[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 741 Reported in Senate (RS)]






                                                       Calendar No. 431
108th CONGRESS
  2d Session
                                 S. 741

                          [Report No. 108-226]

 To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
                 animal drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 27, 2003

  Mr. Sessions (for himself, Mr. Bingaman, Mr. Gregg, Mr. Miller, Mr. 
 Allard, Mrs. Lincoln, Mr. Ensign, Ms. Collins, Mr. Crapo, Mr. Craig, 
Mr. Harkin, Mr. Shelby, Mr. Domenici, Mr. Enzi, Mr. Smith, Mrs. Murray, 
    Mr. Hatch, Ms. Landrieu, Mr. Wyden, Mr. Pryor, and Mr. Durbin) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                           February 18, 2004

  Reported under authority of the order of the Senate of February 12, 
                 2004, by Mr. Gregg, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
                 animal drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Minor Use and Minor Species 
Animal Health Act of 2003''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress makes the following findings:</DELETED>
        <DELETED>    (1) There is a severe shortage of approved new 
        animal drugs for use in minor species.</DELETED>
        <DELETED>    (2) There is a severe shortage of approved new 
        animal drugs for treating animal diseases and conditions that 
        occur infrequently or in limited geographic areas.</DELETED>
        <DELETED>    (3) Because of the small market shares, low-profit 
        margins involved, and capital investment required, it is 
        generally not economically feasible for new animal drug 
        applicants to pursue approvals for these species, diseases, and 
        conditions.</DELETED>
        <DELETED>    (4) Because the populations for which such new 
        animal drugs are intended may be small and conditions of animal 
        management may vary widely, it is often difficult to design and 
        conduct studies to establish drug safety and effectiveness 
        under traditional new animal drug approval processes.</DELETED>
        <DELETED>    (5) It is in the public interest and in the 
        interest of animal welfare to provide for special procedures to 
        allow the lawful use and marketing of certain new animal drugs 
        for minor species and minor uses that take into account these 
        special circumstances and that ensure that such drugs do not 
        endanger animal or public health.</DELETED>
        <DELETED>    (6) Exclusive marketing rights and tax credits for 
        clinical testing expenses have helped encourage the development 
        of ``orphan'' drugs for human use, and comparable incentives 
        should encourage the development of new animal drugs for minor 
        species and minor uses.</DELETED>

<DELETED>SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC 
              ACT.</DELETED>

<DELETED>    (a) Definitions.--Section 201 of the Federal, Food, Drug, 
and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(kk) The term `major species' means cattle, horses, 
swine, chickens, turkeys, dogs, and cats, except that the Secretary may 
revise this definition by regulation.</DELETED>
<DELETED>    ``(ll) The term `minor species' means animals other than 
humans that are not major species.</DELETED>
<DELETED>    ``(mm) The term `minor use' means the intended use of a 
drug in a major species for an indication that occurs infrequently or 
in limited geographical areas.''.</DELETED>
<DELETED>    (b) Three-Year Exclusivity for Minor Use and Minor Species 
Approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the Federal 
Food, Drug, and Cosmetic Act is amended by striking ``(other than 
bioequivalence or residue studies)'' and inserting ``(other than 
bioequivalence studies or residue depletion studies, except residue 
depletion studies for minor uses or minor species)'' every place it 
appears.</DELETED>
<DELETED>    (c) Scope of Review for Minor Use and Minor Species 
Applications.-- Section 512(d) of the Federal Food, Drug, and Cosmetic 
Act is amended by adding at the end the following new 
paragraph:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (d) Minor Use and Minor Species New Animal Drugs.--Chapter 
V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by adding at the end the following:</DELETED>

   <DELETED>``Subchapter F--New Animal Drugs for Minor Use and Minor 
                           Species</DELETED>

