I 
108TH CONGRESS 
1ST SESSION H. R. 2079
To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
animal drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 13, 2003
Mr. PICKERING (for himself, Mr. JOHN, Mr. BERRY, Mr. THOMPSON of Mis-
sissippi, Mr. TOWNS, Mr. ALEXANDER, Mr. ROSS, Mr. GREENWOOD, Ms. 
BORDALLO, Mr. OTTER, Mr. UPTON, Mr. LIPINSKI, Mr. BOSWELL, Mr. 
GOODE, Mr. BONNER, Mr. ADERHOLT, Mr. BACHUS, Mr. DAVIS of Ala-
bama, Mr. BONILLA, Mr. EVERETT, Mr. PUTNAM, Mr. EDWARDS, and 
Mr. SIMPSON) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
regard to new 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,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Minor Use and Minor 
Species Animal Health Act of 2003’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings: 
(1) There is a severe shortage of approved new 
animal drugs for use in minor species. 
(2) There is a severe shortage of approved new 
animal drugs for treating animal diseases and condi-
tions 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 
new animal drug applicants to pursue approvals for 
these species, diseases, and conditions. 
(4) Because the populations for which such new 
animal drugs are intended may be small and condi-
tions of animal management may vary widely, it is 
often difficult to design and conduct studies to es-
tablish drug safety and effectiveness under tradi-
tional new 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 allow the lawful use and marketing of cer-
tain new animal drugs for minor species and minor
uses that take into account these special cir-
cumstances and that ensure that such drugs do not 
endanger animal or 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 should encourage the de-
velopment of new animal drugs for minor species 
and minor uses. 
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEFINITIONS.—Section 201 of the Federal, Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
‘‘(kk) The term ‘major species’ means cattle, horses, 
swine, chickens, turkeys, dogs, and cats, except that the 
Secretary may revise this definition by regulation. 
‘‘(ll) The term ‘minor species’ means animals other 
than humans that are not major species. 
‘‘(mm) The term ‘minor use’ means the intended use 
of a drug in a major species for an indication that occurs 
infrequently or in limited geographical areas.’’. 
(b) THREE-YEAR EXCLUSIVITY FOR MINOR USE AND 
MINOR SPECIES APPROVALS.—Section 512(c)(2)(F) (ii), 
(iii), and (v) of the Federal Food, Drug, and Cosmetic
‘‘Subchapter F—New Animal Drugs for Minor 
Use and Minor Species 
‘‘SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL 
DRUGS FOR MINOR USE AND MINOR SPECIES. 
‘‘(a)(1) Except as provided in paragraph (3) of this 
section, any person may file with the Secretary an applica-
tion for conditional approval of a new animal drug in-
tended for a minor use or a minor species. Such an appli-
cation may not be a supplement to an application ap-
proved under section 512. Such application must comply 
in all respects with the provisions of section 512 of this 
Act except sections 512(a)(4), 512(b)(2), 512(c)(1), 
512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and 
512(n) unless otherwise stated in this section, and any ad-
ditional provisions of this section. 
‘‘(2) The applicant shall submit to the Secretary as 
part of an application for the conditional approval of a 
new animal drug—
‘‘(A) all information necessary to meet the re-
quirements of section 512(b)(1) except section 
512(b)(1)(A); 
‘‘(B) full reports of investigations which have 
been made to show whether or not such drug is safe 
and there is a reasonable expectation of effectiveness 
for use;
‘‘(C) data for establishing a conditional dose; 
‘‘(D) projections of expected need and the jus-
tification for that expectation based on the best in-
formation available; 
‘‘(E) information regarding the quantity of 
drug expected to be distributed on an annual basis 
to meet the expected need; and 
‘‘(F) a commitment that the applicant will con-
duct additional investigations to meet the require-
ments for the full demonstration of effectiveness 
under section 512(d)(1)(E) within 5 years. 
