Pesticides; Revised Fee Schedule for Registration Applications, 61466-61477 [07-5381]
Download as PDF
<![CDATA[
61466
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–1066; FRL–8155–6]
Pesticides; Revised Fee Schedule for
Registration Applications
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 number
of fee categories has been increased, the
registration service fees for some
covered pesticide registration
applications received on or after
October 1, 2007, have been increased,
and certain new procedures have been
established. The new fees became
effective on October 1, 2007.
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:
sroberts on PROD1PC70 with NOTICES
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 (NAICS code 32532).
• Antimicrobial pesticide
manufacturers (NAICS code 32561).
• Antifoulant pesticide
manufacturers (NAICS code 32551).
• Wood preservative manufacturers
(NAICS code 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
you have any questions regarding the
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
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–2007–1066. Publicly available
docket materials are available either in
the electronic docket athttps://
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
https://www.epa.gov/fedrgstr.
II. Background
In accordance with FIFRA section
33(b)(3), EPA published in the Federal
Register of March 17, 2004 (69 FR
12772) (FRL–7348–2), a schedule of the
fees and decision times for review of a
covered application. Section 33 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), establishes 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
established a schedule of decision
review times for applications covered by
the service fee system. Since March 23,
2004, the Agency has been
administering the registration service
fee system. The schedule of fees and
decision review times was published in
the Federal Register of March 17, 2004
(69 FR 12772). Subsequently, as
authorized by FIFRA section 33, fees
were increased by 5% in a notice issued
in the Federal Register of June 2, 2005
(70 FR 32327) (FRL–7706–1).
III. The Pesticide Registration
Improvement Renewal Act (PRIRA)
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
PO 00000
Frm 00002
Fmt 4701
Sfmt 4703
received during fiscal years 2008
through 2012. The publication of this
fee schedule is required by section
33(f)(1) of FIFRA as amended.
Key changes in the new law include
the following:
1. The number of fee categories has
been increased from 90 to 140. In so
doing, new categories were added,
particularly in the area of tolerances,
review of study protocols, risk
assessments not associated with an
application, and plant-incorporated
protectants (PIPs). In addition, some
current categories were split into several
new categories to provide more specific
listings.
2. The EPA identification system for
fee categories has been revised to a 3digit system to accommodate the
increased number of categories. The
new fee schedule continues to preface
fee categories according to the
Divisional responsibilities within OPP
(e.g., R for Registration Division). As an
example, the fee category for the new
category ‘‘Enriched isomer(s) of
registered mixed-isomer active
ingredient’’ is R122.
3. Fees are due at application.
Previously, the application could be
submitted to the Agency in advance of
fee submittal and EPA would ‘‘invoice’’
or ‘‘bill’’ the applicant for the fee. Units
VI. and VII. discuss how the Agency
intends to implement this new
provision.
4. EPA must within 21 days after
receipt of the application and payment
reject any application that does not pass
the initial content screen and that
cannot be corrected. EPA must screen
the application within 21 days and
make a determination, and verify
appropriate fee submission (or a waiver
request with at least 25% of the
applicable fee accompanying the waiver
request).
5. A portion of the fee, 25%, is nonrefundable. The amount of a refund for
an early withdrawal during the first 60
days of the decision time review period
is now 75% of the fee. Previously, the
Agency was required to refund 90% for
an early withdrawal.
6. A small business fee waiver cannot
reduce the fee more than 75% of the
appropriate registration service fee
instead of 100%, previously.
7. Fees will be increased by 5% for
applications received during the period
October 1, 2008 through September 30,
2010, and thereafter increased by an
additional 5% for applications received
as of October 1, 2010. EPA will issue
notice in the Federal Register of the
new fee schedules as appropriate.
E:\FR\FM\30OCN2.SGM
30OCN2
61467
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
IV. 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 and
examples include:
1. The re-establishment of a timelimited tolerance.
2. Review of confirmatory data
submitted in support of an alreadyissued registration.
3. Submission of a sub-registrant/
supplemental distributor label.
4. Special Local Needs Registrations
submitted under FIFRA section 24(c).
5. Emergency Exemption Requests
submitted under FIFRA section 18.
6. Notifications as described in
Pesticide Registration Notice 98–10.
7. Fast track amendments or label
amendments that require no data
review.
8. Minor formulation amendments as
described in Pesticide Registration
Notice 98–10.
9. 6(a)2 evaluations.
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. These corrections included: The
registration service fee for new category
No. 133 should be $78,750, rather than
$278,250; the decision time for new
category No. 47 in fiscal year 3 should
be 12 months; and the action
description for the new category No. 61
should read: ‘‘Non-food use; outdoor;
FIFRA, subsection 2(mm) uses (1).’’ 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
2008, 2009, and 2010 as these are the
only applicable review periods for
applications received on or after
October 1, 2008. Unit V. 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’’ list the decision times in months
for each type of action for Fiscal Years
2008, 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 08
Registration Service Fee ($)’’ lists the
registration service fee for the action for
fiscal year 2008 (October 1, 2007
through September 30, 2008).
