[Senate Report 108-226]
[From the U.S. Government Publishing Office]
Calendar No. 431
108th Congress Report
SENATE
2nd Session 108-226
======================================================================
MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2003
_______
February 18, 2004.--Ordered to be printed
Filed, under authority of the order of the Senate of February 12, 2004
_______
Mr. Gregg, from the Committee on Health, Education, Labor, and
Pensions, submitted the following
R E P O R T
[To accompany S. 741]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 741) to amend the Federal Food,
Drug, and Cosmetic Act with regard to new animal drugs, 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 of Legislation...............................1
II. Committee Action.................................................4
III. Background and Need for Legislation..............................4
IV. Explanation of Bill and Committee Views..........................6
V. Cost Estimate...................................................11
VI. Application of Law to the Legislative Branch....................11
VII. Regulatory Impact Statement.....................................11
VIII.Section-by-Section Analysis.....................................12
IX. Changes in Existing Law.........................................24
I. Purpose and Summary of Legislation
Title I of S. 741, the Minor Use and Minor Species Animal
Health (MUMS) Act, is intended to amend the Federal Food, Drug,
and Cosmetic Act (FFDCA) to address the critical shortage of
approved animal drugs for minor species (species other than
cattle, horses, swine, chickens, turkeys, dogs, and cats) and
for minor uses in major species (the use of a drug in a major
species for a disease that occurs infrequently in a small
number of animals, or in limited geographic areas in a small
number of animals annually). Title I is intended to increase
the availability of new animal drugs for minor species and for
minor uses, while still ensuring appropriate safeguards for
animal and human health.
Title I establishes two new ways to lawfully market new
animal drugs. First, it establishes a conditional approval
mechanism for new animal drugs for minor uses and minor
species. Conditionally-approved new animal drugs must meet the
same new animal drug approval requirements for safety as new
animal drugs approved under section 512 of the FFDCA (21 U.S.C.
360b). However, the effectiveness standard for conditionally-
approved drugs differs from the effectiveness standard for new
animal drugs approved under section 512. An application for a
conditional approval must include data to demonstrate that
there is a ``reasonable expectation of effectiveness'' rather
than ``substantial evidence of effectiveness.'' If an
application for conditional approval is approved, the
conditional approval will be in effect for one year, renewable
for a maximum of four additional one-year terms. During this
period, which ends 5 years from the date of conditional
approval, the applicant is expected to conduct effectiveness
studies and to demonstrate by ``substantial evidence'' that the
animal drug is effective for its intended use. The conditional
approval is intended to allow sponsors to recoup some
development costs through marketing of the product prior to
full, unconditional approval.
Second, Title I provides for an index of legally-marketed
unapproved new animal drugs for non-food minor species and non-
food life stages of food producing minor species under limited
circumstances. The index is intended to provide a way to
lawfully market those minor species drugs for which there is
unlikely to be sufficient financial incentive to seek a full or
conditional approval. A new animal drug deemed by the Food and
Drug Administration (FDA) to be eligible for listing on the
index will be added to the index if the drug meets certain
safety criteria; and if the benefits of using the drug outweigh
the risks to the target animal, taking into account the harm
caused by the absence of an approved or conditionally-approved
drug for the use in question. The addition of a new animal drug
to the index will be based, in part, on the report of an expert
panel based on its review of all available safety and
effectiveness information. Title I also provides a process for
classifying certain new animal drugs for minor uses and minor
species as designated new animal drugs. Persons gathering data
to support approval of a designated new animal drug may qualify
for either or both of two incentives. The first incentive is
the availability of grants for development of certain
designated new animal drugs. The second incentive is an
extension of marketing exclusivity to seven years.
Title I would preserve all FDA requirements for the
approval of an antimicrobial. Section 512 of the FFDCA requires
that any new animal drug submitted for approval under the MUMS
Act, must meet all human safety requirements, including drug
residue and microbial safety criteria. In accordance with this
requirement, all such antimicrobials would be evaluated under
FDA's Guidance for Industry #152, Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health Concern (as
well as other subsequent guidance or regulation). Guidance #152
requires the completion of a qualitative risk assessment that
among other things, would examine whether the use of an
antimicrobial in animals, including aquaculture, could lead to
drug resistance affecting humans. Additionally, antimicrobials,
as well as all other drugs submitted under the provisions of
the MUMS Act, will continue to be subject to an extensive
environmental assessment prior to approval or legal marketing.
Title II of S. 741 responds to the seven million Americans
who suffer from food allergies, approximately 2 percent of whom
are adults and 5 percent of whom are infants and young
children. Eight major foods or food groups--milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans--
account for 90 percent of food allergies. Peanut or tree nut
allergy is reported by over three million Americans and appears
to be increasing in prevalence--the rate of peanut allergy is
reported to almost double among children in the U.S. between
1997 and 2002. There is currently no cure for food allergies.
Instead, people with a food allergy must avoid the food to
which they are allergic.
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires,
with some exceptions, a complete listing of all the ingredients
in a food on the food label. Currently, the FFDCA does not
require the eight major food allergens to be identified, using
plain English, on the food label when ingredients contain
allergenic substances. The names of some ingredients do not
clearly identify in plain English that the ingredient is the
source of an allergen. For example, whey and casein are
required to be identified in the food ingredient list as whey
and casein despite the fact that these ingredients are derived
from milk and may cause allergic reactions in those allergic to
milk. Use of plain English in food labels to identify the
presence of the eight major food allergens will make the food
label much more useful to consumers with food allergies.
There are also two exemptions from the requirement that
each ingredient be listed in the food ingredient label. One
exemption allows for collective naming of flavors, certain
colors, and spices. These terms are not completely descriptive,
however; in particular, they do not identify if any components
of flavors or colors are allergens. Under the second exemption,
incidental additives, which are food substances that are used
in insignificant amounts and that do not have any technical or
functional effect in the food, need not be identified in the
food label. Although additives that are, or that contain, a
major food allergen are not considered to be incidental, these
ingredients are nonetheless sometimes inadvertently left off of
the food label. Requiring the use of plain English to identify
the presence of the eight major food allergens used in flavors
and certain colors will also make the food label more useful to
allergic consumers.
Food allergens sometimes inadvertently find their way into
a food because of a firm's production practices; such as rework
addition or product carryover due to use of common equipment or
production scheduling. Such practices present an unintentional
opportunity for a product that contains an allergen to come
into cross-contact with a product that does not contain that
particular allergen as an ingredient or as a component of an
ingredient. In some instances it may not be possible to
eliminate the possibility of cross-contact following good
manufacturing practice. In such instances, it may be
appropriate for food manufacturers to use advisory labeling
(such as ``may contain'') to indicate the possible presence of
food allergens in a food product. Many food manufacturers
currently use such advisory language. However, ``cross-
contact'' deserves further study by both FDA and the food
industry.
Celiac disease is an immune-mediated disease and is
distinct from food allergy. When gluten from certain cereal
grains is ingested by individuals with celiac disease, damage
to the gastrointestinal tract, central nervous system, and
other organs may occur over time. The current treatment for
individuals with celiac disease is avoidance of glutens in
foods that are associated with celiac disease. Permitting a
``gluten-free'' claim to appear on the labels of food products
will assist individuals with celiac disease to avoid the
glutens associated with the disease.
The major purpose of this legislation is to ensure that the
major food allergens are identified in plain English on food
product labels. Members of this committee have worked in a bi-
partisan fashion to ensure that this legislation will provide
reliable, accurate, and clear allergen information on the food
label. Title II of S. 741, ``The Food Allergen Labeling and
Consumer Protection Act of 2003'' will assist food allergic
consumers in identifying foods that contain major food
allergens.
II. Committee Action
Title I, the Minor Use and Minor Species Animal Health
(MUMS) Act of 2003 (S. 741) was introduced by Senator Sessions
for himself and for Mr. Bingaman, Mr. Gregg, Mr. Miller, Mr.
Allard, Mrs. Lincoln, Mr. Ensign, Ms. Collins, Mr. Crapo, Mr.
Craig, and Mr. Harkin on March 27, 2003 and subsequently marked
up as an original bill at the Committee on Health, Education,
Labor, and Pensions Executive Session on November 21, 2003. At
that time, Senator Gregg offered an amendment in the nature of
a substitute that included technical changes and a new Title
II, the Food Allergens Labeling and Consumer Protection Act.
The chairman's mark was accepted by unanimous consent and
reported favorably from the committee by voice vote.
III. Background and Need for Legislation
TITLE I
Because the markets are small and profit margins low for
new animal drugs intended for minor uses in major species or
for minor species, there are often insufficient economic
incentives to motivate sponsors to develop the data necessary
to support FDA approvals. In addition, some minor species
populations are too small or their management systems too
diverse to make it practical to conduct traditional studies to
demonstrate safety and effectiveness. Consequently,
manufacturers have not, in many cases, been willing to fund
research to collect these data. Accordingly, very few new
animal drugs intended for minor uses or for minor species have
been approved and are legally marketed.
Because of the limited availability of approved new animal
drugs intended for minor uses or minor species, veterinarians,
animal owners, and livestock producers have limited options for
treating these sick animals. In many cases, the choices are to
leave a sick animal untreated or to treat the animal with an
unapproved drug.
Failure to treat sick animals appropriately may increase
public health hazards. For example, the transmission of disease
from animals to humans or the shedding of disease-producing
organisms by untreated animals into the environment may
increase health risks to humans as well as other animals.
Treating an animal with an unapproved drug introduces questions
of effectiveness and safety to the animal, to the environment
and to the public.
FDA has attempted to encourage the submission of New Animal
Drug Applications (NADA) for minor uses and minor species
within the confines of the FFDCA. The FDA's efforts have been
met, thus far, with only limited success.
The Animal Medicinal Drug Use Clarification Act (AMDUCA)
was enacted in 1994 (Public Law 103-396). AMDUCA and the final
implementing regulations permit veterinarians to use approved
new animal drugs for unapproved therapeutic uses in certain
instances. Although AMDUCA does give veterinarians more legal
treatment options, it does not, and was not intended to,
facilitate the approval of new animal drugs for minor uses or
minor species. Because the best drug for a minor use or minor
species often is not available in an appropriate approved
formulation or dosage form, or the best drug is not approved
for use in any species, AMDUCA provides few additional legal
treatment options for minor species and minor uses. In any
case, drug approval is preferable to extra-label use because it
makes dosage information and drug withdrawal periods (for food-
producing animals) more readily available to the veterinarian
or producer.
The Animal Drug Availability Act (ADAA) was enacted on
October 9, 1996 (Public Law 104-250). The ADAA reflected
Congress's concerns about the lack of availability of approved
new animal drugs. Among other things, the legislation
recognized particular problems relating to the availability of
approved new animal drugs for minor uses in major species and
for use in minor species. Section 2(f) of the ADAA directed the
Secretary of Health and Human Services (the Secretary) to
consider legislative and regulatory options for facilitating
approval under section 512 of the FFDCA (21 U.S.C. 360b) of new
animal drugs intended for use in minor species or for minor
uses. The ADAA further required the Secretary to announce
proposals for legislative or regulatory change to the approval
process for new animal drugs intended for use in minor species
or for minor uses.
FDA worked to develop proposals and to make them available
for public comment throughout the process. On October 29, 1998
(63 FR 58056), FDA published a Federal Register notice
announcing the availability of ``Proposals to Increase the
Legal Availability of Animal Drugs for Minor Species and Minor
Uses, ADAA Minor Use/Minor Species Working Group'' to fulfill
that statutory obligation.
After closely examining the existing statutes, FDA
determined that they simply fail to provide adequate options to
fully serve the needs of hundreds of minor animal species.
Congress recognized the possibility that statutory changes
might be needed to fulfill its charge at Section 2(f) of the
ADAA. To achieve the goal of increasing the availability of
safe and effective drugs for minor species and minor uses, FDA
concluded that Federal statutes should be amended. FDA's
proposals provide a conceptual basis for the Minor Use and
Minor Species Animal Health Act of 2003.
TITLE II
The intent of Title II of S. 741 is to require plain
English ingredient labeling of products that contain milk,
eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat,
and soybeans--collectively referred to as the eight major food
allergens. This legislation amends the FFDCA to require that
food ingredient statements identify in plain English when the
food contains a major food allergen, including when a major
food allergen is contained in flavorings, colorings, and
incidental additives.
