May 6, 2015 – Federal Register Recent Federal Regulation Documents
Results 101 - 133 of 133
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary of Defense for Health Affairs 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.
Notice of Intent To Seek Approval To Extend an Information Collection
The National Science Foundation (NSF) is announcing plans to request clearance of this collection. In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting that OMB approve clearance of this collection for no longer than three years.
Prospective Grant of Exclusive Patent License
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the National Institute of Standards and Technology (``NIST''), U.S. Department of Commerce, is contemplating the grant of an exclusive license in the United States of America, its territories, possessions and commonwealths, to NIST's interest in the invention embodied in U.S. Patent No. 8,918,884, entitled ``K-zero day safety,'' (NIST Docket No. 12-017) to the George Mason Research Foundation, Inc. The grant of the license would be for all fields of use.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
NARA gives public notice that it has submitted to OMB for approval the information collection described in this notice. We invite the public to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.
Duke Energy Florida, Inc.; Crystal River Nuclear Generating Plant, Unit 3
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption from certain power reactor liability insurance requirements in response to a request from Duke Energy Florida, Inc. (DEF or the licensee) dated February 25, 2014, as supplemented by letter dated May 7, 2014. This exemption would permit the licensee to reduce its primary offsite liability insurance and withdraw from participation in the secondary retrospective rating pool for deferred premium charges.
Nuclear Innovation North America LLC; South Texas Project, Units 3 and 4
On September 20, 2007, South Texas Project Nuclear Operating Company (STPNOC) submitted to the U.S. Nuclear Regulatory Commission (NRC) an application for combined licenses (COLs) for two additional units (Units 3 and 4) at the South Texas Project (STP) Electric Generating Station site in Matagorda County near Bay City, Texas. The NRC published a notice of receipt and availability for this COL application in the Federal Register on December 5, 2007. In a letter dated January 19, 2011, STPNOC notified the NRC that, effective January 24, 2011, Nuclear Innovation North America LLC (NINA) became the lead applicant for STP, Units 3 and 4. This notice is being published to notify the public of the availability of the COL application for STP, Units 3 and 4.
Defensin Proteins (SoD2 and SoD7) Derived From Spinach (Spinacia oleracea L.) in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance
This regulation establishes a temporary exemption from the requirement of a tolerance for residues of SoD2 and SoD7, two defensin proteins derived from spinach (Spinacia oleracea L.), in or on citrus when used as plant-incorporated protectants (PIPs) in accordance with the terms of Experimental Use Permit (EUP) No. 88232-EUP-1. Southern Gardens Citrus submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of SoD2 and SoD7 in or on citrus. The temporary tolerance exemption expires on April 18, 2018.
Pesticide Product Registration; Receipt of Applications for New Uses
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.'' This draft guidance is being issued to explain the circumstances in which it may be appropriate to leverage existing clinical data to support pediatric device indications in premarket approval applications (PMAs) and humanitarian device exemptions (HDEs). The draft guidance also describes the approach that FDA would use to determine whether extrapolation is appropriate in medical devices, and the factors that would be considered within a statistical model for extrapolation. Extrapolation may be appropriate when the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients and the adult data are of high quality for borrowing. This draft guidance is not final nor is it in effect at this time.
Administrative Applications and the Phased Review Process; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled ``Administrative Applications and the Phased Review Process.'' This guidance defines the ``phased review process'' for reviewing application-level information during the investigational period of new animal drug development, and an ``administrative'' new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review.
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance provides recommendations for sponsors of investigational new drug applications (INDs), and applicants that submit new drug applications, abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of in vivo bioavailability (BA) and/or bioequivalence (BE) studies.
Bioequivalence Recommendations for Clozapine Orally Disintegrating Tablets/Oral; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Clozapine,'' for the orally disintegrating tablets (ODTs). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for clozapine ODTs.
Withdrawal of Draft Guidance Documents Published Before December 31, 2013
The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is taking this action to improve the efficiency and transparency of the guidance development process.
