[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.