A475 PRIA Fee Category

An application for an amendment registration which requires review of product-specific data. This includes product chemistry, acute toxicology and efficacy data. The applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements.

Examples include:

• Any submission that includes efficacy data or that requires an efficacy review.
• Signal word and/or precautionary language changes requiring data review/review of acute toxicity data.
• Changes to active ingredient (a.i.) sources - change from one unregistered source to another or change from a registered source to an unregistered source.
• Any submission requesting a Child Resistant Packaging exemption.
• Any formula change that requires product specific data including toxicity, product chemistry, and efficacy data (including confirmatory data). Routine formula changes are not PRIA actions. Routine formula changes are those which do not require data to support the change such as a surfactant, dye or other addition or modification to the inert ingredients in the formula.

All applications require the following:

• A data matrix.
• All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.
• If a product is using the selective cite or a cite all, the product supporting the data requirements must be clearly identified on the 8570-1 application form. If multiple products are cited, they must be clearly delineated in the cover letter.
• The currently approved Basic CSF and any proposed CSF(s).
• Cover letter, clearly outlining the proposed action by the registrant and any other supportive documentation necessary for EPA to conduct the review.
• Proposed label.

A different pattern of use that significantly changes or increases exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use. The company is required to provide a cited label to support the proposed uses by showing that the use pattern and rates do not exceed currently registered products.

Excludes: product-specific data required as a term of registration, such as storage stability and corrosion characteristics data.

NOTE: Any significant increase in exposure requiring science review/a risk assessment (increase in dosage rate, different method of application (fogging vs. spraying) will be treated under category A572, or as a new use.

Under this PRIA category, a single application may request 51 or more public health organisms for review. The number of supporting data volumes per organism does not impact the total organism count, unless the same organism is used to satisfy various guidelines. Each organism tested with a specific guideline is counted once, this may indicate that one organism is counted multiple times if it is applied to multiple guidelines.

For example:

• If data is submitted in two volumes for one organism; the requested count for that application will be one public health organism.
• If one organism is tested for three different efficacy guidelines/study methods, each guideline would count as one organism. For example, if Staphylococcus aureus is tested to verify efficacy under non-food contact sanitizers, food contact sanitizers and disinfectants guidelines, it would count as three separate organisms.

The Agency will provide the applicant with a pre-decisional determination 2 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested label amendment registration. If the label issues cannot be resolved prior to the PRIA decision review time due the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.

Registration amendment fees:

1. EPA-initiated amendments shall not be charged registration service fees.
2. Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees.
3. Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees.
4. Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees.
5. Submissions with data and requiring data review are subject to registration service fees.