I
106TH CONGRESS
2D SESSION
H. R. 4780
To amend the Federal Food, Drug, and Cosmetic Act and the Internal
Revenue Code of 1986 with respect to drugs for minor animal species,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JUNE 28, 2000
Mr. PICKERING (for himself, Mr. HALL of Texas, Mr. COMBEST, Mr. STEN-
HOLM, and Mr. POMBO) introduced the following bill; which was referred
to the Committee on Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall within
the jurisdiction of the committee concerned
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and
the Internal Revenue Code of 1986 with respect to drugs
for minor animal species, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Minor Animal Species
Health and Welfare Act of 2000’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) There is a severe shortage of approved ani-
mal drugs for use in minor species.
(2) There is a severe shortage of approved
drugs for treating animal diseases and conditions
that occur infrequently or in limited geographic
areas.
(3) Because of the small market shares, low-
profit margins involved, and capital investment re-
quired, it is generally not economically feasible for
animal drug manufacturers to pursue approvals for
these species, diseases, and conditions.
(4) Because the populations for which such
drugs are intended are small and conditions of ani-
mal management may vary widely, it is often dif-
ficult or impossible to design and conduct studies to
establish drug safety and effectiveness under tradi-
tional animal drug approval processes.
(5) It is in the public interest and in the inter-
est of animal welfare to provide for special proce-
dures to sanction the lawful use and marketing of
animal drugs for minor species and minor uses that
take into account these special circumstances and
that ensure that such drugs do not endanger the
public health.
(6) Exclusive marketing rights and tax credits
for clinical testing expenses have helped encourage
the development of orphan drugs for human use,
and comparable incentives will help encourage the
development and sanctioning for lawful marketing of
animal drugs for minor species and minor uses.
SEC. 3. AMENDMENTS AFFECTING THE FOOD AND DRUG
ADMINISTRATION.
(a) DEFINITIONS.—Section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by
adding the following new subsections at the end:
‘‘(kk) The term ‘minor species’ means animals other
than cattle, horses, swine, chickens, turkeys, dogs, and
cats, except that the Secretary may amend this definition
by regulation.
‘‘(ll) The term ‘minor use’ means the use of a drug—
‘‘(1) in a minor species, or
‘‘(2) in an animal species other than a minor
species for a disease or condition that occurs infre-
quently or in limited geographic areas, except that
the Secretary may amend this definition by regula-
tion.
‘‘(mm) The term ‘species with no human food safety
concern’ means an animal species, or life stage of an ani-
mal species, that is not customarily used for food for man
and does not endanger the public health.’’.
(b) MINOR USE ANIMAL DRUGS.—Chapter V of the
Federal Food, Drug, and Cosmetic Act is amended by
adding at the end the following new subchapter:
‘‘SUBCHAPTER F—ANIMAL DRUGS FOR MINOR
USES
‘‘DESIGNATION OF DRUGS FOR MINOR USES
‘‘SEC. 571. (a) The manufacturer or the sponsor of
a drug may request the Secretary to designate the drug
as a drug for a minor use. A request for designation of
a drug shall be made before the submission of an applica-
tion under section 512(b) for the drug. If the Secretary
finds that a drug for which a request is submitted under
this subsection is being or will be investigated for a minor
use and if an application for such drug is approved under
section 512, the approval would be for such minor use,
the Secretary shall designate the drug as a drug for such
minor use. A request for a designation of a drug under
this subsection shall contain the consent of the applicant
to notice being given by the Secretary under subsection
(c) respecting the designation of the drug.
‘‘(b) A designation of a drug under subsection (a)
shall be subject to the condition that—
‘‘(1) if an application was approved for the
drug under section 512(c), the manufacturer of the
drug will notify the Secretary of any discontinuance
of the production of the drug at least one year be-
fore discontinuance; and
‘‘(2) if an application has not been approved for
the drug under section 512(c) and if preclinical in-
vestigations or investigations under section 512(j)
are being conducted with the drug, the manufacturer
or sponsor of the drug will notify the Secretary of
any decision to discontinue active pursuit of ap-
proval of an application under section 512(b).
‘‘(c) Notice respecting the designation of a drug
under subsection (a) shall be made available to the public.
