Implementing the Pesticide Registration Improvement Act Fiscal Year 2017 Fourteenth Annual Report Maintenance Fees Expedited Processing (FIFRA Section 3(c)(3)(B))


Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2017

Fourteenth Annual Report

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March 1, 2018

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2017

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. Their
processing costs are 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 (A530, B660, B710 and R300) 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' 17 was 188, of
which 46 were completed within 90 days and 142 were completed within their PRIA time
frames. The number completed in FY' 17 was greater than in FY' 16 (188 versus 153).

An additional 84 identical or similar new products in categories (A531, A532 and R301) were
completed (78 within the PRIA statutory timeframe and 6 within their due date extension
timeframes). The number completed in FY' 17 was slightly less than in FY' 16 (84 versus 89).

"Fast Track Amendments," label amendments that required no data review, are not subject to
registration service fees. In FY' 17, the agency completed 2,302 fast track amendment decisions
(antimicrobial - 618, biopesticide - 246, and conventional - 1,438), which was greater than in
FY'16 (2,180).

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