June 12, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of August 8, 2011, and the proposed order the Agency issued in the Federal Register of April 4, 2013, in part. In those documents, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, cranial electrotherapy stimulator (CES). In response to information received in response to these two proposed actions, FDA is withdrawing the proposed rule and proposed order.

The Coast Guard has issued a temporary deviation from the operating schedule of the US 70/Alfred C. Cunningham Bridge across the Trent River mile 0.0, at New Bern, NC. The deviation is necessary to facilitate the annual Bike Multiple Sclerosis (MS): Historic New Bern Ride. This deviation allows the bridge to remain in the closed position so that cyclists can safely exit Union Point Park and enter the bike route.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

The Coast Guard is establishing an emergency temporary safety zone for all waters of the Tennessee River, extending the entire width from mile 4.8 to 5.8. This safety zone is needed to protect persons, property and infrastructure from the potential damage and safety hazards associated with structural concerns of the George Rogers Clark Memorial Bridge, mile 5.3 Tennessee River. Entry into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Alabama (FEMA-4176-DR), dated 05/12/2014. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding. Incident Period: 04/28/2014 through 05/05/2014.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection and allow 60 days for public comment in response to this notice. This notice solicits comments on the information needed to audit accountings of fiduciaries.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to waive disability benefits.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to determine continued entitlement to benefits based on unemployment.

As part of the review of the air quality criteria for sulfur oxides (SOX) and primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO2), the Environmental Protection Agency (EPA) is announcing a teleconference workshop to evaluate preliminary draft materials that will inform the development of the SOX Integrated Science Assessment (ISA) for health effects. The workshop is being organized by EPA's National Center for Environmental Assessment (NCEA) within the Office of Research and Development and will be held on June 23-24, 2014. Participation in the workshop will be by webinar or teleconference only.

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 black stem rust quarantine and regulations.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to this notice. This notice solicits comments on information needed to determine a claimant's eligibility for disability insurance benefits.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection and allow 60 days for public comment in response to this notice. This notice solicits comments for information needed to determine a claimant's entitlement to income based benefits and the amount payable.

The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revised collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to obtain an accurate and comprehensive assessment of satisfaction of patients who receive mental health care services and on outcomes for Veterans who seek mental health treatment from VHA. Data will allow the program office to ensure that the target audience is being reached, effective treatments are being offered, and tangible, quantitative results are being measured and tracked for continual program improvement.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. 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 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 U.S. 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 U.S. 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 U.S. 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 U.S.-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 U.S. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 450.

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

This is an amendment of the Economic Injury Disaster Loan (EIDL) declaration for the State of California, dated 09/26/2013. Incident: Rim Fire. Incident Period: 08/17/2013 and continuing through 10/24/2013.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Alabama (FEMA-4176-DR), dated 05/12/2014. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding. Incident Period: 04/28/2014 through 05/05/2014.

The Francis Marion-Sumter Resource Advisory Committee (RAC) will meet in Columbia, South Carolina. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. The meetings are open to the public. The purpose of the meetings is to review project proposals and recommend Title II funds.

The Bureau of Land Management (BLM), Las Vegas Field Office, proposes to sell the Federal reversionary interest in 2.5 acres of land in Las Vegas, Nevada. The land was conveyed out of Federal ownership in 1996 subject to the Federal reversionary interest that is now proposed for sale under the authority of Section 202 and Section 203 of the Federal Land Policy and Management Act of October 21, 1976 (FLPMA), as amended. The appraised fair market value for the Federal reversionary interest is $558,000.00.

The South Central Idaho Resource Advisory Committee (RAC) will meet in Twin Falls, Idaho. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. The meeting is open to the public. The purpose of the meeting is to review and recommend Title II projects for the Salmon-Challis National Forest brought forward by the Central Idaho RAC subcommittee to the South Central Idaho RAC.

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of March 25, 2014. In the proposed rule, FDA requested comments on its proposal to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA), to update its regulations by proposing changes unrelated to the new FDASIA requirements, and to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.