October 16, 2017 – Federal Register Recent Federal Regulation Documents

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Veiled Meanings: Fashioning Jewish Dress from the Collection of The Israel Museum, Jerusalem,'' 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 Jewish Museum, New York, New York, from on or about November 3, 2017, until on or about March 18, 2018, at The Contemporary Jewish Museum, San Francisco, California, from on or about August 30, 2018, until on or about January 6, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

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 information collection requirements for humanitarian use devices (HUDs).

On September 12, 2017, NTE Carolinas II, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) to Sec. 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations. The FUA and regulations thereunder require DOE to publish a notice of filing of self- certification in the Federal Register.

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.

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

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

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) is proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) is proposing to renew an information collection.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010, the National Science Foundation is publishing this notice to advise the public of the availability of NSF's FY 2016 service contract inventory data. This inventory provides information on service contract actions over $25,000 that were made in FY 2016. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010, and December 19, 2011, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). The FY 2016 government-wide service contract inventory is available at https:// www.acquisition.gov/service-contract-inventory/. NSF's FY 2016 service contract inventory data is included in the government-wide inventory posted on https://www.acquisition.gov and the government-wide inventory can be filtered to display the inventory data for NSF. The National Science Foundation has posted its FY 2015 NSF Inventory Analysis including FY 2016 Analysis Plan on the National Science Foundation homepage at the following link: https://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf1713 3.

The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. The collection provides EXIM staff with the information necessary to monitor the borrower's payments for exported goods covered under its short and medium-term export credit insurance policies. It also alerts EXIM staff of defaults, so they can manage the portfolio in an informed manner.

The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated and permits issued under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of a requested permit modification and permit issued.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Black Bayou Pontoon Bridge on State Road 384 across the Gulf Intracoastal Waterway (GIWW) at mile marker (MM) 237.5, West of Harvey Locks (WHL) at Grand Lake, Calcasieu Parish, Louisiana. The deviation is necessary to make extensive repairs to the bridge.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).

The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2017.

This notice announces an open meeting of the Community Development Advisory Board (the Advisory Board), which provides advice to the Director of the Community Development Financial Institutions Fund (CDFI Fund). The meeting will be open to the public via live webcast. The link to the live webcast can be found in the meeting announcement found at the top of www.cdfifund.gov/cdab.

NMFS announces that the State of North Carolina is transferring a portion of its 2017 commercial summer flounder quota to the State of New York. This quota adjustment is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial quotas for North Carolina and New York.