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116th Congress }                                          { Report
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 116-551

======================================================================
 
                           FASTER ACT OF 2020

                                _______
                                

 November 16, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 2117]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2117) 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, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary..............................................2
 II. Background and Need for the Legislation..........................3
III. Committee Hearings...............................................3
 IV. Committee Consideration..........................................4
  V. Committee Votes..................................................5
 VI. Oversight Findings...............................................5
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures5
VIII.Federal Mandates Statement.......................................5

 IX. Statement of General Performance Goals and Objectives............5
  X. Duplication of Federal Programs..................................5
 XI. Committee Cost Estimate..........................................6
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......6
XIII.Advisory Committee Statement.....................................6

XIV. Applicability to Legislative Branch..............................6
 XV. Section-by-Section Analysis of the Legislation...................6
XVI. Changes in Existing Law Made by the Bill, as Reported............7
    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.''.

                         I. Purpose and Summary

    H.R. 2117, the ``Food Allergy Safety, Treatment, Education, 
and Research Act of 2020'' or the ``FASTER Act of 2020'', 
introduced by Representative Doris O. Matsui (D-CA), aims to 
provide consumers and public health agencies with additional 
information related to food allergies. The bill would require 
the Centers for Disease Control and Prevention (CDC) to expand 
the collection of information on specific allergens that cause 
food allergies and include that information in reports to 
Congress. The bill would also amend the Federal Food, Drug, and 
Cosmetic Act (FFDCA) to include sesame as a major allergen and 
allow the Food and Drug Administration (FDA), through 
regulation, to add other food ingredients as major allergens 
based on the prevalence and severity of allergic reactions to 
the food ingredient. Additionally, the bill would require FDA 
to include an assessment on the use of patient experience data 
when making regulatory decisions on treatments for patients 
with food allergies in its reports on patient experience data 
in drug development.

                II. Background and Need for Legislation

    An estimated eight percent of children in the United 
States, which is approximately one in thirteen children, or two 
students in every classroom, are affected by food allergies.\1\ 
Studies suggest that there has been a dramatic increase in 
children affected by allergies over the past few decades.\2\ 
According to the CDC, a food allergy occurs when the body has a 
specific and reproducible immune response, such as anaphylaxis, 
to certain foods.\3\ Currently, the FFDCA defines major food 
allergens as milk, eggs, fish, crustacean shellfish, tree nuts, 
wheat, peanuts, and soybeans.
---------------------------------------------------------------------------
    \1\Centers for Disease Control and Prevention, Food Allergies (May 
29, 2019) (www.cdc.gov/healthyschools/foodallergies/index.htm).
    \2\Jennifer Protudjer and Elissa Abrams, Sesame the New Priority 
Allergen?, JAMA Network Open (Aug. 2, 2019) (jamanetwork.com/journals/
jamanetworkopen/fullarticle/2740776).
    \3\Response Letter from FDA, to Lassman Law + Policy (Nov. 7, 2019) 
(www.regulations.gov/document?D=FDA-2019-P-1679-0079).
---------------------------------------------------------------------------
    Although sesame is an allergen of growing concern, 
affecting 0.23 percent of the population of U.S. children and 
adults, up from 0.1 percent a decade ago, it is not required to 
be listed as an allergen on food packaging.\4\ In fact, in some 
cases, sesame may not be listed at all on ingredient labels, 
being referred to instead through nonspecific terms such as 
``flavors'' or ``words that may not be easily recognized by 
consumers as containing sesame, such as tahini''.\5\ In 
response to a growing concern about sesame allergy, FDA 
released a request for information in 2018, seeking comment on 
the prevalence and severity of sesame allergies and the 
prevalence of sesame-containing foods in the United States.\6\
---------------------------------------------------------------------------
    \4\Christopher M. Warren et al., Prevalence and Severity of Sesame 
Allergy in the United States, JAMA Network Open (Aug. 2, 2019) 
(jamanetwork.com/journals/jamanetworkopen/fullarticle/2740786).
    \5\Id.
    \6\Food and Drug Administration, FDA Asks for Input on Sesame 
Allergies and Food Labeling (Oct. 29, 2018) (www.fda.gov/food/cfsan-
constituent-updates/fda-asks-input-sesame-allergies-and-food-labeling).
---------------------------------------------------------------------------
    FDA has not taken any additional action to list sesame as a 
major allergen since that time. Given the growing concern 
around sesame and other food allergens, legislation is 
necessary to list sesame as a major food allergen and 
streamline processes at FDA to add additional food allergens 
based on the latest science and clinical evidence.

