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 applica-
tions for generic new animal drugs, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged. 
‘‘(k) DEFINITIONS.—In this section and section 742: 
‘‘(1) ABBREVIATED APPLICATION FOR A GENERIC 
NEW ANIMAL DRUG.—The terms ‘abbreviated applica-
tion for a generic new animal drug’ and ‘abbreviated 
application’ mean an abbreviated application 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. 
‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ applicable to a fiscal year is the Con-
sumer Price Index for all urban consumers (all items; 
United States city average) for October of the pre-
ceding fiscal year divided by— 
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‘‘(A) for purposes of subsection (f)(1), such 
Index for October 2002; and 
‘‘(B) for purposes of subsection (g)(2)(A)(ii), 
such Index for October 2007. 
‘‘(3) COSTS OF RESOURCES ALLOCATED FOR THE 
PROCESS FOR THE REVIEW OF ABBREVIATED APPLI-
CATIONS
FOR
GENERIC
NEW
ANIMAL
DRUGS.—The 
term ‘costs of resources allocated for the process for the 
review of abbreviated applications for generic new 
animal drugs’ means the expenses incurred in connec-
tion with the process for the review of abbreviated ap-
plications for generic new animal drugs for— 
‘‘(A) officers and employees of the Food and 
Drug Administration, contractors of the Food 
and Drug Administration, advisory committees 
consulted with respect to the review of specific 
abbreviated applications, supplemental abbre-
viated applications, or investigational submis-
sions, and costs related to such officers, employ-
ees, committees, and contractors, including costs 
for travel, education, and recruitment and other 
personnel activities; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
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‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equip-
ment, and other necessary materials and sup-
plies; and 
‘‘(D) collecting fees under this section and 
accounting for resources allocated for the review 
of abbreviated applications, supplemental abbre-
viated applications, and investigational submis-
sions. 
‘‘(4) FINAL DOSAGE FORM.—The term ‘final dos-
age form’ means, with respect to a generic new ani-
mal 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 
each specific strength or potency of a particular ac-
tive ingredient or ingredients in final dosage form 
marketed by a particular manufacturer or dis-
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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 by the applicant and for which approval 
has not been withdrawn by the Secretary, or a person 
who has submitted an investigational submission for 
a generic new animal drug that has not been termi-
nated 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 subject 
of an abbreviated application or a supplemental 
abbreviated application; or 
‘‘(B) the submission of information for the 
purpose of enabling the Secretary to evaluate the 
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safety or effectiveness of a generic new animal 
drug in the event of the filing of an abbreviated 
application or supplemental abbreviated applica-
tion for such drug. 
‘‘(9) PERSON.—The term ‘person’ includes an af-
filiate 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, sup-
plemental abbreviated applications, and investiga-
tional submissions: 
‘‘(A) The activities necessary for the review 
of abbreviated applications, supplemental abbre-
viated applications, and investigational submis-
sions. 
‘‘(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-
viated applications, supplemental abbreviated 
applications, or investigational submissions and, 
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where appropriate, the actions necessary to place 
such applications, supplemental applications, 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 products 
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 
or supplemental abbreviated application, but not 
after such application has been approved. 
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