The licensee must implement the approved Study Plan. It will conduct the required studies on schedule.1 It must file progress reports, disclose study results to any participant who so requests,2 and seek to resolve disputes that may arise regarding the adequacy of the Study Plan or implementation.
See 18 C.F.R. § 5.15(a).
See 18 C.F.R. § 5.15(b).
In the first year after the Study Plan Determination as provided in the schedule, the licensee must file an initial Study Report. This report will describe progress in implementing the Study Plan. It must include any variance from the approved content or schedule and must also propose appropriate modifications to the approved plan.1 The licensee must file an Updated Study Report in the second year after the Study Plan Determination as provided in the schedule.2
See 18 C.F.R. § 5.15(c).
See 18 C.F.R. § 5.15(f).
A participant may request a modified or new study in response to a Study Report, as follows. Within 15 days of filing the initial Study Report, the licensee will hold a meeting with participants and OEP staff to discuss the study results and any proposed modifications.1 Any participant or the OEP staff may file a disagreement with the meeting summary, which the licensee must prepare within 30 days of that meeting.2 The disagreement may propose a modified or new study. Within 30 days thereafter, the OEP Director will resolve the disagreement and amend the approved Study Plan as appropriate.3 The same procedures for review, disagreement, and resolution apply to the Updated Study Report.4
The licensee, participant, or OEP staff who proposes a new or modified study must show good cause. 5 The burden of persuasion is proportional to how much change is proposed in the approved Study Plan, or how much time has passed since the Study Plan Determination.
See 18 C.F.R. § 5.15(c). Fifteen days after the meeting, the applicant will file a meeting summary. See id.
See id. The licensee may respond to any such filing within 30 days. See id.
See id.
See id.
See 18 C.F.R. § 5.15(d)-(e).
A proposed modified study must comply with the study criteria discussed in Section 4.2.4(A) and must also show that: (1) approved studies were not conducted as provided for in the approved study plan; or (2) the study was conducted under anomalous environmental conditions or that environmental conditions have changed in a material way.”1
18 C.F.R. § 5.15(d).
A proposed new study must satisfy the study criteria discussed in Section 4.2.4(A). It must also meet the additional criteria: (1) whether any material changes in the law or regulations applicable to the information request has occurred; (2) why the goals and objectives of any approved study could not be met with the approved study methodology; (3) why the request was not made earlier; and (4) whether significant change has occurred in the project proposal, or significant new information material to the study objectives has become available.1 Further, any proposal for a new study following the Updated Study Plan must show “extraordinary circumstances,” not just good cause.2
18 C.F.R. § 5.15(e).
18 C.F.R. § 5.15(f).