2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsSafety and Effectiveness Data.'' This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.

The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.

The Environmental Protection Agency (EPA) is taking final action to approve the State Implementation Plan (SIP) submission, submitted by the State of Florida, through the Florida Department of Environmental Protection (FDEP), on January 22, 2013, to demonstrate that the State meets certain infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour nitrogen dioxide (NO2) national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. FDEP certified that the Florida SIP contains provisions that ensure the 2010 1-hour NO2 NAAQS is implemented, enforced, and maintained in Florida. EPA has determined that Florida's infrastructure SIP submission, provided to EPA on January 22, 2013, satisfies certain required infrastructure elements for the 2010 1-hour NO2 NAAQS.

This proposal would amend the research and promotion orders or the regulations under the ordersoverseen by the Agricultural Marketing Service (AMS) to provide uniform authority for the removal of board members and staff who fail to perform their duties or who engage in dishonest actions or willful misconduct. The removal provisions in 13 of the orders would be modified to allow the U.S. Department of Agriculture (USDA) to take action necessary to ensure the boards can continue to fulfill their intended purposes with minimal disruption. Removal provisions would be added to the six orders that do not currently provide for such action.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health.

The Environmental Protection Agency (EPA) is revising the format for materials submitted by the State of Arizona that are incorporated by reference (IBR) into the Arizona State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by the State of Arizona and approved by the EPA. This format revision will primarily affect the ``Identification of plan'' section, as well as the format of the SIP materials that will be available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office. The EPA is also adding a table in the ``Identification of plan'' section which summarizes the approval actions that the EPA has taken on the non- regulatory and quasi-regulatory portions of the Arizona SIP.

This document contains proposed regulations relating to the application of section 514(c)(9)(E) of the Internal Revenue Code (Code) to partnerships that hold debt-financed real property and have one or more (but not all) qualified tax-exempt organization partners within the meaning of section 514(c)(9)(C). The proposed regulations amend the current regulations under section 514(c)(9)(E) to allow certain allocations resulting from specified common business practices to comply with the rules under section 514(c)(9)(E). These regulations affect partnerships with qualified tax-exempt organization partners and their partners.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

In this document, the Federal Communications Commission (Commission) adopts tailored service obligations for Alaska Communications Systems (ACS), a carrier serving a non-contiguous area that elected to receive nearly $20 million annually in Connect America Phase II frozen support amounts in lieu of model-based support.

The Federal Transit Administration (FTA) announces the availability of a draft Programmatic Assessment of Greenhouse Gas Emissions from Transit Projects (Programmatic Assessment) and an accompanying Greenhouse Gas Emissions (GHG) Estimator Tool (Estimator Tool). The purpose of the draft Programmatic Assessment is to: (1) Report on whether certain types of proposed transit projects merit detailed analysis of their GHG emissions at the project-level; and (2) provide a source of data and analysis for FTA and its grantees to reference in future environmental documents for projects where detailed, project-level GHG analysis would provide limited information beyond what is collected and considered in the assessment. The draft Programmatic Assessment presents estimates of GHG emissions generated from the construction, operations, and maintenance phases of projects across select transit modes, as well as an estimate of personal vehicle emissions displaced due to transit's ``ridership effect.'' The associated Estimator Tool is a spreadsheet tool that allows users to calculate partial lifecycle GHG emissions estimates by transit mode based on limited data inputs. FTA's draft Programmatic Assessment or Estimator Tool is not a requirement; agencies and states may use other methods for reporting GHG emissions related to state GHG reporting regulations, as needed and as appropriate. Use of FTA's draft Programmatic Assessment or Estimator Tool is not a requirement, if agencies and states are utilizing other methods for reporting GHG emissions related to state GHG reporting regulations. The FTA requests public comments on the Programmatic Assessment and the Estimator Tool.

This regulation establishes an exemption from the requirement of a tolerance for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 in or on all food commodities when used in accordance with label directions and good agricultural practices. MacIntosh and Associates, Inc. (on behalf of AgBiTech Pty Ltd.) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 under FFDCA.

In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations of certain products containing the active ingredients dimethomorph, metiram, profenofos, propoxur, and sodium acifluorfen and to amend certain captan and propoxur product registrations to terminate one or more uses. For captan, if granted, the requests would terminate the last U.S. registered use on dichondra, grasses (lawn seed beds), turf (golf courses and sod farms), and turf grasses (golf courses and ornamentals in non-pastured areas). For propoxur, if granted, the requests would terminate the last indoor use of aerosol, spray, and liquid formulations, and terminate the last uses in food handling establishments and for indoor crack and crevice. The requests, if granted, would not cancel the last captan, dimethomorph, propoxur, and sodium acifluorfen products registered for use in the United States. The requests, if granted, would cancel the last profenofos and metiram products registered for use in the United States. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the affected registrations have been cancelled/use terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.

The Bureau of Consumer Financial Protection (CFPB) is issuing its thirteenth edition of its Supervisory Highlights. In this issue of Supervisory Highlights, we report examination findings in the areas of auto originations, automobile loan servicing, debt collection, mortgage origination, student loan servicing, and fair lending. As in past editions, this report includes information about a recent public enforcement action that was a result, at least in part, of our supervisory work. The report also includes information on recently released examination procedures and Bureau guidance.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (section 2105) (42 U.S. Code 300aa-5). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various Federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in her capacity as the Director of the National Vaccine Program on matters related to vaccine program responsibilities. Recognizing the changes in the immunization landscape, the ASH charged the NVAC to conduct a Mid-course review to evaluate the progress of the National Vaccine Plan and provide recommendations to optimize priority areas. In March 2016, the NVAC formed the Mid-Course Review Working Group. Through a series of conference calls, electronic communication, and public discussions during the NVAC meetings, the working group identified a number of draft recommendations for consideration by the NVAC. These recommendations serve as a useful tool in refining collective strategies for shaping the future of the U.S. immunization enterprise, both domestically and globally. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in February 2017 at the quarterly NVAC meeting.

The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) OMB No. 3206-0233, Civil Service Retirement System Survivor Annuitant Express Pay Application for Death Benefits, OPM Form RI 25-051. As required by the Paperwork Reduction Act of 1995 (Public Law 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register (81 FR 47444, July 21, 2016) allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments.