June 2016 – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 648
Rescission of Preconstruction Permits Issued Under the Clean Air Act
Document Number: 2016-13303
Type: Proposed Rule
Date: 2016-06-14
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) is proposing to revise a limitation on the rescission of stationary source preconstruction permits that is contained in the federal New Source Review (NSR) regulations. This proposal would amend the EPA's federal Prevention of Significant Deterioration (PSD) regulations to remove a date restriction from the current permit rescission provision. Other than removing the date restriction, the proposed rule is not intended to alter the circumstances under which an NSR permit may be rescinded. This proposal would also add a corresponding permit rescission provision in the federal regulations that apply to major sources in nonattainment areas of Indian country. This rule also proposes to correct an outdated cross-reference to another part of the regulations.
Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole for Vessels Participating in the BSAI Trawl Limited Access Fishery in the Bering Sea and Aleutian Islands Management Area
Document Number: 2016-13952
Type: Rule
Date: 2016-06-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for yellowfin sole in the Bering Sea and Aleutian Islands management area (BSAI) for vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2016 allocation of yellowfin sole total allowable catch for vessels participating in the BSAI trawl limited access fishery in the BSAI.
Amendment of Restricted Areas R-6602A, R-6602B, and R-6602C; Fort Pickett, VA
Document Number: 2016-13934
Type: Rule
Date: 2016-06-13
Agency: Federal Aviation Administration, Department of Transportation
This action updates the using agency information for restricted areas R-6602A, R-6602B, and R-6602C, Fort Pickett, VA. This is an administrative change to reflect the current organization tasked with using agency responsibilities for the restricted areas. It does not affect the boundaries, designated altitudes, time of designation or activities conducted within the restricted areas.
Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within the Fifth Coast Guard District
Document Number: 2016-13932
Type: Rule
Date: 2016-06-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce safety zone for fireworks displays taking place at Urbanna Creek, Urbanna, VA on July 2, 2016. This action is necessary to ensure safety of life on navigable waters during this event. Our regulation for Recurring Marine Events within the Fifth Coast Guard District identifies the regulated area for this fireworks display event. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the regulated area without approval from the Captain of the Port or a designated representative.
Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Trimester Total Allowable Catch Area Closure for the Common Pool Fishery
Document Number: 2016-13929
Type: Rule
Date: 2016-06-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This action closes the witch flounder Trimester Total Allowable Catch Area to Northeast multispecies common pool vessels fishing with trawl gear for the remainder of Trimester 1, through August 31, 2016. The closure is required by regulation because the common pool fishery has caught 90 percent of its Trimester 1 quota for witch flounder. This closure is intended to prevent an overage of the common pool's quota for this stock.
Safety Zone; Southern California Annual Fireworks for the San Diego Captain of the Port Zone
Document Number: 2016-13927
Type: Rule
Date: 2016-06-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce a safety zone for the Sea World Fireworks on the waters of Mission Bay, CA on specific evenings from Memorial Day to Labor Day. This safety zone is necessary to provide for the safety of the participants, spectators, official vessels of the events, and general users of the waterway. Our regulation for the southern California annual fireworks for the San Diego Captain of the Port Zone identifies the regulated area for the events. During the enforcement period, no spectators shall anchor, block, loiter in, or impede the transit of official patrol vessels in the regulated area without the approval of the Captain of the Port, or designated representative.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Extension of the 2016 Gulf of Mexico Private Angling Recreational Red Snapper Season
Document Number: 2016-13909
Type: Rule
Date: 2016-06-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS extends the recreational fishing season for the private angling component for red snapper in the exclusive economic zone (EEZ) of the Gulf of Mexico (Gulf) through this temporary rule. NMFS previously determined the private angling component would reach its annual catch target (ACT) for Gulf red snapper by 12:01 a.m., local time, June 10, 2016. However, due to recent severe weather conditions in the eastern Gulf, fishing opportunities were restricted during the recreational fishing season for the private angling component. NMFS has projected the private angling component will not reach its ACT by the current closure date. Therefore, NMFS is extending the recreational red snapper fishing season for the private angling component for 2 days to allow the ACT to be harvested. The intent of this action is to provide the recreational private angling component the opportunity to harvest its red snapper ACT, and the opportunity to achieve the optimum yield for the fishery, thus enhancing social and economic benefits to the fishery.