‘‘(3) A person may not file an application under para-
graph (1) if—
‘‘(A) the person has previously filed an applica-
tion for conditional approval under paragraph (1) 
for the same drug in the same dosage form for the 
same intended use whether or not subsequently con-
ditionally approved by the Secretary under sub-
section (b), or 
‘‘(B) the person obtained the application, or 
data or other information contained therein, directly 
or indirectly from the person who filed for condi-
tional approval under paragraph (1) for the same 
drug in the same dosage form for the same intended
use whether or not subsequently conditionally ap-
proved by the Secretary under subsection (b). 
‘‘(b) 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—
‘‘(1) issue an order, effective for one year, con-
ditionally approving the application if the Secretary 
finds that none of the grounds for denying condi-
tional approval, specified in subsection (c) of this 
section applies, or 
‘‘(2) give the applicant notice of an opportunity 
for an informal hearing on the question whether 
such application can be conditionally approved. 
‘‘(c) If the Secretary finds, after giving the applicant 
notice and an opportunity for an informal hearing, that—
‘‘(1) any of the provisions of section 512(d)(1) 
(A) through (D) or (F) through (I) are applicable; 
‘‘(2) the information submitted to the Secretary 
as part of the application and any other information 
before the Secretary with respect to such drug, is in-
sufficient to show that there is a reasonable expecta-
tion 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 pro-
posed labeling thereof; or 
‘‘(3) another person has received approval 
under section 512 for the same drug in the same 
dosage form for the same intended 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 opportunity for an informal 
hearing, the Secretary finds that paragraphs (1) through 
(3) do not apply, the Secretary shall issue an order condi-
tionally approving the application effective for one year. 
Any order issued under this subsection refusing to condi-
tionally approve an application shall state the findings 
upon which it is based. 
‘‘(d) A conditional approval under this section is ef-
fective for a 1-year period and is thereafter renewable by 
the Secretary annually for up to 4 additional 1-year terms. 
A conditional approval shall be in effect for no more than 
5 years from the date of approval under subsection (b)(1) 
or (c) of this section unless extended as provided for in 
subsection (h) of this section. The following shall also 
apply:
‘‘(1) No later than 90 days from the end of the 
1-year period for which the original or renewed con-
ditional approval is effective, the applicant may sub-
mit a request to renew a conditional approval for an 
additional 1-year term. 
‘‘(2) A conditional approval shall be deemed re-
newed at the end of the 1-year period, or at the end 
of a 90-day extension that the Secretary may, at the 
Secretary’s discretion, grant by letter in order to 
complete review of the renewal request, unless the 
Secretary determines before the expiration of the 1-
year period or the 90-day extension that—
‘‘(A) the applicant failed to submit a time-
ly renewal request; 
‘‘(B) the request fails to contain sufficient 
information to show that—
‘‘(i) the applicant is making sufficient 
progress toward meeting approval require-
ments under section 512(d)(1)(E), and is 
likely to be able to fulfill those require-
ments and obtain an approval under sec-
tion 512 before the expiration of the 5-year 
maximum term of the conditional approval; 
‘‘(ii) the quantity of the drug that has 
been distributed is consistent with the con-
ditionally approved intended use and condi-
tions of use, unless there is adequate ex-
planation that ensures that the drug is 
only used for its intended purpose; or 
‘‘(iii) the same drug in the same dos-
age form for the same intended use has 
not received approval under section 512, or 
if such a drug has been approved, that the 
holder of the approved application is un-
able to assure the availability of sufficient 
quantities of the drug to meet the needs 
for which the drug is intended; or 
‘‘(C) any of the provisions of section 
512(e)(1) (A) through (B) or (D) through (F) 
are applicable. 
‘‘(3) If the Secretary determines before the end 
of the 1-year period or the 90-day extension, if 
granted, that a conditional approval should not be 
renewed, the Secretary shall issue an order refusing 
to renew the conditional approval, and such condi-
tional approval shall be deemed withdrawn and no 
longer in effect. The Secretary shall thereafter pro-
vide an opportunity for an informal hearing to the 
applicant on the issue whether the conditional ap-
proval shall be reinstated.