Notice of Proposed Changes to the National Handbook of Conservation Practices for the Natural Resources Conservation Service
Notice is hereby given of the intention of NRCS to issue a series of revised conservation practice standards in the National Handbook of Conservation Practices. These standards include: Amending Soil Properties with Gypsum Products (Code 333), Animal Mortality Facility (Code 316), Contour Orchards and Other Perennial Crops (Code 331), Controlled Traffic Farming (Code 334), Denitrifying Bioreactor (Code 605), Emergency Animal Mortality Management (Code 368), Field Operations Emissions Reduction (Code 376), Forest Stand Improvement (Code 666), Herbaceous Wind Barriers (Code 603), Irrigation System, Micro-irrigation (Code 441), Roofs and Covers (Code 367), Sprinkler System (Code 442), Vegetated Treatment Area (Code 635), and Vegetative Barrier (Code 601). NRCS State Conservationists who choose to adopt these practices for use within their States will incorporate them into Section IV of their respective electronic Field Office Technical Guide. These practices may be used in conservation systems that treat highly erodible land (HEL) or on land determined to be a wetland. Section 343 of the Federal Agriculture Improvement and Reform Act of 1996 requires NRCS to make available for public review and comment all proposed revisions to conservation practice standards used to carry out HEL and wetland provisions of the law.
911 Call-Forwarding Requirements for Non-Service-Initialized Phones
The Commission seeks comment on whether the obligation to transmit 911 calls from non-service-initialized (NSI) devices still serves an important public safety objective. Because the cumbersome call validation methods extant when the rules were adopted in the late 1990s are no longer in use, and because of the current ubiquity of low- cost options for wireless services, the Commission proposes to sunset the obligation to transmit 911 calls from an NSI device within six month, accompanied by consumer outreach and education. Public safety representatives have indicated that NSI devices are frequently used to make fraudulent or otherwise non-emergency calls, causing a significant waste of limited public safety resources.
Modernizing Common Carrier Rules
In this document, the Federal Communications Commission (Commission) initiates a rulemaking that seeks to update the Commission's rules to better reflect current requirements and technology by removing outmoded regulations from the CFR. The Commission proposes to update the CFR by eliminating certain rules from which the Commission has forborn and eliminating references to telegraph service in certain rules. The Commission would clarify regulatory requirements, and modernize our rules to better reflect the state of the current telecommunications market.
NOAA RESTORE Act Science Program Science Plan
The National Ocean Service (NOS) of the National Oceanic and Atmospheric Administration (NOAA) publishes this notice to announce the availability of response to comments and release of the final science plan for the NOAA RESTORE Act Science Program.
Clarification of United States Antitrust Laws, Immunity, and Liability Under Marketing Order Programs
This proposal invites comments on an amendment to the general regulations for federal fruit, vegetable, and specialty crop marketing agreements and marketing orders that would accentuate the applicability of U.S. antitrust laws to marketing order programs' domestic and foreign activities. This action would also advise marketing order board and committee members and personnel of the restrictions, limitations, and liabilities imposed by those laws.
National Organic Program Regulations; Section 610 Review
This document summarizes the findings of a USDA Agricultural Marketing Service (AMS) review of the National Organic Program (NOP) which is implemented under the Organic Food Production Act (OFPA). The review criteria are stipulated by the Regulatory Flexibility Act (RFA), in section 610. Based upon this review, the AMS has determined that the USDA organic regulations meet the objectives of the OFPA and should continue. Since becoming effective on the October 21, 2002, there have been multiple amendments to the USDA organic regulations. Most of these amendments were additions to or deletions from the National List of Allowed and Prohibited Substances (National List).
