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108th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     108-608

======================================================================



 
 MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2004; FOOD ALLERGEN 
              LABELING AND CONSUMER PROTECTION ACT OF 2004

                                _______
                                

 July 15, 2004.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 741]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom 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, report favorably thereon without 
amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     3
Committee Consideration..........................................     3
Committee Votes..................................................     3
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     4
Committee Cost Estimate..........................................     4
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................     9
Advisory Committee Statement.....................................    10
Constitutional Authority Statement...............................    10
Applicability to Legislative Branch..............................    10
Section-by-Section Analysis of the Legislation...................    10
Changes in Existing Law Made by the Bill, as Reported............    19

                          Purpose and Summary

    Title I of S. 741 addresses the critical shortage of animal 
drugs available for minor species, which are defined as animals 
other than humans that are not major species (cattle, horses, 
swine, chickens, turkeys, dogs, and cats), and for minor uses 
for major species, which are defined as the use of a drug in a 
major species for a disease that occurs infrequently in a small 
number of animals, or in limited geographic areas in a small 
number of animals annually. The bill does so by creating new 
ways for animal drugs to be legally marketed.
    Title II of S. 741 is the Food Allergen Labeling and 
Consumer Protection Act. It lays out a number of new 
requirements for the labeling of food in order to protect 
consumers with food allergies. Specifically, food that contains 
one of the eight major food allergens (milk, eggs, fish, 
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) 
must list the food source from which the major food allergen is 
derived either immediately after the list of ingredients or in 
parentheses following an ingredient that contains a food 
allergen.

                  Background and Need for Legislation


                                TITLE I

    Congress has recognized for some time that there are not 
adequate market incentives for manufacturers to produce animal 
drugs for minor species and for minor uses in major species. 
Therefore veterinarians, animal owners, and livestock producers 
may have limited options for treating these animals if they 
become ill. Veterinarians are often forced to treat these 
animals with unapproved drugs, or to treat these animals with 
the off-label use of an approved animal drug.
    Congress approved the Animal Medicinal Drug Use 
Clarification Act (AMDUCA) of 1994 (Public Law 103-396), which 
expanded the ability of veterinarians to use approved animal 
drugs for unapprovedpurposes. However, this legislation did not 
create new avenues for FDA approval of new animal drugs for minor uses 
and minor species.
    Congress responded to this shortage by approving the Animal 
Drug Availability Act (ADAA) of 1996 (Public Law 104-250). 
Section 2(f) of ADAA directed the Secretary of Health and Human 
Services to ``consider legislative and regulatory options for 
facilitating the approval under section 512 of the Federal 
Food, Drug, and Cosmetic Act of animal drugs intended for minor 
species and for minor uses and, within 18 months after the date 
of enactment of this Act, announce proposals for legislative or 
regulatory change to the approval process under such section 
for animal drugs intended for use in minor species or for minor 
uses.'' The FDA responded to this directive by forming the ADAA 
Minor Use/Minor Species Working Group, which issued a report 
entitled ``Proposals to Increase the Legal Availability of 
Animal Drugs for Minor Species and Minor Uses.'' This report 
was made available through a Federal Register notice on October 
29, 1998 (63 FR 58058). Included in the report's 
recommendations were proposals to create a conditional approval 
process for new animal drugs and a mechanism to index legally 
marketed, unapproved new animal drugs. Both of these proposals 
are contained in S. 741.

                                TITLE II

    Currently, approximately 2 percent of adults and 5 percent 
of children are allergic to various types of foods. Eight major 
food allergens (fish, Crustacean shellfish, milk, eggs, 
peanuts, tree nuts, soybeans, and wheat) cause over percent of 
food allergies in the United States. Since there is currently 
no cure for food allergies, consumers need to be empowered to 
know whether or not food allergies are present in the food they 
consume. There are no labeling standards currently in place for 
food allergies. S. 741 fills this gap by ensuring that the food 
source from which a major food allergen is derived is clearly 
labeled in plain English.
    The Committee expects, consistent with the November 30, 
1987 Memorandum of Understanding, that the Alcohol and Tobacco 
Tax and Trade Bureau (TTB) of the Department of Treasury will 
pursuant to the Federal Alcohol Administration Act determine 
how, as appropriate, to apply allergen labeling of beverage 
alcohol products and the labeling requirements for those 
products. The Committee expects that the TTB and the FDA will 
work together in promulgation of allergen regulations, with 
respect to those products.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On Tuesday, June 15, 2004, the Subcommittee on Health met 
in open markup session and approved S. 741 for Full Committee 
consideration by a voice vote, a quorum being present. On 
Thursday, June 24, 2004, the Full Committee met in open markup 
session and favorably ordered S. 741 reported by a voice vote, 
a quorum being present.

                            Committee Votes

    There were no record votes taken in connection with 
ordering S. 741 reported. A motion by Mr. Pickering to order S. 
741 reported to the House, as amended, was agreed to by a voice 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The first goal of S. 741 is to address the critical 
shortage of animal drugs available for minor species, and drugs 
for minor uses for major species. The second goal is to protect 
consumers with food allergies by implementing new requirements 
for the labeling of food.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that S. 
741, Minor Use and Minor Species Animal Health Act, would 
result in no new or increased budget authority, entitlement 
authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, July 2, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 741, an act to amend 
the Federal Food, Drug, and Cosmetic Act with regard to new 
animal drugs, and for the other purposes.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Julia 
Christensen (for animal drugs) and Niall Brennan (for food 
allergens).
            Sincerely,
                                      Elizabeth M. Robinson
                                         (For Douglas Holtz-Eakin).
    Enclosure.

S. 741--An act to amend the Federal Food, Drug, and Cosmetic Act with 
        regard to new animal drugs, and for other purposes

    Summary: S. 741 aims to increase the market availability of 
new animal drugs for minor species and for minor uses in major 
species of animals. It would amend the Federal Food, Drug, and 
Cosmetic Act (FFDCA) to authorize the Food and Drug 
Administration (FDA) to establish a conditional approval 
process for such drugs and to create an index of legally 
marketed unapproved drugs to treat certain minor species. It 
also would authorize grants to help defray a portion of the 
cost associated with the development of designated drugs and 
would award seven years of marketing exclusivity to products 
meeting certain criteria.
    S. 741 also would require that labels for food products 
indicate in plain English the presence of any of the eight 
major food allergens, and would direct the Secretary of Health 
and Human Services to engage in a number of activities to 
increase scientific and public understanding of issues related 
to food allergies.
    CBO estimates that implementing S. 741 would cost $6 
million in 2006 and $60 million over the 2005-2009 period, 
assuming appropriation of the necessary funds.
    The legislation would not affect direct spending. There 
would be potential for higher revenues through penalties 
imposed on sponsors of misbranded or illegally marketed drugs 
or of mislabeled food products. However, the FDA generally 
issues warning letters to violators and works with them to 
correct the violation. For chronic violators or for serious 
offenses, the FDA generally pursues injunctions or seizes 
products; prosecution, which can involve penalties, generally 
is a last resort. Therefore, CBO expects that revenues from 
such penalties would be negligible.
    S. 741 contains no intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act (UMRA). The act's provisions 
would increase the availability and broaden the potential uses 
of certain drugs used to treat minor species animals and also 
to treat minorconditions in major species. State and local 
conservation programs, zoos, and animal shelters could take advantage 
of those new drugs or uses, and the impact on their budgets would 
likely be positive.
    S. 741 would impose a private-sector mandate on the 
manufacturers, packagers, and labelers of processed foods by 
requiring them to display on the label the names of the major 
food allergens from which the ingredients are derived. It also 
would impose mandates on some manufacturers of generic animal 
drugs for minor uses or use in minor species by potentially 
delaying the time at which their products could enter the 
market. CBO estimates that the direct cost of these mandates 
would not exceed the threshold established by UMRA ($120 
million in 2004, adjusted annually for inflation) in any of the 
first five years the mandates would be effective.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 741 is shown in the following table. The 
costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                       By fiscal year, in millions of dollars--
                                                                    --------------------------------------------
                                                                       2005     2006     2007     2008     2009
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Title I: Minor Use and Minor Species Animal Health Act of 2004:
    Estimated Authorization Level..................................        1        1        2        3        4
    Estimated Outlays..............................................        1        1        2        3        3
Title II: Food Allergen Labeling and Consumer Protection Act of
 2004:
    Estimated Authorization Level..................................       12       12       12       12       12
    Estimated Outlays..............................................        5       10       11       12       12
Net Effect on Spending by the Food and Drug Administration \1\:
    Estimated Authorization Level..................................       13       13       14       15       16
    Estimated Outlays..............................................        6       11       13       15       15
----------------------------------------------------------------------------------------------------------------
\1\ CBO assumes that a portion of the costs associated with the conditional approval process proposed under S.
  741 would be covered by user fees collected from sponsors seeking approval to market animal drugs. (User fees
  are collected and made available for obligation only to the extent, and in the amount, provided in advance in
  appropriation acts.) We estimate that additional collections associated with activities required by the act
  would total less than $500,000 annually.

    Basis of Estimate: For this estimate, CBO assumes that S. 
741 will be enacted this fall and that the amounts necessary to 
implement the act will be appropriated for each year.

