August 30, 2017 – Federal Register Recent Federal Regulation Documents

This is a notice of an Administrative declaration of a disaster for the State of WISCONSIN dated August 18, 2017.

This is a notice of an Administrative declaration of a disaster for the State of Pennsylvania dated August 23, 2017.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KENGREAL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 Agency) has determined that CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.

This is a notice of an Administrative declaration of a disaster for the State of Louisiana dated August 22, 2017.

The Department of Commerce, 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.

Notice is hereby given that the Department of Veterans Affairs (VA), Office of Research and Development, Technology Transfer Program, intends to grant to the Arizona Board of Regents, for and on behalf of Northern Arizona University (NAU), 1395 South Knoles Drive, PO Box 4087, Flagstaff, AZ 86011-4087, an exclusive license to U.S. Patent No. 9,457,009 (``Methods and Compositions for Preventing and Treating Auditory Dysfunctions'') and related patent applications associated with VA Invention Disclosure number 10-148, titled, ``Otoprotective Uncaria Tomentosa.'' The invention provides methods for treating auditory impairments in a subject in need of treatment comprising administering to said subject an effective amount of a composition comprising, as an active agent, one or more of a carboxy alkyl ester, a quinic acid derivative, a caffeic acid derivative, a ferulic acid derivative, or a quinic acid lactone or derivative thereof or pharmaceutically acceptable salt thereof and an acceptable carrier or excipient, so as to treat auditory impairments in the subject. Ultimately, this invention provides a novel therapeutic option for otoprotection and/or hearing recovery following injury.

NHTSA is extending the public comment period for the Notice of Intent (NOI) to Prepare an Environmental Impact Statement (EIS) for Model Year 2022-2025 Corporate Average Fuel Economy (CAFE) Standards to Monday, September 25, 2017. The NOI was published in the Federal Register on Wednesday, July 26, 2017. The public comment period for the NOI was originally scheduled to end on Friday, August 25, 2017.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey is proposing to renew an information collection.

The NIST Cloud Computing Program (NCCP) announces the reconstitution of its Federated Cloud Public Working Group. The Working Group's activities will resume and initiate work to develop a vocabulary of terms to support federated cloud and federated cloud environments, as well as a conceptual architecture for federated cloud. Participation in the Working Group is open to all interested parties.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the San Francisco Water Emergency Transportation Authority (WETA) to incidentally harass, by Level A and Level B harassment, marine mammals during in-water construction activities associated with the Central Bay Operations and Maintenance Facility Project in Alameda, CA.

The U.S. Department of Agriculture (USDA), Forest Service, Tonto National Forest, has completed an inventory of unassociated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the unassociated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these cultural items should submit a written request to the Tonto National Forest. If no additional requestors come forward, transfer of control of the unassociated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Gulf Coast Ecosystem Restoration Council (Council) seeks public and Tribal comment on a proposal to amend its Initial Funded Priorities List (FPL) to approve implementation funding for the Robinson Preserve Wetlands Restoration project (Robinson Preserve), Florida. The Council is proposing to approve $1,319,636 in implementation funding for Robinson Preserve. The Council is also proposing to reallocate $470,910 from planning to implementation. The total amount of funding available for implementation of Robinson Preserve would be $1,790,546. These funds would be used to restore 118.2 acres of coastal habitat, along with related activities in Tampa Bay. The Department of Commerce's National Oceanic and Atmospheric Administration (NOAA) is the sponsor of the Robinson Preserve project. To comply with the National Environmental Policy Act (NEPA) and other applicable laws, the Council is proposing to adopt an existing 2015 Programmatic Environmental Impact Statement (PEIS) https:// www.habitat.noaa.gov/pdf/NOAA_Restoration_Center_Final_PEIS.p df developed by NOAA's Restoration Center and ensure compliance with the terms and conditions of a Clean Water Act (CWA) Section 404 permit that has been issued for the Robinson Preserve project. In so doing, the Council would expedite project implementation, reduce planning costs and potentially increase the ecological benefits of this project.

The Internal Revenue Service, 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 945 Annual Return of Withheld Federal Income Tax, Form 945-A Annual Record of Federal Tax Liability, Form 945-X Adjusted Annual Return of Withheld Federal Income Tax or Claim for Refund and TD 8672 Reporting of Non-payroll Withheld Tax Liabilities.

The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Vietnam War Commemoration Advisory Committee will take place.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model DC-9-81 (MD- 81), DC-9-82 (MD-82), DC-9-83 (MD-83), and DC-9-87 (MD-87) airplanes, and Model MD-88 airplanes. This AD was prompted by reports of cracking of various structures in the bulkhead. This AD requires an inspection for cracking in these structures, and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.