Department of Health and Human Services May 18, 2016 – Federal Register Recent Federal Regulation Documents

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.

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.

This final rule implements Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. The final rule clarifies and codifies existing nondiscrimination requirements and sets forth new standards to implement Section 1557, particularly with respect to the prohibition of discrimination on the basis of sex in health programs other than those provided by educational institutions and the prohibition of various forms of discrimination in health programs administered by the Department of Health and Human Services (HHS or the Department) and entities established under Title I of the ACA. In addition, the Secretary is authorized to prescribe the Department's governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities.