February 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital- acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). This public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on March 31, 2009, from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis. Contact: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993- 0002, 301-796-1300. Registration: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax numbers) to HAPwkshp@fda.hhs.gov by March 23, 2009. Persons without access to the Internet can call 301-796-1300 to register. Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact) at least 7 days in advance.

The Food and Drug Administration (FDA) is postponing the meeting of the Arthritis Advisory Committee scheduled for March 5, 2009. This meeting was announced in the Federal Register of January 29, 2009 (74 FR 5165). The postponement is due to the need to complete the review of additional data submitted by the applicant. Future meeting dates will be announced in the Federal Register.

This action revises Class D and E airspace at King Salmon, AK, to provide adequate controlled airspace to contain aircraft executing Standard Instrument Approach Procedures (SIAPs). Nine SIAPs, and a textual Obstacle Departure Procedure (ODP) are being amended for the King Salmon Airport. This action revises Class D and E airspace upward from the surface, and from 700 feet (ft.) and 1,200 ft. above the surface at King Salmon Airport, King Salmon, AK.

This document publishes in the Federal Register an amendment adopting airworthiness directive (AD) 2008-24-51 that was sent previously to all known U.S. owners and operators of Boeing Model 737- 600, -700, -700C, -800, and -900 series airplanes by individual notices. This AD requires accomplishing a wiring test of the autoshutoff system to verify continuity and a visual verification that the wiring is correctly installed; doing corrective actions, if necessary; and doing a functional test of the autoshutoff system, and applicable maintenance actions. This AD is prompted by a report of a failure of the left-hand fuel pump of the center wing tank to shut off after being selected ``OFF'' by the flightcrew during flight on a Boeing Model 737-700 series airplane. Subsequent to that report, the failure was found on two additional airplanes. We are issuing this AD to prevent extended dry-running of the fuel pump, which could lead to localized overheating of parts inside the fuel pump, and which could produce an ignition source inside the fuel tank.

This action amends Class E airspace at Sioux City, IA. Additional controlled airspace is necessary to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at Sioux Gateway Airport/Col. Bud Day Field, Sioux City, IA. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at Sioux Gateway Airport/Col. Bud Day Field.

This action proposes to amend Class E airspace at Fulton, MO. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Elton Hensley Memorial Airport, Fulton, MO. This action also would adjust the geographic coordinates of Elton Hensley Memorial Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Elton Hensley Memorial Airport.

This action establishes Class E airspace at Tower, MN. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAPs) at Tower Municipal Airport, Tower, MN. This rule also updates the geographic coordinates for the airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at Tower Municipal Airport.

The Department of State has submitted the following information collection request to the Office of Management and Budget (OMB) for approval in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Department of State Acquisition Regulation (DOSAR). OMB Control Number: 1405-0050. Type of Request: Extension of a Currently Approved Collection. Originating Office: Bureau of Administration, Office of the Procurement Executive (A/OPE). Form Number: N/A. Respondents: Any business, other for-profit, individual, not-for-profit, or household organization wishing to receive Department of State contracts. Estimated Number of Respondents: 3,166. Estimated Number of Responses: 3,166. Average Hours per Response: Varies. Total Estimated Burden: 275,970. Frequency: On occasion. Obligation to Respond: Voluntary.

We are adopting a new airworthiness directive (AD) for the products listed above that will supersede an existing AD. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

This document contains final regulations relating to automatic contribution arrangements. These regulations affect administrators of, employers maintaining, participants in, and beneficiaries of section 401(k) plans and other eligible plans that include an automatic contribution arrangement.

This notice sets forth changes in rates of general applicability for competitive products.

The FAA is superseding an existing airworthiness directive (AD), which applies to certain McDonnell Douglas transport category airplanes. That AD currently requires modification of the installation wiring for the electric motor-operated auxiliary hydraulic pumps in the right wheel well area of the main landing gear; repetitive inspections of the numbers 1 and 2 electric motors of the auxiliary hydraulic pumps for electrical resistance, continuity, mechanical rotation, and associated airplane wiring resistance/voltage; and corrective actions if necessary. This new AD also requires, for certain airplanes, modifying and rerouting, as applicable, certain components of the wiring of the electric motor for the auxiliary hydraulic pump located in the right wheel well. This AD results from reports of failure of the electric motor for the auxiliary hydraulic pump. We are issuing this AD to prevent failure of the electric motors of the hydraulic pump and associated wiring, which could result in fire at the auxiliary hydraulic pump and consequent damage to the adjacent electrical equipment and/or structure.

This establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

In 2001, EPA finalized a new, major program for highway heavy- duty engines. That program, the Clean Diesel Trucks and Buses program, will result in the introduction of advanced emissions control systems such as catalyzed diesel particulate filters (DPF) and catalysts capable of reducing harmful nitrogen oxide (NOX) emissions. This final rule will require that these advanced emissions control systems be monitored for malfunctions via an onboard diagnostic system (OBD), similar to those systems that have been required on passenger cars since the mid-1990s. This final rule will require manufacturers to install OBD systems that monitor the functioning of emission control components and alert the vehicle operator to any detected need for emission related repair. This final rule will also require that manufacturers make available to the service and repair industry information necessary to perform repair and maintenance service on OBD systems and other emission related engine components. Lastly, this final rule revises certain existing OBD requirements for diesel engines used in heavy-duty vehicles under 14,000 pounds.

The Secretary is publishing the following list pursuant to section 607(f) of the Individuals with Disabilities Education Act (IDEA). Under section 607(f) of the IDEA, the Secretary is required, on a quarterly basis, to publish in the Federal Register a list of correspondence from the U.S. Department of Education (Department) received by individuals during the previous quarter that describes the interpretations of the Department of the IDEA or the regulations that implement the IDEA.

On November 17, 2008, we published in the Federal Register (73 FR 67852) a notice inviting applications for the Rehabilitation Long- Term TrainingRehabilitation Counseling FY 2009 competition. That notice established a January 15, 2009 deadline date for eligible applicants to apply for funding under this program. In order to allow applicants the opportunity to respond to a correction in the selection criteria published in the Application Package, we are reopening the Rehabilitation Long-Term Training Rehabilitation Counseling FY 2009 competition to eligible applicants. Specifically, we inadvertently omitted a heading and the point value of the criterion on Quality of Project Services, worth 10 points. The requirements of this criterion were embedded at the end of the criterion on Nature and Scope of Curriculum, worth 20 points. By omitting the heading and points for the criterion on Quality of Project Services, applicants were given the mistaken impression that this criterion was part of the Nature and Scope of Curriculum criterion. We have corrected the selection criteria in the Application Package. This correction of the selection criteria increases the possible points an applicant may receive from 90 points to 100 points and makes it clear that there is a criterion on Quality of Project Services, worth 10 points. We strongly recommend that any eligible applicant that submitted its application using the criteria in the original application package re-submit its application in order to ensure that there is a clear response to the criterion on Quality of Project Services. If an applicant that submitted its application by the January 15, 2009 deadline does not choose to re-submit its application to address separately the Nature and Scope of Curriculum and Quality of Project Services criteria, we will increase the point value of the co- joined criteria contained under the heading Nature and Scope of Curriculum from 20 to 30 points for that applicant and the selection criteria overall from 90 to 100 points. We will separate the applicant's response to the co-joined criteria under the heading of Nature and Scope of Curriculum, and each criteria will be rated separately with the total value of the Nature and Scope of Curriculum criteria being 20 points and the Quality of Project Services criteria being 10 points. All information in the November 17, 2008 notice remains the same for this notice reopening the competition, except for the following updates to Dates and to section IV. 3. Submission Dates and Times. Dates and section IV. 3. Submission Dates and Times: Applications Available: February 23, 2009. Deadline for Transmittal of Applications: March 16, 2009.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/335,705, filed October 18, 2001, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353- 2001/0-US-01]; U.S. Provisional Patent Application No. 60/343,854, filed October 25, 2001, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation And Regeneration'' [HHS Ref. No. E-353-2001/1-US-01]; PCT Patent Application No. PCT/US02/33570, filed October 17, 2002, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-PCT- 01]; U.S. Patent Application No. 10/492,901, filed April 15, 2004, which issued as U.S. Patent No. 7,229,963, on June 12, 2007, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-US-02]; and U.S. Patent Application No. 11/800,151, filed May 4, 2007, which published as 2008/0248994, on October 9, 2008, entitled ``Methods of Using Deacetylase Inhibitors to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-US-03] to ADVANCELL Advanced In Vitro Cell Technologies, S.A. which has an office in Barcelona, Spain. The patent rights in these inventions have been assigned to the United States of America and The Salk Institute for Biological Studies. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``the use of deacetylase inhibitors to treat dystrophies and other disorders involving tissue degeneration.''

We, the Office of Surface Mining (OSM), are announcing the withdrawal of a proposed rule pertaining to a request to delete a required amendment related to the Pennsylvania regulatory program (the Pennsylvania program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Pennsylvania requested that a required amendment pertaining to regulatory exemptions for coal extraction incidental to the extraction of other minerals be removed.

Following receipt of a request on January 28, 2009, from the Office of the United States Trade Representative (USTR) under authority delegated by the President and pursuant to section 103 of the United States-Singapore Free Trade Agreement (USSFTA) Implementation Act, the U.S. International Trade Commission (Commission) instituted investigation No. Singapore FTA-103-22, Certain Yarns and Fabrics FY 2009: Effect of Modification of U.S.-Singapore Free Trade Agreement Rules of Origin.