29–010

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 

2

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. Conditionallyapproved 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 

3

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 crosscontact with a product that does not contain that particular allergen as an ingredient or as a component of an ingredient. In some 

4

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 

5

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 extralabel 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 increasVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
6

ing 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. 

7

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 

8

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 byproduct,’’ 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 inVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00008 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
9

deed 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. 

10

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. 

11

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 ‘‘glutenfree’’ 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 legallymarketed 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 

12

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 suffiVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00012 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
13

cient 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. 

14

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, 

15

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 

16

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 commerciallyproduced 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 inVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00016 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
17

clusion 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 outVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00017 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
18

weigh 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 

19

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 

20

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 aniVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00020 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
21

mal 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 speVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00021 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
22

cies 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 

23

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 (crosscontact); 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 crosscontact 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. 

24

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, ø512¿ 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. 

25

(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), ø512(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, 

ø520¿ 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—

26

(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. 

27

(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), øor 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, 

* * * * * * *

28

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 ø512¿ 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 øsection 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 ø512(b)¿ 512(b), a conditionally-approved application filed pursuant to section 571, or an index listing pursuant to section 572 to 

29

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 ø512(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 

ø512(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)ø(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— ø(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 

ø(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). 

ø(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—

ø(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, 

30

ø(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 

ø(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.

* * * * * * *

31

(b)(1) * * *

* * * * * * *

(3) Any person intending to file an application øunder 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 ø(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 ø(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 supVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00031 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
32

plement 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 ø(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 øhave 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 øsubsection (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 

33

approve such application or reinstate such approval, as may be appropriate. 

(g) Orders of the Secretary issued under øthis 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 øsubsection (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 øsubsection (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 

34

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 

øapplicable 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 øsubsection (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 idenVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00034 Fmt 6659 Sfmt 6602 E:\HR\OC\SR226.XXX SR226
35

tified in the application filed under øsubsection (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 

36

(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 

37

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 

38

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 

39

(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 

40

(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. 

41

(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; 

42

(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. 

43

(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 beVerDate jul 14 2003 20:17 Feb 19, 2004 Jkt 029010 PO 00000 Frm 00043 Fmt 6659 Sfmt 6603 E:\HR\OC\SR226.XXX SR226
44

fore 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 

45

(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 øsection 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.

Æ