March 9, 2015 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is requesting public input on the agency's periodic retrospective review of its regulations. Executive Order 13563, ``Improving Regulation and Regulatory Review,'' and Executive Order 13610, ``Identifying and Reducing Regulatory Burdens,'' call on all federal agencies to conduct a retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome and to modify, streamline, expand, or repeal them in accordance with what has been learned. The EPA is particularly seeking public input on how the agency can promote regulatory modernization through business-process streamlining, facilitated by improved technology.

In this issue of the Federal Register, the Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical InvestigationsQuestions and Answers.'' The draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts. Although the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, OHRP is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed. OHRP asks for public comment about whether a joint guidance document would be useful for the regulated community. In particular, OHRP is interested in public comment regarding whether FDA's draft guidance would be appropriate for all research regulated under 45 CFR part 46, including research studies other than clinical investigations or clinical trials, such as social and behavioral research studies. If different guidance should apply to social and behavioral research, or other non-FDA-regulated studies, OHRP asks that the public comments address how the guidance should differ from the proposed guidance for FDA-regulated clinical investigations. OHRP specifically welcomes feedback regarding when it might or might not be appropriate, for studies other than clinical trials, for OHRP to recommend that researchers verify that the person signing the informed consent form is the subject participating in the research. OHRP and FDA will consider these comments in deciding whether to issue a joint OHRP/FDA guidance document on this topic when the final guidance document is developed.

NIST invites applications from eligible organizations in connection with NIST's funding up to twelve (12) separate MEP cooperative agreements for the operation of an MEP Center in the designated States' service areas and in the funding amounts identified in the corresponding Federal Funding Opportunity (FFO). NIST anticipates awarding one (1) cooperative agreement for each of the identified States. The objective of the MEP Center Program is to provide manufacturing extension services to primarily small and medium- sized manufacturers within the whole State designated in the applications. The selected organization will become part of the MEP national system of extension service providers, currently comprised of more than 400 Centers and field offices located throughout the United States and Puerto Rico.

The Department of Commerce (``the Department'') is conducting an administrative review of the antidumping duty order on utility scale wind towers (``wind towers''), from the Socialist Republic of Vietnam (``Vietnam''). The period of review (``POR'') is February 13, 2013, through January 31, 2014. The review covers one mandatory respondent, CS Wind Vietnam and CS Wind Corporation (``collectively, CS Wind Group''). We preliminarily find that the respondent has not made sales below (``NV'') during the POR. Interested parties are invited to comment on these preliminary results.

The Secretary proposes to waive the requirements in the Education Department General Administrative Regulations that generally prohibit project periods exceeding five years and project period extensions involving the obligation of additional Federal funds. We take this action because this proposed waiver and extension of the project period would enable nine currently funded Community Parent Resource Centers (CPRCs) to receive funding from October 1, 2015, through September 30, 2016.

HUD is proposing to revise information published in the Federal Register about one of its system of records, the Single Family Housing Enterprise Data Warehouse (SFHEDW). The revision implemented under this republication, reflects current corrective and administrative changes to the system of records purpose, location, authority, and records retention captions. This update refines previously published details in a clear and cohesive format. This republication does not meet the threshold criteria established by the Office of Management and Budget (OMB) for a modified system of records report. A more detailed description of the present systems status is republished under this notice. This notice deletes and supersedes prior notice published in the Federal Register at 76 FR 66950 on October 28, 2011. The scope and functional purpose in place for this system remain unchanged.

This notice announces an opportunity to request funding from the Office of Economic Adjustment (OEA), a Department of Defense (DoD) field activity, for community planning assistance and economic diversification in response to major reductions or cancellations in DoD spending, including the cancellation or termination of DoD contracts or failure to proceed with a major weapon system program. Assistance may be granted if the DoD action has a direct and significant adverse effect on a community or its residents. This notice includes proposal submission requirements and instructions, eligibility, and selection criteria that will be used to evaluate proposals from eligible respondents. OEA grants to a state or local government may result from any proposal submitted under this notice, subject to the availability of appropriations.