The legislation requires the Secretary of Health and Human
Services (the Secretary) to issue a report to Congress about
food allergen cross-contact, advisory labeling and food
allergen inspections. The Secretary is required to conduct food
allergen inspections under existing authority under the FFDCA.
This legislation provides for enhanced surveillance and for
recommendations related to research concerning food allergens.
The Centers for Disease Control and Prevention (CDC) is called
upon to track food-allergic-related deaths and other clinically
significant and serious adverse events. Additionally, the
National Institutes of Health (NIH) is directed to convene a
panel of experts to develop recommendations for research
activities concerning food allergies.
This legislation directs the Secretary to pursue revision
of the Food Code to provide guidelines for preparing allergen-
free foods in food establishments. It also directs the
Secretary to provide technical assistance relating to emergency
treatment of allergic responses to foods.
Further, this legislation requires the Secretary to define
by regulation the term ``gluten-free'' for voluntary use in
food labeling.
IV. Explanation of Bill and Committee Views
Requirement of plain English labeling of the eight major food allergens
The legislation amends section 201 of the FFDCA to define
the term ``major food allergen.'' It is defined to mean the
eight most significant food allergens--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--and any food that
contains protein derived from one of these eight food allergens
(except for highly refined oils, ingredients derived from
highly refined oils, and other food ingredients that are exempt
under the legislation). Fish, Crustacean shellfish, and tree
nuts are collective names that include a variety of different
items. For example, the term ``tree nuts'' refers to a variety
of individual nuts, including almonds, Brazil nuts, cashews,
chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pine
nuts, pistachios, and walnuts. The term ``Crustacean
shellfish'' refers to crabs, crawfish/crayfish, lobster,
prawns, and shrimp. The term ``fish'' refers to a variety of
different species of fish.
The committee has provided that food ingredients containing
protein derived from milk, eggs, fish, shellfish, peanuts, tree
nuts, wheat, or soybeans may nevertheless be excluded from the
definition of ``major food allergen'' under one of three
exceptions. First, highly refined oils and ingredients derived
from highly refined oils are excluded from the definition of
``major food allergen.'' ``Highly refined oils'' are intended
to signify refined, bleached, deodorized (RBD) oils. The
committee notes, however, that the legislation does not change
the common or usual name of highly refined oils; that is,
highly refined oils would still be required to be identified by
their common and usual name in the ingredient list, e.g.,
``peanut oil.'' Second, the committee has also excluded from
the definition of ``major food allergen'' food ingredients for
which the Secretary has determined, based on scientific
evidence presented in a petition, that the food ingredient does
not cause an allergic response that pose a risk to human
health.
Finally, the committee has provided for a notification
process to exclude from the definition of a major food allergen
those food ingredients that contain protein derived from one of
the major eight protein sources but do not contain the
allergenic protein and for food ingredients for which the
Secretary has previously made a determination that the use of
the ingredient does not cause an allergic response that poses a
risk to human health under a premarket approval or notification
program under section 409 of the FFDCA. The committee
recognizes that the GRAS notification process is not included
as part of this exception. The committee encourages FDA to
adopt a reasonable standard for determining whether a food
ingredient ``does not contain an allergenic protein.'' For
example, while the committee recognizes that thresholds for the
major eight allergens have not yet been established by the
scientific community, if they are established, ingredients
containing allergenic proteins below the established threshold
would be eligible for the notification procedure.
The committee intends that the Secretary will provide
guidance to industry on the information that would be useful
for making a determination that foods that contain protein
derived from one of the eight food allergens do not cause an
allergic response that poses a risk to human health. The
committee also intends that the Secretary provide an
appropriate process for providing such information to the
Secretary that minimizes the burden on the food manufacturer.
The legislation requires FDA to post the petitions and
notifications for exemption from allergen labeling to a public
site as well as FDA's responses to such petitions and
notifications. In instances when FDA concludes that a
notification or petition has provided data demonstrating that
the food ingredient should be exempt from the definition of
``major food allergen,'' the exemption will apply to any
product bearing or containing the ingredient under the same
conditions of use described in the notification or petition.
The legislation also amends section 403 of the FFDCA to
provide two new misbranding provisions. The first of these,
section 403(w), requires that the eight major food allergens be
labeled on foods that are not raw agricultural products. Under
section 403(w), manufacturers will have two options as to how
they must label the eight major food allergens on such foods.
Under either plain English allergen labeling option, the term
for a major food allergen--milk, egg, wheat, peanuts, soybeans,
or, in the case of the collective terms ``fish,'' ``Crustacean
shellfish,'' or ``tree nuts,'' the common or usual name for the
relevant specific members of the class, such as ``cod,''
``shrimp,'' or ``almond''--will appear in the food label if the
food is, or it bears or contains, a major food allergen as
defined in section 201(qq). These plain English allergen
labeling requirements apply only to foods for which an
ingredient list is required in a label or labeling under the
FFDCA.
Manufacturers may choose to summarize the allergen
information using the terms for the major food allergens from
which any ingredients in the food are derived in a statement at
the end of, or immediately adjacent to, the ingredient list.
This information must appear in a type size no smaller than the
type size used in the ingredient list.
Alternatively, manufacturers may place the term for the
appropriate major food allergen in parentheses within the
ingredient list after the common or usual name of the
ingredient derived from that major food allergen. There are two
exceptions to this requirement. First, the listing of the term
for the food allergen is not required to appear in parentheses
after an ingredient name if the ingredient name uses the term
for the major food allergen (for example, ``milk'' need not
appear in parentheses after ``milk'' or ``milk by-product,''
nor need ``almond'' appear after ``almond''). Second, the term
for a food allergen need not be placed after an ingredient if
the term for that food allergen appears elsewhere in the
ingredient list; the food allergen term need only appear once
in the ingredient statement, unless the name of the food source
that appears elsewhere in the ingredient list appears as part
of the name of a food ingredient that is excluded from the
definition of a major food allergen. For example, if a food
contained highly refined peanut oil and a natural flavoring
containing peanut as a constituent, the term ``peanut'' would
have to appear in parentheses after ``natural flavoring'' in
the ingredient list, because peanut oil is not a ``major food
allergen'' under this legislation.
These two options can be illustrated by an example. If a
food were to have as ingredients semolina, rice flour, rolled
oats, pine nuts, tomato juice, whey, sodium caseinate, and
natural flavoring, with the natural flavoring including peanuts
as a constituent, the major food allergens in the food could be
labeled in two ways. First, the following statement could
appear at the end of, or immediately adjacent to, the list of
ingredients: ``Contains wheat, milk, pine nuts, and peanuts.''
Second, the ingredient list could read: ``Ingredients: semolina
(wheat), rice flour, rolled oats, pine nuts, tomato juice, whey
(milk), sodium caseinate, and natural flavoring (peanuts).''
These two examples illustrate several aspects of the
allergen labeling requirements. In the second example, ``milk''
does not appear in parentheses after ``sodium caseinate''
because it has already appeared after ``whey.'' In the
examples, the natural flavoring includes peanuts as a
constituent and so peanut is labeled as an allergen in the
food. In other words, the food allergen labeling requirement
applies to flavorings, colorings, and incidental additives.
Only the peanut constituent of the natural flavoring ingredient
is identified, however; the other constituents of the
flavoring--or indeed of any coloring or incidental additive--
are not required to be listed under either plain English
labeling option permitted under the legislation.
The term ``pine nuts'' is in the summary of allergy
information in the first example, but it need not appear after
``pine nut'' in the ingredient list in the second example
because the repetition is unnecessary. The first example
illustrates the committee's intent that the term for the
relevant specific member of the class ``fish'' or ``Crustacean
shellfish'' or ``tree nuts'' is required to be used whenever an
ingredient is, or is derived from, an example from one of these
food categories. The second example illustrates the committee's
intent that an ingredient whose common or usual name uses the
term for the major food allergen--in the example, ``pine nuts''
clearly uses the term for pine nuts--need not be followed by a
parenthetical repeating the term. Finally, all major food
allergens are required to be labeled consistently on the food
label: either in the summary of allergen information at the end
of, or immediately adjacent to, the ingredient list, or using
parentheses after ingredients.
The committee intends that the use of the term ``milk'' in
either of these examples does not violate the standard of
identity for milk established under FDA regulations. Used in
this context, the term ``milk'' is used to identify a major
food allergen and not the identity of the ingredient or the
food.
The legislation gives FDA the authority to modify or
eliminate these requirements by regulation. This authority is
limited in a few respects, however. First, FDA may modify one
or both labeling options. Second, FDA may not eliminate all
major food allergen labeling by eliminating both labeling
options; rather, FDA may eliminate only one of the approaches.
Third, and most significantly, FDA must demonstrate in the
regulation that modification or elimination of an allergen
labeling requirement is necessary to protect public health. The
committee considers this standard to impose a high burden on
the Secretary to justify changing these requirements of the
legislation.
In addition, the legislation amends section 403A of the
FFDCA to give the modification to the ingredient label required
by section 403(w) the same preemptive effect over State and
local ingredient labeling that the current ingredient labeling
has.
The committee understands that many manufacturers have
already labeled their foods in conformity with one of the plain
English allergen labeling options, and it expects that most
foods will be labeled in compliance with these requirements
before January 1, 2006. In any case, all foods that contain an
ingredient that is or that contains a major food allergen must
be labeled by January 1, 2006. This fixed date by which all
affected foods must be labeled in accordance with these
requirements will give consumers greater certainty that they
will be able to rely on food labels as of that date.
Importantly, this requirement does not require the relieving of
food products that are in the marketplace before the effective
date. In other words, this legislation does not require food
products to be pulled from the marketplace and relabeled in
conformance with the requirements of this legislation if they
were labeled before January 1, 2006.
The committee intends the requirements of section 403(w) to
be self-implementing. FDA will not be required to issue
regulations to implement section 403(w). FDA may issue
guidance, should the agency find that guidance would assist
manufacturers or distributors, particularly small businesses,
to comply with the requirements in this legislation.
The legislation also adds a second misbranding provision to
account for other food allergens. In particular, section 403(x)
provides that FDA has the authority to require by regulation
appropriate labeling of any spice, flavoring, coloring, or
incidental additive ingredient that is, or includes as a
constituent, a food allergen that is not a major food allergen.
The committee does not intend the listing of all spices or
flavorings in a product but intends that the Secretary will
require the food allergen to be identified on the label in a
manner consistent with this legislation. In addition, the
legislation provides that the amendments made by it do not
otherwise alter FDA's authority to require the labeling of
other food allergens that are not major food allergens.
Finally, the legislation amends section 403A of the FFDCA to
give requirements under section 403(x)--which provides for an
exception to a current labeling exemption for spices,
flavorings, colorings, and incidental additives that has
preemptive effect over State and local labeling requirements--
the same preemptive effect over State and local labeling
requirements that the current exemption has.
Food allergy surveillance, research, and response
The committee is concerned that the prevalence of food
allergies is uncertain and the incidence of clinically
significant and serious adverse events is not being
systematically monitored. In response to these concerns, the
legislation requires the Centers for Disease Control and
Prevention to better capture information on the prevalence of
food allergies, the incidence of clinically significant or
serious adverse events related to food allergies, and the use
of different modes of treatment for and prevention of allergic
responses to foods. In addition, the legislation requires the
National Institutes of Health to convene a panel of nationally
recognized experts to review current clinical research efforts
and develop recommendations for enhancing and coordinating
research activities concerning food allergies.
The legislation directs the Secretary, in the Conference
for Food Protection, to pursue revision of the Food Code to
provide recommendations and guidance on preparing allergen-free
foods in food establishments. The Secretary should refer to
private guidelines, including the Food Allergy and Anaphylaxis
Network and Food Allergy Initiative's document entitled: Food
Allergy Training Guide for Restaurants and Food Services, as a
model during development.
Finally, the legislation directs the Secretary to provide
technical assistance to States and localities about treatment
of food allergic responses by trauma care and emergency medical
services. Currently, the preferred treatment for anaphylaxis
from food allergy is an auto-injector epinephrine device. The
legislation does not specify this treatment, so that the
Secretary will continue to provide such technical assistance as
new treatments are developed.
Celiac disease and gluten labeling
The legislation directs the Secretary, after consulting
with appropriate experts and stakeholders, to promulgate a
regulation to define and permit the use of the term ``gluten-
free'' as a voluntary claim on the food label. The committee
intends that this ``gluten-free'' claim not be a claim for
special dietary use, a nutrient content claim, or a health
claim. The legislation requires that the proposed rule
regarding this claim be issued not later than 2 years after the
date of enactment of the legislation, and that the final rule
be issued not later than 4 years after the date of enactment of
the legislation.
