3) understanding of research design, (4) ability to discuss benefits and risks, and (5) ability to evaluate the safety and efficacy of products under review. In their individual capacity, the consumer member will have the responsibility of representing the consumer perspective on issues and actions before the advisory committee; serving as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitating dialogue with the advisory committee on scientific issues that affect consumers.

3. Patient or Patient-Family Organization Member : Persons nominated for membership on the committee as a patient or patient-family organization member shall have the following: (1) Personal experience with a specific pediatric disease as a patient or patient care-giver; (2) experience in patient advocacy; (3) ability to communicate the interests and perspectives of patients; (4) ability to understand scientific data and technical information about research studies, and/or personal experience as a participant in clinical research; and (5) ability to disseminate information about the advisory committee experience to the patient community. As a member of the Pediatric Advisory Committee, the patient or patient-family organization member will serve in their individual capacity.

1. Industry Representative : Persons nominated for membership on the committee as a nonvoting industry representative shall have the following: (1) Professional experience in the medical product regulated industry, (2) ability to understand and analyze scientific data and issues related to pediatric product development, and (3) ability to communicate and disseminate information about the advisory committee experience to interested parties of industry.

2. Pediatric Health Organization Representative : Persons nominated for membership on the committee as a representative from a pediatric health organization shall have the following: (1) A direct affiliation with a recognized pediatric health organization and (2) the ability to understand and analyze scientific data and technical information.

1. Research and Clinical Scientists : Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations shall include a current resume or curriculum vitae of each nominee, including current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning matters related to financial holdings, employment, and research grants and/or contracts.

2. Consumer Member : Any interested person or organization may nominate one or more qualified persons for membership on the pediatric advisory committee to represent consumer interests. Self-nominations are also accepted.

All nominations must include a cover letter, a curriculum vitae or resume, including current business address and telephone number and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. FDA will ask the potential candidates to provide detailed information concerning matters related to financial holdings, employment, and research grants and/or contracts.

Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing public interest and consumer advocacy groups. The organizations have the responsibility of recommending candidates to the agency for selection.

3. Patient or Patient-Family Organization Member : Individuals, patient advocacy groups and organizations may submit nominations. Self-nominations will also be accepted.

Nominations shall include a current resume of the nominee (including current contact information), shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning matters related to potential financial interests.

4. Pediatric Health Organization Representative : Individuals and pediatric organizations may submit nominations. Self-nominations will also be accepted.

All nominations must include a cover letter, a curriculum vitae or resume, information delineating the mission of the pediatric health organization and the relationship of the nominee to the pediatric health organization.

5. Industry Representative : Interested persons may nominate one or more qualified persons for membership. Self-nominations are also accepted.

Nominations shall include a current resume or curriculum vitae of each nominee, including current business address and telephone number, and shall state that the nominee is aware of the nomination, and is willing to serve as a nonvoting member. Nominees must have demonstrated first hand knowledge or work experience of the industry. Nominees must also demonstrate that they have the mechanisms to disseminate information from the advisory committee experience to their constituents.

Selection of the member representing industry interests will be made in accordance with 21 CFR 14.84(d). Any organization wishing to participate in the selection of a nonvoting member to represent industry on the Pediatric Advisory Committee should send a letter stating that interest to the FDA contact identified previously within 30 days of publication of this notice. Individuals who nominate themselves as industry representatives will not participate in the selection process.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

FDA is announcing the formation of a subcommittee of the Pediatric Advisory Committee. This subcommittee has been established to address pediatric ethical issues, as well as IRB referrals related to clinical investigations involving children as subjects as specified in § 50.54 (21 CFR 50.54) and IRB referrals that involve both FDA regulated products under § 50.54 and research involving children as subjects that is conducted or supported by the Department of Health and Human Services as specified in 45 CFR 46.407.

The subcommittee's preliminary recommendations will be presented to the FDA Pediatric Advisory Committee. The subcommittee will meet approximately two times a year. Meetings of the subcommittee will be open to the public. All meetings will be announced in the Federal Register at least 15 days prior to each scheduled public meeting.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Section 738 of the act (21 U.S.C. 379j) establishes fees for certain medical device applications and supplements. Under statutorily defined conditions, FDA may waive or reduce fees (21 U.S.C. 379j(d) and (e)).

For FY 2003 through 2007, MDUFMA (Public Law 107-250) establishes base revenue amounts for the aggregate of all application fee revenues. Base revenue amounts established for each year after FY 2003 are subject to adjustment for inflation, workload, and compensation for revenue shortfalls from previous years. Fees for applications are to be established each year by FDA so that revenues will approximate the levels established in the statute, after those amounts have been first adjusted for inflation, workload and, if required, revenue shortfalls from previous years.

This document establishes fee rates for FY 2005. These fees are effective on October 1, 2004, and will remain in effect through September 30, 2005.

MDUFMA specifies that the fee revenue amount for FY 2005 is $29,785,000, before any adjustments are made (21 U.S.C. 379j(b)).

MDUFMA provides that fee revenue amounts for each fiscal year after 2003 shall be adjusted for inflation. The adjustment must reflect the greater of the following factors: (1) The total percentage change that occurred in the Consumer Price Index (CPI) (all items; U.S. city average) during the 12-month period ending June 30 preceding the FY for which fees are being set, or (2) the total percentage pay change for the previous FY for Federal employees stationed in the Washington, DC metropolitan area. MDUFMA provides for this annual adjustment to be cumulative and compounded annually after 2003 (21 U.S.C. 379j(c)(1)).

The inflation adjustment for FY 2004 was 4.27 percent. This was the greater of the CPI increase during the 12-month period ending June 30 preceding the FY for which fees were being set (June 30, 2003—which was 2.11 percent) or the increase in pay for the previous FY (2003) for Federal employees stationed in the Washington, DC metropolitan area (4.27 percent).

The inflation increase for FY 2005 is 4.42 percent. This is the greater of the CPI increase for the 12-month period ending June 30, 2004, (3.27 percent) or the increase in pay for FY 2004 for Federal employees stationed in the Washington, DC metropolitan area (4.42 percent).

Compounding these amounts (1.0427 times 1.0442) yields a total compounded inflation adjustment of 8.88 percent for FY 2005.

The inflation-adjusted revenue amount for FY 2005 is the statutory fee amount ($29,785,000) increased by 8.88 percent, the inflation adjuster for FY 2005. The FY 2005 inflation-adjusted revenue amount is $32,429,908.

