II
104TH CONGRESS
2D SESSION
H. R. 2508
IN THE SENATE OF THE UNITED STATES
SEPTEMBER 24 legislative day, SEPTEMBER 20, 1996
Received
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to
provide for improvements in the process of approving
and using animal drugs, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE; REFERENCE.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Animal Drug Availability Act of 1996’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment or repeal is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq.).
SEC. 2. EVIDENCE OF EFFECTIVENESS.
(a) ORIGINAL APPLICATIONS.—Paragraph (3) of sec-
tion 512(d) (21 U.S.C. 360b(d)) is amended to read as
follows:
‘‘(3) As used in this section, the term ‘substantial evi-
dence’ 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 re-
quired under this section and that meets the require-
ments of subsection (b)(3) if a presubmission con-
ference 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
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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 label-
ing or proposed labeling thereof.’’.
(b) CONFORMING AMENDMENTS.—
(1) Clauses (ii) and (iii) of section 512(c)(2)(F)
(21 U.S.C. 360b(c)(2)(F)) are each amended—
(A) by striking ‘‘reports of new clinical or
field investigations (other than bioequivalence
or residue studies) and,’’ and inserting ‘‘sub-
stantial evidence of the effectiveness of the drug
involved, any studies of animal safety, or,’’; and
(B) by striking ‘‘essential to’’ and inserting
‘‘required for’’.
(2) 
Section 
512(c)(2)(F)(v) 
(21 
U.S.C.
360b(c)(2)(F)(v)) is amended—
(A) by striking ‘‘subparagraph (B)(iv)’’
each place it appears and inserting ‘‘clause
(iv)’’;
(B) by striking ‘‘reports of clinical or field
investigations’’ and inserting ‘‘substantial evi-
dence of the effectiveness of the drug involved,
any studies of animal safety,’’; and
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‘‘(ii) none of the active ingredients or
drugs in the combination interferes with the
methods of analysis for another of the active in-
gredients or drugs in the combination, respec-
tively;
‘‘(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 in-
gredients or animal drugs in the combination,
that cannot adequately be evaluated based on
information contained in the application for the
combination (including any investigations, stud-
ies, 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 appli-
cation; and
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‘‘(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 ani-
mal drug, the Secretary shall not issue an order
under paragraph (1)(E) refusing to approve an ap-
plication for a combination animal drug intended for
use other than in animal feed or drinking water un-
less 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 con-
tribution 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 appro-
priate concurrent use for the intended target
population; or
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‘‘(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 ap-
plication for a combination animal drug intended for
use in animal feed or drinking water unless the Sec-
retary 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 con-
tribution to the labeled effectiveness;
‘‘(ii) each of the active ingredients or ani-
mal 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 tar-
get population;
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‘‘(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 la-
beled effectiveness; 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 in-
tended for use in drinking water are physically
compatible.’’.
(d) PRESUBMISSION CONFERENCE.—Section 512(b)
(21 U.S.C. 360b(b)) is amended by adding at the end the
following:
‘‘(3) Any person intending to file an application
under paragraph (1) or a request for an investigational
exemption under subsection (j) shall be entitled to one or
more conferences prior to such submission to reach an
agreement acceptable to the Secretary establishing a sub-
mission or an investigational requirement, which may in-
clude a requirement for a field investigation. A decision
establishing a submission or an investigational require-
ment shall bind the Secretary and the applicant or reques-
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tor unless (A) the Secretary and the applicant or requestor
mutually agree to modify the requirement, or (B) the Sec-
retary by written order determines that a substantiated
scientific requirement essential to the determination of
safety or effectiveness of the animal drug involved has ap-
peared after the conference. No later than 25 calendar
days after each such conference, the Secretary shall pro-
vide a written order setting forth a scientific justification
specific to the animal drug and intended uses under con-
sideration if the agreement referred to in the first sentence
requires more than one field investigation as being essen-
tial 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.’’.
(e) IMPLEMENTATION.—
(1) IN
GENERAL.—Not later than 6 months
after the date of enactment of this Act, the Sec-
retary 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 Sec-
retary shall issue final regulations implementing
such amendments. Not later than 12 months after
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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 en-
actment of this Act, the Secretary shall issue final
regulations implementing such amendments.
(2) CONTENTS.—In issuing regulations imple-
menting the amendments made by this Act, and in
taking an action to review an application for ap-
proval 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 ex-
emption for a new animal drug under subsection (j)
of such section, that is pending or has been submit-
ted 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 in-
vestigations be designed and conducted in a sci-
entifically sound manner, taking into account
practical conditions in the field and differences
between field conditions and laboratory condi-
tions;
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(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 con-
tained in the citizen petition (FDA Docket No.
91P–0434/CP) jointly submitted by the Amer-
ican 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 incon-
sistent with the considerations for scientifically
sound field investigations set forth in subparagraph
(A).
