
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360b]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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 the purposes of section 
351(a)(5) of this title and section 342(a)(2)(D) \1\ of this title 
unless--
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    \1\ See References in Text note below.
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        (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
        (B) such drug, its labeling, and such use conform to such 
    approved application.

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 the purposes of section 351(a)(6) 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 
    drug, as used in such animal feed,
        (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, and
        (C) such animal feed and its labeling, distribution, holding, 
    and use conform to the conditions and indications of use published 
    pursuant to subsection (i) of this section.

    (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 
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) 
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) \2\ holding the patent which is the 
        subject of the certification to be invalid or not infringed,
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    \2\ So in original. Probably should be ``clause (iii)(III)''.

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    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 or residue studies) 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 
or residue studies) 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 or residue 
studies) 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 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.

(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 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 (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 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, 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 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, 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,

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 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 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, 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.

(June 25, 1938, ch. 675, Sec. 512, as added Pub. L. 90-399, Sec. 101(b), 
July 13, 1968, 82 Stat. 343; amended Pub. L. 100-670, title I, 
Secs. 101, 102, 104, 107(a)(2), Nov. 16, 1988, 102 Stat. 3971, 3981, 
3982, 3984; Pub. L. 102-108, Sec. 2(e), Aug. 17, 1991, 105 Stat. 550; 
Pub. L. 103-80, Sec. 3(r), Aug. 13, 1993, 107 Stat. 777; Pub. L. 103-
396, Sec. 2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat. 4153, 4154; Pub. 
L. 104-250, Secs. 2(a)-(d), 3-5(c), 6(a), (b), Oct. 9, 1996, 110 Stat. 
3151-3153, 3155-3157; Pub. L. 105-115, title I, Sec. 124(b), Nov. 21, 
1997, 111 Stat. 2325; Pub. L. 105-277, div. A, Sec. 101(a) [title VII, 
Sec. 737], Oct. 21, 1998, 112 Stat. 2681, 2681-30; Pub. L. 106-113, div. 
B, Sec. 1000(a)(9) [title IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 
Stat. 1536, 1501A-584.)

                       References in Text

    Section 342(a)(2) of this title, referred to in subsec. (a)(1), (6), 
was amended by Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 
Stat. 1514, and, as so amended, no longer contains a subcl. (D). See 
section 342(a)(2)(C)(ii) of this title.


