September 4, 2018 – Federal Register Recent Federal Regulation Documents

The Coast Guard will enforce Special Local Regulations for the Olympia Harbor Days Tug Boat Races, Budd Inlet, WA, from 11 a.m. through 4 p.m. on September 2, 2018. This action is necessary to limit vessel movement within the specified race area immediately prior to, during, and immediately after racing activity in order to ensure the safety of participants, spectators and the maritime public. Entry into, transit through, mooring, or anchoring within the specified race area is prohibited unless authorized by the Captain of the Port Puget Sound or Designated Representatives.

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

The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Physiologically Based Pharmacokinetic AnalysesFormat and Content.'' This guidance outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including, but not limited to, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation or the appropriateness of PBPK analyses for a particular drug or a drug product.

The U.S. Nuclear Regulatory Commission (NRC) is requesting public comments on the scope of the NRC's Environmental Impact Statement (EIS) for the Interim Storage Partners LLC (ISP) proposed consolidated interim storage facility for spent nuclear fuel, to be located on the Waste Control Specialists LLC (WCS) site in Andrews County, Texas. ISP requested on June 8, 2018, that the NRC resume its review, which had been suspended on April 18, 2017, and provided a revised license application. The NRC is reopening the public scoping comment period that had closed on April 28, 2017, to allow more time for members of the public to develop and submit their comments.

The Secretary of Transportation may, on petition of the licensee, amend a deepwater port license issued under the of the Deepwater Port Act of 1974, as amended. For purposes of this notice, the Maritime Administration (MARAD) provides public notice of its decision to approve the request of Neptune LNG LLC (Neptune) for continuation of the suspension of port operations at the Neptune Deepwater Port (Neptune Port) by amending the Neptune Deepwater Port License (License).

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. The information to be collected will be used to apply for admission to the U.S. Merchant Marine Academy. Collection of information is completed digitally through an online candidate portal. Part I of the Candidate Application is used to establish initial eligibility. The Academic Information Request, Candidate Activities Record, School Official Evaluations and Biographical Essay are used by the USMMA admissions staff and its Candidate Evaluation Board to select the best qualified candidates for the Academy. Result from the administration of the Candidate Fitness Assessment are used to determine physical qualification. Candidates may also submit an optional resume and additional recommendation letters with their application. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on June 12, 2018.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. 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 requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. 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 requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.

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 (FACA), that a planning meeting of the New Hampshire Advisory Committee to the Commission will convene at 4:00 p.m. (EDT) on Tuesday, September 11, 2018, in Room P435, University of New Hampshire, 88 Commercial Street, Manchester, NH. The purpose of the meeting is for project planning.

The OCC announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).

The Department of the Treasury, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to comment on an information collection that is due for renewed approval by the Office of Management and Budget. The Office of International Affairs within the Department of the Treasury is soliciting comments concerning recordkeeping requirements associated with Reporting of International Capital and Foreign Currency Transactions and Positions31 CFR part 128.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on June 4, 2018 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on draft protective order templates to be used in hearings associated with closure of inspections, tests, analyses, and acceptance criteria (ITAAC). The templates have the purpose of facilitating quick development of case-specific protective orders to support the accelerated ITAAC hearing schedule. Participants in ITAAC hearings may, but are not required to, use the templates as the basis for proposed protective orders.