2018 – Federal Register Recent Federal Regulation Documents

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Co-Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan, and Panacea Biotec Ltd., having a place of business in New Delhi, India.

The Coast Guard is extending the effective period of the temporary regulated navigation areas and safety zone for the navigable waters of the Hudson River, NY, surrounding the Tappan Zee Bridge. This rule will extend the effective period of the existing temporary interim rule for an additional year, now ending on December 31, 2019. This rule will continue to prohibit all persons and vessel traffic from the safety zone and enforce speed and wake restrictions for the Eastern and Western regulated navigation areas as cited in this rule unless exceptions are authorized by the First District Commander or a designated representative. These regulated navigation areas and safety zone continue to be necessary to protect personnel, vessels, and the marine environment from potential hazards during the removal of the existing Tappan Zee Bridge and construction of a new bridge.

In accordance with the Privacy Act of 1974, we are issuing public notice of our intent to establish a new system of records entitled the Disability Analysis File (DAF) and the National Beneficiary Survey (NBS) Data System, (60-0382). This notice publishes details of the system as set forth under the caption SUPPLEMENTARY INFORMATION.

The Commission is requesting public comment on how we can enhance, or at a minimum maintain, the investor protection attributes of periodic disclosures while reducing administrative and other burdens on reporting companies associated with quarterly reporting. We are specifically requesting public comment on the nature and timing of the disclosures that reporting companies are required to provide in their quarterly reports filed on Form 10-Q, including when the disclosure requirements overlap with disclosures these companies voluntarily provide to the public in the form of an earnings release furnished on Form 8-K. We are interested in exploring ways to promote efficiency in periodic reporting by reducing unnecessary duplication in the information that reporting companies disclose and how such changes could affect capital formation, while enhancing, or at a minimum maintaining, appropriate investor protection. We also are requesting public comment on whether our rules should provide reporting companies, or certain classes of reporting companies, with flexibility as to the frequency of their periodic reporting. In addition, we are seeking comment on how the existing periodic reporting system, earnings releases, and earnings guidance, standing alone or in combination with other factors, may affect corporate decision making and strategic thinkingpositively or negativelyincluding whether these factors foster an inefficient outlook among registrants and market participants by focusing on short-term results, sometimes referred to as ``short- termism.''

The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements regarding animal proteins prohibited in ruminant feed.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry.'' The guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2017.

The National Indian Gaming Commission (NIGC) amends its minimum internal control standards for Class II gaming under the Indian Gaming Regulatory Act to correct an erroneous deletion of the key control standards and to make other minor edits and additions for clarity.

The University of Tennessee, Department of Anthropology (UTK), has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to UTK. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

The Tennessee Valley Authority (TVA) has completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to TVA. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

NMFS is holding a meeting to discuss the future of the U.S. West Coast Pacific bluefin tuna fishery, including objectives and a management framework.

The Mine Safety and Health Administration (MSHA) announces a revised hourly rate for the fees charged to applicants and approval holders for testing, evaluating, and approving products for use in mines. MSHA charges a fee to cover the full cost (direct and indirect costs) of its services associated with the approval program. The new hourly rate is $137.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Tintoretto: Artist of Renaissance Venice,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the National Gallery of Art, Washington, District of Columbia, from on or about March 10, 2019, until on or about July 7, 2019, 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.

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.

The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. By this notice, IMLS is soliciting comments concerning a plan to conduct a research study entitled ``The Social Well-being Impact (SWI) of Libraries and Museums Study''. The study will be designed to demonstrate the impact of libraries and museums on community well-being. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

In accordance with the requirement of the Paperwork Reduction Act of 1995, the National Science Foundation (NSF) is providing opportunity for public comment on the NSF Major Facilities Guide (MFG) and the accompanying NSF Financial Data Collection Tool for Major Facilities. The Major Facilities Guide was previously cleared under the title Large Facilities Manual. The primary purpose of this revision is to update the roles and responsibilities for NSF staff for oversight of Major Facilities, provide requirements for mid-scale projects, and provide content in previously reserved Sections as well as clarify existing content. The draft versions of the NSF MFG and the accompanying NSF Financial Data Collection Tool for Major Facilities are available on the NSF website at: https://www.nsf.gov/bfa/lfo/ lfo_documents.jsp. To facilitate review, a Change Log with brief comment explanations of the changes is provided in the guide. NSF is particularly interested in public comment on the new content provided in Section 5 Guidance for Mid-Scale Research Infrastructure Projects and the previously reserved sections.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.