August 2016 – Federal Register Recent Federal Regulation Documents

GIPSA is announcing the designations of Mid-Iowa Grain Inspection, Inc. (Mid-Iowa); Fremont Grain Inspection Department, Inc. (Fremont); Maryland Department of Agriculture (Maryland); and Titus Grain Inspection, Inc. (Titus) to provide official services under the United States Grain Standards Act (USGSA), as amended.

On July 19, 2016, the National Telecommunications and Information Administration (NTIA) issued a notice and request for public comments on NTIA's preliminary guidance concerning how a qualified state may apply to NTIA for required authority to enter into a spectrum capacity lease with the First Responder Network Authority (FirstNet) and optional grant funds to assist in the construction of its radio access network (RAN) should it opt to do so as allowed under the Middle Class Tax Relief and Job Creation Act of 2012 (Act). In response to requests for additional time in which to comment, NTIA through this notice reopens the comment period. Comments received between the August 18, 2016 due date for comments announced in the July 19, 2016 notice, and publication of this notice in the Federal Register, are deemed to be timely.

The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Louisiana Department of Agriculture and Forestry (Louisiana).

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extension of the approved information collection assigned OMB control number OS-0990-0323, which expires on January 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice sets forth the schedule and proposed topics of discussion for a public meeting of the Advisory Committee on Supply Chain Competitiveness (Committee).

The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.

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

The U.S. Environmental Protection Agency (EPA) proposes to revise its regulations to streamline and clarify processes related to submission and review of title V petitions. This notice covers five key areas, each of which should increase stakeholder access to and understanding of the petition process and aid the EPA's review of petitions. First, the EPA is proposing regulatory provisions that provide direction as to how petitions should be submitted to the agency. Second, the EPA is proposing regulatory provisions that describe the expected format and minimum required content for title V petitions. Third, the proposal clarifies that permitting authorities are required to respond to significant comments received during the public comment period for draft title V permits, and to provide that response with the proposed title V permit to the EPA for the agency's 45-day review period. Fourth, guidance is provided in the form of ``recommended practices'' for various stakeholders to help ensure title V permits have complete administrative records and comport with the requirements of the Clean Air Act (CAA or Act). Fifth, to increase familiarity with the post-petition process, this notice presents information on the agency's interpretation of certain title V provisions of the CAA and its implementing regulations regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders.

The U.S. Department of Energy (``DOE'') is granting in part and denying in part a series of petitions to amend a recently published rule that established a procedure through which a party can, within a prescribed period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before the rule is published in the Federal Register (``error correction rule''). DOE also provided an opportunity for the public to comment on these petitions. This document responds to both the petitions and related comments that were submitted and received in accordance with the timelines established in a prior Federal Register notice inviting such petitions and comments.

The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.

In this document, the Consumer and Governmental Affairs Bureau (CGB or Bureau) of the Federal Communications Commission (FCC or Commission), pursuant to a delegation of authority, proposes to incorporate into the Commission's rules the Video Relay Service (VRS) interoperability and portability standards developed by the VRS Task Group of the Session Initiation Protocol (SIP) Forum and a successor group, the Relay User Equipment (RUE) Forum.

The Bureau of Consumer Financial Protection (Bureau) proposes amendments to the procedures used by the public to obtain information from the Bureau under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings. The Bureau also proposes amendments to its rule regarding the confidential treatment of information obtained from persons in connection with the exercise of its authorities under Federal consumer financial law.

The Environmental Protection Agency (EPA) is finalizing requirements that state, local and tribal air agencies would have to meet as they implement the current and future national ambient air quality standards (NAAQS) for fine particulate matter (PM2.5). Specifically, this document provides details on meeting the statutory state implementation plan (SIP) requirements that apply to areas designated nonattainment for any PM2.5 NAAQS, such as: General requirements for attainment plan due dates and attainment dates; emissions inventories; attainment demonstrations; provisions for demonstrating reasonable further progress; quantitative milestones; contingency measures; and nonattainment New Source Review (NNSR) permitting programs, among other things. This rule clarifies the specific attainment planning requirements that apply to PM2.5 NAAQS nonattainment areas based on their classification (either Moderate or Serious), and the process for reclassifying Moderate areas to Serious. Additionally, in this document the EPA is revoking the 1997 primary annual standard for areas designated as attainment for that standard because the EPA revised the primary annual standard in 2012. The EPA first established the PM2.5 NAAQS in 1997, completed a review and revision of those standards in 2006, and most recently completed a review and revision of the PM2.5 NAAQS on December 14, 2012.

