Processing of an application for approval, including an application for renewal or modification.

(a)No public hearing or other formal proceeding is required under this subpart before the disposition of an application.#

(b)The Associate Administrator will review an application for an approval, modification of an approval, or renewal of an approval in conformance with the standard operating procedures specified in appendix A of this part (“Standard Operating Procedures for Special Permits and Approvals”). The Associate Administrator will conduct an expedited review process for shipments of lithium cells and batteries specifically used for medical devices, as outlined in § 173.185(g) of this chapter. At any time during the processing of an application, the Associate Administrator may request additional information from the applicant. If the applicant does not respond to a written request for additional information within 30 days of the date the request was received, the Associate Administrator may deem the application incomplete and deny it. The Associate Administrator may grant a 30-day extension to respond to the written request for additional information if the applicant makes such a request in writing.#

(c)The Associate Administrator may grant or deny an application, in whole or in part. At the Associate Administrator's discretion, an application may be granted subject to provisions that are appropriate to protect health, safety and property. The Associate Administrator may impose additional provisions not specified in the application, or delete conditions in the application which are unnecessary.#

(d)The Associate Administrator may grant an application on finding that—#

(1)The application complies with this subpart;#

(2)The application demonstrates that the proposed activity will achieve a level of safety that—#

(i)Is at least equal to that required by the regulation, or#

(ii)If the regulations do not establish a level of safety, is consistent with the public interest and adequately will protect against the risks to life and property inherent in the transportation of hazardous materials in commerce;#

(3)The application states all material facts, and contains no materially false or materially misleading statement;#

(4)The applicant meets the qualifications required by applicable regulations; and#

(5)The applicant is fit to conduct the activity authorized by the approval, or renewal or modification of approval. This assessment may be based on information in the application, prior compliance history of the applicant, and other information available to the Associate Administrator.#

(e)Unless otherwise specified in this chapter or by the Associate Administrator, an approval in which a term is not specified does not expire.#

(f)The Associate Administrator notifies the applicant in writing of the decision on the application. A denial contains a brief statement of reasons. For shipments of lithium cells and batteries specifically used for medical devices, as outlined in § 173.185(g) of this chapter, an approval shall be considered and either granted or denied not later than 45 days after receipt of a completed application.#