H. R. 2617—1572 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R310 
New end-use or manu-
facturing-use product 
with registered 
source(s) of active in-
gredient(s); includes 
products containing 
two or more registered 
active ingredients pre-
viously combined in 
other registered prod-
ucts; excludes products 
requiring or citing an 
animal safety study; 
requires review of data 
package within RD 
only; includes data 
and/or waivers of data 
for only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
4. Child-resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy – for up to 3 tar-
get pests. (2) (3) (4) 
10,466
H. R. 2617—1573 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R314 
New end-use product 
containing up to three 
registered active ingre-
dients never before 
registered as this com-
bination in a formu-
lated product; new 
product label is iden-
tical or substantially 
similar to the labels of 
currently registered 
products which sepa-
rately contain the re-
spective component ac-
tive ingredients; ex-
cludes products requir-
ing or citing an animal 
safety study; requires 
review of data package 
within RD only; in-
cludes data and/or 
waivers of data for 
only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy (4) for up to 3 tar-
get pests. (2) (3) 
12,364
H. R. 2617—1574 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R319 
New end-use product 
containing up to three 
registered active ingre-
dients never before 
registered as this com-
bination in a formu-
lated product; new 
product label is iden-
tical or substantially 
similar to the labels of 
currently registered 
products which sepa-
rately contain the re-
spective component ac-
tive ingredients; ex-
cludes products requir-
ing or citing an animal 
safety study; requires 
review of data package 
within RD only; in-
cludes data and/or 
waivers of data for 
only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy (4) - for 4 to 7 tar-
get pests. (2) (3) 
18,097
H. R. 2617—1575 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R318 
New end-use product 
containing four or 
more registered active 
ingredients never be-
fore registered as this 
combination in a for-
mulated product; new 
product label is iden-
tical or substantially 
similar to the labels of 
currently registered 
products which sepa-
rately contain the re-
spective component ac-
tive ingredients; ex-
cludes products requir-
ing or citing an animal 
safety study; requires 
review of data package 
within RD only; in-
cludes data and/or 
waivers of data for 
only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy – for up to 3 tar-
get pests. (2) (3) (4) 
18,994
H. R. 2617—1576 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R321 
New end-use product 
containing four or 
more registered active 
ingredients never be-
fore registered as this 
combination in a for-
mulated product; new 
product label is iden-
tical or substantially 
similar to the labels of 
currently registered 
products which sepa-
rately contain the re-
spective component ac-
tive ingredients; ex-
cludes products requir-
ing or citing an animal 
safety study; requires 
review of data package 
within RD only; in-
cludes data and/or 
waivers of data for 
only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy (4) - for 4 to 7 tar-
get pests. (2) (3) 
24,727 
R315 
New end-use on-animal 
product, registered 
source of active ingre-
dient(s) with submis-
sion of data and/or 
waivers for only: 
1. animal safety and 
2. pest(s) requiring effi-
cacy and/or 
3. product chemistry 
and/or 
4. acute toxicity and/or 
5. child resistant pack-
aging. (2) (3) (4) 
14,075
H. R. 2617—1577 
‘‘TABLE 4. — REGISTRATION DIVISION (RD) — NEW 
PRODUCTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registra-
tion 
Service 
Fee 
($) 
R316 
New end-use or manu-
facturing-use product 
with registered 
source(s) of active in-
gredient(s) including 
products containing 
two or more registered 
active ingredients pre-
viously combined in 
other registered prod-
ucts; excludes products 
requiring or citing an 
animal safety study; 
and requires review of 
data and/or waivers 
for only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. pest(s) requiring effi-
cacy - for 4 to 7 target 
pests. (2) (3) (4) 
16,199 
R317 
New end-use or manu-
facturing-use product 
with registered 
source(s) of active in-
gredient(s) including 
products containing 
two or more registered 
active ingredients pre-
viously combined in 
other registered prod-
ucts; excludes products 
requiring or citing an 
animal safety study; 
and requires review of 
data and/or waivers 
for only: 
1. product chemistry 
and/or 
2. acute toxicity and/or 
3. child resistant pack-
aging and/or 
4. Pest(s) requiring effi-
cacy - for greater than 
7 target pests, (2) (3) 
(4) 
21,932
H. R. 2617—1581 
(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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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. 