<DELETED>``SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR 
              USE AND MINOR SPECIES.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(2) The applicant shall submit to the Secretary as part 
of an application for the conditional approval of a new animal drug--
</DELETED>
        <DELETED>    ``(A) all information necessary to meet the 
        requirements of section 512(b)(1) except section 
        512(b)(1)(A);</DELETED>
        <DELETED>    ``(B) full reports of investigations which have 
        been made to show whether or not such drug is safe and there is 
        a reasonable expectation of effectiveness for use;</DELETED>
        <DELETED>    ``(C) data for establishing a conditional 
        dose;</DELETED>
        <DELETED>    ``(D) projections of expected need and the 
        justification for that expectation based on the best 
        information available;</DELETED>
        <DELETED>    ``(E) information regarding the quantity of drug 
        expected to be distributed on an annual basis to meet the 
        expected need; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(3) A person may not file an application under paragraph 
(1) if--</DELETED>
        <DELETED>    ``(A) 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</DELETED>
        <DELETED>    ``(B) 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).</DELETED>
<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(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, 
        or</DELETED>
        <DELETED>    ``(2) give the applicant notice of an opportunity 
        for an informal hearing on the question whether such 
        application can be conditionally approved.</DELETED>
<DELETED>    ``(c) If the Secretary finds, after giving the applicant 
notice and an opportunity for an informal hearing, that--</DELETED>
        <DELETED>    ``(1) any of the provisions of section 512(d)(1) 
        (A) through (D) or (F) through (I) are applicable;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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;</DELETED>
<DELETED>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. Any order issued 
under this subsection refusing to conditionally approve an application 
shall state the findings upon which it is based.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) the applicant failed to submit a 
                timely renewal request;</DELETED>
                <DELETED>    ``(B) the request fails to contain 
                sufficient information to show that--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) any of the provisions of section 
                512(e)(1) (A) through (B) or (D) through (F) are 
                applicable.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(A) any of the provisions of section 512(e)(1) 
        (A) through (B) or (D) through (F) are applicable; or</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(f)(1) The label and labeling of a new animal drug with 
a conditional approval under this section shall--</DELETED>
        <DELETED>    ``(A) bear the statement, `conditionally approved 
        by FDA pending a full demonstration of effectiveness under 
        application number'; and</DELETED>
        <DELETED>    ``(B) contain such other information as prescribed 
        by the Secretary.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) A conditionally approved new animal drug application 
may not be amended or supplemented to add indications for 
use.</DELETED>
<DELETED>    ``(h) 180 days prior to the termination date established 
under subsection (d)(1) 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--
</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>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)(1) 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.</DELETED>
<DELETED>    ``(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.</DELETED>

