The Department has received timely requests, in accordance with 19 CFR 351.213(b)(2000), for administrative reviews of various antidumping and countervailing duty orders and findings with January anniversary dates.

In accordance with section 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than January 31, 2002.

During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under section 351.211 or a determination under section 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305.

These initiations and this notice are in accordance with section 751(a) of the Tariff Act of 1930, as amended (19 U.S.C. 1675(a)), and 19 CFR 351.221(c)(1)(i).

Because it is not practicable to complete these reviews within the normal statutory time limit, the Department is extending the time limits for completion of the preliminary results until July 31, 2001 in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended. See Memorandum from Richard O. Weible to Joseph A. Spetrini, on file in Room B-099 of the main Commerce building. The deadline for the final results of this review will continue to be 120 days after publication of the preliminary results.

This extension is in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (19 U.S.C. 1675 (a)(3)(A) (2000)).

On October 6, 1987, the Department published the antidumping duty order on TRBs and parts thereof, finished and unfinished, from Japan (A-588-604) (52 FR 37352). On October 30, 2000, NTN, a manufacturer/exporter of TRBs from Japan, requested an administrative review of the antidumping duty order on TRBs for the period October 1, 1999 through December 31, 1999. In accordance with 19 CFR 351.221(c)(1)(i), we published the initiation of the review on November 30, 2000 (65 FR 71299). On December 8, 2000, NTN withdrew its request for review.

The Department's regulations, at 19 CFR 351.213(d)(1), provide that the Department will rescind an administrative review if a party that requested a review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. NTN withdrew its request for an administrative review on December 8, 2000, which is within the 90-day deadline. No other party requested a review of NTN's sales. Therefore, the Department is rescinding this administrative review with respect to NTN.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act. Effective January 20, 2001, Bernard T. Carreau is fulfilling the duties of the Assistant Secretary for Import Administration.

In January 1997, NIST initiated an effort to develop the Advanced Encryption Standard (AES), which would provide cryptographic security well into the twenty-first century. In August 1999, NIST announced five publicly submitted candidate algorithms as finalists for the AES, and invited public review, comment, and analysis in order to make a selection for the Draft FIPS for the AES. During the Round 2 technical evaluation period, these five finalists were subjected to extensive analysis and testing by the cryptographic community. After much careful study and consideration of the finalists and Round 2 public comments, NIST made its selection for the Draft FIPS for the AES, and issued a report explaining that selection. The report is available at http://www.nist.gov/aes/.

NIST strongly encourages the public to continue performing analyses of the security of the AES, and to submit those analyses as official comments in response to this request. Such analyses and other comments received will be considered by NIST in preparing the final version of the FIPS for the AES.

NIST seeks detailed comments regarding any intellectual property that may be infringed by the practice of the algorithm(s) in the Draft FIPS for the AES. This includes comments from all parties regarding specific claims that the practice of a finalists algorithm infringes on their patent(s). Claims regarding infringement of copyrighted software are also particularly solicited. NIST views this input as a critical factor in the eventual widespread adoption and implementation of the Draft FIPS for the AES.

NIST reminds all interested parties that the AES development effort is being conducted as an open standards-setting activity. Specifically, NIST has requested that all interested parties identify to NIST any patents or inventions that may be required for the use of AES. Public comments received in response to this request will be posted periodically during the comment period at http://csrc.nist.gov/cryptval/aes/draftfips/.

To encourage on-going discussions related to the AES, NIST will continue to maintain its AES electronic discussion forum at http://aes.nist.gov/aes/. Please note that comments posted at that site will NOT be considered “official” comments.

No additional conferences are planned for the Draft FIPS for the AES at this time.

NIST intends to develop a Draft FIPS for AES Modes of Operation. Given the need for further public discussion and study of suggested modes of operation, NIST will hold a public workshop to discuss the Draft FIPS. Details on this effort are located at http://www.nist.gov/modes/.

On August 15, 2000, and on November 15, 2000, notices were published in the Federal Register (65 FR 49786 and 68983) that a request for a scientific research permit to take California sea lions and Antarctic pinnipeds had been submitted by the above-named individual.

Project I - The Holder is studying the foraging ecology and energetics of California sea lions of all age and sex classes in southern and central California, including San Nicolas, Ano Nuevo and San Miguel Islands. The Permit authorizes, annually, for 5 years, 40 adult sea lions and 100 pup sea lions will be captured, tagged, bleach marked, instrumented with satellite linked TDRs, blood sampled, and measured. In addition the Holder is authorized to incidentally harass up to 6,650 animals annually and is allowed up to five accidental mortalities over the five-year period.

Project II - The Holder is studying Crabeater seals (Lobodon carcinophagus). The Permit authorizes annually, for up to 5 years, 25 L. carcinophagus and 10 each for leopard seal (Hydrurga leptonyx), Weddell seal (Leptonychotes weddellii), and Ross seal (Ommatophoca rossii). Animals will be captured, immobilized, weighed/measured, sampled [blood and biopsy, whisker], administered tritiated saline water, flipper tagged, marked, lavaged for stomach contents, and instrumented with VHF/satellite transmitters. The project will determine the distribution and foraging behavior of adult Crabeater seals and simultaneously assess the impact that oceanographic features and prey aggregations have on foraging strategies employed. Equivalent data will be obtained for other species. Research will occur in Marguerite Bay, West Antarctic Peninsula. Opportunistic samples will be collected from dead beach cast seals for deposit in the natural history collection at the University.

The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), and the Regulations Governing the Taking and Importing of Marine Mammals (50 CFR part 216).

The United States developed an NPOA-S through a collaborative effort between NMFS, the U.S. Department of State (DOS), and the U.S. Fish & Wildlife Service (FWS), pursuant to the International Plan of Action for the Reduction of Incidental Catch of Seabirds in Longline Fisheries (IPOA-S) that was adopted by the United Nations Food and Agriculture Organization Committee on Fisheries (COFI) in February 1999. The United States will report to COFI by February, 2001, on NPOA-S development and implementation.

An outline describing the proposed structure of the draft NPOA-S was published in the Federal Register on September 9, 1999 (64 FR 48987). The draft NPOA-S was released for public review and comment on December 29, 1999 (64 FR 73017), and the public comment period was subsequently extended through February 7, 2000.

NMFS received 10 written public comments and held one public meeting during the development of the NPOA-S. NMFS considered all comments received on the draft NPOA-S when drafting the final version of the NPOA-S.

Comment 1: The draft NPOA-S does not fulfill the responsibilities outlined in the IPOA-S and compromises U.S. leadership in international negotiations on reducing seabird bycatch in longline fisheries.

Response: The IPOA-S is a voluntary measure that calls on member states to assess their longline fisheries and, if a seabird bycatch problem is determined to exist, to develop an NPOA-S to reduce seabird bycatch within 2 years. NMFS has conducted a preliminary review of seabird bycatch in U.S. longline fisheries and has determined that a seabird bycatch problem exists in several U.S. longline fisheries, including Hawaii-based pelagic longline fisheries and Alaska halibut and groundfish demersal longline fisheries. Consistent with this NPOA-S, seabird bycatch regulations are in place for Alaska longline fisheries and under development for Hawaii longline fisheries, and research is underway in Alaska and Hawaii longline fisheries to determine the effectiveness of seabird bycatch measures and to improve those measures.

NMFS, FWS, and DOS developed this NPOA-S to provide policy guidance to reduce seabird bycatch in those longline fisheries where a problem is already known to exist and to assess all other U.S. longline fisheries within 2 years to determine whether a seabird bycatch problem exists. If a seabird bycatch problem is found to exist, a fishery-specific plan should be developed within 1 year that would implement seabird bycatch mitigation measures in that fishery within 2 years.

Although incidental (i.e., unintended) catch of seabirds in longline fisheries is often termed “bycatch,” the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), which is the primary law covering management of marine fishery resources in U.S. waters, specifically excludes seabirds from the definition of “fish” and, therefore, bycatch. Unless certain requirements under the Endangered Species Act are involved, the Magnuson-Stevens Act does not require implementation of measures to reduce incidental catch of seabirds. However, the Magnuson-Stevens Act authorizes implementation of fishery management measures designed to protect the marine environment from the effects of fishing activities.

In order to strengthen NMFS’ ability to effectively implement seabird conservation measures in U.S. fisheries, NMFS is supporting an amendment to the Magnuson-Stevens Act that would change the definition of bycatch to include seabirds and would require fishery management plans to specifically address seabird bycatch. For the purpose of the NPOA-S, the term “bycatch” is used for incidental seabird catch, and the term “seabird” refers to those bird species that habitually obtain their food from the sea below the low water mark.

NMFS believes that the final NPOA-S demonstrates strong U.S. leadership on this important international seabird conservation issue. The United States already has seabird bycatch mitigation regulations in place for all Alaska longline fisheries and under consideration for implementation in Hawaii longline fisheries. Additionally, the United States is likely to be one of the first COFI members to complete an NPOA-S, which calls on the United States to further advance the IPOA-S at future international fisheries management fora.

Comment 2: The draft NPOA-S does not contain any seabird bycatch reduction guidelines or performance standards.

Response: The final NPOA-S provides policy guidance to the Regional Fishery Management Councils (Councils) and the NMFS Regions to assess all U.S. longline fisheries within the next 2 years to determine if a seabird bycatch problem exists beyond what was determined in the preliminary assessment. If a seabird bycatch problem is found to exist, a fishery-specific plan should be developed within 1 year that would implement seabird bycatch mitigation measures in that fishery within 2 years.

Additionally, NMFS has proposed an amendment to the Magnuson-Stevens Act that would include seabirds in the bycatch definition and thus require that fishery conservation and management measures, to the extent practicable, minimize seabird bycatch and to the extent that seabird bycatch cannot be avoided, minimize the mortality of such bycatch.

NMFS believes that individual longline fishery interactions with seabirds constitute unique situations that require development of fishery-specific seabird bycatch mitigation measures. It is not possible to state explicit seabird bycatch reduction standards for individual fisheries or for the nation as a whole. The NPOA-S recommends that additional data should be collected on seabird-fishery interactions in all U.S. longline fisheries in order to assess seabird bycatch and determine the effectiveness of seabird bycatch mitigation measures.

Comment 3: The NPOA-S should contain a well-defined schedule for seabird bycatch assessments and for implementing seabird protection measures.

Response: NMFS agrees. In response to this comment, the final version of the NPOA-S contains a more detailed implementation schedule. Within a year, and each subsequent year, the Councils and NMFS Regions will jointly prepare annual implementation reports. Within 2 years, assessments of all the U.S. longline fisheries should be completed; if a seabird bycatch problem is found to exist, a fishery-specific plan should be established within 1 year that would implement seabird bycatch mitigation measures in that fishery within 2 years.

NMFS and FWS will assume joint responsibility for preparing a biennial report to COFI on the NPOA-S. Implementation of the NPOA-S will be assessed every 4 years by NMFS and FWS to evaluate progress to date, prioritize future actions, and identify cost-effective strategies for increasing the plan’s effectiveness.

Comment 4: The NPOA-S should state the explicit goal of eliminating seabird bycatch in U.S. longline fisheries.

Response: NMFS disagrees. Such a perspective represents a change of national and international policy on fishery bycatch issues. NMFS believes that the focus of the NPOA-S should be on reducing seabird bycatch to the maximum extent practicable.

