[United States Statutes at Large, Volume 126, 112th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


Public Law 112-177
112th Congress

An Act


 
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide
Act. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE.

This Act may be cited as the ``Pesticide Registration Improvement
Extension Act of 2012''.
SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT.

(a) Maintenance Fees.--
(1) Fees.--Section 4(i) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is amended--
(A) in paragraph (5)--
(i) in subparagraph (C), by striking
``aggregate amount of'' and all that follows
through the end of the subparagraph and inserting
``aggregate amount of $27,800,000 for each of
fiscal years 2013 through 2017.'';
(ii) in subparagraph (D)--
(I) in clause (i), by striking
``shall be'' and all that follows
through the semicolon and inserting
``shall be $115,500 for each of fiscal
years 2013 through 2017;''; and
(II) in clause (ii), by striking
``shall be'' and all that follows
through the period and inserting ``shall
be $184,800 for each of fiscal years
2013 through 2017.'';
(iii) in subparagraph (E)(i)--
(I) in subclause (I), by striking
``shall be'' and all that follows
through the semicolon and inserting
``shall be $70,600 for each of fiscal
years 2013 through 2017;''; and
(II) in subclause (II), by striking
``shall be'' and all that follows
through the period and inserting ``shall
be $122,100 for each of fiscal years
2013 through 2017.'';
(iv) in subparagraph (F)--
(I) by striking ``paragraph (3)''
and inserting ``this paragraph''; and
(II) by striking ``Humans'' and
inserting ``Human'';
(v) by redesignating subparagraphs (F) through
(H) as subparagraphs (G) through (I),
respectively;

[[Page 1328]]

(vi) by inserting after subparagraph (E) the
following:
``(F) Fee reduction for certain small businesses.--
``(i) Definition.--In this subparagraph, the
term `qualified small business entity' means a
corporation, partnership, or unincorporated
business that--
``(I) has 500 or fewer employees;
``(II) during the 3-year period
prior to the most recent maintenance fee
billing cycle, had an average annual
global gross revenue from all sources
that did not exceed $10,000,000; and
``(III) holds not more than 5
pesticide registrations under this
paragraph.
``(ii) Waiver.--Except as provided in clause
(iii), the Administrator shall waive 25 percent of
the fee under this paragraph applicable to the
first registration of any qualified small business
entity under this paragraph.
``(iii) Limitation.--The Administrator shall
not grant a waiver under clause (ii) to a
qualified small business entity if the
Administrator determines that the entity has been
formed or manipulated primarily for the purpose of
qualifying for the waiver.''; and
(vii) in subparagraph (I) (as redesignated by
clause (v)), by striking ``2012'' and inserting
``2017'';
(B) in paragraph (6)--
(i) by striking ``2014'' and inserting
``2019''; and
(ii) by striking ``paragraphs (1) through
(5)'' and inserting ``paragraph (1)'';
(C) by striking paragraphs (1), (2), (3), (4), and
(7); and
(D) by redesignating paragraphs (5) and (6) as
paragraphs (1) and (2), respectively.
(2) Conforming amendments.--
(A) Section 4 of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136a-1) is amended--
(i) in subsection (d)(5)(B)(ii)(III), by
striking ``subsection (i)(1)'' and inserting
``this section'';
(ii) in subsection (j), by striking
``subsection (i)(5)'' and inserting ``subsection
(i)(1)''; and
(iii) in subsection (k)(5)--
(I) in the first sentence, by
striking ``subsection (i)(5)(C)(ii)''
and inserting ``subsection
(i)(1)(C)(ii)''; and
(II) in the third and sixth
sentences, by striking ``subsection
(i)(5)(C)'' each place it appears and
inserting ``subsection (i)(1)(C)''.
(B) Section 33(b)(7)(F) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-
8(b)(7)(F)) is amended--
(i) by striking ``section 4(i)(5)(E)(ii)''
each place it appears in clauses (i), (ii)(I), and
(iv)(I) and inserting ``section 4(i)(1)(E)(ii)'';
(ii) by striking ``section
4(i)(5)(E)(ii)(I)(bb)'' each place it appears in
clauses (ii)(II) and (iv)(II) and inserting
``section 4(i)(1)(E)(ii)(I)(bb)''; and
(iii) in clause (iv)(II)--

[[Page 1329]]

(I) by striking ``applicable.'' and
inserting ``applicable''; and
(II) by striking ``revenues'' and
inserting ``revenue''.
(3) Extension of prohibition on tolerance fees.--Section
408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
346a(m)(3)) is amended by striking ``September 30, 2012'' and
inserting ``September 30, 2017''.
(4) Reregistration and expedited processing fund.--
(A) Source and use.--Section 4(k)(2)(A) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136a-1(k)(2)(A)) is amended--
(i) by inserting ``, to enhance the
information systems capabilities to improve the
tracking of pesticide registration decisions,''
after ``paragraph (3)'' each place it appears; and
(ii) in clause (i)--
(I) by inserting ``offset'' before
``the costs of reregistration''; and
(II) by striking ``in the same
portion as appropriated funds''.
(B) Expedited processing of similar applications.--
Section 4(k)(3)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a-
1(k)(3)(A)) is amended--
(i) in the matter preceding clause (i), by
striking ``2008 through 2012, between \1/8\ and
\1/7\'' and inserting ``2013 through 2017, between
\1/9\ and \1/8\'';
(ii) in clause (i), by striking ``new''; and
(iii) in clause (ii), by striking ``any
application'' and all that follows through
``that--'' and inserting ``any application that--
''.
(C) Enhancements of information technology systems
for improvement in review of pesticide applications.--
Section 4(k) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
(i) by redesignating paragraphs (4) and (5) as
paragraphs (5) and (6), respectively;
(ii) by inserting after paragraph (3) the
following:
``(4) Enhancements of information technology systems for
improvement in review of pesticide applications.--
``(A) In general.--For each of fiscal years 2013
through 2017, the Administrator shall use not more than
$800,000 of the amounts made available to the
Administrator in the Reregistration and Expedited
Processing Fund for the activities described in
subparagraph (B).
``(B) Activities.--The Administrator shall use
amounts made available from the Reregistration and
Expedited Processing Fund to improve the information
systems capabilities for the Office of Pesticide
Programs to enhance tracking of pesticide registration
decisions, which shall include--
``(i) the electronic tracking of--
``(I) registration submissions; and
``(II) the status of conditional
registrations;
``(ii) enhancing the database for information
regarding endangered species assessments for
registration review;

[[Page 1330]]

``(iii) implementing the capability to
electronically review labels submitted with
registration actions; and
``(iv) acquiring and implementing the
capability to electronically assess and evaluate
confidential statements of formula submitted with
registration actions.''; and
(iii) in the first sentence of paragraph (6)
(as redesignated by clause (i)), by striking ``to
carry out the goals established under subsection
(l)'' and inserting ``for the purposes described
in paragraphs (2), (3), and (4) and to carry out
the goals established under subsection (l)''.