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 2117:
    The Subcommittee on Health held a legislative hearing on 
January 29, 2020, entitled, ``Improving Safety and Transparency 
in America's Food and Drugs.'' The hearing focused on H.R. 2117 
and nine other bills. The Subcommittee received testimony from 
the following witnesses:

Panel I:

           Jeff Allen, Ph.D., President and CEO, 
        Friends of Cancer Research.
           Richard Kaeser, Vice President, Global Brand 
        Protection, Johnson & Johnson.
           Fernando Muzzio, Ph.D., Distinguished 
        Professor, Chemical and Biochemical Engineering, 
        Rutgers, the State University of New Jersey.
           Kao-Ping Chua, M.D., Ph.D., Assistant 
        Professor, Department of Pediatrics, University of 
        Michigan Medical School.

Panel II:

           Melanie Benesh, Legislative Attorney, 
        Environmental Working Group.
           Tom Balmer, Executive Vice President, 
        National Milk Producers Federation.
           J. David Carlin, Senior Vice President of 
        Legislative Affairs and Economic Policy, International 
        Dairy Foods Association.
           Douglas Corey, D.V.M., Past President, 
        American Association of Equine Practitioners.
           Talia Day, Patient Advocate.
           Paul C. DeLeo, Ph.D., Principal, Integral 
        Consulting, Inc.
           Mardi Mountford, President, Infant Nutrition 
        Council of America.
           Nancy Perry, Senior Vice President, 
        Government Relations, American Society for the 
        Prevention of Cruelty to Animals.
           Sara Sorscher, Deputy Director of Regulatory 
        Affairs, Center for Science in the Public Interest.

                      IV. Committee Consideration

    Representative Matsui introduced H.R. 2117 on April 8, 
2019, and the bill was referred to the Committee on Energy and 
Commerce. H.R. 2117 was then referred to the Subcommittee on 
Health on April 9, 2019. The Subcommittee held a legislative 
hearing on the bill on January 29, 2020.
    The Subcommittee met in open markup session on March 11, 
2020, pursuant to notice, to consider H.R. 2117 and twelve 
other bills. During consideration of the bill, an amendment in 
the nature of a substitute offered by Ms. Matsui was agreed to 
by a voice vote. Upon conclusion of consideration of the bill, 
the Subcommittee agreed to forward H.R. 2117 favorably to the 
full Committee, amended, by a voice vote, a quorum being 
present.
    On July 15, 2020, the full Committee met in virtual open 
markup session, pursuant to notice, to consider a committee 
print of H.R. 2117 as amended by the Subcommittee on Health on 
March 11, 2020, and twenty-nine other bills. No amendments were 
offered during consideration of the bill. Upon conclusion of 
its consideration, the full Committee agreed to a motion on 
final passage by Mr. Pallone, Chairman of the committee, to 
order H.R. 2117 reported favorably to the House, as amended, by 
a voice vote, a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
2117, including the motion for final passage of the bill.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to improve 
the health and safety of Americans living with food allergies 
and related disorders and streamline processes at the FDA.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 2117 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 2117 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


SEC. 1. Short title

    Section 1 designates that the short title 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 recommendation of the National Academy of 
        Medicine