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
V. PRIRA Fee Schedule Tables—
Effective October 1, 2007
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 V.A. cover
RD actions.
TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS
sroberts on PROD1PC70 with NOTICES
Decision time (in months)
EPA No.
CR No.
Action
FY 08
R010
VerDate Aug<31>2005
1
Food use1
22:56 Oct 29, 2007
Jkt 214001
FY 09
24
PO 00000
Frm 00003
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
24
30OCN2
FY 10
24
FY 08 Registration
Service Fee
($)
516,300
61468
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS—Continued
Decision time (in months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
R020
2
Food use; reduced risk1
18
18
18
516,300
R030
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
24
570,700
R040
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
18
380,500
R050
5
Food use; application submitted after Experimental Use Permit
application; decision time begins after Experimental Use
Permit and temporary tolerance are granted1
14
14
14
190,300
R060
6
Non-food use; outdoor1
21
21
21
358,700
16
16
16
358,700
risk1
R070
7
Non-food use; outdoor; reduced
R080
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
21
396,800
R090
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
16
266,300
R100
10
Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use
Permit isgranted1
12
12
12
130,500
R110
11
Non-food use; indoor1
20
20
20
199,500
14
14
14
199,500
risk1
R120
12
Non-food use; indoor; reduced
R121
13
Non-food use; indoor; Experimental Use Permit application
submitted before application for registration; credit $100,000
toward new active ingredient application that follows
18
18
18
150,000
R122
14
Enriched
isomer(s)
activeingredient1
mixed-isomer
18
18
18
260,900
R123
15
Seed treatment only; includes non-food and food uses; limited
uptake into Raw Agricultural Commodities1
18
18
18
388,200
R124
16
Conditional Ruling on Preapplication Study Waivers; applicantinitiated
6
6
6
2,080
of
registered
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 2.—REGISTRATION DIVISION—NEW USES
Decision time (months)
EPA No.
CR No.
Action
FY 08
FY 09
FY 10
FY 08 Registration
Service Fee
($)
17
First food use; indoor; food/food handling1
21
21
21
157,500
R140
18
Additional food use; Indoor; food/food handling
15
15
15
36,750
R150
sroberts on PROD1PC70 with NOTICES
R130
19
First food use1
21
21
21
217,400
16
16
16
217,400
risk1
R160
20
First food use; reduced
R170
21
Additional food use
15
15
15
54,400
R180
22
Additional food use; reduced risk
10
10
10
54,400
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00004
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61469
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 2.—REGISTRATION DIVISION—NEW USES—Continued
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
R190
23
Additional food uses; six or more submitted in one application
15
15
15
326,400
R200
24
Additional food uses; six or more submitted in one application;
reduced risk
10
10
10
326,400
R210
25
Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration
12
12
12
40,300
R220
26
Additional food use; Experimental Use Permit application; crop
destruct basis; no credit toward new use registration
6
6
6
16,320
R230
27
Additional use; non-food; outdoor
15
15
15
21,740
R240
28
Additional use; non-food; outdoor; reduced risk
10
10
10
21,740
R250
29
Additional use; non-food; outdoor; Experimental Use Permit
application; no credit toward new use registration
6
6
6
16,320
R260
30
New use; non-food; indoor
12
12
12
10,500
R270
31
New use; non-food; indoor; reduced risk
9
9
9
10,500
R271
32
New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration
6
6
6
8,000
R272
33
Review of Study Protocol; applicant-initiated; excludes DART,
pre-registration conferences, Rapid Response review, DNT
protocol review, protocols needing HSRB review
3
3
3
2,080
R273
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
12
41,500
R274
35
Additional uses; seed treatment only; six 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
12
249,000
1All 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
Decision time (months)
EPA No.
CR No.
