[108th Congress Public Law 282]
[From the U.S. Government Printing Office]


[DOCID: f:publ282.108]

[[Page 118 STAT. 891]]

Public Law 108-282
108th Congress

                                 An Act


 
  To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
   animal drugs, and for other purposes. <<NOTE: Aug. 2, 2004 -  [S. 
                                 741]>> 

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

TITLE I--MINOR <<NOTE: Minor Use and Minor Species Animal Health Act of 
2004.>> USE AND MINOR SPECIES HEALTH

SECTION 101. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This title may be cited as the ``Minor Use and Minor Species Animal 
Health Act of 2004''.
SEC. 102. MINOR <<NOTE: 21 USC 360ccc note.>> 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.--

[[Page 118 STAT. 892]]

            (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 <<NOTE: 21 USC 360b.>> 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. <<NOTE: 21 USC 360ccc.>> 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--

[[Page 118 STAT. 893]]

            ``(A) all information necessary to meet the requirements of 
        section 512(b)(1) except section 512(b)(1)(A);
            ``(B) <<NOTE: Reports.>> 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) <<NOTE: Deadline.>> 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) <<NOTE: Federal Register, publication.>> 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

[[Page 118 STAT. 894]]

        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. <<NOTE: Federal Register, publication.>> 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. <<NOTE: Applicability.>> The 
following shall also apply:
            ``(1) <<NOTE: Deadline.>> 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

[[Page 118 STAT. 895]]

        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) <<NOTE: Deadline.>> 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 <<NOTE: Records.>> 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

[[Page 118 STAT. 896]]

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. <<NOTE: 21 USC 360ccc-1.>> 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;

[[Page 118 STAT. 897]]

            ``(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) <<NOTE: Deadline. Notification.>> 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 <<NOTE: Records.>> copy of the Secretary's 
        determination of eligibility issued under subsection (c);
            ``(B) <<NOTE: Reports.>> 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;

[[Page 118 STAT. 898]]

            ``(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 <<NOTE: Regulations.>> Secretary shall define the criteria for 
selection of a qualified expert panel and the procedures for the 
operation of the panel by regulation.

    ``(4) <<NOTE: Deadline.>> 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) <<NOTE: Publication.>> 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--

[[Page 118 STAT. 899]]

            ``(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) <<NOTE: Regulations.>> 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

[[Page 118 STAT. 900]]

            ``(3) such other information as may be prescribed by the 
        Secretary in the index listing.

    ``(i)(1) <<NOTE: Records. Reports.>> 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. <<NOTE: 21 USC 360ccc-2.>> 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

[[Page 118 STAT. 901]]

        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) <<NOTE: Notifications. Terminations.>> 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.--

[[Page 118 STAT. 902]]

            ``(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 <<NOTE: 21 USC 321.>> 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 <<NOTE: 21 USC 331.>> 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 <<NOTE: 21 USC 351.>> 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).''.

[[Page 118 STAT. 903]]

                    (F) Section 503(f) of the Federal Food, Drug, and 
                Cosmetic Act is <<NOTE: 21 USC 353.>> 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 <<NOTE: 21 USC 354.>> 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 <<NOTE: 21 USC 360b.>> 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;

[[Page 118 STAT. 904]]

                    ``(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 <<NOTE: 21 USC 360b.>> 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)''.

[[Page 118 STAT. 905]]

                    (T) Section 108(b)(3) of Public Law 90-399 
                is <<NOTE: 21 USC 360b note.>> amended by striking 
                ``section 201(w) as added by this Act'' and inserting 
                ``section 201(v)''.
            (6) Regulations.--On <<NOTE: Effective 
        date. Deadlines. Publication. 21 USC 360ccc note.>> 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 <<NOTE: Government organization. 21 USC 393 
        note.>> 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. <<NOTE: Appropriation 
        authorization.>> 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 <<NOTE: Food Allergen Labeling and Consumer Protection 
Act of 2004.>> ALLERGEN LABELING AND CONSUMER PROTECTION

SEC. 201. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This title may be cited as the ``Food Allergen Labeling and Consumer 
Protection Act of 2004''.

SEC. 202. <<NOTE: 21 USC 343 note.>> FINDINGS.

    Congress finds that--

[[Page 118 STAT. 906]]

            (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

[[Page 118 STAT. 907]]

            ``(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. <<NOTE: Federal Register, publication.>> 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) <<NOTE: Public information. Deadline.>> 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.

[[Page 118 STAT. 908]]

    ``(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) <<NOTE: Deadlines.>> 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) <<NOTE: Public information. Deadline.>> 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 <<NOTE: 21 USC 343 note.>> 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 <<NOTE: Applicability. 21 USC 321 
note.>> amendments made by this section shall apply to any food that is 
labeled on or after January 1, 2006.

[[Page 118 STAT. 909]]

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. <<NOTE: 21 USC 374a.>> 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

[[Page 118 STAT. 910]]

        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. <<NOTE: Deadlines. Regulations. 21 USC 343 note.>> 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 <<NOTE: 42 USC 242r.>> 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. <<NOTE: 42 USC 243 note.>> FOOD ALLERGIES RESEARCH.

    (a) In General.--The <<NOTE: Government organization.>> 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 <<NOTE: Deadline. Public 
information.>> 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.

[[Page 118 STAT. 911]]

SEC. 210. RECOMMENDATIONS <<NOTE: 42 USC 300d-2 note.>> 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.

    Approved August 2, 2004.

LEGISLATIVE HISTORY--S. 741:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 108-608 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 108-226 (Comm. on Health, Education, Labor, and 
Pensions).
CONGRESSIONAL RECORD, Vol. 150 (2004):
            Mar. 8, considered and passed Senate.
            July 20, considered and passed House.

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