Department of Health and Human Services February 13, 2020 – Federal Register Recent Federal Regulation Documents

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.
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