January 19, 2018 – Federal Register Recent Federal Regulation Documents

This action proposes to modify the San Francisco, CA, Class B airspace area to contain aircraft conducting instrument flight rules (IFR) instrument approach procedures to San Francisco International Airport (SFO), San Francisco, CA. The FAA is taking this action to improve the flow of air traffic, enhance safety, and reduce the potential for midair collision in the SFO Class B airspace area while accommodating the concerns of airspace users. Further, this effort supports the FAA's national airspace redesign goal of optimizing terminal and enroute airspace to reduce aircraft delays and improve system capacity. This notice does not constitute either a final decision of the FAA or a re-opening of the FAA's August 6, 2014, final decision for the Northern California (NorCal) Optimization of Airspace and Procedures in the Metroplex (OAPM) project.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances (Renewal)'' (EPA ICR No. 1432.32, OMB Control No. 2060-0170) 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 August, 2018, combined with two other ICRs for ozone-depleting substances (ODS). 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.

On December 27, 2017, the National Indian Gaming Commission published a rule amending its minimum technical standards for Class II gaming systems and equipment. This document corrects the preamble regarding the OMB Control Number and OMB Control Number expiration date.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division (MVCB) will be submitting to the Office of Management and Budget (OMB) a request for revision and an extension of existing OMB clearances concerning certification of independent price determination and parent company and identifying data.

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 an extension of a previously approved information collection requirement concerning organization and direction of work.

The Department of Commerce (Commerce) is amending the final results of the administrative review of the antidumping duty order on certain circular welded carbon steel pipes and tubes from Taiwan. The period of review (POR) is May 1, 2015, through April 30, 2016. The amended final weighted-average dumping margin is listed below in the section entitled ``Amended Final Results.''

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

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 the availability of a guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms ``commercially available,'' ``essentially a copy of a commercially available drug product,'' and ``regularly or in inordinate amounts.''

As required by the Paperwork Reduction Act (PRA) the Small Business Administration (SBA) announces its intention to request approval from the Office of Management and Budget (OMB) of the reporting requirements described below. Under the PRA federal agencies are required to publish a notice in the Federal Register concerning each collection of information before it is submitted to OMB for review and approval, and to allow 60 days for public comment on the notice. This notice complies with that requirement.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``The Paston Treasure: Microcosm of the Known World,'' 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 Yale Center for British Art, New Haven, Connecticut, from on or about February 15, 2018, until on or about May 27, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Being: New Photography 2018,'' 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 Museum of Modern Art, New York, New York, from on or about March 18, 2018, until on or about August 19, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Like Life: Sculpture, Color, and the Body,'' 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 Metropolitan Museum of Art, New York, New York, from on or about March 20, 2018, until on or about July 22, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

The Committee is proposing to add a product to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Material Threat Medical Countermeasure Priority Review Vouchers.'' There is stakeholder interest in FDA's implementation of the provision of the 21st Century Cures Act (Cures Act) that adds a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure applications. This new section of the FD&C Act makes provisions for awarding priority review vouchers for use with applications to sponsors of material threat medical countermeasure applications that meet the criteria specified by the FD&C Act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of the new section of the FD&C Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' This draft guidance describes the Agency's proposed approach regarding compliance with FDA's performance standards for laser products. FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA's regulations. Accordingly, FDA does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with performance standards in FDA's regulations. This draft guidance is not final nor is it in effect at this time.

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 March 20, 2018) to be assured of consideration.

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 Export-Import Bank of the United States (EXIM), as 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. This collection of information is necessary, to determine eligibility of the export sales for insurance coverage. The Report of Premiums Payable for Financial Institutions Only is used to determine the eligibility of the shipment(s) and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program. EXIM customers will be able to submit this form on paper or electronically. By neutralizing the effect of export credit support offered by foreign governments and by absorbing credit risks that the private sector will not accept, EXIM enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. Under the Working Capital Guarantee Program, EXIM provides repayment guarantees to lenders on secured, short-term working capital loans made to qualified exporters. The guarantee may be approved for a single loan or a revolving line of credit. In the event that a buyer defaults on a transaction insured by EXIM the insured exporter or lender may seek payment by the submission of a claim.

The Export-Import Bank of the United States (EXIM), as 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 Export-Import Bank of the United States, pursuant to the Export-Import Bank Act of 1945, facilitates the finance of the export of U.S. goods and services. The ``Report of Premiums Payable for Exporters Only'' form will be used by exporters to report and pay premiums on insured shipments to various foreign buyers.

The Coast Guard has set the calendar year 2018 minimum random drug testing rate at 25 percent of covered crewmembers.