‘‘PROTECTION FOR DRUGS FOR MINOR USES
‘‘SEC. 572. (a) Except as provided in subsection (b):
‘‘(1) If the Secretary approves an application
filed pursuant to section 512 for a drug designated
under section 571 for minor uses, no active ingre-
dient (including any salt or ester of the active ingre-
dient) of which has been approved in any other ap-
plication under section 512, the Secretary may not
approve or conditionally approve another application
submitted under section 512 or section 573 for such
drug for such minor use for a person who is not
the holder of such approved application until the ex-
piration of ten years from the date of the approval
of the application.
‘‘(2) If the Secretary approves an application
filed pursuant to section 512 for a drug designated
under section 571 for minor uses, which includes an
active ingredient (including an ester or salt of the
active ingredient) that has been approved in any
other application under section 512, the Secretary
may not approve or conditionally approve another
application submitted under section 512 or section
573 for such drug for such minor use for a person
who is not the holder of such approved application
until the expiration of seven years from the date of
approval of the application.
‘‘(b) If an application filed pursuant to section 512
is approved for a drug designated under section 571, the
Secretary may, during the ten-year or seven-year period
beginning on the date of the application approval, approve
or conditionally approve another application under section
512 or section 573 for such drug for such minor use for
a person who is not the holder of such approved applica-
tion if—
‘‘(1) the Secretary finds, after providing the
holder notice and opportunity for the submission of
views, that in such period the holder of the approved
application cannot assure the availability of suffi-
cient quantities of the drug to meet the needs for
which the drug was designated; or
‘‘(2) such holder provides the Secretary in writ-
ing the consent of such holder for the approval or
conditional approval of other applications before the
expiration of such ten-year or seven-year period.
‘‘CONDITIONAL APPROVAL FOR MINOR USE NEW ANIMAL
DRUGS
‘‘SEC. 573. (a)(1) Except as provided in paragraph
(2), any person may file with the Secretary an application
for conditional approval of a new animal drug for minor
use. Such person shall submit to the Secretary as part
of an application—
‘‘(A) reports of investigations which have been
made to show whether or not such drug is safe for
use;
‘‘(B) information to show that there is a rea-
sonable expectation that the drug is effective for its
intended use, such as data from a pilot investigation,
data from an investigation in a related species; data
from a single investigation, data from an investiga-
tion using surrogate endpoints, data based on phar-
macokinetic extrapolations, data from a short-term
investigation, or data from the investigation of close-
ly-related diseases;
‘‘(C) the quantity of drug expected to be manu-
factured and distributed on an annual basis;
‘‘(D) a commitment that the applicant will con-
duct additional investigations to support approval of
an application under section 512 within the time
frame set forth in subsection (d)(1)(A);
‘‘(E) reasonable data for establishing a condi-
tional dose; and
‘‘(F) the information required by section
512(b)(1)(B)–(H).
‘‘(2) A person may not file an application under para-
graph (1) if the person has filed a previous application
under paragraph (1) for the same drug and conditions for
use that was conditionally approved by the Secretary
under subsection (b).
‘‘(b)(1) Within 180 days after the filing of an applica-
tion pursuant to subsection (a), or such additional period
as may be agreed upon by the Secretary and the applicant,
the Secretary shall either (A) issue an order conditionally
approving the application if the Secretary then finds that
none of the grounds for denying conditional approval spec-
ified in subsection (c) applies, or (B) give the applicant
notice of an opportunity for an expedited informal hearing
on the question whether such application is conditionally
approvable.
‘‘(2) A drug manufactured in a pilot or other small
facility may be used to demonstrate the safety and effec-
tiveness of the drug and to obtain conditional approval for
the drug prior to manufacture of the drug in a larger facil-
ity, unless the Secretary makes a determination that a full
scale production facility is necessary to ensure the safety
or effectiveness of the drug.
