February 16, 2016 – Federal Register Recent Federal Regulation Documents
Results 101 - 134 of 134
Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This draft guidance revises the draft guidance for industry entitled ``Allergic Rhinitis: Clinical Development Programs for Drug Products'' issued April 2000.
Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).'' This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The information gathered from the workshop and the public comments submitted to the docket will further inform FDA's development of its pilot project program.
Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist applicants in the development of drug and biological products for the treatment of nonallergic rhinitis (NAR).
Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled ``Draft Guidance on Cyclosporine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Completeness Assessments for Type II API DMFs Under GDUFA''. It finalizes the draft guidance entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA'', which published on October 2, 2012. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).
Notice of Receipt of Petition for Decision That Nonconforming Model Year 2014 Mercedes-Benz SLK Class Passenger Cars Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2014 Mercedes-Benz SLK Class passenger cars (PC) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2014 Mercedes- Benz SLK Class PC) and they are capable of being readily altered to conform to the standards.
Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Evaluation of the Safety of Drugs and Biological Products used during Lactation.'' The purpose of this workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.
Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled ``Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.'' The objective of the workshop is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The promise of using real- world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and healthcare data systems integration.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Educational Conference Co- Sponsored With the Society of Clinical Research Associates (SOCRA).'' The public workshop on FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA, clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRBs, and of research sponsors.
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled ``Inhalational Anthrax (Post- Exposure)Developing Antimicrobial Drugs'' issued in March 2002.
Proposed Extension of Approval of Information Collection; Comment Request-Standards for Full-Size Baby Cribs and Non-Full Size Baby Cribs; Compliance Form
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (``CPSC'' or ``Commission'') requests comments on a proposed extension of approval of information collection requirements regarding a form that will be used to measure child care centers' compliance with the CPSC safety standards for full-size and non-full-size cribs (16 CFR parts 1219 and 1220). The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (``OMB'').
Approval and Promulgation of Air Quality Implementation Plans; 2008 Ozone NAAQS Interstate Transport for Colorado, Montana, North Dakota and South Dakota
The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) submissions from the states of Colorado, Montana, North Dakota and South Dakota that are intended to demonstrate that the SIP for each respective state meets certain interstate transport requirements of the Clean Air Act (Act or CAA) for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These submissions address the requirement that each SIP contain adequate provisions prohibiting air emissions that will have certain adverse air quality effects in other states. The EPA is approving these SIPs for all four states as containing adequate provisions to ensure that air emissions in the states do not significantly contribute to nonattainment or interfere with maintenance of the 2008 8-hour ozone NAAQS in any other state.
Approval of Iowa's Air State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross Media Electronic Reporting Rule (CROMERR)
The Environmental Protection Agency (EPA) is proposing to approve a SIP revision submitted by the State of Iowa. The revision pertains to the approval of Iowa's CROMERR submission which was published in the Federal Register on December 9, 2015, and will revise the Iowa SIP to provide for electronic submittal of emission inventory data.
Approval of Iowa's State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross-Media Electronic Reporting Rule (CROMERR)
The Environmental Protection Agency (EPA) is approving a SIP revision submitted by the State of Iowa. The revision pertains to the approval of Iowa's CROMERR submission which was published in the Federal Register on December 9, 2015, and will revise the Iowa SIP to provide for electronic submittal of emission inventory data.
Approval of Regional Haze BART Alternative Measure: Washington
The Environmental Protection Agency (EPA) is taking final action to approve the Best Available Retrofit Technology (BART) alternative measure for the BP Cherry Point Refinery located near Ferndale, Washington. The BART alternative measure increases the oxides of nitrogen (NOX) emission limit from the R-1 HC Reactor Heater (R-1 Heater), a BART-eligible source currently subject to BART emission limits on NOX. To offset the increase in NOX emissions from this emission unit, the NOX emission limits on the 1st Stage Hydrocracker Fractionator Reboiler (R- 1 Reboiler), also a BART-eligible source subject to BART emission limits on NOX, will be reduced. The net effect of these changes is a decrease of 10.4 tons per year (tpy) of allowable NOX emissions from sources subject to BART at the BP Cherry Point Refinery.
Procedures Related to Motions; Correction
This document corrects the DATES section to a proposed rule published in the Federal Register of February 1, 2016. The Commission did not intend to permit interested persons to file reply comments. The Commission is seeking initial comments only.
