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

Results 1 - 50 of 45,089
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (ICR-Rev) (OMB Approval Number 0985-0004); Maintenance of Effort for Title III and Extension of, and Minor Revisions Due to Statutory Language Changes to the Certification of Long-Term Care Ombudsman Program Expenditures
Document Number: 2017-22914
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995 (the PRA). This 30-Day notice requests comments on the information collection requirements related to the proposed revision of an existing data collection regarding the information collection requirements in the Maintenance of Effort collection form for all ACL/AoA Title III Grantees.
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2017-22911
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2017-22910
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2017-22909
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-22908
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Determination of Regulatory Review Period for Purposes of Patent Extension; OBIZUR
Document Number: 2017-22898
Type: Notice
Date: 2017-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OBIZUR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Inspire Upper Airway Stimulation System
Document Number: 2017-22897
Type: Notice
Date: 2017-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Inspire Upper Airway Stimulation System (Inspire UAS System) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; MITRACLIP CDS
Document Number: 2017-22895
Type: Notice
Date: 2017-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MITRACLIP CDS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Forms Undergoing Paperwork Reduction Act Review-Evaluation of the National Tobacco Prevention and Control Public Education Campaign; Correction
Document Number: 2017-22893
Type: Notice
Date: 2017-10-23
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 on October 13, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewAnnual Progress Report (APR) for Injury Control Research Centers (ICRC). The document provided the incorrect proposed project title, number of annual reporting responses for each respondent and average burden per response estimate.
Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-22892
Type: Notice
Date: 2017-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and regulatory requirements are met.
Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability
Document Number: 2017-22891
Type: Notice
Date: 2017-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled ``Draft Guidance on Methylphenidate Hydrochloride.'' The new 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 methylphenidate hydrochloride oral extended-release tablets.
Division of Behavioral Health; Youth Regional Treatment Center Aftercare Pilot Project; Correction of Due Dates
Document Number: 2017-22864
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a notice in the Federal Register (FR) on October 11, 2017, for the Fiscal Year 2018 Youth Regional Treatment Center Aftercare Pilot Project, Funding Announcement Number: HHS-2018-IHS-YRTC-0001. Several Key Dates have been modified. The Application Due Date is November 12, 2017 and the Earliest Anticipated Start Date is December 1, 2017.
Performance Review Board Members
Document Number: 2017-22863
Type: Notice
Date: 2017-10-23
Agency: Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22825
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2017-22824
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
Document Number: 2017-22813
Type: Rule
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
Medicare and Medicaid Programs; Application by Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Accreditation Program
Document Number: 2017-22812
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Analyses, Research and Studies To Address the Impact of CMS Programs on American Indian/Alaska Native (AI/AN) Beneficiaries and the Health Care System Serving These Beneficiaries
Document Number: 2017-22811
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice supports expansion of research on the impact of CMS programs on the Indian health care system through a single source award. The Indian Health Service (IHS), Tribes and Tribal Organizations and Urban programs, deliver health care services to American Indian/ Alaska Native (AI/AN) people through a network of hospitals, clinics and other providers. This award expands research on the impact of CMS programs and the delivery of health care to AI/AN beneficiaries.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22774
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to provide comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Respiratory Protective Devices information collection project.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22773
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22772
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
Document Number: 2017-22769
Type: Rule
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes
Document Number: 2017-22768
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2017-22736
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.
Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate; Draft Guidances for Industry; Availability
Document Number: 2017-22735
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder, entitled ``Draft Guidance on Salmeteral Xinafoate'' and ``Draft Guidance on Fluticasone Propionate.'' The guidances, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder.
Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability
Document Number: 2017-22734
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled ``Draft Guidance on Tiotropium Bromide.'' The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation powder.
Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability
Document Number: 2017-22731
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 507; Draft Guidance for Industry.'' The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are ``solely engaged'' in certain activities. Establishments and facilities ``solely engaged'' in certain activities are exempt from some or all requirements of the regulations.
Current Good Manufacturing Practice Requirements for Food for Animals; Guidance for Industry; Availability
Document Number: 2017-22730
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-22729
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2017-22728
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2017-22727
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22726
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22725
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2017-22720
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22718
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22716
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-22713
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-22699
Type: Notice
Date: 2017-10-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Patient Safety Organizations: Voluntary Relinquishment From the American College of Physicians Patient Safety Organization
Document Number: 2017-22671
Type: Notice
Date: 2017-10-19
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the American College of Physicians Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-22630
Type: Notice
Date: 2017-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2017-22626
Type: Notice
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2018 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/ input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System
Document Number: 2017-22590
Type: Rule
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2017-22574
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-22573
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22572
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22571
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-22570
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22569
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-22568
Type: Notice
Date: 2017-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
Document Number: 2017-22550
Type: Notice
Date: 2017-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.