June 2013 – Federal Register Recent Federal Regulation Documents

This Notice is to invite applications for loans and grants under the Rural Economic Development Loan and Grant (REDLG) program pursuant to 7 CFR part 4280, subpart A for fiscal year (FY) 2013. Funding to support $33 million in loans and $10 million in grants is currently available. The commitment of program dollars will be made to applicants of selected responses that have fulfilled the necessary requirements for obligation. All applicants are responsible for any expenses incurred in developing their applications.

Notice is hereby given of the following hearing of the U.S.- China Economic and Security Review Commission. Name: William A. Reinsch, Chairman of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to investigate, assess, and report to Congress annually on ``the national security implications of the economic relationship between the United States and the People's Republic of China.'' Pursuant to this mandate, the Commission will hold a public hearing in Washington, DC on June 27, 2013, ``Macau and Hong Kong.'' Background: This is the seventh public hearing the Commission will hold during its 2013 report cycle to collect input from academic, industry, and government experts on national security implications of the U.S. bilateral trade and economic relationship with China. The hearing will examine two of China's special administrative regions, Macau and Hong Kong. The Commission will focus on money laundering and financial fraud related to casino gambling in Macau and issues related to democracy, press freedom, and human rights in Hong Kong. The hearing will be co-chaired by Commissioners William A. Reinsch and Dennis C. Shea. Any interested party may file a written statement by June 27, 2013, by mailing to the contact below. A portion of each panel will include a question and answer period between the Commissioners and the witnesses. Location, Date and Time: Dirksen Senate Office Building, Room 608. Thursday, June 27, 2013, 9:00 a.m.-2:45 p.m. Eastern Time. A detailed agenda for the hearing is posted to the Commission's Web site at www.uscc.gov. Also, please check our Web site for possible changes to the hearing schedule. Reservations are not required to attend the hearing.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or we) is confirming the effective date of May 2, 2013, for the final rule that published in the Federal Register of April 1, 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.

The Southwest Fisheries Science Center (SWFSC) will hold an online Pre-Assessment Workshop webinar to provide an overview of the data sources, data trends and population models that will be used in the upcoming Pacific coast groundfish stock assessments for Pacific sanddab and cowcod (rockfish). The online SWFSC Pre-Assessment Workshop webinar is open to the public, although space for online access is limited to the first 20 participants.

Notice is hereby given that the Department of Veterans Affairs (VA), Office of Research and Development (ORD), intends to grant to Somahlution, Inc., a Delaware corporation, doing business at 3401 Fiechtner Drive, Fargo, North Dakota 58103, USA, an exclusive license to practice the following patent: U.S. Patent No. 6,569,615, ``Composition and Methods for Tissue Preservation,'' issued May 27, 2003. Copies of the published patent may be obtained from the U.S. Patent and Trademark Office at www.uspto.gov.