<DELETED>``SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL 
              DRUGS FOR MINOR SPECIES.</DELETED>

<DELETED>    ``(a) The Secretary shall establish an index of unapproved 
minor species new animal drugs that may be lawfully marketed for use in 
minor species. The index shall be limited to--</DELETED>
        <DELETED>    ``(1) 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</DELETED>
        <DELETED>    ``(2) new animal drugs intended for use in an 
        early life stage of a food-producing minor species where human 
        food safety can be demonstrated in accordance with the standard 
        of section 512(d) by showing that--</DELETED>
                <DELETED>    ``(A) there is no significant likelihood 
                that harmful residues will be present in the animal or 
                edible products from the animal presented as food for 
                humans as a result of treatment at the early life 
                stage;</DELETED>
                <DELETED>    ``(B) there is no significant likelihood 
                that harmful residues will be present in the animal or 
                edible products from the animal presented as food for 
                food-producing animals as a result of treatment at the 
                early life stage; and</DELETED>
                <DELETED>    ``(C) there are no concerns about the use 
                of the drug at later life stages because a tolerance 
                and regulatory method to test for the drug at later 
                life stages are available or there is no practical use 
                for the drug in later life stages.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(B) information to support the conclusion that 
        the proposed use meets the conditions of subsection (a)(1) or 
        (a)(2) of this section;</DELETED>
        <DELETED>    ``(C) information regarding the components and 
        composition of the new animal drug;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(E) an environmental assessment or information 
        to support a categorical exclusion from the requirement to 
        prepare an environmental assessment;</DELETED>
        <DELETED>    ``(F) information sufficient to support the 
        conclusion that the proposed use of the new animal drug does 
        not present a threat to the safety of individuals exposed to 
        the new animal drug through its manufacture or use; 
        and</DELETED>
        <DELETED>    ``(G) such other information as the Secretary may 
        deem necessary to make this eligibility 
        determination.</DELETED>
<DELETED>    ``(2) Within 90 days after the submission of a request for 
a determination of eligibility for indexing based on subsection (a)(1) 
of this section, or 180 days for a request submitted based on 
subsection (a)(2) 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--</DELETED>
        <DELETED>    ``(A) the same drug in the same dosage form for 
        the same intended use is not approved or conditionally 
        approved;</DELETED>
        <DELETED>    ``(B) the proposed use does not raise concerns 
        related to safety; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>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.</DELETED>
<DELETED>    ``(d)(1) With respect to a new animal drug for which the 
Secretary has made a determination of eligibility under subsection (b), 
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--</DELETED>
        <DELETED>    ``(A) a copy of the Secretary's determination of 
        eligibility issued under subsection (b);</DELETED>
        <DELETED>    ``(B) a written report that meets the requirements 
        in subsection (d)(2) of this section;</DELETED>
        <DELETED>    ``(C) a proposed index entry;</DELETED>
        <DELETED>    ``(D) facsimile labeling;</DELETED>
        <DELETED>    ``(E) anticipated annual distribution of the new 
        animal drug;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(G) a written commitment to label, distribute, 
        and promote the new animal drug only in accordance with the 
        index entry;</DELETED>
        <DELETED>    ``(H) upon specific request of the Secretary, 
        information submitted to the expert panel described in 
        paragraph (3); and</DELETED>
        <DELETED>    ``(I) any additional requirements that the 
        Secretary may prescribe by general regulation or specific 
        order.</DELETED>
<DELETED>    ``(2) The report required in paragraph (1) shall--
</DELETED>
        <DELETED>    ``(A) be authored by a qualified expert 
        panel;</DELETED>
        <DELETED>    ``(B) include an evaluation of all available 
        target animal safety and effectiveness information, including 
        anecdotal information;</DELETED>
        <DELETED>    ``(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, 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;</DELETED>
        <DELETED>    ``(D) include information from which labeling can 
        be written; and</DELETED>
        <DELETED>    ``(E) include a recommendation regarding whether 
        the new animal drug should be limited to use under the 
        professional supervision of a licensed veterinarian.</DELETED>
<DELETED>    ``(3) A qualified expert panel, as used in this section, 
is a panel that--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(B) operates external to FDA; and</DELETED>
        <DELETED>    ``(C) is not subject to the Federal Advisory 
        Committee Act, 5 U.S.C. App. 2.</DELETED>
<DELETED>The Secretary shall define the criteria for selection of a 
qualified expert panel and the procedures for the operation of the 
panel by regulation.</DELETED>
<DELETED>    ``(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, 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.</DELETED>
<DELETED>    ``(e)(1) The index established under subsection (a) shall 
include the following information for each listed drug--</DELETED>
        <DELETED>    ``(A) the name and address of the person who holds 
        the index listing;</DELETED>
        <DELETED>    ``(B) the name of the drug and the intended use 
        and conditions of use for which it is being indexed;</DELETED>
        <DELETED>    ``(C) product labeling; and</DELETED>
        <DELETED>    ``(D) conditions and any limitations that the 
        Secretary deems necessary regarding use of the drug.</DELETED>
<DELETED>    ``(2) The Secretary shall publish the index, and revise it 
periodically.</DELETED>
<DELETED>    ``(3) The Secretary may establish by regulation a process 
for reporting changes in the conditions of manufacturing or labeling of 
indexed products.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(A) the expert panel failed to meet the 
        requirements as set forth by the Secretary by 
        regulation;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(C) the conditions of subsection (c)(2) of this 
        section are no longer satisfied;</DELETED>
        <DELETED>    ``(D) the manufacture of the new animal drug is 
        not in accordance with current good manufacturing 
        practices;</DELETED>
        <DELETED>    ``(E) the labeling, distribution, or promotion of 
        the new animal drug is not in accordance with the index 
        entry;</DELETED>
        <DELETED>    ``(F) the conditions and limitations of use 
        associated with the index listing have not been followed; 
        or</DELETED>
        <DELETED>    ``(G) the request for indexing contains any untrue 
        statement of material fact,</DELETED>
<DELETED>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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(A) suspend the listing of such drug 
        immediately;</DELETED>
        <DELETED>    ``(B) give the person listed in the index prompt 
        notice of the Secretary's action; and</DELETED>
        <DELETED>    ``(C) afford that person the opportunity for an 
        informal conference.</DELETED>
<DELETED>The decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) The labeling of a new animal drug that is the 
subject of an index listing shall state, prominently and 
conspicuously--</DELETED>
        <DELETED>    ``(1) `Not approved by fda.--Legally marketed as 
        an FDA indexed product. Extra-label use is 
        prohibited.';</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(3) such other information as may be prescribed 
        by the Secretary in the index listing.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(A) if no work is being or will be undertaken to 
        have the drug indexed in accordance with the request,</DELETED>
        <DELETED>    ``(B) if the Secretary has determined that such 
        drug cannot be indexed and all legal appeals have been 
        exhausted,</DELETED>
        <DELETED>    ``(C) if the indexing of such drug is terminated 
        and all legal appeals have been exhausted, or</DELETED>
        <DELETED>    ``(D) if the Secretary has determined that such 
        drug is not a new animal drug.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>

<DELETED>``SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR 
              SPECIES.</DELETED>

