June 2018 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), to EPA on May 12, 2017, for attaining the 2010 1- hour sulfur dioxide (SO2) primary national ambient air quality standard (NAAQS) for the Sullivan County SO2 nonattainment area (hereafter referred to as the ``Sullivan County Area'' or ``Area''). The Sullivan County Area is comprised of a portion of Sullivan County in Tennessee surrounding the Eastman Chemical Company (hereafter referred to as ``Eastman''). This plan (herein called a ``nonattainment plan or SIP'' or ``attainment plan or SIP'') includes Tennessee's attainment demonstration and other elements required under the Clean Air Act (CAA or Act). In addition to an attainment demonstration, the plan addresses the requirement for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures and reasonably available control technology (RACM/RACT), base-year and projection-year emissions inventories, enforceable emissions limitations and control measures, and contingency measures. EPA proposes to conclude that Tennessee has appropriately demonstrated that the plan's provisions provide for attainment of the 2010 1-hour primary SO2 NAAQS in the Sullivan County Area and that the plan meets the other applicable requirements under the CAA.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Notice of Termination, Suspension, Reduction or Increase in Benefit Payments (CM-908). A copy of the information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is removing from the Code of Federal Regulations the Sudanese Sanctions Regulations as a result of the revocation of certain provisions of one Executive Order and the entirety of another Executive Order on which the regulations were based. OFAC is also amending the Terrorism List Government Sanctions Regulations to incorporate a general license authorizing certain transactions related to exports of agricultural commodities, medicines, and medical devices, which has, until now, appeared only on OFAC's website.

Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on January 1, 2018 and ending on March 31, 2018.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the Community Disaster Loan (CDL) Program. This collection allows the government to make loans to communities that have suffered economic problems due to disasters.

In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness 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.

In this document, the Federal Communications Commission (the Commission or FCC) addresses the current funding shortfall in the Rural Health Care (RHC) Program, including by raising the annual Program funding cap and applying it to the current funding year to fully fund eligible funding requests for funding year (FY) 2017, adjusting the funding cap to reflect inflation, and establishing a process to carry-forward unused funds from past funding years for use in future funding years.

NMFS issues regulations to modify specific provisions of the North Pacific Observer Program. The first two elements of this final rule implement requirements for an observer to obtain a nontrawl lead level 2 (LL2) deployment endorsement and implement a pre-cruise meeting requirement for vessels required to carry an observer with a nontrawl LL2 deployment endorsement. These two elements are intended to increase the number of observers that qualify for a nontrawl LL2 deployment endorsement and maintain observer safety and data quality. The third element of this final rule removes duplicative and unnecessary reporting requirements and makes minor changes to reduce observer requirements for specific vessels when participating in the Western Alaska Community Development Quota (CDQ) Program. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan for Groundfish of the Gulf of Alaska, and the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area, and other applicable law.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify the entity to which contractors submit Summary Subcontract Reports in the Electronic Subcontracting Reporting System (eSRS) and to clarify the entity that acknowledges receipt of, or rejects, the reports in eSRS.

Pursuant to the Clean Air Act (CAA or Act), the Environmental Protection Agency (EPA) is proposing to approve portions of the Arkansas State Implementation Plan (SIP) submittal addressing the CAA requirement that SIPs address the potential for interstate transport of air pollution to significantly contribute to nonattainment or interfere with maintenance of the 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS) in other states. EPA is proposing to determine that emissions from Arkansas sources do not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2012 PM2.5 NAAQS. The EPA is also proposing to approve a revision to update incorporation by reference of NAAQS germane to this proposed action.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify policies and procedures for submission of payment requests and receiving reports in electronic form.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection supporting the Agency's Biosimilars User Fee Program.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in nonclinical studies and product labeling, and reduce the conduct of nonclinical studies that are not informative for product use.

The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2018. The notice announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, effective April 13, 2018. In particular, the notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, and 2 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 076045 is still in effect.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) is proposing to renew an information collection.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove a clause that is duplicative of an existing Federal Acquisition Regulation (FAR) clause rendering the DFARS clause unnecessary.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to provide a more transparent means of documenting the impact of costs incurred during the undefinitized period of an undefinitized contract action on allowable profit.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices, pursuant to action taken by the Regulatory Reform Task Force.