Sen. Roger Marshall

This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

This resolution recognizes the efforts of the Trump Administration and Operation Warp Speed in the development of the COVID-19 (i.e., coronavirus disease 2019) vaccine. Operation Warp Speed is an interagency partnership that coordinates federal efforts to accelerate the development, acquisition, and distribution of medical countermeasures for COVID-19.

This bill provides for the award of Congressional Gold Medals posthumously to Glen Doherty, Tyrone Woods, J. Christopher Stevens, and Sean Smith (four Americans who were killed in the September 11, 2012, attack on the U.S. consulate in Benghazi, Libya) in recognition of their contributions to the nation.

Presumptive Benefits for War Fighters Exposed to Burn Pits and Other Toxins Act of 2021 This bill establishes a presumption of service-connection for specified diseases associated with exposure to burn pits (an area used for burning solid waste in open air without equipment) and other toxins by veterans who were awarded specified medals on or after August 2, 1990. Under a presumption of service-connection, specific conditions diagnosed in certain veterans are presumed to have been caused by the circumstances of their military service. Health care benefits and disability compensation may then be awarded. Under the bill, if the Department of Veterans Affairs (VA) receives a written petition to add a disease to the list, the VA must request a determination by the National Academies of Sciences, Engineering, and Medicine with respect to whether there is a positive association between the exposure of humans to a covered toxin and the occurrence of the disease in humans. The bill makes disability or death of certain employees from specified diseases compensable as a work injury. Specifically, such employees are those who were employees of the Department of State, the Department of Defense, or an element of the intelligence community on or after August 2, 1990, and carried out job responsibilities for at least 30 days during a contingency operation.

Veterans Burn Pits Exposure Recognition Act of 2021 This bill requires the Department of Veterans Affairs (VA) to concede, for the purposes of health care benefits and wartime disability compensation, that a veteran was exposed to certain toxic substances, chemicals, and hazards from burn pits if such veteran served on active duty in a covered location during a specified time frame (unless there is affirmative evidence to establish that the veteran was not exposed during such service). A burn pit is an area used for burning solid waste in open air without equipment. Specifically, the bill covers the following locations and corresponding time periods: Iraq between August 2, 1990, and February 28, 1991, as well as from March 19, 2003, until burn pits are no longer used in this location; Southwest Asia (including Kuwait, Saudi Arabia, Oman, and Qatar) from August 2, 1990, until burn pits are no longer used in these locations; and Afghanistan, Syria, Jordan, Egypt, Lebanon, Yemen, and Djibouti from September 11, 2001, until burn pits are no longer used in these locations. Under the bill, if an exposed veteran submits insufficient evidence to establish a service-connection for purposes of disability compensation, the VA shall provide a medical examination and request a medical opinion regarding a causal link between the disability and a toxin, chemical, or hazard.

Animal Freedom from Testing, Experiments, and Research Act of 2021 or the AFTER Act of 2021 This bill requires departments, agencies, or instrumentalities that operate federal research facilities or exhibit animals to promulgate regulations that facilitate and encourage the adoption of certain animals that are suitable for retirement.

Abortion Providers Loan Elimination Act This bill makes abortion providers ineligible to receive a loan under the Paycheck Protection Program, which was established to support small businesses in response to COVID-19. This prohibition shall not apply to hospitals or entities that exclusively provide abortions (1) where the pregnancy is the result of rape or incest, or (2) where the pregnancy endangers the life of the mother. The Inspector General of the Small Business Administration must report on the number of paycheck protection loans made to the Planned Parenthood Federation of America and to other abortion providers.

Pharmacy and Medically Underserved Areas Enhancement Act This bill provides for Medicare coverage and payment with respect to certain pharmacist services that (1) are furnished by a pharmacist in a health-professional shortage area, and (2) would otherwise be covered under Medicare if furnished by a physician.

Food Allergy Safety, Treatment, Education, and Research Act of 2021 or the FASTER Act of 2021 This bill expands the definition of major food allergen for purposes of certain food-labeling requirements to specifically include sesame. In addition, the Department of Health and Human Services must report on certain information related to food allergy research and data collection activities.

This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.