Comment 5: The draft NPOA-S advocates a regional approach to reducing seabird bycatch in U.S. longline fisheries. Such an approach without required actions will not effectively reduce seabird bycatch.

Response: Addressing seabird bycatch at the regional level is consistent with the IPOA-S and calls on the Councils to recommend seabird bycatch mitigation measures that are tailored to individual longline fisheries and that would be incorporated in regulations. NMFS will use these regionally based Council recommendations to take action to require fishery management measures that effectively reduce seabird bycatch.

Comment 6: There should be national-level coordination and oversight to ensure consistent and effective regional implementation of the NPOA-S.

Response: NMFS agrees. NMFS and FWS will continue to work in close partnership and with the DOS through the activities of the Interagency Seabird Working Group (ISWG) to accomplish the goals of the NPOA-S, including consistent and effective regional implementation of the NPOA-S. The ISWG was formed in February, 1999 for the express purpose of drafting the NPOA-S based on the IPOA-S guidelines. This working group was composed of members from NMFS, FWS, and DOS, many of whom served on a similar U.S. working group during development of the IPOA-S.

Several commenters suggested continuing the ISWG in varying capacities during NPOA-S implementation. NMFS agrees that the ISWG has continuing value as a resource for helping ensure consistent and effective regional implementation of the NPOA-S, for helping prepare a biennial report to COFI on the NPOA-S, and for helping assess implementation of the NPOA-S every 4 years to evaluate progress to date, prioritize future actions, and identify cost-effective strategies for increasing its effectiveness. However, the ISWG will not function as a certifying body for fishery management measures, as some commenters have suggested, and ISWG membership will be limited to NMFS, FWS, and DOS staff.

NMFS has assigned coordination and oversight responsibility to the Domestic Fisheries Division of the Office of Sustainable Fisheries (Sustainable Fisheries) to help ensure consistent and effective regional implementation of the NPOA-S. All Council-developed fishery management actions are submitted to Sustainable Fisheries for review, and are implemented under authority of the Secretary of Commerce.

Comment 7: The draft NPOA-S does not state the need for additional funding and does not identify specific research goals or projects.

Response: The final NPOA-S suggests that there should be research into developing effective, fishery-specific seabird bycatch mitigation measures. In addition to regional assessments of seabird/longline interactions, the NPOA-S emphasizes the importance of increased NMFS observer coverage and additional observer training on seabird identification. The NPOA-S also emphasizes continued cooperation between FWS and NMFS on seabird bycatch mitigation issues, including assessment of existing seabird bycatch mitigation measures and research and development of new measures.

NMFS acknowledges that assessing seabird bycatch and researching the effectiveness of mitigation measures is costly, and that the final NPOA-S includes ambitious objectives and goals. Additional funding required for implementing the final NPOA-S needs to be addressed by the individual management entities. NMFS has historically not received sufficient appropriated funds to monitor seabird bycatch in all U.S. longline fisheries. The cost of previous seabird bycatch mitigation research studies ranged between $150,000 and $227,000. NMFS further acknowledges that cooperation with the fishing industry led to the use of commercial longline vessels in seabird mitigation research studies, which resulted in significant cost savings. NMFS will use the final NPOA-S as guidance in its strategic planning and budget processes.

Assessment of seabird bycatch via fishery observer programs is also expensive, with variable costs relating to the degree of necessary program development (i.e., creation of a new program or modification of an existing program), and whether industry shares costs or fully funds individual longline observer programs. Agency costs for observer programs have ranged from several hundred thousand to several million dollars annually.

Comment 8: The draft NPOA-S does not state or impose regulations requiring the use of seabird bycatch mitigating measures, even in those longline fisheries where a seabird bycatch problem is known to already exist.

Response: NMFS agrees. The Magnuson-Stevens Act provides the authority for managing fishery resources in the United States. Fishery management plans (FMPs) are developed by the Councils, in consultation with NMFS, and are implemented by regulations promulgated under the authority of the Secretary of Commerce. Public participation is an important part of the Council process, where a wide variety of viewpoints are considered when developing FMPs and FMP amendments.

NMFS considers the NPOA-S to be a clear statement of policy that provides guidance to the Councils and NMFS Regions to conduct seabird bycatch assessments and reduce seabird bycatch in U.S. longline fisheries. In those U.S. longline fisheries where seabird bycatch problems are already known to exist, including Alaska groundfish and halibut demersal longline fisheries and Hawaii pelagic longline fisheries, seabird bycatch regulations are already in place, are undergoing further refinement, or are under development. NMFS considers it inappropriate to include regulations in the NPOA-S that were not developed through the Council process.

NMFS notes, however, that the final NPOA-S does call on the Councils, in partnership with NMFS, to prescribe appropriate and effective mitigation measures and to develop regulations if a seabird bycatch problem exists. Additionally, the NPOA-S provides guidance to the Councils and NMFS to consider all existing information in determining whether development of precautionary seabird bycatch mitigation measures is warranted, even prior to completing formal seabird bycatch assessments. Such an approach is consistent with U.S. marine fisheries policy on using the precautionary approach for developing fisheries management actions in the face of scientific uncertainty.

Comment 9: The draft NPOA-S does not contain specific guidelines for education, outreach, and training on the seabird bycatch issues.

Response: NMFS considers outreach and education to be of utmost importance. The final NPOA-S states that the Councils and NMFS should engage longline fishermen in education and outreach activities that will increase awareness of seabird bycatch issues and the importance of employing seabird bycatch mitigation measures.

NMFS made a number of changes in the final NPOA-S pursuant to public comments that were submitted on the draft NPOA-S. The final NPOA-S requires that seabird bycatch be reduced to the maximum extent practicable. The final NPOA-S provides a time line for Council and NMFS action when a seabird bycatch problem is found to exist, and requires that a fishery-specific plan be established within 1 year to develop seabird bycatch mitigation measures in that fishery within 2 years. The final NPOA-S also calls for additional NMFS observer training in seabird identification, cooperative research between the longline fishing industry and seabird scientists, and coordination of U.S. research with international research efforts to reduce seabird bycatch. The section describing efforts that should be taken by the United States to encourage other nations to develop individual NPOA-S is expanded. The annual report describing seabird bycatch research and mitigation efforts is explained in greater detail. Finally, Executive Order 13186, “Responsibilities of Federal Agencies to Protect Migratory Birds,” is addressed.

The U.S. Customs Service has conducted on-site verification of textile and textile product production in a number of foreign countries. Based on information obtained through on-site verifications and from other sources, U.S. Customs has informed CITA that certain companies were illegally transshipping, were closed, or were unable to produce records to verify production. The Chairman of CITA has directed the U.S. Customs Service to issue regulations regarding the denial of entry of shipments from such companies (see Federal Register notice 64 FR 41395, published on July 30, 1999). In order to secure compliance with U.S. law, including Section 204 and U.S. customs law, to carry out textile and textile product agreements, and to avoid circumvention of textile agreements, the Chairman of CITA is directing the U.S. Customs Service to deny entry to textiles and textile products manufactured by the following Bangladesh companies for two years: Eldest Garments, A.M. Inspection, Fashion International, Newtex Apparel and Runa Textile. Customs has informed CITA that these companies were found to have been illegally transshipping, closed, or unable to produce records to verify production.

Should CITA determine that this decision should be amended, such amendment will be published in the Federal Register.

Dear Commissioner: The U.S. Customs Service has conducted on- site verification of textile and textile product production in a number of foreign countries. Based on information obtained through on-site verifications and from other sources, U.S. Customs has informed CITA that certain companies were illegally transshipping, were closed, or were unable to produce records to verify production. The Chairman of CITA has directed the U.S. Customs Service to issue regulations regarding the denial of entry of shipments from such companies (see directive dated July 27, 1999 (64 FR 41395), published on July 30, 1999). In order to secure compliance with U.S. law, including Section 204 and U.S. customs law, to carry out textile and textile product agreements, and to avoid circumvention of textile agreements, the Chairman of CITA directs the U.S. Customs Service, effective for goods exported on and after March 1, 2001 and extending through February 28, 2003, to deny entry to textiles and textile products manufactured by the following Bangladesh companies: Eldest Garments, A.M. Inspection, Fashion International, Newtex Apparel and Runa Textile. Customs has informed CITA that these companies were found to have been illegally transshipping, closed, or unable to produce records to verify production.

The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception to the rulemaking provisions of 5 U.S.C. 553(a)(1).

The current limits for certain categories are being increased for carryover.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 65 FR 82328, published on December 28, 2000). Also see 65 FR 66718, published on November 7, 2000.

The National Assessment Governing Board is established under section 412 of the National Education Statistics Act of 1994 (Title IV of the Improving America's Schools Act of 1994) (Pub. L. 103-382).

The Board is established to formulate policy guidelines for the National Assessment of Educational Progress. The Board is responsible for selecting subject areas to be assessed, developing assessment objectives, identifying appropriate achievement goals for each grade and subject tested, and establishing standards and procedures for interstate and national comparisons. Under P.L. 105-78, the National Assessment Governing Board is also granted exclusive authority over developing the Voluntary National Tests pursuant to contract number RJ97153001.

The Executive Committee will meet on March 1 in open session from 5 p.m. to 6:15 p.m., and in closed session from 6:15 p.m. to 7 p.m.

In the open session, the Executive Committee will receive updates on the status of the VNT contract and on the NAEP Reauthorization. The Committee will then receive briefings on the implications of President Bush's education proposal for the NAEP schedule; on the appointment of the Trial Urban Advisory Panel; and on NAEP participation issues.

From 6:15-7 p.m. the Committee will meet in closed session to make a contractual decision pertaining to the VNT; to discuss future cost estimates on contracts for the National Assessment of Education Progress (NAEP) project; and to receive independent government cost estimates on contract initiatives for NAEP.

The meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program. The discussion of this information would be likely to significantly frustrate implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of 522b(c) of Title 5 U.S.C.

On March 2, the full Board will convene in open session from 8:30 a.m.-12:15 p.m. the Board will approve the agenda; hear a report from the Executive Director of the National Assessment Governing Board; and receive an update on NAEP activities. Beginning at 10:15 a.m., the Board's Standing committees will meet in open session.

The Assessment Development Committee will meet from 10:15 a.m.-12:15 p.m. to discuss NAEP participation issues, a proposal for a ten-year follow-up of NAEP's oral reading study, the 2004 NAEP math framework project, and other NAEP assessment development issues.

The Committee on Standards, Design, and Methodology will meet from 10:15 a.m.-11:15 p.m. to hear a report from the Ad Hoc Committee on enhancing NAEP participation; to discuss the Tribal Urban Assessment; and to receive an update on Achievement Levels.

The Reporting and Dissemination Committee will meet from 10:15 a.m.-11:15 p.m. to receive and take action on the release plan for NAEP 2000 Fourth Grade National Reading Report Card; to discuss the schedule for release of future NAEP reports; and to discuss and take action on recommendations of the Ad Hoc Committee on NAEP Participation. The Reporting and Dissemination Committee will also hear a presentation on reporting results for subgroups.

There will be a Joint Meeting of the Committee on Standards, Design, and Methodology and the Committee on Reporting and Dissemination from 11:15 a.m.-12:15 p.m. to discuss new models for reporting achievement levels and new NCES recommendations for presenting differences in exclusion and accommodation rates for reporting NAEP 2000 results in reading, mathematics, and science.

