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Guidance for Pre-Application Meetings on New Active Ingredients, Major
New Uses and Other Registration Actions
The Antimicrobials Division (AD) of the Office
of Pesticide Programs (OPP) is providing guidance to its staff concerning
meetings with companies that are considering submitting an application
involving a new active ingredient, new use, new technology, or any innovation
that requires significant data to be generated and submitted. This guidance
also can be applied to any other meetings that registrants or applicants
may request concerning their applications or products. By following this
guidance, AD staff should be able to set up, run and record meetings that
are as productive and efficient as possible, and that will assist applicants
in submitting applications that contain all of the information required
to make a decision on whether to register the product.
Pre-application meetings should cover only topics related to the preparation
of an application that will be complete and ready to enter EPA review.
Such topics could include, for example, appropriate categorization of
use pattern based on proposed labeling, data requirements, and testing
methodologies. Pre-application meetings should not be used to obtain EPA
decisions on the content of the application package, for example, the
acceptability of test data. Finally, AD staff should discourage prospective
applicants from using pre-application meetings to make marketing presentations
or to raise other matters that are outside EPA's regulatory purview. Post-application
meetings should focus on issues of completeness of the application or
what further steps need to be taken by the applicant or the Agency before
a registration decision may be made.
Necessity for Meeting. The first question for AD and potential
applicants should be "Is a meeting necessary?" Both EPA and
potential applicants have limited resources, and it is important that
everyone's time be used as efficiently and productively as possible. Therefore,
AD staff should not hold meetings to address matters that are already
adequately addressed in existing Agency guidance, or by correspondence
or telephone conversations with Agency staff. To the extent possible,
AD staff should encourage potential applicants to raise issues in writing
in advance of a meeting, and, where appropriate, AD will respond in writing,
thus eliminating the need for a meeting. AD staff should anticipate that
there may be several exchanges of information before EPA and the company
have determined whether it would be beneficial to schedule a meeting.
Initial Request. AD staff should encourage a company interested
in a pre_application meeting with AD for the following topics to submit
a written request to the Associate Director, AD:
- New active ingredients
- Significant new uses of old chemicals
- New technologies (such as treated articles with public health
claims)
- New or revised efficacy protocols (such as for new pests and new
methods of application)
- Data waiver requests related to unregistered products or uses
(involving reasons such as low risk, naturally occurring substances,
historical use, GRAS, etc.)
The request would ideally include the following information:
Identity of any new active ingredient: chemical name, chemical
formula, structural formula, and chemical class. [EPA will use this
information to make a decision about which regulatory branch will
handle any application.]
Description of the proposed use(s) and product claims (labeling):
whether the product will make public health claims, whether a "food
use" is involved, and the method of application.
Issues: what the company wishes to raise for AD consideration.
Summary of any previous discussions involving EPA staff on the issues.
Tentative dates for meeting desired by the requestor.
Agency Response to Initial Requests. AD staff should respond to
initial requests for meetings within two to four weeks of receipt of the
request with the following:
Branch and Product Manager assignments for new active ingredients:
If AD agrees that a meeting is needed, AD staff will contact the requestor
to determine a feasible date/time for a meeting and to ask for the
additional material described below. If AD believes that the issues
posed may be more efficiently handled through correspondence or a
telephone discussion, AD staff will confer with the requestor and
then respond accordingly. In any case, the decision as to whether
a meeting is needed will be made by mutual agreement
Additional Material. If AD decides to hold a meeting with a company,
AD staff should encourage the company to supply additional information
needed to make the meeting productive and efficient. The materials should
include:
List of Data Requirements: List the applicable data requirements
derived from EPA's data requirements rule at 40 CFR 158, Subpart W
(when proposed), and identify any specific requirements for which
the company would anticipate seeking a waiver, together with a brief
explanation of the basis for the waiver request.
Compliance with the FFDCA: State whether any clearances under
the FFDCA are needed for the pesticide product (section 408 and/or
409), and, if so, whether such clearances have been obtained or are
being sought.
Draft labeling: Provide a label for the product or equivalent
document setting out product use directions and associated claims.
Non_pesticidal uses: Describe any non_pesticidal uses of the
new active ingredient.
Agenda and likely attendees for the meeting: List the topics
to be covered and the people from the company who will be attending
[the latter information is essential to ensure that an adequate sized
room is available].
Company handouts: Provide a copy of any materials that will
be used by the company in its presentation at the meeting at least
two weeks before the meeting .
Timing of AD_Company Meeting. AD staff should encourage the company
to identify several possible dates and times for the meeting. Generally,
given the busy schedules of AD managers and senior scientists, the proposed
meeting dates should be at least four weeks after the date of the letter
containing the proposed meeting dates. Moreover, the proposed meeting
dates should be at least two weeks after the date on which the company
plans to submit the "Advance Materials" specified in the paragraph
above.
Conduct of the Meeting. The meeting length should be adequate
to allow for presentations by the company and discussion between the company
and Agency staff. Generally, the meetings should generally be from one
to no more than two hours in length. AD staff should encourage the company
d to clearly identify any material handed out or discussed at the meeting
that it considers to be trade secret or CBI. AD will designate a staff
person to take notes during the meeting and record who attended.
Summary of Meeting. Within 30 days after the meeting, AD intends
to provide a set of minutes describing the matters discussed, any commitments
made by any party, and any conclusions reached at the meeting (see attached
sample format for a letter summarizing the meeting). In some cases, AD
staff may prepare a summary document and agree upon it at the close of
the meeting. While AD intends to honor the written commitments it makes
through the process of pre_application meetings, it reserves the discretion
to change its decision with respect to a written commitment in the event
that either statutory or regulatory provisions would require a different
outcome. In addition, AD may change its position if new facts, additional
information, or analysis raise concerns about potential risk or unreasonable
adverse effects on the environment. AD staff should endeavor to communicate
any changes to the applicant as they occur.
Sample Letter Format for a Registration Meeting Summary
[Insert name & address person representing the registrant]
Subject:
Meeting of [insert date]
Brand X New Disinfectant Product
[Insert EPA File Symbol or EPA Reg. No., if available]
Dear Ms./Mr. (insert company representative):
On [insert date], the Agency met with your company
[insert name of the primary company and any other companies or entities
present] to [state purpose of meeting, such as "discuss draft efficacy
protocols that you submitted for use of your product as a fruit and vegetable
rinse"].
Attending the meeting were [insert names, titles,
and affiliations of all those present].
Following is a summary of the key points addressed
in the meeting along with EPA's guidance, conclusions or commitments for
further action:
1. [Insert the major points discussed and the
outcome of each.]
If you believe that this summary is not complete,
please let me know. Should you have any questions about this letter, you
may contact (inert EPA staff name] at [insert telephone number and e-mail
address].
Sincerely,
[insert name]
Product Manager
Regulatory Branch [I or II]
Antimicrobials Division (7510C)
[Note: All EPA staff involved in the meeting should concur on this letter
prior to its issuance.]
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