The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, persons who wish to bring matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by September 18, 2003, will have the opportunity to address the committee at those sessions.

The meetings are open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-226).

The applicant proposes to test two types of large mesh gillnets to ascertain which type of net will better reduce sea turtle interactions while maintaining targeted fish catch rates. The control net will be constructed of 6.5 inch monofilament webbing with a twine diameter of 0.57mm, 25 meshes deep. The low profile net will be constructed of 6.5 inch monofilament webbing with a twine diameter of 0.57 mm, eight meshes deep. Nets will be set at dusk and retrieved in the early morning. Captured sea turtles will be examined for any possible injuries and held for approximately two hours to ensure they are healthy before being transported away from the fishing area and released. Turtles will be identified to species, measured, photographed, and flipper and PIT tagged. Any comatose or debilitated turtles will be transported to a rehabilitation center. During the life of the permit, the applicant requests authorization to capture 21 animals, representing a combination of Kemp's ridley ( Lepidochelys kempii ), loggerhead ( Caretta caretta ) and green ( Chelonia mydas ) sea turtles. An additional 2 hawksbill ( Eretmochelys imbricata ) and 2 leatherback ( Dermochelys coriacea ) turtles may also be captured. Of the captured turtles, 9 of the Kemp's/loggerhead/green turtle aggregate, 1 hawksbill, and 1 leatherback may be mortalities. Research will be conducted in Pamlico Sound, North Carolina and the permit would expire in December 2004.

Written comments or requests for a public hearing on this application should be mailed to the Chief, Permits, Conservation and Education Division, F/PR1, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910. Those individuals requesting a hearing should set forth the specific reasons why a hearing on this particular request would be appropriate.

Comments may also be submitted by facsimile to (301)713-0376, provided the facsimile is confirmed by hard copy submitted by mail and postmarked no later than the closing date of the comment period. Please note that comments will not be accepted by e-mail or by other electronic media.

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

The National Security Education Board Group of Advisors meeting is open to the public.

The Board meeting is open to the Public.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE and its regulators in the areas of environmental restoration and waste management activities.

Copies of the final agenda will be available at the meeting.

Public Participation: The meeting is open to the public. Written statements may be filed with the Committee either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact David Dollins at the address listed below or by telephone at (270) 441-6819. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Each individual wishing to make public comments will be provided a maximum of five minutes to present their comments as the first item of the meeting agenda.

Minutes: The minutes of this meeting will be available for public review and copying at the Freedom of Information Public Reading Room, 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585 between 9 a.m. and 4 p.m., Monday-Friday, except Federal holidays. Minutes will also be available at the Department of Energy's Environmental Information Center and Reading Room at 115 Memorial Drive, Barkley Centre, Paducah, Kentucky between 8 a.m. and 5 p.m. on Monday thru Friday or by writing to David Dollins, Department of Energy Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001 or by calling him at (270) 441-6819.

In its Requests for Applications (RFA) the U.S. Environmental Protection Agency invites fellowship applications in the following areas of special interest to its mission: (1) Fall 2004 EPA Science to Achieve Results (STAR) Fellowships for Graduate Study, (2) Fall 2004 Minority Academic Institutions (MAI) Fellowships for Graduate Study, and (3) Fall 2004 Minority Academic Institutions (MAI) Undergraduate Student Fellowships.

This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0170. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. EPA also established two dockets containing documents in support of the diazinon IRED. They are dockets OPP-34225 and OPP-2002-0251. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

This notice announces cancellation, as requested by Syngenta, of all of Syngenta's diazinon products registered under section 3 of FIFRA. These registrations are listed in sequence by registration number in Tables 1, 2, and 3 of this unit.

Diazinon is an organophosphorous insecticide and is one of the most widely used insecticides in the U.S. It is used for outdoor non-agricultural, as well as agricultural, pest control.

Under a December 5, 2000 Memorandum of Agreement (MOA) between Syngenta Crop Protection, Inc. and EPA, Syngenta requested, under FIFRA section 6(f), that EPA cancel, effective as of June 30, 2003, the registrations of all of Syngenta's diazinon manufacturing-use products permitting formulation for outdoor non-agricultural use. In the MOA, EPA expressed that it would not contemplate permitting sale, distribution or use of existing stocks of these outdoor non-agricultural manufacturing-use products, except for return to the Registrant for purposes of re-labeling for export or disposal. In a letter dated April 8, 2003, Syngenta Crop Protection, Inc. requested a voluntary cancellation of all its remaining registrations for products containing diazinon, to be effective June 30, 2003. The request applied to outdoor non-agricultural end-use products and agricultural products. The request is contingent upon EPA's granting of certain existing stocks provisions, which are set forth in Unit V. EPA announced its receipt of the above-mentioned cancellation requests in a Federal Register Notice dated May 30, 2003 (68 FR 32501) (FRL-7309-2).

Syngenta's April 8, 2003 request for cancellations is consistent with the December 5, 2000 MOA. EPA has approved both the December 5, 2000 and the April 8, 2003 requests to terminate registrations for all of Syngenta's diazinon products and has published its cancellation order in this Notice. All of Syngenta's diazinon products subject to cancellation, which include outdoor non-agricultural and agricultural product registrations, are identified in Tables 1, 2, and 3 of this unit.

The Reregistration Eligibility Decision (RED) document summarizes the findings of EPA's reregistration process for individual chemical cases, and reflects the Agency's decision on risk assessment and risk management for uses of the individual pesticides known as organophosphates (OPs). EPA has issued an Interim Reregistration Eligibility Decision (IRED) document assessing the risks of exposure from agricultural uses of diazinon.

The manufacturing-use product registrations for which cancellation was requested are identified below in Table 1. The end-use product registrations for which cancellation was requested are identified below in Tables 2 and 3. EPA did not receive any substantive comments regarding these product registrations. Accordingly, the Agency has issued an order in this notice canceling the registrations identified in Tables 1, 2, and 3.

Table 4 of this unit includes the name and address of record for the registrant of the products in Tables 1, 2, and 3 of this unit:

Pursuant to section 6(f) of FIFRA, EPA hereby approves the requested cancellations of diazinon product registrations identified in Tables 1, 2, and 3 in Unit II. Accordingly, the Agency orders that the diazinon manufacturing-use product registrations identified in Table 1 in Unit II., as well as the end-use product registrations listed in Tables 2 and 3 in Unit II., are hereby canceled. Any distribution, sale, or use of existing stocks of the products identified in Tables 1, 2, and 3 in Unit II. in a manner inconsistent with any of the Provisions for Disposition of Existing Stocks set forth below in Unit V. will be considered a violation of FIFRA.

Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register . Thereafter, the Administrator may approve such a request.

Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The cancellation order issued in this Notice includes the following existing stocks provisions.

1. Distribution or sale . The distribution or sale of existing stocks of any outdoor non-agricultural manufacturing-use product identified in Table 1 in Unit II. is no longer lawful under FIFRA, except for the purposes of export consistent with FIFRA section 17 and proper disposal in accordance with applicable law.

2. Use for producing other products . The use of existing stocks of any manufacturing-use product identified in Table 1 in Unit II. for formulation into any other product labeled for outdoor non-agricultural use is no longer lawful under FIFRA.

1. Distribution or sale by registrant . The distribution, or sale, of existing stocks by Syngenta of any product listed in Table 2 in Unit II. will not be lawful under FIFRA after August 31, 2003, except for purposes of shipping such stocks for export consistent with the requirements of FIFRA section 17 or proper disposal in accordance with applicable law.

2. Retail and other distribution or sale . The distribution or sale of existing stocks by persons other than Syngenta will be prohibited after December 31, 2004, except for purposes of product recovery pursuant to the 2000 MOA, shipping such stocks for export consistent with the requirements of FIFRA section 17, or proper disposal in accordance with applicable law.

3. Use of existing stocks . Use of existing stocks may continue until stocks are exhausted. Any such use must be in accordance with the label.

1. Distribution or sale, or use by registrant . The distribution, sale, or use of existing stocks by Syngenta of any manufacturing-use product identified in Table 1 in Unit II. for formulation into any other product labeled for agricultural use will not be lawful under FIFRA after August 31, 2003, except for purposes of shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or proper disposal in accordance with applicable law.

2. Retail and other distribution, sale, or use . The distribution, sale, or use of existing stocks of any manufacturing-use product identified in Table 1 in Unit II. for formulation into any other product labeled for agricultural use by any person other than Syngenta may continue until stocks are exhausted. Any such use must be in accordance with the label.

1. Distribution or sale by registrant . The distribution or sale of existing stocks by Syngenta of any product listed in Table 3 in Unit II. will not be lawful under FIFRA after August 31, 2003, except for purposes of shipping for exports consistent with the requirements of FIFRA section 17 or proper disposal in accordance with the applicable law.

2. Retail and other distribution, sale, or use . The distribution, sale, or use of existing stocks by any person other than Syngenta may continue until stocks are exhausted. Any such use must be in accordance with the label.

This notice announces the vacature of two applicability determinations made concerning the NESHAP for Secondary Aluminum, 40 CFR part 63, subpart RRR. An applicability determination concerning the U.S. Granules facility in Plymouth, Indiana was made by the EPA Region 5 Air Enforcement and Compliance Assurance Branch on August 21, 2002, in response to a request for such a determination by U.S. Granules dated August 14, 2002. Notice of this applicability determination (Control No. M020112) was published in the Federal Register on February 13, 2003. 68 FR 7373. The decision to vacate this determination was subsequently announced in a letter to U.S. Granules dated June 19, 2003.

An applicability determination concerning the U.S. Granules facility in Henrietta, Missouri was made by the EPA Region 7 Air Permitting and Compliance Branch on October 22, 2002, in response to a request for such a determination by U.S. Granules dated October 11, 2002. Notice of this applicability determination (Control No. M020117) was also published in the Federal Register on February 13, 2003. 68 FR 7373. The decision to vacate this determination was subsequently announced in a letter to U.S. Granules dated June 23, 2003.

After issuance of these two applicability determinations, EPA determined that these determinations reflect conflicting constructions concerning the applicability of Subpart RRR to operations like those conducted at the U.S. Granules facilities. EPA also determined that the retention of such conflicting constructions would be inappropriate as a matter of law and policy. Accordingly, EPA decided to vacate both of these applicability determinations and to commence a process to adopt a single uniform construction of Subpart RRR which will apply to all operations like those conducted at the U.S. Granules facilities.

The vacature of each of the applicability determinations concerning U.S. Granules facilities described in this notice was final and effective on the date that the letter announcing that vacature was signed. This notice is being published to assure that parties other than U.S. Granules who may be interested in these determinations are also notified that they have been vacated. In addition to this notice, EPA will update the Applicability Determination Index maintained by OECA to reflect the vacature of these determinations.

ATSDR is mandated to conduct public health assessments under Section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) [42 U.S.C. 9604(i)] and the Resource Conservation and Recovery Act (RCRA) [42 U.S.C. 6939a(c)].

The general procedures for the conduct of public health assessments are included in the ATSDR Final Rule on Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities (55 FR 5136, February 13, 1990, codified at 42 CFR Part 90).

Areas emphasized in the online learning program include community involvement, exposure assessment, weight-of-evidence approaches to decision making, and developing public health action plans to address any public health hazards found during investigations.

The online learning program may be used by individuals to learn more about the public health assessment process, by community groups during meetings, and by individuals and groups as a communication tool when discussing concerns with the public health assessment team assigned to a site in their community. The program may also be used by agents of ATSDR to introduce new staff to the concepts of the public health assessment process and as a tool to stimulate communications with community members.

This notice announces the projected availability of the draft online learning program. The program has undergone extensive internal review. ATSDR encourages the public's participation and comment on the further development of this online learning program.

The President's Committee for People with Intellectual Disabilities acts in an advisory capacity to the President and the Secretary of the U.S. Department of Health and Human Services on a broad range of topics relating to programs, services, and supports for persons with mental retardation. The Committee, by Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with mental retardation, and for reviewing legislative proposals that impact on the quality of life that is experienced by citizens with mental retardation and their families.

In accordance with 21 CFR 130.17, FDA issued a temporary permit to Del Monte Corp., One Market @ The Landmark, P.O. Box 193575, San Francisco, CA 94119-3575, to market test canned tomato products that deviate from the U.S. standards of identity for canned tomatoes § 155.190 (21 CFR 155.190) (67 FR 43325, June 27, 2002). The agency issued the permit to facilitate market testing of foods deviating from the requirements of the standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341).

The permit covered limited interstate marketing tests of products identified as “Stewed Tomatoes, Original Recipe,” “Chunky Tomatoes, Pasta Style,” “Diced Tomatoes, basil, garlic & oregano,” “Diced Tomatoes, garlic & onion,” “Diced Tomatoes, green pepper & onion,” “Tomato Wedges,” “Zesty Chunky Tomatoes, Chili Style,” “Stewed Tomatoes, Cajun Recipe with pepper, garlic, and Cajun spices,” “Stewed Tomatoes, Italian Recipe with basil, garlic & oregano,” “Stewed Tomatoes, Mexican Recipe with garlic, cumin, and jalapeños,” and “Stewed Tomatoes, no salt added.” These canned tomato products deviate from the U.S. standard of identity for canned tomatoes (§ 155.190) in two ways. First, a liquid carbohydrate sweetener, either corn syrup or high fructose corn syrup, is used as an optional ingredient in lieu of dry nutritive carbohydrate sweeteners. The liquid carbohydrate sweetener, corn syrup or high fructose corn syrup, is used in a quantity reasonably necessary to compensate for the tartness resulting from added organic acids, except that such addition of the liquid sweetener, in no case, may result in a finished canned tomato product with a tomato soluble solids content of less than 5.0 percent by weight as defined in 21 CFR 155.3(e) (which accounts for any added salt) and accounting for the soluble solids of the liquid sweetener. Second, the permit provided for use of the term “chunky” in lieu of the styles (i.e., whole, sliced, diced, and wedges) required by the standard. Except for the use of a liquid sweetener and the use of the alternative term “chunky” on some products, the test products meet all the requirements of the standard.

On April 23, 2003, Del Monte Corp. requested that its temporary marketing permit be extended to allow for additional time for the market testing of its test products. The petitioner requested FDA to amend the standard of identity for canned tomatoes. In addition, Del Monte Corp. also requested that additional varieties of canned tomatoes be included under this permit extension. The additional products are as follows: (1) Del Monte Brand “Diced Tomatoes, Petite Cut, garlic and olive oil;” (2) Contadina Brand “Stewed Tomatoes with onions, celery, and green peppers,” “Stewed Tomatoes with garlic, oregano, and basil, Italian Style,” “Diced Tomatoes with roasted garlic,” “Diced Tomatoes, Italian Herbs,” “Diced Tomatoes with Roasted Red Pepper,” “Diced Tomatoes, Primavera with zucchini, bell peppers, and carrots,” “Diced Tomatoes, Marinara with burgundy wine and olive oil;” and (3) S&W Brand “Stewed Tomatoes, Italian Recipe, sliced pear tomatoes with oregano and basil, 14 1/2 ounces,” “Stewed Tomatoes, Italian Recipe, sliced pear tomatoes with oregano and basil, 28 ounces,” “Diced Tomatoes in tomato juice with roasted garlic,” “Stewed Tomatoes with onion, celery, and bell pepper,” “Stewed Tomatoes with bell pepper, celery, and onion, no salt added,” “Diced tomatoes, Petite Cut, with roasted garlic and sweet onions,” “Stewed Tomatoes, Mexican Recipe with mild chili and Mexican seasoning,” and “Stewed Tomatoes, Cajun Recipe with bell pepper, onion, and Creole spices.”

The agency finds that it is in the interest of consumers to issue an extension of the time period for the market testing of products identified in the original permit (67 FR 43325) as well as to permit limited interstate marketing tests of additional canned tomato products identified in the previous paragraph. FDA is inviting interested persons to participate in the market test under the conditions that apply to Del Monte Corp. except that the designated area of distribution shall not apply. Any person who wishes to participate in the extended market test must notify, in writing, the Team Leader, Regulations and Review Team, Division of Food Labeling and Standards, Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. The notification must include a description of the test product to be distributed, a justification statement for the amount requested, the area of distribution, and the labeling that will be used for the test product (i.e., a draft label for each size of container and each brand of product to be market tested). The information panel of the label must bear nutrition labeling in accordance with 21 CFR 101.9. Each of the ingredients used in the food must be declared on the label as required by applicable sections of 21 CFR part 101.

Therefore, under the provisions of 21 CFR 130.17(i), FDA is extending the temporary permit granted to Del Monte Corp., One Market @ The Landmark, P.O. Box 193575, San Francisco, CA 94119-3575 to provide for continued marketing tests of approximately 10.3 million cases (226.6 million pounds or 103.0 million kilograms in weight) annually of canned tomatoes previously identified . FDA is extending the expiration date of the permit so that the permit expires either on the effective date of a final rule to amend the standard of identity for canned tomatoes that may result from the petition, or 30 days after termination of such rulemaking. All other conditions and terms of this permit remain the same.

FDA recently became aware of possible inaccuracies in the CMC section of two of Solvay's applications approved by the agency. The two Solvay NDAs involved were: (1) NDA 19-919 for ROWASA (mesalamine) Rectal Suppositories, 500 mg, and (2) NDA 20-243 for LUVOX (fluvoxamine maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets. These findings, along with other information submitted to the agency by Solvay, provided sufficient justification to initiate proceedings to withdraw approval of these two products. The agency notified Solvay in writing of these eterminations and, in accordance with § 314.150(d) (21 CFR 314.150(d)), offered Solvay the opportunity to permit FDA to withdraw approval of the applications.

Subsequently, in letters dated March 28, 2002, and May 14, 2002, respectively, Solvay requested withdrawal of the NDAs under § 314.150(d), thereby waiving its opportunity for a hearing. Solvay also withdrew these drug products from the market. Under § 314.150(d), approval of these two NDAs is being withdrawn.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved under an NDA. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved or, (2) whenever a listed drug is voluntarily withdrawn from sale, and ANDAs that referred to the listed drug have been approved. FDA may not approve an ANDA that does not refer to a listed drug.

The agency has already determined that ROWASA (mesalamine) Rectal Suppositories, 500 mg, was not withdrawn from sale for reasons of safety and effectiveness. On May 24, 2001, FDA published its determination in the Federal Register (66 FR 28753). Since that time, ANDAs that refer to ROWASA (mesalamine) Rectal Suppositories, 500 mg, may be approved by the agency.

Because numerous approved ANDAs for fluvoxamine maleate relied on LUVOX as the reference listed drug in their applications, FDA must also make a determination of reasons for voluntary withdrawal of LUVOX under § 314.161(a)(2). The agency has determined that Solvay Pharmaceuticals, Inc.'s, LUVOX (fluvoxamine maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets was not withdrawn from sale for reasons of safety or effectiveness.

LUVOX is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder. In the course of an audit, FDA discovered inaccuracies in the CMC section of the LUVOX (fluvoxamine maleate) application. Although these findings raised concerns about the drug product as manufactured by Solvay, they do not affect the safety or efficacy of fluvoxamine maleate in treating obsessive compulsive disorder. LUVOX was withdrawn from sale following FDA's written request under § 314.150(d). The agency's independent evaluation of relevant information has not found any data that would indicate LUVOX (fluvoxamine maleate) was withdrawn for reasons of safety or effectiveness.

After reviewing its records, FDA determines that, for the reasons outlined in the previous paragraph, LUVOX (fluvoxamine maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will list Solvay's LUVOX (fluvoxamine maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets in the “Discontinued Drug Product List” section of the “Orange Book.” The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs for fluvoxamine maleate 25-mg, 50-mg, 100-mg, and 150-mg tablets may continue to be approved by the agency.

Therefore, under section 505(e) of the act approval of the NDAs listed above, and all amendments and supplements thereto, is withdrawn, effective September 3, 2003.

On March 1, 2003, the functions of the Immigration and Naturalization Service (Service) transferred from the Department of Justice to the Department of Homeland Security (DHS) pursuant to the Homeland Security Act of 2002, Pub. L. 107-296. The responsibilities for administering the TPS program held by the Service were transferred to the Bureau of Citizenship and Immigration Services (BCIS).

Under section 244 of the Immigration and Nationality Act (Act), 8 U.S.C. 1254a, the Secretary of DHS, after consultation with appropriate agencies of the Government, is authorized to designate a foreign state or (part thereof) for TPS. The Secretary of DHS may then grant TPS to eligible nationals of that foreign state (or aliens having no nationality who last habitually resided in that state).

Section 244(b)(3)(A) of the Act requires the Secretary of DHS to review, at least 60 days before the end of the TPS designation or any extension thereof, the conditions in a foreign state designated under the TPS program to determine whether the conditions for a TPS designation continue to be met and, if so, the length of an extension of TPS. 8 U.S.C. 1254a(b)(3)(A). If the Secretary of DHS determines that the foreign state no longer meets the conditions for TPS designation, he shall terminate the designation, as provided in section 244(b)(3)(B) of the Act. 8 U.S.C. 1254a(b)(3)(B). Finally, if the Secretary of DHS does not determine that a foreign state (or part thereof) no longer meets the conditions for designation at least 60 days before the designation or extension is due to expire, section 244(b)(3)(C) of the Act provides for an automatic extension of TPS for an additional period of 6 months (or, in the discretion of the Secretary of DHS, a period of 12 or 18 months). 8 U.S.C. 1254a(b)(3)(C).