Agency Information Collection Activities; Submission for OMB Review; Comment Request-Safety Standard for Automatic Residential Garage Door Operators
In accordance with the requirements of the Paperwork Reduction Act (``PRA'') of 1995 (44 U.S.C. chapter 35), the Consumer Product Safety Commission (``Commission'' or ``CPSC'') announces that the Commission has submitted to the Office of Management and Budget (``OMB'') a request for extension of approval of a collection of information associated with the CPSC's Safety Standard for Automatic Residential Garage Door Operators (OMB No. 3041-0125). In the Federal Register of December 3, 2015 (80 FR 75664), the CPSC published a notice to announce the agency's intention to seek extension of approval of the collection of information. The Commission received no comments. Therefore, by publication of this notice, the Commission announces that CPSC has submitted to the OMB a request for extension of approval of that collection of information, without change.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary of Defense 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.
Privacy Act of 1974; System of Records
The Department of the Navy proposes to alter a system of records notice N05350-1, entitled ``Navy Drug and Alcohol Program System.'' This system is used to train, educate, identify, screen, counsel, rehabilitate, and monitor the progress of individuals in drug and alcohol abuse programs. Information is used to screen and evaluate the certified counselors, counselor interns, and counselor applicants throughout the course of their duties.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (AEA), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from January 16, 2016, to February 1, 2016. The last biweekly notice was published on February 2, 2016.
Regulatory Review Schedule
As part of its ongoing, systematic review of all Federal Trade Commission rules and guides, the Commission announces a modified ten- year regulatory review schedule. No Commission determination on the need for, or the substance of, the rules and guides listed below should be inferred from this notice.
Notice of FTA Transit Program Changes, Authorized Funding Levels and Implementation of Federal Public Transportation Law as Amended by the Fixing America's Surface Transportation (FAST) Act and FTA Fiscal Year 2016 Apportionments, Allocations, Program Information and Interim Guidance
This notice announces changes in the Federal Transit Administration (FTA) programs in accordance with Federal public transportation law by the Fixing America's Surface Transportation (FAST) Act, which authorizes surface transportation programs of the Department of Transportation (DOT) for Federal fiscal years (FY) 2016 through 2020. This notice provides preliminary implementation instructions and guidance for the new and revised programs in FY 2016, announces the apportionment for programs authorized and funded with FY 2016 contract authority, and describes future plans for several discretionary programs. The notice also includes locations of FY 2016 apportionment tables and unobligated (or carryover) funds allocated under the discretionary programs from prior years.
Occupational Exposure to Beryllium
OSHA is rescheduling the informal public hearing on its proposed rule ``Occupational Exposure to Beryllium and Beryllium Compounds.'' The public hearing will now begin on Monday March 21, 2016 at 2 p.m., local time. The public hearing notice was published in the Federal Register on December 30, 2015. The proposed rule was published in the Federal Register on August 7, 2015 and the 90-day public comment period ended on November 5, 2015. The December 30, 2015 Federal Register notice of informal public hearing describes the procedures that will govern this hearing https://www.regulations.gov/ #!documentDetail;D=OSHA-H005C-2006-0870-1706. All other information from this Federal Register notice remains the same.
Endangered and Threatened Wildlife and Plants; Removing the San Miguel Island Fox, Santa Rosa Island Fox, and Santa Cruz Island Fox From the Federal List of Endangered and Threatened Wildlife, and Reclassifying the Santa Catalina Island Fox From Endangered to Threatened
We, the U.S. Fish and Wildlife Service (USFWS), propose to remove the San Miguel Island fox (Urocyon littoralis littoralis), Santa Rosa Island fox (U. l. santarosae), and Santa Cruz Island fox (U. l. santacruzae) from the Federal List of Endangered and Threatened Wildlife and to reclassify the Santa Catalina Island fox (U. l. catalinae) from an endangered species to a threatened species. This determination is based on a thorough review of the best available scientific and commercial information, which indicates that the threats to the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox have been eliminated or reduced to the point that each of the subspecies no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended (Act), and that the threats to the Santa Catalina Island fox have been reduced to the point that the subspecies can be reclassified as a threatened species. We are seeking information and comments from the public regarding this proposed rule and the draft post-delisting monitoring plan for the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox.
Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
The Office of the Chief Financial Officer, Farm Service Agency, Commodity Credit Corporation, National Institute of Food and Agriculture, Rural Utilities Service, Rural Business-Cooperative Service and Rural Housing Service finalize their portion of the uniform federal assistance rule and amend specific regulations to reference the conforming changes published by the Office of Management and Budget (OMB) in the Federal Register on December 19, 2014.
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