<DELETED>    ``(a) Designation.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) The Secretary may declare a new animal drug 
        a `designated new animal drug' for an intended use if--
        </DELETED>
                <DELETED>    ``(A) it is intended for a minor use or 
                use in a minor species; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Regarding the termination of a designation--
        </DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(D) the designation shall terminate upon 
                the expiration of any applicable exclusivity period 
                under subsection (c).</DELETED>
        <DELETED>    ``(4) Notice respecting the designation or 
        termination of designation of a new animal drug shall be made 
        available to the public.</DELETED>
<DELETED>    ``(b) Grants and Contracts for Development of Designated 
New Animal Drugs.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) For purposes of paragraph (1) of this 
        section--</DELETED>
                <DELETED>    ``(A) The term `qualified safety and 
                effectiveness testing' means testing--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) which is carried out under 
                        an investigational exemption under section 
                        512(j).</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Exclusivity for Designated New Animal Drugs.--
</DELETED>
        <DELETED>    ``(1) Except as provided in subsection (c)(2), if 
        the Secretary--</DELETED>
                <DELETED>    ``(A) approves or conditionally approves 
                an application for a designated new animal drug, and no 
                active ingredient (including any salt or ester of the 
                active ingredient) of that designated new animal drug 
                has been approved or conditionally approved previously, 
                the Secretary may not approve or conditionally approve 
                another application submitted for a new animal drug 
                with the same active ingredient and intended use as the 
                designated new animal drug for another applicant before 
                the expiration of ten years from the date of the 
                approval or conditional approval of the 
                application.</DELETED>
                <DELETED>    ``(B) approves or conditionally approves 
                an application for a designated new animal drug, and an 
                active ingredient (including an ester or salt of the 
                active ingredient) of that designated new animal drug 
                has been approved or conditionally approved previously, 
                the Secretary may not approve or conditionally approve 
                another application submitted for a new animal drug 
                with the same active ingredient and 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.</DELETED>
        <DELETED>    ``(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 10-year or 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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (e) Conforming Amendments.--</DELETED>
        <DELETED>    (1) Section 201(u) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking ``512'' and inserting 
        ``512, 571''.</DELETED>
        <DELETED>    (2) Section 201(v) of the Federal Food, Drug, and 
        Cosmetic Act is amended by inserting the following after 
        paragraph (2): ``Provided that any drug intended for minor use 
        or use in a minor species that is not the subject of a final 
        regulation published by the Secretary through notice and 
        comment rulemaking finding that the criteria of paragraphs (1) 
        and (2) have not been met (or that the exception to the 
        criterion in paragraph (1) has been met) is a new animal 
        drug.''.</DELETED>
        <DELETED>    (3) Section 301(e) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking ``512(a)(4)(C), 512(j), (l) 
        or (m)'' and inserting ``512(a)(4)(C), 512 (j), (l) or (m), 
        572(i).''</DELETED>
        <DELETED>    (4) Section 301(j) of the Federal Food, Drug, and 
        Cosmetic Act is amended by deleting ``520'' and inserting 
        ``520, 571, 572, 573.''</DELETED>
        <DELETED>    (5) Section 502 of the Federal Food, Drug, and 
        Cosmetic Act is amended by adding at the end the following new 
        subsection:</DELETED>
<DELETED>    ``(u) If it is a new animal drug--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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).''.</DELETED>
        <DELETED>    (6) Section 503(f) of the Federal Food, Drug, and 
        Cosmetic Act is amended by--</DELETED>
                <DELETED>    (A) in paragraph (1)(A)(ii) by striking 
                ``512'' and inserting ``512, a conditionally-approved 
                application under section 571, or an index listing 
                under section 572''; and</DELETED>
                <DELETED>    (B) in paragraph (3) by striking ``section 
                512'' and inserting ``section 512, 571, or 
                572''.</DELETED>
        <DELETED>    (7) Section 504(a)(1) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``512(b)'' and 
        inserting ``512(b), a conditionally-approved application filed 
        pursuant to section 571, or an index listing pursuant to 
        section 572''.</DELETED>
        <DELETED>    (8) Sections 504(a)(2)(B) and 504(b) of the 
        Federal Food, Drug, and Cosmetic Act are amended by striking 
        ``512(i)'' each place it appears and inserting ``512(i), or the 
        index listing pursuant to section 572(e)''.</DELETED>
        <DELETED>    (9) Section 512(a) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking paragraphs (1) and (2) and 
        inserting the following:</DELETED>
<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>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).</DELETED>
<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(A) there is in effect--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.''.</DELETED>
        <DELETED>    (10) Section 512(b)(3) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``under paragraph (1) 
        or a request for an investigational exemption under subsection 
        (j)'' and inserting ``under paragraph (1), section 571, or a 
        request for an investigational exemption under subsection 
        (j)''.</DELETED>
        <DELETED>    (11) Section 512(d)(4) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``have previously been 
        separately approved'' and inserting ``have previously been 
        separately approved pursuant to an application submitted under 
        section 512(b)(1)''.</DELETED>
        <DELETED>    (12) Section 512(f) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking ``subsection (d), (e), or 
        (m)'' and inserting ``subsection (d), (e), or (m), or section 
        571 (c), (d), or (e)''.</DELETED>
        <DELETED>    (13) Section 512(g) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking ``this section'' and 
        inserting ``this section, or section 571''.</DELETED>
        <DELETED>    (14) Section 512(i) of the Federal Food, Drug, and 
        Cosmetic Act is amended by striking ``subsection (b)'' and 
        inserting ``subsection (b) or section 571'' and by inserting 
        ``or upon failure to renew a conditional approval under section 
        571'' after ``or upon its suspension''.</DELETED>
        <DELETED>    (15) Section 512(l)(1) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``subsection (b)'' and 
        inserting ``subsection (b) or section 571''.</DELETED>
        <DELETED>    (16) Section 512(m)(1)(C) of the Federal Food, 
        Drug, and Cosmetic Act is amended by striking ``applicable 
        regulations published pursuant to subsection (i)'' and 
        inserting ``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)''.</DELETED>
        <DELETED>    (17) Section 512(m)(3) of the Federal Food, Drug, 
        and Cosmetic Act is amended by inserting ``or an index listing 
        pursuant to section 572(e)'' after ``subsection (i)'' each 
        place it appears.</DELETED>
        <DELETED>    (18) Section 512(p)(1) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``subsection (b)(1)'' 
        and inserting ``subsection (b)(1) or section 
        571(a)''.</DELETED>
        <DELETED>    (19) Section 512(p)(2) of the Federal Food, Drug, 
        and Cosmetic Act is amended by striking ``subsection (b)(1)'' 
        and inserting ``subsection (b)(1) or section 
        571(a)''.</DELETED>
        <DELETED>    (20) Section 108(b)(3) of Public Law 90-399 is 
        amended by striking ``section 201(w) as added by this Act'' and 
        inserting ``section 201(v) as added by the Minor Use and Minor 
        Species Animal Health Act of 2003''.</DELETED>
<DELETED>    (f) Regulations.--The Secretary of Health and Human 
Services shall implement sections 571 and 573 of the Federal Food, 
Drug, and Cosmetic Act and subsequently publish implementing 
regulations. Not later than 12 months after the date of enactment of 
this Act, the Secretary shall issue proposed regulations to implement 
section 573 of the Federal Food, Drug, and Cosmetic Act (as added by 
this Act), and not later than 24 months after the date of enactment of 
this Act, the Secretary shall issue final regulations implementing 
section 573 of the Federal Food, Drug, and Cosmetic Act. Not later than 
18 months after the date of enactment of this Act, the Secretary shall 
issue proposed regulations to implement section 572 of the Federal 
Food, Drug, and Cosmetic Act (as added by this Act), and not later than 
36 months after the date of enactment of this Act, the Secretary shall 
issue final regulations implementing section 572 of the Federal Food, 
Drug, and Cosmetic Act. Not later than 30 months after the date of 
enactment of this Act, the Secretary shall issue proposed regulations 
to implement section 571 of the Federal Food, Drug, and Cosmetic Act 
(as added by this Act), and not later than 42 months after the date of 
enactment of this Act, the Secretary shall issue final regulations 
implementing section 571 of the Federal Food, Drug, and Cosmetic Act. 
These timeframes shall be extended by 12 months for each fiscal year, 
in which the funds authorized to be appropriated under subsection (i) 
are not in fact appropriated.</DELETED>
<DELETED>    (g) Office.--The Secretary of Health and Human Services 
shall establish within the Center for Veterinary Medicine (of the Food 
and Drug Administration), an Office of Minor Use and Minor Species 
Animal Drug Development that reports directly to the Director of the 
Center for Veterinary Medicine. This office shall be responsible for 
overseeing the development and legal marketing of new animal drugs for 
minor uses and minor species. There is authorized to be appropriated to 
carry out this subsection $1,200,000 for fiscal year 2003 and such sums 
as may be necessary for each fiscal year thereafter.</DELETED>
<DELETED>    (h) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out section 573(b) of the Federal Food, 
Drug, and Cosmetic Act (as added by this Act) $1,000,000 for the fiscal 
year following publication of final implementing regulations, 
$2,000,000 for the subsequent fiscal year, and such sums as may be 
necessary for each fiscal year thereafter.</DELETED>