For each fiscal year beginning in FY 2004, MDUFMA provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect increases in workload for the process for the review of medical device applications (see 21 U.S.C. 379j(c)(2)). FDA is developing a methodology to determine the extent of workload changes for the device program, but has not completed the data gathering and analysis necessary to accurately account for differences in how the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health (CBER and CDRH) define and manage their device review processes. Until FDA develops a sound methodology, we will not invoke the workload adjustment to further increase inflation-adjusted MDUFMA fees and will not be applying a workload adjustment to the FY 2005 inflation-adjusted revenue amount of $32,429,908. The need for workload adjustment will be assessed anew next year when FY 2006 fees are established.

For each fiscal year beginning in FY 2004, MDUFMA provides that fee revenue amounts, after they have been adjusted for inflation and workload, shall be further adjusted, if necessary, to compensate for the cumulative shortfall in fee revenue from previous years (see 21 U.S.C. 379j(c)(3)).

In FY 2003, FDA had expected to collect a total of $25,125,000 in MDUFMA fees. This was the fee revenue amount stated in the statute (see 21 U.S.C. 379j(b)). As of June 30, 2003, just before fees for FY 2004 had to be published, for the first 9 months of the fiscal year, total fee collections were only $14,360,304. If fee collections in the last 3 months had remained proportional to collections in the first 9 months, FDA would have collected another $4,786,768 million—for a total of about $19,647,000 million for the year—still $5,478,000 million less than the statutory revenue amount for FY 2003. Accordingly, FDA used this amount ($5,478,000) as the compensating adjustment when fees for FY 2004 were set a year ago. However, collections in the final quarter were higher than expected, and the compensating adjustment should only have been $3,235,211.

Because experience has shown that it is difficult to predict the amount by which revenues may fall short of the revenue target before the end of the fiscal year, FDA has decided not to assess a compensating adjustment in setting fees for FY 2005. However a year from now when fees for FY 2006 are set, FDA will know with certainty the extent to which fees for FY 2004 fell short of the revised FY 2004 revenue target of $31,654,000. The shortfall, if any, will be applied, in part or in total, as the compensating adjuster in FY 2006.

Under MDUFMA, the amount of fee revenue collected is a function of two factors—the fee rate for the application and the number of applications that will pay each type of fee.

To set fees for FY 2005, FDA must first estimate the number of applications that will pay each type of fee. Before MDUFMA was enacted, FDA estimated the number of applications that would pay each type of fee. That estimate was based on the average number of each category of application over the 5-year period, FY 1997 through 2001. Those estimates took into account FDA's estimates of the number of applications that would qualify for a small business reduction or exemption. The original FY 2003 estimates are shown in the “Original Estimate” column of table 1 of this document.

The reason that MDUFMA fee revenues fell short of the revenue target in FY 2003 by $3,235,211 is that FDA collected fewer full fees than projected for original premarket approval applications (PMAs) and biologic license applications (BLAs) and their full-fee supplements, and fewer fees for 180-day supplements, as shown in the “2003 Actuals” column of table 1 of this document.

FDA is expecting that the numbers of fee-paying applications that will be received in FY 2004 will again be less than the amounts expected when MDUFMA was enacted. The “2004 Estimate” column of table 1 of this document shows the current estimate of each type of application that will pay fees, based on all fees received through June 30, 2004, the first 9 months of the fiscal year, and assuming that fee-paying applications for the remaining 3 months of the fiscal year will come in at the same rate as they were received in the first 9 months.

There are several reasons for last year's shortfall and the expected shortfall in FY 2004. The number of original PMA applications that did not pay a fee in FY 2003 because they were the first applications from a qualifying small business was much higher than expected. In addition, the number of applications submitted as 180-day supplements (paying about 3 times the fee of a real-time supplement) has been declining markedly since the enactment of MDUFMA, and the number of supplements submitted as real-time supplements has been increasing correspondingly. While the workload has remained about the same for the two categories combined, the result is substantially less fee revenue. Finally, a number of the applications in each category have been “bundled” and did not have to pay separate fees.

Because of the receipt of fewer than expected fee-paying applications in FY 2003, FDA considered basing fees for FY 2004 on lower estimates of the number of full PMA/BLA fees and 180-day supplement fees. The agency did not revise the estimated numbers of fee-paying applications in setting the FY 2004 fees, however, because such a revision would have been based on data from too brief a period—the 3 months from April 1 through June 30, 2003. A year ago, however, the agency stated its intention to reassess whether it should adjust its original estimates of the number of each type of fee-paying application when it sets fees for FY 2005, when the agency would have almost 2 years of data to determine whether its original estimates for annual numbers of applications were too high.

FDA has determined that it needs to revise the numbers of fee-paying applications it expects to receive each year based on the experience of FY 2003 and the first 9 months of FY 2004. The last column of table 1 of this document provides the more realistic estimates of numbers of fee-paying applications upon which FDA will base its fee calculations for FY 2005. Recognizing that industry also needs predictability in fee assessments, the agency is committing to using these same estimates of numbers of each type of fee-paying application when fees are set for FY 2006 and 2007.

In accordance with 21 CFR 20.108(c), which states that all written agreements and MOU's between FDA and others shall be published in the Federal Register , the agency is publishing notice of this MOU.

In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register , the agency is publishing notice of this MOU.

Sections 735 and 736 of the act (21 U.S.C. 379g and h), establish three different kinds of user fees. Fees are assessed on: (1) Certain types of applications and supplements for approval of drug and biological products, (2) certain establishments where such products are made, and (3) certain products (21 U.S.C. 379h(a)). When certain conditions are met, FDA may waive or reduce fees (21 U.S.C. 379h(d)).

For FY 2003 through 2007 base revenue amounts for application fees, establishment fees, and product fees are established by PDUFA III (title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002). Base revenue amounts established for years after FY 2003 are subject to adjustment for inflation and workload. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the levels established in the statute, after those amounts have been first adjusted for inflation and workload. The revenue levels established by PDUFA III continue the arrangement under which one-third of the total user fee revenue is projected to come from each of the three types of fees: Application fees, establishment fees, and product fees.

This notice establishes fee rates for FY 2005 for application, establishment, and product fees. These fees are effective on October 1, 2004, and will remain in effect through September 30, 2005.

PDUFA III specifies that the fee revenue amount for fiscal year 2005 for each category of fees (application, product, and establishment) is $84,000,000, for a total of $252,000,000 from all three categories of fees (21 U.S.C. 379h(b), before any adjustments are made.

