May 4, 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 128
Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler)
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Henning Oeltjenbruns, general manager of the Daimler Truck Plant in Cleveland, NC, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in ``real world'' environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler)
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Sebastian Boehm, a project engineer, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in ``real world'' environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
National Advisory Committee on Institutional Quality and Integrity Meeting
This meeting notice is an update to the previous notice published in the Federal Register (81 FR 14846) on March 18, 2016, and sets forth the time and location for the June 22-24, 2016 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA) and Section 114(d)(1)(B) of the Higher Education Act of 1965 (HEA), as amended.
Financial Assistance and Social Services Programs; Burial Assistance
The Bureau of Indian Affairs (BIA) is confirming the interim final rule published on March 1, 2016, extending the deadline for filing an application for burial assistance to 180 days to address hardships resulting from the current short timeframe. The Department of the Interior (Department) did not receive any significant adverse comments during the public comment period on the interim final rule, and therefore confirms the rule without change.
Indian Entities Recognized and Eligible To Receive Services From the United States Bureau of Indian Affairs
This notice publishes the current list of 567 Tribal entities recognized and eligible for funding and services from the Bureau of Indian Affairs (BIA) by virtue of their status as Indian Tribes. The list is updated from the notice published on January 29, 2016 (81 FR 5019).
SEC Advisory Committee on Small and Emerging Companies
The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing notice that it will hold a public meeting on Wednesday, May 18, 2016, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (EDT) and will be open to the public. The meeting will be webcast on the Commission's Web site at www.sec.gov. Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The public is invited to submit written statements to the Committee. The agenda for the meeting includes matters relating to rules and regulations affecting small and emerging companies under the federal securities laws.
Agency Information Collection Activities: Comment Request
The National Science Foundation (NSF) is requesting renewal of the Generic Clearance of the National Center for Science & Engineering Statistics' Survey Improvement Projects (3145-0174), and has submitted an information collection requirement to OMB for review and clearance. In accordance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), this is the second notice for public comment; the first was published in the Federal Register at 81 FR 7833; no comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at https://www.reginfo.gov/ public/do/PRAMain. Comments: Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the NSF, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, use, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Notice of Intent To Prepare an Environmental Impact Statement for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland
The United States Air Force (Air Force) is issuing this notice to advise the public of its intent to prepare an Environmental Impact Statement (EIS) for the Presidential Aircraft Recapitalization (PAR) Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland (JBA). The EIS will assess the potential environmental consequences of the proposal to beddown versions of the Boeing 747-8 passenger aircraft at JBA as replacements to the two existing VC-25A aircraft currently used to transport the President of the United States (POTUS).
Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed information collection project entitled ``Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients''.
Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OOPD) Natural History Grants Program. The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Quantitative Assessment of Assumptions To Support Extrapolation of Efficacy in Pediatrics; Public Workshop
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is announcing a public workshop entitled ``Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.'' The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Special Protocol Assessment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Special Protocol Assessment.'' This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled ``Special Protocol Assessment'' issued May 17, 2002.
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This draft guidance revises the draft guidance of the same name that was issued on October 23, 2013.
Mefenoxam; Pesticide Tolerances
This regulation establishes tolerances for residues of mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document 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 that refer to the products as long as they meet relevant legal and regulatory requirements.
Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule
The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.
Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products
The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity
In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations that clarify the employment tax treatment of partners in a partnership that owns a disregarded entity. These regulations affect partners in a partnership that owns a disregarded entity. The text of those temporary regulations serves as the text of these proposed regulations.
Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity
This document contains final and temporary regulations that clarify the employment tax treatment of partners in a partnership that owns a disregarded entity. These regulations affect partners in a partnership that owns a disregarded entity. The text of these temporary regulations serves as the text of proposed regulations (REG-114307-15) published in the Proposed Rules section in this issue of the Federal Register.
Identification Markings Placed on Firearm Silencers and Firearm Mufflers
The Department of Justice is considering amending the regulations of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to require licensed manufacturers, licensed importers, and nonlicensed makers to place identification markings on the outer tube of firearm silencers and firearm mufflers. The Department wishes to gather information and comments from the public and industry concerning whether or not the regulations should be amended.
