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

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Document Number: 2015-16028
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the National Healthcare Safety Network (NHSN). NHSN is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety.
Document Number: 2015-16027
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``Prevent Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of this study is to address the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties.
Document Number: 2015-16023
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Export Certificates for FDA Regulated Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-16022
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2015-16020
Type: Notice
Date: 2015-06-30
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 a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Evaluation of FDA's Multicultural Youth Tobacco Prevention Campaigns.
Document Number: 2015-16013
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Document Number: 2015-16011
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this draft 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 draft 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 industry, the standards community, and health care professionals. This draft guidance is not final nor is it in effect at this time.
Document Number: 2015-15946
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15945
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15944
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15943
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15942
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15941
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15925
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-15844
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Document Number: 2015-15842
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Document Number: 2015-15841
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 8, 2015, page 18853 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 National Institutes of Health (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.
Document Number: 2015-15902
Type: Proposed Rule
Date: 2015-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is seeking public comment on whether the uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated products currently designated essential are no longer essential under the Clean Air Act due to the availability of alternatives that do not use CFCs or because the products are no longer being marketed. Essential-use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act. FDA is soliciting comments to assist the Agency in striking an appropriate balance that will best protect the public health, both by ensuring the availability of an adequate number of alternatives and by curtailing the release of ODSs.
Document Number: 2015-15889
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-15859
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given of a preliminary determination that funds from the Federal Fiscal Year (FY) 2014 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that receive FY 2015 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), (42 U.S.C. 8626(b)(1)) requires that, if the Secretary of the U.S. Department of Health and Human Services (HHS) determines that, as of September 1 of any fiscal year, an amount in excess of 10 percent of the amount awarded to a grantee for that fiscal year (excluding Leveraging, REACH, and reallotted funds) will not be used by the grantee during that fiscal year, then the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be reallotted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2015.
Document Number: 2015-15833
Type: Notice
Date: 2015-06-29
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 draft guidance entitled ``Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.'' The purpose of this guidance is to provide an assessment paradigm for radiofrequency (RF)-induced heating on, or near, multi-component, or multi-configuration, passive medical devices in the magnetic resonance environment. This draft guidance is not final nor is it in effect at this time.
Document Number: 2015-15832
Type: Notice
Date: 2015-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-15831
Type: Notice
Date: 2015-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-15820
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15819
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15818
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15817
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15802
Type: Notice
Date: 2015-06-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
The National Practitioner Data Bank (NPDB) announces the release of the revised user Guidebook. The NPDB is a confidential information clearinghouse created by Congress and intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, and suppliers. The Guidebook is the primary policy document explaining the statutes and regulations behind and operation of the NPDB. It serves as an essential reference for NPDB users, offering reporting and querying examples, explanations, definitions, and frequently asked questions. The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the NPDB's merger with the Healthcare Integrity and Protection Data Bank. In November 2013, the Health Resources and Services Administration (HRSA) released a draft Guidebook to the public for review and comment by NPDB stakeholders and other interested parties. It announced the draft Guidebook's availability in the Federal Register. HRSA received more than 360 separate comments, consisting of analyses of issues raised by the draft Guidebook. The NPDB carefully studied all comments received, and many led to detailed analyses of how NPDB explains its policies to its audiences. The final Guidebook is now available at www.npdb.hrsa.gov and replaces previous Guidebooks.
Document Number: 2015-15771
Type: Notice
Date: 2015-06-26
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.
Document Number: 2015-15770
Type: Notice
Date: 2015-06-26
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.
Document Number: 2015-15745
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living announces a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, we announce a priority for an RRTC on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness (SMI). The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to improved health and wellness for individuals with serious mental illness.
Document Number: 2015-15744
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services
The Health Resources and Services Administration (HRSA) is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee.
Document Number: 2015-15741
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2015-15740
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2015-15719
Type: Notice
Date: 2015-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' Direct marking is an important feature of FDA's unique device identification system. This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of ``reprocessing'' for purposes of UDI direct marking requirements.
Document Number: 2015-15711
Type: Notice
Date: 2015-06-26
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on Electronic User Fee Payment Request Forms.
Document Number: 2015-15659
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15658
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services
Document Number: 2015-15657
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, 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 U.S. Provisional Patent Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in 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 worldwide, and the field of use may be limited to: ``All prophylactic and therapeutic uses for CD19-associated diseases, states and conditions in humans.''
Document Number: 2015-15656
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, 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 U.S. Provisional Patent Application 61/912,948 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-2014/0-US-01], U.S. Provisional Patent Application 61/ 991,697 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008- 2014/1-US-01], PCT Patent Application PCT/US2014/063096 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-2014/2-PCT-01], and all related continuing and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights in 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 worldwide, and the field of use may be limited to: ``The development of a TSLPR-CAR-based immunotherapy using chimeric antigen receptors (CARs) having:
Document Number: 2015-15655
Type: Notice
Date: 2015-06-26
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license agreement to practice the inventions embodied in US Provisional Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed December 1, 2010 [HHS Ref. E-039-2011/0-US-01]; PCT Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT- 02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039- 2011/0-AU-03]; Canadian Patent Application No. 2818992 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04]; European Patent Application No. 11791733.6 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05]; and U.S. Patent Application No. 13/ 990,977 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed May 31, 2013 [HHS Ref. E-039-2011/0-US-06] and all related continuing and foreign patents/patent applications for the technology family to Emergent BioSolutions. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, make, have made, sell, have sold, import and export bi-specific and multi-specific fusion proteins that are capable of eliciting redirected T-cell cytotoxicity for the treatment of human receptor tyrosine kinase-like orphan receptor 1 (ROR1) expressing cancers, wherein said fusion proteins comprise one or more single-chain variable fragment (scFv) ROR1 binding domains from the anti-ROR1 antibodies designated as R11 or R12, one or more of Licensee's proprietary scFv CD3 binding domains, and optionally a fragment crystallizable (Fc) domain.
Document Number: 2015-15644
Type: Notice
Date: 2015-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties.
Document Number: 2015-15641
Type: Notice
Date: 2015-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2015-15638
Type: Notice
Date: 2015-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2015-15637
Type: Notice
Date: 2015-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' It replaces the draft of the same name that was published on March 14, 2014. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.
Document Number: 2015-15605
Type: Notice
Date: 2015-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15603
Type: Notice
Date: 2015-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15602
Type: Notice
Date: 2015-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-15601
Type: Notice
Date: 2015-06-25
Agency: Department of Health and Human Services, National Institutes of Health
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