November 2014 – Federal Register Recent Federal Regulation Documents

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), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted 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: Ms. Suzanne White, 6701 Rockledge, Office of Grants Management, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., MSC 7926, Bethesda, MD 20892-7926, or call non-toll-free number 301-435-0166, or Email your request, including your address to whitesa@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: Electronic Prior Approval Submission System (ePASS), 0925New, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose and use of the information collection for this project is to collect and track certain requests (such as budget modifications or undertaking particular activities) from NIH grantees in an electronic format. This new electronic system, ePASS (electronic Prior Approval Submission System), will enable grantees to have a standard way to submit requests for their projects per NIH policy. The grantee will initiate a request for a certain action as required by NIH policy: Use of unobligated balances/carryover, change of PI, change of effort, Training Grant (NRSA) waivers, significant rebudgeting, 2nd and 3rd no cost extensions, and change of scope. These are all prior approvals as required by the NIH Grants Policy, and need to be reviewed and approved by the NHLBI. ePASS will provide a template to ensure that all specific points are addressed and documented in the official grant file. All information is submitted via the internet, tracked in ePASS, and the documentation will automatically be forwarded to the official grant file. The system will ensure that individuals authorized by the grantee are submitting requests and that the appropriate NIH staff is receiving the requests. The requests will be template driven so that the grantee is including the minimally required information, thus eliminating the usual back and forth to obtain missing information. Forms will have automatic fill-in capability that will reduce typos in grant numbers and PI names, further reducing approval time. Reminders will be sent to NIH staff within ePASS based on roles to ensure timely responses to the grantee. The system will facilitate email communication with applicants by automatic notifications when applications are received and when NIH has made a determination regarding a request (approval issued or request denied with explanation for denial). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 470.

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 Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Harold Perl, Ph.D., Chief, Prevention Research Branch, Division of Epidemiology, Services & Prevention Research, NIDA, 6001 Executive Blvd., Rockville, MD 20852 or call this non-toll-free number (301) 443-6504, or email your request, including your address to: hperl@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Assessing an Online Process to Study the Prevalence of Drugged Driving in the U.S: Development of the Drugged Driving Reporting System. Type of Information Collection Request: 0925- NEW. National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: The study seeks to provide an improved understanding of the prevalence of drugged driving among adult drivers in the U.S and will assess the effectiveness of the online survey implementation process. The primary objectives of the study are to: (a) To provide comprehensive data on drugged driving; (b) determine if the Drugged Driving Survey Instrument (DDS) is an effective and accurate measure of drugged driving among licensed U.S. Drivers aged 18 and older; and, (c) to assess the effectiveness of the survey implementation process, including various levels of incentives for participation to determine the appropriate/optimal incentive amount needed to obtain the desired number of total survey respondents within the timeframe within which survey data will be collected. The findings will provide valuable information concerning various aspects of substance use and driving behavior, including: (1) Demographic information about drivers who do and do not drive while impaired by medication and/or drugs (e.g. age, zip code, type of driver's license); (2) which drugs/medications are most likely to be used while driving; (3) drivers' beliefs and attitudes toward drugged driving. OMB approval is requested for 2 years. There are no direct costs to respondents other than their time. The total annualized estimated burden hours are 750.

We, the U.S. Fish and Wildlife Service, announce the availability of the draft recovery plan for the Santa Ana sucker for public review and comment. The draft recovery plan includes recovery objectives and criteria, and specific actions necessary to achieve recovery and removal of the species from the Federal List of Endangered and Threatened Wildlife. We request review and comment on this draft recovery plan from local, State, and Federal agencies, and the public.

FMCSA announces receipt of applications from 12 individuals for an exemption from the prohibition against persons with a clinical diagnosis of epilepsy or any other condition which is likely to cause a loss of consciousness or any loss of ability to operate a commercial motor vehicle (CMV) from operating CMVs in interstate commerce. The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ``Instructions for Performing and Recording Physical Examinations'' have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they have had one or more seizures and are taking anti- seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner. If granted, the exemptions would enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs for 2 years in interstate commerce.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 13, 2014, at 79 FR 47470, allowing for a 60-day public comment period. USCIS did not receive any comment in connection with the 60-day notice.

FMCSA announces receipt of applications from 34 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. If granted, the exemptions would enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye.

In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Securities and Exchange Commission (``Commission'' or ``SEC'') proposes to revise two existing systems of records, ``Administrative Proceeding Files (SEC-36)'', last published in the Federal Register Volume 62 FR 47884 (September 11, 1997) and ``Information Pertaining or Relevant to SEC Regulated Entities and Their Activities'' (SEC-55), last published in the Federal Register Volume 75 FR 35853 (June 23, 2010).

FMCSA announces that it has received an application from the Specialized Carriers & Rigging Association (SC&RA) for an exemption from the 30-minute rest break provision of the Agency's hours-of- service (HOS) regulations for commercial motor vehicle (CMV) drivers. The requested exemption would apply to specialized carriers and drivers responsible for the transportation of loads that exceed normal weight and dimensional limitsoversize/overweight (OS/OW) loadsand require a permit issued by a government authority. Due to the nature of their operation, SC&RA believes that compliance with the 30-minute rest break rule is extremely difficult, primarily due to the limited (usually daylight) hours in which an OS/OW load can be transported as restricted by State permit requirements. SC&RA therefore requests this exemption for all permitted loads. FMCSA requests public comment on SC&RA's application for exemption.