‘‘(c)(1) If the Secretary finds, after due notice to the
applicant and giving the applicant an opportunity for an
expedited informal hearing, that—
‘‘(A) the investigations, reports of which are re-
quired to be submitted to the Secretary pursuant to
subsection (a), 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 pro-
posed 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 sub-
mitted to the Secretary as part of the application, or
upon the basis of any other information before the
Secretary with respect to such drug, the Secretary
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 the Secretary as part of the application
and any other information before the Secretary with
respect to such drug, there is insufficient informa-
tion to show that there is a reasonable expectation
that the drug will have the effect it purports or is
represented to have under the conditions of use pre-
scribed, 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 re-
sult in a residue of such drug in excess of a toler-
ance found by the Secretary to be safe for such
drug;
‘‘(G) based on a fair evaluation of all material
facts, such labeling is false or misleading in any par-
ticular; or
‘‘(H) such drug induces cancer when ingested
by man or animal or, after tests which are appro-
priate 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 for use specified in
proposed labeling and reasonably certain to be fol-
lowed in practice (i) such drug will not adversely af-
fect 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)), in any edible portion of such ani-
mals after slaughter or in any food yielded by or de-
rived from the living animals; or
‘‘(I) another person has received approval under
section 512 for a drug with the same active ingre-
dient or ingredients and the same conditions of use,
and that person is able to assure the availability of
sufficient quantities of the drug to meet the needs
for which the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and oppor-
tunity for hearing, the Secretary finds that subparagraphs
(A) through (I) do not apply, the Secretary shall issue an
order conditionally approving the application.
‘‘(2) In determining whether such drug is safe for use
under the conditions prescribed, recommended, or sug-
gested 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 ex-
perts, 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 fol-
lowed in practice. Any order issued under this subsection
refusing to approve an application shall state the findings
upon which it is based.
‘‘(d)(1) A conditional approval granted by the Sec-
retary under this section shall be effective for a one-year
period. The Secretary shall, upon request, renew a condi-
tional approval for up to four additional one-year terms,
unless the Secretary by order makes a finding that—
‘‘(A) the applicant is not making appropriate
progress toward meeting approval requirements
under section 512, and is unlikely to be able to ful-
fill those requirements and obtain an approval under
section 512 before the expiration of the five year
maximum term of the conditional approval;
‘‘(B) excessive quantities of the drug have been
produced, without adequate explanation; or
‘‘(C) another drug with the same active ingre-
dient or ingredients for the same conditions of use
has received approval under section 512, and the
holder of the approved application is able to assure
the availability of sufficient quantities of the drug to
meet the needs for which the drug is intended.
‘‘(2) If the Secretary does not renew a conditional
approval, the Secretary shall provide due notice and an
opportunity for an expedited informal hearing to the appli-
cant.
‘‘(e)(1) The Secretary shall, after due notice and op-
portunity for an expedited informal hearing to the appli-
cant, issue an order withdrawing conditional approval of
an application filed pursuant to subsection (a) if the Sec-
retary finds—
‘‘(A) that experience or scientific data show
that such drug is unsafe for use under the condi-
tions of use upon the basis of which the application
was conditionally approved;
‘‘(B) that new evidence not contained in such
application or not available to the Secretary until
after such application was conditionally approved, or
tests by new methods, or tests by methods not
deemed reasonably applicable when such application
was conditionally approved, evaluated together with
the evidence available to the Secretary when the ap-
plication was conditionally approved, shows that
such drug is not shown to be safe for use under the
conditions of use upon the basis of which the appli-
cation was conditionally approved;
‘‘(C) on the basis of new information before the
Secretary with respect to such drug, evaluated to-
gether with the evidence available to the Secretary
when the application was conditionally approved,
that there is not a reasonable expectation that such
drug will have the effect it purports or is rep-
resented to have under the conditions of use pre-
scribed, recommended, or suggested in the labeling
thereof;
‘‘(D) that the application contains any untrue
statement of a material fact; or
‘‘(E) that the applicant has made any changes
from the standpoint of safety or effectiveness beyond
the variations provided for in the application unless
the applicant has supplemented the application by
filing with the Secretary adequate information re-
specting all such changes and unless there is in ef-
fect a conditional approval of the supplemental ap-
plication, which supplemental application shall be
treated in the same manner as the original applica-
tion.
If the Secretary finds that there is an imminent hazard
to the health of man or of the animals for which such
drug is intended, the Secretary may suspend the condi-
tional approval of such application immediately, and give
the applicant prompt notice of the Secretary’s action and
afford the applicant the opportunity for an expedited in-
formal hearing, but the authority conferred by this sen-
tence to suspend the conditional approval of an application
shall not be delegated below the Commissioner of Food
and Drugs.