Optional Method of Filing Ocean Common Carrier and Marine Terminal Operator Agreements Subject to the Shipping Act of 1984
Document Number: 2016-13889
Type: Rule
Date: 2016-06-13
Agency: Federal Maritime Commission, Agencies and Commissions
The Federal Maritime Commission (Commission) is publishing this document to confirm the effective date of the direct final rule published on April 27, 2016.
Recordkeeping Regulations
Document Number: 2016-13878
Type: Rule
Date: 2016-06-13
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives
This final rule makes technical amendments to regulations pertaining to certain firearms recordkeeping requirements to provide clarity and enhance uniformity. The technical changes are being made in the wording of three tables to reflect the same wording in the body of the regulations associated with the tables regarding the required description of firearms for recordkeeping purposes.
Special Local Regulations; Marine Events in the Seventh Coast Guard District
Document Number: 2016-13875
Type: Rule
Date: 2016-06-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is updating the regulation that governs recurring special local regulations in the Seventh Coast Guard District. These regulations will apply to all recurring events held on navigable waters of the Seventh District, such as regattas and parades. This update is to ensure that all known recurring marine events are included in the final regulation and to allow respective Captains of the Port greater ease in enacting or modifying those portions of the regulation which apply to their respective areas.
Safety Zone; Ohio River Mile 25.2 to Mile 25.6, Beaver, PA
Document Number: 2016-13864
Type: Rule
Date: 2016-06-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for navigable waters of the Ohio River from mile 25.2-25.6. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Pittsburgh.
Regulated Navigation Areas; Escorted Submarines Sector Jacksonville Captain of the Port Zone
Document Number: 2016-13861
Type: Proposed Rule
Date: 2016-06-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to establish regulated navigation areas (RNA) covering the St. Marys Entrance Channel, portions of the Cumberland Sound, and the Atlantic Ocean, that will be in effect whenever any Navy submarine (foreign or domestic) is being escorted by the Coast Guard and operating within the jurisdictional waters of the Sector Jacksonville Captain of the Port Zone. These RNAs are necessary to help ensure the safety and security of submarines, their Coast Guard escorts, and the public. The RNAs will do so by requiring all persons and vessels located within a RNA to follow orders and/or directions given to them by Coast Guard escort personnel. Additionally, these proposed RNAs will supersede the current temporary safety/security zone for Cumberland Sound, Georgia and St. Mary's River Entrance Channel. We invite your comments on this proposed rulemaking.
Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes
Document Number: 2016-13854
Type: Proposed Rule
Date: 2016-06-13
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes installed with an affected engine mounting frame assembly. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as longitudinal material separation on the internal surface of the engine mounting frame assembly tubes. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
Mariana Archipelago Fisheries; Remove the CNMI Medium and Large Vessel Bottomfish Prohibited Areas
Document Number: 2016-13852
Type: Proposed Rule
Date: 2016-06-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This proposed rule would remove the medium and large vessel bottomfish prohibited fishing areas in the Commonwealth of the Northern Mariana Islands (CNMI). Conditions in the fishery that led to establishing the prohibited areas are no longer present, and the restriction is no longer necessary. The Western Pacific Fishery Management Council recommended Amendment 4 to the Fishery Ecosystem Plan for the Mariana Archipelago (FEP) to remove these prohibited areas, and this proposed rule would implement the recommended change. The intent of the proposed rule is to improve the viability of the CNMI bottomfish fishery and promote optimum yield while preventing overfishing. This proposed rule would also make an administrative housekeeping change to the regulations for the CNMI management subarea crustacean fishing.