(b) Pesticide Registration Service Fees.--
(1) Amount of fees.--Section 33(b) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b))
is amended--
(A) by striking paragraph (3) and inserting the
following:
``(3) Schedule of covered applications and registration
service fees.--Subject to paragraph (6), the schedule of covered
pesticide registration applications and corresponding
registration service fees shall be as follows:

``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R010              1                New Active Ingredient, Food use (2) (3)     24                        569,221
----------------------------------------------------------------------------------------------------------------
R020              2                New Active Ingredient, Food use; reduced    18                        569,221
risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R040              3                New Active Ingredient, Food use;            18                        419,502
Experimental Use Permit application;
establish temporary tolerance; submitted
before application for registration;
credit 45% of fee toward new active
ingredient application that follows (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1331]]


R060              4                New Active Ingredient, Non-food use;        21                        395,467
outdoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R070              5                New Active Ingredient, Non-food use;        16                        395,467
outdoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R090              6                New Active Ingredient, Non-food use;        16                        293,596
outdoor; Experimental Use Permit
application; submitted before application
for registration; credit 45% of fee
toward new active ingredient (3)
----------------------------------------------------------------------------------------------------------------
R110              7                New Active Ingredient, Non-food use;        20                        219,949
indoor (2) (3)
----------------------------------------------------------------------------------------------------------------
R120              8                New Active Ingredient, Non-food use;        14                        219,949
indoor; reduced risk (2) (3)
----------------------------------------------------------------------------------------------------------------
R121              9                New Active Ingredient, Non-food use;        18                        165,375
indoor; Experimental Use Permit
application; submitted before application
for registration; credit 45% of fee
toward new active ingredient application
that follows (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1332]]


R122              10               Enriched isomer(s) of registered mixed-     18                        287,643
isomer active ingredient (2) (3)
----------------------------------------------------------------------------------------------------------------
R123              11               New Active Ingredient, Seed treatment       18                        427,991
only; includes agricultural and non-
agricultural seeds; residues not expected
in raw agricultural commodities (2) (3)
----------------------------------------------------------------------------------------------------------------
R125              12               New Active Ingredient, Seed treatment;      16                        293,596
New                                 Experimental Use Permit application;
submitted before application for
registration; credit 45% of fee toward
new active ingredient application that
follows (3)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1333]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered registration application, must be assessed 25% of
the full registration service fee for the new active ingredient or first
food use application.
(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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1334]]



``TABLE 2. -- REGISTRATION DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R130              13               First food use; indoor; food/food handling  21                        173,644
(2) (3)
----------------------------------------------------------------------------------------------------------------
R140              14               Additional food use; Indoor; food/food      15                         40,518
handling (3) (4)
----------------------------------------------------------------------------------------------------------------
R150              15               First food use (2) (3)                      21                        239,684
----------------------------------------------------------------------------------------------------------------
R160              16               First food use; reduced risk (2) (3)        16                        239,684
----------------------------------------------------------------------------------------------------------------
R170              17               Additional food use (3) (4)                 15                         59,976
----------------------------------------------------------------------------------------------------------------
R175              18               Additional food uses covered within a crop  10                         59,976
New                                 group resulting from the conversion of
existing approved crop group(s) to one or
more revised crop groups. (3) (4)
----------------------------------------------------------------------------------------------------------------
R180              19               Additional food use; reduced risk (3) (4)   10                         59,976
----------------------------------------------------------------------------------------------------------------
R190              20               Additional food uses; 6 or more submitted   15                        359,856
in one application (3) (4)
----------------------------------------------------------------------------------------------------------------
R200              21               Additional food uses; 6 or more submitted   10                        359,856
in one application; reduced risk (3) (4)
----------------------------------------------------------------------------------------------------------------


[[Page 1335]]


R210              22               Additional food use; Experimental Use       12                         44,431
Permit application; establish temporary
tolerance; no credit toward new use
registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R220              23               Additional food use; Experimental Use       6                          17,993
Permit application; crop destruct basis;
no credit toward new use registration (3)
(4)
----------------------------------------------------------------------------------------------------------------
R230              24               Additional use; non-food; outdoor (3) (4)   15                         23,969
----------------------------------------------------------------------------------------------------------------
R240              25               Additional use; non-food; outdoor; reduced  10                         23,969
risk (3) (4)
----------------------------------------------------------------------------------------------------------------
R250              26               Additional use; non-food; outdoor;          6                          17,993
Experimental Use Permit application; no
credit toward new use registration (3)
(4)
----------------------------------------------------------------------------------------------------------------
R251              27               Experimental Use Permit application which   8                          17,993
New                                 requires no changes to the tolerance(s);
non-crop destruct basis (3)
----------------------------------------------------------------------------------------------------------------
R260              28               New use; non-food; indoor (3) (4)           12                         11,577
----------------------------------------------------------------------------------------------------------------


[[Page 1336]]


R270              29               New use; non-food; indoor; reduced risk     9                          11,577
(3) (4)
----------------------------------------------------------------------------------------------------------------
R271              30               New use; non-food; indoor; Experimental     6                           8,820
Use Permit application; no credit toward
new use registration (3) (4)
----------------------------------------------------------------------------------------------------------------
R273              31               Additional use; seed treatment; limited     12                         45,754
uptake into raw agricultural commodities;
includes crops with established
tolerances (e.g., for soil or foliar
application); includes food or non-food
uses (3) (4)
----------------------------------------------------------------------------------------------------------------
R274              32               Additional uses; seed treatment only; 6 or  12                        274,523
more submitted in one application;
limited uptake into raw agricultural
commodities; includes crops with
established tolerances (e.g., for soil or
foliar application); includes food and/or
non-food uses (3) (4)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1337]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered registration application, must be assessed 25% of
the full registration service fee for the new active ingredient or first
food use application.
(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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.

[[Page 1338]]

(4) 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 product registra-
tion and new inert approval(s) that is submitted in the new use ap-
plication 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 associ-
ated applications 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 sepa-
rate 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 appropriate fee is
due for each type of new use and the longest decision review time
applies 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 applicant at the applicant's ini-
tiative to support the application after completion of the technical
deficiency screen, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the
new use application.


``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R280              33               Establish import tolerance; new active      21                        289,407
ingredient or first food use (2)
----------------------------------------------------------------------------------------------------------------
R290              34               Establish import tolerance; additional      15                         57,882
food use
----------------------------------------------------------------------------------------------------------------
R291              35               Establish import tolerances; additional     15                        347,288
food uses; 6 or more crops submitted in
one petition
----------------------------------------------------------------------------------------------------------------


[[Page 1339]]


R292              36               Amend an established tolerance (e.g.,       11                         41,124
decrease or increase); domestic or
import; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293              37               Establish tolerance(s) for inadvertent      12                         48,510
residues in one crop; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R294              38               Establish tolerances for inadvertent        12                        291,060
residues; 6 or more crops submitted in
one application; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R295              39               Establish tolerance(s) for residues in one  15                         59,976
rotational crop in response to a specific
rotational crop application; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R296              40               Establish tolerances for residues in        15                        359,856
rotational crops in response to a
specific rotational crop petition; 6 or
more crops submitted in one application;
applicant-initiated
----------------------------------------------------------------------------------------------------------------


[[Page 1340]]


R297              41               Amend 6 or more established tolerances      11                        246,744
New                                 (e.g., decrease or increase) in one
petition; domestic or import; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R298              42               Amend an established tolerance (e.g.,       13                         53,120
New                                 decrease or increase); domestic or
import; submission of amended labels
(requiring science review) in addition to
those associated with the amended
tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------
R299              43               Amend 6 or more established tolerances      13                        258,740
New                                 (e.g., decrease or increase); domestic or
import; submission of amended labels
(requiring science review) in addition to
those associated with the amended
tolerance; applicant-initiated (3)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1341]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered registration application, must be assessed 25% of
the full registration service fee for the new active ingredient or first
food use application.
(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, includ- ing 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 ei- ther
(a) agrees to all of the terms associated with the draft accept- ed
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
resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1342]]



