Department of Health and Human Services October 2017 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 326
Proposed Data Collection Submitted for Public Comment and Recommendations
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.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
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
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
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
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
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
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
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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
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
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
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
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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
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 Standards for the Children's Hospitals Graduate Medical Education Payment Program's Quality Bonus System
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
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
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
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
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
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 https://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/ .
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media
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
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.
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
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
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.
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