```

[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) * * *

           *       *       *       *       *       *       *

          (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.

                                

```