              TITLE I--MINOR USE AND MINOR SPECIES HEALTH

SECTION 101. SHORT TITLE.

    This title may be cited as the ``Minor Use and Minor Species Animal 
Health Act of 2003''.

SEC. 102. MINOR USE AND MINOR SPECIES ANIMAL HEALTH.

    (a) Findings.--Congress makes the following findings:
            (1) There is a severe shortage of approved new animal drugs 
        for use in minor species.
            (2) There is a severe shortage of approved new animal drugs 
        for treating animal diseases and conditions that occur 
        infrequently or in limited geographic areas.
            (3) Because of the small market shares, low-profit margins 
        involved, and capital investment required, it is generally not 
        economically feasible for new animal drug applicants to pursue 
        approvals for these species, diseases, and conditions.
            (4) Because the populations for which such new animal drugs 
        are intended may be small and conditions of animal management 
        may vary widely, it is often difficult to design and conduct 
        studies to establish drug safety and effectiveness under 
        traditional new animal drug approval processes.
            (5) It is in the public interest and in the interest of 
        animal welfare to provide for special procedures to allow the 
        lawful use and marketing of certain new animal drugs for minor 
        species and minor uses that take into account these special 
        circumstances and that ensure that such drugs do not endanger 
        animal or public health.
            (6) Exclusive marketing rights for clinical testing 
        expenses have helped encourage the development of ``orphan'' 
        drugs for human use, and comparable incentives should encourage 
        the development of new animal drugs for minor species and minor 
        uses.
    (b) Amendments to the Federal Food, Drug, and Cosmetic Act.--
            (1) Definitions.--Section 201 of the Federal, Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321) is amended by adding at the 
        end the following:
    ``(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.''.
            (2) Three-year exclusivity for minor use and minor species 
        approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the 
        Federal Food, Drug, and Cosmetic Act is amended by striking 
        ``(other than bioequivalence or residue studies)'' and 
        inserting ``(other than bioequivalence studies or residue 
        depletion studies, except residue depletion studies for minor 
        uses or minor species)'' every place it appears.
            (3) Scope of review for minor use and minor species 
        applications.--Section 512(d) of the Federal Food, Drug, and 
        Cosmetic Act is amended by adding at the end the following new 
        paragraph:
            ``(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.''.
    (4) Minor use and minor species new animal drugs.--Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by adding at the end the following:

