Or. Admin. Code § 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 836-200-0532,
the director or director's designee may submit one or more written requests 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 ORS
646A.689.
(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 836-200-0532, a
prescription drug manufacturer must provide a full and complete written
response, including any requested documentation. Supporting documentation or
additional information submitted will be part of the report published to the
department's website. If the manufacturer asserts that any of the requested
information is conditionally exempt from disclosure as a trade secret, the
manufacturer must clearly identify the information claimed as trade secret and
provide an explanation, as specified under OAR
836-200-0540, for each piece of
information that is claimed to be exempt from disclosure.
(4) If additional time is needed, within 15
calendar days of receiving the department's request for supporting
documentation or additional information following a report provided in
accordance with ORS 646A.689 and OAR
836-200-0515 to 836-200-0532, a
prescription drug manufacturer must submit a notice to the department for 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. The
department will automatically grant requests submitted in accordance with this
section.
Notes
Statutory/Other Authority: ORS 646A.689
Statutes/Other Implemented: ORS 646A.689
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(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.
Notes
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7