August 8, 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 100
Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting
The Food and Drug Administration (FDA) is reopening the comment period for the document that announced a public meeting in the Federal Register of May 11, 2016. In the document, FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be a followup to the June 10, 2016, public meeting on this topic and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016.
Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Ulcerative Colitis: Clinical Trial Endpoints.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance addresses FDA's current thinking regarding efficacy endpoints for UC clinical trials.
Fisheries of the Northeastern United States; Small-Mesh Multispecies Fishery; Adjustment to the Commercial Northern Red Hake Inseason Possession Limit
We announce the reduction of the commercial possession limit for northern red hake for the remainder of the 2016 fishing year. This action is required to prevent the northern red hake total allowable landing limit from being exceeded. This announcement informs the public that the northern red hake possession limit is reduced.
Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This draft guidance is not final nor is it in effect at this time.
Deciding When To Submit a 510(k) for a Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. When finalized, this document will supersede ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' issued January 10, 1997. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows
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.
Drawbridge Operation Regulation; Umpqua River, Reedsport, OR
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 101 Bridge across the Umpqua River, mile 11.1, at Reedsport, OR. The deviation is necessary to accommodate updating the electric control panels on the bridge. This deviation allows the US 101 Bridge to remain in the closed-to- navigation position during upgrades.
Determination That BENTYL (Dicyclomine Hydrochloride) Syrup 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.
Sanctions Actions Pursuant to Executive Order 13315, as Amended by Executive Order 13350
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is removing the name of an individual whose property and interests in property have been blocked pursuant to Executive Order 13315 of August 28, 2003, ``Blocking Property of the Former Iraqi Regime, Its Senior Officials and Their Family Members, and Taking Certain Other Actions,'' as amended by Executive Order 13350 of July 30, 2004, from the List of Specially Designated Nationals and Blocked Persons (SDN List).
Pacific Fishery Management Council; Public Meetings and Hearings
The Pacific Fishery Management Council (Pacific Council) has begun the five-year review of its groundfish trawl catch share program, as required by the Magnuson Stevens Fishery Management and Conservation Act. It will also begin a concurrent review of its groundfish inter- sector allocations. This document announces the dates and locations of Pacific Council public hearings that will inform Council decisions on the content and focus for the review (review plan).
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.
Reconsideration on the Mercury and Air Toxics Standards (MATS) and the Utility New Source Performance Standards Startup and Shutdown Provisions; Final Action
The U.S. Environmental Protection Agency (EPA) is providing notice that it has responded to two petitions for reconsideration of the final rule titled ``Reconsideration of Certain Startup/Shutdown Issues: National Emission Standards for Hazardous Air Pollutants (NESHAP) From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance (NSPS) for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units,'' published in the Federal Register on November 19, 2014. The Administrator denied the requests for reconsideration in separate letters to the petitioners. The letters and a document providing a full explanation of the agency's rationale for each denial is in the docket for these rules.
Technical Amendments to Performance Specification 18 and Procedure 6
Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing a portion of the May 19, 2016, direct final rule that made several minor technical amendments to the performance specifications and test procedures for hydrogen chloride (HCl) continuous emission monitoring systems (CEMS). The adverse comments related to revisions to Procedure 6 and thus the EPA is withdrawing the portion of the direct final rule that revised Procedure 6.
Snapper-Grouper Fishery of the South Atlantic; 2016 Recreational Accountability Measure and Closure for the South Atlantic Other Jacks Complex
NMFS implements an accountability measure (AM) for the recreational sector for the other jacks complex (lesser amberjack, almaco jack, and banded rudderfish) in the South Atlantic for the 2016 fishing year through this temporary rule. NMFS projects that recreational landings of the other jacks complex will reach their combined recreational annual catch limit (ACL) by August 9, 2016. Therefore, NMFS closes the recreational sector for this complex on August 9, 2016, through the remainder of the fishing year in the exclusive economic zone (EEZ) of the South Atlantic. This closure is necessary to protect the lesser amberjack, almaco jack, and banded rudderfish resources.
Proposed Amendment of Class E Airspace, Blue Mesa, CO
This action proposes to amend Class E en route domestic airspace extending upward from 1,200 feet above the surface near the Blue Mesa VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME), Blue Mesa, CO. The FAA has transitioned to a more accurate method of measuring, publishing, and charting airspace areas. This transition has revealed some small areas of uncharted uncontrolled airspace. The FAA found modification of these areas of uncontrolled airspace necessary to ensure the safety of Instrument Flight Rules (IFR) operations and the efficient use of navigable airspace, including point-to-point off-airway clearances, and aircraft vectoring services.
Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection
The Food and Drug Administration (FDA) is announcing the completion of the target of the goal established to address the Center for Devices and Radiological Health's (CDRH) 2014-2015 Strategic Priority ``Strike the Right Balance Between Premarket and Postmarket Data Collection.'' To achieve this Strategic Priority, CDRH established a goal to assure the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance. We established a target date of December 31, 2015, by which to review 100 percent of product codes subject to a premarket approval application (PMA) that are legally marketed and were approved prior to 2010 to determine, for each such product code, whether or not, based on our current understanding of the technology, to reduce premarket data collection by relying more on postmarket controls, and whether to shift some premarket data collection to the postmarket setting or to pursue down-classification.
Flonicamid; Pesticide Tolerances
This regulation establishes tolerances for residues of flonicamid in or on hops, tree nuts (crop group 14-12 except pistachio), and pistachio. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Civil Penalties Inflation Adjustments; Correction
The Office of the Secretary of the Interior is correcting an interim final rule that appeared in the Federal Register on Tuesday June 28, 2016 (81 FR 41858). This rule adjusts the level of civil monetary penalties contained in U.S. Department of the Interior regulations implementing the Native American Graves Protection and Repatriation Act with an initial ``catch-up'' adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance. The corrections are administrative and procedural related to submitting comments.
Safety Zones; Marine Events Held in the Sector Long Island Sound Captain of the Port Zone
The Coast Guard is establishing nine temporary safety zones for fireworks displays within the Coast Guard Sector Long Island Sound (LIS) Captain of the Port (COTP) Zone. This temporary final rule is necessary to provide for the safety of life on navigable waters during these events. Entry into, transit through, mooring or anchoring within these regulated areas is prohibited unless authorized by COTP Sector Long Island Sound.
Massachusetts Institute of Technology; Renewal of Special Nuclear Materials License
The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the renewal of Special Nuclear Materials (SNM) License No. SNM-986, which currently authorizes the Massachusetts Institute of Technology (MIT) to possess and use SNM for education, research, and training programs. The renewed license would authorize MIT to continue to possess and use SNM for an additional 10 years from the date of issuance. The NRC proposes to determine that the renewal involves no significant hazards consideration. Because this application contains sensitive unclassified non-safeguards information (SUNSI) an order imposes procedures to obtain access to SUNSI for contention preparation.
Improving Outage Reporting for Submarine Cables and Enhanced Submarine Outage Data
In this document, the Federal Communications Commission (Commission or FCC) adopts final rules of a Report and Order requiring submarine cable licensees to report service outages through the network outage reporting systems (NORS). In doing so, the FCC seeks to improve overall submarine cable reliability and resiliency by enhancing the FCC's visibility into the operational status of submarine cables, which will permit the FCC to track and analyze outage trends. The Report and Order requires all submarine cable licensees to report service outages to the FCC, defined as a failure or significant degradation in the performance of a licensee's cable service regardless of whether the traffic can be re-routed to an alternate path. Licensees must report outages, including those caused by planned maintenance, of a portion of a submarine cable system for more than 30 minutes, or the failure or significant degradation of any fiber pair lasing for four hours or more. Lastly, the Report and Order will improve submarine cable deployment conditions and resiliency through better coordination of inter-agency permit review.
Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of September 16, 2016, for the final rule that appeared in the Federal Register of May 4, 2016. The direct final rule amends the general biological products standards relating to dating periods and removes 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 concerns. This action is part of FDA's retrospective review of its regulations in response to an Executive order. This document confirms the effective date of the direct final rule.
Safety Zone; 2016 Wings Over Vermont Air Show, Lake Champlain, Burlington, VT
The Coast Guard is establishing a temporary safety zone for an aerobatic demonstration over the navigable waters of Lake Champlain along the shoreline in Burlington, VT. This temporary safety zone will be necessary to protect spectators and vessels from hazards associated with the air show. Entry into, transit through, mooring or anchoring within this regulated area will be prohibited unless authorized by the Captain of the Port (COTP) Sector Northern New England (SNNE).
Refuse To Accept Procedures for Premarket Tobacco Product Submissions
The Food and Drug Administration (FDA) is issuing a rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. FDA is issuing this action directly as a final rule because we believe there is little likelihood that we will receive any significant adverse comments opposing the rule given the specific deficiencies identified that will result in FDA's refusal to accept the submission.