On November 4, 1997, the Attorney General published a notice in the Federal Register designating Burundi under the TPS program based upon ongoing armed conflict occurring within the country. 62 FR 59735. The Attorney General extended this TPS designation annually and re-designated Burundi by publishing a notice on November 9, 1999, determining in each instance that the conditions warranting such designation continued to be met. 64 FR 61123.

Since the date of the last extension, the Departments of Homeland Security and State have continued to review conditions in Burundi. It is determined that a 12-month extension is warranted due to ongoing armed conflict within Burundi that would pose a serious threat to the personal safety of returning nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi). 8 U.S.C. 1254a(b)(1)(A).

The BCIS Resource Information Center (RIC) notes that, although there have been important advances in the Burundi peace process, fighting between the government and rebel forces has intensified. RIC Report (June 26, 2003). Both sides are still committing serious human rights violations. Id. The humanitarian situation remains dire. Id.

Burundi has seen some progress. Id. The transitional government of Burundi and two of the three main rebel forces signed ceasefire agreements in December 2002. Id. In addition, there has been some headway in implementing the Burundian peace accords. Id. Cooperation between the major Hutu and Tutsi political parties has improved, laws have been enacted to address past human rights violations and prevent future abuses, and civil service and provincial administration reforms have been initiated. Id. Most significantly, there was a smooth transition of power in May 2003 from a Tutsi to a Hutu president to lead the second half of the three-year transitional power-sharing government set forth in the peace accords. Id.

The Department of State (DOS) notes that, despite these advances, the December 2002 ceasefire has been largely ignored. DOS Recommendation (June 19, 2003). The conflict between the government forces and rebel groups continues unabated in many areas of the country. Id. Rebel attacks on the military are followed by army reprisals against civilians suspected of cooperating with the insurgents. Id. Rebels reportedly often kill persons for suspected collaboration with the government and for their refusal to pay “taxes” to the rebels. Id.

The prospects for a sustained halt to the armed conflict are uncertain. Id. While the United Nations High Commissioner for Refugees (UNHCR) is currently facilitating voluntary repatriations to the northern provinces of Burundi, much of the country remains unsafe for repatriation. Id. UNHCR has yet to begin facilitated returns to the southern and central provinces of Burundi because those regions have not yet been deemed secure. Id.

Based upon this review, the Secretary of DHS, after consultation with appropriate government agencies, finds that the conditions that prompted designation of Burundi under the TPS program continue to be met. 8 U.S.C. 1254a(b)(3)(A). There is an ongoing armed conflict within Burundi and, due to such conflict, requiring the return of aliens who are nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) would pose a serious threat to their personal safety. 8 U.S.C. 1254a(b)(1). On the basis of these findings, the Secretary of DHS concludes that the TPS designation for Burundi should be extended for an additional 12-month period. 8 U.S.C. 1254a(b)(3)(C).

Yes. If you already have received TPS benefits through the Burundi TPS program, your benefits will expire on November 2, 2003. Accordingly, individual TPS beneficiaries must comply with the re-registration requirements described below in order to maintain their TPS benefits through November 2, 2004. TPS benefits include temporary protection against removal from the United States, as well as employment authorization, during the TPS designation period and any extension thereof. 8 U.S.C. 1254a(a)(1).

All persons previously granted TPS under the Burundi program who wish to maintain such status must apply for an extension by filing (1) a Form I-821, Application for Temporary Protected Status, without the filing fee; (2) a Form I-765, Application for Employment Authorization; and (3) two identification photographs (1 1/2 inches × 1 1/2 inches). See the chart below to determine whether you must submit the one hundred and twenty dollar ($120) filing fee with Form I-765. Applicants for an extension of TPS benefits do not need to be re-fingerprinted and thus need not pay the $50 fingerprint fee. Children beneficiaries of TPS who have reached the age of fourteen (14) but were not previously fingerprinted must pay the fifty dollar ($50) fingerprint fee with the application for extension.

An application submitted without the required fee and/or photos will be returned to the applicant. Submit the completed forms and applicable fee, if any, to the BCIS District Office having jurisdiction over your place of residence during the 60-day re-registration period that begins September 3, 2003 and ends November 3, 2003.

An application for TPS does not affect an application for asylum or any other immigration benefit. Denial of an application for asylum or any other immigration benefit does not affect an applicant's TPS eligibility, although the grounds for denying one form of relief may also be grounds for denying TPS. For example, a person who has been convicted of a particularly serious crime is not eligible for asylum or TPS. 8 U.S.C. 1158(b)(2)(A)(ii); 8 U.S.C. 1254a(c)(2)(B)(ii).

No. This is a notice of an extension of TPS, not a notice of re-designation of Burundi under the TPS program. An extension of TPS does not change the required dates of continuous residence and continuous physical presence in the United States. This extension does not expand TPS availability to those who do not meet the current eligibility requirements for Burundi. To be eligible for benefits under this extension, nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) must have been continuously physically present and continuously resided in the United States since November 9, 1999.

Some persons may be eligible for late initial registration under 8 U.S.C. 1254a(c)(1)(A) and 8 CFR 244.2(f)(2). To apply for late initial registration an applicant must:

(1) Be a national of Burundi (or alien who has no nationality and who last habitually resided in Burundi);

(2) Have been continuously physically present in the United States since November 9, 1999;

(3) Have continuously resided in the United States since November 9, 1999; and

(4) Be both admissible as an immigrant, except as provided under section 244(c)(2)(A) of the Act, and not ineligible under section 244(c)(2)(B) of the Act.

Additionally, the applicant must be able to demonstrate that during the registration period for the initial designation (from November 4, 1997 to November 3, 1998), or during the registration period for the redesignation (from November 9, 1999 to November 2, 2000), he or she:

(1) Was a nonimmigrant or had been granted voluntary departure status or any relief from removal;

(2) Had an application for change of status, adjustment of status, asylum, voluntary departure, or any relief from removal or change of status pending or subject to further review or appeal;

(3) Was a parolee or had a pending request for reparole; or

(4) Was the spouse or child of an alien currently eligible to be a TPS registrant.

An applicant for late initial registration must file an application for late registration no later than 60 days after the expiration or termination of the conditions described above. 8 CFR 244.2(g).

At least 60 days before this extension of TPS expires on November 2, 2004, the Secretary of DHS will review conditions in Burundi and determine whether the conditions for designation under the TPS program continue to be met at that time, or whether the TPS designation should be terminated. Notice of that determination, including the basis for the determination, will be published in the Federal Register .

If the TPS designation is extended at that time, an alien who has received TPS benefits must re-register under the extension in order to maintain TPS benefits. If, however, the Secretary of DHS terminates the TPS designation, TPS beneficiaries will maintain the immigration status they had before TPS (unless that status had since expired or been terminated) or any other status they may have acquired while registered for TPS. Accordingly, if an alien had no lawful immigration status prior to receiving TPS and did not obtain any status during the TPS period, he or she will revert to that unlawful status upon termination of the TPS designation.

By the authority vested in me as Secretary of DHS under sections 244(b)(1)(A), (b)(3)(A), and (b)(3)(C) of the Act, I have consulted with the appropriate government agencies and determine that the conditions that prompted designation of Burundi for TPS continue to be met. 8 U.S.C. 1254a(b)(3)(A). Accordingly, I order as follows:

(1) The designation of Burundi under section 244(b)(1)(A) of the Act is extended for an additional 12-month period from November 2, 2003, to November 2, 2004. 8 U.S.C. 1254a(b)(3)(C).

(2) There are approximately 30 nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) who have been granted TPS and who are eligible for re-registration.

(3) To maintain TPS, a national of Burundi (or an alien having no nationality who last habitually resided in Burundi) who was granted TPS during the initial designation period or redesignation period must re-register for TPS during the 60-day re-registration period from September 3, 2003 until November 3, 2003.

(4) To re-register, the applicant must file the following: (1) Form I-821, Application for Temporary Protected Status; (2) Form I-765, Application for Employment Authorization; and (3) two identification photographs (1 1/2 inches by 1 1/2 inches). Applications submitted without the required fee and/or photos will be returned to the applicant. There is no fee for filing a Form I-821 for re-registration application. If the applicant requests employment authorization, he or she must submit one hundred and twenty dollars ($120) or a properly documented fee waiver request, pursuant to 8 CFR 244.20, with the Form I-765. An applicant who does not request employment authorization must nonetheless file Form I-765 along with Form I-821, but is not required to submit the fee. The fifty-dollar ($50) fingerprint fee is required only for children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted. Failure to re-register without good cause will result in the withdrawal of TPS. 8 CFR 244.17(c). Some persons who had not previously applied for TPS may be eligible for late initial registration under 8 CFR 244.2.

(5) At least 60 days before this extension terminates on November 2, 2004, the Secretary will review the designation of Burundi under the TPS program and determine whether the conditions for designation continue to be met. 8 U.S.C. 1254a(b)(3)(A). Notice of that determination, including the basis for the determination, will be published in the Federal Register . 8 U.S.C. 1254a(b)(3)(A).

(6) Information concerning the extension of designation of Burundi under the TPS program will be available at local BCIS offices upon publication of this notice and on the BCIS Web site at http://www.bcis.gov.

On March 1, 2003, the functions of the Immigration and Naturalization Service (Service) transferred from the Department of Justice to the Department of Homeland Security (DHS) pursuant to the Homeland Security Act of 2002, Public Law 107-296. The responsibilities for administering the TPS program held by the Service were transferred to the Bureau of Citizenship and Immigration Services (BCIS).

Under section 244 of the Immigration and Nationality Act (Act), 8 U.S.C. 1254a, the Secretary of DHS, after consultation with appropriate agencies of the Government, is authorized to designate a foreign state or (part thereof) for TPS. The Secretary of DHS may then grant TPS to eligible nationals of that foreign state (or aliens having no nationality who last habitually resided in that state).

Section 244(b)(3)(A) of the Act requires the Secretary of DHS to review, at least 60 days before the end of the TPS designation or any extension thereof, the conditions in a foreign state designated under the TPS program to determine whether the conditions for a TPS designation continue to be met and, if so, the length of an extension of TPS. 8 U.S.C. 1254a(b)(3)(A). If the Secretary of DHS determines that the foreign state no longer meets the conditions for TPS designation, he shall terminate the designation, but such termination may not take effect earlier than 60 days after the date the Federal Register notice of termination is published. 8 U.S.C. 1254a(b)(3)(B). The Secretary of DHS may determine the appropriate effective date of the termination in order to provide an orderly transition. 8 U.S.C. 1254a(d)(3).

On November 4, 1997, the Attorney General published a notice in the Federal Register designating Sierra Leone under the TPS program based upon ongoing armed conflict occurring within the country. 62 FR 59736. The Attorney General extended this TPS designation annually and re-designated Sierra Leone by publishing a notice on November 9, 1999, determining in each instance that the conditions warranting such designation continued to be met. 64 FR 61125.

Since the date of the last extension, the Departments of Homeland Security and State have continued to review conditions in Sierra Leone. It is determined that termination of the TPS designation of Sierra Leone is warranted because there is no longer an ongoing armed conflict within Sierra Leone that would pose a serious threat to the personal safety of returning nationals of Sierra Leone (or aliens having no nationality who last habitually resided in Sierra Leone). 8 U.S.C. 1254a(b)(1)(A) and (B).

The Department of State (DOS) notes that the armed conflict that provided the basis for the Sierra Leone TPS designation is over. DOS Recommendation (June 19, 2003). Most of Sierra Leone has been at peace for nearly three years. Id. More than 66,000 ex-combatants have entered into a program of disarmament, demobilization, and reintegration into society. Id. Disarmament was largely complete by January 2002, and there has been no fighting since that time. Id. Peaceful multiparty presidential and parliamentary elections took place in May 2002. Id.

A year ago, the overall political situation was fragile. Id. Since then, however, human rights abuses have decreased dramatically nationwide. Id. The United Nations High Commissioner for Refugees (UNHCR) considers no area of the country unsafe to return. Id. More than 400,000 refugees have returned home to participate in the reconstruction of their country. Id. Of the approximately 45,000 refugees remaining in neighboring countries, two-thirds are expected to return home by December 2003. Id. In addition, reintegration of the 300,000 internally displaced persons (IDPs) is nearly complete. Id.

While there are approximately 60,000 Liberian refugees in Sierra Leone, they are concentrated along the eastern border with Liberia and have not caused any instability in Sierra Leone. Id. Furthermore, there have been no recent cross-border attacks from Liberia into Sierra Leone. Id.

The BCIS Resource Information Center (RIC) notes additional indications of stability. RIC Report (July 10, 2003). A special court has been created to bring to justice those most responsible for war crimes and other major human rights violations. Id. A Truth and Reconciliation Commission has been established to establish a record of the conflict and promote reconciliation. Id. Humanitarian and economic conditions have improved markedly. Id.

The newly elected government enjoys significant international support and has extended police control across the country. DOS Recommendation. A British-trained police force is in place. RIC Report. The British government continues to assist and train Sierra Leone's 10,000-member armed forces and has committed to providing significant support for at least six years. DOS Recommendation. The United Nations (U.N.) Security Council has determined that security conditions have improved so much that the international U.N. peacekeeping force, which once numbered 17,500 troops, can be phased out. Id. The peacekeeping force currently numbers 14,000, and will further decrease to about 9,000 by year's end. Id.

Based upon this review, the Secretary of DHS, after consultation with appropriate government agencies, finds that the conditions that prompted designation of Sierra Leone under the TPS program no longer exist. 8 U.S.C. 1254a(b)(3). There is not an ongoing armed conflict within Sierra Leone that would pose a serious threat to the personal safety of returning aliens who are nationals of Sierra Leone (or aliens having no nationality who last habitually resided in Sierra Leone). 8 U.S.C. 1254a(b)(1)(A). Based upon these findings, the Secretary of DHS is terminating the TPS designation for Sierra Leone as of May 3, 2004. 8 U.S.C. 1254a(b)(3)(B).

To provide for an orderly transition, nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) who have been granted TPS under the Sierra Leone designation or redesignation will automatically retain TPS status and have their current employment authorization documents (EADs) extended until the termination date. 8 U.S.C. 1254a(a)(2) and (d)(3). These persons are urged to use the time before termination of their TPS to apply for any other immigration benefits they are eligible for or, in the alternative, prepare for and arrange their return to Sierra Leone.

No. If you already have been granted TPS benefits through the Sierra Leone TPS program, you do not have to re-register to keep your TPS benefits. You will automatically retain TPS until the termination date. However, your TPS status may still be withdrawn pursuant to section 244(c)(3) of the Act because of ineligibility for TPS, prior failure to timely re-register if there was not good cause for such failure, or failure to maintain continuous physical presence in the United States. 8 U.S.C. 1254a(c)(3), 8 CFR 244.14. When termination occurs on May 3, 2004, you will no longer have TPS.

The Secretary of DHS has decided to extend automatically the validity of EADs to provide for an orderly transition leading up to the effective date for the termination of the Sierra Leone TPS designation. Therefore, the validity of the applicable EADs is extended for a period of 6 months, to May 3, 2004. 8 U.S.C. 1254a(a)(2) and (d)(3).

To receive an automatic extension of his or her EAD, an individual must be a national of Sierra Leone (or an alien having no nationality who last habitually resided in Sierra Leone) who has applied for and received an EAD under the TPS designation or redesignation of Sierra Leone. This automatic extension is limited to EADs issued on either Form I-766, Employment Authorization Document, or Form I-688B, Employment Authorization Card, bearing an expiration date of November 2, 2003. The EAD must also be either (1) a Form I-766 bearing the notation “A-12” or “C-19” on the face of the card under “Category”; or (2) a Form I-688B bearing the notation “274A.12(A)(12)” or “274A.12(C)(19)” on the face of the card under “Provision of Law”.

No. Qualified individuals do not have to apply for this extension of their TPS-related EADs to May 3, 2004.

For completion of the Form I-9 at the time of hire or re-verification, qualified individuals who have received an extension of their EADs by virtue of this Federal Register notice may present to their employer a TPS-related EAD as proof of identity and employment authorization until May 3, 2004. To minimize confusion over this extension at the time of hire or re-verification, qualified individuals may also present to their employer a copy of this Federal Register notice regarding the automatic extension of employment authorization documentation to May 3, 2004. In the alternative, any legally acceptable document or combination of documents listed in List A, List B, or List C of the Form I-9 may be presented as proof of identity and employment eligibility; it is the choice of the employee.

For purposes of verifying identity and employment eligibility or re-verifying employment eligibility on the Form I-9 until May 3, 2004, employers of Sierra Leone TPS class members whose EADs have been automatically extended by this notice must accept such EAD if presented. An EAD that has been automatically extended by this notice will contain an expiration date of November 2, 2003, and must be either (1) a Form I-766 bearing the notation “A-12” or “C-19” on the face of the card under “Category”, or (2) a Form I-688B bearing the notation “274A.12(A)(12)” or “274A.12(C)(19)” on the face of the card under “Provision of Law”. New EADs or extension stickers showing the May 3, 2004 expiration date will not be issued.

Employers should not request proof of Sierra Leone citizenship. Employers presented with an EAD that this Federal Register notice has extended automatically, that appears to be genuine and appears to relate to the employee should accept the document as a valid “List A” document and should not ask for additional Form I-9 documentation. This action by the Secretary of the DHS through this Federal Register notice does not affect the right of an employee to present any legally acceptable document as proof of identity and eligibility for employment.

Employers are reminded that the laws prohibiting unfair immigration-related employment practices remain in full force. For questions, employers may call the BCIS Office of Business Liaison Employer Hotline at 1-800-357-2099 to speak to a BCIS representative. Also, employers may call the U.S. Department of Justice Office of Special Counsel for Immigration Related Unfair Employment Practices (OSC) Employer Hotline at 1-800-255-8155 or 1-800-362-2735 (TDD). Employees or applicants may call the OSC Employee Hotline at 1-800-255-7688 or 1-800-237-2515 (TDD) for information regarding the automatic extension. Additional information is available on the OSC Web site at http://www.usdoj.gov/crt/osc/index.html .

This notice terminates the designation of Sierra Leone for TPS. For nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) in the United States who believe that their particular circumstances make return to Sierra Leone unsafe, there may be avenues of immigration relief and protection available. Such avenues may include, but are not limited to, asylum, withholding of removal, or protection under Article 3 of the Torture Convention.

Eligibility for these and other immigration benefits is determined individually on a case-by-case basis. For information on eligibility and how to apply, visit the BCIS web site at http://www.bcis.gov or call the BCIS National Customer Service Center at 1-800-375-5283.

After the designation of Sierra Leone for TPS is terminated on May 3, 2004, former TPS beneficiaries will maintain the same immigration status they held prior to TPS (unless that status has since expired or been terminated) or any other status they may have acquired while registered for TPS. Accordingly, if an alien held no lawful immigration status prior to receiving TPS benefits and did not obtain any other status during the TPS period, he or she will maintain that unlawful status upon the termination of the TPS designation.

Former TPS beneficiaries will no longer be eligible for a stay of removal or an EAD pursuant to the TPS program. TPS-related EADs will expire on May 3, 2004, and will not be renewed.

Termination of the TPS designation for Sierra Leone does not necessarily affect pending applications for other forms of immigration relief or protection, though former TPS beneficiaries will begin to accrue unlawful presence as of May 3, 2004, if they have not been granted any other immigration status or protection or if they have no pending application for certain benefits.

By the authority vested in me as Secretary of the Department of Homeland Security under section 244(b)(3) of the Act, I have consulted with the appropriate agencies of government concerning conditions in Sierra Leone. 8 U.S.C. 1254a(b)(3). Based on these consultations, I have determined that Sierra Leone no longer meets the conditions for designation of TPS under section 244(b)(1) of the Act. 8 U.S.C. 1254a(b)(1).

Accordingly, I order as follows:

(1) Pursuant to sections 244(b) of the Act, the TPS designation of Sierra Leone for TPS terminated effective May 3, 2004, six months from the end of the current extension.

(2) I estimate that there are approximately 2,700 nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) who currently receive TPS benefits.

(3) To provide for an orderly transition, nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) who have been granted TPS under the Sierra Leone designation or redesignation will automatically retain temporary protected status until the termination date. However, an individual's TPS may still be withdrawn pursuant to section 244(c)(3) of the Immigration and Nationality Act and 8 CFR 244.14 because of ineligibility for TPS, prior failure to timely re-register if there was not good cause for such failure, or failure to maintain continuous physical presence in the United States.

(4) TPS-related Employment Authorization Documents that expire on November 2, 2003, are extended automatically until May 3, 2004, for qualified nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone).

(5) Information concerning the termination of the TPS program for nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) will be available at local BCIS offices upon publication of this notice and through the BCIS National Customer Service Center at 1-800-375-5283. This information will also be published on the BCIS Web site at http://www.bcis.gov .