Tree Care Operations
Document Number: 2016-13844
Type: Proposed Rule
Date: 2016-06-13
Agency: Department of Labor, Occupational Safety and Health Administration
OSHA invites interested parties to participate in an informal stakeholder meeting concerning tree care operations on July 13, 2016, in Washington, DC. This meeting is a continuation of OSHA's information collection on tree care operations. OSHA plans to use the information gathered at this meeting, together with other information in the record, to explore the possible development of a proposed standard to protect workers from hazards, fatalities, and injuries in tree care operations.
D-glucurono-6-deoxy-L-manno-D-glucan, Acetate, Calcium Magnesium Potassium Sodium Salt (Diutan Gum); Exemption From the Requirement of a Tolerance
Document Number: 2016-13805
Type: Rule
Date: 2016-06-13
Agency: Environmental Protection Agency
This regulation establishes an exemption from the requirement of a tolerance for residues of D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) Chemical Abstract Service Registration Number ((CAS Reg. No.) 595585-15-2) when used as an inert ingredient stabilizer/suspension agent applied to crops pre- and post-harvest and to food contact surfaces. Keller and Heckman on behalf of CP Kelco U.S., Inc submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum).
Alcohols, C>14
Document Number: 2016-13794
Type: Rule
Date: 2016-06-13
Agency: Environmental Protection Agency
This regulation amends an exemption from the requirement of a tolerance for residues of [alpha]-alkyl-[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons, and [alpha] alkyl-[omega]- hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number average molecular weight (in amu) 1,100 (herein referred to as ``AAAs'' (alkyl alcohol alkoxylates)) to include alcohols, C>14, ethoxylated, Chemical Abstract Service Registry Number (CAS Reg. No.) 251553-55-6 when used as an inert ingredient (surfactant) in pesticide formulations. Baker Petrolite LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alcohols, C>14, ethoxylated.
Common Crop Insurance Regulations; Texas Citrus Fruit Crop Insurance Provisions
Document Number: 2016-13770
Type: Rule
Date: 2016-06-13
Agency: Department of Agriculture, Federal Crop Insurance Corporation
The Federal Crop Insurance Corporation (FCIC) finalizes the Common Crop Insurance Regulations, Texas Citrus Fruit Crop Insurance Provisions, to provide policy changes to better meet the needs of policyholders, to clarify existing policy provisions, and to reduce vulnerability to program fraud, waste, and abuse. Specifically, this final rule modifies or clarifies certain definitions, clarifies unit establishment, clarifies substantive provisions for consistency with terminology changes, modifies the insured causes of loss, clarifies required timing for loss notices, modifies portions of loss calculation formulas, and addresses potential misinterpretations or ambiguity related to these issues. The changes will be effective for the 2018 and succeeding crop years.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2016-13734
Type: Proposed Rule
Date: 2016-06-13
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model MD-90-30 airplanes. This proposed AD was prompted by reports of stick shaker activation at airspeeds that were above the stall protection system's stick shaker schedule. This proposed AD would require installing angle-of-attack (AOA) sensor external case heaters and AOA sensors, changing wires, and doing a functional test and applicable corrective actions. We are proposing this AD to correct water intrusion and subsequent ice formation between the AOA sensor vane and face plate, which could cause the vane to become immobilized. If the vane becomes immobilized, the stall protection system could become unreliable or non-functional, which could result in loss of control of the airplane.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Northwest Fisheries Science Center Fisheries Research
Document Number: 2016-13655
Type: Proposed Rule
Date: 2016-06-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS' Office of Protected Resources has received a request from NMFS' Northwest Fisheries Science Center (NWFSC) for authorization to take marine mammals incidental to fisheries research conducted in the Pacific Ocean off the northwest United States, over the course of five years from the date of issuance. As required by the Marine Mammal Protection Act (MMPA), NMFS is proposing regulations to govern that take, and requests comments on the proposed regulations.