V. Cost Estimate
Due to time constraints, the Congressional Budget Office
estimate was not included in the report. When received by the
committee, it will appear in the Congressional Record.
VI. Application of Law to the Legislative Branch
Section 102(b) (3) of Public Law 104-1, the Congressional
Accountability Act (CAA), requires a description of the
application of this bill to the legislative branch. Title I,
the Minor Use and Minor Species Animal Health Act of 2003 would
amend the Federal FFDCA by creating a program authorizing FDA
to establish a conditional approval mechanism for animal drugs,
an index of legally-marketed unapproved new animal drugs for
certain uses in some minor species, and up to seven years of
marketing exclusivity for some new animal drugs approved or
conditionally approved for minor uses or minor species. As
such, the legislation would not apply to the legislative
branch.
Title II of S. 741 adds two misbranding provisions to
section 403 of the FFDCA to provide, first, that food labels
include plain English labeling of the eight major food
allergens and second, that food allergens other than the eight
major food allergens can be identified when they are contained
in flavorings, colorings, or other incidental additives. It
also requires certain other actions by the Department of Health
and Human Services relating to food allergens and gluten. As
such, it has no application to the legislative branch.
VII. Regulatory Impact Statement
Title I would establish a new Office of Minor Use and Minor
Species Animal Drug Development within the FDA's Center for
Veterinary Medicine. This office will be responsible for
designating minor use and minor species animal drugs, for
administering grants and contracts under section 573 of the
FFDCA, for reviewing minor species drug index listing requests,
and for serving as liaison to other government agencies
interested in minor use and minor species animal drug
development. This legislation requires the Secretary to issue
proposed and final regulations to implement section 573 no
later than 12 months and 24 months after the date of enactment
of this act, respectively. The Secretary is also required to
publish proposed and final regulations to implement section 572
no later than 18 months and 36 months after the date of
enactment of this act, respectively. Finally, the Secretary is
required to issue proposed and final regulations implementing
section 571 no later than 30 months and 42 months after
enactment of this act, respectively. Accordingly, this
legislation is expected to increase costs to government
minimally.
Title II requires foods that contain one or more of the
eight major food allergens to be labeled so as to disclose the
presence of those allergens in plain English. Because many in
the food industry have already begun the process of labeling
their products to disclose these allergens, and because the
legislation requires food manufacturers to comply with this
requirement by January 1, 2006, by which time most in the food
industry may be expected to produce new labels for their foods
notwithstanding the requirements of this legislation, the costs
to most members of the food industry and to the food industry
in aggregate of this requirement will be minimized.
Accordingly, this legislation is not expected to increase costs
to government.
VIII. Section-by-Section Analysis
TITLE I
Sec. 101. Short title
Section 101 provides that the short title of Title I of
this bill is the Minor Use and Minor Species Animal Health Act
of 2003.
Sec. 102(a). Findings
Section 102(a) sets forth Congressional findings regarding
the need for incentives and new ways to lawfully market new
animal drugs for minor species and minor uses.
Sec. 102(b). Amendments to the Federal Food, Drug, and Cosmetic Act
Subsection (b)(1) amends the FFDCA to add relevant
definitions. New section 201(nn) of the FFDCA defines ``major
species'' as cattle, horses, swine, chickens, turkeys, dogs,
and cats. The FDA is authorized to amend this definition to add
species to the major species list through rulemaking. New
section 201(oo) defines ``minor species'' as species other than
humans or major species. Minor species are defined by exclusion
consistent with the existing definition in the Code of Federal
Regulations (21 CFR 514.1(d)(1)). New section 201(pp) of the
FFDCA defines ``minor use'' as 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 geographic areas
and in only a small number of animals annually. This definition
incorporates the existing definition in the Code of Federal
Regulations (21 CFR 514.1(d)(1)) with a further limitation to
small numbers to assure that such intended uses will not be
extended to a wider use. The Secretary is expected to further
clarify this definition in regulations implementing this
section. FDA is given broad latitude in determining what
constitutes a minor use in a major species. The Congress
intends for FDA to make the determination of minor use by
evaluating, in the context of the drug development process,
whether the incidence of the disease or condition occurs so
infrequently that the sponsor of a drug intended for such use
has no reasonable expectation of its sales generating
sufficient revenues to offset the costs of development. The
Congress does not intend for FDA to establish a test of
commercial value, but rather directs FDA to determine whether
the expected low use of a drug would discourage its
development. FDA will make this determination, in part, based
upon documentation from the drug sponsor demonstrating that the
disease or condition occurs infrequently and in a small number
of animals, or occurs in limited geographic areas and in a
small number of animals annually. FDA may initially make such
determinations on a case-by-case basis. These initial
determinations may form the basis for establishing or revising
regulations which clarify the grounds or the process for
determining whether a new animal drug is intended for a ``minor
use''.
Subsection (b)(2) of this bill amends section 512(c) of the
FFDCA to allow FDA to award three years of market exclusivity
in connection with the approval of a minor use or minor species
NADA or supplemental NADA when the approval is based on a
residue depletion study that is used to calculate a withdrawal
time. The typical minor species supplement to an approved
application for a new animal drug intended for use in a food-
producing animal uses or incorporates by reference most of the
human food safety data from the approved application. The
exception is the residue depletion study or studies (e.g.,
tissue, milk, eggs) which the sponsor must conduct in the
target minor species to support approval. Such studies are not
granted exclusivity under the current statute. These studies
must be done using Good Laboratory Practices (21 CFR 58), and
can be as costly as target animal safety or effectiveness
studies which, under current law, can serve as the basis for
the exclusivity period. Granting marketing exclusivity based on
a residue depletion study or studies is intended to encourage
sponsors to conduct such studies to support minor species
supplements.
Subsection (b)(3) adds new section 512(d)(5) to the FFDCA
to direct FDA to review only the existing information in the
approved NADA that is relevant to a minor use or minor species
supplemental NADA. Animal drug manufacturers have been
concerned that filing a supplemental NADA to add a claim for a
minor use or use in a minor species could lead to automatic
reevaluation of the underlying major species approval, thereby
putting the entire NADA in jeopardy. This concern has served as
a disincentive to the filing of minor use and minor species
supplemental NADAs. This section is intended to mitigate that
concern. Therefore, the legislation provides that FDA's review
of a supplemental application for a minor use or minor species
approval does not constitute a reaffirmation of the approval(s)
for the major species. Section 512(d)(5) does not in any way
change FDA's current authority to reevaluate any application at
any time under section 512 of the FFDCA.
Subsection (b)(4) adds a new subchapter (F) to the FFDCA
consisting of sections 571 to 573.
New Sec. 571. Conditional approval of new animal drugs for minor use
and minor species
Section 571(a)(1) establishes a conditional approval
process for minor use and minor species new animal drugs.
Subsection (a)(2) establishes the information that sponsors
must submit as part of an application for conditional approval.
Subsection (a)(2)(A) indicates that the standards and
requirements for conditional approval of new animal drugs are
identical to those for new animal drugs approved under section
512 except with respect to effectiveness.
Under subsection (a)(2)(B), the drug sponsor must provide
information to establish that the drug is safe (including, for
an antimicrobial new animal drug, with respect to antimicrobial
resistance) and that there is a reasonable expectation that the
drug is effective for use. Data from such sources as pilot
studies, investigations using surrogate endpoints, short-term
investigations, pharmacokinetic extrapolations, or
investigations of closely-related diseases may be used to
demonstrate a reasonable expectation of effectiveness. Data
from some of these sources may also be used to meet the
``substantial evidence'' standard of effectiveness under
section 512 of the FFDCA. Under section 512, a sponsor must
have a sufficient number of ``adequate and well-controlled''
studies to demonstrate by substantial evidence that a new
animal drug is effective. But, to meet the conditional approval
standard, the studies need not be of the same quality or
quantity as studies that meet the ``substantial evidence''
standard. Within five years of the date of the conditional
approval, the sponsor must conduct a sufficient number of
adequate and well-controlled studies to demonstrate by
``substantial evidence'' that the new animal drug is effective
under section 512(d)(1)(E).
Subsection (a)(2)(C) requires submission of data to
establish a conditional dose.
Subsections (a)(2)(D) and (E) require sponsors to provide
projections and justification for the expected need for the
drug and an estimate of the quantity of drug to be distributed
on an annual basis to meet that need. Information to support
these projections could include market research, surveys of
veterinarians, producers, or academic institutions, or
statistics compiled by private or government agencies.
Regulations will specify ways that sponsors may adjust
distribution amounts based on changes in demand prior to the
submission of a renewal request. Subsection (a)(2)(F) requires
a sponsor to commit to conducting additional investigations to
meet the full requirements for the demonstration of
effectiveness under section 512 (d)(1)(e) within five years.
Subsection (a)(3)(A) prohibits a person from filing an
application for conditional approval for a new animal drug that
is contained in or the product of a transgenic animal.
Subsection (a)(3)(B) prohibits persons from filing an
application for conditional approval of the same drug, in the
same dosage form, for the same intended use as a product for
which they have previously filed an application for conditional
approval. The Secretary has discretion to define the term
``same drug'' as used here and throughout section 571. In
defining ``same drug,'' the Secretary should take into account
that the purpose of this legislation is to promote the
development of minor use and minor species new animal drugs. A
sponsor should be able to reap a conditional approval's
benefit, recouping some development costs through marketing of
a product prior to full approval, only once per product. This
section, therefore, is intended to limit conditional approval
applications to products that differ materially from products
for which a sponsor has previously filed a conditional approval
application. So, for example, where two products differ only
with respect to one or more inactive ingredients, they are the
``same drug'' for purposes of this section.
Similarly, subsection (a)(3)(C) prevents a sponsor from
marketing in excess of the five years it is given to get full
approval of a conditionally approved drug by preventing the
sponsor from reapplying or transferring the conditional
approval to someone else who will apply for a new conditional
approval for the drug. A sponsor change (e.g., as the result of
a sale or merger) does not require a new application. The new
sponsor assumes all the existing deadlines and requirements
inherent to the existing application.
Subsection (b) provides the Secretary 180 days (or an
agreed upon timeframe) after the filing of an application
pursuant to subsection (a) to issue an order either to
conditionally approve a new animal drug for one year or give
the sponsor notice of an opportunity for an informal hearing on
whether the application can be conditionally approved. If any
of the provisions of section 512(d) except (d)(1)(E) are
applicable, or insufficient information is available to show
that there is a reasonable expectation that the drug will be
effective for its intended purpose, the Secretary will issue an
order under section 571(c) refusing to conditionally approve
the application. The Secretary will also refuse to
conditionally approve a new animal drug for a minor use or a
minor species if another person has received approval under
section 512 for the same drug in the same dosage form for the
same intended use and that person is able to assure the
availability of sufficient quantities of the drug to meet the
needs for which the drug is intended.
Subsection (d) establishes that a conditional approval is
renewable annually for up to four additional one-year terms
upon submission of a request for renewal. A conditional
approval cannot be in effect for more than five years from the
date of the original conditional approval, unless the Secretary
extends its review of effectiveness information. If the sponsor
files a timely request for renewal, i.e. no later than 90 days
prior to the end of the one-year conditional approval, the
application will be renewed automatically at the expiration of
the one-year term, unless the Secretary issues a written order
denying the renewal. The Secretary may grant an extension of 90
additional days to complete review of the renewal request if
necessary. The renewal, if granted, will expire one year from
the end of the previous one-year term, not one year from the
end of a 90-day extension.
Under subsection (e)(1), the Secretary will withdraw
conditional approval of a new animal drug if the Secretary
finds that another person has received approval under section
512 for the same drug in the same dosage form for the same
intended use.
Subsection (e)(2) requires the Secretary, after an
opportunity for an informal hearing to the applicant, to
withdraw a conditional approval if any of the provisions of
section 512(e)(1) except 512(e)(1)(C), which relates to
effectiveness, are applicable, or if new information becomes
available to suggest that there is not a reasonable expectation
that the drug will have its purported effect.
Subsection (e)(3) also allows the Secretary to withdraw a
conditional approval, after an opportunity for an informal
hearing, if any of the provisions of section 512(e)(2) are
applicable. Subsection (f) establishes labeling requirements
for conditionally-approved new animal drugs. Labeling for a
conditionally-approved new animal drug must bear a statement
identifying the new animal drug as conditionally approved. A
conditionally-approved indication cannot be included on the
same label as a fully-approved indication. Multiple
conditionally-approved indications may appear on the same
printed label. However, the sponsor must remove indications
from the label of a conditionally-approved product when they
are either fully approved under section 512 or withdrawn for
any reason.
