21 U.S.C. § 360b : US Code - Section 360B: New animal drugs

Search 21 U.S.C. § 360b : US Code - Section 360B: New animal drugs

(a) Unsafe new animal drugs and animal feed containing such drugs;
conditions of safety; exemption of drugs for research; import
tolerances
(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 351(a)(5) of this title and section 342(a)(2)(C)(ii) of
this title unless -
(A) there is in effect an approval of an application filed
pursuant to subsection (b) of this section 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 360ccc of this title 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
360ccc-1 of this title 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) of this section 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) of this section.
(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 351(a)(6) of this
title unless -
(A) there is in effect -
(i) an approval of an application filed pursuant to
subsection (b) of this section 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 360ccc of this title 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 360ccc-1 of this
title 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) of
this section to manufacture such animal feed.
(3) A new animal drug or an animal feed bearing or containing a
new animal drug shall not be deemed unsafe for the purposes of
section 351(a)(5) or (6) of this title if such article is for
investigational use and conforms to the terms of an exemption in
effect with respect thereto under subsection (j) of this section.
(4)(A) Except as provided in subparagraph (B), if an approval of
an application filed under subsection (b) of this section is in
effect with respect to a particular use or intended use of a new
animal drug, the drug shall not be deemed unsafe for the purposes
of paragraph (1) and shall be exempt from the requirements of
section 352(f) of this title with respect to a different use or
intended use of the drug, other than a use in or on animal feed, if
such use or intended use -
(i) is by or on the lawful written or oral order of a licensed
veterinarian within the context of a veterinarian-client-patient
relationship, as defined by the Secretary; and
(ii) is in compliance with regulations promulgated by the
Secretary that establish the conditions for such different use or
intended use.
The regulations promulgated by the Secretary under clause (ii) may
prohibit particular uses of an animal drug and shall not permit
such different use of an animal drug if the labeling of another
animal drug that contains the same active ingredient and which is
in the same dosage form and concentration provides for such
different use.
(B) If the Secretary finds that there is a reasonable probability
that a use of an animal drug authorized under subparagraph (A) may
present a risk to the public health, the Secretary may -
(i) establish a safe level for a residue of an animal drug when
it is used for such different use authorized by subparagraph (A);
and
(ii) require the development of a practical, analytical method
for the detection of residues of such drug above the safe level
established under clause (i).
The use of an animal drug that results in residues exceeding a safe
level established under clause (i) shall be considered an unsafe
use of such drug under paragraph (1). Safe levels may be
established under clause (i) either by regulation or order.
(C) The Secretary may by general regulation provide access to the
records of veterinarians to ascertain any use or intended use
authorized under subparagraph (A) that the Secretary has determined
may present a risk to the public health.
(D) If the Secretary finds, after affording an opportunity for
public comment, that a use of an animal drug authorized under
subparagraph (A) presents a risk to the public health or that an
analytical method required under subparagraph (B) has not been
developed and submitted to the Secretary, the Secretary may, by
order, prohibit any such use.
(5) If the approval of an application filed under section 355 of
this title is in effect, the drug under such application shall not
be deemed unsafe for purposes of paragraph (1) and shall be exempt
from the requirements of section 352(f) of this title with respect
to a use or intended use of the drug in animals if such use or
intended use -
(A) is by or on the lawful written or oral order of a licensed
veterinarian within the context of a veterinarian-client-patient
relationship, as defined by the Secretary; and
(B) is in compliance with regulations promulgated by the
Secretary that establish the conditions for the use or intended
use of the drug in animals.
(6) For purposes of section 342(a)(2)(D) (!1) of this title, a
use or intended use of a new animal drug shall not be deemed unsafe
under this section if the Secretary establishes a tolerance for
such drug and any edible portion of any animal imported into the
United States does not contain residues exceeding such tolerance.
In establishing such tolerance, the Secretary shall rely on data
sufficient to demonstrate that a proposed tolerance is safe based
on similar food safety criteria used by the Secretary to establish
tolerances for applications for new animal drugs filed under
subsection (b)(1) of this section. The Secretary may consider and
rely on data submitted by the drug manufacturer, including data
submitted to appropriate regulatory authorities in any country
where the new animal drug is lawfully used or data available from a
relevant international organization, to the extent such data are
not inconsistent with the criteria used by the Secretary to
establish a tolerance for applications for new animal drugs filed
under subsection (b)(1) of this section. For purposes of this
paragraph, "relevant international organization" means the Codex
Alimenterius (!2) Commission or other international organization
deemed appropriate by the Secretary. The Secretary may, under
procedures specified by regulation, revoke a tolerance established
under this paragraph if information demonstrates that the use of
the new animal drug under actual use conditions results in food
being imported into the United States with residues exceeding the
tolerance or if scientific evidence shows the tolerance to be
unsafe.
(b) Filing application for uses of new animal drug; contents;
patent information; abbreviated application; presubmission
conference
(1) Any person may file with the Secretary an application with
respect to any intended use or uses of a new animal drug. Such
person shall submit to the Secretary as a part of the application
(A) full reports of investigations which have been made to show
whether or not such drug is safe and effective for use; (B) a full
list of the articles used as components of such drug; (C) a full
statement of the composition of such drug; (D) a full description
of the methods used in, and the facilities and controls used for,
the manufacture, processing, and packing of such drug; (E) such
samples of such drug and of the articles used as components
thereof, of any animal feed for use in or on which such drug is
intended, and of the edible portions or products (before or after
slaughter) of animals to which such drug (directly or in or on
animal feed) is intended to be administered, as the Secretary may
require; (F) specimens of the labeling proposed to be used for such
drug, or in case such drug is intended for use in animal feed,
proposed labeling appropriate for such use, and specimens of the
labeling for the drug to be manufactured, packed, or distributed by
the applicant; (G) a description of practicable methods for
determining the quantity, if any, of such drug in or on food, and
any substance formed in or on food, because of its use; and (H) the
proposed tolerance or withdrawal period or other use restrictions
for such drug if any tolerance or withdrawal period or other use
restrictions are required in order to assure that the proposed use
of such drug will be safe. The applicant shall file with the
application the patent number and the expiration date of any patent
which claims the new animal drug for which the applicant filed the
application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug. If an application is filed
under this subsection for a drug and a patent which claims such
drug or a method of using such drug is issued after the filing date
but before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the Secretary
shall publish information submitted under the two preceding
sentences.