‘‘(e)(1) The Secretary shall issue an order with-
drawing conditional approval of an application filed pursu-
ant to subsection (a) if the Secretary finds that another 
person has received approval under section 512 for the 
same drug in the same dosage form for the same intended 
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. 
‘‘(2) The Secretary shall, after due notice and oppor-
tunity for an informal hearing to the applicant, issue an 
order withdrawing conditional approval of an application 
filed pursuant to subsection (a) if the Secretary finds 
that—
‘‘(A) any of the provisions of section 512(e)(1) 
(A) through (B) or (D) through (F) are applicable; 
or 
‘‘(B) 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.
‘‘(3) The Secretary may also, after due notice and 
opportunity for an informal hearing to the applicant, issue 
an order withdrawing conditional approval of an applica-
tion filed pursuant to subsection (a) if the Secretary finds 
that any of the provisions of section 512(e)(2) are applica-
ble. 
‘‘(f)(1) The label and labeling of a new animal drug 
with a conditional approval under this section shall—
‘‘(A) bear the statement, ‘conditionally ap-
proved by FDA pending a full demonstration of ef-
fectiveness under application [number]’; and 
‘‘(B) contain such other information as pre-
scribed by the Secretary. 
‘‘(2) An intended use that is the subject of a condi-
tional approval under this section shall not be included 
in the same product label with any intended use approved 
under section 512. 
‘‘(g) A conditionally approved new animal drug appli-
cation may not be amended or supplemented to add indi-
cations for use. 
‘‘(h) 180 days prior to the termination date estab-
lished under subsection (d)(1) of this section, an applicant 
shall have submitted all the information necessary to sup-
port a complete new animal drug application in accordance 
with section 512(b)(1) or the conditional approval issued
under this section is no longer in effect. Following review 
of this information, the Secretary shall either—
‘‘(1) issue an order approving the application 
under section 512(c) if the Secretary finds that none 
of the grounds for denying approval specified in sec-
tion 512(d)(1) applies, or 
‘‘(2) give the applicant an opportunity for a 
hearing before the Secretary under section 512(d) 
on the question whether such application can be ap-
proved. 
Upon issuance of an order approving the application, 
product labeling and administrative records of approval 
shall be modified accordingly. If the Secretary has not 
issued an order under section 512(c) approving such appli-
cation prior to the termination date established under sub-
section (d)(1) of this section, the conditional approval 
issued under this section is no longer in effect unless the 
Secretary grants an extension of an additional 180-day pe-
riod so that the Secretary can complete review of the ap-
plication. The decision to grant an extension is committed 
to the discretion of the Secretary and not subject to judi-
cial review. 
‘‘(i) The decision of the Secretary under subsection 
(c), (d), or (e) of this section refusing or withdrawing con-
ditional approval of an application shall constitute final 
agency action subject to judicial review. 
‘‘SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED 
NEW ANIMAL DRUGS FOR MINOR SPECIES. 
‘‘(a) The Secretary shall establish an index of unap-
proved minor species new animal drugs that may be law-
fully marketed for use in minor species. The index shall 
be limited to—
‘‘(1) new animal drugs intended for use in a 
minor species for which there is a reasonable cer-
tainty that the animal or edible products from the 
animal will not be consumed by humans or food-pro-
ducing animals, and 
‘‘(2) new animal drugs intended for use in an 
early life stage of a food-producing minor species 
where human food safety can be demonstrated in ac-
cordance with the standard of section 512(d) by 
showing that—
‘‘(A) there is no significant likelihood that 
harmful residues will be present in the animal 
or edible products from the animal presented as 
food for humans as a result of treatment at the 
early life stage; 
‘‘(B) there is no significant likelihood that 
harmful residues will be present in the animal
or edible products from the animal presented as 
food for food-producing animals as a result of 
treatment at the early life stage; and 
‘‘(C) there are no concerns about the use 
of the drug at later life stages because a toler-
ance and regulatory method to test for the drug 
at later life stages are available or there is no 
practical use for the drug in later life stages. 