                               Amendments

    1999--Subsec. (o). Pub. L. 106-113 substituted ``United States 
Patent and Trademark Office'' for ``Patent and Trademark Office of the 
Department of Commerce''.
    1998--Subsec. (d)(4)(D)(iii). Pub. L. 105-277 inserted before 
semicolon ``, except that for purposes of this clause, antibacterial 
ingredient or animal drug does not include the ionophore or arsenical 
classes of animal drugs''.
    1997--Subsec. (c)(4). Pub. L. 105-115 added par. (4).
    1996--Subsec. (a)(1). Pub. L. 104-250, Sec. 6(a), amended par. (1) 
generally. Prior to amendment, par. (1) read as follows: ``A new animal 
drug shall, with respect to any particular use or intended use of such 
drug, be deemed unsafe for the purposes of section 351(a)(5) and section 
342(a)(2)(D) 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
        ``(B) such drug, its labeling, and such use conform to such 
    approved application.
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) is the holder of an approved application under subsection 
    (m) of this section; or
        ``(ii) will, if the consignee is not a user of the drug, ship 
    such drug only to a holder of an approved application under 
    subsection (m) of this section.''
    Subsec. (a)(2). Pub. L. 104-250, Sec. 6(a), amended par. (2) 
generally. Prior to amendment, par. (2) read as follows: ``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 
the purposes of section 351(a)(6) 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 
    drugs, as used in such animal feed,
        ``(B) there is in effect an approval of an application pursuant 
    to subsection (m)(1) of this section with respect to such animal 
    feed, and
        ``(C) such animal feed, its labeling, and such use conform to 
    the conditions and indications of use published pursuant to 
    subsection (i) of this section and to the application with respect 
    thereto approved under subsection (m) of this section.''
    Subsec. (a)(6). Pub. L. 104-250, Sec. 4, added par. (6).
    Subsec. (b)(3). Pub. L. 104-250, Sec. 2(d), added par. (3).
    Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104-250, Sec. 2(b)(1), 
substituted ``substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety, or,'' for ``reports of new 
clinical or field investigations (other than bioequivalence or residue 
studies) and,'' and ``required for the approval'' for ``essential to the 
approval''.
    Subsec. (c)(2)(F)(v). Pub. L. 104-250, Sec. 2(b)(2), substituted 
``clause (iv)'' for ``subparagraph (B)(iv)'' in two places, 
``substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety,'' for ``reports of clinical or field 
investigations'' and ``required for the new approval'' for ``essential 
to the new approval''.
    Subsec. (d)(1)(F). Pub. L. 104-250, Sec. 3, amended subpar. (F) 
generally. Prior to amendment, subpar. (F) read as follows: ``upon the 
basis of the information submitted to him as part of the application or 
any other information before him with respect to such drug, the 
tolerance limitation proposed, if any, exceeds that reasonably required 
to accomplish the physical or other technical effect for which the drug 
is intended;''.
    Subsec. (d)(3). Pub. L. 104-250, Sec. 2(a), amended par. (3) 
generally. Prior to amendment, par. (3) read as follows: ``As used in 
this subsection and subsection (e) of this section, the term 
`substantial evidence' means evidence consisting of adequate and well-
controlled investigations, including field investigation, 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.''
    Subsec. (d)(4). Pub. L. 104-250, Sec. 2(c), added par. (4).
    Subsec. (i). Pub. L. 104-250, Sec. 5(c), inserted ``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'' after ``(including special labeling requirements''.