``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R300              44               New product; or similar combination         4                           1,434
product (already registered) to an
identical or substantially similar in
composition and use to a registered
product; registered source of active
ingredient; no data review on acute
toxicity, efficacy or CRP - only product
chemistry data; cite-all data citation,
or selective data citation where
applicant owns all required data, or
applicant submits specific authorization
letter from data owner. Category also
includes 100% re-package of registered
end-use or manufacturing-use product that
requires no data submission nor data
matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1343]]


R301              45               New product; or similar combination         4                           1,720
product (already registered) to an
identical or substantially similar in
composition and use to a registered
product; registered source of active
ingredient; selective data citation only
for data on product chemistry and/or
acute toxicity and/or public health pest
efficacy, where applicant does not own
all required data and does not have a
specific authorization letter from data
owner. (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1344]]


R310              46               New end-use or manufacturing-use product    7                           4,807
with registered source(s) of active
ingredient(s); includes products
containing two or more registered active
ingredients previously combined in other
registered products; requires review of
data package within RD only; includes
data and/or waivers of data for only:
 product chemistry and/or
 acute toxicity and/or
 public health pest efficacy and/
or
 child resistant packaging. (2)
(3)
----------------------------------------------------------------------------------------------------------------


[[Page 1345]]


R314              47               New end use product containing two or more  8                           6,009
New                                 registered active ingredients never
before registered as this combination in
a formulated product; new product label
is identical or substantially similar to
the labels of currently registered
products which separately contain the
respective component active ingredients;
requires review of data package within RD
only; includes data and/or waivers of
data for only:
 product chemistry and/or
 acute toxicity and/or
 public health pest efficacy and/
or
 child resistant packaging. (2)
(3)
----------------------------------------------------------------------------------------------------------------


[[Page 1346]]


R315              48               New end-use non-food animal product with    9                           8,000
New                                 submission of two or more target animal
safety studies; includes data and/or
waivers of data for only:
 product chemistry and/or
 acute toxicity and/or
 public health pest efficacy and/
or
 animal safety studies and/or
 child resistant packaging (2) (3)
----------------------------------------------------------------------------------------------------------------
R320              49               New product; new physical form; requires    12                         11,996
data review in science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R331              50               New product; repack of identical            3                           2,294
registered end-use product as a
manufacturing-use product; same
registered uses only (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1347]]


R332              51               New manufacturing-use product; registered   24                        256,883
active ingredient; unregistered source of
active ingredient; submission of
completely new generic data package;
registered uses only; requires review in
RD and science divisions (2) (3)
----------------------------------------------------------------------------------------------------------------
R333              52               New product; MUP or End use product with    10                         17,993
New                                 unregistered source of active ingredient;
requires science data review; new
physical form; etc. Cite-all or selective
data citation where applicant owns all
required data. (2) (3)
----------------------------------------------------------------------------------------------------------------




[[Page 1348]]


R334              53               New product; MUP or End use product with    11                         17,993
New                                 unregistered source of the active
ingredient; requires science data review;
new physical form; etc. Selective data
citation. (2) (3)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, 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 ac-
tive ingredient that (a) is not yet registered but (b) has an applica-
tion pending with the Agency for review, will be considered an ap-
plication for a new product with an unregistered source of active
ingredient.
(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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1349]]



``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R340              54               Amendment requiring data review within RD   4                           3,617
(e.g., changes to precautionary label
statements) (2) (3)
----------------------------------------------------------------------------------------------------------------
R345              55               Amending non-food animal product that       7                           8,000
New                                 includes submission of target animal
safety data; previously registered (2)
(3)
----------------------------------------------------------------------------------------------------------------
R350              56               Amendment requiring data review in science  9                          11,996
divisions (e.g., changes to REI, or PPE,
or PHI, or use rate, or number of
applications; or add aerial application;
or modify GW/SW advisory statement) (2)
(3)
----------------------------------------------------------------------------------------------------------------
R351              57               Amendment adding a new unregistered source  8                          11,996
New                                 of active ingredient. (2) (3)
----------------------------------------------------------------------------------------------------------------
R352              58               Amendment adding already approved uses;     8                          11,996
New                                 selective method of support; does not
apply if the applicant owns all cited
data (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1350]]


R371              59               Amendment to Experimental Use Permit;       6                           9,151
(does not include extending a permit's
time period) (3)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

(2) (a) EPA-initiated amendments shall not be charged registra- tion
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 amendments 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
amendments submitted by no- tification under 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 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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1351]]



``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
R124              60               Conditional Ruling on Preapplication Study  6                           2,294
Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R272              61               Review of Study Protocol applicant-         3                           2,294
initiated; excludes DART, pre-
registration conference, Rapid Response
review, DNT protocol review, protocol
needing HSRB review
----------------------------------------------------------------------------------------------------------------
R275              62               Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------
R370              63               Cancer reassessment; applicant-initiated    18                        179,818
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.


``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A380              64               Food use; establish tolerance exemption     24                        104,187
(2) (3)
----------------------------------------------------------------------------------------------------------------
A390              65               Food use; establish tolerance (2) (3)       24                        173,644
----------------------------------------------------------------------------------------------------------------


[[Page 1352]]


A400              66               Non-food use; outdoor; FIFRA Sec. 2(mm)     18                         86,823
uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A410              67               Non-food use; outdoor; uses other than      21                        173,644
FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A420              68               Non-food use; indoor; FIFRA Sec. 2(mm)      18                         57,882
uses (2) (3)
----------------------------------------------------------------------------------------------------------------
A430              69               Non-food use; indoor; uses other than       20                         86,823
FIFRA Sec. 2(mm) (2) (3)
----------------------------------------------------------------------------------------------------------------
A431              70               Non-food use; indoor; low-risk, low-        12                         60,638
toxicity food-grade active ingredient(s);
efficacy testing for public health claims
required under GLP and following DIS/TSS
or AD-approved study protocol (2) (3)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1353]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered registration application, must be assessed 25% of
the full registration service fee for the new active ingredient or first
food use application.
(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, includ- ing 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 ei- ther
(a) agrees to all of the terms associated with the draft accept- ed
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
resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1354]]



``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A440              71               First food use; establish tolerance         21                         28,942
exemption (2) (3) (4)
----------------------------------------------------------------------------------------------------------------
A450              72               First food use; establish tolerance (2)     21                         86,823
(3) (4)
----------------------------------------------------------------------------------------------------------------
A460              73               Additional food use; establish tolerance    15                         11,577
exemption (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A470              74               Additional food use; establish tolerance    15                         28,942
(3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A471              75               Additional food uses; establish             15                        173,652
New                                 tolerances; 6 or more submitted in one
application (3) (4) (5)
----------------------------------------------------------------------------------------------------------------
A480              76               Additional use; non-food; outdoor; FIFRA    9                          17,365
Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A481              77               Additional non-food outdoor uses; FIFRA     9                         104,190
New                                 Sec. 2(mm) uses; 6 or more submitted in
one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A490              78               Additional use; non-food; outdoor; uses     15                         28,942
other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------


[[Page 1355]]


A491              79               Additional non-food; outdoor; uses other    15                        173,652
New                                 than FIFRA Sec. 2(mm); 6 or more
submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------
A500              80               Additional use; non-food, indoor, FIFRA     9                          11,577
Sec. 2(mm) uses (4) (5)
----------------------------------------------------------------------------------------------------------------
A501              81               Additional non-food; indoor; FIFRA Sec.     9                          69,462
New                                 2(mm) uses; 6 or more submitted in one
application (4) (5)
----------------------------------------------------------------------------------------------------------------
A510              82               Additional use; non-food; indoor; uses      12                         11,577
other than FIFRA Sec. 2(mm) (4) (5)
----------------------------------------------------------------------------------------------------------------
A511              83               Additional non-food; indoor; uses other     12                         69,462
New                                 than FIFRA Sec. 2(mm); 6 or more
submitted in one application (4) (5)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1356]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered 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 FFDCA for an ingredient of an
anti- microbial 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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.