    Subsection (a) of section 2 amends the Public Health 
Service Act by inserting before section 318 a new section on 
the Collection of Food Allergy Data. This new section requires 
the Secretary of Health and Human Services (the Secretary), 
acting through the Director of the CDC, to (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 
Congress and the public; and (3) encourage research to improve 
the accuracy of food allergy prevalence data. Any research 
conducted under this section is required to include the 
identification of biomarkers and tests that can be used to 
validate data generated from such research and the 
investigation of the use of identified biomarkers and tests in 
national surveys conducted as part of that research.
    Subsection (b) of section 2 amends the FFDCA to add sesame 
as a major food allergen and sets the effective date of this 
amendment as January 1, 2022. Subsection (b) also amends the 
FFDCA to allow the Secretary, through regulation, to add 
additional food allergens to the list of major food allergens 
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. Finally, subsection 
(b) makes a technical correction to the FFDCA.

SEC. 3. Report on use by FDA of patient experience data on treatments 
        for patients with food allergies

    Section 3 amends the 21st Century Cures Act to require that 
a report on patient experience data in drug development must 
include a synopsis of the use by FDA in regulatory decision 
making of patient experience data on products with an 
indication for the treatment of a food allergy.

       XVI. Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



Part B--Federal-State Cooperation

           *       *       *       *       *       *       *



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.