(f) MINOR SPECIES AND USES.—The Secretary of
Health and Human Services shall consider legislative and
regulatory options for facilitating the approval under sec-
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tion 512 of the Federal Food, Drug, and Cosmetic Act
of animal drugs intended for minor species and for minor
uses and, within 18 months after the date of enactment
of this Act, announce proposals for legislative or regu-
latory change to the approval process under such section
for animal drugs intended for use in minor species or for
minor uses.
SEC. 3. LIMITATION ON RESIDUES.
Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is
amended to read as follows:
‘‘(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 re-
sult in a residue of such drug in excess of a toler-
ance found by the Secretary to be safe for such
drug;’’.
SEC. 4. IMPORT TOLERANCES.
Section 512(a) (21 U.S.C. 360b(a)) is amended by
adding the following new paragraph at the end:
‘‘(6) For purposes of section 402(a)(2)(D), a use or
intended use of a new animal drug shall not be deemed
unsafe under this section if the Secretary establishes a tol-
erance for such drug and any edible portion of any animal
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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 toler-
ances for applications for new animal drugs filed under
subsection (b)(1). 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 cri-
teria used by the Secretary to establish a tolerance for
applications for new animal drugs filed under subsection
(b)(1). For purposes of this paragraph, ‘relevant inter-
national 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 es-
tablished under this paragraph if information dem-
onstrates 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.’’.
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SEC. 5. VETERINARY FEED DIRECTIVES.
(a) SECTION 503.—Section 503(f)(1)(A) (21 U.S.C.
353(f)(1)(A)) is amended by inserting after ‘‘other than
man’’ the following: ‘‘, other than a veterinary feed direc-
tive drug intended for use in animal feed or an animal
feed bearing or containing a veterinary feed directive
drug,’’.
(b) SECTION 504.—The Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 503
the following:
‘‘VETERINARY FEED DIRECTIVE DRUGS
‘‘SEC. 504. (a)(1) A drug intended for use in or on
animal feed which is limited by an approved application
filed pursuant to section 512(b) to use under the profes-
sional supervision of a licensed veterinarian is a veterinary
feed directive drug. Any animal feed bearing or containing
a veterinary feed directive drug shall be fed to animals
only by or upon a lawful veterinary feed directive issued
by a licensed veterinarian in the course of the veterinar-
ian’s professional practice. When labeled, distributed,
held, and used in accordance with this section, a veteri-
nary feed directive drug and any animal feed bearing or
containing a veterinary feed directive drug shall be exempt
from section 502(f).
‘‘(2) A veterinary feed directive is lawful if it—
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‘‘(A) contains such information as the Secretary
may by general regulation or by order require; and
‘‘(B) is in compliance with the conditions and
indications for use of the drug set forth in the notice
published pursuant to section 512(i).
‘‘(3)(A) Any persons involved in the distribution or
use of animal feed bearing or containing a veterinary feed
directive drug and the licensed veterinarian issuing the
veterinary feed directive shall maintain a copy of the vet-
erinary feed directive applicable to each such feed, except
in the case of a person distributing such feed to another
person for further distribution. Such person distributing
the feed shall maintain a written acknowledgment from
the person to whom the feed is shipped stating that that
person shall not ship or move such feed to an animal pro-
duction facility without a veterinary feed directive or ship
such feed to another person for further distribution unless
that person has provided the same written acknowledg-
ment to its immediate supplier.
‘‘(B) Every person required under subparagraph (A)
to maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee des-
ignated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and
verify such records.
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‘‘(C) Any person who distributes animal feed bearing
or containing a veterinary feed directive drug shall upon
first engaging in such distribution notify the Secretary of
that person’s name and place of business. The failure to
provide such notification shall be deemed to be an act
which results in the drug being misbranded.
‘‘(b) A veterinary feed directive drug and any feed
bearing or containing a veterinary feed directive drug shall
be deemed to be misbranded if their labeling fails to bear
such cautionary statement and such other information as
the Secretary may by general regulation or by order pre-
scribe, or their advertising fails to conform to the condi-
tions and indications for use published pursuant to section
512(i) or fails to contain the general cautionary statement
prescribed by the Secretary.
‘‘(c) Neither a drug subject to this section, nor ani-
mal feed bearing or containing such a drug, shall be
deemed to be a prescription article under any Federal or
State law.’’.
(c) CONFORMING AMENDMENT.—Section 512 (21
U.S.C. 360b) is amended in subsection (i) by inserting
after ‘‘(including special labeling requirements’’ the follow-
ing: ‘‘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’’.
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(d) SECTION 301(e).—Section 301(e) (21 U.S.C.
331(e)) is amended by inserting after ‘‘by section 412’’
the following: ‘‘, 504,’’; and by inserting after ‘‘under sec-
tion 412,’’ the following: ‘‘504,’’.
SEC. 6. FEED MILL LICENSES.
