(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant- 
initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 
3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amend-
ments handled by the Antimicrobials Division are to be completed within the timelines specified in 
FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amend-
ments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR 
Notice timelines and are not subject to registration service fees. (e) Submissions with data and re-
quiring data review are subject to registration service fees. 
(3) Where the action involves approval of a new or amended label, on or before the end date of the 
decision review time, the Agency shall provide to the applicant a draft accepted label, including any 
changes made by the Agency that differ from the applicant-submitted label and relevant supporting 
data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) 
agrees to all of the terms associated with the draft accepted label as amended by the Agency and re-
quests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or 
more of the terms of the draft accepted label as amended by the Agency and requests additional 
time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent 
resubmission, but forfeits the associated registration service fee. For cases described in (b), the ap-
plicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of 
the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), 
including upon resolution of differences in (b), the Agency shall provide an accepted final Agency- 
stamped label to the registrant within 2 business days following the registrant’s written or electronic 
confirmation of agreement to the Agency. 
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B690 
142 
New active in-
gredient; food 
or non-food 
use. (2)(6) 
2,554 
B700 
143 
Experimental 
Use Permit 
application; 
new active in-
gredient or 
new use. (6) 
1,278 
B701 
144 
Extend or amend 
Experimental 
Use Permit. 
(6) 
1,278
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B710 
145 
New product; 
registered 
source of ac-
tive ingre-
dient(s); iden-
tical or sub-
stantially simi-
lar in composi-
tion and use 
to a registered 
product; no 
change in an 
established tol-
erance or tol-
erance exemp-
tion. No data 
review, or only 
product chem-
istry data; 
cite-all data ci-
tation, or se-
lective data ci-
tation where 
applicant owns 
all required 
data or au-
thorization 
from data 
owner is dem-
onstrated. 
Category in-
cludes 100% 
re-package of 
registered end- 
use or manu-
facturing-use 
product that 
requires no 
data submis-
sion or data 
matrix. (3)(6) 
1,278
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B720 
146 
New product; 
registered 
source of ac-
tive ingre-
dient(s); re-
quires: 1) sub-
mission of 
product spe-
cific data; or 
2) citation of 
previously re-
viewed and ac-
cepted data; or 
3) submission 
or citation of 
data generated 
at government 
expense; or 4) 
submission or 
citation of a 
scientifically- 
sound ration-
ale based on 
publicly avail-
able literature 
or other rel-
evant informa-
tion that ad-
dresses the 
data require-
ment; or 5) 
submission of 
a request for a 
data require-
ment to be 
waived sup-
ported by a 
scientifically- 
sound ration-
ale explaining 
why the data 
requirement 
does not 
apply. (3)(6) 
1,278
‘‘TABLE 15. — BIOPESTICIDES DIVISION — SCLP— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
B721 
147 
New product; 
unregistered 
source of ac-
tive ingre-
dient. (3)(6) 
2,676 
B722 
148 
New use and/or 
amendment; 
petition to es-
tablish a toler-
ance or toler-
ance exemp-
tion. (4)(5)(6) 
2,477 
B730 
149 
Label amend-
ment requiring 
data submis-
sion. (4)(6) 
1,278 
(1) A decision review time that would otherwise end on a Saturday, Sunday, 
or federal holiday, will be extended to end on the next business day. 
(2) All requests for new uses (food and/or nonfood) contained in any applica-
tion for a new active ingredient or a first food use are covered by the base fee 
for that new active ingredient or first food use application and retain the same 
decision time review period as the new active ingredient or first food use applica-
tion. The application must be received by the agency in one package. The base 
fee for the category covers a maximum of five new products. Each application 
for an additional new product registration and new inert approval that is sub-
mitted in the new active ingredient application package or first food use applica-
tion package is subject to the registration service fee for a new product or a new 
inert approval. All such associated applications that are submitted together will 
be subject to the new active ingredient or first food use decision review time. In 
the case of a new active ingredient application, until that new active ingredient 
is approved, any subsequent application for another new product containing the 
same active ingredient or an amendment to the proposed labeling will be deemed 
a new active ingredient application, subject to the registration service fee and 
decision review time for a new active ingredient. In the case of a first food use 
application, until that first food use is approved, any subsequent application for 
an additional new food use or uses will be subject to the registration service fee 
and decision review time for a first food use. Any information that (a) was nei-
ther requested nor required by the Agency, and (b) is submitted by the applicant 
at the applicant’s initiative to support the application after completion of the 
technical deficiency screening, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the new active 
ingredient or first food use application. 
(3) An application for a new end-use product using a source of active ingre-
dient that (a) is not yet registered but (b) has an application pending with the 
Agency for review, will be considered an application for a new product with an 
unregistered source of active ingredient.