August 2, 2016 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 105
Amendment of Class E Airspace for the following Indiana Towns; Goshen, IN; Greencastle, IN; Huntingburg, IN; North Vernon, IN; Rensselaer, IN; Tell City, IN; and Washington, IN
Document Number: 2016-18229
Type: Rule
Date: 2016-08-02
Agency: Federal Aviation Administration, Department of Transportation
This action modifies Class E airspace extending upward from 700 feet above the surface at Virgil I. Grissom Municipal Airport, Bedford, IN; Goshen Municipal Airport, Goshen, IN; Putnam County Airport, Greencastle, IN; Huntingburg Airport, Huntingburg, IN; North Vernon Airport, North Vernon, IN; Jasper County Airport, Rensselaer, IN; Perry County Municipal Airport, Tell City, IN; and Daviess County Airport, Washington, IN. Decommissioning of non-directional radio beacons (NDBs), cancellation of NDB approaches, and implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at these airports. This action also updates the geographic coordinates of Goshen Municipal Airport, Putnam County Airport, North Vernon Airport, Jasper County Airport, and Perry County Municipal Airport to coincide with the FAA's aeronautical database. O'Neal Airport, Vincennes, IN, is removed from this rule as the Class E airspace area was removed in a rule published in the Federal Register of October 23, 2015.
Notice of Receipt of Petition for Decision That Nonconforming Model Year 2014 Bentley Flying Spur Saloon/Continental Passenger Cars Are Eligible for Importation
Document Number: 2016-18227
Type: Notice
Date: 2016-08-02
Agency: National Highway Traffic Safety Administration, Department of Transportation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2014 Bentley Flying Spur 4-door (Saloon) and 2-Door (Continental) passenger cars (PC's) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.- certified version of the 2014 Bentley Flying Spur Saloon/Continental PC's) and they are capable of being readily altered to conform to the standards.
Agency Information Collection Activity Under OMB Review
Document Number: 2016-18226
Type: Notice
Date: 2016-08-02
Agency: Federal Transit Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICRs describes the nature of the information collection and the expected burdens.
Agency Information Collection Activity Under OMB Review
Document Number: 2016-18225
Type: Notice
Date: 2016-08-02
Agency: Federal Transit Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICRs describes the nature of the information collection and the expected burdens.
Agency Information Collection Activity Under OMB Review
Document Number: 2016-18224
Type: Notice
Date: 2016-08-02
Agency: Federal Transit Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICRs describes the nature of the information collection and the expected burdens.
Notice of Industry Meeting
Document Number: 2016-18219
Type: Notice
Date: 2016-08-02
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration (FAA) is hosting a public meeting to conclude the Aircraft Access to System Wide Information Management (AAtS) Demonstration project. The meeting will inform flight operations stakeholders and information service providers on the demonstrated concept, prototype applications developed, and results collected throughout the project. This meeting is not a precursor to a request for proposal (RFP) or request for offer (RFO). The FAA is not seeking or accepting unsolicited proposals.
Gulf of Mexico Fishery Management Council; Public Meeting
Document Number: 2016-18218
Type: Notice
Date: 2016-08-02
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Gulf of Mexico Fishery Management Council (Council) will hold a four-day meeting to consider actions affecting the Gulf of Mexico fisheries in the exclusive economic zone (EEZ).
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2016-18217
Type: Notice
Date: 2016-08-02
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council (Council) will hold a Webinar-based meeting of its River Herring and Shad (RH/S) Committee.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2016-18216
Type: Notice
Date: 2016-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Drawbridge Operation Regulation; York River, Yorktown, VA
Document Number: 2016-18214
Type: Rule
Date: 2016-08-02
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has modified a temporary deviation from the operating schedule that governs the Coleman Memorial Bridge (US 17) across the York River, mile 7.0, Yorktown, VA. This modified deviation is necessary to perform additional bridge maintenance. This modified deviation allows the bridge to remain in the closed-to-navigation position.
