May 2016 – Federal Register Recent Federal Regulation Documents

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/ 654,232 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-US-01]; PCT Patent Application PCT/US2013/043633 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-PCT-02]; Chinese Patent Application 201380039993.7 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN- 03]; Japanese Patent Application 2015-515243 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136- 2012/0-JP-04]; South Korea Patent Application 10-2014-7037046 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-KR-05]; Singapore Patent Application 11201407972R entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-SG-06]; United States Patent Application 14/403,896 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136- 2012/0-US-07]; and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ``The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) the complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.''

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Department of the Treasury, 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, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 2439, Notice to Shareholder of Undistributed Long-Term Capital Gains.

The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning source of income from certain space and ocean activities; source of communications income.

This document contains final regulations eliminating the requirement that each disbursement from a designated Roth account that is directly rolled over to an eligible retirement plan be treated as a separate distribution from any amount paid directly to the employee and therefore separately subject to the rule in section 72(e)(2) of the Internal Revenue Code (the Code) allocating pretax and after-tax amounts to each distribution. As a result of this change, if disbursements are made from a taxpayer's designated Roth account to the taxpayer and also to the taxpayer's Roth IRA or designated Roth account in a direct rollover, then pretax amounts will be allocated first to the direct rollover, rather than being allocated pro rata to each destination. Also, a taxpayer will be able to direct the allocation of pretax and after-tax amounts that are included in disbursements from a designated Roth account that are directly rolled over to multiple destinations, applying the same allocation rules to distributions from designated Roth accounts that apply to distributions from other types of accounts. These regulations affect participants in, beneficiaries of, employers maintaining, and administrators of designated Roth accounts under tax-favored retirement plans.

Notice is hereby given that the U.S. International Trade Commission has determined to suspend the limited exclusion order and cease and desist orders issued in this investigation pending remand proceedings.

This document extends the comment period on planned guidelines for the safe deployment and operation of automated vehicles. The intent of the operational guidance is to encourage innovative and safe deployment of automated vehicle technologies. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public meetings. The comment due date was May 9, 2016. Comments continue to come in and requests have been made to extend the period to provide comments on this important topic. This document grants that request and extends the comment due date for the planned Guidelines to May 31, 2016.

The Environmental Protection Agency (EPA) is proposing to grant a 1-year extension of the attainment date for the Oakridge, Oregon nonattainment area to meet the 2006 24-hour PM2.5 NAAQS from December 31, 2015 to December 31, 2016, on the basis that the State has met the criteria for such an extension under the Clean Air Act (CAA or Act).

The Rural Housing Service (RHS or Agency) is amending the current regulation for the Single Family Housing Guaranteed Loan Program (SFHGLP) on the subject of liquidation value appraisals. In order to reduce overall processing time, reduce cost, and expedite claim submission, lenders will order the liquidation value appraisal used to estimate a loss claim against the SFHGLP instead of the Agency. Currently, if a Real Estate Owned (REO) property remains unsold by the lender at the end of the permissible marketing period, the Agency orders a liquidation value appraisal and applies an acquisition and management resale factor to estimate holding and disposition cost. This amendment requires the servicing lender to order the liquidation value appraisal. The costs associated with obtaining the liquidation value appraisal can then be included in the liquidation costs paid under the guarantee.

The Environmental Protection Agency (EPA) is issuing a final rule to make administrative changes to the Environmental Protection Agency Acquisition Regulation (EPAAR). EPA does not anticipate any adverse comments.

Through this proposed rule, HUD continues its efforts to narrow the digital divide in low-income communities served by HUD by providing, where feasible and with HUD funding, broadband infrastructure to communities in need of such infrastructure. Broadband is the common term used to refer to a very fast connection to the Internet. Such connection is also referred to as high-speed broadband, broadband Internet, or high-speed Internet. In this proposed rule, HUD proposes to require installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental housing that is funded or supported by HUD. Installation of broadband infrastructure at the time of new construction or substantial rehabilitation is generally easier and less costly than when such installation is undertaken as a stand-alone effort. The proposed rule, however, recognizes that installation of broadband infrastructure may not be feasible for all new construction or substantial rehabilitation, and, therefore, the proposed rule allows limited exceptions to the installation requirements. Installing unit-based broadband infrastructure in multifamily rental housing that is newly constructed or substantially rehabilitated with or supported by HUD funding will provide a platform for individuals and families residing in such housing to participate in the digital economy, and increase their access to economic opportunities.

The Environmental Protection Agency (EPA) proposes revisions to the National Pollutant Discharge Elimination System regulations to eliminate regulatory and application form inconsistencies; improve permit documentation, transparency and oversight; clarify existing regulations; and remove outdated provisions. This proposal would make specific targeted changes to the existing regulations and would not reopen the regulations for other specific or comprehensive revision. These proposed regulatory changes cover 15 topics in the following major categories: permit applications; the water quality-based permitting process; permit objection, documentation and process efficiencies; the vessels exclusion; and the Clean Water Act (CWA) section 401 certification process. These revisions would further align NPDES regulations with statutory requirements from the 1987 CWA Amendments and more recent case law requirements. By modernizing the NPDES regulations, the proposed revisions would provide NPDES permit writers with improved tools to write well-documented permits to protect human health and the environment. The revisions would also provide the public with enhanced opportunities for public participation in permitting actions.

On May 10, 2016, we published in the Federal Register (81 FR 28837) a notice inviting applications for new awards for fiscal year (FY) 2016 for the CSP Grants for Replication and Expansion of High-Quality Charter Schools program. This correction notice amends (1) the date of the pre- application webinar from June 16, 2016, to May 24, 2016; and (2) the deadline for transmittal of applications from June 20, 2016, to June 24, 2016. All other requirements and conditions stated in the notice inviting applications, including the deadline for intergovernmental review, remain the same.

Pursuant to section 7058(c) of the Department of State, Foreign Operations, and Related Appropriations Act, 2015 (Div. J, Pub. L. 113-235) and the authority delegated to her by the Secretary of State under Delegation of Authority 245-1, notice is hereby given that, on April 5, 2016, Deputy Secretary of State for Management and Resources Heather Higginbottom has determined that an international outbreak of the Zika virus is sustained, severe, and is spreading internationally, and that it is in the national interest to respond to the related Public Health Emergency of International Concern.

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces two public teleconferences of the Environmental Economics Advisory Committee (EEAC) to review its draft report regarding the EPA's proposed methodology for updating its mortality risk valuation estimates for policy analysis.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 19, 2016, and page numbers 8514-8516, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674- 14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., DC, N.D., O.D., D.V.M., or equivalent degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one or two-year renewal application. Affected Public: Individuals or households; Nonprofits; and Businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 33,242.

This notice announces HUD's intention to competitively sell certain unsubsidized single family mortgage loans, in a sealed bid sale offering called ADPLS, without Federal Housing Administration (FHA) mortgage insurance. This notice also generally describes the bidding process for the sale and certain persons who are ineligible to bid. This is the first ADPLS offering, and the sale will be held on May 18, 2016.