Home > 108th Congressional Bills > S. 741 (es) To amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes. [Engrossed in Senate] ...S. 741 (es) To amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes. [Engrossed in Senate] ...
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
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