(2) Any person may file with the Secretary an abbreviated
application for the approval of a new animal drug. An abbreviated
application shall contain the information required by subsection
(n) of this section.
(3) Any person intending to file an application under paragraph
(1), section 360ccc of this title, or a request for an
investigational exemption under subsection (j) of this section
shall be entitled to one or more conferences prior to such
submission to reach an agreement acceptable to the Secretary
establishing a submission or an investigational requirement, which
may include a requirement for a field investigation. A decision
establishing a submission or an investigational requirement shall
bind the Secretary and the applicant or requestor unless (A) the
Secretary and the applicant or requestor mutually agree to modify
the requirement, or (B) the Secretary by written order determines
that a substantiated scientific requirement essential to the
determination of safety or effectiveness of the animal drug
involved has appeared after the conference. No later than 25
calendar days after each such conference, the Secretary shall
provide a written order setting forth a scientific justification
specific to the animal drug and intended uses under consideration
if the agreement referred to in the first sentence requires more
than one field investigation as being essential to provide
substantial evidence of effectiveness for the intended uses of the
drug. Nothing in this paragraph shall be construed as compelling
the Secretary to require a field investigation.
(c) Period for submission and approval of application; period for
notice and expedition of hearing; period for issuance of order;
abbreviated applications; withdrawal periods; effective date of
approval; relationship to other applications; withdrawal or
suspension of approval; bioequivalence; filing of additional
patent information
(1) Within one hundred and eighty days after the filing of an
application pursuant to subsection (b) of this section, or such
additional period as may be agreed upon by the Secretary and the
applicant, the Secretary shall either (A) issue an order approving
the application if he then finds that none of the grounds for
denying approval specified in subsection (d) of this section
applies, or (B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) of this section
on the question whether such application is approvable. If the
applicant elects to accept the opportunity for a hearing by written
request within thirty days after such notice, such hearing shall
commence not more than ninety days after the expiration of such
thirty days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing final
briefs.
(2)(A) Subject to subparagraph (C), the Secretary shall approve
an abbreviated application for a drug unless the Secretary finds -
(i) the methods used in, or the facilities and controls used
for, the manufacture, processing, and packing of the drug are
inadequate to assure and preserve its identity, strength,
quality, and purity;
(ii) the conditions of use prescribed, recommended, or
suggested in the proposed labeling are not reasonably certain to
be followed in practice or, except as provided in subparagraph
(B), information submitted with the application is insufficient
to show that each of the proposed conditions of use or similar
limitations (whether in the labeling or published pursuant to
subsection (i) of this section) have been previously approved for
the approved new animal drug referred to in the application;
(iii) information submitted with the application is
insufficient to show that the active ingredients are the same as
those of the approved new animal drug referred to in the
application;
(iv)(I) if the application is for a drug whose active
ingredients, route of administration, dosage form, strength, or
use with other animal drugs in animal feed is the same as the
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed of the
approved new animal drug referred to in the application,
information submitted in the application is insufficient to show
that the active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed is
the same as that of the approved new animal drug, or
(II) if the application is for a drug whose active ingredients,
route of administration, dosage form, strength, or use with other
animal drugs in animal feed is different from that of the
approved new animal drug referred to in the application, no
petition to file an application for the drug with the different
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed was
approved under subsection (n)(3) of this section;
(v) if the application was filed pursuant to the approval of a
petition under subsection (n)(3) of this section, the application
did not contain the information required by the Secretary
respecting the active ingredients, route of administration,
dosage form, strength, or use with other animal drugs in animal
feed which is not the same;
(vi) information submitted in the application is insufficient
to show that the drug is bioequivalent to the approved new animal
drug referred to in the application, or if the application is
filed under a petition approved pursuant to subsection (n)(3) of
this section, information submitted in the application is
insufficient to show that the active ingredients of the new
animal drug are of the same pharmacological or therapeutic class
as the pharmacological or therapeutic class of the approved new
animal drug and that the new animal drug can be expected to have
the same therapeutic effect as the approved new animal drug when
used in accordance with the labeling;
(vii) information submitted in the application is insufficient
to show that the labeling proposed for the drug is the same as
the labeling approved for the approved new animal drug referred
to in the application except for changes required because of
differences approved under a petition filed under subsection
(n)(3) of this section, because of a different withdrawal period,
or because the drug and the approved new animal drug are produced
or distributed by different manufacturers;
(viii) information submitted in the application or any other
information available to the Secretary shows that (I) the
inactive ingredients of the drug are unsafe for use under the
conditions prescribed, recommended, or suggested in the labeling
proposed for the drug, (II) the composition of the drug is unsafe
under such conditions because of the type or quantity of inactive
ingredients included or the manner in which the inactive
ingredients are included, or (III) in the case of a drug for food
producing animals, the inactive ingredients of the drug or its
composition may be unsafe with respect to human food safety;
(ix) the approval under subsection (b)(1) of this section of
the approved new animal drug referred to in the application filed
under subsection (b)(2) of this section has been withdrawn or
suspended for grounds described in paragraph (1) of subsection
(e) of this section, the Secretary has published a notice of a
hearing to withdraw approval of the approved new animal drug for
such grounds, the approval under this paragraph of the new animal
drug for which the application under subsection (b)(2) of this
section was filed has been withdrawn or suspended under
subparagraph (G) for such grounds, or the Secretary has
determined that the approved new animal drug has been withdrawn
from sale for safety or effectiveness reasons;
(x) the application does not meet any other requirement of
subsection (n) of this section; or
(xi) the application contains an untrue statement of material
fact.
(B) If the Secretary finds that a new animal drug for which an
application is submitted under subsection (b)(2) of this section is
bioequivalent to the approved new animal drug referred to in such
application and that residues of the new animal drug are consistent
with the tolerances established for such approved new animal drug
but at a withdrawal period which is different than the withdrawal
period approved for such approved new animal drug, the Secretary
may establish, on the basis of information submitted, such
different withdrawal period as the withdrawal period for the new
animal drug for purposes of the approval of such application for
such drug.