Subsection (g) prohibits amending or supplementing a
conditionally-approved new animal drug application to add
indications for use. To get approval for a different/new
indication, a sponsor must submit a new animal drug application
or another application for conditional approval for the new
intended use. However, such application may incorporate
information from an existing application by right of reference.
Subsection (h) provides that if a conditionally-approved
new animal drug is not approved under section 512(c) within
five years of the conditional approval, the conditional
approval is no longer in effect, unless extended by the
Secretary for an additional 180 days to complete review of the
application.
Subsection (i) establishes that the decision of the
Secretary to refuse or withdraw conditional approval of an
application constitutes final agency action subject to judicial
review.
Subsection (j) defines the term ``transgenic animal''.
New Sec. 572. Index of legally-marketed unapproved new animal drugs for
minor species
Section 572(a)(1) of the FFDCA requires the Secretary to
establish an index of legally-marketed new animal drugs for
minor species. New animal drugs intended for minor uses in
major species do not qualify to be indexed. The index is
limited to animal drugs for minor species for which there is a
reasonable certainty that the animal or edible products from
the animal will not be consumed by humans or food-producing
animals, as well as new animal drugs intended for use in an
appropriately contained non-food early life stage of a food-
producing minor species, where safety of the indexed drug is
demonstrated in accordance with the standard of section 512(d)
(including, for an antimicrobial new animal drug, with respect
to antimicrobial resistance). The index is primarily intended
to benefit zoo and wildlife species, aquarium fish, reptiles,
caged birds, small pet mammals, and wildlife, some
commercially-produced species, such as crickets and earthworms,
and non-food life stages of some minor human food species, such
as shellfish and some finfish. For most of these species, it is
highly unlikely there will ever be sufficient economic
incentive for the development of data packages to support full
or conditional approvals. The index established by this section
provides an alternative process for making drug products
legally available for these species.
Subsection (a)(2) precludes the indexing of a new animal
drug that is contained in or the product of a transgenic
animal.
Subsection (b) provides that anyone interested in indexing
a new animal drug is entitled to one or more conferences with
the Secretary to discuss indexing requirements.
Subsection (c) entitles any person to submit a request to
the Secretary to determine whether a new animal drug is
eligible for inclusion in the index. This request will include
information to support the need for the drug, conditions of its
intended use, and the expected annual distribution. Information
also must be provided to support safety for humans (if
applicable), and details of the drug's chemistry and
manufacturing processes. In addition, a request must include an
environmental assessment that meets the requirements of the
National Environmental Policy Act, or information to support a
categorical exclusion from the requirement to prepare an
environmental assessment. Finally, occupational and user safety
must be addressed, as well as any other issue the Secretary
deems necessary. The Secretary has 90 days to determine whether
the new animal drug is eligible for inclusion in the index.
However, the Secretary has 180 days to grant or deny the
request in the case where the request is for indexing of a new
animal drug which is intended for use in an early life stage of
a minor species food animal. The additional 90 days allows the
Secretary sufficient time to ensure that the drug is safe for
humans under section 512(d) (including, with respect to a new
antimicrobial drug, antimicrobial safety); that the same drug
in the same dosage form for the same intended use is not
approved or conditionally approved; the sponsor has established
appropriate specifications for the manufacture and control of
the new animal drug; the person requesting the index listing
has demonstrated that the drug is safe for users; and the
requirements of the National Environmental Policy Act have been
met. The Secretary will grant the eligibility request only if
the foregoing requirements are satisfied. As in section 571,
the Secretary has discretion to define the term ``same drug''
as used in this section. In defining ``same drug'' the
Secretary should take into account the intent of limiting the
index to drugs which are materially different from drugs that
have previously been approved or conditionally approved. So,
for example, where two products differ only with respect to one
or more inactive ingredients, they are the ``same drug'' for
purposes of this section. If the Secretary denies the request
for eligibility, the sponsor may request an informal
conference. Such a conference will be conducted in a more
informal manner than a hearing conducted under 21 CFR part 16.
The record compiled for the informal conference will form the
record for judicial review.
If the Secretary makes a determination that a drug is
eligible for inclusion in the index, new section 572(d) permits
the person who made the request for index eligibility to ask
the Secretary to add the drug to the index. The request for
indexing must include: the Secretary's determination of
eligibility; the report of a panel of qualified experts
operating external to FDA and not subject to the Federal
Advisory Committee Act; a proposed index entry; facsimile
product labeling; anticipated annual distribution; and written
commitments to manufacture the product in accordance with good
manufacturing practices and to label, distribute and promote
the product only in accordance with the index entry. Upon
request of the Secretary, the information provided to the
expert panel must also be provided. The report of the expert
panel must address all available target animal safety and
effectiveness information, including anecdotal information. The
report of the expert panel must include the panel's opinion
regarding whether the benefits of using the new animal drug for
the proposed use in a minor species outweigh its risks to the
target animal, taking into account the harm caused by the
absence of an approved or conditionally-approved new animal
drug for the minor species in question. Many of the species for
which indexing is the only viable option are either too
valuable or too rare to be used in controlled investigations.
Thus, the recommendations of experts with extensive experience
in the care of these species are an important source of
information regarding whether or not to include a drug in the
index. The report must also include information on the basis of
which product labeling can be written, including a
recommendation regarding whether the drug should be limited to
use under the supervision of a veterinarian. The Secretary may
request copies of the information provided to the expert panel,
and any other information prescribed by general regulation or
specific order. The Secretary will establish by regulation the
criteria for selection of members, and the procedures for
operation of the expert panel. The Secretary has 180 days to
grant or deny a request for listing a drug on the index, based
upon whether the request continues to meet the eligibility
criteria in subsection (a), and the Secretary finds, on the
basis of the expert panel report and any other information
available, that the benefits of using the product for the
proposed use in the minor species outweigh its risks to the
target animal, taking into account the harm caused by the
absence of an approved or conditionally-approved drug for the
minor species in question.
Subsection (e) requires that the index include the name and
address of the person who holds the index listing, the name of
the drug and the intended use and conditions of use for which
it is being indexed, product labeling, and any other conditions
and limitations that are necessary regarding use of the drug.
Although an index listing is specific to its sponsor, more than
one person can obtain an index listing for the same drug in the
same dosage form for the same intended use. There is no
marketing exclusivity provision for indexed drugs. The
Secretary will publish the index and update it periodically.
The Secretary may establish by regulation a process for minor
changes in the conditions of manufacturing or labeling of
indexed products. Subsection (f) lists the bases on which the
Secretary must remove a drug from the index after the
opportunity for an informal conference. The Secretary may
immediately suspend the index listing of a new animal drug if
the Secretary finds that there is a reasonable probability that
the use of the indexed product would present a risk to the
health of humans or other animals. Subsection (g) requires the
Secretary to promulgate regulations to permit the
investigational use of new animal drugs intended to be indexed.
Subsection (h) requires that the labeling of a new animal
drug listed in the index include, prominently and
conspicuously, the statement: ``Not approved by FDA. Legally
marketed as an FDA indexed product. Extra-label use is
prohibited.'' Except in the case of a product indexed for use
in an early life-stage of a minor species food-producing
animal, the label of the indexed product must also bear the
statement: ``This product is not to be used in animals intended
for use as food for humans or other animals.''
Subsection (i) gives the Secretary the authority to impose
recordkeeping and reporting requirements, either by general
regulation or by specific order. These requirements may include
reporting to the Secretary the quantity of the drug
manufactured and distributed.
The Secretary has the authority to inspect and copy any
records required to be maintained. Subsection (j) provides for
safety and effectiveness data to be made public under specified
conditions or circumstances. Section 572 of the FFDCA contains
no provision parallel to current section 512(n) that would
permit index listing to serve as the basis for the submission
of an abbreviated new animal drug application or a subsequent
index listing based on a demonstration of bioequivalence to an
indexed product.
New Sec. 573. Designated new animal drugs for minor use or minor
species
Section 573(a) establishes a designation procedure. Under
subsection (a), the manufacturer or sponsor of a new animal
drug may request that the Secretary declare the drug a
``designated new animal drug.'' The decision to request the
designation is entirely within the discretion of the
manufacturer or sponsor. A request for designation must be made
before the submission of a new animal drug application under
section 512 or submission of an application for a new animal
drug under section 571 seeking conditional approval. Once the
Secretary determines that a drug is a ``designated new animal
drug,'' individuals or entities pursuing legal marketing of
such drug may be eligible for grants for qualified safety and
effectiveness testing of the drug, and for manufacturing
expenses incurred in connection with the development of such
drug. A designated new animal drug will qualify for an extended
period of marketing exclusivity upon approval.
Whether a new animal drug is designated depends on its
intended use. A new animal drug will be designated only if the
drug is intended for use in a minor species or for minor use in
a major species and the same new animal drug in the same dosage
form for the same intended use has not previously been approved
or conditionally approved for such use and is not currently
designated. The Secretary has discretion to define the term
``same drug'' as used in this section. In defining ``same
drug'' the Secretary should take into account the purpose of
this legislation to promote the development of minor use and
minor species new animal drugs. A sponsor should be able to
reap the benefits of designation only for products that are
materially different from products that have already been
approved, conditionally approved, or designated. So, for
example, where two products differ only with respect to one or
more inactive ingredients, they are the ``same drug'' for
purposes of this section.
The goal of designation is to facilitate the approval of
new animal drugs for minor species and minor uses in major
species. Thus, the Secretary will terminate a designation if
the sponsor discontinues active pursuit of approval so that
other sponsors can seek designation and pursue approval of the
new animal drug. Notice of designation and termination of
designation of a new animal drug will be made available to the
public.
Subsection (b) gives the Secretary the authority to make
grants to and enter into contracts with public and private
entities and individuals to assist in defraying the costs of
safety and effectiveness testing and manufacturing costs
relating to the development of designated new animal drugs.
Such grants and contracts may only be used to defray costs that
are incurred after the date the new animal drug is designated
and before the date on which the application under section 512
is submitted.
Subsection (c) provides for a period of marketing
exclusivity for designated new animal drugs from the date of
approval. If the Secretary approves or conditionally approves
an application for a designated new animal drug, the Secretary
cannot approve or conditionally approve another application for
such new animal drug for the same intended use as the
designated new animal drug before the expiration of seven years
from the date of the approval or conditional approval of the
designated new animal drug. By providing for a period of
exclusive marketing, i.e., exclusivity, this bill gives
sponsors a period in which they can recoup research and
development costs without competition.
In certain circumstances, the Secretary can approve or
conditionally approve a new animal drug during the exclusivity
period for the same use for which the designated new animal
drug was approved. One circumstance is when the Secretary finds
that at any time during the exclusivity period the holder of
the approved application cannot assure the availability of
sufficient quantities of the drug to meet the need for the
drug. The Secretary must provide the holder of the approved
application with notice and an opportunity for submission of
views before taking this action. A second circumstance is when
the holder of the approved application gives written consent to
the Secretary for the approval or conditional approval of other
applications before the expiration of the exclusivity period.
Sec. 5. Conforming amendments
This section makes conforming amendments to the FFDCA. An
amendment to section 201(v) of the FFDCA makes any drug
intended for minor uses or for use in minor species animals a
new animal drug unless it is the subject of a final regulation
issued by the Secretary finding that the drug: (1) is generally
recognized as safe and effective for use under the conditions
prescribed, recommended, or suggested in the drug's labeling
and has been used to a material extent and for a material time
under such conditions; or (2) has been ``grandfathered'' under
the provisions of section 201(v)(1) of the FFDCA or section 108
of Public Law 90-399. The purpose of this provision is to
facilitate enforcement actions against illegally-marketed minor
use or minor species animal drugs. A major disincentive to the
submission of NADAs for minor uses and minor species is a
prospective sponsor's knowledge that due to limited resources
the Secretary is unable to pursue enforcement actions against
all firms that market competing illegal animal drugs. Under the
Act, as amended, the Secretary will be able to show that such a
product is an unapproved new animal drug by demonstrating that
it is not approved, conditionally approved, indexed, or the
subject of a final regulation finding that it meets the
criteria of section 201(v) of the FFDCA for the use or uses for
which it is intended. This will allow the Secretary to remove
from the market in a timely manner unapproved products marketed
for the same claim as approved or indexed products.
