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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 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’’. 
SEC. 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: 
‘‘SEC. 317W. COLLECTION OF FOOD ALLERGY DATA. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall— 
‘‘(1) expand and intensify the collection of in-
formation on the prevalence of food allergies for spe-
cific 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 accu-
racy of food allergy prevalence data. 
‘‘(b) BIOMARKERS.—Any research conducted pursu-
ant to subsection (a)(3) shall include— 
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‘‘(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 re-
spect to food introduced or delivered for intro-
duction 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 Sec-
retary determines by regulation to be a major food 
allergen, based on the scientific criteria determined 
by the Secretary (including the prevalence and sever-
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ity 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’’. 
SEC. 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 AL-
LERGIES.—Each report under subsection (a) shall include 
a synopsis of the use by the Food and Drug Administra-
tion in regulatory decisionmaking of patient experience 
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