On March 2, the full Board will meet in closed session from 12:15-1:45 p.m. to receive a briefing on the NAEP 2000 Reading Report Card: Fourth Grade. This meeting must be closed because the report has not gone through complete National Center for Education Statistics (NCES) adjudication process and has not been released by the Secretary of Education. Premature disclosure of the information presented for review would be likely to significantly frustrate implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of Section 552b(c) of Title 5 U.S.C.

The full Board will meet in open session from 1:45-2:15 p.m. to receive an update on the 2002 Math Framework Project. From 2:15-3:30 p.m., the Board will hear a panel discussion on the Trial Urban Assessment.

On March 2, the full Board will meet in closed session from 3:30-5 p.m. to review NAEP Long Term Trend Assessment Items. This meeting must be closed because the Long Term Trend Assessment uses the same secure items for testing and thus cannot be reviewed in an open meeting. Premature disclosure of the information would be likely to significantly frustrate implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of Section 552b(c) of Title 5 U.S.C.

On March 3, the full Board will meet from 8:30 a.m.-12:00 p.m. From 8:30-9:30 a.m., the full Board will receive a briefing on Student Motivation and NAEP, followed by a presentation on NAEP Interactive from 9:30-10:00 a.m. The Board will then hear and take action on the Committee reports from 10:00 a.m. to 12:00 p.m. whereupon the meeting will adjourn.

Summaries of the activities of the closed sessions and related matters, which are informative to the public and consistent with the policy of section 5 U.S.C. 552b(c), will be available to the public within 14 days of the meeting. Records are kept of all Board proceedings and are available for public inspection at the U.S. Department of Education, National Assessment Governing Board, Suite #825, 800 North Capitol Street, NW., Washington, DC, from 8:30 a.m. to 5 p.m. Eastern Standard Time.

Title: Air Emission Standards for Tanks, Surface Impoundments and Containers, RCRA subpart CC; OMB number 2060-0318; EPA ICR Number 1593.05; expiring on February 28, 2001. This is a request for extension of a currently approved collection.

Abstract: This ICR contains recordkeeping and reporting requirements that are mandatory for compliance with 40 CFR part 264, subpart CC and 40 CFR part 265, subpart CC. RCRA subpart CC requires controls for minimizing release of volatile organic air emissions from tanks, surface impoundments and containers holding hazardous waste. Records and reports are necessary in order for the EPA to determine that the standards are implemented and maintained to protect human health and the environment.

Organic air emissions from hazardous waste Treatment, Storage and Disposal Facilities (TSDFs) can contain toxic chemical compounds. Cancer and other adverse noncancerous human health effects can result from exposure to these emissions. Organic emissions from TSDFs react photochemically with other compounds in the atmosphere to form ground level ozone. Excessive ambient ozone concentrations are a major air quality problem in many cities throughout the United States. Nationwide organic emissions from TSDFs are estimated to be approximately one million megagrams per year. These organic emissions are estimated to result in 48 excess incidences of cancer per year nationwide and a 3 × 10−2 maximum individual risk (MIR). The experience of the EPA in implementing and enforcing New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) promulgated under authority of the Clean Air Act has demonstrated that certain information must be collected to ensure compliance with air emission standards. Information collection is needed by the EPA to determine: (a) Whether a hazardous waste contains sufficiently low concentrations of volatile organics to allow the waste to be managed in a tank, surface impoundment, or container without the use of emission controls, and (b) for units requiring emission controls, whether the controls are being properly operated and maintained. The collected information will be used by the EPA enforcement personnel to ensure that the requirements of the recommended rules are being properly applied and that emission control devices are being properly operated and maintained on a continuous basis.

In addition, records and reports are necessary to enable the EPA to identify TSDF owners or operators that may not be operating in compliance with the standards. The reported information is used by the EPA to target TSDFs for inspection and identify what records or waste management units should be inspected at the TSDF. The information that TSDF owners or operators are required to maintain is recorded in sufficient detail to enable owners or operators to demonstrate their means of complying with the applicable standards. The data collected by the affected facility is retained at the facility for a minimum of three years.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on August 17, 2000; no comments were received.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 106 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Hazardous waste treatment, storage and disposal facilities and large quantity generators.

Estimated Number of Respondents: 6,318.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 672,640.

Estimated Total Annualized Capital, O&M Cost Burden: $1,460,333.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1593.05 and OMB Control No. 2060-0318 in any correspondence.

Affected entities: Entities potentially affected by this action are those which own, operate or regulate public water systems but not limited to: Owners/operator of public water systems, State Environmental Water Quality Agencies, State Departments of Health.

Title: Operator Certification Guidelines and Operator Certification Expense Reimbursement Grants Program, EPA ICR #1955.01.

Abstract: The purpose of this information collection is to determine if states are meeting the requirements of EPA's operator certification guidelines. Section 1419(a) of the Safe Drinking Water Act (SDWA) Amendments of 1996 requires to EPA to develop guidelines specifying minimum standards for certification and recertification of operators of community and nontransient noncommunity public water systems and to publish final guidelines by February 6, 1999. The final guidelines were published in the Federal Register on February 5, 1999 (64 FR 5916). Pursuant to section 1419(b) of the SDWA, beginning two years after the date on which EPA publishes guidelines for the certification (and recertification) of operators of community and nontransient noncommunity public water systems (or February 5, 2001), EPA shall withhold 20 percent of the funds a state is otherwise entitled to receive under SDWA section 1452 unless a state has adopted and is implementing a program that meets the requirements of EPA's operator certification guidelines. EPA is required under SDWA section 1419 to make an annual determination on whether to withhold 20 percent of a state's Drinking Water State Revolving Fund (DWSRF) allotment. In order to make these decisions, EPA must collect information from the states as required by EPA's operator certification guidelines. States, in turn, must collect information from water systems as required by their respective programs.

SDWA section 1419(d) requires EPA to reimburse (through grants to states) the costs of training, including an appropriate per diem for unsalaried operators, and certification for persons operating community and nontransient noncommunity public water systems serving 3,300 persons or fewer that are required to undergo training pursuant to EPA's operator certification guidelines. Prior to awarding expense reimbursement grants to states, EPA will need to collect information from states to ensure that the state has a plan for distributing the funds to small system operators.

The EPA would like to solicit comments to:

(i) 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;

(ii) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(iii) enhance the quality, utility, and clarity of the information to be collected; and

(iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Burden Statement: EPA estimates that the cost and burden to states for this ICR is $412,449 and 11,914 hours over the three year period between FY2001 and FY2003. EPA also estimates the cost and burden to public water systems for this ICR is $6,514,596 and 290,511 hours over the three year period between FY2001 and FY2003. The average annual cost and burden per state is $2,695 and 78 hours. On a per system level, an average annual cost and burden of $31 and 2 hours is estimated.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.

This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Title: Exports from and Imports to the United States under International and Bilateral Waste Agreements; OMB Control Number 2050-0143; EPA ICR No. 1647.03; expiring March 31, 2001. This is a request for extension of a currently approved collection.

Abstract: Authority for this information collection is found in sections 2002(a) and 3017(a)(2) and (f) of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, and as amended by the Hazardous and Solid Waste Amendments, 42 U.S.C. 6901 et seq. The Organization for Economic Cooperation and Development (OECD) Decision is considered legally binding on the United States under Articles 5(a) and 6(2) of the OECD Convention, 12 U.S.T. 1728. In addition, the OECD Decision and EPA's rule implementing the OECD Decision in 40 CFR part 262, subpart H (61 FR 16290; April 12, 1996) impose requirements on U.S. exporters and importers for shipments of hazardous waste for recovery to and from OECD member countries. EPA also imposes requirements on hazardous waste exports and imports to and from other countries in 40 CFR part 262, subparts E and F, respectively (August 8, 1986; 51 FR 28664). U.S. EPA's Office of Enforcement and Compliance Assurance uses the information provided by each U.S. exporter and importer to determine compliance with the applicable RCRA regulatory provisions. In addition, the information will be used to determine the number, origin, destination, and type of exports from and imports to the U.S. for tracking purposes and for reporting to the OECD. This information also will be used to assess the efficiency of the program. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register Notice required under 5 CFR 1320.8(d), soliciting comments on this collection of information, was published on November 1, 2000 (65 FR 65304); no comments were received.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 10 hours per exporter and 1 hour per importer. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Exporters and Importers of Hazardous Wastes to U.S.

Estimated Number of Respondents: 1,562.

Estimated Total Annual Hour Burden: 9,334.

Estimated Total Annualized Capital, O&M Cost Burden: $1,015.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggestions for minimizing respondent burden, including the use of automated estimates, and any suggestions for minimizing respondent burden, including the use of automated collection techniques to the addresses listed above. Please refer to the EPA ICR Number 1647.03 Control Number 2050-0143 in any correspondence.

Title: Establishing No-Discharge Zones Under Clean Water Act Section 312 (OMB Control Number 2040-0187; EPA ICR Number 1791.03) expiring 02/28/2001. This is a request for extension of a currently approved collection.

Abstract: (A) UNDS No-discharge Zones: Under section 312(n) of the Clean Water Act (“Uniform National Discharge Standards for Vessels of the Armed Forces” or “UNDS”) no-discharge zones (“NDZs”) for discharges from Armed Forces vessels may be established by either State prohibition or EPA prohibition following the procedures in 40 CFR part 1700. UNDS also provides that the Governor of any State may petition EPA and the Secretary of Defense to review any determination or standard promulgated under the UNDS program if there is significant new information that could reasonably result in a change to the determination or standard. This ICR discusses the information that will be required from a State if it decides to establish a NDZ by State prohibition or apply for a NDZ by EPA prohibition, and the information that will be required from a State if it decides to submit a petition for review. The responses to this collection of information are required to obtain the benefit of an UNDS NDZ or a review of an UNDS determination or standard (see 33 U.S.C. 1322(n)). The information collection activities discussed in this ICR do not require the submission of any confidential information.

(B) Sewage No-discharge Zones: The need for EPA to obtain information for the establishment of no-discharge zones (NDZs) for vessel sewage in State waters stems from CWA sections 312(f)(3), (f)(4)(A), and (f)(4)(B), and subsequent regulations at 40 CFR 140.4(a-c). No-discharge zones are established to provide State and local governments with additional protection of waters from treated or untreated vessel sewage. There are 3 ways in which NDZs for vessel sewage can be established. This ICR discusses the information requirements associated with the establishment of NDZs for vessel sewage. The responses to this collection of information are required to obtain the benefit of a sewage NDZ (see 33 U.S.C. 1322). The information collection activities discussed in this ICR do not require the submission of any confidential information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on May 19, 2000 (65 FR 31894) of the Federal Register and no comments were received.

Burden Statement: The annual public reporting and record keeping burden for this collection of information is estimated to average 144 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: States.

Estimated Number of Respondents: 16 per year.

Frequency of Response: one time collection.

Estimated Total Annual Hour Burden: 2207 hours per year.

Estimated Total Annualized Capital, O&M Cost Burden: $2,300.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above. Please refer to EPA ICR No. 1791.03 and OMB Control No. 2040-0187 in any correspondence.

