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 Environmental Protection Agency [EPA-HQ-OPP-2008-0545; FRL-8375-9]
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Notice.
 SUMMARY: EPA is publishing a revised list of pesticide registration service fees applicable to specified pesticide applications and tolerance actions. Under the Pesticide Registration Improvement Renewal Act, the registration service fees for covered pesticide registration applications received on or after October 1, 2008, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2008, and certain decision review periods have been reduced. The new fees and decision review periods become effective on October 1, 2008.
 FOR FURTHER INFORMATION CONTACT: Elizabeth Leovey (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7328; fax number: (703) 308-4776; e-mail address: 
                        *leovey.elizabeth@epa.gov.*


SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you register pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially affected entities may include, but are not limited to: Agricultural pesticide manufacturers (32532).
                Antimicrobial pesticide manufacturers (32561).
                Antifoulant pesticide manufacturers (32551).
                Wood preservative manufacturers (32519). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the notice and in FIFRA section 33. If 
                    ( print page 45439)
                    you have any questions regarding the applicability of this action to a particular entity, consult the person listed under 
                    **FOR FURTHER INFORMATION CONTACT**
                    . B. How Can I Get Copies of this Document and Other Related Information? 1. 
                    *Docket*. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-[0545]. Publicly available docket materials are available either in the electronic docket at 
                    *http://www.regulations.gov*, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805. 2. 
                    *Electronic access*. You may access this 
                    **Federal Register**
                     document electronically through the EPA Internet under the “
                    **Federal Register**
                    ” listings at 
                    *http://www.epa.gov/​fedrgstr*. II. Background A. What Action is the Agency Taking? The Pesticide Registration Improvement Act of 2003 established a new section 33 of FIFRA creating a registration service fee system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004. On October 9, 2007, the Pesticide Registration Improvement Renewal Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through 2012 and established fees and review times for applications received during fiscal years 2008 through 2012. As required by section 33(b)(6)(A) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2008, increase by five percent rounding up to the nearest dollar from the fees published in the October 30, 2007, 
                    **Federal Register**
                     Notice (72 FR 61466). In addition, this notice provides shorter decision review periods for certain application categories. B. What is the Agency's Authority for Taking this Action? The publication of this fee schedule is required by section 33(b)(6)(C) of FIFRA as amended. III. Elements of the Fee Schedule This unit explains how EPA has organized the fee schedule identified in the statute and how to read the fee schedule tables, and includes a key to terminology published with the table in the Congressional Review. EPA's organization and presentation of the fee schedule information does not affect the categories of registration service fees or the structure or procedures for submitting applications or petitions for tolerance. A. The Congressional Record Fee Schedule The fee schedule published in the Congressional Record of July 21, 2007 identifies the registration service fees and decision times and is organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. Thereafter, the categories within the organizational unit sections of the table are further categorized according to the type of application being submitted, the use patterns involved, or, in some cases, upon the type of pesticide that is the subject of the application. The fee categories differ by Division. Not all application types are covered by, or subject to, the fee system. B. Fee Schedule and Decision Review Times In today's notice, EPA has retained the format of previous schedule notices and included the corrections to the schedule published in the September 24, 2007 issue of the Congressional Record. The schedules are presented as 11 tables, organized by OPP Division and by type of application or pesticide subject to the fee. These tables only list the decision time review periods for fiscal years 2009 and 2010 as these are the only applicable review periods for applications received on or after October 1, 2008. Unit IV. presents fee tables for the Registration Division (RD) (5 tables), the Antimicrobials Division (AD) (3 tables), and the Biopesticides and Pollution Prevention Division (BPPD) (3 tables). C. How to Read the Tables 1. 
                    *Each table consists of the following columns*: The column entitled “EPA No.” assigns an EPA identifier to each fee category. There are 140 categories spread across the 3 Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD and BPPD categories. The categories are prefaced with a letter designation indicating which Division of OPP is responsible for applications in that category (R= Registration Division, A=Antimicrobials Division, B=Biopesticides and Pollution Prevention Division).
                The column entitled “CR No.” cross-references the current Congressional Record category number for convenience. However, EPA will be using the categories as numbered in the “EPA No.” column in its tracking systems.
