### Question
How is the "costs of resources allocated for the process for the review of biosimilar biological product applications" defined?


### Answer
The term **costs of resources allocated for the process for the review of biosimilar biological product applications** is defined in *21 U.S.C. § 379j* as follows -

> the expenses in connection with the process for the review of biosimilar biological product applications for—


(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 8-fees relating to biosimilar biological products**

