Department of Health and Human Services December 9, 2019 – Federal Register Recent Federal Regulation Documents

Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-26470
Type: Notice
Date: 2019-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Magnetic Resonance (MR) CoilPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.'' This draft guidance is not final nor is it in effect at this time.
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated With Internal or External Hemorrhoids; Draft Guidance for Industry; Availability
Document Number: 2019-26464
Type: Notice
Date: 2019-12-09
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Locally Applied Corticosteroid Products for the Short- Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.'' This draft guidance will serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Error Products, pharmaceutical sponsors, the academic community, and the public.
Notice to Announce the National Eye Institute (NEI) Draft Strategic Plan, 2020 Vision for the Future; Request for Information
Document Number: 2019-26451
Type: Notice
Date: 2019-12-09
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 Eye Institute (NEI), National Institutes of Health (NIH) in developing its next strategic plan titled, 2020 Vision for the Future. NEI invites input from vison 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 their organization and their membership as a whole.
Meeting of the Tick-Borne Disease Working Group
Document Number: 2019-26441
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the TBDWG will (1) hear presentations from eight subcommittees on findings and potential actions from reports prepared for the TBDWG to consider and (2) further discuss plans for developing the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 report. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data Collection Tool for State Offices of Rural Health Grant Program, OMB No. 0915-0322-Revision
Document Number: 2019-26440
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Request for Information: Family Caregiving Advisory Council
Document Number: 2019-26438
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living and the Family Caregiving Advisory Council seek information to be used in the development of the Initial Report, the Family Caregiving Strategy and public listening sessions being planned for 2020.
Request for Information: Family Caregiving Advisory Council
Document Number: 2019-26437
Type: Notice
Date: 2019-12-09
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living and the Advisory Council to Support Grandparents Raising Grandchildren seek information to be used in the development of the Initial Report, as required by the Supporting Grandparents Raising Grandchildren Act.