January 21, 2009 – Federal Register Recent Federal Regulation Documents

This Treasury decision expands by 2,635 acres the existing 609,673-acre Paso Robles American viticultural area in San Luis Obispo County, California. The expanded Paso Robles viticultural area lies entirely within San Luis Obispo County and the multicounty Central Coast viticultural area. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.

Illinois has scheduled elections on March 3, 2009, and April 7, 2009, to fill the U.S. House of Representatives seat in the Fifth Congressional District vacated by Representative Rahm Emanuel. Committees required to file reports in connection with the Special Primary Election on March 3, 2009, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on April 7, 2009, shall file a 12-day Pre-Primary Report, a 12-day Pre-General Report, and a 30-day Post-General Report.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This document contains a correction to the Notice ``Gifts to Federal Employees From Foreign Government Sources Reported to Employing Agencies in Calendar Year 2007'' published in the Federal Register on December 2, 2008, in FR Volume 73, Number 246. This notice is a request to change the identity of the foreign donor and government of a gift given to the Honorable Condoleezza Rice, Secretary of State of the United States, on January 5, 2007.

This document contains exemptions issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). A notice was published in the Federal Register of the pendency before the Department of a proposal to grant such exemption. The notice set forth a summary of facts and representations contained in the application for exemption and referred interested persons to the application for a complete statement of the facts and representations. The application has been available for public inspection at the Department in Washington, DC. The notice also invited interested persons to submit comments on the requested exemption to the Department. In addition the notice stated that any interested person might submit a written request that a public hearing be held (where appropriate). The applicant has represented that it has complied with the requirements of the notification to interested persons. No requests for a hearing were received by the Department. Public comments were received by the Department as described in the granted exemption. The notice of proposed exemption was issued and the exemption is being granted solely by the Department because, effective December 31, 1978, section 102 of Reorganization Plan No. 4 of 1978, 5 U.S.C. App. 1 (1996), transferred the authority of the Secretary of the Treasury to issue exemptions of the type proposed to the Secretary of Labor.

The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods sliced, prepared, and/or packaged in retail facilities. The purpose of the risk assessment is to ascertain the impact on public health of current practices and potential interventions that reduce or prevent L. monocytogenes contamination in ready-to-eat food.

FDA is announcing the availability of a draft guidance entitled ``Animal ModelsEssential Elements to Address Efficacy Under the Animal Rule.'' When human efficacy studies are neither ethical nor feasible, animal efficacy studies may be relied on under the Animal Rule to support approval or licensure of a drug or biological product. This guidance identifies and discusses the critical characteristics of an animal model that should be addressed when developing products for approval under the Animal Rule. The guidance is intended to help sponsors determine whether the model meets the requirements of the Animal Rule.

OSHA is proposing to add two PortaCount[supreg] quantitative fit-testing protocols to its Respiratory Protection Standard (29 CFR 1910.134); the proposed protocols would apply to employers in general industry, shipyard employment, and the construction industry. The first of the two proposed protocols consists of the eight fit-testing exercises described in Part I.A.14 of Appendix A of the Respiratory Protection Standard, except each exercise would last 30 seconds instead of the currently required 60 seconds.\1\ The second proposed protocol would eliminate two of the eight fit-testing exercises, and each of the remaining six exercises would last 40 seconds; in addition, this proposed protocol would increase the current minimum pass-fail fit- testing criterion from a fit factor of 100 to 200 for half masks, and from 500 to 1,000 for full facepieces.

On January 31, 2007, the Commission adopted its first acceptable practices for Section 5(d)(15) (``Core Principle 15'') of the Commodity Exchange Act (``Act'').\1\ As with all other acceptable practices, those for Core Principle 15 are a safe harbor that designated contract markets (``DCMs'') can use to demonstrate core principle compliance. The acceptable practices contain four provisionsthree are ``operational provisions'' and one provides necessary definitions, including a definition of ``public director.'' All four provisions were published simultaneously in the Federal Register on February 14, 2007, and became effective on March 16, 2007.\2\ Existing DCMs were given a two-year phase-in period to implement the acceptable practices or otherwise demonstrate full compliance with Core Principle 15.