PDUFA III provides that fee revenue amounts for each fiscal year after 2003 shall be adjusted for inflation. The adjustment must reflect the greater of: (1) The total percentage change that occurred in the consumer price index (CPI) (all items; U.S. city average) during the 12-month period ending June 30 preceding the fiscal year for which fees are being set, or (2) the total percentage pay change for the previous fiscal year for Federal employees stationed in the Washington, DC, metropolitan area. PDUFA III provides for this annual adjustment to be cumulative and compounded annually after FY 2003 (see 21 U.S.C. 379h(c)(1)).

The inflation increase for FY 2004 was 4.27 percent. This was the greater of the CPI increase during the 12-month period ending June 30 preceding the fiscal year for which fees are being set (June 30, 2003—which was 2.11 percent) or the increase in pay for the previous fiscal year (2003 in this case) for Federal employees stationed in the Washington, DC, metropolitan area (4.27 percent).

The inflation increase for FY 2005 is 4.42 percent. This is the greater of the CPI increase during the 12-month period ending June 30 preceding the fiscal year for which fees are being set (June 30, 2004—which was 3.27 percent) or the increase in pay for the previous fiscal year (2004 in this case) for Federal employees stationed in the Washington, DC, metropolitan area (4.42 percent).

Compounding these amounts (1.0427 times 1.0442) yields a total compounded inflation adjustment of 8.88 percent for FY 2005.

The inflation adjustment for each category of fees for FY 2005 is the statutory fee amount ($84,000,000) increased by 8.88 percent, the inflation adjuster for FY 2005. The FY 2005 inflation-adjusted revenue amount is $91,459,200 for each category of fee, for a total inflation-adjusted fee revenue amount of $274,377,600 in FY 2005.

For each fiscal year beginning in FY 2004, PDUFA III provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect changes in workload for the process for the review of human drug applications (see 21 U.S.C. 379h(c)(2)).

The conference report accompanying PDUFA III, House of Representatives report number 107-481, provides additional instructions on how the workload adjustment provision of PDUFA III is to be implemented. Following that guidance, FDA calculated the average number each of the four types of applications specified in the workload adjustment provision (human drug applications, commercial investigational new drug applications (INDs), efficacy supplements, and manufacturing supplements) received over the 5-year period that ended on June 30, 2002 (base years), and the average number of each of these types of applications over the most recent 5-year period that ended June 30, 2004.

The results of these calculations are presented in the first 2 columns of table 1 of this document. Table 1, column 3 of this document, reflects the percent change in workload over the two 5-year periods and column 4 shows the weighting factor for each type of application, reflecting how much of the total FDA drug review workload was accounted for by each type of application in the table during the most recent 5 years. This weighting factor was developed by averaging data generated in a 2002 KPMG study of FDA's drug review workload and data from FDA's time reporting systems to submission data for the most recent 5-year period. Column 5 of table 1 of this document, is the weighted percent change in each category of workload, and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of table 1 of this document, the sum of the values in column 5 is added, reflecting a total change in workload of 1.47 percent for FY 2005.

Increasing the inflation-adjusted revenue amount of $91,459,200 for each category of fee by the FY 2005 workload adjuster (1.47 percent) results in an increase of $1,344,450, for a total inflation and workload adjusted revenue amount for each fee category of $92,803,650. The total FY 2005 inflation and workload adjusted fee revenue target for all three fee categories combined is $278,410,950.

PDUFA III provides that the rates for application, product, and establishment fees be established 60 days before the beginning of each fiscal year (21 U.S.C. 379h(c)(4)). The fees are to be established so that they will generate the fee revenue amounts specified in the statute, as adjusted for inflation and workload.

The application fee revenue amount that PDUFA III established for FY 2005 is $92,803,650, as calculated in the previous section. Application fees will be set to generate this amount.

For FY 2003 through 2007, FDA will estimate the total number of fee-paying full application equivalents (FAEs) it expects to receive the next fiscal year by averaging the number of fee-paying FAEs received in the 5 most recent fiscal years. This use of the rolling average of the 5 most recent fiscal years is the same method that was applied in making the workload adjustment.

In estimating the number of fee-paying FAEs that FDA will receive in FY 2005, the 5-year rolling average for the most recent 5 years will be based on actual counts of fee-paying FAEs received for FYs 2000 through 2004. For FY 2004, FDA is estimating the number of fee-paying FAEs for the full year based on the actual count for the first 9 months and estimating the number for the final 3 months.

Table 2, column 1 of this document, shows the total number of each type of FAE received in the first 9 months of FY 2004, whether fees were paid or not. Table 2, column 2 of this document shows the number of FAEs for which fees were waived or exempted during this period, and column 3 shows the number of fee-paying FAEs received through June 30, 2004. Column 4 estimates the 12-month total fee-paying FAEs for FY 2004 based on the applications received through June 30, 2004. All of the counts are in FAEs. A full application requiring clinical data counts as one FAE. An application not requiring clinical data counts one-half an FAE, as does a supplement requiring clinical data. An application that is withdrawn or refused for filing counts as one-fourth of an FAE if it initially paid a full application fee, or one-eighth of an FAE if it initially paid one-half of the full application fee amount.

In the first 9 months of FY 2004 FDA received 143.25 FAEs, of which 110.25 were fee-paying. Based on data from the last seven FYs, on average, 25 percent of the applications submitted each year come in the final 3 months. Dividing 110.25 by 3 and multiplying by 4 extrapolates the amount to the full 12 months of the fiscal year and projects the number of fee-paying FAEs in FY 2004 at 147.

All pediatric supplements, which had been exempt from fees prior to January 4, 2002, were required to pay fees effective January 4, 2002. This is the result of section 5 of the Best Pharmaceuticals for Children Act that repealed the fee exemption for pediatric supplements effective January 4, 2002. Thus, in estimating FY 2004 fee-paying receipts, we must add all the pediatric supplements that were previously exempt from fees prior to January 4, 2002. The exempted number of FAEs for pediatric supplements for FY 2000, FY 2001, and FY 2002, respectively, were 12.5, 19, and 4.5. Since fees on these supplements are paid for pediatric applications submitted in FY 2004 and beyond, the number of pediatric supplement FAEs exempted from fees each year from FY 2000 through 2002 (the years in table 3 of this document when fees were exempted) are added to the total of fee-paying FAEs received each year.

