Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 3,196
Submission for OMB Review; Comment Request
Document Number: 2015-31314
Type: Notice
Date: 2015-12-14
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-31302
Type: Notice
Date: 2015-12-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications; Corrections and Clarifications
Document Number: 2015-31255
Type: Rule
Date: 2015-12-11
Agency: Department of Health and Human Services, Office of the Secretary
This document corrects errors and clarifies provisions of the final rule entitled ``2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications.''
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2015-31240
Type: Notice
Date: 2015-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Notice of Charter Renewal
Document Number: 2015-31239
Type: Notice
Date: 2015-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, Office of Science Policy, Office of Biotechnology Activities; Notice of Meeting
Document Number: 2015-31238
Type: Notice
Date: 2015-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date
Document Number: 2015-31232
Type: Rule
Date: 2015-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of November 2, 2015, for the final rule that appeared in the Federal Register of September 30, 2015, and that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as a color additive in certain distilled spirits.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-31226
Type: Notice
Date: 2015-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of The Director, National Institutes of Health; Notice of Meeting
Document Number: 2015-31162
Type: Notice
Date: 2015-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-31159
Type: Notice
Date: 2015-12-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Submission Form for Supplemental Evidence and Data for Systematic reviews for the Evidence-based Practice Center Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 21st, 2015 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-31158
Type: Notice
Date: 2015-12-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Developing a Registry of Registries.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 21st, 2015 and allowed 60 days for public comment. AHRQ received no substantive comments from the public. The purpose of this notice is to allow an additional 30 days for public comment.
Viral Hepatitis Action Plan-Community Stakeholder Activities Request for Information
Document Number: 2015-31131
Type: Notice
Date: 2015-12-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is seeking public input from state and local governments, community based organizations, academic institutions, professional organizations, advocacy groups, private industry, and other non-federal stakeholders on activities undertaken in 2014-2015 in support of the goals of the national Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-31105
Type: Notice
Date: 2015-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-31104
Type: Notice
Date: 2015-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts
Document Number: 2015-31100
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (the Program) during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017.
Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX
Document Number: 2015-31099
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for VERAFLOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO
Document Number: 2015-31098
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SIRTURO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ
Document Number: 2015-31097
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for FULYZAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS
Document Number: 2015-31096
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ELIQUIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM
Document Number: 2015-31095
Type: Notice
Date: 2015-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Findings of Research Misconduct
Document Number: 2015-31057
Type: Notice
Date: 2015-12-10
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Girija Dasmahapatra, Ph.D., Virginia Commonwealth University: Based on the report of an inquiry conducted by Virginia Commonwealth University (VCU), the willingness of the Respondent to settle this matter, and analysis conducted by ORI in its oversight review, ORI found that Dr. Girija Dasmahapatra, former Instructor, Department of Internal Medicine, VCU, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA063753, R01 CA093738, and R01 CA100866. ORI found that false data were included in the following eleven (11) publications:
Acute Radiation Syndrome Medical Countermeasures-Amendment
Document Number: 2015-31094
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the declaration issued on October 10, 2008, (73 FR 61866) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: include countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); clarify and expand the description of covered countermeasures; extend the effective time period of the declaration; reformat the declaration; modify or clarify terms of the declaration; and republish the declaration in its entirety, as amended.
Smallpox Medical Countermeasures-Amendment
Document Number: 2015-31092
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the declaration issued on October 10, 2008, (73 FR 61869) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Include countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); clarify the description of covered countermeasures; extend the effective time period of the declaration; reformat the declaration; modify or clarify terms of the declaration; and republish the declaration in its entirety, as amended.
Botulinum Toxin Medical Countermeasures-Amendment
Document Number: 2015-31091
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the declaration issued on October 10, 2008 (73 FR 61864) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Include countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); clarify the description of covered countermeasures; extend the effective time period of the declaration; reformat the declaration; modify or clarify terms of the declaration; and republish the declaration in its entirety, as amended.
Anthrax Medical Countermeasures-Amendment
Document Number: 2015-31090
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the declaration issued on October 1, 2008 (73 FR 58239) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Include countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); revise the description of covered countermeasures and the disease threat; extend the effective time period of the declaration; reformat the declaration; modify or clarify terms of the declaration; and republish the declaration in its entirety, as amended.
Ebola Virus Disease Therapeutics-Amendment
Document Number: 2015-31089
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the February 27, 2015 Declaration issued pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) (80 FR 22534) to extend the effective time period for an additional twelve (12) months consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.
Ebola Virus Disease Vaccines-Amendment
Document Number: 2015-31088
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the Declaration issued pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) on December 3, 2014 (79 FR 73314) to extend the effective time period for an additional twelve (12 months) to clarify the list of Covered Countermeasures, and to clarify Covered Persons consistent with the terms of the declaration and republishing the Declaration in its entirety as amended.