Agency Information Collection Activities Under OMB Review
Document Number: 2016-18213
Type: Notice
Date: 2016-08-02
Agency: Commodity Futures Trading Commission, Agencies and Commissions
In compliance with the Paperwork Reduction Act of 1995, (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Agency Information Collection Activities Under OMB Review
Document Number: 2016-18212
Type: Notice
Date: 2016-08-02
Agency: Commodity Futures Trading Commission, Agencies and Commissions
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
Document Number: 2016-18209
Type: Notice
Date: 2016-08-02
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Privacy Act of 1974; Department of Transportation, Federal Aviation Administration, DOT/FAA854 Requests for Waivers and Authorizations Under 14 CFR Part 107 System of Records Notice
Document Number: 2016-18208
Type: Notice
Date: 2016-08-02
Agency: Department of Transportation, Office of the Secretary
In accordance with the Privacy Act of 1974, the United States Department of Transportation proposes to issue a Department of Transportation system of records titled, ``Department of Transportation Federal Aviation Administration; DOT/FAA854 Requests for Waivers and Authorizations Under 14 CFR part 107.'' On June 28, 2016 the FAA issued a Final Rule setting forth standards for operation and certification of small unmanned aircraft systems (hereinafter, ``small UAS''). RIN 2120- AJ60. Small UAS operators may request waivers of operational rules applicable to small UAS, requirements such as the requirement to maintain visual line of sight and yield right of way to manned aircraft, as well as prohibitions on operations over people and in certain airspace. Small UAS operators who determine to seek a waiver or authorization must request such by electronically completing a form on the FAA Web site or by mailing a completed paper form to the FAA. The forms will contain: aircraft operator name; aircraft owner name; name of person requesting a waiver or authorization; contact information for person applying for waiver or authorization: mailing address, telephone number, and email address of person submitting application for waiver or authorization; responses to inquiries concerning the applicant's previous and current waivers; remote pilot in command name; contact information for remote pilot in command: address and telephone number; remote pilot in command certificate number; aircraft manufacturer name and model; aircraft registration number; regulations subject to waiver or authorization; requested date and time operations will commence and conclude under waiver or authorization; requested altitude applicable to the waiver or authorization; description of proposed operations. In addition to the entries on the completed form, the applicant may provide additional information, such as maps, illustrations, specifications, or other items the applicant would like the FAA to consider. After reviewing the information the applicant provides, the FAA will determine whether it can assure safety in the national airspace when granting the waiver; often, such grants will include provisions to which the requester must adhere, to mitigate the risk associated with the waiver. The final rule prohibits operation of small UAS in Class B, Class C, or Class D airspace, as well as operation within the lateral boundaries of the surface area of Class E airspace designated for an airport unless the person has prior authorization from Air Traffic Control. To obtain this authorization, operators may complete and submit an electronic form available on the FAA's Web site. This system will consist of records (1) relevant to waivers of certain provisions of 14 CFR part 107 and (2) airspace authorization requests.
Self-Regulatory Organizations; ISE Gemini, LLC; Order Disapproving a Proposed Rule Change To Amend Rule 804(g)
Document Number: 2016-18202
Type: Notice
Date: 2016-08-02
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Information Collection; Comment Request: Socioeconomics of Ocean Recreation Operations in the Monterey Bay, Greater Farallones and Cordell Bank National Marine Sanctuaries
Document Number: 2016-18195
Type: Notice
Date: 2016-08-02
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Defense Federal Acquisition Regulation Supplement: Amendments Related to Sources of Electronic Parts (DFARS Case 2016-D013)
Document Number: 2016-18194
Type: Proposed Rule
Date: 2016-08-02
Agency: Defense Acquisition Regulations System, Department of Defense
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that makes contractors and subcontractors subject to approval (as well as review and audit) by appropriate DoD officials when identifying a contractor-approved supplier of electronic parts.
Margin and Capital Requirements for Covered Swap Entities
Document Number: 2016-18193
Type: Rule
Date: 2016-08-02
Agency: Farm Credit Administration, Agencies and Commissions, Federal Deposit Insurance Corporation, Federal Reserve System, Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury, Federal Housing Finance Agency
The OCC, Board, FDIC, FCA, and FHFA (each an ``Agency'' and, collectively, the ``Agencies'') are adopting exemptions from the initial and variation margin requirements published by the Agencies in November 2015 pursuant to sections 731 and 764 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act'' or the ``Act''). Pursuant to Title III of the Terrorism Risk Insurance Program Reauthorization Act of 2015 (``TRIPRA''), this final rule exempts certain non-cleared swaps and non-cleared security-based swaps with certain financial and non-financial end users that qualify for an exception or exemption from clearing.
Republic of Tunisia Loan Guarantees Issued Under Section 7034(o) of the Department of State, Foreign Operations, and Related Programs Appropriations Act of 2016-Standard Terms and Conditions
Document Number: 2016-18192
Type: Rule
Date: 2016-08-02
Agency: Agency for International Development, Agencies and Commissions
This regulation prescribes the procedures and standard terms and conditions applicable to loan guarantees to be issued for the benefit of the Republic of Tunisia pursuant to Section 7034(o) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016.
Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability
Document Number: 2016-18191
Type: Notice
Date: 2016-08-02
Agency: Food and Drug Administration, Department of Health and Human Services, Office of the Secretary
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.