[[Page 1357]]

(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 product registra-
tion and new inert approval(s) that is submitted in the new use ap-
plication 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 associ-
ated applications 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 sepa-
rate 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 appropriate fee is
due for each type of new use and the longest decision review time
applies 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 applicant at the applicant's ini-
tiative to support the application after completion of the technical
deficiency screen, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the
new use application.


[[Page 1358]]



``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A530              84               New product; identical or substantially     4                           1,159
similar in composition and use to a
registered product; no data review or
only product chemistry data; cite-all
data citation, or selective data citation
when applicant owns all required data, or
applicant submits specific authorization
letter for data owner. Category also
includes 100% re-package of registered
end-use or manufacturing-use product that
requires no data submission nor data
matrix. (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1359]]


A531              85               New product; identical or substantially     4                           1,654
similar in composition and use to a
registered product; registered source of
active ingredient: selective data
citation only for data on product
chemistry and/or acute toxicity and/or
public health pest efficacy, where
applicant does not own all required data
and does not have a specific
authorization letter from data owner. (2)
(3)
----------------------------------------------------------------------------------------------------------------
A532              86               New product; identical or substantially     5                           4,631
similar in composition and use to a
registered product; registered active
ingredient; unregistered source of active
ingredient; cite-all data citation except
for product chemistry; product chemistry
data submitted (2) (3)
----------------------------------------------------------------------------------------------------------------
A540              87               New end use product; FIFRA Sec. 2(mm) uses  5                           4,631
only (2) (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1360]]


A550              88               New end-use product; uses other than FIFRA  7                           4,631
Sec. 2(mm); non-FQPA product (2) (3)
----------------------------------------------------------------------------------------------------------------
A560              89               New manufacturing-use product; registered   12                         17,365
active ingredient; selective data
citation (2) (3)
----------------------------------------------------------------------------------------------------------------
A570              90               Label amendment requiring data review (3)   4                           3,474
(4)
----------------------------------------------------------------------------------------------------------------
A572              91               New Product or amendment requiring data     9                          11,996
New                                 review for risk assessment by Science
Branch (e.g., changes to REI, or PPE, or
use rate) (2) (3) (4)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, 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 ac-
tive ingredient that (a) is not yet registered but (b) has an applica-
tion pending with the Agency for review, will be considered an ap-
plication for a new product with an unregistered source of active
ingredient.

[[Page 1361]]

(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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.

(4) (a) EPA-initiated amendments shall not be charged registra- tion
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 amendments 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
amendments submitted by no- tification under 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 registration service fees.


``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
A520              92               Experimental Use Permit application, Non-   9                           5,789
Food Use (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1362]]


A521              93               Review of public health efficacy study      3                           2,250
protocol within AD, per AD Internal
Guidance for the Efficacy Protocol Review
Process; Code will also include review of
public health efficacy study protocol and
data review for devices making pesticidal
claims; applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522              94               Review of public health efficacy study      12                         11,025
protocol outside AD by members of AD
Efficacy Protocol Review Expert Panel;
Code will also include review of public
health efficacy study protocol and data
review for devices making pesticidal
claims; applicant-initiated; Tier 2
----------------------------------------------------------------------------------------------------------------


[[Page 1363]]


A524              95               New Active Ingredient, Experimental Use     18                        138,916
New                                 Permit application; Food Use Requires
Tolerance. Credit 45% of fee toward new
active ingredient application that
follows. (2)
----------------------------------------------------------------------------------------------------------------
A525              96               New Active Ingredient, Experimental Use     18                         83,594
New                                 Permit application; Food Use Requires
Tolerance Exemption. Credit 45% of fee
toward new active ingredient application
that follows. (2)
----------------------------------------------------------------------------------------------------------------
A526              97               New Active Ingredient, Experimental Use     15                         86,823
New                                 Permit application; Non-Food, Outdoor
Use. Credit 45% of fee toward new active
ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------
A527              98               New Active Ingredient, Experimental Use     15                         58,000
New                                 Permit application; Non-Food, Indoor Use.
Credit 45% of fee toward new active
ingredient application that follows. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1364]]


A528              99               Experimental Use Permit application, Food   15                         20,260
New                                 Use; Requires Tolerance or Tolerance
Exemption (2)
----------------------------------------------------------------------------------------------------------------
A529              100              Amendment to Experimental Use Permit;       9                          10,365
New                                 requires data review or risk assessment
(2)
----------------------------------------------------------------------------------------------------------------
A523              101              Review of protocol other than a public      9                          11,025
New                                 health efficacy study (i.e., Toxicology
or Exposure Protocols)
----------------------------------------------------------------------------------------------------------------




[[Page 1365]]


A571              102              Science reassessment: Cancer risk, refined  18                         86,823
New                                 ecological risk, and/or endangered
species; applicant-initiated
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, 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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.


[[Page 1366]]



``TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B580              103              New active ingredient; food use; petition   19                         46,305
to establish a tolerance (2)
----------------------------------------------------------------------------------------------------------------
B590              104              New active ingredient; food use; petition   17                         28,942
to establish a tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B600              105              New active ingredient; non-food use (2)     13                         17,365
----------------------------------------------------------------------------------------------------------------
B610              106              New active ingredient; Experimental Use     10                         11,577
Permit application; petition to establish
a temporary tolerance or temporary
tolerance exemption
----------------------------------------------------------------------------------------------------------------
B611              107              New active ingredient; Experimental Use     12                         11,577
New                                 Permit application; petition to establish
permanent tolerance exemption
----------------------------------------------------------------------------------------------------------------
B612              108              New active ingredient; no change to a       10                         15,918
New                                 permanent tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1367]]


B613              109              New active ingredient; petition to convert  11                         15,918
New                                 a temporary tolerance or a temporary
tolerance exemption to a permanent
tolerance or tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------




[[Page 1368]]


B620              110              New active ingredient; Experimental Use     7                           5,789
Permit application; non-food use
including crop destruct
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, 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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view time, except where the new inert
approval decision review time is greater than that for the new active
ingredient, in which case the associated new active ingredient will be
subject to the new inert approval decision review time. In the case of a
new active in- gredient 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 addi-
tional new food use or uses will be subject to the registration serv-
ice fee and decision review time for a first food use. Any informa-
tion 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 technical deficiency screening,
and (c) is not itself a covered registration application, must be
assessed 25% of the full registration service fee for the new active
ingredient or first food use application.


[[Page 1369]]



``TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B630              111              First food use; petition to establish a     13                         11,577
tolerance exemption (2)
----------------------------------------------------------------------------------------------------------------
B631              112              New food use; petition to amend an          12                         11,577
established tolerance (3)
----------------------------------------------------------------------------------------------------------------
B640              113              First food use; petition to establish a     19                         17,365
tolerance (2)
----------------------------------------------------------------------------------------------------------------
B643              114              New Food use; petition to amend tolerance   10                         11,577
New                                 exemption (3)
----------------------------------------------------------------------------------------------------------------
B642              115              First food use; indoor; food/food handling  12                         28,942
New                                 (2)
----------------------------------------------------------------------------------------------------------------
B644              116              New use, no change to an established        8                          11,577
New                                 tolerance or tolerance exemption (3)
----------------------------------------------------------------------------------------------------------------
B650              117              New use; non-food (3)                       7                           5,789
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1370]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view 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 ac- tive 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
neither re- quested 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 technical deficiency screening, and (c) is
not itself a covered registration application, must be assessed 25% of
the full registration service fee for the new active ingredient or first
food use application.
(3) 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 product registra-
tion and new inert approval(s) that is submitted in the new use ap-
plication 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 associ-
ated applications 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 sepa-
rate 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 appropriate fee is
due for each type of new use and the longest decision review time
applies 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 applicant at the applicant's ini-
tiative to support the application after completion of the technical
deficiency screen, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the
new use application.