‘‘(2) The Secretary may also, after due notice and
opportunity for an expedited informal hearing to the appli-
cant, issue an order withdrawing the conditional 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 (h), 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 be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when the application was
conditionally 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 be-
fore the Secretary, evaluated together with the evi-
dence before the Secretary when the application was
conditionally 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) The decision of the Secretary under subsections
(c), (d), or (e) shall constitute a final agency decision for
purposes of judicial review.
‘‘(g) When an application filed pursuant to subsection
(a) is conditionally approved, the Secretary shall by notice
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, includ-
ing any tolerance and withdrawal period or other use re-
striction 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 require-
ment that an animal feed bearing or containing the new
animal drug be limited to use under the professional su-
pervision of a licensed veterinarian) applicable to any ani-
mal feed for use in which such drug is conditionally ap-
proved, the expiration date of the conditional approval,
and such other information, upon the basis of which such
application was conditionally approved, as the Secretary
deems necessary to assure the safe and effective use of
such drug. Upon withdrawal of conditional approval of
such new animal drug application or upon its suspension,
the Secretary shall publish a notice in the Federal Reg-
ister.
‘‘(h)(1) In the case of any new animal drug for which
a conditional approval of an application filed pursuant to
subsection (a) is in effect, the applicant shall establish and
maintain such records, and make such reports to the Sec-
retary, of data relating to experience, and other data or
information, received or otherwise obtained by such appli-
cant 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 refusing to renew
the conditional approval under subsection (d) or for invok-
ing subsection (e). 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 re-
ceived 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 des-
ignated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and
verify such records.
‘‘(i)(1) The label and labeling of a drug with a condi-
tional approval under this section shall state that fact
prominently and conspicuously.
‘‘(2) Conditions of use that are the subject of an con-
ditional approval under this section shall not be combined
in product labeling with any conditions of use approved
under section 512.
‘‘(j)(1) Safety and effectiveness data and information
which has been submitted in an application filed under
subsection (a) 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 conditionally approved,
‘‘(B) if the Secretary has determined that the
application is not conditionally approvable and all
legal appeals have been exhausted,
‘‘(C) if conditional approval of the application
under subsection (c) is withdrawn and all legal ap-
peals have been exhausted, or
‘‘(D) if the Secretary has determined that such
drug is not a new animal drug.
‘‘(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, out-
side the United States, the drug identified in the ap-
plication filed under subsection (a), 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.
‘‘(k) 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, in-
tended 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 con-
ditions relating to the protection of the public health, pro-
vide for conditioning such exemption upon the establish-
ment 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 inves-
tigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable the Sec-
retary to evaluate the safety and effectiveness of such arti-
cle 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 treat-
ed with such articles, and any products of such animals
(before or after slaughter), may be marketed for food use.
‘‘INDEX
OF
LEGALLY
MARKETED
UNAPPROVED
MINOR
USE ANIMAL DRUGS FOR MINOR SPECIES WITH NO
HUMAN FOOD SAFETY CONCERN
‘‘SEC. 574. (a) The Secretary shall establish an index
of unapproved minor use new animal drugs that may be
lawfully marketed for use in minor species with no human
food safety concern. The index is intended to benefit pri-
marily zoo and wildlife species, aquarium and bait fish,
reptiles and amphibians, caged birds, and small pet mam-
mals as well as some commercially produced species such
as cricket, earthworms and possibly nonfood life stages of
some minor species used for human food such as oysters
and shellfish. The index shall conform to the requirements
in subsection (d).
‘‘(b)(1) Any person may submit a request to the Sec-
retary for a preliminary determination that a drug may
be eligible for inclusion in the index. Such a request shall
include—
‘‘(A) information regarding the proposed spe-
cies, conditions of use, and anticipated annual pro-
duction;
‘‘(B) information regarding product formulation
and manufacturing; and
‘‘(C) information sufficient for the Secretary to
determine that there does not appear to be human
food safety, environmental safety, occupational safe-
ty, or bioavailability concerns with the proposed use
of the drug.
‘‘(2) Within 90 days after the submission of a request
for a preliminary determination under paragraph (1), the
Secretary shall grant or deny the request, and notify the
submitter of the Secretary’s conclusion. The Secretary
shall grant the request if it appears that—
‘‘(A) the request addresses the need for a minor
use animal drug for which there is no approved or
conditionally approved drug, and
‘‘(B) the proposed drug use does not appear to
raise human food safety, environmental safety, occu-
pational safety, or bioavailability concerns.