(4) For the purposes of classifying proposed registration actions into PRIA cat-
egories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests. In-
vertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), struc-
tural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain 
invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are 
listed in the product performance rule, subpart R of part 158 of title 40, Code of 
Federal Regulations. This list may be updated/refined as invasive pest needs arise. 
All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 
2002-1. To determine the number of pests for the PRIA categories, pest groups, sub-
groups, and pest specific claims as listed in part 158 of title 40, Code of Federal 
Regulations, should be counted as follows. If seeking a label claim against a general 
pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. 
If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or 
specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, 
then each subgroup or specific pest will count as 1. 
(5) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 5. — REGISTRATION DIVISION (RD) — 
AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R340 
Amendment requiring 
data review within 
RD (e.g., changes to 
precautionary label 
statements); in-
cludes adding/modi-
fying pest(s) claims 
for up to 2 target 
pests; excludes 
products requiring 
or citing an animal 
safety study. (2) (3) 
7,150
H. R. 2617—1582 
‘‘TABLE 5. — REGISTRATION DIVISION (RD) — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R341 
Amendment requiring 
data review within 
RD (e.g., changes to 
precautionary label 
statements), in-
cludes adding/modi-
fying pest(s) claims 
for greater than 2 
target pests; ex-
cludes products re-
quiring or citing an 
animal safety study. 
(2) (3) 
8,584 
R345 
Amending on-animal 
products previously 
registered, with the 
submission of data 
and/or waivers for 
only: 
1. animal safety and 
2. pest(s) requiring ef-
ficacy and/or 
3. product chemistry 
and/or 
4. acute toxicity and/ 
or 
5. child resistant 
packaging. (2) (3) 
(4) 
12,643 
R350 
Amendment requiring 
data review in 
science divisions 
(e.g., changes to Re-
stricted Entry In-
terval, or Personal 
Protective Equip-
ment, or Preharvest 
Interval, or use 
rate, or number of 
applications; or add 
aerial application; 
or modify Ground 
Water/Surface 
Water advisory 
statement). (2) (3) 
(5) 
18,958 
R351 
Amendment adding a 
new unregistered 
source of active in-
gredient. (2) (3) 
18,958
H. R. 2617—1583 
‘‘TABLE 5. — REGISTRATION DIVISION (RD) — 
AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R352 
Amendment adding 
already approved 
uses; selective 
method of support; 
does not apply if 
the applicant owns 
all cited data. (2) (3) 
18,958 
R371 
Amendment to Exper-
imental Use Permit; 
(does not include 
extending a per-
mit’s time period). 
(3) 
14,463 
(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) (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 section 3(c)(3)(B) and are not subject to registration service 
fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials 
Division are to be completed within the timelines specified in section 3(h) and are 
not subject to registration service fees. (d) Registrant initiated amendments sub-
mitted 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 requiring 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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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. 
(4) For the purposes of classifying proposed registration actions into PRIA cat-
egories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests. In-
vertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), struc-
tural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain 
invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are 
listed in the product performance rule, subpart R of part 158 of title 40, Code of 
Federal Regulations. This list may be updated/refined as invasive pest needs arise. 
All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 
2002-1. To determine the number of pests for the PRIA categories, pest groups, sub-
groups, and pest specific claims as listed in part 158 of title 40, Code of Federal 
Regulations, should be counted as follows. If seeking a label claim against a general 
pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. 
If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or 
specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, 
then each subgroup or specific pest will count as 1.
H. R. 2617—1584 
(5) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 6. — REGISTRATION DIVISION (RD) — OTHER 
ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
R124 
Conditional Ruling on 
Pre-application 
Study Waivers; ap-
plicant-initiated. 
3,627 
R272 
Review of Study Pro-
tocol applicant- ini-
tiated; excludes 
Data Analysis Re-
porting Tool, pre- 
registration con-
ference, Rapid Re-
sponse review, de-
velopmental 
neurotoxicity pro-
tocol review, pro-
tocol needing 
Human Studies Re-
view Board review, 
companion animal 
safety protocol. 
3,627 
R275 
Rebuttal of Agency re-
viewed protocol, ap-
plicant initiated. 
3,627 
R278 
(new) 
Review of Protocol for 
companion animal 
safety study. 
4,927 
R279 
(new) 
Comparative product 
determination for 
reduced risk sub-
mission, applicant 
initiated; submitted 
before application 
for reduced risk 
new active ingre-
dient or reduced 
risk new use. 
5,200 
(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.
H. R. 2617—1585 
‘‘TABLE 7. — ANTIMICROBIAL DIVISION (AD) — NEW ACTIVE 
INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A380 
New Active Ingre-
dient; Indirect Food 
use; establish toler-
ance or tolerance 
exemption if re-
quired. (2) (3) (4) 
227,957 
A390 
New Active Ingre-
dient; Direct Food 
use; establish toler-
ance or tolerance 
exemption if re-
quired. (2) (3) (4) 
329,265 
A410 
New Active Ingredient 
Non-food use. (2) (3) 
(4) 
278,659 
A431 
New Active Ingre-
dient, Non-food use; 
low-risk. (2) (3) (4) 
114,984 
(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 application 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 re-
view period as the new active ingredient or first food use application. The applica-
tion 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 submitted in the new active in-
gredient application package or first food use application package is subject to the 
registration service fee for a new product or a new inert approval. All such associ-
ated applications that are submitted together will be subject to the new active ingre-
dient 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 applica-
tion for another new product containing the same active ingredient or an amend-
ment 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 in-
gredient. In the case of a first food use application, until that first food use is ap-
proved, 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 neither 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 preliminary technical screening, and (c) is not itself a cov-
ered registration application, must be assessed 25% of the full registration service 
fee for the new active ingredient or first food use application.
H. R. 2617—1586 
(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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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. 
(4) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 8. — ANTIMICROBIAL DIVISION (AD) — NEW USES 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A440 
New Use, Indirect 
Food Use, establish 
tolerance or toler-
ance exemption. (2) 
(3) (4) (6) 
45,737 
A441 
Additional Indirect 
food uses; establish 
tolerances or toler-
ance exemptions if 
required; 6 or more 
submitted in one 
application. (3) (4) 
(5) (6) 
164,639 
A450 
New use, Direct food 
use, establish toler-
ance or tolerance 
exemption. (2) (3) 
(4) (6) 
137,198 
A451 
Additional Direct food 
uses; establish tol-
erances or tolerance 
exemptions if re-
quired; 6 or more 
submitted in one 
application. (3) (4) 
(5) (6) 
261,333 
A500 
New use, non-food. (4) 
(5) (6) 
45,737
H. R. 2617—1587 
‘‘TABLE 8. — ANTIMICROBIAL DIVISION (AD) — NEW USES— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A501 
New use, non-food; 6 
or more submitted 
in one application. 
(4) (5) (6) 
109,764 
(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 application 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 re-
view period as the new active ingredient or first food use application. The applica-
tion 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 submitted in the new active in-
gredient application package or first food use application package is subject to the 
registration service fee for a new product or a new inert approval. All such associ-
ated applications that are submitted together will be subject to the new active ingre-
dient 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 applica-
tion for another new product containing the same active ingredient or an amend-
ment 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 in-
gredient. In the case of a first food use application, until that first food use is ap-
proved, 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 neither 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 preliminary technical screening, and (c) is not itself a cov-
ered registration application, must be assessed 25% of the full registration service 
fee for the new active ingredient or first food use application. 
(3) If EPA data rules are amended to newly require clearance under section 408 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) for an ingredient of an 
antimicrobial product where such ingredient 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) 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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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.
H. R. 2617—1588 
(5) Amendment applications to add the new use(s) to registered product labels are 
covered by the base fee for the new use(s). All items in the covered application must 
be submitted together in one package. Each application for an additional new prod-
uct registration and new inert approval(s) that is submitted in the new use applica-
tion package is subject to the registration service fee for a new product or a new 
inert approval. However, if a new use application only proposes to register the new 
use for a new product and there are no amendments in the application, then review 
of one new product application is covered by the new use fee. All such associated ap-
plications that are submitted together will be subject to the new use decision review 
time. Any application for a new product or an amendment to the proposed labeling 
(a) submitted subsequent to submission of the new use application and (b) prior to 
conclusion of its decision review time and (c) containing the same new uses, will be 
deemed a separate new-use application, subject to a separate registration service fee 
and new decision review time for a new use. If the new-use application includes 
non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appro-
priate fee is due for each type of new use and the longest decision review time ap-
plies to all of the new uses requested in the application. Any information that (a) 
was neither requested nor required by the Agency, and (b) is submitted by the ap-
plicant at the applicant’s initiative to support the application after completion of the 
preliminary technical screening, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the new use appli-
cation. 
(6) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 9. — ANTIMICROBIAL DIVISION (AD) — NEW 
PRODUCTS AND AMENDMENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A530 
New product, iden-
tical or substan-
tially similar in 
composition and use 
to a registered prod-
uct; no data review 
or only product 
chemistry data; cite 
all data citation or 
selective data cita-
tion where appli-
cant owns all re-
quired data; or ap-
plicant submits spe-
cific authorization 
letter from data 
owner. Category 
also includes 100% 
re-package of reg-
istered end-use or 
manufacturing-use 
product that re-
quires no data sub-
mission nor data 
matrix. (2) (3) 
1,833
H. R. 2617—1589 
‘‘TABLE 9. — ANTIMICROBIAL DIVISION (AD) — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A531 
New product; iden-
tical or substan-
tially similar in 
composition and use 
to a registered prod-
uct; registered 
source of active in-
gredient: selective 
data citation only 
for data on product 
chemistry and/or 
acute toxicity and/or 
public health pest 
efficacy, where ap-
plicant does not 
own all required 
data and does not 
have a specific au-
thorization letter 
from data owner. 
(2) (3) 
2,616 
A532 
New product; iden-
tical or substan-
tially similar in 
composition and use 
to a registered prod-
uct; registered ac-
tive ingredient; un-
registered source of 
active ingredient; 
cite-all data citation 
except for product 
chemistry; product 
chemistry data sub-
mitted. (2) (3) 
7,322 
A550 
New end-use product; 
uses other than 
FIFRA §2(mm); 
non-FQPA product. 
(2) (3) (5) 
18,958 
A560 
New manufacturing- 
use product; reg-
istered active ingre-
dient; selective data 
citation. (2) (3) 
18,054
H. R. 2617—1590 
‘‘TABLE 9. — ANTIMICROBIAL DIVISION (AD) — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A565 
New manufacturing- 
use product; reg-
istered active ingre-
dient; unregistered 
source of active in-
gredient; submis-
sion of new generic 
data package; reg-
istered uses only; 
requires science re-
view. (2) (3) 
26,135 
A572 
New Product or 
amendment requir-
ing data review for 
risk assessment by 
Science Branch 
(e.g., changes to Re-
stricted Entry In-
terval, or Personal 
Protective Equip-
ment, or use rate). 
(2) (3) (4) (7) 
18,958 
A460 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 0 to 10 public 
health organisms. 
(2) (3) (5) (6) 
7,322 
A461 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 11 to 20 public 
health organisms. 
(2) (3) (5) (6) 
10,158 
A462 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 21 to 30 public 
health organisms. 
(2) (3) (5) (6) 
12,995 
A463 
100 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 31 to 40 public 
health organisms. 
(2) (3) (5) (6) 
15,831 
A464 
101 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 41 to 50 public 
health organisms. 
(2) (3) (5) (6) 
18,668
H. R. 2617—1591 
‘‘TABLE 9. — ANTIMICROBIAL DIVISION (AD) — NEW 
PRODUCTS AND AMENDMENTS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A465 
102 
(new) 
New end-use product; 
FIFRA §2(mm) uses 
only; 51 or more 
public health orga-
nisms. (2) (3) (5) (6) 
21,505 
A470 
103 
(new) 
Label amendment re-
quiring data review; 
0 to 10 public 
health organisms. 
(3) (4) (5) (6) 
5,493 
A471 
104 
(new) 
Label amendment re-
quiring data review; 
11 to 20 public 
health organisms. 
(3) (4) (5) (6) 
8,506 
A472 
105 
(new) 
Label amendment re-
quiring data review; 
21 to 30 public 
health organisms. 
(3) (4) (5) (6) 
10,219 
A473 
106 
(new) 
Label amendment re-
quiring data review; 
31 to 40 public 
health organisms. 
(3) (4) (5) (6) 
11,933 
A474 
107 
(new) 
Label amendment re-
quiring data review; 
41 to 50 public 
health organisms. 
(3) (4) (5) (6) 
13,646 
A475 
108 
(new) 
Label amendment re-
quiring data review; 
51 or more public 
health organisms. 
(3) (4) (5) (6) 
15,766 
(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) An application for a new end-use product using a source of active ingredient 
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.
H. R. 2617—1592 
(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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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. 
(4) (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 section 3(c)(3)(B) and are not subject to registration service 
fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials 
Division are to be completed within the timelines specified in section 3(h) and are 
not subject to registration service fees. (d) Registrant initiated amendments sub-
mitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 
98–10, continue under PR Notice timelines and are not subject to registration serv-
ice fees. (e) Submissions with data and requiring data review are subject to registra-
tion service fees. 
(5) The applicant must identify the substantially similar product if opting to use 
cite-all or the selective method to support acute toxicity data requirements. 
(6) Once an application for an amendment or a new product with public health or-
ganisms has been submitted and classified into any of categories A460 through 
A465 or A470 through A475, additional organisms submitted for the same product 
before the first application is granted will result in combination and reclassification 
of both the original and subsequent submissions into the appropriate new category 
based on the sum of the number of organisms in both submissions. Submission of 
additional organisms would result in a new PRIA start date and may require addi-
tional fees to meet the fee of a new category. 
(7) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 10. — ANTIMICROBIAL DIVISION (AD) — 
EXPERIMENTAL USE PERMITS AND OTHER ACTIONS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A520 
109 
Experimental Use 
Permit application, 
non-food use. (2) (3) 
9,151
H. R. 2617—1593 
‘‘TABLE 10. — ANTIMICROBIAL DIVISION (AD) — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A521 
110 
Review of public 
health efficacy 
study protocol with-
in AD, per AD In-
ternal Guidance for 
the Efficacy Pro-
tocol Review Proc-
ess; Code will also 
include review of 
public health effi-
cacy study protocol; 
applicant-initiated; 
Tier 1. 
6,776 
A522 
111 
Review of public 
health efficacy 
study protocol out-
side AD by mem-
bers of AD Efficacy 
Protocol Review Ex-
pert Panel; Code 
will also include re-
view of public 
health efficacy 
study protocol; ap-
plicant-initiated; 
Tier 2. 
17,424 
A537 
112 
New Active Ingre-
dient/New Use, Ex-
perimental Use Per-
mit application; Di-
rect food use; Estab-
lish tolerance or tol-
erance exemption if 
required. Credit 
45% of fee toward 
new active ingre-
dient/new use appli-
cation that follows. 
(3) 
219,512 
A538 
113 
New Active Ingre-
dient/New Use, Ex-
perimental Use Per-
mit application; In-
direct food use; Es-
tablish tolerance or 
tolerance exemption 
if required Credit 
45% of fee toward 
new active ingre-
dient/new use appli-
cation that follows. 
(3) 
137,198
H. R. 2617—1594 
‘‘TABLE 10. — ANTIMICROBIAL DIVISION (AD) — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A539 
114 
New Active Ingre-
dient/New Use, Ex-
perimental Use Per-
mit application; 
Nonfood use. Credit 
45% of fee toward 
new active ingre-
dient/new use appli-
cation that follows. 
(3) 
132,094 
A529 
115 
Amendment to Exper-
imental Use Permit; 
requires data re-
view or risk assess-
ment. (2) (3) 
16,383 
A523 
116 
Review of protocol 
other than a public 
health efficacy 
study (i.e., Toxi-
cology or Exposure 
Protocols). 
17,424 
A571 
117 
Science reassessment: 
refined ecological 
risk, and/or endan-
gered species; appli-
cant-initiated. (3) 
137,198 
A533 
118 
Exemption from the 
requirement of an 
Experimental Use 
Permit. (2) 
3,559 
A534 
119 
Rebuttal of Agency re-
viewed protocol, ap-
plicant initiated. 
6,776 
A535 
120 
Conditional ruling on 
pre-application 
study waiver or 
data bridging argu-
ment; applicant-ini-
tiated. 
3,454 
A536 
121 
Conditional ruling on 
pre-application di-
rect food, indirect 
food, nonfood use 
determination; ap-
plicant-initiated. 
3,559
H. R. 2617—1595 
‘‘TABLE 10. — ANTIMICROBIAL DIVISION (AD) — EXPERI-
MENTAL USE PERMITS AND OTHER ACTIONS—Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
A575 
122 
(new) 
Efficacy similarity de-
termination; if two 
products can be 
bridged or if con-
firmatory efficacy 
data are needed. 
3,389 
(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) 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 asso-
ciated registration service fee. For cases described in (b), the applicant 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 pro-
vide 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. 
3) If the Administrator determines that endangered species analysis is required 
for this action, using guidance finalized according to section 33(c)(3)(B) for this spe-
cific type of action, the decision review time can be extended for endangered species 
assessment one time only for up to 50%, upon written notification to the applicant, 
prior to completion of the technical screening. To the extent practicable, any reason 
for renegotiation should be resolved during the same extension. 
‘‘TABLE 11. — BIOPESTICIDES AND POLLUTION PREVEN-
TION DIVISION (BPPD) — NEW ACTIVE INGREDIENTS 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B580 
123 
New active ingre-
dient; petition to es-
tablish a tolerance. 
(2) (3) (4) 
73,173 
B590 
124 
New active ingre-
dient; petition to es-
tablish a tolerance 
exemption. (2) (3) 
(4) 
45,737
H. R. 2617—1596 
‘‘TABLE 11. — BIOPESTICIDES AND POLLUTION PREVEN-
TION DIVISION (BPPD) — NEW ACTIVE INGREDIENTS— 
Continued 
EPA 
No. 
New 
CR 
No. 
Action 
Decision 
Review Time 
(Months)(1) 
Registration 
Service Fee 
($) 
B600 
125 
New active ingre-
dient; no change to 
a permanent toler-
ance or tolerance 
exemption (includes 
non-food uses). (2) 
(3) (4) 
27,443 
B610 
126 
New active ingre-
dient; Experimental 
Use Permit applica-
tion; petition to es-
tablish a permanent 
or temporary toler-
ance or temporary 
tolerance exemp-
tion. (3) (4) 
18,296 
B620 
127 
New active ingre-
dient; Experimental 
Use Permit applica-
tion; non-food use 
(includes crop de-
struct). (3) (4) 
9,151 
(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 application 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 re-
view period as the new active ingredient or first food use application. The applica-
tion 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 submitted in the new active in-
gredient application package or first food use application package is subject to the 
registration service fee for a new product or a new inert approval. All such associ-
ated applications that are submitted together will be subject to the new active ingre-
dient 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 applica-
tion for another new product containing the same active ingredient or an amend-
ment 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 in-
gredient. In the case of a first food use application, until that first food use is ap-
proved, 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 neither 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 preliminary technical screening, and (c) is not itself a cov-
ered registration application, must be assessed 25% of the full registration service 
fee for the new active ingredient or first food use application.