June 29, 2016 – Federal Register Recent Federal Regulation Documents

The United States Patent and Trademark Office (USPTO or Office) is implementing a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy (``Cancer Immunotherapy Pilot Program'' or ``Pilot Program'') in support of the White House national $1 billion initiative to achieve ten years' worth of cancer research in the next five years (``National Cancer Moonshot''). The USPTO will advance applications containing a claim(s) to a method of treating a cancer using immunotherapy out of turn for examination if the applicant files a grantable petition to make special under the Pilot Program. The objective of the Pilot Program is to complete the examination of the application within twelve months of special status being granted. Under the Cancer Immunotherapy Pilot Program, an application will be advanced out of turn for examination without meeting all of the current requirements of the accelerated examination program (e.g., the requirement for an examination support document) or the Prioritized Examination (Track I) program. This notice outlines the conditions, eligibility requirements, and guidelines of the Pilot Program.

HUD is seeking approval from the Office of Management and Budget (OMB) for renewal of the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

The Coast Guard is establishing a safety zone in Lake Superior near Bayfield, WI. This safety zone is intended to restrict vessels from specified waters in Lake Superior during the Bayfield Fourth of July Fireworks Display. This safety zone is necessary to protect spectators from the hazards associated with the fireworks display.

In accordance with section 113(g) of the Clean Air Act, as amended (``CAA'' or the ``Act''), notice is hereby given of a proposed consent decree to address a lawsuit filed by the Sierra Club (``Plaintiff'') in the United States District Court for the Northern District of California: Sierra Club v. Gina McCarthy, No. 3:15-cv- 04328-JD (N.D. Cal.). On September 22, 2015, Plaintiffs filed this matter against Gina McCarthy, in her official capacity as Administrator of the United States Environmental Protection Agency (``EPA''). On February 9, 2016, Plaintiff filed a first amended complaint alleging that, with respect to the 2008 ozone national ambient air quality standards (``NAAQS''), EPA has failed to perform non-discretionary duties (1) to take final action on portions of state implementation plan (``SIP'') submissions from Louisiana, Montana, New Jersey, New York, South Dakota, Wisconsin, and Wyoming intended to address various interstate transport requirements, and (2) to promulgate a federal implementation plan (``FIP'') for certain SIP elements for California and Kentucky. The proposed consent decree would establish a deadline for EPA to take certain specified actions.

The Environmental Protection Agency (EPA) is notifying the public that it has found that the motor vehicle emissions budgets (MVEBs) in the Baton Rouge, Louisiana 2008 8-hour Ozone National Ambient Air Quality Standard (NAAQS) Maintenance Plan State Implementation Plan (SIP) revision, submitted on May 2, 2016 by the Louisiana Department of Environmental Quality (LDEQ) are adequate for transportation conformity purposes. As a result of EPA's finding, the Baton Rouge area must use these budgets for future conformity determinations.

PHMSA is revising the maximum and minimum civil penalties for a knowing violation of the Federal hazardous material transportation law or a regulation, order, special permit, or approval issued under that law. The ``Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015'' (the 2015 Act), which amended the Federal Civil Penalties, Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), requires Agencies to update their civil monetary penalties through interim final rulemaking. The maximum civil penalty for a knowing violation is now $77,114, except for violations that result in death, serious illness, or severe injury to any person or substantial destruction of property, for which the maximum civil penalty is $179,933. In addition, the minimum civil penalty amount for a violation relating to training is now $463.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Kai Althoff: and then leave me to the common swifts,'' 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 September 18, 2016, until on or about January 22, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.

The Shoshone National Forest (SNF) is extending the public scoping period for the SNF Travel Management environmental impact statement (EIS). The SNF previously published a notice of intent to prepare an EIS as well as notice of public scoping in the Federal Register on May 27, 2016 [81 FR 33655]. The previous notice provided for public scoping through June 27, 2016.

In compliance with the Paperwork Reduction Act of 1995, the Defense Logistics Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff.'' This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes FDA's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. This draft guidance is not final nor is it in effect at this time. FDA is also requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization.

This order extends the duration of the withdrawal created by Public Land Order No. 7209 for an additional 20-year period, which would otherwise expire on July 24, 2016. This extension is necessary to continue to protect the fragile, unique, and endangered natural and cultural resources at Cape Johnson, which is located adjacent to the Olympic National Park in Clallam County, Washington.

NMFS is prohibitingbeginning June 27, 2016, and ending August 31, 2016Federal longfin squid vessel permit holders from fishing for, catching, possessing, transferring, or landing more than 2,500 lb (907.2 kg) of longfin squid per trip and landing such squid more than once per calendar day. This prohibition is required by regulation because NMFS projects that 90 percent of the 2016 annual Trimester II seasonal catch limit will have been caught by the effective date. In addition, based on this determination, other restrictions regarding catch of longfin squid by federally permitted Illex squid vessels and buying longfin squid by federally permit dealers go into place. This action is intended to prevent over harvest of longfin squid during Trimester II.

In accordance with regulations implementing the Marine Mammal Protection Act (MMPA), notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to Deepwater Wind Block Island, LLC (DWBI) to take marine mammals, by harassment, incidental to the installation of the Block Island Wind Farm (BIWF) Export and Inter-Array Cables.