August 2014 – Federal Register Recent Federal Regulation Documents

The Bureau of Consumer Financial Protection (Bureau) is publishing for public comment a proposed rule amending Regulation C to implement amendments to the Home Mortgage Disclosure Act (HMDA) made by section 1094 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Consistent with section 1094 of the Dodd-Frank Act, the Bureau proposes to add several new reporting requirements and to clarify several existing requirements. The Bureau is also proposing changes to institutional and transactional coverage under Regulation C.

We are extending the expiration date of our rule that authorizes State agency disability examiners to make fully favorable determinations without the approval of a State agency medical or psychological consultant in claims that we consider under our quick disability determination (QDD) and compassionate allowance (CAL) processes. The current rule will expire on November 14, 2014. In this final rule, we are changing the November 14, 2014 expiration or ``sunset'' date to November 13, 2015, extending the authority for 1 year. We are making no other substantive changes.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 79, June 12, 2014 on page 33764 and allowed 60-days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: glynnsa@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: HIV Study in Blood Donors from Five Chinese Regions, 0925-0596 reinstatement with change, National Heart, Lung and Blood Institute (NHLBI). Need and Use of Information Collection: This Study is a reinstatement with change of OMB Number: 0925-0596 expiration date, January 31, 2012. To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). The major objectives of the study will be to evaluate the proportion of blood donors in China who test positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV-1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status. The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad cross-section of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, the study objectives have direct relevance for HIV control in the US and globally. Recent years have seen an increase in blood donations from repeat donors in most Chinese regions. This increase permits longer-term follow-up and testing of repeat donors which allow for calculation of new HIV infection rates and residual risks. The HIV data, for both recently and remotely acquired infections, from the proposed study will complement existing data on HIV risks obtained from general and high risk populations to provide comprehensive HIV surveillance data for China. This study will also monitor genetic characteristics of recently acquired infections through genotyping and drug resistance testing, thus serving a US and global public health imperative to monitor the genotypes of HIV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Genotyping and host response information are scientifically important not only to China, but to the US and other nations since they provide a broader global understanding of how to most effectively manage and potentially prevent HIV, for example through vaccine development. Efforts to develop vaccines funded by the National Institutes of Health and other US-based organizations may directly benefit from the findings of this study. Blood donors are tested for transfusion-transmissible infections including HIV when they present to donate, and test result information as well as demographic data will be routinely collected in a database at the five blood centers participating in REDS-III studies (located in the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These data will allow for calculation of HIV incidence, prevalence, and residual risk. Additionally, a case-control study will be conducted over a 2 and \1/2\ year period to evaluate the risk factors associated with HIV infection among blood donors. Cases will be defined as potential donors who deny risks on the donor screening questionnaire but are found to be positive on HIV testing (their donation is discarded), HIV-positive donors who gave blood at one of the five blood centers as stated above (primary sites) or at blood centers located in the Guangxi Autonomous Region (peripheral sites, recruited through the Guangxi CDC for this study only but not other REDS-III studies) will be eligible to participate and complete a Risk Factor Questionnaire that will assess general demographic and risk factor information pertinent to HIV infection. Controls will be negative for HIV on confirmatory testing. Assuming 50% response rate, it is anticipated that 390 HIV- positive donors and 960 controls will participate in the case control study. The results of this study will contribute to global HIV surveillance and prevention, provide a broader global understanding of HIV epidemiology, and support public health efforts to most effectively manage and potentially prevent HIV transmission both worldwide and in the US. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 450.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to require scientific and technical reports be submitted in electronic format.

On March 24, 2014, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain frozen warmwater shrimp from Thailand.\1\ The period of review (POR) is February 1, 2012, through January 31, 2013. Based on our analysis of the comments received, we made certain changes in the margin calculations. Therefore, the final results differ from the preliminary results. For the final results, we continue to find that all companies involved in this review sold subject merchandise at less than normal value. Finally, we find that 12 companies had no shipments of subject merchandise during the POR.

The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty order on certain polyester staple fiber (PSF) from the Republic of Korea (Korea) for the period of review May 1, 2013, through April 30, 2014, based on the withdrawal of requests for review.

The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a revision of a currently approved collection, which is summarized below under SUPPLEMENTARY INFORMATION. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan- 1-yl][5- methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle suvorexant.

