‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, AND REFUNDS.—To qualify for consideration for 
a waiver or reduction under subsection (d), or for a refund 
of any fee collected in accordance with subsection (a), a 
person shall submit to the Secretary a written request for 
such waiver, reduction, or refund not later than 180 days 
after such fee is due. 
‘‘(j) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not 
engaged in the process of the review of abbreviated appli-
cations for generic new animal drugs, be reduced to offset 
the number of officers, employees, and advisory commit-
tees so engaged. 
‘‘(k) DEFINITIONS.—In this section and section 742: 
‘‘(1) ABBREVIATED
APPLICATION
FOR
A
GE-
NERIC NEW ANIMAL DRUG.—The terms ‘abbreviated 
application for a generic new animal drug’ and ‘ab-
breviated application’ mean an abbreviated applica-
tion for the approval of any generic new animal drug 
submitted under section 512(b)(2). Such term does 
not include a supplemental abbreviated application 
for a generic new animal drug. 
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‘‘(2) ADJUSTMENT
FACTOR.—Subject to sub-
sections (f)(1) and (g)(2)(A)(ii), the term ‘adjust-
ment factor’ applicable to a fiscal year refers to the 
formula set forth in section 735(8). 
‘‘(3) COSTS
OF
RESOURCES
ALLOCATED
FOR 
THE PROCESS FOR THE REVIEW OF ABBREVIATED 
APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.— 
The term ‘costs of resources allocated for the proc-
ess for the review of abbreviated applications for ge-
neric new animal drugs’ means the expenses in-
curred in connection with the process for the review 
of abbreviated applications for generic new animal 
drugs for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees consulted with respect to the review of 
specific abbreviated applications, supplemental 
abbreviated applications, or investigational sub-
missions, and costs related to such officers, em-
ployees, committees, and contractors, including 
costs for travel, education, and recruitment and 
other personnel activities; 
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‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(D) collecting fees under this section and 
accounting for resources allocated for the re-
view of abbreviated applications, supplemental 
abbreviated applications, and investigational 
submissions. 
‘‘(4) FINAL
DOSAGE
FORM.—The term ‘final 
dosage form’ means, with respect to a generic new 
animal drug product, a finished dosage form which 
is approved for administration to an animal without 
substantial further manufacturing. Such term in-
cludes generic new animal drug products intended 
for mixing in animal feeds. 
‘‘(5) GENERIC NEW ANIMAL DRUG.—The term 
‘generic new animal drug’ means a new animal drug 
that is the subject of an abbreviated application. 
‘‘(6) GENERIC NEW ANIMAL DRUG PRODUCT.— 
The term ‘generic new animal drug product’ means 
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each specific strength or potency of a particular ac-
tive ingredient or ingredients in final dosage form 
marketed by a particular manufacturer or dis-
tributor, which is uniquely identified by the labeler 
code and product code portions of the national drug 
code, and for which an abbreviated application for a 
generic new animal drug or a supplemental abbre-
viated application has been approved. 
‘‘(7) GENERIC NEW ANIMAL DRUG SPONSOR.— 
The term ‘generic new animal drug sponsor’ means 
either an applicant named in an abbreviated applica-
tion for a generic new animal drug that has not been 
withdrawn, or a person who has submitted an inves-
tigational submission for a generic new animal drug 
that has not been terminated or otherwise rendered 
inactive by the Secretary. 
‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE-
NERIC NEW ANIMAL DRUG.—The terms ‘investiga-
tional submission for a generic new animal drug’ 
and ‘investigational submission’ mean— 
‘‘(A) the filing of a claim for an investiga-
tional exemption under section 512(j) for a ge-
neric new animal drug intended to be the sub-
ject of an abbreviated application or a supple-
mental abbreviated application; or 
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‘‘(B) the submission of information for the 
purpose of enabling the Secretary to evaluate 
the safety or effectiveness of a generic new ani-
mal drug in the event of the filing of an abbre-
viated application or supplemental abbreviated 
application for such drug. 
‘‘(9) PERSON.—The term ‘person’ includes an 
affliliate thereof (as such term is defined in section 
735(11)). 
‘‘(10) PROCESS FOR THE REVIEW OF ABBRE-
VIATED APPLICATIONS FOR GENERIC NEW ANIMAL 
DRUGS.—The term ‘process for the review of abbre-
viated applications for generic new animal drugs’ 
means the following activities of the Secretary with 
respect to the review of abbreviated applications, 
supplemental abbreviated applications, and inves-
tigational submissions: 
‘‘(A) The activities necessary for the re-
view of abbreviated applications, supplemental 
abbreviated applications, and investigational 
submissions. 
‘‘(B) The issuance of action letters which 
approve abbreviated applications or supple-
mental abbreviated applications or which set 
forth in detail the specific deficiencies in abbre-
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viated applications, supplemental abbreviated 
applications, or investigational submissions and, 
where appropriate, the actions necessary to 
place such applications, supplemental applica-
tions, or submissions in condition for approval. 
‘‘(C) The inspection of generic new animal 
drug establishments and other facilities under-
taken as part of the Secretary’s review of pend-
ing abbreviated applications, supplemental ab-
breviated applications, and investigational sub-
missions. 
‘‘(D) Monitoring of research conducted in 
connection with the review of abbreviated appli-
cations, supplemental abbreviated applications, 
and investigational submissions. 
‘‘(E) The development of regulations and 
policy related to the review of abbreviated appli-
cations, supplemental abbreviated applications, 
and investigational submissions. 
‘‘(F) Development of standards for prod-
ucts subject to review. 
‘‘(G) Meetings between the agency and the 
generic new animal drug sponsor. 
‘‘(H) Review of advertising and labeling 
prior to approval of an abbreviated application 
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