August 17, 2015 – Federal Register Recent Federal Regulation Documents

VA is announcing the availability of funds for supportive services grants under the SSVF Program. This NOFA contains information concerning the SSVF Program, initial supportive services grant application processes, and the amount of funding available. Funding Opportunity Title: SSVF Program. Announcement Type: Initial. Funding Opportunity Number: VA-SSVF-021015. Catalog of Federal Domestic Assistance Number: 64.033, VA SSVF Program. VA is announcing the availability of funds for supportive services grants under the SSVF Program. This NOFA contains information concerning the SSVF Program, initial supportive services grant application processes, and the amount of funding available. Awards made for supportive services grants will fund operations beginning October 1, 2015.

This document contains corrections to the preamble to the proposed rule published on August 6, 2015, that would establish a framework for authorizing the take of marine mammals incidental to the NEFSC's fisheries research activities in the Atlantic coast region for a five-year period, 2015-2020. This action is necessary to correct typographical errors in the annual estimates presented for Level B harassment of northern bottlenose whales (Hyperoodon ampullatus) from 10 to 12. This change accounts for the annual estimate of level B harassment for this species in both inshore (10 individuals) and offshore waters (2 individuals) in the Atlantic coast region. The Federal Register proposed rule published on July 9, 2015, indicated that written comments were due by August 10, 2015, which allowed 30 calendar days for public input. On August 6, 2015, NMFS published a correction and extended the public comment period to August 17, 2015. NMFS has decided to extend the public comment period by an additional 30 calendar days for public input.

This action expands the lateral boundary of restricted area R- 3804B, Fort Polk, LA, and raises the restricted area ceiling to, but not including 10,000 feet mean sea level (MSL). The expanded restricted area airspace will contain new live fire ranges to support mission requirements of the U.S. Army in order to fully exploit the capabilities of modern weapons systems and complex training scenarios that replicate conditions encountered during military deployments today. This action also amends time of designation for R-3804A and R- 3804B to better reflect when the restricted areas are in use by the U.S. Army and when the airspace is available to nonparticipants. Lastly, this action makes administrative editorial corrections to the R-3804A, R-3804B, and R-3804C legal descriptions.

The FAA is issuing this notice to advise the public of the first meeting of the RTCA Special Committee 235.

Consistent with the regulations implementing the National Environmental Policy Act (NEPA), as amended (42 U.S.C. 4321 et seq.), BOEM is announcing its intent to prepare a Supplemental Environmental Impact Statement (EIS) for proposed Gulf of Mexico Outer Continental Shelf (OCS) Central Planning Area (CPA) Oil and Gas Lease Sale 247 (CPA 247 Supplemental EIS). The CPA 247 Supplemental EIS will expand or update the environmental and socioeconomic analyses in: Gulf of Mexico OCS Oil and Gas Lease Sales: 2012-2017; Western Planning Area Lease Sales 229, 233, 238, 246, and 248; Central Planning Area Lease Sales 227, 231, 235, 241, and 247, Final Environmental Impact Statement (2012-2017 WPA/CPA Multisale EIS); Gulf of Mexico OCS Oil and Gas Lease Sales: 2013-2014; Western Planning Area Lease Sale 233; Central Planning Area Lease Sale 231, Final Supplemental Environmental Impact Statement (WPA 233/CPA 231 Supplemental EIS); Gulf of Mexico OCS Oil and Gas Lease Sales: 2015-2017; Central Planning Area Lease Sales 235, 241, and 247, Final Supplemental EIS (CPA 235/241/247 Supplemental EIS); and Central Planning Area Lease Sales 241 and 247 and Eastern Planning Area Lease Sale 226, Final Supplemental EIS (CPA 241/247 and EPA 226 Supplemental EIS). The CPA 247 Supplemental EIS will supplement the NEPA documents cited above in order to consider new circumstances and information arising from, among other things, the Deepwater Horizon explosion, oil spill, and response. It will focus on updating the baseline conditions and any new information on the potential environmental effects of oil and natural gas leasing, exploration, development, and production in the CPA identified through the Area Identification procedure as the proposed lease sale area. In addition to the no action alternative (i.e., canceling a proposed lease sale), other alternatives may be considered for the proposed CPA lease sales, such as deferring certain areas from the proposed lease sale area.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E. O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Painting the Modern Garden: Monet to Matisse,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Cleveland Museum of Art, Cleveland, Ohio, from on or about October 6, 2015, until on or about January 5, 2016, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

This regulation establishes an exemption from the requirement of a tolerance for residues of the arthropod pheromone, lavandulyl senecioate, in or on all raw agricultural commodities when applied or used in microbeads/dispensers at a rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices. Suterra, LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of lavandulyl senecioate.