In the Tier 2/Gasoline Sulfur final rule, we established standards to limit the sulfur content of gasoline beginning in 2004. As part of this rule, we included provisions permitting refiners to seek temporary relief from these requirements based on a showing of unusual circumstances that impose extreme hardship and significantly affect the refiner's ability to comply by the required date, as well as other factors. This provision also requires the refiners to make best efforts to comply with the low sulfur gasoline requirements (see 40 CFR 80.270). At this time, we are actively considering applications from three refiners. These applicants are identified below with their refinery's total crude oil capacity in barrels per calendar day and a general description of the relief they are seeking:

On October 7, 1992, we proposed Method 203 (57 FR 46114) as a means of providing states with an instrumental test method which could be used in determining, on a continuous basis, compliance with stationary source opacity emission limitations. In view of the significant amount of time that has passed since the proposal was published, we believe it is appropriate to offer the public another opportunity to comment on proposed Method 203. In particular, we are seeking comment on whether the requirements and procedures outlined in the proposal remain appropriate, or whether newer technologies and/or procedures have become available which we should consider before taking final action on this proposed rule.

Subsequent to the proposal, we received comments questioning whether Method 203, when adopted, should be codified at 40 CFR part 51, appendix M, as proposed. Commenters suggested that it would be more appropriate to codify this method at 40 CFR part 60, appendix F because the proposed method outlines the quality assurance procedures for COMS, and appendix F contains quality assurance procedures for continuous monitoring equipment. For this reason, we also seek public comment on placing Method 203 in part 60, appendix F as “Procedure 2. Quality Assurance Requirements for Continuous Opacity Monitoring Systems Used for Compliance Determination.” Based on comments provided during this additional 30-day comment period, we will take appropriate action on the proposed Method 203, which may include re-proposing the rule in its entirety, issuing a supplemental notice of proposed rulemaking, or adopting the rule in final form, with only minor changes. We will make the comments received during this comment period available to the public through the public docket (Docket Number A-91-08). A draft document containing a summary of the comments received on the 1992 proposal is also available in the public docket.

You may download a copy of proposed Method 203 via the world wide web at http://www.epa.gov/ttnemc01/frpromth.html. In addition, you may obtain copies of the 1992 proposal and previously submitted public comments through Docket Number A-91-08, which contains all materials relevant to this rulemaking, and is available for public inspection between 8:00 a.m. and 5:30 p.m., Monday through Friday (except for Federal holidays) at the following address: U.S. Environmental Protection Agency, Office of Air and Radiation Docket and Information Center (MC-6102), Room M-1500, 401 M Street S.W., Washington, DC 20460, telephone: (202) 260-7548. A reasonable fee may be charged for copying.

You may find this notice applicable if you manufacture, process, or otherwise use any EPCRA section 313 listed toxic chemical. Potentially applicable categories and entities may include, but are not limited to:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to find this notice of training course offerings applicable. Other types of entities not listed in the table may also find this notice applicable. To determine whether your facility could find this notice applicable, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding “FOR FURTHER INFORMATION CONTACT” section. You may be able to take advantage of the training courses if:

The EPA conducts annual training courses to assist you with your reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA) or Executive Order 13148 (for federal facilities). You must submit your annual release and other waste management activity reports (i.e., Form R or Form A) if your facility meets the descriptions for the following Standard Industrial Classification (SIC) codes and qualifiers, and meets other criteria specified in part 372 of Title 40 of the Code of Federal Regulations:

The training courses present reporting requirements of EPCRA section 313 and PPA section 6607. A variety of hands-on exercises using the reporting forms (i.e., Form R or Form A) along with supporting materials will be used to help you understand any reporting obligations you might have under EPCRA section 313. The training courses are scheduled in the spring so that you can prepare and submit your report(s) for the Reporting Year 2000, forms due on or before July 1, 2001.

The full training course runs two days and a schedule for the 2-day workshops is provided below (see Table 1). The course is divided into three modules. The first module encompasses the first day and is devoted to a general discussion of EPCRA section 313 and PPA section 6607 reporting requirements with exercises used to reinforce key concepts. The second module is given in the morning of the second day, and is designed to provide detailed information about the persistent, bioaccumulative, and toxic (PBT) chemicals within the TRI program. The third and final module is given in the afternoon of the second day, and this module is designed to provide an update to the TRI program and information about difficult policy topics. Interested persons may register for both days (persons with little or no background in EPCRA section 313 and PPA section 6607 reporting requirements) or just the second day (persons experienced in preparing either Form R or Form A). In addition, EPA is conducting abbreviated training courses. These courses are one day in duration and, in some cases, are focused for a particular industry sector(s) (see Table 2).

The schedules for training courses are provided in the tables below. You should note, however, that changes to the schedules may occur without further notice so it is important to check your registration materials and confirmation notice (see below). Also, you may access current training course schedule information via the TRI Home Page (http://www.epa.gov/tri) or via the TRI training course Home Page (http://www.epcra-tri.com).

You should direct your requests for training course registration materials, including schedules of dates and locations, to the designated contacts in Table 3 (if registration contact is other than SAIC).

To register for any of the EPA training courses supported by SAIC, you can direct your requests to SAIC (www.epcra-tri.com). If you do not have access to the internet, you may fax your request to: (703) 318-4644.

To register, you must provide all of the following information to the registration contact indicated: your name, your company's name and SIC code, your postal address, your telephone number, your fax number, your email address, and your preferred training location(s). Requests should be directed to the indicated registration contact.

You will receive an acknowledgment of application receipt via fax or email. If your application is accepted, a confirmation notice will be sent to you that will contain important information regarding date, location, directions, etc. If the training course you applied for is filled or canceled, alternate training courses will be suggested. Since space is limited, you are encouraged to submit your registration application as early as possible but not less than one week before your preferred training course.

This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain copies of this document and certain other available documents from the EPA Internet Home Page at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPPTS-51964. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, any test data submitted by the manufacturer/importer and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260-7099.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-51964 and the specific PMN number in the subject line on the first page of your response.

1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.

3. Electronically. You may submit your comments electronically by e-mail to: “oppt.ncic@epa.gov,” or mail your computer disk to the address identified in this unit. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-51964 and the specific PMN number. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.”

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

Section 5 of TSCA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a notice of receipt of a PMN or an application for a TME and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from January 10, 2001 to January 26, 2001, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

This status report identifies the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. If you are interested in information that is not included in the following tables, you may contact EPA as described in Unit II. to access additional non-CBI information that may be available. The “S” and “G” that precede the chemical names denote whether the chemical idenity is specific or generic.

In table I, EPA provides the following information (to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: the EPA case number assigned to the PMN; the date the PMN was received by EPA; the projected end date for EPA's review of the PMN; the submitting manufacturer; the potential uses identified by the manufacturer in the PMN; and the chemical identity.

In table II, EPA provides the following information (to the extent that such information is not claimed as CBI) on the Notices of Commencement to manufacture received:

Electronic Copies: Electronic copies of this document are available from the EPA Home Page under the link “Laws and Regulations” at the Federal Register—Environmental Documents entry (http://www.epa.gov/fedrgstr).

Broadwing Communications Services Inc., a telecommunications company incorporated in the State of Delaware and located at 201 E. Fourth Street (102-700), Cincinnati, Ohio 45202 failed to prepare SPCC plans for thirty-six facilities. Broadwing Communications Services Inc. disclosed, pursuant to the EPA “Incentives for Self-Policing: Discovery, Disclosures, Correction and Prevention of Violations” (“Audit Policy”), 60 FR 66,706 (December 22, 1995), that they failed to prepare SPCC plans for thirty-six facilities where they stored diesel oil in above ground storage tanks, in violation of the CWA section 311(b)(3) and 40 CFR Part 112. EPA determined that Broadwing met the criteria set out in the Audit Policy for a 100% waiver of the gravity component of the penalty. As a result, EPA waived the gravity based penalty ($137,500) and proposed a settlement penalty amount of eight thousand, one hundred and eight ($8,108). This is the amount of the economic benefit gained by Broadwing, attributable to their delayed compliance with the SPCC regulations. Broadwing Communications Services Inc. has agreed to pay this amount in civil penalties. EPA and Broadwing negotiated and signed an administrative consent agreement, following the Consolidated Rules of Procedure, 40 CFR section 22.13, on January 30, 2001 (In Re: Broadwing Communications Services Inc., Docket No. MM-HQ-2001-0015). This consent agreement is subject to public notice and comment under CWA section 311(b)(6), 33 U.S.C. section 1321(b)(6).

Under CWA section 311(b)(6)(A), 33 U.S.C. 1321 (b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of the CWA section 311 (b)(3), 33 U.S.C. 1321 (b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA section 311 (j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $137,500 by EPA. Class II proceedings under CWA section 311(b)(6) are conducted in accordance with 40 CFR Part 22.

The procedures by which the public may comment on a proposed Class II penalty order, or participate in a Clean Water Act Class II penalty proceeding, are set forth in 40 CFR 22.45. The deadline for submitting public comment on this proposed final order is March 30, 2001. All comments will be transferred to the Environmental Appeals Board (“EAB”) of EPA for consideration. The powers and duties of the EAB are outlined in 40 CFR 22.04(a).

Pursuant to CWA section 311(b)(6)(C), EPA will not issue an order in this proceeding prior to the close of the public comment period.

Maine's application was described in the Federal Register (64 FR 73552) on December 30, 1999 in which EPA requested comments. Notices of Maine's application were published in the Bangor Daily News, Lewiston Sun Journal and Portland Press Herald newspapers on January 12, 2000. A public hearing on the application was held on February 16, 2000 in Augusta, ME. EPA extended the comment period on June 28, 2000 (65 FR 3989) and August 4, 2000 (65 FR 6845) through August 21, 2000, solely for the purpose of taking further comment on the Indian law issues.

In response to public comments, Maine submitted a revised Memorandum of Agreement on April 25, 2000 and a Supplemental Attorney General's Statement on June 2, 2000. In addition, by letter dated September 19, 2000, the EPA proposed revisions to Attachment A to the Memorandum of Agreement. By letter from DEP Commissioner Martha Kirkpatrick dated September 26, 2000, the State agreed to the revisions.

A summary of those public comments received which relate to the final action EPA has taken on the portion of Maine's program outside Indian country and the EPA's responses to those comments are discussed below in the section of this Notice entitled “Responsiveness Summary.” (In this notice the term Indian country refers to the land and territory reserved or taken into trust for the federally recognized Maine Indian tribes pursuant to the Maine Indian Claims Settlement Act, 25 U.S.C. 1721 et seq., and the Aroostook Bank of Micmacs Settlement Act, Public Law 102-171, Nov. 26, 1991, 105 Stat. 1143, including any disputed areas as discussed further in this document.)

The State and EPA agreed to extend the CWA section 402(c)(1) deadline for EPA to make a decision on the application through September 26, 2000, pursuant to 40 CFR 123.21(d). However, because of the many complex issues that were raised with respect to the State's program and the need to address them in a comprehensive and thoughtful manner, the EPA did not make a final decision by September 26, 2000. Thus the EPA suspended issuance of NPDES permits in Maine on September 26, 2000 as required by section 402(c)(1) of the CWA. However, failure to make a decision by the September 26, 2000 deadline did not mean that the State automatically gained NPDES authority. It is EPA's interpretation that a State agency does not gain NPDES authority unless and until EPA approves the State program, consistent with CWA section 402(b) and 40 CFR 123.1. As of January 12, 2001, the State DEP is now authorized to issue MEPDES permits under the CWA in all areas of the State except for Indian country. As discussed below, EPA remains the permitting authority for the NPDES program in Indian country during the interim period, but must suspend issuing such permits pursuant to CWA section 402(c)(1).

