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

Results 401 - 450 of 26,202
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-07755
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-07754
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-07753
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-07747
Type: Notice
Date: 2018-04-13
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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Notice of Meeting Center for Mental Health Services
Document Number: 2018-07693
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended To Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Document Number: 2018-07687
Type: Notice
Date: 2018-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff.'' FDA's vision is that NGS- based tests can be developed, validated, and offered for clinical use through a process that leverages appropriate standards, quality systems controls, and community assessment of clinical validity to streamline the premarket review process. This guidance provides recommendations for designing, developing, and establishing analytical performance for NGS-based tests used for whole exome human DNA sequencing (WES) or targeted human DNA sequencing intended to aid in the diagnosis of symptomatic individuals with suspected germline diseases or other conditions. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests.
Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Document Number: 2018-07686
Type: Notice
Date: 2018-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff.'' This guidance document describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA's regulatory review of genetic and genomic-based tests. This guidance further outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases.
Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products
Document Number: 2018-07684
Type: Notice
Date: 2018-04-13
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 ``Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-07680
Type: Notice
Date: 2018-04-13
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-07679
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2018-07646
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-07439
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program
Document Number: 2018-07619
Type: Notice
Date: 2018-04-12
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.
National Institute of Environmental Health Sciences; Notice to Close Meeting
Document Number: 2018-07614
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2018-07613
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2018-07612
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-07611
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-07610
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-07609
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-07608
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2018-07574
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-07564
Type: Notice
Date: 2018-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance provides FDA's current thinking on expanding the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the draft guidance is to describe an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific, submitter-identified predicate device as part of a demonstration of substantial equivalence. This draft guidance is not final nor is it in effect at this time.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2018-07563
Type: Notice
Date: 2018-04-12
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 comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Coal Workers' Health Surveillance Program (CWHSP). The CWHSP is a congressionally-mandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-07562
Type: Notice
Date: 2018-04-12
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 comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle that will provide data that links turnout gear use conditions to its resulting performance characteristics.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
Document Number: 2018-07545
Type: Notice
Date: 2018-04-12
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.
Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration
Document Number: 2018-07544
Type: Notice
Date: 2018-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Reagan-Udall Foundation (the Foundation) for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Administration Amendments Act of 2007, is announcing its annual public meeting. The Foundation will discuss its activities and how it supports FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Document Number: 2018-07543
Type: Notice
Date: 2018-04-12
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.
Agency Emergency Information Collection Clearance Request for Public Comment
Document Number: 2018-07535
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2018-07534
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
National Advisory Council on Migrant Health
Document Number: 2018-07523
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a National Advisory Council on Migrant Health (NACMH) meeting has been scheduled. This meeting will be open to the public. The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the NACMH website: https://bphc.hrsa.gov/qualityimprovement/strategicpartnership s/nacmh/ index.html.
Submission for OMB Review; Comment Request
Document Number: 2018-07522
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
Findings of Research Misconduct
Document Number: 2018-07521
Type: Notice
Date: 2018-04-12
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Brandi M. Baughman, Ph.D., postdoctoral fellow in the Center for Integrative Chemical Biology and Drug Discovery, Division of Chemical Biology and Medicinal Chemistry, University of North Carolina at Chapel Hill (UNC). Dr. Baughman engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM100919. The administrative actions, including debarment for a period of two (2) years, were implemented beginning on March 19, 2018, and are detailed below.
Draft-National Occupational Research Agenda for Public Safety
Document Number: 2018-07374
Type: Notice
Date: 2018-04-12
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 NORA Agenda entitled National Occupational Research Agenda for Public Safety for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2018-0033 in the search field and click ``Search.''
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2018-07493
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)-Correction
Document Number: 2018-07479
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This is a correction to the meeting announcement of the Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee published on the Federal Register, Vol. 83, No. 66/Thursday, April 5, 2018/Notices. FR Doc. 2018-06913. The notice of the meeting should have included the following statement: Members of the public can attend the meeting via telephone or webcast only, and not in person. The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting is open to the public and will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss ISMICC member relationship to implementation workgroups, establishing the prevalence of SMI and SED, communication with non-federal organizations to engage non-federal support for ISMICC, and future meetings. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee.
Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications
Document Number: 2018-07440
Type: Notice
Date: 2018-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-07438
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal
Document Number: 2018-07437
Type: Notice
Date: 2018-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs 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 Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2020.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2018-07426
Type: Notice
Date: 2018-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
Preparation for International Cooperation on Cosmetics Regulation Twelfth Annual Meeting; Public Meeting
Document Number: 2018-07416
Type: Notice
Date: 2018-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-12 Meeting.'' The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-12 meeting that will be held July 10 to 12, 2018, in Tokyo, Japan.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-07415
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-07414
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Reconciling National Coverage Determinations on Positron Emission Tomography (PET) Neuroimaging for Dementia
Document Number: 2018-07410
Type: Notice
Date: 2018-04-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the court order on July 19, 2016 (Kort v. Burwell), this notice provides further explanation on the National Coverage Determinations for positron emission tomography (PET) neuroimaging for dementia.
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2018-07396
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-07395
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-07394
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-07393
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2018-07392
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-07391
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-07390
Type: Notice
Date: 2018-04-11
Agency: Department of Health and Human Services, National Institutes of Health