On March 1, 2003, the functions of the Immigration and Naturalization Service (Service) transferred from the Department of Justice to the Department of Homeland Security (DHS) pursuant to the Homeland Security Act of 2002, Pub. L. 107-296. The responsibilities for administering the TPS program held by the Service were transferred to the Bureau of Citizenship and Immigration Services (BCIS).

Under section 244 of the Immigration and Nationality Act (Act), 8 U.S.C. 1254a, the Secretary of DHS, after consultation with appropriate agencies of the Government, is authorized to designate a foreign state or (part thereof) for TPS. The Secretary of DHS may then grant TPS to eligible nationals of that foreign state (or aliens having no nationality who last habitually resided in that state).

Section 244(b)(3)(A) of the Act requires the Secretary of DHS to review, at least 60 days before the end of the TPS designation or any extension thereof, the conditions in a foreign state designated under the TPS program to determine whether the conditions for a TPS designation continue to be met and, if so, the length of an extension of TPS. 8 U.S.C. 1254a(b)(3)(A). If the Secretary of DHS determines that the foreign state no longer meets the conditions for TPS designation, he shall terminate the designation, as provided in section 244(b)(3)(B) of the Act. 8 U.S.C. 1254a(b)(3)(B). Finally, if the Secretary of DHS does not determine that a foreign state (or part thereof) no longer meets the conditions for designation at least 60 days before the designation or extension is due to expire, section 244(b)(3)(C) of the Act provides for an automatic extension of TPS for an additional period of 6 months (or, in the discretion of the Secretary of DHS, a period of 12 or 18 months). 8 U.S.C. 1254a(b)(3)(C).

On November 4, 1997, the Attorney General published a notice in the Federal Register designating Sudan under the TPS program based upon ongoing armed conflict occurring within the country. 62 FR 59735. The Attorney General extended this TPS designation annually and re-designated Sudan by publishing a notice on November 9, 1999, determining in each instance that the conditions warranting such designation continued to be met. 64 FR 61123.

Since the date of the last extension, the Departments of Homeland Security and State have continued to review conditions in Sudan. It is determined that a 12-month extension is warranted due to ongoing armed conflict within Sudan that would pose a serious threat to the personal safety of returning nationals of Sudan (or aliens having no nationality who last habitually resided in Sudan). 8 U.S.C. 1254a(b)(1)(A).

The Department of State observes that civil war continues to endanger thousands of Sudanese civilians. DOS Recommendation (June 19, 2003). Despite the signing of an October 2002 agreement, fighting between government and rebel forces has continued in several regions, especially those rich in oil. Id. In July 2002, warring parties signed the Machakos Protocol, a general framework for peace. Id. Peace talks continue in Kenya. Id. It remains to be seen whether a working peace agreement will be achieved; past efforts have failed. Id.

The BCIS Resource Information Center (RIC) notes that, despite a period of relative peace and stability in southern Sudan, there is a general consensus among human rights monitors and other close observers of Sudan that there the human rights situation in Sudan has not improved significantly. RIC Report (July 16, 2003). The lessening of conflict following the October 2002 agreement appears to have resulted in fewer war-related human rights violations. Id. However, human rights abuses, including massacres and the targeting and displacement of civilians, have continued in the South and in other conflicted areas, including the Upper Nile and Darfur regions. Id. Detention and harassment of human rights advocates and political opponents remains in the North despite increased organization by civil society groups. Id.

The government's human rights record remains extremely poor and includes extrajudicial killings, disappearances, arbitrary arrest and detention, rape, slavery, forced labor, and forced conscription of male children. DOS Recommendation. Rebel groups are also responsible for serious abuses, including killings, beatings, rapes, arbitrary detention, and forced conscription of boys. Id.

Based upon this review, the Secretary of DHS, after consultation with appropriate government agencies, finds that the conditions that prompted designation of Sudan under the TPS program continue to be met. 8 U.S.C. 1254a(b)(3). There is an ongoing armed conflict within Sudan and, due to such conflict, requiring the return of aliens who are nationals of Sudan (or aliens having no nationality who last habitually resided in Sudan) would pose a serious threat to their personal safety. 8 U.S.C. 1254a(b)(1)(A). On the basis of these findings, the Secretary of DHS concludes that the TPS designation for Sudan should be extended for an additional 12-month period. 8 U.S.C. 1254a(b)(3)(C).

Yes. If you already have received TPS benefits through the Sudan TPS program, your benefits will expire on November 2, 2003. Accordingly, individual TPS beneficiaries must comply with the re-registration requirements described below in order to maintain their TPS benefits through November 2, 2004. TPS benefits include temporary protection against removal from the United States, as well as employment authorization, during the TPS designation period and any extension thereof. 8 U.S.C. 1254a(a)(1).

All persons previously granted TPS under the Sudan program who wish to maintain such status must apply for an extension by filing (1) a Form I-821, Application for Temporary Protected Status, without the filing fee; (2) a Form I-765, Application for Employment Authorization; and (3) two identification photographs (1 1/2 inches x 1 1/2 inches). See the chart below to determine whether you must submit the one hundred and twenty dollar ($120) filing fee with Form I-765. Applicants for an extension of TPS benefits do not need to be re-fingerprinted and thus need not pay the $50 fingerprint fee. Children beneficiaries of TPS who have reached the age of fourteen (14) but were not previously fingerprinted must pay the fifty dollar ($50) fingerprint fee with the application for extension.

An application submitted without the required fee and/or photos will be returned to the applicant. Submit the completed forms and applicable fee, if any, to the BCIS District Office having jurisdiction over your place of residence during the 60-day re-registration period that begins September 3, 2003 and ends November 3, 2003.

CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). The comments should address: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection:

Title: Customs Declaration.

OMB Number: 1651-0009.

Form Number: CBP Form 6059B.

Abstract: The Customs Declaration, CBP Form 6059B, requires basic information to facilitate the clearance of persons and goods arriving in the United States and helps CBP officers determine if any duties of taxes are due. The form is also used for the enforcement of CBP and other agencies laws and regulations. CBP is proposing to revise this form by expanding question number 11 (which asks about agricultural items entering the U.S.) to include “vegetables” and “seeds.”

Current Actions: This information collection includes some increases due to new information that will be collected. This submission is being submitted as a revision to a current collection.

Type of Review: Revision to an existing collection.

Affected Public: Traveling public.

Estimated Number of Respondents: 60,000,000.

Estimated Time Per Respondent: 4 minutes and 5 seconds.

Estimated Total Annual Burden Hours: 4,038,000.

Estimated Total Annualized Cost on the Public: N/A.

The Bureau of Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Your comments should address one of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency/component, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agencies/components' estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collections of information on those who are to respond, including 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.

Title: Declaration for Free Entry of Unaccompanied Articles.

OMB Number: 1651-0014.

Form Number: CBP Form 3299.

Abstract: The Declaration for Free Entry of Unaccompanied Articles, Form 3299, is prepared by the individual or the broker acting as agent for the individual, or in some cases, the CBP officer. It serves as a declaration for duty-free entry of merchandise under one of the applicable provisions of the tariff schedule.

Current Actions: This submission is being submitted to extend the expiration date with no change to the burden hours.

Type of Review: Extension (without change).

Affected Public: Businesses, Individuals, Institutions.

Estimated Number of Respondents: 150,000.

Estimated Time Per Respondent: 10 minutes.

Estimated Total Annual Burden Hours: 25,000.

Estimated Total Annualized Cost on the Public: $660,000.

If additional information is required contact: Tracey Denning, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229, at 202-927-1429.

The Bureau of Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Your comments should address one of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the Proper performance of the functions of the agency/component, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collections of information on those who are to respond, including 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.

Title: Application to Establish Centralized Examination Station.

OMB Number: 1651-0061.

Form Number: N/A.

Abstract: If a port director decides their port needs one or more Centralized Examination Stations (CES), they solicit applications to operate a CES. The information contained in the application will be used to determine the suitability of the applicant's facility, fairness of fee structure, knowledge of cargo handling operations and of CBP procedures.

Current Actions: This submission is to extend the expiration date without a change to the burden hours.

Type of Review: Extension (without change).

Affected Public: Businesses, Individuals, Institutions.

Estimated Number of Respondents: 50.

Estimated Time Per Respondent: 2 hours (120 minutes).

Estimated Total Annual Burden Hours: 100.

Estimated Total Annualized Cost on the Public: $1,450.

If additional information is required contact: Tracey Denning, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.2.C, Washington, DC 20229, at 202-927-1429.

The Bureau of Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L.104-13). Your comments should address one of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the Proper performance of the functions of the agency/component, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collections of information on those who are to respond, including 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.

Title: Application for Allowance in Duties.

OMB Number: 1651-0007.

Form Number: Form CBP-4315.

Abstract: This collection is required by the CBP in instances of claims of damaged or defective merchandise on which an allowance in duty is made in the liquidation of the entry. The information is used to substantiate importer's claims for such duty allowances.

Current Actions: This submission is to extend the expiration date without a change to the burden hours.

Type of Review: Extension (without change).

Affected Public: Businesses, Individuals, Institutions.

Estimated Number of Respondents: 12,000.

Estimated Time Per Respondent: 8 minutes.

Estimated Total Annual Burden Hours: 1,600.

Estimated Total Annualized Cost on the Public: $29,000.

If additional information is required contact: Tracey Denning, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.2.C, Washington, DC 20229, at 202-927-1429.

The Bureau of Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Your comments should address one of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the Proper performance of the functions of the agency/component, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collections of information on those who are to respond, including 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.

Title: Delivery Ticket (Form 6043).

OMB Number: 1651-0081.

Form Number: Form-6043.

Abstract: This information is used by CBP to ensure compliance with regulations pertaining to the movement of merchandise into general order facilities. importer, exporter, shipper, or cruise line.

Current Actions: This submission is being submitted to extend the expiration date with a change to the burden hours.

Type of Review: Extension (with change).

Estimated Number of Respondents: 200,000

Estimated Time Per Respondent: 20 minutes.

Estimated Total Annual Burden Hours: 66,000.

Estimated Total Annualized Cost on the Public: $825,000.

If additional information is required contact: Tracey Denning, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.2.C, Washington, DC 20229, at 202-927-1429.

The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

This Notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This Notice also lists the following information:

Title of Proposal: Rural Housing and Economic Development.

OMB Control Number, if applicable: 2506-0169.

Description of the need for the information and proposed use: The information collection is essential so that HUD staff may determine the eligibility, qualifications and capacity of applicants to carry out activities under the Rural Housing and Economic Development program. HUD will review the information provided by the applicants against the selection criteria contained in the NOFA in order to rate and rank the applications and select the best and most qualified applicant for funding. The selection criteria are: (1) Capacity of the Applicant and Relevant Organizational Experience; (2) Need/Extent of the Problem; (3) Soundness of Approach; (4) Leveraging of Resources; and (5) Achieving Results and Program Evaluation.

Agency form numbers, if applicable: SF 424 (including a maximum 15 page application narrative in response to the factors for award).

Members of affected public: Eligible applicants include local rural non-profit organizations, Community Development Corporations, State Housing Finance Agencies, state and community development agencies and Federally Recognized Indian Tribes.

Estimation of the total number of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The total number of applicants for Fiscal Years 2000, 2001, and 2002 is 1,252, with 314 awardees. The proposed frequency of the response to the collection of the information is one time; the application needs to be submitted only one time.

Status of the proposed information collection: Reinstatement of a previously approved collection for which approval has expired.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

This Notice also lists the following information:

Title of Proposal: Certified Eligibility for Adjustments for Damage or Neglect.

OMB Approval Number: 2502-0349.

Form Numbers: None.

Description of the Need for the Information and Its Proposed Use: One-time certification by mortgagees to show that they have acquired hazard insurance acceptable to HUD at a reasonable rate and that the mortgagee may convey fire damaged properties without a surcharge to the claim.

Respondents: Business or other for-profit.

Frequency of Submission: On occasion.

Reporting Burden: Number of Respondents 250: Average annual responses per respondent 1; Total annual responses 250; Average burden per response 30 minutes.

Total Estimated Burden Hours: 125.

Status: Extension of a currently approved collection.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

This Notice also lists the following information:

Title of Proposal: Single Family Application for Insurance Benefits.

OMB Approval Number: 2502-0429.

Form Numbers: HUD-27011, Parts A, B, C, D & E.

Description of the Need for the Information and Its Proposed Use: This information collection is used to provide HUD the information needed to process and pay claims on defaulted FHA-insured home mortgage loans.

Respondents: Business or other for-profit.

Frequency of Submission: On occasion.

Reporting Burden: Number of Respondents 450: Average annual responses per respondent 1-5,000; Total annual responses 200,000; Average burden per response 45 minutes.

Total Estimated Burden Hours: 150,000.

Status: Extension of a currently approved collection.

The Salishan Public Housing Development (Salishan) was originally constructed in 1942 as war-time housing. Located in what is known as the East Side neighborhood, Salishan is bordered on the west by Portland Avenue and on the east by Swan Creek. There are currently 786 housing units on the site, of which 778 are occupied, and other related community/social service buildings.

In 2000, THA submitted a successful HOPE VI grant application for the redevelopment of Salishan. The amount of the HOPE VI grant awarded in connection with the Salishan revitalization project was $35 million. Under the proposed Revitalization Plan, existing housing will be demolished and Salishan will be redeveloped into a mixed-use, mixed-income community of approximately 1,270 to 1,500 units. The project will require the relocation of all existing residents. The new unit mix will incorporate low-income, affordable, and market rate housing with single- and multi-family dwellings, and senior and special needs housing. The redevelopment project will also include a mixture of commercial uses and improvements to community facilities such as expanding the existing health clinic, day care, family investment center, and gymnasium. Alternatives to be considered in the EIS include a no action alternative, a 1,270-unit alternative, and a 1,500-unit development.

Questions may be directed to the individual named above under the heading For Further Information Contact .

By Federal law, all lands within the National Wildlife Refuge System are to be managed in accordance with an approved comprehensive conservation plan. The plan guides management decisions and identifies refuge goals, long-range objectives, and strategies for achieving refuge purposes. The planning process will consider many elements including wildlife and habitat management, public recreational activities, and cultural resource protection. Public input in the planning process is essential as the Service establishes management priorities and explores opportunities for non-invasive and low-impact activities such as ecotourism. Restoration of degraded habitats through reforestation, reestablishment of hydrology, and removal of exotic species will be a priority.

Vieques National Wildlife Refuge, comprising just over 18,000 acres, is the largest national wildlife refuge in Puerto Rico. The refuge includes beaches used by threatened and endangered sea turtles for nesting, subtropical dry forests, mangrove lagoons, salt flats, and bioluminescent bays.

On February 13, 2003, the Commission instituted this investigation based on a complaint filed by Deere, alleging a violation of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and sale within the United States after importation of certain agricultural vehicles and components thereof by reason of infringement and dilution of U.S. registered Trademark Nos. 1,254,339, 1,502,103, 1,503,576, and 91,860. The complaint further alleged that an industry in the United States exists as required by subsections (a)(1)(A) and (a)(2) of section 337.

In the complaint, Deere stated that it owned an unregistered “leaping deer” mark, in addition to its registered trademarks. It stated also that it had applied for federal registration of the mark, and that it “intend[ed] to amend this Complaint to include the leaping deer registration as soon as the registration is issued.” (Complaint at ¶¶ 46-47). In the motion, Deere represented that its application for registration of the mark was granted on June 24, 2003, and it attached certified copies of the registration (U.S. Trademark Registration No. 2,729,766).

By Commission rule 210.14(b), the complaint and notice of investigation may be amended after the institution of the investigation “only * * * for good cause shown and upon such conditions as are necessary to avoid prejudicing the public interest and the rights of the parties to the investigation.” The ALJ found good cause for the amendment because the trademark registration in question did not issue until June 24, 2003. The ALJ also found that the amendment would not result in any prejudice to any of the parties in the investigation. The ALJ noted that Deere disclosed in the original complaint that it intended to assert infringement of the “leaping deer” mark when the registration issued. The ALJ found that the proposed amendments will not change the scope of the investigation in terms of either the products or issues involved. Finally, he noted that “Deere has not asserted infringement of the ‘leaping deer’ mark by any products other than the agricultural vehicles already at issue.”

No party petitioned for review of the ID.

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and Commission rule 210.42, 19 CFR 210.42.

Notice is hereby given of the pendency before the Department of a proposed amendment to PTE 84-14 (49 FR 9494, March 13, 1984, as corrected at 50 FR 41430, October 10, 1985). PTE 84-14 provides an exemption from certain of the restrictions of section 406 of ERISA, and from certain taxes imposed by section 4975(a) and (b) of the Code, by reason of section 4975(c)(1) of the Code. The Department is proposing this amendment to PTE 84-14 on its own motion, pursuant to section 408(a) of ERISA and section 4975(c)(2) of the Code, and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, 32847, August 10, 1990). 1

Under Executive Order 12866, the Department must determine whether the regulatory action is “significant” and therefore subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Under section 3(f), the order defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as “economically significant”); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

This proposed amendment has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. The Department has determined that this proposed amendment is not a “significant regulatory action” under Executive Order 12866, section 3(f). Accordingly, it does not require an assessment of potential costs and benefits under section 6(a)(3) of that order.

This Notice of Proposed Rulemaking is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) because it does not contain a “collection of information” as defined in 44 U.S.C. 3502(3).

PTE 84-14, which was proposed on the Department's own motion on December 21, 1982, was granted as part of a continuing effort by the Department to improve the administration of the prohibited transaction rules of ERISA. The rules set forth in section 406 of ERISA prohibit various transactions between a plan and a party in interest (including a fiduciary) with respect to such plan. Unless a statutory or administrative exemption applies to the transaction, section 406(a) of ERISA prohibits, among other things: sales, leases, loans or the provision of services between a party in interest and a plan, as well as a use of plan assets by or for the benefit of, or a transfer of plan assets to, a party in interest. In addition, unless exempted, a fiduciary of a plan is not permitted to engage in any acts of self-dealing or make decisions on behalf of a plan if the fiduciary is in a conflict of interest situation.

The Department has frequently exercised its statutory authority under section 408(a) of ERISA to grant both individual and class exemptions from the prohibited transaction provisions where it has been able to find that the criteria for granting such exemptions have been satisfied. Based on its experience considering requests for individual and class exemptions, and in dealing with instances of abusive violations of the fiduciary responsibility rules of ERISA, the Department determined that as a general matter, transactions entered into on behalf of plans with parties in interest are most likely to conform to ERISA's general fiduciary standards where the decision to enter into the transaction is made by an independent fiduciary. As granted, PTE 84-14 provides broad relief for various party in interest transactions that involve plan assets that are transferred to a qualified professional asset manager (QPAM) for discretionary management.

PTE 84-14 consists of four separate parts. The General Exemption, set forth in Part I, permits an investment fund managed by a QPAM to engage in a wide variety of transactions described in ERISA section 406(a)(1)(A) through (D) with virtually all parties in interest except the QPAM which manages the assets involved in the transaction and those parties most likely to have the power to influence the QPAM. In this regard, under section I(a), the exemption would not be available if a QPAM caused the investment fund to enter into a transaction with a party in interest dealing with the fund, if the party in interest or its “affiliate,” (1) was authorized to appoint or terminate the QPAM as a manager of any of the plan's assets, (2) was authorized to negotiate the terms of the management agreement with the QPAM (including renewals or modifications thereof) on behalf of the plan, or (3) had exercised such powers in the immediately preceding one year. Additionally, under section I(d), the QPAM may not cause the investment fund which it manages to engage in a transaction with itself or a “related” party. Section V(h) provides generally that a party in interest and a QPAM are “related” if either entity (or parties controlling or controlled by either entity) owns a five percent or more interest in the other entity. Section I(e) makes explicit the Department's view that a plan (and its sponsor) which provides a significant portion of the QPAM's business as a manager of plan funds would, in many cases, be in a position to improperly influence investment decisions of the QPAM. Accordingly, the exemption would not be available for transactions with parties in interest of a plan if the amount of the plan's assets that are managed by a QPAM, together with the assets managed by the same QPAM that are attributable to other plans maintained by the same employer (or its affiliate), represent more than 20 percent of all client assets under the management of the QPAM at the time of the transaction.

Part II of the exemption provides limited relief under both section 406(a) and (b) of ERISA for certain transactions involving those employers and certain of their affiliates which could not qualify for the General Exemption provided by Part I. Section II(a) of the exemption provides conditional relief for employers and their affiliates to furnish limited amounts of goods and services to an investment fund managed by a QPAM. Section II(b) of the exemption permits such employers and their affiliates to lease office or commercial space from an investment fund managed by a QPAM.

Part III of the exemption provides limited relief under section 406(a) and (b) of ERISA for the leasing of office or commercial space by an investment fund to the QPAM, an affiliate of the QPAM, or a person who could not qualify for the General Exemption provided by Part I because it held the power of appointment described in section I(a).

Part IV of the exemption provides limited relief under section 406(a) and 406(b)(1) and (2) of ERISA for the furnishing of services and facilities by a place of public accommodation owned by an investment fund managed by a QPAM, to all parties in interest, if the services and facilities are furnished on a comparable basis to the general public.

