42 CFR 84.22 - Unlisted fees; additional fees; payment by applicant prior to approval.
(a) Applicants will be invoiced for all fees incurred in the processing of an application when all required reviews, analyses, evaluations, and tests are completed or the application is withdrawn. Invoices will contain specific payment instructions and identify authorized methods of payment.
(b) Applicants who hold active and/or obsolete certificates of approval will be invoiced by NIOSH annually for applicable maintenance fees, in accordance with the fee schedule published in Appendix A of this part.
(c) NIOSH reserves the right to impose sanctions for any missed payment, and will administer such penalties after assessing the circumstances of the manufacturer and the needs of other stakeholders. Sanctions may include but are not limited to:
(1) Refusal to accept future applications for approval;
(2) Stop-sale of all approved product; and
(3) Engaging appropriate government authorities to initiate debt collection procedures for the unpaid fees.