161.25—Applicability of data requirements.
(a)
Some kinds of data and information are specified in subparts C and D of this part as “required” (“R”) for the evaluation of some or all types of products. Other kinds of data and information are specified in those sections as “conditionally required” (“CR”), that is, they are required if the product's proposed pattern of use, results of other tests, or other pertinent factors meet the criteria specified in those sections. The terms “required” and “conditionally required” are further discussed in §§ 161.100 and 161.101.
(b)
The Agency recognizes that certain data requirements may not be applicable to (or should be waived for) some products, and has made provisions for such cases in this part as specified in § 161.35
Flexibility of the data requirements, § 161.40
Consultation with the Agency, § 161.45
Waivers, and § 161.60
Minor uses.