Maine is being approved to administer both the NPDES permit program covering point source dischargers to State waters and the pretreatment program covering industrial sources discharging to publicly owned treatment works. The EPA and State initially had contemplated that the State would assume program responsibility in phases, first for the permit program and subsequently for the pretreatment program. But in light of the delay in approving the State's program and since it always was contemplated that the State would assume responsibility for the pretreatment program by now, both components of the State's program are being approved now, to start at the same time.

Maine is not being approved at this time to regulate cooling water intake structures under CWA section 316(b). In response to a public comment, the EPA has determined that the State currently lacks the necessary statutory authority to administer this NPDES program element. Thus the State is being approved to operate a partial permit program, pursuant to CWA section 402(n)(4). At first, the State program will cover all NPDES permitting responsibilities other than under CWA section 316(b). Sources with cooling water intake structures subject to CWA section 316(b) will need to obtain permits from the State regulating their discharges (including thermal discharges regulated under CWA section 316(a)), but also will need to obtain supplemental permits from the EPA regulating their cooling water intake structures pursuant to CWA section 316(b). The State has committed to promptly seeking legislation to obtain the needed additional statutory authority. When such statutory authority is obtained, the EPA will determine after a further opportunity for public comment whether to approve the State to operate the CWA section 316(b) program element.

The State is not applying for authorization for the municipal sewage sludge program at this time. EPA will continue to regulate sewage sludge in Maine in accordance with section 405 of the Act and 40 CFR part 503.

Pursuant to CWA section 402(d), EPA retains the right to object to MEPDES permits proposed by MEDEP, and if the objections are not resolved, to issue the permits itself. EPA also will retain jurisdiction over all NPDES permits it has issued in Maine until MEDEP reissues them as MEPDES permits. Finally, the EPA and State have agreed that the EPA may retain permitting authority over draft permits for which EPA has issued public notice at the time of program approval, until final issuance. A list of these permits that the EPA may issue following the approval of the State program is set forth in Attachment A to the EPA-State Memorandum of Agreement, as amended.

To address questions from the regulated community, EPA also has prepared a guidance document entitled “Status of EPA Issued NPDES Permits After Maine Program Approval.” Copies of this document are available upon request.

As part of operating the approved program, the Maine DEP generally will have the lead responsibility for enforcement. However, the EPA will retain its full statutory enforcement authorities under CWA sections 308, 309, 402(i) and 504. Thus the EPA may continue to bring federal enforcement action under the CWA in response to any violation of the CWA. In particular, if the EPA determines that the State has not taken timely enforcement action against a violator and/or that its action has not been appropriate, the EPA may take its own enforcement action in Maine.

The EPA received numerous public comments concerning the Maine program. However, EPA is not addressing the many comments concerning the State's assertion of jurisdiction and the applicability of State law in Indian country, because the Agency is taking no final action on these issues at this time, as described below.

Other commenters urged the EPA to approve the State's program. The EPA agrees that the State program should be approved at this time outside Indian country.

Several commenters who expressed concerns about possible State administration of the program in Indian country also indicated some concern about State administration of the program outside those areas. These comments are addressed in a memorandum from Stephen Silva, Director of EPA's Maine Program, entitled “Responses to Comments on Maine General Program,” dated January 12, 2001.

Finally, the National Environmental Law Center of the United States Public Interest Group (“NELC”) submitted extensive comments urging that the EPA reject Maine's program application on a variety of grounds. These comments are addressed in the following memoranda from Jeffry Fowley of the EPA Office of Regional Counsel: (i) “Response to Comments Opposing Approval of Maine to Administer the NPDES Program,” dated April 2000, (ii) “Further Response to Comments Opposing Approval of Maine to Administer the NPDES Program,” dated May 9, 2000, and (iii) “Further Response to Comments Opposing Approval of Maine to Administer the NPDES Program,” dated January 12, 2001.

The EPA Regional Administrator hereby concurs with and adopts the responses to comments set forth in the four memoranda referenced above. These memoranda, together with this Federal Register Notice, constitute EPA's Responsiveness Summary. Copies of the memoranda are available upon request.

EPA is not taking final action at this time on Maine's application to administer its program in Indian country. Maine has argued that the Maine Indian Claims Settlement Act, 25 U.S.C. 1721-1735 (MICSA), makes State law applicable and grants the State jurisdiction to implement its program in Indian country. EPA invited comment on this question, and received strongly conflicting views from the Maine Indian tribes, the State, and interested parties on both sides of the issue. On May 16, 2000 EPA received an opinion from the Department of Interior (DOI) interpreting how MICSA applies to the question of the State's jurisdiction over water quality regulation in Indian lands and territories. EPA made DOI's opinion available for public review, and invited further comment on the question of State jurisdiction in Indian lands and territories, as well as comment on the geographic scope of those areas, See 65 FR 3989 (June 28, 2000) and 65 FR 6845 (August 4, 2000). In response to this invitation, EPA received even more extensive comments on both sides of the question of the State's jurisdiction.

In addition, the parties contested the geographic scope of Indian country in Maine. While there appears to be several disputes about the boundaries of Indian country, it appears that the only dispute which implicates existing NPDES permitted dischargers is the question of the scope of the Penobscot Nation's reservation on the Penobscot River. DOI has concluded that the Penobscot Nation's reservation includes the bed and banks of the Penobscot River. Letter from Edward B. Cohen to John P. DeVillars, September 2, 1997 at 6. The Penobscot Nation asserts that its reservation includes the Penobscot River and its branches from Indian Island northward to the headwaters of the river and its tributaries, including the east and west branches, the Mattawamkeag, and the Piscataquis River. See Supplemental Public Comments of the Penobscot Nation, August 21, 2000 at 30. The State of Maine argues that the reservation does not include the Penobscot River bank to bank, and is limited to the area from Indian Island northward to the fork where the east and west branches divide, the so-called “Main Stem” of the Penobscot River. Letter from Paul Stern to Stephen Silva, August 18, 2000 at 1-2.

In light of the difficulty of determining jurisdiction in Indian country in Maine, EPA is further considering the question of the State's jurisdiction in Indian lands and territories. EPA will consult with the U.S. Department of Justice in addition to continuing to consult with DOI regarding the interpretation of MICSA. EPA is working to resolve this question promptly. If EPA's conclusion concerning the jurisdictional question makes it necessary to define the geographic boundaries of Indian country, EPA will work with DOI to clarify which areas are within Indian country in Maine and, thus, which dischargers are covered by the State's program. But until EPA takes final action on these issues, as an interim step, EPA is not authorizing the State's program in Indian country, including disputed areas.

EPA has not reached any final conclusion concerning the boundaries of Indian country, but for the purposes of clarifying which facilities are covered by the State program EPA has approved, EPA has listed in Appendix 1 of this notice the facilities that are not included in the program EPA has authorized due to the dispute over the applicability of State law in Indian country. This list includes all the currently permitted NPDES facilities that appear to discharge into waters where EPA has received substantial arguments disputing the status of those waters. Generally speaking, EPA is temporarily withholding trust lands for all the Maine tribes, the reservations for the Passamaquoddy Tribe at Pleasant Point and Indian Township and for the Penobscot Nation, and any disputed areas. We are withholding the Penobscot River extending from bank to bank of the river, starting at Indian Island and proceeding northward to the headwaters, including all tributaries. EPA has taken this approach to preserve the status quo in Indian country until the Agency takes final action on these issues. In addition, we are temporarily withholding the land owned by the Aroostook Band of Micmac Indians which the Band has applied to DOI to place into trust. Temporarily withholding this land will avoid the disruption of removing this land from the State's program if EPA ultimately determines that state environmental law will not apply to the Micmac's land once it is taken into trust. Moreover, temporarily withholding the Micmac's lands does not affect Maine's program substantially, because EPA is not aware of any dischargers in Micmac lands. This cautionary approach to withholding action temporarily while resolving jurisdictional disputes in Indian country is consistent with the federal government's trust responsibility to protect Indian interests in land and jurisdiction. See HRI, Inc. v. E.P.A., 298 F.3d 1224, 1245 (10th Cir. 2000), amended on denial of rehearing (March 30, 2000). Similarly, any new facilities in Indian country that require an NPDES permit while EPA is considering the question of Maine's jurisdiction in Indian country are not included in the program EPA has authorized.

The State of Maine has not agreed to extend EPA's deadline for acting on the State's program application in Indian country in Maine. Therefore, pursuant to CWA section 402(c)(1), EPA will continue to suspend issuing or modifying NPDES permits in these areas. This suspension will remain in effect until the Agency takes final action in these areas or the State agrees to extend the Agency's deadline for action.

Section 7(a)(2) of the Endangered Species Act (ESA), 33 U.S.C. 1536(a)(2), requires that federal agencies insure, in consultation with the United States Fish & Wildlife Service (FWS) and/or National Marine Fisheries Service (NMFS), that actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed threatened or endangered species (listed species) or result in the destruction or adverse modification of critical habitat. Additionally, section 7(a)(4) of the ESA, 33 U.S.C. 1536(a)(4), requires federal agencies to confer with FWS and/or NMFS on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed as threatened or endangered (proposed species) or result in the destruction or adverse modification of proposed critical habitat.

EPA consulted with both FWS and NMFS (the Services) under section 7(a)(2) of the ESA regarding the effects of the MEPDES program approval on listed species. Additionally, EPA engaged in a conference with the Services pursuant to section 7(a)(4) of the ESA regarding the effects of the action on the Gulf of Maine distinct population segment of Atlantic salmon (salmo salar), which had been a proposed species. Following the Services' final listing of the wild Atlantic salmon, EPA and the Services converted that conference into a consultation under section 7(a)(2) of the ESA. EPA addressed issues raised during the conference and consultation by establishing coordination procedures between EPA and the Services and by providing assurances to the Services that endangered species, and in particular the recently listed wild Atlantic salmon, will be protected. After careful consideration, the Services concluded in a biological opinion that approving the MEPDES program is not likely to jeopardize the continued existence of the wild Atlantic salmon. Further, the Services concluded that approval of the MEPDES program is not likely to adversely affect any other listed species or critical habitat. The Services' conclusion is based in part on assurances provided by EPA to the Services as described below that EPA will coordinate its review of MEPDES permits with the Services and use its CWA oversight authority to assure that water quality standards are met.