If the Secretary denies the request, the Secretary shall
provide due notice and an opportunity for an expedited
informal hearing. If the Secretary does not grant or deny
the request within 90 days, the Secretary shall provide the
Committee on Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and
Pensions of the Senate with the reasons action on the re-
quest did not occur within such 90 days. The decision of
the Secretary under this paragraph shall constitute a final
agency decision for purposes of judicial review.
‘‘(c)(1) With respect to a drug for which the Sec-
retary has made a preliminary determination of eligibility
under subsection (b), the submitter of that request may
request that the Secretary add the drug to the index estab-
lished by subsection (a). Such a request shall include—
‘‘(A) a copy of the Secretary’s preliminary de-
termination of eligibility issued under subsection (b);
‘‘(B) a qualified expert panel report that meets
the requirements in paragraph (2);
‘‘(C) a proposed index entry;
‘‘(D) proposed labeling;
‘‘(E) anticipated annual production of the drug;
and
‘‘(F) a commitment to manufacture, label, and
distribute the drug in accordance with the index
entry and any additional requirements that the Sec-
retary may prescribe by general regulation or spe-
cific order.
‘‘(2) For purposes of paragraph (1), a ‘qualified ex-
pert panel report’ is a written report that—
‘‘(A) is authored by a panel of individuals quali-
fied by scientific training and experience to evaluate
the safety and effectiveness of animal drugs for the
intended uses and species in question and operating
external to the Food and Drug Administration;
‘‘(B) addresses all available target animal safe-
ty and effectiveness information, including anecdotal
information where necessary;
‘‘(C) addresses proposed labeling;
‘‘(D) addresses whether the drug should be lim-
ited to use under the professional supervision of a li-
censed veterinarian; and
‘‘(E) addresses whether, in the expert panel’s
opinion, the benefits of using the drug outweigh its
risks, taking into account the harm being caused by
the absence of an approved or conditionally approved
new animal drug for the minor use in question.
‘‘(3) Within 180 days after the receipt of a request
for listing a drug in the index, the Secretary shall grant
or deny the request. The Secretary shall grant the request
if the Secretary finds, on the basis of the expert panel
report and other information available to the Secretary,
that the benefits of using the drug outweigh its risks, tak-
ing into account the harm caused by the absence of an
approved or conditionally approved new animal drug for
the minor use in question. If the Secretary denies the re-
quest, the Secretary shall provide due notice and the op-
portunity for an expedited informal hearing. If the Sec-
retary does not grant or deny the request within 180 days,
the Secretary shall provide the Committee on Commerce
of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate
with the reasons action on the request did not occur within
such 180 days. The decision of the Secretary under this
paragraph shall constitute a final agency decision for pur-
poses of judicial review.
‘‘(d)(1) The index established by subsection (a) shall
include the following information for each listed drug:
‘‘(A) The name and address of the sponsor of
the index listing.
‘‘(B) The name of the drug, its dosage form,
and its strength.
‘‘(C) Labeling.
‘‘(D) Production limits or other conditions the
Secretary deems necessary to prevent misuse of the
drug.
‘‘(E) Requirements that the Secretary deems
necessary for the safe and effective use of the drug.
‘‘(2) The Secretary shall publish the index, and revise
it monthly.
‘‘(e)(1) If the Secretary finds, after due notice to the
sponsor and an opportunity for an expedited informal
hearing, that—
‘‘(A) on the basis of new information before the
Secretary, evaluated together with the evidence
available to the Secretary when the drug was listed
in the index, the benefits of using the drug do not
outweigh its risks; or
‘‘(B) the conditions and limitations of use in
the index listing have not been followed, the Sec-
retary shall remove the drug from the index. The
decision of the Secretary shall constitute final agen-
cy decision for purposes of judicial review.
‘‘(2) If the Secretary finds that there is an imminent
hazard to the health of man or of the animals for which
such drug is intended, the Secretary may suspend the list-
ing of such drug immediately, and give the sponsor prompt
notice of the Secretary’s action and afford the sponsor the
opportunity for an expedited informal hearing, but the au-
thority conferred by this sentence to suspend the listing
of a drug shall not be delegated below the Commissioner
of Food and Drugs.