‘‘(b) Any person intending to file a request under this 
section shall be entitled to one or more conferences to dis-
cuss the requirements for indexing a new animal drug. 
‘‘(c)(1) Any person may submit a request to the Sec-
retary for a determination whether a new animal drug 
may be eligible for inclusion in the index. Such a request 
shall include—
‘‘(A) information regarding the need for the 
new animal drug, the species for which the new ani-
mal drug is intended, the proposed intended use and 
conditions of use, and anticipated annual distribu-
tion; 
‘‘(B) information to support the conclusion that 
the proposed use meets the conditions of subsection 
(a)(1) or (a)(2) of this section; 
‘‘(C) information regarding the components and 
composition of the new animal drug;
‘‘(D) a description of the methods used in, and 
the facilities and controls used for, the manufacture, 
processing, and packing of such new animal drug; 
‘‘(E) an environmental assessment or informa-
tion to support a categorical exclusion from the re-
quirement to prepare an environmental assessment; 
‘‘(F) information sufficient to support the con-
clusion that the proposed use of the new animal 
drug does not present a threat to the safety of indi-
viduals exposed to the new animal drug through its 
manufacture or use; and 
‘‘(G) such other information as the Secretary 
may deem necessary to make this eligibility deter-
mination. 
‘‘(2) Within 90 days after the submission of a request 
for a determination of eligibility for indexing based on sub-
section (a)(1) of this section, or 180 days for a request 
submitted based on subsection (a)(2) of this section, the 
Secretary shall grant or deny the request, and notify the 
person who requested such determination of the Sec-
retary’s decision. The Secretary shall grant the request if 
the Secretary finds that—
‘‘(A) the same drug in the same dosage form 
for the same intended use is not approved or condi-
tionally approved;
‘‘(B) the proposed use does not raise concerns 
related to safety; and 
‘‘(C) the person requesting the determination 
has established appropriate specifications for the 
manufacture and control of the new animal drug 
and has demonstrated an understanding of the re-
quirements of current good manufacturing practices. 
If the Secretary denies the request, the Secretary shall 
thereafter provide due notice and an opportunity for an 
informal conference. A decision of the Secretary to deny 
an eligibility request following an informal conference shall 
constitute final agency action subject to judicial review. 
‘‘(d)(1) With respect to a new animal drug for which 
the Secretary has made a determination of eligibility 
under subsection (b), the person who made such a request 
may ask that the Secretary add the new animal drug to 
the index established under subsection (a). The request 
for addition to the index shall include—
‘‘(A) a copy of the Secretary’s determination of 
eligibility issued under subsection (b); 
‘‘(B) a written report that meets the require-
ments in subsection (d)(2) of this section; 
‘‘(C) a proposed index entry; 
‘‘(D) facsimile labeling;
‘‘(E) anticipated annual distribution of the new 
animal drug; 
‘‘(F) a written commitment to manufacture the 
new animal drug and animal feeds bearing or con-
taining such new animal drug according to current 
good manufacturing practices; 
‘‘(G) a written commitment to label, distribute, 
and promote the new animal drug only in accordance 
with the index entry; 
‘‘(H) upon specific request of the Secretary, in-
formation submitted to the expert panel described in 
paragraph (3); and 
‘‘(I) any additional requirements that the Sec-
retary may prescribe by general regulation or spe-
cific order. 
‘‘(2) The report required in paragraph (1) shall—
‘‘(A) be authored by a qualified expert panel; 
‘‘(B) include an evaluation of all available tar-
get animal safety and effectiveness information, in-
cluding anecdotal information; 
‘‘(C) state the expert panel’s opinion regarding 
whether the benefits of using the new animal drug 
for the proposed use in a minor species 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 species in question; 
‘‘(D) include information from which labeling 
can be written; and 
‘‘(E) include a recommendation regarding 
whether the new animal drug should be limited to 
use under the professional supervision of a licensed 
veterinarian. 