The FHWA and the Port Authority of New York and New Jersey (PANYNJ) are extending the public comment period for the Cross Harbor Freight Program Tier 1 Draft Environmental Impact Statement (DEIS) until Friday, March 20, 2015.

FMCSA confirms its decision to exempt 69 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals to operate CMVs in interstate commerce.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the West Virginia State Implementation Plan (SIP). The SIP revision addresses the State Boards requirements for all criteria pollutants of the National Ambient Air Quality Standards (NAAQS). EPA is also approving a related infrastructure element from the West Virginia February 21, 2012 SIP submittal for the 2008 ozone (O3) NAAQS, the December 13, 2012 SIP submittal for the 2010 nitrogen dioxide (NO2) NAAQS, and the July 1, 2013 SIP submittal for the 2010 sulfur dioxide (SO2) NAAQS. EPA is approving this SIP revision in accordance with the requirements of the Clean Air Act (CAA).

This action proposes to remove Class E Airspace at Lexington, TN, as the Franklin Wilkins Airport has been abandoned, and controlled airspace is no longer required. This action would enhance the safety and airspace management around the Lexington, TN, area.

This action amends Class E Airspace at Manchester, NH, as a new approach procedure has been developed, requiring airspace redesign at Manchester Airport. This enhances the safety and management of instrument flight rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.

This action establishes Class E Airspace at Plainville, CT, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Robertson Field Airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations within the National Airspace System.

We are revising an earlier proposed Airworthiness Directive (AD) for certain Airbus Model A330 series airplanes. The NPRM proposed to require revising the maintenance program or inspection program, as applicable, to incorporate certain maintenance requirements and airworthiness limitations. The NPRM was prompted by a determination that more restrictive maintenance requirements and airworthiness limitations are necessary. This action revises the NPRM by proposing to supersede AD 2007-05-12, AD 2009-18-20, and AD 2010-15-02 in addition to those ADs already identified in the NPRM, as well as to require more restrictive limitations and to add Airbus Model A330-323 airplanes to the applicability. We are proposing this supplemental NPRM (SNPRM) to address the aging effects of aircraft systems. Such aging effects could change the characteristics of those systems, which, in isolation or in combination with one or more other specific failures or events, could result in failure of certain life limited parts, which could reduce the structural integrity of the airplane or reduce the controllability of the airplane. Since these actions impose an additional burden over those proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.

This final rule implements the Pima Agriculture Cotton Trust Fund (Agriculture Pima Trust) and the Agriculture Wool Apparel Manufacturers Trust Fund (Agriculture Wool Trust) Fund established in the Agricultural Act of 2014 (Farm Bill). The Agriculture Pima Trust provides annually for one payment, called the Pima Cotton Payments. The Agriculture Wool Trust provides annually for four payments. The first payment under the Agriculture Wool Trust is currently administered by the Department of Commerce's Office of Textiles and Apparel (OTEXA), and is called the Grants to Manufacturers of Certain Worsted Wool Fabrics. This program is being transferred from OTEXA to the Secretary of Agriculture (Secretary), who will administer the payment for the 2015-2019 calendar years, and will be called Payments to Manufacturers of Certain Worsted Wool Fabrics. The second payment is called Monetization of the Wool TRQ. The Farm Bill requires the Secretary to determine a monetary amount equivalent to what a person would have saved if OTEXA's Wool Tariff Rate Quota program (Wool TRQ) were still in effect. This payment will be based on OTEXA's Wool Tariff Rate Quota program, which terminated at the end of calendar year 2014. The Monetization of the Wool TRQ will be administered by the Secretary for the 2015-2019 calendar years. The third payment is called the Wool Yarn, Wool Fiber, and Wool Top Duty Compensation Payment. Payments are made to processors of wool yarn, wool fiber, and wool top to compensate them for termination of the suspension of import duties on such wool. This payment will be administered by the Secretary for the 2015-2019 calendar years. The fourth payment is called the Refund of Duties Paid on Imports of Certain Wool Products. This program is currently administered by the Department of Homeland Security's Customs and Border Protection (CBP) through calendar year 2015. The program will be transferred in calendar year 2016 to the Secretary, who will administer the program for the 2016-2019 calendar years. Regulations for the fourth payment will be published at a later date.