As table 3 of this document shows, the average number of fee-paying FAEs received annually in the most recent 5-year period, assuming all pediatric supplements had paid fees, and including our estimate for FY 2004, is 138.1 FAEs. FDA will set fees for FY 2005 based on this estimate as the number of FAEs that will pay fees.

The FY 2005 application fee is estimated by dividing the average number of full applications that paid fees over the latest 5 years, 138.1, into the fee revenue amount to be derived from application fees in FY 2005, $92,803,650. The result, rounded to the nearest one hundred dollars, is a fee of $672,000 per full application requiring clinical data, and $336,000 per application not requiring clinical data or per supplement requiring clinical data.

Under the provisions of PDUFA, as amended, if the agency collects more fees than were provided for in appropriations in any year after 1997, FDA is required to reduce its anticipated fee collections in a subsequent year by that amount (21 U.S.C. 379h(g)(4)). In FY 1998, Congress appropriated a total of $117,122,000 to FDA in PDUFA fee revenue. To date, collections for FY 1998 total $117,737,470—a total of $615,470 in excess of the appropriation limit. This is the only fiscal year since 1997 in which FDA has collected more in PDUFA fees than Congress appropriated.

FDA also has some requests for waivers or reductions of FY 1998 fees that have been decided but that are pending appeals. For this reason, FDA is not reducing its FY 2005 fees to offset excess collections at this time. An offset will be considered in a future year, if FDA still has collections in excess of appropriations for FY 1998 after the pending appeals for FY 1998 waivers and reductions have been resolved.

At the beginning of FY 2004, the establishment fee was based on an estimate that 354 establishments would be subject to and would pay fees. By the end of FY 2004, FDA estimates that 379 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made. FDA again estimates that a total of 25 establishment fee waivers or reductions will be made for FY 2004, for a net of 354 fee-paying establishments. FDA will use this same number again, 354, for its FY 2005 estimate of establishments paying fees, after taking waivers and reductions into account. The fee per establishment is determined by dividing the adjusted total fee revenue to be derived from establishments ($92,803,650) by the estimated 354 establishments, for an establishment fee rate for FY 2005 of $262,200 (rounded to the nearest one hundred dollars).

At the beginning of FY 2004, the product fee was based on an estimate that 2,225 products would be subject to and pay product fees. By the end of FY 2004, FDA estimates that 2,260 products will have been billed for product fees, before all decisions on requests for waivers or reductions are made. Assuming that there will be about 35 waivers and reductions granted, FDA estimates that 2,225 products will qualify for product fees in FY 2004, after allowing for waivers and reductions, and will use this number for its FY 2005 estimate. Accordingly, the FY 2005 product fee rate is determined by dividing the adjusted total fee revenue to be derived from product fees ($92,803,650) by the estimated 2,225 products for a FY 2005 product fee of $41,710 (rounded to the nearest ten dollars).

The fee rates for FY 2005 are set out in table 4 of this document:

The appropriate application fee established in the new fee schedule must be paid for any application or supplement subject to fees under PDUFA that is received after September 30, 2004. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the Food and Drug Administration. Please include the user fee identification (ID) number on your check. Your payment can be mailed to: Food and Drug Administration, P.O. Box 360909, Pittsburgh, PA 15251-6909

If checks are to be sent by a courier that requests a street address, the courier can deliver the checks to: Food and Drug Administration (360909), Mellon Client Service Center, rm. 670, 500 Ross St., Pittsburgh, PA 15262-0001. (Note: This Mellon Bank address is for courier delivery only.)

Please make sure that the FDA post office box number (P.O. Box 360909) is written on the check. The tax ID number of the FDA is 530 19 6965.

By August 31, 2004, FDA will issue invoices for establishment and product fees for FY 2005 under the new fee schedule. Payment will be due on October 1, 2004. FDA will issue invoices in October 2005 for any products and

The technology describes methods and compositions for treating a subject (human or animal) suffering from hair loss. More specifically, the technology relates to the discovery that actin binding peptides promote hair growth. In one example, the technology describes the exogenous delivery of a seven amino acid peptide of Thymosin- β 4 to promote hair growth.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

On July 26, 2004, DHS published a notice in the Federal Register stating that DHS would submit a new information collection request (ICR) to OMB pursuant to the PRA and estimating burden hours associated with that request.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), a Federal agency must obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. This information collection, does not meet the definition of “information collection” as defined under 5 CFR part 1320, and is therefore exempt from the requirements of the PRA. Accordingly, there is no requirement to obtain OMB approval for this information collection, as previously stated and reported in the federal notice published July 26, 2004.

The July 26, 2004 Federal Register notice published contained incorrect information regarding the frequency of information collection, estimated time per respondent, total burden hours, and the description for the collection. As noted, the submission of information is exempt from PRA. The corrections are as follows:

Frequency: One-time.

Estimated Time Per Respondent: 15 minutes per response.

Total Burden Hours: 125 hours.

Please note the description was also amended for clarity.

Description: The Department of Homeland Security is launching an expansion of the Ready campaign, called Ready for Kids, designed for children grades 4-8. As part of Ready for Kids, the Department of Homeland Security will conduct a “name the mascot” contest.

The International Convention for the Prevention of Pollution from Ships (MARPOL 73/78), 33 U.S.C. § 1901 et seq. , is the primary international agreement aimed at reducing pollution of the marine environment from a variety of vessel-generated sources. Annex I to MARPOL 73/78, “Prevention of Pollution by Oil,” contains provisions intended to reduce both intentional and accidental discharges of oil. Regulation 13G of Annex I, “Prevention of oil pollution in the event of collision or stranding-Measures for existing tankers,” establishes the phase-out schedule for single hull oil tank vessels. On December 4, 2003, the IMO adopted an amendment to Regulation 13G to accelerate the phase-out of single hull tank vessels. During the same session, the IMO also adopted a new Regulation 13H to Annex I, entitled “Prevention of oil pollution when carrying heavy grades of oil,” to ban the carriage of heavy grade oil in single hull tank vessels.

Although the international maritime community is moving closer to U.S. standards, significant differences between Regulation 13G and the Oil Pollution Act of 1990 (OPA 90), 46 U.S.C. 3703, remain. For example, OPA 90 is generally more aggressive in its phase-out schedule for a majority of single hull oil tank vessels, based on size and age of the ship. During similar circumstances in 1992 and 2002, the U.S. Embassy in London deposited declarations with the International Maritime Organization (IMO) stating that the express approval of the United States would be necessary before Regulation 13F of Annex I, “Prevention of oil pollution in the event of collision or stranding” or amended Regulation 13G would enter into force for the United States. Furthermore, the link between Regulation 13H and Regulations 13F and 13G is such that it is difficult to apply Regulation 13H without also giving effect to Regulations 13F and 13G.