           *       *       *       *       *       *       *

                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a)(1) The term ``State'', except as used in the last 
sentence of section 702(a), means any State or Territory of the 
United States, the District of Columbia, and the Commonwealth 
of Puerto Rico.
  (2) The term ``Territory'' means any Territory or possession 
of the United States, including the District of Columbia, and 
excluding the Commonwealth of Puerto Rico and the Canal Zone.
  (b) The term ``interstate commerce'' means (1) commerce 
between any State or Territory and any place outside thereof, 
and (2) commerce within the District of Columbia or within any 
other Territory not organized with a legislative body.
  (c) The term ``Department'' means the Department of Health 
and Human Services.
  (d) The term ``Secretary'' means the Secretary of Health and 
Human Services.
  (e) The term ``person'' includes individual, partnership, 
corporation, and association.
  (f) The term ``food'' means (1) articles used for food or 
drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article.
  (g)(1) The term ``drug'' means (A) articles recognized in the 
official United States Pharmacopeia, official Homeopathic 
Pharmacopeia of the United States, or official National 
Formulary, or any supplement to any of them; and (B) articles 
intended for use in the diagnosis, cure, mitigation, treatment, 
or prevention of disease in man or other animals; and (C) 
articles (other than food) intended to affect the structure or 
any function of the body of man or other animals; and (D) 
articles intended for use as a component of any articles 
specified in clause (A), (B), or (C). A food or dietary 
supplement for which a claim, subject to sections 403(r)(1)(B) 
and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is 
made in accordance with the requirements of section 403(r) is 
not a drug solely because the label or the labeling contains 
such a claim. A food, dietary ingredient, or dietary supplement 
for which a truthful and not misleading statement is made in 
accordance with section 403(r)(6) is not a drug under clause 
(C) solely because the label or the labeling contains such a 
statement.
  (2) The term ``counterfeit drug'' means a drug which, or the 
container or labeling of which, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a drug manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such drug and which thereby falsely purports or is 
represented to be the product of, or to have been packed or 
distributed by, such other drug manufacturer, processor, 
packer, or distributor.
  (h) The term ``device'' (except when used in paragraph (n) of 
this section and in sections 301(i), 403(f), 502(c), and 
602(c)) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, 
which is--
          (1) recognized in the official National Formulary, or 
        the United States Pharmacopeia, or any supplement to 
        them,
          (2) intended for use in the diagnosis of disease or 
        other conditions, or in the cure, mitigation, 
        treatment, or prevention of disease, in man or other 
        animals, or
          (3) intended to affect the structure or any function 
        of the body of man or other animals, and
which does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals 
and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes. The term 
``device'' does not include software functions excluded 
pursuant to section 520(o).
  (i) The term ``cosmetic'' means (1) articles intended to be 
rubbed, poured, sprinkled, or sprayed on, introduced into, or 
otherwise applied to the human body or any part thereof for 
cleansing, beautifying, promoting attractiveness, or altering 
the appearance, and (2) articles intended for use as a 
component of any such articles; except that such term shall not 
include soap.
  (j) The term ``official compendium'' means the official 
United States Pharmacopeia, official Homeopathic Pharmacopeia 
of the United States, official National Formulary, or any 
supplement to any of them.
  (k) The term ``label'' means a display of written, printed, 
or graphic matter upon the immediate container of any article; 
and a requirement made by or under authority of this Act that 
any word, statement, or other information appear on the label 
shall not be considered to be complied with unless such word, 
statement, or other information also appears on the outside 
container or wrapper, if any there be, of the retail package of 
such article, or is easily legible through the outside 
container or wrapper.
  (l) The term ``immediate container'' does not include package 
liners.
  (m) The term ``labeling'' means all labels and other written, 
printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.
  (n) If an article is alleged to be misbranded because the 
labeling or advertising is misleading, then in determining 
whether the labeling or advertising is misleading there shall 
be taken into account (among other things) not only 
representations made or suggested by statement, word, design, 
device, or any combination thereof, but also the extent to 
which the labeling or advertising fails to reveal facts 
material in the light of such representations or material with 
respect to consequences which may result from the use of the 
article to which the labeling or advertising relates under the 
conditions of use prescribed in the labeling or advertising 
thereof or under such conditions of use as are customary or 
usual.
  (o) The representation of a drug, in its labeling, as an 
antiseptic shall be considered to be a representation that it 
is a germicide, except in the case of a drug purporting to be, 
or represented as, an antiseptic for inhibitory use as a wet 
dressing, ointment, dusting powder, or such other use as 
involves prolonged contact with the body.
  (p) The term ``new drug'' means--
          (1) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug is not 
        generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof, 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new drug'' if at any time prior to the 
        enactment of this Act it was subject to the Food and 
        Drugs Act of June 30, 1906, as amended, and if at such 
        time its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug, as a 
        result of investigations to determine its safety and 
        effectiveness for use under such conditions, has become 
        so recognized, but which has not, otherwise than in 
        such investigations, been used to a material extent or 
        for a material time under such conditions.
  (q)(1)(A) Except as provided in clause (B), the term 
``pesticide chemical'' means any substance that is a pesticide 
within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of 
such pesticide. Notwithstanding any other provision of law, the 
term ``pesticide'' within such meaning includes ethylene oxide 
and propylene oxide when such substances are applied on food.
  (B) In the case of the use, with respect to food, of a 
substance described in clause (A) to prevent, destroy, repel, 
or mitigate microorganisms (including bacteria, viruses, fungi, 
protozoa, algae, and slime), the following applies for purposes 
of clause (A):
          (i) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is applied for such use on food, or 
        the substance is included for such use in water that 
        comes into contact with the food, in the preparing, 
        packing, or holding of the food for commercial 
        purposes. The substance is not excluded under this 
        subclause from such definition if the substance is 
        ethylene oxide or propylene oxide, and is applied for 
        such use on food. The substance is not so excluded if 
        the substance is applied for such use on a raw 
        agricultural commodity, or the substance is included 
        for such use in water that comes into contact with the 
        commodity, as follows:
                  (I) The substance is applied in the field.
                  (II) The substance is applied at a treatment 
                facility where raw agricultural commodities are 
                the only food treated, and the treatment is in 
                a manner that does not change the status of the 
                food as a raw agricultural commodity (including 
                treatment through washing, waxing, fumigating, 
                and packing such commodities in such manner).
                  (III) The substance is applied during the 
                transportation of such commodity between the 
                field and such a treatment facility.
          (ii) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is a food contact substance as defined 
        in section 409(h)(6), and any of the following 
        circumstances exist: The substance is included for such 
        use in an object that has a food contact surface but is 
        not intended to have an ongoing effect on any portion 
        of the object; the substance is included for such use 
        in an object that has a food contact surface and is 
        intended to have an ongoing effect on a portion of the 
        object but not on the food contact surface; or the 
        substance is included for such use in or is applied for 
        such use on food packaging (without regard to whether 
        the substance is intended to have an ongoing effect on 
        any portion of the packaging). The food contact 
        substance is not excluded under this subclause from 
        such definition if any of the following circumstances 
        exist: The substance is applied for such use on a 
        semipermanent or permanent food contact surface (other 
        than being applied on food packaging); or the substance 
        is included for such use in an object that has a 
        semipermanent or permanent food contact surface (other 
        than being included in food packaging) and the 
        substance is intended to have an ongoing effect on the 
        food contact surface.
With respect to the definition of the term ``pesticide'' that 
is applicable to the Federal Insecticide, Fungicide, and 
Rodenticide Act, this clause does not exclude any substance 
from such definition.
  (2) The term ``pesticide chemical residue'' means a residue 
in or on raw agricultural commodity or processed food of--
          (A) a pesticide chemical; or
          (B) any other added substance that is present on or 
        in the commodity or food primarily as a result of the 
        metabolism or other degradation of a pesticide 
        chemical.
  (3) Notwithstanding subparagraphs (1) and (2), the 
Administrator may by regulation except a substance from the 
definition of ``pesticide chemical'' or ``pesticide chemical 
residue'' if--
          (A) its occurrence as a residue on or in a raw 
        agricultural commodity or processed food is 
        attributable primarily to natural causes or to human 
        activities not involving the use of any substances for 
        a pesticidal purpose in the production, storage, 
        processing, or transportation of any raw agricultural 
        commodity or processed food; and
          (B) the Administrator, after consultation with the 
        Secretary, determines that the substance more 
        appropriately should be regulated under one or more 
        provisions of this Act other than sections 402(a)(2)(B) 
        and 408.
  (r) The term ``raw agricultural commodity'' means any food in 
its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form 
prior to marketing.
  (s) The term ``food additive'' means any substance the 
intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food (including 
any substance intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding food; and including any source of 
radiation intended for any such use), if such substance is not 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use; 