Spending subject to appropriation

    S. 741 would increase the availability of approved or 
legally marketed animal drugs for minor species and for minor 
uses in major species and would modify food labeling 
requirements regarding food allergens. CBO estimates that 
implementing S. 741 would cost the FDA $6 million in 2005 and 
$60 million over the 2005-2009 period, subject to the 
availability of appropriated funds.
    Title I: Minor Use and Minor Species Animal Health Act of 
2004. S. 741 would create two procedures within the FDA to 
allow sponsors to lawfully market animal drugs without final 
approval for use in minor species and for minor uses in major 
species. (Minor species are species other than cattle, horses, 
swine, chickens, turkey, dogs, and cats. A minor use in a major 
species refers to the intended use of a drug in a major species 
for a disease that occurs in a small number of animals and 
occurs either infrequently or in limited geographic areas.) The 
act also would authorize grants and award market exclusivity to 
encourage the development of new drugs for animals, and it 
would establish a new office within the FDA to administer 
activities related to regulating animal drugs for minor uses 
and minor species.
    New procedures for legal marketing of animal drugs. Under 
current law, the FDA will approve drugs for marketing only 
after the sponsor has demonstrated that the drug is both safe 
and effective. S. 741 would require the Secretary of the Health 
and Human Services to establish a process for granting 
conditional approval of new animal drugs intended for minor 
uses and for use in minor species. Conditional approval would 
be granted for one year at a time, and could be renewed for a 
total of five years.
    S. 741 also would require the Secretary to establish a 
process for listing on an index unapproved drugs that may be 
marketed legally for use in certain minor species. Eligibility 
for listing on the index would apply to drugs for animals that 
are not consumed by humans or food-producing animals, or for 
use in a non-food life stage of a minor species (such as the 
larval form of shellfish) in a contained man-made structure 
(such as a hatchery pond or tank). The Secretary could place a 
drug on the index if the sponsor demonstrates that the drug 
meets certain safety criteria and if an expert panel concludes 
that the benefits of using the drug outweigh it risks to the 
target animal.
    Based on information from the FDA, CBO anticipates that the 
cost to the FDA associated with implementing those procedures 
to allow sponsors to lawfully market animal drugs without final 
approval would total less than $500,000 annually. CBO assumes a 
portion of the costs associated with the conditional approval 
process would be covered by higher user fees collected from 
sponsors seeking approval to market animal drugs, but we 
estimate that additional collections associated with activities 
required under S. 741 would be negligible.
    Incentives to develop new drugs for animals. The act would 
provide two incentives to encourage development of new animal 
drugs for minor uses and for minor species through the awarding 
of grants and of market exclusivity to qualifying sponsors of 
designated drugs.
    First, the act would direct the FDA to award market 
exclusivity for seven years on the approved indication of 
certain designated drugs. As a result, a sponsor could sell its 
product without competition in the market and recover a portion 
of the research and development costs. CBO anticipates that the 
cost to the FDA associated with implementing this provision 
would be negligible.
    Second, S. 741 would authorize the appropriation of 
specific amounts for making grants to sponsors of designated 
drugs in the two fiscal years following the issuance of final 
regulations for the new program and would authorize the 
appropriation of such sums as necessary in later years. Grants 
awarded under the program would defray some of the costs for 
qualified safety and effectiveness testing and for certain 
manufacturing expenses associated with developing the 
qualifying drug. Based on the time frame outlined in the act, 
CBO assumes that funding for grants would not be authorized 
until fiscal year 2007. We estimate that outlays for the new 
grant program would total $4 million over the 2007-2009 period, 
assuming the availability of appropriated funds.
    New Office. S. 741 would establish a new Office of Minor 
Use and Minor Species Animal Drug Development within the Center 
for Veterinary Medicine at the FDA. The office would designate 
minor use and minor species drugs, administer grants authorized 
under the act, and review requests for listing of drugs on the 
newly created index. S. 741 would authorize the appropriation 
of $1.2 million in 2004 and such sums as necessary in later 
years. Assuming the appropriation of the necessary amounts, CBO 
estimates that creating and funding the new office would cost 
$1 million in 2005 and $6 million over the 2005-2009 period.
    Title II: Food Allergen Labeling and Consumer Protection 
Act of 2004. Title II of the act would direct the Secretary to 
engage in a number of activities to increase scientific and 
public understanding of issues related to food allergies. CBO 
estimates that implementing title II would cost $5 million in 
2005 and $50 million over the 2005-2009 period, assuming the 
appropriation of the necessary amounts.
    S. 741 would amend the FFDCA to require that any food that 
contains a major food allergen be labeled in such a way that 
the presence of the food allergen is easily visible to 
consumers. Major food allergens are defined as ``milk, egg, 
fish, crustacean shellfish, tree nuts, wheat, peanuts, and 
soybeans.'' Section 203 also would provide for an appeal 
process whereby an individual or company could petition the 
Secretary to exempt a food ingredient from that labeling 
requirement. The Secretary would be required to approve or deny 
the petition within 180 days of receiving such an appeal. Based 
on information from the FDA, CBO estimates that spending by the 
FDA to carry out those responsibilities would amount to $1 
million in 2005 and $5 million over the 2005-2009 period, 
assuming appropriation of the necessary funds.
    The act also would direct the Secretary, through the 
Centers for Disease Control and Prevention (CDC), to engage in 
the collection of, and publication of data on the prevalence of 
food allergies, the incidence of serious adverse events related 
to food allergies, and the treatment and prevention of food 
allergies. Because true food allergy events are relatively rare 
(in contrast to food poisoning events), CBO expects that the 
CDC would engage in multiple strategies to identify and collect 
useful data, such as:
           Analyzing existing data, including questions 
        recently added to the National Health Interview Survey 
        (NHIS) to better assess the prevalence of known food 
        allergies.
           Adding laboratory tests to the National 
        Health and Nutrition Examination Survey (NHANES) to 
        identify conditions that may be unknown to the survey 
        participant.
           Testing stored blood specimens that were 
        collected in a previous cycle of the NHANES, and stored 
        for future analysis, to estimate the prevalence of food 
        allergy reactivity in the U.S. population.
           Improving the ability of the nation's vital 
        statistics system to monitor food allergy-related 
        deaths by using intelligent automated systems to help 
        physicians more accurately record cause of death, and 
        by working with physicians' organizations to improve 
        education on recording cause of death.
           Increasing the precision of surveys of 
        health care providers, and improving the quality of 
        information recorded by providers, so that 
        comparatively small numbers of events could be better 
        detected.
    Based on information from the FDA and CDC, CBO estimates 
that federal spending to develop and operate the system for 
collecting data on food allergies would total $3 million in 
2005 and $41 million over the 2005-2009 period, subject to 
appropriation of the necessary amounts.
    S. 741 would require the Secretary to submit a report to 
the Congress within 18 months of enactment. That report should 
analyze the extent to which foods are unintentionally 
contaminated with major food allergens during the manufacturing 
process, recommend manufacturing practices that would reduce 
the incidence of such contamination, and describe the types of 
advisory labeling currently being used by food producers, the 
extent to which such labeling is being used, and the 
preferences of those likely to be affected by food allergies 
regarding labeling information. Assuming the availability of 
appropriated funds, CBO estimates that the FDA would spend less 
than $500,000 in 2005 and a total of $1 million over the 2005-
2009 period to produce that report.
    S. 741 would require the Secretary to conduct inspections 
of food and manufacturing, processing, and packing facilities 
to ensure that such entities are engaging in efforts to reduce 
the possibility of food allergen contamination and to ensure 
that food allergens are being appropriately labeled. Based on 
information provided by the FDA, CBO expects those tasks would 
be accomplished without increasing the number of inspections of 
food facilities and without having a significant effect on the 
cost of those inspections.
    The act also would require the Secretary to develop 
guidelines for preparing allergen-free foods in food 
establishments (such as restaurants, bakeries, delicatessens, 
and cafeterias), and to issue regulations to define and permit 
the use of the term ``gluten-free'' on the labeling of foods. 
Based on information from the FDA about the cost of similar 
activities, CBO estimates that spending by the FDA to carry out 
those responsibilities would total $1 million in 2005 and $3 
million over the 2005-2009 period.
    Estimated impact on state, local, and tribal governments: 
S. 741 contains no intergovernmental mandates ad defined in 
UMRA. The act's provisions would increase the availability and 
broaden the potential uses of certain drugs used to treat minor 
species animals and also to treat minor conditions in major 
species. State and local conservation programs, zoos, and 
animal shelters could take advantage of those new drugs or 
uses, and the impact on their budgets would likely be positive.
    Estimated impact on the private sector: S. 741 would impose 
private-sector mandates, as defined in UMRA, on the 
manufacturers, packagers and labelers of processed foods 
regulated by the Food and Drug Administration and on the 
manufacturers of certain animal drugs. CBO estimates that the 
direct cost of these mandates would not exceed the threshold 
established by UMRA ($120 million in 2004, adjusted annually 
for inflation) in any of the first five years the mandates 
would be effective.
    Section 203 would require the labels of processed foods 
containing major food allergens to display the names of those 
allergens from which ingredients are derived. According to 
industry sources, the majority of the approximately 300,000 
food labels regulated by the FDA are currently in compliance 
with the requirement of S. 741. Moreover, the requirement would 
not become effective until January 1, 2006, allowing many food 
processors to incorporate the required changes during planned 
label revisions, further decreasing the cost of the mandate. 
This compliance period also would provide food processors with 
sufficient time to exhaust most label inventories, resulting in 
small costs due to lost inventories. Based on information 
provided by the FDA and industry sources, CBO estimates that 
the administrative, printing, analytical, and label inventory 
costs associated with this mandate would total less than $75 
million through fiscal year 2006, and would be negligible in 
later years.
    Section 102 also would impose private-sector mandates, as 
defined in UMRA, on some manufacturers of generic animal drugs 
for minor uses or use in minor species by providing additional 
market exclusivity to innovators. This additional exclusivity 
would potentially delay the time at which the generic products 
of some animal drug manufacturers could enter the market. Based 
on information provided by the FDA and the Department of 
Agriculture, CBO estimates the cost of these mandates to be 
small.
    Previous CBO estimate: On July 1, 2004, CBO transmitted a 
cost estimate for S. 741 as passed by the Senate on March 8, 
2004. The two versions of the legislation are identical, as are 
CBO's two estimates.
    Estimate prepared by: Federal Costs: Niall Brennan and 
Julia Christensen; Impact on State, Local, and Tribal 
Governments: Leo Lex; and Impact on the Private Sector: Daniel 
Wilmoth.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

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

                      Advisory Committee Statement

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

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

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

             Section-by-Section Analysis of the Legislation


                                TITLE I

Section 101. Short title

    Section 101 designates the short title of Title I of this 
bill as the ``Minor Use and Minor Species Animal Health Act of 
2004.''

Section 102(a). Findings

    Section 102(a) includes a number of Congressional findings 
regarding the need for new procedures to increase the number of 
new animal drugs available for minor species and for minor uses 
for major species.

Section 102(b). Amendments to the Federal Food, Drug, and Cosmetic Act

    Section (b)(1) amends section 201 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA) to include definitions for major 
species, minor species, and minor use. Section (b)(2) amends 
sections 512(c)(2)(F)(ii), (iii), and (v) to create a new 
exclusivity provision. Residue depletion studies will be 
considered ``significant new data'' for granting three years of 
market exclusivity for minor species or minor use approvals. 
Currently, only effectiveness and target animal safety studies 
qualify to get this marketing exclusivity. Subsection (b)(3) 
creates a new subsection (d)(5) to clarify that in reviewing an 
application to add an intended use for a minor use or a minor 
species, the Secretary of Health and Human Services shall 
reevaluate only the information needed to determine whether the 
application can be approved. This review of only the 
information relevant to whether the application can be approved 
should not be construed to constitute reaffirmation of the 
original new drug application.
    Subsection (b)(4) adds new sections 571, 572, and 573 to 
FFDCA.