An amendment to section 502 of the FFDCA adds new
subsection (u). New section 502(u) deems any conditionally-
approved new animal drug misbranded if its labeling does not
conform to its approved application or does not bear the
statements required under new section 571(f). A new animal drug
is also deemed misbranded if its labeling bears the statement
set forth in new section 571(f)(1)(A) saying it is
conditionally approved when it is not conditionally approved.
An indexed drug is deemed misbranded if its labeling does not
conform to its index listing or does not bear the statements
required under new section 572(h). A drug is also deemed
misbranded if its labeling bears the statement set forth in new
section 572(h) saying it is indexed when it is not.
Amendments to sections 503 and 504 of the FFDCA describe
when new animal drugs that are conditionally approved or
indexed must be approved as prescription or veterinary feed
directive drugs, respectively.
Amendments to section 512(a)(1) and (2) of the FFDCA
provide for lawful marketing of conditionally-approved new
animal drugs and animal feed bearing or containing
conditionally-approved new animal drugs, and of indexed new
animal drugs and animal feed bearing or containing indexed new
animal drugs. Any new animal drug or feed bearing or containing
a new animal drug that is not approved, conditionally approved,
or listed in the index is deemed unsafe and would therefore be
adulterated.
An amendment to section 512(d)(4) of the FFDCA clarifies
that a new animal drug that has been individually conditionally
approved may not be approved for use in combination under this
section, either in combination with a fully-approved drug, or
with another conditionally-approved drug. Section 512(d)(4) of
the FFDCA provides a modified approval process for certain
combinations of new animal drugs that were previously
separately approved under section 512. One of the underlying
bases for permitting use of the modified combination approval
process is that the individual drugs to be used in combination
have been shown to be safe and effective for their intended
uses. Conditionally-approved new animal drugs do not qualify
because they have not been demonstrated by substantial evidence
to be effective. An amendment to section 512(m)(1)(C) of the
FFDCA describes the conditions that must be met for the use of
indexed drugs in medicated feeds.
Sec. 6. Regulations
This section requires FDA to issue proposed and final
implementing regulations. Section 571, conditional approval,
and section 573, designation, will be implemented immediately
upon the enactment of this legislation. FDA cannot implement
section 572, indexing, of the FFDCA until final regulations
become effective.
Sec. 7. Office
This section establishes an Office of Minor Use and Minor
Species Animal Drug Development, reporting directly to the
Director of the Center for Veterinary Medicine of FDA. This
office will be responsible for designating minor use and minor
species animal drugs, for administering grants and contracts
under section 573 of the FFDCA, for reviewing minor species
drug index listing requests, and for serving as liaison to
other government agencies interested in minor use and minor
species animal drug development. This office is not responsible
for reviewing minor use or minor species approval or
conditional approval applications. This section also authorizes
the appropriation of 1.2 million dollars for this office for
the first year, to be adjusted to meet actual needs for
subsequent years.
Sec. 8. Authorization of appropriations
This section provides authorization for the appropriation
of funds to carry out section 573(b). This will provide funding
for grants for designated new animal drugs for minor species
and minor uses.
TITLE II
Sec. 201. Short title of title II
The ``Food Allergen Labeling and Consumer Protection Act of
2003.''
Sec. 202. Findings
Establishes a series of findings, which point to the
critical need for plain English food allergen labeling on
packaged food products.
Sec. 203. Food labeling; requirement of information regarding
allergenic substances
Amends section 201 of the FFDCA to define the term ``major
food allergen'' to mean one of the 8 major food allergens
(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) and
any food that contains a protein derived from one of these
eight food allergens, except highly refined oils, ingredients
derived from highly refined oils, and other food ingredients
that are exempt from the labeling under this legislation.
Section 203 amends section 403 of the FFDCA to provide that
a food is misbranded if it is not a raw agricultural commodity
and it is, or it contains an ingredient that bears or contains,
a major food allergen, unless its label identifies the
ingredient that is or that bears or contains the major food
allergen. This information is required to appear consistently
within each such food's label in one of two ways, either within
the ingredient list in parentheses after the first ingredient
that contains the allergen, or in summary form at the end of,
or immediately adjacent to, the ingredient list. Section 203
requires that food ingredient statements identify in one of
these ways when a major food allergen is used in flavorings,
colorings, or incidental additives. All foods, other than raw
agricultural commodities, that contain ingredients that are, or
that bear or contain, major food allergens must be labeled by
January 1, 2006. Section 203 also amends section 403A of the
FFDCA to give the allergen labeling the same preemptive effect
over State and local ingredient labeling as current ingredient
labeling.
Section 203 provides that FDA has the authority to require
by regulation appropriate labeling of any spice, flavoring,
coloring, or incidental additive that is, or that bears or
contains, a food allergen that is not a major food allergen.
Section 203 also provides that this regulatory exception to the
current labeling exemption for spices, flavorings, colorings,
and incidental additives has the same preemptive effect over
State and local labeling requirements as the current exemption.
In addition, section 203 provides that the amendments made by
it do not otherwise alter FDA's authority to require the
labeling of other food allergens that are not major food
allergens.
Section 204. Report on food allergens
Requires the Secretary to issue a report to Congress not
later than 18 months after the date of enactment of this Act,
analyzing the ways in which foods, during manufacturing and
processing, can be unintentionally contaminated with major food
allergens (cross-contact); estimating how common these
practices are; advising whether methods can be used to reduce
or eliminate cross-contact of foods with the major food
allergens; describing the types of advisory labeling used by
the food industry, the conditions of manufacture associated
with use of advisory labeling, and the extent of use of
advisory labeling; determining how consumers with food
allergies or the caretakers of consumers would prefer
information about the risk of cross-contact be communicated on
food labels; stating the number of inspections of food
manufacturing and processing facilities conducted in the
previous 2 years and discussing the findings of these
inspections; and assessing the extent to which cross-contact
issues have been addressed by the Secretary and the food
industry.
Section 205. Inspections relating to food allergens
Requires the Secretary to conduct inspections under its
existing authority under Section 704 to ensure that food
facilities comply with practices to reduce or eliminate cross-
contact of a food with major food allergen residues and that
food allergens are properly labeled.
Sec. 206. Gluten labeling
Requires the Secretary to issue a proposed rule no later
than 2 years, and a final rule no later than 4 years, after the
date of enactment of this legislation to define, and permit the
use of, the term ``gluten-free'' on the labeling of foods.
Sec. 207. Improvement and publication of data on food-related allergic
responses
Requires the CDC to improve the collection of national data
on the prevalence of food allergies, the incidence of
clinically significant or serious adverse events related to
food allergies, and the use of different modes of treatment for
and prevention of allergic responses to foods, and publish it
as it becomes available. Section 207 authorizes the
appropriation of such sums as may be necessary to carry out its
purposes.
Sec. 208. Food allergies research
Directs the NIH to convene a panel of nationally recognized
experts in allergy and immunology to review current basic and
clinical research efforts related to food allergies and to make
recommendations--which the Secretary will make public--to
enhance and coordinate research activities concerning food
allergies not later than 1 year after the date of enactment of
the legislation.
Sec. 209. Food allergens in the Food Code
Directs the Secretary, in the Conference for Food
Protection, as part of its cooperative activities between the
States under section 311 of the Public Health Service Act, to
pursue revision of the Food Code to provide guidelines for
preparing allergen-free foods in food establishments, including
in restaurants, grocery store delicatessens and bakeries, and
elementary and secondary school cafeterias.
Sec. 210. Recommendations regarding responding to food-related allergic
responses
Directs the Secretary to provide technical assistance
relating to the use of different modes of treatment for and
prevention of allergic responses to foods when it provides
technical assistance relating to trauma care and emergency
medical services under section 1202(b)(3) of the Public Health
Service Act.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER II--DEFINITIONS
Sec. 201. For the purposes of this Act--
(a)(1) * * *
(u) The term ``safe'' as used in paragraph (s) of this
section and in sections 409, [512] 512, 571, and 721, has
reference to the health of man or animal.
(v) * * *
* * * * * * *
(2) * * *
* * * * * * *
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.
* * * * * * *
(mm)(1) * * *
(2) * * *
(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.
(2) A food ingredient that contains protein derived
from a food specified in paragraph (1), except the
following:
(A) Any highly refined oil derived from a
food specified in paragraph (1) and any
ingredient derived from such highly refined
oil.
(B) A food ingredient that is exempt under
paragraph (6) or (7) of section 403(w).
CHAPTER III--PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) * * *
* * * * * * *
(e) The refusal to permit access to or copying of any
record as required by section 412, 414, 504, 564, 703, or
704(a); or the failure to establish or maintain any record, or
make any report, required under section 412, 414(b), 504, 505
(i) or (k), [512(a)(4)(C), 512 (j), (l) or (m)] 512(a)(4)(C),
512 (j), (l) or (m), 572(i), 515(f), 519, or 564 or the refusal
to permit access to or verification or copying of any such
required record.
* * * * * * *
(j) The using by any person to his own advantage, or
revealing, other than to the Secretary or officers or employees
of the Department, or to the courts when relevant in any
judicial proceeding under this Act, any information acquired
under authority of section 404, 409, 412, 414, 505, 510, 512,
513, 514, 515, 516, 518, 519, [520] 520, 571, 572, 573, 704,
708, or 721 concerning any method or process which as a trade
secret is entitled to protection; or the violating of section
408(i)(2) or any regulation issued under that section. This
paragraph does not authorize the withholding of information
from either House of Congress or from, to the extent of matter
within its jurisdiction, any committee or subcommittee of such
committee or any joint committee of Congress or any
subcommittee of such joint committee.
* * * * * * *
FOOD ALLERGEN LABELING AND CONSUMER PROTECTION ACT OF 2003
* * * * * * *
MISBRANDED FOOD
Sec. 403. A food shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(w)(1) If it is not a raw agricultural commodity and it is,
or it contains an ingredient that bears or contains, a major
food allergen, unless either--
(A) the word ``Contains'', followed by the name of
the food source from which the major food allergen is
derived, is printed immediately after or is adjacent to
the list of ingredients (in a type size no smaller than
the type size used in the list of ingredients) required
under subsections (g) and (i); or
(B) the common or usual name of the major food
allergen in the list of ingredients required under
subsections (g) and (i) is followed in parentheses by
the name of the food source from which the major food
allergen is derived, except that the name of the food
source is not required when--
(i) the common or usual name of the
ingredient uses the name of the food source
from which the major food allergen is derived;
or
(ii) the name of the food source from which
the major food allergen is derived appears
elsewhere in the ingredient list, unless the
name of the food source that appears elsewhere
in the ingredient list appears as part of the
name of a food ingredient that is not a major
food allergen under section 201(qq)(2)(A) or
(B).
(2) As used in this subsection, the term ``name of the food
source from which the major food allergen is derived'' means
the same described in section 201(qq)(1); provided that in the
case of a tree nut, fish, or Crustacean shellfish, the term
``name of the food source from which the major food allergen is
derived'' means the name of the specific type of nut or species
of fish or Crustacean shellfish.
(3) The information required under this subsection may
appear in labeling in lieu of appearing on the label only if
the Secretary finds that such other labeling is sufficient to
protect the public health. A finding by the Secretary under
this paragraph (including any change in an earlier finding
under this paragraph) is effective upon publication in the
Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k), or any
other law, a flavoring, coloring, or incidental additive that
is, or that bears or contains, a major food allergen shall be
subject to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements
of subparagraph (A) or (B) of paragraph (1), or eliminate
either the requirement of subparagraph (A) or the requirements
of subparagraph (B) of paragraph (1), if the Secretary
determines that the modification or elimination of the
requirement of subparagraph (A) or the requirements of
subparagraph (B) is necessary to protect the public health.
(6)(A) Any person may petition the Secretary to exempt a
food ingredient described in section 201(qq)(2) from the
allergen labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition
within 180 days of receipt of the petition or the petition
shall be deemed denied, unless an extension of time is mutually
agreed upon by the Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide
scientific evidence (including the analytical method used to
produce the evidence) that demonstrates that such food
ingredient, as derived by the method specified in the petition,
does not cause an allergic response that poses a risk to human
health.
(D) A determination regarding a petition under this
paragraph shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all
petitions received under this paragraph within 14 days of
receipt and the Secretary shall promptly post the Secretary's
response to each.