Through its July 2, 2004 declaration, which is available in the docket, the U.S. declared a position with the IMO that the express approval of the U.S. will be necessary before these amendments will be applied in lieu of existing U.S. law. As a result, the U.S. has reaffirmed with the IMO that OPA 90 continues to be the national governing standard for tank vessels operating in U.S. waters.

The Department of Housing and Urban Development will submit the proposed extension of information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed 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 the agency's estimate for the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology (e.g., permitting electronic submission of responses).

This Notice also lists the following information:

Title of Proposal: Notice of Funding Availability for the Urban Scholars Fellowship Program.

OMB Control Number: 2528-0214.

Description of the Need for the Information and Proposed Use: The information is being collected to select applicants for awards in this statutorily created competitive grant program and to monitor performance of grantees to ensure that they meet statutory and program goals and requirements.

Agency Form Numbers: SF-424, HUD-424B, SFLLL, HUD-27061, HUD-2880, HUD-2730, HUD-96010, HUD-2993, and HUD-2994.

Members of the Affected Public: Urban Scholar Fellowship Program applicants.

Estimation of the total number of hours needed to prepare the information collection including numbers of respondents, frequency of response, and hours of response: Information pursuant to grant award will be submitted once a year. The following chart details the respondent burden on a quarterly, semi-annual and annual basis:

Status of the proposed information collection: Pending OMB approval.

This notice informs the public that the U.S. Department of Housing and Urban Development (HUD) has submitted to OMB, for emergency processing, a survey instrument to obtain information from faith based and community organizations on their likelihood and success at applying for various funding programs. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed 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 the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: HUD Conditional Commitment/Direct Endorsement Statement of Appraised Value.

OMB Approval Number: 2502-0518.

Form Numbers: HUD-92800.5B.

Description of the Need for the Information and Its Proposed Use: The Conditional Commitment/Direct Endorsement Statement of Appraised Value, is used by appraisers and/or underwriters upon their review of the appraisal report (URAR) to determine if a property meets FHA guidelines to be eligible for HUD mortgage insurance. Underwriters are required to sign and submit a copy of the completed form to HUD for endorsement as part of the case binder; to provide a copy to the homebuyer; and to maintain a copy for the mortgagee.

The copy provided to the homebuyer explains in detail the purpose of an appraisal, the need for a home inspection and special commitment conditions that may need to be met before FHA can insure the property. The information is also used for test cases to determine a mortgagees eligibility in becoming a FHA approved lender.

Frequency of Submission: On Occasion.

Section 202(c)(5) of the National Housing Act (added by section 142 of the Department of Housing and Urban Development Reform Act of 1989, Pub. L. 101-235, approved December 15, 1989), requires that HUD publish a description of and the cause for administrative actions against a HUD-approved mortgagee by the Department's Mortgagee Review Board. In compliance with the requirements of section 202(c)(5), this notice advises of administrative actions that have been taken by the Mortgagee Review Board from October 1, 2003 through March 31, 2004, related to the failure of Title I lenders and Title II mortgagees to submit the required audited annual financial statement, an acceptable annual audited financial statement and/or payment of the annual recertification fee.

Action: Withdrawal of HUD/FHA Title I lender approval and Title II mortgagee approval.

Cause: Failure to submit to the Department the required annual audited financial statement, an acceptable annual audited financial statement, and/or remit the required annual recertification fee.

Committee meetings are open to the public. Verbal comments may be submitted during the course of the meeting, written comments may be submitted at the close of the meeting, as described under addressees.

The 15-member Council advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in southwestern Idaho. At this meeting, the following actions will occur/topics will be discussed:

• Overview of Natural Resource Issues on the Duck Valley Reservation;

• Review of RAC and BLM co-sponsored Community Discussion on Western Juniper Management—Workshop held on July 22, 2004;

• Report on Off-Highway Vehicle Route Designation efforts in the Lower Snake River District;

• Update on BLM-Idaho Organizational Refinement;

• Update: Implementation of LEPA Candidate Conservation Agreement;

• Update on Sage Grouse Habitat Restoration efforts;

• Hot Topics—Snail Lawsuit; Overview on Information Memorandum on Implementation of Idaho Rangeland Standards and Guidelines, and;

• Update on status of District's Fire and Fuels Management Plan, and Normal Year Fire Rehab. Plans;

• Subcommittee Reports

◦ Off-Highway Vehicles (OHV) and Transportation Management, Resource Management Plans (RAC assistance requested with finalizing draft alternatives), Sage Grouse Habitat Management, and, River and Recreation Management;

• Three Field Office Managers and District Fire Manager provide updates on current issues and planned activities in their Field Offices and the District.

Agenda items may change due to changing circumstances. All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM as provided below. Expedited publication is requested to give the public adequate notice.

The Commission's original investigation in this matter was terminated on June 2, 1999, with a finding of violation of section 337 by 26 respondents by reason of importation or sales after importation of certain lens-fitted film packages ( i.e. , disposable cameras) that were found to infringe one or more claims of 15 patents held by complainant Fuji Photo Film Co. (Fuji). 64 FR 30541 (June 8, 1999). The Commission issued a general exclusion order, prohibiting the importation of LFFPs that infringe any of the claims at issue, and issued cease and desist orders to twenty domestic respondents. Id . The Commission's orders were upheld by the U.S. Court of Appeals for the Federal Circuit. Jazz Photo Corp. v. Int'l Trade Comm'n, 264 F.3d 1094 (Fed. Cir. 2001), cert. denied 536 U.S. 950 (2002).

On September 24, 2002, the Commission initiated enforcement proceedings at the request of complainant Fuji under Commission rule 210.75(b) to determine whether respondent Jazz and/or two individuals associated with Jazz, Mr. Jack Benun and Mr. Anthony Cossentino, violated the general exclusion order and/or the cease and desist orders, issued on June 2, 1999, in the original Film Packages investigation. The proceedings were referred to the presiding ALJ for issuance of an EID. The proceedings were suspended for several months due to the outbreak of severe acute respiratory syndrome (SARS) in areas of China where discovery had to be completed.

