2008 – Federal Register Recent Federal Regulation Documents

The Bureau of Reclamation (Reclamation) will begin charging a recreation user fee to take the guided tour of Glen Canyon Dam and Powerplant. Reclamation has determined that the new fee is reasonable and appropriate to specifically offset at least, in part, increased costs associated with public visitation to the Carl Hayden Visitor Center. The Visitor Center, located 700 feet above the Colorado River overlooking Glen Canyon Dam and Bridge, accommodates about one million visitors each year. The Visitor Center is jointly operated by Reclamation and the National Park Service. The new fee will initially be $5.00 per adult with a reduced fee schedule for certain groups as follows: seniors (age 62 and over) will be $4.00, children ages 7-16 will be $2.50, members of the U.S. military will be $4.00, and school groups will be $0.50 per person. There will be no fee charged for children six years of age and under. These fees will be reviewed and adjusted, as appropriate, in subsequent years.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. 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: NA; 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 can be delayed under certain circumstances. 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 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 hrs each. Results reporting 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. The total burden for results reporting is therefore estimated at 40,400 hours per year. There are no capital costs to report. 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.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

This action confirms the effective date of the direct final rule that established Class E airspace at Muldrow Army Heliport, Lexington, OK, published in the Federal Register August 6, 2008 (73 FR 45607) Docket No. FAA-2008-0003.

In Fiscal Year 2005, in an effort to assist local school systems that were being strained by the arrivals of large numbers of refugee children, The Office of Refugee Resettlement (ORR) awarded, through competition, a Refugee School Impact grant to the Tennessee Department of Human Services, Nashville, TN, for a project period of August 15, 2005 through August 14, 2010. The Tennessee Department of Human Services served as the fiscal sponsor and legal entity for the project. As of June 30, 2008, the Tennessee Department of Human Services relinquished the grant. Catholic Charities of Tennessee, Inc., Nashville, TN, is now awarded a non-competitive replacement grant to continue to provide services under the Refugee School Impact project. Services provided under the grant to Catholic Charities of Tennessee, Inc., are within the scope and operation of the original award. Under the award, Catholic Charities of Tennessee, Inc., is eligible apply for a non-competitive continuation award for the period of August 15, 2009 through August 14, 2010.

The National Offshore Safety Advisory Committee (NOSAC) will meet, in New Orleans, LA, to discuss various issues relating to offshore safety and security. The meeting will be open to the public.

This action confirms the effective date of the direct final rule that amended Class E airspace at Black River Falls, WI, published in the Federal Register August 6, 2008 (73 FR 45606) Docket No. FAA- 2008-0024.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.

The Food and Drug Administration (FDA) is confirming the effective date of October 15, 2008, for the final rule that appeared in the Federal Register of June 2, 2008 (73 FR 31358). The direct final rule amends the hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. This document confirms the effective date of the direct final rule.

The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.

Today's final rule amends the definition of the term, ``designated seating position,'' as used in the Federal motor vehicle safety standards (FMVSS), to indicate more clearly which areas within the interior of a vehicle meet that definition. Today's final rule also establishes a calculation procedure for determining the number of designated seating positions at a seat location for trucks and multipurpose passenger vehicles with a gross vehicle weight rating less than 10,000 lbs, passenger cars, and buses. Further, this document eliminates the existing exclusion of auxiliary seats (i.e., temporary or folding jump seats) from the definition of ``designated seating position.'' Today's final rule encourages manufacturers to use a variety of visual cues in the design of the vehicle interior to help improve occupant awareness as to which areas of a vehicle are not intended to be used as seating positions. This will help to ensure that occupants sit in locations where they are afforded the crash protection required by the FMVSSs.

In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel and amend their registrations to terminate uses of certain products. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests within this period. Upon acceptance of these requests, any sale, distribution, or use of products listed in this notice will be permitted only if such sale, distribution, or use is consistent with the terms as described in the final order.

This notice announces the availability of EPA's proposed registration review decisions for the pesticides cases,Pseudomonas fluorescens and Pseudomonas syringae, and opens a public comment period on the proposed registration review decisions. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

The Office of Personnel Management (OPM) is adopting as final, without change, the proposed rule published April 7, 2008 to remove the designation of the Armed Services Board of Contract Appeals (ASBCA) from the Federal Employees Health Benefits Acquisition Regulation (FEHBAR).

EPA proposes to revise and update the existing data requirements for antimicrobial pesticides. The proposed revisions are needed to reflect current scientific knowledge and current Agency regulatory practices, and to improve protection of the general population as well as sensitive subpopulations. The proposed requirements are intended to further enhance the Agency's ability to make regulatory decisions about the human health and environmental fate and effects of antimicrobial pesticide products.