First, EPA intends to follow the procedures described in the draft Memorandum of Agreement Between the Environmental Protection Agency—New England, Fish and Wildlife Service, and National Marine Fisheries Service Regarding Enhanced Coordination Under the Clean Water Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act for NPDES Permits Issued by the State of Maine (April 19, 2000) (“Draft EPA—New England—Services MOA”), or any subsequently negotiated MOA for all species. In addition, the Services sought specific coordination procedures and further assurances from EPA-Region 1 with regard to the recently listed wild Atlantic salmon. On December 4, 2000, the EPA Regional Administrator sent a letter to the Regional Administrator of the National Marine Fisheries Service and the Acting Regional Director of the U.S. Fish and Wildlife Service specifying the oversight measures that the EPA intends to implement with respect to MEPDES permits to be issued to salmon fish farms and hatcheries by Maine. This letter affirmed EPA's commitment, based on EPA's analysis of current information including that contained in the Services' listing documents, to utilize its CWA authorities to ensure compliance with Maine water quality standards by ensuring that conditions to protect the wild Atlantic salmon are included in MEPDES permits for salmon fish farms and hatcheries. Specifically, EPA committed, in accordance with 40 CFR 123.44(c) and section 402(d) of the CWA, that it will object to any permit proposed by MEDEP authorizing activities that would adversely affect the wild Atlantic salmon where such adverse effects would cause or contribute to a failure of a water body to meet State water quality standards, unless such adverse effects are avoided by incorporating permit conditions that would protect the wild Atlantic salmon. In the event EPA objects to a proposed permit, and where that objection is not resolved such that effects on the wild Atlantic salmon resulting in a failure to meet water quality standards are avoided, EPA will assume permitting authority for the subject facility. Any permit issued by EPA will, following consultation under section 7 of the ESA, include conditions necessary to protect the Wild Salmon. The EPA's December 4, 2000 letter to the Services is included in the record.

In addition, with respect to bald eagles, the FWS sought assurances that any permits issued by Maine would require the monitoring plan included in the Services' August 18, 2000 biological opinion on the EPA's proposed reissuance of NPDES permits for six kraft pulp and paper mills in Maine. The monitoring plan is designed to analyze bird samples downstream of the mills for pollutants which either have historically or may still be discharged by the mills in quantities likely too low to be detected by direct effluent sampling. In a letter dated May 2, 2000, EPA provided the requested assurance and will require, consistent with its CWA oversight authority, that Maine include the plan within permits it issues to the mills. This letter, and the biological opinion, are included in the record.

On January 12, 2001, the Services issued a biological opinion concluding that in light of the EPA's oversight commitments, the approval of the Maine State NPDES program is not likely to jeopardize the continued existence of the endangered wild Atlantic salmon. No critical habitat has been designated for this species; therefore none will be affected. Further, the Services concluded that approval of the Maine NPDES program is not likely to adversely affect any other listed species or critical habitat. Issuance of the biological opinion with these findings concludes the consultation process required by ESA section 7(a)(2) and reflects the Services' agreement with EPA that the approval of the State program meets the substantive requirements of that provision.

Section 305(b)(3) of the Magnuson-Stevens Fishery Conservation and Management Act requires all Federal agencies to consult with NMFS on actions undertaken by the Agency that may affect Essential Fish Habitat (EFH). EPA consulted with NMFS regarding EFH in reviewing the MEPDES program approval request, and responded to NMFS recommendations for avoiding, mitigating, or offsetting any impact from EPA's action in a letter dated March 28, 2000. This letter is included as part of the record. As noted in that letter, as part of EPA's response to NMFS recommendations EPA agreed to follow the procedures described in the Draft EPA—New England—Services MOA or any subsequently negotiated MOA to specifically take into account EFH when coordinating its MEPDES permit review with NMFS.

Section 106 of the National Historic Preservation Act, 16 U.S.C. 470(f), requires Federal agencies to take into account the effects of their undertakings on historic properties and to provide the Advisory Council on Historic Preservation (ACHP) an opportunity to comment on such undertakings. Under the ACHP's regulations (36 CFR part 800), the Agency consults with the appropriate State Historic Preservation Officer (SHPO) and/or Tribal Historic Preservation Officer on federal undertakings that have the potential to affect historic properties listed or eligible for listing in the National Register of Historic Places. During EPA's review of the Maine NPDES application, EPA engaged in discussions with the Maine SHPO and sought public comment regarding EPA's determination that approval of the State permitting program would have no effect on historic properties. As noted below, the EPA also has held discussions with Indian Tribes in Maine regarding any potential effects of MEPDES program approval on historic properties of interest to Tribes.

On July 7, 1999, EPA sought the Maine SHPO's concurrence with its determination that EPA's approval of Maine's application would have No Effect on historic properties in Maine. The Maine SHPO provided EPA with a determination that there would be “No Historic Properties Affected” or “No Adverse Effect” to historic properties in Maine from EPA's approval, on the condition that MEDEP provides relevant notice and information regarding draft permits to the SHPO and coordinates with the SHPO. On November 26, 2000 the SHPO and MEDEP entered into a Memorandum of Understanding (MOU) assuring the SHPO that it would receive the requested notices. This MOU further provides for coordination between MEDEP and the SHPO to resolve any identified issues to ensure that MEPDES permits will comply with Maine water quality standards and Maine laws protecting historic properties. For those permits with the potential to adversely affect historic properties, MEDEP and the SHPO agreed to seek ways to avoid, minimize or mitigate any adverse effects to historic properties stemming from the proposed permit. Thus, EPA believes that the agreement between MEDEP and the SHPO satisfies the conditions underlying the SHPO's determination of “No Historic Properties Affected” or “No Adverse Effect” as a result of EPA's approval of Maine's application.

In addition, EPA has engaged in extensive discussions with the Maine Tribes regarding any potential effects on Tribal historic properties. In light of certain complex jurisdictional issues still being evaluated by EPA, today's program approval does not include Indian country within the State of Maine. EPA intends to continue discussions with the Maine Tribes regarding any issues related to historic properties of interest to the Tribes prior to reaching a final decision on Maine's application within Indian country.

Pursuant to section 307(c)(1)(C) of the Coastal Zone Management Act, Federal agencies carrying out an activity which affects any land or water use or natural resource within the Coastal Zone of a state with an approved Coastal Zone Management Plan must determine whether that activity is, to the maximum extent practicable, consistent with the enforceable requirements of the Plan and provide its determination to the State agency responsible for implementation of the Plan for review. Maine's approved Coastal Zone Management Plan is administered by the Maine Office of State Planning. Maine's permit actions are themselves subject to consistency review under State law; thus approval of the MEPDES program would not affect Maine's coastal zone and would be consistent with the enforceable requirements of Maine's Coastal Zone Management Plan.

Based on General Counsel Opinion 78-7 (April 18, 1978), EPA has long considered a determination to approve or deny a State NPDES program submission to constitute an adjudication because an “approval,” within the meaning of the APA, constitutes a “license,” which, in turn, is the product of an “adjudication.” For this reason, the statutes and Executive Orders that apply to rulemaking action are not applicable here. Among these are provisions of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq. Under the RFA, whenever a Federal agency proposes or promulgates a rule under section 553 of the Administrative Procedure Act (APA), after being required by that section or any other law to publish a general notice of proposed rulemaking, the Agency must prepare a regulatory flexibility analysis for the rule, unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. If the Agency does not certify the rule, the regulatory flexibility analysis must describe and assess the impact of a rule on small entities affected by the rule.

Even if the NPDES program approval were a rule subject to the RFA, the Agency would certify that approval of the State's proposed MEPDES program would not have a significant economic impact on a substantial number of small entities. EPA's action to approve an NPDES program merely recognizes that the necessary elements of an NPDES program have already been enacted as a matter of State law; it would, therefore, impose no additional obligations upon those subject to the State's program. Accordingly, the Regional Administrator would certify that this program, even if a rule, would not have a significant economic impact on a substantial number of small entities.

I hereby provide public notice that EPA has taken final action authorizing Maine to implement the NPDES program in the areas outside disputed Indian territory to the extent described in this notice, and review of the issues related to this action is available as provided in CWA section 509(b)(1)(D). EPA has not taken final action on the issues related to the State's jurisdiction and the applicability of State law in Indian country for the purposes of implementing the NPDES program in those areas, and review of those issues is not available until EPA takes final action on Maine's program as it applies in those areas.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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 through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services has the authority to prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a device but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to CGMP, as described in such regulations, to assure that the device will be safe and effective and otherwise in compliance with the act.

The CGMP/QS regulation implementing the authority provided by this statutory provision is found in part 820 (21 CFR part 820) of the Code of Federal Regulations and sets forth basic CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. Section 820.20(a) through (e) requires management with executive responsibility to establish, maintain, and/or review: The quality policy; the organizational structure; the quality plan; and the quality system procedures of the organization. Section 820.22 requires the conduct and documentation of quality system audits and reaudits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training.

Section 820.30(a)(1) and (b) through (j) requires, in the following respective order, the establishment, maintenance, and/or documentation of: Procedures to control design of class III and class II devices, and certain class I devices as listed therein; plans for design and development activities and updates; procedures identifying, documenting, and approving design input requirements; procedures defining design output, including acceptance criteria, and documentation of approved records; procedures for formal review of design results and documentation of results in the design history file (DHF); procedures for verifying device design and documentation of results and approvals in the DHF; procedures for validating device design, including documentation of results in the DHF; procedures for translating device design into production specifications; procedures for documenting, verifying and validating approved design changes before implementation of changes; and the records and references constituting the DHF for each type of device.

Section 820.40 requires the establishment and maintenance of procedures for the review, approval, issuance, and documentation of required records (documents) and changes to those records.

Section 820.50 requires the establishment and maintenance of procedures and requirements to ensure service and product quality, records of acceptable suppliers and purchasing data describing specified requirements for products and services.

Sections 820.60 and 820.65 require, respectively, the establishment and maintenance of procedures for identifying all products from receipt to distribution and for using control numbers to track surgical implants and life-sustaining or supporting devices and their components.

Section 820.70(a) through (e), and (g) through (i) requires the establishment, maintenance, and/or documentation of: Process control procedures; procedures for verifying or validating changes to specification, method, process, or procedure; procedures to control environmental conditions and inspection result records; requirements for personnel hygiene; procedures for preventing contamination of equipment and products; equipment adjustment, cleaning and maintenance schedules; equipment inspection records; equipment tolerance postings; procedures for utilizing manufacturing materials expected to have an adverse effect on product quality; and validation protocols and validation records for computer software and software changes.

Sections 820.72 and 820.75(a), (b), (b)(2), and (c) require, respectively, the establishment, maintenance, and/or documentation of: Equipment calibration and inspection procedures; national, international or in-house calibration standards; records that identify calibrated equipment and next calibration dates; validation procedures and validation results for processes not verifiable by inspections and tests; procedures for keeping validated processes within specified limits; records for monitoring and controlling validated processes; and records of the results of revalidation where necessitated by process changes or deviations.

Sections 820.80 and 820.86, respectively, require the establishment, maintenance, and/or documentation of: Procedures for incoming acceptance by inspection, test or other verification; procedures for ensuring that in-process products meet specified requirements and the control of product until inspection and tests are completed; procedures for, and records that show, incoming acceptance or rejection is conducted by inspections, tests or other verifications; procedures for, and records that show, finished devices meet acceptance criteria and are not distributed until device master (DMR) activities are completed; records in the device history record (DHR) showing acceptance dates, results and equipment used; and the acceptance/rejection identification of products from receipt to installation and servicing.

Sections 820.90 and 820.100 require, respectively, the establishment, maintenance and/or documentation of: Procedures for identifying, recording, evaluating, and disposing of nonconforming product; procedures for reviewing and recording concessions made for, and disposition of, nonconforming product; procedures for reworking products, evaluating possible adverse rework effect and recording results in the DHR; procedures and requirements for corrective and preventive actions, including analysis, investigation, identification and review of data, records, causes and results; and records for all corrective and preventive action activities.

