FDA_19-233-1209847_Attachment_3_Data_Disclosure_Clearance_Procedures.pdf

Attachment 3 Data Disclosure Clearance Procedures

1. PURPOSE:

As part of its regulatory activities, FDA may require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures (Attachment 5). In the event the contractor identifies Limited Rights Data in provision 52.227-15, 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.

2. 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.

a. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (located within Attachment 5) 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.

b. For each proposed disclosure, FDA shall submit a Clearance Request Form, a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

c. FDA shall identify contractor as the data source when disclosing Aggregated Limited Rights Data or Limited Rights Data.

d. Within 24 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.

e. Within 48 hours of receipt by the contractor's contact of the Clearance Request Form, the Contractor shall provide a clearance decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

(1) The third party must be actively engaged in a project initiated by FDA;

(2) 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;

(3) 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

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

f. 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.

g. 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.

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.

h. Notwithstanding any of the above provisions, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the information will be shared in a manner intended to protect the information from public disclosure.

Contractors submitting proposals to perform work under this contract must assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.