June 13, 2018 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.

The Coast Guard is establishing a temporary safety zone for navigable waters of the Lewis River near Ridgefield, WA. This action is necessary to provide for the safety of life on these navigable waters during a fireworks display on June 30, 2018. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port Columbia River or a designated representative.

The Commission has before it a petition for rulemaking filed by Ocean State Television, LLC (Petitioner or OST), licensee of television station WPXQ-TV, channel 17, Block Island, Rhode Island (WPXQ). WPXQ operates on channel 17 on a shared basis with commercial television station WLWC, New Bedford, Massachusetts, also licensed to OST. OST requests an amendment of the DTV Table of Allotments to delete channel 17 at Block Island, Rhode Island, and substitute channel 17 at Newport, Rhode Island. Petitioner also requests modification of WPXQ's license to specify Newport as its community of license pursuant to agency rules. The Petitioner asserts that substantial public interests weigh heavily in favor of reallocating WPXQ to Newport. Newport has a population of 24,027 while Block Island's population consists of approximately 1,000. Petitioner asserts that the proposed reallotment will cause no public harm because Block Island will not only continue to be served by five full-power commercial and one full-power non- commercial television stations, but will also continue to receive the exact same over-the-air service from Petitioner that they are receiving currently. The proposal would result in a preferential allotment by providing Newport with its first local full-power television services in satisfaction of the Commission's second allotment priority, which is also consistent with Commission precedent and consistent with the public interest.

The National Endowment for the Humanities will hold six meetings of the Humanities Panel, a federal advisory committee, during July 2018. 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.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Convertible Sofas and Components Thereof, DN 3321; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

The Coast Guard will enforce the safety zone for the Wendell Family Fourth of July Fireworks Display on July 4, 2018, to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Rockport, TX. During the enforcement periods, entry into these zones is prohibited unless authorized by the Captain of the Port Sector Corpus Christi (COTP) or a designated representative.

On April 5, 2018, FEMA published in the Federal Register a changes in flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 83 FR 14646-14650. The table provided here represents the changes in flood hazard determinations and communities affected for City of Appleton, Outagamie County, Wisconsin.

This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-4361-DR), dated April 26, 2018, and related determinations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance (Guidance 1) is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.

As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA or Agency) is proposing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar EntitiesQuestions and Answers.'' This guidance provides answers to common questions regarding the communication of health care economic information (d) about approved prescription drugs and approved or cleared medical devices by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also provides answers to common questions about both firms' dissemination of information to payors about medical products that are not yet approved or cleared for any use and firms' dissemination of information to payors about unapproved uses of approved or cleared medical products. The Agency is issuing this guidance to explain FDA's current thinking on frequently asked questions regarding these topics in order to provide clarity for firms and payors. FDA is also 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 National Park Service is soliciting comments on the significance of properties nominated before May 19, 2018, for listing or related actions in the National Register of Historic Places.

In this document, the Federal Communications Commission (Commission) seeks comment on how best to structure the second stage of the Uniendo a Puerto Rico and Connect USVI Funds to speed longer-term efforts to rebuild fixed and mobile voice and broadband networks in the territories and harden them against future natural disasters. The Commission intends to target high-cost support over the next several years in a tailored and cost-effective manner, using competitive processes where appropriate.