Sec. 302. Certain department of health and human services and food and drug administration reporting requirements
616 words·~3 min read·
/bill/118/hr/6028/ih/section-302·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than one calendar year after the date of the enactment of this Act, and annually thereafter for the following five calendar years, the Secretary of Health and Human Services shall submit to the appropriate congressional committees, reports on the following: A report detailing— administrative actions taken pursuant to section 301 of this Act (and the amendments made by such section) to ensure certification of designated State medical cannabis products, including timelines and reasons for any delays past statutory deadlines; the number, nature, and kind of designated State medical cannabis products granted or denied certification in the previous year; any variances or lingering potential conflicts with State laws regarding medical cannabis products and section 301 of this Act (and the amendments made by such section), and any plans for resolving these variances; and the impact of section 301 of this Act (and the amendments made by such section) with respect to patient access to designated State medical cannabis products.
A report detailing— what the current market for cannabidiol (hereainfter referred to as CBD ) and other hemp-derived cannabinoid products looks like, including the types and forms of products available, manufacturing practices within the industry, market supply chain, how products are marketed and sold, the types of cannabinoids used in products, the marketed effects of CBD and other hemp-derived cannabinoid products, and the range of CBD and other hemp derived cannabinoid doses currently found in the market; what State-based regulations have been created to CBD and other hemp derived cannabinoids and what is their interaction with Agricultural Marketing Act of 1946 in general, including Public Law 115–334 , the Agriculture Improvement Act of 2018 ( the 2018 Farm Bill ); how the lack of national standards for CBD and other hemp derived cannabinoid products affects the market; and what is currently known about the safety and risk-benefit profile of CBD and other hemp derived cannabinoids, including what safety and toxicity data are available to support this knowledge and any relevant information about safety with regard to specific populations, such as children and pregnant individuals A report detailing— the number and type of appropriately registered individuals and entities under the Act, including the number of applications for registration received, the number of applications for registration approved, the number of applications for registration denied; the impact of any rescheduling on cannabis or cannabis-derived substances to Schedules III–V or full decontrol, on further drug research, including new use and new safety research; the number and type of any new drugs developed and approved pursuant to section 201 of Public Law 117–215 , the Medical Marijuana and Cannabidiol Research Expansion Act; and the number and type of commercial drug manufacturer registrants approved and denied pursuant to section 202 of Public Law 117–215 , the Medical Marijuana and Cannabidiol Research Expansion Act.
A report detailing— administrative actions taken to implement part J of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, including and with specific reference to actions taken to implement non-designated State medical cannabis product provisions, such as new drug, dietary supplement, cosmetic, and food use provisions; and administrative actions taken to implement part J of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, including and with specific reference to actions taken to implement designated State medical cannabis product provisions.
In this section— the term appropriate congressional committees means the Committee on Energy and Commerce of the House of Representatives and the Committee on Committee on Health Education, Labor, and Pensions of the United States Senate; and the term hemp has the meaning given the term in section 297A of the Agricultural Marketing Act of 1946.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Sec. 302
Certain department of health and human services and food and drug administration reporting requirements
Cites 2Cited by 0 across 0 sources