Disclosure of Certain Documents in Enforcement and Other Matters
Document Number: 2016-18190
Type: Notice
Date: 2016-08-02
Agency: Federal Election Commission, Agencies and Commissions
The Commission is adopting a policy with respect to placing certain documents on the public record in enforcement, administrative fines, and alternative dispute resolution cases, as well as administrative matters. The categories of records that will be included in the public record are described below.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Sale of Securities To Reduce Indebtedness of Party in Interest, Prohibited Transaction Class Exemption 1980-83
Document Number: 2016-18189
Type: Notice
Date: 2016-08-02
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) will submit the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ``Sale of Securities to Reduce Indebtedness of Party in Interest, Prohibited Transaction Class Exemption 1980-83,'' to the Office of Management and Budget (OMB) on July 29, 2016, for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.
Environmental Management Site-Specific Advisory Board, Northern New Mexico
Document Number: 2016-18187
Type: Notice
Date: 2016-08-02
Agency: Department of Energy
This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Environmental Management Site-Specific Advisory Board, Paducah
Document Number: 2016-18186
Type: Notice
Date: 2016-08-02
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
President's Council of Advisors on Science and Technology
Document Number: 2016-18185
Type: Notice
Date: 2016-08-02
Agency: Department of Energy
This notice sets forth the schedule and summary agenda for a conference call of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use-Compliance Policy; Guidance for Industry; Availability
Document Number: 2016-18183
Type: Notice
Date: 2016-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a document titled ``Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous UseCompliance Policy; Guidance for Industry.'' This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) intended solely for autologous use. On May 22, 2015, in order to better assure the safety of the nation's blood supply and to help protect donor health, FDA finalized its revision of the applicable requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture (``Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use'' (donor eligibility rule)). The donor eligibility rule includes requirements related to current good manufacturing practice, donation testing, donor eligibility, and donation suitability. It became effective on May 23, 2016. FDA has developed this guidance in response to questions from blood establishments concerning the applicability of the donor eligibility rule to autologous donations. The guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use.
National Institute on Aging; Notice of Meeting
Document Number: 2016-18166
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2016-18165
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2016-18164
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2016-18163
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2016-18162
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services
Agenda and Notice of Public Meeting of the Connecticut Advisory Committee
Document Number: 2016-18160
Type: Notice
Date: 2016-08-02
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that an orientation and planning meeting of the Connecticut Advisory Committee to the Commission will convene at 12:00 p.m. (EDT) on Wednesday, August 10, 2016, at the ACLU, 330 Main Street, Hartford, CT 06106. The purpose of the orientation meeting is to inform the newly appointed Committee members about the rules of operation of federal advisory committees and to select additional officers, as determined by the Committee. The purpose of the planning meeting is to discuss potential topics that the Committee may wish to study. Persons who plan to attend the meeting and who require other accommodations, please contact Evelyn Bohor at ebohor@usccr.gov at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting. Members of the public are invited to submit written comments; the comments must be received in the regional office by Monday, September 12, 2016. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at ero@usccr.gov. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533. The activities of this advisory committee, including records and documents discussed during the meeting, will be available for public viewing, as they become available at: https://database.faca.gov/committee/meetings.aspx?cid=239. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2016-18159
Type: Notice
Date: 2016-08-02
Agency: Department of Health and Human Services, National Institutes of Health
Air Plan Approval; Florida; Regional Haze Progress Report
Document Number: 2016-18155
Type: Rule
Date: 2016-08-02
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Florida through the Florida Department of Environmental Protection (FDEP) on March 10, 2015. Florida's March 10, 2015, SIP revision (Progress Report) addresses requirements of the Clean Air Act (CAA or Act) and EPA's rules that require states to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of a state's existing SIP addressing regional haze (regional haze plan). EPA is approving Florida's Progress Report on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.
Promulgation of State Implementation Plan Revisions; Infrastructure Requirements for the 2008 Lead, 2008 Ozone, 2010 NO2,
Document Number: 2016-18154
Type: Rule
Date: 2016-08-02
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving elements of State Implementation Plan (SIP) revisions from the State of Utah to demonstrate the State meets infrastructure requirements of the Clean Air Act (CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for ozone on March 12, 2008, lead (Pb) on October 15, 2008, nitrogen dioxide (NO2) on January 22, 2010, sulfur dioxide (SO2) on June 2, 2010 and fine particulate matter (PM2.5) on December 14, 2012. The EPA is also approving 110(a)(2)(D)(ii) for the 1997 and 2006 PM2.5 NAAQS. Finally, the EPA is approving SIP revisions the State submitted regarding state boards.
