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

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Document Number: 2014-17871
Type: Notice
Date: 2014-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on September 9, 2014, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health, Dallas Regional Office, 1301 Young Street, Room 801, 8th Floor Dallas, Texas 75202 to reconsider CMS' decision to disapprove Louisiana's Medicaid SPAs 13-23, 13-25 and 13-28. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by August 13, 2014.
Document Number: 2014-17805
Type: Notice
Date: 2014-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the expansion of the Medicare Prior Authorization for Power Mobility Devices (PMDs) Demonstration to 12 additional states.
Document Number: 2014-17804
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17801
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Indian Health Service
Document Number: 2014-17800
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Indian Health Service
Document Number: 2014-17767
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2014-17739
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17737
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17736
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17725
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-17711
Type: Notice
Date: 2014-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-17710
Type: Notice
Date: 2014-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-17660
Type: Notice
Date: 2014-07-29
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: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' 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 April 23rd and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-17712
Type: Notice
Date: 2014-07-28
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 ``Animal Generic Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17691
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of ``reserving'' proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.
Document Number: 2014-17685
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 12, 2014 about assessing public health interventions in chronic kidney disease (CKD). The meeting is open to the public.
Document Number: 2014-17684
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) 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. 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. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Teri Brown, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free number 240-276-5810 or Email your request, including your address to: brownte@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Global Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health Collaborations is proposing new program specific progress report guidelines. The CGH LMIC Global Health Collaborations are part of a pilot initiative and partnership, between the NCI CGH and the Office of Cancer Centers (OCC), to promote collaborations between the NCI designated Cancer Centers and foreign institutions from Low and Middle Income Countries (LMICs). This collaboration is designed to develop and implement mutually beneficial global cancer research programs by increasing the capability of these countries to participate and partner in cancer research. The proposed guidelines request information about award performance related to objectives, accomplishments, barriers and challenges, collaborators, and findings. The information is gathered six months into the award and 12 months after the award (upon expiry). This information is needed to monitor the performance of this special program within NCI, funded through three Request for Proposals (RFPs); the first was released April 18, 2013 and CGH expects to release another in 2014 and the final one in 2015. The respondents are the Principal Investigators of the awards. The information will be used to monitor individual award performance and the effectiveness of the program as a whole. Since these projects are funded through the contract mechanism, the PIs will not be required to submit interim and final progress reports like other National Institutes of Health grantees must. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 83.
Document Number: 2014-17676
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17675
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17674
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17673
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17672
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17671
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17670
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17668
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-17666
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.
Document Number: 2014-17665
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-17664
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-17654
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-17651
Type: Notice
Date: 2014-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17646
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2014-17633
Type: Notice
Date: 2014-07-28
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 ``Medical Devices; Reports of Corrections and Removals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17625
Type: Notice
Date: 2014-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the 11th Statement of Work (SOW) in May 2014 titled, ``Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) Contract'' (HHSM-500-2014-RFP-BFCC-QIO). This contract allows for a transition period from the incumbent QIOs to the successor QIOs. The activities for the BFCC-QIO SOW begin August 1, 2014. The evaluation of a BFCC-QIO's performance related to the SOW will be based on evaluation criteria specified for the tasks set forth in Attachment J-10 of the BFCC-QIOs' SOW contract.
Document Number: 2014-17590
Type: Notice
Date: 2014-07-25
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: 2014-17589
Type: Notice
Date: 2014-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-17588
Type: Notice
Date: 2014-07-25
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 revised draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of the final version of the guidance on that topic. The draft guidance outlines Electronic Common Technical Document (eCTD) specification requirements for certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This draft guidance revises and replaces a previous draft guidance entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in January 2013 (2013 draft guidance on eCTD Specifications). When finalized, this revised draft guidance will supersede the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatHuman Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in June 2008.
Document Number: 2014-17586
Type: Notice
Date: 2014-07-25
Agency: Department of Health and Human Services
A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) by any amendments. The State Plan will be used (2) by the Council as a planning document; (3) by the citizenry of the State as a mechanism for commenting on the plans of the Council; (4) by the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making.
Document Number: 2014-17585
Type: Notice
Date: 2014-07-25
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing the application deadline and supplemental funding for the Eldercare Locator program. The Eldercare Locator program helps older adults and their families and caregivers find their way through the maze of services for older adults by linking to a trustworthy network of national, State, Tribal and community organizations and services through a nationally recognized toll-free number. The Eldercare Locator also provides older adults and caregivers who require more in depth support the opportunity to speak with highly trained eldercare consultants who can better triage the situation. The purpose of this notice is to award supplemental funds to the National Association of Area Agencies on Aging to provide for additional eldercare consultants. Program Name: Eldercare Locator. Award Amount: $250,000. Project Period: 6/1/2013 to 5/31/2018. Award Type: Cooperative Agreement.
Document Number: 2014-17563
Type: Notice
Date: 2014-07-25
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its eighteenth meeting on August 20, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.
Document Number: 2014-17555
Type: Notice
Date: 2014-07-25
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: 2014-17543
Type: Notice
Date: 2014-07-25
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 ``Potential Tobacco Product Violations Reporting Form'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17542
Type: Rule
Date: 2014-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the implantable transprostatic tissue retractor 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. 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: 2014-17521
Type: Notice
Date: 2014-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2014-17488
Type: Notice
Date: 2014-07-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2014, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Document Number: 2014-17482
Type: Notice
Date: 2014-07-25
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 ``Annual Reporting for Custom Device Exemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17481
Type: Notice
Date: 2014-07-25
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 ``Guidance for Industry Pharmacogenomic Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17477
Type: Rule
Date: 2014-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.
Document Number: 2014-17458
Type: Proposed Rule
Date: 2014-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of sodium formate as an acidifier in swine feed.
Document Number: 2014-17457
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Office of Policy and Planning (OPP), intends to provide a Single Source Cooperative Agreement Award to the Pasteur Foundation for project activities carried out by the Pasteur Institute to support global health security enhancements and International Health Regulations (IHR) (2005) implementation in select Sub-Saharan African and Southeast Asian countries. Specifically, ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with the Pasteur Institute and select affiliate institutes within the Pasteur Institute International Network (IPIN) in Cameroon, Central African Republic, Ivory Coast, Madagascar, Senegal, and Cambodia to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in support of IHR (2005). Recognizing that the health security of the American people is intrinsically linked to the world's health security, and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs State Parties to collaborate to detect, assess, and respond to events while developing, strengthening, and maintaining core public health surveillance and response capacities. The proposed cooperative agreement is also aligned with the Global Health Security Agenda that calls for action to accelerate progress toward a world safe and secure from infectious disease threats, and to promote global health security as an international security priority by preventing and reducing the likelihood of infectious diseases outbreaks, detecting threats early, and rapidly and effective responding to disease outbreaks that require multi-sectorial, international coordination and communication.\1\
Document Number: 2014-17456
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the Gorgas Memorial Institute (GMI) in Panama. The Cooperative Agreement will support enhancement of global and regional health security through enhanced implementation of International Health Regulations (IHR) (2005) in Panama. ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with the GMI to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in Panama and its area of influence in Central America and the Caribbean. Recognizing that the health security of the American people is intrinsically linked to the world's health security, and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs State Parties to collaborate to detect, assess, and respond to events while developing, strengthening, and maintaining core public health surveillance and response capacities.