[[Page 1371]]



``TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B652              118              New product; registered source of active    13                         11,577
New                                 ingredient; requires petition to amend
established tolerance or tolerance
exemption; requires 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data; or
3) submission or citation of data
generated at government expense; or 4)
submission or citation of scientifically-
sound rationale based on publicly
available literature or other relevant
information that addresses the data
requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1372]]


B660              119              New product; registered source of active    4                           1,159
ingredient(s); identical or substantially
similar in composition and use to a
registered product; no change in an
established tolerance or tolerance
exemption. No data review, or only
product chemistry data; cite-all data
citation, or selective data citation
where applicant owns all required data or
authorization from data owner is
demonstrated. Category includes 100% re-
package of registered end-use or
manufacturing-use product that requires
no data submission or data matrix. For
microbial pesticides, the active
ingredient(s) must not be re-isolated.
(2)
----------------------------------------------------------------------------------------------------------------


[[Page 1373]]


B670              120              New product; registered source of active    7                           4,631
ingredient(s); no change in an
established tolerance or tolerance
exemption; requires: 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data; or
3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1374]]


B671              121              New product; unregistered source of active  17                         11,577
ingredient(s); requires a petition to
amend an established tolerance or
tolerance exemption; requires: 1)
submission of product specific data; or
2) citation of previously reviewed and
accepted data; or 3) submission or
citation of data generated at government
expense; or 4) submission or citation of
a scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1375]]


B672              122              New product; unregistered source of active  13                          8,269
ingredient(s); non-food use or food use
with a tolerance or tolerance exemption
previously established for the active
ingredient(s); requires: 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data; or
3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1376]]


B673              123              New product MUP/EP; unregistered source of  10                          4,631
New                                 active ingredient(s); citation of
Technical Grade Active Ingredient (TGAI)
data previously reviewed and accepted by
the Agency. Requires an Agency
determination that the cited data
supports the new product. (2)
----------------------------------------------------------------------------------------------------------------
B674              124              New product MUP; Repack of identical        4                           1,159
New                                 registered end-use product as a
manufacturing-use product; same
registered uses only (2)
----------------------------------------------------------------------------------------------------------------
B675              125              New Product MUP; registered source of       10                          8,269
New                                 active ingredient; submission of
completely new generic data package;
registered uses only. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1377]]


B676              126              New product; more than one active           13                          8,269
New                                 ingredient where one active ingredient is
an unregistered source; product chemistry
data must be submitted; requires: 1)
submission of product specific data, and
2) citation of previously reviewed and
accepted data; or 3) submission or
citation of data generated at government
expense; or 4) submission or citation of
a scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1378]]


B677              127              New end-use non-food animal product with    10                          8,000
New                                 submission of two or more target animal
safety studies; includes data and/or
waivers of data for only:
 product chemistry and/or
 acute toxicity and/or
 public health pest efficacy and/
or
 animal safety studies and/or
 child resistant packaging (2)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, 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 ac-
tive ingredient that (a) is not yet registered but (b) has an applica-
tion pending with the Agency for review, will be considered an ap-
plication for a new product with an unregistered source of active
ingredient.


[[Page 1379]]



``TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES;
AMENDMENTS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B621              128              Amendment; Experimental Use Permit; no      7                           4,631
change to an established temporary
tolerance or tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B622              129              Amendment; Experimental Use Permit;         11                         11,577
New                                 petition to amend an established or
temporary tolerance or tolerance
exemption.
----------------------------------------------------------------------------------------------------------------
B641              130              Amendment of an established tolerance or    13                         11,577
tolerance exemption.
----------------------------------------------------------------------------------------------------------------
B680              131              Amendment; registered source of active      5                           4,631
ingredient(s); no new use(s); no changes
to an established tolerance or tolerance
exemption. Requires data submission. (2)
----------------------------------------------------------------------------------------------------------------
B681              132              Amendment; unregistered source of active    7                           5,513
ingredient(s). Requires data submission.
(2)
----------------------------------------------------------------------------------------------------------------


[[Page 1380]]


B683              133              Label amendment; requires review/update of  6                           4,631
New                                 previous risk assessment(s) without data
submission (e.g., labeling changes to
REI, PPE, PHI). (2)
----------------------------------------------------------------------------------------------------------------
B684              134              Amending non-food animal product that       8                           8,000
New                                 includes submission of target animal
safety data; previously registered (2)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

(2) (a) EPA-initiated amendments shall not be charged registra- tion
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 amendments 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
amendments submitted by no- tification under 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 registration service fees.


[[Page 1381]]



``TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B690              135              New active ingredient; food or non-food     7                           2,316
use. (2)
----------------------------------------------------------------------------------------------------------------
B700              136              Experimental Use Permit application; new    7                           1,159
active ingredient or new use.
----------------------------------------------------------------------------------------------------------------
B701              137              Extend or amend Experimental Use Permit.    4                           1,159
----------------------------------------------------------------------------------------------------------------


[[Page 1382]]


B710              138              New product; registered source of active    4                           1,159
ingredient(s); identical or substantially
similar in composition and use to a
registered product; no change in an
established tolerance or tolerance
exemption. No data review, or only
product chemistry data; cite-all data
citation, or selective data citation
where applicant owns all required data or
authorization from data owner is
demonstrated. Category includes 100% re-
package of registered end-use or
manufacturing-use product that requires
no data submission or data matrix. (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1383]]


B720              139              New product; registered source of active    5                           1,159
ingredient(s); requires: 1) submission of
product specific data; or 2) citation of
previously reviewed and accepted data; or
3) submission or citation of data
generated at government expense; or 4)
submission or citation of a
scientifically-sound rationale based on
publicly available literature or other
relevant information that addresses the
data requirement; or 5) submission of a
request for a data requirement to be
waived supported by a scientifically-
sound rationale explaining why the data
requirement does not apply. (3)
----------------------------------------------------------------------------------------------------------------
B721              140              New product; unregistered source of active  7                           2,426
ingredient. (3)
----------------------------------------------------------------------------------------------------------------


[[Page 1384]]


B722              141              New use and/or amendment; petition to       7                           2,246
establish a tolerance or tolerance
exemption. (4) (5)
----------------------------------------------------------------------------------------------------------------
B730              142              Label amendment requiring data submission.  5                           1,159
(4)
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

[[Page 1385]]

(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 review 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 ap- plication for
an additional new product registration and new inert approval that is
submitted in the new active ingredient application package or first food
use application package is subject to the reg- istration 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 re- view time, except where the new inert
approval decision review time is greater than that for the new active
ingredient, in which case the associated new active ingredient will be
subject to the new inert approval decision review time. In the case of a
new active in- gredient 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 addi-
tional new food use or uses will be subject to the registration serv-
ice fee and decision review time for a first food use. Any informa-
tion 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 technical deficiency screening,
and (c) is not itself a covered registration application, 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 ac-
tive ingredient that (a) is not yet registered but (b) has an applica-
tion pending with the Agency for review, will be considered an ap-
plication for a new product with an unregistered source of active
ingredient.
(4) (a) EPA-initiated amendments shall not be charged registra- tion
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 amendments 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
amendments submitted by no- tification under 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 registration service fees.