(7)(A) A person need not file a petition under paragraph
(6) to exempt a food ingredient described in section 201(qq)(2)
from the allergen labeling requirements of this subsection, if
the person files with the Secretary a notification containing--
(i) scientific evidence (including the analytical
method used) that demonstrates that the food ingredient
(as derived by the method specified in the
notification, where applicable) does not contain
allergenic protein; or
(ii) a determination by the Secretary that the
ingredient does not cause an allergic response that
poses a risk to human health under a premarket approval
or notification program under section 409.
(B) The food ingredient may be introduced or delivered for
introduction into interstate commerce as a food ingredient that
is not a major food allergen 90 days after the date of receipt
of the notification by the Secretary, unless the Secretary
determines within the 90-day period that the notification does
not meet the requirements of this paragraph, or there is
insufficient scientific evidence to determine that the food
ingredient does not contain allergenic protein or does not
cause an allergenic response that poses a risk to human health.
(C) The Secretary shall promptly post to a public site all
notifications received under this subparagraph within 14 days
of receipt and promptly post any objections thereto by the
Secretary.
(x) Notwithstanding subsection (g), (i), or (k), or any
other law, a spice, flavoring, coloring, or incidental additive
that is, or that bears or contains, a food allergen (other than
a major food allergen), as determined by the Secretary by
regulation, shall be disclosed in a manner specified by the
Secretary by regulation.
Sec. 403A. (a) * * *
* * * * * * *
(2) any requirement for the labeling of food of the
type required by section 403(c), 403(e), [or 403(i)(2)]
403(i)(2), 403(w), or 403(x) that is not identical to
the requirement of such section, except that this
paragraph does not apply to a requirement of a State or
political subdivision of a State that is of the type
required by section 403(c) and that is applicable to
maple syrup,
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
ADULTERATED DRUGS AND DEVICES
Sec. 501. A drug or device shall be deemed to be
adulterated--
(a)(1) * * *
* * * * * * *
MISBRANDED DRUGS AND DEVICES
Sec. 502. A drug or device shall be deemed to be
misbranded--
(a) * * *
* * * * * * *
(w) If it is a new animal drug--
(1) that is conditionally approved under section 571
and its labeling does not conform with the approved
application or section 571(f), or that is not
conditionally approved under section 751 and its label
bears the statement set forth in section 571(f)(1)(A);
or
(2) that is indexed under section 572 and its
labeling does not conform with the index listing under
section 572(e) or 572(h), or that has not been indexed
under section 572 and its label bears the statement set
forth in section 572(h).
* * * * * * *
EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL
PRODUCTS
Sec. 503. (a) * * *
* * * * * * *
(f)(1)(A) A drug intended for use by animals other than
man, other than a veterinary feed directive drug intended for
use in animal feed or an animal feed bearing or containing a
veterinary feed directive drug, which--
(i) * * *
* * * * * * *
(ii) is limited by an approved application under
subsection (b) of section [512] 512, a conditionally-
approved application under section 571, or an index
listing under section 572 to use under the professional
supervision of a licensed veterinarian,
* * * * * * *
(3) The Secretary may by regulation exempt drugs for
animals other than man subject to [section 512] section 512,
571, or 572 from the requirements of paragraph (1) when such
requirements are not necessary for the protection of the public
health.
* * * * * * *
VETERINARY FEED DIRECTIVE DRUGS
Sec. 504. (a)(1) A drug intended for use in or on animal
feed which is limited by an approved application filed pursuant
to section [512(b)] 512(b), a conditionally-approved
application filed pursuant to section 571, or an index listing
pursuant to section 572 to use under the professional
supervision of a licensed veterinarian is a veterinary feed
directive drug. Any animal feed bearing or containing a
veterinary feed directive drug shall be fed to animals only by
or upon a lawful veterinary feed directive issued by a licensed
veterinarian in the course of the veterinarian's professional
practice. When labeled, distributed, held, and used in
accordance with this section, a veterinary feed directive drug
and any animal feed bearing or containing a veterinary feed
directive drug shall be exempt from section 502(f).
* * * * * * *
(B) is in compliance with the conditions and
indications for use of the drug set forth in the notice
published pursuant to section [512(i)] 512(i), or the
index listing pursuant to section 572(e).
(b) A veterinary feed directive drug and any feed bearing
or containing a veterinary feed directive drug shall be deemed
to be misbranded if their labeling fails to bear such
cautionary statement and such other information as the
Secretary may by general regulation or by order prescribe, or
their advertising fails to conform to the conditions and
indications for use published pursuant to section [512(i)]
512(i), or the index listing pursuant to section 572(e) or
fails to contain the general cautionary statement prescribed by
the Secretary.
* * * * * * *
NEW ANIMAL DRUGS
Sec. 512. (a)[(1) A new animal drug shall, with respect to
any particular use or intended use of such drug, be deemed
unsafe for the purposes of section 501(a)(5) and section
402(a)(2)(D) unless--
[(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
use or intended use of such drug, and
[(B) such drug, its labeling, and such use conform to
such approved application.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the time
of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee for such
drug, or notice from the Secretary, to the effect that, with
respect to the use of such drug in animal feed, such consignee
(i) holds a license issued under subsection (m) and has in its
possession current approved labeling for such drug in animal
feed; or (ii) will, if the consignee is not a user of the drug,
ship such drug only to a holder of a license issued under
subsection (m).
[(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of
such animal feed be deemed unsafe for the purposes of section
501(a)(6) unless--
[(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
drug, as used in such animal feed,
[(B) such animal feed is manufactured at a site for
which there is in effect a license issued pursuant to
subsection (m)(1) to manufacture such animal feed, and
[(C) such animal feed and its labeling, distribution,
holding, and use conform to the conditions and
indications of use published pursuant to subsection
(i).] (1) A new animal drug shall, with respect to any
particular use or intended use of such drug, be deemed
unsafe for purposes of section 501(a)(5) and section
402(a)(2)(C)(ii) unless--
(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
use or intended use of such drug, and such drug, its
labeling, and such use conform to such approved
application;
(B) there is in effect a conditional approval of an
application filed pursuant to section 571 with respect
to such use or intended use of such drug, and such
drug, its labeling, and such use conform to such
conditionally approved application; or
(C) there is in effect an index listing pursuant to
section 572 with respect to such use or intended use of
such drug in a minor species, and such drug, its
labeling, and such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the time
of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee of such drug,
or notice from the Secretary, to the effect that, with respect
to the use of such drug in animal feed, such consignee (i)
holds a license issued under subsection (m) and has in its
possession current approved labeling for such drug in animal
feed; or (ii) will, if the consignee is not a user of the drug,
ship such drug only to a holder of a license issued under
subsection (m).
(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of
such animal feed be deemed unsafe for purposes of section
501(a)(6) unless--
(A) there is in effect--
(i) an approval of an application filed
pursuant to subsection (b) with respect to such
drug, as used in such animal feed, and such
animal feed and its labeling, distribution,
holding, and use conform to such approved
application;
(ii) a conditional approval of an application
filed pursuant to section 571 with respect to
such drug, as used in such animal feed, and
such animal feed and its labeling,
distribution, holding, and use conform to such
conditionally approved application; or
(iii) an index listing pursuant to section
572 with respect to such drug, as used in such
animal feed, and such animal feed and its
labeling, distribution, holding, and use
conform to such index listing; and
(B) such animal feed is manufactured at a site for
which there is in effect a license issued pursuant to
subsection (m)(1) to manufacture such animal feed.
* * * * * * *
(b)(1) * * *
* * * * * * *
(3) Any person intending to file an application [under
paragraph (1) or a request for an investigational exemption
under subsection (j)] under paragraph (1), section 571, or a
request for an investigational exemption under subsection (j)
shall be entitled to one or more conferences prior to such
submission to reach an agreement acceptable to the Secretary
establishing a submission or an investigational requirement,
which may include a requirement for a field investigation. A
decision establishing a submission or an investigational
requirement shall bind the Secretary and the applicant or
requestor unless (A) the Secretary and the applicant or
requestor mutually agree to modify the requirement, or (B) the
Secretary by written order determines that a substantiated
scientific requirement essential to the determination of safety
or effectiveness of the animal drug involved has appeared after
the conference. No later than 25 calendar days after each such
conference, the Secretary shall provide a written order setting
forth a scientific justification specific to the animal drug
and intended uses under consideration if the agreement referred
to in the first sentence requires more than one field
investigation as being essential to provide substantial
evidence of effectiveness for the intended uses of the drug.
Nothing in this paragraph shall be construed as compelling the
Secretary to require a field investigation.
* * * * * * *
(c)(1) * * *
(2)(A) * * *
* * * * * * *
(F)(i) * * *
(ii) If an application submitted under subsection (b)(1)
for a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved
in another application approved under such subsection, is
approved after the date of enactment of this paragraph and if
such application contains substantial evidence of the
effectiveness of the drug involved, any studies of animal
safety, or, in the case of food producing animals, human food
safety studies [(other than bioequivalence or residue studies)]
(other than bioequivalance studies or residue depletion
studies, except residue depletion studies for minor uses or
minor species) required for the approval of the application and
conducted or sponsored by the applicant, the Secretary may not
make the approval of an application submitted under subsection
(b)(2) for the conditions of approval of such drug in the
subsection (b)(1) application effective before the expiration
of 3 years from the date of the approval of the application
under subsection (b)(1) for such drug.
(iii) If a supplement to an application approved under
subsection (b)(1) is approved after the date of enactment of
this paragraph and the supplement contains substantial evidence
of the effectiveness of the drug involved, any studies of
animal safety, or, in the case of food producing animals, human
food safety studies [(other than bioequivalence or residue
studies)] (other than bioequivalence studies or residue
depletion studies, except residue depletion studies for minor
uses or minor species) required for the approval of the
supplement and conducted or sponsored by the person submitting
the supplement, the Secretary may not make the approval of an
application submitted under subsection (b)(2) for a change
approved in the supplement effective before the expiration of 3
years from the date of the approval of the supplement.
(iv) * * *
(v) If an application (including any supplement to a new
animal drug application) submitted under subsection (b)(1) for
a new animal drug for a food-producing animal use, which
includes an active ingredient (including any ester or salt of
the active ingredient) which has been the subject of a waiver
under clause (iv) is approved after the date of enactment of
this paragraph, and if the application contains substantial
evidence of the effectiveness of the drug involved, any studies
of animal safety, or human food safety studies [(other than
bioequivalence or residue studies)] (other than bioequivalence
studies or residue depletion studies, except residue depletion
studies for minor uses or minor species) required for the new
approval of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of an
application (including any supplement to such application)
submitted under subsection (b)(2) for the new conditions of
approval of such drug in the subsection (b)(1) application
effective before the expiration of five years from the date of
approval of the application under subsection (b)(1) for such
drug. The provisions of this paragraph shall apply only to the
first approval for a food-producing animal use for the same
applicant after the waiver under clause (iv).
* * * * * * *
(d)(1) * * *
* * * * * * *
(4) In a case in which an animal drug contains more than
one active ingredient, or the labeling of the drug prescribes,
recommends, or suggests use of the drug in combination with one
or more other animal drugs, and the active ingredients or drugs
intended for use in the combination [have previously been
separately approved] have previously been separately approved
pursuant to an application submitted under section 512(b)(1)
for particular uses and conditions of use for which they are
intended for use in the combination--
* * * * * * *
(5) In reviewing an application that proposes a change to
add an intended use for a minor use or a minor species to an
approved new animal drug application, the Secretary shall
reevaluate only the relevant information in the approved
application to determine whether the application for the minor
use or minor species can be approved. A decision to approve the
application for the minor use or minor species is not,
implicitly or explicitly, a reaffirmation of the approval of
the original application.
* * * * * * *
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under [subsection (d), (e),
or (m)] subsection (d), (e), or (m), or section 571, (c), (d),
or (e) refusing, withdrawing, or suspending approval of an
application and shall approve such application or reinstate
such approval, as may be appropriate.
(g) Orders of the Secretary issued under [this section]
this section, or section 571 (other than orders issuing,
amending, or repealing regulations) shall be served (1) in
person by any officer or employee of the department designated
by the Secretary or (2) by mailing the order by registered mail
or by certified mail addressed to the applicant or respondent
at his last known address in the records of the Secretary.