except that such term does not include--
          (1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
          (2) a pesticide chemical; or
          (3) a color additive; or
          (4) any substance used in accordance with a sanction 
        or approval granted prior to the enactment of this 
        paragraph pursuant to this Act, the Poultry Products 
        Inspection Act (21 U.S.C. 451 and the following) or the 
        Meat Inspection Act of March 4, 1907 (34 Stat. 1260), 
        as amended and extended (21 U.S.C. 71 and the 
        following);
          (5) a new animal drug; or
          (6) an ingredient described in paragraph (ff) in, or 
        intended for use in, a dietary supplement.
  (t)(1) The term ``color additive'' means a material which--
          (A) is a dye, pigment, or other substance made by a 
        process of synthesis or similar artifice, or extracted, 
        isolated, or otherwise derived, with or without 
        intermediate or final change of identity, from a 
        vegetable, animal, mineral, or other source, and
          (B) when added or applied to a food, drug, or 
        cosmetic, or to the human body or any part thereof, is 
        capable (alone or through reaction with other 
        substance) of imparting color thereto;
except that such term does not include any material which the 
Secretary, by regulation, determines is used (or intended to be 
used) solely for a purpose or purposes other than coloring.
  (2) The term ``color'' includes black, white, and 
intermediate grays.
  (3) Nothing in subparagraph (1) of this paragraph shall be 
construed to apply to any pesticide chemical, soil or plant 
nutrient, or other agricultural chemical solely because of its 
effect in aiding, retarding, or otherwise affecting, directly 
or indirectly, the growth or other natural physiological 
processes of produce of the soil and thereby affecting its 
color, whether before or after harvest.
  (u) The term ``safe,'' as used in paragraph (s) of this 
section and in sections 409, 512, 571, and 721, has reference 
to the health of man or animal.
  (v) The term ``new animal drug'' means any drug intended for 
use for animals other than man, including any drug intended for 
use in animal feed but not including such animal feed--
          (1) the composition of which is such that such drug 
        is not generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of animal drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof; 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new animal drug'' if at any time prior 
        to June 25, 1938, it was subject to the Food and Drug 
        Act of June 30, 1906, as amended, and if at such time 
        its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) the composition of which is such that such drug, 
        as a result of investigations to determine its safety 
        and effectiveness for use under such conditions, has 
        become so recognized but which has not, otherwise than 
        in such investigations, been used to a material extent 
        or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor 
species that is not the subject of a final regulation published 
by the Secretary through notice and comment rulemaking finding 
that the criteria of paragraphs (1) and (2) have not been met 
(or that the exception to the criterion in paragraph (1) has 
been met) is a new animal drug.
  (w) The term ``animal feed'', as used in paragraph (w) of 
this section, in section 512, and in provisions of this Act 
referring to such paragraph or section, means an article which 
is intended for use for food for animals other than man and 
which is intended for use as a substantial source of nutrients 
in the diet of the animal, and is not limited to a mixture 
intended to be the sole ration of the animal.
  (x) The term ``informal hearing'' means a hearing which is 
not subject to section 554, 556, or 557 of title 5 of the 
United States Code and which provides for the following:
          (1) The presiding officer in the hearing shall be 
        designated by the Secretary from officers and employees 
        of the Department who have not participated in any 
        action of the Secretary which is the subject of the 
        hearing and who are not directly responsible to an 
        officer or employee of the Department who has 
        participated in any such action.
          (2) Each party to the hearing shall have the right at 
        all times to be advised and accompanied by an attorney.
          (3) Before the hearing, each party to the hearing 
        shall be given reasonable notice of the matters to be 
        considered at the hearing, including a comprehensive 
        statement of the basis for the action taken or proposed 
        by the Secretary which is the subject of the hearing 
        and a general summary of the information which will be 
        presented by the Secretary at the hearing in support of 
        such action.
          (4) At the hearing the parties to the hearing shall 
        have the right to hear a full and complete statement of 
        the action of the Secretary which is the subject of the 
        hearing together with the information and reasons 
        supporting such action, to conduct reasonable 
        questioning, and to present any oral or written 
        information relevant to such action.
          (5) The presiding officer in such hearing shall 
        prepare a written report of the hearing to which shall 
        be attached all written material presented at the 
        hearing. The participants in the hearing shall be given 
        the opportunity to review and correct or supplement the 
        presiding officer's report of the hearing.
          (6) The Secretary may require the hearing to be 
        transcribed. A party to the hearing shall have the 
        right to have the hearing transcribed at his expense. 
        Any transcription of a hearing shall be included in the 