Refuse To Accept Procedures for Premarket Tobacco Product Submissions
The Food and Drug Administration (FDA) is issuing a proposed rule describing when FDA would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA would be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Final Priorities-Enhanced Assessment Instruments
The Assistant Secretary for Elementary and Secondary Education announces priorities under the Enhanced Assessment Instruments Grant program, also called the Enhanced Assessment Grants (EAG) program. The Assistant Secretary may use one or more of these priorities for competitions using funds from fiscal year (FY) 2016 and later years. These priorities are designed to support projects to improve States' assessment systems.
Section 610 Review of the 2008 Lead; Renovation, Repair, and Painting Program (RRP); Extension of Comment Period
On June 9, 2016 the Environmental Protection Agency (EPA) published a request for comments on a Regulatory Flexibility Act section 610 review titled, Section 610 Review of Lead-Based Paint Activities; Training and Certification for Renovation and Remodeling Section 402(C)(3) (Section 610 Review). As initially published in the Federal Register, written comments were to be submitted to the EPA on or before August 8, 2016 (a 60-day public comment period). Since publication, the EPA has received a request for additional time to submit comments. Therefore, the EPA is extending the public comment period for 30 days until September 7, 2016.
Suspension of Community Eligibility
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB).
Safety Zones; Point to LaPointe Swim, Lake Superior, LaPointe, WI
The Coast Guard will enforce the Safety Zone for the Point to LaPointe Swim in LaPointe, WI on August 6, 2016. This action is necessary to protect participants and spectators during the Point to LaPointe Swim in Lake Superior between Bayfield, WI and LaPointe, WI. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative.
Tuberculosis in Cattle and Bison; State and Zone Designations; California
We are amending the bovine tuberculosis regulations regarding State and zone classifications by reclassifying the State of California as accredited-free. We have determined that the State meets the criteria for accredited-free status. This action relieves certain restrictions on the interstate movement of cattle and bison from the State of California.
Juvenile Justice and Delinquency Prevention Act Formula Grant Program
The Office of Justice Programs (``OJP'') proposes to update the implementing regulation for the Formula Grant Program authorized by Title II, Part B, of the Juvenile Justice and Delinquency Prevention Act of 1974 (``the Act'' or ``JJDPA''). The purpose of the Formula Grant Program is to provide formula grant awards to states to support juvenile delinquency prevention programs and to improve their juvenile justice systems. The proposed rule would supersede the existing Formula Grant Program regulations to reflect changes in the 2002 JJDPA reauthorization as well as policy changes to the Formula Grant Program.
Technical Amendment
This final rule amends the U.S. Department of Transportation's (DOT) regulation to conform to recent legislation that changed the definition of the term ``service agent'' in the DOT drug and alcohol testing regulations. The final rule also revises the definition of ``service agent'' to include all entities that provide services for DOT mandated drug and alcohol programs.
Amendment to the Export Administration Regulations To Add Targets for the Production of Tritium and Related Development and Production Technology to the List of 0Y521 Series
In this interim final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to make certain items subject to the EAR and to impose on those items a license requirement for export and reexport to all destinations, except Canada. Specifically, this rule classifies certain specified targets ``specially designed'' for the production of tritium and related ``development'' and ``production'' technology under Export Control Classification Numbers (ECCNs) 0A521 and 0E521, respectively, on the Commerce Control List (CCL). As described in the final rule that established the 0Y521 series and that was published in the Federal Register on April 13, 2012, items are added to the 0Y521 series upon a determination by the Department of Commerce, with the concurrence of the Departments of Defense and State, and other agencies as appropriate, that the items should be controlled for export because the items provide at least a significant military or intelligence advantage to the United States or foreign policy reasons justify control. In this matter, the Department of Energy also concurred in the control imposed. The items identified in this rule are controlled for regional stability (RS) Column 1 reasons. The only license exception available for these items is for exports, reexports, and transfers (in-country) made by or consigned to a department or agency of the U.S. Government.
Subsistence Management Regulations for Public Lands in Alaska-2016-17 and 2017-18 Subsistence Taking of Wildlife Regulations
This final rule establishes regulations for seasons, harvest limits, and methods and means related to the taking of wildlife for subsistence uses in Alaska for the 2016-17 and 2017-18 regulatory years. The Federal Subsistence Board (Board) completes the biennial process of revising subsistence hunting and trapping regulations in even-numbered years and subsistence fishing and shellfish regulations in odd-numbered years; public proposal and review processes take place during the preceding year. The Board also addresses customary and traditional use determinations during the applicable biennial cycle. This rule also revises wildlife customary and traditional use determinations.
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