May 18, 2016 – Federal Register Recent Federal Regulation Documents

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one individual whose property and interests in property are blocked pursuant to Executive Order 13726 of April 19, 2016, ``Blocking Property and Suspending Entry into the United States of Persons Contributing to the Situation in Libya,'' and whose name has been added to OFAC's list of Specially Designated Nationals and Blocked Persons (SDN List).

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

Petitions for Reconsideration (Petitions) have been filed in the Commission's rulemaking proceeding by: Lawrence M. Miller, on behalf of Public Broadcasting Parties, Sylvia Strobel, on behalf of American Public Media Group, Todd D. Gray, on behalf of NCE Licensees and Joseph B. Porter, on behalf of The State University of New York.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning anti-kickback procedures.

The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing supplemental information on the List of Specially Designated Nationals and Blocked Persons (SDN List) for 57 individuals and 42 entities whose property and interests in property are blocked pursuant to one or more of the following authorities: Executive Order 13224, ``Blocking Property and Prohibiting Transactions with Persons who Commit, Threaten to Commit, or Support Terrorism;'' Executive Order 12947, ``Prohibiting Transactions With Terrorists Who Threaten To Disrupt the Middle East Peace Process;'' and Executive Order 13582, ``Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria.'' The SDN List entry for each of these individuals and entities has been amended to include the language ``Additional Sanctions InformationSubject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations.''

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a reinstatement of a previously approved information collection.

FRA announces the charter renewal of the RSAC, a Federal Advisory Committee that develops railroad safety regulations through a consensus process. This charter renewal will take effect on May 16, 2016, and will expire after 2 years.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 14, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of ResMed Corp. of San Diego, California; ResMed Inc. of San Diego, California; and ResMed Ltd. of Australia. A corrected complaint was filed on April 18, 2016, and a supplement was filed on April 19, 2016. The corrected complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain sleeping-disordered breathing treatment systems and components thereof by reason of infringement of certain claims of U.S. Patent No. RE44,453 (``the '453 patent''); U.S. Patent No. 8,020,551 (``the '551 patent''); U.S. Patent No. 8,006,691 (``the '691 patent''); and U.S. Patent No. 9,072,860 (``the '860 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

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 8404, Interest Charge on DISC-Related Deferred Tax Liability.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to practice the inventions embodied in the following patent applications to Chimeron Bio Corporation, a company incorporated under the laws of Delaware and having an office in Philadelphia, PA. Intellectual Property: U.S. Provisional Patent Application No.: 61/ 615,687 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-01 Filed March 26, 2012; International Patent Application No.: PCT/US2013/031876 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-PCT-02 Filed March 15, 2013; Australian Patent Application No.: 2013-240248 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264- 2011/0-AU-03 Filed October 17, 2014; European Patent Application No.: 13712661.1 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-EP-04 Filed October 24, 2014; Japanese Patent Application No.: 2015-503322 entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-JP-05 Filed September 25, 2014; U.S. Patent Application No.: 14/388,441 Entitled Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-06 Filed September 26, 2014; U.S. Provisional Patent Application No.: 61/ 916,394 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP- Replicon'' HHS Ref. No.: E-050-2014/0-US-01 Filed December 16, 2013; International Patent Application No.: PCT/US2014/070552 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP-Replicon'' HHS Ref. No.: E-050-2014/0-PCT-02 Filed December 16, 2014; The patent rights to these inventions have been assigned to the Government of the United States of America. The prospective exclusive start-up licensed territory may be worldwide and the field of use may be limited to: ``Use of virus like particles comprising MHCII and CD80 for the treatment of breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.''

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.