‘‘(3) A qualified expert panel, as used in this section, 
is a panel that—
‘‘(A) is composed of experts qualified by sci-
entific training and experience to evaluate the target 
animal safety and effectiveness of the new animal 
drug under consideration; 
‘‘(B) operates external to FDA; and 
‘‘(C) is not subject to the Federal Advisory 
Committee Act, 5 U.S.C. App.2. 
The Secretary shall define the criteria for selection of a 
qualified expert panel and the procedures for the operation 
of the panel by regulation. 
‘‘(4) Within 180 days after the receipt of a request 
for listing a new animal drug in the index, the Secretary 
shall grant or deny the request. The Secretary shall grant 
the request if the request for indexing continues to meet 
the eligibility criteria in subsection (a) and the Secretary
finds, on the basis of the report of the qualified expert 
panel and other information available to the Secretary, 
that the benefits of using the new animal drug for the 
proposed use in a minor species outweigh its risks, taking 
into account the harm caused by the absence of an ap-
proved or conditionally-approved new animal drug for the 
minor species in question. If the Secretary denies the re-
quest, the Secretary shall thereafter provide due notice 
and the opportunity for an informal conference. The deci-
sion of the Secretary following an informal conference 
shall constitute final agency action subject to judicial re-
view. 
‘‘(e)(1) The index established under subsection (a) 
shall include the following information for each listed 
drug—
‘‘(A) the name and address of the person who 
holds the index listing; 
‘‘(B) the name of the drug and the intended 
use and conditions of use for which it is being in-
dexed; 
‘‘(C) product labeling; and 
‘‘(D) conditions and any limitations that the 
Secretary deems necessary regarding use of the 
drug.
‘‘(2) The Secretary shall publish the index, and revise 
it periodically. 
‘‘(3) The Secretary may establish by regulation a 
process for reporting changes in the conditions of manu-
facturing or labeling of indexed products. 
‘‘(f)(1) If the Secretary finds, after due notice to the 
person who requested the index listing and an opportunity 
for an informal conference, that—
‘‘(A) the expert panel failed to meet the re-
quirements as set forth by the Secretary by regula-
tion; 
‘‘(B) on the basis of new information before the 
Secretary, evaluated together with the evidence 
available to the Secretary when the new animal drug 
was listed in the index, the benefits of using the new 
animal drug for the indexed use do not outweigh its 
risks; 
‘‘(C) the conditions of subsection (c)(2) of this 
section are no longer satisfied; 
‘‘(D) the manufacture of the new animal drug 
is not in accordance with current good manufac-
turing practices; 
‘‘(E) the labeling, distribution, or promotion of 
the new animal drug is not in accordance with the 
index entry;
‘‘(F) the conditions and limitations of use asso-
ciated with the index listing have not been followed; 
or 
‘‘(G) the request for indexing contains any un-
true statement of material fact, 
the Secretary shall remove the new animal drug from the 
index. The decision of the Secretary following an informal 
conference shall constitute final agency action subject to 
judicial review. 
‘‘(2) If the Secretary finds that there is a reasonable 
probability that the use of the drug would present a risk 
to the health of humans or other animals, the Secretary 
may—
‘‘(A) suspend the listing of such drug imme-
diately; 
‘‘(B) give the person listed in the index prompt 
notice of the Secretary’s action; and 
‘‘(C) afford that person the opportunity for an 
informal conference. 
The decision of the Secretary following an informal con-
ference shall constitute final agency action subject to judi-
cial review. 
‘‘(g) For purposes of indexing new animal drugs 
under this section, to the extent consistent with the public 
health, the Secretary shall promulgate regulations for ex-
empting from the operation of section 512 minor species 
new animal drugs and animal feeds bearing or containing 
new animal drugs intended solely for investigational use 
by experts qualified by scientific training and experience 
to investigate the safety and effectiveness of minor species 
animal drugs. Such regulations may, at the discretion of 
the Secretary, among other conditions relating to the pro-
tection of the public health, provide for conditioning such 
exemption upon the establishment and maintenance of 
such records, and the making of such reports to the Sec-
retary, by the manufacturer or the sponsor of the inves-
tigation of such article, of data (including but not limited 
to analytical reports by investigators) obtained as a result 
of such investigational use of such article, as the Secretary 
finds will enable the Secretary to evaluate the safety and 
effectiveness of such article in the event of the filing of 
a request for an index listing pursuant to this section. 
