§ 26.603 General provisions.

(a) FFD program description. An applicant's description of the FFD program in its Final Safety Analysis Report, required by subpart H of part 53 of this chapter, must include— (1) Whether the applicant demonstrates compliance with § 73.100(a)(1)(i) of this chapter; (2) A statement whether the FFD program will be implemented pursuant to § 26.605(a) or (b) or § 26.605(a) and (b), or will satisfy all requirements under this part, except for the requirements in subpart K and this subpart; (3) A discussion of the applicability of the FFD program to those individuals described in § 26.4 and how the program will be implemented offsite at a U.S. Nuclear Regulatory Commission (NRC)-licensed facility authorized to assemble or test a manufactured reactor, if applicable; and (4) A description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations. (b) FFD program implementation and availability. For the licensees and other entities in § 26.3(f), other than the holder of a manufacturing license (ML), the FFD program must be maintained until the NRC's docketing of the license holder's certifications described in § 53.1070 of this chapter. For holders of an ML, the FFD program must be maintained until expiration of the ML. (c)-(d) [Reserved] (e) FFD program change control. (1) The licensee or other entity may make changes to its FFD program under this subpart if— (i) The licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program; or (ii) The change was necessitated or justified by a change to this part, laboratory processes or procedures, or guidance issued by the U.S. Department of Health and Human Services (HHS) or NRC, as implemented by the licensee or other entity though its procedures. (2) A licensee or other entity desiring to make a change that decreases FFD program effectiveness must implement a mitigating strategy so the FFD program, as revised, will continue to satisfy the performance objectives in § 26.23 and not result in a reduction in FFD program effectiveness. (3) Except for phencyclidine, and notwithstanding paragraph (e)(1)(ii) of this section, the change control process may not be used to reduce the minimum panel of drugs to be tested in § 26.607(c)(1). (4) The licensee must retain a record of each change made under this section for a period of at least 5 years from the date the change was implemented and summarize this change in its annual FFD performance report required by § 26.617(b)(2) or § 26.717, as applicable.