                The column entitled “Action” describes the categories of action. In establishing the expanded fee schedule categories, Congress eliminated some of the more confusing terminology of the original categories. For example, instead of the term “fast-track,” the schedule in the Congressional Record uses the regulatory phrase “identical or substantially similar in composition and use to a registered product.”
                The column entitled “Decision Time” lists the decision times in months for each type of action for Fiscal Years 2009 and 2010. The 2010 decision times apply to 2011 and 2012. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30.
                The column entitled “FY 09/FY 10 Registration Service Fee ($)” lists the registration service fee for the action for fiscal year 2009 (October 1, 2008 through September 30, 2009) and fiscal year 2010 (October 1, 2009 through September 30, 2010). 2. 
                    *The following acronyms are used in some of the tables*: DART-Dose Adequacy Response Team
                DNT-Developmental Neurotoxicity
                HSRB-Human Studies Review Board
                GW/SW-Ground Water/Surface Water
                PHI-Pre-Harvest Interval
                PPE-Personal Protective Equipment
                REI-Restricted Entry Interval
                SAP-FIFRA Scientific Advisory Panel( print page 45440) IV. PRIRA Fee Schedule Tables—Effective October 1, 2008 A. Registration Division (RD) The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed “conventional chemicals,” excluding pesticides intended for antimicrobial uses. The term “conventional chemical” is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally-occurring chemicals and microbial pesticides. Tables 1 through 5 of Unit IV.A. cover RD actions. **Table 1.—Registration Division—New Active Ingredients**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10R010
1
Food use1
24
24
542,115R020
2
Food use; reduced risk1
18
18
542,115R030
3
Food use; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit and temporary tolerance same as #R0401
24
24
599,235R040
4
Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows
18
18
399,525R050
5
Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted1
14
14
199,815R060
6
Non-food use; outdoor1
21
21
376,635R070
7
Non-food use; outdoor; reduced risk1
16
16
376,635R080
8
Non-food use; outdoor; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit same as #R0901
21
21
416,640R090
9
Non-food use; outdoor; Experimental Use Permit application submitted before application for registration; credit $228,225 toward new active ingredient application that follows
16
16
279,615R100
10
Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit is granted1
12
12
137,025R110
11
Non-food use; indoor1
20
20
209,475R120
12
Non-food use; indoor; reduced risk1
14
14
209,475R121
13
Non-food use; indoor; Experimental Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows
18
18
157,500R122
14
Enriched isomer(s) of registered mixed-isomer active ingredient1
18
18
273,945R123
15
Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1
18
18
407,610R124
16
Conditional Ruling on Preapplication Study Waivers; applicant-initiated
6
6
2,1841
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 
 
 **Table 2.—Registration Division—New Uses**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10R130
17
First food use; indoor; food/food handling1
21
21
165,375R140
18
Additional food use; indoor; food/food handling
15
15
38,588R150
19
First food use1
21
21
228,270R160
20
First food use; reduced risk1
16
16
228,270R170
21
Additional food use
15
15
57,120R180
22
Additional food use; reduced risk
10
10
57,120R190
23
Additional food uses; 6 or more submitted in one application
15
15
342,720R200
24
Additional food uses; 6 or more submitted in one application; reduced risk
10
10
342,720R210
25
Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration
12
12
42,315R220
26
Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration
6
6
17,136R230
27
Additional use; non-food; outdoor
15
15
22,827R240
28
Additional use; non-food; outdoor; reduced risk
10
10
22,827R250
29
Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration
6
6
17,136R260
30
New use; non-food; indoor
12
12
11,025R270
31
New use; non-food; indoor; reduced risk
9
9
11,025R271
32
New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration
6
6
8,400R272
33
Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review
3
3
2,184R273
34
Additional use; seed treatment; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses
12
12
43,575R274
35
Additional uses; seed treatment only; 6 or 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
12
12
261,4501
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 
 
 **Table 3.—Registration Division—Import and Other Tolerances**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10R280
36
Establish import tolerance; new active ingredient or first food use1
21
21
275,625R290
37
Establish import tolerance; additional food use
15
15
55,125R291
38
Establish import tolerances; additional food uses; 6 or more crops submitted in one petition
15
15
330,750R292
39
Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated
10
10
39,165R293
40
Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated
12
12
46,200R294
41
Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated
12
12
277,200R295
42
Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated
15
15
57,120R296
43
Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated
15
15
342,7201
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 **Table 4.—Registration Division—New Products**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10R300
44
New product; identical or substantially 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 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.