‘‘(h) The labeling of a new animal drug that is the 
subject of an index listing shall state, prominently and 
conspicuously—
‘‘(1) ‘NOT APPROVED BY FDA.—Legally mar-
keted as an FDA indexed product. Extra-label use 
is prohibited.’; 
‘‘(2) except in the case of new animal drugs in-
dexed for use in an early life stage of a food-pro-
ducing animal, ‘This product is not to be used in 
animals intended for use as food for humans or 
other animals.’; and 
‘‘(3) such other information as may be pre-
scribed by the Secretary in the index listing. 
‘‘(i)(1) In the case of any new animal drug for which 
an index listing pursuant to subsection (a) is in effect, 
the person who has an index listing 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 person 
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 (f). Such regula-
tion 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 applica-
ble, of similar information received or otherwise obtained 
by the Secretary. 
‘‘(2) Every person required under this subsection to 
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee des-
ignated by the Secretary, permit such officer or employee 
at all reasonable times to have access to and copy and 
verify such records. 
‘‘(j)(1) Safety and effectiveness data and information 
which has been submitted in support of a request for a 
new animal drug to be indexed under this section and 
which has not been previously disclosed to the public shall 
be made available to the public, upon request, unless ex-
traordinary circumstances are shown—
‘‘(A) if no work is being or will be undertaken 
to have the drug indexed in accordance with the re-
quest, 
‘‘(B) if the Secretary has determined that such 
drug cannot be indexed and all legal appeals have 
been exhausted, 
‘‘(C) if the indexing of such drug is terminated 
and all legal appeals 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 re-
quest for indexing; 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. 
‘‘SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR 
USE OR MINOR SPECIES. 
‘‘(a) DESIGNATION.—
‘‘(1) The manufacturer or the sponsor of a new 
animal drug for a minor use or use in a minor spe-
cies may request that the Secretary declare that 
drug a ‘designated new animal drug’. A request for 
designation of a new animal drug shall be made be-
fore the submission of an application under section 
512(b) or section 571 for the new animal drug. 
‘‘(2) The Secretary may declare a new animal 
drug a ‘designated new animal drug’ for an intended 
use if—
‘‘(A) it is intended for a minor use or use 
in a minor species; and
‘‘(B) the same drug in the same dosage 
form for the same intended use is not approved 
under section 512 or 571 or designated under 
this section at the time the request is made. 
‘‘(3) Regarding the termination of a designa-
tion—
‘‘(A) the sponsor of a new animal drug 
shall notify the Secretary of any decision to dis-
continue active pursuit of approval under sec-
tion 512 or 571 of an application for a des-
ignated new animal drug. The Secretary shall 
terminate the designation upon such notifica-
tion; 
‘‘(B) the Secretary may also terminate des-
ignation if the Secretary independently deter-
mines that the sponsor is not actively pursuing 
approval under section 512 or 571 with due 
diligence; 
‘‘(C) the sponsor of an approved des-
ignated new animal drug shall notify the Sec-
retary of any discontinuance of the manufac-
ture of such new animal drug at least one year 
before discontinuance. The Secretary shall ter-
minate the designation upon such notification; 
and
‘‘(D) the designation shall terminate upon 
the expiration of any applicable exclusivity pe-
riod under subsection (c). 
‘‘(4) Notice respecting the designation or termi-
nation of designation of a new animal drug shall be 
made available to the public. 
‘‘(b) GRANTS AND CONTRACTS FOR DEVELOPMENT 
OF DESIGNATED NEW ANIMAL DRUGS.—
‘‘(1) 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 safety and effectiveness testing expenses 
and manufacturing expenses incurred in connection 
with the development of designated new animal 
drugs. 
