[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 741 Enrolled Bill (ENR)]

        S.741

                       One Hundred Eighth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
           the twentieth day of January, two thousand and four


                                 An Act


 
  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,

              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 2004''.
    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 2004''.

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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.