August 2017 – Federal Register Recent Federal Regulation Documents

Notice is hereby given of a meeting of the Sanctuary System Business Advisory Council (council). The meeting is open to the public, and participants may provide comments at the appropriate time during the meeting.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (Renewal)'' (EPA ICR No. 2260.05, OMB Control No. 2090-0029) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through February 28, 2018. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Notice is hereby given that the Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce is announcing a 30-day public comment period for the Jobos Bay National Estuarine Research Reserve Management Plan revision. Pursuant to 15 CFR 921.33(c), the revised plan will bring the reserve into compliance. The Jobos Bay Reserve revised plan will replace the plan approved in 2000. The revised management plan outlines the administrative structure; the research/monitoring, stewardship, education, and training programs and priorities of the reserve; plans for a proposed boundary expansion through future land acquisition; and facility development priorities to support reserve operations. The Jobos Bay Reserve takes an integrated approach to management, linking research and education, coastal training, and stewardship functions. The Puerto Rico Department of Natural and Environmental Resources (PRDNER) has outlined how it will administer the reserve and its core programs by providing detailed actions that will enable it to accomplish specific goals and objectives. Since the last management plan, the reserve has: developed core programs; expanded monitoring programs within Jobos Bay and its watershed; expanded its dorm, and remodeled the historic train depot and visitor center; conducted training workshops; implemented K-12 education programs; and built new and innovative partnerships with local, Commonwealth, and U.S. organizations and universities. The total number of acres within the boundary is 2800 acres, which is a slight modification of the original 2883 acres identified in the previous management plan. The revised acreage is a result of survey contracted by the PRDNER to clarify the boundary. The revised management plan will serve as the guiding document for the Jobos Bay Reserve for the next five years. View the Jobos Bay Reserve Management Plan revision at (https://drna.pr.gov/jbnerr/) and provide comments to the Reserve's Manager, Aitza Pabon (apabon@drna.pr.gov).

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Beyond ImpressionismParis, Fin-de-Si[egrave]cle: The Art of Signac, Redon, Toulouse-Lautrec and their Contemporaries,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Columbus Museum of Art, Columbus, Ohio, from on or about October 20, 2017, until on or about January 21, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

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

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 047'' (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted no later than October 20, 2017 to be assured of consideration.

OMB is issuing the OMB Sequestration Update Report to the President and Congress for Fiscal Year 2018 to report on the status of the discretionary caps and on the compliance of pending discretionary appropriations legislation with those caps. For fiscal year 2017, the report finds enacted appropriations to be within the spending limits. For fiscal year 2018, the report finds that, if the current limits remain unchanged, under OMB's estimates of actions to date by the House of Representatives for the 12 annual appropriations bills would result in a sequestration of approximately $72.4 billion in defense programs. The report also finds that actions or funding guidance by the Senate would result in a sequestration of approximately $2.0 billion in defense programs and $3.8 billion for non-defense programs. Finally, the report also contains OMB's Preview Estimate of the Disaster Relief Funding Adjustment for FY 2018.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement for Service Contracts Reporting Requirements. A notice published in the Federal Register at 82 FR 24349 on May 26, 2017. No comments were received.

The National Endowment for the Humanities will hold nine meetings of the Humanities Panel, a Federal advisory committee, during September, 2017. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ``private-label distributors'' of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing support for the 3.1 version of Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of support for the 3.0 version of SEND IG, and an update to the FDA Data Standards Catalog (Catalog). (See https://www.fda.gov/forindustry/ datastandards/studydatastandards/default.htm.) SEND IG 3.1 has been available from CDISC (www.cdisc.org) since July 2016. FDA is encouraging sponsors and applicants to use SEND IG 3.1 in investigational study data provided in regulatory submissions to CDER.

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 comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.

Notice is hereby given of a meeting of the National Geospatial Advisory Committee (NGAC). The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee (FGDC) on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure (NSDI), and the implementation of Office of Management and Budget (OMB) Circular A-16.