June 11, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry.'' The guidance document is to assist sponsors and investigators in designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products). The guidance document provides recommendations regarding clinical trials in which the primary objectives are the initial assessments of safety, tolerability, or feasibility of administration of investigational products. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2013.

Goodyear Tire & Rubber Company (Goodyear), has determined that certain Goodyear G316 LHT commercial truck trailer replacement tires do not fully comply with paragraph S6.5(f) of Federal Motor Vehicle Safety Standard (FMVSS) No. 119, New Pneumatic Radial Tires for motor vehicles with a GVWR of more than 4,536 Kilograms (10,000 pounds) and Motorcycles. Goodyear has filed an appropriate report dated April 27, 2015, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports.

General Motors, LLC, (GM) has determined that certain model year (MY) 2015 GMC multipurpose passenger vehicles (MPV) do not fully comply with paragraph S7.8.5 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, Reflective Devices and Associated Equipment. GM has filed an appropriate report dated November 5, 2014, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports.

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.

In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 115 Health Center Program awardees whose budget period ends October 31, 2015, for up to 4 months. The extension allows BPHC to eliminate the November 1 budget period start date by redistributing these grants to established starting dates later in the fiscal year, thereby allowing awardees comparable opportunity to prepare and submit applications while allowing BPHC to remain compliant with internal process timelines.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``IHS Loan Repayment Program (LRP)'' (OMB Control Number 0917-0014), which expires July 31, 2015. This proposed information collection project was recently published in the Federal Register (80 FR 23558) on April 28, 2015, and allowed 60 days for public comment, as required by 44 U.S.C. 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0003). Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension of currently approved information collection, 0917-0014, ``Indian Health Service Loan Repayment Program.'' The LRP application is available in an electronically fillable and fileable format. Form(s): The IHS LRP Information Booklet contains the instructions and the application format. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness in exchange for an initial two-year service commitment to practice full- time at an eligible Indian health program. The LRP is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an eligible Indian health program location and provide health services to American Indian and Alaska Native individuals. The information collected via the on-line application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, the applicant in turn ``picks-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Bureau of Indian Affairs (BIA) owns or has an interest in irrigation projects located on or associated with various Indian reservations throughout the United States. We are required to establish irrigation assessment rates to recover the costs to administer, operate, maintain, and rehabilitate these projects. We request your comments on the proposed rate adjustments.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one entity and one individual whose property and interests in property are being unblocked pursuant to Executive Order (E.O.) 13219 of June 26, 2001, as amended by E.O. 13304 of May 28, 2003.

We, the U.S. Fish and Wildlife Service (Service), proposed in an earlier document to establish annual hunting regulations for certain migratory game birds for the 2015-16 hunting season. This supplement to the proposed rule provides the regulatory schedule, announces the Service Migratory Bird Regulations Committee and Flyway Council meetings, and provides Flyway Council recommendations resulting from their March meetings.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the State Implementation Plan (SIP) for the State of Iowa to amend Best Management Practices (BMPs) for grain vacuuming operations at Group 1 grain elevators. Additional revisions to the SIP include revised definitions, revised requirements for Department forms, and rescinding rule requirements and references for conditional permits.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Butte County Air Quality Management District (BCAQMD), Feather River Air Quality Management District (FRAQMD), and San Luis Obispo County Air Pollution Control District (SLOCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern emission statements, definitions, and vehicle and mobile equipment coating operations (VMECO). We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).

This document contains proposed amendments to the consolidated return regulations. These amendments would revise the rules concerning the use of a consolidated group's losses in a consolidated return year in which stock of a subsidiary is disposed of. The regulations would affect corporations filing consolidated returns.

We are revising an NPRM for SOCATA Model TBM 700 airplaness (type certificate previously held by EADS SOCATA) that was proposed to revise AD 2007-04-13. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracks found on the main landing gear cylinders. This action revises the NPRM by including the actions against those airplanes that reach a certain number of landings after the effective date of the AD. We are proposing this supplemental NPRM (SNPRM) to correct the unsafe condition on these products. Since this action imposes an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on this proposed change.

This is an announcement of a conference call meeting of DOJ's National Motor Vehicle Title Information System (NMVTIS) Federal Advisory Committee to discuss various issues relating to the operation and implementation of NMVTIS.