February 29, 2016 – Federal Register Recent Federal Regulation Documents

Results 101 - 130 of 130
Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act-Compliance Policy; Guidance for Industry; Availability
Document Number: 2016-04227
Type: Notice
Date: 2016-02-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic ActCompliance Policy.'' This guidance describes FDA's compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading partners engaged in transactions with first responders. This compliance policy is in effect until further notice by FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting; Electronic Submissions
Document Number: 2016-04223
Type: Notice
Date: 2016-02-29
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
Document Number: 2016-04222
Type: Notice
Date: 2016-02-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop
Document Number: 2016-04221
Type: Notice
Date: 2016-02-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office, in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled ``Medical DevicesQuality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action''. The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to insure compliance with FDA regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Direct-to-Consumer Advertising Survey
Document Number: 2016-04220
Type: Notice
Date: 2016-02-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``National Direct-to- Consumer Advertising Survey.'' The objective of this research is to survey the public about their experiences with and attitudes toward direct-to-consumer (DTC) advertising of prescription drugs.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-04216
Type: Rule
Date: 2016-02-29
Agency: Federal Aviation Administration, Department of Transportation
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Atlantic Ocean South of Entrance to Chesapeake Bay Off Camp Pendleton, Virginia; Firing Range
Document Number: 2016-04215
Type: Rule
Date: 2016-02-29
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Corps of Engineers is establishing a permanent danger zone in waters of the Atlantic Ocean south of Rudee Inlet in Virginia Beach, Virginia. The Camp Pendleton firing range supports a myriad of stakeholders that include all components of the Department of Defense, including: U.S. Army, Army National Guard, Army Reserve, U.S. Navy, Navy Reserve, U.S. Marine Corps, U.S. Marine Corps Reserve, U.S. Air Force, Air Force National Guard, Air Force Reserve, U.S. Coast Guard, and the U.S. Coast Guard Reserve, as well as many non-Department of Defense units. Camp Pendleton, VA will provide an economical, safe training environment for individual live fire exercises, and collective units to conduct the minimum requirements for weapons qualification. The danger zone will increase the level of safety to the public in the vicinity of the live firing operations by providing additional notice of the hazards present.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-04213
Type: Rule
Date: 2016-02-29
Agency: Federal Aviation Administration, Department of Transportation
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Notice of Intent To Revise a Currently Approved Information Collection
Document Number: 2016-04188
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, National Institute of Food and Agriculture
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations at 5 CFR part 1320 (60 FR 44977, August 29, 1995), this notice announces the National Institute of Food and Agriculture's (NIFA) intention to revise a currently approved information collection entitled, ``Research, Education, and Extension project online reporting tool (REEport).''
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2016-04138
Type: Rule
Date: 2016-02-29
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 airplanes. This AD requires an inspection of the station 337 (door number 1) outboard partitions for a tie rod and quick release pins, and to ensure that both partition supports are engaged in the structural bracket at each outboard partition, and corrective actions if necessary. This AD was prompted by reports of missing right and left outboard partition tie rods at door number 1. We are issuing this AD to detect and correct partitions with missing tie rods or release pins or with supports that are not engaged in the structural bracket. These partitions could come loose during a high-acceleration event and strike the flight attendant seats in the door 1 location, causing serious injury to the seat occupants, or could affect safe egress from the airplane.
Airworthiness Directives; Fokker Services B.V. Airplanes
Document Number: 2016-04137
Type: Rule
Date: 2016-02-29
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F.27 Mark 200, 300, 400, 500, 600, and 700 airplanes. This AD was prompted by a design review conducted by Fokker Services B.V. that indicated no controlled bonding provisions were present on many critical locations outside the fuel tank or connected to the fuel tank wall. This AD requires installing the additional bonding provisions, and revising the maintenance or inspection program, as applicable, by incorporating fuel airworthiness limitation items and critical design configuration control limitations. We are issuing this AD to prevent an ignition source in the fuel tank vapor space, which could result in a fuel tank explosion and consequent loss of the airplane.
