date:May 30, 2016
ments on Specific Provisions
A. Revisions to Definitions Also Used in Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)
B. Other Definitions That We Proposed To Establish in Part 121
C. Additional Definitions to Clarify Terms Not Defined in the Proposed Rule
D. Comments Asking FDA to Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule
E. Proposed 121.5Exemptions
V. Subpart C: Commen