February 3, 2016 – Federal Register Recent Federal Regulation Documents

Results 101 - 140 of 140
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-01908
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-01907
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-01906
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-01905
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01904
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-01903
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01902
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Guard Youth ChalleNGe Job ChalleNGe Evaluation; Correction
Document Number: 2016-01900
Type: Notice
Date: 2016-02-03
Agency: Department of Labor, Office of the Secretary
The Department of Labor published a document in the Federal Register of December 28, 2015, inviting public comments on the National Guard Youth ChalleNGe Job ChalleNGe Evaluation Information Collection Request (80 FR 80816). The document contained an incorrect date.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Placement Verification and Follow Up of Job Corps Participants; Correction
Document Number: 2016-01899
Type: Notice
Date: 2016-02-03
Agency: Department of Labor, Office of the Secretary
The Department of Labor published a document in the Federal Register of December 24, 2015, inviting public comments on the Placement Verification and Follow Up of Job Corps Participants Information Collection Request (80 FR 80389). The document contained an incorrect date.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Institutional Analysis of American Job Centers Study; Correction
Document Number: 2016-01898
Type: Notice
Date: 2016-02-03
Agency: Department of Labor, Office of the Secretary
The Department of Labor published a document in the Federal Register of December 28, 2015, inviting public comments on the Institutional Analysis of American Job Centers Study Information Collection Request (80 FR 80814). The document contained an incorrect date.
Drawbridge Operation Regulation; Broad Creek, Laurel, DE
Document Number: 2016-01897
Type: Proposed Rule
Date: 2016-02-03
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to change the operating schedule that governs the Norfolk Southern Railroad Bridge over Broad Creek, mile 8.0, at Laurel, DE. This proposed rule will change the current regulation requiring a four-hour advance notice and allow the bridge to remain in the closed position for the passage of vessels.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0001
Document Number: 2016-01896
Type: Notice
Date: 2016-02-03
Agency: Coast Guard, Department of Homeland Security
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0001, Report of Marine Casualty & Chemical Testing of Commercial Vessel Personnel. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0112
Document Number: 2016-01895
Type: Notice
Date: 2016-02-03
Agency: Coast Guard, Department of Homeland Security
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, with change, of the following collection of information: 1625-0112, Enhanced Maritime Domain Awareness via Electronic Transmission of Vessel Transit Data. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0016
Document Number: 2016-01894
Type: Notice
Date: 2016-02-03
Agency: Coast Guard, Department of Homeland Security
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0016, Welding and Hot Works Permits; Posting of Warning Signs. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Hispanic-Serving Agricultural Colleges and Universities (HSACU)
Document Number: 2016-01893
Type: Rule
Date: 2016-02-03
Agency: Department of Agriculture, National Institute of Food and Agriculture
This rule updates the list of institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2015, and ending September 30, 2016.
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
Document Number: 2016-01892
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.'' When finalized, this draft document will describe the Agency's intent not to enforce, before September 24, 2021, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to September 24, 2018. In addition, when finalized, this draft guidance will describe the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until September 24, 2018. This draft guidance is not the final version of the guidance nor is it in effect at this time.
Pacific Island Pelagic Fisheries; Exemption for Large U.S. Longline Vessels To Fish in Portions of the American Samoa Large Vessel Prohibited Area
Document Number: 2016-01891
Type: Rule
Date: 2016-02-03
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In this final rule, NMFS allows large federally permitted U.S. longline vessels to fish in certain areas of the Large Vessel Prohibited Area (LVPA). NMFS will continue to prohibit fishing in the LVPA by large purse seine vessels. The fishing requirements for the Rose Atoll Marine National Monument remain unchanged. The intent of the rule is to improve the viability of the American Samoa longline fishery and achieve optimum yield from the fishery while preventing overfishing, in accordance with National Standard 1.
Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock Fishery
Document Number: 2016-01890
Type: Proposed Rule
Date: 2016-02-03
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations to implement Amendment 110 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). If approved, Amendment 110 and this proposed rule would 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 within specified prohibited species catch 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.
List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01889
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``List of Highest Priority Devices for Human Factors Review.'' FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. This draft guidance is not final nor is it in effect at this time.