Final Affordability Determination-Energy Efficiency Standards
The U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Agriculture (USDA) have determined that adoption of the 2009 edition of the International Energy Conservation Code (IECC) for single family homes and the 2007 edition of the American Society of Heating, Refrigerating and Air-conditioning Engineers (ASHRAE) 90.1 for multifamily buildings will not negatively affect the affordability and availability of certain HUD- and USDA-assisted housing specified in section 481 of the Energy and Independence and Security Act of 2007 (EISA). This determination fulfills a statutory requirement established under EISA that HUD and USDA adopt revisions to the 2006 IECC and ASHRAE 90.1-2004 subject to: A determination that the revised codes do not negatively affect the availability or affordability of new construction of single family and multifamily housing covered by EISA; and a determination by the Secretary of Energy that the revised codes ``would improve energy efficiency.'' For the more recent IECC and ASHRAE codes that have been published since the publication of the 2009 IECC and ASHRAE 90.1-2007, HUD and USDA intend to follow this Notice of Final Determination with an advance notice that addresses the next steps the agencies plan to take on the 2015 IECC and ASHRAE 90.1-2013 codes.
Fenazaquin; Pesticide Tolerances
This regulation establishes tolerances for residues of fenazaquin in or on almonds and cherries. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Advisory Committee Act; Technological Advisory Council
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting on Thursday, June 11, 2015 in the Commission Meeting Room, from 1 p.m. to 4 p.m. at the Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Pesticide Product Registration; Receipt of Applications for New Active Ingredients
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
1-Octanol; Exemption From the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide 1-octanol in or on root and tuber vegetables. D-I-1-4, Inc., a division of 1,4- Group, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to the exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1-octanol in or on root and tuber vegetables.
Request for Information: Public Input on the Sustained Assessment Process of the U.S. National Climate Assessment
The U.S. Global Change Research Program (USGCRP) has a legal mandate to conduct a National Climate Assessment (NCA) not less frequently than every four years. Under its current decadal strategic plan (https://go.usa.gov/3qGU4), USGCRP is building sustained assessment capacity to support the Nation's ability to understand, anticipate, and respond to global change impacts and vulnerabilities. The recent Third NCA process and resulting 2014 Report (https://nca2014.globalchange.gov/) provide a foundation for subsequent activities and reports under the sustained assessment process. More broadly, climate assessments increasingly involve participation and leadership by state, local, and tribal governments as well as the private sector. Noting these developments in the climate assessment landscape, USGCRP seeks ideas about (1) what scientific information on climate change, impacts, and responses would be of most value to inform future assessment activities; (2) how to effectively communicate climate change assessment information; and (3) what mechanisms could be used to more effectively connect to other assessment-related efforts. Public responses to these questions will be evaluated and, if appropriate, used to inform the structure and content of USGCRP's sustained National Climate Assessment process. Updates on the sustained assessment will be posted on the NCA Web site (https:// assessment.globalchange.gov) as they are available.
Rocky Mountain Arsenal National Wildlife Refuge, Commerce City, CO; Draft Comprehensive Conservation Plan and Environmental Impact Statement
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft comprehensive conservation plan (CCP) and environmental impact statement (EIS) for the Rocky Mountain Arsenal National Wildlife Refuge (refuge). In these documents, we describe alternatives, including our proposed action alternative, to manage the refuge for the 15 years following approval of the final CCP.
Notice of Request for Applications for the Veterinary Medicine Loan Repayment Program
The National Institute of Food and Agriculture (NIFA) is announcing the release of the Veterinary Medicine Loan Repayment Program (VMLRP). General information regarding the VMLRP can be obtained at: www.nifa.usda.gov/vmlrp. The Request for Applications (RFA) can be obtained at: https:// nifa.usda.gov/vmlrp-request-applications-rfa.
Boating Infrastructure Grant Program
We, the U.S. Fish and Wildlife Service (Service), are revising regulations governing the administration of the national Boating Infrastructure Grant Program (BIG). We published a proposed rule in the Federal Register on March 28, 2012. We received responses from the public during the 60-day comment period with recommendations for changes, support for certain parts of the proposed rule, and requests for more time to review the proposed rule. We published a second proposed rule in the Federal Register on April 25, 2014, with a 90-day comment period. The final rule simplifies and clarifies some sections, responds to comments on both proposed rules, and considers other approaches to carrying out this grant program.
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