* * * * * * *
(i) When a new animal drug application filed pursuant to
[subsection (b)] subsection (b) or section 571 is approved, the
Secretary shall by notice, which upon publication shall be
effective as a regulation, publish in the Federal Register the
name and address of the applicant and the conditions and
indications of use of the new animal drug covered by such
application, including any tolerance and withdrawal period or
other use restrictions and, if such new animal drug is intended
for use in animal feed, appropriate purposes and conditions of
use (including special labeling requirements and any
requirement that an animal feed bearing or containing the new
animal drug be limited to use under the professional
supervision of a licensed veterinarian) applicable to any
animal feed for use in which such drug is approved, and such
other information, upon the basis of which such application was
approved, as the Secretary deems necessary to assure the safe
and effective use of such drug. Upon withdrawal of approval of
such new animal drug application or upon its suspension or upon
failure to renew a conditional approval under section 571, the
Secretary shall forthwith revoke or suspend, as the case may
be, the regulation published pursuant to this subsection (i)
insofar as it is based on the approval of such application.
* * * * * * *
(l)(1) In the case of any new animal drug for which an
approval of an application filed pursuant to [subsection (b)]
subsection (b) or section 571 is in effect, the applicant shall
establish and maintain such records, and make such reports to
the Secretary, of data relating to experience, including
experience with uses authorized under subsection (a)(4)(A), and
other data or information, received or otherwise obtained by
such applicant with respect to such drug, or with respect to
animal feeds bearing or containing such drug, as the Secretary
may by general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) or
subsection (m)(4) of this section. Such regulation or order
shall provide, where the Secretary deems it to be appropriate,
for the examination, upon request, by the persons to whom such
regulation or order is applicable, of similar information
received or otherwise obtained by the Secretary.
* * * * * * *
(m)(1) Any person may file with the Secretary an
application for a license to manufacture animal feeds bearing
or containing new animal drugs. Such person shall submit to the
Secretary as part of the application (A) a full statement of
the business name and address of the specific facility at which
the manufacturing is to take place and the facility's
registration number, (B) the name and signature of the
responsible individual or individuals for that facility, (C) a
certification that the animal feeds bearing or containing new
animal drugs are manufactured and labeled in accordance with
the [applicable regulations published pursuant to subsection
(i)] applicable regulations published pursuant to subsection
(i) or for indexed new animal drugs in accordance with the
index listing published pursuant to section 572(e)(2) and the
labeling requirements set forth in section 572(h), and (D) a
certification that the methods used in, and the facilities and
controls used for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity with current good
manufacturing practice as described in section 501(a)(2)(B).
* * * * * * *
(3) * * *
(A) * * *
* * * * * * *
(C) that the facility manufactures animal feeds
bearing or containing new animal drugs in a manner that
does not accord with the specifications for manufacture
or labels animal feeds bearing or containing new animal
drugs in a manner that does not accord with the
conditions or indications of use that are published
pursuant to subsection (i) or an index listing pursuant
to section 572(e),
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing,
the Secretary finds that subparagraphs (A) through (C) do not
apply, the Secretary shall issue an order approving the
application. An order under this subsection approving an
application for a license to manufacture animal feeds bearing
or containing new animal drugs shall permit a facility to
manufacture only those animal feeds bearing or containing new
animal drugs for which there are in effect regulations pursuant
to subsection (i) or an index listing pursuant to section
572(e) relating to the use of such drugs in or on such animal
feed.
* * * * * * *
(p)(1) Safety and effectiveness data and information which
has been submitted in an application filed under [subsection
(b)(1)] subsection (b)(1) or section 571(a) for a drug and
which has not previously been disclosed to the public shall be
made available to the public, upon request, unless
extraordinary circumstances are shown--
* * * * * * *
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the application
filed under [subsection (b)(1)] subsection (b)(1) or
section 571(a), and
* * * * * * *
SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
(a) In General.--
(1) Emergency uses.-- * * *
* * * * * * *
Subchapter F--New Animal Drugs for Minor Use and Minor Species
SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND
MINOR SPECIES.
(a)(1) Except as provided in paragraph (3) of this section,
any person may file with the Secretary an application for
conditional approval of a new animal drug intended for a minor
use or a minor species. Such an application may not be a
supplement to an application approved under section 512. Such
application must comply in all respects with the provisions of
section 512 of this Act except sections 512(a)(4), 512(b)(2),
512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and
512(n) unless otherwise stated in this section, and any
additional provisions of this section. New animal drugs are
subject to application of the same safety standards that would
be applied to such drugs under section 512(d) (including, for
antimicrobial new animal drugs, with respect to antimicrobial
resistance).
(2) The applicant shall submit to the Secretary as part of
an application for the conditional approval of a new animal
drug--
(A) all information necessary to meet the
requirements of section 512(b)(1) except section
512(b)(1)(A);
(B) full reports of investigations which have been
made to show whether or not such drug is safe under
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance)
and there is a reasonable expectation of effectiveness
for use;
(C) data for establishing a conditional dose;
(D) projections of expected need and the
justification for that expectation based on the best
information available;
(E) information regarding the quantity of drug
expected to be distributed on an annual basis to meet
the expected need; and
(F) a commitment that the applicant will conduct
additional investigations to meet the requirements for
the full demonstration of effectiveness under section
512(d)(1)(E) within 5 years.
(3) A person may not file an application under paragraph
(1) if--
(A) the application seeks conditional approval of a
new animal drug that is contained in, or is a product
of, a transgenic animal.
(B) the person has previously filed an application
for conditional approval under paragraph (1) for the
same drug in the same dosage form for the same intended
use whether or not subsequently conditionally approved
by the Secretary under subsection (b), or
(C) the person obtained the application, or data or
other information contained therein, directly or
indirectly from the person who filed for conditional
approval under paragraph (1) for the same drug in the
same dosage form for the same intended use whether or
not subsequently conditionally approved by the
Secretary under subsection (b).
(b) Within 180 days after the filing of an application
pursuant to subsection (a), or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary
shall either--
(1) issue an order, effective for one year,
conditionally approving the application if the
Secretary finds that none of the grounds for denying
conditional approval, specified in subsection (c) of
this section applies and publish a Federal Register
notice of the conditional approval, or
(2) give the applicant notice of an opportunity for
an informal hearing on the question whether such
application can be conditionally approved.
(c) If the Secretary finds, after giving the applicant
notice and an opportunity for an informal hearing, that--
(1) any of the provisions of section 512(d)(1) (A)
through (D) or (F) through(I) are applicable;
(2) the information submitted to the Secretary as
part of the application and any other information
before the Secretary with respect to such drug, is
insufficient to show that there is a reasonable
expectation that the drug will have the effect it
purports or is represented to have under the conditions
of use prescribed, recommended, or suggested in the
proposed labeling thereof; or
(3) another person has received approval under
section 512 for the same drug in the same dosage form
for the same intended use, and that person is able to
assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and opportunity
for an informal hearing, the Secretary finds that paragraphs
(1) through (3) do not apply, the Secretary shall issue an
order conditionally approving the application effective for one
year and publish a Federal Register notice of the conditional
approval. Any order issued under this subsection refusing to
conditionally approve an application shall state the findings
upon which it is based.
(d) A conditional approval under this section is effective
for a 1-year period and is thereafter renewable by the
Secretary annually for up to 4 additional 1-year terms. A
conditional approval shall be in effect for no more than 5
years from the date of approval under subsection (b)(1) or (c)
of this section unless extended as provided for in subsection
(h) of this section. The following shall also apply:
(1) No later than 90 days from the end of the 1-year
period for which the original or renewed conditional
approval is effective, the applicant may submit a
request to renew a conditional approval for an
additional 1-year term.
(2) A conditional approval shall be deemed renewed at
the end of the 1-year period, or at the end of a 90-day
extension that the Secretary may, at the Secretary's
discretion, grant by letter in order to complete review
of the renewal request, unless the Secretary determines
before the expiration of the 1-year period or the 90-
day extension that--
(A) the applicant failed to submit a timely
renewal request;
(B) the request fails to contain sufficient
information show that--
(i) the applicant is making
sufficient progress toward meeting
approval requirements under section
512(d)(1)(E), and is likely to be able
to fulfill those requirements and
obtain an approval under section 512
before the expiration of the 5-year
maximum term of the conditional
approval;
(ii) the quantity of the drug that
has been distributed is consistent with
the conditionally approved intended use
and conditions of use, unless there is
adequate explanation that ensures that
the drug is only used for its intended
purpose; or
(iii) the same drug in the same
dosage form for the same intended use
has not received approval under section
512, or if such a drug has been
approved, that the holder of the
approved application is unable to
assure the availability of sufficient
quantities of the drug to meet the
needs for which the drug is intended;
or
(C) any of the provisions of section
512(e)(1) (A) through (B) or (D) through (F)
are applicable.
(3) If the Secretary determines before the end of the
1-year period or the 90-day extensions, if granted,
that a conditional approval should not be renewed, the
Secretary shall issue an order refusing to renew the
conditional approval, and such conditional approval
shall be deemed withdrawn and no longer in effect. The
Secretary shall thereafter provide an opportunity for
an informal hearing to the applicant on the issue
whether the conditional approval shall be reinstated.
(e)(1) The Secretary shall issue an order withdrawing
conditional approval of an application filed pursuant to
subsection (a) if the Secretary finds that another person has
received approval under section 512 for the same drug in the
same dosage form for the same intended use and that person is
able to assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended.
(2) The Secretary shall, after due notice and opportunity
for an informal hearing to the applicant, issue an order
withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that--
(A) any of the provisions of section 512(e)(1) (A)
through (B) or (D) through (F) are applicable; or
(B) on the basis of new information before the
Secretary with respect to such drug, evaluated together
with the evidence available to the Secretary when the
application was conditionally approved, that there is
not a reasonable expectation that such drug will have
the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or
suggested in the labeling thereof.
(3) The Secretary may also, after due notice and
opportunity for an informal hearing to the applicant, issue an
order withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that any of
the provisions of section 512(e)(2) are applicable.
(f)(1) The label and labeling of a new animal drug with a
conditional approval under this section shall--
(A) bear the statement, conditionally approved by FDA
pending a full demonstration of effectiveness under
application number; and
(B) contain such other information as prescribed by
the Secretary.
(2) An intended use that is the subject of a conditional
approval under this section shall not be included in the same
product label with any intended use approved under section 512.
(g) A conditionally approved new animal drug application
may not be amended or supplemented to add indications for use.
(h) 180 days prior to the termination date established
under subsection (d) of this section, an applicant shall have
submitted all the information necessary to support a complete
new animal drug application in accordance with section
512(b)(1) or the conditional approval issued under this section
is no longer in effect. Following review of this information,
the Secretary shall either--
(1) issue an order approving the application under
section 512(c) if the Secretary finds that none of the
grounds for denying approval specified in section
512(d)(1) applies, or
(2) give the applicant an opportunity for a hearing
before the Secretary under section 512(d) on the
question whether such application can be approved.
Upon issuance of an order approving the application, product
labeling and administrative records of approval shall be
modified accordingly. If the Secretary has not issued an order
under section 512(c) approving such application prior to the
termination date established under subsection (d) of this
section, the conditional approval issued under this section is
no longer in effect unless the Secretary grants an extension of
an additional 180-day period so that the Secretary can complete
review of the application. The decision to grant an extension
is committed to the discretion of the Secretary and not subject
to judicial review.
(i) The decision of the Secretary under subsection (c),
(d), or (e) of this section refusing or withdrawing conditional
approval of an application shall constitute final agency action
subject to judicial review.
(j) In this section and section 572, the term ``transgenic
animal'' means an animal whose genome contains a nucleotide
sequence that has been intentionally modified in vitro, and the
progeny of such an animal; Provided that the term ``transgenic
animal'' does not include an animal of which the nucleotide
sequence of the genome has been modified solely by selective
breeding.
SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES.
(a)(1) The Secretary shall establish an index limited to--
(A) new animal drugs intended for use in a minor
species for which there is a reasonable certainty that
the animal or edible products from the animal will not
be consumed by humans or food-producing animals; and
(B) new animal drugs intended for use only in a
hatchery, tank, pond, or other similar contained man-
made structure in an early, non-food life stage of a
food-producing minor species, where safety for humans
is demonstrated in accordance with the standard of
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance).
(2) The index shall not include a new animal drug that is
contained in or a product of a transgenic animal.
(b) Any person intending to file a request under this
section shall be entitled to one or more conferences to discuss
the requirements for indexing a new animal drug.
