[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 741 Engrossed in Senate (ES)]
108th CONGRESS
2d Session
S. 741
_______________________________________________________________________
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.
Passed the Senate March 8, 2004.
Attest:
Secretary.
108th CONGRESS
2d Session
S. 741
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with regard to new
animal drugs, and for other purposes.