Sections 820.120(b) and (d), 820.130, 820.140, 820.150, 820.160, and 820.170, respectively, require the establishment, maintenance, and/or documentation of: Procedures for controlling and recording the storage, examination, release and use of labeling; the filing of labels/labeling used in the DHR; procedures for controlling product storage areas and receipt/dispatch authorizations; procedures for controlling the release of products for distribution; distribution records that identify consignee, product, date and control numbers; and instructions, inspection and test procedures that are made available, and the recording of results for devices requiring installation.

Sections 820.180(b) and (c), 820.181, 820.184, and 820.186 require, respectively, the maintenance of records: That are retained at prescribed site(s), made readily available and accessible to FDA and retained for the device's life expectancy or for 2 years; that are contained or referenced in a DMR consisting of device, process, quality assurance, packaging and labeling, and installation, maintenance, and servicing specifications and procedures; that are contained in DHR's, demonstrate the manufacture of each unit, lot or batch of product in conformance with DMR and regulatory requirements, and include manufacturing and distribution dates and quantities, acceptance documents, labels and labeling, and control numbers; and that are contained in a quality system record (QSR) consisting of references, documents, procedures, and activities not specific to particular devices.

Sections 820.198(a) through (c) and 820.200(a) and (d), respectively, require the establishment, maintenance and/or documentation of: Complaint files and procedures for receiving, reviewing, and evaluating complaints; complaint investigation records identifying the device, complainant, and relationship of the device to the incident; complaint records that are reasonably accessible to the manufacturing site or at prescribed sites; procedures for performing and verifying that device servicing requirements are met and that service reports involving complaints are processed as complaints; and service reports that record the device, service activity, and test and inspection data.

Section 820.250 requires the establishment and maintenance of procedures to identify valid statistical techniques necessary to verify process and product acceptability; and sampling plans, when used, that are written and based on a valid statistical rationale, and procedures for ensuring adequate sampling methods.

The CGMP/QS regulation amends and revises the CGMP requirements for medical devices set out at part 820. It adds design and purchasing controls; modifies previous critical device requirements; revises previous validation and other requirements; and harmonizes device CGMP requirements with quality system specifications in the international standard, ISO (International Organization for Standardization) 9001:1994 “Quality Systems—Model for Quality Assurance in Design, Development Production, Installation and Servicing.” The rule does not apply to manufacturers of components or parts of finished devices, nor to manufacturers of human blood and blood components subject to 21 CFR part 606. With respect to devices classified in class I, design control requirements apply only to class I devices listed in § 820.30(a)(2) of the regulation.

The rule imposes burdens upon finished device manufacturer firms, which are subject to all recordkeeping requirements, and upon finished device contract manufacturer, specification developer, repacker and relabeler, and contract sterilizer firms, which are subject only to requirements applicable to their activities. Due to modifications to the guidance given for remanufacturers of hospital single use devices, reusers of hospital single-use devices will now be considered to have the same requirements as manufacturers in regard to this regulation. The establishment, maintenance, and/or documentation of procedures, records and data required by this final regulation will assist FDA in determining whether firms are in compliance with CGMP requirements, which are intended to ensure that devices meet their design, production, labeling, installation, and servicing specifications and, thus are safe, effective, and suitable for their intended purpose. In particular, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries.

If FDA did not impose these recordkeeping requirements, it anticipates that design-related device failures would continue to occur in the same numbers as before and continue to result in a significant number of device recalls and preventable deaths and serious injuries. Moreover, manufacturers would be unable to take advantage of substantial savings attributable to reduced recall costs, improved manufacturing efficiency, and improved access to international markets through compliance with CGMP requirements that are harmonized with international quality system standards.

The CGMP/QS regulation applies to some 9,229 respondents. These recordkeepers consist of 7,229 original respondents and an estimated 2,000 hospitals that remanufacture or reuse single use medical devices. They include manufacturers, subject to all requirements and contract manufacturers, specification developers, repackers/relabelers and contract sterilizers, subject only to requirements applicable to their activities. Hospital remanufacturers of single use medical devices (SUD's) are now defined to be manufacturers under guidelines issued by the Center for Devices and Radiological Health's (CDRH's) Office of Surveillance and Biometrics. Respondents to this collection have no reporting activities, but must make required records available for review or copying during FDA inspection. The regulation contains additional recordkeeping requirements in such areas as design control, purchasing, installation, and information relating to the remanufacture of single use medical devices. The estimates for burden are derived from those incremental tasks that were determined when the new CGMP/QS regulation became final (October 7, 1996, 61 FR 52602) as well as those carry-over requirements. The carry-over requirements are based on decisions made by the agency on July 16, 1992, under OMB Paperwork Reduction Act submission No. 0910-0073. This still provides valid baseline data.

FDA estimates respondents will have a total annual recordkeeping burden of approximately 3,167,670 hours (shown as 3,167,670 in table 1, of this document, of this justification statement due to rounding). This figure also consists of approximately 114,882 hours spent on a startup basis by 650 new firms. Table 1 below identifies burden estimates per sections of the regulation.

FDA estimates information collection burdens imposed as follows:

Burden (labor) hour and cost estimates were developed under FDA contract by the Eastern Research Group, Inc. (ERG), in 1996 when the CGMP/QS regulation became final. These figures are still accurate. Additional factors considered in deriving estimates included:

f Establishment type: Query has been made of CDRH's registration/listing data bank and has counted 7,229 domestic firms subject to CGMP's. They were then grouped as: Manufacturers (5,463), contract manufacturers (204), specification developers (960), repackers/relabelers (574), remanufacturer (21) and contract sterilizers (7). In addition, hospitals that reuse or remanufacture devices are now considered manufacturers under new FDA guidance. It is estimated that out of the 6,000 hospitals in the United States, one-third of them (or 2,000 hospitals) will reuse or remanufacture single use medical devices. Thus, the number of manufacturers will increase from 5,463 to 7,463 making the total number of firms subject to CGMP's 9,229.

f Potentially affected establishments: Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to quality policy (§ 820.20(a)), document control (§ 820.40), and other requirements, whereas only manufacturers and specification developers are subject to part 820 Subpart C—Design Controls. The type of firm subject to each requirement was identified by ERG.

FDA estimated the burden hours (and costs) for the previous CGMP regulation in 1992. That estimate was submitted to OMB on May 4, 1992, under OMB Paperwork Reduction Act submission No. 0910-0073. It was approved by OMB on July 16, 1992, and it expired on June 30, 1995. The methodology used is different than that used by ERG in estimating incremental tasks when the new CGMP/QS became a final rule. Nevertheless, the agency believes its 1992 estimate adequately represents labor hours (and costs) needed to comply with previous CGMP requirements carried over into the new CGMP/QS regulation. The 1992 estimate used 9,289 respondents (rather than 9,229 respondents), which compensates for differences in methodology.

FDA estimates that some 650 “new” establishments (marketing devices for the first time) will expend some 114,882 “development” hours on a one-time startup basis to develop records and procedures for the CGMP/QS regulation.

FDA estimates that annual labor hours are apportioned as follows: 40 percent—to requirements dealing with manufacturing specifications, process controls and the DHR; 20 percent—to requirements dealing with components and acceptance activities; 25 percent—to requirements dealing with equipment, records (the DMR and QSR), complaint investigations, labeling/packaging and reprocessing/investigating product nonconformance; and 15 percent—to quality audit, traceability, handling, distribution, statistical, and other requirements.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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 through the use of automated collection techniques, when appropriate, and other forms of information technology.

EC is a group of 15 European countries that have agreed to harmonize their commodity requirements to facilitate commerce among member States. EC legislation for intra-EC trade has been extended to trade with non-EC countries, including the United States. For certain food products, including those listed below in this document, EC legislation requires assurances from the responsible authority of the country of origin that the processor of the food is in compliance with applicable regulatory requirements.

With the assistance of trade associations and State authorities, FDA requests information from processors that export certain animal-derived products (e.g., shell eggs, dairy products, game meat, game meat products, animal casings, and gelatin) to EC. FDA uses the information to maintain lists of processors that have demonstrated current compliance with U.S. requirements and provides the lists to EC quarterly. Inclusion on the list is voluntary. EC member countries refer to the lists at ports of entry to verify that products offered for importation to EC from the United States are from processors that meet U.S. regulatory requirements. Products processed by firms not on the list are subject to detention and possible refusal at the port. FDA requests the following information from each processor:

1. Business name and address;

2. Name and telephone number of person designated as business contact;

3. Lists of products presently being shipped to EC and those intended to be shipped in the next 6 months;

4. Name and address of manufacturing plants for each product;

5. Names and affiliations of any Federal, State, or local governmental agencies that inspect the plant, government-assigned plant identifier, such as plant number, and last date of inspection; and

6. Assurance that the firm or individual representing the firm and submitting a certificate for signature to FDA is aware of and knows that they are subject to the provisions of section 1001 of Title 18, United States Code. This law provides that it is a criminal offense to knowingly and willfully make a false statement or alter or counterfeit documents in a matter within the jurisdiction of a U.S. agency.

FDA estimates the burden of this collection of information as follows:

The estimated number of respondents is based on the volume of exports and responses received to date. The estimated number of yearly responses has decreased from the estimate in FDA's previous notice seeking comment for this collection of information (63 FR 29738, June 1, 1998) because the actual number of responses has been decreasing. Companies do not need to reapply unless they have a compliance problem. An estimate for processors that export gelatin also has been added because these processors are now being included in the listing process.

The burden estimated for the trade associations assumes the trade associations will disseminate FDA's information request through mass mailings to their membership or publish it in their trade magazine or newsletter. The burden estimated for State authorities assumes dissemination of information to the processors or dissemination of information about processors to FDA.

In the Federal Register of December 5, 2000 (65 FR 75942), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0297. The approval expires on February 29, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In the Federal Register of October 30, 2000 (65 FR 64607), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0433. The approval expires on February 29, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(q)) requires that the label or labeling of a food bear nutrition information, including information on: (1) The serving size and number of servings per container, and (2) the number of calories present in a serving of the food. Under FDA's nutrition labeling regulations in § 101.9(d)(3) (21 CFR 101.9(d)(3)), the nutrition facts panel of the food label must disclose the serving size of the food product and the number of servings in each package. Under § 101.9(c)(1), the nutrition facts panel must disclose the number of calories present in a serving of the food.

In the Federal Register of December 30, 1997 (62 FR 67775), FDA published a proposed rule to amend the nutrition labeling regulations by changing the label serving size for the product category “Hard candies, breath mints” to one unit. FDA proposed this change in response to a petition to provide a serving size for breath mints that more accurately reflects the amount customarily consumed per eating occasion. In a related issue, FDA also proposed to: (1) Modify the rounding rules for calories to allow the declaration of caloric amounts of less than 5 calories on the nutrition label, and (2) require that the number of calories declared on the nutrition label of a food product be consistent with any claims about caloric content that are made in its labeling. As a result of this proposed rule, manufacturers, packers, or distributors who make labeling claims that their products contain between 1 and 5 calories would be required to change the declaration of the amount of calories on the nutrition label. In addition, manufacturers of small breath mints would be required, under § 101.9(b), to change the serving size and, under § 101.9(c) and (d), to modify the amounts and daily values for nutrients listed in the nutrition label for their products. The proposal included burden estimates for the proposed changes and solicited public comment. In the interim, however, FDA is seeking an extension of OMB approval for the current regulations.