Although the Department is proposing this amendment on its own motion, its proposal is based, in part, on information received from a number of interested persons concerning the difficulties encountered in complying with several conditions contained in PTE 84-14. The Department has been informed that, due to the consolidation in the financial services industry and the large size of the resulting institutions, many financial institutions have found it more difficult to ensure that section I(a) (power of appointment) and section I(d) (parties “related” to the QPAM), are satisfied.

As understood by the Department, the difficulties encountered by large financial institutions under the current exemption may be illustrated by the following examples:

To address these concerns, the interested persons made a number of suggestions to modify several of the conditions of PTE 84-14 without sacrificing the protections embodied in the class exemption. First, with respect to section I(a) (power of appointment), several persons suggested that the Department delete the “one year look-back rule” under which the exemption would be unavailable to a party in interest if it had exercised the power of appointment within the one-year period preceding the transaction. Second, the interested persons suggested that the Department clarify that section I(a)'s power of appointment refers only to the power to appoint the QPAM as manager of the assets involved in the transaction, as opposed to any of the plan's assets.

The Department has determined to adopt these suggested modifications. The Department recognizes that the burdens of compliance in the current financial marketplace outweigh the benefits of the one year look-back rule. The Department believes that deletion of the rule would not significantly diminish the safeguards contained in the exemption. In addition, the Department believes that the focus of the “power of appointment” rule should be on the assets involved in the transaction, as opposed to all of the plan's assets. This proposed modification is consistent with the approach taken by the Department in more recent class exemptions. 2

As amended, section I(a) would provide that at the time of the transaction, the party in interest or its affiliate does not have the authority to: (i) Appoint or terminate the QPAM as a manager of the plan assets involved in the transaction, or (ii) negotiate on behalf of the plan the terms of the management agreement with the QPAM (including renewals or modifications thereof) with respect to the plan assets involved in the transaction.

In addition, one of the interested persons suggested a modification to section I(a) in connection with commingled investment funds. In the preamble to PTE 84-14, the Department explained that a party in interest who has the authority to redeem or acquire units of such a fund is considered, for purposes of the exemption, to have the authority to appoint or terminate the QPAM as a manager of plan assets. To further reduce administrative burdens, it was suggested that section I(a) be amended to make the class exemption available to a party in interest with respect to a plan investing in a commingled investment fund, notwithstanding that the party in interest has the authority to redeem or acquire units of such a fund on behalf of the plan, if the plan's interest in the fund represents less than 25 percent of the investment fund's total assets. According to the interested person, a party in interest to a plan with a relatively small interest in a commingled investment fund is less likely to be in a position to exercise undue influence over the QPAM's investment decisions. On the basis of this suggestion, the Department has proposed an amendment to section I(a) of the class exemption. However, contrary to the opinion of the interested person, the Department views 10 percent, and not 25 percent, as the meaningful measure for determining whether a QPAM may be susceptible to undue influence.

Therefore, the Department proposes to further amend the class exemption by adding the following paragraph at the end of section I(a):

Finally, the Department proposes to amend section V(c), the definition of affiliate as it applies to section I(a) and Part II. The definition currently provides that “an affiliate of a person means—

Interested persons requested that the Department narrow those persons and entities listed as affiliates under section V(c) of the exemption. According to the interested persons, the definition is difficult to monitor, particularly the portion of the definition that includes 5 percent or more partners and employees. Accordingly, after considering the suggestion, the Department has determined to delete those partnerships in which the person has less than a 10 percent interest. In addition, the Department proposes to amend section V(c)(2) to only include highly compensated employees as defined in section 4975(e)(2)(H) of the Code.

Over the years, a number of interested persons have sought clarification regarding the application of section I(b) of PTE 84-14. Section I(b) excludes from exemptive relief those transactions described in PTEs 81-6 (relating to securities lending arrangements), 83-1 (relating to acquisitions by plans of interests in mortgage pools) and 82-87 (relating to certain mortgage financing arrangements). According to the interested persons, there is uncertainty regarding the application of PTE 84-14 to certain types of transactions that, although similar to the transactions that are the subject of the three specialized exemptions, are beyond the scope of relief provided by those exemptions. Thus, for example, PTE 81-6 would not provide relief for the lending of securities that are assets of a plan to a foreign broker-dealer. 3 It is the view of the Department that PTE 84-14 would provide relief for such transactions if the conditions of that exemption were otherwise met. The Department cautions, however, that PTE 84-14 would not be available for any transaction specifically described in PTEs 81-6, 83-1 or 82-87, if a person determines not to satisfy one or more of the conditions of the specialized exemptions solely in order to take advantage of the relief provided by PTE 84-14.

With respect to section I(d) and the definition of “related” under section V(h), interested persons suggested that the threshold for determining whether a party in interest is related to the QPAM should be increased from a 5 percent ownership interest to a 20 percent ownership interest, and that the definition of “interest” under section V(h)(1) should be narrowed to exclude ownership interests held for the benefit of clients. Additionally, one interested person suggested that section I(d) be revised to make it easier to monitor for compliance. In this regard, the interested person suggested that the exemption permit a determination as to whether a party in interest is related to the QPAM to be made as of the last day of the preceding calendar quarter.

After considering the suggestions, the Department recognizes that compliance with section I(d) may create administrative burdens for a number of financial institutions. However, the Department does not believe that raising the percentage limitation to 20 percent would be appropriate in all cases. For example, while it may be more difficult to monitor the ownership interests of entities that “control” or are “controlled by” the QPAM and the party in interest, the Department believes that the QPAM and the party in interest should be able to determine any ownership interests in each other without excessive administrative burden. Accordingly, the Department is proposing to amend section V(h) to provide that a QPAM is “related” to a party in interest for purposes of section I(d) if:

• The QPAM or the party in interest owns a ten percent or more interest in the other entity;

• A person controlling or controlled by the QPAM or the party in interest owns a twenty percent or more interest in the other entity; or

• A person controlling, or controlled, by the QPAM or the party in interest owns less than a twenty percent interest in the other entity, but nevertheless exercises control over the management or policies of the other party by reason of its ownership interest.

In addition, the Department proposes to modify section V(h) to provide that generally determinations of whether the QPAM is “related” to a party in interest for purposes of section I(d) may be made as of the last day of the most recent calendar quarter. Finally, the Department is proposing to amend section V(h)(1) to provide that shares held in a fiduciary capacity need not be considered in applying the percentage limitation. The Department believes that these modifications should further lessen the compliance burdens under the class exemption.

Accordingly, the Department is proposing to amend the definition of “related” to in section V(h) as follows:

An interested person also requested that the Department clarify the language in section V(a)(4) which defines a QPAM to include “[a]n investment adviser registered under the Investment Advisers Act of 1940 that has, as of the last day of its most recent fiscal year, total client assets under its management and control in excess of $50,000,000, and either (A) shareholders' or partners' equity (as defined in section V(m)) in excess of $750,000* * *” The interested person noted that section V(m) provides that:

The Department also notes that the $50 million of client assets under management standard utilized in section V(a)(4) for investment advisers has not been revised since 1984 and may no longer provide significant protections for plans in the current financial marketplace. The Department has determined to adjust the $50 million figure to $85 million, to reflect the change in the Consumer Price Index. Additionally, the Department proposes to increase the shareholders' and partners' equity requirement from $750,000 to $1,000,000, to correspond to the preceding subsections of section V(a).

As amended, section V(a)(4) would read as follows:

In response to inquiries regarding the definition of QPAM contained in section V(a), the Department proposes to modify the exemption to specifically provide that a QPAM must be independent of an employer with respect to a plan whose assets are managed by the QPAM. As the Department noted in the preamble to PTE 84-14 (49 FR 9497):

The Department also has received inquiries about section V(i) of PTE 84-14, which defines “the time as of which any transaction occurs.” The Department understands there is uncertainty regarding the role of a QPAM in a continuing transaction. Section V(i) states the following with respect to a continuing transaction:

In the Department's view, the exemption would be available for a continuing transaction ( e.g., a loan or lease), provided that all the conditions of the exemption are satisfied on the date on which the transaction is entered into (or on the date of a renewal that requires the consent of the QPAM), notwithstanding the subsequent failure to satisfy one or more of the conditions of the exemption. The only exception to the availability of the exemption for a continuing transaction is the requirement that section I(e) must be satisfied throughout the duration of the transaction. Nonetheless, the Department cautions that, although Part I may continue to be available for the entire term of a continuing transaction which subsequently fails to satisfy one or more of the conditions of that Part, no relief would be provided for an act of self-dealing described in section 406(b)(1) of ERISA if the QPAM has an interest in the person which may affect the exercise of its best judgment as a fiduciary. Although Part I provides an exemption from section 406(a)(1)(A) through (D) of ERISA, it does not provide relief from acts described in section 406(b) of ERISA. The Department urges fiduciaries to take appropriate steps to avoid engaging in 406(b) violations should circumstances change during the course of a continuing transaction.

An interested person also was concerned about the availability of Part I in the context of a continuing transaction where the QPAM becomes unable to continue to serve as a QPAM, or is terminated, prior to the appointment of a replacement QPAM. In the Department's view, the exemption would continue to be available provided no decisions were required to be made by the QPAM on behalf of the investment fund with respect to the transaction ( e.g. , how to respond to a default in payments on a lease) during the interim period before the appointment of the replacement QPAM.

The attention of interested persons is directed to the following:

(1) The fact that a transaction is the subject of an exemption under section 408(a) of ERISA and section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person with respect to a plan from certain other provisions of ERISA and the Code, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of ERISA which require, among other things, that a fiduciary discharge his or her duties respecting plan solely in the interests of the participants and beneficiaries of the plan. Additionally, the fact that a transaction is the subject of an exemption does not affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;

(2) Before an exemption may be granted under section 408(a) of ERISA and 4975(c)(2) of the Code, the Department must find that the exemption is administratively feasible, in the interests of the plan and of its participants and beneficiaries, and protective of the rights of participants and beneficiaries of the plan;

(3) If granted, the proposed amendment is applicable to a particular transaction only if the transaction satisfies the conditions specified in the exemption; and

(4) The proposed amendment, if granted, will be supplemental to, and not in derogation of, any other provisions of ERISA and the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction.

The Department invites all interested persons to submit written comments on the proposed amendment to the address and within the time period set forth above. All comments received will be made a part of the record. Comments should state the reasons for the writer's interest in the proposed exemption. Comments received will be available for public inspection at the above address.

Under section 408(a) of the Act and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, 32847, August 10, 1990), the Department proposes to amend PTE 84-14 as set forth below:

Effective as of the date of publication of the final class exemption in the Federal Register , the restrictions of ERISA section 406(a)(1)(A) through (D) and the taxes imposed by Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) through (D), shall not apply to a transaction between a party in interest with respect to an employee benefit plan and an investment fund (as defined in section V(b)) in which the plan has an interest, and which is managed by a qualified professional asset manager (QPAM) (as defined in section V(a)), if the following conditions are satisfied:

(a) At the time of the transaction (as defined in section V(i)) the party in interest, or its affiliate (as defined in section V(c)), does not have the authority to—

(1) Appoint or terminate the QPAM as a manager of the plan assets involved in the transaction, or

(2) Negotiate on behalf of the plan the terms of the management agreement with the QPAM (including renewals or modifications thereof) with respect to the plan assets involved in the transaction;

Notwithstanding the foregoing, in the case of an investment fund in which two or more unrelated plans have an interest, a transaction with a party in interest with respect to an employee benefit plan will be deemed to satisfy the requirements of section I(a) if the assets of the plan managed by the QPAM in the investment fund, when combined with the assets of other plans established or maintained by the same employer (or affiliate thereof described in section V(c)(1) of the exemption) or by the same employee organization, and managed in the same investment fund, represent less than 10 percent of the assets of the investment fund;

(b) The transaction is not described in—

(1) Prohibited Transaction Exemption 81-6 (46 FR 7527; January 23, 1981) (relating to securities lending arrangements),

(2) Prohibited Transaction Exemption 83-1 (48 FR 895; January 7, 1983) (relating to acquisitions by plans of interests in mortgage pools), or

(3) Prohibited Transaction Exemption 82-87 (47 FR 21331; May 18, 1982) (relating to certain mortgage financing arrangements);

(c) The terms of the transaction are negotiated on behalf of the investment fund by, or under the authority and general direction of, the QPAM, and either the QPAM, or (so long as the QPAM retains full fiduciary responsibility with respect to the transaction) a property manager acting in accordance with written guidelines established and administered by the QPAM, makes the decision on behalf of the investment fund to enter into the transaction, provided that the transaction is not part of an agreement, arrangement or understanding designed to benefit a party in interest;

(d) The party in interest dealing with the investment fund is neither the QPAM nor a person related to the QPAM (within the meaning of section V(h));

(e) The transaction is not entered into with a party in interest with respect to any plan whose assets managed by the QPAM, when combined with the assets of other plans established or maintained by the same employer (or affiliate thereof described in section V(c)(1) of this exemption) or by the same employee organization, and managed by the QPAM, represent more than 20 percent of the total client assets managed by the QPAM at the time of the transaction;

(f) At the time the transaction is entered into, and at the time of any subsequent renewal or modification thereof that requires the consent of the QPAM, the terms of the transaction are at least as favorable to the investment fund as the terms generally available in arm's length transactions between unrelated parties;

(g) Neither the QPAM nor any affiliate thereof (as defined in section V(d)), nor any owner, direct or indirect, of a 5 percent or more interest in the QPAM is a person who within the 10 years immediately preceding the transaction has been either convicted or released from imprisonment, whichever is later, as a result of: Any felony involving abuse or misuse of such person's employee benefit plan position or employment, or position or employment with a labor organization; any felony arising out of the conduct of the business of a broker, dealer, investment adviser, bank, insurance company or fiduciary; income tax evasion; any felony involving the larceny, theft, robbery, extortion, forgery, counterfeiting, fraudulent concealment, embezzlement, fraudulent conversion, or misappropriation of funds or securities; conspiracy or attempt to commit any such crimes or a crime in which any of the foregoing crimes is an element; or any other crime described in section 411 of ERISA. For purposes of this section (g), a person shall be deemed to have been “convicted” from the date of the judgment of the trial court, regardless of whether that judgment remains under appeal.

Effective December 21, 1982, the restrictions of sections 406(a), 406(b)(1) and 407(a) of ERISA and the taxes imposed by section 4975(a) and (b) of the Code, by reason of Code section 4975(c)(1)(A) through (E), shall not apply to:

(a) The sale, leasing, or servicing of goods (as defined in section V(j)), or to the furnishing of services, to an investment fund managed by a QPAM by a party in interest with respect to a plan having an interest in the fund, if—

(1) The party in interest is an employer any of whose employees are covered by the plan or is a person who is a party in interest by virtue of a relationship to such an employer described in section V(c),

(2) The transaction is necessary for the administration or management of the investment fund,

(3) The transaction takes place in the ordinary course of a business engaged in by the party in interest with the general public,

(4) Effective for taxable years of the party in interest furnishing goods and services after the date this exemption is granted, the amount attributable in any taxable year of the party in interest to transactions engaged in with an investment fund pursuant to section II(a) of this exemption does not exceed one (1) percent of the gross receipts derived from all sources for the prior taxable year of the party in interest, and

(5) The requirements of sections I(c) through (g) are satisfied with respect to the transaction;

(b) The leasing of office or commercial space by an investment fund maintained by a QPAM to a party in interest with respect to a plan having an interest in the investment fund, if—

(1) The party in interest is an employer any of whose employees are covered by the plan or is a person who is a party in interest by virtue of a relationship to such an employer described in section V(c),

(2) No commission or other fee is paid by the investment fund to the QPAM or to the employer, or to an affiliate of the QPAM or employer (as defined in section V(c)), in connection with the transaction,

(3) Any unit of space leased to the party in interest by the investment fund is suitable (or adaptable without excessive cost) for use by different tenants,

(4) The amount of space covered by the lease does not exceed fifteen (15) percent of the rentable space of the office building, integrated office park, or of the commercial center (if the lease does not pertain to office space),

(5) In the case of a plan that is not an eligible individual account plan (as defined in section 407(d)(3) of ERISA), immediately after the transaction is entered into, the aggregate fair market value of employer real property and employer securities held by investment funds of the QPAM in which the plan has an interest does not exceed 10 percent of the fair market value of the assets of the plan held in those investment funds. In determining the aggregate fair market value of employer real property and employer securities as described herein, a plan shall be considered to own the same proportionate undivided interest in each asset of the investment fund or funds as its proportionate interest in the total assets of the investment fund(s). For purposes of this requirement, the term “employer real property” means real property leased to, and the term “employer securities” means securities issued by, an employer any of whose employees are covered by the plan or a party in interest of the plan by reason of a relationship to the employer described in subparagraphs (E) or (G) of ERISA section 3(14), and

(6) The requirements of sections I(c) through (g) are satisfied with respect to the transaction.

Effective December 21, 1982, the restrictions of section 406(a)(1)(A) through (D) and 406(b)(1) and (2) of ERISA and the taxes imposed by Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) through (E), shall not apply to the leasing of office or commercial space by an investment fund managed by a QPAM to the QPAM, a person who is a party in interest of a plan by virtue of a relationship to such QPAM described in subparagraphs (G), (H), or (I) of ERISA section 3(14) or a person not eligible for the General Exemption of Part I by reason of section I(a), if—

(a) The amount of space covered by the lease does not exceed the greater of 7500 square feet or one (1) percent of the rentable space of the office building, integrated office park or of the commercial center in which the investment fund has the investment,

(b) The unit of space subject to the lease is suitable (or adaptable without excessive cost) for use by different tenants,

(c) At the time the transaction is entered into, and at the time of any subsequent renewal or modification thereof that requires the consent of the QPAM, the terms of the transaction are not more favorable to the lessee than the terms generally available in arm's length transactions between unrelated parties, and

(d) No commission or other fee is paid by the investment fund to the QPAM, any person possessing the disqualifying powers described in section I(a), or any affiliate of such persons (as defined in section V(c)), in connection with the transaction.

Effective December 21, 1982, the restrictions of section 406(a)(1)(A) through (D) and 406(b)(1) and (2) of ERISA and the taxes imposed by Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) through (E), shall not apply to the furnishing of services and facilities (and goods incidental thereto) by a place of public accommodation owned by an investment fund managed by a QPAM to a party in interest with respect to a plan having an interest in the investment fund, if the services and facilities (and incidental goods) are furnished on a comparable basis to the general public.

For purposes of this exemption:

(a) The term “qualified professional asset manager” or “QPAM” means an independent fiduciary (as defined in section V(n)) which is—

(1) A bank, as defined in section 202(a)(2) of the Investment Advisers Act of 1940 that has the power to manage, acquire or dispose of assets of a plan, which bank has, as of the last day of its most recent fiscal year, equity capital (as defined in section V(k)) in excess of $1,000,000 or

(2) A savings and loan association, the accounts of which are insured by the Federal Savings and Loan Insurance Corporation, that has made application for and been granted trust powers to manage, acquire or dispose of assets of a plan by a State or Federal authority having supervision over savings and loan associations, which savings and loan association has, as of the last day of its most recent fiscal year, equity capital (as defined in section V(k)) or net worth (as defined in section V(l)) in excess of $1,000,000 or

(3) An insurance company which is qualified under the laws of more than one State to manage, acquire, or dispose of any assets of a plan, which company has, as of the last day of its most recent fiscal year, net worth (as defined in section V(l)) in excess of $1,000,000 and which is subject to supervision and examination by a State authority having supervision over insurance companies, or

(4) An investment adviser registered under the Investment Advisers Act of 1940 that has total client assets under its management and control in excess of $85,000,000 as of the last day of its most recent fiscal year, and either (A) shareholders' or partners' equity (as defined in section V(m)) in excess of $1,000,000, or (B) payment of all of its liabilities including any liabilities that may arise by reason of a breach or violation of a duty described in sections 404 and 406 of ERISA is unconditionally guaranteed by—(i) A person with a relationship to such investment adviser described in section V(c)(1) if the investment adviser and such affiliate have, as of the last day of their most recent fiscal year, shareholders' or partners' equity, in the aggregate, in excess of $1,000,000, or (ii) A person described in (a)(1), (a)(2) or (a)(3) of section V above, or (iii) A broker-dealer registered under the Securities Exchange Act of 1934 that has, as of the last day of its most recent fiscal year, net worth in excess of $1,000,000; Provided that such bank, savings and loan association, insurance company or investment adviser has acknowledged in a written management agreement that it is a fiduciary with respect to each plan that has retained the QPAM.

(b) An “investment fund” includes single customer and pooled separate accounts maintained by an insurance company, individual trusts and common, collective or group trusts maintained by a bank, and any other account or fund to the extent that the disposition of its assets (whether or not in the custody of the QPAM) is subject to the discretionary authority of the QPAM.