[[Page 1386]]

(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 product registra-
tion and new inert approval(s) that is submitted in the new use ap-
plication 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 associ-
ated applications 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 sepa-
rate 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 appropriate fee is
due for each type of new use and the longest decision review time
applies 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 applicant at the applicant's ini-
tiative to support the application after completion of the technical
deficiency screen, and (c) is not itself a covered registration applica-
tion, must be assessed 25% of the full registration service fee for the
new use application.


``TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B614              143              Conditional Ruling on Preapplication Study  3                           2,294
New                                 Waivers; applicant-initiated
----------------------------------------------------------------------------------------------------------------
B615              144              Rebuttal of agency reviewed protocol,       3                           2,294
New                                 applicant initiated
----------------------------------------------------------------------------------------------------------------


[[Page 1387]]


B682              145              Protocol review; applicant initiated;       3                           2,205
excludes time for HSRB review
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.



``TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
B740              146              Experimental Use Permit application; no     6                          86,823
petition for tolerance/tolerance
exemption. Includes:
1) non-food/feed use(s) for a new (2) or
registered (3) PIP;
2) food/feed use(s) for a new or
registered PIP with crop destruct;
3) food/feed use(s) for a new or
registered PIP in which an established
tolerance/tolerance exemption exists for
the intended use(s). (4)
----------------------------------------------------------------------------------------------------------------


[[Page 1388]]


B750              147              Experimental Use Permit application; with   9                         115,763
a petition to establish a temporary or
permanent tolerance/tolerance exemption
for the active ingredient. Includes new
food/feed use for a registered (3) PIP.
(4)
----------------------------------------------------------------------------------------------------------------
B770              148              Experimental Use Permit application; new    15                        173,644
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows;
SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B771              149              Experimental Use Permit application; new    10                        115,763
(2) PIP; with petition to establish a
temporary tolerance/tolerance exemption
for the active ingredient; credit 75% of
B771 fee toward registration application
for a new active ingredient that follows.
----------------------------------------------------------------------------------------------------------------


[[Page 1389]]


B772              150              Application to amend or extend an           3                          11,577
Experimental Use Permit; no petition
since the established tolerance/tolerance
exemption for the active ingredient is
unaffected.
----------------------------------------------------------------------------------------------------------------
B773              151              Application to amend or extend an           5                          28,942
Experimental Use Permit; with petition to
extend a temporary tolerance/tolerance
exemption for the active ingredient.
----------------------------------------------------------------------------------------------------------------
B780              152              Registration application; new (2) PIP; non- 12                        144,704
food/feed.
----------------------------------------------------------------------------------------------------------------
B790              153              Registration application; new (2) PIP; non- 18                        202,585
food/feed; SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B800              154              Registration application; new (2) PIP;      12                        231,585
with petition to establish permanent
tolerance/tolerance exemption for the
active ingredient based on an existing
temporary tolerance/tolerance exemption.
----------------------------------------------------------------------------------------------------------------


[[Page 1390]]


B810              155              Registration application; new (2) PIP;      18                        289,407
with petition to establish permanent
tolerance/tolerance exemption for the
active ingredient based on an existing
temporary tolerance/tolerance exemption.
SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B820              156              Registration application; new (2) PIP;      15                        289,407
with petition to establish or amend a
permanent tolerance/tolerance exemption
of an active ingredient.
----------------------------------------------------------------------------------------------------------------
B840              157              Registration application; new (2) PIP;      21                        347,288
with petition to establish or amend a
permanent tolerance/tolerance exemption
of an active ingredient. SAP review. (5)
----------------------------------------------------------------------------------------------------------------


[[Page 1391]]


B851              158              Registration application; new event of a    9                         115,763
previously registered PIP active
ingredient(s); no petition since
permanent tolerance/tolerance exemption
is already established for the active
ingredient(s).
----------------------------------------------------------------------------------------------------------------
B870              159              Registration application; registered (3)    9                          34,729
PIP; new product; new use; no petition
since a permanent tolerance/tolerance
exemption is already established for the
active ingredient(s). (4)
----------------------------------------------------------------------------------------------------------------
B880              160              Registration application; registered (3)    9                          28,942
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already
established for the active ingredient(s).
(6) (7)
----------------------------------------------------------------------------------------------------------------


[[Page 1392]]


B881              161              Registration application; registered (3)    15                         86,823
PIP; new product or new terms of
registration; additional data submitted;
no petition since a permanent tolerance/
tolerance exemption is already
established for the active ingredient(s).
SAP review. (5) (6) (7)
----------------------------------------------------------------------------------------------------------------
B883              162              Registration application; new (2) PIP,      9                         115,763
New                                 seed increase with negotiated acreage cap
and time-limited registration; with
petition to establish a permanent
tolerance/tolerance exemption for the
active ingredient based on an existing
temporary tolerance/tolerance exemption.
(8)
----------------------------------------------------------------------------------------------------------------


[[Page 1393]]


B884              163              Registration application; new (2) PIP,      12                        144,704
New                                 seed increase with negotiated acreage cap
and time-limited registration; with
petition to establish a permanent
tolerance/tolerance exemption for the
active ingredient. (8)
----------------------------------------------------------------------------------------------------------------
B885              164              Registration application; registered (3)    9                          86,823
New                                 PIP, seed increase; breeding stack of
previously approved PIPs, same crop; no
petition since a permanent tolerance/
tolerance exemption is already
established for the active ingredient(s).
(9)
----------------------------------------------------------------------------------------------------------------
B890              165              Application to amend a seed increase        9                          57,882
registration; converts registration to
commercial registration; no petition
since permanent tolerance/tolerance
exemption is already established for the
active ingredient(s).
----------------------------------------------------------------------------------------------------------------


[[Page 1394]]


B891              166              Application to amend a seed increase        15                        115,763
registration; converts registration to a
commercial registration; no petition
since a permanent tolerance/tolerance
exemption already established for the
active ingredient(s); SAP review. (5)
----------------------------------------------------------------------------------------------------------------
B900              167              Application to amend a registration,        6                          11,577
including actions such as extending an
expiration date, modifying an IRM plan,
or adding an insect to be controlled.
(10) (11)
----------------------------------------------------------------------------------------------------------------
B901              168              Application to amend a registration,        12                         69,458
including actions such as extending an
expiration date, modifying an IRM plan,
or adding an insect to be controlled. SAP
review. (10) (11)
----------------------------------------------------------------------------------------------------------------
B902              169              PIP protocol review                         3                           5,789
----------------------------------------------------------------------------------------------------------------


[[Page 1395]]


B903              170              Inert ingredient tolerance exemption;       6                          57,882
e.g., a marker such as NPT II; reviewed
in BPPD.
----------------------------------------------------------------------------------------------------------------




[[Page 1396]]


B904              171              Import tolerance or tolerance exemption;    9                         115,763
processed commodities/food only (inert or
active ingredient).
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

(2) New PIP = a PIP with an active ingredient that has not been
registered.
(3) Registered PIP = a PIP with an active ingredient that is cur-
rently registered.
(4) Transfer registered PIP through conventional breeding for new
food/feed use, such as from field corn to sweet corn.
(5) The scientific data involved in this category are complex. EPA
often seeks technical advice from the Scientific Advisory Panel on
risks that pesticides pose to wildlife, farm workers, pesticide appli-
cators, non-target species, as well as insect resistance, and novel
scientific issues surrounding new technologies. The scientists of the
SAP neither make nor recommend policy decisions. They provide advice on
the science used to make these decisions. Their advice is invaluable to
the EPA as it strives to protect humans and the envi- ronment from risks
posed by pesticides. Due to the time it takes to schedule and prepare
for meetings with the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g.,
seed blend).
(8) The negotiated acreage cap will depend upon EPA's deter- mination
of the potential environmental exposure, risk(s) to non- target
organisms, and the risk of targeted pest developing resist- ance to the
pesticidal substance. The uncertainty of these risks may reduce the
allowable acreage, based upon the quantity and type of non-target
organism data submitted and the lack of insect resistance management
data, which is usually not required for seed-increase registrations.
Registrants are encouraged to consult with EPA prior to submission of a
registration application in this category.
(9) Application can be submitted prior to or concurrently with an
application for commercial registration.
(10) For example, IRM plan modifications that are applicant-ini-
tiated.
(11) EPA-initiated amendments shall not be charged fees.


[[Page 1397]]



``TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
----------------------------------------------------------------------------------------------------------------
Registration
EPA No.         New CR No.                      Action                      Decision Review     Service Fee
Time (Months) (1)        ($)
----------------------------------------------------------------------------------------------------------------
I001              172              Approval of new food use inert ingredient   12                         18,000
(2) (3)
----------------------------------------------------------------------------------------------------------------
I002              173              Amend currently approved inert ingredient   10                          5,000
New                                 tolerance or exemption from tolerance;
new data (2)
----------------------------------------------------------------------------------------------------------------
I003              174              Amend currently approved inert ingredient   8                           3,000
New                                 tolerance or exemption from tolerance; no
new data (2)
----------------------------------------------------------------------------------------------------------------
I004              175              Approval of new non-food use inert          8                          10,000
New                                 ingredient (2)
----------------------------------------------------------------------------------------------------------------
I005              176              Amend currently approved non-food use       8                           5,000
New                                 inert ingredient with new use pattern;
new data (2)
----------------------------------------------------------------------------------------------------------------
I006              177              Amend currently approved non-food use       6                           3,000
New                                 inert ingredient with new use pattern; no
new data (2)
----------------------------------------------------------------------------------------------------------------


[[Page 1398]]


I007              178              Approval of substantially similar non-food  4                           1,500
New                                 use inert ingredients when original inert
is compositionally similar with similar
use pattern (2)
----------------------------------------------------------------------------------------------------------------
I008              179              Approval of new polymer inert ingredient,   5                           3,400
New                                 food use (2)
----------------------------------------------------------------------------------------------------------------
I009              180              Approval of new polymer inert ingredient,   4                           2,800
New                                 non food use (2)
----------------------------------------------------------------------------------------------------------------
I010              181              Petition to amend a tolerance exemption     6                           1,500
New                                 descriptor to add one or more CASRNs; no
new data (2)
----------------------------------------------------------------------------------------------------------------
M001              182              Study protocol requiring Human Studies      9                           7,200
New                                 Review Board review as defined in 40 CFR
26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------
M002              183              Completed study requiring Human Studies     9                           7,200
New                                 Review Board review as defined in 40 CFR
26 in support of an active ingredient (4)
----------------------------------------------------------------------------------------------------------------


[[Page 1399]]


M003              184              External technical peer review of new       12                         58,000
New                                 active ingredient, product, or amendment
(e.g., consultation with FIFRA Scientific
Advisory Panel) for an action with a
decision timeframe of less than 12
months. Applicant initiated request based
on a requirement of the Administrator, as
defined by FIFRA Sec.  25(d), in support
of a novel active ingredient, or unique
use pattern or application technology.
Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------


[[Page 1400]]


M004              185              External technical peer review of new       18                         58,000
New                                 active ingredient, product, or amendment
(e.g., consultation with FIFRA Scientific
Advisory Panel) for an action with a
decision timeframe of greater than 12
months. Applicant initiated request based
on a requirement of the Administrator, as
defined by FIFRA Sec.  25(d), in support
of a novel active ingredient, or unique
use pattern or application technology.
Excludes PIP active ingredients. (5)
----------------------------------------------------------------------------------------------------------------


[[Page 1401]]


M005              186              New Product: Combination, Contains a        9                          20,000
New                                 combination of active ingredients from a
registered and/or unregistered source;
conventional, antimicrobial and/or
biopesticide. Requires coordination with
other regulatory divisions to conduct
review of data, label and/or verify the
validity of existing data as cited. Only
existing uses for each active ingredient
in the combination product. (6) (7)
----------------------------------------------------------------------------------------------------------------
M006              187              Request for up to 5 letters of              1                             250
New                                 certification (Gold Seal) for one
actively registered product.
----------------------------------------------------------------------------------------------------------------
M007              188              Request to extend Exclusive Use of data as  12                          5,000
New                                 provided by FIFRA Section 3(c)(1)(F)(ii)
----------------------------------------------------------------------------------------------------------------


[[Page 1402]]


M008              189              Request to grant Exclusive Use of data as   10                          1,500
New                                 provided by FIFRA Section 3(c)(1)(F)(vi)
for a minor use, when a FIFRA Section
2(ll)(2) determination is required
----------------------------------------------------------------------------------------------------------------

(1) <> A decision review time that would otherwise
end on a Satur- day, Sunday, or
federal holiday, will be extended to end on the next business day.

(2) If another covered application is associated with and depend-
ent upon a pending application for an inert ingredient action, each
application will be subject to its respective registration service fee.
The decision review time for the other associated covered applica- tion
will be extended to match the PRIA due date of the pending
inert ingredient action, unless the PRIA due date for the other as-
sociated covered action is further out, in which case it will be sub-
ject to its own decision review time. If the application covers multiple
ingredients grouped by EPA into one chemical class, a single
registration service fee will be assessed for approval of those ingre-
dients.
(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 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 tol- erance action for two
years from the effective date of the rule.
(4) Any other covered application that is associated with and de-
pendent on the HSRB review will be subject to its separate reg-
istration service fee. The decision review times for the associated
actions run concurrently, but will end at the date of the latest re-
view time.
(5) Any other covered application that is associated with and de-
pendent on the SAP review will be subject to its separate registration
service fee. The decision 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 ac-
tive ingredient that (a) is not yet registered but (b) has an applica-
tion pending with the Agency for review, will be considered an ap-
plication for a new product with an unregistered source of active
ingredient.

[[Page 1403]]

(7) <> 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, includ- ing 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 ei- ther (a) agrees to all of the terms associated
with the draft accept- ed 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 resubmission, but forfeits the associated 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 reso- lution 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.'';

(B) in paragraph (6)--
(i) in subparagraph (A)--
(I) by striking ``October 1, 2008''
and inserting ``October 1, 2013''; and
(II) by striking ``September 30,
2010'' and inserting ``September 30,
2015''; and
(ii) in subparagraph (B)--
(I) by striking ``October 1, 2010''
and inserting ``October 1, 2015''; and
(II) by striking ``September 30,
2010'' and inserting ``September 30,
2015''; and
(C) in paragraph (8)(C)(ii)--
(i) in subclause (I), by striking ``or'' at
the end;
(ii) in subclause (II), by striking the period
at the end and inserting ``; or''; and
(iii) by adding at the end the following:
``(III) on the basis that the
Administrator rejected the application
under subsection (f)(4)(B).''.
(2) Pesticide registration fund.--Section 33(c)(3)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(c)(3)(B)) is amended--
(A) in clause (i), by striking ``2008 through 2012''
and inserting ``2013 through 2017'';
(B) in clause (ii), by striking ``grants'' and all
that follows through the end of the clause and inserting
``grants, for each of fiscal years 2013 through 2017,
$500,000.''; and
(C) in clause (iii), by striking ``2008 through
2012'' and inserting ``2013 through 2017''.
(3) Assessment of fees.--Section 33(d) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d))
is amended--
(A) in paragraph (2), by striking ``2002'' each
place it appears and inserting ``2012'';

