Results 1 - 50 of 26,202
Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2018-11330
Type: Notice
Date: 2018-05-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the Joint Commission for reapproval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the Joint Commission meets or exceeds the applicable CLIA requirements. We are announcing the reapproval and grant the Joint Commission deeming authority for a period of 6 years.
Advisory Commission on Childhood Vaccines
Document Number: 2018-11298
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold a public meeting. This meeting will be open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Document Number: 2018-11281
Type: Notice
Date: 2018-05-25
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 the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.
Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
Document Number: 2018-11258
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan.
Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
Document Number: 2018-11257
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to to Fundacao Butantan, having a place of business in Sao Paulo, Brazil.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-11256
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-11255
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-11220
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-11216
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-11215
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-11213
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center; Notice of Closed Meeting
Document Number: 2018-11212
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Amended Notice of Meeting
Document Number: 2018-11211
Type: Notice
Date: 2018-05-25
Agency: Department of Health and Human Services, National Institutes of Health
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-11166
Type: Notice
Date: 2018-05-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments
Document Number: 2018-11132
Type: Notice
Date: 2018-05-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is evaluating its current thinking regarding the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. We are specifically requesting public input on possible alternative approaches for evaluating such products or information to assist in the potential development of alternative recommended study designs.
Office of the Deputy Assistant Secretary for Administration Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-11125
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) has realigned The Office of the Deputy Assistant Secretary for Administration (ODASA). This realignment removes the Office of the Chief Information Officer as a direct report to the Assistant Secretary for Children and Families and realigns the Office within the ODASA. It moves the National Grants Center of Excellence to the ODASA's Immediate Office. It also removes the Ethics and Facilities team from the Immediate Office of the ODASA and places the functions in the Office of Workforce Planning and Development.
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability
Document Number: 2018-11117
Type: Notice
Date: 2018-05-24
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 entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This guidance finalizes the draft guidance of the same name issued on February 16, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Document Number: 2018-11114
Type: Notice
Date: 2018-05-24
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 the information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for animal food.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
Document Number: 2018-11113
Type: Notice
Date: 2018-05-24
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.
Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR); Correction
Document Number: 2018-11097
Type: Notice
Date: 2018-05-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-11081
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11080
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-11056
Type: Notice
Date: 2018-05-23
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.
Solicitation of Nominations for Membership To Serve on the National Advisory Council on the National Health Service Corps
Document Number: 2018-11034
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the National Advisory Council on the National Health Service Corps (NACNHSC). NACNHSC advises the Secretary of HHS and, by designation, HRSA's Administrator on the priorities and policies impacting the National Health Service Corps (NHSC) and provides specific recommendations for policy revisions.
Enhancement and Update of the National HIV Curriculum e-Learning Platform
Document Number: 2018-11033
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau (HAB) intends to issue a single source award to the University of Washington for $300,000 for activities authorized under Section 2692(a) of the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009. This notice is subject to the appropriation of funds and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can award funds in a timely manner. Subject to the availability of funds and the University of Washington's satisfactory performance, HAB will also issue non- competitive, single source awards of $300,000 each in fiscal years (FYs) 2019 to 2022. This will allow the University of Washington to update and enhance the National HIV Curriculum (NHC) and the electronic platform that supports it, and to keep pace with the latest HIV science, federal guidelines, and treatment protocols and practices for educating health professionals on the optimal care and treatment of people living with HIV over its four-year project period.
Notice of Correction
Document Number: 2018-11032
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is correcting a notice published in the September 26, 2017 issue of the Federal Register entitled Improving Care for Children and YouthIncentive Prize. This correction amends the subject of the challenge and the timeline. Please note, however, that this correction notice, along with future updates, as needed and pursuant to recent changes to the applicable law, will be posted on challenge.gov and mchbgrandchallenges.hrsa.gov.
Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
Document Number: 2018-10994
Type: Notice
Date: 2018-05-23
Agency: Food and Drug Administration, Department of Health and Human Services, Department of Health and Human Service
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.
Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability
Document Number: 2018-10993
Type: Notice
Date: 2018-05-23
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 entitled ``Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.'' This draft guidance addresses FDA's current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an over-the-counter (OTC) monograph.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10935
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10934
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10933
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10932
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability
Document Number: 2018-10928
Type: Notice
Date: 2018-05-22
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 entitled ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.'' This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19, 2005.
Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket; Request for Comments
Document Number: 2018-10927
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to assist with the development of a policy or guidance document on the assessment of pH-dependent drug-drug interactions (DDIs). In October 2017, FDA published two draft guidance documents on DDIs entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' (In Vitro Studies Draft Guidance) and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' (Clinical Drug Interaction Studies Draft Guidance). These two draft guidances focus on enzyme- and transporter-based DDIs and do not include a framework to assess pH-dependent DDIs. FDA is seeking public input on best practices in the planning and evaluation of pH-dependent DDIs.
Bioanalytical Method Validation; Guidance for Industry; Availability
Document Number: 2018-10926
Type: Notice
Date: 2018-05-22
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 final guidance for industry entitled ``Bioanalytical Method Validation.'' This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2018-10924
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections
Document Number: 2018-10923
Type: Rule
Date: 2018-05-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' (hereinafter referred to as the ``CY 2018 Quality Payment Program final rule'').
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10910
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10888
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
Document Number: 2018-10856
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 controlled correspondence related to generic drug development.
Advisory Committee; Blood Products Advisory Committee; Renewal
Document Number: 2018-10848
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 13, 2020.
National Institute of Environmental Health Sciences; Notice to Close Meeting
Document Number: 2018-10838
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-10837
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-10836
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10835
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2018-10834
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Grants to States for Access and Visitation
Document Number: 2018-10820
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Information for the Development of the Fiscal Year 2021-2023 Trans-NIH Strategic Plan for HIV and HIV-Related Research
Document Number: 2018-10784
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH), invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, community, and other interested constituents on the development of the fiscal year (FY) 2021-2023 Trans-NIH Strategic Plan for HIV and HIV-Related Research (the Plan). The Plan is designed to identify and articulate future directions to maximize the NIH's investments in HIV research.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2018-10734
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Draft Guidance for Industry; Availability
Document Number: 2018-10733
Type: Notice
Date: 2018-05-21
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 entitled ``Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.'' The purpose of this guidance is to assist sponsors in all phases of development of drugs and biologics for the treatment or prevention of cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT).