100 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M001 
202 
Study protocol 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient (4) 
7,938 
M002 
203 
Completed study 
requiring 
Human Stud-
ies Review 
Board review 
as defined in 
40 CFR Part 
26 in support 
of an active 
ingredient (4) 
7,938 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00100
Fmt 6652
Sfmt 6201
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS
101 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M003 
204 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
less than 12 
months. Appli-
cant initiated 
request based 
on a require-
ment of the 
Administrator, 
as defined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00101
Fmt 6652
Sfmt 6201
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS
102 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M004 
205 
External tech-
nical peer re-
view of new 
active ingre-
dient, product, 
or amendment 
(e.g., consulta-
tion with 
FIFRA Sci-
entific Advi-
sory Panel) 
for an action 
with a decision 
timeframe of 
greater than 
12 months. 
Applicant ini-
tiated request 
based on a re-
quirement of 
the Adminis-
trator, as de-
fined by 
FIFRA § 
25(d), in sup-
port of a novel 
active ingre-
dient, or 
unique use 
pattern or ap-
plication tech-
nology. Ex-
cludes PIP ac-
tive ingredi-
ents. (5) 
63,945 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00102
Fmt 6652
Sfmt 6201
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS
103 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M005 
206 
New Product: 
Combination, 
Contains a 
combination of 
active ingredi-
ents from a 
registered and/ 
or unregis-
tered source; 
conventional, 
antimicrobial 
and/or biopes-
ticide. Re-
quires coordi-
nation with 
other regu-
latory divi-
sions to con-
duct review of 
data, label 
and/or verify 
the validity of 
existing data 
as cited. Only 
existing uses 
for each active 
ingredient in 
the combina-
tion product. 
(6)(7) 
22,050 
M006 
207 
Request for up 
to 5 letters of 
certification 
(Gold Seal) 
for one ac-
tively reg-
istered prod-
uct (excludes 
distributor 
products) (8) 
277 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00103
Fmt 6652
Sfmt 6201
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS
104 
‘‘TABLE 19. — EXTERNAL REVIEW AND 
MISCELLANEOUS ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review 
Time 
(Months)(1) 
FY’17 & 
FY’18 Reg-
istration 
Service Fee 
($) 
M007 
208 
Request to ex-
tend Exclusive 
Use of data as 
provided by 
FIFRA Sec-
tion 
3(c)(1)(F)(ii) 
5,513 
M008 
209 
Request to grant 
Exclusive Use 
of data as pro-
vided by 
FIFRA Sec-
tion 
3(c)(1)(F)(vi) 
for a minor 
use, when a 
FIFRA Sec-
tion 2(ll)(2) 
determination 
is required 
1,654 
M009 
210 (new) Non-FIFRA 
Regulated De-
termination: 
Applicant ini-
tiated, per 
product 
2,363 
M010 
211 (new) Conditional rul-
ing on pre-ap-
plication, 
product sub-
stantial simi-
larity 
2,363 
M011 
212 (new) Label amend-
ment to add 
the DfE logo; 
requires data 
review; no 
other label 
changes (9) 
3,648 
(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. 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00104
Fmt 6652
Sfmt 6201
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS
105 
(2) If another covered application is submitted that depends upon an applica-
tion to approve an inert ingredient, each application will be subject to its respec-
tive registration service fee. The decision review time line for both submissions 
will be the longest of the associated applications. If the application covers mul-
tiple ingredients grouped by EPA into one chemical class, a single registration 
service fee will be assessed for approval of those ingredients. 
(3) If EPA data rules are amended to newly require clearance under section 
408 of the FFDCA for an ingredient of an antimicrobial product where such in-
gredient was not previously subject to such a clearance, then review of the data 
for such clearance of such product is not subject to a registration service fee for 
the tolerance action for two years from the effective date of the rule. 
(4) Any other covered application that is associated with and dependent on 
the HSRB review will be subject to its separate registration service fee. The de-
cision review times for the associated actions run concurrently, but will end at 
the date of the latest review time. 
(5) Any other covered application that is associated with and dependent on 
the SAP review will be subject to its separate registration service fee. The deci-
sion review time for the associated action will be extended by the decision review 
time for the SAP review. 
(6) 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. 
(7) Where the action involves approval of a new or amended label, on or be-
fore the end date of the decision review time, the Agency shall provide to the ap-
plicant 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 requests 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 dif-
ference(s); or (c) withdraws the application without prejudice for subsequent re-
submission, but forfeits the associated registration service fee. For cases de-
scribed in (b), the applicant shall have up to 30 calendar days to reach agree-
ment with the Agency on the final terms of the Agency-accepted label. If the ap-
plicant 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 Agen-
cy-stamped label to the registrant within 2 business days following the reg-
istrant’s written or electronic confirmation of agreement to the Agency. 
(8) Due to low fee and short time frame this category is not eligible for small 
business waivers. Gold seal applies to one registered product. 
(9) This category includes amendments the sole purpose of which is to add 
DfE (or equivalent terms that do not use ‘‘safe’’ or derivatives of ‘‘safe’’) logos 
to a label. DfE is a voluntary program. A label bearing a DfE logo is not con-
sidered an Agency endorsement because the ingredients in the qualifying prod-
uct must meet objective, scientific criteria established and widely publicized by 
EPA.’’. 
Æ 
VerDate Sep 11 2014 
00:32 Feb 15, 2017
Jkt 069200
PO 00000
Frm 00105
Fmt 6652
Sfmt 6301
E:\BILLS\H1029.IH
H1029
SSpencer on DSK4SPTVN1PROD with BILLS