October 24, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.'' Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The guidance document provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2021.

NMFS solicits nominations for the Atlantic Highly Migratory Species (HMS) Southeast Data, Assessment, and Review (SEDAR) Workshops Advisory Panel, also known as the ``SEDAR Pool.'' The SEDAR Pool is comprised of a group of individuals who may be selected to consider data and advise NMFS regarding the scientific information including, but not limited to, data and models used in stock assessments for oceanic sharks in the Atlantic Ocean, Gulf of Mexico, and Caribbean Sea. Nominations are being sought for 5-year appointments (2023-2028). Individuals with definable interests in the recreational and commercial fishing and related industries, environmental community, academia, and non-governmental organizations will be considered for membership on the SEDAR Pool.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

Fisher Clinical Services, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

In compliance with the Paperwork Reduction Act of 1995 (``PRA''), this notice announces that the Information Collection Request (``ICR'') abstracted below has been forwarded to the Office of Information and Regulatory Affairs (``OIRA''), of the Office of Management and Budget (``OMB''), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.