On April 6, 2004, the ALJ issued his EID, finding that all respondents had violated the general exclusion order and cease and desist orders. Fuji, Jazz, Benun and Cossentino filed petitions for review of the EID on April 22, 2004. Those parties, as well as the Commission investigative attorneys filed responses to the petitions on May 10, 2004.

The Commission, having examined the petitions for review, and the responses thereto has determined not to review the EID's determination that the general exclusion order and cease and desist order issued to Jazz have been violated, as well as his determination to find Mr. Cossentino and Mr. Benun subject to the cease and desist order issued to Jazz. In connection with the final disposition of the enforcement proceedings, the Commission may issue civil penalties for violations of its cease and desist order. The Commission has not yet ruled on whether it will adopt the specific enforcement measures recommended in the EID.

Written Submissions: The parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the specific enforcement measures recommended by the ALJ in his EID no later than close of business on August 20, 2004. Response submissions must be filed no later than the close of business on September 3, 2004. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file with the Office of the Secretary the original document and 14 true copies thereof on or before the deadlines stated above. Any person desiring to submit a document (or portion thereof) to the Commission in confidence must request confidential treatment unless the information has already been granted such treatment during the proceedings. All such requests should be directed to the Secretary of the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See section 201.6 of the Commission's Rules of Practice and Procedure, 19 CFR 201.6. Documents for which confidential treatment by the Commission is sought will be treated accordingly. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary.

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and sections 210.75 of the Commission's Rules of Practice and Procedure (19 CFR 210.75).

Background. On February 2, 1977, the Department of the Treasury issued an antidumping finding on imports of melamine from Japan (42 FR 6366). Following five-year reviews by Commerce and the Commission, effective September 1, 1999, Commerce issued a continuation of the antidumping finding on imports of melamine from Japan (64 FR 47764). The Commission is now conducting a second review to determine whether revocation of the finding would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. It will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full review or an expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice.

Definitions. The following definitions apply to this review:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by the Department of Commerce.

(2) The Subject Country in this review is Japan.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. The Commission did not make a Domestic Like Product determination per se in its original determination but effectively treated all melamine in crystal form as a single Domestic Like Product . In its full five-year review determination, the Commission found one Domestic Like Product consisting of all melamine in crystal form and inclusive of all particle sizes.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product , or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination and its full five-year review determination, the Commission defined the Domestic Industry as producers of melamine in crystal form.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the review and public service list. Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the review as parties must file an entry of appearance with the Secretary to the Commission, as provided in section 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the review.

Former Commission employees who are seeking to appear in Commission five-year reviews are reminded that they are required, pursuant to 19 CFR 201.15, to seek Commission approval if the matter in which they are seeking to appear was pending in any manner or form during their Commission employment. The Commission is seeking guidance as to whether a second transition five-year review is the “same particular matter” as the underlying original investigation for purposes of 19 CFR 201.15 and 18 U.S.C. 207, the post employment statute for Federal employees. Former employees may seek informal advice from Commission ethics officials with respect to this and the related issue of whether the employee's participation was “personal and substantial.” However, any informal consultation will not relieve former employees of the obligation to seek approval to appear from the Commission under its rule 201.15. For ethics advice, contact Carol McCue Verratti, Deputy Agency Ethics Official, at (202) 205-3088.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this review available to authorized applicants under the APO issued in the review, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the review. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this review must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will be deemed to consent, unless otherwise specified, for the Commission, its employees, and contract personnel to use the information provided in any other reviews or investigations of the same or comparable products which the Commission conducts under Title VII of the Act, or in internal audits and investigations relating to the programs and operations of the Commission pursuant to 5 U.S.C. Appendix 3.

Written submissions. Pursuant to section 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is September 21, 2004. Pursuant to section 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is October 18, 2004. All written submissions must conform with the provisions of sections 201.8 and 207.3 of the Commission's rules and any submissions that contain BPI must also conform with the requirements of sections 201.6 and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Also, in accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the review you do not need to serve your response).

Inability to provide requested information. Pursuant to section 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to section 776(b) of the Act in making its determination in the review.

Information to be provided in response to this Notice of Institution: As used below, the term “firm” includes any related firms.

(1) The name and address of your firm or entity (including World Wide Web address if available) and name, telephone number, fax number, and e-mail address of the certifying official.

(2) A statement indicating whether your firm/entity is a U.S. producer of the Domestic Like Product , a U.S. union or worker group, a U.S. importer of the Subject Merchandise , a foreign producer or exporter of the Subject Merchandise , a U.S. or foreign trade or business association, or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this review by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping finding on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry .

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product . Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 1998.

(7) If you are a U.S. producer of the Domestic Like Product , provide the following information on your firm's operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s); and

(c) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s).

(8) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country , provide the following information on your firm's(s') operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country ; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country .

(9) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country , provide the following information on your firm's(s') operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production; and

(b) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(10) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 1998, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country , and such merchandise from other countries.

(11) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry ; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Background. On August 28, 1986, the Department of Commerce issued an antidumping duty order on imports of petroleum wax candles from China (51 FR 30686). Following five-year reviews by Commerce and the Commission, effective September 23, 1999, Commerce issued a continuation of the antidumping duty order on imports of petroleum wax candles from China (64 FR 51514). The Commission is now conducting a second review to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. It will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full review or an expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice.

Definitions . The following definitions apply to this review:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by the Department of Commerce.

(2) The Subject Country in this review is China.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise . In its original determination and its expedited five-year review determination, the Commission defined the Domestic Like Product as petroleum wax candles.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product , or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination and its expedited five-year review determination, the Commission defined the Domestic Industry as producers of petroleum wax candles.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the review and public service list . Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the review as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the review.

Former Commission employees who are seeking to appear in Commission five-year reviews are reminded that they are required, pursuant to 19 CFR 201.15, to seek Commission approval if the matter in which they are seeking to appear was pending in any manner or form during their Commission employment. The Commission is seeking guidance as to whether a second transition five-year review is the “same particular matter” as the underlying original investigation for purposes of 19 CFR 201.15 and 18 U.S.C. 207, the post employment statute for Federal employees. Former employees may seek informal advice from Commission ethics officials with respect to this and the related issue of whether the employee's participation was “personal and substantial.” However, any informal consultation will not relieve former employees of the obligation to seek approval to appear from the Commission under its rule 201.15. For ethics advice, contact Carol McCue Verratti, Deputy Agency Ethics Official, at (202) 205-3088.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list . Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this review available to authorized applicants under the APO issued in the review, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the review. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this review must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will be deemed to consent, unless otherwise specified, for the Commission, its employees, and contract personnel to use the information provided in any other reviews or investigations of the same or comparable products which the Commission conducts under Title VII of the Act, or in internal audits and investigations relating to the programs and operations of the Commission pursuant to 5 U.S.C. Appendix 3.

