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

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Document Number: 2015-04178
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2015 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. (Please note that two of CMS' 2015 HCPCS public meetings have a late starting time.)
Document Number: 2015-04175
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces four new membership appointments to the Advisory Panel on Hospital Outpatient Payment (the Panel). The four new appointments to the Panel will each serve a four-year period. The new members have terms that began on January 14, 2015 and continue through January 31, 2019. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Document Number: 2015-04174
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the renewal of the Advisory Panel (the Panel) on Outreach and Education (APOE) charter. It also requests nominations for individuals to serve on the APOE.
Document Number: 2015-04173
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Document Number: 2015-04169
Type: Proposed Rule
Date: 2015-02-27
Agency: Department of Health and Human Services
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A (Department of Health and Human Services) of Title II (Enhancing Controls on Dangerous Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has initiated the review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. We are considering whether to propose amending the HHS list by removing six biological agents.
Document Number: 2015-04143
Type: Rule
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements provisions of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act) which require us to provide a right of appeal and an appeal process for liability insurance (including self-insurance), no-fault insurance, and workers' compensation laws or plans when Medicare pursues a Medicare Secondary Payer (MSP) recovery claim directly from the liability insurance (including self-insurance), no-fault insurance, or workers' compensation law or plan.
Document Number: 2015-04141
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-04138
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-04131
Type: Notice
Date: 2015-02-27
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: 2015-04128
Type: Notice
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-04123
Type: Notice
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-04121
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 6, 2015, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Document Number: 2015-04120
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.
Document Number: 2015-04115
Type: Notice
Date: 2015-02-27
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: 2015-04113
Type: Notice
Date: 2015-02-27
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: 2015-04101
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-04057
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-04056
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-04055
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-04054
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-04053
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03943
Type: Rule
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations.
Document Number: 2015-03751
Type: Rule
Date: 2015-02-27
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also finalizes additional standards for the individual market annual open enrollment period for the 2016 benefit year, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential coverage, the rate review program, the medical loss ratio program, and other related topics.
Document Number: 2015-04069
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing of this information collection by March 7, 2015. NIAID is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NIAID cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand the causes of severity of influenza and associated morbidity and mortality during the Northern hemisphere 2014-15 influenza season. The National Institutes of Health 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Document Number: 2015-03989
Type: Notice
Date: 2015-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-03985
Type: Notice
Date: 2015-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-03974
Type: Notice
Date: 2015-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient groups, consumer groups, regulated industry, academia and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).
Document Number: 2015-03952
Type: Notice
Date: 2015-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects a notice that was published in the Federal Register on February 9, 2015, Volume 80, Number 26, pages 6971 and 6972. The times and dates should read as follows:
Document Number: 2015-03949
Type: Notice
Date: 2015-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces a public meeting and an opportunity to comment on future directions for the surveillance of injuries within the agricultural production industry. To view the notice and related materials visit http:// www.regulations.gov and enter CDC-2015-0005 in the search field and click ``Search.'' Public comment period: Comments must be received May 27, 2015.
Document Number: 2015-03941
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03940
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03939
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03938
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03937
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03936
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03935
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-03934
Type: Rule
Date: 2015-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Document Number: 2015-03929
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2015-03924
Type: Notice
Date: 2015-02-26
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-03900
Type: Notice
Date: 2015-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-03888
Type: Notice
Date: 2015-02-25
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living proposes a priority for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for Promoting Universal Design in the Built Environment. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved access to the built environment by individuals with disabilities.
Document Number: 2015-03886
Type: Notice
Date: 2015-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the report and Web site location where the Agency has posted the report entitled ``Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,'' developed by the National Medical Device Postmarket Surveillance System Planning Board. In addition, FDA has established a docket where stakeholders may provide comments.
Document Number: 2015-03885
Type: Notice
Date: 2015-02-25
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living proposes 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, this notice proposes a priority for an RRTC on Employment for Individuals with Blindness or other Visual Impairments. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with blindness or other visual impairments.
Document Number: 2015-03884
Type: Proposed Rule
Date: 2015-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the- counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
Document Number: 2015-03883
Type: Proposed Rule
Date: 2015-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that ecamsule (also known as terephthalylidene dicamphor sulfonic acid) at concentrations up to 10 percent is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
Document Number: 2015-03882
Type: Notice
Date: 2015-02-25
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living proposes 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, this notice proposes a priority for an RRTC on Employment Policy and Measurement. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment outcomes for individuals with disabilities.
Document Number: 2015-03881
Type: Notice
Date: 2015-02-25
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: 2015-03880
Type: Notice
Date: 2015-02-25
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living proposes 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, this notice proposes a priority for an RRTC on Self- Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with serious mental illness (SMI) and co-occurring conditions.
Document Number: 2015-03877
Type: Notice
Date: 2015-02-25
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living proposes 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, this notice proposes a priority for an RRTC on Employer Practices Leading to Successful Employment Outcomes for Individuals with Disabilities. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment practices and successful employment outcomes for individuals with disabilities.
Document Number: 2015-03846
Type: Notice
Date: 2015-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is opening a docket to obtain information and comments on specific areas of public health concern for racial/ethnic demographic subgroup populations, focusing on certain disease areas where significant outcome differences may be anticipated. The Agency is seeking public input on identifying areas that can be addressed through regulatory science research.
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