Amendments to study plans Clause Samples

Amendments to study plans. Test sponsors shall submit all amendments to study plans to the Director, Office of Compliance Monitoring at the address in § 790.5(d). [50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713, June 30, 1986; 52 FR 36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989; 55 FR 18884, May 7, 1990; 58 FR 34205, June 23, 1993; 60 FR 34466, July 3, 1995] (a) If EPA determines that the pro- posed study plan described in § 790.50(a)(2) complies with § 790.50(c), EPA will publish a proposed Phase II test rule in the FEDERAL REGISTER re- questing comments on the ability of the proposed study plan to ensure that data from the test will be reliable and adequate. (b) EPA will provide a 45-day com- ment period and will provide an oppor- tunity for an oral presentation upon the request of any person. EPA may ex- tend the comment period if it appears from the nature of the issues raised by EPA’s review or from public comments that further comment is warranted. (c) After receiving and considering public comments on the study plan, EPA will adopt, as proposed or as modified in response to EPA review and public comments, the study pro- tocol section of the study plan, as de- fined by § 790.50(c)(1)(v) of this chapter, as the test standard for the required testing, and the schedule section of the study plan, as defined by § 790.50(c)(1)(vi) of this chapter, as the schedule for the required testing in a final Phase II test rule. [50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 52 FR 36569, Sept. 30, 1987]