The Environmental Protection Agency (EPA) is proposing to approve elements of a State Implementation Plan (SIP) submission from the State of Kansas addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2010 National Ambient Air Quality Standards (NAAQS) for Nitrogen Dioxide (NO2). Section 110 requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Imperial County Air Pollution Control District (ICAPCD) and the Shasta County Air Quality Management District (SHAQMD) portion of the California State Implementation Plan (SIP). We are proposing to approve local rules regarding enhanced monitoring under the Clean Air Act (CAA or the Act).

EPA is holding a workshop entitled, ``Ecotoxicity Testing of Difficult-to-Test Substances in the Aquatic Environment: Evaluation and Testing of Poorly Water Soluble Substances,'' on September 10-11, 2014. The objective of this workshop is to better understand the state of the science for evaluating chemical substances which are difficult-to-test in aquatic test systems. The workshop will include a limited number of invited experts and observers, and will also provide web connection and teleconference capabilities for others to participate remotely. Due to space limitations, the Agency anticipates that approximately 50 invited experts and 40 observers will be able to attend the workshop in person. EPA invites the public to register to attend the meetings as observers and to provide comments during the meeting as discussed in this notice.

FMCSA requests public comment on an application for exemption from Atwood Forest Products, Inc. (Atwood) to allow the use of a camera system installed at the sides and rear of up to 15 of its commercial motor vehicles (CMV) in lieu of rear-vision mirrors as specified in the Federal Motor Carrier Safety Regulations (FMCSR). Section 393.80 of the FMCSRs currently requires every bus, truck, and truck tractor to be equipped with two rear-vision mirrors, one at each side, firmly attached to the outside of the motor vehicle, and so located as to reflect to the driver a view of the highway to the rear along both sides of the vehicle. All such mirrors must, at a minimum, meet the requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 111 in effect at the time the vehicle was manufactured. The exemption would enable Atwood to install the camera system on its vehicles for use in an evaluation study, in a location that will offer the best opportunity to optimize data to evaluate the safety and economic benefits of eliminating outside mirrors.

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment our environmental assessment for the field release of diamondback moths which have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. The purpose of the field release is to assess the feasibility and efficacy of these moths in reducing populations of non-genetically engineered diamondback moths.

We are proposing to amend the fruits and vegetables regulations to allow the importation of several varieties of fresh citrus fruit, as well as Citrus hybrids, into the continental United States from areas in the Republic of South Africa where citrus black spot has been known to occur. As a condition of entry, the fruit would have to be produced in accordance with a systems approach that would include shipment traceability, packinghouse registration and procedures, and phytosanitary treatment. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of the Republic of South Africa with an additional declaration confirming that the fruit has been produced in accordance with the systems approach. This action would allow for the importation of fresh citrus fruit, including Citrus hybrids, from the Republic of South Africa while continuing to provide protection against the introduction of plant pests into the United States.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations to prevent the introduction of gypsy moth from Canada into noninfested areas of the United States.

Notice is hereby given that a permit has been issued to the Alaska Department of Fish and Game (ADF&G), Division of Wildlife Conservation, Juneau, AK, (Principal Investigator: Michael Rehberg), to conduct research on Steller sea lions (Eumetopias jubatus), within incidental disturbance of several pinniped species.

The NOAA Office of Ocean and Coastal Resource Management (OCRM) published a notice in the Federal Register on 25 July 2014 announcing its intent to evaluate the Chesapeake Bay National Estuarine Research Reserve in Virginia, Waquoit Bay National Estuarine Research Reserve, and Indiana Coastal Management Program. This document contains corrections to that notice, regarding the date of the public meeting for the Chesapeake Bay National Estuarine Research Reserve in Virginia and the dates for which written comments will be accepted for the Chesapeake Bay National Estuarine Research Reserve in Virginia, Waquoit Bay National Estuarine Research, and Indiana Coastal Management Program.

The Pike & San Isabel Resource Advisory Committee will meet in Pueblo, Colorado. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee Act. The purpose of the meetings is for project discussion and recommendation to the Designated Federal Official.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated September 2014. The guidance document provides recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title, dated March 2013 (2013 draft guidance), and supersedes the memorandum of December 12, 1991, entitled ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''