New Section 571. Conditional approval of new animal drugs for minor use 
        and minor species

    Subsection (a)(1) permits any person to file an application 
for conditional approval of a new animal drug intended for a 
minor use or a minor species.
    Subsection (a)(2) describes the information an applicant is 
required to submit to the Secretary as part of an application 
for conditional approval of a new animal drug. Included as part 
of an application is a commitment that an applicant will 
perform the research necessary to secure approval as a new 
animal drug under section 512(d) within five years of the 
Secretary's original conditional approval.
    Subsection (a)(3) lists a number of reasons that would 
prevent a person from submitting an application for conditional 
approval of a new animal drug under section 571. Conditional 
approval of a new animal drug that is contained in, or is a 
product of, a transgenic animal is prohibited under this 
subsection.
    Subsection (b) directs the Secretary to either approve an 
application for conditional approval of a new animal drug 
within 180 days of the filing of an application (or after a 
period of time agreed to by both the Secretary and the 
applicant) or notify the applicant of the opportunity for an 
informal hearing on the question of whether or not the 
conditional approval should be granted.
    Subsection (c) lists circumstances under which the 
Secretary should refuse to conditionally approve an application 
submitted under subsection (a). If the application fails to 
meet the criteria established under sections 512(d)(1)(A) 
through (D) or (F) through (I), then the Secretary is directed 
to refuse to conditionally approve the application. 
Additionally, the Secretary may not conditionally approve an 
application if the applicant presents insufficient evidence to 
show that there is a reasonable expectation that the drug will 
be effective. Finally, an application may not be conditionally 
approved if another application has been approved under section 
512 for the same drug, for the same dosage, for the same 
intended use, and there are sufficient quantities of the drug 
available. If none of these categories apply, then the 
Secretary is directed to conditionally approve the new animal 
drug and publish a notice in the Federal Register indicating as 
much.
    Subsection (d) states that a conditional approval is 
effective for one year, renewable for up to four additional 
years. The Secretary may granta 90-day extension to review the 
renewal request. The request shall be deemed to be approved unless the 
applicant failed to submit a timely application; the application fails 
to demonstrate that the applicant is making sufficient progress towards 
gaining full approval under section 512(d), that there is a large 
enough quantity of the drug available, or that the same drug in the 
same dosage form for the same intended use has not received approval 
under section 512; and the applicant is not able to prove that the drug 
does not violate sections 512(e)(1)(A) through (B) or (D) through (F). 
If the Secretary declines to renew the conditional approval, then the 
Secretary shall provide an opportunity for the applicant to engage in 
an informal hearing to discuss whether the conditional approval should 
be reinstated.
    Subsection (e)(1) directs the Secretary to withdraw any 
conditional approval if the Secretary finds that another 
applicant has received approval for the same drug in the same 
dosage form for the same intended use and there is sufficient 
quantity of the drug to meet the needs for which the drug is 
intended. Under subsection (e)(2), the Secretary is required to 
withdraw the conditional approval of an application if the 
Secretary finds that any of the provisions of section 
512(e)(1)(A) through (B) or (D) through (F) or if the Secretary 
believes that there is not a reasonable expectation that the 
drug will have the effect for which it was originally approved.
    Subsection (f) describes labeling requirements for 
conditionally approved new animal drugs. A label on a 
conditionally approved new animal drug must read 
``conditionally approved by FDA pending a full demonstration of 
effectiveness under application ___'' and must include other 
information specified by the Secretary. Additionally, an 
intended use that is the subject of a conditional approval is 
not to be included as part of a product label under section 
512.
    Subsection (g) states that a new animal drug that has been 
conditionally approved may not be amended or supplemented to 
add a new indication for use.
    Subsection (h) states that 180 days prior to the 
termination date established for a conditionally approved 
animal drug the applicant should have all materials submitted 
to the Secretary to make a decision whether or not to fully 
approve the drug under section 512(d).
    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 Section 572. Index of legally marketed unapproved new animal drugs 
        for minor species

    New subsection (a) directs the Secretary to establish an 
index of legally marketed, unapproved new animal drugs for 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 (new subsection (a)(1)(A)), and for 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 (new 
subsection (a)(1)(B)). In the latter case, the law requires 
that safety for humans is demonstrated in accordance with 
section 512(d) of the FFDCA. New animal drugs that are 
contained in, or are a product of, a transgenic animal are not 
eligible for inclusion in the index.
    New subsection (b) states that any entity intending to file 
a request under this new section 572 shall be entitled to one 
or more conferences to discuss the requirements for indexing a 
new animal drug.
    New subsection (c) provides for a mechanism whereby an 
entity can request that the Secretary make a decision regarding 
the eligibility of a particular new animal drug for inclusion 
in the index. After submitting a request to the Secretary, the 
Secretary will make a determination of eligibility within 90 
days for new animal drugs requesting inclusion in the index 
under new subsection (a)(1)(A) and 180 days for new animal 
drugs requesting inclusion in the index under new subsection 
(a)(1)(B). The Secretary may approve the eligibility request 
if: the same drug in the same dosage form for the same intended 
use is not approved under section 512 or conditionally approved 
under section 571; the proposed use of the drug meets the 
conditions of subsections (a)(1)(A) or (a)(1)(B), as 
appropriate; 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; the new animal drug will not significantly affect 
the human environment; and 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.
    New subsection (d) provides for a mechanism whereby an 
entity may request that the Secretary add a new animal drug to 
the index of legally marketed unapproved new animal drugs for 
minor species. The entity requesting inclusion in the index 
must provide the Secretary with a number of items that are 
described in subsection (d)(1). Among those items is a report 
described in subsection (d)(2), which must be authored by a 
qualified expert panel as defined in subsection (d)(3). 
Included in the report is an evaluation of all available target 
animal safety and effectiveness information, including 
anecdotal information. The report must 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 caused by 
the absence of an approved or conditionally approved new animal 
drug for the minor species in question. The Committee notes 
that while the focus of the expert panel is on the benefits and 
risks to the target animal, the Secretary will have already 
determined that the new animal drug in question is either not 
going to be used on animals that humans or food-producing 
animals will consume, or is in full compliance with the human 
safety standards described in section 512(d) of the FFDCA. The 
report must also include information from which labeling can be 
written and a recommendation regarding whether the new 
animaldrug should be limited to use under the professional supervision 
of a licensed veterinarian. Subsection (d)(3) describes the 
requirements for a ``qualified expert panel.'' The panel must operate 
external to the FDA and be composed of experts qualified by scientific 
training and experience to evaluate the target animal safety and 
effectiveness of the new animal drug under consideration. Qualified 
expert panels are not subject to the Federal Advisory Committee Act, 5 
U.S.C. App. 2. The Secretary by regulation shall define the criteria 
for selection of a qualified expert panel and the procedures for the 
operation of the panel.
    Subsection (d)(4) requires the Secretary to grant or deny a 
request for inclusion in the index of legally marketed 
unapproved new animal drugs for minor species within 180 days 
of receipt of the information required in subsection (d)(2). 
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 information 
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 provide the 
entity with the opportunity for an informal conference. The 
decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.
    New subsection (e) describes the information that must be 
included for each new animal drug listed under the index. This 
includes 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 conditions and any limitations that the Secretary 
deems necessary regarding use of the drug. The Secretary is 
directed to publish the index, and revise it periodically; 
additionally, the Secretary may establish a process for 
reporting changes in the conditions of manufacturing or 
labeling of indexed products.
    New subsection (f) lists a number of circumstances whereby 
the Secretary may remove a new animal drug from the index. New 
subsection (f)(1) provides the Secretary with a number of 
justifications for removing a new animal drug from the index. 
New subsection (f)(2) provides the Secretary with additional 
authority to remove a new animal drug from the index. Under new 
subsection (f)(2), the Secretary must only find 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 
must give the entity listed in the index the opportunity for an 
informal conference if he or she uses the authority available 
under new subsections (f)(1) and (f)(2) to remove a new animal 
drug from the index. The decision of the Secretary following an 
informal conference shall constitute final agency action 
subject to judicial review.
    New subsection (g) directs the Secretary to promulgate 
regulations (to the extent consistent with the public health) 
to exempt 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 from the safety and effectiveness standards 
described in section 512 of the FFDCA.
    New subsection (h) describes labeling requirements for new 
animal drugs included in the index of legally marketed 
unapproved new animal drugs for minor species. Specifically, 
the labeling of such a drug shall read ``NOT APPROVED BY FDA.--
Legally marketed as an FDA indexed product. Extra-label use is 
prohibited.'' Additionally, the labeling shall include the 
following statement 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.'' The Secretary 
may require other information in the index listing.
    New subsection (i) requires that the entity who has a new 
animal drug included in the index shall establish and maintain 
such records, and make such reports to the Secretary that he or 
she determines, either through regulation or by order with 
respect to a particular listing, is needed to determine whether 
there is or may be ground for using new subsection (f) to 
remove a new animal drug from the index.
    Finally, new subsection (j) requires that 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 be made available to the public under certain 
circumstances.

New Section 573. Designated new animal drugs for minor use or minor 
        species

    New section 573(a) provides the Secretary with the 
authority to declare a new animal drug to be a ``designated new 
animal drug.'' A designated new animal drug is eligible for two 
different kinds of incentives to encourage the development of 
new animal drugs for minor use or minor species. Under new 
section 573(b), the Secretary may award grants and enter into 
contracts with public and private entities to subsidize the 
costs incurred by qualified safety and effectiveness testing 
and manufacturing expenses. Qualified safety and effectiveness 
testing is defined as testing that occurs after a new animal 
drug is declared to be a designated new animal drug and is 
carried out under an investigational exemption under section 
512(j) of the FFDCA. Manufacturing expenses are defined as 
expenses incurred in developing processes and procedures 
associated with manufacture of the designated new animal drug 
which occur after the new animal drug is declared to be a 
designated new animal drug and before the sponsor files an 
application for approval under section 512 or conditional 
approval under new section 571. Under new section 573(c), if 
the Secretary approves an application for approval under 
section 512 or for conditional approval under new section 571, 
the sponsor of the new animal drug will receive seven years of 
marketing exclusivity. During this time, the Secretary may not 
approve or conditionally approve another application for a new 
animal drug with the same intended use as the designated new 
animal drug unless the Secretary finds that the holder of the 
approved application cannot assure the availability of 
sufficient quantities of the drug or the holder provides 
written consent to the Secretary for the approval or 
conditional approvalof a new animal drug. The Secretary may 
terminate the designation of a new animal drug if the sponsor of the 
drug in question discontinues active pursuit of a full approval under 
section 512 or conditional approval under section 571. In addition, 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. The sponsor of an approved 
designated new animal drug shall notify the Secretary of any 
discontinuance of the manufacture of such new animal drug at least one 
year before discontinuance.
    Subsection (b)(5) makes a number of technical and 
conforming changes to the FFDCA.
    Subsection (b)(6) lists the timelines for implementing 
regulations for new sections 571, 572, and 573.
    Subsection (b)(7) creates an Office of Minor Use and Minor 
Species Animal Drug Development at the Center for Veterinary 
Medicine at the Food and Drug Administration. $1.2 million is 
authorized to be appropriated for the office in fiscal year 
2004, and such sums as may be necessary for each fiscal year 
thereafter.
    Subsection (b)(8) authorizes $1 million for the grants for 
designated new animal drugs for the fiscal year following 
publication of the final regulations implementing section 
573(b), $2 million for the subsequent fiscal year, and such 
sums as may be necessary for each fiscal year thereafter.

                                TITLE II

Section 201. Short title

    Section 201 designates the short title of Title II of this 
bill as the ``Food Allergen Labeling and Consumer Protection 
Act of 2004.''

Section 202. Findings

    Section 202 makes a number of findings regarding the 
prevalence of food allergies. Specifically, approximately 2 
percent of adults and 5 percent of children suffer from food 
allergies--further, eight major foods or food groups account 
for 90 percent of food allergies. These eight are milk, eggs, 
fish, Crustacean shellfish, tree nuts, peanuts, wheat, and 
soybeans.

Section 203. Food labeling; requirement of information regarding 
        allergenic substances

    Section 203(a) creates a new section 403(w) in the FFDCA. 
New section 403(w)(1) states that a food shall be deemed to be 
misbranded if it, or one of its ingredients, is a major food 
allergen, unless the food allergen is properly labeled. First, 
under new section 403(w)(1)(A), the manufacturer may include a 
list, either immediately after or adjacent to the list of 
ingredients, which identifies the food source from which the 
major food allergen is derived. Second, under new section 
403(w)(1)(B), the manufacturer may include the common or usual 
name of the major food allergen in the list of ingredients 
followed in parentheses by the name of the food source from 
which the major food allergen is derived. There are two 
exceptions to this provision. The manufacturer is not required 
to include the food source from which the major food allergen 
is derived if the common or usual name of the ingredient uses 
the name of the food source from which the major food allergen 
is derived. For example, if ``milk casing'' is included in the 
list of ingredients, it is not necessary for the manufacturer 
to include the word ``milk'' in parentheses following this 
ingredient. Additionally, the manufacturer is not required to 
include the name of the food source from which the major food 
allergen is derived if the name of the food source appears 
elsewhere in the list of ingredients. For example, if the list 
of ingredients includes ``milk casing,'' then it is not 
necessary to include the word ``milk'' in parentheses after 
``whey.'' However, this exception does not hold when the name 
of the food source that appears elsewhere in the list of 
ingredients is not a major food allergen. For example, peanut 
oil is a highly refined oil and does not cause food allergies. 
In this case, the list of ingredients would have to include 
``peanuts'' in parentheses after an ingredient that includes 
peanuts.
    Under new section 403(w)(2), the definition of ``major food 
allergen,'' which is defined under new section 201(q)(q) of the 
FFDCA, means that in the case of a tree nut, fish, or 
Crustacean shellfish, the specific tree nut (pecans), fish 
(salmon), or Crustacean shellfish (lobster) must be listed.
    New section 403(w)(3) holds that this labeling information 
required under new section 403(w) 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. 
The Secretary must publish any such finding in the Federal 
Register as a notice. The finding will be effective as of the 
date the notice is published.
    New section 403(w)(4) states that notwithstanding the 
provision in current law for flavorings, coloring, or 
incidental additives that exempts them from other food labeling 
requirements, a flavoring, coloring, or incidental additive 
that is or contains a major food allergen shall be subject to 
the labeling requirements 403(w)(1).
    New section 403(w)(5) gives the Secretary the authority to 
modify the food labeling requirements of subparagraph (A) or 
(B) of new section 403(w)(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 one of the new food 
labeling requirements is necessary to protect the public 
health.
    New section 403(w)(6) creates a procedure by which any 
entity may petition the Secretary to exempt a food ingredient 
from the new food allergen labeling requirements created under 
section 403(w)(1). Within 180 days, the Secretary will be 
required to approve or deny such petition or the petition shall 
be deemed denied, unless the Secretary and the petitioner 
mutually agree upon an extension of time. The burden is on the 
entity filing the petition to provide scientific evidence that 
the food ingredient does not cause an allergic response that 
poses a risk to human health.
    New section 403(w)(7) provides industry with a different 
process for securing an exemption from the food allergen 
labeling requirements. An entity may file a notification with 
the Secretary stating that scientific evidence demonstrates 
that the food ingredient does not contain allergenic protein or 
that the ingredient does not cause an allergic response that 
poses a risk to human health. An entity filing a notification 
may use the food ingredient in question 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 decides to not approve the notification. Note that in 
the case of a petition, the petition is deemed denied unless 
the Secretary affirmatively approves the petition; in the case 
of a notification, the burden is on the Secretary to explicitly 
deny the notification request. While the Committee recognizes 
that thresholds for the eight major 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.
    New section 403(x) states that the exemption from current 
law food labeling requirements for spices, flavorings, 
colorings, or incidental additives does not apply in cases 
where these ingredients contain a food allergen that is not a 
major food allergen. In such a case, the food allergen shall be 
disclosed in a manner specified by the Secretary by regulation.
    Section 203(b) states that the labeling requirements 
established under new section 403(w) do not prevent the 
Secretary from requiring labels or labeling changes for other 
food allergens that are not major food allergens.
    Section 203(c) adds a new section 201qq to the FFDCA. New 
section 201qq defines a ``major food allergen'' to be milk, 
egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and 
soybeans. Included in the definition are food ingredients that 
contain proteins derived from one of the eight major food 
allergens, with two exceptions. First, any highly refined oil 
or ingredient derived from a highly refined oil is exempted 
from the food allergy labeling requirements. Second, any food 
ingredient that is exempted through either the petition or 
notification procedures is not included in the definition of 
major food allergens.
    The requirements of section 203 will take effect on January 
1, 2006.

Section 204. Report on food allergies

    Section 204 directs the Secretary to produce a report on a 
number of issues related to food allergies within 18 months of 
enactment of S. 741. In reference to paragraph 4, it is the 
Committee's intention that the Secretary focus on which types 
of advisory labeling are effective in alerting consumers with 
food allergies or their caregivers about the risk of cross-
contact. Appropriate survey mechanisms would be a particularly 
useful way to gather this information.

Section 205. Inspections relating to food allergens

    Section 205 directs the Secretary to continue conducting 
inspections under section 704 of the FFDCA to ensure that 
manufacturers, processors, and packagers are taking appropriate 
steps to reduce or eliminate cross-contact between food 
ingredients that are major food allergens and food ingredients 
that are not major food allergens. In addition, the Secretary 
is to use these inspections to ensure that major food allergens 
are properly labeled.

Section 206. Gluten labeling

    Section 206 directs the Secretary to issue a proposed rule 
to define, and permit use of the term ``gluten-free'' on the 
labeling of foods within two years of enactment of S. 741. The 
Secretary is required to consult with appropriate experts and 
stakeholders before promulgating this proposed rule. The 
Secretary shall issue a final rule to define, and permit the 
use of, the term ``gluten-free'' on the labeling of foods 
within four years of the enactment of S. 741. Given the 
devastating nature of celiac disease, the Committee urges the 
Secretary to move expeditiously in implementing the 
requirements of this section.

Section 207. Improvement and publication of data on food-related 
        allergic responses

    Section 207 directs the Secretary, acting through the 
Centers for Disease Control and Prevention and in consultation 
with the Food and Drug Administration, to improve the 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. There are 
authorized such sums as may be necessary to carry out this 
section.

Section 208. Food allergies research

    Section 208 directs the Secretary, acting through the 
Director of the National Institutes of Health, to convene an ad 
hoc panel of nationally recognized experts in allergy and 
immunology to review current basic and clinical research 
efforts related to food allergies. The Committee encourages the 
panel to review existing scientific data on food allergy 
reaction thresholds for each of the major food allergens. It is 
the Committee's hope that this information will be helpful to 
the FDA as it continues to review scientific data on food 
allergy reaction thresholds. The panel shall make 
recommendations to the Secretary for enhancing and coordinating 
research activities concerning food allergies not later than 
one year after the enactment of S. 741. The Secretary shall 
make these recommendations public.

Section 209. Food allergies in the food code

    Section 209 directs the Secretary, in the Conference for 
Food Protection, 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. The Secretary is directed to consider guidelines 
and recommendations developed by public and private entities 
for public and private food establishments for preparing 
allergen-free foods in pursuing this revision, including 
guidelines and recommendations preventing unintentional cross-
contact with major food allergens.

Section 210. Recommendation regarding responding to food-related 
        allergic responses

    Section 210 directs the Secretary to include technical 
assistance relating to the use of different modes of treatment 
for and prevention of allergic responses to foods when 
providing technical assistance relating to trauma care and 
emergency medical services to State and local agencies.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, 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) * * *

           *       *       *       *       *       *       *

  (u) The term ``safe,'' as used in paragraph (s) of this 
section and in sections 409, 512, 571, and 721, has reference 
to the health of man or animal.
  (v) The term ``new animal drug'' means any drug intended for 
use for animals other than man, including any drug intended for 
use in animal feed but not including such animal feed--
          (1) * * *

           *       *       *       *       *       *       *

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.

           *       *       *       *       *       *       *

  (nn) The term ``major species'' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary 
may add species to this definition by regulation.
  (oo) The term ``minor species'' means animals other than 
humans that are not major species.
  (pp) The term ``minor use'' means the intended use of a drug 
in a major species for an indication that occurs infrequently 
and in only a small number of animals or in limited 
geographical areas and in only a small number of animals 
annually.
  (qq) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), 
        tree nuts (e.g., almonds, pecans, or walnuts), wheat, 
        peanuts, and soybeans.
          (2) A food ingredient that contains protein derived 
        from a food specified in paragraph (1), except the 
        following:
                  (A) Any highly refined oil derived from a 
                food specified in paragraph (1) and any 
                ingredient derived from such highly refined 
                oil.
                  (B) A food ingredient that is exempt under 
                paragraph (6) or (7) of section 403(w).

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *

           *       *       *       *       *       *       *

  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 504, 564, 703, or 704(a); or 
the failure to establish or maintain any record, or make any 
report, required under section 412, 414(b), 504, 505 (i) or 
(k), [512(a)(4)(C), 512 (j), (l) or (m)] 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i)., 515(f), 519, or 564 or the refusal to 
permit access to or verification or copying of any such 
required record.

           *       *       *       *       *       *       *

  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 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.

