§ 53.1295 Renewal of manufacturing licenses.
(a)(1) Not less than 12 months, nor more than 5 years before the expiration of the ML, or any later renewal period, the holder of the ML issued under this part may apply for a renewal of the license. An application for renewal must contain all information necessary to bring up to date the information and data contained in the previous application.
(2) The filing of an application for a renewed license must be in accordance with subpart A of 10 CFR part 2 and § 53.1100.
(3) An ML issued under this part, either original or renewed, for which a timely application for renewal has been filed, remains in effect until the Commission has made a final determination on the renewal application.
(4) Any person whose interest may be affected by renewal of the license may request a hearing on the application for renewal. The request for a hearing must comply with § 2.309 of this chapter. If a hearing is granted, notice of the hearing will be published in accordance with § 2.104 of this chapter.
(b) The Commission may grant the renewal if the Commission determines—
(1) The ML complies with the Act and the Commission's regulations and orders applicable and in effect at the time the ML was originally issued; and
(2) Any new requirements the Commission may wish to impose are—
(i) Necessary for adequate protection to public health and safety or common defense and security;
(ii) Necessary for compliance with the Commission's regulations and orders applicable and in effect at the time the ML was originally issued; or
(iii) A substantial increase in overall protection of the public health and safety or the common defense and security to be derived from the new requirements, and the direct and indirect costs of implementation of those requirements are justified in view of this increased protection.
(c) A renewed ML may be issued for a term of not less than 5, nor more than 40 years, plus any remaining years on the ML then in effect before renewal. The renewed license must be subject to the requirements of § 53.1288.