(a) SECTION 512(a).—Paragraphs (1) and (2) of sec-
tion 512(a) (21 U.S.C. 360b(a)) are amended to read as
follows:
‘‘(a)(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 501(a)(5) and section
402(a)(2)(D) unless —
‘‘(A) there is in effect an approval of an appli-
cation filed pursuant to subsection (b) with respect
to such use or intended use of such drug, and
‘‘(B) such drug, its labeling, and such use con-
form 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
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in animal feed, such consignee (i) holds a license issued
under subsection (m) and has in its possession current ap-
proved labeling for such drug in animal feed; or (ii) will,
if the consignee is not a user of the drug, ship such drug
only to a holder of a license issued under subsection (m).
‘‘(2) An animal feed bearing or containing a new ani-
mal drug shall, with respect to any particular use or in-
tended use of such animal feed be deemed unsafe for the
purposes of section 501(a)(6) unless—
‘‘(A) there is in effect an approval of an appli-
cation filed pursuant to subsection (b) 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) to manufacture such animal
feed, and
‘‘(C) such animal feed and its labeling, distribu-
tion, holding, and use conform to the conditions and
indications of use published pursuant to subsection
(i) .’’.
(b) SECTION 512(m).—Section 512(m) (21 U.S.C.
360b(m)) is amended to read as follows:
‘‘(m)(1) Any person may file with the Secretary an
application for a license to manufacture animal feeds bear-
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ing 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), and (D) a certifi-
cation that the methods used in, and the facilities and con-
trols used for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity with current
good manufacturing practice as described in section
501(a)(2)(B).
‘‘(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 appli-
cation 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 pro-
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cedure governing such a hearing shall be the procedure
set forth in the last two sentences of subsection (c)(1).
‘‘(3) If the Secretary, after due notice to the appli-
cant in accordance with paragraph (2) and giving the ap-
plicant an opportunity for a hearing in accordance with
such paragraph, finds, on the basis of information submit-
ted 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 facili-
ties and controls used for, the manufacture, process-
ing, 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),
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hear-
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ing, the Secretary finds that subparagraphs (A) through
(C) do not apply, the Secretary shall issue an order ap-
proving the application. An order under this subsection
approving an application for a license to manufacture ani-
mal 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) relating
to the use of such drugs in or on such animal feed.
‘‘(4)(A) The Secretary shall, after due notice and op-
portunity for hearing to the applicant, revoke a license to
manufacture animal feeds bearing or containing new ani-
mal drugs under this subsection if the Secretary finds—
‘‘(i) that the application for such license con-
tains 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 manufac-
tured at the facility unless the applicant has supple-
mented the application by filing with the Secretary
adequate information respecting all such changes
and unless there is in effect an approval of the sup-
plemental application.
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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 no-
tice 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 re-
peatedly 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 504(a)(3)(A), or the ap-
plicant has refused to permit access to, or copying
or verification of, such records as required by sub-
paragraph (B) of such paragraph or section
504(a)(3)(B);
‘‘(ii) that on the basis of new information be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when such license was is-
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sued, the methods used in, or the facilities and con-
trols 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, specify-
ing the matter complained of;
‘‘(iii) that on the basis of new information be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when such license was is-
sued, the labeling of any animal feeds, based on a
fair evaluation of all material facts, is false or mis-
leading in any particular and was not corrected
within a reasonable time after receipt of written no-
tice from the Secretary specifying the matter com-
plained of; or
‘‘(iv) that on the basis of new information be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when such license was is-
sued, the facility has manufactured, processed,
packed, or held animal feed bearing or containing a
new 
animal 
drug 
adulterated 
under 
section
501(a)(6) and the facility did not discontinue the
manufacture, processing, packing, or holding of such
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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 man-
ufacture 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 sub-
section 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 Sec-
retary, or (at the option of the Secretary) to the ap-
propriate person or persons holding an approved ap-
plication filed under subsection (b), as the Secretary
may by general regulation, or by order with respect
to such application, prescribe on the basis of a find-
ing that such records and reports are necessary in
order to enable the Secretary to determine, or facili-
tate a determination, whether there is or may be
ground for invoking subsection (e) or paragraph (4);
and
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‘‘(B) every person required under this sub-
section to maintain records, and every person in
charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, per-
mit 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 manu-
facture, process, pack, or hold animal feeds bearing or
containing new animal drugs.’’.
(c) TRANSITIONAL PROVISION.—A person engaged in
the manufacture of animal feeds bearing or containing
new animal drugs who holds at least one approved medi-
cated feed application for an animal feed bearing or con-
taining new animal drugs, the manufacture of which was
not otherwise exempt from the requirement for an ap-
proved medicated feed application on the date of the en-
actment of this Act, shall be deemed to hold a license for
the manufacturing site identified in the approved medi-
cated feed application. The revocation of license provisions
of section 512(m)(4) of the Federal Food, Drug, and Cos-
metic Act, 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 sub-