Hazardous Chemical Reporting: Community Right-to-Know; Revisions to Hazard Categories and Minor Corrections
Document Number: 2016-13582
Type: Rule
Date: 2016-06-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA or the Agency) is amending its hazardous chemical reporting regulations due to the changes in the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS). OSHA's HCS was recently revised to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Under the revised HCS, chemical manufacturers and importers are required to evaluate their chemicals according to the new criteria adopted from GHS to ensure that they are classified and labeled appropriately. Manufacturers and importers are also required to develop standardized Safety Data Sheets (formerly known as ``Material Safety Data Sheets'') and distribute them to downstream users of their chemicals. These changes in HCS affect the reporting requirements under sections 311 and 312 of the Emergency Planning and Community Right-to- Know Act (EPCRA). Based on the new classification criteria that OSHA adopted, EPA is revising the existing hazard categories for hazardous chemical inventory form reporting under EPCRA Section 312 and for list reporting under section 311. In this action, EPA is also making a few minor corrections in the hazardous chemical reporting regulations.
Special Conditions: Ultramagic, S.A., Mark-32 Burner Series
Document Number: 2016-13556
Type: Rule
Date: 2016-06-13
Agency: Federal Aviation Administration, Department of Transportation
This action proposes special conditions for the Ultramagic, S.A., balloon models F-18, H-56, H-65, H-77, M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N- 250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T- 180, T-210, V-56, V-65, V-77, V-90, V-105, and Z-90. These models will have a novel or unusual design feature associated with having the new Mark-32 Burner series. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These final special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Energy Conservation Program: Energy Conservation Standards for Portable Air Conditioners
Document Number: 2016-13549
Type: Proposed Rule
Date: 2016-06-13
Agency: Department of Energy
The Energy Policy and Conservation Act of 1975 (EPCA), as amended, sets forth various provisions designed to improve energy efficiency for consumer products and certain commercial and industrial equipment. In addition to specifying a list of covered residential products and commercial equipment, EPCA contains provisions that enable the Secretary of Energy to classify additional types of consumer products as covered products. The U.S. Department of Energy (DOE) has previously published a proposed determination of coverage to classify portable air conditioners (ACs) as covered consumer products under the applicable provisions in EPCA. In this document, DOE proposes energy conservation standards for portable ACs following its notice of final determination of coverage. This document also announces a public meeting to receive comment on these proposed standards and associated analyses and results.
National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production
Document Number: 2016-13505
Type: Rule
Date: 2016-06-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking direct final action to amend the National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production (Secondary Aluminum NESHAP). This direct final rule amends the final rule that was published in the Federal Register on September 18, 2015, by correcting inadvertent errors, clarifying rule requirements for initial performance tests and submittal of malfunction reports, providing an additional option for new round top furnaces to account for unmeasured emissions during compliance testing, and clarifying what constitutes a change in furnace operating mode. The direct final rule also updates Web site addresses for the EPA's Electronic Reporting Tool (ERT) and the Compliance and Emissions Data Reporting Interface (CEDRI). These amendments will help to improve compliance and implementation of the rule.
National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production
Document Number: 2016-13504
Type: Proposed Rule
Date: 2016-06-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to amend the National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production (Secondary Aluminum NESHAP). In the ``Rules and Regulations'' section of this Federal Register, we are publishing a direct final rule, without a prior proposed rule, that amends the final rule that was published in the Federal Register on September 18, 2015, to correct inadvertent errors, to clarify rule requirements for initial performance tests and submittal of malfunction reports, to provide an additional option for new round top furnaces to account for unmeasured emissions during compliance testing and to clarify what constitutes a change in furnace operating mode. The direct final rule also updates Web site addresses for the EPA's Electronic Reporting Tool (ERT) and the Compliance and Emissions Data Reporting Interface (CEDRI). If we receive no adverse comment, we will not take further action on this proposed rule.