    Subsec. (m). Pub. L. 104-250, Sec. 6(b), amended subsec. (m) 
generally, substituting provisions relating to application for feed mill 
licenses, including approval, refusal, revocation, and suspension of 
such licenses, and provisions for record and reporting requirements for, 
as well as exemption from, such licenses, for provisions relating to 
application for uses of animal feed containing new animal drug, 
including required contents, approval, refusal, and withdrawal of 
approval or suspension of such usage applications, and provisions for 
record and reporting requirements of such usage applications.
    1994--Subsec. (a)(4), (5). Pub. L. 103-396, Sec. 2(a), added pars. 
(4) and (5).
    Subsec. (e)(1)(A). Pub. L. 103-396, Sec. 2(b)(2), inserted before 
semicolon at end ``or the condition of use authorized under subsection 
(a)(4)(A) of this section''.
    Subsec. (l)(1). Pub. L. 103-396, Sec. 2(b)(3), substituted 
``relating to experience, including experience with uses authorized 
under subsection (a)(4)(A) of this section,'' for ``relating to 
experience''.
    1993--Subsec. (c)(2)(A)(ii). Pub. L. 103-80, Sec. 3(r)(1), inserted 
``in'' after ``except as provided''.
    Subsec. (c)(2)(F)(i). Pub. L. 103-80, Sec. 3(r)(2), substituted 
``subparagraph (D)(iii)'' for ``subparagraph (C)(iii)''.
    Subsec. (c)(2)(H)(ii). Pub. L. 103-80, Sec. 3(r)(3), substituted 
``subclauses'' for ``subclause'' after ``bioequivalency information 
described in'' in concluding provisions.
    Subsec. (d)(1). Pub. L. 103-80, Sec. 3(r)(4), substituted 
``subparagraphs (A) through (I)'' for ``subparagraphs (A) through (G)'' 
in concluding provisions.
    Subsec. (n)(1). Pub. L. 103-80, Sec. 3(r)(5), substituted ``section 
321(v) of this title'' for ``section 321(w) of this title'' in subpars. 
(B)(ii)(II) and (C)(ii)(I) and substituted ``through (I)'' for ``through 
(H)'' in concluding provisions.
    1991--Subsec. (e)(1)(B). Pub. L. 102-108 substituted ``(I)'' for 
``(H)''.
    1988--Subsec. (a)(1)(C). Pub. L. 100-670, Sec. 107(a)(2), struck out 
subpar. (C) which read as follows: ``in the case of a new animal drug 
subject to subsection (n) of this section and not exempted therefrom by 
regulations it is from a batch with respect to which a certificate or 
release issued pursuant to subsection (n) of this section is in effect 
with respect to such drug.''
    Subsec. (b). Pub. L. 100-670, Secs. 101(a), 102(a), designated 
existing provisions as par. (1), redesignated cls. (1) to (8) as cls. 
(A) to (H), respectively, added par. (2), and inserted provisions at end 
of par. (1) which require applicant to file with application, patent 
number and expiration date of any patent which claims new animal drug, 
to amend application to include such information if patent which claims 
such drug or method of using such drug is issued after filing date but 
before approval of application, and to publish such information upon 
approval.
    Subsec. (c). Pub. L. 100-670, Secs. 101(c), 102(b)(1), designated 
existing provisions as par. (1), redesignated cls. (1) and (2) as cls. 
(A) and (B), respectively, and added pars. (2) and (3).
    Subsec. (d)(1). Pub. L. 100-670, Sec. 102(b)(3), substituted ``(G)'' 
for ``(H)'' in last sentence.
    Subsec. (d)(1)(G) to (I). Pub. L. 100-670, Sec. 102(b)(2), added 
subpar. (G) and redesignated former subpars. (G) and (H) as (H) and (I), 
respectively.
    Subsec. (e)(1)(D) to (F). Pub. L. 100-670, Sec. 102(b)(4), added 
subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), 
respectively.
    Subsecs. (n) to (p). Pub. L. 100-670, Sec. 101(b), added subsecs. 
(n) to (p) and struck out former subsec. (n) which related to 
certification of new drugs containing penicillin, streptomycin, 
chlortetracycline, chloramphenicol, or bacitracin, and release prior to 
certification.