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01888
Type: Notice
Date: 2016-02-03
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 draft guidance for industry and FDA staff entitled ``Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.'' This document provides guidance to industry and FDA staff on the underlying principles of human factors (HF) studies during the development of combination products. Combination products are comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product.
Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01887
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Applying Human Factors and Usability Engineering to Medical Devices.'' FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Document Number: 2016-01885
Type: Notice
Date: 2016-02-03
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 on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Postmarketing Adverse Drug Experience Reporting
Document Number: 2016-01884
Type: Notice
Date: 2016-02-03
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 ``Postmarketing Adverse Drug Experience Reporting'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792
Document Number: 2016-01883
Type: Notice
Date: 2016-02-03
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 ``Biosimilar User Fee Cover Sheet; Form FDA 3792'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Arts Advisory Panel Meetings
Document Number: 2016-01882
Type: Notice
Date: 2016-02-03
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, National Endowment for the Arts
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 1 meeting of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
Proposed Establishment of Class E Airspace; Moriarty, NM
Document Number: 2016-01877
Type: Proposed Rule
Date: 2016-02-03
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to establish Class E airspace at Moriarty, NM. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at Moriarty Airport, for the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Agency Information Collection Activities; Proposed eCollection; eComments Requested; Renewal of a Currently Approved Collection: Office of Justice Programs' Community Partnership Grants Management System (GMS)
Document Number: 2016-01875
Type: Notice
Date: 2016-02-03
Agency: Department of Justice
The Department of Justice (DOJ), Office of Justice Programs (OJP), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Advisory Committee for Environmental Research and Education; Notice of Meeting
Document Number: 2016-01869
Type: Notice
Date: 2016-02-03
Agency: National Science Foundation, Agencies and Commissions
Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance
Document Number: 2016-01868
Type: Notice
Date: 2016-02-03
Agency: Employment and Training Administration, Department of Labor
Investigations Regarding Eligibility To Apply for Worker Adjustment Assistance
Document Number: 2016-01867
Type: Notice
Date: 2016-02-03
Agency: Employment and Training Administration, Department of Labor
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-01864
Type: Rule
Date: 2016-02-03
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.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-01858
Type: Rule
Date: 2016-02-03
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.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-01857
Type: Rule
Date: 2016-02-03
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.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2016-01856
Type: Rule
Date: 2016-02-03
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.
Animal Welfare; Marine Mammals
Document Number: 2016-01837
Type: Proposed Rule
Date: 2016-02-03
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are proposing to amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. These proposed changes would affect sections in the regulations relating to variances and implementation dates, indoor facilities, outdoor facilities, space requirements, and water quality. We are also proposing to revise the regulations that relate to swim-with-the-dolphin programs. We believe these actions are necessary to ensure that the minimum standards for the humane handling, care, treatment, and transportation of marine mammals in captivity are based on current industry and scientific knowledge and experience.
Notice of Request for Clearance of a Revision of a Currently Approved Information Collection: National Census of Ferry Operators
Document Number: 2016-01831
Type: Notice
Date: 2016-02-03
Agency: Department of Transportation
In accordance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, this notice announces the intention of the BTS to request the Office of Management and Budget's (OMB's) approval for an information collection related to the nation's ferry operations. The information collected will be used to produce a descriptive database of existing ferry operations. A summary report of survey findings will also be published by BTS on the BTS Web page.
Center for Food Safety and Applied Nutrition Library Address; Technical Amendments
Document Number: 2016-01787
Type: Rule
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.
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: 2016-01748
Type: Proposed Rule
Date: 2016-02-03
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 proposed rule addresses changes to the Shared Savings Program that would modify the program's benchmark rebasing methodology to encourage ACOs' continued investment in care coordination and quality improvement, and identifies publicly available data to support modeling and analysis of these proposed changes. In addition, it would streamline the methodology used to adjust an ACO's historical benchmark for changes in its ACO participant composition, offer an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program, and establish 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.
Pole Attachment Rates
Document Number: 2016-01182
Type: Rule
Date: 2016-02-03
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission builds on its prior efforts to harmonize pole attachment rates that cable and telecom service providers pay utility pole owners. The Communications Act of 1934, as amended (Act), contains two formulas for calculating pole attachment rates, a formula adopted in 1978 applicable to cable television systems solely providing cable service, and a formula adopted in 1996 applicable to telecommunications carriers providing telecommunications service.