Ask X3What does 49 CFR 107.709 (Processing of an application for approval, including an application for renewal or modification) require?
Generated guidance. Confirm the source and its applicability before you act. How we check sources.
As Ask X3, your fleet-compliance assistant, here is what is required for processing an application under 49 CFR 107.709:
* Review Process: The Associate Administrator reviews your application (for an approval, renewal, or modification) following standard operating procedures. An expedited review is conducted for shipments of lithium cells and batteries specifically used for medical devices.
* Responding to Information Requests: If the Associate Administrator sends a written request for additional information, you must respond. If you do not respond within 30 days of receiving the request, the application may be deemed incomplete and denied. However, you can request a 30-day extension in writing.
* Application Standards: To be granted, your application must:
* Comply with the applicable subpart.
* Demonstrate that your proposed activity achieves a level of safety at least equal to required regulations (or is consistent with the public interest and protects against risks to life and property if no regulation sets a safety level).
* State all material facts without any materially false or misleading statements.
* Meet the required qualifications.
* Prove you are fit to conduct the authorized activity (based on your application, prior compliance history, and other available information).
* Notification of Decision: You will be notified of the decision in writing. If your application is denied, you will receive a brief statement of the reasons. For medical-device lithium cell and battery shipments, a completed application will be granted or denied within 45 days of receipt.