(C) Within 180 days of the initial receipt of an application
under subsection (b)(2) of this section or within such additional
period as may be agreed upon by the Secretary and the applicant,
the Secretary shall approve or disapprove the application.
(D) The approval of an application filed under subsection (b)(2)
of this section shall be made effective on the last applicable date
determined under the following:
(i) If the applicant only made a certification described in
clause (i) or (ii) of subsection (n)(1)(G) of this section or in
both such clauses, the approval may be made effective
immediately.
(ii) If the applicant made a certification described in clause
(iii) of subsection (n)(1)(G) of this section, the approval may
be made effective on the date certified under clause (iii).
(iii) If the applicant made a certification described in clause
(iv) of subsection (n)(1)(G) of this section, the approval shall
be made effective immediately unless an action is brought for
infringement of a patent which is the subject of the
certification before the expiration of 45 days from the date the
notice provided under subsection (n)(2)(B)(i) of this section is
received. If such an action is brought before the expiration of
such days, the approval shall be made effective upon the
expiration of the 30 month period beginning on the date of the
receipt of the notice provided under subsection (n)(2)(B) of this
section or such shorter or longer period as the court may order
because either party to the action failed to reasonably cooperate
in expediting the action, except that if before the expiration of
such period -
(I) the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date of
the court decision,
(II) the court decides that such patent has been infringed,
the approval shall be made effective on such date as the court
orders under section 271(e)(4)(A) of title 35, or
(III) the court grants a preliminary injunction prohibiting
the applicant from engaging in the commercial manufacture or
sale of the drug until the court decides the issues of patent
validity and infringement and if the court decides that such
patent is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate
in expediting the action. Until the expiration of 45 days from
the date the notice made under subsection (n)(2)(B) of this
section is received, no action may be brought under section 2201
of title 28 for a declaratory judgment with respect to the
patent. Any action brought under section 2201 of title 28 shall
be brought in the judicial district where the defendant has its
principal place of business or a regular and established place of
business.
(iv) If the application contains a certification described in
clause (iv) of subsection (n)(1)(G) of this section and is for a
drug for which a previous application has been filed under this
subsection containing such a certification, the application shall
be made effective not earlier than 180 days after -
(I) the date the Secretary receives notice from the applicant
under the previous application of the first commercial
marketing of the drug under the previous application, or
(II) the date of a decision of a court in an action described
in subclause (III) (!3) holding the patent which is the subject
of the certification to be invalid or not infringed,
whichever is earlier.
(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such
application is approvable. If the applicant elects to accept the
opportunity for hearing by written request within 30 days after
such notice, such hearing shall commence not more than 90 days
after the expiration of such 30 days unless the Secretary and the
applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order thereon
shall be issued within 90 days after the date fixed by the
Secretary for filing final briefs.
(F)(i) If an application submitted under subsection (b)(1) of
this section for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been approved in any
other application under subsection (b)(1) of this section, is
approved after November 16, 1988, no application may be submitted
under subsection (b)(2) of this section which refers to the drug
for which the subsection (b)(1) application was submitted before
the expiration of 5 years from the date of the approval of the
application under subsection (b)(1) of this section, except that
such an application may be submitted under subsection (b)(2) of
this section after the expiration of 4 years from the date of the
approval of the subsection (b)(1) application if it contains a
certification of patent invalidity or noninfringement described in
clause (iv) of subsection (n)(1)(G) of this section. The approval
of such an application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent infringement
is commenced during the one-year period beginning 48 months after
the date of the approval of the subsection (b) application, the 30
month period referred to in subparagraph (D)(iii) shall be extended
by such amount of time (if any) which is required for seven and one-
half years to have elapsed from the date of approval of the
subsection (b) application.
(ii) If an application submitted under subsection (b)(1) of this
section for a drug, which includes an active ingredient (including
any ester or salt of the active ingredient) that has been approved
in another application approved under such subsection, is approved
after November 16, 1988, and if such application contains
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety, or, in the case of food producing
animals, human food safety studies (other than bioequivalence
studies or residue depletion studies, except residue depletion
studies for minor uses or minor species) required for the approval
of the application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under subsection (b)(2) of this section for the conditions of
approval of such drug in the subsection (b)(1) application
effective before the expiration of 3 years from the date of the
approval of the application under subsection (b)(1) of this section
for such drug.
(iii) If a supplement to an application approved under subsection
(b)(1) of this section is approved after November 16, 1988, and the
supplement contains substantial evidence of the effectiveness of
the drug involved, any studies of animal safety, or, in the case of
food producing animals, human food safety studies (other than
bioequivalence studies or residue depletion studies, except residue
depletion studies for minor uses or minor species) required for the
approval of the supplement and conducted or sponsored by the person
submitting the supplement, the Secretary may not make the approval
of an application submitted under subsection (b)(2) of this section
for a change approved in the supplement effective before the
expiration of 3 years from the date of the approval of the
supplement.
(iv) An applicant under subsection (b)(1) of this section who
comes within the provisions of clause (i) of this subparagraph as a
result of an application which seeks approval for a use solely in
non-food producing animals, may elect, within 10 days of receiving
such approval, to waive clause (i) of this subparagraph, in which
event the limitation on approval of applications submitted under
subsection (b)(2) of this section set forth in clause (ii) of this
subparagraph shall be applicable to the subsection (b)(1)
application.
(v) If an application (including any supplement to a new animal
drug application) submitted under subsection (b)(1) of this section
for a new animal drug for a food-producing animal use, which
includes an active ingredient (including any ester or salt of the
active ingredient) which has been the subject of a waiver under
clause (iv) is approved after November 16, 1988, and if the
application contains substantial evidence of the effectiveness of
the drug involved, any studies of animal safety, or human food
safety studies (other than bioequivalence studies or residue
depletion studies, except residue depletion studies for minor uses
or minor species) required for the new approval of the application
and conducted or sponsored by the applicant, the Secretary may not
make the approval of an application (including any supplement to
such application) submitted under subsection (b)(2) of this section
for the new conditions of approval of such drug in the subsection
(b)(1) application effective before the expiration of five years
from the date of approval of the application under subsection
(b)(1) of this section for such drug. The provisions of this
paragraph shall apply only to the first approval for a food-
producing animal use for the same applicant after the waiver under
clause (iv).