Expansion of Online Public File Obligations to Cable and Satellite TV Operators and Broadcast and Satellite Radio Licensees
Document Number: 2016-04117
Type: Rule
Date: 2016-02-29
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission expand the list of entities that will be required to post their public inspection files to the FCC's online database. In 2012, the Commission adopted online public file rules that required broadcast television stations to post public file documents to a central, FCC-hosted online database rather than maintaining paper files locally at their main studios. Our goals were to modernize the procedures television broadcasters use to inform the public about how they are serving their communities, to make information concerning broadcast service more accessible to the public, and, over time, to reduce the cost of broadcasters' compliance. This final rule document continues our modernization effort by expanding the online file to other media entities to extend the benefits of improved public access to public inspection files and, ultimately, reduce the burden of maintaining these files.
Agency Information Collection Activities: Affidavit of Support; Form I-134; Revision of a Currently Approved Collection
Document Number: 2016-04089
Type: Notice
Date: 2016-02-29
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on December 30, 2015, at 80 FR 81556, allowing for a 60-day public comment period. USCIS did receive comments in connection with the 60-day notice. Note: USCIS published the 60-day notice as an extension without change; USCIS has updated the I-134 Form and Instructions with standardized language that the agency is now inserting into all forms; these changes do not impact the time to complete the form.
Regional Monitoring Networks (RMNs) To Detect Changing Baselines in Freshwater Wadeable Streams
Document Number: 2016-04087
Type: Notice
Date: 2016-02-29
Agency: Environmental Protection Agency
Environmental Protection Agency (EPA) is announcing the availability of a document titled, ``Regional Monitoring Networks (RMNs) to Detect Changing Baselines in Freshwater Wadeable Streams'' (EPA/600/R-15/280). The document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development. The document describes the development of the current regional monitoring networks (RMNs) for riffle-dominated, freshwater wadeable streams. The final document is available via the Internet on the NCEA home page under the Recent Additions and the Data and Publications menus at http://www.epa.gov/risk/ecological-risk-assessment-products-a nd- publications.
Approval of Air Quality Implementation Plans; Missouri State Implementation Plan for the 2008 Lead Standard
Document Number: 2016-04083
Type: Proposed Rule
Date: 2016-02-29
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) proposes to grant full approval of Missouri's attainment demonstration State Implementation Plan (SIP) for the lead National Ambient Air Quality Standard (NAAQS) for the Exide Technologies Canon Hollow facility in Forest City, Missouri, received by EPA on October 20, 2014. The applicable standard addressed in this action is the lead NAAQS promulgated by EPA in 2008. EPA believes that the SIP submitted by the state satisfies the applicable requirements of the Clean Air Act (CAA) identified in EPA's Final Rule published on October 15, 2008 in the Federal Register, and will bring the violating area into attainment of the 0.15 microgram per cubic meter (ug/m\3\) lead NAAQS.
Approval and Promulgation of Air Quality Implementation Plans; State of Kansas; 2015 Kansas State Implementation Plan for the 2008 Lead Standard
Document Number: 2016-04080
Type: Proposed Rule
Date: 2016-02-29
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) proposes to grant full approval of Kansas's attainment demonstration State Implementation Plan (SIP) for the lead National Ambient Air Quality Standard (NAAQS) nonattainment area of Salina, Saline County, Kansas, received by EPA on February 25, 2015. The applicable standard addressed in this action is the lead NAAQS promulgated by EPA in 2008. EPA believes that the SIP submitted by the state satisfies the applicable requirements of the Clean Air Act identified in EPA's Final Rule published in the Federal Register on October 15, 2008, and will bring the designated portions of Salina, Kansas, into attainment of the 0.15 microgram per cubic meter ([mu]g/m\3\) lead NAAQS.
Use of Chemical Agents or Other Less-Than-Lethal Force in Immediate Use of Force Situations
Document Number: 2016-04069
Type: Proposed Rule
Date: 2016-02-29
Agency: Department of Justice, Bureau of Prisons
In this document, the Bureau of Prisons (Bureau) proposes to amend its regulation on the use of chemical agents or other less-than- lethal force to provide that such use is authorized for staff in immediate use of force (emergency) situations.