Allocations of Cross-State Air Pollution Rule Allowances From New Unit Set-Asides for the 2016 Compliance Year
Document Number: 2016-18152
Type: Rule
Date: 2016-08-02
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is providing notice of emission allowance allocations to certain units under the new unit set-aside (NUSA) provisions of the Cross-State Air Pollution Rule (CSAPR) federal implementation plans (FIPs) and is responding to objections to preliminary calculations. EPA has completed final calculations for the first round of NUSA allowance allocations for the 2016 compliance year and has posted spreadsheets containing the calculations on EPA's Web site. The final allocations are unchanged from the preliminary calculations. EPA will record the allocated allowances in sources' Allowance Management System (AMS) accounts by August 1, 2016.
Request for Comments on Post-Quantum Cryptography Requirements and Evaluation Criteria
Document Number: 2016-18150
Type: Notice
Date: 2016-08-02
Agency: Department of Commerce, National Institute of Standards and Technology
The National Institute of Standards and Technology (NIST) is requesting comments on a proposed process to solicit, evaluate, and standardize one or more quantum-resistant public-key cryptographic algorithms. Current algorithms are vulnerable to attacks from large- scale quantum computers. The purpose of this notice is to solicit comments on the draft minimum acceptability requirements, submission requirements, evaluation criteria, and evaluation process of candidate algorithms from the public, the cryptographic community, academic/ research communities, manufacturers, voluntary standards organizations, and Federal, state, and local government organizations so that their needs can be considered in the process of developing new public-key cryptography standards. The draft requirements and evaluation criteria are available on the NIST Computer Security Resource Center Web site: https://www.nist.gov/pqcrypto.
Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-18139
Type: Notice
Date: 2016-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met.
Information Reporting of Catastrophic Health Coverage and Other Issues Under Section 6055
Document Number: 2016-18100
Type: Proposed Rule
Date: 2016-08-02
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed regulations relating to information reporting of minimum essential coverage under section 6055 of the Internal Revenue Code (Code). Health insurance issuers, certain employers, and others that provide minimum essential coverage to individuals must report to the IRS information about the type and period of coverage and furnish related statements to covered individuals. These proposed regulations affect health insurance issuers, employers, governments, and other persons that provide minimum essential coverage to individuals.
Reporting for Qualified Tuition and Related Expenses; Education Tax Credits
Document Number: 2016-18032
Type: Proposed Rule
Date: 2016-08-02
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed regulations that revise the rules for reporting qualified tuition and related expenses under section 6050S on a Form 1098-T, ``Tuition Statement,'' and conforms the regulations to the changes made to section 6050S by the Protecting Americans from Tax Hikes Act of 2015. This document also seeks to amend the regulations on the education tax credits under section 25A generally as well as to conform the regulations to changes made to section 25A by the Trade Preferences Extension Act of 2015 and the Protecting Americans from Tax Hikes Act of 2015. The proposed regulations affect certain higher educational institutions required to file Form 1098-T and taxpayers eligible to claim an education tax credit. This document also provides notice of a public hearing on these proposed regulations.
Privacy Shield Framework
Document Number: 2016-17961
Type: Notice
Date: 2016-08-02
Agency: Department of Commerce, International Trade Administration
The International Trade Administration (ITA) is publishing this notice to announce the availability of the Privacy Shield Framework documents. The EU-U.S. Privacy Shield Framework was designed by the U.S. Department of Commerce and European Commission to provide companies on both sides of the Atlantic with a mechanism to comply with European Union data protection requirements when transferring personal data from the European Union to the United States in support of transatlantic commerce. The Privacy Shield Framework documents published in this notice include the Privacy Shield Principles and Annex I describing the new arbitral model available under the Privacy Shield, letters from the Secretary of Commerce and Acting Under Secretary for International Trade describing the Department of Commerce's administration of the Privacy Shield, letters from the Chairwoman of the Federal Trade Commission and Secretary of Transportation describing their enforcement of the Privacy Shield, a letter from the Secretary of State regarding the Privacy Shield Ombudsperson, two letters from the Office of the Director of National Intelligence regarding safeguards and limitations applicable to U.S. national security authorities, and a letter from the Department of Justice regarding safeguards and limitations on U.S. Government access for law enforcement and public interest purposes.
Defense Federal Acquisition Regulation Supplement; Technical Amendments
Document Number: 2016-17959
Type: Rule
Date: 2016-08-02
Agency: Defense Acquisition Regulations System, Department of Defense
DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.
Defense Federal Acquisition Regulation Supplement: New Qualifying Countries-Japan and Slovenia (DFARS Case 2016-D023)
Document Number: 2016-17958
Type: Rule
Date: 2016-08-02
Agency: Defense Acquisition Regulations System, Department of Defense
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to add Japan and Slovenia as qualifying countries.
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