    ``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.''.
            (5) Conforming amendments.--
                    (A) Section 201(u) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``512'' and 
                inserting ``512, 571''.
                    (B) Section 201(v) of the Federal Food, Drug, and 
                Cosmetic Act is amended by inserting the following 
                after paragraph (2): ``Provided that any drug intended 
                for minor use or use in a minor species that is not the 
                subject of a final regulation published by the 
                Secretary through notice and comment rulemaking finding 
                that the criteria of paragraphs (1) and (2) have not 
                been met (or that the exception to the criterion in 
                paragraph (1) has been met) is a new animal drug.''.
                    (C) Section 301(e) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``512(a)(4)(C), 
                512(j), (l) or (m)'' and inserting ``512(a)(4)(C), 512 
                (j), (l) or (m), 572(i).''
                    (D) Section 301(j) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``520'' and 
                inserting ``520, 571, 572, 573.''
                    (E) Section 502 of the Federal Food, Drug, and 
                Cosmetic Act is amended by adding at the end the 
                following new subsection:
    ``(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).''.
                    (F) Section 503(f) of the Federal Food, Drug, and 
                Cosmetic Act is amended--
                            (i) in paragraph (1)(A)(ii) by striking 
                        ``512'' and inserting ``512, a conditionally-
                        approved application under section 571, or an 
                        index listing under section 572''; and
                            (ii) in paragraph (3) by striking ``section 
                        512'' and inserting ``section 512, 571, or 
                        572''.
                    (G) Section 504(a)(1) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``512(b)'' and 
                inserting ``512(b), a conditionally-approved 
                application filed pursuant to section 571, or an index 
                listing pursuant to section 572''.
                    (H) Sections 504(a)(2)(B) and 504(b) of the Federal 
                Food, Drug, and Cosmetic Act are amended by striking 
                ``512(i)'' each place it appears and inserting 
                ``512(i), or the index listing pursuant to section 
                572(e)''.
                    (I) Section 512(a) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking paragraphs (1) and 
                (2) and inserting the following:
    ``(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.''.
                    (J) Section 512(b)(3) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``under 
                paragraph (1) or a request for an investigational 
                exemption under subsection (j)'' and inserting ``under 
                paragraph (1), section 571, or a request for an 
                investigational exemption under subsection (j)''.
                    (K) Section 512(d)(4) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``have 
                previously been separately approved'' and inserting 
                ``have previously been separately approved pursuant to 
                an application submitted under section 512(b)(1)''.
                    (L) Section 512(f) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``subsection (d), 
                (e), or (m)'' and inserting ``subsection (d), (e), or 
                (m), or section 571 (c), (d), or (e)''.
                    (M) Section 512(g) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``this section'' 
                and inserting ``this section, or section 571''.
                    (N) Section 512(i) of the Federal Food, Drug, and 
                Cosmetic Act is amended by striking ``subsection (b)'' 
                and inserting ``subsection (b) or section 571'' and by 
inserting ``or upon failure to renew a conditional approval under 
section 571'' after ``or upon its suspension''.
                    (O) Section 512(l)(1) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``subsection 
                (b)'' and inserting ``subsection (b) or section 571''.
                    (P) Section 512(m)(1)(C) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``applicable 
                regulations published pursuant to subsection (i)'' and 
                inserting ``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)''.
                    (Q) Section 512(m)(3) of the Federal Food, Drug, 
                and Cosmetic Act is amended by inserting ``or an index 
                listing pursuant to section 572(e)'' after ``subsection 
                (i)'' each place it appears.
                    (R) Section 512(p)(1) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``subsection 
                (b)(1)'' and inserting ``subsection (b)(1) or section 
                571(a)''.
                    (S) Section 512(p)(2) of the Federal Food, Drug, 
                and Cosmetic Act is amended by striking ``subsection 
                (b)(1)'' and inserting ``subsection (b)(1) or section 
                571(a)''.
                    (T) Section 108(b)(3) of Public Law 90-399 is 
                amended by striking ``section 201(w) as added by this 
                Act'' and inserting ``section 201(v)''.
            (6) Regulations.--On the date of enactment of this Act, the 
        Secretary of Health and Human Services shall implement sections 
        571 and 573 of the Federal Food, Drug, and Cosmetic Act and 
        subsequently publish implementing regulations. Not later than 
        12 months after the date of enactment of this Act, the 
        Secretary shall issue proposed regulations to implement section 
        573 of the Federal Food, Drug, and Cosmetic Act (as added by 
        this Act), and not later than 24 months after the date of 
        enactment of this Act, the Secretary shall issue final 
        regulations implementing section 573 of the Federal Food, Drug, 
        and Cosmetic Act. Not later than 18 months after the date of 
        enactment of this Act, the Secretary shall issue proposed 
        regulations to implement section 572 of the Federal Food, Drug, 
        and Cosmetic Act (as added by this Act), and not later than 36 
        months after the date of enactment of this Act, the Secretary 
        shall issue final regulations implementing section 572 of the 
        Federal Food, Drug, and Cosmetic Act. Not later than 30 months 
        after the date of enactment of this Act, the Secretary shall 
        issue proposed regulations to implement section 571 of the 
        Federal Food, Drug, and Cosmetic Act (as added by this Act), 
        and not later than 42 months after the date of enactment of 
        this Act, the Secretary shall issue final regulations 
        implementing section 571 of the Federal Food, Drug, and 
        Cosmetic Act. These timeframes shall be extended by 12 months 
        for each fiscal year, in which the funds authorized to be 
        appropriated under subsection (i) are not in fact appropriated.
            (7) Office.--The Secretary of Health and Human Services 
        shall establish within the Center for Veterinary Medicine (of 
        the Food and Drug Administration), an Office of Minor Use and 
        Minor Species Animal Drug Development that reports directly to 
        the Director of the Center for Veterinary Medicine. This office 
        shall be responsible for overseeing the development and legal 
        marketing of new animal drugs for minor uses and minor species. 
        There is authorized to be appropriated to carry out this 
        subsection $1,200,000 for fiscal year 2004 and such sums as may 
        be necessary for each fiscal year thereafter.
            (8) Authorization of Appropriations.--There is authorized 
        to be appropriated to carry out section 573(b) of the Federal 
        Food, Drug, and Cosmetic Act (as added by this section) 
        $1,000,000 for the fiscal year following publication of final 
        implementing regulations, $2,000,000 for the subsequent fiscal 
        year, and such sums as may be necessary for each fiscal year 
        thereafter.