(G) If an approved application submitted under subsection (b)(2)
of this section for a new animal drug refers to a drug the approval
of which was withdrawn or suspended for grounds described in
paragraph (1) or (2) of subsection (e) of this section or was
withdrawn or suspended under this subparagraph or which, as
determined by the Secretary, has been withdrawn from sale for
safety or effectiveness reasons, the approval of the drug under
this paragraph shall be withdrawn or suspended -
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or this subparagraph, or
(ii) if the approved new animal drug has been withdrawn from
sale, for the period of withdrawal from sale or, if earlier, the
period ending on the date the Secretary determines that the
withdrawal from sale is not for safety or effectiveness reasons.
(H) For purposes of this paragraph:
(i) The term "bioequivalence" means the rate and extent to
which the active ingredient or therapeutic ingredient is absorbed
from a new animal drug and becomes available at the site of drug
action.
(ii) A new animal drug shall be considered to be bioequivalent
to the approved new animal drug referred to in its application
under subsection (n) of this section if -
(I) the rate and extent of absorption of the drug do not show
a significant difference from the rate and extent of absorption
of the approved new animal drug referred to in the application
when administered at the same dose of the active ingredient
under similar experimental conditions in either a single dose
or multiple doses;
(II) the extent of absorption of the drug does not show a
significant difference from the extent of absorption of the
approved new animal drug referred to in the application when
administered at the same dose of the active ingredient under
similar experimental conditions in either a single dose or
multiple doses and the difference from the approved new animal
drug in the rate of absorption of the drug is intentional, is
reflected in its proposed labeling, is not essential to the
attainment of effective drug concentrations in use, and is
considered scientifically insignificant for the drug in
attaining the intended purposes of its use and preserving human
food safety; or
(III) in any case in which the Secretary determines that the
measurement of the rate and extent of absorption or excretion
of the new animal drug in biological fluids is inappropriate or
impractical, an appropriate acute pharmacological effects test
or other test of the new animal drug and, when deemed
scientifically necessary, of the approved new animal drug
referred to in the application in the species to be tested or
in an appropriate animal model does not show a significant
difference between the new animal drug and such approved new
animal drug when administered at the same dose under similar
experimental conditions.
If the approved new animal drug referred to in the application
for a new animal drug under subsection (n) of this section is
approved for use in more than one animal species, the
bioequivalency information described in subclauses (I), (II), and
(III) shall be obtained for one species, or if the Secretary
deems appropriate based on scientific principles, shall be
obtained for more than one species. The Secretary may prescribe
the dose to be used in determining bioequivalency under subclause
(I), (II), or (III). To assure that the residues of the new
animal drug will be consistent with the established tolerances
for the approved new animal drug referred to in the application
under subsection (b)(2) of this section upon the expiration of
the withdrawal period contained in the application for the new
animal drug, the Secretary shall require bioequivalency data or
residue depletion studies of the new animal drug or such other
data or studies as the Secretary considers appropriate based on
scientific principles. If the Secretary requires one or more
residue studies under the preceding sentence, the Secretary may
not require that the assay methodology used to determine the
withdrawal period of the new animal drug be more rigorous than
the methodology used to determine the withdrawal period for the
approved new animal drug referred to in the application. If such
studies are required and if the approved new animal drug,
referred to in the application for the new animal drug for which
such studies are required, is approved for use in more than one
animal species, such studies shall be conducted for one species,
or if the Secretary deems appropriate based on scientific
principles, shall be conducted for more than one species.
(3) If the patent information described in subsection (b)(1) of
this section could not be filed with the submission of an
application under subsection (b)(1) of this section because the
application was filed before the patent information was required
under subsection (b)(1) of this section or a patent was issued
after the application was approved under such subsection, the
holder of an approved application shall file with the Secretary the
patent number and the expiration date of any patent which claims
the new animal drug for which the application was filed or which
claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted if a
person not licensed by the owner engaged in the manufacture, use,
or sale of the drug. If the holder of an approved application could
not file patent information under subsection (b)(1) of this section
because it was not required at the time the application was
approved, the holder shall file such information under this
subsection not later than 30 days after November 16, 1988, and if
the holder of an approved application could not file patent
information under subsection (b)(1) of this section because no
patent had been issued when an application was filed or approved,
the holder shall file such information under this subsection not
later than 30 days after the date the patent involved is issued.
Upon the submission of patent information under this subsection,
the Secretary shall publish it.
(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a
full scale production facility is necessary to ensure the safety or
effectiveness of the drug.
(d) Grounds for refusing application; approval of application;
factors; "substantial evidence" defined; combination drugs
(1) If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that
-
(A) the investigations, reports of which are required to be
submitted to the Secretary pursuant to subsection (b) of this
section, do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof;
(B) the results of such tests show that such drug is unsafe for
use under such conditions or do not show that such drug is safe
for use under such conditions;
(C) the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity;
(D) upon the basis of the information submitted to him as part
of the application, or upon the basis of any other information
before him with respect to such drug, he has insufficient
information to determine whether such drug is safe for use under
such conditions;
(E) evaluated on the basis of the information submitted to him
as part of the application and any other information before him
with respect to such drug, there is a lack of substantial
evidence 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;
(F) upon the basis of information submitted to the Secretary as
part of the application or any other information before the
Secretary with respect to such drug, any use prescribed,
recommended, or suggested in labeling proposed for such drug will
result in a residue of such drug in excess of a tolerance found
by the Secretary to be safe for such drug;
(G) the application failed to contain the patent information
prescribed by subsection (b)(1) of this section;
(H) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; or
(I) such drug induces cancer when ingested by man or animal or,
after tests which are appropriate for the evaluation of the
safety of such drug, induces cancer in man or animal, except that
the foregoing provisions of this subparagraph shall not apply
with respect to such drug if the Secretary finds that, under the
conditions of use specified in proposed labeling and reasonably
certain to be followed in practice (i) such drug will not
adversely affect the animals for which it is intended, and (ii)
no residue of such drug will be found (by methods of examination
prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (c), (d), and (h)
of this section), in any edible portion of such animals after
slaughter or in any food yielded by or derived from the living
animals;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearings, the Secretary finds
that subparagraphs (A) through (I) do not apply, he shall issue an
order approving the application.