(c) For purposes of section I(a) and Part II, an “affiliate” of a person means—

(1) Any person directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with the person,

(2) Any corporation, partnership, trust or unincorporated enterprise of which such person is an officer, director, 10 percent or more partner (except with respect to part II this figure shall be 5 percent), or highly compensated employee as defined in section 4975(e)(2)(H) of the Code (but only if the employer of such employee is the plan sponsor), and

(3) Any director of the person or any employee of the person who is a highly compensated employee, as defined in section 4975(e)(2)(H) of the Code, or who has direct or indirect authority, responsibility or control regarding the custody, management or disposition of plan assets. A named fiduciary (within the meaning of section 402(a)(2) of ERISA) of a plan and an employer any of whose employees are covered by the plan will also be considered affiliates with respect to each other for purposes of section I(a) if such employer or an affiliate of such employer has the authority, alone or shared with others, to appoint or terminate the named fiduciary or otherwise negotiate the terms of the named fiduciary's employment agreement.

(d) For purposes of section I(g) an “affiliate” of a person means—

(1) Any person directly or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person,

(2) Any director of, relative of, or partner in, any such person,

(3) Any corporation, partnership, trust or unincorporated enterprise of which such person is an officer, director, or a 5 percent or more partner or owner, and

(4) Any employee or officer of the person who—

(A) Is a highly compensated employee (as defined in section 4975(e)(2)(H) of the Code) or officer (earning 10 percent or more of the yearly wages of such person), or

(B) Has direct or indirect authority, responsibility or control regarding the custody, management or disposition of plan assets.

(e) The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.

(f) The term “party in interest” means a person described in ERISA section 3(14) and includes a “disqualified person,” as defined in Code section 4975(e)(2).

(g) The term “relative” means a relative as that term is defined in ERISA section 3(15), or a brother, a sister, or a spouse of a brother or sister.

(h) A QPAM is “related” to a party in interest for purposes of section I(d) of this exemption if, as of the last day of its most recent calendar quarter: (i) The QPAM owns a ten percent or more interest in the party in interest; (ii) a person controlling, or controlled by, the QPAM owns a twenty percent or more interest in the party in interest; (iii) the party in interest owns a ten percent or more interest in the QPAM; or (iv) a person controlling, or controlled by, the party in interest owns a twenty percent or more interest in the QPAM. Notwithstanding the foregoing, a party in interest is “related” to a QPAM if: (i) a person controlling, or controlled by, the party in interest owns less than a twenty percent interest in the QPAM and such person exercises control over the management or policies of the QPAM by reason of its ownership interest; (ii) a person controlling, or controlled by, the QPAM owns less than a twenty percent interest in the party in interest and such person exercises control over the management or policies of the party in interest by reason of its ownership interest. For purposes of this definition:

(1) The term “interest” means with respect to ownership of an entity—

(A) The combined voting power of all classes of stock entitled to vote or the total value of the shares of all classes of stock of the entity if the entity is a corporation,

(B) The capital interest or the profits interest of the entity if the entity is a partnership, or

(C) The beneficial interest of the entity if the entity is a trust or unincorporated enterprise; and

(2) A person is considered to own an interest if, other than in a fiduciary capacity, the person has or shares the authority—

(A) To exercise any voting rights or to direct some other person to exercise the voting rights relating to such interest, or

(B) To dispose or to direct the disposition of such interest.

(i) The time as of which any transaction occurs is the date upon which the transaction is entered into. In addition, in the case of a transaction that is continuing, the transaction shall be deemed to occur until it is terminated. If any transaction is entered into on or after December 21, 1982, or a renewal that requires the consent of the QPAM occurs on or after December 21, 1982 and the requirements of this exemption are satisfied at the time the transaction is entered into or renewed, respectively, the requirements will continue to be satisfied thereafter with respect to the transaction. Notwithstanding the foregoing, this exemption shall cease to apply to a transaction exempt by virtue of Part I or Part II at such time as the percentage requirement contained in section I(e) is exceeded, unless no portion of such excess results from an increase in the assets transferred for discretionary management to a QPAM. For this purpose, assets transferred do not include the reinvestment of earnings attributable to those plan assets already under the discretionary management of the QPAM. Nothing in this paragraph shall be construed as exempting a transaction entered into by an investment fund which becomes a transaction described in section 406 of ERISA or section 4975 of the Code while the transaction is continuing, unless the conditions of this exemption were met either at the time the transaction was entered into or at the time the transaction would have become prohibited but for this exemption.

(j) The term “goods” includes all things which are movable or which are fixtures used by an investment fund but does not include securities, commodities, commodities futures, money, documents, instruments, accounts, chattel paper, contract rights and any other property, tangible or intangible, which, under the relevant facts and circumstances, is held primarily for investment.

(k) For purposes of section V(a)(1) and (2), the term “equity capital” means stock (common and preferred), surplus, undivided profits, contingency reserves and other capital reserves.

(l) For purposes of section V(a)(3), the term “net worth” means capital, paid-in and contributed surplus, unassigned surplus, contingency reserves, group contingency reserves, and special reserves.

(m) For purposes of section V(a)(4), the term “shareholders” or partners' equity” means the equity shown in the most recent balance sheet prepared within the two years immediately preceding a transaction undertaken pursuant to this exemption, in accordance with generally accepted accounting principles.

(n) For purposes of section V(a), the term “independent fiduciary” means a fiduciary managing the assets of a plan in an investment fund that is independent of and unrelated to the employer sponsoring such plan. For purposes of this exemption, the independent fiduciary will not be deemed to be independent of and unrelated to the employer sponsoring the plan if such fiduciary directly or indirectly controls, is controlled by, or is under common control with the employer sponsoring the plan.

The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Public Law 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas as requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.

Description of Permit Modification Requested: The Foundation issued a permit (2001-011) to Dr. Wayne Z. Trivelpiece on September 28, 2000. The issued permit allows the applicant to capture and release up to 1,000 Adelie, Gentoo, Chinstrap penguins, and other various seabirds for banding, weighing, blood sampling, stomach pumping and attaching radio Txs, PTTs, and TDRs. The collection of samples and data will be used to study the behavioral ecology and population biology of the penguins and the interaction among these species and their principal seabird predators.

The applicant requests a modification to his permit to allow: capture and release of 10 individuals each of Brown and South Polar Skuas; collect tissue samples from dead individuals of all species of birds; collect up to 12 uropygial gland oil from 3 species of penguin; and, collect up to 12 eggs each from 3 species of penguins (1 egg per nest) for egg yolk lipid analysis.

Location: ASPA 128—Western Shore of Admiralty Bay, King George Island.

Dates: October 1, 2003 to April 1, 2005.

NSF's Antarctic Waste Regulation, 45 CFR part 671, requires all U.S. citizens and entities to obtain a permit for the use or release of a designated pollutant in Antarctica, and for the release of waste in Antarctica. NSF has received a permit application under this Regulation for the operation of an expedition to Antarctica. Ice Axe Productions, Inc., with a team of 5 experienced climbers and photographers will travel by air from Novolarevskaya Station to the Patriot Hills, then ski to Holtanna in the Orvin Fjella Mountain Range, then proceed to the Wohlthat Mountains. The team's camping facilities will be basic and mobile. The team will use white gas for cooking. All wastes will be collected and transported back to Novolrevskaya for disposition.

Application for the permit is made by: Doug Stoup, President, Ice Axe Productions, Inc., 3650, NW., 5th Avenue, Boca Raton, FL 33431.

Location: Patriot Hills, the Orvin Fjella Mountain Range, and the Wohlthat Mountains, Antarctica.

Dates: October 1, 2003, to March 31, 2008.

On June 27, 2003, the National Science Foundation published a notice in the Federal Register of a permit application received. A permit was issued on August 26, 2003, to Erick Chiang, Permit No. 2004-006.

By a vote of 3-0 on August 27, the Commission determined pursuant to U.S.C. 552b(e) and § 9.107(a) of the Commission's rules that “Discussion of Security Issues (Closed—Ex. 1)” be held August 27, and on less than one week's notice to the public.

By a vote of 3-0 on August 27, the Commission determined pursuant to U.S.C. 552b(e) and § 9.107(a) of the Commission's rules that “Affirmation of (1) Final Rule: 10 CFR Parts 30, 40, and 70: Financial Assurance for Materials Licensees; (2) Final Rulemaking—Risk-Informed 10 CFR 50.44, “Combustible Gas Control in Containment”; (3) Final Rule on Electronic Maintenance and Submission of Information; and (4) Tennessee Valley Authority (Watts Bar Nuclear Plant, Units 1 & 2, Browns Ferry Nuclear Plant, Units 1, 2 & 3), Docket Nos. 50-390-CIVP; 50-0327-CIVP; 50-328-CIVP; 50-259-CIVP; 50-260-CIVP; 50-296-CIVP; LBP-03-10 (June 26, 2003)'' be held on August 28, and on less than one week's notice to the public.

Section 38(g)(4) of the AECA, 22 U.S.C. 2778, prohibits licenses and other approvals for the export of defense articles or defense services to be issued to a person, or any party to the export, who has been convicted of violating certain U.S. criminal statutes, including the AECA.

In implementing this section of the AECA, the Assistant Secretary of State for Political-Military Affairs is authorized by section 127.7 of the ITAR to prohibit any person who has been convicted of violating or conspiring to violate the AECA from participating directly or indirectly in the export of defense articles, including technical data or in the furnishing of defense services for which a license or approval is required. This prohibition is referred to as “statutory debarment.”

Statutory debarment is based solely upon conviction in a criminal proceeding, conducted by a court of the United States, and as such the administrative debarment proceedings outlined in part 128 of the ITAR are not applicable.

The period for debarment will be determined by the Assistant Secretary of State for Political-Military Affairs based upon the underlying nature of the violations, but will normally be three years from the date of conviction. Please note however, that unless licensing privileges are reinstated, the person/entity will remain debarred. At the end of the debarment period, licensing privileges may be reinstated only at the request of the debarred person following the necessary interagency consultations, after a thorough review of the circumstances surrounding the conviction, and a finding that appropriate steps have been taken to mitigate any law enforcement concerns, as required by section 38(g)(4) of the AECA and in accordance with section 127.11(b) of the ITAR.

Department of State policy permits debarred persons to apply to the Director of the Office of Defense Trade Controls Compliance for an exception from the period of debarment, in accordance with section 38(g)(4) of the AECA and section 127.11(b) of the ITAR. Any decision to grant an exception can be made only after the statutory requirements under section 38(g)(4) of the AECA have been satisfied. If the exception is granted, the debarment will be suspended.

Debarred persons are generally ineligible to participate in activity regulated under the ITAR ( see e.g. , sections 120.1(c) and (d), 126.7, 127.1(c), and 127.11(a)). The Department of State will not consider applications for licenses or requests for approvals that involve any person or any party to the export who has been convicted of violating or conspiring to violate the AECA during the period of statutory debarment. Persons who have been statutorily debarred may appeal to the Under Secretary for Arms Control and International Security for reconsideration of the ineligibility determination. A request for reconsideration must be submitted in writing within 30 days after a person has been informed of the adverse decision, in accordance with 22 CFR 127.7(d).

Pursuant to section 38 of the AECA and section 127.7 of the ITAR, the following persons have been statutorily debarred by the Assistant Secretary of State for Political-Military Affairs for a period of three years following their AECA conviction:

(1) Saeed Homayouni, June 11, 2001 (entry date of June 14, 2001), U.S. District Court, Southern District of California (San Diego), Docket # 00-CR-3843-ALL.

(2) Quality Aviation & Power Support, Inc., August 21, 2001 (entry date of August 27, 2001), U.S. District Court for the Central District of California (Western Division), Docket # 2:00-CR-787.

(3) Earlene L. Christensen aka Earlene Larson Christenson aka Earlene Larson, August 21, 2002 (entry date August 27, 2002), Central District of California, (Western Division), Docket # 2:00-CR-787.

(4) Richard Kelly Smyth, December 28, 2001 (entry date of January 8, 2002), U.S. District Court, Central District of California (Western Division), Docket # 85-CR-483-ALL.

(5) Diaa Mohsen, November 16, 2001 (entry date November 20, 2001), U.S. District Court, Southern District of Florida (West Palm Beach), Docket # 01-CR-8087-ALL.

(6) Jonathan Reynolds, September 28, 2000 (entry date October 2, 2000), U.S. District Court, District of Massachusetts (Boston), Docket # 00-CR-10267-ALL.

(7) Fadi Boutros, aka Fadi E. Sitto, aka Fadi Jirjis, aka Fred Boutros, February 11, 1999 (entry date February 17, 1999), U.S. District Court, District of Connecticut (New Haven), Docket # 3:99-CR-19.

(8) Paul Siroky, October 5, 2000 (entry date October 6, 2000), U.S. District Court, Central District of California (Western Division), Docket # 2:00-CR-884.

(9) Steven Picatti, October 19, 1998 (entry date November 18, 1998), U.S. District Court, Central District of California (Western Division), Docket # 2:98-CR-860.

(10) Peter Appelbaum, August 18, 1999 (entry date August 24, 1999), U.S. District Court, Southern District of Florida (Miami), Docket # 99-CR-530-ALL.

(11) Bing Sun, August 1, 2000 (entry date August 2, 2000), U.S. District Court, Eastern District of Virginia (Norfolk), Docket # 2:00-CR-28.

(12) Patte Sun, August 1, 2000 (entry date August 2, 2000), U.S. District Court, Eastern District of Virginia (Norfolk), Docket # 2:00-CR-28.

(13) All Ports Inc., August 1, 2000 (entry date August 2, 2000), U.S. District Court, Eastern District of Virginia (Norfolk), Docket # 2:00-CR-28.

(14) Beta Trading Company, August 28, 1998 (entry date September 1, 1998), U.S. District Court, District of South Carolina (Charleston), Docket # 98-CR-332-ALL.

(15) Genaro Lopez-Gonsales, October 5, 1999 (entry date October 19, 1999), U.S. District Court, Southern District of Texas (McAllen), Docket #99-CR-434-ALL.

(16) Octabio Merida Gonzalez, July 1, 1998 (entry date July 8, 1998), U.S. District Court, Southern District of Texas (Brownsville), Docket # 98-CR-255-ALL.

(17) Collin Xu, aka Collin Shu, aka Zhihong Xu, November 9, 2000 (entry date November 15, 2000), U.S. District Court, District of Massachusetts (Boston), Docket #99-CR-10075-ALL.

(18) Yi Yao, aka Yao Yi, February 2, 2000 (entry date February 8, 2000), U.S. District Court of Massachusetts (Boston), Docket # 99-CR-10075-ALL.

(19) Mariano Recinos-Rivera, June 5, 2000 (entry date June 20, 2000), U.S. District Court, Southern District of Texas (McAllen), Docket #00-CR-218-ALL.

(20) Gunther Kohlke, February 27, 2002 (entry date March 1, 2002), U.S. District Court, District of New York (Brooklyn), Docket #01-CR-738-ALL.

(21) Eugene Yon-Tsai Hsu, April 30, 2002 (entry date May 5, 2002), U.S. District Court, District of Maryland (Baltimore), Docket #01-CR-485-ALL.

(22) David Tzuwei Yang, April 30, 2002 (entry date May 5, 2002), U.S. District Court, District of Maryland (Baltimore), Docket #01-CR-485-ALL.

(23) Dennis Ritiche Jones, March 23, 1999 (entry date March 26, 1999), U.S. District Court, District of Arizona, Docket # CR-99-346-01.

(24) Carlos Fernando Chirinos, September 13, 2002 (entry date September 17, 2002), U.S. District Court, District of Arizona, Docket # 02-20605-CR.

(25) Daniel Jose Uribazo, August 29, 2002 (entry date August 30, 2002), U.S. District Court, District of Arizona, Docket # 02-20605-CR.

(26) Maximo de los Santos, November 18, 1999 (entry date November 19, 1999), U.S. District Court, District of Hawaii, Docket # 1:99CR00426-001.

(27) Jesse Radona Ponce, November 18, 1999 (entry date November 19, 1999), U.S. District Court, District of Hawaii, Docket # 1:99CR00426-001.

(28) Jesus Pascual Domingo, April 6, 2000 (entry date April 6, 2000), U.S. District Court, District of Hawaii, Docket # 1:99CR00426-001.

(29) Paul Guzman, November 22, 1999 (entry date November 24, 1999), U.S. District Court, District of Hawaii, Docket # 1:99CR00426-001.

As noted above, at the end of the three-year period, the above-named persons/entities will remain debarred unless licensing privileges are reinstated.

This notice is provided in order to make the public aware that the persons listed above are prohibited from participating directly or indirectly in any brokering activities and in any export from or temporary import into the United States of defense articles or defense services, including technical data, in all situations covered by the ITAR. Specific case information may be obtained from the Office of the Clerk of Court for each respective US District Court, citing the court docket number where provided.

Exceptions may be made to this denial policy on a case-by-case basis at the discretion of the Directorate of Defense Trade Controls pursuant to 22 CFR 126.3. However, such an exception would be granted only after a full review of all circumstances, paying particular attention to the following factors: whether an exception is warranted by overriding U.S. foreign policy or national security interest; whether an exception would further law enforcement concerns which are consistent with the foreign policy or national security interests of the United States; or whether other compelling circumstances exist which are consistent with the foreign policy or national security interests of the United States, and which do not conflict with law enforcement concerns.

This notice involves a foreign affairs function of the United States encompassed within the meaning of the military and foreign affairs exclusion of the Administrative Procedure Act. Because the exercise of this foreign affair function is discretionary, it is excluded from review under the Administrative Procedure Act.

The GSP provides for the duty-free importation of designated articles from designated beneficiary developing countries. The GSP is authorized by title V of the Trade Act of 1974 (“the 1974 Act”), as amended (19 U.S.C. 2461, et seq. ), and is implemented in accordance with Executive Order 11888 of November 24, 1975, as modified by subsequent Executive Orders and Presidential Proclamations.

In a Federal Register notice dated April 13, 2001, USTR initiated the 2001 GSP Annual Review and announced a deadline of June 13, 2001, for the filing of petitions (66 FR 19278). In a Federal Register notice dated November 1, 2002, USTR initiated the 2002 GSP Annual Review and announced a deadline of December 2, 2002, for the filing of petitions (67 FR 66699). Several of the petitions received requested the review of certain practices in certain beneficiary developing countries to determine whether such countries are in compliance with the eligibility criteria set forth in sections 502(b) and 502(c) of the 1974 Act.

The GSP program expired on October 1, 2001, and was not reauthorized until August 6, 2002. Consequently, the interagency TPSC made no announcement of the acceptance of country practice petitions for the 2001 GSP Annual Review, and merged the 2001 petitions into the 2002 GSP Annual Review.

The TPSC has decided to accept certain petitions for review, as indicated in Annex I to this notice. Annex I sets out the case number and status of, and subject country and practice addressed in each petition, and updates the status of other, previously initiated, ongoing country practice reviews. If the TPSC decides to accept any other 2001 or 2002 country practice petition for review, it will make an announcement in the Federal Register at a later date.

Acceptance of a petition for review does not indicate any opinion with respect to disposition on the merits. Acceptance indicates only that the TPSC has found the petition eligible for review, and that such review will take place. The GSP regulations provide the schedule of dates for conducting a review unless otherwise specified in a Federal Register notice. The revised schedule for public comment and hearings is contained in Annex II.

USTR will announce in the Federal Register any modifications to the list of beneficiary developing countries or eligible articles for purposes of the GSP program resulting from this Review, as well as the date on which the modifications will take effect.

The GSP Subcommittee invites comments on any petition included in this Review. Submissions should comply with the GSP regulations (15 CFR Part 2007), including section 2007.0, except as modified below. All submissions should be identified by the relevant case number and country name as shown in Annex I.

In order to facilitate prompt processing of submissions, USTR strongly urges and prefers electronic e-mail submissions in response to this notice. Hand-delivered submissions will not be accepted. Submissions should be single copy transmissions in English, and the total submission should not exceed 50 single-spaced pages. E-mail submissions should use the subject line “GSP Country Practices Review,” followed by the case number and country name found in Annex I and, as appropriate, “Written Comments,” “Notice of Intent to Testify,” “Pre-hearing brief,” or “Post-hearing brief.” (For example, an e-mail subject line might read, “GSP Country Practices Review, 001-CP-02, Bangladesh, “Pre-hearing brief.”) Documents must be submitted as either WordPerfect (.WPD), MSWord (.DOC) , or text (.TXT) files. Documents should not be submitted as electronic image files or contain imbedded images (for example, “.JPG”, “PDF”, “.BMP”, or “.GIF”), as these type files are generally excessively large and may impede electronic transmission and redistribution. E-mail submissions containing such files may not be accepted. Supporting documentation submitted as spreadsheets are acceptable as Quattro Pro or Excel suitable for printing on 8 1/2 x 11 inch paper. To the extent possible, any data attachments to the submission should be included in the same file as the submission itself, and not as separate files.

If the submission contains business confidential information, a non-confidential version of the submission must also be submitted that indicates where confidential information was redacted by inserting asterisks where material was deleted. In addition, the confidential submission must be clearly marked “BUSINESS CONFIDENTIAL” at the top and bottom of every page, and the non-confidential submission must be clearly marked either “PUBLIC VERSION” or “NON-CONFIDENTIAL” at the top and bottom of every page.