Environmental Policies and Procedures; Corrections
This document corrects errors in the final rule that appeared in the Federal Register of March 2, 2016, entitled ``Environmental Policies and Procedures.'' The rule replaced two existing rules relating to the Agency's procedures for implementing NEPA.
Endangered and Threatened Species; Take of Anadromous Fish; Reopening of Comment Period
On March 28, 2016, the National Marine Fisheries Service (NMFS) announced the availability of a Hatchery and Genetic Management Plan (HGMP) pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). The HGMP, provided by the California Department of Fish and Wildlife, specifies the operation of a hatchery program rearing steelhead in the Mad River subbasin within the State of California. The announcement opened a 30-day public comment period on the HGMP and associated draft environmental assessment (EA). In response to a request received from the public, NMFS is reopening the comment period for an additional 15 days. This action reopens the comment period for the notice that published March 28, 2016.
Agency Information Collection Activities: Request for Comments
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. This collection consists of 1 form. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on October 31, 2016.
Notice of Public Meeting of the Illinois Advisory Committee To Discuss Approval of a Draft Advisory Memorandum Regarding Civil Rights and Environmental Justice in the State
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Illinois Advisory Committee (Committee) will hold a meeting on Friday, May 06, 2016, at 12:00 p.m. CDT. The purpose of this meeting is to review and discuss approval of an advisory memorandum to be issued to the Commission regarding civil rights and environmental justice in the State. This memorandum is in support of the Commission's nationally focused 2016 statutory enforcement study. This meeting is available to the public through the following toll- free call-in number: 888-427-9419, conference ID: 7143536. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Member of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at callen@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// database.faca.gov/committee/meetings.aspx?cid=246. Click on the ``Meeting Details'' and ``Documents'' links to download. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.
Environmental Policies and Procedures; Correction
The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the Federal Register on March 2, 2016 (81 FR 11000), entitled ``Environmental Policies and Procedures.'' The rule replaced two existing rules related to the Agency's procedures for implementing NEPA. This correction will replace the introductory text to paragraph (a) of Sec. 1955.136.
Notice of Intent To Grant Exclusive License
Notice is hereby given that the U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), intends to grant to Picarro, Inc. of Santa Clara, California, an exclusive global license to its rights in ``Methods For Rapid Gas Sampling With High Horizontal Spatial Resolution In A Manner Suitable For Subsequent Constituent Gas Analysis''.
Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO): Meeting
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the ACVETEO. The ACVETEO will discuss the DOL core programs and services that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for individuals or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green at 202-693-4734. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, and/or materials in alternative format) should notify the Advisory Committee no later than Friday, May 27, 2016 by contacting Mr. Gregory Green at 202-693-4734. Requests made after this date will be reviewed, but availability of the requested accommodations cannot be guaranteed. The meeting site is accessible to individuals with disabilities. This Notice also describes the functions of the ACVETEO. Notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act. This document is intended to notify the general public.
Agency Information Collection Activities OMB Responses
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Proposed Collection of Information: FS Form 2001-Release
The Department of the Treasury, 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Release.
Fisheries of the Exclusive Economic Zone Off Alaska; Western Alaska Community Development Quota Program
NMFS issues a final rule to implement Amendment 109 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP). This final rule amends regulations governing the Western Alaska Community Development Quota (CDQ) Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 feet (ft) (14.0 meters (m)) length overall (LOA) using hook-and-line gear. Specifically, this final rule exempts operators of registered catcher vessels greater than 32 ft (9.8 m) LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry a License Limitation Program (LLP) license when groundfish CDQ fishing. This final rule also reduces observer coverage requirements for catcher vessels less than or equal to 46 ft LOA when groundfish CDQ fishing, and implements new in-season management and catch accounting requirements to properly account for the harvest of groundfish and halibut and the accrual of halibut prohibited species catch in these fisheries. In addition to the regulations necessary to implement Amendment 109, this final rule removes from the regulations a table and some explanatory text that are no longer necessary. This final rule is intended to facilitate increased participation by residents of CDQ communities in the groundfish fisheries in the Bering Sea and Aleutian Islands management area (BSAI), and to support economic development in western Alaska. This final rule also is intended to promote the goals of the CDQ Program, the goals and objectives of the BSAI FMP, the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable laws.
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