Sol_Doc_75F40125R00037_Attachment 3 - Data Disclosure Clearance Procedures.docx

Access to Outpatient Longitudinal Data IDIQ 75F40125R00037 Attachment 3

ATTACHMENT 3: DISCLOSURE CLEARANCE PROCEDURES

PURPOSE:

As provided for at FAR 52.227-14 (Alt II), [Name of Contractor] (“Contractor”) has provided a Limited Rights Notice to FDA dentifying Limited Rights Data (see definition below). This Limited Rights Notice authorizes FDA to disclose these Limited Rights Data for public health, safety, and regulatory purposes, provided that the disclosures of these data are made subject to prohibition against their further disclosure.

In accordance with the Limited Rights Notice, the purpose of this document is to establish timely clearance procedures for the FDA and Contractor to follow when FDA seeks either (1) to make Aggregated Limited Rights Data (see definition below) publicly available, or (2) to disclose actual Limited Rights Data to specific third parties subject to prohibition against their further disclosure.

DEFINITIONS:

Aggregated Limited Rights Data – Any collective or summary presentation of Limited Rights Data that does not disclose any raw data accessed by FDA from [Name of Contractor] (Contractor) [Database System].

De-identified Data – Data that have had patient, hospital, and physician information removed, e.g., names, addresses, social security numbers, and dates of birth, so that any user or audience cannot purposefully or inadvertently discover a patient’s identity.

Limited Rights Data – For purposes of these data disclosure clearance procedures, the definition of Limited Rights Data provided at FAR 52.227-14 is understood to include raw data, accessed by FDA personnel through the [Database Systems].

Public Release – Any communications, meetings, or interactions where FDA personnel make information publicly available, including by disclosing it: to any private, public, or governmental entity other than in accordance with paragraph 5 of these procedures; at any public event, such as the public portion of an advisory committee meeting or a public presentation or demonstration; through any publication in any media, such as scientific and technical articles; or in any agency record that FDA makes available on a non-confidential basis to anyone outside FDA, including in accordance with the Freedom of Information Act.

PROCEDURES:

These clearance procedures do not apply to disclosure of information, including of Limited Rights Data and/or Aggregated Limited Rights Data, made in response to an authorized request of Congress or any other government body of competent jurisdiction (see [section of primary agreement in which such disclosures are discussed] [Database System] (“Agreement”).

1. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (Attachment 4) is a blank copy) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party. Each party must update the Cover Sheet any time any of its contact information or its Contact changes.

1. For each proposed disclosure, FDA shall submit a Clearance Request Form (Attachment 4) is a blank copy), a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

1. FDA shall identify Contractor as the data source when disclosing Aggregated Limited Rights Data or Limited Rights Data.

1. Within 48 hours of receipt by the Contractor's Contact of the Clearance Request Form, Contractor shall provide a clearance decision for the requested Public Release of Aggregated Limited Rights Data. For urgent clearances requests, the Contractor shall provide a clearance decision within 24 hours of receipt.

1. Disclosure approval applies to the life of the materials as approved. FDA shall notify the contractor of further release, at the contractor’s request.

1. Within 72 hours of receipt by the Contractor's Contact of the Clearance/Third Party Request Form, the Contractor shall provide a decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

5. The third party must be actively engaged in a project initiated by FDA;

5. Clearance to share the data with the third party shall be granted only for purposes of the FDA initiated project and shall not extend beyond the duration of the third party's active engagement in that project;

5. The third party must execute in a timely manner the required Contractor Third Party Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing; and

5. The third party must agree in writing not to release the Limited Rights Data to any additional party.

If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files relied upon to FDA for submission to Contractor for clearance approval. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools. TERM: This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.