Written submissions . Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is September 21, 2004. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is October 18, 2004. All written submissions must conform with the provisions of §§ 201.8 and 207.3 of the Commission's rules and any submissions that contain BPI must also conform with the requirements of §§ 201.6 and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by § 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the review you do not need to serve your response).

Inability to provide requested information . Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to section 776(b) of the Act in making its determination in the review.

Information To Be Provided in Response to This Notice of Institution: As used below, the term “firm” includes any related firms.

(1) The name and address of your firm or entity (including World Wide Web address if available) and name, telephone number, fax number, and e-mail address of the certifying official.

(2) A statement indicating whether your firm/entity is a U.S. producer of the Domestic Like Product , a U.S. union or worker group, a U.S. importer of the Subject Merchandise , a foreign producer or exporter of the Subject Merchandise , a U.S. or foreign trade or business association, or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this review by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping duty order on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry .

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product . Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 1998.

(7) If you are a U.S. producer of the Domestic Like Product , provide the following information on your firm's operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s’) production;

(b) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s); and

(c) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s).

(8) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country , provide the following information on your firm's(s') operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country .

(9) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country , provide the following information on your firm's(s') operations on that product during calendar year 2003 (report quantity data in pounds and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production; and

(b) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(10) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 1998, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country , and such merchandise from other countries.

(11) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry ; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), NARA invites the general public and other Federal agencies to comment on proposed information collections. NARA published a notice of proposed collection for this information collection on May 13, 2004 (69 FR 26623-26624). No comments were received. NARA has submitted the described information collection to OMB for approval.

In response to this notice, comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for the proper performance of the functions of NARA; (b) the accuracy of NARA's estimate of the burden of the proposed information collection; (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 the use of information technology. In this notice, NARA is soliciting comments concerning the following information collection:

Title: Request for and Record of Pass.

OMB number: 3095-0026.

Agency form number: NA Form 6006.

Type of review: Regular.

Affected public: Individuals or households, business or other for-profit organizations and institutions, and Federal government.

Estimated number of respondents: 1,300.

Estimated time per response: 3 minutes.

Frequency of response: On occasion.

Estimated total annual burden hours: 65 hours.

Abstract: The collection of information is necessary as a security measure to protect employees, information, and property in NARA facilities and to facilitate the issuance of passes. Use of the form is authorized by 44 U.S.C. 2104. Respondents who are contractors are given a building pass which expires at the end of each fiscal year; those who are volunteers are given a pass valid for 2 years. At the NARA College Park facility, individuals receive an access card with the pass that is electronically coded to permit access to secure zones ranging from a general nominal level to stricter access levels for classified records zones. The access card system is part of the security management system which meets the accreditation standards of the Government intelligence agencies for storage of classified information, and serves to comply with E.O. 12958, as amended.

Pursuant to section 201 of the United States-Chile Free Trade Agreement Implementation Act (Pub. L. 108-77; 117 Stat. 909, 913; 19 U.S.C. 3805 note), Presidential Proclamation No. 7746 of December 30, 2003 (68 FR 75789), implemented on behalf of the United States the United States-Chile Free Trade Agreement (FTA) and modified the HTS to reflect therein the tariff and rules of origin treatment provided for in the FTA.

Pursuant to U.S. Note 12(a) to subchapter XI of HTS chapter 99, beginning in 2004 and annually thereafter, USTR is required to publish in the Federal Register a determination of the amount of Chile's trade surplus, by volume, with all sources for goods in Harmonized System (HS) subheadings 1701.11, 1701.12, 1701.91, 1701.99, 1702.20, 1702.30, 1702.40, 1702.60, 1701.90, 1806.10, 2101.12, 2101.20, and 2106.90, except that Chile's imports of U.S. goods under HS subheadings 1702.40 and 1702.60 that qualify for preferential treatment under the FTA may not be included in the calculation of Chile's trade surplus. During calendar year 2003, the most recent year for which data is available, Chile's imports of the foregoing goods exceeded its exports by 186,269.7 metric tons according to data published by its customs authority, the Servicio Nacional de Aduana. Accordingly, based on this data, USTR determines that Chile's trade surplus for 2004 is negative.

Pursuant to Additional U.S. Note 5 to chapter 17 of the Harmonized Tariff Schedule of the United States (HTS), the United States maintains tariff-rate quotas for imports of raw cane and refined sugar. Pursuant to additional U.S. Note 8 to chapter 17 of the HTS, the United States also maintains a tariff-rate quota for certain sugar-containing products.

Section 404(d)(3) of the Uruguay Round Agreements Act (19 U.S.C. 3601(d)(3)) authorizes the President to allocate the in-quota quantity of a tariff-rate quota for any agricultural product among supplying countries or customs areas. The President delegated this authority to the United States Trade Representative under Presidential Proclamation 6763 (60 FR 1007).

The in-quota quantity of the tariff-rate quota for raw cane sugar for the period October 1, 2004-September 30, 2005, has been established by the Secretary of Agriculture at 1,117,195 metric tons, raw value (1,231,497 short tons), the minimum to which the United States is committed under the World Trade Organization Agreement. The quantity of 1,117,195 metric tons, raw value is being allocated to the following countries:

These allocations are based on the countries' historical shipments to the United States. The allocations of the raw cane sugar tariff-rate quota to countries that are net importers of sugar are conditioned on receipt of the appropriate verifications of origin.

This allocation includes the following minimum quota-holding countries: Congo, Cote d'Ivoire, Gabon, Haiti, Madagascar, Papua New Guinea, Paraguay, St. Kitts & Nevis, and Uruguay.

The in-quota quantity of the tariff-rate quota for refined sugar for the period October 1, 2004-September 30, 2005, has been established by the Secretary of Agriculture at 43,000 metric tons, raw value (47,399 short tons), of which the Secretary has reserved 22,656 metric tons (24,974 short tons) for specialty sugars. Of the quantity not reserved for specialty sugars, a total of 10,300 metric tons (11,354 short tons) is being allocated to Canada and 2,954 metric tons (3,256 short tons) is being allocated to Mexico. The remaining 7,090 metric tons (7,815 short tons) of the in-quota quantity not reserved for specialty sugars may be supplied by any country on a first-come, first-served basis, subject to any other provision of law. The 22,656 metric tons (24,974 short tons) reserved for specialty sugars is also not being allocated among supplying countries and is available on a first-come, first-served basis, subject to any other provision of law.

