[House Report 116-581]
[From the U.S. Government Publishing Office]
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).
* * * * * * *
----------
21ST CENTURY CURES ACT
* * * * * * *
DIVISION A--21ST CENTURY CURES
* * * * * * *
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
* * * * * * *
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.
* * * * * * *
[all]