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

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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using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 The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal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 The draft guidance outlines Electronic Common Technical Document (eCTD) specification requirements for certain submissions to new drug applications (NDAs), abbreviated new drug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 This draft guidance revises and replaces a previous draft guidance entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in January 2013 (2013 draft guidance on eCTD Specifications). When finalized, this revised draft guidance will supersede the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatHuman Pharmaceutical Product Applications and Related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.
Document Number: 2014-17453
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the U.S.-Mexico Foundation for Science (Fundaci[oacute]n M[eacute]xico-Estados Unidos para la Ciencia [FUMEC]), who will be the awardee for project activities carried out by Mexico's Ministry of Health (MOH). This Cooperative Agreement will contribute to enhancing global health security and advancing the implementation and maintenance of International Health Regulations (IHR) (2005) core capacities in Mexico. 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 FUMEC and the Mexican MOH to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in Mexico, focusing on IHR National Focal Point and Points of Entry capacities. 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. Additionally, this program intends to support the collaboration with the Mexican MOH under the North American Plan for Animal and Pandemic Influenza (NAPAPI). Period Of Performance: September 30, 2014 to September 29, 2017.
Document Number: 2014-17452
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Document Number: 2014-17439
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-17403
Type: Rule
Date: 2014-07-24
Agency: Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule, published in the Federal Register on May 27, 2014, entitled ``Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond.''
Document Number: 2014-17388
Type: Notice
Date: 2014-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17356
Type: Notice
Date: 2014-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17409
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Document Number: 2014-17330
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of General Medical Sciences (NIGMS), one of the components of the National Institutes of Health (NIH), announces a challenge titled ``Stories of Basic Science to Medical Advances.'' This Challenge aims to track medical advances stemming from NIGMS-supported basic science.
Document Number: 2014-17328
Type: Notice
Date: 2014-07-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17320
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 11, 2014, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Document Number: 2014-17294
Type: Notice
Date: 2014-07-23
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 the collection of information regarding pH of smokeless tobacco products.
Document Number: 2014-17293
Type: Notice
Date: 2014-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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,'' which 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: 2014-17292
Type: Notice
Date: 2014-07-23
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 ``Generic FDA Rapid Response Surveys'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-17271
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss HIV/AIDS in the Southern United States, HIV related workforce issues, and Hepatitis C and the impact of the Affordable Care Act. The meeting will be open to the public.
Document Number: 2014-17262
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17261
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17260
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services
Document Number: 2014-17259
Type: Notice
Date: 2014-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-17126
Type: Notice
Date: 2014-07-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Document Number: 2014-17079
Type: Notice
Date: 2014-07-21
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 in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.
Document Number: 2014-17063
Type: Notice
Date: 2014-07-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Energy Assistance (DEA) announces the estimated median income of four-person households in each state, the District of Columbia, and Puerto Rico for FFY 2015 (October 1, 2014, to September 30, 2015).
Document Number: 2014-17059
Type: Notice
Date: 2014-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17058
Type: Notice
Date: 2014-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17057
Type: Notice
Date: 2014-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17051
Type: Notice
Date: 2014-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17033
Type: Notice
Date: 2014-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-17011
Type: Notice
Date: 2014-07-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration for Native Americans (ANA) announces the award of an emergency single-source grant in the amount of $153,021 to the Louden Tribal Council in Galena, AK. The award will be made under ANA's program for Social and Economic Development Strategies.
Document Number: 2014-16998
Type: Notice
Date: 2014-07-21
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: 2014-16981
Type: Notice
Date: 2014-07-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-16669
Type: Notice
Date: 2014-07-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Behavioral Programs for Diabetes Mellitus, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Document Number: 2014-16960
Type: Notice
Date: 2014-07-18
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: 2014-16931
Type: Notice
Date: 2014-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Providing Submissions in Electronic FormatPostmarketing Safety Reports for Vaccines'' dated July 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). FDA recently published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants required to submit postmarketing safety reports comply with the final rule. The draft guidance, when finalized, also will supersede the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.