        TITLE II--FOOD ALLERGEN LABELING AND CONSUMER PROTECTION

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Food Allergen Labeling and 
Consumer Protection Act of 2003''.

SEC. 202. FINDINGS.

    Congress finds that--
            (1) it is estimated that--
                    (A) approximately 2 percent of adults and about 5 
                percent of infants and young children in the United 
                States suffer from food allergies; and
                    (B) each year, roughly 30,000 individuals require 
                emergency room treatment and 150 individuals die 
                because of allergic reactions to food;
            (2)(A) eight major foods or food groups--milk, eggs, fish, 
        Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans--
        account for 90 percent of food allergies;
            (B) at present, there is no cure for food allergies; and
            (C) a food allergic consumer must avoid the food to which 
        the consumer is allergic;
            (3)(A) in a review of the foods of randomly selected 
        manufacturers of baked goods, ice cream, and candy in Minnesota 
        and Wisconsin in 1999, the Food and Drug Administration found 
        that 25 percent of sampled foods failed to list peanuts or eggs 
        as ingredients on the food labels; and
            (B) nationally, the number of recalls because of unlabeled 
        allergens rose to 121 in 2000 from about 35 a decade earlier;
            (4) a recent study shows that many parents of children with 
        a food allergy were unable to correctly identify in each of 
        several food labels the ingredients derived from major food 
        allergens;
            (5)(A) ingredients in foods must be listed by their 
        ``common or usual name'';
            (B) in some cases, the common or usual name of an 
        ingredient may be unfamiliar to consumers, and many consumers 
        may not realize the ingredient is derived from, or contains, a 
        major food allergen; and
            (C) in other cases, the ingredients may be declared as a 
        class, including spices, flavorings, and certain colorings, or 
        are exempt from the ingredient labeling requirements, such as 
        incidental additives; and
            (6)(A) celiac disease is an immune-mediated disease that 
        causes damage to the gastrointestinal tract, central nervous 
        system, and other organs;
            (B) the current recommended treatment is avoidance of 
        glutens in foods that are associated with celiac disease; and
            (C) a multicenter, multiyear study estimated that the 
        prevalence of celiac disease in the United States is 0.5 to 1 
        percent of the general population.

SEC. 203. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING 
              ALLERGENIC SUBSTANCES.

    (a) In General.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(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.''.
    (b) Effect on Other Authority.--The amendments made by this section 
that require a label or labeling for major food allergens do not alter 
the authority of the Secretary of Health and Human Services under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require 
a label or labeling for other food allergens.
    (c) Conforming Amendments.--
            (1) Section 201 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321) (as amended by section 102(b)) is amended by 
        adding at the end the following:
    ``(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).''.
            (2) Section 403A(a)(2) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking 
        ``or 403(i)(2)'' and inserting ``403(i)(2), 403(w), or 
        403(x)''.
    (d) Effective Date.--The amendments made by this section shall 
apply to any food that is labeled on or after January 1, 2006.