The file name of any document containing business confidential information attached to an e-mail transmission should begin with the characters “BC-”, and the file name of the public version should begin with the characters “P-”. The “P-” or “BC-” should be followed by the name of the party (government, company, union, association, etc.) making the submission. E-mail submissions should not include separate cover letters or messages in the message area of the e-mail; information that might appear in any cover letter should be included directly in the attached file containing the submission itself. The e-mail address for submissions is FR0052@USTR.GOV. Documents not submitted in accordance with these instructions might not be considered in this review.

Submissions will be open to public inspection shortly after the due date by appointment with the staff of the USTR public reading room, 1724 F Street, NW., Washington, DC, except for submitted information granted “business confidential” status pursuant to 15 CFR 2003.6 and other qualifying information submitted in confidence pursuant to 15 CFR 2007.7. Appointments may be made from 9:30 a.m. to noon and 1 p.m. to 4 p.m., Monday through Friday, by calling (202) 395-6186.

The GSP Subcommittee will hold a hearing on October 7, 2003, beginning at 10 a.m. at the Office of the U.S. Trade Representative, 1724 F Street, NW., Washington, DC. The hearing will be open to the public and a transcript will be made available for public inspection or can be purchased from the reporting company. No electronic media coverage will be allowed.

Any interested party wishing to make an oral presentation at the hearing must submit the name, address, telephone number, facsimile number, and e-mail address (if available) of the witness(es) representing the party to the Chairman of the GSP Subcommittee by 5 p.m., September 26, 2003. Requests to present oral testimony in connection with the public hearing must be accompanied by a written brief or statement, in English, which must also be received by 5 p.m., September 26, 2003. Oral presentations should be approximately five-minutes long and summarize or supplement information contained in the brief or statement. Post-hearing briefs or statements must be submitted, in English, by 5 p.m., October 31, 2003. Any party not wishing to appear at the public hearing may submit a post-hearing written brief or statement, in English, by 5 p.m., October 31, 2003. Written briefs, statements, and oral testimony should conform with section 2007.5 of the GSP regulations.

Docket: For access to the docket to read background documents or comments received, go to http://dms.dot.gov at any time, or to Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review the Department of Transportation's (DOT) complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477), or you may visit http://dms.dot.gov.

The agency established the current standard for diabetes in 1970 because several risk studies indicated that diabetic drivers had a higher rate of accident involvement than the general population. The diabetes requirement provides that: A person is physically qualified to drive a commercial motor vehicle if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control (49 CFR 391.41(b)(3)).

Since 1970, the agency has considered the diabetes requirement and undertaken studies to determine if its diabetes standard for commercial drivers in interstate commerce should be amended. It is FMCSA's view that its physical qualification standards should be based on sound medical, scientific and technological grounds, and that individual determinations should be made to the maximum extent possible consistent with FMCSA's responsibility to ensure safety on the nation's highways. The FMCSA published a notice of intent to issue exemptions to insulin-using diabetic drivers in the Federal Register on July 31, 2001 (66 FR 39548). This notice of intent discussed the regulatory history and research activity addressing the issue of diabetes and CMV operation.

Section 4018 of the Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107) directed the Secretary of Transportation (the Secretary) to determine if it is feasible to develop a safe and practicable program for allowing individuals with insulin-treated diabetes mellitus (ITDM) to operate CMVs in interstate commerce. In making the determination, the Secretary was directed to evaluate research and other relevant information on the effects of ITDM on driving performance. TEA-21 stated that, to accomplish this, the Secretary shall consult the states with regard to their programs for CMV operation by ITDM drivers, evaluate the DOT policies in other modes of transportation, analyze pertinent risk data, consult with interested groups knowledgeable about diabetes and related issues, and assess the possible legal consequences of permitting ITDM individuals to operate CMVs in interstate commerce. TEA-21 also directed the Secretary to report the findings to Congress and, if a program is feasible, describe the elements of a protocol to permit individuals with ITDM to operate CMVs. The FMCSA submitted the report to Congress on August 23, 2000. It is entitled “A Report to Congress on the Feasibility of a Program to Qualify Individuals with Insulin Treated Diabetes Mellitus to Operate Commercial Motor Vehicles in Interstate Commerce as Directed by the Transportation Equity Act for the 21st Century,” July 2000 (TEA-21 Report to Congress). It concludes that a safe and practicable protocol to allow some ITDM individuals to operate CMVs is feasible. For a detailed discussion of the report findings and conclusions, see July 31, 2001 (66 FR 39548). A copy of the report is on FMCSA's Web site at www.fmcsa.dot.gov/rulesregs/medreports.htm.

Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption for a period up to two years if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” The statute also allows the agency to renew exemptions at the end of the two-year period, or after the current exemption expires.

FMCSA must publish a notice in the Federal Register for each exemption requested, explaining that the request has been filed, and providing the public an opportunity to inspect the safety analysis and any other relevant information known to the agency, and comment on the request. Prior to granting a request for an exemption, the agency must publish a notice in the Federal Register identifying the person or class of persons who will receive the exemption, the provisions from which the person will be exempt, the effective period, and all terms and conditions of the exemption. The terms and conditions established by FMCSA must ensure that the exemption will likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with the regulation.

In addition, the agency is required to monitor the implementation of each exemption to ensure compliance with its terms and conditions. If FMCSA denies a request for an exemption, the agency must periodically publish a notice in the Federal Register identifying the person(s) whom the agency denied the exemption to and the reasons for the denial.

Generally, the duration of exemptions is limited to two years from the date of approval, but may be renewed. FMCSA is required to immediately revoke an exemption if:

(1) The person fails to comply with the terms and conditions of the exemption;

(2) The exemption has resulted in a lower level of safety than was maintained before the exemption was granted; or

(3) Continuation of the exemption would not be consistent with the goals and objectives of the regulations issued under the authority of 49 U.S.C. 31315 and 31136(e).

The procedures for applying for an exemption may be found at 49 CFR 381.300 through 381.330. The person applying for an exemption is required to send a written request to the FMCSA Administrator. The written request must include basic information such as the identity of the person who would be covered by the exemption, the name of the motor carrier or other entity that would be responsible for the use or operation of CMVs during the exemption period, and the principal place of business of the motor carrier or other entity. Under section 381.310, the application must include a written statement that:

(1) Describes the event or CMV operation for which the exemption would be used;

(2) Identifies the regulation from which the applicant is requesting relief;

(3) Estimates the total number of drivers and CMVs that would be operating under the terms and conditions of the exemption; and

(4) Explains how the recipient of the exemption would ensure that they achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation.

Section 381.315 requires FMCSA to review an application for an exemption and prepare, for the Administrator's signature, a Federal Register notice requesting public comment. After a review of the comments received, FMCSA staff will make a recommendation to the Administrator. FMCSA will publish a notice of the Administrator's final decision in the Federal Register . FMCSA will issue a final decision within 180 days of the date it receives an individual's completed application. However, if the applicant should omit important details or other information necessary for the agency to conduct a comprehensive evaluation, FMCSA will issue a final decision within 180 days of the date that it receives sufficient information (49 CFR 381.315 and 381.320). FMCSA recognizes that this potential six-month waiting period may seem burdensome. However, the agency must carefully evaluate each and every application for regulatory relief from the diabetes standard, to assess the potential safety performance of each applicant. In addition, the agency must prepare and submit the candidate's application for public notice and comment in the Federal Register and then evaluate comments received before making a final decision. FMCSA's overriding concern is to ensure the safety of interstate CMV operations. The agency will notify all applicants in writing once it makes a final decision.

In considering exemptions, the FMCSA must ensure that the issuance of diabetes exemptions will not be contrary to the public interest and that the exemption achieves an acceptable level of safety. The FMCSA will only grant exemptions, therefore, to ITDM individuals who meet certain conditions. These conditions are set forth below and the FMCSA based the conditions on the research literature, relevant DOT and State exemption programs, and substantial medical input from a panel of endocrinologists. FMCSA will require applicants for an exemption from the ITDM prohibition to submit their applications in a letter (there will be no application form), include all supporting documentation, and use the following format:

In addition, the applications must include supporting documentation showing that the applicant:

(1) Possesses a valid intrastate CDL or a license (non-CDL) to operate a CMV;

(2) Has operated a CMV, with a diabetic condition controlled by the use of insulin, for the three-year period immediately preceding application;

(3) Has a driving record for that three-year period that:

Contains no suspensions or revocations of the applicant's driver's license for the operation of any motor vehicle (including their personal vehicle),

Contains no involvement in an accident for which the applicant received a citation for a moving traffic violation while operating a CMV,

Contains no involvement in an accident for which the applicant contributed to the cause of the accident, and

Contains no convictions for a disqualifying offense or more than one serious traffic violation, as defined in 49 CFR 383.5, while operating a CMV;

(4) Has no other disqualifying conditions including diabetes-related complications;

(5) Has had no recurrent (two or more) hypoglycemic reactions resulting in a loss of consciousness or seizure within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia;

(6) Has had no recurrent hypoglycemic reactions requiring the assistance of another person within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia;

(7) Has had no recurrent hypoglycemic reactions resulting in impaired cognitive function that occurred without warning symptoms within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia,

(8) Has been examined by a board-certified or board-eligible endocrinologist (who is knowledgeable about diabetes) who has conducted a complete medical examination. The complete medical examination must consist of a comprehensive evaluation of the applicant's medical history and current status with a report including the following information:

(A) The date insulin use began,

(B) Diabetes diagnosis and disease history,

(C) Hospitalization records,

(D) Consultation notes for diagnostic examinations,

(E) Special studies pertaining to the diabetes,

(F) Follow-up reports,

(G) Reports of any hypoglycemic insulin reactions within the last five years,

(H) Two measures of glycosylated hemoglobin, the first 90 days before the last and current measure,

(I) Insulin dosages and types, diet utilized for control and any significant factors such as smoking, alcohol use, and other medications or drugs taken, and

(J) Examinations to detect any peripheral neuropathy or circulatory insufficiency of the extremities;

(9) Submits a signed statement from an examining endocrinologist indicating the following medical determinations:

The endocrinologist is familiar with the applicant's medical history for the past five years, either through actual treatment over that time or through consultation with a physician who has treated the applicant during that time,

The applicant has been using insulin to control his/her diabetes from the date of the application back to the date the three years of driving experience began,

The applicant has been educated in diabetes and its management, thoroughly informed of and understands the procedures which must be followed to monitor and manage his/her diabetes and what procedures should be followed if complications arise, and

The applicant has the ability and has demonstrated willingness to properly monitor and manage his/her diabetes; and

(10) Submits a separate signed statement from an ophthalmologist or optometrist that the applicant has been examined and that the applicant does not have diabetic retinopathy and meets the vision standard at 49 CFR 391.41(b)(10), or has been issued a valid medical exemption. If the applicant has any evidence of diabetic retinopathy, he or she must be examined by an ophthalmologist and submit a separate signed statement from the ophthalmologist that he or she does not have unstable proliferative diabetic retinopathy ( i.e., unstable advancing disease of blood vessels in the retina).

There are special conditions attached to the issuance of any exemption for ITDM. The FMCSA will impose the following requirements:

(1) Individuals with ITDM shall maintain appropriate medical supplies for glucose management while preparing for the operation of a CMV and during its operation. The supplies shall include the following:

(A) An acceptable glucose monitor with memory,

(B) Supplies needed to obtain adequate blood samples and to measure blood glucose,

(C) Insulin to be used as necessary, and

(D) An amount of rapidly absorbable glucose to be used as necessary;

(2) Individuals with ITDM shall maintain a daily record of actual driving time to correlate with the daily glucose measurements; and

(3) Prior to and while driving, the individual with ITDM shall adhere to the following protocol for monitoring and maintaining appropriate blood glucose levels:

Check glucose before starting to drive and take corrective action if necessary. If glucose is less than 100 milligrams per deciliter (mg/dl), take glucose or food and recheck in 30 minutes. Do not drive if glucose is less than 100 mg/dl. Repeat the process until glucose is greater than 100 mg/dl;

While driving check glucose every two to four hours and take appropriate action to maintain it in the range of 100 to 400 mg/dl;

Have food available at all times when driving. If glucose is less than 100 mg/dl, stop driving and eat. Recheck in 30 minutes and repeat procedure until glucose is greater than 100 mg/dl; and

If glucose is greater than 400 mg/dl, stop driving until glucose returns to the 100 to 400 mg/dl range. If more than two hours after last insulin injection and eating, take additional insulin. Recheck blood glucose in 30 minutes. Do not resume driving until glucose is less than 400 mg/dl.

In addition to the requirements for controlling ITDM, FMCSA will monitor exemption recipients during the period that the exemption is valid. FMCSA will conduct monitoring by requiring the exemption recipients to submit the following information to the Diabetes Exemption Program, MC-PSP, Office of Bus and Truck Standards and Operations, Federal Motor Carrier Safety Administration, 400 Seventh Street, SW., Washington, DC 20590-0001:

(1) Provide written confirmation from the endocrinologist on a quarterly basis:

(A) The make and model of the glucose monitoring device with memory;

(B) The individual's blood glucose measurements and glycosylated hemoglobin are generally in an adequate range based on:

a. All daily glucose measurements taken with the glucose monitoring device and correlated with the daily records of driving time; and

b. A current measurement of glycosylated hemoglobin.

(2) Submit on an annual basis, a comprehensive medical evaluation by an endocrinologist. The evaluation will include a general physical examination and a report of glycosylated hemoglobin concentration. The evaluation will also involve an assessment of the individual's willingness and ability to monitor and manage the diabetic condition;

(3) Provide on an annual basis confirmation by an ophthalmologist or optometrist that there is no diabetic retinopathy and the individual meets the current vision standards at 49 CFR 391.41(b)(10). If there is any evidence of diabetic retinopathy, provide annual documentation by an ophthalmologist that the individual does not have unstable proliferative diabetic retinopathy;

(4) Submit annual documentation by an endocrinologist of ongoing education in management of diabetes and hypoglycemia awareness;

(5) Report all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes; and

(6) Report any involvement in an accident or any other adverse event whether or not they are related to an episode of hypoglycemia.

Because diabetes is a chronic disease requiring constant control and monitoring, FMCSA will impose conditions on ITDM individuals, who have been issued an exemption, similar to the provisions that apply to drivers who participated in the agency's diabetes waiver program before March 31, 1996 under 49 CFR 391.64. The required conditions include the following:

(1) Each individual must have a physical examination every year:

(a) The physical examination must first be conducted by an endocrinologist indicating the driver is:

1. Free of insulin reactions. “Free of insulin reactions” in this context means that the individual has had:

(A) No recurrent (two or more) hypoglycemic reactions resulting in a loss of consciousness or seizure within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia,

(B) No recurrent hypoglycemic reactions requiring the assistance of another person within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia, and

(C) No recurrent hypoglycemic reactions resulting in impaired cognitive function that occurred without warning symptoms within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia,

2. Able to and has demonstrated willingness to properly monitor and manage his/her diabetes, and

3. Will not likely suffer any diminution in driving ability due to his/her diabetic condition; and

(b) Secondly, the physical examination must be conducted by a medical examiner who attests that the individual is physically qualified under 49 CFR 391.41, or holds a valid exemption.

(2) Each individual must agree to and must comply with the following conditions:

(a) Carry a source of rapidly absorbable glucose at all times while driving;

(b) Self-monitor blood glucose levels prior to driving and every two to four hours while driving using a portable glucose monitoring device equipped with a computerized memory;

(c) Submit blood glucose records to both the endocrinologist and medical examiner at the annual examinations or when otherwise directed by an authorized agent of FMCSA; and

(d) Provide a copy of the endocrinologist's report to the medical examiner at the time of the annual medical examination; and

(3) Each individual must provide a copy of the optometrist's or ophthalmologist's report indicating that there is no diabetic retinopathy and the individual meets the current vision standards at 49 CFR 391.41(b)(10). If there is any evidence of diabetic retinopathy, the individual must provide to the medical examiner at the time of the annual medical examination a copy of the ophthalmologist's report indicating that the individual does not have unstable proliferative diabetic retinopathy; and

(4) Each individual must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or must keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the certification when driving for presentation to a duly authorized Federal, State, or local enforcement official.

Under 49 U.S.C. 31315 and 31136 (e), the FMCSA may grant an exemption for up to a two-year period if it finds that the action would likely achieve a level of safety that is equivalent to, or greater than, the level of safety that would be achieved absent such exemption. This requirement sets the criteria for safety in developing new programs. In this context, relative to diabetes, Section 4018 of TEA-21 directed the Secretary to determine if it is feasible to develop a safe and practicable program for allowing individuals with ITDM to operate CMVs in interstate commerce. In making that determination, the primary focus was on whether such a program could achieve a level of safety that is equal to or greater than the level that exists without the program. To do this, multiple sources of information were sought.

The sources of information sought to reach a determination ranged from background research and risk assessment to consultation with experts and an examination of how other similar programs were conducted. Specifically, this involved: (1) Literature reviews to identify earlier risk studies and how ITDM is treated and managed, (2) investigation of the policies and programs of other DOT modal administrations, (3) an examination of how such States treated drivers with ITDM and their experience in allowing such drivers to operate CMVs, and (4) examining the results of recent risk studies. Further, to obtain expert input concerning the treatment of ITDM, the agency assembled a panel of physicians whose main focus was the treatment of diabetes. Overall, the conclusions reached in this determination were, therefore, based on a broad range of relevant information.

The approach was guided by the best principles of risk assessment in conjunction with program development. The feasibility focused primarily on the potential safety of such a program, and the procedures that can ensure safety, while providing a benefit to the public. The results of the determination led to a conclusion that a safe and practicable program was feasible. The conclusions further showed that a viable program protocol for allowing certain individuals with ITDM to operate CMVs would require three components.

The first component is screening applicants to identify qualified drivers. This process examines the applicant's experience and safety in operating a CMV. As stated above, the screening criteria require three years of safe CMV operation with ITDM. The criteria are based on the evidence available from the above referenced waiver program, previous program reviews by researchers in the field, and the safety prediction literature. FMCSA believes that a safe driving history is a required basis for screening, because the primary focus of the determination is to develop a program with the necessary safety level. The screening component requires an acceptable history of hypoglycemia along with the results of examinations by required medical specialists. An important aspect of screening also involves education in the management of the condition and awareness of hypoglycemia.

The second component provides guidelines for managing ITDM for the qualified applicants. This includes direction in the supplies to be used and the protocol for monitoring and maintaining appropriate blood glucose levels. This is based on the experience of other successful programs and detailed input from the above referenced medical panel.

The last component specifies the process to be used for monitoring qualified ITDM operators of CMVs. This addresses the required medical examinations and the schedule for their submission. It also specifies how glucose measures should be taken and reviewed and the methods for reporting episodes of severe hypoglycemia and accidents. The monitoring component increases the degree of rigor to meet the needed level of safety. In the program, qualified drivers will be required to reapply and be screened every two years to renew their exemptions. This means that the drivers in the program will need to verify their safe driving behavior, health status, and education in a manner that involves ongoing monitoring. In addition, to monitor health status, the drivers will be required to be examined by an endocrinologist and obtain medical certification on an annual basis.

The FMCSA believes this is a comprehensive program. It thoroughly addresses the wide range of concerns about this type of program. The program's structure reflects the range of input from numerous sources. It also reflects how the most feasible and effective aspects of each input were combined to develop a program that provides great benefit with a primary focus on safety.

There were 396 comments to the notice of intent to issue exemptions published in the Federal Register on July 31, 2001 (66 FR 39548), with 373 commenters generally in favor of the proposal and 23 in opposition. Among the comments submitted, some were sent multiple times by the same individuals or organizations. Those in support of the proposed program largely directed their comments to the removal of a comprehensive prohibition on the operation of CMVs by insulin-using diabetics, which would be replaced by an individual assessment of their ability to drive the CMVs. Those in support often did not agree with all aspects of the proposed program, citing complexities of the application process, the extent of the medical examination, and the length of time until FMCSA grants an exemption. Among the comments in support, while citing problems with other elements of the program, 191 wrote specific comments about the requirement for three years of driving experience with the condition.

Nine organizations and individuals submitted 23 comments in opposition to the proposal. They argued that available evidence does not support implementation of an exemption program that must meet the safety requirements for new programs. They assert that the medical examination process cannot conclusively identify safe drivers with ITDM, that interstate driving is too arduous for such individuals, and the risk assessment results are not sufficient to justify a program that will be as safe or safer than the existing absence of a program.

The comments on the proposed program are further discussed below. Numerous commenters have substantive concerns about the same issues. The FMCSA presents its response after the comments are described.

The American Diabetes Association (ADA) generally supports the FMCSA proposal to end the blanket ban prohibiting insulin-treated diabetics from operating CMVs. It believes that this proposal is long overdue and it would institute a process for the individual assessment of applicants. The ADA said that it does not believe all individuals with insulin-treated diabetes should qualify for a CDL. It strongly supports replacing the blanket ban with a medically sound protocol that maximizes safety and employment opportunities for individuals with diabetes. Consistent with that support, the ADA states that it supports most aspects of the proposed program. Specifically, the ADA agrees with three aspects of the proposed protocol; the careful medical screening, the stringent guidelines for drivers to use when driving, and the aggressive monitoring for safety. It supports the rigorous approach to assuring the highest levels of safety and believes that most aspects of the proposal are excellent.