FMCSA announces that 10 individuals have applied for a medical exemption from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). In accordance with the statutory requirements concerning applications for exemptions, FMCSA requests public comments on these requests. The statute and implementing regulations concerning exemptions require that exemptions must provide an equivalent or greater level of safety than if they were not granted. If the Agency determines the exemptions would satisfy the statutory requirements and decides to grant theses requests after reviewing the public comments submitted in response to this notice, the exemptions would enable 10 individuals to operate CMVs in interstate commerce.

NARA is giving public notice that the agency has submitted to OMB for approval the information collection described in this notice. The public is invited to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.

This technical amendment corrects codification, terminology, and technical errors in the requirements for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) at 42 CFR 424.57.

The Industry Trade Advisory Committee on Small and Minority Business (ITAC-11) will hold a meeting on Monday, December 8, 2014. The meeting will be open to the public from 1:00 p.m. to 3:30 p.m.

The Food and Drug Administration (FDA) is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on September 19, 2014, at 79 FR 56384, allowing for a 60-day public comment period. USCIS received a comment in connection with the 60-day notice.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on July 16, 2014, at 79 FR 41585, allowing for a 60-day public comment period. USCIS did receive a comment in connection with the 60-day notice.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 21, 2014, at 79 FR 49529, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.

The Sabine Pass to Galveston Bay, Texas, study area encompasses six coastal counties on the upper Texas Gulf coastOrange, Jefferson, Chambers, Harris, Galveston and Brazoria. The Draft Integrated Feasibility Report and Environmental Impact Statement (DIFR- EIS) will evaluate structural and non-structural alternatives which address coastal storm risk management (CSRM) and ecosystem restoration (ER) impacts in the study area. The environmental impact study will focus on environmental and social conditions currently present and those likely to be affected by potential future impacts of storm surge and ecosystem restoration opportunities. Several major historical surge events have occurred in the study area in the past 120 years. The most notable is perhaps the 1900 Storm, which inundated most of the island city of Galveston, TX, and adjacent areas on the mainland. The storm was responsible for over eight thousand deaths and up to $30 million in property damage. Hurricane Rita in 2005 resulted in storm surge of 9.2 feet in Port Arthur, TX, and just over 8 feet in Sabine Pass. Most recently, Hurricane Ike in 2008 produced storm surges of 14 feet near Sabine Pass and 11 to 12 feet across Sabine Lake. The City of Port Arthur was spared from the impacts of storm surge thanks to its existing 14- to 17-foot hurricane flood protection system. However, the remaining southern half of Jefferson County was inundated, with estimated high water marks reaching 18 to19 feet to the south and east of High Island. The City of Galveston was protected from Hurricane Ike's high energy surge impacts by the Galveston Seawall, but much of the City of Galveston was later flooded by about 6 to 10 feet of surge coming from the bay. The City of Texas City was protected from Ike's surge impacts by its existing hurricane flood protection system. At risk within the study area are approximately 2.26 million people living within the storm-surge inundation zone, three of the nine largest oil refineries in the world, 40 percent of the nation's petrochemical industry, 25 percent of the nation's petroleum-refining capacity, and three of the ten largest U.S. seaports.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this continuing information collection, as required by the Paperwork Reduction Act of 1995. Under the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment on proposed revisions to the regulatory reporting templates and documentation for covered institutions with total consolidated assets of $10 billion to $50 billion.

The Commander of the Northwestern Division of the U.S. Army Corps of Engineers (Corps) is soliciting applications to fill vacant stakeholder representative member positions on the Missouri River Recovery Implementation Committee (MRRIC). Members are sought to fill vacancies on a committee to represent various categories of interests within the Missouri River basin. The MRRIC was formed to advise the Corps on a study of the Missouri River and its tributaries and to provide guidance to the Corps with respect to the Missouri River recovery and mitigation activities currently underway. The Corps established the MRRIC as required by the U.S. Congress through the Water Resources Development Act of 2007 (WRDA), Section 5018.

This notice is issued in accordance with 51 U.S.C. 20144(c). The Cube Quest (CQ) Challenge is scheduled and teams that wish to compete may now register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The Cube Quest Challenge is a prize competition designed to encourage development of new technologies or application of existing technologies in unique ways to advance cubsat communication and propulsion systems. NASA is providing the prize purse.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1309, ``Guidelines for Evaluating the Effects of Light-Water Reactor Coolant Environments in Fatigue Analyses of Metal Components.'' This guide, Revision 1 of Regulatory Guide 1.207 has been revised to consolidate, update, and replace previous NRC staff guidance on the effects of light-water reactor coolant environments on the fatigue lives of nuclear power plant components. This proposed revision provides an alternative to previous guidance provided for new reactors in Revision 0 of this guide, as well as to previous guidance provided for license renewal of operating reactors in the Generic Aging Lessons Learned (GALL) Report and the Standard Review Plan for License Renewal (SRP-LR). This guide supports reviews of applications for new nuclear reactor construction that are licensed under the NRC's regulations.