Action
FY 08
FY 09
FY 10
FY 08 Registration
Service Fee
($)
36
Establish import tolerance; new active ingredient or first food
use1
21
21
21
262,500
R290
37
Establish import tolerance; additional food use
15
15
15
52,500
R291
38
Establish import tolerances; additional food uses; six or more
crops submitted in one petition
15
15
15
315,000
R292
sroberts on PROD1PC70 with NOTICES
R280
39
Amend an established tolerance (e.g., decrease or increase);
domestic or import; applicant-initiated
10
10
10
37,300
R293
40
Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated
12
12
12
44,000
R294
41
Establish tolerances for inadvertent residues; six or more
crops submitted in one application; applicant-initiated
12
12
12
264,000
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00005
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61470
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 3.—REGISTRATION DIVISION—IMPORT AND OTHER TOLERANCES—Continued
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
R295
42
Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated
15
15
15
54,400
R296
43
Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more
crops submitted in one application; applicant-initiated
15
15
15
326,400
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 4.—REGISTRATION DIVISION—NEW PRODUCTS
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
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 enduse or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,300
R301
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
4
1,560
R310
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
6
4,360
R311
49
New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners
12
12
12
15,540
R312
50
New product; requires approval of new non-food-use inert; applicant-initiated
6
6
6
8,300
R313
51
New product; requires amendment to existing inert tolerance
exemption (e.g., adding post-harvest use); applicant-initiated
10
10
10
11,420
R320
47
New product; new physical form; requires data review in
science divisions
12
12
12
10,880
R330
48
New manufacturing-use product; registered active ingredient;
selective data citation
12
12
12
16,320
R331
52
New product; repack of identical registered end-use product as
a manufacturing-use product; same registered uses only
3
3
3
2,080
R332
sroberts on PROD1PC70 with NOTICES
R300
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
24
233,000
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00006
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61471
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 5.—REGISTRATION DIVISION—AMENDMENTS TO REGISTRATION
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
R340
54
Amendment requiring data review within RD (e.g., changes to
precautionary label statements, or source changes to an unregistered source of active ingredient)1
4
4
4
3,280
R350
55
Amendment requiring data review in science divisions (e.g.,
changes to REI, or PPE, or PHI, or use rate, or number of
applications; or add aerial application; or modify GW/SW advisory statement)1
8
8
8
10,880
R370
56
Cancer reassessment; applicant-initiated
18
18
18
163,100
R371
57
Amendment to Experimental Use Permit; requires data review/
risk assessment
6
6
6
8,300
R372
58
Refined ecological and/or endangered species assessment;
applicant-initiated
18
18
12
155,300
1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is
responsible for the processing of
pesticide applications and associated
tolerances for conventional chemicals
intended for antimicrobial uses, that is,
uses that are defined under FIFRA
section 2(mm)(1)(A), including products
for use against bacteria, protozoa, nonagricultural fungi, and viruses. AD is
also responsible for a selected set of
conventional chemicals intended for
other uses, including most wood
preservatives and antifoulants. Tables 6
through 8 of Unit V.B. cover AD actions.
TABLE 6.—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS
Decision time (months)
EPA No.
CR No.
Action
FY 08
A380
59
Food use; establish tolerance exemption1
FY 09
FY 10
FY 08 Registration
Service Fee
($)
24
24
24
94,500
tolerance1
24
24
24
157,500
A390
60
Food use; establish
A400
61
Non-food use; outdoor; FIFRA section 2(mm) uses1
18
18
18
78,750
A410
62
Non-food use; outdoor; uses other than FIFRAsection 2(mm)1
21
21
21
157,500
A420
63
Non-food use; indoor; FIFRA section 2(mm) uses1
18
18
18
52,500
A430
64
Non-food use; indoor; uses other than FIFRAsection 2(mm)1
20
20
20
78,750
A431
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
12
55,000
1All 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
Decision time (months)
EPA No.
CR No.
Action
FY 08
sroberts on PROD1PC70 with NOTICES
A440
66
First food use; establish tolerance exemption1
FY 09
FY 10
FY 08 Registration
Service Fee
($)
21
21
21
26,250
21
tolerance1
21
21
78,750
A450
67
First food use; establish
A460
68
Additional food use; establish tolerance exemption
15
15
15
10,500
A470
69
Additional food use; establish tolerance
15
15
15
26,250
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00007
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61472
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 7.—ANTIMICROBIALS DIVISION—NEW USES—Continued
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
A480
70
Additional use; non-food; outdoor; FIFRA section 2(mm) uses
9
9
9
15,750
A490
71
Additional use; non-food; outdoor; uses other than FIFRA section 2(mm)
15
15
15
26,250
A500
72
Additional use; non-food; indoor; FIFRA section 2(mm) uses
9
9
9
10,500
A510
73
Additional use; non-food; indoor; uses other than FIFRA section 2(mm)
12
12
12
10,500
A520
74
Experimental Use Permit application
9
9
9
5,250
A521
75
Review of public health efficacy study protocol within AD; per
AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1
6
4
3
2,000
A522
76
Review of public health efficacy study protocol outside AD by
members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2
18
15
12
10,000
1All 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
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
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 enduse or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050
A531
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
4
1,500
A532
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
4,200
A540
79
New end use product; FIFRA section 2(mm) uses only
4
4
4
4,200
A550
80
New end-use product; uses other than FIFRA section 2(mm);
non-FQPA product
6
6
6
4,200
A560
81
New manufacturing-use product; registered active ingredient;
selective data citation
12
12
12
15,750
A570
82
Label amendment requiring data submission1
4
4
4
3,150
A571
sroberts on PROD1PC70 with NOTICES
A530
83
Cancer reassessment; applicant-initiated
18
18
18
78,750
A572
84
Refined ecological risk and/or endangered species assessment; applicant-initiated
18
18
12
75,000
1EPA-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.
