2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this guidance to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. FDA considered comments received on the draft guidance and revised the guidance as appropriate.

This document corrects the Overview of Comments Received section to a final rule published in the Federal Register as of October 24, 2016, regarding Revision of Regulations Governing Freedom of Information Act Requests and Appeals, and Revision of Touhy Regulations Governing Release of Information in Response to Legal Proceedings. This correction addresses the final paragraph of Section II, Overview of Comments Received, which should be disregarded or removed.

The U.S. Commission on Civil Rights published a document in the Federal Register of October 3, 2016, concerning the announcement of a meeting on November 15, 2016. The document contained incorrect dates.

The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of November 7, 2016, for the direct final rule that was published in the Federal Register on August 23, 2016. The direct final rule amended the NRC's spent fuel storage regulations by revising the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2 to Certificate of Compliance (CoC) No. 1032 for the Holtec International (Holtec) HI-STORM Flood/Wind (FW) Multipurpose Canister (MPC) Storage System.

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program- community-status-book.

Daimler Trucks North America (DTNA), has determined that certain model year (MY) 2016-2017 Freightliner and Western Star trucks do not fully comply with Table 2 of Federal Motor Vehicle Safety Standard (FMVSS) No. 101, Controls and Displays. DTNA filed a report dated September 22, 2016, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports. DTNA also petitioned NHTSA on September 22, 2016, under 49 CFR part 556 for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety.

The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to its Enforcement Policy (Policy) to incorporate changes approved by the Commission.

This action expands the restricted airspace at Chincoteague Inlet, VA, to support the National Aeronautics and Space Administration's (NASA) Wallops Island Flight Facility (WFF) test requirements. This action adds 3 new restricted areas, designated R- 6604C, R-6604D, and R-6604E. Additionally, a minor change is made to 2 points in the boundary of existing area R-6604A to match the updated 3- nautical mile (NM) line from the shoreline of the United States (U.S.) as provided by the National Oceanic and Atmospheric Administration (NOAA).

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in FDA's Tobacco Product Violations Reporting Form.

On June 21, 2016, the NCUA Board (Board) published an interim final rule amending its regulations to adjust the maximum amount of each civil monetary penalty (CMP) within its jurisdiction to account for inflation. This action, including the amount of the adjustments, is required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This final rule confirms those amendments while making a clarification regarding the prospective effect of the 2015 legislation.

In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Departmental Offices (DO) is publishing its Privacy Act systems of records.

The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of New Hampshire on March 31, 2011 and on July 23, 2013. These SIP revisions establish particulate matter (PM) and visible emissions (VE) standards for the following sources: foundries, smelters, and investment casting operations; hot mix asphalt plants; and sand and gravel sources, non- metallic mineral processing plants, and cement and concrete sources. In addition, EPA is approving a part of a SIP revision submitted by New Hampshire on March 12, 2003 that establishes procedures for testing opacity of emissions (i.e., VE). This action is being taken under the Clean Air Act.

We propose to supersede Airworthiness Directive (AD) 2012-22- 12, for all Airbus Model A330-243, -243F, -341, -342, and -343 airplanes. AD 2012-22-12 currently requires inspecting piccolo tubes, piccolo tube mount links, the aft side of the forward bulkhead, and outer boundary angles (OBAs) for cracks, fractures, and broken links, and doing corrective actions if necessary. Since we issued AD 2012-22- 12, we have received reports of loose and missing attachment rivets of the inner boundary angles (IBA) and OBA of the forward bulkhead. This proposed AD would retain certain requirements of AD 2012-22-12, and add repetitive inspections for pulled, loose, and missing attachment rivets of the IBA and OBA of the forward bulkhead, and related investigative and corrective actions if necessary. We are proposing this AD to detect and correct degraded structural integrity of the engine nose cowl, which in the case of forward bulkhead damage in conjunction with a broken piccolo tube, could lead to damage to the engine and operation in icing conditions with reduced thermal anti-ice (TAI) performance.

The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (Board), the Federal Deposit Insurance Corporation (FDIC), the Farm Credit Administration (FCA), and the National Credit Union Administration (NCUA) are issuing a new proposal to amend their regulations regarding loans in areas having special flood hazards to implement the private flood insurance provisions of the Biggert-Waters Flood Insurance Reform Act of 2012 (Biggert-Waters Act). Specifically, the proposed rule would require regulated lending institutions to accept policies that meet the statutory definition of private flood insurance in the Biggert-Waters Act and permit regulated lending institutions to accept flood insurance provided by private insurers that does not meet the statutory definition of ``private flood insurance'' on a discretionary basis, subject to certain restrictions.

This notice of proposed rulemaking (NPRM) is the last in a sequence of six NPRM documents in this Federal Register that collectively establishes for DoD grants and cooperative agreements an updated interim implementation of Governmentwide guidance on administrative requirements, cost principles, and audit requirements for Federal awards and make other needed updates to the DoD Grant and Agreement Regulations (DoDGARs). This NPRM removes two existing DoDGARs parts and revises four others in order to conform them with the 11 parts of the DoDGARs proposed in the NPRMs preceding this one in this section of this Federal Register.

This notice of proposed rulemaking (NPRM) is the third of a sequence of six NPRM documents in this section of this issue of the Federal Register that propose updates to the Department of Defense Grant and Agreement Regulations (DoDGARs). This NPRM proposes to add seven new DoDGARs parts to address the administrative requirements included in general terms and conditions of DoD cost-type grants and cooperative agreements awarded to institutions of higher education, nonprofit organizations, States, local governments, and Indian tribes. The administrative requirements are in areas such as financial and program management; property administration; recipient procurement procedures; financial, programmatic, and property reporting; and subawards. The proposed new parts establish a uniform way for approximately 100 DoD Component awarding offices to organize the administrative requirements in their general terms and conditions. The proposed new parts also provide standard wording of terms and conditions for the administrative requirements, with associated regulatory prescriptions for DoD Components to provide latitude to vary from the standard wording where variation is appropriate.

This notice of proposed rulemaking (NPRM) is the second of a sequence of six NPRM documents in this issue of the Federal Register that collectively establish for DoD grants and cooperative agreements an updated interim implementation of Governmentwide guidance on administrative requirements, cost principles, and audit requirements for Federal awards and make other needed updates to the DoD Grant and Agreement Regulations (DoDGARs). This NPRM adds a new DoDGARs part to establish a standard format for organizing the content of DoD Components' grant and cooperative agreement awards and modifications to them.

The Agricultural Marketing Service (AMS) proposes to amend its regulations to better reflect the current needs of Quality Systems Verification Program (QSVP) activities and to implement changes created by the merger of the AMS Livestock and Seed Program and the AMS Poultry Programs. These proposed changes include amending the Livestock, Meat, and Other Agricultural Commodities QSVP to expand the commodities under the QSVP to include those authorized under the Agricultural Marketing Act of 1946 (hereafter referred to as ``the Act''), remove reference to ``Livestock, Meat, and Other Commodities'' in the title, more clearly identify and define the types of programs and services offered under QSVP, and make other technical and administrative changes. Simultaneously, AMS proposes to make conforming changes to the regulations pertaining to the Voluntary Grading of Shell Eggs and Voluntary Grading of Poultry Products and Rabbit Products to remove references to audit activities.