OAR 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 (Threshold for Reporting Drug Price Increase) to 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting), 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 (Threshold for Reporting Drug Price Increase) to 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting), 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 (Expectations of Reporting Manufacturers). 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 (Threshold for Reporting Drug Price Increase) to 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting), 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.

Source: Rule 836-200-0535 — Additional Information Requests, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=836-200-0535.

836‑200‑0000
Statutory Authority 836‑200‑0010
Assessments 836‑200‑0020
Filing Procedures 836‑200‑0030
Form 10 K and Other Financial Stability Filings 836‑200‑0040
Reimbursement Insurance Policy 836‑200‑0050
Registration Requirements Not Exclusive 836‑200‑0055
Annual Report 836‑200‑0060
Service on Registrant 836‑200‑0100
Notice, Collision Damage Waivers 836‑200‑0105
Statutory Authority 836‑200‑0110
Registration Procedures 836‑200‑0120
Warranty 836‑200‑0130
Reimbursement Insurance Policy 836‑200‑0140
Registration Requirements Not Exclusive 836‑200‑0200
License, Discount Medical Plan Organization 836‑200‑0210
Renewal of expired license 836‑200‑0215
One-time processing fee, cancelled application 836‑200‑0220
License Requirement Not Exclusive 836‑200‑0250
Purpose and Authority 836‑200‑0255
Registration of Contracting Entity 836‑200‑0300
Statement of Purpose 836‑200‑0305
Retainer Medical Practice Application for Certification 836‑200‑0310
Retainer Medical Practice Application for Renewal 836‑200‑0315
Disclosures 836‑200‑0401
Statement of Purpose 836‑200‑0406
Application Requirements for Pharmacy Benefit Manager 836‑200‑0411
Renewal of Pharmacy Benefit Registration 836‑200‑0416
Registration Requirements Not Exclusive 836‑200‑0421
Service on Registrant 836‑200‑0436
Submission of Complaints 836‑200‑0440
Market Conduct Requirements for Pharmacy Benefit Managers 836‑200‑0500
Purpose and Statutory Authority 836‑200‑0505
Definitions 836‑200‑0510
Account Generation Requirement 836‑200‑0515
Threshold for Reporting Drug Price Increase 836‑200‑0520
Threshold for Reporting New Specialty Drug 836‑200‑0525
Expectations of Reporting Manufacturers 836‑200‑0530
Form and Manner Requirements for Drug Pricing Reporting 836‑200‑0535
Additional Information Requests 836‑200‑0540
Information Claimed to be Trade Secret 836‑200‑0545
Public Disclosure of Prescription Drug Manufacturer Filings 836‑200‑0550
Consumer Notices to the Department 836‑200‑0555
Assessments Against Prescription Drug Manufacturers 836‑200‑0560
Civil Penalties
Last Updated

Jun. 8, 2021

Rule 836-200-0535’s source at or​.us