        presiding officer's report of the hearing.
  (y) The term ``saccharin'' includes calcium saccharin, sodium 
saccharin, and ammonium saccharin.
  (z) The term ``infant formula'' means a food which purports 
to be or is represented for special dietary use solely as a 
food for infants by reason of its simulation of human milk or 
its suitability as a complete or partial substitute for human 
milk.
  (aa) The term ``abbreviated drug application'' means an 
application submitted under section 505(j) for the approval of 
a drug that relies on the approved application of another drug 
with the same active ingredient to establish safety and 
efficacy, and--
          (1) in the case of section 306, includes a supplement 
        to such an application for a different or additional 
        use of the drug but does not include a supplement to 
        such an application for other than a different or 
        additional use of the drug, and
          (2) in the case of sections 307 and 308, includes any 
        supplement to such an application.
  (bb) The term ``knowingly'' or ``knew'' means that a person, 
with respect to information--
          (1) has actual knowledge of the information, or
          (2) acts in deliberate ignorance or reckless 
        disregard of the truth or falsity of the information.
  (cc) For purposes of section 306, the term ``high managerial 
agent''--
          (1) means--
                  (A) an officer or director of a corporation 
                or an association,
                  (B) a partner of a partnership, or
                  (C) any employee or other agent of a 
                corporation, association, or partnership,
        having duties such that the conduct of such officer, 
        director, partner, employee, or agent may fairly be 
        assumed to represent the policy of the corporation, 
        association, or partnership, and
          (2) includes persons having management responsibility 
        for--
                  (A) submissions to the Food and Drug 
                Administration regarding the development or 
                approval of any drug product,
                  (B) production, quality assurance, or quality 
                control of any drug product, or
                  (C) research and development of any drug 
                product.
  (dd) For purposes of sections 306 and 307, the term ``drug 
product'' means a drug subject to regulation under section 505, 
512, or 802 of this Act or under section 351 of the Public 
Health Service Act.
  (ee) The term ``Commissioner'' means the Commissioner of Food 
and Drugs.
  (ff) The term ``dietary supplement''--
          (1) means a product (other than tobacco) intended to 
        supplement the diet that bears or contains one or more 
        of the following dietary ingredients:
                  (A) a vitamin;
                  (B) a mineral;
                  (C) an herb or other botanical;
                  (D) an amino acid;
                  (E) a dietary substance for use by man to 
                supplement the diet by increasing the total 
                dietary intake; or
                  (F) a concentrate, metabolite, constituent, 
                extract, or combination of any ingredient 
                described in clause (A), (B), (C), (D), or (E);
          (2) means a product that--
                  (A)(i) is intended for ingestion in a form 
                described in section 411(c)(1)(B)(i); or
                  (ii) complies with section 411(c)(1)(B)(ii);
                  (B) is not represented for use as a 
                conventional food or as a sole item of a meal 
                or the diet; and
                  (C) is labeled as a dietary supplement; and
          (3) does--
                  (A) include an article that is approved as a 
                new drug under section 505 or licensed as a 
                biologic under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) and was, prior to 
                such approval, certification, or license, 
                marketed as a dietary supplement or as a food 
                unless the Secretary has issued a regulation, 
                after notice and comment, finding that the 
                article, when used as or in a dietary 
                supplement under the conditions of use and 
                dosages set forth in the labeling for such 
                dietary supplement, is unlawful under section 
                402(f); and
                  (B) not include--
                          (i) an article that is approved as a 
                        new drug under section 505, certified 
                        as an antibiotic under section 507, or 
                        licensed as a biologic under section 
                        351 of the Public Health Service Act 
                        (42 U.S.C. 262), or
                          (ii) an article authorized for 
                        investigation as a new drug, 
                        antibiotic, or biological for which 
                        substantial clinical investigations 
                        have been instituted and for which the 
                        existence of such investigations has 
                        been made public,
        which was not before such approval, certification, 
        licensing, or authorization marketed as a dietary 
        supplement or as a food unless the Secretary, in the 
        Secretary's discretion, has issued a regulation, after 
        notice and comment, finding that the article would be 
        lawful under this Act.
Except for purposes of sections 201(g) and 417, a dietary 
supplement shall be deemed to be a food within the meaning of 
this Act.
  (gg) The term ``processed food'' means any food other than a 
raw agricultural commodity and includes any raw agricultural 
commodity that has been subject to processing, such as canning, 
cooking, freezing, dehydration, or milling.