Position Limits for Derivatives: Certain Exemptions and Guidance
Document Number: 2016-12964
Type: Proposed Rule
Date: 2016-06-13
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing revisions and additions to regulations and guidance proposed in 2013 concerning speculative position limits in response to comments received on that proposal. The Commission is proposing new alternative processes for designated contract markets (``DCMs'') and swap execution facilities (``SEFs'') to recognize certain positions in commodity derivative contracts as non-enumerated bona fide hedges or enumerated anticipatory bona fide hedges, as well as to exempt from federal position limits certain spread positions, in each case subject to Commission review. In this regard, the Commission proposes to amend certain of the regulations proposed in 2013 regarding exemptions from federal position limits and exchange-set position limits to take into account these new alternative processes. In connection with these changes, the Commission proposes to further amend certain relevant definitions, including to clearly define the general definition of bona fide hedging for physical commodities under the standards in CEA section 4a(c). Separately, the Commission proposes to delay for DCMs and SEFs that lack access to sufficient swap position information the requirement to establish and monitor position limits on swaps.
Energy Conservation Program: Energy Conservation Standards for Dehumidifiers
Document Number: 2016-12881
Type: Rule
Date: 2016-06-13
Agency: Department of Energy
The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including dehumidifiers. EPCA also requires the U.S. Department of Energy (DOE) to periodically determine whether more-stringent standards would be technologically feasible and economically justified, and would save a significant amount of energy. In this final rule, DOE is adopting more- stringent energy conservation standards for dehumidifiers. It has determined that the amended energy conservation standards for these products would result in significant conservation of energy, and are technologically feasible and economically justified.
Energy Conservation Program: Energy Conservation Standards for Battery Chargers
Document Number: 2016-12835
Type: Rule
Date: 2016-06-13
Agency: Department of Energy
The Energy Policy and Conservation Act of 1975, as amended (``EPCA'' or in context, ``the Act''), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including battery chargers. EPCA also requires the U.S. Department of Energy (``DOE'' or, in context, ``the Department'') to determine whether Federal energy conservation standards for a particular type of product or equipment would be technologically feasible and economically justified, and would save a significant amount of energy. On March 27, 2012, DOE published a notice of proposed rulemaking (``NOPR'') to establish energy conservation standards for battery chargers. Responding to stakeholder comments, DOE updated its analysis and revised its proposed approach, resulting in a supplemental notice of proposed rulemaking (``SNOPR'') published on September 1, 2015. After considering all the stakeholder comments responding to the SNOPR, DOE is adopting the proposed energy conservation standards for battery chargers in this final rule. DOE has determined that these standards will result in the significant conservation of energy and are technologically feasible and economically justified.
Suspension of Community Eligibility
Document Number: C1-2016-12123
Type: Rule
Date: 2016-06-10
Agency: Federal Emergency Management Agency, Department of Homeland Security
Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega-hydroxypoly(oxyethylene) poly(oxypropylene) Copolymer; Tolerance Exemption; Technical Correction
Document Number: 2016-13816
Type: Rule
Date: 2016-06-10
Agency: Environmental Protection Agency
EPA issued a final rule in the Federal Register of March 2, 2016, concerning Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega- hydroxypoly(oxyethylene) poly(oxypropylene) copolymer; Tolerance Exemption. This document corrects typographical errors.
Mandatory Deposit of Electronic Books and Sound Recordings Available Only Online
Document Number: 2016-13814
Type: Proposed Rule
Date: 2016-06-10
Agency: Library of Congress, Agencies and Commissions
The United States Copyright Office is extending the deadline for the submission of written comments in response to its May 17, 2016 Notice of Inquiry regarding the mandatory deposit of online-only electronic books and sound recordings.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.
