August 2016 – Federal Register Recent Federal Regulation Documents

FHWA announces the establishment of the Emergency Route Working Group (ERWG) for a 2-year period. The ERWG will provide the U.S. Secretary of Transportation, through the Administrator of the FHWA, with advice and recommendations for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG will provide the U.S. Secretary of Transportation a written report by December 4, 2016, on its findings and recommendation for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG's advice and recommendations will work within existing legal authorities and not require changes in State or Federal law for DOT to implement.

Pursuant to Section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations (40 CFR parts 1500-1508), the Department of the Navy (DON) announces its intent to prepare a Supplemental Environmental Impact Statement (EIS) to evaluate the potential environmental impacts that may result from implementing alternative desert tortoise translocation plans at the Marine Corps Air Ground Combat Center, Twentynine Palms (hereinafter ``the Combat Center''). The Supplemental EIS is a supplement to the Final EIS for ``Land Acquisition and Airspace Establishment to Support Large-Scale Marine Air Ground Task Force Live Fire and Maneuver Training'' dated July 2012 (hereinafter ``2012 Final EIS'') (77 FR 44234).

In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.

As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Patient Preference InformationVoluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI), which may inform FDA's benefit-risk determinations in the premarket review of premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, and de novo classification requests. This guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' originally issued on March 28, 2012, that has been edited to be consistent with this guidance document.

As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records currently entitled ``My HealtheVet Administrative Records-VA'' (130VA19) as set forth in the Federal Register 75 FR 70365. VA is amending the system by revising the System Number, System Location, Categories of Individuals Covered by the System, Categories of Records in the System, Records Source Categories, Routine Uses of Records Maintained in the System, Retention and Disposal, System Manager, Record Access Procedure, and Notification Procedure. VA is republishing the system notice in its entirety.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 6) of the presiding administrative law judge (``ALJ'') terminating the above-captioned investigation based upon a consent order stipulation and proposed consent order. The Commission has also determined to issue a consent order.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of the following meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT).

This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/ 2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/16/2016. Physical Loan Application Deadline Date: 10/13/2016. EIDL Loan Application Deadline Date: 05/15/2017.

This is a Notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/14/2016. Physical Loan Application Deadline Date: 10/13/2016. Economic Injury (EIDL) Loan Application Deadline Date: 05/15/2017.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management intends to submit to the Office of Management and Budget (OMB) a request for clearance to revise an information collection. Combined Federal Campaign Applications, OMB Control No. 3206-0131, which include OPM Forms 1647-A, -B, and -E, are used to review the eligibility of national, international, and local charitable organizations and Department of Defense morale, welfare, and recreation (MWR)/Family Support and Youth Activities/Programs (FSYA/FSYP) organizations that wish to participate in the Combined Federal Campaign. The proposed revisions reflect changes in eligibility guidance from the Office of Personnel Management. On March 10, 2016, we published a 60-day notice and request for comments. We received two comments recommending the addition of a ``thank you statement'' field that would facilitate immediate acknowledgement of electronic pledges. This recommended revision is included below. We estimate 20,500 responses to this information collection annually. Each form takes approximately three hours to complete. The annual estimated burden is 40,500 hours.

This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\ and the Medicare, Medicaid, and Children's Health Insurance Programs consumer education strategies. This meeting is open to the public.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Application to Use the Automated Commercial Environment (ACE). CBP is proposing that this information collection be extended with a change to the burden hours resulting from the addition of a new application for brokers, importers, sureties, attorneys and other parties to establish an ACE Portal account to file protests. There are no proposed changes to the existing ACE Portal application for imported merchandise. This document is published to obtain comments from the public and affected agencies.

The U.S. Office of Personnel Management (OPM) is issuing a proposed rule that would define Kent County, Michigan, as an area of application county to the Macomb, MI, nonappropriated fund (NAF) Federal Wage System (FWS) wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area. These changes are necessary because there are NAF FWS employees working in Kent and Cameron Counties, and the counties are not currently defined to NAF wage areas.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.''

This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The National Aeronautics and Space Administration (NASA) hereby gives notice of its intent to grant an exclusive license in the United States to practice the inventions described and claimed in U.S. Patent Number 8,401,217, titled ``Extreme Low Frequency Acoustic Measurement System,'' NASA Case Number LAR- 17317-1, and U.S. Patent Application Serial Number 13/771,735, titled ``Extreme Low Frequency Acoustic Measurement System,'' NASA Case Number LAR-17317-2, to Infrasonix Inc., having its principal place of business in Lawrenceville, GA. The fields of use may be limited to, but not necessarily limited to, human and/or animal healthcare. Certain patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.