[[Page 1404]]

(B) by striking paragraph (4); and
(C) by redesignating paragraph (5) as paragraph (4).
(4) Reforms to reduce decision time review periods.--Section
33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136w-8(e)) is amended by striking ``Pesticide
Registration Improvement Act of 2003'' and inserting ``Pesticide
Registration Improvement Extension Act of 2012''.
(5) Decision time review periods.--Section 33(f) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(f)) is amended--
(A) in paragraph (1), by striking ``Pesticide
Registration Improvement Renewal Act, the Administrator
shall publish in the Federal Register'' and inserting
``Pesticide Registration Improvement Extension Act of
2012, the Administrator shall make publicly available'';
(B) in paragraph (2), by striking ``appearing in the
Congressional Record on pages S10409'' and all that
follows through the period and inserting ``provided
under subsection (b)(3).''; and
(C) in paragraph (4)--
(i) in subparagraph (A), by inserting ``and
fee'' before the period; and
(ii) in subparagraph (B)--
(I) by striking ``(B) Completeness
of application'' and all that follows
through ``Not later'' in clause (i) and
inserting the following:
``(B) Initial content and preliminary technical
screenings.--
``(i) Screenings.--
``(I) Initial content.--Not later'';
(II) in clause (i) (as so
designated) by adding at the end the
following:
``(II) <>
Preliminary technical screening.--After
conducting the initial content screening
described in subclause (I) and in
accordance with clause (iv), the
Administrator shall conduct a
preliminary technical screening--
``(aa) not later than 45
days after the date on which the
decision time review period
begins (for applications with
decision time review periods of
not more than 180 days); and
``(bb) not later than 90
days after the date on which the
decision time review period
begins (for applications with
decision time review periods
greater than 180 days).'';
(III) by striking clause (ii) and
inserting the following:
``(ii) Rejection.--
``(I) <>  In
general.--If the Administrator
determines at any time before the
Administrator completes the preliminary
technical screening under clause (i)(II)
that the application failed the initial
content or preliminary technical
screening and the applicant does not
correct the failure before the date that
is 10 business days after the applicant

[[Page 1405]]

receives a notification of the failure,
the Administrator shall reject the
application.
``(II) <>
Written notification.--The Administrator
shall make every effort to provide a
written notification of a rejection
under subclause (I) during the 10-day
period that begins on the date the
Administrator completes the preliminary
technical screening.'';
(IV) in clause (iii)--
(aa) in the heading, by
inserting ``initial content''
before ``screening'' ;
(bb) in the matter preceding
subclause (I), by inserting
``content'' after ``initial'';
and
(cc) in subclause (II), by
striking ``contains'' and
inserting ``appears to
contain''; and
(V) by adding at the end the
following:
``(iv) Requirements of preliminary technical
screening.--In <> conducting
a preliminary technical screening of an
application, the Administrator shall determine
if--
``(I) the application and the data
and information submitted with the
application are accurate and complete;
and
``(II) the application, data, and
information are consistent with the
proposed labeling and any proposal for a
tolerance or exemption from the
requirement for a tolerance under
section 408 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 346a), and
are such that, subject to full review
under the standards of this Act, could
result in the granting of the
application.''.
(6) Reports.--Section 33(k) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended--
(A) in paragraph (1), by striking ``March 1, 2014''
and inserting ``March 1, 2017'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (vi)(V), by striking
``and'' at the end;
(II) in clause (vii)(II), by
inserting ``and'' at the end; and
(III) by adding at the end the
following:
``(viii) the number of extensions of decision
time review periods agreed to under subsection
(f)(5) along with a description of the reason that
the Administrator was unable to make a decision
within the initial decision time review period;'';
(ii) in subparagraph (E), by striking ``and''
at the end;
(iii) in subparagraph (F), by striking the
period and inserting a semicolon; and
(iv) by adding at the end the following:
``(G) a review of the progress made toward--
``(i) carrying out section 4(k)(4) and the
amounts from the Reregistration and Expedited
Processing Fund used for the purposes described in
that section;

[[Page 1406]]

``(ii) implementing systems for the electronic
tracking of registration submissions by December
31, 2013;
``(iii) <> implementing a system for
tracking the status of conditional registrations,
including making nonconfidential information
related to the conditional registrations publicly
available by December 31, 2013;
``(iv) implementing enhancements to the
endangered species knowledge database, including
making nonconfidential information related to the
database publicly available;
``(v) implementing the capability to
electronically submit and review labels submitted
with registration actions;

``(vi) <>
acquiring and implementing the capability to
electronically assess and evaluate confidential
statements of formula submitted with registration
actions by December 31, 2014; and
``(vii) <> facilitating
public participation in certain registration
actions and the registration review process by
providing electronic notification to interested
parties of additions to the public docket;
``(H) the number of applications rejected by the
Administrator under the initial content and preliminary
technical screening conducted under subsection (f)(4);
``(I) <> a review of the progress
made in updating the Pesticide Incident Data System,
including progress toward making the information
contained in the System available to the public (as the
Administrator determines is appropriate); and
``(J) <> an assessment of the
public availability of summary pesticide usage data.'';
and
(C) by adding at the end the following:
``(4) Other report.--
``(A) Scope.--In addition to the annual report
described in paragraph (1), not later than October 1,
2016, the Administrator shall submit to the Committee on
Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the
Senate a report that includes an analysis of the impact
of maintenance fees on small businesses that have--
``(i) 10 or fewer employees; and
``(ii) annual global gross revenue that does
not exceed $2,000,000.
``(B) Information required.--In conducting the
analysis described in subparagraph (A), the
Administrator shall collect, and include in the report
under that subparagraph, information on--
``(i) the number of small businesses described
in subparagraph (A) that are paying maintenance
fees; and
``(ii) the number of registrations each
company holds.''.
(7) Termination of effectiveness.--Section 33(m) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w-8(m)) is amended--

[[Page 1407]]

(A) in paragraph (1), by striking ``2012'' and
inserting ``2017''; and
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in the heading, by striking
``2013'' and inserting ``2018'';
(II) by striking ``2013,'' and
inserting ``2018,''; and
(III) by striking ``September 30,
2012'' and inserting ``September 30,
2017'';
(ii) in subparagraph (B)--
(I) in the heading, by striking
``2014'' and inserting ``2019'';
(II) by striking ``2014,'' and
inserting ``2019,''; and
(III) by striking ``September 30,
2012'' and inserting ``September 30,
2017'';
(iii) in subparagraph (C)--
(I) in the heading, by striking
``2014'' and inserting ``2019''; and
(II) by striking ``September 30,
2014'' and inserting ``September 30,
2019''; and
(iv) in subparagraph (D), by striking ``2012''
each place it appears and inserting ``2017''.

(c) <>  Effective Date.--This section and
the amendments made by this section take effect on October 1, 2012.

(d) <>  Relationship to Other Law.--In the
case of any conflict between this section (including the amendments made
by this section) and a joint resolution making continuing appropriations
for fiscal year 2013 (including any amendments made by such a joint
resolution), this section and the amendments made by this section shall
control.

Approved September 28, 2012.

LEGISLATIVE HISTORY--S. 3552:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 158 (2012):
Sept. 13, considered and passed Senate.
Sept. 14, considered and passed House.