‘‘(f)(1) In the case of any new animal drug for which
an index listing pursuant to subsection (a) is in effect,
the sponsor shall establish and maintain such records, and
make such reports to the Secretary, of data relating to
experience, and other data or information, received or oth-
erwise obtained by such sponsor 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 listing, 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). 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 informa-
tion 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 des-
ignated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and
verify such records.
‘‘(g) The labeling of a drug that is the subject of an
index listing shall state, prominently and conspicuously,
that the drug is legally marketed but not approved.
‘‘(h) The Secretary shall promulgate regulations to
implement this section. Such regulations shall address,
among other subjects, the composition of the expert panel,
sponsorship of the expert panel under the auspices of a
recognized professional organization, conflict of interest
criteria for panel members, and the use of advisory com-
mittees convened by the Food and Drug Administration.
‘‘(i) To the extent consistent with the public health,
the Secretary shall promulgate regulations for exempting
from the operation of this section new animal drugs in-
tended 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 con-
ditions relating to the protection of the public health, pro-
vide for conditioning such exemption upon the establish-
ment 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 inves-
tigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable the Sec-
retary to evaluate the safety and effectiveness of such arti-
cle in the event of the filing of a request for an index list-
ing 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 mar-
keted for food use.
‘‘GRANTS AND CONTRACTS FOR DEVELOPMENT OF
ANIMAL DRUGS FOR MINOR USES
‘‘SEC. 575. (a) The Secretary may make grants to
and enter into contracts with public and private entities
and individuals to assist in defraying the costs of qualified
testing expenses and manufacturing expenses incurred in
connection with the development of drugs for minor uses.
‘‘(b) For purposes of subsection (a) of this section:
‘‘(1) The term ‘qualified testing’ means—
‘‘(A) clinical testing—
‘‘(i) which is carried out under an ex-
emption for a drug for minor uses under
section 512(j), 573(k), or 574(i); and
‘‘(ii) which occurs after the date such
drug is designated under section 571 and
before the date on which an application
with respect to such drug is submitted
under section 512; and
‘‘(B) preclinical testing involving a drug
for minor use which occurs after the date such
drug is designated under section 571 and before
the date on which an application with respect to
such drug is submitted under section 512.
‘‘(2) The term ‘manufacturing expenses’ means
expenses incurred in developing processes and proce-
dures intended to meet current good manufacturing
practice requirements which occur after such drug is
designated under section 571 and before the date on
which an application with respect to such drug is
submitted under section 512.
‘‘(c) For grants and contracts under subsection (a),
there are authorized to be appropriated $1,000,000 for fis-
cal year 2001, $1,500,000 for fiscal year 2002, and
$2,000,000 for fiscal year 2003.’’.
(c) THREE-YEAR EXCLUSIVITY FOR MINOR USE AP-
PROVALS.—Section 512(c)(2)(F)(ii), (iii), and (v) of the
Federal Food, Drug, and Cosmetic Act is amended by
striking ‘‘(other than bioequivalence or residue studies)’’
and inserting the following: ‘‘(other than bioequivalence
studies or, except in the case of a new animal drug for
minor uses, residue studies)’’.
(d) SCOPE OF REVIEW FOR MINOR USE APPLICA-
TIONS.—Section 512(d) of the Federal Food, Drug, and
Cosmetic Act is amended by adding the following new
paragraph at the end:
‘‘(5) In reviewing a supplement to an approved appli-
cation that seeks a minor use approval, the Secretary shall
not reconsider information in the approved application to
determine whether it meets current standards for ap-
proval.’’.
(e) PRESUMPTION
OF NEW ANIMAL DRUG STA-
TUS.—Section 709 of the Federal Food, Drug, and Cos-
metic Act is amended by designating the existing text as
subsection (a), and by adding the following new subsection
(b):
‘‘(b) In any action to enforce the requirements of this
Act respecting a drug for minor use that is not the subject
of an approval under section 512, a conditional approval
under section 573, or an index listing under section 574,
it shall be presumed that the drug is a new animal drug.’’.
