January 6, 2009 – Federal Register Recent Federal Regulation Documents

On December 23, 2008, we published in the Federal Register (73 FR 78751) a notice inviting applications for new awards for FY 2009 under the High School Equivalency Program. We are correcting the notice to specify the Deadline for Intergovernmental Review of applications submitted in this competition. On page 78751, first column, under DATES:, after ``Deadline for Transmittal of Applications: February 23, 2009.'' add ``Deadline for Intergovernmental Review: April 24, 2009.''. On page 78752, first column, under 3. Submission Dates and Times:, after ``Deadline for Transmittal of Applications: February 23, 2009.'' add ``Deadline for Intergovernmental Review: April 24, 2009.''.

The Nuclear Regulatory Commission (NRC) has conducted a comprehensive review of all its Privacy Act systems of records. The NRC is revising and republishing all its systems of records notices as a result of this review. The revisions are minor corrective and administrative changes that do not meet the threshold criteria established by the Office of Management and Budget (OMB) for either a new or altered system of records.

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement regarding preparation, submission, and negotiation of subcontracting plans. The clearance currently expires on June 30, 2009. This information collection will ensure that small and small disadvantaged business concerns are afforded the maximum practicable opportunity to participate as subcontractors in construction, repair, and alteration or lease contracts. Preparation, submission, and negotiation of subcontracting plans requires for all negotiated solicitations having an anticipated award value over $500,000 ($1,000,000 for construction), submission of a subcontracting plan with other than small business concerns when a negotiated acquisition meets all four of the following conditions. 1. When the contracting officer anticipates receiving individual subcontracting plans (not commercial plans). 2. When the award is based on trade-offs among cost or price and technical and/or management factors under FAR 15.101-1. 3. The acquisition is not a commercial item acquisition. 4. The acquisition offers more than minimal subcontracting opportunities. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on 270 species from a petition to list 475 species in the southwestern United States as threatened or endangered under the Endangered Species Act of 1973, as amended (Act). We find that for these 270 species the petition does not present substantial scientific or commercial information indicating that listing these species may be warranted. Therefore, for these 270 species, we will not initiate a further status review in response to this petition. We ask the public to submit to us any new information that becomes available concerning the status of these 270 species or threats to them or their habitat at any time. This information will help us monitor and encourage the conservation of these species. An additional 5 species of the 475 included in the petition do not fall within the scope of the petition or are not a listable entity and, therefore, were not considered in this finding (see Petition).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 8, 2008 (Vol. 73, No. 196, p. 58973) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925-0586, expiration date 01/31/2009], Form Number: N/A; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The databank is widely used by patients, physicians, and medical researchers; in particular, those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov, increases the clinical trial information that must be submitted as part of each registration, and requires the submission of basic results information for registered trials of approved drugs, biologics and devices. Frequency of Response: Responsible parties must submit the required registration information not later than 21 days after enrolling the first subject. Results information is to be reported not later than 12 months after the completion date (as defined in the law), but the responsible party may request an extension of the deadline or delay submission by certifying that the drug or device under study has not yet been approved. Updates to submitted information are required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Description of Respondents: Respondents are referred to in the law as ``responsible parties,'' and are defined as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ``the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements'' for submitting information under the law. Estimate of Burden: The burden associated with this information collection consists of two parts: the burden associated with registration of clinical trials; and the burden associated with the reporting of results information. In both cases, the burden includes the time necessary to extract information from the study protocol or results record, reformat and review it, enter it into the databank, and provide necessary updating over the course of the study. It is estimated that registration information will be required for 3,000 trials of drugs and biologics and 445 trials of medical devices each year. Each initial registration is estimated to take 7 hours and each of the subsequent 8 updates to the record are estimated to take 2 hours, resulting in an annual burden of 79,235 hours. It is estimated that there will be voluntary submissions of registration information for 6,000 trials of drugs and biologics, 545 trials of devices, and 5,280 trials of other types of medical interventions. Using the same hour estimates as for mandatory registration, the burden associated with voluntary registrations is estimated at 271,975 hours, bringing the total registration burden to 351,210 hours. In the first year of operation, it is estimated that there will be an additional burden of 84,150 hours associated with the updating of information for 7,000 trials of drugs and biologics and 650 trials of medical devices that were previously registered in the databank and ongoing as of December 26, 2007 (90 days after enactment). It is estimated that such trials will require one update of 3 hours to bring them into compliance with the new law (FDAAA) and 4 subsequent updates of 2 hours each. Submisson of results information is required only for those applicable clinical trials of drugs, biologics, and devices that are subject to the mandatory registration requirements of FDAAA and for which the product(s) under study have been approved or cleared by the FDA. It is estimated that results reporting will be required for 1,645 trials of drugs and biologics and 375 trials of medical devices each year. Initial submission of results information is estimated to require 10 hours, and each result submission is expected to require two updates that take 5 hours each. It is estimated that 2,345 trials per year will submit certifications for delayed reporting of results information or a request for an extension of the reporting deadline. Preparation and submission of such information is estimated to take 1 hour. The total burden for results reporting is therefore estimated at 42,745 hours per year. There are no capital costs to report. The operating and maintenance budget for the Clinical Trials Registry Databank in FY2009 is projected to be approximately $3 million. Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll free number 301-402-9680 or e-mail your request to sharlipd@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The New England Fishery Management Council's (Council) Herring Oversight Committee will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

Notice is hereby given that effective immediately, certain public lands in Fremont County, Colorado, are temporarily closed to all types of motorized travel. The purpose of this closure is to prevent the development of unauthorized user-created trails and damage to soils and vegetation, and to protect sensitive paleontological resources. Approximately 1,600 acres of public lands are affected by this closure. These lands will remain closed while travel management planning is completed in 2009. This closure is made under the authority of 43 CFR 8364.1.