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00008
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61473
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
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 V.C. cover BPPD
actions.
TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS AND AMENDMENTS
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
86
New active ingredient; food use; establish tolerance1
18
18
18
42,000
B590
87
New active ingredient; food use; establish toleranceexemption1
16
16
16
26,250
B600
88
New active ingredient; non-food use1
12
12
12
15,750
B610
89
Food use; Experimental Use Permit application; establish temporary tolerance exemption
9
9
9
10,500
B620
90
Non-food use; Experimental Use Permit application
6
6
6
5,250
B621
91
Extend or amend Experimental Use Permit
6
6
6
4,200
B630
92
First food use; establish tolerance exemption
12
12
12
10,500
B631
93
Amend established tolerance exemption
9
9
9
10,500
B640
94
First food use; establish tolerance1
18
18
18
15,750
B641
95
Amend established tolerance (e.g., decrease or increase)
12
12
12
10,500
B650
96
New use; non-food
6
6
6
5,250
B660
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 enduse or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050
B670
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 productspecific data or with request for data waivers supported by
scientific rationales
6
6
6
4,200
B671
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
16
10,500
B672
sroberts on PROD1PC70 with NOTICES
B580
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
12
7,500
B680
101
Label amendment requiring data submission2
4
4
4
4,200
B681
102
Label amendment; unregistered source of active ingredient;
supporting data require scientific review
6
6
6
5,000
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00009
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61474
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS AND AMENDMENTS—Continued
Decision time (months)
EPA No.
CR No.
FY 08
B682
103
FY 08 Registration
Service Fee
($)
Action
Protocol review; applicant-initiated; excludes time for HSRB review (preapplication)
FY 09
3
FY 10
3
3
2,000
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 10.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES
(SCLPS)
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
B690
104
New active ingredient; food or non-food use1
6
6
6
2,100
B700
105
Experimental Use Permit application; new active ingredient or
new use
6
6
6
1,050
B701
106
Extend or amend Experimental Use Permit
3
3
3
1,050
B710
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 enduse or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050
B720
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 productspecific data or with request for data waivers supported by
scientific rationales
4
4
4
1,050
B721
109
New product; unregistered source of active ingredient
6
6
6
2,200
B722
110
New use and/or amendment to tolerance or tolerance exemption
6
6
6
2,200
B730
111
Label amendment requiring data submission2
4
4
4
1,050
1All 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.
2EPA-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 PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
sroberts on PROD1PC70 with NOTICES
B740
112
Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review
required1
6
6
6
78,750
B750
113
Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption;
no SAP reviewrequired1
9
9
9
105,000
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00010
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61475
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)—
Continued
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
FY 09
FY 10
B760
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
12
131,250
B761
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
7
78,750
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
15
157,500
B771
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
10
105,000
B772
118
Amend or extend Experimental Use Permit; minor changes to
experimental design; established temporary tolerance or tolerance exemption is unaffected
3
3
3
10,500
B773
119
Amend or extend existing Experimental Use Permit; minor
changes to experimental design; extend established temporary tolerance or tolerance exemption
5
5
5
26,250
B860
120
Amend Experimental Use Permit; first food use or major revision of experimental design
6
6
6
10,500
B780
121
New active ingredient; non-food/feed; no SAP reviewrequired2
12
12
12
131,250
18
18
18
183,750
reviewrequired2
122
New active ingredient; Non-food/feed; SAP
B800
123
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance
exemption; no SAP review required2
12
12
12
210,000
B810
124
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance
exemption; SAP review required2
18
18
18
262,500
B820
125
New active ingredient; establish tolerance or tolerance exemption; no SAP review required2
15
15
15
262,500
B840
126
New active ingredient; establish tolerance or tolerance exemption; SAP review required2
21
21
21
315,000
B830
127
New active ingredient; Experimental Use Permit application
submitted simultaneously; establish tolerance or tolerance
exemption; no SAP review required2
15
15
15
315,000
B850
128
New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption;
SAP review required2
21
21
21
367,500
B851
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
9
105,000
B852
sroberts on PROD1PC70 with NOTICES
B790
130
New active ingredient; different genetic event of a previously
approved active ingredient; same crop; no tolerance action
required; SAP review required
9
9
9
157,500
B870
131
New use1
9
9
9
31,500
B880
132
New product; no SAP review required3
9
9
9
26,250
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
PO 00000
Frm 00011
Fmt 4701
Sfmt 4703
E:\FR\FM\30OCN2.SGM
30OCN2
61476
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)—
Continued
Decision time (months)
EPA No.
