Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 494
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-03046
Type: Notice
Date: 2020-02-14
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.
Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications
Document Number: 2020-03025
Type: Notice
Date: 2020-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 28 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2020-03023
Type: Notice
Date: 2020-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 19, 2019. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``Bridging for Drug-Device and Biologic-Device Combination Products.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-02999
Type: Notice
Date: 2020-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Requirements and Registration for the 2020 Million Hearts Hypertension Control Challenge
Document Number: 2020-02987
Type: Notice
Date: 2020-02-14
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) announces the launch of the 2020 Million Hearts Hypertension Control Challenge.
Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability
Document Number: 2020-02986
Type: Notice
Date: 2020-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a supplemental draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This supplemental draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''
Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correcting Amendment
Document Number: 2020-02847
Type: Rule
Date: 2020-02-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In the November 12, 2019 issue of the Federal Register, we published a final rule with comment period that made changes to the conditions for therapeutic outpatient hospital or CAH services and supplies incident to a physician's or nonphysician practitioner's service. This correcting amendment corrects a technical error in the regulations resulting from an error in that final rule with comment period.
Coal Workers' Health Surveillance Program: B Reader Decertification and Autopsy Payment
Document Number: 2020-02705
Type: Proposed Rule
Date: 2020-02-14
Agency: Department of Health and Human Services
HHS proposes to revise the National Institute for Occupational Safety and Health (NIOSH), Coal Workers' Health Surveillance Program (Program) regulations by adding a provision to allow NIOSH to suspend or revoke B Reader certification. Certification may be revoked for any B Reader found by NIOSH to have engaged in a pattern of providing unreasonably inaccurate chest radiograph classifications in practice those that are found by the Program to diverge substantially from a competent interpretation of the radiographs, as determined by a panel of practicing, certified B Readers selected by NIOSH. In addition to the B Reader provisions, HHS would also amend existing regulatory text to allow compensation for pathologists who perform autopsies on coal miners at a market rate, on a discretionary basis as needed for public health purposes.
Assistant Secretary for Administration; Delegation of Authority
Document Number: 2020-02944
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services
Request for Information (RFI): Inviting Comments and Suggestions on a Framework for the NIH-Wide Strategic Plan for FYs 2021-2025
Document Number: 2020-02919
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
This Request for Information (RFI) is intended to gather broad public input to assist the National Institutes of Health (NIH) in developing the NIH-Wide Strategic Plan for Fiscal Years (FYs) 2021- 2025. NIH invites input from stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, regarding the proposed framework for the FY 2021-2025 NIH-Wide Strategic Plan. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.
Request for Information: Stakeholder Input on Opportunities for Increased Collaboration to Advance Prevention Research
Document Number: 2020-02918
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), Office of the Director, Office of Disease Prevention (ODP) issues this Request for Information (RFI) to identify opportunities to foster and engage in partnerships and dialogue with stakeholders to advance prevention research. The ODP hopes this will help us determine areas where we can collaboratively advance prevention research priorities, training opportunities, and better meet the needs of our stakeholders. The ODP invites input from researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of the organization and membership as a whole.
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-02916
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2020-02915
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2020-02914
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, (National Cancer Institute)
Document Number: 2020-02913
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; 30-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)
Document Number: 2020-02911
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2020-02873
Type: Notice
Date: 2020-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues related to blood and products derived from blood. Matters considered at the meeting will include current strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components, an update on the Transfusion Transmissible Infections Monitoring System (TTIMS), and testing blood donations for hepatitis B surface antigen. The meeting will be open to the public.
Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee
Document Number: 2020-02872
Type: Notice
Date: 2020-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives from different medical device areas based on expertise relevant to the topics being considered by the Committee. Nominations will be accepted for upcoming vacancies effective with this notice. 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.
Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-02871
Type: Notice
Date: 2020-02-13
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 final guidance entitled ``Peripheral Vascular Atherectomy DevicesPremarket Notification Submissions.'' This guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Membership Forms for Organ Procurement and Transplantation Network OMB No. 0915-0184-Revision
Document Number: 2020-02870
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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 or any other aspect of the ICR.
Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices; Draft Guidance for Industry; Availability
Document Number: 2020-02867
Type: Notice
Date: 2020-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #262 entitled ``Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.'' This draft guidance document, when finalized, will help industry submit information for effective and efficient consultations with FDA regarding investigational animal food substances.
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2020-02861
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2020-02860
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2020-02859
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting; Advisory Committee for Women's Services (ACWS)
Document Number: 2020-02850
Type: Notice
Date: 2020-02-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2020-02846
Type: Notice
Date: 2020-02-13
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.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2019
Document Number: 2020-02845
Type: Notice
Date: 2020-02-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Patient-Focused Drug Development for Vitiligo; Public Meeting; Request for Comments
Document Number: 2020-02767
Type: Notice
Date: 2020-02-12
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 ``Patient-Focused Drug Development for Vitiligo.'' The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-02754
Type: Notice
Date: 2020-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-02753
Type: Notice
Date: 2020-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-02752
Type: Notice
Date: 2020-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-02751
Type: Notice
Date: 2020-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Control of Communicable Diseases; Foreign Quarantine
Document Number: 2020-02731
Type: Rule
Date: 2020-02-12
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) is issuing this interim final rule to amend its Foreign Quarantine regulations, to enable CDC to require airlines to collect, and provide to CDC, certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including travel restrictions.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2020-02698
Type: Notice
Date: 2020-02-11
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.
Notice of Closed Meeting
Document Number: 2020-02694
Type: Notice
Date: 2020-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2020-02693
Type: Notice
Date: 2020-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2020-02691
Type: Notice
Date: 2020-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-02671
Type: Notice
Date: 2020-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
LANXESS Corporation; Filing of Food Additive Petition (Animal Use)
Document Number: 2020-02664
Type: Proposed Rule
Date: 2020-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that LANXESS Corporation has filed a petition proposing that the food additive regulations be amended to provide for the safe use of calcium formate as a feed acidifying agent, to lower the pH, in complete feeds for swine or poultry.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Ryan White HIV/AIDS Program: Allocation and Expenditure Forms, OMB No. 0915-0318-Revision
Document Number: 2020-02657
Type: Notice
Date: 2020-02-11
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.
2019 Interagency Autism Coordinating Committee Call for Nominations Announcement
Document Number: 2020-02645
Type: Notice
Date: 2020-02-11
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 26, 2019, seeking nominations of individuals to serve as non- federal public members on the Interagency Autism Coordinating Committee (IACC). The purpose of this Notice is to provide an extension to allow additional time for the acceptance of nominations to the IACC.
Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
Document Number: 2020-02644
Type: Rule
Date: 2020-02-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the continuation of prior authorization for 45 Healthcare Common Procedure Coding System (HCPCS) codes on the Required Prior Authorization List of DMEPOS Items that require prior authorization as a condition of payment, as well as the addition of six HCPCS codes to this list. Prior authorization for the additional codes will be implemented in two phases.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-02641
Type: Notice
Date: 2020-02-11
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: 2020-02640
Type: Notice
Date: 2020-02-11
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: 2020-02639
Type: Notice
Date: 2020-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-02638
Type: Notice
Date: 2020-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-02637
Type: Notice
Date: 2020-02-11
Agency: Department of Health and Human Services, National Institutes of Health