Announcement regarding a change in eligibility for Unemployment Insurance (UI) claimants in Alabama, Alaska, Delaware, Illinois, Louisiana, Michigan, Mississippi, Ohio, the Virgin Islands and Wisconsin in the Emergency Unemployment Compensation (EUC08) program, and the Federal-State Extended Benefits (EB) program. The U.S. Department of Labor (Department) produces trigger notices indicating which states qualify for both EB and EUC08 benefits, and provides the beginning and ending dates of payable periods for each qualifying state. The trigger notices covering state eligibility for these programs can be found at: https://ows.doleta.gov/unemploy/claims arch.asp. The following changes have occurred since the publication of the last notice regarding states EUC08 and EB trigger status: Alabama's trigger value had fallen below the 7.0% threshold and has triggered ``off'' Tier 3 of EUC08. Based on data released by the Bureau of Labor Statistics on March 18, 2013, the three month average, seasonally adjusted total unemployment rate (TUR) in Alabama was 6.9%, falling below the 7.0% trigger threshold necessary to remain ``on'' Tier 3 of EUC08. The week ending April 13, 2013, was the last week in which EUC08 claimants in Alabama could exhaust Tier 2 and establish Tier 3 eligibility. Under the phase-out provisions, claimants could receive any remaining entitlement they had for Tier 3 after April 13, 2013. Alaska's insured unemployment rate (IUR) has fallen below the 6.0% trigger threshold and has triggered ``off'' of EB. Based on data from Alaska for the week ending April 13, 2013, the 13 week IUR in Alaska fell below the 6.0% trigger threshold necessary to remain ``on'' EB. The payable period in EB for Alaska ended May 4, 2013. Alaska's IUR has fallen below the 6.0% trigger threshold and has triggered ``off'' Tier 4 of EUC08. Based on data from Alaska for the week ending April 13, 2013, the 13 week IUR in Alaska fell below the 6.0% trigger rate threshold to remain ``on'' Tier 4 of EUC08. The week ending May 4, 2013, was the last week in which EUC08 claimants in Alaska could exhaust Tier 3, and establish Tier 4 eligibility. Under the phase-out provisions, claimants could receive any remaining entitlement they had for Tier 4 after May 4, 2013. Delaware's trigger value exceeds the 7.0% trigger threshold and has triggered ``on'' Tier 3 of EUC08. Based on data released by the Bureau of Labor Statistics on March 18, 2013, the three month average, seasonally adjusted TUR in Delaware was 7.1%, exceeding the 7.0% threshold necessary to trigger ``on'' Tier 3 of EUC08. The week beginning April 7, 2013, was the first week in which EUC08 claimants in Delaware who had exhausted Tier 2, and are otherwise eligible, could establish Tier 3 eligibility. Illinois' trigger value met the 9.0% trigger threshold and has triggered ``on'' Tier 4 of EUC08. Based on data released by the Bureau of Labor Statistics on March 29, 2013, the three month average, seasonally adjusted TUR in Illinois met the 9.0% trigger threshold to trigger ``on'' Tier 4 of EUC08. The week beginning April 14, 2013, was the first week in which EUC08 claimants in Illinois who had exhausted Tier 3, and were otherwise eligible, could establish Tier 4 eligibility. Louisiana's trigger value has fallen below the 6.0% trigger threshold and has triggered ``off'' Tier 2 of EUC08. Based on data released by the Bureau of Labor Statistics on March 18, 2013, the three month average, seasonally adjusted TUR in Louisiana was 5.8%, falling below the 6.0% trigger threshold to remain ``on'' Tier 2 of EUC08. The week ending April 13, 2013, was the last week in which EUC08 claimants in Louisiana could exhaust Tier 1, and establish Tier 2 eligibility. Under the phase-out provisions, claimants could receive any remaining entitlement they had in Tier 2 after April 13, 2013. Michigan's trigger value has fallen below the 9.0% trigger threshold and has triggered ``off'' Tier 4 of EUC08. Based on data released by the Bureau of Labor Statistics on March 18, 2013, the three month average, seasonally adjusted TUR for Michigan was 8.9%, falling below the 9.0% trigger threshold to remain ``on'' Tier 4 of EUC08. The week ending April 13, 2013, was the last week in which EUC08 claimants in Michigan could exhaust Tier 3, and establish Tier 4 eligibility. Under the phase-out provisions, claimants could receive any remaining entitlement they had in Tier 4 after April 13, 2013. Mississippi's trigger value exceeds the 9.0% trigger threshold and has triggered ``on'' Tier 4 of EUC08. Based on data released by the Bureau of Labor Statistics on March 29, 2013, the three month average, seasonally adjusted TUR in Mississippi was 9.3%, exceeding the 9.0% trigger threshold to trigger ``on'' Tier 4 of EUC08. The week beginning April 14, 2013, was the first week in which EUC08 claimants in Mississippi who had exhausted Tier 3, and are otherwise eligible, could establish Tier 4 eligibility. Ohio's trigger value met the 7.0% trigger threshold and has triggered ``on'' Tier 3 of EUC08. Based on data released by the Bureau of Labor Statistics on April 19, 2013, the three month average, seasonally adjusted total unemployment rate in Ohio had met 7.0% trigger threshold to trigger ``on'' in Tier 3 of EUC08. The week beginning May 5, 2013, was the first week in which EUC08 claimants in Ohio who had exhausted Tier 2, and were otherwise eligible, could establish Tier 3 eligibility. The Virgin Islands' estimated trigger rate fell below the 6.0% threshold and has triggered ``off'' both Tier 2 and Tier 3 of EUC08. Based on data released by the Bureau of Labor Statistics on March 8, 2013, the estimated three month average, seasonally adjusted TUR in the Virgin Islands fell below the 6.0% trigger threshold rate to remain ``on'' both Tier 2 and Tier 3 of EUC08. That triggered the Virgin Islands off both Tier 2 and Tier 3 of EUC08. The week ending March, 30 2013, was the last week in which EUC08 claimants in the Virgin Islands could exhaust Tier 1 and establish Tier 2 eligibility, or exhaust Tier 2 and establish Tier 3 eligibility. Wisconsin's trigger value met the 7.0% threshold and has triggered ``on'' Tier 3 of EUC08, however mandatory 13 week ``off'' period delayed effective date. Based on data released by the Bureau of Labor Statistics on April 19, 2013, the three month average, seasonally adjusted TUR for Wisconsin has met the 7.0% trigger rate threshold to trigger ``on'' Tier 3 of EUC08. However, Wisconsin was in a 13 week mandatory ``off'' period that started February 9, 2013, and did not conclude until May 11, 2013. As a result, Wisconsin remained in an ``off'' period for Tier 3 of EUC08 through May 11, 2013, and triggered ``on'' Tier 3 of EUC08 effective May 12, 2013. The week beginning May 12, 2013, was the first week in which EUC08 claimants in Wisconsin who have exhausted Tier 2, and are otherwise eligible, can establish Tier 3 eligibility.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 17, 2013, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Graphics Properties Holdings, Inc. of New Rochelle, New York. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain consumer electronics with display and processing capabilities by reason of infringement of U.S. Patent No. 6,650,327 (``the '327 patent''); U.S. Patent No. 8,144,158 (``the '158 patent''); and U.S. Patent No. 5,717,881 (``the '881 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. A letter supplementing the complaint was filed on June 7, 2013. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of International Programs. The goal of the Cooperative Agreement is to strengthen global regulatory capacity through activities that may include: Development of global norms and standards for product regulation; generation and analysis of evidence of regulatory systems performance; and provision of technical support to national regulatory systems strengthening efforts.