‘‘(2) For purposes of paragraph (1) of this sec-
tion—
‘‘(A) The term ‘qualified safety and effec-
tiveness testing’ means testing—
‘‘(i) which occurs after the date such 
new animal drug is designated under this 
section and before the date on which an 
application with respect to such drug is 
submitted under section 512; and
‘‘(ii) which is carried out under an in-
vestigational 
exemption 
under 
section 
512(j). 
‘‘(B) The term ‘manufacturing expenses’ 
means expenses incurred in developing proc-
esses and procedures associated with manufac-
ture of the designated new animal drug which 
occur after the new animal drug is designated 
under this section and before the date on which 
an application with respect to such new animal 
drug is submitted under section 512 or 571. 
‘‘(c) EXCLUSIVITY FOR DESIGNATED NEW ANIMAL 
DRUGS.—
‘‘(1) Except as provided in subsection (c)(2), if 
the Secretary—
‘‘(A) approves or conditionally approves an 
application for a designated new animal drug, 
and no active ingredient (including any salt or 
ester of the active ingredient) of that des-
ignated new animal drug has been approved or 
conditionally approved previously, the Secretary 
may not approve or conditionally approve an-
other application submitted for a new animal 
drug with the same active ingredient and in-
tended use as the designated new animal drug
for another applicant before the expiration of 
ten years from the date of the approval or con-
ditional approval of the application. 
‘‘(B) approves or conditionally approves an 
application for a designated new animal drug, 
and an active ingredient (including an ester or 
salt of the active ingredient) of that designated 
new animal drug has been approved or condi-
tionally approved previously, the Secretary may 
not approve or conditionally approve another 
application submitted for a new animal drug 
with the same active ingredient and intended 
use as the designated new animal drug for an-
other applicant before the expiration of seven 
years from the date of approval or conditional 
approval of the application. 
‘‘(2) If an application filed pursuant to section 
512 or section 571 is approved for a designated new 
animal drug, the Secretary may, during the 10-year 
or 7-year exclusivity period beginning on the date of 
the application approval or conditional approval, ap-
prove or conditionally approve another application 
under section 512 or section 571 for such drug for 
such minor use or minor species for another appli-
cant if—
‘‘(A) the Secretary finds, after providing 
the holder of such an approved application no-
tice and opportunity for the submission of 
views, that in the granted exclusivity period the 
holder of the approved application cannot as-
sure the availability of sufficient quantities of 
the drug to meet the needs for which the drug 
was designated; or 
‘‘(B) such holder provides written consent 
to the Secretary for the approval or conditional 
approval of other applications before the expira-
tion of such exclusivity period.’’. 
(g) CONFORMING AMENDMENTS.—
(1) Section 201(u) of the Federal Food, Drug, 
and Cosmetic Act is amended by striking ‘‘512’’ and 
inserting ‘‘512, 571’’. 
(2) Section 201(v) of the Federal Food, Drug, 
and Cosmetic Act is amended by inserting the fol-
lowing after paragraph (2): ‘‘Provided that any drug 
intended for minor use or use in a minor species 
that is not the subject of a final regulation published 
by the Secretary through notice and comment rule-
making finding that the criteria of paragraphs (1) 
and (2) have not been met (or that the exception to
the criterion in paragraph (1) has been met) is a 
new animal drug.’’. 
(3) Section 301(e) of the Federal Food, Drug, 
and 
Cosmetic 
Act 
is 
amended 
by 
striking 
‘‘512(a)(4)(C), 512(j), (l) or (m)’’ and inserting 
‘‘512(a)(4)(C), 512 (j), (l) or (m), 572(i).’’
(4) Section 301(j) of the Federal Food, Drug, 
and Cosmetic Act is amended by deleting ‘‘520’’ and 
inserting ‘‘520, 571, 572, 573.’’