CR No.
FY 08 Registration
Service Fee
($)
Action
FY 08
B881
133
New product; SAP review required3
B890
134
B891
FY 09
FY 10
15
15
15
78,750
Amendment; seed production to commercial registration; no
SAP review required
9
9
9
52,500
135
Amendment; seed production to commercial registration; SAP
review required
15
15
15
105,000
B900
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
6
10,500
B901
137
Amendment (except B890); SAP review required4
12
12
12
63,000
B902
138
PIP Protocol review
3
3
3
5,250
B903
139
Inert ingredient tolerance exemption; e.g., a marker such as
NPT II; reviewed in BPPD
6
6
6
52,500
B904
140
Import tolerance or tolerance exemption; processed commodities/food only
9
9
9
105,000
1Example:
Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
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.
3Example: Stacking PIP traits within a crop using traditional breeding techniques.
4EPA-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.
2May
sroberts on PROD1PC70 with NOTICES
VI. How to Pay Fees
Applicants must now 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 athttps://www.epa.gov/
pesticides/fees/tool/index.htm to help
applicants identify the fee category and
the fee. All fees (and other amounts)
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
websitewww.pay.gov.
1. From the pay.gov home page, under
‘‘Find Public Forms.’’
2. Select ‘‘search by form name.’’
3. On the A-Z Index of Forms page,
select ‘‘P.’’
4. From the list of forms on the
second page, select ‘‘Pre-payment of
Pesticide Registration Improvement Act
Fee.’’
5. Complete the form entering the
PRIA fee category and fee.
6. 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
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
application to assure that EPA can
match the application with the
payment.
B. By Check or Money Order
All payments should 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
PO 00000
Frm 00012
Fmt 4701
Sfmt 4703
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.
VII. How to Submit Applications
Submissions to the Agency should be
made at the address given in Unit VIII.
The applicant should attach
documentation that the fee has been
paid which may be a copy of the check
or pay.gov payment acknowledgement.
If the applicant is applying for a fee
waiver, the applicant should provide
sufficient documentation as described
in FIFRA section 33(b)(7) andhttps://
www.epa.gov/pesticides/fees/questions/
waivers.htm. The fee waiver request
should be easy to identify and separate
E:\FR\FM\30OCN2.SGM
30OCN2
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
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.
VerDate Aug<31>2005
22:56 Oct 29, 2007
Jkt 214001
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 email address is provided on the
application.
VIII. 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
PO 00000
Frm 00013
Fmt 4701
Sfmt 4703
61477
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: October 23, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
[FR Doc. 07–5381 Filed 10–29–07; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\30OCN2.SGM
30OCN2
]]>Agencies
[Federal Register Volume 72, Number 209 (Tuesday, October 30, 2007)]
[Notices]
[Pages 61466-61477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5381]
[[Page 61465]]
-----------------------------------------------------------------------
Part III
Environmental Protection Agency
-----------------------------------------------------------------------
Pesticides; Revised Fee Schedule for Registration Applications; Notice
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 /
Notices
[[Page 61466]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1066; FRL-8155-6]
Pesticides; Revised Fee Schedule for Registration Applications
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 number of fee categories has been increased, the registration
service fees for some covered pesticide registration applications
received on or after October 1, 2007, have been increased, and certain
new procedures have been established. The new fees became effective on
October 1, 2007.
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 (NAICS code 32532).
Antimicrobial pesticide manufacturers (NAICS code 32561).
Antifoulant pesticide manufacturers (NAICS code 32551).
Wood preservative manufacturers (NAICS code 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 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-2007-1066. Publicly
available docket materials are available either in the electronic
docket athttps://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 https://www.epa.gov/fedrgstr.
II. Background
In accordance with FIFRA section 33(b)(3), EPA published in the
Federal Register of March 17, 2004 (69 FR 12772) (FRL-7348-2), a
schedule of the fees and decision times for review of a covered
application. Section 33 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), establishes 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
established a schedule of decision review times for applications
covered by the service fee system. Since March 23, 2004, the Agency has
been administering the registration service fee system. The schedule of
fees and decision review times was published in the Federal Register of
March 17, 2004 (69 FR 12772). Subsequently, as authorized by FIFRA
section 33, fees were increased by 5% in a notice issued in the Federal
Register of June 2, 2005 (70 FR 32327) (FRL-7706-1).
III. The Pesticide Registration Improvement Renewal Act (PRIRA)
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. The publication of this fee
schedule is required by section 33(f)(1) of FIFRA as amended.