  (hh) The term ``Administrator'' means the Administrator of 
the United States Environmental Protection Agency.
  (ii) The term ``compounded positron emission tomography 
drug''--
          (1) means a drug that--
                  (A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons 
                and is used for the purpose of providing dual 
                photon positron emission tomographic diagnostic 
                images; and
                  (B) has been compounded by or on the order of 
                a practitioner who is licensed by a State to 
                compound or order compounding for a drug 
                described in subparagraph (A), and is 
                compounded in accordance with that State's law, 
                for a patient or for research, teaching, or 
                quality control; and
          (2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target 
        material, electronic synthesizer, or other apparatus or 
        computer program to be used in the preparation of such 
        a drug.
  (jj) The term ``antibiotic drug'' means any drug (except 
drugs for use in animals other than humans) composed wholly or 
partly of any kind of penicillin, streptomycin, 
chlortetracycline, chloramphenicol, bacitracin, or any other 
drug intended for human use containing any quantity of any 
chemical substance which is produced by a micro-organism and 
which has the capacity to inhibit or destroy micro-organisms in 
dilute solution (including a chemically synthesized equivalent 
of any such substance) or any derivative thereof.
          (kk) Priority supplement.--The term ``priority 
        supplement'' means a drug application referred to in 
        section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997 (111 Stat. 2298).
  (ll)(1) The term ``single-use device'' means a device that is 
intended for one use, or on a single patient during a single 
procedure.
  (2)(A) The term ``reprocessed'', with respect to a single-use 
device, means an original device that has previously been used 
on a patient and has been subjected to additional processing 
and manufacturing for the purpose of an additional single use 
on a patient. The subsequent processing and manufacture of a 
reprocessed single-use device shall result in a device that is 
reprocessed within the meaning of this definition.
  (B) A single-use device that meets the definition under 
clause (A) shall be considered a reprocessed device without 
regard to any description of the device used by the 
manufacturer of the device or other persons, including a 
description that uses the term ``recycled'' rather than the 
term ``reprocessed''.
  (3) The term ``original device'' means a new, unused single-
use device.
  (mm)(1) The term ``critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact normally sterile tissue or body spaces during use.
  (2) The term ``semi-critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact intact mucous membranes and not penetrate normally 
sterile areas of the body.
  (nn) The term ``major species'' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary 
may add species to this definition by regulation.
  (oo) The term ``minor species'' means animals other than 
humans that are not major species.
  (pp) The term ``minor use'' means the intended use of a drug 
in a major species for an indication that occurs infrequently 
and in only a small number of animals or in limited 
geographical areas and in only a small number of animals 
annually.
  (qq) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), 
        tree nuts (e.g., almonds, pecans, or walnuts), wheat, 
        peanuts, [and soybeans] soybeans, and sesame.
          (2) A food ingredient that contains protein derived 
        from a food specified in [paragraph] subparagraph (1), 
        except the following:
                  (A) Any highly refined oil derived from a 
                food specified in [paragraph] subparagraph (1) 
                and any ingredient derived from such highly 
                refined oil.
                  (B) A food ingredient that is exempt under 
                [paragraph] subparagraph (6) or (7) of section 
                403(w).
          (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.
  (rr)(1) The term ``tobacco product'' means any product made 
or derived from tobacco that is intended for human consumption, 
including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco 
product).
  (2) The term ``tobacco product'' does not mean an article 
that is a drug under subsection (g)(1), a device under 
subsection (h), or a combination product described in section 
503(g).
  (3) The products described in paragraph (2) shall be subject 
to chapter V of this Act.
  (4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act 
(including a drug, biologic, food, cosmetic, medical device, or 
a dietary supplement).

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                         21ST CENTURY CURES ACT



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DIVISION A--21ST CENTURY CURES

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                         TITLE III--DEVELOPMENT

Subtitle A--Patient-Focused Drug Development

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SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.

   [Not later than] (a)  In General._Not later than  June 1 of 
2021, 2026, and 2031, the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, 
shall prepare and publish on the Internet website of the Food 
and Drug Administration a report assessing the use of patient 
experience data in regulatory decisionmaking, in particular 
with respect to the review of patient experience data and 
information on patient-focused drug development tools as part 
of applications approved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
  (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.

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