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

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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
Document Number: 2019-07464
Type: Notice
Date: 2019-04-16
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.
Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021
Document Number: 2019-06822
Type: Rule
Date: 2019-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies for MA, Part D, and cost plans and PACE organizations; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This final rule will also revise the appeals and grievances requirements for certain Medicaid managed care and MA special needs plans for dual eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.
Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
Document Number: 2019-07463
Type: Rule
Date: 2019-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the ventilatory electrical impedance tomograph 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 ventilatory electrical impedance tomograph'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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SYMPROIC
Document Number: 2019-07459
Type: Notice
Date: 2019-04-15
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 SYMPROIC 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 human drug product.
The National Healthcare Safety Network's Proposed Requirement for Submission of Billing Codes as Part of Surgical Site Infection (SSI) Event Reporting; Request for Information
Document Number: 2019-07387
Type: Notice
Date: 2019-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention, in the Department of Health and Human Services, announces the opening of a docket to obtain information regarding the proposed requirement for reporting of International Classification of Diseases, 10th Revision, Procedural Classification System (ICD-10-PCS) or Current Procedures Terminology (CPT) Codes (collectively, Billing Codes) when reporting data to the National Healthcare Safety Network's (NHSN) Surgical Site Infection (SSI) Module of the Patient Safety Component. CDC is opening this docket to provide the opportunity to identify challenges for facilities to include ICD-10-PCS or CPT Codes when reporting SSI data to the NHSN, which is proposed to begin in 2021.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-07379
Type: Notice
Date: 2019-04-15
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.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Document Number: 2019-07354
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07341
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
Document Number: 2019-07324
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07303
Type: Notice
Date: 2019-04-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care.''
Supplemental Evidence and Data Request on Skin Substitutes for Treating Chronic Wounds
Document Number: 2019-07302
Type: Notice
Date: 2019-04-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Skin Substitutes for Treating Chronic Wounds, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I
Document Number: 2019-07290
Type: Rule
Date: 2019-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.
Meeting of the Advisory Committee on Organ Transplantation
Document Number: 2019-07278
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Organ Transplantation (ACOT) meeting has been rescheduled due to an unanticipated conflict and will now be held on Monday, May 20, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACOT website at https:// www.organdonor.gov/about-dot/acot.html.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2019-07275
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 30-31, 2019. The topic for this meeting will be ``Opportunities for Research Supported by the Special Statutory Funding Program for Type 1 Diabetes Research.'' The meeting is open to the public. Individuals planning to attend the workshop should register at https://www.scgcorp.com/dmiccworkshop2019 at least 7 days prior to the workshop.
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
Document Number: 2019-07269
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/iccvamforum- 2019.
Notice of Closed Meeting
Document Number: 2019-07266
Type: Notice
Date: 2019-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-07250
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-07249
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-07248
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-07232
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-xxxx, New
Document Number: 2019-07221
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07126
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, National Vaccine Program Office organization has modified its organizational structure.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07125
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion organization has modified its organizational structure.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07124
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, Office of Population Affairs organization has modified its organizational structure.
Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Document Number: 2019-06791
Type: Rule
Date: 2019-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final action establishing that certain active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are not eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rubs. Drug products containing these ineligible active ingredients will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. FDA is issuing this final action after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on the Agency's notices of proposed rulemaking, and all data and information on OTC consumer antiseptic rub products that have come to the Agency's attention. This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2019-07210
Type: Notice
Date: 2019-04-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-07183
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human; Notice of Meeting
Document Number: 2019-07182
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-07181
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07180
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Responsible Innovation in Dietary Supplements; Public Meeting; Request for Comments
Document Number: 2019-07168
Type: Notice
Date: 2019-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Responsible Innovation in Dietary Supplements.'' The purpose of the public meeting is to give interested parties an opportunity to present ideas for facilitating responsible innovation in the dietary supplement industry while preserving and strengthening FDA's ability to efficiently and effectively protect the public from unsafe and unlawful products.
Privacy Act; Implementation
Document Number: 2019-07122
Type: Rule
Date: 2019-04-11
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or Department) is issuing this final rule to make effective the exemptions that HHS proposed for certain records covered in a new Privacy Act system of records, System No. 09-90-1701, HHS Insider Threat Program Records.
Medicare and Medicaid Programs: Approval of an Application From Accreditation Commission for Health Care, Inc. for CMS Approval of Its End Stage Renal Disease (ESRD) Facility Accreditation Program
Document Number: 2019-07135
Type: Notice
Date: 2019-04-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our approval of the Accreditation Commission for Health Care, Inc. (ACHC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities that wish to participate in the Medicare or Medicaid programs.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-07089
Type: Notice
Date: 2019-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-07085
Type: Notice
Date: 2019-04-10
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP); Notice of Meeting and Request for Comment
Document Number: 2019-07064
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Room 245, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 18 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for meeting registration and more information on ACIP please visit the ACIP website: http://www.cdc.gov/vaccines/acip/index.html.
Notice of Closed Meeting
Document Number: 2019-07063
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07035
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07022
Type: Notice
Date: 2019-04-10
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.
Compliance With Statutory Program Integrity Requirements
Document Number: 2019-06971
Type: Rule
Date: 2019-04-10
Agency: Department of Health and Human Services
This document corrects technical errors in the provisions that appeared in the final rule published in the Federal Register on March 4, 2019 titled ``Compliance with Statutory Program Integrity Requirements''.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-07005
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse: Notice of Closed Meeting
Document Number: 2019-07004
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2019-07003
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-07002
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-07001
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting
Document Number: 2019-07000
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-06999
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-06998
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health