August 4, 2009 – Federal Register Recent Federal Regulation Documents

This notice with comment period describes the methodology for calculating the higher federal matching funding that is made available under Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for temporary increases in the Federal Medical Assistance Percentage (FMAP) rates to provide fiscal relief to States and to protect and maintain State Medicaid programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period that is defined as the period beginning on October 1, 2008 and ending on December 31, 2010.

The Federal Election Commission (``Commission'') is establishing a new agency procedure that will provide respondents in certain enforcement matters brought under the Federal Election Campaign Act of 1971, as amended (``FECA'') with notice of a non-complaint generated referral and an opportunity to respond thereto, prior to the Commission's consideration of whether it has reason to believe that a violation of the Act has been or is about to be committed by such respondent. This program will provide respondents in non-complaint generated matters procedural protections similar to those of respondents in complaint-generated matters. Further information about the procedures for providing notice to respondents in non-complaint generated matters is provided in the supplementary information that follows.

The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that modified the minimum size requirement under the Colorado potato marketing order, Area No. 2. For most long potato varieties, the interim final rule changed the minimum size requirement from 2 inches in diameter to 1\7/8\ inches in diameter and removed the minimum weight requirement. The change is expected to improve the marketing of Colorado Area No. 2 potatoes while increasing returns to producers and potato supplies to consumers.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy and educating the general public.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for RECOTHROM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.

The Office of Refugee Resettlement (ORR) announces the award of program expansion supplements to five Wilson-Fish Program grantees. The Wilson-Fish Program is an alternative to traditional State- administered refugee assistance programs and provides integrated assistance and services to refugees, asylees, Amerasian Immigrants, Cuban and Haitian Entrants, Trafficking Victims and Iraqi/Afghani Special Immigrant Visas (SIVs). The five supplemental awards will allow the grantees to provide cash and medical assistance to arriving refugees and to others who are also eligible for refugee benefits through the remainder of Fiscal Year (FY) 2009. The expansion supplement awards will enable the grantees to provide services needed to a higher number of arrivals than originally planned. The Refugee Act of 1980 mandates that the ORR reimburse State agencies and Wilson-Fish projects for the costs of cash and medical assistance for newly arriving refugees. Since 1991, ORR has reimbursed State agencies and Wilson-Fish agencies for providing cash and medical assistance to eligible individuals during their first eight months in the United States. The following Wilson-Fish Program grantees are awarded program expansion supplemental funding:

The National Maritime Security Advisory Committee (NMSAC) will conduct a meeting by teleconference on August 24, 2009. This teleconference will be open to the public.

The Recovery Accountability and Transparency Board (Board) is adopting regulations to establish its chapter and to adopt requirements on the use of its official seal. Use by any person or organization may be made only with the Board's prior written approval. Wrongful use of an official seal is subject to administrative action and/or criminal penalty.

The South Atlantic Fishery Management Council (Council) will hold a meeting of its Coral Advisory Panel in North Charleston, SC. See SUPPLEMENTARY INFORMATION.

The Coast Guard is establishing a temporary safety zone on the navigable waters of San Francisco Bay near San Francisco, CA in support of a Fleet Week fireworks display. This safety zone is necessary to ensure the safety of participants and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zones without permission of the Captain of the Port or his designated representative.

Section 1218 of the Housing and Economic Recovery Act of 2008 (HERA) requires the Federal Housing Finance Agency (FHFA) to permit the Federal Home Loan Banks (Banks) until July 30, 2010, to use Affordable Housing Program (AHP) homeownership set-aside funds to refinance low- or moderate-income households' mortgage loans. On October 17, 2008, FHFA amended its AHP regulation to authorize the Banks to provide AHP direct subsidies under their homeownership set-aside programs to low- or moderate-income households who qualify for refinancing assistance under the Hope for Homeowners Program established by the Federal Housing Administration (FHA) under Title IV of HERA. Based on the comments received on the amendments and continuing adverse conditions of the mortgage market, FHFA has determined that in order for the AHP set-aside refinancing program to be implemented successfully for the benefit of the intended households, the scope of the program authority should be broadened and the Banks should have greater flexibility in implementing the program. Accordingly, FHFA is issuing and seeking comment on an interim final rule that authorizes the Banks to provide AHP subsidy through their members to assist in the refinancing of eligible households' mortgages under eligible Federal, State and local programs for targeted refinancing in addition to the Hope for Homeowners Program. These programs would include the Administration's Making Home Affordable Refinancing program. The interim final rule permits the Banks to provide AHP direct subsidy to members and to use the subsidy for principal reduction and for loan closing costs, and requires that households obtain counseling for qualification for refinancing and foreclosure mitigation.

The Copyright Royalty Board is issuing an interim regulation to amend its procedural regulations to include a provision governing remands of final determinations pursuant to the Copyright Act, which sets forth in significant detail the procedural structure to be followed by the Copyright Royalty Judges in making determinations to distribute royalty fees and establish royalty rates and terms under the various statutory licenses of the Copyright Act. The Judges have adopted regulations governing the conduct of these proceedings.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This guidance document describes a means by which manufacturers of dental amalgam, mercury, and amalgam alloy may comply with special controls that apply to these class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify dental amalgam into class II (special controls), reclassify dental mercury from class I (general controls) to class II (special controls), and designate a special controls guidance document to support the class II classification of these two devices, as well as the current class II classification of amalgam alloy.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009-H1N1 Influenza A, or 2009-H1N1 influenza) that affects or has significant potential to affect national security. On the basis of this determination, on April 26 and April 27, 2009, the Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices.

This is Supplement No. I to the Treasury Department Circular 570, 2009 Revision, published July 1, 2009, at 74 FR 31536.

We, the U.S. Fish and Wildlife Service (Service), announce that our draft environmental assessment (EA) for limiting mountain lion (Puma concolor) predation on desert bighorn sheep (Ovis canadensis mexicana) on the Kofa National Wildlife Refuge (Refuge) is available. The Refuge is located in southwest Arizona. The draft EA describes