Source: https://www.federalregister.gov/documents/2010/12/03/2010-30316/agency-information-collection-activities-proposed-collection-comment-request-index-of-legally
Timestamp: 2018-03-22 14:18:31
Document Index: 143640689

Matched Legal Cases: ['art 516', 'art 516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516']

75475-75477 (3 pages)
https://www.federalregister.gov/d/2010-30316 https://www.federalregister.gov/d/2010-30316
Start Printed Page 75476
Under the new subpart C of part 516 (21 CFR part 516, subpart C), § 516.119 provides requirements for naming a permanent-resident U.S. agent by foreign drug companies, and § 516.121 provides for informational meetings with FDA. Section 516.123 provides requirements for requesting informal conferences regarding agency administrative actions and § 516.125 provides for investigational use of new animal drugs intended for indexing. Provisions for requesting a determination of eligibility for indexing can be found under § 516.129 and provisions for subsequent requests for addition to the index can be found under § 516.145. A description of the written report required in § 516.145 can be found under § 516.143. Under § 516.141 are provisions for drug companies to nominate a qualified expert panel as well as the panel's recordkeeping requirements. This section also calls for the submission of a written conflict of interest statement to FDA by each proposed panel member. Index holders are able to modify their index listing under § 516.161 or change drug ownership under § 516.163. Requirements for records and reports are under § 516.165.
Start Printed Page 75477
[FR Doc. 2010-30316 Filed 12-2-10; 8:45 am]