SEC. 204. REPORT ON FOOD ALLERGENS.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services (in this section referred to 
as the ``Secretary'') shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report that--
            (1)(A) analyzes--
                    (i) the ways in which foods, during manufacturing 
                and processing, are unintentionally contaminated with 
                major food allergens, including contamination caused by 
                the use by manufacturers of the same production line to 
                produce both products for which major food allergens 
                are intentional ingredients and products for which 
                major food allergens are not intentional ingredients; 
                and
                    (ii) the ways in which foods produced on dedicated 
                production lines are unintentionally contaminated with 
                major food allergens; and
            (B) estimates how common the practices described in 
        subparagraph (A) are in the food industry, with breakdowns by 
        food type as appropriate;
            (2) advises whether good manufacturing practices or other 
        methods can be used to reduce or eliminate cross-contact of 
        foods with the major food allergens;
            (3) describes--
                    (A) the various types of advisory labeling (such as 
                labeling that uses the words ``may contain'') used by 
                food producers;
                    (B) the conditions of manufacture of food that are 
                associated with the various types of advisory labeling; 
                and
                    (C) the extent to which advisory labels are being 
                used on food products;
            (4) describes how consumers with food allergies or the 
        caretakers of consumers would prefer that information about the 
        risk of cross-contact be communicated on food labels as 
        determined by using appropriate survey mechanisms;
            (5) states the number of inspections of food manufacturing 
        and processing facilities conducted in the previous 2 years and 
        describes--
                    (A) the number of facilities and food labels that 
                were found to be in compliance or out of compliance 
                with respect to cross-contact of foods with residues of 
                major food allergens and the proper labeling of major 
                food allergens;
                    (B) the nature of the violations found; and
                    (C) the number of voluntary recalls, and their 
                classifications, of foods containing undeclared major 
                food allergens; and
            (6) assesses the extent to which the Secretary and the food 
        industry have effectively addressed cross-contact issues.

SEC. 205. INSPECTIONS RELATING TO FOOD ALLERGENS.

    The Secretary of Health and Human Services shall conduct 
inspections consistent with the authority under section 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in 
which foods are manufactured, processed, packed, or held--
            (1) to ensure that the entities operating the facilities 
        comply with practices to reduce or eliminate cross-contact of a 
        food with residues of major food allergens that are not 
        intentional ingredients of the food; and
            (2) to ensure that major food allergens are properly 
        labeled on foods.

SEC. 206. GLUTEN LABELING.

    Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services, in consultation with 
appropriate experts and stakeholders, shall issue a proposed rule to 
define, and permit use of, the term ``gluten-free'' on the labeling of 
foods. Not later than 4 years after the date of enactment of this Act, 
the Secretary shall issue a final rule to define, and permit use of, 
the term ``gluten-free'' on the labeling of foods.

SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED ALLERGIC 
              RESPONSES.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the Centers for Disease Control and Prevention 
and in consultation with the Commissioner of Food and Drugs, shall 
improve (including by educating physicians and other health care 
providers) the collection of, and publish as it becomes available, 
national data on--
            (1) the prevalence of food allergies;
            (2) the incidence of clinically significant or serious 
        adverse events related to food allergies; and
            (3) the use of different modes of treatment for and 
        prevention of allergic responses to foods.
    (b) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary.

SEC. 208. FOOD ALLERGIES RESEARCH.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the National Institutes of Health, shall 
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.
    (b) Recommendations.--Not later than 1 year after the date of 
enactment of this Act, the panel shall make recommendations to the 
Secretary for enhancing and coordinating research activities concerning 
food allergies, which the Secretary shall make public.

SEC. 209. FOOD ALLERGENS IN THE FOOD CODE.

    The Secretary of Health and Human Services shall, in the Conference 
for Food Protection, as part of its efforts to encourage cooperative 
activities between the States under section 311 of the Public Health 
Service Act (42 U.S.C. 243), 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 shall 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.

SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-RELATED ALLERGIC 
              RESPONSES.

    The Secretary of Health and Human Services shall, in providing 
technical assistance relating to trauma care and emergency medical 
services to State and local agencies under section 1202(b)(3) of the 
Public Health Service Act (42 U.S.C. 300d-2(b)(3)), include technical 
assistance relating to the use of different modes of treatment for and 
prevention of allergic responses to foods.




                                                       Calendar No. 431

108th CONGRESS

  2d Session

                                 S. 741

                          [Report No. 108-226]

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
                 animal drugs, and for other purposes.

_______________________________________________________________________

                           February 18, 2004

  Reported under authority of the order of the Senate of February 12, 
                        2004, with an amendment