Key changes in the new law include the following:
1. The number of fee categories has been increased from 90 to 140.
In so doing, new categories were added, particularly in the area of
tolerances, review of study protocols, risk assessments not associated
with an application, and plant-incorporated protectants (PIPs). In
addition, some current categories were split into several new
categories to provide more specific listings.
2. The EPA identification system for fee categories has been
revised to a 3-digit system to accommodate the increased number of
categories. The new fee schedule continues to preface fee categories
according to the Divisional responsibilities within OPP (e.g., R for
Registration Division). As an example, the fee category for the new
category ``Enriched isomer(s) of registered mixed-isomer active
ingredient'' is R122.
3. Fees are due at application. Previously, the application could
be submitted to the Agency in advance of fee submittal and EPA would
``invoice'' or ``bill'' the applicant for the fee. Units VI. and VII.
discuss how the Agency intends to implement this new provision.
4. EPA must within 21 days after receipt of the application and
payment reject any application that does not pass the initial content
screen and that cannot be corrected. EPA must screen the application
within 21 days and make a determination, and verify appropriate fee
submission (or a waiver request with at least 25% of the applicable fee
accompanying the waiver request).
5. A portion of the fee, 25%, is non-refundable. The amount of a
refund for an early withdrawal during the first 60 days of the decision
time review period is now 75% of the fee. Previously, the Agency was
required to refund 90% for an early withdrawal.
6. A small business fee waiver cannot reduce the fee more than 75%
of the appropriate registration service fee instead of 100%,
previously.
7. Fees will be increased by 5% for applications received during
the period October 1, 2008 through September 30, 2010, and thereafter
increased by an additional 5% for applications received as of October
1, 2010. EPA will issue notice in the Federal Register of the new fee
schedules as appropriate.
[[Page 61467]]
IV. 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 and examples include:
1. The re-establishment of a time-limited tolerance.
2. Review of confirmatory data submitted in support of an already-
issued registration.
3. Submission of a sub-registrant/supplemental distributor label.
4. Special Local Needs Registrations submitted under FIFRA section
24(c).
5. Emergency Exemption Requests submitted under FIFRA section 18.
6. Notifications as described in Pesticide Registration Notice 98-
10.
7. Fast track amendments or label amendments that require no data
review.
8. Minor formulation amendments as described in Pesticide
Registration Notice 98-10.
9. 6(a)2 evaluations.
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. These corrections
included: The registration service fee for new category No. 133 should
be $78,750, rather than $278,250; the decision time for new category
No. 47 in fiscal year 3 should be 12 months; and the action description
for the new category No. 61 should read: ``Non-food use; outdoor;
FIFRA, subsection 2(mm) uses (1).'' 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 2008, 2009, and 2010 as these are the
only applicable review periods for applications received on or after
October 1, 2008. Unit V. 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'' list the decision
times in months for each type of action for Fiscal Years 2008, 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 08 Registration Service Fee ($)''
lists the registration service fee for the action for fiscal year 2008
(October 1, 2007 through September 30, 2008).
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
V. PRIRA Fee Schedule Tables--Effective October 1, 2007
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 V.A.
cover RD actions.
Table 1.-Registration Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision time (in months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R010 1 Food use\1\ 24 24 24 516,300
----------------------------------------------------------------------------------------------------------------
[[Page 61468]]
R020 2 Food use; reduced 18 18 18 516,300
risk\1\
----------------------------------------------------------------------------------------------------------------
R030 3 Food use; 24 24 24 570,700
Experimental Use
Permit application
submitted
simultaneously
with application
for registration;
decision time for
Experimental Use
Permit and
temporary
tolerance same as
R040\1\
----------------------------------------------------------------------------------------------------------------
R040 4 Food use; 18 18 18 380,500
Experimental Use
Permit
application;
establish
temporary
tolerance;
submitted before
application for
registration;
credit $326,025
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R050 5 Food use; 14 14 14 190,300
application
submitted after
Experimental Use
Permit
application;
decision time
begins after
Experimental Use
Permit and
temporary
tolerance are
granted\1\
----------------------------------------------------------------------------------------------------------------
R060 6 Non-food use; 21 21 21 358,700
outdoor\1\
----------------------------------------------------------------------------------------------------------------
R070 7 Non-food use; 16 16 16 358,700
outdoor; reduced
risk\1\
----------------------------------------------------------------------------------------------------------------
R080 8 Non-food use; 21 21 21 396,800
outdoor;
Experimental Use
Permit application
submitted
simultaneously
with application
for registration;
decision time for
Experimental Use
Permit same as
R090\1\
----------------------------------------------------------------------------------------------------------------
R090 9 Non-food use; 16 16 16 266,300
outdoor;
Experimental Use
Permit application
submitted before
application for
registration;
credit $228,225
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R100 10 Non-food use; 12 12 12 130,500
outdoor; submitted
after Experimental
Use Permit
application;
decision time
begins after
Experimental Use
Permit
isgranted\1\
----------------------------------------------------------------------------------------------------------------
R110 11 Non-food use; 20 20 20 199,500
indoor\1\
----------------------------------------------------------------------------------------------------------------
R120 12 Non-food use; 14 14 14 199,500
indoor; reduced
risk\1\
----------------------------------------------------------------------------------------------------------------
R121 13 Non-food use; 18 18 18 150,000
indoor;
Experimental Use
Permit application
submitted before
application for
registration;
credit $100,000
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R122 14 Enriched isomer(s) 18 18 18 260,900
of registered
mixed-isomer
activeingredient\1
\
----------------------------------------------------------------------------------------------------------------
R123 15 Seed treatment 18 18 18 388,200
only; includes non-
food and food
uses; limited
uptake into Raw
Agricultural
Commodities\1\
----------------------------------------------------------------------------------------------------------------
R124 16 Conditional Ruling 6 6 6 2,080
on Preapplication
Study Waivers;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
that application.