(5) Section 502 of the Federal Food, Drug, and 
Cosmetic Act is amended by adding at the end the 
following new subsection: 
‘‘(u) If it is a new animal drug—
‘‘(1) that is conditionally approved under sec-
tion 571 and its labeling does not conform with the 
approved application or section 571(f), or that is not 
conditionally approved under section 571 and its 
label bears the statement set forth in section 
571(f)(1)(A); or 
‘‘(2) that is indexed under section 572 and its 
labeling does not conform with the index listing 
under section 572(e) or 572(h), or that has not been 
indexed under section 572 and its label bears the 
statement set forth in section 572(h).’’.
(6) Section 503(f) of the Federal Food, Drug, 
and Cosmetic Act is amended by—
(A) in paragraph (1)(A)(ii) by striking 
‘‘512’’ and inserting ‘‘512, a conditionally-ap-
proved application under section 571, or an 
index listing under section 572’’; and 
(B) in paragraph (3) by striking ‘‘section 
512’’ and inserting ‘‘section 512, 571, or 572’’. 
(7) Section 504(a)(1) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘512(b)’’ and inserting ‘‘512(b), a conditionally-ap-
proved application filed pursuant to section 571, or 
an index listing pursuant to section 572’’. 
(8) Sections 504(a)(2)(B) and 504(b) of the 
Federal Food, Drug, and Cosmetic Act are amended 
by striking ‘‘512(i)’’ each place it appears and in-
serting ‘‘512(i), or the index listing pursuant to sec-
tion 572(e)’’. 
(9) Section 512(a) of the Federal Food, Drug, 
and Cosmetic Act is amended by striking paragraphs 
(1) and (2) and inserting the following: 
‘‘(1) A new animal drug shall, with respect to any 
particular use or intended use of such drug, be deemed 
unsafe for purposes of section 501(a)(5) and section 
402(a)(2)(C)(ii) 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 such 
drug, its labeling, and such use conform to such ap-
proved application; 
‘‘(B) there is in effect a conditional approval of 
an application filed pursuant to section 571 with re-
spect to such use or intended use of such drug, and 
such drug, its labeling, and such use conform to 
such conditionally approved application; or 
‘‘(C) there is in effect an index listing pursuant 
to section 572 with respect to such use or intended 
use of such drug in a minor species, and such drug, 
its labeling, and such use conform to such index list-
ing. 
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 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 pur-
poses of section 501(a)(6) unless—
‘‘(A) there is in effect—
‘‘(i) an approval of an application filed 
pursuant to subsection (b) with respect to such 
drug, as used in such animal feed, and such 
animal feed and its labeling, distribution, hold-
ing, and use conform to such approved applica-
tion; 
‘‘(ii) a conditional approval of an applica-
tion filed pursuant to section 571 with respect 
to such drug, as used in such animal feed, and 
such animal feed and its labeling, distribution, 
holding, and use conform to such conditionally 
approved application; or 
‘‘(iii) an index listing pursuant to section 
572 with respect to such drug, as used in such 
animal feed, and such animal feed and its label-
ing, distribution, holding, and use conform to 
such index listing; and
‘‘(B) such animal feed is manufactured at a site 
for which there is in effect a license issued pursuant 
to subsection (m)(1) to manufacture such animal 
feed.’’. 
(10) Section 512(b)(3) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘under paragraph (1) or a request for an investiga-
tional exemption under subsection (j)’’ and inserting 
‘‘under paragraph (1), section 571, or a request for 
an investigational exemption under subsection (j)’’. 
(11) Section 512(d)(4) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘have previously been separately approved’’ and in-
serting ‘‘have previously been separately approved 
pursuant to an application submitted under section 
512(b)(1)’’. 
(12) Section 512(f) of the Federal Food, Drug, 
and Cosmetic Act is amended by striking ‘‘sub-
section (d), (e), or (m)’’ and inserting ‘‘subsection 
(d), (e), or (m), or section 571 (c), (d), or (e)’’. 
(13) Section 512(g) of the Federal Food, Drug, 
and Cosmetic Act is amended by striking ‘‘this sec-
tion’’ and inserting ‘‘this section, or section 571’’. 
(14) Section 512(i) of the Federal Food, Drug, 
and Cosmetic Act is amended by striking ‘‘sub-