Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2018
Fifteenth Annual Report
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Maintenance Fees
Expedited Processing (FIFRA Section 3(c)(3)(B))
Under FIFRA Section 33(k)(2)(A)(iv), the Agency is to report the number of applications
completed for identical or substantially similar applications under FIFRA 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 has 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 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 new 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
new products (A530, B660, B710, and R300) completed in FY' 17 was 239, of which 41 were
completed within 90 days and 198 were completed within their PRIA time frames. The number
completed in FY' 18 was greater than in FY' 17 (239 versus 188).
An additional 113 identical or substantially similar new products in categories A531, A532
and R301 were completed (104 within the PRIA statutory timeframe and 9 within their due
date extension timeframes). The number completed in FY' 18 was greater than in FY' 17 (113
versus 84).
"Fast Track Amendments," label amendments that required no data review, are not subject to
registration service fees. In FY'18, the agency completed 1,951 fast track amendment decisions
(antimicrobial - 583, biopesticide - 237, and conventional - 1,131), which was less than in
FY'17 (2,302).
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