TABLE 2.--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R130 17 First food use; 21 21 21 157,500
indoor; food/food
handling\1\
----------------------------------------------------------------------------------------------------------------
R140 18 Additional food 15 15 15 36,750
use; Indoor; food/
food handling
----------------------------------------------------------------------------------------------------------------
R150 19 First food use\1\ 21 21 21 217,400
----------------------------------------------------------------------------------------------------------------
R160 20 First food use; 16 16 16 217,400
reduced risk\1\
----------------------------------------------------------------------------------------------------------------
R170 21 Additional food use 15 15 15 54,400
----------------------------------------------------------------------------------------------------------------
R180 22 Additional food 10 10 10 54,400
use; reduced risk
----------------------------------------------------------------------------------------------------------------
[[Page 61469]]
R190 23 Additional food 15 15 15 326,400
uses; six or more
submitted in one
application
----------------------------------------------------------------------------------------------------------------
R200 24 Additional food 10 10 10 326,400
uses; six or more
submitted in one
application;
reduced risk
----------------------------------------------------------------------------------------------------------------
R210 25 Additional food 12 12 12 40,300
use; Experimental
Use Permit
application;
establish
temporary
tolerance; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R220 26 Additional food 6 6 6 16,320
use; Experimental
Use Permit
application; crop
destruct basis; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R230 27 Additional use; non- 15 15 15 21,740
food; outdoor
----------------------------------------------------------------------------------------------------------------
R240 28 Additional use; non- 10 10 10 21,740
food; outdoor;
reduced risk
----------------------------------------------------------------------------------------------------------------
R250 29 Additional use; non- 6 6 6 16,320
food; outdoor;
Experimental Use
Permit
application; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R260 30 New use; non-food; 12 12 12 10,500
indoor
----------------------------------------------------------------------------------------------------------------
R270 31 New use; non-food; 9 9 9 10,500
indoor; reduced
risk
----------------------------------------------------------------------------------------------------------------
R271 32 New use; non-food; 6 6 6 8,000
indoor;
Experimental Use
Permit
application; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R272 33 Review of Study 3 3 3 2,080
Protocol;
applicant-
initiated;
excludes DART, pre-
registration
conferences, Rapid
Response review,
DNT protocol
review, protocols
needing HSRB
review
----------------------------------------------------------------------------------------------------------------
R273 34 Additional use; 12 12 12 41,500
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
----------------------------------------------------------------------------------------------------------------
R274 35 Additional uses; 12 12 12 249,000
seed treatment
only; six 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
----------------------------------------------------------------------------------------------------------------
\1\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
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R280 36 Establish import 21 21 21 262,500
tolerance; new
active ingredient
or first food
use\1\
----------------------------------------------------------------------------------------------------------------
R290 37 Establish import 15 15 15 52,500
tolerance;
additional food
use
----------------------------------------------------------------------------------------------------------------
R291 38 Establish import 15 15 15 315,000
tolerances;
additional food
uses; six or more
crops submitted in
one petition
----------------------------------------------------------------------------------------------------------------
R292 39 Amend an 10 10 10 37,300
established
tolerance (e.g.,
decrease or
increase);
domestic or
import; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R293 40 Establish 12 12 12 44,000
tolerance(s) for
inadvertent
residues in one
crop; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R294 41 Establish 12 12 12 264,000
tolerances for
inadvertent
residues; six or
more crops
submitted in one
application;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
[[Page 61470]]
R295 42 Establish 15 15 15 54,400
tolerance(s) for
residues in one
rotational crop in
response to a
specific
rotational crop
application;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R296 43 Establish 15 15 15 326,400
tolerances for
residues in
rotational crops
in response to a
specific
rotational crop
petition; six or
more crops
submitted in one
application;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\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
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R300 44 New product; 3 3 3 1,300
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.