Pandemic Influenza Medical Countermeasures-Amendment
Document Number: 2015-31087
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending the declarations issued on October 10, 2008 (73 FR 61861), as amended June 11, 2009 (74 FR 29213); December 17, 2008 (73 FR 78362); and February 29, 2012 (77 FR 13329), pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Cover vaccines, antivirals, diagnostics and devices used against pandemic influenza A viruses in a single declaration; extend coverage to additional antivirals and devices and to biologics and other drugs; simplify descriptions of covered diagnostics and devices; clarify the disease threat and description of pandemic influenza A viruses and influenza A viruses with pandemic potential; include coverage for countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); extend the effective time period of the prior declarations; reformat the declarations for antivirals and for diagnostics and devices; modify or clarify terms of the declarations; and republish the prior declarations as a single declaration in its entirety, as amended.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: 2015-31042
Type: Rule
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 September and October 2015. 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 September and October 2015.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2015-31040
Type: Rule
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and two abbreviated new animal drug applications (ANADAs). This action is being taken at the sponsors' requests because these products are no longer manufactured or marketed.
Center For Scientific Review; Amended Notice of Meeting
Document Number: 2015-31028
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2015-31027
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-31026
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-31024
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-31023
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2015-30994
Type: Notice
Date: 2015-12-09
Agency: Department of Health and Human Services, Administration for Children and Families
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-30972
Type: Notice
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by FDA, industry, the standards community, and health care professionals.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2015-30970
Type: Notice
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2015-30968
Type: Notice
Date: 2015-12-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period
Document Number: 2015-30937
Type: Notice
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics about the proposed standards-based regulatory strategy for next-generation sequencing (NGS) tests that produce results on variation in the human genome. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments.
Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Reopening of Comment Period
Document Number: 2015-30936
Type: Notice
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics about the use of databases that contain information linking human genetic variations to disease, where such information has been curated by qualified professionals, to inform regulatory oversight of the clinical performance of genetic tests. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments.
Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability
Document Number: 2015-30931
Type: Notice
Date: 2015-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-30892
Type: Notice
Date: 2015-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-30891
Type: Notice
Date: 2015-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Request for Public Comment on the Proposed Adoption of Administration for Native Americans Program Policies and Procedures
Document Number: 2015-30868
Type: Notice
Date: 2015-12-08
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy, and to give notice of the proposed adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2016 Funding Opportunity Announcements (FOA) for the following programs: (1) Social and Economic Development Strategies (hereinafter referred to as SEDS) (HHS-2014-ACF-ANA-NA-0776); (2) Social and Economic Development Strategies- Alaska (hereinafter referred to as SEDS-AK) (HHS-2015-ACF- ANA-NK-0960); (3) Native Asset Building Initiative (hereinafter referred to as NABI) (HHS-2015-ACF-ANA-NO-0954); (4) Sustainable Employment and Economic Development Strategies (hereinafter referred to as SEEDS) (HHS-2014-ACF-ANA-NE-0779); (5) Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation) (HHS-2014-ACF-ANA-NL-0778); (6) Native Language Preservation and MaintenanceEsther Martinez Immersion (hereinafter referred to as LanguageEMI) (HHS-2014-ACF-ANA-NB-0780); (7) Environmental Regulatory Enhancement (hereinafter referred to as ERE) (HHS-2014-ACF-ANA-NR- 0777); and new FOAs for FY2016(8) Native Language Community Coordination Demonstration Project (hereinafter referred to as NLCC) (HHS-2016-ACF-ANA-NS-1168); and (9) Native Youth Initiative for Leadership, Empowerment, and Development (hereinafter referred to as Native Youth I-LEAD) (HHS-2016-ACF-ANA-NC-1167) . This notice of public comment also provides additional information about ANA's plan for administering the programs.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-30854
Type: Notice
Date: 2015-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Moving Forward: Collaborative Approaches to Medical Device Cybersecurity; Public Workshop; Request for Comments
Document Number: 2015-30772
Type: Notice
Date: 2015-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.'' FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services, and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts; increase awareness of existing maturity models (i.e. frameworks leveraged for benchmarking an organization's processes) which are used to evaluate cybersecurity status, standards, and tools in development; and to engage the multi- stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development and Commercialization of Aza-Epoxy Guaiane Derivatives for Treatment of Renal Cancer
Document Number: 2015-30752
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to ElexiMed LLC, a company having a place of business at 5003 Green Mountain Circle, Suite 4, Columbia, MD 21044, USA, to practice the inventions embodied in the following patent applications. Intellectual PropertyPCT Patent Application No. PCT/US2015/ 014601, entitled ``Aza-Englerin AnaloguesNovel Natural Product-Based Nitrogen-Containing Anti-Cancer Agents'' filed February 5, 2015 (HHS Ref. No.: E-090-2014/2-PCT-01); US Provisional Patent Application No. 62/018,381, entitled ``Aza-epoxy-guaiane derivatives and treatment of cancer'' filed June 27, 2014 (HHS Ref. No. E-090-2014/ 1-US-01); and US Provisional Patent Application No. 61/936,285, entitled ``Aza-englerin analogues and use in cancer therapy'' filed February 5, 2014 (HHS Ref. No. E-090-2014/0-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America and the University of Hawaii. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development and commercialization of aza-epoxy guaiane derivatives for treatment of renal cancer.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, ElexiMed LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
National Institute on Aging; Notice of Meeting
Document Number: 2015-30751
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2015-30750
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, National Institutes of Health
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