February 15, 2018 – Federal Register Recent Federal Regulation Documents

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday February 21, 2018, at 3:00 p.m. EST for the purpose of preparing for its public meeting on voting rights issues in the state.

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR1A Bridge across the Hampton River, mile 0.0, at Hampton, NH. The deviation is necessary to allow the replacement of couplers on the bridge. This deviation allows the bridge to be closed to navigation.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Wantagh State Parkway Bridge across Sloop Channel, mile 15.4, at Hempstead, New York. This deviation is necessary in order to facilitate an annual fireworks display and allows the bridge to remain in the closed position for three hours.

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Council on the Humanities will meet to advise the Chairman of the National Endowment for the Humanities (NEH) with respect to policies, programs and procedures for carrying out his functions; to review applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 and make recommendations thereon to the Chairman; and to consider gifts offered to NEH and make recommendations thereon to the Chairman.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZONTIVITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic AP1000 design control document (DCD) and is issuing License Amendment Nos. 95 and 94 to Combined Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the changes to Tier 1 information that is requested in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.

The Department of Commerce (Commerce) is rescinding its administrative review of the antidumping duty order on certain magnesia carbon bricks from Mexico for the period of review (POR) September 1, 2016, through August 31, 2017.

In accordance with the regulations implementing the Atlantic Herring Fishery Management Plan, this action adjusts the 2018 catch limits in the four herring management areas (Areas 1A, 1B, 2, and 3) to account for underages and overages in those areas during 2016. In order to ensure that the carryover of underages do not cause overfishing of the herring resource, management area-specific carryover does not increase the stock-wide annual catch limit. This action is necessary to ensure that NMFS accounts for herring catch consistent with the requirements of the Atlantic Herring Fishery Management Plan.

As required by the Veterans' Compensation Cost-of-Living Adjustment Act of 2017, Public Law 115-75, the Department of Veterans Affairs (VA) is hereby giving notice of adjustments in certain benefit rates. These adjustments affect the compensation program.

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Recordkeeping and Disclosure Requirements Associated with Securities Transactions Pursuant to Regulation H (Reg H-3; OMB No. 7100-0196).

Pursuant to the Privacy Act of 1974, as amended, notice is hereby given that the Office of Policy Development and Research (PD&R), U.S. Department of Housing and Urban Development (HUD), provides public notice regarding its System of Records for the HUD Supportive Services Demonstration (SSD)/Integrated Wellness in Supportive Housing (IWISH). The demonstration will test a model of housing and supportive services in HUD-assisted Multifamily housing with the potential to delay or avoid nursing home care for low-income elderly residents in HUD- assisted housing. Primary data collection includes a Resident Assessment and uses a standardized, web-based platform to capture and store self-reported demographic and health and social status information from demonstration participants, including personally identifying information (PII) and protected health information (PHI). A more detailed description of the proposed system of records is contained in the purpose section of this notice.

The National Advisory Council on Innovation and Entrepreneurship (NACIE) will hold a public meeting via teleconference on Wednesday, March 14, 2018. During this time, members will discuss, consider, and vote on an innovation and entrepreneurship policy framework and related principles.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIDION and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This guidance finalizes the draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals'' published in August 2016.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FETZIMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORKAMBI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the Federal Register on December 12, 2017, and no comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at: https:// www.reginfo.gov/public/do/PRAMain. Comments: Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the NSF, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.