                    Effective Date of 1999 Amendment

    Amendment by Pub. L. 106-113 effective 4 months after Nov. 29, 1999, 
see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-113, set out 
as a note under section 1 of Title 35, Patents.


                    Effective Date of 1997 Amendment

    Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, 
except as otherwise provided, see section 501 of Pub. L. 105-115, set 
out as a note under section 321 of this title.


                    Effective Date of 1994 Amendment

    Section 2(d) of Pub. L. 103-396 provided that: ``The amendments made 
by this section [amending this section and section 331 of this title] 
shall take effect upon the adoption of the final regulations under 
subsection (c) [set out below].'' [Final regulations were dated Oct. 22, 
1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61 F.R. 57732, and 
effective Dec. 9, 1996.]


                    Effective Date of 1988 Amendment

    Section 108 of Pub. L. 100-670 provided that: ``The Secretary of 
Health and Human Services may not make an approval of an application 
submitted under section 512(b)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991.''


               Effective Date and Transitional Provisions

    Section 108 of Pub. L. 90-399 provided that:
    ``(a) Except as otherwise provided in this section, the amendments 
made by the foregoing sections [see Short Title of 1968 Amendment note 
set out under section 301 of this title] shall take effect on the first 
day of the thirteenth calendar month which begins after the date of 
enactment of this Act [July 13, 1968].
    ``(b)(1) As used in this subsection, the term `effective date' means 
the effective date specified in subsection (a) of this section; the term 
`basic Act' means the Federal Food, Drug, and Cosmetic Act [this 
chapter]; and other terms used both in this section and the basic Act 
shall have the same meaning as they have, or had, at the time referred 
to in the context, under the basic Act.
    ``(2) Any approval, prior to the effective date, of a new animal 
drug or of an animal feed bearing or containing a new animal drug, 
whether granted by approval of a new-drug application, master file, 
antibiotic regulation, or food additive regulations, shall continue in 
effect, and shall be subject to change in accordance with the provisions 
of the basic Act as amended by this Act [see Short Title of 1968 
Amendment note set out under section 301 of this title].
    ``(3) In the case of any drug (other than a drug subject to section 
512(n) of the basic Act as amended by this Act) [subsection (n) of this 
section] intended for use in animals other than man which, on October 9, 
1962, (A) was commercially used or sold in the United States, (B) was 
not a new drug as defined by section 201(p) of the basic Act [section 
321(p) of this title] as then in force, and (C) was not covered by an 
effective application under section 505 of that Act [section 355 of this 
title], the words `effectiveness' and `effective' contained in section 
201(w) as added by this Act to the basic Act [section 321(w) of this 
title] shall not apply to such drug when intended solely for use under 
conditions prescribed, recommended, or suggested in labeling with 
respect to such drug on that day.
    ``(4) Regulations providing for fees (and advance deposits to cover 
fees) which on the day preceding the effective date applicable under 
subsection (a) of this section were in effect pursuant to section 507 of 
the basic Act [section 357 of this title] shall, except as the Secretary 
may otherwise prescribe, be deemed to apply also under section 512(n) of 
the basic Act [subsection (n) of this section], and appropriations of 
fees (and of advance deposits to cover fees) available for the purposes 
specified in such section 507 [section 357 of this title] as in effect 
prior to the effective date shall also be available for the purposes 
specified in section 512(n) [subsection (n) of this section], including 
preparatory work or proceedings prior to that date.''


                               Regulations

    Section 2(e) of Pub. L. 104-250 provided that:
    ``(1) In general.--Not later than 6 months after the date of 
enactment of this Act [Oct. 9, 1996], the Secretary of Health and Human 
Services shall issue proposed regulations implementing the amendments 
made by this Act as described in paragraph (2)(A) of this subsection, 
and not later than 18 months after the date of enactment of this Act, 
the Secretary shall issue final regulations implementing such 
amendments. Not later than 12 months after the date of enactment of this 
Act, the Secretary shall issue proposed regulations implementing the 
other amendments made by this Act as described in paragraphs (2)(B) and 
(2)(C) of this subsection, and not later than 24 months after the date 
of enactment of this Act, the Secretary shall issue final regulations 
implementing such amendments.
    ``(2) Contents.--In issuing regulations implementing the amendments 
made by this Act [see Short Title of 1996 Amendments note set out under 
section 301 of this title], and in taking an action to review an 
application for approval of a new animal drug under section 512 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b), or a request for 
an investigational exemption for a new animal drug under subsection (j) 
of such section, that is pending or has been submitted prior to the 
effective date of the regulations, the Secretary shall--
        ``(A) further define the term `adequate and well controlled', as 
    used in subsection (d)(3) of section 512 of such Act, to require 
    that field investigations be designed and conducted in a 
    scientifically sound manner, taking into account practical 
    conditions in the field and differences between field conditions and 
    laboratory conditions;
        ``(B) further define the term `substantial evidence', as defined 
    in subsection (d)(3) of such section, in a manner that encourages 
    the submission of applications and supplemental applications; and
        ``(C) take into account the proposals contained in the citizen 
    petition (FDA Docket No. 91P-0434/CP) jointly submitted by the 
    American Veterinary Medical Association and the Animal Health 
    Institute, dated October 21, 1991.
Until the regulations required by subparagraph (A) are issued, nothing 
in the regulations published at 21 C.F.R. 514.111(a)(5) (April 1, 1996) 
shall be construed to compel the Secretary of Health and Human Services 
to require a field investigation under section 512(d)(1)(E) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(E)) or to 
apply any of its provisions in a manner inconsistent with the 
considerations for scientifically sound field investigations set forth 
in subparagraph (A).''
    Section 2(c) of Pub. L. 103-396 provided that: ``Not later than 2 
years after the date of the enactment of this Act [Oct. 22, 1994], the 
Secretary of Health and Human Services shall promulgate regulations to 
implement paragraphs (4)(A) and (5) of section 512(a) of the Federal 
Food, Drug, and Cosmetic Act [21 U.S.C. 360b(a)(4)(A), (5)] (as amended 
by subsection (a)).''
    Section 103 of Pub. L. 100-670 provided that:
    ``(a) General Rule.--The Secretary of Health and Human Services 
shall promulgate, in accordance with the notice and comment requirements 
of section 553 of title 5, United States Code, such regulations as may 
be necessary for the administration of section 512 of the Federal Food, 
Drug, and Cosmetic Act [21 U.S.C. 360b], as amended by sections 101 
through 103 of this title, within one year of the date of enactment of 
this Act [Nov. 16, 1988].
    ``(b) Transition.--During the period beginning 60 days after the 
date of enactment of this Act [Nov. 16, 1988] and ending on the date 
regulations promulgated under subsection (a) take effect, abbreviated 
new animal drug applications may be submitted in accordance with the 
provisions of section 314.55 and part 320 of title 21 of the Code of 
Federal Regulations and shall be considered as suitable for any drug 
which has been approved for safety and effectiveness under section 
512(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(c)] 
before the date of enactment of this Act. If any such provision of 
section 314.55 or part 320 is inconsistent with the requirements of 
section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by 
this title), the Secretary shall consider the application under the 
applicable requirements of section 512 (as so amended).''


