### Question
What is the definition of master file holder?


### Answer
The definition of **master file holder** is as follows in *21 U.S.C. § 360bbb*:

> a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a)

#### Citation:
  - *21 U.S.C. § 360bbb*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part E-General Provisions Relating to Drugs and Devices**

