April 18, 2016 – Federal Register Recent Federal Regulation Documents

The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), herein referred to as RUS or the Agency, announces its Community Connect Grant Program application window for Fiscal Year (FY) 2016. This notice is being issued in order to allow potential applicants time to submit proposals and give the Agency time to process applications within the current fiscal year. In addition to announcing the application window, RUS announces the minimum and maximum amounts for Community Connect grants applicable for the fiscal year. The Community Connect Grant Program regulation can be found at 7 CFR part 1739 (Subpart A).

This notice sets forth the schedule of an upcoming public meeting conducted by the National Advisory Council on Indian Education (NACIE). Notice of the meeting is required by section 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. In order to facilitate the Secretary's attendance, this notice is being published less than 15 days prior to the scheduled meeting date.

Pursuant to the Federal Advisory Committee Act, as amended, this notice announces the solicitation of applications for additional Commission membership to fill a current vacancy to support digital evidence.

The U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), is announcing the availability of the final 2016 National Wetland Plant List (NWPL). The NWPL is used to determine whether the hydrophytic vegetation parameter is met when conducting wetland determinations under the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. The list will become effective on May 1, 2016 and will be used in any wetland delineation performed after this date. Delineations received prior to this date may still use the 2014 NWPL, or you may choose to use the 2016 list. Always reference the list used on any wetland delineation/ determination forms.

The Department of Commerce (``the Department'') is rescinding the administrative review of the countervailing duty order on calcium hypochlorite from the People's Republic of China (``PRC'') for May 27, 2014 through December 31, 2015.

Notice is hereby given that NMFS has received an update to an application for a direct take permit, in the form of a Hatchery and Genetic Management Plan (HGMP), from the Chelan County Public Utility District (PUD) pursuant to the Endangered Species Act (ESA). The HGMP specifies the operation of a portion of a hatchery program rearing salmon in the Methow Basin within the State of Washington. This document serves to notify the public of the availability of the update to the existing permit application for comment prior to a decision by NMFS whether to issue the permit for the proposed hatchery program. NMFS also notifies the public of the intention to issue a separate ESA permit to the Confederated Tribes and Bands of the Yakama Nation for operation of a component of the program described in the application update.

In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued Orders, dated March 2, 2016, with respect to stress test reporting as of December 31, 2015, under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Summary Instructions and Guidance accompanied the Orders to provide testing scenarios.

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP.

The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepatuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate participants of the 2016 ``Island 2 Island'' Half Marathon.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for ADVICOR (niacin extended-release (ER) and lovastatin) tablets and SIMCOR (niacin ER and simvastatin) tablets. The holder of these two applications, AbbVie Inc., has requested that FDA withdraw approval of the applications and has waived its opportunity for a hearing. The Agency has also determined that ADVICOR and SIMCOR were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated new drug applications (ANDAs) that reference ADVICOR or SIMCOR.

In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), have approved the publication of proposed revisions to the Regulatory Capital Reporting for Institutions Subject to the Advanced Capital Adequacy Framework (FFIEC 101) for public comment. The proposed revisions to the FFIEC 101 are consistent with the revised regulatory capital rule approved by the agencies in July 2013 (regulatory capital rule), as amended by subsequent revisions to the supplementary leverage ratio (SLR). The proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to all banking organizations subject to the advanced approaches risk-based capital rule (generally, banking organizations with $250 billion or more in total consolidated assets or $10 billion or more in on-balance sheet foreign exposures) (advanced approaches banking organizations), unless the advanced approaches banking organization is (i) a consolidated subsidiary of a bank holding company (BHC), savings and loan holding company (SLHC), or depository institution that is subject to the disclosure requirements in Table 13 of section 173 of the advanced approaches risk-based capital rule (advanced approaches rule), or (ii) a subsidiary of a non-U.S. banking organization that is subject to comparable public disclosure requirements in its home jurisdiction. Advanced approaches banking organizations would begin reporting the proposed SLR data items in FFIEC 101 Schedule A, Tables 1 and 2, effective with the September 30, 2016, reporting date. Separately, the proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to any U.S. intermediate holding companies (IHCs) formed or designated for purposes of compliance with the Board's Regulation YY (12 CFR 252.153) that are advanced approaches banking organizations, effective with the March 31, 2018, reporting date. Any subsidiary BHC controlled by a foreign banking organization (FBO) that was subject to the SLR requirements prior to the formation of an IHC would complete FFIEC 101 Schedule A, Tables 1 and 2, through the December 31, 2017, reporting date. The agencies would release publicly Tables 1 and 2 of FFIEC 101 Schedule A for all covered banking organizations, including IHCs that are required to complete Schedule A. At the end of the comment period, the comments will be analyzed to determine the extent to which the FFIEC and the agencies should modify the proposed revisions. The agencies will then submit the proposed revisions to OMB for review and final approval.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments.

The Department of Energy (DOE) announces public meetings and webinars for the DPPP Working Group. The Federal Advisory Committee Act requires that agencies publish notice of an advisory committee meeting in the Federal Register.

This document provides a notice of public hearing on proposed regulations that would require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.

NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on these reinstatements of previously approved collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).

NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the submission for reinstatement of a previously approved collection, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). NCUA is soliciting comment on the reinstatement of the information collection described below.