### Question
What does major change mean?


### Answer
**Major change** has the following meaning in *21 U.S.C. § 350a*:

> given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.

#### Citation:
  - *21 U.S.C. § 350a*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER IV-FOOD**

