Department of Health and Human Services June 8, 2016 – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed information collection plan entitled ``Generic Clearance for Lyme and other Tickborne Diseases Knowledge, Attitudes, and Practices Surveys.'' CDC's Division of Vector-Borne Diseases (DVBD), National Center for Emerging and Zoonotic Diseases (NCEZID) will use the plan to conduct survey development, pre-testing activities, and survey administration actions in 2016-2018. The data collection for which approval is sought will allow DVBD to use survey results to inform implementation of future TBD prevention interventions.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/inde x.html.
Announcement of Requirements and Registration for “A Bill You Can Understand” Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health; Correction
This document corrects technical errors that appeared in the notice published in the May 10, 2016 Federal Register entitled ``Announcement of Requirements and Registration for ``A Bill You Can Understand'' Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.''
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Meredyth M. Forbes, Albert Einstein College of Medicine: Based on an assessment conducted by the Albert Einstein College of Medicine (AECM), an admission from the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Meredyth M. Forbes, former Graduate Student, AECM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM089979, T32 GM007491, R01 GM55101, and R01 GM88202 and National Institute of Child Health and Human Development (NICHD), NIH, grant T32 HD007502. ORI found that Respondent engaged in research misconduct by intentionally falsifying and/or fabricating data reported in the following three (3) published papers and four (4) meeting presentations:
Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers
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 61/477,020 entitled ``Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-14], 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.''
Determination of Regulatory Review Period for Purposes of Patent Extension; ALPROLIX
The Food and Drug Administration (FDA) has determined the regulatory review period for ALPROLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE
The Food and Drug Administration (FDA) has determined the regulatory review period for ELOCTATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
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