           *       *       *       *       *       *       *


CHAPTER IV--FOOD

           *       *       *       *       *       *       *


                            MISBRANDED FOOD

  Sec. 403. A food shall be deemed to be misbranded--
  (a) * * *

           *       *       *       *       *       *       *

  (w)(1) If it is not a raw agricultural commodity and it is, 
or it contains an ingredient that bears or contains, a major 
food allergen, unless either--
          (A) the word ``Contains'', followed by the name of 
        the food source from which the major food allergen is 
        derived, is printed immediately after or is adjacent to 
        the list of ingredients (in a type size no smaller than 
        the type size used in the list of ingredients) required 
        under subsections (g) and (i); or
          (B) the common or usual name of the major food 
        allergen in the list of ingredients required under 
        subsections (g) and (i) is followed in parentheses by 
        the name of the food source from which the major food 
        allergen is derived, except that the name of the food 
        source is not required when--
                  (i) the common or usual name of the 
                ingredient uses the name of the food source 
                from which the major food allergen is derived; 
                or
                  (ii) the name of the food source from which 
                the major food allergen is derived appears 
                elsewhere in the ingredient list, unless the 
                name of the food source that appears elsewhere 
                in the ingredient list appears as part of the 
                name of a food ingredient that is not a major 
                food allergen under section 201(qq)(2)(A) or 
                (B).
  (2) As used in this subsection, the term ``name of the food 
source from which the major food allergen is derived'' means 
the name described in section 201(qq)(1); provided that in the 
case of a tree nut, fish, or Crustacean shellfish, the term 
``name of the food source from which the major food allergen is 
derived'' means the name of the specific type of nut or species 
of fish or Crustacean shellfish.
  (3) The information required under this subsection may appear 
in labeling in lieu of appearing on the label only if the 
Secretary finds that such other labeling is sufficient to 
protect the public health. A finding by the Secretary under 
this paragraph (including any change in an earlier finding 
under this paragraph) is effective upon publication in the 
Federal Register as a notice.
  (4) Notwithstanding subsection (g), (i), or (k), or any other 
law, a flavoring, coloring, or incidental additive that is, or 
that bears or contains, a major food allergen shall be subject 
to the labeling requirements of this subsection.
  (5) The Secretary may by regulation modify the requirements 
of subparagraph (A) or (B) of paragraph (1), or eliminate 
either the requirement of subparagraph (A) or the requirements 
of subparagraph (B) of paragraph (1), if the Secretary 
determines that the modification or elimination of the 
requirement of subparagraph (A) or the requirements of 
subparagraph (B) is necessary to protect the public health.
  (6)(A) Any person may petition the Secretary to exempt a food 
ingredient described in section 201(qq)(2) from the allergen 
labeling requirements of this subsection.
  (B) The Secretary shall approve or deny such petition within 
180 days of receipt of the petition or the petition shall be 
deemed denied, unless an extension of time is mutually agreed 
upon by the Secretary and the petitioner.
  (C) The burden shall be on the petitioner to provide 
scientific evidence (including the analytical method used to 
produce the evidence) that demonstrates that such food 
ingredient, as derived by the method specified in the petition, 
does not cause an allergic response that poses a risk to human 
health.
  (D) A determination regarding a petition under this paragraph 
shall constitute final agency action.
  (E) The Secretary shall promptly post to a public site all 
petitions received under this paragraph within 14 days of 
receipt and the Secretary shall promptly post the Secretary's 
response to each.
  (7)(A) A person need not file a petition under paragraph (6) 
to exempt a food ingredient described in section 201(qq)(2) 
from the allergen labeling requirements of this subsection, if 
the person files with the Secretary a notification containing--
          (i) scientific evidence (including the analytical 
        method used) that demonstrates that the food ingredient 
        (as derived by the method specified in the 
        notification, where applicable) does not contain 
        allergenic protein; or
          (ii) a determination by the Secretary that the 
        ingredient does not cause an allergic response that 
        poses a risk to human health under a premarket approval 
        or notification program under section 409.
  (B) The food ingredient may be introduced or delivered for 
introduction into interstate commerce as a food ingredient that 
is not a major food allergen 90 days after the date of receipt 
of the notification by the Secretary, unless the Secretary 
determines within the 90-day period that the notification does 
not meet the requirements of this paragraph, or there is 
insufficient scientific evidence to determine that the food 
ingredient does not contain allergenic protein or does not 
cause an allergenic response that poses a risk to human health.
  (C) The Secretary shall promptly post to a public site all 
notifications received under this subparagraph within 14 days 
of receipt and promptly post any objections thereto by the 
Secretary.
  (x) Notwithstanding subsection (g), (i), or (k), or any other 
law, a spice, flavoring, coloring, or incidental additive that 
is, or that bears or contains, a food allergen (other than a 
major food allergen), as determined by the Secretary by 
regulation, shall be disclosed in a manner specified by the 
Secretary by regulation.
  Sec. 403A. (a) Except as provided in subsection (b), no State 
or political subdivision of a State may directly or indirectly 
establish under any authority or continue in effect as to any 
food in interstate commerce--
          (1) * * *
          (2) any requirement for the labeling of food of the 
        type required by section 403(c), 403(e), [or 403(i)(2)] 
        403(i)(2), 403(w), or 403(x) that is not identical to 
        the requirement of such section, except that this 
        paragraph does not apply to a requirement of a State or 
        political subdivision of a State that is of the type 
        required by section 403(c) and that is applicable to 
        maple syrup,

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                      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 571 and its label 
        bears the statement set forth in section 571(f)(1)(A); 
        or
          (2) that is indexed under section 572 and its 
        labeling does not conform with the index listing under 
        section 572(e) or 572(h), or that has not been indexed 
        under section 572 and its label bears the statement set 
        forth in section 572(h).

EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL 
                                PRODUCTS

  Sec. 503. (a) * * *

           *       *       *       *       *       *       *

  (f)(1)(A) A drug intended for use by animals other than man, 
other than a veterinary feed directive drug intended for use in 
animal feed or an animal feed bearing or containing a 
veterinary feed directive drug, which--
          (i) * * *
          (ii) is limited by an approved application under 
        subsection (b) of section 512, a conditionally-approved 
        application under section 571, or an index listing 
        under section 572 to use under the professional 
        supervision of a licensed veterinarian,

           *       *       *       *       *       *       *

  (3) The Secretary may by regulation exempt drugs for animals 
other than man subject to section 512, 571, or 572 from the 
requirements of paragraph (1) when such requirements are not 
necessary for the protection of the public health.

           *       *       *       *       *       *       *


                    VETERINARY FEED DIRECTIVE DRUGS

  Sec. 504. (a)(1) A drug intended for use in or on animal feed 
which is limited by an approved application filed pursuant to 
section 512(b), a conditionally-approved application filed 
pursuant to section 571, or an index listing pursuant to 
section 572 to use under the professional supervision of a 
licensed veterinarian is a veterinary feed directive drug. Any 
animal feed bearing or containing a veterinary feed directive 
drug shall be fed to animals only by or upon a lawful 
veterinary feed directive issued by a licensed veterinarian in 
the course of the veterinarian's professional practice. When 
labeled, distributed, held, and used in accordance with this 
section, a veterinary feed directive drug and any animal feed 
bearing or containing a veterinary feed directive drug shall be 
exempt from section 502(f).
  (2) A veterinary feed directive is lawful if it--
          (A) * * *
          (B) is in compliance with the conditions and 
        indications for use of the drug set forth in the notice 
        published pursuant to section 512(i), or the index 
        listing pursuant to section 572(e).

           *       *       *       *       *       *       *

  (b) A veterinary feed directive drug and any feed bearing or 
containing a veterinary feed directive drug shall be deemed to 
be misbranded if their labeling fails to bear such cautionary 
statement and such other information as the Secretary may by 
general regulation or by order prescribe, or their advertising 
fails to conform to the conditions and indications for use 
published pursuant to section 512(i), or the index listing 
pursuant to section 572(e) or fails to contain the general 
cautionary statement prescribed by the Secretary.

           *       *       *       *       *       *       *


                            NEW ANIMAL DRUGS

  Sec. 512. (a)[(1) A new animal drug shall, with respect to 
any particular use or intended use of such drug, be deemed 
unsafe for the purposes of section 501(a)(5) and section 
402(a)(2)(D) unless--
          [(A) there is in effect an approval of an application 
        filed pursuant to subsection (b) with respect to such 
        use or intended use of such drug, and
          [(B) such drug, its labeling, and such use conform to 
        such approved application.
A new animal drug shall also be deemed unsafe for such purposes 
in the event of removal from the establishment of a 
manufacturer, packer, or distributor of such drug for use in 
the manufacture of animal feed in any State unless at the time 
of such removal such manufacturer, packer, or distributor has 
an unrevoked written statement from the consignee 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 the purposes of section 
501(a)(6) unless--
          [(A) there is in effect an approval of an application 
        filed pursuant to subsection (b) with respect to such 
        drug, as used in such animal feed,
          [(B) such animal feed is manufactured at a site for 
        which there is in effect a license issued pursuant to 
        subsection (m)(1) to manufacture such animal feed, and
          [(C) such animal feed and its labeling, distribution, 
        holding, and use conform to the conditions and 
        indications of use published pursuant to subsection 
        (i).] (1) A new animal drug shall, with respect to any 
        particular use or intended use of such drug, be deemed 
        unsafe for purposes of section 501(a)(5) and section 
        402(a)(2)(C)(ii) unless--
          (A) there is in effect an approval of an application 
        filed pursuant to subsection (b) with respect to such 
        use or intended use of such drug, and such drug, its 
        labeling, and such use conform to such approved 
        application;
          (B) there is in effect a conditional approval of an 
        application filed pursuant to section 571 with respect 
        to such use or intended use of such drug, and such 
        drug, its labeling, and such use conform to such 
        conditionally approved application; or
          (C) there is in effect an index listing pursuant to 
        section 572 with respect to such use or intended use of 
        such drug in a minor species, and such drug, its 
        labeling, and such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes 
in the event of removal from the establishment of a 
manufacturer, packer, or distributor of such drug for use in 
the manufacture of animal feed in any State unless at the time 
of such removal such manufacturer, packer, or distributor has 
an unrevoked written statement from the consignee of such drug, 
or notice from the Secretary, to the effect that, with respect 
to the use of such drug in animal feed, such consignee (i) 
holds a license issued under subsection (m) and has in its 
possession current approved labeling for such drug in animal 
feed; or (ii) will, if the consignee is not a user of the drug, 
ship such drug only to a holder of a license issued under 
subsection (m).
  (2) An animal feed bearing or containing a new animal drug 
shall, with respect to any particular use or intended use of 
such animal feed be deemed unsafe for purposes of section 
501(a)(6) unless--
          (A) there is in effect--
                  (i) an approval of an application filed 
                pursuant to subsection (b) with respect to such 
                drug, as used in such animal feed, and such 
                animal feed and its labeling, distribution, 
                holding, and use conform to such approved 
                application;
                  (ii) a conditional approval of an application 
                filed pursuant to section 571 with respect to 
                such drug, as used in such animal feed, and 
                such animal feed and its labeling, 
                distribution, holding, and use conform to such 
                conditionally approved application; or
                  (iii) an index listing pursuant to section 
                572 with respect to such drug, as used in such 
                animal feed, and such animal feed and its 
                labeling, distribution, holding, and use 
                conform to such index listing; and
          (B) such animal feed is manufactured at a site for 
        which there is in effect a license issued pursuant to 
        subsection (m)(1) to manufacture such animal feed.

