```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2117 Referred in Senate (RFS)]

<DOC>
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 Representatives of the 
United States of America in Congress assembled,

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 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''.

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 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.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.
```