2015 – Federal Register Recent Federal Regulation Documents

The Department of Housing and Urban Development announces the establishment of two Performance Review Boards to make recommendations to the appointing authority on the performance of its senior executives. Towanda A. Brooks, John P. Benison, Camille E. Acevedo, Matthew E. Ammon, and Dominique G. Blom will serve as members of the Departmental Performance Review Board to review career SES performance. Laura H. Hogshead, Rafael C. Diaz, Tonya T. Robinson, and Lynn M. Ross will serve as members of the Departmental Performance Review Board to review noncareer SES performance. The address is: Department of Housing and Urban Development, Washington, DC 20410-0050.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment its draft Interim Staff Guidance (ISG) DSS-ISG-2015-XX, ``Clarification of Licensee Actions in Receipt of Enforcement Discretion per Enforcement Guidance Memorandum (EGM) 15-002, `Enforcement Discretion for Tornado-generated Missile Protection Noncompliance.' '' This draft ISG will provide clarifying guidance for NRC staff understanding of expectations for consistent oversight associated with implementing enforcement discretion for tornado missile protection noncompliance per EGM 15-002. This guidance will allow consistent enforcement and regulation of licensees that implement corrective actions outlined in EGM 15-002.

The U.S. Nuclear Regulatory Commission (NRC) is adopting new cyber security regulations that govern nuclear power reactor licensees. This final rule codifies certain reporting activities associated with cyber security events contained in security advisories issued by the NRC. This rule establishes new cyber security event notification requirements that contribute to the NRC's analysis of the reliability and effectiveness of licensees' cyber security programs and plays an important role in the continuing effort to provide high assurance that digital computer and communication systems and networks are adequately protected against cyber attacks, up to and including the design basis threat.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Carolina (FEMA-4241-DR), dated 10/15/2015. Incident: Severe Storms and Flooding. Incident Period: 10/01/2015 through 10/23/2015. Effective Date: 10/26/2015. Physical Loan Application Deadline Date: 12/14/2015. Economic Injury (EIDL) Loan Application Deadline Date: 07/14/2016.

Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that the 71st meeting of the President's Committee on the Arts and the Humanities (PCAH) will tentatively be held in the Monument Room, Occidental Grill & Seafood, 1475 Pennsylvania Avenue NW., Washington, DC 20004. Ending time is approximate.

The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled ``DSCSA Implementation: Product Tracing Requirements for DispensersCompliance Policy.'' This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act.

The Caribbean Fishery Management Council (CFMC) is considering modifying the timing for the implementation of accountability measure (AM)-based closures in the Caribbean Exclusive Economic Zone (EEZ) and specifying how often to revisit the modification. The Council is considering these management measures in order to ensure AM-based closures successfully achieve their conservation objective and, to the extent practicable, minimize adverse economic impacts to fishers and fishing communities, consistent with National Standard 8 of the Magnuson-Stevens Fishery Conservation and Management Act. Following are the actions and management alternatives: The Draft Amendment consists of two actions: Action 1: Modify the timing for the implementation of AM-based closures in the EEZ; Alternative 1: No action. Continue AM-based closures resulting from an annual catch limit (ACL) overage beginning on December 31st of the closure year and extending backward into the year for the number of days neccesary to achieve the required reduction in landings. Preferred Alternative 2: Accountability measure-based closures resulting from an ACL overage will begin on September 30th of the closure year and would extend backward into the year for the number of days necessary to achieve the required reduction in landings. This closure start date would apply to all fishery management units (FMUs) for each of Puerto Rico commercial and recreational sectors, St. Thomas/St. John, St. Croix, and Caribbean-wide. If for any FMU in any year, the number of available days running from September 30th backward to the beginning of the year is not enough to achieve the required reduction in landings, then the additional days needed would be captured by extending the closure forward, beginning on October 1st and continuing for however many days are needed to fulfill the required reduction. Alternative 3: Accountability measure-based closures resulting from an ACL overage will begin on January 1st of the closure year and extend forward into the year for the number of days necessary to achieve the required reduction in landing. This closure start date would apply to all FMUs for each of Puerto Rico commercial and recreational sectors, St. Thomas/St. John, St. Croix, and Caribbean-wide. Alternative 4: Establish a fixed fishing closure start date for the implementation of AMs for each FMU by island/island group (A. Puerto Rico, B. St. Thomas/St. John, C. St. Croix, and D. Caribbean-wide). A different start date may be chosen for each FMU on each island/island group. The start date will begin on the last day of the identified month and go backward towards the beginning of the year. If for any FMU in any year, the number of days left in the year is not enough to achieve the required reduction in landings, then those additional days would be captured by extending the closure forward toward the end of the year.

The FDIC, 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 the renewal of existing information collections, as required by the Paperwork Reduction Act of 1995. The FDIC recently requested comment for 60 days on proposals to renew the information collections described below. Only one comment was received, as explained below. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these information collections, and again invites comment on these renewals.

The North Pacific Fishery Management Council (Council) Groundfish Plan Team will meet in Seattle, WA.

The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 151 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Recreational Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that nonconforming 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006) 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 2006 Mercedes-Benz SL that was manufactured before September 1, 2006) and they are capable of being readily altered to conform to the standards.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Fire Protection (Underground Coal Mines).

Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices.'' This guidance describes the types of information that should be provided to support a claim of electromagnetic compatibility (EMC) in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference (EMI)). EMC assessment helps to ensure that a device is able to function in its intended environment without introducing excessive electromagnetic disturbances that might interfere with other devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled ``Draft Guidance on Progesterone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel.

The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the consumer tipping survey study.