May 14, 2014 – Federal Register Recent Federal Regulation Documents

Section 366 of the National Defense Authorization Act for Fiscal Year 2012 directs the Secretary of Defense to determine a fair and reasonable rate of payment for airlift services provided to the Department of Defense by air carriers who are participants in the Civil Reserve Air Fleet Program. The Department of Defense (the Department or DoD) proposes to promulgate regulations to establish ratemaking procedures for civil reserve air fleet contracts as required by Section 366(a) in order to determine a fair and reasonable rate of payment.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. This draft guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

NMFS proposes regulations to implement Amendment 100 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP) and Amendment 91 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA FMP). This proposed action would add regulations to improve reporting of grenadiers, limit retention of grenadiers, and prevent direct fishing for grenadiers by federally permitted groundfish fishermen and is necessary to limit and monitor the incidental catch of grenadiers in the groundfish fisheries. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMPs, and other applicable law.

Public Law 105-220, the Workforce Investment Act (WIA), requires the Secretary of Labor (Secretary) to conduct reallotment of dislocated worker formula allotted funds based on State financial reports submitted as of the end of the prior program year (PY). This notice publishes the dislocated worker PY 2013 funds for recapture by State and the amount to be reallotted to eligible States.

The Corporation for National and Community Service (CNCS), submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, (PRA 95) (44 U.S.C. Chapter 35). CNCS requested that OMB review and approve this emergency request by June 11, 2014, for a period of six months.

The Federal Energy Regulatory Commission (Commission) invites public comment in Docket No. RD14-5-000 on a proposed collection of information that the Commission is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. Comments are invited on: (a) 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; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

The North Pacific Fishery Management Council (Council) and its advisory committees will hold public meetings, June 2-10, 2014.

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0051, abstracted below that we will submit to OMB for renewal in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of contact information of Rail Security Coordinators (RSCs) and alternate RSCs from freight railroad carriers; shippers and receivers of certain hazardous materials; passenger railroad carriers, including each carrier operating light rail or heavy rail transit service on track that is part of the general railroad system of transportation and rail transit systems. Also, these persons are required to report significant security concerns, including security incidents, suspicious activity, and any threat information. In addition, freight railroad carriers and the affected shippers and receivers of hazardous materials are required to document the transfer of custody of certain hazardous materials.

EPA issued a proposed rule in the Federal Register issue of March 19, 2014, concerning protections from pesticides for agricultural workers. This document extends the comment period for 60 days, from June 17, 2014, to August 18, 2014. The comment period is being extended to provide additional time for commenters to prepare their responses.