September 5, 2013 – Federal Register Recent Federal Regulation Documents

We propose to supersede an existing airworthiness directive (AD) for Agusta Model AB139 and AW139 helicopters. The existing AD currently requires establishing a revised life limit for each tail rotor blade (blade), updating the helicopter's historical records, repetitively inspecting each blade for a crack, and replacing certain blades. Since we issued that AD, the manufacturer has improved the design of the blades using different materials and established life limits for each newly-designed blade. This proposed AD would expand the applicability to include the newly-designed blades and establish their life limits. This proposed AD would also retain the requirement to inspect each blade for a crack and, if there is a crack, replace each blade with an airworthy blade. The proposed actions are intended to detect a crack in a blade to prevent failure of a blade and subsequent loss of control of the helicopter.

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 for the importation of emerald ash borer host material from Canada to prevent the introduction and spread of emerald ash borer in the United States.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Securities and Exchange Commission (``Commission'') has submitted the sponsored information collection request (ICR) titled, ``Regulation D Rule 506(e) Felons and Other Bad Actors Disclosure Statement,'' to the Office of Management and Budget (OMB) for review and clearance under the emergency processing procedures in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35) and 5 CFR 1320.13. OMB approval has been requested by September 23, 2013. In addition, this notice also solicits comment on the three-year extension of the same information collection under 5 CFR 1320.12.

The Department of the Interior, Office of the Secretary is announcing a public meeting of the Exxon Valdez Oil Spill Public Advisory Committee.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 credit account approval for reimbursable services.

In accordance with the Federal Advisory Committee Act, as amended, (5 U.S.C. App.), the Agricultural Marketing Service (AMS) is announcing an upcoming meeting of the National Organic Standards Board (NOSB). Written public comments are invited in advance of the meeting, and the meeting will include scheduled time for oral comments from the public.

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 swine health protection program.

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.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.

ASPR requires collaboration with local health departments and officials to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems. This project aims to improve collaboration between ASPR and the local health departments (LHDs) to enhance national health security, foster community health resilience, and strengthen health care, public health, and emergency management systems. One of the overarching goals of both the National Health Security Strategy (2009) and the ASPR Strategic Plan 2011-2015 is to build community health resilience. ASPR seeks to partner with LHDs and health officials which play a critical role in building community health resilience by employing and evaluating localized public health strategies, such as preparing local communities to withstand and recover from public health emergencies and disasters, and engaging local health departments and health care organizations to build healthcare coalitions. The project will foster better approaches for building community health resilience. LHDs and health officials are intimately familiar with the communities and populations that they serve and are an essential partner in carrying out the mission of ASPR. ASPR seeks to engage LHDs and health officials as well as other appropriate local stakeholders in bi-directional communications to evaluate the effectiveness of, and ensure that, ASPR's strategies, policies, and programmatic activities are informed by and support the needs of local communities. The project will foster collaboration with local health officials to achieve, for example, national health security and strengthen local emergency preparedness, response, and recovery systems and capabilities, and build well-functioning healthcare coalitions, among other activities. ASPR seeks to partner with LHDs and local communities which frequently prepare for, respond to, and recover from localized emergency incidents and to identify valuable lessons and promising practices to collect and share these practices with other LHDs and communities. This project will capture lessons learned and promising practices from local communities and share them more widely. Justification: The National Association of County and City Health Officials (NACCHO) is the national nonprofit organization representing all local and tribal health officials from across the country. Members are elected by their peers, and include ex officio members representing the National Association of Counties, of which NACCHO is an affiliate, and the U.S. Conference of Mayors. NACCHO advocates on the behalf of county and city health departments by providing Congressional testimony, submitting letters to the Administration, and endorsing proposed legislation. NACCHO has demonstrated experience establishing partnerships with both traditional and non-traditional organizations to impact both county and city public health departments and the broader public health system. NACCHO's existing network of health officials will provide ASPR with the unique ability to collaborate on federal programs and actions that could impact the preparation for, response to or recovery from emergencies and disasters impacting public health and health care. Additional Information: The agency program contact is Lisa Kaplowitz, who can be contacted by phone at (202) 202-2882 or via email at Lisa.Kaplowitz@hhs.gov.

ASPR requires collaboration with state and territorial health departments and officials to ensure that state and local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems. This project aims to improve collaboration between ASPR and the state health departments (SHDs) to enhance national health security, foster community health resilience, and strengthen health care, public health, and emergency management systems. One of the overarching goals of both the National Health Security Strategy (2009) and the ASPR Strategic Plan 2011-2015 is to build community health resilience. ASPR seeks to partner with SHDs and territorial health officials, which play a critical role in building community health resilience by employing and evaluating public health strategies such as preparing local communities to withstand and recover from public health emergencies and disasters, and engaging health care organizations to build healthcare coalitions. The project will foster better approaches for building community health resilience. SHDs and territorial health officials are intimately familiar with the communities and populations that they serve and are an essential partner in carrying out the mission of ASPR. ASPR seeks to engage SHDs and health officials as well as other appropriate stakeholders in bi- directional communications to evaluate the effectiveness of, and ensure that, ASPR's strategies, policies, and programmatic activities are informed by and support the needs of states, territories, and local communities. The project will foster collaboration with state health officials to achieve, for example, national health security and strengthen emergency preparedness, response, and recovery systems and capabilities, and build well-functioning healthcare coalitions, among other activities. ASPR seeks to partner with SHDs and territorial health officials and local communities which frequently prepare for, respond to, and recover from emergency incidents and to identify valuable lessons learned and promising practices to collect and share these practices with other SHDs and communities. This project will capture lessons and promising practices and share them more widely. Justification: The Association for State and Territorial Health Officials (ASTHO) is the only national nonprofit membership organization that includes membership representation from every state and local public health agency in the United States (U.S.), the U.S. Territories, the District of Columbia, and over 100,000 public health professionals employed by these agencies. ASTHO members, the chief health officials of these jurisdictions, formulate and influence sound public health policy and ensure excellence in state-based public health practice. The ASTHO organization has the unique ability to represent the perspectives of all the state and territorial health officials across the nation. Additional Information: The agency program contact is Lisa Kaplowitz, who can be contacted by phone at (202) 202-2882 or via email at Lisa.Kaplowitz@hhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Tobacco Retailer Training Programs.'' The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not require retailers to implement retailer training programs. However, the Tobacco Control Act does provide for lower civil money penalties for violations of sale and distribution, including youth access, advertising, and promotion restrictions issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to issue regulations establishing standards for approved retailer training programs. In the interim, this guidance document is intended to assist tobacco retailers who wish to implement training programs for employees.

The Food and Drug Administration (FDA) is announcing the availability of the Draft Standard Operating Procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues. The SOP describes the Center for Devices and Radiological Health's (CDRH's or the Center's) draft process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification 510(k), a Premarket Approval (PMA), or a Humanitarian Device Exemption (HDE) that needs to be disseminated in a timely manner.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2014.

This document contains final and temporary regulations relating to the application of the straddle rules to a debt instrument. The temporary regulations clarify that a taxpayer's obligation under a debt instrument can be a position in personal property that is part of a straddle. The temporary regulations primarily affect taxpayers that issue debt instruments that provide for one or more payments that reference the value of personal property or a position in personal property. The text of these temporary regulations also serves as the text of the proposed regulations (REG-111753-12) set forth in the Proposed Rules section in this issue of the Federal Register.

The Department of Commerce, 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.