3
3
1,365R301
45
New product; 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.
4
4
1,638R310
46
New end-use or manufacturing-use product; requires review of data package within RD; includes reviews and/or waivers of data for only:
                             • Product chemistry and/or 
                             • Acute toxicity and/or 
                             • Public health pest efficacy
6
6
4,578R311
49
New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners
12
12
16,317R312
50
New product; requires approval of new non-food-use inert; applicant-initiated
6
6
8,715( print page 45443)R313
51
New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated
10
10
11,991R320
47
New product; new physical form; requires data review in science divisions
12
12
11,424R330
48
New manufacturing-use product; registered active ingredient; selective data citation
12
12
17,136R331
52
New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only
3
3
2,184R332
53
New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only
24
24
244,650
 **Table 5.—Registration Division—Amendments to Registration**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10R340
54
Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)1
4
4
3,444R350
55
Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)1
8
8
11,424R370
56
Cancer reassessment; applicant-initiated
18
18
171,255R371
57
Amendment to Experimental Use Permit; requires data review/risk assessment
6
6
8,715R372
58
Refined ecological and/or endangered species assessment; applicant-initiated
18
12
163,0651
                        EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 B. Antimicrobials Division (AD) The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 6 through 8 of Unit IV.B. cover AD actions. **Table 6.—Antimicrobials Division—New Active Ingredients**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10A380
59
Food use; establish tolerance exemption1
24
24
99,225A390
60
Food use; establish tolerance1
24
24
165,375A400
61
Non-food use; outdoor; FIFRA section 2(mm) uses1
18
18
82,688( print page 45444)A410
62
Non-food use; outdoor; uses other than FIFRA section 2(mm)1
21
21
165,375A420
63
Non-food use; indoor; FIFRA section 2(mm) uses1
18
18
55,125A430
64
Non-food use; indoor; uses other than FIFRA section 2(mm)1
20
20
82,688A431
65
Non-food use; indoor; low-risk and low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol
12
12
57,7501
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 **Table 7.—Antimicrobials Division—New Uses**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10A440
66
First food use; establish tolerance exemption1
21
21
27,563A450
67
First food use; establish tolerance1
21
21
82,688A460
68
Additional food use; establish tolerance exemption
15
15
11,025A470
69
Additional food use; establish tolerance
15
15
27,563A480
70
Additional use; non-food; outdoor; FIFRA section 2(mm) uses
9
9
16,538A490
71
Additional use; non-food; outdoor; uses other than FIFRA section 2(mm)
15
15
27,563A500
72
Additional use; non-food; indoor; FIFRA section 2(mm) uses
9
9
11,025A510
73
Additional use; non-food; indoor; uses other than FIFRA section 2(mm)
12
12
11,025A520
74
Experimental Use Permit application
9
9
5,513A521
75
Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1
4
3
2,100A522
76
Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2
15
12
10,5001
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 
 
 **Table 8.—Antimicrobials Division—New Products and Amendments**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10A530
77
New product; identical or substantially 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 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.
3
3
1,103A531
78
New product; 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
4
4
1,575A532
85
New product; identical or substantially 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
4
4
4,410A540
79
New end-use product; FIFRA section 2(mm) uses only
4
4
4,410A550
80
New end-use product; uses other than FIFRA section 2(mm); non-FQPA product
6
6
4,410A560
81
New manufacturing-use product; registered active ingredient; selective data citation
12
12
16,538A570
82
Label amendment requiring data submission1
4
4
3,308A571
83
Cancer reassessment; applicant-initiated
18
18
82,688A572
84
Refined ecological risk and/or endangered species assessment; applicant-initiated
18
12
78,7501
                        EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 C. Biopesticides and Pollution Prevention Division (BPPD) The Biopesticides and Pollution Prevention Division of OPP is responsible for the processing of pesticide applications for biochemical pesticides, microbial pesticides, and plant-incorporated protectants (PIPs). The fee tables for BPPD tables are presented by type of pesticide rather than by type of action: Microbial and biochemical pesticides, straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each table, the types of application are the same as those in other divisions and use the same terminology as in Unit III. Tables 9 through 11 of Unit IV.C. cover BPPD actions. **Table 9.—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products and Amendments**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10B580
86
New active ingredient; food use; establish tolerance1
18
18
44,100B590
87
New active ingredient; food use; establish tolerance exemption1
16
16
27,563( print page 45446)B600
88
New active ingredient; non-food use1
12
12
16,538B610
89
Food use; Experimental Use Permit application; establish temporary tolerance exemption
9
9
11,025B620
90
Non-food use; Experimental Use Permit application
6
6
5,513B621
91
Extend or amend Experimental Use Permit
6
6
4,410B630
92
First food use; establish tolerance exemption
12
12
11,025B631
93
Amend established tolerance exemption
9
9
11,025B640
94
First food use; establish tolerance1
18
18
16,538B641
95
Amend established tolerance (e.g., decrease or increase)
12
12
11,025B650
96
New use; non-food
6
6
5,513B660
97
New product; identical or substantially 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 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.