With respect to the tariff-rate quota of 64,709 metric tons (71,329 short tons) for certain sugar-containing products maintained pursuant to additional U.S. Note 8 to chapter 17 of the HTS, 59,250 metric tons (65,312 short tons) of sugar-containing products is being allocated to Canada. The remaining in-quota quantity for this tariff-rate quota is available to other countries on a first-come, first-served basis.

Conversion factor: 1 metric ton = 1.10231125 short tons.

The FAA is making available a ROD and a Written Reevaluation of new information an avigation easement and trimming/removal at Cleveland Hopkins International Airport, Cleveland, Ohio. The purpose of the ROD and Written Reevaluation was to evaluate potential environmental impacts arising from Cleveland Metroparks issuance an authorization for an easement for tree trimming/removal on their property.

These documents will be available during normal business hours at the following locations: FAA Detroit Airports District Office, 11677 South Wayne Road, Suite 107, Romulus, MI 48174; FAA Airports Division Office, 2300 East Devon Ave., Des Plaines, IL 60018; Cleveland Hopkins International Airport, 5300 Riverside Drive, Cleveland, OH 44135.

Due to current security requirements, arrangements must be made with the point of contact prior to visiting these offices.

The Federal Aviation Act (the Act) at 49 U.S.C. 41722, authorizes the Secretary of Transportation to request air carriers to attend a meeting with the FAA Administrator to discuss flight schedule reductions at any severely congested airport during peak operating hours. On January 8, 2004, following several months in which delays at O'Hare and emanating from the airport through the national airspace system had reached unacceptable levels, the Administrator determined that such a meeting regarding severe congestion at O'Hare was necessary. On January 16, 2004, the Secretary then made a similar determination that a meeting was needed to meet a serious transportation need or important public benefit.

Before the scheduling reduction meeting was to occur, the FAA separately obtained the agreement of the two largest operators at O'Hare, American Airlines and United Airlines, to reduce their scheduled operations, and the FAA thereafter issued an order implementing the reductions in their scheduled service during peak hours. See FAA Orders issued in this Docket on January 21, 2004, and amended on April 21, 2004. In these Orders, we made clear our intention to conduct a scheduling reduction meeting if the consensual reductions did not achieve their desired effect.

The Orders limiting scheduled operations during certain hours at O'Hare by American Airlines and United Airlines will expire as of October 30, 2004. Moreover, even with the reductions by those carriers, the statistics for air traffic at O'Hare continue to show overscheduling and excessive delays. Daily scheduled operations published for August remain approximately 170 flights above the daily August 2003 scheduled flights. Several of the busiest traffic days ever recorded at O'Hare occurred since late June. On July 1, there were 2,968 operations, just 8 fewer than the previous record on August 31, 2001. In May 2004, a NAS monthly record of 14,495 total delays was also established. Although the level of delays has fluctuated from month to month, and weather has played a major factor, the overall trend of delays remains unacceptably high when recent periods are compared to the period before November 2003. The cumulative number of delays for this calendar year as of June 30 is 58,578; that figure is more than the respective full-year totals for each of 2000, 2001, and 2002.

Based on these and other factors, the Administrator has again determined, pursuant to the Act, that O'Hare is a severely congested airport and that a scheduling reduction meeting is necessary in order to discuss flight reductions in an effort to reduce overscheduling and flight delays at O'Hare during peak operating hours. The Secretary of Transportation has also determined, pursuant to the Act, that a scheduling reduction meeting regarding flight reductions at O'Hare is necessary to meet a serious transportation need or to achieve an important public benefit. In light of these determinations, the FAA will conduct a scheduling reduction meeting pursuant to the Act.

The FAA will hold the scheduling reduction meeting on August 4, 2004, beginning at 9:30 a.m. at the location indicated above. The meeting will continue on August 5, 2004, if necessary. As provided in the Act, no later than forty-eight hours before convening the meeting, the FAA will identify on the FAA's Web site, http://www.faa.gov , the peak periods of operation O'Hare and the FAA's targets for flight operations during the peak periods of operation.

The FAA will transcribe the scheduling reduction meeting including those sessions in which air carriers offer flight reductions to the FAA, as provided for by the procedures outlined below. The transcript and other documents related to the meeting will be available for inspection in Department of Transportation Docket FAA-2004-16944. In addition, any interested person may submit written information to the public docket no later than August 11, 2004. The docket is accessible through the Department of Transportation's Docket Management system and may be accessed via the Internet at http://dms.dot.gov.

After conducting the scheduling reduction meeting and considering all submitted information, the FAA will publish its final order on delay reductions at O'Hare in the Federal Register . The order is expected to be effective for no more than six months and may restrict service during peak hours by all air carriers, including air carriers that are not currently operating at O'Hare.

To ensure that proper accommodations are afforded to the meeting, all scheduled carriers that wish to attend the scheduling reduction meeting should register for the meeting on or before August 2, 2004. Registration may be accomplished by contacting Gerry Shakley, System Operations, Air Traffic Organization; telephone—(202) 267-9424; facsimile—(202) 267-7277; e-mail— gerry.shakley@faa.gov, identifying the air carrier and its intention to attend the meeting, and identifying who will represent the air carrier at the meeting.

Because the scheduling reduction meeting and all preparations for it are subject to the antitrust laws, the FAA has worked closely with the Department of Justice, Antitrust Division on procedures for the conduct of the meeting that should help ensure legal compliance. Copies of the FAA letter to the Antitrust Division and their response are incorporated below. As noted in this correspondence, communications among carriers regarding competitively sensitive information could result in a violation of the antitrust laws and lead to civil or criminal liability. Thus, the procedures outlined in the notice provide for a series of scheduling reduction sessions to be conducted separately by FAA staff with each air carrier attending the meeting. We will also meet with representatives of the airport operator. During those sessions any scheduled air carrier or the airport operator, if in attendance, may provide other supplemental information to the FAA regarding the targeted schedule reductions at O'Hare. The FAA requests the cooperation of all participants at the meeting in adhering to the procedures outlined in the notice.

The text of the FAA letter describing the planned procedures and the text of the Department of Justice letter assessing those procedures are as follows: