The Santa Rosa and San Jacinto Mountains National Monument was established by Act of Congress and signed into law on October 24, 2000, by the President. The National Monument was established in order to preserve the nationally significant biological, cultural, recreational, geological, educational and scientific values found in the Santa Rosa and San Jacinto Mountains. This legislation established the first monument to be jointly managed by the Bureau of Land Management (BLM) and the U.S. Forest Service (USFS). The Santa Rosa and San Jacinto Mountains National Monument Act of 2000 affects only Federal lands and Federal interests located within the established boundaries.

The 272,000-acre National Monument encompasses 86,400 acres of Bureau of Land Management lands, 64,400 acres of Forest Service lands, 23,000 acres of Agua Caliente Band of Cahuilla Indians lands, 8,500 acres of California Department of Parks and Recreation lands, 35,800 acres of other State of California agencies lands, and 53,900 acres of private land.

The BLM and the Forest Service jointly manage all Federal lands in the National Monument in coordination with the Agua Caliente Band of Cahuilla Indians, other Federal Agencies, State agencies and local governments.

All committee and subcommittee meetings, including field examinations, are open to the public, including representatives of the media. Any organization, association, or individual may file a statement with, or appear before the committee and/or its subcommittees regarding topics on a meeting agenda.

The Grain Inspection, Packers and Stockyards Administration (GIPSA) administers and enforces the Packers and Stockyards Act of 1921, as amended and supplemented (7 U.S.C. 181-229) (P&S Act). The P&S Act prohibits unfair, deceptive, and fraudulent practices by livestock market agencies, dealers, stockyard owners, meat packers, swine contractors, and live poultry dealers in the livestock, poultry, and meatpacking industries.

Section 302 of the P&S Act (7 U.S.C. 202) defines the term “stockyard” as follows:

Section 302 (b) of the P&S Act requires the Secretary to determine which stockyards meet this definition, and to notify the owner of the stockyard and the public of that determination by posting a notice in each designated stockyard. After giving notice to the stockyard owner and to the public, the stockyard remains subject to the provisions of Title III of the P&S Act (7 U.S.C. 201-203 and 205-217a) until the Secretary deposts the stockyard by public notice.

We published notices proposing to post the two stockyards on October 8, 2001 and November 7, 2003 (66 FR 52887 and 68 FR 63055-63056, respectively). We received no comments in response to either of these proposed posting notices.

This document notifies the public that the following two stockyards meet the definition of stockyard and that we posted the stockyards. To post stockyards, we assign the stockyard a facility number, notify the owner of the stockyard facility, and send notices to the owner of the stockyard to post on display in public areas of the stockyard. The date of posting is the date on which the posting notices are physically displayed.

A determination has been made by Michael Somerville that the proposed works of improvement for the White Tank Mountains Watershed project will not be installed. The sponsoring local organizations have concurred in this determination and agree that Federal funding should be deauthorized for the project. Information regarding this determination may be obtained from Michael Somerville, State Conservationist, at the above address and telephone number.

No administrative action on implementation of the proposed deauthorization will be taken until 60 days after the date of this publication in the Federal Register .

Scope of Order

The merchandise subject to this antidumping duty order consists of hand trucks manufactured from any material, whether assembled or unassembled, complete or incomplete, suitable for any use, and certain parts thereof, namely the vertical frame, the handling area and the projecting edges or toe plate, and any combination thereof.

A complete or fully assembled hand truck is a hand-propelled barrow consisting of a vertically disposed frame having a handle or more than one handle at or near the upper section of the vertical frame; at least two wheels at or near the lower section of the vertical frame; and a horizontal projecting edge or edges, or toe plate, perpendicular or angled to the vertical frame, at or near the lower section of the vertical frame. The projecting edge or edges, or toe plate, slides under a load for purposes of lifting and/or moving the load.

That the vertical frame can be converted from a vertical setting to a horizontal setting, then operated in that horizontal setting as a platform, is not a basis for exclusion of the hand truck from the scope of this petition. That the vertical frame, handling area, wheels, projecting edges or other parts of the hand truck can be collapsed or folded is not a basis for exclusion of the hand truck from the scope of the petition. That other wheels may be connected to the vertical frame, handling area, projecting edges, or other parts of the hand truck, in addition to the two or more wheels located at or near the lower section of the vertical frame, is not a basis for exclusion of the hand truck from the scope of the petition. Finally, that the hand truck may exhibit physical characteristics in addition to the vertical frame, the handling area, the projecting edges or toe plate, and the two wheels at or near the lower section of the vertical frame, is not a basis for exclusion of the hand truck from the scope of the petition.

Examples of names commonly used to reference hand trucks are hand truck, convertible hand truck, appliance hand truck, cylinder hand truck, bag truck, dolly, or hand trolley. They are typically imported under heading 8716.80.50.10 of the Harmonized Tariff Schedule of the United States (“HTSUS”), although they may also be imported under heading 8716.80.50.90. Specific parts of a hand truck, namely the vertical frame, the handling area and the projecting edges or toe plate, or any combination thereof, are typically imported under heading 8716.90.50.60 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the Department's written description of the scope is dispositive.

Excluded from the scope are small two-wheel or four-wheel utility carts specifically designed for carrying loads like personal bags or luggage in which the frame is made from telescoping tubular material measuring less than 5/8 inch in diameter; hand trucks that use motorized operations either to move the hand truck from one location to the next or to assist in the lifting of items placed on the hand truck; vertical carriers designed specifically to transport golf bags; and wheels and tires used in the manufacture of hand trucks.

In accordance with section 735(d) of the Tariff Act of 1930, as amended (“the Act”), the Department published its final determination that hand trucks from the PRC are being sold in the United States at less than fair value. See Notice of Final Determination of Sales at Less Than Fair Value: Hand Trucks and Certain Parts Thereof from the People's Republic of China , 69 FR 60980 (October 14, 2004). Subsequently, the Department amended its final determination of the antidumping duty investigation of hand trucks from the PRC to correct certain ministerial errors in the final margin calculation. See Notice of Amended Final Determination of Sales at Less Than Fair Value: Hand Trucks and Certain Parts Thereof from the People's Republic of China, 69 FR 65410 (November 12, 2004). On November 23, 2004, in accordance with section 735(d) of the Act, the U.S. International Trade Commission (“ITC”) notified the Department that a U.S. industry is “threatened with material injury,” within the meaning of section 735(b)(1)(A)(ii) of the Act, by reason of less-than-fair-value imports of hand trucks from the PRC.

According to section 736(b)(2) of the Act, duties shall be assessed on subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the ITC's notice of final determination if that determination is based on the threat of material injury and is not accompanied by a finding that injury would have resulted without the imposition of suspension of liquidation of entries since the Department's preliminary determination. In addition, section 736(b)(2) of the Act requires U.S. Customs and Border Protection (“CBP”) to refund any cash deposits or bonds of estimated antidumping duties posted since the Department's preliminary antidumping determination if the ITC's final determination is threat-based.

Because the ITC's final determination is based on the threat of material injury and is not accompanied by a finding that injury would have resulted but for the imposition of suspension of liquidation of entries since the Department's preliminary determination, section 736(b)(2) of the Act is applicable to this order. Therefore, the Department will direct CBP to assess, upon further advice, antidumping duties on all unliquidated entries of hand trucks from the PRC entered, or withdrawn from warehouse, for consumption on or after the date of publication of the ITC's notice of final determination of threat of material injury in the Federal Register and to terminate the suspension of liquidation for entries of hand trucks from the PRC entered, or withdrawn from warehouse, for consumption prior to that date. The Department will also instruct CBP to refund any cash deposits made, or bonds posted, between the publication date of the Department's preliminary antidumping determination and the publication date of the ITC's final determination.

On or after the date of publication of the ITC's notice of final determination in the Federal Register , CBP must require, at the same time as importers would normally deposit estimated duties, cash deposits for the subject merchandise equal to the weighted-average antidumping duty margins as noted below:

This notice constitutes the antidumping duty order with respect to hand trucks from the PRC, pursuant to section 736(a) of the Act. Interested parties may contact the Central Records Unit, Room B-099 of the main Commerce building, for copies of an updated list of antidumping duty orders currently in effect.

This order is published in accordance with section 736(a) of the Act and 19 CFR 351.211.

On July 2, 2003, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on pistachios from Iran, 68 FR 39511. On July 30, 2003, Tehran Negah Nima Trading Company, Inc. (Nima), an exporter of subject merchandise during the period of review, requested that the Department conduct an administrative review of its sales to the United States covered by the antidumping duty order. On August 22, 2003, the Department initiated an administrative review of the antidumping duty order on pistachios from Iran for the period July 1, 2002, through June 30, 2003, in order to determine whether merchandise imported into the United States was sold at less than fair value by Nima. See Initiation of Antidumping and Countervailing Duty Administrative Review and Requests for Revocations in Part, 68 FR 50750.

On February 5, 2004, the Department extended fully its deadline for the preliminary results of this review. See Certain In-Shell Raw Pistachios from Iran; Extension of Time Limit for Preliminary Results of Administrative Review, 69 FR 5487.

On August 9, 2004, the Department published the preliminary results of this review (69 FR 48197).

Pursuant to section 751(a)(3)(A) of the Act, the Department may extend the deadline for completion of the final results of an administrative review if it determines that it is not practicable to complete the final results within the statutory time limit of 120 days from the date on which the preliminary results were published. The Department has determined that due to the complexity of the issues in this review, including (1) whether the producer of the subject merchandise ( i.e., Razi Domghan Agricultural and Animal Husbandry Company) had known or should have known that the pistachios it sold to Nima were destined for the United States, and (2) the calculation of profit for purposes of constructed value, it is not practicable to complete this review within the time limits mandated by section 751(a)(3)(A) of the Act and section 19 CFR 351.213(h)(1) of the Department's regulations. Therefore, the Department is extending the time limit for the completion of these final results by 60 days. Accordingly, the final results of this review will now be due no later than February 7, 2005. 1

This notice is published in accordance with section 751(a)(3)(A) of the Act and section 19 CFR 351.213(h)(2) of the Department's regulations.

On May 3, 2004, the Department initiated and the ITC instituted a sunset review of the antidumping duty order on paint brushes from the PRC pursuant to section 751(c) of the Act. 3 As a result of its review, the Department found that revocation of the antidumping duty order would be likely to lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margins likely to prevail were the order to be revoked. See Department's Final Results.

On November 19, 2004, the ITC determined, pursuant to section 751(c) of the Act, that revocation of the antidumping duty order on paint brushes from the PRC would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. See ITC Determination.

The products covered by the order are natural bristle paintbrushes and brush heads from the PRC. Excluded from the order are paintbrushes and brush heads with a blend of 40 percent natural bristles and 60 percent synthetic filaments. The merchandise under review is currently classifiable under item 9603.40.40.40 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS subheading is provided for convenience and customs purposes, the Department's written description of the merchandise is dispositive.

As a result of the determinations by the Department and the ITC that revocation of this antidumping duty order would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on paint brushes from the PRC.

The Department will instruct U.S. Customs and Border Protection to continue to collect antidumping duty deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of continuation of this order will be the date of publication in the Federal Register of this Notice of Continuation. Pursuant to section 751(c)(2) and 751(c)(6) of the Act, the Department intends to initiate the next five-year review of this order not later than November 2009.

On July 2, 2003, the Department published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty order on SSSS from Italy. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 68 FR 39511. On July 31, 2003, ThyssenKrupp Acciai Speciali Terni S.p.A. (TKAST) and petitioners requested that the Department conduct an administrative review of the antidumping duty order. On August 22, 2003, the Department initiated an administrative review of the antidumping duty order on SSSS from Italy with regard to TKAST. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part, 68 FR 50750.

On February 9, 2004, the Department extended by 60 days the deadline for issuing the preliminary results of this review. See Extension of Time Limit of the Preliminary Results of Antidumping Duty Administrative Review: Stainless Steel Sheet and Strip in Coils from Italy, 69 FR 9590 (March 1, 2004). On August 9, 2004, the Department published the preliminary results of this review (69 FR 48205).

Pursuant to section 751(a)(3)(A) of the Act, the Department may extend the deadline for completion of the final results of an administrative review if it determines that it is not practicable to complete the final results within the statutory time limit of 120 days from the date on which the preliminary results were published. The Department has determined that due to the complexity of the issues raised in this review, including how to treat premiums paid by respondent's ( i.e., ThyssenKrupp Acciai Speciali Terni S.p.A.'s) parent company to buyback company stock held by an Iranian company, it is not practicable to complete this review within the time limits mandated by section 751(a)(3)(A) of the Act and section 19 CFR 351.213(h)(1) of the Department's regulations. Therefore, the Department is extending the time limit for the completion of these final results by 60 days. Accordingly, the final results of this review will now be due no later than February 7, 2005. 1

This notice is published in accordance with section 751(a)(3)(A) of the Act and section 19 CFR 351.213(h)(2) of the Department's regulations.

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 parts 222-226).

The applicant proposes to conduct five sea turtle studies under the same permit. The first would involve in-water research of marine turtle populations in the central region of the Indian River Lagoon of Florida. The research would continue a study designed to determine the long-term trends in abundance, distribution and population structure of sea turtles in this region. The applicant proposes to capture by tangle net, flipper and passive integrated transponder (PIT) tag, measure, weigh, blood sample, photograph and release 600 green, 135 loggerhead, 3 Kemp's ridley and 2 hawksbill turtles. Green sea turtles would also be lavaged.

The information collection submitted for OMB review contains the following:

1. Collection of Information: FERC-515 “Declaration of Intention”.

2. Sponsor: Federal Energy Regulatory Commission.

3. Control No.: 1902-0079.

The Commission is now requesting that OMB approve and reinstate with a three-year extension of the expiration date, with no changes to the existing collection. The information filed with the Commission is mandatory.

3. Necessity of the Collection of Information: Submission of this information is necessary to enable the Commission to carry out its responsibilities in implementing the statutory provisions of part I, Sections 23(b) of the Federal Power Act (FPA). Section 23(b) authorizes the Commission to make a determination as to whether it has jurisdiction over a proposed hydroelectric project. Section 23(b) also requires that any person intending to construct project works on navigable commerce clause waters must file a declaration of their intention to do so with the Commission. If the Commission finds the proposed project will have an impact on “interstate or foreign commerce”, then the person(s) intending to construct the project must obtain a Commission license or exemption before construction. Such sites are generally on streams defined as U.S. navigation waters, and over which the Commission has jurisdiction under its authority to regulate foreign and interstate commerce. The information is collected in the form of a written application, declaring the applicant's intent and used by Commission staff to research the jurisdictional aspects of the project. A finding of non-jurisdictional by the Commission eliminates a substantial paperwork burden for the applicant who might otherwise have to file for a license or an exemption application.

The information filed with the Commission is a mandatory requirement. The Commission implements these filing requirements in the Code of Federal Regulations (CFR) under 18 CFR part 24.

5. Respondent Description: The respondent universe currently comprises 10 respondents (average) subject to the Commission's jurisdiction.

6. Estimated Burden: 800 total hours, 10 respondent (average per year), 1 response per respondent, and 80 hours per response (average).

7. Estimated Cost Burden to respondents: 800 hours/2080 hours per years × $108,588 per year = $41,764.

The information collection submitted for OMB review contains the following:

1. Collection of Information: FERC-511 “Application for Transfer of License”.

2. Sponsor: Federal Energy Regulatory Commission.

3. Control No.: 1902-0069.

The Commission is now requesting that OMB approve and reinstate with a three-year extension of the expiration date, with no changes to the existing collection. The information filed with the Commission is mandatory.

4. Necessity of the Collection of Information: Submission of this information is necessary to enable the Commission to carry out its responsibilities in implementing the statutory provisions of sections 4(e) and 8 of the Federal Power Act (FPA). Section 4(e) authorizes the Commission to issue licenses for the construction, operation and maintenance of reservoirs, power houses and transmission lines or other facilities necessary for development and improvement of navigation and for the development, transmission, and utilization of power from bodies of water that Congress has jurisdiction over. Section 8 of the FPA provides that the voluntary transfer of any license can only be made with the written approval of the Commission. Any successor to the licensee may assign the rights of the original license but is subject to all of the conditions of the license.

The information filed with the Commission is mandatory requirement contained in the format of a written application for transfer of license, executed jointly by the parties to the proposed transfer. The transfer of a license may be occasioned by the sale or merger of a licensed hydroelectric project. It is used by the Commission's staff to determine the qualifications of the proposed transferee to hold the license, and to prepare the transfer of the license order. The Commission implements these requirements in the Code of Federal Regulations (CFR) under 18 CFR part 9 and 131.20.

5. Respondent Description: The respondent universe currently comprises 23 respondents (average) subject to the Commission's jurisdiction

6. Estimated Burden: 920 total hours, 23 respondents (average per year), 1 response per respondent, and 40 hours per response (average).

7. Estimated Cost Burden to respondents: 920 hours/2080 hours per years × $108,588 per year = $48,029.

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On August 19, 2004 (69 FR 51462), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.

EPA has established a public docket for this ICR under Docket ID No. OARM-2004-0001, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Office of Environmental Information Docket is (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket . Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to http://www.epa.gov/edocket .

Title: General Administrative Requirements For Assistance Programs: EPA Administrative Capability Questionnaire.

Abstract: The Environmental Protection Agency (EPA) is establishing procedures for assessing administrative capability of non-profit organizations applying for EPA grants. Under the new procedures, EPA will require certain non-profit applicants to complete a checklist entitled “EPA Administrative Capability Questionnaire” and return it to EPA with supporting documentation. The responses to the form will be a basis for assessing administrative capability and deciding whether to award grants to the non-profit applicant. Applicants that provide information that demonstrates they are administratively capable will be “certified” for the next four years, and therefore, would not have to resubmit the questionnaire and supporting documents in the next four years unless administrative management issues arise before the certification period has ended. Note: One potentially significant revision since the publication of the first Federal Register notice has been the inclusion of an additional (optional) data element. This data element “CPA CERTIFICATION (OPTIONAL),” at the end of the questionnaire, allows the applicant to further demonstrate that the recipient has established fiscal controls and accounting procedures which assure that project funds are distributed and accounted for properly.

In applying for a non-construction, discretionary grant from EPA, each applicant is currently required to complete and submit Standard Form (SF) series forms SF424, SF424A, and SF424B. By signing the SF424B, “Assurances—Non-Construction Programs”, the applicant is assuring compliance with various statutory and regulatory requirements (40 CFR part 30—Grants and Agreements with Institutions of Higher Education, Hospitals, and other Non-Profit Organizations) and is assuring that it “[h]as the legal authority to apply for Federal assistance and the institutional, managerial and financial capability (including funds sufficient to pay the non Federal share of project cost) to ensure proper planning, management and completion of the project described in this application”. Despite this assurance, EPA's Office of the Inspector General and Office of Grants and Debarment within EPA's Office of Administration and Resources Management have documented numerous instances of non-profit recipients that have inadequate administrative systems to manage EPA funds or lack the capability to successfully perform the project scope of work.

Recognizing that it is preferable to address such issues before, rather than after a grant is awarded, EPA is prescribing uniform pre-award procedures for evaluating the administrative and programmatic capability of non-profit applicants. As part of these procedures, EPA will require that non-profit applicants seeking funding for a new award in excess of $200,000 complete a checklist entitled “EPA Administrative Capability Questionnaire” and return it to the designated EPA office with supporting documentation. In limited cases EPA may also require non-profit applicants seeking new awards below this threshold to complete the same questionnaire, where the Agency learns that significant weakness/deficiencies may be present that could compromise a non-profit's administrative capability. Note that much of the information to be collected in the proposed questionnaire is currently being collected from grant recipients during EPA's post-award monitoring activities (ref.: OMB 2030—0020, Expiration date 12/31/05). The information to be collected also directly relates to the administrative management systems which recipients are required to establish under 40 CFR part 30.

For purposes of this Notice, EPA uses the term “administrative capability” interchangeably with the term “managerial and financial capability”. The term “administrative capability” means the capability of an applicant or recipient to develop and implement administrative systems required by 40 CFR part 30, including systems related to financial management, property management, procurement standards and financial reporting and recordkeeping. For purposes of this Notice, EPA uses the term “programmatic capability” interchangeably with the term “institutional capability”. The term “programmatic capability” means the technical capability of an applicant or recipient to successfully carry out a project, taking into account factors such as past performance on similar projects, prior experience, timely progress reporting, the qualifications of key personnel and allocation of roles and responsibilities for proper project management, and the adequacy of equipment, resources and facilities.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 4.0 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: EPA non-profit applicants recommended for new assistance awards of greater than $200,000.

Estimated Number of Respondents: 100.

Frequency of Response: Once every four years.

Estimated Total Annual Hour Burden: 400.

Estimated Total Annual Cost: $16,875, includes $0 annualized capital or O&M costs.

Changes in the Estimates: There is a increase of 400 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to the addition of a new Data Collection Instrument (protocol) to the others already utilized in EPA's “General Administrative Requirements For Assistance Programs”—OMB Control Number 2030-0020 (Expiration Date: 12/31/2005). This new protocol is necessary to maintain and enhance EPA's Federal stewardship responsibilities.

OMB Control Number: 3060-XXXX.

Title: Radio Frequency Identification Equipment, 47 CFR 15.240.

Type of Review: New collection.

Form Number: N/A.

Respondents: Not-for-profit institutions; business or other for-profit; and State, local, or tribal governments.

Number of Respondents: 10.

Estimated Time per Response: 2 hour.

Frequency of Response: On occasion reporting requirement; Third party disclosure.

Total Annual Burden: 200 hours.

Total Annual Cost: None.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: On April 15, 2004, the FCC adopted a Third Report and Order, In the Matter of Review of part 15 and other Parts of the Commission's Rules, ET Docket No. 01-278, RM-9375, RM-10051, FCC 04-98. The Third Report and Order requires each grantee of certification for Radio Frequency Identification (RFID) Equipment to register the location of the equipment/devices its markets with the Commission. The information the grantee must supply to the Commission when registering the devices shall include the name, address and other pertinent contact information of users, the geographic coordinates of the operating location, and the FCC identification number(s) of the equipment. The improved RFID equipment could benefit commercial shippers and have significant homeland security benefits by enabling the entire contents of shipping containers to be easily and immediately identified, and by allowing a determination of whether tampering with their contents has occurred during shipping.

OMB Control Number: 3060-0004.

Title: Guidelines for Evaluating the Environmental Effects of Radiofrequency Radiation, Second Memorandum Opinion and Order, ET Docket No. 93-62.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Not-for-profit institutions; business or other for-profit; and State, local or tribal government.

Number of Respondents: 122,985.

Estimated Time per Response: 2.02 hours (avg.).

Frequency of Response: On occasion reporting requirement; third party disclosure.

Total Annual Burden: 256,080 hours.

Total Annual Cost: $1,193,000.

Privacy Act Impact Assessment: N.A.

Needs and Uses: The National Environmental Policy Act of 1969 (NEPA) required Federal agencies to evaluate the effects of their actions on “human environmental quality.” To comply with NEPA, the Commission adopted rules, 47 CFR 1.1307, which revised the Radio Frequency (RF) exposure guidelines for FCC-regulated facilities. The new guidelines reflect more recent scientific studies of RF electromagnetic fields and their biological effects and are designed to ensure that the public and workers receive adequate protection from exposure to potentially harmful RF electromagnetic fields. The FCC staff uses the information required under section 1.1307 to determine whether the environmental evaluation is sufficiently complete and in compliance with the FCC Rules to be acceptable for filing.

OMB Control Number: 3060-0188.

Title: Call Sign Reservation and Authorization System, FCC Form 380.

Form Number: FCC Form 380.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; Not-for-profit institutions.

Number of Respondents: 1,600.

Estimated Time per Response: 0.166—0.25 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 333 hours.

Total Annual Cost: $142,000.

Privacy Impact Assessment: No impact(s).

Needs and Uses: 47 CFR 73.3550 provides that all requests for new or modified call signs be made via the on-line call sign reservation and authorization. The FCC Form 380 is an on-line system for electronic preparation and submission of requests for the reservation and authorization of new and modified call signs. Access to the call sign reservation and authorization system is made by broadcast licensees and permittees, or by persons acting on their behalf, via the Internet's World Wide Web. This on-line, electronic call sign system enables users to determine the availability and licensing status of call signs; to request an initial, or change an existing, call sign; and to determine and submit more easily the appropriate fee, if any. 47 CFR 74.783 also permits any low power television (LPTV) station to request a four-letter call sign after receiving its construction permit. All initial LPTV construction permits will continue to be issued with a five-character alpha-numeric LPTV call sign. LPTV licensees/permittees are also required to use the on-line call sign reservation and authorization system. The call sign reservation and authorization system is used by permittees, licensees or persons acting on their behalf to determine the availability of a call sign and to request an initial call sign or change an existing call sign.

OMB Control Number: 3060-0844.

Title: Carriage of the Transmissions of Digital Television Broadcast Stations, Report & Order (R&O) and Further Notice of Proposed Rulemaking (FNPRM).

Form Number: Not Applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 10,100.

Estimated Time per Response: 30 minutes—40 hours.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

Total Annual Burden: 81,296 hours.

Total Annual Cost: $2,359,681.

Privacy Impact Assessment: No impact(s).

Needs and Uses: The FCC adopted a Report and Order (R&O) on January 23, 2001, and Further Notice of Proposed Rulemaking (FNPRM). The R&O modified 47 CFR 76.64(f) to provide that stations that return their analog spectrum and broadcast only in digital format are entitled to elect must-carry or retransmission consent status following the procedures previously applicable to new television stations. The R&O also provided only carriage rights for a very limited number of digital-only television broadcast station (DTV) and may result in voluntary carriage for a subset of other DTV stations. Furthermore, the R&O established a framework for voluntary retransmission consent agreements between DTV station licensees and multi-channel video programming distributors and modified several sections of the rules accordingly. The FNPRM sought additional comments on carriage requirements relating to digital television stations generally, as proposed in the initial NPRM.

OMB Control No.: 3060-0851.

Title: Application for Assignment of a Multipoint Distribution Service Authorization.

Form No: FCC Form 305.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit and not-for-profit institutions.

Number of Respondents: 160.

Estimated Time Per Response: 1.5-5 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 800 hours.

Total Annual Cost: $1,610,350.

Privacy Act Impact Assessment: Not applicable.

Needs and Uses: The Commission is now revising FCC Form 305 to request additional information to complete the Universal Licensing System (ULS) data elements since Multipoint Distribution Service (MDS) has been integrated into ULS. Additional information such as the licensee's e-mail address, fax number, type of applicant, contact's e-mail address and fax number will be added to this form. There will also be clarification of data elements, instructions and corrections of mailing addresses and Web sites.

OMB Control No.: 3060-0852.

Title: Application for Transfer of Control of a Multipoint Distribution Service Authorization.

Form No: FCC Form 306.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit and not-for-profit institutions.

Number of Respondents: 20.

Estimated Time Per Response: .75-3.5 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 110 hours.

Total Annual Cost: $211,275.

Privacy Act Impact Assessment: Not applicable.

Needs and Uses: The Commission is now revising FCC Form 306 to request additional information to complete the Universal Licensing System (ULS) data elements since Multipoint Distribution Service (MDS) has been integrated into ULS. Additional information such as the licensee's e-mail address, fax number, type of applicant, contact's e-mail address and fax number will be added to this form. There will also be clarification of data elements, instructions and corrections of mailing addresses and Web sites.

OMB Control No.: 3060-0395.

Title: The ARMIS USOA Report (ARMIS Report 43-02); the ARMIS Service Quality Report (ARMIS Report 43-05); and the ARMIS Infrastructure Report (ARMIS Report 43-07).

Report Nos.: FCC Reports 43-02, 43-05 and 43-07.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 50.

Estimated Time Per Response: 415 hours.

Frequency of Response: Annual reporting requirement.

Total Annual Burden: 20,750 hours.

Total Annual Cost: $4,347,000.

Privacy Act Impact Assessment: N/A.

Needs and Uses: The FCC Report 43-02 provides the annual results of the carriers' activities for each account of the Uniform System of Accounts. The FCC Report 43-05 provides service quality information in the areas of inter-exchange access service, installation and repair intervals, local service installation and repair intervals, trunk blockage, and total switch downtime for price cap carriers. FCC Report 43-07 provides switch deployment and capabilities data.

OMB Control No.: 3060-0410.

Title: Forecast of Investment Usage Report and Actual Usage of Investment Report.

Form Nos.: FCC Forms 495A and 495B.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 97.

Estimated Time Per Response: 80 hours.

Frequency of Response: Annual reporting requirement.

Total Annual Burden: 7,760 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Needs and Uses: FCC Forms 495A and 495B are needed to detect and correct forecast errors that could lead to significant misallocation of network plant between regulated and non-regulated activities. FCC's purpose is to protect the regulated ratepayer from subsidizing the non-regulated activities of rate regulated telephone companies. Only large incumbent local exchange carriers (ILECs) file these forms/reports.

OMB Control No.: 3060-0496.

Title: The ARMIS Operating Data Report.

Report No.: FCC Report 43-08.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 56.

Estimated Time Per Response: 139 hours.

Frequency of Response: Annual reporting requirement.

Total Annual Burden: 7,784 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Needs and Uses: FCC Report 43-08 collects annual statistical data in a consistent format that is essential for the Commission to monitor network growth, usage, and reliability.

OMB Control No.: 3060-0511.

Title: ARMIS Access Report.

Report No.: FCC Report 43-04.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 82.

Estimated Time Per Response: 153 hours.

Frequency of Response: Annual reporting requirement.

Total Annual Burden: 12,546 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Needs and Uses: FCC Report 43-04 is needed to administer the Commission's accounting, jurisdictional separations and access charge rule; to analyze revenue requirements and rates of return; and to collect financial data from Tier 1 incumbent local exchange carriers (ILECs).

OMB Control No.: 3060-0512.

Title: The ARMIS Annual Summary Report.

Report No.: FCC Report 43-01.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 124.

Estimated Time Per Response: 89 hours.

Frequency of Response: Annual reporting requirement.

Total Annual Burden: 11,036 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Needs and Uses: FCC Report 43-01 contains financial and operating data and is used to monitor the incumbent local exchange carrier (ILEC) industry and to perform routine analyses of costs and revenues on behalf of the Commission. For this collection, and the ones referenced above, the Commission is seeking extension (no change in requirements) in order to obtain the full three year clearance from the Office of Management and Budget (OMB).

OMB Control No.: 3060-0986.

Title: Federal State Joint Board on Universal Service—Plan for Reforming the Rural Universal Service Support Mechanism, CC Docket No. 96-45.

Form No.: FCC Form 525.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit and state, local or tribal government.

Number of Respondents: 2,000.

Estimated Time Per Response: 1.5 hours.

Frequency of Response: On occasion, annual, and quarterly reporting requirements and third party disclosure requirements.

Total Annual Burden: 3,000 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Needs and Uses: With this revision, the Commission plans to implement a new form (FCC Form 525) in which competitive eligible telecommunications carriers (CETCs) will submit line count data. CETCs currently submit this data in a letter format for this and other collections under various OMB control numbers. The use of one form, i.e. , FCC Form 525, will now facilitate this information for all reporting requirements. Finally, this collection is also being revised to eliminate one time filing requirements that have now expired and are being removed from this collection.

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

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the Nation's food supply. FDA is planning to conduct a consumer survey about food safety under this authority. The food safety survey will provide information about consumers' food safety awareness, knowledge, concerns, and practices. A nationally representative sample of 4,000 adults in households with telephones will be selected at random and interviewed by telephone. This survey will include an oversample of Hispanics with a minimum of 500 Hispanics sampled. Additionally, 200 initial nonrespondents will be asked to participate in a short version of the survey to conduct a nonresponse analysis. Participation will be voluntary. Detailed information will be obtained about food safety risk perception, perceived sources of food contamination, knowledge of particular microorganisms, food handling practices, consumption of raw foods from animals, and perceived foodborne illness and food allergy experience.

The majority of the questions to be asked are identical to ones asked in the 2001 Food Safety Survey (the 2001 survey). Because of recent national consumer education campaigns about food safety and the large amount of media attention to food safety issues in the past few years, consumer attitudes, knowledge, and practices are likely to have changed greatly since the 2001 survey. FDA needs current information to support consumer education programs and regulatory development. Additionally, this data will be used to measure changes in food safety handling practices and food allergy reactions as part of the Healthy People 2010 food safety objectives and allergen goals. New areas on the survey include awareness of bovine spongiform encephalopathy and acrylamide, refrigeration practices, and updated questions on washing practices for fresh fruits and vegetables.

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

The burden estimate is based on FDA's experience with the 2001 survey mentioned previously in this document.

On February 12, 1996, Mr. Bhutani, former President and Treasurer of Alra Laboratories, Inc. (Alra), was found guilty of one count of conspiracy, a Federal felony offense under 18 U.S.C. 371, and six other counts, also Federal felonies, related to violations under sections 301(a), (e), and (k) and 303 of the act (21 U.S.C. 331(a), (e), and (k) and 333(a)(2)). A new trial was ordered by the U.S. District Court for the Northern District of Illinois-Eastern Division on December 17, 1997. On April 28, 1999, the U.S. Court of Appeals for the Seventh Circuit reversed the District Court's ruling that Mr. Bhutani was entitled to a new trial and reinstated his convictions. On October 12, 1999, Mr. Bhutani pled guilty to one count of wire fraud, a Federal felony under 18 U.S.C. 1343. On February 15, 2000, Mr. Bhutani was adjudged guilty of all of these offenses and sentenced by the U.S. District Court for the Northern District of Illinois-Eastern Division. The U.S. Court of Appeals for the Seventh Circuit affirmed the District Court's denial of a motion for a new trial on September 12, 2001.

The basis for these convictions were Mr. Bhutani's violations of various sections of the act involving the drug products LACTULOSE Syrup and K+10 (potassium chloride extended-release tablets). Specifically, Mr. Bhutani, the President and Treasurer of Alra, was convicted of the following:

• Conspiracy (in violation of 18 U.S.C. 371) to commit the following offenses against the United States: (1) Manufacturing and introducing adulterated and misbranded generic drug products into interstate commerce (in violation of 21 U.S.C. 331(a)); (2) failing to establish and maintain records as required under the act (in violation of 21 U.S.C. 331(e)); (3) making false statements to FDA (in violation of 18 U.S.C. 1001); (4) obstructing the administration of law in proceedings pending before FDA (in violation of 18 U.S.C. 1505); and (5) obstructing proceedings before a Federal grand jury (in violation of 18 U.S.C. 1503).

• Adulterating the drug product LACTULOSE Syrup, United States Pharmacopeia (USP), lot 52-230-P, in violation of 21 U.S.C. 331(k), by including decomposed LACTULOSE raw material in the finished drug product, and by deviating from the approved manufacturing procedures by adding an undocumented substance, sodium hydroxide, to this drug product in an unapproved manner.

• Failing to establish and maintain records as required under the act (in violation of 21 U.S.C. 331(e)), specifically failing to establish and maintain accurate drug manufacturing batch production records for the drug product LACTULOSE Syrup, USP, lot 52-230-P, in that he failed to document the unauthorized addition of sodium hydroxide more than 2 years after the original manufacture of this lot.

• Introducing into interstate commerce, in violation of 21 U.S.C. 331(a), the drug product LACTULOSE Syrup, USP, lot 52-230-P, which (1) was not manufactured in accordance with current good manufacturing practice regulations and (2) contained an undocumented substance, sodium hydroxide.

• Adulterating the drug product LACTULOSE Syrup, USP, lot 92-558-P, by violating current good manufacturing practice regulations and by preparing and holding the drug product under unsanitary conditions whereby it may have been contaminated with filth (21 U.S.C. 331(k)). Specifically, Mr. Bhutani received the drug product's active raw material, LACTULOSE concentrate, in punctured drums and then directed Alra employees to inject hot glue into the punctures to plug the leaks, and to wrap self-adhesive duct tape over the punctures, and thereafter used this contaminated raw material in the manufacture of a finished drug product.

• Introducing into interstate commerce the drug product LACTULOSE, lot 92-558-P, which was adulterated in that it was not manufactured in accordance with current good manufacturing practice regulations, and it was prepared and held under unsanitary conditions whereby it may have been contaminated with filth, in violation of 21 U.S.C. 331(a). Alra then used this contaminated raw material in the manufacture of a finished drug product and shipped it in interstate commerce to customers.

• Adulterating the drug product K+10 by violating current good manufacturing practice regulations under 21 U.S.C. 331(k), by contaminating this drug product with metal shavings from a stainless steel pipe, and by preparing and holding the drug product under unsanitary conditions whereby it may have been contaminated with filth and rendered injurious to health. Specifically, Mr. Bhutani directed employees to make tablets from the drug product when he knew the granulation powder contained metal fragments from a stainless steel pipe.

As a result of Mr. Bhutani's convictions and because he was convicted of felonies that were clearly related to the regulation of a drug product under the act, FDA served him by certified letter on February 6, 2003, a proposal to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal also offered Mr. Bhutani an opportunity for a hearing on the proposal. FDA based the debarment proposal on a finding that Mr. Bhutani was convicted of a felony under Federal law for conduct relating to the regulation of Alra's drug products.

The certified letter informed Mr. Bhutani that his request for a hearing could not rest upon mere allegations or denials, but must present specific facts showing that there was a genuine and substantial issue of fact requiring a hearing. The letter also informed Mr. Bhutani that the only material issue of fact was whether he was convicted as alleged in the letter. Finally, the letter informed Mr. Bhutani that if it conclusively appeared from the face of the information and factual analyses in his request for a hearing that there was no genuine and substantial issue of fact that precluded the order of debarment, FDA would enter summary judgment against him and deny his request for a hearing.

In a letter dated January 30, 2003,  1 Mr. Bhutani requested a hearing on the proposal and attached supporting materials. In his request for a hearing, Mr. Bhutani acknowledges his convictions under Federal law as alleged by FDA. However, he disputes many of the facts and judicial decisions that formed the basis for his convictions.

We reviewed these materials, as well as supplementary submissions from Mr. Bhutani dated February 25, 2003, March 17, 2003, February 17, 2004, and November 12, 2004, and find that they do not create a basis for a hearing because hearings will be granted only if there is a genuine and substantial issue of fact. Hearings will be granted neither on issues of policy or law or on mere allegations, denials, or general descriptions of positions and contentions, nor on data and information insufficient to justify the factual determination urged. (See 21 CFR 12.24(b).)

The Associate Commissioner for Regulatory Affairs has considered Mr. Bhutani's arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing.

Mr. Bhutani raised a number of legal arguments in support of his hearing request. These legal arguments are not relevant to the decision to grant a hearing because Mr. Bhutani has not raised a genuine and substantial issue of fact. A hearing will not be granted on issues of law. See 21 CFR 12.24(b)(1). Mr. Bhutani's legal arguments are discussed in the following paragraphs.

Mr. Bhutani contends that “materiality” as an element of “intent to defraud” was erroneously not given as a jury instruction, citing U.S. v. Neder , 527 U.S. 1 (1999). Neder held that when Congress used the term “to defraud” in the mail and wire fraud statutes, Congress incorporated the common law requirement of materiality as an element of the offense.

Mr. Bhutani maintains that the violations cited by the proposal to debar are not material and that there is no evidence that the acts underlying the violations affected the quality, strength, purity, or potency of the drug products under his control.

The act requires FDA to mandatorily debar an individual who has been convicted of certain Federal felonies. Thus, the only relevant factual issue here is whether Mr. Bhutani was, in fact, convicted of a Federal felony for conduct related to the regulation of a drug product, and not whether the acts underlying the violations are material. Accordingly, Mr. Bhutani's argument is without merit.

Mr. Bhutani maintains that in 1988, section 301(e) of the act did not specifically require batch documentation, as it does now, and therefore ex post facto principles apply. An ex post facto law is one that reaches back to punish acts that occurred before enactment of the law or that adds a new punishment to one that was in effect when the crime was committed. Ex Parte Garland , 4 Wall 333, 337, 18L. Ed 366 (1866); Collins v. Youngblood , 497 U.S. 37 (1990).

Mr. Bhutani's assertion regarding section 301(e) relates to the facts and findings underlying his conviction. These facts and findings are not relevant to this debarment proceeding. As stated previously in this document, the only relevant consideration under section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)) is whether Mr. Bhutani was convicted of a felony under Federal law for conduct related to the regulation of a drug product under the act. Therefore, Mr. Bhutani's argument regarding section 301(e) and the Ex Post Facto Clause in connection with this debarment proceeding is without merit.

Mr. Bhutani also suggests that, in general, the Ex Post Facto Clause of the U.S. Constitution prohibits application of section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)) to him because this section was not in effect at the time of Mr. Bhutani's criminal conduct.

With the enactment of the Generic Drug Enforcement Act (GDEA) on May 13, 1992, Congress amended the act to include section 306(a)(2) of the act. Mr. Bhutani's implication that application of the mandatory debarment provisions of the act is prohibited by the Ex Post Facto Clause is unpersuasive. Because the intent behind debarment under section 306(a)(2) of the act is remedial rather than punitive, this section does not violate the Ex Post Facto Clause. The congressional intent with respect to actions under section 306(a)(2) of the act is clearly remedial. Congress created the GDEA in response to findings of fraud and corruption in the generic drug industry. Both the language of the GDEA itself and its legislative history reveal that the purpose of the debarment provisions set forth in the GDEA is “to restore and ensure the integrity of the ANDA [abbreviated new drug application] approval process and to protect the public health.” (See section 1, Public Law 102-282, the Generic Drug Enforcement Act of 1992.) This is a remedial rather than punitive goal. In Bae v. Shalala , 44 F. 3d 489 (7th Cir. 1995), the Seventh Circuit upheld FDA's debarment under the GDEA of the former president of a generic drug manufacturing firm, based on his antecedent conviction for providing an “unlawful gratuity” to an FDA official. Although Bae argued that his debarment was “retroactive punishment” in violation of the Ex Post Facto Clause of the U.S. Constitution, the Seventh Circuit found that Bae's debarment was remedial, not punitive, and therefore did not violate the Ex Post Facto Clause. ( Bae , 44 F. 3d at 493, 495-96). The Seventh Circuit recognized that, to achieve its remedial goal of restoring consumer confidence in the generic drug industry, Congress appropriately determined that it could prohibit felons such as Bae from future activity in the industry. ( Id . at 496.) (See also DiCola v. FDA , 77 F. 3d 504 (D.C. Cir. 1996 (debarment of a convicted felon did not violate Ex Post Facto Clause); Manocchio v. Kusserow , 961 F. 2d 1539, 1542 (11th Cir. 1992) (exclusion of physician from participation in Medicare programs because of criminal conviction is remedial, not punitive and therefore did not violate the Ex Post Facto Clause).)

The Supreme Court has long held that statutes that deny future privileges to convicted offenders because of their previous criminal activities to insure against corruption in specified areas do not impose penalties for past conduct and, therefore, do not violate the ex post facto prohibitions. (See, e.g., Hawker v. New York , 170 U.S. 189, 190 (1898) (physician barred from practicing medicine for a prior felony conviction); De Veau v. Braisted , 363 U.S. 144 (1960) (convicted felon's exclusion from employment as officer of waterfront union is not a violation of the Ex Post Facto Clause).) In De Veau , the court upheld a law that prohibited a convicted felon from employment as an officer in a waterfront union. The purpose of the law was to remedy the past corruption and to insure against future corruption in the waterfront unions. The court in De Veau , 363 U.S. at 160, stated:

As in De Veau , the legislative purpose of section 306(a)(2) of the act is to ensure that fraud and corruption are eliminated from the drug industry. The restrictions placed on individuals convicted of a felony under Federal law are not intended as punishment but are “incident to a regulation of a present situation” ( De Veau , 363 U.S. at 160) and are necessary to remedy the past fraud and corruption in the industry. Because the intent of the GDEA is remedial rather than punitive, Mr. Bhutani's argument that the GDEA violates the Ex Post Facto Clause must fail.

Mr. Bhutani asserts that the proposal to debar him and the debarment provisions themselves (section 306(a)(2)(B) of the act) are too broad and not specific, so he is entitled to a hearing. This argument is without merit.

Neither the proposal to debar nor the act's debarment provisions, on which the proposal to debar was based, are broad or unspecific. The debarment proposal set forth expressly the conduct on which the proposal is based, the findings of FDA, the agency's proposed action, and the procedure for requesting a hearing. Section 306(a)(2)(B) of the act clearly mandates the debarment of an individual who has been convicted of a Federal felony for conduct relating to the regulation of any drug product. The act defines the conduct and felony conviction that lead to debarment. The period of debarment is also in section 306(c)(2) of the act, which states that the debarment is permanent.

In fact, the debarment provisions are narrowly drawn to accomplish the legitimate government purposes of ensuring the integrity of the drug regulatory process and protecting the public health. The debarment provisions further the compelling governmental interest of “restor[ing] consumer confidence in generic drugs by eradicating the widespread corruption in the generic drug approval process.” ( Bae v. Shalala , 44 F. 3d 489, 493 (7th Cir. 1995).)

Mr. Bhutani asserts that as he has already been convicted and sentenced for his actions, further punishment in the form of a permanent debarment violates the Double Jeopardy Clause of the Fifth Amendment to the U.S. Constitution. The Double Jeopardy Clause states that no person shall “be subject for the same offense to be twice put in jeopardy of life or limb.” Mr. Bhutani relies on U.S. v. Halper , 490 U.S. 435 (1989), which held that a civil sanction can constitute a multiple punishment of the sort prohibited by the Double Jeopardy Clause, to argue that permanent debarment is not rationally related to any remedial purpose and is disproportionate to damages resulting from his violative acts.

Mr. Bhutani's arguments are unpersuasive. First, “jeopardy” cannot attach because the effect of section 306(a)(2) of the act is remedial, not punitive. As previously stated, the legislative goal of this section of the act is to restore and ensure the integrity of the drug approval process and to protect the public health by eradicating fraud and corruption from the drug industry. This is plainly a remedial rather than punitive goal.

Second, the Supreme Court in Hudson v. United States , 522 U.S. 93 (1997), in large part disavowed the method of analysis used in Halper to determine whether a sanction violates the Double Jeopardy Clause. The Court in Hudson stated that the Double Jeopardy Clause protects only against the imposition of multiple criminal punishments for the same offense in successive proceedings. ( Hudson , 522 U.S. at 98-99). It does not prohibit the imposition of any additional sanction that could, “in common parlance,” be described as punishment. ( Id .) (Internal quotation marks and citations omitted).

The Court added that whether a particular punishment is considered criminal or civil is first a matter of statutory construction. ( Id .) That is, a court first must ask whether the legislature, “in establishing the penalizing mechanism, indicated either expressly or impliedly a preference for one label or the other.” ( Id . at 99 (quoting United States v. Ward , 448 U.S. 242, 248 (1980)).) Moreover, where the legislature has indicated an intention to establish a civil penalty, a court must inquire further whether the statutory scheme is “so punitive either in purpose or effect” as to “transform what was clearly intended as a civil remedy into a criminal penalty.” ( Id . at 99 (quoting Rex Trailer Co . v. United States , 350 U.S. 148, 154 (1956)).)

The debarment of Mr. Bhutani is not a criminal penalty under Hudson . In enacting the GDEA, Congress clearly intended that debarment serve as a civil penalty. In Hudson , the Court found “it significant that the authority to issue debarment orders is conferred [by statute] upon the ‘appropriate Federal banking agencies’,” holding “[t]hat such [debarment] authority was conferred upon administrative agencies is prima facie evidence that Congress intended to provide for a civil sanction.” ( Id . at 103 (citations omitted).)

The GDEA explicitly provides FDA with the authority to permanently debar individuals convicted of certain felonies, such as Mr. Bhutani, from “providing services in any capacity to a person that has an approved or pending drug product application” (section 306(a)(2) of the act). Thus, under Hudson , the terms of the GDEA are prima facie evidence that Congress intended the debarment provisions to be civil in nature.

Under the second prong of Hudson , the debarment authorized by the GDEA is not so punitive either in purpose or effect as to transform this civil remedy into a criminal penalty. In Hudson , the Court considered whether a permanent debarment sanction prohibiting participation in any banking activities had such a punitive purpose or effect. The Court concluded that there was no evidence to establish that the debarment sanction at issue was “so punitive in form and effect as to render [it] criminal despite Congress' intent to the contrary.” ( Hudson v. United States , 522 U.S. at 104 (quoting United States v. Ursery , 518 U.S. 267, 290 (1996)).) The Court in Hudson relied on the analysis of Kennedy v. Mendoza-Martinez , 372 U.S. 144, 168-169 (1963), in reaching this holding.

The Hudson court further noted that debarment proceedings have not historically been viewed as punishment. ( Hudson , 552 U.S. at 104). The Court found that “the [debarment] sanctions imposed do not involve an ‘affirmative disability or restraint, ’ as that term is normally understood.” ( Id. (quoting Flemming v. Nestor , 363 U.S. 603, 617 (1960)).) The Court also found that the debarment sanction in the banking statute at issue in the Hudson case does not “come into play ‘only ’ on a finding of scienter,” because willfulness is not a prerequisite to the imposition of the debarment sanction. ( Id . (quoting Kennedy , 372 U.S. at 169).) Likewise, the GDEA does not require a finding of willfulness as a prerequisite to imposing debarment. In addition, the Court explained that the fact that the conduct for which the debarment is imposed may also be criminal is insufficient to render the debarment sanctions criminally punitive. ( Id .) Finally, and significantly, the Court explained that the general deterrence of the conduct at issue resulting from an individual debarment is insufficient to render the debarment criminal. ( Id .) These factors apply as much to debarment under the GDEA.

Furthermore, the GDEA's permanent prohibition on services in any capacity to a person with an approved or pending drug product application is not excessive in relation to the statute's remedial purpose. The Supreme Court has upheld similar statutes which, for remedial purposes, impose permanent prohibitions. (See Hudson v. United States , 522 U.S. 93 (1997); Hawker v. New York , 170 U.S. 189, 190 (1898); De Veau v. Braisted , 363 U.S. 144 (1960).)

The preclusion of Mr. Bhutani from providing any type of service to holders of pending or approved drug product applications is not excessive in relation to the remedial goals of the GDEA. The D.C. Circuit has held that the GDEA's prohibition on services in any capacity serves the statute's remedial purpose. ( FDA v. DiCola , 77 F. 3d 504 (D.C. Cir. 1996).) Congress prohibited all services to avoid the serious administrative difficulties involved in distinguishing between those positions clearly related to drug regulation and those not clearly related. ( Id. at 507; see also Siegel v. Lyng , 851 F. 2d 412, 416 (D.C. Cir. 1988).) Furthermore, the GDEA's prohibition ensures that the purposes underlying the debarment provisions are not circumvented or undermined. ( DiCola , 77 F. 3d at 507; see also Farley and Calfee, Inc . v. USDA , 941 F. 2d 964, 968 (9th Cir. 1991).) Finally, as previously noted, the Supreme Court in Hudson upheld a similar statute that, for remedial purposes, imposes a prohibition on participation in any banking activity. (See also DiCola , 77 F. 3d at 506-507 (debarment of a convicted felon does not violate the Double Jeopardy Clause); Manocchio v. Kusserow , 961 F. 2d 1539, 1542 (11th Cir. 1992) (exclusion of a physician from the Medicaid program because of a criminal conviction does not violate the Double Jeopardy Clause).)

Under Hudson , debarment under the GDEA is not so punitive either in purpose or effect as to render the penalty criminal. Thus, Mr. Bhutani's argument that debarment under the GDEA violates the Double Jeopardy Clause is unpersuasive.

Mr. Bhutani maintains that FDA is estopped from seeking to debar him because the agency waived additional remedial, civil, or criminal actions against him by entering into “agreements” with him concerning his cooperation in bringing Alra's operations in compliance with FDA regulations. Mr. Bhutani also asserts that the proposal to debar is punitive rather than remedial. These arguments are also unpersuasive.

As discussed in section II.D of this document, a debarment is a remedial, not punitive, action. Furthermore, Mr. Bhutani's argument that FDA is estopped from pursuing further administrative action by virtue of prior “agreements” is unpersuasive. Mr. Bhutani cites no legal authority, and we are unaware of any such authority, that would bar FDA from pursuing this appropriate remedial action as mandated by the GDEA.

Mr. Bhutani maintains that he and Alra entered into two agreements (a consent agreement and a voluntary agreement) with FDA that he and Alra complied with and that FDA was satisfied with. He asserts that under Congressional pressure, FDA initiated a seizure action and a criminal proceeding against Alra. Mr. Bhutani contends that FDA has acted in bad faith and, under the “clean hands” doctrine, should not be allowed to seek additional remedies and relief. This argument is also without merit.

Under the “clean hands” doctrine, a party seeking a judgment is not entitled to relief in equity if the person has done anything unfair or illegal in relation to the subject of the lawsuit. Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co. , 324 U.S. 806, 814 (1945). FDA has not acted in bad faith with respect to any agreements with Mr. Bhutani or Alra. Furthermore, FDA is not seeking any judgment or relief in equity against Mr. Bhutani. FDA is applying to Mr. Bhutani the statutory requirement regarding mandatory debarment of individuals convicted of a felony under Federal law for conduct related to the regulation of a drug product under the act. Therefore, Mr. Bhutani's argument regarding the “clean hands” doctrine is without merit.

Mr. Bhutani maintains that FDA is estopped from taking this regulatory action due to an “unreasonable amount of time that has elapsed.” He cites Costello v. U.S. , 365 U.S. 265 (1961), in support of his contention. Costello involved an individual whose U.S. naturalization was revoked 27 years after his application. The Costello case is not in any way relevant or analogous to the circumstances at issue here, but even if it were, the Court's holding that the petitioner's rights were not violated by a 27-year delay in initiating citizenship revocation undermines, as opposed to supports, Mr. Bhutani's argument. The Court cited, as is the case here, the availability of accurate records and documents attesting to the petitioner's misdeeds ( Id . at 282-283).

FDA initiated administrative action to debar Mr. Bhutani in a timely fashion. Section 306(l)(2) of the act provides a 5-year window from the date of conviction for the agency to initiate the debarment process. Mr. Bhutani's conviction was reinstated on April 29, 1999. The agency issued a proposal to debar on February 6, 2003, within the 5-year statutory window. Therefore, Mr. Bhutani's assertion is unpersuasive.

Finally, Mr. Bhutani argues that FDA must consider a number of factors in this debarment proceeding, including the nature and seriousness of the offense; management participation in the offense; voluntary steps taken to minimize the impact of the offense on the public; changes in ownership, management, or operations that have corrected the cause of the offense and decreased the likelihood of a recurrence; evidence that current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements; and prior convictions. Again, the only relevant fact under section 306(a)(2) of the act is whether Mr. Bhutani was convicted of a felony under Federal law for conduct related to the regulation of a drug product. Therefore, Mr. Bhutani's argument that FDA must consider other factors is without merit.

In his requests for a hearing, Mr. Bhutani does not present any information showing there is a genuine and substantial issue of fact requiring a hearing. Mr. Bhutani does not dispute that he pled guilty to one count of wire fraud and that he was found guilty of seven other counts, all felonies under Federal law. Nor does he dispute that he was convicted of felonies that were clearly related to the regulation of a drug product under the act. The facts underlying Mr. Bhutani's convictions have been established by his convictions and, therefore, are not at issue. Thus, FDA finds that Mr. Bhutani has failed to identify any genuine and substantial issue of fact requiring a hearing. In addition, Mr. Bhutani's legal arguments do not create a basis for a hearing and, in any event, are unpersuasive. Accordingly, FDA denies Mr. Bhutani's request for a hearing.

Therefore, the Associate Commissioner for Regulatory Affairs, under section 306(a) of the act and under authority delegated to him, finds that Mr. Baldev Bhutani has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act (Section 306(a)(2)(B)) of the act).

As a result of the foregoing findings, Mr. Baldev Raj Bhutani is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES ) (sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an approved or pending drug product application who knowingly uses the services of Mr. Bhutani in any capacity, during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6)). If Mr. Bhutani, during the period of his debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any ANDAs submitted by or with the assistance of Mr. Bhutani during the period of his debarment.

FDA is announcing the availability of a draft guidance for industry entitled “Recommended Approaches to Integration of Genetic Toxicology Study Results.” Risk for carcinogenesis is usually determined in rodent assays, in either 2-year studies or shorter-term studies using alternative models (ICH S1B). Regulatory decisions involving both single- and repeat-dose clinical studies are discussed in this guidance. Pharmaceuticals administered through oral, intravenous, topical, and other routes, as appropriate, are subject to this guidance.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on recommended approaches to integration of genetic toxicology study results. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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

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

Section 110 of the Employment Retirement Income Security Act (ERISA) authorizes the Secretary to prescribe alternative methods of compliance with the reporting and disclosure requirements of Title I of ERISA for pension plans. Simplified employee pensions (SEPs) are established in section 408(k) of the Internal Revenue Code (Code). Although SEPs are primarily a development of the Code and subject to its requirements, SEPs are also pension plans subject to the reporting and disclosure requirements of Title I of ERISA.

The Department previously issued a regulation under the authority of section 110 of ERISA (29 CFR 2520.104-49) that intended to relieve sponsors of certain SEPs from ERISA's Title I reporting and disclosure requirements by prescribing an alternative method of compliance. These SEPs are, for purposes of this Notice, referred to as “non-model” SEPs because they exclude (1) those SEPs which are created through use of Internal Revenue Service (IRS) Form 5305-SEP, and (2) those SEPs in which the employer limits or influences the employees' choice to IRAs into which employers' contributions will be made and on which participant withdrawals are prohibited. The disclosure requirements in this regulation were developed in conjunction with the Internal Revenue Service (IRS Notice 81-1). Accordingly, sponsors of “non-model” SEPs that satisfy the limited disclosure requirements of the regulation are relieved from otherwise applicable reporting and disclosure requirements under Title I of ERISA, including the requirements to file annual reports (Form 5500 Series) with the Department, and to furnish summary plan descriptions and summary annual reports to participants and beneficiaries.

This ICR includes four separate disclosure requirements. First, at the time an employee becomes eligible to participate in the SEP, the administrator of the SEP must furnish the employee in writing specific and general information concerning the SEP; a statement on rates, transfers and withdrawals; and a statement on tax treatment. Second, the administrator of the SEP must furnish participants with information concerning any amendments. Third, the administrator must notify participants of any employer contributions made to the IRA. Fourth, in the case of a SEP that provides integration with Social Security, the administrator shall provide participants with statement on Social Security taxes and the integration formula used by the employer.

The Department of Labor (Department) is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's (OMB) approval of this ICR will expire on February 28, 2005. The ICR should be continued because the alternative disclosure arrangement provided through this regulation relieves sponsors of “non-model” SEPs of most of the reporting and disclosure requirements under Title I of ERISA. Additionally, the disclosure requirements set forth in this regulation, insure that administrators of “non-model” SEPs provide participants with specific written information concerning SEPs. After considering comments received in response to this notice, the Department intends to submit the ICR to OMB for continuing approval. No change to the existing ICR is proposed or made at this time.

Agency: Employee Benefits Security Administration, Department of Labor.

Title: Alternative Method of Compliance for Certain SEPs pursuant to 29 CFR 2520.104-49.

Type of Review: Extension of a currently approved collection of information.

OMB Number: 1210-0034.

Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions.

Respondents: 460.

Responses: 20,700.

Frequency of Response: On occasion.

Average Response Time: 35 minutes.

Estimated Total Burden Hours: 2,000.

Total Burden Cost (operating/maintenance): $7,900.

PTE 98-54 permits certain foreign exchange transactions between employee benefit plans and certain banks, broker-dealers, and domestic affiliates thereof, which are parties in interest with respect to such plans, pursuant to standing instructions. In the absence of an exemption, foreign exchange transactions pursuant to standing instructions would be prohibited under circumstances where the bank or broker-dealer is a party in interest or disqualified person with respect to the plan under the Employee Retirement Income Securities Act (ERISA) or the Internal Revenue Code (Code).

The class exemption has five basic information collection requirements. The first requires the bank or broker-dealer to maintain written policies and procedures for handling foreign exchange transactions for plans for which it is a party in interest which ensure that the party acting for the bank or broker-dealer knows it is dealing with a plan. The second requires that the transactions are performed in accordance with a written authorization executed in advance by an independent fiduciary of the plan. The third requires that the bank or broker-dealer provides the authorizing fiduciary with a copy of its written policies and procedures for foreign exchange transactions involving income item conversions and de minimis purchase and sale transactions prior to the execution of a transaction. The fourth requires the bank or broker-dealer to furnish the authorizing fiduciary a written confirmation statement with respect to each covered transaction within five days of execution. The fifth requires that the bank or broker-dealer maintains records necessary for plan fiduciaries, participants, and the Department and Internal Revenue Service to determine whether the conditions of the exemption are being met for period of six years form the date of execution of a transaction.

By requiring that records pertaining to the exempted transaction be maintained for six years, this ICR insures that the exemption is not abused, the rights of the participants and beneficiaries are protected, and that compliance with the exemption's conditions can be confirmed. The exemption affects participants and beneficiaries of the plans that are involved in such transactions as well as certain banks, broker-dealers, and domestic affiliates thereof .

The Department of Labor (Department) is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's (OMB) approval of this ICR will expire on February 28, 2005. After considering comments received in response to this notice, the Department intends to submit the ICR to OMB for continuing approval. No change to the existing ICR is proposed or made at this time.

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

Agency: Employee Benefits Security Administration, Department of Labor.

Title: Prohibited Transaction Class Exemption 98-54 relating to Certain Employee Benefit Plan Foreign Exchange Transactions Executed Pursuant to Standing Instructions.

Type of Review: Extension of a currently approved collection of information.

OMB Number: 1210-0111.

Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions.

Respondents: 35.

Responses: 8,400.

Average Response Time: 30 minutes.

Estimated Total Burden Hours: 4,200.

Total Annualized Capital/Startup Costs: $0.

Total Annual Costs (operating/maintaining systems or purchasing services): $0.

The Secretary of Labor has the authority, under section 502(c)(2) of the Employee Retirement Income Security Act of 1974 (ERISA), to assess civil penalties of up to $1,000 a day  1 against plan administrators who fail or refuse to file complete and timely annual reports (Form 5500 Series Annual Return/Reports) as required under section 101(b)(4) of ERISA related regulations. Pursuant to 29 CFR 2560.502c-2 and 2570.60 et seq. , EBSA has maintained a program for the assessment of civil penalties for noncompliance with the annual reporting requirements. Under this program, plan administrators filing annual reports after the date on which the report was required to be filed may be assessed $50 per day for each day an annual report is filed after the date on which the annual report(s) was required to be filed, without regard to any extensions for filing.

Plan administrators who fail to file an annual report may be assessed a penalty of $300 per day, up to $30,000 per year, until a complete annual report is filed. Penalties are applicable to each annual report required to be filed under Title I of ERISA. The Department may, in its discretion, waive all or part of a civil penalty assessed under section 502(c)(2) upon a showing by the administrator that there was reasonable cause for the failure to file a complete and timely annual report.

The Department has determined that the possible assessment of these civil penalties may deter certain delinquent filers from voluntarily complying with the annual reporting requirements under Title I of ERISA. In an effort to encourage annual reporting compliance, therefore, the Department implemented the Delinquent Filer Voluntary Compliance (DFVC) Program (the Program) on April 27, 1995 (60 FR 20873). Under the Program, administrators otherwise subject to the assessment of higher civil penalties are permitted to pay reduced civil penalties for voluntarily complying with the annual reporting requirements under Title I of ERISA.

This ICR covers the requirement of providing data necessary to identify the plan along with the penalty payment. This data is the means by which each penalty payment is associated with the appropriate plan. With respect to most pension plans and welfare plans, the requirement is satisfied by sending a photocopy of the delinquent Form 5500 annual report  2 that has been filed, along with the penalty payment.

Under current regulations, apprenticeship and training plans may be exempted from the reporting and disclosure requirements of Part 1 of Title I, and certain pension plans maintained for highly compensated employees, commonly called “top hat” plans may comply with these reporting and disclosure requirements by using an alternate method by filing a one-time identifying statement with the Department. The DFVC Program provides that apprenticeship and training plans and top hat plans may, in lieu of filing any past due annual reports and paying otherwise applicable civil penalties, complete and file specific portions of a Form 5500, file the identifying statements that were required to be filed, and pay a one-time penalty.

The Department of Labor is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's (OMB) approval of this ICR will expire on February 28, 2005. After considering comments received in response to this notice, the Department intends to submit the ICR to OMB for continuing approval. No change to the existing ICR is proposed or made at this time.

Type of Review: Extension of a currently approved collection.

Agency: U.S. Department of Labor, Employee Benefits Security Administration.

Title: Delinquent Filer Voluntary Compliance Program.

OMB Number: 1210-0089.

Affected Public: Business or other for-profit; not-for-profit institutions.

Frequency: On occasion.

Average Burden Hours/Minutes Per Response: 21 minutes.

Number of Respondents: 4,100.

Total Annual Responses: 4,100.

Total Annual Burden Hours: 145.

Total Burden Cost (Operating and Maintenance): $107,300.

I. Background

Section 203(a)(3)(B) of ERISA governs the circumstances under which pension plans may suspend pension benefit payments to retirees that return to work or to participants that continue to work beyond normal retirement age. Furthermore, section 203(a)(3)(B) of ERISA authorizes the Secretary to prescribe regulations necessary to carry out the provisions of this section.

In this regard, the Department issued a regulation which describes the circumstances and conditions under which plans may suspend the pension benefits of retirees that return to work, or of participants that continue to work beyond normal retirement age (29 CFR 2530.203-3). In order for a plan to suspend benefits pursuant to the regulation, it must notify affected retirees or participants (by first class mail or personal delivery) during the first calendar month or payroll period in which the plan withholds payment, that benefits are suspended. This notice must include the specific reasons for such suspension, a general description of the plan provisions authorizing the suspension, a copy of the relevant plan provisions, and a statement indicating where the applicable regulations may be found, ( i.e. , 29 CFR 2530.203-3). In addition, the suspension notification must inform the retiree or participant of the plan's procedure for affording a review of the suspension of benefits.

The Department of Labor (Department) is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's approval of this ICR will expire on February 28, 2005. This notice requests comments on the extension of the ICR. The Department is not proposing or implementing changes to the existing ICR at this time in connection with this extension. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the information collection request; they will also become a matter of public record.

AGENCY: Department of Labor, Employee Benefits Security Administration.

Title: Suspension of Benefits Regulation pursuant to 29 CFR 2530.203-3.

Type of Review: Extension of a currently approved collection.

OMB Number: 1210-0048.

Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions.

Total Respondents: 74,872.

Total Responses: 74,872.

Frequency of Response: On occasion.

Total Annual Burden: 18,718.

Total Burden Cost (Operating and Maintenance): $63,000.

Without the relief provided by this exemption, an open-end mutual fund would be unable to sell shares to or purchase shares from a plan when the fiduciary with respect to the plan is also the investment advisor for the mutual fund. As a result, plans would be compelled to liquidate their existing investments involving such transactions and to amend their plan documents to establish new investment structures and policies.

In order to insure that the exemption is not abused and that the rights of participants and beneficiaries are protected, the Department has included in the exemption three basic disclosure requirements. The first requires at the time of the purchase or sale of such mutual fund shares that the plan's independent fiduciary receive a copy of the current prospectus issued by the open-end mutual fund and a full and detailed written statement of the investment advisory fees charges to or paid by the plan and the open-end mutual fund to the investment advisor. The second requires that the independent fiduciary approve in writing such purchases and sales. The third requires that the independent fiduciary, once notified of changes in the fees, re-approve in writing the purchase and sale of mutual fund shares.

