2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is soliciting volunteers to participate in the SEQC (Sequencing Quality Control) project to objectively assess the technical performance of different next-generation sequencing technologies in DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) analyses and to evaluate the advantages and limitations of various bioinformatics solutions in handling and analyzing the massive new data sets. The SEQC project is a natural extension of the MicroArray Quality Control (MAQC) project (https:// www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/) and is being coordinated by the FDA. This project is open to the public. Vendors of next-generation sequencing technologies and institutions interested in the generation, management, analysis, and interpretation of the resulting sequence data are welcome to participate.

The FAA invites public comments about our intention to request the Office of Management and Budget (OMB) to approve a current information collection. Certain organizations may apply to perform certification functions on behalf of the FAA. This information collection is required for compliance with the final rule that codifies special flight rules and airspace and flight restrictions for certain operations in the Washington, DC Metropolitan Area. The final rule published on December 16, 2008 (73 FR 76195). A notice for comments was published in error in advance of the publication of the final rule on December 3, 2008 (73 FR 73688), followed by a withdrawal of this notice published on December 8, 2008 (73 FR 74559). FAA will consider any comments received in response to the first notice.

This action corrects an error in the airspace description contained in a Final Rule that was published in the Federal Register on Thursday, November 20, 2008 (73 FR 70271). Airspace Docket No. 08-AAL- 13.

Notice is hereby given that following two entities have been issued permits to collect/receive/import/export protected species parts for scientific research purposes: National Marine Mammal Laboratory (NMML, Dr. John Bengtson, Responsible Party), 7600 Sand Point Way NE, Seattle, WA 98115 (File No. 13583) and National Ocean Service Marine Forensic Lab (NOS Lab, Julie Carter, Responsible Party), 219 Fort Johnson Road, Charleston, SC 29412 (File No. 13599).

The Board is publishing a final rule amending the staff commentary that interprets the requirements of Regulation C (Home Mortgage Disclosure). The staff commentary is amended to increase the asset-size exemption threshold for depository institutions based on the annual percentage change in the Consumer Price Index for Urban Wage Earners and Clerical Workers. The adjustment from $37 million to $39 million reflects the increase of that index by 4.49% percent during the twelve-month period ending in November 2008. Thus, depository institutions with assets of $39 million or less as of December 31, 2008, are exempt from collecting data in 2009.

This document contains amendments to the project review regulations of the Susquehanna River Basin Commission (Commission) requiring review and approval of any natural gas well development project targeting the Marcellus or Utica shale formations and involving the withdrawal, diversion, or consumptive use of waters of the Susquehanna River Basin, adding a provision providing for a specific approval by rule process for consumptive water use associated with such projects, and modifying the definitions of ``construction'' and ``project.'' In addition, editorial changes are made to the existing approval by rule provision related to the consumptive use of water withdrawn from public water supply systems to make that provision consistent with the new approval by rule provision for natural gas well development projects.

The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to implement the Protocol Additional to the Agreement Between the United States of America and the International Atomic Energy Agency for the Application of Safeguards in the United States of America (Additional Protocol). The Additional Protocol requires the U.S. to report additional information on various nuclear fuel cycle- related activities and to provide the International Atomic Energy Agency (IAEA) with access to those locations beyond the information currently reported for nuclear facilities under the existing Agreement Between the United States of America and the International Atomic Energy Agency for the Application of Safeguards in the United States of America (Safeguards Agreement). The amended regulations codify the requirement for certain NRC and Agreement State licensees to report information and provide access under the Additional Protocol that are currently not subject to inspections or reporting under the Safeguards Agreement. These amendments enable the U.S. Government to meet its obligations related to the Safeguards Agreement and the Additional Protocol.

EPA is proposing to adjust the allowance system for control of U.S. consumption and production of hydrochlorofluorocarbons (HCFCs) by apportioning baselines and allocating production and consumption allowances for several HCFCs for which the Agency previously allocated allowances and other HCFCs that were not allocated allowances previously, for the control periods 2010- 2014. The HCFC allowance system is part of EPA's Clean Air Act program to phase out ozone-depleting substances (ODSs) to protect the stratospheric ozone layer. Protection of the stratospheric ozone layer helps reduce rates of skin cancer and cataracts, as well as other health and ecological effects. The U.S. is obligated under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) to limit HCFC consumption and production to a specific level and, using stepwise reductions, to decrease the specific level culminating in a complete HCFC phaseout in 2030. The next major milestone, to occur on January 1, 2010, is a 75 percent reduction from the aggregate U.S. HCFC baseline for production and consumption. In this action EPA proposes to allocate the allowances for 2010-2014 that will ensure compliance with the international stepwise reduction, consistent with the 1990 Clean Air Act Amendments. In addition, EPA proposes to amend the regulatory provisions concerning allowances for HCFC production for developing countries' basic domestic needs to be consistent with the September 2007 adjustments to the Montreal Protocol. Also, the Agency is providing its interpretation of a self-effectuating ban on introduction into interstate commerce and use of HCFCs contained in section 605(a) of the Clean Air Act and proposes to amend existing regulatory provisions to facilitate implementation of the statutory requirements.

An application has been filed by Randy Lynne Jackson, personal representative of the estate of Donald F. Jackson, deceased, for a Recordable Disclaimer of Interest from the United States for land in Bingham County, Idaho. This notice is intended to inform the public of the pending application.

This document corrects technical errors that appeared in the update notice published in the Federal Register on November 3, 2008, entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009.''

In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the initial meeting of the WRC- 11 Advisory Committee will be held on January 13, 2009, at the Federal Communications Commission. The purpose of the meeting is to begin preparations for the 2011 World Radiocommunication Conference.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Expander.'' This draft guidance document describes a means by which the tissue expander device type may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify this device type into class II (special controls). This draft guidance is not final nor is it in effect at this time.

We (Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. The ICR, which is summarized below, describes the nature of the collection and the estimated burden and cost. This ICR is scheduled to expire on December 31, 2008. We 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. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.