Since 1988, the Environmental Protection Agency (EPA) has maintained a Federal Agency Hazardous Waste Compliance Docket (``Docket'') under Section 120(c) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Section 120(c) requires EPA to establish a Docket that contains certain information reported to EPA by Federal facilities that manage hazardous waste or from which a reportable quantity of hazardous substances has been released. As explained further below, the Docket is used to identify Federal facilities that should be evaluated to determine if they pose a threat to public health or welfare and the environment and to provide a mechanism to make this information available to the public. This notice identifies the Federal facilities not previously listed on the Docket and reported to EPA since the last update of the Docket on December 31, 2014. In addition to the list of additions to the Docket, this notice includes a section with revisions of the previous Docket list. Thus, the revisions in this update include 21 additions and 90 deletions to the Docket since the previous update. At the time of publication of this notice, the new total number of Federal facilities listed on the Docket is 2,323.

The Bureau of Indian Education (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Washington, DC. The purpose of the meeting is to meet the mandates of the Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. 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 60 days for public comment preceding submission of the collection to OMB.

The U.S. Office of Personnel Management (OPM) is issuing a proposed rule to delay the effective date that appeared in the final rule published in the Federal Register on April 17, 2014 titled ``Solicitation of Federal Civilian and Uniformed Service Personnel for Contributions to Private Voluntary Organizations'' to January 1, 2017. OPM is requesting comments on the proposed rule.

On June 29, 2015, President Obama signed into law the Trade Adjustment Assistance Reauthorization Act of 2015 (TAARA 2015), title IV of the Trade Preferences Extension Act of 2015, Public Law 114-27. In accordance with Section 405(a) of TAARA 2015, which amended the Trade Act of 1974, Public Law 93-618 (``the Trade Act''), the Director of the Office of Trade Adjustment Assistance, Employment and Training Administration (OTAA) has taken the following action for petitions that were filed with the Secretary of Labor under section 221(a) of the Trade Act on or after January 1, 2014, and before June 29, 2015, and are identified in the Appendices to this notice. OTAA has reopened investigations of petitions identified in Appendix A to reconsider all negative determinations on petitions filed on or after January 1, 2014, and before June 29, 2015, and will further investigate those petitions to determine whether the workers are eligible to apply for adjustment assistance under the provisions of section 222 of the Trade Act in effect on June 29, 2015, which were in effect before January 1, 2014. If eligible under these requirements, OTAA will certify the group of workers as eligible to apply for adjustment assistance under title II of the Trade Act, as amended by TAARA 2015. OTAA also is continuing to investigate those petitions identified in Appendix B for which no determination was issued before June 29, 2015, to determine whether the workers are eligible to apply for adjustment assistance under the provisions of section 222 of the Trade Act in effect on June 29, 2015, which were in effect before January 1, 2014. If eligible under these requirements, OTAA will certify the group of workers as eligible to apply for adjustment assistance under title II of the Trade Act. Further, worker groups that did not submit petitions between January 1, 2014 and June 29, 2015, but wish to be considered under the group eligibility for workers based on the 2015 Program may file a new petition within 90 days of enactment of the new 2015 law which was signed by President Barak Obama on June 29, 2015. This would include service sector workers as well as worker groups whose jobs are adversely affected by trade from countries that are not parties to Free Trade Agreements (FTAs) with the United States, including China and India. While all petitions filed on and after June 29, 2015, will be investigated under the 2015 Program worker group eligibility criteria, the TAARA 2015 provides that for petitions filed by MIDNIGHT (12:00 AM EASTERN TIME), SUNDAY, SEPTEMBER 27, 2015, that are certified, the certification will cover all members of the worker group who are separated or threatened with separations during the period beginning January 1, 2014, instead of a beginning date of no more than one year before the date of the petition, and generally ending two years after the date of certification. Each of those certifications will describe the worker group and specify the January 1, 2014, beginning date and the ending dates of the certification period.

The Commission is noticing a recent Postal Service filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to analytical principles relating to periodic reports (Proposal Seven). This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This draft guidance revises the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualification of BiomarkerTotal Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This draft guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This draft guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications, new drug applications, and biologics license applications without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. In the Federal Register of January 7, 2014, FDA announced the availability of a final guidance for industry entitled ``Qualification Process for Drug Development Tools'' that described the process that would be used to qualify Drug Development Tools (DDTs) and to make new DDT qualification recommendations available on FDA's Web site. The qualification recommendations in this draft guidance were developed using the process described in that guidance.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

This document corrects the ADDRESSES section to the Notice of public meeting and webinar/conference call that was published on August 5, 2015, which did not contain all of the necessary information for those interested in participating in the webinar/conference call portion of the Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in September 2015. This correction changes the webinar event addresses, conference call-in number, and participant codes.