The Department of Labor (Department) is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's approval of this ICR will expire on February 28, 2005. This notice requests comments on the extension of the ICR. The Department is not proposing or implementing changes to the existing ICR at this time in connection with this extension. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the information collection request; they will also become a matter of public record.

Agency: Department of Labor, Employee Benefits Security Administration.

Title: Prohibited Transaction Class Exemption 77-4 for Certain Transactions Between Investment Companies and Employee Benefit Plans.

Type of Review: Extension of currently approved collections.

OMB Numbers: 1210-0049.

Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions.

Total Respondents: 431.

Total Responses: 82,000.

Frequency of Response: On occasion.

Average Time per Response: 5 minutes.

Total Annual Burden: 7,000 hour.

Prohibited Transaction Class Exemption 75-1 provides an exemption from prohibited transaction provisions of the Employment Retirement Income Security Act of 1974 (ERISA). The exemption permits, under certain conditions, an employee benefit plan to purchase securities from broker-dealers' personal inventories of stocks, from underwriting syndicates in which a plan fiduciary is a member, from banks, from reporting dealers, and from a market makers even if a market-maker is a plan fiduciary. The exemption also permits, under certain conditions, a plan to accept an extension of credit from a broker-dealer for the purpose of facilitating settlement of a securities transaction.

By requiring that records pertaining to the exempted transaction be maintained for six years, this ICR insures that the exemption is not abused, the rights of the participants and beneficiaries are protected, and that compliance with the exemption's conditions can be confirmed. The exemption affects participants and beneficiaries of the plans that are involved in such transactions as well as certain broker-dealers, reporting dealers, banks, underwriting syndicates, and market makers.

The Department of Labor (Department) is particularly interested in comments that:

• 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;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Office of Management and Budget's (OMB) approval of this ICR will expire on January 31, 2005. After considering comments received in response to this notice, the Department intends to submit the ICR to OMB for continuing approval. No change to the existing ICR is proposed or made at this time.

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

Agency: Employee Benefits Security Administration, Department of Labor.

Title: Prohibited Transaction Class Exemption 75-1—Broker-Dealers, Reporting Dealers, Banks Engaging in Securities Transactions.

Type of Review: Extension of a currently approved collection of information.

OMB Number: 1210-0060.

Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions.

Respondents: 10,750.

Responses: 10,750.

Average Response Time: 5 minutes.

Estimated Total Burden Hours: 896.

Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for a Program Management Committee meeting. The revised agenda will include:

Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Members of the public may present a written statement to the committee at any time.

We announced the availability of the policy statement on July 23, 2004 (69 FR 44075). Several comments were received, and the policy has been revised where necessary to respond to those comments.

The Paperwork Reduction Act of 1995 (PRA), Pub. L. 104-13, § 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On September 22, 2004, FRA published a 60-day notice in the Federal Register soliciting comment on ICRs that the agency was seeking OMB approval. 69 FR 56819. FRA received two comments after issuing this notice.

The first comment (letter) came from the Brotherhood of Locomotive Engineers and Trainmen (BLET), which represents both locomotive engineers and trainmen. BLET expressed its wholehearted support for the proposed study. In his letter, Don M. Hahs, the President of BLET, observed:

Mr. M. Hahs further remarked:

BLET did address the paperwork burden for this proposed collection of information. Mr. Hahs noted: “BLET considers the estimates of the burden of information collection activities, its methodologies, and assumptions to be valid.”

The Union Pacific Railroad also expressed its support for the project. In his comment (letter), Dr. Dennis W. Holland, Director, Occupational Health Psychology, Union Pacific Safety Department, stated the following:

There is no cost for materials to study participants, and the total burden hours are minimal. It should be also be noted that FRA and its contractor, University of Denver, have been in contact with representatives of the Association of American Railroads (AAR), the BLET, and the United Transportation Union (UTU) from the beginning concerning the need for this study and the proposed procedures. These representatives have made several useful suggestions, which have been incorporated into the design of this study. Several useful suggestions were also provided, and used, by members of the CISD resource group—an entity established to assist in the development of this study. This resource group consists of representatives from the AAR, BLE, UTU, and several Class 1 and short line carriers. Finally, a team of epidemiologists and statisticians from reputable universities and establishments, including Yale University, the University of California at San Francisco, Colorado State University (Fort Collins), the University of Denver, the Denver VA Medical Center, the Centers for Disease Control and Prevention, and individuals from the U.S. Department of Transportation's Volpe National Transportation Systems Center, reviewed the sampling plan of the proposed study and offered useful recommendations and feedback.

Before OMB decides whether to approve this proposed collection of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30 day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also 60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30 day notice informs the regulated community to file relevant comments and affords the agency adequate time to digest public comments before it renders a decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should submit their respective comments to OMB within 30 days of publication to best ensure having their full effect. 5 CFR 1320.12(c); see also 60 FR 44983, Aug. 29, 1995.

The summary below describe the nature of the information collection requirements (ICRs) and the expected burden. These requirements are being submitted for clearance by OMB as required by the PRA.

Title: Post-Traumatic Stress in Train Crew Members After a Critical Incident.

OMB Control Number: 2130-NEW.

Type of Request: Approval of a new collection of information.

Affected Public: Train crew members (locomotive engineers, firers, and conductors).

Form(s): FRA F 6180.120; FRA F 6180.121; FRA F 6180.122.

Abstract: Nearly 1,000 fatalities occur every year in this country from trains striking motor vehicles at grade crossings and individual trespassers along the track. These events can be very traumatic to train crew members, who invariably are powerless to prevent such collisions. Exposure of train crews to such work-related traumas can cause extreme stress and result in safety-impairing behaviors, such as are seen in Post-Traumatic Stress Disorder or Acute Stress Disorder. Most railroads have Critical Incident Stress Debriefing (CISD) intervention programs designed to mitigate problems caused by exposure to these traumas. However, they are quite varied in their approach, and it is not certain which components of these programs are most effective. The purpose of this collection of information is to identify “best practices” for CISD programs in the railroad industry. By means of written and subsequent oral interviews with train crew members that will each take approximately 45 minutes, the proposed study aims to accomplish the following: (1) Benchmark rail industry best practices of CISD programs; (2) Establish the extent of traumatic stress disorders due to grade crossing and trespasser incidents in the rail industry (not by region or railroad) and identify at-risk populations; and (3) Evaluate the effectiveness of individual components of CISD programs. It should be noted that only the components of CISD programs will be evaluated, not an individual railroad's overall intervention program.

Annual Estimated Burden Hours: 2,043 hours.

Addressee: Send comments regarding these information collections to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 Seventeenth Street, NW., Washington, DC 20503, Attention: FRA Desk Officer.

Comments Are Invited on the Following: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimates of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.

A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this notice in the Federal Register.

National Highway Traffic Safety Administration

Title: Consolidated Labeling Requirements for Motor Vehicles (Except the VIN).

OMB Number: 2127-0512.

Type of Request: Extension of a currently approved collection.

Abstract: In order to ensure that manufacturers are complying with the FMVSS and regulations, NHTSA requires a number of specific labeling requirements. FMVSS No. 105, “Hydraulic and electric brake systems” and FMVSS No. 135, “Passenger car brake systems,” require that each vehicle shall have a brake fluid warning statement in letters at least one-eighth of an inch high on the master cylinder reservoirs and located so as to be visible by direct view. FMVSS No. 205, “Glazing materials,” requires that manufacturers mark their automotive glazing with certain label information. In addition, for certain specialty glazing items, manufacturers are required to affix a removable label to each item. FMVSS No. 209, “Seat belt assemblies,” requires safety belts to be labeled with the year of manufacture, the model, and the name or trademark of the manufacturer. Additionally, replacement safety belts that are for use only in specifically stated motor vehicles must have labels or accompanying instruction sheets to specify the applicable vehicle models and seating positions. All other replacement belts are required to be accompanied by an installation instruction sheet. Part 567, “Certification,” requires each manufacturer or distributor of motor vehicles to furnish to the dealer, or distributor of the vehicle, a certification that the vehicle meets all applicable FMVSS. This certification is required to be in the form of a label permanently affixed to the vehicle.

Affected Public: Manufacturers are required to place these labels on each master cylinder reservoir, each piece of motor vehicle glazing, each safety belt and every motor vehicle intended for retail sale in the United States.

Estimated Total Annual Burden: 73,071 hours.

The Financial Literacy and Education Improvement Act, which is Title V of the Fair and Accurate Credit Transactions Act of 2003 (the “FACT Act”) (Public Law 108-159), established the Financial Literacy and Education Commission (the “Commission”) to improve financial literacy and education of persons in the United States. The Commission is composed of the Secretary of the Treasury and the head of the Office of the Comptroller of the Currency; the Office of Thrift Supervision; the Federal Reserve; the Federal Deposit Insurance Corporation; the National Credit Union Administration; the Securities and Exchange Commission; the Departments of Education, Agriculture, Defense, Health and Human Services, Housing and Urban Development, Labor, and Veterans Affairs; the Federal Trade Commission; the General Services Administration; the Small Business Administration; the Social Security Administration; the Commodity Futures Trading Commission; and the Office of Personnel Management. The Commission is required to hold meetings that are open to the public every four months, with its first meeting occurring within 60 days of the enactment of the FACT Act. The FACT Act was enacted on December 4, 2003.

The fourth meeting of the Commission, which will be open to the public, will be held in the Cash Room at the Department of the Treasury, 1500 Pennsylvania Avenue, NW., Washington, DC. The room will accommodate 80 members of the public. Seating is available on a first-come basis. Participation in the discussion at the meeting will be limited to Commission members, their staffs, and/or special guest presenters.