             Drugs Intended for Minor Species and Minor Uses

    Section 2(f) of Pub. L. 104-250 provided that: ``The Secretary of 
Health and Human Services shall consider legislative and regulatory 
options for facilitating the approval under section 512 of the Federal 
Food, Drug, and Cosmetic Act [21 U.S.C. 360b] of animal drugs intended 
for minor species and for minor uses and, within 18 months after the 
date of enactment of this Act [Oct. 9, 1996], announce proposals for 
legislative or regulatory change to the approval process under such 
section for animal drugs intended for use in minor species or for minor 
uses.''


  Transitional Provision Regarding Implementation of Pub. L. 104-250; 
           Approved Medicated Feed Application Deemed License

    Section 6(c) of Pub. L. 104-250 provided that: ``A person engaged in 
the manufacture of animal feeds bearing or containing new animal drugs 
who holds at least one approved medicated feed application for an animal 
feed bearing or containing new animal drugs, the manufacture of which 
was not otherwise exempt from the requirement for an approved medicated 
feed application on the date of the enactment of this Act [Oct. 9, 
1996], shall be deemed to hold a license for the manufacturing site 
identified in the approved medicated feed application. The revocation of 
license provisions of section 512(m)(4) of the Federal Food, Drug, and 
Cosmetic Act [21 U.S.C. 360b(m)(4)], as amended by this Act, shall apply 
to such licenses. Such license shall expire within 18 months from the 
date of enactment of this Act unless the person submits to the Secretary 
a completed license application for the manufacturing site accompanied 
by a copy of an approved medicated feed application for such site, which 
license application shall be deemed to be approved upon receipt by the 
Secretary.''


            Drugs Primarily Manufactured Using Biotechnology

    Section 106 of Pub. L. 100-670 provided that: ``Notwithstanding 
section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
360b(b)(2)], the Secretary of Health and Human Services may not approve 
an abbreviated application submitted under such section for a new animal 
drug which is primarily manufactured using recombinant DNA, recombinant 
RNA, hybridoma technology, or other processes involving site specific 
genetic manipulation techniques.''

                  Section Referred to in Other Sections

    This section is referred to in sections 321, 331, 342, 351, 353, 
354, 356a, 360, 381, 827 of this title; title 7 section 7642; title 28 
section 2201; title 35 sections 156, 271.