The Lake Tahoe Basin Federal Advisory Committee will hold a meeting on January 21, 2009 on the north shore of Lake Tahoe. This Committee, established by the Secretary of Agriculture on December 15, 1998 (64 FR 2876), is chartered to provide advice to the Secretary on implementing the terms of the Federal Interagency Partnership on the Lake Tahoe Region and other matters raised by the Secretary.

The Department of Labor's Employment Standards Administration (``ESA'') Office of Labor-Management Standards (``OLMS'') publishes this Final Rule to make several revisions to the current Form LM-2 (used by the largest labor organizations to file their annual financial reports) that will provide additional information on Schedules 3, 4, 11 and 12, clarify reporting under certain functional categories and add itemization schedules corresponding to categories of receipts, and establish a procedure and standards by which the Secretary of Labor may revoke a particular labor organization's privilege to file a simplified annual report, Form LM-3, where appropriate, after investigation, due notice, and opportunity for a hearing. The changes are made pursuant to section 208 of the Labor-Management Reporting and Disclosure Act (``LMRDA''), 29 U.S.C. 438. The final rule will apply prospectively.

The Department of Commerce is issuing interim procedures implementing provisions under the Andean Trade Preference Act of 2008 (``the Act''), enacted in its entirety by Congress on October 3, 2008. Section 2 of the Act contains amendments to Title IV of the Dominican Republic-Central America-United States Free Trade Agreement Implementation Act (Public Law 109-53; 119 Stat. 495). Under Section 2 of the Act, Title IV of the Dominican Republic-Central America-United States Free Trade Agreement Implementation Act is amended by adding Section 404 of the Act creating a benefit for eligible apparel articles wholly assembled in the Dominican Republic that meet the requirements for a ``2 for 1'' earned import allowance. The amendment requires the Secretary of Commerce to establish a program to provide earned import allowance certificates to any producer or entity controlling production of eligible apparel articles in the Dominican Republic, such that apparel wholly assembled in the Dominican Republic from fabric or yarns, regardless of their source, and imported directly from the Dominican Republic may enter the United States duty-free, pursuant to the satisfaction of the terms governing issuance of the earned import allowance certificate by the producer or entity controlling production of eligible apparel articles in the Dominican Republic.

EPA Region 6 Water Quality Protection Division, today is proposing for public comment the issuance of a National Pollutant Discharge Elimination System general permit for discharges from eligible owners/operators of existing concentrated animal feeding operations (CAFOs), in New Mexico, except those discharges on Indian Country. All currently operating animal feeding operations that are defined as CAFOs or designated as CAFOs by the permitting authority (See Part VII Definitions, ``CAFOs'') and that are subject to 40 CFR Part 412, Subparts A (Horses) and C (Dairy Cows and Cattle Other than Veal Calves) are eligible for coverage under this permit. Hereinafter, this NPDES general permit will be referred to as ``permit'' or ``CAFO permit'' or ``CAFO general permit.'' Eligible CAFOs may apply for authorization under the terms and conditions of this permit, by submitting a notice of intent (NOI) to be covered by this permit. This permit covers the types of animal feeding operations listed above which meet the definition of a CAFO and discharge or propose to discharge pollutants to waters of the United States. A CAFO proposes to discharge if it is designed, constructed, operated, or maintained such that a discharge will occur.

The Food and Drug Administration (FDA or agency) is announcing the availability of a guidance for industry entitled ``Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007'' dated January 2009. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

This final rule amends existing EEOC regulations by changing two office addresses and one post office box.

The Commodity Futures Trading Commission (Commission) is providing notice requiring foreign boards of trade that may receive Commission staff no-action relief permitting them to make their automated trading systems directly available from the U.S. to comply with additional conditions for the no-action relief to remain effective if they list for trading from the U.S. contracts that are linked to contracts traded on certain U.S.-based entities. Separately, the Commission is providing notice that it is revising its policy regarding the notification procedures applicable to listing an option on a futures contract that already is (or can be) listed for trading from the U.S.