----------------------------------------------------------------------------------------------------------------
R301 45 New product; 4 4 4 1,560
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
----------------------------------------------------------------------------------------------------------------
R310 46 New end-use or 6 6 6 4,360
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.
----------------------------------------------------------------------------------------------------------------
R311 49 New product; 12 12 12 15,540
requires approval
of new food-use
inert; applicant-
initiated;
excludes approval
of safeners
----------------------------------------------------------------------------------------------------------------
R312 50 New product; 6 6 6 8,300
requires approval
of new non-food-
use inert;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R313 51 New product; 10 10 10 11,420
requires amendment
to existing inert
tolerance
exemption (e.g.,
adding post-
harvest use);
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R320 47 New product; new 12 12 12 10,880
physical form;
requires data
review in science
divisions
----------------------------------------------------------------------------------------------------------------
R330 48 New manufacturing- 12 12 12 16,320
use product;
registered active
ingredient;
selective data
citation
----------------------------------------------------------------------------------------------------------------
R331 52 New product; repack 3 3 3 2,080
of identical
registered end-use
product as a
manufacturing-use
product; same
registered uses
only
----------------------------------------------------------------------------------------------------------------
R332 53 New manufacturing- 24 24 24 233,000
use product;
registered active
ingredient;
unregistered
source of active
ingredient;
submission of
completely new
generic data
package;
registered uses
only
----------------------------------------------------------------------------------------------------------------
[[Page 61471]]
Table 5.--Registration Division--Amendments to Registration
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring 4 4 4 3,280
data review within
RD (e.g., changes
to precautionary
label statements,
or source changes
to an unregistered
source of active
ingredient)\1\
----------------------------------------------------------------------------------------------------------------
R350 55 Amendment requiring 8 8 8 10,880
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\
----------------------------------------------------------------------------------------------------------------
R370 56 Cancer 18 18 18 163,100
reassessment;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R371 57 Amendment to 6 6 6 8,300
Experimental Use
Permit; requires
data review/risk
assessment
----------------------------------------------------------------------------------------------------------------
R372 58 Refined ecological 18 18 12 155,300
and/or endangered
species
assessment;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\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 V.B. cover AD actions.
Table 6.--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
A380 59 Food use; establish 24 24 24 94,500
tolerance
exemption\1\
----------------------------------------------------------------------------------------------------------------
A390 60 Food use; establish 24 24 24 157,500
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A400 61 Non-food use; 18 18 18 78,750
outdoor; FIFRA
section 2(mm)
uses\1\
----------------------------------------------------------------------------------------------------------------
A410 62 Non-food use; 21 21 21 157,500
outdoor; uses
other than
FIFRAsection
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A420 63 Non-food use; 18 18 18 52,500
indoor; FIFRA
section 2(mm)
uses\1\
----------------------------------------------------------------------------------------------------------------
A430 64 Non-food use; 20 20 20 78,750
indoor; uses other
than FIFRAsection
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A431 65 Non-food use; 12 12 12 55,000
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
----------------------------------------------------------------------------------------------------------------
\1\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
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
A440 66 First food use; 21 21 21 26,250
establish
tolerance
exemption\1\
----------------------------------------------------------------------------------------------------------------
A450 67 First food use; 21 21 21 78,750
establish
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A460 68 Additional food 15 15 15 10,500
use; establish
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
A470 69 Additional food 15 15 15 26,250
use; establish
tolerance
----------------------------------------------------------------------------------------------------------------
[[Page 61472]]
A480 70 Additional use; non- 9 9 9 15,750
food; outdoor;
FIFRA section
2(mm) uses
----------------------------------------------------------------------------------------------------------------
A490 71 Additional use; non- 15 15 15 26,250
food; outdoor;
uses other than
FIFRA section
2(mm)
----------------------------------------------------------------------------------------------------------------
A500 72 Additional use; non- 9 9 9 10,500
food; indoor;
FIFRA section
2(mm) uses
----------------------------------------------------------------------------------------------------------------
A510 73 Additional use; non- 12 12 12 10,500
food; indoor; uses
other than FIFRA
section 2(mm)
----------------------------------------------------------------------------------------------------------------
A520 74 Experimental Use 9 9 9 5,250
Permit application
----------------------------------------------------------------------------------------------------------------
A521 75 Review of public 6 4 3 2,000
health efficacy
study protocol
within AD; per AD
Internal Guidance
for the Efficacy
Protocol Review
Process; applicant-
initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522 76 Review of public 18 15 12 10,000
health efficacy
study protocol