(c)(1) Any person may submit a request to the Secretary for
a determination whether a new animal drug may be eligible for
inclusion in the index. Such a request shall include--
(A) information regarding the need for the new animal
drug, the species for which the new animal drug is
intended, the proposed intended use and conditions of
use, and anticipated annual distribution;
(B) information to support the conclusion that the
proposed use meets the conditions of subparagraph (A)
or (B) of subsection (a)(1) of this section;
(C) information regarding the components and
composition of the new animal drug;
(D) a description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and packing of such new animal drug;
(E) an environmental assessment that meets the
requirements of the National Environmental Policy Act
of 1969, as amended, and as defined in 21 CFR Part 25,
as it appears on the date of enactment of this
provision and amended thereafter or information to
support a categorical exclusion from the requirement to
prepare an environmental assessment;
(F) information sufficient to support the conclusion
that the proposed use of the new animal drug is safe
under section 512(d) with respect to individuals
exposed to the new animal drug through its manufacture
or use; and
(G) such other information as the Secretary may deem
necessary to make this eligibility determination.
(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on subsection
(a)(1)(A) of this section, or 180 days for a request submitted
based on subsection (a)(1)(B) of this section, the Secretary
shall grant or deny the request, and notify the person who
requested such determination of the Secretary's decision. The
Secretary shall grant the request if the Secretary finds that--
(A) the same drug in the same dosage form for the
same intended use is not approved or conditionally
approved;
(B) the proposed use of the drug meets the conditions
of subparagraph (A) or (B) of subsection (a)(1), as
appropriate;
(C) the person requesting the determination has
established appropriate specifications for the
manufacture and control of the new animal drug and has
demonstrated an understanding of the requirements of
current good manufacturing practices;
(D) the new animal drug will not significantly affect
the human environment; and
(E) the new animal drug is safe with respect to
individuals exposed to the new animal drug through its
manufacture or use.
If the Secretary denies the request, the Secretary shall
thereafter provide due notice and an opportunity for an
informal conference. A decision of the Secretary to deny an
eligibility request following an informal conference shall
constitute final agency action subject to judicial review.
(d)(1) With respect to a new animal drug for which the
Secretary has made a determination of eligibility under
subsection (c), the person who made such a request may ask that
the Secretary add the new animal drug to the index established
under subsection (a). The request for addition to the index
shall include--
(A) a copy of the Secretary's determination of
eligibility issued under subsection (c);
(B) a written report that meets the requirements in
subsection (d)(2) of this section;
(C) a proposed index entry;
(D) facsimile labeling;
(E) anticipated annual distribution of the new animal
drug;
(F) a written commitment to manufacture the new
animal drug and animal feeds bearing or containing such
new animal drug according to current good manufacturing
practices;
(G) a written commitment to label, distribute, and
promote the new animal drug only in accordance with the
index entry;
(H) upon specific request of the Secretary,
information submitted to the expert panel described in
paragraph (3); and
(I) any additional requirements that the Secretary
may prescribe by general regulation or specific order.
(2) The report required in paragraph (1) shall--
(A) be authored by a qualified expert panel;
(B) include an evaluation of all available target
animal safety and effectiveness information, including
anecdotal information;
(C) state the expert panel's opinion regarding
whether the benefits of using the new animal drug for
the proposed use in a minor species outweigh its risks
to the target animal, taking into account the harm
being caused by the absence of an approved or
conditionally approved new animal drug for the minor
species in question;
(D) include information from which labeling can be
written; and
(E) include a recommendation regarding whether the
new animal drug should be limited to use under the
professional supervision of a licensed veterinarian.
(3) A qualified expert panel, as used in this section, is a
panel that--
(A) is composed of experts qualified by scientific
training and experience to evaluate the target animal
safety and effectiveness of the new animal drug under
consideration;
(B) operates external to FDA; and
(C) is not subject to the Federal Advisory Committee
Act, 5 U.S.C. App. 2.
The Secretary shall define the criteria for section of a
qualified expert panel and the procedure for the operation of
the panel by regulation.
(4) Within 180 days after the receipt of a request for
listing a new animal drug in the index, the Secretary shall
grant or deny the request. The Secretary shall grant the
request if the request for indexing continues to meet the
eligibility criteria in subsection (a) and the Secretary finds,
on the basis of the report of the qualified expert panel and
other informal available to the Secretary, that the benefits of
using the new animal drug for the proposed use in a minor
species outweigh its risks to the target animal, taking into
account the harm caused by the absence of an approved or
conditionally-approved new animal drug for the minor species in
question. If the Secretary denies the request, the Secretary
shall thereafter provide due notice and the opportunity for an
informal conference. The decision of the Secretary following an
informal conference shall constitute final agency action
subject to judicial review.
(e)(1) The index established under subsection (a) shall
include the following information for each listed drug--
(A) the name and address of the person who holds the
index listing;
(B) the name of the drug and the intended use and
conditions of use for which it is being indexed;
(C) product labeling; and
(D) conditions and any limitations that the Secretary
deems necessary regarding use of the drug.
(2) The Secretary shall publish the index, and revise it
periodically.
(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or
labeling of indexed products.
(f)(1) If the Secretary finds, after due notice to the
person who requested the index listing and an opportunity for
an informal conference, that--
(A) the expert panel failed to meet the requirements
as set forth by the Secretary by regulation;
(B) on the basis of new information before the
Secretary, evaluated together with the evidence
available to the Secretary when the new animal drug was
listed in the index, the benefits of using the new
animal drug for the indexed use do not outweigh its
risks to the target animal;
(C) the conditions of subsection (c)(2) of this
section are no longer satisfied;
(D) the manufacture of the new animal drug is not in
accordance with current good manufacturing practices;
(E) the labeling, distribution, or promotion of the
new animal drug is not in accordance with the index
entry;
(F) the conditions and limitations of use associated
with the index listing have not been followed; or
(G) the request for indexing contains any untrue
statement of material fact,
the Secretary shall remove the new animal drug from the index.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(2) If the Secretary finds that there is a reasonable
probability that the use of the drug would present a risk to
the health of humans or other animals, the Secretary may--
(A) suspend the listing of such drug immediately;
(B) give the person listed in the index prompt notice
of the Secretary's action; and
(C) afford that person the opportunity for an
informal conference.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(g) For purposes of indexing new animal drugs under this
section, to the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of section 512 minor species new animal drugs and
animal feeds bearing or containing new animal drugs intended
solely for investigational use by experts qualified by
scientific training and experience to investigate the safety
and effectiveness of minor species animal drugs. Such
regulations may, at the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon the
establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the
sponsor of the investigation of such article, of data
(including but not limited to analytical reports by
investigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable the
Secretary to evaluate the safety and effectiveness of such
article in the event of the filing of a request for an index
listing pursuant to this section.
(h) The labeling of a new animal drug that is the subject
of an index listing shall state, prominently and
conspicuously--
(1) ``Not approved by fda.--Legally marketed as an
FDA indexed product. Extra-label use is prohibited.'';
(2) except in the case of new animal drugs indexed
for use in an early life stage of a food-producing
animal, ``This product is not to be used in animals
intended for use as food for humans or other
animals.''; and
(3) such other information as may be prescribed by
the Secretary in the index listing.
(i)(1) In the case of any new animal drug for which an
index listing pursuant to subsection (a) is in effect, the
person who has an index listing shall establish and maintain
such records, and make such reports to the Secretary, of data
relating to experience, and other data or information, received
or otherwise obtained by such person with respect to such drug,
or with respect to animal feeds bearing or containing such
drug, as the Secretary may by general regulation, or by order
with respect to such listing, prescribe on the basis of a
finding that such records and reports are necessary in order to
enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking
subsection (f). Such regulation or order shall provide, where
the Secretary deems it to be appropriate, for the examination,
upon request, by the persons to whom such regulation or order
is applicable, of similar information received or otherwise
obtained by the Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(j)(1) Safety and effectiveness data and information which
has been submitted in support of a request for a new animal
drug to be indexed under this section and which has not been
previously disclosed to the public shall be made available to
the public, upon request, unless extraordinary circumstances
are shown--
(A) if no work is being or will be undertaken to have
the drug indexed in accordance with the request,
(B) if the Secretary has determined that such drug
cannot be indexed and all legal appeals have been
exhausted,
(C) if the indexing of such drug is terminated and
all legal appeals have been exhausted, or
(D) if the Secretary has determined that such drug is
not a new animal drug.
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the request for
indexing; and
(B) without obtaining from any person to whom the
data and information are disclosed an identical
verified statement, a copy of which is to be provided
by such person to the Secretary, which meets the
requirements of this paragraph.
SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.
(a) Designation.--
(1) The manufacturer or the sponsor of a new animal
drug for a minor use or use in a minor species may
request that the Secretary declare that drug a
``designated new animal drug''. A request for
designation of a new animal drug shall be made before
the submission of an application under section 512(b)
or section 571 for the new animal drug.
(2) The Secretary may declare a new animal drug a
``designated new animal drug'' if--
(A) it is intended for a minor use or use in
a minor species; and
(B) the same drug in the same dosage form for
the same intended use is not approved under
section 512 or 571 or designated under this
section at the time the request is made.
(3) Regarding the termination of a designation--
(A) the sponsor of a new animal drug shall
notify the Secretary of any decision to
discontinue active pursuit of approval under
section 512 or 571 of an application for a
designated new animal drug. The Secretary shall
terminate the designation upon notification;
(B) the Secretary may also terminate
designation if the Secretary independently
determines that the sponsor is not actively
pursuing approval under section 512 or 571 with
due diligence;
(C) the sponsor of an approved designated new
animal drug shall notify the Secretary of any
discontinuance of the manufacture of such new
animal drug at least one year before
discontinuance. The Secretary shall terminate
the designation upon such notification; and
(D) the designation shall terminate upon the
expiration of any applicable exclusivity period
under subsection (c).
(4) Notice respecting the designation or termination
of designation of a new animal drug shall be made
available to the public.
(b) Grants and Contracts for Development of Designated New
Animal Drugs.--
(1) The Secretary may make grants to and enter into
contracts with public and private entities and
individuals to assist in defraying the costs of
qualified safety and effectiveness testing expenses and
manufacturing expenses incurred in connection with the
development of designated new animal drugs.
(2) For purposes of paragraph (1) of this section--
(A) The term ``qualified safety and
effectiveness testing'' means testing--
(i) which occurs after the date such
new animal drug is designated under
this section and before the date on
which an application with respect to
such drug is submitted under section
512; and
(ii) which is carried out under an
investigational exemption under section
512(j).
(B) The term ``manufactured expenses'' means
expenses incurred in developing processes and
procedures associated with manufacture of the
designated new animal drug which occur after
the new animal drug is designated under this
section and before the date on which an
application with respect to such new animal
drug is submitted under section 512 or 571.
(c) Exclusivity for Designated New Animal Drugs.--
(1) Except as provided in subsection (c)(2), if the
Secretary approves or conditionally approves an
application for a designated new animal drug, the
Secretary may not approve or conditionally approve
another application submitted for such new animal drug
with the same intended use as the designated new animal
drug for another applicant before the expiration of
seven years from the date of approval or conditional
approval of the application.
(2) If an application filed pursuant to section 512
or section 571 is approved for a designated new animal
drug, the Secretary may, during the 7-year exclusivity
period beginning on the date of the application
approval or conditional approval, approve or
conditionally approve another application under section
512 or section 571 for such drug for such minor use or
minor species for another applicant if--
(A) the Secretary finds, after providing the
holder of such an approved application notice
and opportunity for the submission of views,
that in the granted exclusivity period the
holder of the approved application cannot
assure the availability of sufficient
quantities of the drug to meet the needs for
which the drug was designated; or
(B) such holder provides written consent to
the Secretary for the approval or conditional
approval of other applications before the
expiration of such exclusivity period.
* * * * * * *
Public Law 90-399--July 13, 1968
EFFECTIVE DATE AND TRANSITIONAL PROVISIONS
Sec. 108. (a) * * *
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(3) In the case of any drug (other than a drug
subject to section 512(n) of the basic Act as amended
by this Act) intended for use in animals other than man
which, on October 9, 1962, (A) was commercially used or
sold in the United States, (B) was not a new drug as
defined by section 201(p) of the basic Act as then in
force, and (C) was not covered by an effective
application under section 505 of that Act the words
``effectiveness'' and ``effective'' contained in
[section 201 (w) as added by this Act] section 201(v)
to the basic Act shall not apply to such drug when
intended solely for use under conditions prescribed,
recommended, or suggested in labeling with respect to
such drug on that day.