H. R. 2508—3
unless the Secretary finds that the application fails to dem-
onstrate 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 combina-
tion 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 dem-
onstrate 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 combina-
tion 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 com-
bination provides appropriate concurrent use for the
intended target population;
‘‘(iii) where a combination contains more than one non-
topical antibacterial ingredient or animal drug, there is
substantial evidence that each of the nontopical anti-
bacterial ingredients or animal drugs makes a contribution
to the labeled 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 intended 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 submis-
sion 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 Sec-
retary and the applicant or requestor unless (A) the Secretary
and the applicant or requestor mutually agree to modify the require-
ment, 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
H. R. 2508—4
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 investiga-
tion.’’.
(e) IMPLEMENTATION.—
(1) IN GENERAL.—Not later than 6 months after the date
of enactment of this Act, 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 amend-
ments 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, 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 supple-
mental 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 subpara-
graph (A).
(f) MINOR SPECIES AND USES.—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 of animal drugs intended for minor species
H. R. 2508—5
and for minor uses and, within 18 months after the date of enact-
ment of this Act, 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.
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 Sec-
retary as part of the application or any other information
before the Secretary with respect to such drug, any use pre-
scribed, 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;’’.
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 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).
The Secretary may consider and rely on data submitted by the
drug manufacturer, including data submitted to appropriate regu-
latory 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).
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 exceed-
ing the tolerance or if scientific evidence shows the tolerance to
be unsafe.’’.
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 directive 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 professional supervision of a
H. R. 2508—6
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 veterinarian’s
professional practice. When labeled, distributed, held, and used
in accordance with this section, a veterinary feed directive drug
and any animal feed bearing or containing a veterinary feed direc-
tive drug shall be exempt from section 502(f).
‘‘(2) A veterinary feed directive is lawful if it—
‘‘(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 veterinary 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 production facility without
a veterinary feed directive or ship such feed to another person
for further distribution unless that person has provided the same
written acknowledgment 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 designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
‘‘(C) Any person who distributes animal feed bearing or contain-
ing 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 prescribe, or their advertising fails
to conform to the conditions 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 animal feed
bearing or containing such a drug, shall be deemed to be a prescrip-
tion 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 following: ‘‘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’’.
(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 section 412,’’ the following: ‘‘504,’’.
H. R. 2508—7
SEC. 6. FEED MILL LICENSES.
(a) SECTION 512(a).—Paragraphs (1) and (2) of section 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 application 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 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) and has in its possession current approved labeling
for such drug in animal feed; or (ii) will, if the consignee is not
a user of the drug, ship such drug only to a holder of a license
issued under subsection (m).
‘‘(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of such
animal feed be deemed unsafe for the purposes of section 501(a)(6)
unless—
‘‘(A) there is in effect an approval of an application 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, distribution, 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 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), and (D) a certification that the methods used
in, and the facilities and controls used for, manufacturing, process-
ing, 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 application if the Secretary then finds
H. R. 2508—8
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).
‘‘(3) If the Secretary, after due notice to the applicant in accord-
ance 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 con-
trols 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),
the Secretary shall issue an order refusing to approve the applica-
tion. 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 manufac-
ture 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 regula-
tions 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 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.
H. R. 2508—9
‘‘(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 delib-
erately failed to maintain such records or to make required
reports in accordance with a regulation or order under para-
graph (5)(A) of this subsection or section 504(a)(3)(A), or the
applicant has refused to permit access to, or copying or verifica-
tion of, such records as required by subparagraph (B) of such
paragraph or section 504(a)(3)(B);
‘‘(ii) that on the basis of new information before the
Secretary, evaluated together with the evidence before the Sec-
retary when such license was issued, the methods used in,
or the facilities and controls used for, the manufacture, process-
ing, 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 Sec-
retary 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 Sec-
retary specifying the matter complained of; or
‘‘(iv) that on the basis of new information before the
Secretary, evaluated together with the evidence before the Sec-
retary when such license was issued, the facility has manufac-
tured, 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 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 oppor-
tunity 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), 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 paragraph (4); and
H. R. 2508—10
‘‘(B) every person required under this subsection to main-
tain 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 oper-
ation of this subsection facilities that manufacture, process, pack,
or hold animal feeds bearing or containing new animal drugs.’’.
(c) TRANSITIONAL PROVISION.—A person engaged in the manu-
facture 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 manu-
facture of which was not otherwise exempt from the requirement
for an approved medicated feed application on the date of the
enactment of this Act, 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, 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.