Livestock Mandatory Reporting: Revision of Lamb Reporting Requirements
Document Number: 2016-04047
Type: Rule
Date: 2016-02-29
Agency: Agricultural Marketing Service, Department of Agriculture
On April 2, 2001, the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) implemented the Livestock Mandatory Reporting (LMR) program as required by the Livestock Mandatory Reporting Act of 1999 (1999 Act). The LMR program was reauthorized in October 2006 and again in September 2010. On September 30, 2015, the Agriculture Reauthorizations Act of 2015 (2015 Reauthorization Act) reauthorized the LMR program for an additional 5 years and directed the Secretary of Agriculture (Secretary) to amend the LMR lamb reporting requirements by redefining terms within the Code of Federal Regulations not later than 180 days after enactment. This direct final rule incorporates the lamb reporting changes contained within the 2015 Reauthorization Act under the USDA LMR regulations.
Notice of Request for Revision to and Extension of a Currently Approved Information Collection for Commodities Covered by the Livestock Mandatory Reporting Act of 1999
Document Number: 2016-04045
Type: Notice
Date: 2016-02-29
Agency: Agricultural Marketing Service, Department of Agriculture
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of Management and Budget (OMB), for an extension of and revision to the currently approved information collection used to compile and generate cattle, swine, lamb, and boxed beef market news reports under the Livestock Mandatory Reporting Act of 1999 (1999 Act) (OMB 0581-0186). One new form is introduced in this collection.
Pecans Grown in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas; Secretary's Decision and Referendum Order on Proposed Marketing Agreement and Order No. 986
Document Number: 2016-04043
Type: Proposed Rule
Date: 2016-02-29
Agency: Agricultural Marketing Service, Department of Agriculture
This Secretary's Decision proposes the issuance of a marketing agreement and order (order) under the Agricultural Marketing Agreement Act of 1937 to cover pecans grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas, and provides growers with the opportunity to vote in a referendum to determine if they favor its establishment. The proposed order would provide authority to collect industry data and to conduct research and promotion activities. In addition, the order would provide authority for the industry to recommend grade, quality and size regulation, as well as pack and container regulation, subject to approval by the Department of Agriculture (USDA). The program would be financed by assessments on pecan handlers and would be locally administered, under USDA oversight, by a Council of seventeen growers and shellers (handlers) nominated by the industry and appointed by USDA.
Airworthiness Directives; The Boeing Company Model 757-200 Series Airplanes Modified by Supplemental Type Certificate (STC) ST01529SE or STC ST02278SE
Document Number: 2016-04036
Type: Rule
Date: 2016-02-29
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 757-200 series airplanes modified by particular STCs. This AD was prompted by reports of a main cargo door being blown past its full open position while on the ground during gusty wind conditions, which resulted in uncontrolled fall down to its closed position. This AD requires installing a new placard and bracket, replacing an existing placard, and replacing the main cargo door control panel. We are issuing this AD to prevent damage to the main cargo door, which could result in rapid decompression of the airplane, or injury to maintenance and ground crew during ground operations.
El Dorado County Resource Advisory Committee
Document Number: 2016-04010
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, Forest Service
The El Dorado County Resource Advisory Committee (RAC) will meet in Placerville, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110- 343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. RAC information can be found at the following Web site: www.fs.usda.gov/eldorado.
El Dorado County Resource Advisory Committee
Document Number: 2016-04009
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, Forest Service
The El Dorado County Resource Advisory Committee (RAC) will meet in Placerville, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110- 343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. RAC information can be found at the following Web site: www.fs.usda.gov/eldorado.
