September 14, 2017 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a)(2) of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by the space available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is October 11, 2017. Written comments must include full name, address, organizational affiliation, email address of the speaker, topic being addressed and specific comments. Written comments must not exceed one single-spaced typed page with 1- inch margins containing all items above. Only those written comments received 10 business days in advance of the meeting will be included in the official record of the meeting. Public comments made in attendance must be no longer than 3 minutes and the person giving comments must attend the public comment session at the start time listed on the agenda. Time for public comments may start before the time indicated on the agenda. The meeting will be webcast live via the World Wide Web; for instructions and more information on ACIP please visit the ACIP Web site: https://www.cdc.gov/vaccines/acip/.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2017, through September 30, 2018.

The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.

The United States Patent and Trademark Office (USPTO) will host a roundtable discussion at its headquarters in Alexandria, Virginia, on October 18, 2017, on addressing intellectual property infringements at trade shows.

NMFS has received an application from Barney M. Davis L.P. for an incidental take permit, pursuant to the Endangered Species Act (ESA) of 1973, as amended, for Barney M. Davis Power Station in Corpus Christi, TX. The facility monitors the intake canal in an effort to intercept sea turtles prior to their contact with the facility's cooling water intake structure. The facility is requesting the permit be issued for a duration of 10 years. Although the facility has been in operation since 1974, the presence of sea turtles in the intake canal has only occurred during the past 10 years, and is associated with cold-stunning events. Under the proposed action, when a sea turtle is located in the intake canal of the facility, the sea turtle will be collected by Texas Parks and Wildlife Department and held at their nearby facility until the United States Fish and Wildlife Service collects the sea turtles for tagging and rehabilitation at the Animal Rehabilitation Keep prior to release back into the Gulf of Mexico. Although every effort will be made to intercept sea turtles prior to the cooling water intake structure, it is possible that a stunned sea turtle may become impinged on the automatic rake prior to entering the structure. Although unlikely, due to the physical characteristics and operations of the structure, any impingement of turtles would be lethal. NMFS is furnishing this notice in order to allow other agencies and the public an opportunity to review and comment on this document. All comments received will become part of the public record and will be available for review.

NMFS announces seven inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 10) finding the sole remaining respondent in default. The Commission requests written submissions, under the schedule set forth below, on remedy, public interest, and bonding.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted to the EPA by the State of Montana. On September 19, 2016, the Governor of Montana's designee submitted a Clean Air Act (CAA) section 175A(b) second 10-year limited maintenance plan for the Missoula area for the carbon monoxide (CO) National Ambient Air Quality Standard (NAAQS). This limited maintenance plan addresses maintenance of the CO NAAQS for a second 10-year period beyond the original redesignation. This action is being taken under sections 110 and 175A of the CAA.

The Environmental Protection Agency (EPA) is taking final action to approve revisions to the South Coast Air Quality Management District (SCAQMD or ``District'') portion of the California State Implementation Plan (SIP). These revisions concern emissions of oxides of nitrogen (NOX) and oxides of sulfur (SOX) from facilities that emit four or more tons per year of NOX or SOX, which are regulated by SCAQMD's Regional Clean Air Incentives Market (RECLAIM) program. We are approving revisions to local rules in the SIP that regulate these emission sources under the Clean Air Act (CAA or the Act).

The Environmental Protection Agency (EPA) is proposing action on a revision to the Bay Area Air Quality Management District (BAAQMD or District) portion of the California State Implementation Plan (SIP). We are proposing a conditional approval of one rule. This revision consists of updates to provisions governing the issuance and banking of Emission Reduction Credits for use in the review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA). We are taking comments on this proposal and plan to follow with a final action.

We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 900EX airplanes. This AD was prompted by a determination that new or more restrictive maintenance requirements and/or airworthiness limitations are necessary. This AD requires revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and/or airworthiness limitations. We are issuing this AD to address the unsafe condition on these products.

The Council on Environmental Quality (CEQ) is publishing its initial list of actions pursuant to Executive Order 13807 of August 15, 2017, titled ``Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects,'' and published on August 24, 2017.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

We are superseding Airworthiness Directive (AD) 2004-23-20, which applied to certain Airbus Model A300, A300 B4-600, and A300 B4- 600R series airplanes; and Model A300 F4-605R and A300 C4-605R Variant F airplanes. AD 2004-23-20 required, for certain airplanes, repetitive inspections for cracking around certain attachment holes, installation of new fasteners for certain airplanes, and follow-on corrective actions if necessary. AD 2004-23-20 also required modifying certain fuselage frames, which terminated certain repetitive inspections. This new AD reduces certain compliance times, expands the applicability, and requires an additional repair on certain modified airplanes. This AD was prompted by a report indicating that the material used to manufacture the upper frame feet was changed and negatively affected the fatigue life of the frame feet. We are issuing this AD to address the unsafe condition on these products.

The U.S. Department of the Interior is announcing its intent to establish the Bureau of Indian Education (BIE) Standards, Assessments, and Accountability System Negotiated Rulemaking Committee (Committee) to advise the Secretary of the Interior (Secretary) through the BIE on a proposed rule to revise the Adequate Yearly Progress regulation and invite Tribes whose students attend BIE-funded schools operated by either the BIE or by the Tribe through a contract or grant who would be affected by the final rule to nominate a representative for membership on the Committee. The BIE also invites nominations for Committee members who will adequately represent the interests that are likely to be significantly affected by the proposed rule such as: Students enrolled, or parents of students enrolled at the 174 BIE- funded schools, school teachers and administrators, Tribes, and Indian communities served by these schools. The BIE also solicits comments on the proposal to establish the Committee.

We are adopting a new airworthiness directive (AD) for all Airbus Model A300 B4-600R and Model A300 F4-600R series airplanes; Model A300 B4-603, B4-622, and C4-605R Variant F airplanes; and Model A310-203, -221, -222, -304, -322, -324, and -325 airplanes. This AD was prompted by an evaluation by the design approval holder indicating that a section of the fuselage structure above the forward cargo door is subject to widespread fatigue damage (WFD). This AD requires an inspection for cracks of the fastener and tooling holes at certain locations and a check of the diameter of the holes, and repair or modification of the affected fuselage structure if necessary. We are issuing this AD to address the unsafe condition on these products.