September 2015 – Federal Register Recent Federal Regulation Documents

The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App 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 Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Commission is noticing a recent Postal Service filing concerning an amendment to Parcel Return Service Contract 5 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR part 1320 (60 FR 44978, August 29, 1995), this notice announces the National Agricultural Library's intent to request renewal of an approved electronic mailing list subscription form from those whose who work in the field of nutrition.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific & Statistical Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, 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.

On September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the ``Common Rule'') published a notice of proposed rulemaking (``NPR'') amending the Common Rule. Through this proposed rule, the Consumer Product Safety Commission (``CPSC'' or ``Commission'') proposes to adopt the Common Rule NPR and solicits public comment on the proposal.

The FHWA announces a Notice of Funding Availability (NOFA) for a Pilot On-the-Job-Training Supportive Services (OJT/SS) Program through the Ladders of Opportunity Initiative in the amount of $3 million. The FHWA seeks to award discretionary grants to State Departments of Transportation (State DOTs), or to other State agencies or local governments applying through their State DOTs as subrecipients, in award amounts of up to $500,000 each. The FHWA may choose to fund the program for more or less than the announced amount, including applying any future appropriated funds toward the projects proposed in response to this NOFA. This NOFA solicits proposals that promote innovative, nationally and regionally significant, highway construction workforce development programs that invest in America's economic growth and build ladders of opportunity into the middle class for American workers. The term ``highway construction workforce'' should be read broadly to encompass the workforce necessary to carry out activities eligible for funding under FHWA's Surface Transportation Program (STP) at section 133(b) of title 23, United States Code (U.S.C.). Applications should outline areas of upcoming demand in the State's highway construction workforce and ensure that proposed programs would train workers in skills to fill specific workforce shortages.

Pursuant to the provisions of The Federal Advisory Committee Act (Pub. L. 92-463, as amended), notice is hereby given that the following meeting of the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College and its two subcommittees will be held. This meeting will be open to the public.

The Federal Transit Administration (FTA) announces the availability of $22.5 million of Fiscal Year (FY) 2015 funds for the deployment of low or no emission transit buses. Of that amount, a minimum of $3.0 million is available for supporting facilities and related equipment. If additional funding is appropriated for this program in FY 2016, FTA may, at its discretion, also make those funds available under this announcement.

Notice is hereby given, pursuant to CBP regulations, that AmSpec Services, LLC, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 29, 2015.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the United States Department of Agriculture (USDA) Rural Utilities Service (RUS) invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 19, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Silicon Genesis Corp. (``Complainant'' or ``SiGen''). An amended complaint was filed on September 8, 2015. The complaint, as amended, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and/or the sale within the United States after importation of certain silicon-on-insulator wafers by reason of infringement of certain claims of U.S. Patent Nos. 5,985,742 (``the '742 patent''); 6,013,563 (``the '563 patent''); 6,103,599 (``the '599 patent''); 6,162,705 (``the '705 patent''); 6,180,496 (``the '496 patent''); 6,294,814 (``the '814 patent''); 6,790,747 (``the '747 patent''); and 7,811,901 (``the '901 patent''). The amended complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and desist order.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled ``Use of Investigational Tobacco Products.'' The draft guidance, when finalized, will describe FDA's current thinking regarding the definition of ``investigational tobacco product'' and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.

The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) and Approved Resource Management Plan Amendments (ARMPAs) for the Great Basin Region Greater Sage-Grouse (GRSG) sub-regions of Idaho and Southwestern Montana, Nevada and Northeastern California, Oregon, and Utah. The Assistant Secretary for Land and Minerals Management of the U.S. Department of the Interior signed the ROD.