Document Number: 2016-13799
Type: Rule
Date: 2016-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2016-13798
Type: Rule
Date: 2016-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Hazardous Waste Management System; Tentative Denial of Petition To Revise the RCRA Corrosivity Hazardous Characteristic
Document Number: 2016-13793
Type: Proposed Rule
Date: 2016-06-10
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA or the Agency) is extending the comment period on the tentative denial of a petition to revise the Resource Conservation and Recovery Act (RCRA) corrosivity hazardous waste characteristic regulation, published in the Federal Register on April 11, 2016. EPA is tentatively denying the rulemaking petition because the materials submitted in support of the petition fail to demonstrate that the requested regulatory revisions are warranted, as further explained in the tentative denial. The Agency's review of additional materials it identified as relevant to the petition similarly did not demonstrate that any change to the corrosivity characteristic regulation is warranted at this time. The comment period is being extended to December 7, 2016.
Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device
Document Number: 2016-13788
Type: Rule
Date: 2016-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Special Local Regulations; Harborfest Dragon Boat Race, South Haven, MI
Document Number: 2016-13783
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce the special local regulation on the Black River in South Haven, Michigan for the Harborfest Dragonboat Race on June 18 and 19, 2016. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the Dragonboat race. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the special regulated area.
Special Local Regulation; Cumberland River, Mile 190.0 to 191.5; Nashville, TN
Document Number: 2016-13782
Type: Proposed Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to establish a special local regulation for all waters of the Cumberland River beginning at mile marker 190.0 and ending at mile marker 191.5 from 9 a.m. until noon on July 30, 2016. This proposed special regulation is necessary to provide safety for the participants in the ``Music City SUP Race'' marine event. This proposed rulemaking would prohibit persons and vessels from being in the special local regulated area unless authorized by the Captain of the Port Ohio Valley or a designated representative. We invite your comments on this proposed rulemaking.
Security Zone; Military Ocean Terminal Concord (MOTCO); Concord, California
Document Number: 2016-13781
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is revising the existing conditional security zone regulation currently in place in the navigable waters of Suisun Bay, California, near Concord, California around each of the three piers at the Military Ocean Terminal Concord (MOTCO), California (formerly United States Naval Weapons Center Concord, California). This action is intended to clarify responsibilities and authorities for enforcement of the security zone.
Special Local Regulation; On Water Activities Associated With the 2016 Macy's 4th of July Fireworks, East River, Manhattan, NY
Document Number: 2016-13780
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary special local regulation on the navigable waters of the East River and Upper New York Bay Manhattan and Brooklyn, NY for on water vessel management associated with the Macy's 4th of July fireworks show. This Special Local Regulation allows the Coast Guard to enforce spectator vessel movement and prohibit all vessel traffic from entering the fireworks barge buffer zone during times when the associated event could pose an imminent hazard to persons and vessels operating in the area. This rule is necessary to provide for the safety of life on the navigable waters and to establish public viewing areas during the event.
Guidance Under Section 108(a) Concerning the Exclusion of Section 61(a)(12) Discharge of Indebtedness Income of a Grantor Trust or a Disregarded Entity
Document Number: 2016-13779
Type: Rule
Date: 2016-06-10
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations relating to the exclusion from gross income of discharge of indebtedness income of a grantor trust or an entity that is disregarded as an entity separate from its owner. These final regulations provide rules regarding the term ``taxpayer'' for purposes of applying the exclusion from gross income of discharge of indebtedness income of a grantor trust or a disregarded entity. These final regulations affect grantor trusts, disregarded entities, and their owners.
Drawbridge Operation Regulation; Isle of Wight (Sinepuxent) Bay, Ocean City, MD
Document Number: 2016-13777
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate the increased vehicular traffic of the 2016 Ocean City Air Show. This deviation allows the bridge to remain in the closed-to-navigation position.
