IIB 116th CONGRESS 2d Session H. R. 2117 IN THE SENATE OF THE UNITED STATES November 18, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To improve the health and safety of Americans living with food allergies and related disorders, including potentially life-threatening anaphylaxis, food protein-induced enterocolitis syndrome, and eosinophilic gastrointestinal diseases, and for other purposes.

1. Short title This Act may be cited as the Food Allergy Safety, Treatment, Education, and Research Act of 2020 or the FASTER Act of 2020 . 2. Food allergy safety recommendations of the National Academy of Medicine (a) Collection of food allergy data The Public Health Service Act is amended by inserting before section 318 of such Act ( 42 U.S.C. 247c ) the following new section: 317W. Collection of food allergy data (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— (1) expand and intensify the collection of information on the prevalence of food allergies for specific allergens in the United States, such as through the National Health and Nutrition Examination Survey and the National Health Interview Survey; (2) include such information within annual or other periodic reporting to the Congress and the public on other surveillance activities; and (3) encourage research to improve the accuracy of food allergy prevalence data. (b) Biomarkers Any research conducted pursuant to subsection (a)(3) shall include— (1) the identification of biomarkers and tests to validate data generated from such research; and (2) the investigation of the use of identified biomarkers and tests in national surveys conducted as part of that research. . (b) Allergen labeling (1) Major food allergen definition (A) In general Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(qq)(1) ) is amended by striking and soybeans and inserting soybeans, and sesame . (B) Effective date The amendment made by subparagraph (A) shall apply with respect to food introduced or delivered for introduction into interstate commerce on or after January 1, 2022. (2) Additional allergens Section 201(qq) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(qq) ) is amended by adding at the end the following: (3) Any other food ingredient that the Secretary determines by regulation to be a major food allergen, based on the scientific criteria determined by the Secretary (including the prevalence and severity of allergic reactions to the food ingredient) that establish that such food ingredient is an allergen of public health concern. . (3) Technical corrections Section 201(qq)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(qq)(2) ) is amended by striking paragraph each place it appears and inserting subparagraph . 3. Report on use by FDA of patient experience data on treatments for patients with food allergies Section 3004 of the 21st Century Cures Act ( 21 U.S.C. 355 note) is amended— (1) by striking Not later than and inserting the following: (a) In general Not later than ; and (2) by adding at the end the following: (b) Treatments for patients with food allergies Each report under subsection (a) shall include a synopsis of the use by the Food and Drug Administration in regulatory decisionmaking of patient experience data on products with an indication for the treatment of a food allergy. .

Passed the House of Representatives November 17, 2020. Cheryl L. Johnson, Clerk.