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

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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 .
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media
Document Number: 2017-22305
Type: Rule
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media 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 automated image assessment system for microbial colonies on solid culture media'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.
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction
Document Number: 2017-22299
Type: Notice
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications'' that appeared in the Federal Register of September 21, 2017 (82 FR 44185). The document announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The document was published with the incorrect docket number. This document corrects that error.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22294
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
Document Number: 2017-22288
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 the availability of a draft guidance for industry entitled ``Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).
Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens
Document Number: 2017-22287
Type: Rule
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens 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 nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' 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.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge
Document Number: 2017-22286
Type: Rule
Date: 2017-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge 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 enzyme packed cartridge'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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
Document Number: 2017-22285
Type: Notice
Date: 2017-10-16
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2017-22284
Type: Notice
Date: 2017-10-16
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 Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2017-22283
Type: Notice
Date: 2017-10-16
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.
Performance Review Board Members
Document Number: 2017-22282
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) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2017.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22259
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22258
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review-Evaluation of the National Tobacco Prevention and Control Public Education Campaign; Correction
Document Number: 2017-22256
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) published a document in the Federal Register of October 3, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewEvaluation of the National Tobacco Prevention and Control Public Education Campaign. The document provided the incorrect proposed project type (Revision).
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-22247
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-22246
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2017-22245
Type: Notice
Date: 2017-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-22207
Type: Notice
Date: 2017-10-13
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 (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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22206
Type: Notice
Date: 2017-10-13
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 Contact Investigation Outcome Reporting Forms, a collection that facilitates CDC working with state and local health departments in conducting contact investigations of individuals exposed to a communicable illness during travel.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2017-22202
Type: Notice
Date: 2017-10-13
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 efforts 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 proposed revision of the information collection project entitled National Youth Tobacco Surveys (NYTS) 2018-2020, which aims to collect data on tobacco use among middle- and high school students.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22201
Type: Notice
Date: 2017-10-13
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 efforts 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 ``Online training for law enforcement to reduce risks associated with shift work and long work hours''. This study will develop and pilot test a new, online, interactive training program tailored for the law enforcement community that relays the health and safety risks associated with shift work, long work hours, and related workplace sleep issues and presents strategies for managers and officers to reduce these risks.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22200
Type: Notice
Date: 2017-10-13
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 entitled Implementing the 6[verbar]18 Initiative: Case Studies. CDC proposes to seek a three-year clearance to conduct semi-structured interviews with state public health department and Medicaid agency officials. CDC designed this information collection project to improve understanding of facilitators and barriers to increased utilization of evidence-based interventions for selected chronic and infectious diseases.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22199
Type: Notice
Date: 2017-10-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22198
Type: Notice
Date: 2017-10-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22197
Type: Notice
Date: 2017-10-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability
Document Number: 2017-22196
Type: Notice
Date: 2017-10-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA.
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability
Document Number: 2017-22192
Type: Notice
Date: 2017-10-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017 and certain proposed changes in policies and procedures surrounding its application.