3
3
1,103B670
98
New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales
6
6
4,410B671
99
New product; food use; unregistered source of active ingredient; requires amendment of established tolerance or tolerance exemption; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales
16
16
11,025B672
100
New product; non-food use or food use having established tolerance or tolerance exemption; unregistered source of active ingredient; no data compensation issues; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales
12
12
7,875B680
101
Label amendment requiring data submission2
4
4
4,410B681
102
Label amendment; unregistered source of active ingredient; supporting data require scientific review
6
6
5,250B682
103
Protocol review; applicant-initiated; excludes time for HSRB review (pre-application)
3
3
2,1001
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.2
                        EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 **Table 10.—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPS)**
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10B690
104
New active ingredient; food or non-food use1
6
6
2,205B700
105
Experimental Use Permit application; new active ingredient or new use
6
6
1,103B701
106
Extend or amend Experimental Use Permit
3
3
1,103B710
107
New product; identical or substantially 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 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.
3
3
1,103B720
108
New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product specific data or with request for data waivers supported by scientific rationales
4
4
1,103B721
109
New product; unregistered source of active ingredient
6
6
2,310B722
110
New use and/or amendment to tolerance or tolerance exemption
6
6
2,310B730
111
Label amendment requiring data submission2
4
4
1,1031
                        All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.2
                        EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 Table 11.—Biopesticide and Pollution Prevention Division—Plant Incorporated Protectants (PIPS)
EPA No.
CR No.
Action
Decision time (months)
FY 09/FY 10 Registration Service Fee ($)FY 09
FY 10B740
112
Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required1
6
6
82,688B750
113
Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required1
9
9
110,250B760
114
Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct basis; SAP review required; credit $78,750 toward new active ingredient application that follows
12
12
137,813B761
115
Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows
7
7
82,688( print page 45448)B770
116
Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; SAP review required; credit $105,000 toward new active ingredient application that follows
15
15
165,375B771
117
Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; credit $105,000 toward new active ingredient application that follows
10
10
110,250B772
118
Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected
3
3
11,025B773
119
Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption
5
5
27,563B860
120
Amend Experimental Use Permit; first food use or major revision of experimental design
6
6
11,025B780
121
New active ingredient; non-food/feed; no SAP review required2
12
12
137,813B790
122
New active ingredient; Non-food/feed; SAP review required2
18
18
192,938B800
123
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2
12
12
220,500B810
124
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2
18
18
275,625B820
125
New active ingredient; establish tolerance or tolerance exemption; no SAP review required2
15
15
275,625B840
126
New active ingredient; establish tolerance or tolerance exemption; SAP review required2
21
21
330,750B830
127
New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required2
15
15
330,750B850
128
New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2
21
21
385,875B851
129
New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required
9
9
110,250B852
130
New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required
9
9
165,375B870
131
New use1
9
9
33,075B880
132
New product; no SAP review required3
9
9
27,563( print page 45449)B881
133
New product; SAP review required3
15
15
82,688B890
134
Amendment; seed production to commercial registration; no SAP review required
9
9
55,125B891
135
Amendment; seed production to commercial registration; SAP review required
15
15
110,250B900
136
Amendment (except #B890); no SAP review required; (e.g., new IRM requirements that are applicant-initiated; or amending a conditional registration to extend the registration expiration date with additional data submitted)4
6
6
11,025B901
137
Amendment (except #B890); SAP review required4
12
12
66,150B902
138
PIP protocol review
3
3
5,513B903
139
Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD
6
6
55,125B904
140
Import tolerance or tolerance exemption; processed commodities/food only
9
9
110,2501
                        Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.2
                        May be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial registration is obtained using B890.3
                        Example: Stacking PIP traits within a crop using traditional breeding techniques.4
