The OIG may impose a penalty against—

(a) Any wholesaler, manufacturer, or direct seller of a covered outpatient drug that—

(1) Refuses a request for information by, or

(2) Knowingly provides false information to, the Secretary about charges or prices in connection with a survey being conducted pursuant to section 1927(b)(3)(B) of the Act; and

(b) Any manufacturer with an agreement under section 1927 of the Act that—

(1) Fails to provide any information required by section 1927(b)(3)(A) of the Act by the deadlines specified therein, or

(2) Knowingly provides any item information required by section 1927(b)(3)(A) or (B) of the Act that is false.

The OIG may impose a penalty of not more than—

(a) $100,000 for each individual violation of § 1003.1200(a) or § 1003.1200(b)(2); and

(b) $10,000 for each day that such information has not been provided in violation of § 1003.1200(b)(1).

In determining the amount of the penalty in accordance with this subpart, the OIG will consider the factors listed in § 1003.140.