August 23, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.'' The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). This draft guidance does not address improvement of symptoms of OA, such as pain or functional impairment, which will be addressed in future guidances.

The Department of Labor (DOL or Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps 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. Currently, the Employment and Training Administration (ETA) is soliciting comments concerning its proposal to extend the approval of this information collection. Current expiration of the information collection is November 30, 2018.

The National Institute of Standards and Technology (NIST) announces that the Manufacturing Extension Partnership (MEP) Advisory Board will hold an open meeting on September 12, 2018.

The Riverside Metropolitan Museum, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of sacred objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Riverside Metropolitan Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Brooklyn Museum has completed an inventory of associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the associated 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 associated funerary objects should submit a written request to the Brooklyn Museum. If no additional requestors come forward, transfer of control of the associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The State Center Community College DistrictFresno City College 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 a cultural affiliation between the human remains and associated 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 human remains and associated funerary objects should submit a written request to the State Center Community College DistrictFresno City College. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Florida Department of State has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains 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 human remains should submit a written request to the Florida Department of State. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The State Center Community College DistrictFresno City College 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 the State Center Community College DistrictFresno City College. 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 Department of Commerce (Commerce) is amending the final results of the countervailing duty expedited review of certain carbon and alloy steel cut-to-length plate (CTL plate) from the People's Republic of China (China) to correct a ministerial error. The period of review (POR) January 1, 2015, through December 31, 2015.

This document seeks input on the state of competition in the marketplace for the delivery of audio programming as it would relate to the overall goal of providing the Communications Marketplace Report to Congress as required by the Repack Airwaves Yielding Better Access for Users of Modern Services Act of 2018 (RAY BAUM'S Act of 2018). Title IV of the RAY BAUM'S Act of 2018 requires that the Commission publish a Communications Marketplace Report in the last quarter of every even numbered year.

The Board of Veterans' Appeals, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, OID. The BSC, OID, consists of 17 experts in fields associated with the issues addressed by CDC's infectious disease national centers (e.g., respiratory diseases, antimicrobial resistance, foodborne diseases, zoonotic and vectorborne diseases, sexually transmitted diseases) and specialties, including clinical and public health practice (including state and local health departments), research and diagnostics, bioinformatics, health policy/communications, and industry. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases and related specialties. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC, OID, objectives (www.cdc.gov/ oid/BSC.html).

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC), Metal Mining Automation and Advanced Technologies (MMAAT) Workgroup. This meeting is open to the public, limited only by the space available. The public is welcome to submit written comments in advance of the meeting to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Understanding multi-sectoral collaboration for strengthening public health capacities in Ethiopia. The goal of this study is to explore multi-sectoral collaboration in Ethiopia, in the context of strengthening public health capacities under the Global Health Security Agenda.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Chagall, Lissitzky, Malevich: The Russian Avant Garde in Vitebsk, 1918-1922,'' 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 Jewish Museum, New York, New York, from on or about September 14, 2018, until on or about January 6, 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 U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft plant-specific Supplement 59, to ``Generic Environmental Impact Statement GEIS for License Renewal of Nuclear Plants'' NUREG-1437, regarding the renewal of Entergy Nuclear Operations, Inc. (Entergy) operating license NPF-38 for Waterford 3 for an additional 20 years of operation. Possible alternatives to the proposed action (license renewal) include the no action alternative and reasonable alternative energy sources.

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.