Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2013

Tenth Annual Report

March 1, 2014

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013

Maintenance Fees

Expedited Processing (FIFRA Section 3(c)(3)(B))

Under Section 33(k)(2)(A)(iv), the agency is to report the number of applications completed for
identical or substantially similar applications under section 3(c)(3)(B), including the number of
such applications completed within 90 days pursuant to that section. There are two types of
identical or substantially similar applications - new products and label amendments that require
no data review. The former have been called in the past "Fast Track New Products," while the
label amendments are still called "Fast Track Amendments".

Identical or substantially similar new products (formerly "Fast Track New Products") are subject
to registration service fees and have mandated decision review time frames under PRIA, and
processing costs are also supported by maintenance fees. Identical or substantially similar
products, or Fast Track New Products, are subdivided into separate fee categories, all of which
have time frames greater than three months. With the passage of PRIA 3, the decision review
timeframes for identical or substantially similar product categories (R300, A530, B660 and
B710) were increased from 3 months (in PRIA 2) to 4 months (in PRIA 3). The number of
identical or substantially similar products (A530, B660, B710, and R300) completed in FY'13
was 227, of which 104 were completed within 90 days; 112 were completed within their PRIA
time frames; 8 were completed within their extended due date timeframes and 3 were completed
late. The number completed in FY' 13 was less than that in FY' 12 (227 versus 306).

An additional 90 identical or similar new products in categories (A531, A532 and R301) were
completed (80 within the PRIA statutory time frame and 10 within their due date extension
timeframes). The number completed in FY' 13 was greater than in FY' 12 (90 versus 58).

The time frame for "Fast Track Amendments," label amendments that required no data review,
remained 90 days. These amendments are not subject to registration service fees. In FY' 13, the
agency completed 2,194 fast track amendment decisions (antimicrobial 872, biopesticide 130,
and conventional 1,192), which was fewer than in FY'12 (2,555), FY'11 (2899) and FY'10
(3384).

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