(2) In determining whether such drug is safe for use under the
conditions prescribed, recommended, or suggested in the proposed
labeling thereof, the Secretary shall consider, among other
relevant factors, (A) the probable consumption of such drug and of
any substance formed in or on food because of the use of such drug,
(B) the cumulative effect on man or animal of such drug, taking
into account any chemically or pharmacologically related substance,
(C) safety factors which in the opinion of experts, qualified by
scientific training and experience to evaluate the safety of such
drugs, are appropriate for the use of animal experimentation data,
and (D) whether the conditions of use prescribed, recommended, or
suggested in the proposed labeling are reasonably certain to be
followed in practice. Any order issued under this subsection
refusing to approve an application shall state the findings upon
which it is based.
(3) As used in this section, the term "substantial evidence"
means evidence consisting of one or more adequate and well
controlled investigations, such as -
(A) a study in a target species;
(B) a study in laboratory animals;
(C) any field investigation that may be required under this
section and that meets the requirements of subsection (b)(3) of
this section if a presubmission conference is requested by the
applicant;
(D) a bioequivalence study; or
(E) an in vitro study;
by experts qualified by scientific training and experience to
evaluate the effectiveness of the drug involved, on the basis of
which it could fairly and reasonably be concluded by such experts
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 labeling or proposed labeling thereof.
(4) In a case in which an animal drug contains more than one
active ingredient, or the labeling of the drug prescribes,
recommends, or suggests use of the drug in combination with one or
more other animal drugs, and the active ingredients or drugs
intended for use in the combination have previously been separately
approved pursuant to an application submitted under subsection
(b)(1) of this section for particular uses and conditions of use
for which they are intended for use in the combination -
(A) the Secretary shall not issue an order under paragraph
(1)(A), (1)(B), or (1)(D) refusing to approve the application for
such combination on human food safety grounds unless the
Secretary finds that the application fails to establish that -
(i) none of the active ingredients or drugs intended for use
in the combination, respectively, at the longest withdrawal
time of any of the active ingredients or drugs in the
combination, respectively, exceeds its established tolerance;
or
(ii) none of the active ingredients or drugs in the
combination interferes with the methods of analysis for another
of the active ingredients or drugs in the combination,
respectively;
(B) the Secretary shall not issue an order under paragraph
(1)(A), (1)(B), or (1)(D) refusing to approve the application for
such combination on target animal safety grounds unless the
Secretary finds that -
(i)(I) there is a substantiated scientific issue, specific to
one or more of the active ingredients or animal drugs in the
combination, that cannot adequately be evaluated based on
information contained in the application for the combination
(including any investigations, studies, or tests for which the
applicant has a right of reference or use from the person by or
for whom the investigations, studies, or tests were conducted);
or
(II) there is a scientific issue raised by target animal
observations contained in studies submitted to the Secretary as
part of the application; and
(ii) based on the Secretary's evaluation of the information
contained in the application with respect to the issues
identified in clauses (i)(I) and (II), paragraph (1)(A), (B),
or (D) apply;
(C) except in the case of a combination that contains a
nontopical antibacterial ingredient or animal drug, the Secretary
shall not issue an order under paragraph (1)(E) refusing to
approve an application for a combination animal drug intended for
use other than in animal feed or drinking water unless the
Secretary finds that the application fails to demonstrate that -
(i) there is substantial evidence that any active ingredient
or animal drug intended only for the same use as another active
ingredient or animal drug in the combination makes a
contribution to labeled effectiveness;
(ii) each active ingredient or animal drug intended for at
least one use that is different from all other active
ingredients or animal drugs used in the combination provides
appropriate concurrent use for the intended target population;
or
(iii) where based on scientific information the Secretary has
reason to believe the active ingredients or animal drugs may be
physically incompatible or have disparate dosing regimens, such
active ingredients or animal drugs are physically compatible or
do not have disparate dosing regimens; and
(D) the Secretary shall not issue an order under paragraph
(1)(E) refusing to approve an application for a combination
animal drug intended for use in animal feed or drinking water
unless the Secretary finds that the application fails to
demonstrate that -
(i) there is substantial evidence that any active ingredient
or animal drug intended only for the same use as another active
ingredient or animal drug in the combination makes a
contribution to the labeled effectiveness;
(ii) each of the active ingredients or animal drugs intended
for at least one use that is different from all other active
ingredients or animal drugs used in the combination provides
appropriate concurrent use for the intended target population;
(iii) where a combination contains more than one nontopical
antibacterial ingredient or animal drug, there is substantial
evidence that each of the nontopical antibacterial ingredients
or animal drugs makes a contribution to the labeled
effectiveness, except that for purposes of this clause,
antibacterial ingredient or animal drug does not include the
ionophore or arsenical classes of animal drugs; or
(iv) where based on scientific information the Secretary has
reason to believe the active ingredients or animal drugs
intended for use in drinking water may be physically
incompatible, such active ingredients or animal drugs intended
for use in drinking water are physically compatible.
(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.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals
(1) The Secretary shall, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing approval of an
application filed pursuant to subsection (b) of this section with
respect to any new animal drug if the Secretary finds -
(A) that experience or scientific data show that such drug is
unsafe for use under the conditions of use upon the basis of
which the application was approved or the condition of use
authorized under subsection (a)(4)(A) of this section;
(B) that new evidence not contained in such application or not
available to the Secretary until after such application was
approved, or tests by new methods, or tests by methods not deemed
reasonably applicable when such application was approved,
evaluated together with the evidence available to the Secretary
when the application was approved, shows that such drug is not
shown to be safe for use under the conditions of use upon the
basis of which the application was approved or that subparagraph
(I) of paragraph (1) of subsection (d) of this section applies to
such drug;
(C) on the basis of new information before him with respect to
such drug, evaluated together with the evidence available to him
when the application was approved, that there is a lack of
substantial evidence 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;
(D) the patent information prescribed by subsection (c)(3) of
this section was not filed within 30 days after the receipt of
written notice from the Secretary specifying the failure to file
such information;
(E) that the application contains any untrue statement of a
material fact; or
(F) that the applicant has made any changes from the standpoint
of safety or effectiveness beyond the variations provided for in
the application unless he has supplemented the application by
filing with the Secretary adequate information respecting all
such changes and unless there is in effect an approval of the
supplemental application. The supplemental application shall be
treated in the same manner as the original application.