           *       *       *       *       *       *       *

  (b)(1) * * *

           *       *       *       *       *       *       *

  (3) Any person intending to file an application [under 
paragraph (1) or a request for an investigational exemption 
under subsection (j)] under paragraph (1), section 571, or a 
request for an investigational exemption under subsection (j) 
shall be entitled to one or more conferences prior to such 
submission to reach an agreement acceptable to the Secretary 
establishing a submission or an investigational requirement, 
which may include a requirement for a field investigation. A 
decision establishing a submission or an investigational 
requirement shall bind the Secretary and the applicant or 
requestor unless (A) the Secretary and the applicant or 
requestor mutually agree to modify the requirement, or (B) the 
Secretary by written order determines that a substantiated 
scientific requirement essential to the determination of safety 
or effectiveness of the animal drug involved has appeared after 
the conference. No later than 25 calendar days after each such 
conference, the Secretary shall provide a written order setting 
forth a scientific justification specific to the animal drug 
and intended uses under consideration if the agreement referred 
to in the first sentence requires more than one field 
investigation as being essential to provide substantial 
evidence of effectiveness for the intended uses of the drug. 
Nothing in this paragraph shall be construed as compelling the 
Secretary to require a field investigation.
  (c)(1) * * *
  (2)(A) * * *

           *       *       *       *       *       *       *

  (F)(i) * * *
  (ii) If an application submitted under subsection (b)(1) for 
a drug, which includes an active ingredient (including any 
ester or salt of the active ingredient) that has been approved 
in another application approved under such subsection, is 
approved after the date of enactment of this paragraph and if 
such application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal 
safety, or, in the case of food producing animals, human food 
safety studies [(other than bioequivalence or residue studies)] 
(other than bioequivalence studies or residue depletion 
studies, except residue depletion studies for minor uses or 
minor species) required for the approval of the application and 
conducted or sponsored by the applicant, the Secretary may not 
make the approval of an application submitted under subsection 
(b)(2) for the conditions of approval of such drug in the 
subsection (b)(1) application effective before the expiration 
of 3 years from the date of the approval of the application 
under subsection (b)(1) for such drug.
  (iii) If a supplement to an application approved under 
subsection (b)(1) is approved after the date of enactment of 
this paragraph and the supplement contains substantial evidence 
of the effectiveness of the drug involved, any studies of 
animal safety, or, in the case of food producing animals, human 
food safety studies [(other than bioequivalence or residue 
studies)] (other than bioequivalence studies or residue 
depletion studies, except residue depletion studies for minor 
uses or minor species) required for the approval of the 
supplement and conducted or sponsored by the person submitting 
the supplement, the Secretary may not make the approval of an 
application submitted under subsection (b)(2) for a change 
approved in the supplement effective before the expiration of 3 
years from the date of the approval of the supplement.

           *       *       *       *       *       *       *

  (v) If an application (including any supplement to a new 
animal drug application) submitted under subsection (b)(1) for 
a new animal drug for a food-producing animal use, which 
includes an active ingredient (including any ester or salt of 
the active ingredient) which has been the subject of a waiver 
under clause (iv) is approved after the date of enactment of 
this paragraph, and if the application contains substantial 
evidence of the effectiveness of the drug involved, any studies 
of animal safety, or human food safety studies [(other than 
bioequivalence or residue studies)] (other than bioequivalence 
studies or residue depletion studies, except residue depletion 
studies for minor uses or minor species) required for the new 
approval of the application and conducted or sponsored by the 
applicant, the Secretary may not make the approval of an 
application (including any supplement to such application) 
submitted under subsection (b)(2) for the new conditions of 
approval of such drug in the subsection (b)(1) application 
effective before the expiration of five years from the date of 
approval of the application under subsection (b)(1) for such 
drug. The provisions of this paragraph shall apply only to the 
first approval for a food-producing animal use for the same 
applicant after the waiver under clause (iv).

           *       *       *       *       *       *       *

  (d)(1) * * *

           *       *       *       *       *       *       *

  (4) In a case in which an animal drug contains more than one 
active ingredient, or the labeling of the drug prescribes, 
recommends, or suggests use of the drug in combination with one 
or more other animal drugs, and the active ingredients or drugs 
intended for use in the combination [have previously been 
separately approved] have previously been separately approved 
pursuant to an application submitted under section 512(b)(1) 
for particular uses and conditions of use for which they are 
intended for use in the combination--
          (A) * * *

           *       *       *       *       *       *       *

          (5) In reviewing an application that proposes a 
        change to add an intended use for a minor use or a 
        minor species to an approved new animal drug 
        application, the Secretary shall reevaluate only the 
        relevant information in the approved application to 
        determine whether the application for the minor use or 
        minor species can be approved. A decision to approve 
        the application for the minor use or minor species is 
        not, implicitly or explicitly, a reaffirmation of the 
        approval of the original application.

           *       *       *       *       *       *       *

  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under [subsection (d), (e), 
or (m)] subsection (d), (e), or (m), or section 571 (c), (d), 
or (e) refusing, withdrawing, or suspending approval of an 
application and shall approve such application or reinstate 
such approval, as may be appropriate.
  (g) Orders of the Secretary issued under this section, or 
section 571 (other than orders issuing, amending, or repealing 
regulations) shall be served (1) in person by any officer or 
employee of the department designated by the Secretary or (2) 
by mailing the order by registered mail or by certified mail 
addressed to the applicant or respondent at his last known 
address in the records of the Secretary.

           *       *       *       *       *       *       *

  (i) When a new animal drug application filed pursuant to 
subsection (b) or section 571 is approved, the Secretary shall 
by notice, which upon publication shall be effective as a 
regulation, publish in the Federal Register the name and 
address of the applicant and the conditions and indications of 
use of the new animal drug covered by such application, 
including any tolerance and withdrawal period or other use 
restrictions and, if such new animal drug is intended for use 
in animal feed, appropriate purposes and conditions of use 
(including special labeling requirements and any requirement 
that an animal feed bearing or containing the new animal drug 
be limited to use under the professional supervision of a 
licensed veterinarian) applicable to any animal feed for use in 
which such drug is approved, and such other information, upon 
the basis of which such application was approved, as the 
Secretary deems necessary to assure the safe and effective use 
of such drug. Upon withdrawal of approval of such new animal 
drug application or upon its suspension or upon failure to 
renew a conditional approval under section 571, the Secretary 
shall forthwith revoke or suspend, as the case may be, the 
regulation published pursuant to this subsection (i) insofar as 
it is based on the approval of such application.

           *       *       *       *       *       *       *

  (l)(1) In the case of any new animal drug for which an 
approval of an application filed pursuant to subsection (b) or 
section 571 is in effect, the applicant shall establish and 
maintain such records, and make such reports to the Secretary, 
of data relating to experience, including experience with uses 
authorized under subsection (a)(4)(A), and other data or 
information, received or otherwise obtained by such applicant 
with respect to such drug, or with respect to animal feeds 
bearing or containing such drug, as the Secretary may by 
general regulation, or by order with respect to such 
application, prescribe on the basis of a finding that such 
records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) or 
subsection (m)(4) of this section. Such regulation or order 
shall provide, where the Secretary deems it to be appropriate, 
for the examination, upon request, by the persons to whom such 
regulation or order is applicable, of similar information 
received or otherwise obtained by the Secretary.

           *       *       *       *       *       *       *

  (m)(1) Any person may file with the Secretary an application 
for a license to manufacture animal feeds bearing or containing 
new animal drugs. Such person shall submit to the Secretary as 
part of the application (A) a full statement of the business 
name and address of the specific facility at which the 
manufacturing is to take place and the facility's registration 
number, (B) the name and signature of the responsible 
individual or individuals for that facility, (C) a 
certification that the animal feeds bearing or containing new 
animal drugs are manufactured and labeled in accordance with 
the [applicable regulations published pursuant to subsection 
(i)] applicable regulations published pursuant to subsection 
(i) or for indexed new animal drugs in accordance with the 
index listing published pursuant to section 572(e)(2) and the 
labeling requirements set forth in section 572(h), and (D) a 
certification that the methods used in, and the facilities and 
controls used for, manufacturing, processing, packaging, and 
holding such animal feeds are in conformity with current good 
manufacturing practice as described in section 501(a)(2)(B).

           *       *       *       *       *       *       *

  (3) If the Secretary, after due notice to the applicant in 
accordance with paragraph (2) and giving the applicant an 
opportunity for a hearing in accordance with such paragraph, 
finds, on the basis of information submitted to the Secretary 
as part of the application, on the basis of a preapproval 
inspection, or on the basis of any other information before the 
Secretary--
          (A) * * *

           *       *       *       *       *       *       *

          (C) that the facility manufactures animal feeds 
        bearing or containing new animal drugs in a manner that 
        does not accord with the specifications for manufacture 
        or labels animal feeds bearing or containing new animal 
        drugs in a manner that does not accord with the 
        conditions or indications of use that are published 
        pursuant to subsection (i) or an index listing pursuant 
        to section 572(e),
the Secretary shall issue an order refusing to approve the 
application. If, after such notice and opportunity for hearing, 
the Secretary finds that subparagraphs (A) through (C) do not 
apply, the Secretary shall issue an order approving the 
application. An order under this subsection approving an 
application for a license to manufacture animal feeds bearing 
or containing new animal drugs shall permit a facility to 
manufacture only those animal feeds bearing or containing new 
animal drugs for which there are in effect regulations pursuant 
to subsection (i) or an index listing pursuant to section 
572(e) relating to the use of such drugs in or on such animal 
feed.

           *       *       *       *       *       *       *

  (p)(1) Safety and effectiveness data and information which 
has been submitted in an application filed under subsection 
(b)(1) 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--
          (A) * * *

           *       *       *       *       *       *       *

  (2) Any request for data and information pursuant to 
paragraph (1) shall include a verified statement by the person 
making the request that any data or information received under 
such paragraph shall not be disclosed by such person to any 
other person--
          (A) for the purpose of, or as part of a plan, scheme, 
        or device for, obtaining the right to make, use, or 
        market, or making, using, or marketing, outside the 
        United States, the drug identified in the application 
        filed under subsection (b)(1) or section 571(a), and

           *       *       *       *       *       *       *


     Subchapter F--New Animal Drugs for Minor Use and Minor Species

SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND 
                    MINOR SPECIES.

