Oregon Administrative Rules
Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION
Division 200 - DEPARTMENT REGULATORY PROGRAMS
Section 836-200-0535 - Additional Information Requests

(1) Within 60 calendar days of receiving a report from a prescription drug manufacturer in accordance with OAR 836-200-0515 to 836-200-0530, the director or director's designee may submit a written request for supporting documentation or additional information to the manufacturer.

(2) The department's request shall be limited to information necessary to clarify or substantiate the material previously reported, or to enable the department to conduct an analysis of factors affecting drug prices for the purposes of providing recommendations to the Legislature as provided by 2018 Or Laws ch 7.

(3) Within 60 calendar days of receiving the department's request for supporting documentation or additional information following a report provided in accordance with OAR 836-200-0515 to 836-200-0530, a prescription drug manufacturer must provide a full and complete written response, including any requested documentation. If any of the requested information or documentation is unavailable to a prescription drug manufacturer, the response must include an explanation as specified by 836-200-0525. If the manufacturer asserts that any of the requested information is conditionally exempt from disclosure as a trade secret, the manufacturer must clearly indicate that information and provide an explanation, as specified under 836-200-540, for each piece of information that is claimed to be exempt from disclosure.

(4) Within 15 calendar days of receiving the department's request for supporting documentation or additional information following a report provided in accordance with 2018 Or Laws ch 7 and OAR 836-200-0515 to 836-200-0530, a prescription drug manufacturer may request up to 30 additional days to prepare and submit a response. A drug manufacturer's request for additional time must be in writing, and must explain the grounds for the request and the need for additional time to prepare a response.

(5) Within 15 days of receiving a manufacturer's request for additional time under subsection (4), the director or director's designee shall respond to the manufacturer in writing to specify that the director or director's designee grants the request, denies the request, or grants an amount of additional time less than requested, and explain the basis for the decision.