Migratory Bird Hunting; Proposed 2017-18 Migratory Game Bird Hunting Regulations (Preliminary) With Requests for Indian Tribal Proposals; Notice of Meetings
Document Number: 2016-13766
Type: Proposed Rule
Date: 2016-06-10
Agency: Fish and Wildlife Service, Department of the Interior
The U.S. Fish and Wildlife Service (hereinafter the Service or we) proposes to establish annual hunting regulations for certain migratory game birds for the 2017-18 hunting season. We annually prescribe outside limits (frameworks) within which States may select hunting seasons. This proposed rule provides the regulatory schedule, announces the Service Migratory Bird Regulations Committee (SRC) and Flyway Council meetings, describes the proposed regulatory alternatives for the 2017-18 duck hunting seasons, and requests proposals from Indian tribes that wish to establish special migratory game bird hunting regulations on Federal Indian reservations and ceded lands. Migratory game bird hunting seasons provide opportunities for recreation and sustenance; aid Federal, State, and tribal governments in the management of migratory game birds; and permit harvests at levels compatible with migratory game bird population status and habitat conditions.
Special Local Regulation; Midwest Masters Sprints; Maumee River; Toledo, OH
Document Number: 2016-13746
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary special local regulation controlling movement of vessels for certain waters of the Maumee River. This action is necessary and is intended to ensure safety of life on navigable waters to be used for a rowing event immediately prior to, during, and immediately after this event. This regulation requires vessels to maintain a minimum speed for safe navigation and maneuvering.
Evidence From Statutorily Excluded Medical Sources
Document Number: 2016-13744
Type: Proposed Rule
Date: 2016-06-10
Agency: Social Security Administration, Agencies and Commissions
In accordance with section 812 of the Bipartisan Budget Act of 2015 (BBA section 812), we propose to revise our rules to explain how we would address evidence furnished by medical sources that meet one of BBA section 812's exclusionary categories (statutorily excluded medical sources). Under this proposed rule, we would not consider evidence furnished by a statutorily excluded medical source unless we find good cause to do so. We propose several circumstances in which we would find good cause, and we also propose to require statutorily excluded medical sources to notify us of their excluded status when they furnish evidence to us. These rules would allow us to fulfill obligations that we have under the Bipartisan Budget Act of 2015 (BBA).
Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction
Document Number: 2016-13739
Type: Proposed Rule
Date: 2016-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting a notice entitled ``Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition'' that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho- phthalates, but omitted two items. This document corrects that error.
Air Plan Approval; Illinois; NAAQS Updates
Document Number: 2016-13700
Type: Rule
Date: 2016-06-10
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the ``sunset provisions'' in our regulations. In addition, the revised rules contain the timing requirements for the ``flagging of exceptional events'' and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual PM2.5 standard.
Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock Fishery
Document Number: 2016-13697
Type: Rule
Date: 2016-06-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues this final rule to implement Amendment 110 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands management area (FMP). Amendment 110 and this final rule improve the management of Chinook and chum salmon bycatch in the Bering Sea pollock fishery by creating a comprehensive salmon bycatch avoidance program. This action is necessary to minimize Chinook and chum salmon bycatch in the Bering Sea pollock fishery to the extent practicable while maintaining the potential for the full harvest of the pollock total allowable catch (TAC) within specified prohibited species catch (PSC) limits. Amendment 110 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Air Plan Approval; Illinois; NAAQS Update
Document Number: 2016-13695
Type: Proposed Rule
Date: 2016-06-10
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the ``sunset provisions'' in our regulation, finding that the 1971 NAAQS for sulfur dioxide no longer applies to the Lemont and Pekin areas in Illinois. In addition, the revised rules contain the timing requirements for the ``flagging of exceptional events'' and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual averaged PM2.5 standard.
Drawbridge Operation Regulation; Sloop Channel and Long Creek, Nassau, NY
Document Number: 2016-13692
Type: Rule
Date: 2016-06-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Loop Parkway Bridge, mile 0.7, across Long Creek and the Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel, at Nassau, New York. This temporary deviation is necessary to facilitate public safety during a public event, the Annual Salute to Veterans and Fireworks Display.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations
Document Number: 2016-13651
Type: Rule
Date: 2016-06-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.