The Acting Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

This document corrects a notice appearing in the Federal Register on December 9, 2008 (73 FR 74766), that announces a public meeting for the license renewal of Three Mile Island Nuclear Station, Unit 1. This action is necessary to update the location where the meeting will take place.

On September 23, 2008, the U.S. Coast Guard published a notice in the Federal Register requesting comments on our intent to submit an Information Collection Request (ICR) and Analysis to the Office of Management and Budget (OMB) requesting a revision of its approval for the following collection of information: 1625-0040, Continuous Discharge Book, Application, Physical Exam Report, Sea Service Report, Chemical Testing, Entry Level Physical. That notice stated the complete ICR would be available through both the online docket and at the Coast Guard facility in Washington, DC. Because the complete ICR was not made available online during the stated comment period, we are reopening it until February 5, 2008.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit Information Collection Requests (ICRs) and Analyses to the Office of Management and Budget (OMB) requesting an extension of its approval for the following collections of information: (1) 1625-0022, Application for Tonnage Measurement of Vessels; (2) 1625-0093, Facilities Transferring Oil or Hazardous Materials in BulkLetter of Intent and Operations Manual; (3) 1625- 0094, Ships Carrying Bulk Hazardous Liquids; and (4) 1625-0095, Oil and Hazardous Material Pollution Prevention and Safety Records, Equivalents/Alternatives and Exemptions. Before submitting these ICRs to OMB, the Coast Guard is inviting comments as described below.

The Coast Guard proposes to amend the commercial diving regulations. We request public comment on industry standards and current practices that might be incorporated in our regulations or accepted as regulatory equivalents; the use of third-party auditing; new requirements for compliance documentation; the adoption of recommendations made following the investigation of a 1996 fatality; and possible additional regulatory revisions. This rulemaking will promote the enhancement of maritime safety which is a strategic goal of the Coast Guard.

The Commission is establishing a docket for consideration of the Postal Service's compliance with statutory provisions pertaining to costs, revenues, rates, and quality of service. The Postal Service's recently-filed FY 2008 report forms the basis for consideration. The public is invited to comment.

The Secretary of the Interior is extending the deadline from December 8, 2008, to January 23, 2009, for tribes to nominate individuals for membership on the No Child Left Behind Negotiated Rulemaking Committee. This committee will work with the Department of the Interior to develop recommendations for proposed regulations regarding the BIE-funded school facilities as required by the No Child Left Behind Act of 2001.

The Department of Energy (DOE) is initiating the rulemaking to consider establishing energy conservation standards for walk-in coolers and walk-in freezers. Accordingly, DOE will hold an informal public meeting to discuss and receive comments on its planned analytical approach and issues it will address in this rulemaking proceeding. DOE welcomes written comments from the public on our stated approach for this rulemaking. To inform stakeholders and to facilitate this process, DOE has prepared a Framework Document which details the analytical approach and identifies several issues on which DOE is particularly interested in receiving comment. A copy of the Framework Document is available at: https://www.eere.energy.gov/buildings/appliance_ standards/commercial/walkinrefrigeration_equipment.html.

The Surface Transportation Board (Board or STB) proposes to amend its rules to provide that where an agreement for rail carriage contains the disclosure statement to be set forth in this new rule, the Board will not find jurisdiction over a dispute involving the rate or service under the agreement and will treat that agreement as a rail transportation contract governed by 49 U.S.C. 10709; and conversely where an agreement for rail carriage fails to contain the disclosure statement, the Board will find jurisdiction over a dispute involving the rate or service under the agreement, absent clear and convincing evidence that the parties intended to enter into a rail transportation contract governed by 49 U.S.C. 10709; and the shipper was made aware that it could request service under a common carrier tariff rate that would be subject to STB jurisdiction.

To determine the appropriate extent and scope of U.S. export controls on foreign products that are the direct products of U.S.- origin encryption technology or software, BIS is seeking information on the potential impact of controlling such foreign made items for Encryption Items (``EI'') reasons under the EAR (i.e., those that are classified under ECCN 5A002 or 5D002) if the direct product of U.S.- origin ECCN 5E002 technology or ECCN 5D002 software. Specifically, BIS is requesting comments regarding the impact this control would have on both U.S. exporters of encryption technology and software and foreign manufacturers of products that are derived in whole or in part from U.S.-origin encryption technology or software.