(f) CONFORMING AMENDMENTS.—
(1) Section 512(a)(1) of the Federal Food,
Drug, and Cosmetic Act is amended by striking sub-
paragraphs (A) and (B) and inserting the following:
‘‘(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 such drug, its labeling, and such use
conform to such approved application;
‘‘(B) there is in effect a conditional ap-
proval of an application filed pursuant to sec-
tion 573 with respect to such use or intended
use of such drug, and such drug, its labeling,
and such use conform to such conditionally ap-
proved application; or
‘‘(C) there is in effect an index listing pur-
suant to section 574 with respect to such use
or intended use of such drug, and such drug, its
labeling, and such use conform to such index
listing.’’.
(2) Section 512(a)(4) of the Federal Food,
Drug, and Cosmetic Act is amended by adding after
‘‘if an approval of an application filed under sub-
section (b)’’ the following: ‘‘or a conditional approval
of an application filed under section 573’’.
(3) Section 503(f) of the Federal Food, Drug,
and Cosmetic Act is amended as follows:
(A) In paragraph (1)(A)(ii) by striking
‘‘512’’ and inserting the following: ‘‘512, a con-
ditionally approved application under subsection
(b) of section 573, or an index listing under
subsection (a) of section 574.’’.
(B) In paragraph (3) by striking ‘‘section
512’’ and inserting the following: ‘‘sections 512,
573, or 574.’’.
(4) Section 504(a)(1) of the Federal Food,
Drug, and Cosmetic Act is amended by striking
‘‘512(b)’’ and inserting the following: ‘‘512(b), a
conditionally approved application filed pursuant to
section 573, or an index listing pursuant to section
574.’’.
(5) Section 504(a)(2)(B) and (b) of the Federal
Food, Drug, and Cosmetic Act are amended by
striking ‘‘512(i)’’ and inserting the following:
‘‘512(i) or section 573(g), or the index listing pursu-
ant to section 574.’’.
(6) Section 403(a) of the Food and Drug Ad-
ministration Modernization Act (Public Law 105–
115) is amended by adding the following sentence at
the end: ‘‘For purposes of this section, an approved
article includes a new animal drug that is the sub-
ject of a conditional approval or an index listing
under sections 573 and 574 of the Federal Food,
Drug, and Cosmetic Act, respectively.’’.
(g) REGULATIONS.—The Secretary of Health and
Human Services shall publish proposed regulations to im-
plement amendments to the Federal Food, Drug, and Cos-
metic Act made by this Act within 6 months of the date
of enactment, and final regulations within 24 months of
the date of enactment.
(h) OFFICE OF MINOR USE ANIMAL DRUG DEVEL-
OPMENT.—
(1) The Secretary shall establish within the
Food and Drug Administration, Center of Veteri-
nary Medicine, an Office of Minor Use Animal Drug
Development that reports directly to the Director of
the Center for Veterinary Medicine. This office shall
be responsible for designating minor use animal
drugs under section 571 of the Federal Food, Drug,
and Cosmetic Act, for administering grants and con-
tracts for the development of animal drugs for minor
uses under section 575 of the Federal Food, Drug,
and Cosmetic Act, and for serving as liaison with
amounts which are paid or incurred by the tax-
payer during the taxable year which would be
described in subsection (b) of section 41 if such
subsection were applied with the modifications
set forth in subparagraph (B).
‘‘(B) MODIFICATIONS.—For purposes of
subparagraph (A), subsection (b) of section 41
shall be applied—
‘‘(i) by substituting ‘animal clinical
testing’ for ‘qualified research’ each place
it appears in paragraphs (2) and (3) of
such subsection, and
‘‘(ii) by substituting ‘100 percent’ for
‘65 percent’ in paragraph (3)(A) of such
subsection.
‘‘(C) EXCLUSION FOR AMOUNTS FUNDED
BY GRANTS, ETC.—The term ‘qualified animal
clinical testing expenses’ shall not include any
amount to the extent such amount is funded by
any grant, contract, or otherwise by another
person (or any governmental entity).
‘‘(D) SPECIAL
RULE.—For purposes of
this paragraph:
‘‘(i) section 41 shall be deemed to re-
main in effect for periods after June 30,
2000; and
‘‘(ii) the trade or business require-
ment of section 41(b)(1) shall be deemed
to be satisfied in the case of a taxpayer
that owns animals and that conducts clin-
ical testing on such animals.