The Employment and Training Administration (ETA) of the U.S. Department of Labor (Department) issues this final rule to implement statutory amendments to the Extended Benefits (EB) program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the Total Unemployment Rate (TUR) indicator which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the object to be included in the exhibition ``In the Tower: Barbara Kruger,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the National Gallery of Art, Washington, District of Columbia, from on or about September 30, 2016, until on or about January 22, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

This notice seeks to collect comments on revisions to an existing collection: Annual Protection and Advocacy Systems Program Performance Report (0985-0027). State Protection and Advocacy (P&A) Systems in each State and Territory provide individual legal advocacy, systemic advocacy, monitoring and investigations to protect and advance the rights of people with developmental disabilities, using funding administered by the Administration on Intellectual and Developmental Disabilities, Administration on Disability, Administration on Community Living, HHS. The Developmental Disabilities and Bill of Rights Act, 42 U.S.C. 15044, requires each P&A to annually prepare a report that describes the activities and accomplishments of the system during the preceding fiscal year and a Statement of Goals and Priorities (SGP) (0985-0034) for each coming fiscal year. P&As are required to annually report on ``the activities, accomplishments, and expenditures of the system during the preceding fiscal year, including a description of the system's goals, the extent to which the goals were achieved, barriers to their achievement, the process used to obtain public input, the nature of such input, and how such input was used.'' To meet it statutory reporting requirements, P&As have used separate forms for submitting the annual report (0985-0027) and the SGP (0985-0034). It is proposed that the two be combined by creating the Protection and Advocacy Annual Program Performance Report and Statement of Goals and Priorities form. By combining the forms, P&As will have a reduced burden by submitting only one report annually. The combined form will also allow federal reviewers to analyze patterns more readily between goals and priority setting and program performance. The annual program performance report (PPR) and SGP is reviewed by federal staff for compliance and program outcomes. Information in the PPRs and SGPs is analyzed to create a national profile of programmatic compliance, program outcomes, and goals and priorities for P&A Systems. These profiles are used to track accomplishments against goals, develop technical assistance, and determine compliance with Federal requirements. Information collected in the unified report also will inform AIDD of trends in P&A advocacy, collaboration with other federally-funded entities, and best practices for efficient use of federal funds.

The Environmental Protection Agency (EPA) announces a public teleconference of the Science and Information Subcommittee (SIS) to the Great Lakes Advisory Board (Board). The purpose of this meeting is to discuss the Great Lakes Restoration Initiative (GLRI).

This final rule amends the Export Administration Regulations (EAR) by adding ten persons under fourteen entries to the Entity List. The ten persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These ten persons will be listed on the Entity List under the destinations of Iraq, the Philippines, Syria, and Turkey.

In this action, the Environmental Protection Agency (EPA) is determining that 60 days is insufficient time to complete the technical and other analyses and public notice-and-comment process required for our review of a petition submitted by the state of Delaware pursuant to section 126 of the Clean Air Act (CAA). The petition requests that the EPA make a finding that the Brunner Island Steam Electric Station located in York County, Pennsylvania, emit air pollution that significantly contributes to nonattainment and interferes with maintenance of the 2008 and 2015 ozone national ambient air quality standards (NAAQS) in state of Delaware. Under section 307(d)(10) of CAA, the EPA is authorized to grant a time extension for responding to a petition if the EPA determines that the extension is necessary to afford the public, and the agency, adequate opportunity to carry out the purposes of the section 307(d)'s notice-and-comment rulemaking requirements. By this action, the EPA is making that determination. The EPA is therefore extending the deadline for acting on the petition to no later than March 5, 2017.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.