The ADA, however, disagrees with the exemption requirement that insulin-treated drivers should have three years of safe driving experience with the condition. It states that nothing in the TEA-21 Report to Congress supports this requirement, and that the proposed requirement disregards currently available medical treatment and supplies for people with diabetes. The ADA claims that the agency's own medical panel recommended a one or two month period for a person to adjust to insulin before applying for a CDL, and urges the adoption of that standard. It goes on to state that the three-year screening criteria should be replaced with a one-month adjustment period for those with non-ITDM that are moving to the use of insulin, and a two month adjustment period for those newly diagnosed with the ITDM condition. Individual circumstances could extend this latter period. Moreover, the ADA believes that there should be no requirement for the CDL applicant to have any experience driving a CMV.

The ADA also believes that DOT should change the regulations in relation to diabetes. It believes that the proposed exemption program has a number of difficulties that a regulatory change would not. The ADA believes the exemption program could be terminated at any time in the same manner the FHWA did when it ended the diabetes waiver program. It also believes that an exemption program may not be able to protect qualified ITDM drivers from employer discrimination, citing a supreme court decision, Albertson's Inc. v. Kirkingberg, 527 U.S. 555 (1999). The ADA states that an exemption program could result in more discrimination and litigation. As a result, the ADA argues that the general regulatory standard in 49 CFR 391.41(b)(3) should not continue when the DOT has determined that individual assessment is feasible.

The U.S. Equal Employment Opportunity Commission (EEOC) states that the proposed exemption program is intended to increase employment opportunities for individuals with disabilities while monitoring for safety. In this sense, the EEOC claims that the process is consistent with the Americans with Disabilities Act. However, the EEOC is concerned about the requirement for three years of driving experience with the condition. It is concerned that this screening process may exclude a large number of drivers from interstate commerce, which may limit diabetic drivers to a small number of lower paying jobs. It was also concerned that some drivers may live in states that do not allow diabetic drivers to operate CMVs in intrastate commerce. The EEOC urges the FMCSA to monitor the three-year experience requirement if it is used and reassess it if it becomes too exclusionary.

The Congressional Diabetic Caucus (Caucus) generally supports the program, saying that it is pleased that the TEA-21 Report to Congress “concludes that a safe and practicable protocol to allow some individuals with insulin-treated diabetes mellitus to operate commercial motor vehicles is feasible.” However, it has concerns about the three-year requirement for driving experience. It claims that the proposed three-year requirement ignores advances in medical treatment. The Caucus points to the input given by a DOT medical advisory panel which recommended a one to two month adjustment period before driving for those individuals newly treated with insulin.

The Caucus also believes that DOT should not implement the proposed policy through another exemption or waiver program. It believes the vast majority of States and the Federal Government have successfully experimented with allowing a limited number of insulin-treated drivers to operate CMVs. With the Federal government's analysis of the issue, another exemption (waiver) program would be inadequate to provide benefits for all involved. Based on this, it urged DOT to permanently change the regulations concerning insulin-treated diabetes and the operation of CMVs.

The Civil Rights Division of the U.S. Department of Justice (DOJ) generally supports the proposed exemption program as a positive step toward permitting an individual assessment of persons with ITDM to operate CMVs in interstate commerce. The DOJ, however, has concerns regarding the three-year driving requirement and urged the FMCSA to continue to obtain and analyze data on the safety records of CMV operators with ITDM from all available sources. This should permit the FMCSA to consider if it is appropriate to modify the three-year requirement. The DOJ believes that among those States that allow drivers with ITDM to operate CMVs, some monitor the drivers for a variety of reasons. As a result, those states should be able to provide the FMCSA with several years of data to examine the risk associated with relaxing the three-year requirement.

The Amalgamated Transit Union (ATU), which represents over 175,000 members maintaining and operating bus, light rail, ferry, over-the-road bus, school bus, and paratransit vehicles in the U.S. and Canada, strongly supports the proposed program because advances in the treatment of diabetes make it possible for some ITDM individuals to operate a CMV. However, the ATU strongly opposes the requirement for three years of safe CMV operation with the condition. This aspect of the proposal, the ATU argues, would place a huge obstacle in the path of qualified individuals with ITDM. This requirement discriminates against drivers in non-waiver States. In light of the medical advances in the treatment of ITDM, the ATU states there is no justification for the three-year requirement. Instead, the ATU claims that the FMCSA should adopt the recommendation of the medical panel in the TEA-21 Report to Congress, wherein a one or two-month period for adjustment to insulin would be required for seeking or maintaining a CDL.

The International Brotherhood of Teamsters (IBT) applauds the FMCSA's efforts to eliminate the blanket ban on insulin-using diabetic drivers. However, the IBT agrees with the other organizations relative to the three-year driving requirement. In their opposition to the requirement, the IBT cites the absence of waivers in some States that would exclude many drivers. The IBT also claims that it is not easy for drivers to obtain the required experience even in States with waiver programs because there are significantly fewer jobs in intrastate operation. They also point to the unfairness of experienced interstate drivers losing their CDL when newly diagnosed with ITDM.

The IBT is also concerned about the requirement that a CDL applicant have a safe driving record. It states that the requirement bears no relation to the applicant's medical condition and that this goes too far even in trying to ensure safety. It is most concerned about the requirement that a driving record could prevent the applicant from obtaining an exemption based on the applicant's accident involvement for which the driver “contributed to the cause.” The IBT believes this standard is too broad and subjective.

The IBT also believes that rulemaking rather than an exemption program would better serve the process of granting CDLs to insulin-using diabetics. It sees little benefit in the exemption process of publishing an application in the Federal Register and requesting comments on the applicants' diabetic conditions. The IBT states that it understands that rulemaking can be a lengthy process and encourages the FMCSA to proceed with the exemption program while continuing to work on the more permanent solution through a change in the regulations.

The Owner-Operator Independent Drivers Association, Inc. (OOIDA) generally supports and welcomes the changes proposed by the FMCSA in the exemption program. Based on reports from its membership, OOIDA believes that a number of drivers with ITDM can safely operate CMVs in interstate commerce. OOIDA believes that FMCSA's proposed program has a number of steps that will ensure that no increased safety risks will be present. However, OOIDA is concerned about the three-year driving requirement, and believes that it runs counter to the proposal to require an activity currently prohibited in interstate commerce. It believes that the requirement limits access to the CDL program because there are few intrastate driving opportunities. OOIDA is further concerned about experienced drivers who would be using insulin, but choose not to do so because they will lose their CDLs. While the proposed exemption program may help lessen this problem, the three-year requirement places them in a difficult economic and health position.

The National Private Truck Council (NPTC) agrees with the FMCSA that a blanket prohibition on the operation of CMVs by individuals with ITDM is unwarranted and understands the agency's concerns relative to the safe performance of drivers with this condition. The NPTC, however, believes that the protocol is so burdensome that it will discourage participation in the program. The most onerous provision in the program, according to the NPTC, is the requirement for three years of CMV driving experience with the diabetic condition. They believe that the requirement is unnecessary from a safety standpoint, and presents an excessive burden on applicants to the program.

The American Trucking Associations, Inc. (ATA) supports FMCSA's proposed exemption program. ATA recognizes the advances made in the treatment of ITDM, the advances in the treatment of diabetes related heart disease, and the success of the agency's earlier diabetes waiver program. ATA's support is given if the proposed exemption program contains specific components related to screening, safe driving experience, medical history and examinations, guidelines, and monitoring.

The American Optometric Association (AOA), while supporting the proposal, takes exception with the omission of optometrists from the examination requirements in the application process. The AOA states that this omission is inconsistent with all existing Federal guidelines on the matter in addition to those put forth by the AOA, the National Committee on Quality Assurance, and the recommendations of the agency's medical panel member Edward S. Horton, M.D. Moreover, the AOA argues that the omission of optometrists implies that they are not able to monitor proliferative diabetic retinopathy. The AOA states that this is not true because studies indicate that optometrists can detect non-proliferative and proliferative retinopathy, as well as general ophthalmologists. The AOA clinical guidelines for the optometric care of diabetic patients is identical to the procedure used by ophthalmologists to detect proliferative diabetic retinopathy. Finally, the AOA argues that it would be inconsistent for the agency to include optometrists in the annual medical examination for diabetics in 49 CFR 391.64, and then exclude them in the proposed exemption process.

The Oregon Department of Transportation and the Illinois State Police both endorse the proposed exemption program. Oregon has extensive experience in issuing intrastate waivers to insulin-using diabetic CMV drivers based on stringent medical requirements. Oregon maintains crash data for intrastate commercial operations and had found no accidents related to complications from diabetes. Likewise, the State of Illinois currently allows diabetic drivers under its grandfather provisions and has no data to indicate ITDM drivers are a greater safety risk than other drivers. The Illinois State Police takes no exception to the proposed exemption program if there is strict oversight and careful scrutiny of each applicant.

The State of Delaware also supports the proposed exemption program since it has had a similar program in effect for 15 years. Delaware states that it has no indication that the program has reduced highway safety. However, the State believes that the agency proposal is overly complex. It points specifically to the publication of individual exemptions in the Federal Register for comment, the decision period of up to six months, the annual physician report, and the quarterly specialist review. It suggests a reduction in these requirements.

The comments about the requirement for three years of driving experience with the ITDM condition are understandable. It does place a constraint on some ITDM drivers who want to operate a CMV in interstate commerce. However, under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption from the diabetes standard only if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. FMCSA believes that thorough screening of exemption applicants, and periodic monitoring of their safety performance, are the most practical and effective ways to ensure the diabetes exemption program satisfies the statutory requirement achieving a level of safety equivalent to, or greater than, the level of safety obtained by complying with the safety regulation. FMCSA believes that the three-year requirement is crucial to this screening and monitoring protocol until data supports a different threshold. The three-year requirement provides sufficient time to expose anomalies in driving records that enhance predictability of future driving performance. It also allows the driver to develop a routine for managing his or her diabetic condition and establish a driving record demonstrating those adaptive skills.

FMCSA based the three-year driving experience requirement on the best available scientific evidence. The previous work the agency performed under its diabetes waiver program in the mid-1990s supports the three-year requirement. Drivers in that program, who had three years of experience while using insulin, had accident rates lower than the national rate. The driving performance of those who met the three-year requirement and other program requirements was analyzed relative to 1993 through 1996 large truck national accident rates found in the National Highway Traffic Safety Administration's General Estimates System. The accident rate of the waiver group with over 9 million miles of driving exposure was 1.960 accidents per million miles versus a national accident rate of 2.272 for the same period.

On August 24, 1994, the agency convened a meeting to conduct a review of the vision waiver program. The diabetes waiver program used the same three-year requirement as the vision program. Agency officials and a variety of researchers in highway safety and vision attended the meeting. (See the Final Descriptive Report “Qualification of Drivers—Vision, Diabetes, Hearing and Epilepsy;” FHWA; DTFH61-92-Z-00158, May 30, 1997). The group discussed both the formation of the waiver program and the design of the associated study. Relative to the design of the waiver program and the enrollment of drivers, it was decided that the program was well conceived within the context of congressional mandate expressed in the Motor Carrier Safety Act of 1984. The group determined that the conditions developed for screening and enrolling drivers into the waiver program were appropriate. To qualify for a vision waiver, a driver had to have an extremely safe driving record for three full years before applying to the program. The group agreed based on the safety literature that the best predictor of future driving performance is past performance. As a result, the group concluded that the enrolled drivers would be as safe in the waiver program as they were before the program.

Because the FMCSA is required to develop programs that are as safe as or safer than the prevailing norm, the agency believes this is compelling evidence to require the three-year driving experience requirement in its diabetes exemption program. However, the agency will revisit the issue in the future. FMCSA will examine how reducing the three-year experience requirement can be accomplished while satisfying the statutory requirement under 49 U.S.C. 31315 and 31136(e).

FMCSA believes that its medical advisory panel recommendation that persons could be qualified to drive a CMV, after a one-or two-month period of adjustment to insulin use, does not take into account the complex demands of operating a large vehicle in interstate commerce. Diabetes is a chronic disease requiring constant control and monitoring. CMV drivers, however, are frequently required to work long hours and travel significant distances, often requiring overnight stays away from home. Because of economic pressures to arrive at a delivery site on schedule, drivers may often have difficulty maintaining a regular diet, exercise, and the blood sugar monitoring patterns necessary to manage their diabetes properly. Failure to manage diabetes properly significantly increases the likelihood of an adverse event, such as loss of consciousness while driving due to hypoglycemia (low levels of glucose in the blood). Advances in the medical treatment of diabetes do not equal compliance. There is a strong behavioral component in managing diabetes.

With respect to comments urging FMCSA to change the regulations on ITDM and CMV operation, FMCSA does not believe there is evidence to support such a change. In the TEA-21 Report to Congress conducted for this program, the FMCSA could find no precedence for regulatory change for a condition like ITDM. ITDM is a chronic health problem.

Diabetes is a condition that is potentially quite labile, even if an individual demonstrates good control of blood glucose levels at a point in time. The expert medical panel convened for the TEA-21 Report to Congress agreed that diabetics have special medical problems. For this reason, they concurred that diabetics should be examined by endocrinologists who are experienced with the condition. In relation to monitoring the ITDM driver's management of the condition, the panel suggested, among other things, that quarterly reporting of glucose monitoring data would be a good method of determining whether the driver is following the monitoring guidelines. The panel also agreed that these drivers should receive ongoing education in hypoglycemia awareness, and that this education should be monitored on an annual basis. For this reason, FMCSA believes the evidence supports the requirement that a responsible, qualified driver should undergo periodic examinations. The need for periodic examinations is underscored by the possible occurrence of diabetic complications such as retinal disease and peripheral neuropathy.

FMCSA believes that the periodic examinations, and the monitoring of the examinations, both assure the health of the individual and the safety of the public at large. Consequently, FMCSA has determined that the prefered context in which to guarantee such screening and monitoring is in an exemption program.

IBT was concerned about the driver record requirement that prevents the applicant from obtaining an exemption because of involvement in an accident for which the driver “contributed to the cause.” IBT believes this type of assessment is too subjective. However, FMCSA's analysis of the driving record of each individual driver is not subjective. The analysis of the accident report seeks to determine whether the reporting police officer has issued a citation indicating that the driver is at fault or has contributed to the cause of the accident. The analysis also examines the accident report to determine whether there is evidence of driving behavior that could indicate a hypoglycemic event, such as crossing the median, swerving, or driving off the road. In cases where a diabetic driver receives medical attention, reports on glucose levels can be obtained.

The AOA took exception to the exclusion of optometrists from the proposed exemption process. The protocols that were in the proposed program have been revised, today's final disposition notice allows applicants to obtain and submit a signed statement from an ophthalmologist or optometrist, indicating that they have been examined, the applicant does not have diabetic retinopathy, and meets the vision standard at 49 CFR 391.41(b)(10). However, if the driver has any evidence of diabetic retinopathy, FMCSA requires an examination by an ophthalmologist to offer additional expert opinion regarding stability and risk of progression of the condition. This change covers the screening process in both the initial application and the annual examination.

The Insurance Institute for Highway Safety (IIHS) opposes FMCSA's proposal to issue exemptions to certain insulin-using drivers of CMVs. In voicing its opposition, IIHS resubmitted the various comments it had submitted to the agency between 1991 through 1996 concerning the implementation and disposition of the diabetes waiver program. In those comments, IIHS raised concerns that: (1) Diabetes Mellitus is a risk factor for motor vehicle crash involvement, (2) severe hypoglycemia and hypoglycemia unawareness are a common consequence of insulin therapy and of tight control of blood glucose levels in particular, (3) no studies support the protocols in a program that would issue exemptions, (4) compliance by drivers and employers to program requirements is unlikely, (5) studies designed to investigate the safety of issuing waivers or exemptions would produce no scientifically valid conclusions, and (6) the research design used to investigate safety in an earlier waiver program was inadequate. The issues raised in these previous comments have been addressed at length in 58 FR 40690 (July 29, 1993) (FHWA Docket No. MC-87-17) and 61 FR 13337 (March 26,1996) (FHWA Docket No. MC-96-2). FMCSA will not address these points again here, but refer interested parties to the earlier discussions. The IIHS has, however, raised a new issue and this is discussed in the following paragraph.

The IIHS stated that the agency has ignored the concern that the working conditions of interstate truck drivers are not compatible with the medical needs of people with insulin-treated diabetes. IIHS states that long and irregular work hours, night responsibilities, variations in the amount of exercise, and variations in the amount of food consumed are integral aspects of long-haul trucking. These factors, IIHS argues, make it difficult to calibrate insulin doses to maintain blood glucose at healthy levels.

FMSCA is aware that operating a CMV in interstate commerce is an arduous occupation. The agency designed the screening criteria in the exemption program to identify those insulin-using diabetics, who will have a high degree of responsibility in managing the condition while driving in interstate commerce. The agency bases this assertion on the experience obtained in the above referenced diabetes waiver program. The evidence generated by that program, which had the same screening criteria as that proposed for the exemption program, demonstrated that responsible insulin-using diabetics can safely operate a CMV in interstate commerce. The evidence obtained in that program represents over 9 million miles of CMV operation by individuals who were successfully screened by the criteria. In addition, FMCSA will require that an applicant for the diabetes exemption program be educated in diabetes and its management, and have demonstrated a willingness to properly monitor and manage his or her diabetes. Finally, not all operations in interstate commerce are long-haul.

The Advocates for Highway Safety (AHAS) stated strong opposition to the FMCSA proposal to issue exemptions to selected insulin-using diabetic CMV operators. In stating its opposition, AHAS claims that the proposed exemption program lacks a sufficient scientific foundation. In particular, AHAS argues that FMCSA's assertion that the ITDM exemption is scientifically sound and based on good medical information is conclusionary and not an accurate representation of the factual record. AHAS states that FMCSA is reaching a conclusion that selectively highlights the most salient pieces of evidence in the TEA-21 Report to Congress, to support the implementation of an ITDM exemption program. In making this claim, AHAS points to FMCSA's reference to two studies in the TEA-21 Report to Congress (“The Diabetes Control and Complications Trial” (1995) and the “United Kingdom Prospective Diabetes Study” (1998)), as the most extensive investigation of insulin therapy to date.

In the presentation of these studies, AHAS argues that FMCSA claims the studies show positive results for reduction in blood glucose levels and microvascular complications, and that the agency also reports results that show significantly higher rates of hypoglycemia due to the use of insulin. AHAS states that the agency's notice of intent did not explain how these results support the agency's determination that an exemption program for ITDM will have a safety level that is equal to or better than the prevailing level.

FMCSA is acutely aware of the threat presented by tight control of blood glucose levels and hypoglycemia. It was not the agency's intent to use the results of those studies to support the determination of safety. Rather, the intent was to identify a potential threat that had to be accounted for in the protocols of the proposed exemption program. To this end, the expert medical panel addressed this issue in the FMCSA's TEA-21 Report to Congress. The panel, while clearly recognizing hypoglycemia as a threat, also thought awareness was a bigger problem. It noted that there was a correlation between hypoglycemia awareness and recurrent, severe hypoglycemic episodes, as shown in the Diabetes Control and Complications Trial data. The panel stated that individuals who are prone to severe hypoglycemia should not drive. The panel agreed that severe hypoglycemia in the past year or several episodes in the past five years can predict the future. The panel also agreed that training in the awareness of hypoglycemia is necessary for drivers of CMVs. Because of this, awareness education is a requirement in the protocols of the exemption program announced today.

AHAS points to a 1999 study (Clarke, W. et al. “Hypoglycemia and the Decision to Drive a Motor Vehicle by Persons with Diabetes.” JAMA, August 1999, Vol. 282, No. 8, 750-754) to raise questions about an exemption program. According to AHAS, the study found that even when individuals accurately estimated low blood sugars levels, a significant proportion still decided to drive. However, the researchers in this study also said that these findings did not mean ITDM individuals should be prohibited from driving. They said it was reasonable for individuals to measure their blood sugar levels before driving and take steps to raise potentially low levels. The researchers said that drivers with ITDM should always carry rapid-acting glucose when they drive. Moreover, these researchers claim that individuals with ITDM could benefit from awareness training. In fact, in a subsequent study by these same researchers, the results showed that awareness training improved the detection of hypoglycemia and improved judgment for knowing when to raise low blood glucose, or to lower elevated blood glucose, and for knowing when not to drive while hypoglycemia is a threat (Cox, D. J. et al. “Blood Glucose Awareness Training; Long-Term Benefits, Diabetic Care, 2001, 24:637-642). Because of the concerns about hypoglycemia, FMCSA has incorporated all of the suggested interventions in the protocols of today's exemption program. The California Department of Motor Vehicles also described the same article as AHAS raising the same concerns. There is an additional response to their comments later in this discussion.

AHAS also took exception to FMCSA's interpretation of four recent risk studies presented in the TEA-21 Report to Congress and the July 2001 notice of intent. It first addressed two Canadian studies:

1. Dionne, G. et al. “Medical Conditions, Risk Exposure, and Truck Drivers' Accidents: An Analysis with Count Data Regression Models,” Accident and Prevention, 27(3): 295-305 (1995); and

2. Dionne G. et al. “Analysis of the Economic Impact of Medical and Optometric Driving Standards on Costs Incurred By Trucking Firms and on the Social Costs of Traffic Accidents” in Dionne, G. and Laberge-Nadeau, C. (Eds.) Automobile Insurance: Road Safety, New Drivers, Risk Insurance Fraud and Regulation, Kluwer Academic Publishers, Boston (1999).

AHAS states that these studies do not offer any evidence in support of an exemption program.

The first of these studies (1995) examined truck drivers in two licensure classes. One class was for the operation of large combination trucks, while the other included truck drivers holding all other classes of license that were mostly holders of permits for straight trucks. The risk analysis in each class considered diabetic drivers versus all other drivers. The diabetic drivers of large combination trucks had an accident rate that was not significant, while the diabetic drivers of small trucks had a significantly higher accident rate. The analysis did not consider the use of insulin by the diabetic drivers. Relative to this, AHAS alleges that FMCSA's notice of intent does not state to the public that although the researchers were actually at a loss to explain the results, they believed that the results could be due to the use of insulin since the diabetic drivers of large trucks had fewer individuals treated in this manner than those with other classes of license.

For the second study, AHAS states that the results FMCSA relies on were not the focus of the study nor its primary consideration, and that the primary focus of the study was estimation of cost per accident. FMCSA reported a secondary finding, according to AHAS, in that the data showed that drivers with diabetes did not have significantly more severe accidents than those in the comparison groups. Severity was measured as the total number of individuals injured or killed in an accident. AHAS points out that the work in the second study was based on the data used in the first and was a continuation of that study. It also states that the use of insulin was not considered in the second study.

FMCSA believes the AHAS claim that the studies do not contribute to the finding that ITDM drivers have an acceptable level of risk is unfounded. Aside from the finding that diabetic drivers of small truck CMVs had a significantly higher accident rate, none of the other findings refute the position that diabetics could operate CMVs in interstate commerce with a level of safety that is the same or better than the prevailing standard. While insulin was not taken into consideration in the analyses, the studies do nonetheless offer evidence in support of the exemption program by virtue of not contradicting the conceptual design. Contradiction and refutation are acceptable approaches in science to revise a stated theory. None of the work contradicts the determination that diabetic drivers have an acceptable level of risk. In performing risk assessments through observational studies, it is necessary to examine all of the evidence to determine the direction the preponderance of evidence supports.

After the FMCSA issued the notice of intent, there has been an additional contribution to the collection of evidence on this issue. Some of the same Canadian researchers who conducted the previous studies used the same insurance database to conduct a third study (Laberge-Nadeau, C. et al. “Impact of Diabetes on Crash Risks of Truck-Permit Holders and Commercial Drivers.” Diabetes Care, Vol. 23(5): 612-617, 2000). These data were augmented with health status data from a public health insurer where insulin use was identified, along with the existence of complications due to diabetes. Portions of the database were analyzed with the new information in a new research design where diabetic driver permit holders were group-matched by age to a random sample of healthy permit-holders. Risk was analyzed relative to type of permit holder (large combination trucks and straight trucks), use of insulin, and diabetic complications. Relative to both classes of trucks, insulin-using diabetics showed no significant risk regardless of complication status. The only group of diabetics to show significant risk was the permit holders for straight trucks who did not use insulin and were without complications. To explain the results concerning insulin use and complications, the researchers stated that employers hiring drivers for large combination trucks use higher medical standards presumably for insulin-using diabetics and other drivers. This is what the protocols in the FMCSA diabetes exemption program are designed to do.

Many of the points argued by AHAS in relation to their criticism of the research design in the waiver program and their rejection of the legal basis for the exemption program, have been previously presented and have been addressed at length in 58 FR 40690 (July 29, 1993) (FHWA Docket No. MC-87-17), 61 FR 13337 (March 26, 1996) (FHWA Docket No. MC-96-2), 63 FR 67601 (December 8, 1998) (DMS Docket No. FMCSA-1998-4145) and 64 FR 51568 (September 23, 1999) (DMS Docket No. FMCSA-1999-5578). FMCSA will not address the points again here. Interested parties are referred to the earlier discussions.

In its comments to this notice, AHAS also raises some new issues. In particular, it has some concerns relative to the most recent risk study conducted by the agency (“A Study of the Risk Associated with the Operation of Commercial Motor Vehicles by Drivers with Insulin-Treated Diabetes Mellitus,” FHWA, 1999). AHAS states that the comparisons made in the study could be suspect because the comparison group was composed of interstate drivers, while the diabetes group contained mostly intrastate drivers. While it is true that the diabetes group did primarily contain intrastate drivers, the comparison group of CDL holders also had intrastate drivers, albeit in smaller proportion. This disparity in representation by the two groups did contribute to the range of CMV operation (intrastate versus interstate) being identified as a confounding factor in the study. As a result, FMCSA used the factor to adjust the initial results. Observational study research literature supports this type of adjustment. Had this factor and others been ignored in the analyses, the unadjusted results would have been biased and detracted from the internal validity of the study.

This aspect of FMCSA's response also addresses another AHAS concern involving the nature of the unadjusted study results. AHAS correctly pointed out that the initial (unadjusted) results show that the diabetes group had a higher crash rate than the comparison group. However, since this study was observational in nature, as are almost all practical risk investigations, it is necessary to assess the factors that could introduce bias into the results and invalidate the findings. FMCSA did this and found several factors, including intrastate versus interstate operation and marital status. The other source of potential bias that FMCSA found was over-dispersion in the distribution of accidents (a larger than expected variation in the number of accidents). Both of these sources of bias tend to produce false positive (significant) results if not subjected to adjustment. FMCSA analyzed the two sources of potential bias with adjustment procedures, both separately and jointly, and found the results were consistent across all analyses showing no significant difference in risk between the two groups. While the AHAS seemed to characterize this multifaceted approach to analysis as a contrived strategy, it is the approach which is required in an observational study (see U.S. General Accounting Office, “Cross Design Synthesis; A New Strategy for Medical Effectiveness Research,” March 1992 GAO/PEMD-92-18). It is the consistent results across the varied adjustment procedures that gives the FMCSA confidence that bias was present in the initial (unadjusted) results and was eliminated in the ensuing analysis.

AHAS also claims that the Federal Aviation Administration (FAA) exemption program for ITDM individuals is an inappropriate model for FMCSA's program for the operation of CMVs. It stated that the FAA program issues exemptions only for third-class airman medical certificates and not for commercial pilots. The AHAS is correct in their assessment of the FAA program; however, the FMCSA had no intention of using the FAA's program as a model for the FMCSA program with respect to type of target population. FMCSA used the FAA program as evidence that it could develop a process of medical examination and screening to issue exemptions to individuals with ITDM. To this end, FMCSA used the FAA process as part of the template for development of the proposed medical examination and screening protocol. That is why the protocol is analogous to that of the FAA.

In its opposition, the California Department of Motor Vehicles (California) states that the proposed FMCSA program will unnecessarily increase the risk to the public and the drivers receiving the exemptions. While California regulatory guidelines allow some experienced ITDM individuals to operate intrastate, it believes that the FMCSA exemption program could greatly expand the number of these drivers who operate interstate and thereby increase risk. California limits the number of exemptions because of the risk of hypoglycemia. It states blood sugar is affected by almost everything including exercise and stress. This in combination with arduous work conditions associated with interstate operation makes it difficult for drivers with ITDM to control their blood sugar.

California does not believe that the proposed FMCSA screening procedures adequately address the issue of hypoglycemia. The requirement for a complete medical examination, by a board-certified or eligible endocrinologist with a statement of familiarity with the applicant's five-year medical history, will not preclude an ITDM driver from experiencing a hypoglycemia episode.

FMCSA believes it has addressed this type of circumstance in the exemption program's screening protocol. Specifically, the criteria state that the applicant must have had no recurrent (two or more) hypoglycemia reactions resulting in a loss of consciousness or seizure within the past five years. A period of one year of demonstrated stability is required following the first episode of hypoglycemia. Moreover, the criteria require that the applicant does not have recurrent hypoglycemia reactions requiring the assistance of another person and does not have reactions resulting in impaired cognitive function that occurred without warning symptoms within the past five years. In addition, as a test of these responses under arduous working conditions, the screening criteria also require three years of CMV operation with ITDM. The same screening criteria were used in the agency's previous diabetes waiver program, and in the three years of that program, there were no reported cases of impairment due to episodes of hypoglycemia. Moreover, screening is stricter now. In place of a single screening episode under the previous program, the driver must reapply for an exemption every two years, or sooner if the exemption was issued for a shorter period. Screening is performed at each reapplication. In addition, screening is performed annually by an endocrinologist, as well as the medical examiner performing the annual examination and certification required under 49 CFR 391.43.

In another issue of concern for California, it points out that the protocol proposed in the FMCSA program requires the exempted drivers to check their blood sugar levels every two to four hours. Because of this and other measures needed to control blood sugar, California believes that employers would not let the drivers take the time necessary to perform all of these activities. FMCSA, based on its previous experience, is not aware of any evidence to suggest that employers would not allow drivers to take the time needed to check their blood sugar levels.

California points to a 1999 study as another basis for its opposition (Clark, W. L. et al. “Hypoglycemia and the Decision to Drive a Motor Vehicle by Persons with Diabetes.” JAMA, August 1999, Vol. 282, No. 8, 750-754). An objective of the study was to examine an ITDM individual's decision to drive during the individual's daily routine, based on perception of blood sugar levels compared to actual levels. The researchers found that significant numbers of subjects did not correctly estimate how low their blood sugar was, and therefore decided to drive. The findings also showed that even when individuals accurately estimated low blood sugar levels, a significant portion still decided to drive. California, however, does not indicate the researchers stated that ITDM individuals should not be permitted to drive. California did say the data suggested that individuals with ITDM need to be cautious before driving a motor vehicle. The researchers said that the suggestion that individuals measure their blood sugar levels, and raise potentially low levels before driving, did not seem unreasonable. They said that drivers with diabetes should always carry rapid-acting glucose with them when they drive. Moreover, the researchers claim that individuals with ITDM could benefit from awareness training to help detect blood sugar levels. They stated that this type of training has been shown to improve the detection abilities of even those with reduced awareness of hypoglycemia, and that the improvement has been sustained for at least a year.

The protocol being adopted in this final disposition is very consistent with the conclusions of these researchers. In the screening component the applicant must present a signed statement prepared by the examining endocrinologist indicating that the applicant has been educated in diabetes and its management, thoroughly informed of and understands the procedures which must be followed to monitor and manage his/her diabetes, and what procedures should be followed if complications arise. In addition, the protocol requires, in the guideline component, that the qualified applicant have a supply of rapidly absorbable glucose to be used as necessary. The protocol also requires, in the monitoring component, that the qualified driver provide annual documentation by a specialist of ongoing education in diabetes management and hypoglycemia awareness. While Clark W. L., et al. was valuable in identifying the potential problems with hypoglycemia awareness, it also suggested methods for intervention. The suggestions of the researchers concerning how they believe the problem should be addressed are clearly contained in the protocols of the exemption program.

After analyzing the comments to the notice of intent, the FMCSA is convinced that the proposed program is responsive to the need and requirements of the various interested individuals and organizations. The comments raised a number of valid issues of concern. The agency believes that it has successfully addressed those concerns in the development of this program. The public's concerns must be addressed because they mainly focus on safety issues. This is the reason there is a three-year driving experience requirement in a part of the exemption program, in addition to medical screening, guidance, and monitoring. The three-year requirement of the program provides certainty to public safety, and also protects ITDM drivers. The ability to operate CMVs safely for three years clearly helps to indicate that applicants can perform the arduous work required in this type of job category. While we believe this requirement to be essential, all of the proposed components are required for a safe and practicable program.

Nonetheless, FMCSA recognizes that the three-year requirement will restrict the number of drivers eligible for an exemption. The agency has no desire to make the program more stringent than necessary and will therefore leave this docket open indefinitely in order to provide a means for the submission of additional views and data on the need for three years of driving experience. FMCSA is particularly interested in obtaining statistical data on the accident rates of ITDM drivers before and after they begin a course of insulin treatment. This analysis depends on knowing, among other things: (1) The number of miles driven and accidents experienced by the driver before beginning insulin treatment, thus providing a baseline accident rate; (2) the length of time an ITDM driver has taken insulin before resuming a driving career; (3) the date the ITDM driver resumed driving and the interval to the first (and any subsequent) accident; and (4) the number of miles driven by an ITDM driver, preferably on a monthly and annual basis. Although FMCSA will not ignore any relevant information that may be submitted, the statutory standard for an exemption requires the agency to focus its attention on the question whether ITDM drivers with less experience driving CMVs can achieve accident rates comparable to those of ITDM drivers who have at least three years of experience driving CMVs prior to applying for an exemption. This is an issue that can be resolved only by more and better data. FMCSA is also interested in learning which segments of the motor carrier industry have work conditions most (or least) conducive to the self-monitoring routines that ITDM drivers must maintain in order to control their blood sugar level.

For the reasons above, the FMCSA has determined that the most desirable structure to support these components is an exemption program. Therefore, in accordance with 49 U.S.C. 31315 and 31136(e), the FMCSA will implement a program that will issue exemptions to qualified ITDM drivers. Each exemption will be valid for up to two years and require renewal at the end of that period. Qualified ITDM drivers may request a diabetes exemption from the 49 CFR 391.41(b)(3) regulation by sending an exemption request on or after September 22, 2003, to the Diabetes Exemption Program at the address in the ADDRESSES section above.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. An analysis of this proposal was made by the FMCSA, and it has determined that this Notice of Final Disposition would add an element, i.e. , diabetes exemption program, to a currently-approved information collection (OMB Approval No. 2126-0006), titled Medical Qualifications Requirements.

The FMCSA estimates that approximately 700 applications for exemption could be filed annually, and that it would take an average of 90 minutes to complete an application. The addition of the diabetes exemption program to this existing information collection would increase the annual burden by 1,050 hours (700 × 90 minutes / 60 minutes).

Interested parties are invited to send comments regarding any aspect of this information collection requirement, including, but not limited to: (1) Whether the collection of information is necessary for the performance of the functions of the FMCSA, including whether the information has practical utility, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the collected information, and (4) ways to minimize the collection burden without reducing the quality of the information collected.

You may submit comments on this information collection burden directly to OMB. The OMB must receive your comments by November 3, 2003. You must mail or hand deliver your comments to: Attention: Desk Officer for the Department of Transportation, Docket Library, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, 725 17th Street, NW., Washington, DC 20503.

The FTA and MTA invite all interested individuals and organizations, and Federal, State, regional, and local agencies to provide comments on the scope of the project. The goals of the Bi-County Transitway are to: Provide improved suburb to suburb transit alternatives and enhanced access to key civic, educational and employment activity centers; improve system connectivity and increase transit usage by providing an essential link to the Metrorail radial lines, as well as to other rail or bus services in Montgomery and Prince George's County; optimize public investment by providing, at a reasonable cost, efficient, safe, and reliable transit service, while minimizing environmental impacts; improve regional mobility by increasing the speed, reliability, and access to transit services in Montgomery and Prince George's Counties; support economic development and revitalization through improved connections to central business districts and activity centers; and support regional clean air quality goals with a cost effective transit alternative. Comments should focus on the alternatives for analysis and environmental issues, rather than on a preference for a particular alternative.

Public meetings and hearings, newsletters, project Web site and other outreach methods and forums will be used to inform the public of the progress of the project and to solicit input from the community on the proposed project as it develops. Outreach activities will include meetings with local officials, community leaders, local stakeholders, and the general public throughout the area. Public attendance at meetings will be sought through mailings, notices, advertisements, press releases and other efforts.

Additional agency coordination will be carried out through the Project Team, which will meet throughout the study process to address key issues. Members of the Project Team will include representatives of Montgomery County, Prince George's County, Washington Metropolitan Area Transit Authority, Maryland-National Capital Park and Planning Commission, and the State Highway Administration.

The project is located in Montgomery and Prince George's Counties, north of Washington, DC. The project area includes established communities characterized by medium-density residential uses, with pockets of high-density development (Bethesda, Silver Spring, Langley Park/Takoma Park, College Park, and New Carrollton), and the University of Maryland. The earliest development in the area corresponded with the construction of electric railways that radiated from the District of Columbia and facilitated movement into outlying areas. The primary roadways centered on downtown Washington, DC, and mainly traversed the corridor north to south. These arterials include Wisconsin Avenue (MD 355), Connecticut Avenue (MD 185), Georgia Avenue (MD 97), New Hampshire Avenue (MD 650), and Baltimore Avenue (US 1). The area has limited infrastructure for east-west travel, with two primary routes consisting of East-West Highway (MD 410) and University Boulevard (MD 193).

This portion of the Metropolitan Washington Region experienced rapid suburban development following World War II, and now contains mature neighborhoods accompanied by the development of supportive commercial activity centers along the primary roadways with the majority of housing stock constructed prior to 1960. Many of the commercial activity centers have access, parking, and pedestrian circulation deficiencies. The service employment sector is very strong throughout the corridor. In addition, professional and office employment are located in clusters near Metro stations in Bethesda, Silver Spring and, to a lesser extent, College Park and New Carrollton.

Numerous communities along the corridor contain populations that rely on transit to reach employment and activity centers. New transit services in the corridor have been limited to bus service, which is subject to roadway congestion. To date, there has been no investment in fixed guideway systems or in new highways to facilitate commuting and links between the development centers along radial transportation routes that cross the corridor. The current east-west connections include bus transit and to a lesser degree, roadways. Commuters must use a north and south means to travel east-west. The area has limited infrastructure for east-west travel, with two primary routes consisting of East-West Highway (MD 410) and University Boulevard (MD 193), neither of which provides a direct connection between Silver Spring and New Carrollton. These routes are heavily congested during peak periods and increasingly unable to accommodate the traffic demands. The focus of the EIS will be to identify a preferred transit alternative that will reduce travel time, provide an alternative to traveling on congested roadways, and improve transit access to central business districts within the area while examining the socioeconomic, cultural and natural environmental considerations on a local and regional basis.

The alternatives proposed for evaluation include:

• A no-build alternative, which includes the current network plus all ongoing, programmed, and committed projects listed in the latest Transportation Improvement Program;

• A TSM alternative, which would include improving existing transit services such as additional bus service and routes, and which also serves as a baseline for evaluation against which all other alternatives may be compared for federal funding purposes (referred to as the FTA Future Baseline);

• Bus Rapid Transit alternatives; and

• Light rail alternatives.

Each build alternative will explore the construction of new transportation infrastructure, such as tracks, stations, and maintenance yards. Underground, surface and/or aerial design options may be developed for each of the build alternative alignments. Multi-modal alternatives will also be explored.

The FTA and MTA will evaluate all potential changes to the social, cultural, economic, built and natural environment, including land acquisition and displacements; land use, zoning, economic development; parklands; community disruption; aesthetics; historical and archaeological resources; traffic and parking; air quality; noise and vibration; water quality; wetlands; environmentally sensitive areas; endangered species; energy requirements and potential for conservation; hazardous waste; environmental justice; safety and security; and secondary and cumulative impacts. Key areas of environmental concern include areas of potential new construction ( e.g. , structures, new transit stations, new track, etc. ). Impacts will be evaluated for both the short-term construction period and for the long-term period of operation associated with each alternative. Measures to avoid, minimize and mitigate any significant adverse impacts will be identified.

Previously, a Notice of Intent (NOI) was published in the Federal Register on September 21, 1994, which announced the preparation of an Environmental Impact Statement for the Georgetown Branch Transitway/Trail in Montgomery County, Maryland. The subsequent Draft Environment Impact Statement (DEIS) was completed in May 1996, and evaluated transportation improvements between the central business districts (CBDs) in Bethesda and Silver Spring, Maryland. The DEIS evaluated both a busway and light rail transit alternative in conjunction with a parallel hiker/biker trail. A Final Environmental Impact Statement was never produced for this study.

This NOI for the Bi-County Transitway Project extends the previous projects limits beyond Silver Spring to New Carrollton. An EIS will be prepared in accordance with section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969 (as amended), as implemented by the Council of Environmental Quality (CEQ) regulations (40 CFR parts 1500-1508), Federal Transit Administration (FTA) regulations (23 CFR part 771), and the FTA Statewide Planning/Metropolitan Planning regulations (23 CFR part 450). These studies will comply with the requirements of the National Historical Preservation Act of 1966, as amended, section 4(f) of the 1966 U.S. Department of Transportation Act, the 1990 Clean Air Act Amendments, Executive Order 12898 on Environmental Justice, and other applicable rules, regulations, and guidance documents.

In addition, MTA intends to seek Section 5309 New Starts funding for the project. As provided in the FTA New Starts regulation (49 CFR part 611), New Starts funding requires the submission of certain specific information to FTA to support a request to initiate preliminary engineering, which is normally done in conjunction with the NEPA process.

Upon completion, the Draft EIS will be available for public and agency review and comment. Public hearings will be held. Based on the findings of the Draft EIS and the public and agency comments received, a preferred alternative will be selected that will be further detailed in the Final EIS.