If the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the health of
man or of the animals for which such drug is intended, he may
suspend the approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the
authority conferred by this sentence to suspend the approval of an
application shall not be delegated.
(2) The Secretary may also, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing the approval
of an application with respect to any new animal drug under this
section if the Secretary finds -
(A) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately
failed to maintain such records or to make required reports in
accordance with a regulation or order under subsection (1) of
this section, or the applicant has refused to permit access to,
or copying or verification of, such records as required by
paragraph (2) of such subsection;
(B) that on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of such drug
are inadequate to assure and preserve its identity, strength,
quality, and purity and were not made adequate within a
reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or
(C) that on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, the labeling of such drug, based on a fair evaluation
of all material facts, is false or misleading in any particular
and was not corrected within a reasonable time after receipt of
written notice from the Secretary specifying the matter
complained of.
(3) Any order under this subsection shall state the findings upon
which it is based.
(f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d), (e), or (m) of this
section, or section 360ccc(c), (d), or (e) of this title refusing,
withdrawing, or suspending approval of an application and shall
approve such application or reinstate such approval, as may be
appropriate.
(g) Service of orders
Orders of the Secretary issued under this section, or section
360ccc of this title (other than orders issuing, amending, or
repealing regulations) shall be served (1) in person by any officer
or employee of the department designated by the Secretary or (2) by
mailing the order by registered mail or by certified mail addressed
to the applicant or respondent at his last known address in the
records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application filed
under subsection (b) or (m) of this section. The provisions of
subsection (h) of section 355 of this title shall govern any such
appeal.
(i) Publication in Federal Register; effective date and revocation
or suspension of regulation
When a new animal drug application filed pursuant to subsection
(b) of this section or section 360ccc of this title is approved,
the Secretary shall by notice, which upon publication shall be
effective as a regulation, publish in the Federal Register the name
and address of the applicant and the conditions and indications of
use of the new animal drug covered by such application, including
any tolerance and withdrawal period or other use restrictions and,
if such new animal drug is intended for use in animal feed,
appropriate purposes and conditions of use (including special
labeling requirements and any requirement that an animal feed
bearing or containing the new animal drug be limited to use under
the professional supervision of a licensed veterinarian) applicable
to any animal feed for use in which such drug is approved, and such
other information, upon the basis of which such application was
approved, as the Secretary deems necessary to assure the safe and
effective use of such drug. Upon withdrawal of approval of such new
animal drug application or upon its suspension or upon failure to
renew a conditional approval under section 360ccc of this title,
the Secretary shall forthwith revoke or suspend, as the case may
be, the regulation published pursuant to this subsection (i)
insofar as it is based on the approval of such application.
(j) Exemption of drugs for research; discretionary and mandatory
conditions
To the extent consistent with the public health, the Secretary
shall promulgate regulations for exempting from the operation of
this section 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 animal drugs. Such
regulations may, in 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 him to evaluate the safety and effectiveness of such article
in the event of the filing of an application pursuant to this
section. Such regulations, among other things, shall set forth the
conditions (if any) upon which animals treated with such articles,
and any products of such animals (before or after slaughter), may
be marketed for food use.
(k) Food containing new animal drug considered unadulterated while
approval of application for such drug is effective
While approval of an application for a new animal drug is
effective, a food shall not, by reason of bearing or containing
such drug or any substance formed in or on the food because of its
use in accordance with such application (including the conditions
and indications of use prescribed pursuant to subsection (i) of
this section), be considered adulterated within the meaning of
clause (1) of section 342(a) of this title.
(l) Records and reports; required information; regulations and
orders; examination of data; access to records
(1) In the case of any new animal drug for which an approval of
an application filed pursuant to subsection (b) of this section or
section 360ccc of this title is in effect, the applicant shall
establish and maintain such records, and make such reports to the
Secretary, of data relating to experience, including experience
with uses authorized under subsection (a)(4)(A) of this section,
and other data or information, received or otherwise obtained by
such applicant 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 application,
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 (e) or subsection (m)(4) of this section. 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.
(m) Feed mill licenses
(1) Any person may file with the Secretary an application for a
license to manufacture animal feeds bearing or containing new
animal drugs. Such person shall submit to the Secretary as part of
the application (A) a full statement of the business name and
address of the specific facility at which the manufacturing is to
take place and the facility's registration number, (B) the name and
signature of the responsible individual or individuals for that
facility, (C) a certification that the animal feeds bearing or
containing new animal drugs are manufactured and labeled in
accordance with the applicable regulations published pursuant to
subsection (i) of this section or for indexed new animal drugs in
accordance with the index listing published pursuant to section
360ccc-1(e)(2) of this title and the labeling requirements set
forth in section 360ccc-1(h) of this title, and (D) a certification
that the methods used in, and the facilities and controls used for,
manufacturing, processing, packaging, and holding such animal feeds
are in conformity with current good manufacturing practice as
described in section 351(a)(2)(B) of this title.
(2) Within 90 days after the filing of an application pursuant to
paragraph (1), or such additional period as may be agreed upon by
the Secretary and the applicant, the Secretary shall (A) issue an
order approving the application if the Secretary then finds that
none of the grounds for denying approval specified in paragraph (3)
applies, or (B) give the applicant notice of an opportunity for a
hearing before the Secretary under paragraph (3) on the question
whether such application is approvable. The procedure governing
such a hearing shall be the procedure set forth in the last two
sentences of subsection (c)(1) of this section.