‘‘(2) ANIMAL CLINICAL TESTING.—
‘‘(A) IN GENERAL.—The term ‘animal clin-
ical testing’ means any clinical testing—
‘‘(i) which is carried out under an ex-
emption for a drug being tested for minor
use under section 512(j), 573(k), or 574(i)
of the Federal Food, Drug, and Cosmetic
Act (or regulations issued under such sec-
tions),
‘‘(ii) which occurs—
‘‘(I) after the date such drug is
designated under section 571 of such
Act, and
‘‘(II) before the date on which an
application with respect to such drug
is approved under section 512(c) of
such Act, and
‘‘(iii) which is conducted by or on be-
half of—
‘‘(I) the taxpayer to whom the
designation under such section 571
applies, or
‘‘(II) the owner of the animals
that are the subject of clinical testing.
‘‘(B) TESTING
MUST
BE
FOR
MINOR
USE.—Animal clinical testing shall be taken
into account under subparagraph (A) only to
the extent such testing is related to the use of
a drug for the minor use for which it was des-
ignated under section 571 of the Federal Food,
Drug, and Cosmetic Act.
‘‘(c) COORDINATION WITH CREDIT FOR INCREASING
RESEARCH EXPENDITURES.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), any qualified animal clinical testing ex-
penses for a taxable year to which an election under
this section applies shall not be taken into account
for purposes of determining the credit allowable
under section 41 for such taxable year.
‘‘(2) EXPENSES
INCLUDED
IN
DETERMINING
BASE PERIOD RESEARCH EXPENSES.—Any qualified
animal clinical testing expenses for any taxable year
which are qualified research expenses (within the
meaning of section 41(b)) shall be taken into ac-
count in determining base period research expenses
for purposes of applying section 41 to subsequent
taxable years.
‘‘(d) DEFINITION AND SPECIAL RULES.—
‘‘(1) MINOR USE.—For purposes of this section,
the term ‘minor use’ has the meaning given such
term by section 201(ll) of the Federal Food, Drug,
and Cosmetic Act. Determinations under the pre-
ceding sentence with respect to any drug shall be
made on the basis of the facts and circumstances as
of the date such drug is designated under section
571 of the Federal Food, Drug, and Cosmetic Act.
‘‘(2) DENIAL OF CREDIT FOR TESTING CON-
DUCTED BY CORPORATIONS TO WHICH SECTION 936
APPLIES.—No credit shall be allowed under this sec-
tion with respect to any animal clinical testing con-
ducted by a corporation to which an election under
section 936 applies.
‘‘(3) CERTAIN
RULES
MADE
APPLICABLE.—
Rules similar to the rules of paragraphs (1) and (2)
of section 41(f) shall apply for purposes of this sec-
tion.
‘‘(4) ELECTION.—This section shall apply to
any taxpayer for any taxable year only if such tax-
payer elects (at such time and in such manner as
the Secretary may by regulations prescribe) to have
this section apply for such taxable year.’’.
(b) CONFORMING AMENDMENTS.—
(1) Section 38(b) of such Code is amended—
(A) by striking ‘‘plus’’ at end of paragraph
(11),
(B) by striking the period at the end of
paragraph (12) and inserting ‘‘, plus’’, and
(C) by adding at the end the following new
paragraph:
‘‘(13) the minor use animal drug credit deter-
mined under section 45D(a).’’.
(2) Section 280C(b) of such Code is amended—
(A) in paragraph (1), by striking ‘‘section
45C(b)’’ and inserting ‘‘section 45C(b) or
45D(b)’’, and
(B) in paragraphs (1) and (2), by striking
‘‘section 45C’’ each place it appears and insert-
ing ‘‘section 45C or 45D’’.
(c) CLERICAL AMENDMENT.—The table of sections
for subpart D of part IV of subchapter A of chapter 1
of such Code is amended by inserting after the item relat-
ing to section 45C the following new item:
‘‘Sec. 45D. Clinical testing expenses for certain animal drugs for
minor uses.’’.
(d) EFFECTIVE DATE.—The amendments made by
this section shall apply to taxable years beginning after
the date of the enactment of this Act.
(e) REGULATIONS.—The Secretary of the Treasury
shall publish proposed regulations to implement amend-
ments to the Internal Revenue Code of 1986 made by this
Act within 6 months after the date of the enactment of
this Act, and final regulations within 24 months after such
date.
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