                        EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 V. How to Pay Fees Applicants must submit fee payments at the time of application, and EPA will reject any application that does not contain evidence that the fee has been paid. EPA has developed a web site at 
                    *http://www.epa.gov/​pesticides/​fees/​tool/​index.htm*
                     to help applicants identify the fee category and the fee. All fees should be rounded up to the whole dollar. Payments may be made by check, bank draft, or money order or online with a credit card or wire transfer. A. Online You may pay electronically through the government payment website 
                    *www.pay.gov*. 1. From the pay.gov home page, under “Find Public Forms.” 2. Select “search by Agency name.” 3. On the A-Z Index of Forms page, select “E.” 4. Select “Environmental Protection Agency.” 5. From the list of forms, select “Pre-payment of Pesticide Registration Improvement Act Fee.” 6. Complete the form entering the PRIA fee category and fee. 7. Keep a copy of the pay.gov acknowledgement of payment. A copy of the acknowledgement must be printed and attached to the front of the application to assure that EPA can match the application with the payment. B. By Check or Money Order All payments must be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. On the check, the applicant must supply in the information line either the registration number of the product or the company number. A copy of the check must accompany the application to the Agency, specifically attached to the front of the application. The copy of the check ensures that payment has been made at the time of application and will enable the Agency to properly connect the payment with the application sent to the Agency. If you send the Agency a check, it will be converted into an electronic funds transfer (EFT). This means the Agency will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours and will be shown on your regular account statement. You will not receive your original check back. The Agency will destroy your original check but will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize the Agency to process the copy in place of your original check. If the EFT cannot be completed because of insufficient funds, the Agency may try to make the transfer up to two times. All paper-based payments should be sent to the following address: 1. 
                    *By U.S. Postal Service*. U.S. Environmental Protection Agency, Washington Finance Center, FIFRA Service Fees, P.O. Box 979074, St. Louis, MO 63197-9000. 2. 
                    *By courier or personal delivery*. U.S. Bank, Government Lockbox 979074, 1005 Convention Plaza, SL-MO-C2-GL, St. Louis, MO 63197, (314) 418-4990. VI. How to Submit Applications Submissions to the Agency should be made at the address given in Unit VII. The applicant should attach documentation that the fee has been paid which may be pay.gov payment acknowledgement or a copy of the check. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described 
                    ( print page 45450)
                    in FIFRA section 33(b)(7) and 
                    *http://www.epa.gov/​pesticides/​fees/​questions/​waivers.htm*. The fee waiver request should be easy to identify and separate from the rest of the application and submitted with documentation that at least 25% of the fee has been paid. If evidence of fee payment (electronic acknowledgement or copy of check properly identified as to company) is not submitted with the application, EPA will reject the application and will not process it further. After EPA receives an application and payment, EPA performs a screen on the application to determine that the category is correct and that the proper fee amount has been paid. If either is incorrect, EPA will notify the applicant and require payment of any additional amount due. A refund will be provided in case of an overpayment. EPA will not process the application further until the proper fee has been paid for the category of application or a request for a fee waiver accompanies the application and the appropriate portion of the fee has been paid. EPA will assign a unique identification number to each covered application for which payment has been made. EPA notifies the applicant of the unique identification number. This information is sent by e-mail if EPA has either an e-mail address on file or an e-mail address is provided on the application. VII. Addresses New covered applications should be identified in the title line with the mail code REGFEE. 1. 
                    *By USPS mail*. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001. 2. 
                    *By courier*. Document Processing Desk (REGFEE), Office of Pesticide Programs, U.S. Environmental Protection Agency, Room S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202-4501. Couriers and delivery personnel must present a valid picture identification card to gain access to the building. Hours of operation for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. List of Subjects Environmental protection
Administrative practice and procedure
Pesticides
 Dated: July 28, 2008. Marty Monell, Acting Director, Office of Pesticide Programs.


[FR Doc. E8-17936 Filed 8-4-08; 8:45 am] **BILLING CODE**
                 6560-50-S