The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) Extended-Release Tablet products approved under new drug application (NDA) 21-610 were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended-release tablets if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Tobacco Product's (CTP's) Building Research Capacity in Global Tobacco Product Regulation Program. FDA intends to accept and consider a single source application for award to the World Health Organization (WHO) to identify, support, develop, conduct, and coordinate research efforts relating to tobacco control laws and rules in foreign countries that will directly inform and support FDA's exercise of its authority to regulate the manufacture, distribution, marketing, and sale of tobacco products in the United States. The Building Research Capacity in Global Tobacco Product Regulation Program seeks to advance and expand research in support of tobacco product regulation, in order to reduce the morbidity and mortality associated with tobacco use both within the United States and internationally. The program will advance FDA's and CTP's mission by utilizing WHO Member States' expertise and extensive international contacts in global tobacco control, as well as WHO's own programmatic expertise, to inform and support adequate manufacture, distribution, and market regulations of tobacco products for the protection of public health in the United States.

The Coast Guard is withdrawing its proposed rule concerning amendments to the regattas and marine parades regulations. The rulemaking was initiated to establish special local regulations during the ``Annual Leonardtown Wharf Boat Races,'' a marine event to be held on the waters of Breton Bay in St. Mary's County, Maryland on July 13, 2013, and July 14, 2013. The Coast Guard was notified on April 23, 2013, that the event had been cancelled.

The Coast Guard is withdrawing its proposed rule concerning amendments to the regattas and marine parades regulations. The rulemaking was initiated to establish special local regulations during the swim segment of the ``TriRock Triathlon Series,'' a marine event to be held on the waters of Spa Creek and Annapolis Harbor on July 20, 2013. The Coast Guard was notified on May 21, 2013, that the event had been cancelled.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

The FTC seeks public comments on its proposal to the Office of Management and Budget (``OMB'') to extend through August 31, 2016, the current Paperwork Reduction Act (``PRA'') clearance for the FTC's enforcement of the information collection requirements in its in its Telemarketing Sales Rule (``TSR''). That clearance expires on August 31, 2013.

U.S. Customs and Border Protection (CBP) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: United States-Caribbean Basin Trade Partnership Act (CBTPA). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with a change to the burden hours. This document is published to obtain comments from the public and affected agencies. This information collection was previously published in the Federal Register (78 FR 23280) on April 18, 2013, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.