  (a)(1) Except as provided in paragraph (3) of this section, 
any person may file with the Secretary an application for 
conditional approval of a new animal drug intended for a minor 
use or a minor species. Such an application may not be a 
supplement to an application approved under section 512. Such 
application must comply in all respects with the provisions of 
section 512 of this Act except sections 512(a)(4), 512(b)(2), 
512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and 
512(n) unless otherwise stated in this section, and any 
additional provisions of this section. New animal drugs are 
subject to application of the same safety standards that would 
be applied to such drugs under section 512(d) (including, for 
antimicrobial new animal drugs, with respect to antimicrobial 
resistance).
  (2) The applicant shall submit to the Secretary as part of an 
application for the conditional approval of a new animal drug--
          (A) all information necessary to meet the 
        requirements of section 512(b)(1) except section 
        512(b)(1)(A);
          (B) full reports of investigations which have been 
        made to show whether or not such drug is safe under 
        section 512(d) (including, for an antimicrobial new 
        animal drug, with respect to antimicrobial resistance) 
        and there is a reasonable expectation of effectiveness 
        for use;
          (C) data for establishing a conditional dose;
          (D) projections of expected need and the 
        justification for that expectation based on the best 
        information available;
          (E) information regarding the quantity of drug 
        expected to be distributed on an annual basis to meet 
        the expected need; and
          (F) a commitment that the applicant will conduct 
        additional investigations to meet the requirements for 
        the full demonstration of effectiveness under section 
        512(d)(1)(E) within 5 years.
  (3) A person may not file an application under paragraph (1) 
if--
          (A) the application seeks conditional approval of a 
        new animal drug that is contained in, or is a product 
        of, a transgenic animal.
          (B) the person has previously filed an application 
        for conditional approval under paragraph (1) for the 
        same drug in the same dosage form for the same intended 
        use whether or not subsequently conditionally approved 
        by the Secretary under subsection (b), or
          (C) the person obtained the application, or data or 
        other information contained therein, directly or 
        indirectly from the person who filed for conditional 
        approval under paragraph (1) for the same drug in the 
        same dosage form for the same intended use whether or 
        not subsequently conditionally approved by the 
        Secretary under subsection (b).
  (b) Within 180 days after the filing of an application 
pursuant to subsection (a), or such additional period as may be 
agreed upon by the Secretary and the applicant, the Secretary 
shall either--
          (1) issue an order, effective for one year, 
        conditionally approving the application if the 
        Secretary finds that none of the grounds for denying 
        conditional approval, specified in subsection (c) of 
        this section applies and publish a Federal Register 
        notice of the conditional approval, or
          (2) give the applicant notice of an opportunity for 
        an informal hearing on the question whether such 
        application can be conditionally approved.
  (c) If the Secretary finds, after giving the applicant notice 
and an opportunity for an informal hearing, that--
          (1) any of the provisions of section 512(d)(1) (A) 
        through (D) or (F) through (I) are applicable;
          (2) the information submitted to the Secretary as 
        part of the application and any other information 
        before the Secretary with respect to such drug, is 
        insufficient to show that there is a reasonable 
        expectation that the drug will have the effect it 
        purports or is represented to have under the conditions 
        of use prescribed, recommended, or suggested in the 
        proposed labeling thereof; or
          (3) another person has received approval under 
        section 512 for the same drug in the same dosage form 
        for the same intended use, and that person is able to 
        assure the availability of sufficient quantities of the 
        drug to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally 
approve the application. If, after such notice and opportunity 
for an informal hearing, the Secretary finds that paragraphs 
(1) through (3) do not apply, the Secretary shall issue an 
order conditionally approving the application effective for one 
year and publish a Federal Register notice of the conditional 
approval. Any order issued under this subsection refusing to 
conditionally approve an application shall state the findings 
upon which it is based.
  (d) A conditional approval under this section is effective 
for a 1-year period and is thereafter renewable by the 
Secretary annually for up to 4 additional 1-year terms. A 
conditional approval shall be in effect for no more than 5 
years from the date of approval under subsection (b)(1) or (c) 
of this section unless extended as provided for in subsection 
(h) of this section. The following shall also apply:
          (1) No later than 90 days from the end of the 1-year 
        period for which the original or renewed conditional 
        approval is effective, the applicant may submit a 
        request to renew a conditional approval for an 
        additional 1-year term.
          (2) A conditional approval shall be deemed renewed at 
        the end of the 1-year period, or at the end of a 90-day 
        extension that the Secretary may, at the Secretary's 
        discretion, grant by letter in order to complete review 
        of the renewal request, unless the Secretary determines 
        before the expiration of the 1-year period or the 90-
        day extension that--
                  (A) the applicant failed to submit a timely 
                renewal request;
                  (B) the request fails to contain sufficient 
                information to 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 extension, if granted, that 
        a conditional approval should not be renewed, the 
        Secretary shall issue an order refusing to renew the 
        conditional approval, and such conditional approval 
        shall be deemed withdrawn and no longer in effect. The 
        Secretary shall thereafter provide an opportunity for 
        an informal hearing to the applicant on the issue 
        whether the conditional approval shall be reinstated.
  (e)(1) The Secretary shall issue an order withdrawing 
conditional approval of an application filed pursuant to 
subsection (a) if the Secretary finds that another person has 
received approval under section 512 for the same drug in the 
same dosage form for the same intended use and that person is 
able to assure the availability of sufficient quantities of the 
drug to meet the needs for which the drug is intended.
  (2) The Secretary shall, after due notice and opportunity for 
an informal hearing to the applicant, issue an order 
withdrawing conditional approval of an application filed 
pursuant to subsection (a) if the Secretary finds that--
          (A) any of the provisions of section 512(e)(1) (A) 
        through (B) or (D) through (F) are applicable; or
          (B) on the basis of new information before the 
        Secretary with respect to such drug, evaluated together 
        with the evidence available to the Secretary when the 
        application was conditionally approved, that there is 
        not a reasonable expectation that such drug will have 
        the effect it purports or is represented to have under 
        the conditions of use prescribed, recommended, or 
        suggested in the labeling thereof.
  (3) The Secretary may also, after due notice and opportunity 
for an informal hearing to the applicant, issue an order 
withdrawing conditional approval of an application filed 
pursuant to subsection (a) if the Secretary finds that any of 
the provisions of section 512(e)(2) are applicable.
  (f)(1) The label and labeling of a new animal drug with a 
conditional approval under this section shall--
          (A) bear the statement, ``conditionally approved by 
        FDA pending a full demonstration of effectiveness under 
        application number''; and
          (B) contain such other information as prescribed by 
        the Secretary.
  (2) An intended use that is the subject of a conditional 
approval under this section shall not be included in the same 
product label with any intended use approved under section 512.
  (g) A conditionally approved new animal drug application may 
not be amended or supplemented to add indications for use.
  (h) 180 days prior to the termination date established under 
subsection (d) of this section, an applicant shall have 
submitted all the information necessary to support a complete 
new animal drug application in accordance with section 
512(b)(1) or the conditional approval issued under this section 
is no longer in effect. Following review of this information, 
the Secretary shall either--
          (1) issue an order approving the application under 
        section 512(c) if the Secretary finds that none of the 
        grounds for denying approval specified in section 
        512(d)(1) applies, or
          (2) give the applicant an opportunity for a hearing 
        before the Secretary under section 512(d) on the 
        question whether such application can be approved.
Upon issuance of an order approving the application, product 
labeling and administrative records of approval shall be 
modified accordingly. If the Secretary has not issued an order 
under section 512(c) approving such application prior to the 
termination date established under subsection (d) of this 
section, the conditional approval issued under this section is 
no longer in effect unless the Secretary grants an extension of 
an additional 180-day period so that the Secretary can complete 
review of the application. The decision to grant an extension 
is committed to the discretion of the Secretary and not subject 
to judicial review.
  (i) The decision of the Secretary under subsection (c), (d), 
or (e) of this section refusing or withdrawing conditional 
approval of an application shall constitute final agency action 
subject to judicial review.
  (j) In this section and section 572, the term ``transgenic 
animal'' means an animal whose genome contains a nucleotide 
sequence that has been intentionally modified in vitro, and the 
progeny of such an animal; Provided that the term ``transgenic 
animal'' does not include an animal of which the nucleotide 
sequence of the genome has been modified solely by selective 
breeding.

SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR 
                    MINOR SPECIES.