Livestock Mandatory Reporting: Reauthorization of Livestock Mandatory Reporting and Revision of Swine and Lamb Reporting Requirements
Document Number: 2016-03956
Type: Proposed Rule
Date: 2016-02-29
Agency: Agricultural Marketing Service, Department of Agriculture
On April 2, 2001, the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) implemented the Livestock Mandatory Reporting (LMR) program as required by the Livestock Mandatory Reporting Act of 1999 (1999 Act). The LMR program was reauthorized in October 2006 and September 2010. On September 30, 2015, the Agriculture Reauthorizations Act of 2015 (2015 Reauthorization Act) reauthorized the LMR program for an additional 5 years until September 30, 2020, and directed the Secretary of Agriculture (Secretary) to amend the LMR swine reporting requirements. In addition, the lamb industry requested revisions to the lamb reporting requirements as authorized through the 1999 Act. This proposed rule would incorporate the requested lamb reporting revisions, and would incorporate the swine reporting revisions contained within the 2015 Reauthorization Act under the Agricultural Marketing Act of 1946, USDA Livestock Mandatory Reporting regulations.
Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018
Document Number: 2016-03902
Type: Rule
Date: 2016-02-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges (hereinafter referred to as the Exchanges).
Expanded Examination Cycle for Certain Small Insured Depository Institutions and U.S. Branches and Agencies of Foreign Banks
Document Number: 2016-03877
Type: Rule
Date: 2016-02-29
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions, Federal Reserve System, Department of Treasury, Office of the Comptroller of the Currency
The OCC, Board, and FDIC (collectively, the agencies) are jointly issuing and requesting public comment on interim final rules to implement section 83001 of the Fixing America's Surface Transportation Act (FAST Act), which was enacted on December 4, 2015. Section 83001 of the FAST Act permits the agencies to examine qualifying insured depository institutions with less than $1 billion in total assets no less than once during each 18-month period. Prior to enactment of the FAST Act, only qualifying insured depository institutions with less than $500 million in total assets were eligible for an 18-month on-site examination cycle. The interim final rules generally would allow well capitalized and well managed institutions with less than $1 billion in total assets to benefit from the extended 18-month examination schedule. In addition, the interim final rules make parallel changes to the agencies' regulations governing the on-site examination cycle for U.S. branches and agencies of foreign banks, consistent with the International Banking Act of 1978. Finally, the FDIC is integrating its regulations regarding the frequency of safety and soundness examinations for State nonmember banks and State savings associations.
Lake Tahoe Basin Federal Advisory Committee (LTFAC)
Document Number: 2016-03842
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, Forest Service
The Lake Tahoe Basin Federal Advisory Committee (Committee) will meet in South Lake Tahoe, California. The Committee is established consistent with the Federal Advisory Committee Act of 1972. Additional information concerning the Committee, including meeting summary/ minutes, can be found by visiting the Committee's Web site at: http:// www.fs.usda.gov/goto/ltbmu/LTFAC. The summary/minutes of the meetings will be posted within 21 days of the meeting.
Southwest Idaho Resource Advisory Committee
Document Number: 2016-03564
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, Forest Service
The Southwest Idaho Resource Advisory Committee (RAC) will meet in Emmett, Idaho. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http:// www.idahorac.org/.
Southwest Idaho Resource Advisory Committee Meeting
Document Number: 2016-03563
Type: Notice
Date: 2016-02-29
Agency: Department of Agriculture, Forest Service
The Southwest Idaho Resource Advisory Committee (RAC) will meet in Emmett, Idaho. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http:// www.idahorac.org/.
Addition of a Subsurface Intrusion Component to the Hazard Ranking System
Document Number: 2016-02749
Type: Proposed Rule
Date: 2016-02-29
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) is proposing to add a subsurface intrusion (SsI) component to the Hazard Ranking System (HRS) which is the principal mechanism that EPA uses to evaluate sites for placement on the National Priorities List (NPL). The subsurface intrusion component (this addition) would expand the number of available options for EPA and state and tribal organizations performing work on behalf of EPA to evaluate potential threats to public health from releases of hazardous substances, pollutants, or contaminants. This addition will allow an HRS evaluation to directly consider human exposure to hazardous substances, pollutants, or contaminants that enter regularly occupied structures through subsurface intrusion in assessing a site's relative risk, and thus, enable subsurface intrusion contamination to be evaluated for placement of sites on the NPL. The agency is not considering changes to the remainder of the HRS except for minor updates reflecting changes in terminology.