Department of Health and Human Services January 3, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of the Chief Scientist (OCS) has modified their organizational structure. The new organizational structure was approved by the Deputy Secretary of Health and Human Services and effective on November 24, 2021.

HRSA, a sub-agency of the Department of Health and Human Services, is announcing a change in the NPDB Basis for Action Code Lists for Federal Licensure, and State Licensure or Certification Actions to individuals and entities authorized to report and request information from the NPDB. These changes will contain updated codes and code use guidance applicable to organizations submitting Federal Licensure, or State Licensure or Certification Actions. The code modifications and guidance are intended to provide improved report accuracy and promote a better understanding of the use and application of the basis of action codes available for report submission. The modifications are based in part upon recommendations made through a collaborative effort with NPDB industry partners: the Federation of State Boards of Physical Therapy, the National Council of State Boards of Nursing, the Federation of State Medical Boards, the Association of State and Provincial Psychology Boards, the National Board for Certification in Occupational Therapy, the Association of Social Work Boards, and the National Association of Boards of Pharmacy. Basis for Action codes help to accurately describe the basis for licensure actions reported. Basis for Action codes have no impact on the licensure action reported or the applicability of NPDB reporting criteria. New, modified, and retired codes have no impact on historical reporting. The coding of previously submitted reports will remain unchanged.

The National Center for Advancing Translational Sciences (NCATS) will host a public online forum to enable public discussion of the Center's proposals to reorganize its Office of Rare Diseases Research and Office of Grants Management and Scientific Review to the Division of Rare Diseases Innovation and the Division of Extramural Activities, respectively. The proposals seek to recognize the importance of rare diseases research to the Center and to align its extramural activities with those of other Institutes and Centers at the National Institutes of Health. The online forum will allow members of the public to review the reorganization proposals and submit comments.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January 24, 2022 meeting the Advisory Council will hear about the National Plan to Address Alzheimer's Disease: 2021 Update, as well as update from federal agencies. The Advisory Council will also hear presentations about dementia risk reduction for veterans and research on the potential relationship between COVID-19 and dementia. The Advisory Council will also hear about a recent report on the current capacity of the dementia care workforce. A panel will present on dementia assessment tools for special populations, such as individuals with intellectual and developmental disabilities. Finally, the Advisory Council will hear from a panel on the inclusion of caregivers in clinical care settings, including those in rural communities.