  (a)(1) The Secretary shall establish an index limited to--
          (A) new animal drugs intended for use in a minor 
        species for which there is a reasonable certainty that 
        the animal or edible products from the animal will not 
        be consumed by humans or food-producing animals; and
          (B) new animal drugs intended for use only in a 
        hatchery, tank, pond, or other similar contained man-
        made structure in an early, non-food life stage of a 
        food-producing minor species, where safety for humans 
        is demonstrated in accordance with the standard of 
        section 512(d) (including, for an antimicrobial new 
        animal drug, with respect to antimicrobial resistance).
  (2) The index shall not include a new animal drug that is 
contained in or a product of a transgenic animal.
  (b) Any person intending to file a request under this section 
shall be entitled to one or more conferences to discuss the 
requirements for indexing a new animal drug.
  (c)(1) Any person may submit a request to the Secretary for a 
determination whether a new animal drug may be eligible for 
inclusion in the index. Such a request shall include--
          (A) information regarding the need for the new animal 
        drug, the species for which the new animal drug is 
        intended, the proposed intended use and conditions of 
        use, and anticipated annual distribution;
          (B) information to support the conclusion that the 
        proposed use meets the conditions of subparagraph (A) 
        or (B) of subsection (a)(1) of this section;
          (C) information regarding the components and 
        composition of the new animal drug;
          (D) a description of the methods used in, and the 
        facilities and controls used for, the manufacture, 
        processing, and packing of such new animal drug;
          (E) an environmental assessment that meets the 
        requirements of the National Environmental Policy Act 
        of 1969, as amended, and as defined in 21 CFR Part 25, 
        as it appears on the date of enactment of this 
        provision and amended thereafter or information to 
        support a categorical exclusion from the requirement to 
        prepare an environmental assessment;
          (F) information sufficient to support the conclusion 
        that the proposed use of the new animal drug is safe 
        under section 512(d) with respect to individuals 
        exposed to the new animal drug through its manufacture 
        or use; and
          (G) such other information as the Secretary may deem 
        necessary to make this eligibility determination.
  (2) Within 90 days after the submission of a request for a 
determination of eligibility for indexing based on subsection 
(a)(1)(A) of this section, or 180 days for a request submitted 
based on subsection (a)(1)(B) of this section, the Secretary 
shall grant or deny the request, and notify the person who 
requested such determination of the Secretary's decision. The 
Secretary shall grant the request if the Secretary finds that--
          (A) the same drug in the same dosage form for the 
        same intended use is not approved or conditionally 
        approved;
          (B) the proposed use of the drug meets the conditions 
        of subparagraph (A) or (B) of subsection (a)(1), as 
        appropriate;
          (C) the person requesting the determination has 
        established appropriate specifications for the 
        manufacture and control of the new animal drug and has 
        demonstrated an understanding of the requirements of 
        current good manufacturing practices;
          (D) the new animal drug will not significantly affect 
        the human environment; and
          (E) the new animal drug is safe with respect to 
        individuals exposed to the new animal drug through its 
        manufacture or use.
If the Secretary denies the request, the Secretary shall 
thereafter provide due notice and an opportunity for an 
informal conference. A decision of the Secretary to deny an 
eligibility request following an informal conference shall 
constitute final agency action subject to judicial review.
  (d)(1) With respect to a new animal drug for which the 
Secretary has made a determination of eligibility under 
subsection (c), the person who made such a request may ask that 
the Secretary add the new animal drug to the index established 
under subsection (a). The request for addition to the index 
shall include--
          (A) a copy of the Secretary's determination of 
        eligibility issued under subsection (c);
          (B) a written report that meets the requirements in 
        subsection (d)(2) of this section;
          (C) a proposed index entry;
          (D) facsimile labeling;
          (E) anticipated annual distribution of the new animal 
        drug;
          (F) a written commitment to manufacture the new 
        animal drug and animal feeds bearing or containing such 
        new animal drug according to current good manufacturing 
        practices;
          (G) a written commitment to label, distribute, and 
        promote the new animal drug only in accordance with the 
        index entry;
          (H) upon specific request of the Secretary, 
        information submitted to the expert panel described in 
        paragraph (3); and
          (I) any additional requirements that the Secretary 
        may prescribe by general regulation or specific order.
  (2) The report required in paragraph (1) shall--
          (A) be authored by a qualified expert panel;
          (B) include an evaluation of all available target 
        animal safety and effectiveness information, including 
        anecdotal information;
          (C) state the expert panel's opinion regarding 
        whether the benefits of using the new animal drug for 
        the proposed use in a minor species outweigh its risks 
        to the target animal, taking into account the harm 
        being caused by the absence of an approved or 
        conditionally approved new animal drug for the minor 
        species in question;
          (D) include information from which labeling can be 
        written; and
          (E) include a recommendation regarding whether the 
        new animal drug should be limited to use under the 
        professional supervision of a licensed veterinarian.
  (3) A qualified expert panel, as used in this section, is a 
panel that--
          (A) is composed of experts qualified by scientific 
        training and experience to evaluate the target animal 
        safety and effectiveness of the new animal drug under 
        consideration;
          (B) operates external to FDA; and
          (C) is not subject to the Federal Advisory Committee 
        Act, 5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a 
qualified expert panel and the procedures for the operation of 
the panel by regulation.
  (4) Within 180 days after the receipt of a request for 
listing a new animal drug in the index, the Secretary shall 
grant or deny the request. The Secretary shall grant the 
request if the request for indexing continues to meet the 
eligibility criteria in subsection (a) and the Secretary finds, 
on the basis of the report of the qualified expert panel and 
other information available to the Secretary, that the benefits 
of using the new animal drug for the proposed use in a minor 
species outweigh its risks to the target animal, taking into 
account the harm caused by the absence of an approved or 
conditionally-approved new animal drug for the minor species in 
question. If the Secretary denies the request, the Secretary 
shall thereafter provide due notice and the opportunity for an 
informal conference. The decision of the Secretary following an 
informal conference shall constitute final agency action 
subject to judicial review.
  (e)(1) The index established under subsection (a) shall 
include the following information for each listed drug--
          (A) the name and address of the person who holds the 
        index listing;
          (B) the name of the drug and the intended use and 
        conditions of use for which it is being indexed;
          (C) product labeling; and
          (D) conditions and any limitations that the Secretary 
        deems necessary regarding use of the drug.
  (2) The Secretary shall publish the index, and revise it 
periodically.
  (3) The Secretary may establish by regulation a process for 
reporting changes in the conditions of manufacturing or 
labeling of indexed products.
  (f)(1) If the Secretary finds, after due notice to the person 
who requested the index listing and an opportunity for an 
informal conference, that--
          (A) the expert panel failed to meet the requirements 
        as set forth by the Secretary by regulation;
          (B) on the basis of new information before the 
        Secretary, evaluated together with the evidence 
        available to the Secretary when the new animal drug was 
        listed in the index, the benefits of using the new 
        animal drug for the indexed use do not outweigh its 
        risks to the target animal;
          (C) the conditions of subsection (c)(2) of this 
        section are no longer satisfied;
          (D) the manufacture of the new animal drug is not in 
        accordance with current good manufacturing practices;
          (E) the labeling, distribution, or promotion of the 
        new animal drug is not in accordance with the index 
        entry;
          (F) the conditions and limitations of use associated 
        with the index listing have not been followed; or
          (G) the request for indexing contains any untrue 
        statement of material fact,
the Secretary shall remove the new animal drug from the index. 
The decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.
  (2) If the Secretary finds that there is a reasonable 
probability that the use of the drug would present a risk to 
the health of humans or other animals, the Secretary may--
          (A) suspend the listing of such drug immediately;
          (B) give the person listed in the index prompt notice 
        of the Secretary's action; and
          (C) afford that person the opportunity for an 
        informal conference.
The decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.
  (g) For purposes of indexing new animal drugs under this 
section, to the extent consistent with the public health, the 
Secretary shall promulgate regulations for exempting from the 
operation of section 512 minor species new animal drugs and 
animal feeds bearing or containing new animal drugs intended 
solely for investigational use by experts qualified by 
scientific training and experience to investigate the safety 
and effectiveness of minor species animal drugs. Such 
regulations may, at the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon the 
establishment and maintenance of such records, and the making 
of such reports to the Secretary, by the manufacturer or the 
sponsor of the investigation of such article, of data 
(including but not limited to analytical reports by 
investigators) obtained as a result of such investigational use 
of such article, as the Secretary finds will enable the 
Secretary to evaluate the safety and effectiveness of such 
article in the event of the filing of a request for an index 
listing pursuant to this section.
  (h) The labeling of a new animal drug that is the subject of 
an index listing shall state, prominently and conspicuously--
          (1) ``Not approved by fda.--Legally marketed as an 
        FDA indexed product. Extra-label use is prohibited.'';
          (2) except in the case of new animal drugs indexed 
        for use in an early life stage of a food-producing 
        animal, ``This product is not to be used in animals 
        intended for use as food for humans or other 
        animals.''; and
          (3) such other information as may be prescribed by 
        the Secretary in the index listing.
  (i)(1) In the case of any new animal drug for which an index 
listing pursuant to subsection (a) is in effect, the person who 
has an index listing shall establish and maintain such records, 
and make such reports to the Secretary, of data relating to 
experience, and other data or information, received or 
otherwise obtained by such person with respect to such drug, or 
with respect to animal feeds bearing or containing such drug, 
as the Secretary may by general regulation, or by order with 
respect to such listing, prescribe on the basis of a finding 
that such records and reports are necessary in order to enable 
the Secretary to determine, or facilitate a determination, 
whether there is or may be ground for invoking subsection (f). 
Such regulation or order shall provide, where the Secretary 
deems it to be appropriate, for the examination, upon request, 
by the persons to whom such regulation or order is applicable, 
of similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this subsection to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
  (j)(1) Safety and effectiveness data and information which 
has been submitted in support of a request for a new animal 
drug to be indexed under this section and which has not been 
previously disclosed to the public shall be made available to 
the public, upon request, unless extraordinary circumstances 
are shown--
          (A) if no work is being or will be undertaken to have 
        the drug indexed in accordance with the request,
          (B) if the Secretary has determined that such drug 
        cannot be indexed and all legal appeals have been 
        exhausted,
          (C) if the indexing of such drug is terminated and 
        all legal appeals have been exhausted, or
          (D) if the Secretary has determined that such drug is 
        not a new animal drug.
  (2) Any request for data and information pursuant to 
paragraph (1) shall include a verified statement by the person 
making the request that any data or information received under 
such paragraph shall not be disclosed by such person to any 
other person--
          (A) for the purpose of, or as part of a plan, scheme, 
        or device for, obtaining the right to make, use, or 
        market, or making, using, or marketing, outside the 
        United States, the drug identified in the request for 
        indexing; and
          (B) without obtaining from any person to whom the 
        data and information are disclosed an identical 
        verified statement, a copy of which is to be provided 
        by such person to the Secretary, which meets the 
        requirements of this paragraph.

SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.

  (a) Designation.--
          (1) The manufacturer or the sponsor of a new animal 
        drug for a minor use or use in a minor species may 
        request that the Secretary declare that drug a 
        ``designated new animal drug''. A request for 
        designation of a new animal drug shall be made before 
        the submission of an application under section 512(b) 
        or section 571 for the new animal drug.
          (2) The Secretary may declare a new animal drug a 
        ``designated new animal drug'' if--
                  (A) it is intended for a minor use or use in 
                a minor species; and
                  (B) the same drug in the same dosage form for 
                the same intended use is not approved under 
                section 512 or 571 or designated under this 
                section at the time the request is made.
          (3) Regarding the termination of a designation--
                  (A) the sponsor of a new animal drug shall 
                notify the Secretary of any decision to 
                discontinue active pursuit of approval under 
                section 512 or 571 of an application for a 
                designated new animal drug. The Secretary shall 
                terminate the designation upon such 
                notification;
                  (B) the Secretary may also terminate 
                designation if the Secretary independently 
                determines that the sponsor is not actively 
                pursuing approval under section 512 or 571 with 
                due diligence;
                  (C) the sponsor of an approved designated new 
                animal drug shall notify the Secretary of any 
                discontinuance of the manufacture of such new 
                animal drug at least one year before 
                discontinuance. The Secretary shall terminate 
                the designation upon such notification; and
                  (D) the designation shall terminate upon the 
                expiration of any applicable exclusivity period 
                under subsection (c).
          (4) Notice respecting the designation or termination 
        of designation of a new animal drug shall be made 
        available to the public.
  (b) Grants and Contracts for Development of Designated New 
Animal Drugs.--
          (1) The Secretary may make grants to and enter into 
        contracts with public and private entities and 
        individuals to assist in defraying the costs of 
        qualified safety and effectiveness testing expenses and 
        manufacturing expenses incurred in connection with the 
        development of designated new animal drugs.
          (2) For purposes of paragraph (1) of this section--
                  (A) The term ``qualified safety and 
                effectiveness testing'' means testing--
                          (i) which occurs after the date such 
                        new animal drug is designated under 
                        this section and before the date on 
                        which an application with respect to 
                        such drug is submitted under section 
                        512; and
                          (ii) which is carried out under an 
                        investigational exemption under section 
                        512(j).
                  (B) The term ``manufacturing expenses'' means 
                expenses incurred in developing processes and 
                procedures associated with manufacture of the 
                designated new animal drug which occur after 
                the new animal drug is designated under this 
                section and before the date on which an 
                application with respect to such new animal 
                drug is submitted under section 512 or 571.
  (c) Exclusivity for Designated New Animal Drugs.--
          (1) Except as provided in subsection (c)(2), if the 
        Secretary approves or conditionally approves an 
        application for a designated new animal drug, the 
        Secretary may not approve or conditionally approve 
        another application submitted for such new animal drug 
        with the same intended use as the designated new animal 
        drug for another applicant before the expiration of 
        seven years from the date of approval or conditional 
        approval of the application.
          (2) If an application filed pursuant to section 512 
        or section 571 is approved for a designated new animal 
        drug, the Secretary may, during the 7-year exclusivity 
        period beginning on the date of the application 
        approval or conditional approval, approve or 
        conditionally approve another application under section 
        512 or section 571 for such drug for such minor use or 
        minor species for another applicant if--
                  (A) the Secretary finds, after providing the 
                holder of such an approved application notice 
                and opportunity for the submission of views, 
                that in the granted exclusivity period the 
                holder of the approved application cannot 
                assure the availability of sufficient 
                quantities of the drug to meet the needs for 
                which the drug was designated; or
                  (B) such holder provides written consent to 
                the Secretary for the approval or conditional 
                approval of other applications before the 
                expiration of such exclusivity period.

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                              ----------                              


           SECTION 108 OF THE ANIMAL DRUG AMENDMENTS OF 1968

                          (Public Law 90-399)

               EFFECTIVE DATE AND TRANSITIONAL PROVISIONS

  Sec. 108. (a) * * *
  (b)(1) * * *

           *       *       *       *       *       *       *

  (3) In the case of any drug (other than a drug subject to 
section 512(n) of the basic Act as amended by this Act) 
intended for use in animals other than man which, on October 9, 
1962, (A) was commercially used or sold in the United States, 
(B) was not a new drug as defined by section 201(p) of the 
basic Act as then in force, and (C) was not covered by an 
effective application under section 505 of that Act, the words 
``effectiveness'' and ``effective'' contained in [section 
201(w) as added by this Act] section 201(v) to the basic Act 
shall not apply to such drug when intended solely for use under 
conditions prescribed, recommended, or suggested in labeling 
with respect to such drug on that day.

           *       *       *       *       *       *       *