(3) If the Secretary, after due notice to the applicant in
accordance with paragraph (2) and giving the applicant an
opportunity for a hearing in accordance with such paragraph, finds,
on the basis of information submitted to the Secretary as part of
the application, on the basis of a preapproval inspection, or on
the basis of any other information before the Secretary -
(A) that the application is incomplete, false, or misleading in
any particular;
(B) that the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such animal
feed are inadequate to preserve the identity, strength, quality,
and purity of the new animal drug therein; or
(C) that the facility manufactures animal feeds bearing or
containing new animal drugs in a manner that does not accord with
the specifications for manufacture or labels animal feeds bearing
or containing new animal drugs in a manner that does not accord
with the conditions or indications of use that are published
pursuant to subsection (i) of this section or an index listing
pursuant to section 360ccc-1(e) of this title,
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing, the
Secretary finds that subparagraphs (A) through (C) do not apply,
the Secretary shall issue an order approving the application. An
order under this subsection approving an application for a license
to manufacture animal feeds bearing or containing new animal drugs
shall permit a facility to manufacture only those animal feeds
bearing or containing new animal drugs for which there are in
effect regulations pursuant to subsection (i) of this section or an
index listing pursuant to section 360ccc-1(e) of this title
relating to the use of such drugs in or on such animal feed.
(4)(A) The Secretary shall, after due notice and opportunity for
hearing to the applicant, revoke a license to manufacture animal
feeds bearing or containing new animal drugs under this subsection
if the Secretary finds -
(i) that the application for such license contains any untrue
statement of a material fact; or
(ii) that the applicant has made changes that would cause the
application to contain any untrue statements of material fact or
that would affect the safety or effectiveness of the animal feeds
manufactured at the facility unless the applicant has
supplemented the application by filing with the Secretary
adequate information respecting all such changes and unless there
is in effect an approval of the supplemental application.
If the Secretary (or in the Secretary's absence the officer acting
as the Secretary) finds that there is an imminent hazard to the
health of humans or of the animals for which such animal feed is
intended, the Secretary may suspend the license immediately, and
give the applicant prompt notice of the action and afford the
applicant the opportunity for an expedited hearing under this
subsection; but the authority conferred by this sentence shall not
be delegated.
(B) The Secretary may also, after due notice and opportunity for
hearing to the applicant, revoke a license to manufacture animal
feed under this subsection if the Secretary finds -
(i) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately
failed to maintain such records or to make required reports in
accordance with a regulation or order under paragraph (5)(A) of
this subsection or section 354(a)(3)(A) of this title, or the
applicant has refused to permit access to, or copying or
verification of, such records as required by subparagraph (B) of
such paragraph or section 354(a)(3)(B) of this title;
(ii) that on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when
such license was issued, the methods used in, or the facilities
and controls used for, the manufacture, processing, packing, and
holding of such animal feed are inadequate to assure and preserve
the identity, strength, quality, and purity of the new animal
drug therein, and were not made adequate within a reasonable time
after receipt of written notice from the Secretary, specifying
the matter complained of;
(iii) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when such license was issued, the labeling of any
animal feeds, based on a fair evaluation of all material facts,
is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or
(iv) that on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when
such license was issued, the facility has manufactured,
processed, packed, or held animal feed bearing or containing a
new animal drug adulterated under section 351(a)(6) of this title
and the facility did not discontinue the manufacture, processing,
packing, or holding of such animal feed within a reasonable time
after receipt of written notice from the Secretary specifying the
matter complained of.
(C) The Secretary may also revoke a license to manufacture animal
feeds under this subsection if an applicant gives notice to the
Secretary of intention to discontinue the manufacture of all animal
feed covered under this subsection and waives an opportunity for a
hearing on the matter.
(D) Any order under this paragraph shall state the findings upon
which it is based.
(5) When a license to manufacture animal feeds bearing or
containing new animal drugs has been issued -
(A) the applicant shall establish and maintain such records,
and make such reports to the Secretary, or (at the option of the
Secretary) to the appropriate person or persons holding an
approved application filed under subsection (b) of this section,
as the Secretary may by general regulation, or by order with
respect to such application, 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 (e) of
this section or paragraph (4); and
(B) 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.
(6) To the extent consistent with the public health, the
Secretary may promulgate regulations for exempting from the
operation of this subsection facilities that manufacture, process,
pack, or hold animal feeds bearing or containing new animal drugs.
(n) Abbreviated applications for new animal drugs; contents,
filing, etc.; lists of approved drugs
(1) An abbreviated application for a new animal drug shall
contain -
(A)(i) except as provided in clause (ii), information to show
that the conditions of use or similar limitations (whether in the
labeling or published pursuant to subsection (i) of this section)
prescribed, recommended, or suggested in the labeling proposed
for the new animal drug have been previously approved for a new
animal drug listed under paragraph (4) (hereinafter in this
subsection referred to as an "approved new animal drug"), and
(ii) information to show that the withdrawal period at which
residues of the new animal drug will be consistent with the
tolerances established for the approved new animal drug is the
same as the withdrawal period previously established for the
approved new animal drug or, if the withdrawal period is proposed
to be different, information showing that the residues of the new
animal drug at the proposed different withdrawal period will be
consistent with the tolerances established for the approved new
animal drug;
(B)(i) information to show that the active ingredients of the
new animal drug are the same as those of the approved new animal
drug, and
(ii) if the approved new animal drug has more than one active
ingredient, and if one of the active ingredients of the new
animal drug is different from one of the active ingredients of
the approved new animal drug and the application is filed
pursuant to the approval of a petition filed under paragraph (3) -

(I) information to show that the other active ingredients of
the new animal drug are the same as the active ingredients of
the approved new animal drug,
(II) information to show either that the different active
ingredient is an active ingredient of another approved new
animal drug or of an animal drug which does not meet the
requirements of section 321(v) of this title, and
(III) such other information respecting the different active
ingredients as the Secretary may require;
(C)(i) if the approved new animal drug is permitted to be used
with one or more animal drugs in animal feed, information to show
that the proposed uses of the new animal drug with other animal
drugs in animal feed are the same as the uses of the approved new
animal drug, and
(ii) if the approved new animal drug is permitted to be used
with one or more other animal drugs in animal feed, and one of
the other animal drugs proposed for use with the new animal drug
in animal feed is different from one of the other animal drugs
permitted to be used in animal feed with the approved new animal
drug, and the application is filed pursuant to the approval of a
petition filed under paragraph (3) -
(I) information to show either that the different animal drug
proposed for use with the approved new animal drug in animal
feed is an approved new animal drug permitted to be used in
animal feed or does not meet the requirements of section 321(v)
of this title when used with another animal drug in animal
feed,
(II) information to show that other animal drugs proposed for
use with the new animal drug in animal feed are the same as the
other animal drugs permitted to be used with the approved new
animal drug, and
(III) such other information respecting the different animal
drug or combination with respect to which the petition was
filed as the Secretary may require,
(D) information to show that the route of administration, the
dosage form, and the strength of the new animal drug are the same
as those of the approved new animal drug or, if the route of
administration, the dosage form, or the strength of the new
animal drug is different and the application is filed pursuant to
the approval of a petition filed under paragraph (3), such
information respecting the route of administration, dosage form,
or strength with respect to which the petition was filed as the
Secretary may require;
(E) information to show that the new animal drug is
bioequivalent to the approved new animal drug, except that if the
application is filed pursuant to the approval of a petition filed
under paragraph (3) for the purposes described in subparagraph
(B) or (C), information to show that the active ingredients of
the new animal drug are of the same pharmacological or
therapeutic class as the pharmacological or therapeutic class of
the approved new animal drug and that the new animal drug can be
expected to have the same therapeutic effect as the approved new
animal drug when used in accordance with the labeling;
(F) information to show that the labeling proposed for the new
animal drug is the same as the labeling approved for the approved
new animal drug except for changes required because of
differences approved under a petition filed under paragraph (3),
because of a different withdrawal period, or because the new
animal drug and the approved new animal drug are produced or
distributed by different manufacturers;
(G) the items specified in clauses (B) through (F) of
subsection (b)(1) of this section;
(H) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims
the approved new animal drug or which claims a use for such
approved new animal drug for which the applicant is seeking
approval under this subsection and for which information is
required to be filed under subsection (b)(1) or (c)(3) of this
section -
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new animal drug for which
the application is filed; and
(I) if with respect to the approved new animal drug information
was filed under subsection (b)(1) or (c)(3) of this section for a
method of use patent which does not claim a use for which the
applicant is seeking approval of an application under subsection
(c)(2) of this section, a statement that the method of use patent
does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by subparagraphs
(A) through (I).