In the Federal Register of December 5, 2000 (65 FR 75940), the agency requested comments on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

In a notice published in the Federal Register of January 23, 2001 (66 FR 7498), FDA announced that a food additive petition (FAP 1B4726) had been filed by Avecia, Inc., 1405 Foulk Rd., P.O. Box 15457, Wilmington, DE 19850-5457. The petition proposed to amend the food additive regulations in § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods (21 CFR 176.170) and § 176.180 Components of paper and paperboard in contact with dry food (21 CFR 176.180) to provide for the safe use of poly(hexamethylenebiguanide) hydrochloride as a preservative for food-contact paper coating formulations. Avecia, Inc., has now withdrawn the petition without prejudice to a future filing (21 CFR 171.7).

Battle Mountain Gold Company (BMG), a wholly owned subsidiary of Newmont Mining Corporation, proposes to expand its current operations near Battle Mountain, Nevada, to include mining and beneficiation of gold, silver, and copper ores. The proposed Phoenix Project would require up to an additional 4,295 acres of disturbance. BMG would develop the Phoenix and Reona pits and expand the Midas and Iron Canyon pits. Mining these ore deposits would be coupled with excavating and beneficiating low-grade gold ore stockpiles associated with the previous Tomboy, Northeast Extension, and Fortitude mining operations. Beneficiation operations would include heap leach facility expansion and new milling facilities. The projected mine life is up to 28 years, followed by five years of reclamation.

The purpose of the Resource Advisory Council is to advise the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with the management of public lands. The Council's responsibilities include providing advice on long-range planning, establishing resource management priorities and assisting the BLM to identify State and regional standards for rangeland health and guidelines for grazing management.

On February 2, 2001, the U.S. Department of Agriculture, Forest Service, filed an application to withdraw the following described National Forest System land from the public land laws, including location and entry under the United States mining laws, subject to valid existing rights:

For a period of 90 days from the date of publication of this notice, all persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal may present their views in writing to the Alaska State Director of the Bureau of Land Management at the address indicated above.

Notice is hereby given that an opportunity for a public meeting is afforded in connection with the proposed withdrawal. All interested persons who desire a public meeting for the purpose of being heard on the proposed withdrawal must submit a written request to the Alaska State Director within 90 days from the date of publication of this notice. Upon determination by the authorized officer that a public meeting will be held, a notice of the time and place will be published in the Federal Register at least 30 days before the scheduled date of the meeting.

The application will be processed in accordance with the regulations set forth in 43 CFR 2300.

For a period of 2 years from the date of publication of this notice in the Federal Register, the land will be segregated as specified above unless the application is denied or canceled or the withdrawal is approved prior to that date.

The land will be managed in accordance with the various acts that govern occupancy and use of National Forest System lands. Temporary uses which may be permitted during this segregative period would be for land use authorizations that are compatible with intended uses allowed under the discretion of the authorized officer.

The location and dates of future meetings will be published in the Federal Register and posted on our Internet site at http://www.mrm.mms.gov//Laws_R_D/RoyPC/RoyPC.htm. The meetings will be open to the public without advanced registration on a space available basis. The public may make statements during the meetings, to the extent time permits, and file written statements with the Committee for its consideration.

Written statements should be submitted to Gary L. Fields at the e-mail or mailing address listed in the FOR FURTHER INFORMATION CONTACT section. Transcripts of Committee meetings will be available two weeks after each meeting for public inspection and copying at MMS's Minerals Revenue Management, Building No. 85, Denver Federal Center, Denver, Colorado. Meeting minutes will be posted on our Internet site at http://www.mrm.mms.gov//Laws_R_D/RoyPC/RoyPC.htm about one month after the meeting.

These meetings are conducted under the authority of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. appendix 1) and Office of Management and Budget (Circular No. A-63, revised).

The Commission believes that Respondents have justified the need for a closed session. Respondents seek a closed session to allow testimony on a producer-specific basis and on allegations of lost sales due to competition with subject imports. Because such discussions will necessitate disclosure of business proprietary information (BPI), they can only occur if a portion of the hearing is held in camera. In making this decision, the Commission nevertheless reaffirms its belief that whenever possible its business should be conducted in public.

The hearing will include the usual public presentations by petitioners and by Respondents, with questions from the Commission. In addition, the hearing will include an in camera session for a confidential presentation by Respondents and for questions from the Commission relating to the BPI, followed by an in camera rebuttal presentation by petitioners. For any in camera session the room will be cleared of all persons except those who have been granted access to BPI under a Commission administrative protective order (APO) and are included on the Commission's APO service list in this investigation. See 19 CFR 201.35(b)(1), (2). The time for the parties' presentations and rebuttals in the in camera session will be taken from their respective overall allotments for the hearing. All persons planning to attend the in camera portions of the hearing should be prepared to present proper identification.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (e.g., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information burden is correct.

The Agency is responsible for investigating alleged violations of “whistle blower” provisions contained in a number of Federal statutes. These provisions prohibit retaliation by employers against employees who report unsafe or unlawful practices used by the employers that may damage the environment. Accordingly, these provisions prohibit an employer from discharging or taking any other retaliatory action against an employee with respect to compensation, or the terms, conditions, or privileges of employment because the employee engages in any of the protected activities specified by the “whistle blower” provisions of the Federal statutes. These provisions include the: Safe Water Drinking Act, 42 U.S.C. 300j-9(i); Water Pollution Control Act, 33 U.S.C. 1367; Toxic Substances Control Act, 15 U.S.C. 2622; Solid Waste Disposal Act, 42 U.S.C. 6971; Clean Air Act, 42 U.S.C. 7622; Energy Reorganization Act of 1974, 42 U.S.C. 5851; and Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 U.S.C. 9610.

Under 29 CFR part 24 (“Procedures for the Handling of Discrimination Complaints under Federal Employee Protection Statutes”), section 24.3 (“Complaint”) specifies the procedures that an employee must use to file a complaint with OSHA alleging that their employer violated a “whistle blower” provision for which the Agency has investigative responsibility. Any employee who believes that such a violation occurred may file a complaint, or have the complaint filed on their behalf. While OSHA specifies no particular form for filing a complaint, paragraph (c) of 29 CFR 24.3 (“Form of complaint”) requires that “a complaint must be in writing and should include a full statement of the acts and omissions, with pertinent dates, which are believed to constitute the violation.”

The Agency has a particular interest in comments on the following issues:

• Whether the proposed information-collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;

• The accuracy of the Agency's estimate of the burden (time and costs) of the information-collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information-collection and -transmission techniques.

OSHA proposes to extend OMB's approval of the collection-of-information (paperwork) requirements contained in the paragraph (c) of 29 CFR 24.3 (“Complaints”). The Agency will summarize the comments submitted in response to this notice, and will include this summary, along with the comments, in its request to OMB to extend the approval of these information-collection requirements.

Type of Review: Extension of currently approved information-collection requirements.

Title: Procedures for the Handling of Discrimination Complaints.

OMB Number: 1218-0236.

Affected Public: Individuals.

Number of Respondents: 1,700.

Frequency: On occasion.

Total Responses: 1,700.

Average Time Per Response: 1 hour.

Estimated Total Burden Hours: 1,700 hours.

Estimated Cost (Operation and Maintenance): $0.

R. Davis Layne, Acting Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506) and Secretary of Labor's Order No 3-2000 (65 FR 50017).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (e.g., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information burden is correct.

Section 21 of the Occupational Safety and Health Act of 1970 (the “OSH Act”) (29 U.S.C. 670) authorizes the Occupational Safety and Health Administration (“OSHA” or the “Agency”) to conduct education and training courses. These courses must ensure an adequate number of qualified personnel to fulfill the purposes of the Act, provide them with short-term training, inform them of the importance and proper use of safety and health equipment, and train employers and employees to recognize, avoid, and prevent unsafe and unhealthful working conditions, occupational education and training courses.

Under Section 21 of the Act, the OSHA Training Institute (the “Institute”) provides basic, intermediate, and advanced training and education in occupational safety and health for Federal and State compliance officers, Agency professionals and technical-support personnel, employers, employees, organizations representing employees and employers, educators who develop curricula and teach occupational safety and health courses, and representatives of professional safety and health groups. The Institute provides courses on occupational safety and health at its national training facility in Des Plaines, Illinois.

Students attending Institute courses complete a one-page Student Data Form (OSHA Form 182, 5/98 edition) on the first day of class. The form provides information under five major categories titled “Course Information,” “Personal Data,” “Employer Data,” “Emergency Contacts,” and “Student Groups.” The OSHA Office of Training and Education (the “Office”) compiles, for each fiscal year, the following information from the “Course Information” and “Student Groups” categories: Total student attendance at the Institute; the number of students attending each training course offered by the Institute; and the types of students attending these courses (for example, students from Federal or State occupational safety and health agencies). The Office uses this information to demonstrate, in an accurate and timely manner, that the Agency is providing the training and employee education mandated by Section 21 of the Act. OSHA also uses this information to evaluate training, and to make decisions regarding program/course revisions, budget support, and tuition costs.

The Agency uses the information collected under the “Course Information,” “Personal Data,” and “Employer Data” to identify private-sector students so that it can collect tuition costs from them or their employers as authorized by 31 U.S.C. 9701 (“Fees and Charges for Government Services and Things of Value”); Office of Management and Budget Circular A-25 (“User Charges”); and 29 CFR part 1949 (“Office of Training and Education, Occupational Safety and Health Administration”). The information in the “Personal Data” and Emergency Contacts” categories permits OSHA to contact students who are residing in local hotels/motels if an emergency arises at their home or place of employment, and to alert supervisors/alternate contacts of a trainee's injury or illness.

The Agency has a particular interest in comments on the following issues:

• Whether the proposed information-collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;

• The accuracy of the Agency's estimate of the burden (time and costs) of the information-collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information-collection and -transmission techniques.

OSHA proposes to extend OMB's approval of the collection-of-information (paperwork) requirements specified in the Student Data Form. The Agency will summarize the comments submitted in response to this notice, and will include this summary, along with the comments, in its request to OMB to extend the approval of these information-collection requirements.

Type of Review: Extension of currently approved information-collection requirements.

Title: Student Data Form.

OMB Number: 1218-0172.

Affected Public: Individuals; business or other for-profit organizations; Federal government; State, Local, or Tribal governments.

Number of Respondents: 5,000.

Frequency: On occasion.

Total Responses: 5,000.

Average Time Per Response: 5 minutes.

Estimated Total Burden Hours: 417 hours.

Estimated Cost (Operation and Maintenance): $8,092.

R. Davis Layne, Acting Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506) and Secretary of Labor's Order No 3-2000 (65 FR 50017).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of information burden is correct.

Section 21 of the Occupational Safety and Health Act of 1970 (the “OSH Act”) (29 U.S.C. 670) authorizes the Occupational Safety and Health Administration (“OSHA” or the “Agency”) to conduct directly, or through grants and contracts, education and training courses. These courses must ensure an adequate number of qualified personnel to fulfill the purposes of the Act, provide them with short-term training, inform them of the importance and proper use of safety and health equipment, and train employers and employees to recognize, avoid, and prevent unsafe and unhealthful working conditions.