Results 1 - 50 of 24,165
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22825
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2017-22824
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
Document Number: 2017-22813
Type: Rule
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
Medicare and Medicaid Programs; Application by Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Accreditation Program
Document Number: 2017-22812
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Analyses, Research and Studies To Address the Impact of CMS Programs on American Indian/Alaska Native (AI/AN) Beneficiaries and the Health Care System Serving These Beneficiaries
Document Number: 2017-22811
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice supports expansion of research on the impact of CMS programs on the Indian health care system through a single source award. The Indian Health Service (IHS), Tribes and Tribal Organizations and Urban programs, deliver health care services to American Indian/ Alaska Native (AI/AN) people through a network of hospitals, clinics and other providers. This award expands research on the impact of CMS programs and the delivery of health care to AI/AN beneficiaries.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22774
Type: Notice
Date: 2017-10-20
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to provide comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Respiratory Protective Devices information collection project.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22773
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22772
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
Document Number: 2017-22769
Type: Rule
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes
Document Number: 2017-22768
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2017-22736
Type: Notice
Date: 2017-10-20
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 guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (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 guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.
Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate; Draft Guidances for Industry; Availability
Document Number: 2017-22735
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder, entitled ``Draft Guidance on Salmeteral Xinafoate'' and ``Draft Guidance on Fluticasone Propionate.'' The guidances, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder.
Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability
Document Number: 2017-22734
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled ``Draft Guidance on Tiotropium Bromide.'' The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation powder.
Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability
Document Number: 2017-22731
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 507; Draft Guidance for Industry.'' The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are ``solely engaged'' in certain activities. Establishments and facilities ``solely engaged'' in certain activities are exempt from some or all requirements of the regulations.
Current Good Manufacturing Practice Requirements for Food for Animals; Guidance for Industry; Availability
Document Number: 2017-22730
Type: Notice
Date: 2017-10-20
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 guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-22729
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2017-22728
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2017-22727
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22726
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22725
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2017-22720
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22718
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22716
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22713
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-22699
Type: Notice
Date: 2017-10-19
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Patient Safety Organizations: Voluntary Relinquishment From the American College of Physicians Patient Safety Organization
Document Number: 2017-22671
Type: Notice
Date: 2017-10-19
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the American College of Physicians Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-22630
Type: Notice
Date: 2017-10-18
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2017-22626
Type: Notice
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2018 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/ input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System
Document Number: 2017-22590
Type: Rule
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2017-22574
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-22573
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22572
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22571
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-22570
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22569
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22568
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
Document Number: 2017-22550
Type: Notice
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.
Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel
Document Number: 2017-22436
Type: Notice
Date: 2017-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for possible membership on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) in the National Institute for Occupational Safety and Health (NIOSH), World Trade Center Health Program (WTCHP). The Disease, Disability, and Injury Prevention and Control Special Emphasis Panel provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC), and the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR) regarding the concept review, scientific and technical merit of grant and cooperative agreement assistance applications, and contract proposals relating to the causes, prevention, and control of diseases, disabilities, injuries, and impairments of public health significance; exposure to hazardous substances in the environment; health promotion and education; and other related activities that promote health and well-being. Members and Chairs shall be selected by the Secretary, HHS, or other official to whom the authority has been delegated, on an ``as needed'' basis in response to specific applications being reviewed with expertise to provide advice. Members will be selected from authorities in the various fields of prevention and control of diseases, disabilities, and injuries. Members of other chartered HHS advisory committees may serve on the panel if their expertise is required. Consideration is given to professional training and background, points of view represented, and upcoming applications to be reviewed by the committee.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22422
Type: Notice
Date: 2017-10-17
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-22400
Type: Notice
Date: 2017-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2017-22399
Type: Notice
Date: 2017-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2017-22398
Type: Notice
Date: 2017-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2017-22377
Type: Notice
Date: 2017-10-17
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Standards for the Children's Hospitals Graduate Medical Education Payment Program's Quality Bonus System
Document Number: 2017-22381
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice seeks public comment on establishing a quality bonus system for the Children's Hospitals Graduate Medical Education (CHGME) Payment Program. The CHGME Support Reauthorization Act of 2013 states that the Secretary may establish a quality bonus system, whereby the Secretary distributes bonus payments to hospitals participating in the program that meet standards specified by the Secretary. The goal of this notice is to seek comment to assist HRSA in the development of the standards, payment structure, and outcome measures for the CHGME Quality Bonus System.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2017-22344
Type: Notice
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Application of Biological Monitoring Methods for Chemical Exposures in Occupational Health
Document Number: 2017-22342
Type: Notice
Date: 2017-10-16
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 the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods (NMAM) entitled ``Application of Biological Monitoring Methods for Chemical Exposures in Occupational Health'' now available for public comment. To view the draft chapter and related materials, visit https://www.regulations.gov and enter CDC-2017-0090 in the search field and click ``Search.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
Document Number: 2017-22320
Type: Notice
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for humanitarian use devices (HUDs).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22317
Type: Notice
Date: 2017-10-16
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 effort 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 Behavioral Risk Factor Surveillance System (BRFSS), a system of customized telephone surveys conducted by U.S. states, territories, and the District of Columbia to produce state-level data about health-related risk behaviors, chronic health conditions, use of preventive services, and emerging health issues.
Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2017-22313
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This meeting will be open to the public but advance registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. Eastern Time on November 6, 2017. Information about the ACHDNC can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders/index.html .