(2)(A) An applicant who makes a certification described in
paragraph (1)(G)(iv) shall include in the application a statement
that the applicant will give the notice required by subparagraph
(B) to -
(i) each owner of the patent which is the subject of the
certification or the representative of such owner designated to
receive such notice, and
(ii) the holder of the approved application under subsection
(c)(1) of this section for the drug which is claimed by the
patent or a use of which is claimed by the patent or the
representative of such holder designated to receive such notice.
(B) The notice referred to in subparagraph (A) shall state that
an application, which contains data from bioequivalence studies,
has been filed under this subsection for the drug with respect to
which the certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of such drug before the
expiration of the patent referred to in the certification. Such
notice shall include a detailed statement of the factual and legal
basis of the applicant's opinion that the patent is not valid or
will not be infringed.
(C) If an application is amended to include a certification
described in paragraph (1)(G)(iv), the notice required by
subparagraph (B) shall be given when the amended application is
filed.
(3) If a person wants to submit an abbreviated application for a
new animal drug -
(A) whose active ingredients, route of administration, dosage
form, or strength differ from that of an approved new animal
drug, or
(B) whose use with other animal drugs in animal feed differs
from that of an approved new animal drug,
such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve
a petition for a new animal drug unless the Secretary finds that -
(C) investigations must be conducted to show the safety and
effectiveness, in animals to be treated with the drug, of the
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed which
differ from the approved new animal drug, or
(D) investigations must be conducted to show the safety for
human consumption of any residues in food resulting from the
proposed active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed for
the new animal drug which is different from the active
ingredients, route of administration, dosage form, strength, or
use with other animal drugs in animal feed of the approved new
animal drug.
The Secretary shall approve or disapprove a petition submitted
under this paragraph within 90 days of the date the petition is
submitted.
(4)(A)(i) Within 60 days of November 16, 1988, the Secretary
shall publish and make available to the public a list in
alphabetical order of the official and proprietary name of each new
animal drug which has been approved for safety and effectiveness
before November 16, 1988.
(ii) Every 30 days after the publication of the first list under
clause (i) the Secretary shall revise the list to include each new
animal drug which has been approved for safety and effectiveness
under subsection (c) of this section during the 30 day period.
(iii) When patent information submitted under subsection (b)(1)
or (c)(3) of this section respecting a new animal drug included on
the list is to be published by the Secretary, the Secretary shall,
in revisions made under clause (ii), include such information for
such drug.
(B) A new animal drug approved for safety and effectiveness
before November 16, 1988, or approved for safety and effectiveness
under subsection (c) of this section shall, for purposes of this
subsection, be considered to have been published under subparagraph
(A) on the date of its approval or November 16, 1988, whichever is
later.
(C) If the approval of a new animal drug was withdrawn or
suspended under subsection (c)(2)(G) of this section or for grounds
described in subsection (e) of this section or if the Secretary
determines that a drug has been withdrawn from sale for safety or
effectiveness reasons, it may not be published in the list under
subparagraph (A) or, if the withdrawal or suspension occurred after
its publication in such list, it shall be immediately removed from
such list -
(i) for the same period as the withdrawal or suspension under
subsection (c)(2)(G) or (e) of this section, or
(ii) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(5) If an application contains the information required by
clauses (A), (G), and (H) of subsection (b)(1) of this section and
such information -
(A) is relied on by the applicant for the approval of the
application, and
(B) is not information derived either from investigations,
studies, or tests conducted by or for the applicant or for which
the applicant had obtained a right of reference or use from the
person by or for whom the investigations, studies, or tests were
conducted,
such application shall be considered to be an application filed
under subsection (b)(2) of this section.
(o) "Patent" defined
For purposes of this section, the term "patent" means a patent
issued by the United States Patent and Trademark Office.
(p) Safety and effectiveness data
(1) Safety and effectiveness data and information which has been
submitted in an application filed under subsection (b)(1) of this
section or section 360ccc(a) of this title for a drug and which has
not previously been 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
application approved,
(B) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(C) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(D) if the Secretary has determined that such drug is not a new
drug, or
(E) upon the effective date of the approval of the first
application filed under subsection (b)(2) of this section which
refers to such drug or upon the date upon which the approval of
an application filed under subsection (b)(2) of this section
which refers to such drug could be made effective if such an
application had been filed.
(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 application filed under subsection (b)(1) of
this section or section 360ccc(a) of this title, 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.