Consolidation of PMN Submissions

When a potential chemical manufacturer wants to submit PMN on several (up to 6) closely similar substances, there are economies for the Agency in reviewing them together. In recognition of these economies, and to encourage manufacturers to submit such PMN together, the Agency will only charge a fee equal to that for a single submission for a consolidated submission of up to six chemical substances. Preapproval before PMN is required for a consolidated submission: contact the New Chemical Branch (current prenotice coordinators, to contact for consolidation approval, are Miriam Wiggins-Lewis 202-564-9373; Adella Underdown 202-564-9364; and David Schutz 202-564-9262). Approval will be given if the substances are adequately similar chemically and toxicologically, if the planned uses are similar enough for combined review, and if intended volumes are not excessively different. Approved consolidations will be given a prenotice communication number, which must be entered on the Section 5 submission form. Usually it is easiest to send a letter or facsimile (fax 202-564-9490) giving the chemical structures, and to the attention of a prenotice coordinator. Though the facsimile machine is in a secure area, the facsimile line is not a secured line, and persons sending confidential material by facsimile assume the risk of doing so.In some cases, some intermediate substances can be consolidated, as well.

Consolidation of PMN Submissions

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