Attachment_5_-_Data_Disclosure.doc

ATTACHMENT #5, DATA DISCLOSURE CLEARANCE PROCEDURES

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..

DATA DISCLOSURE CLEARANCE FORMS

COVER SHEET

Date: __________

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079

FDA CLEARANCE/THIRD PARTY REQUEST FORM

INSTRUCTIONS:

- Review Data Disclosure Clearance Procedures before completing this form.

- For all requests, complete "Clearance Type/Requestor Information" and "Project" sections.

- For requests to publicly disclose Aggregated Limited Rights Data, complete "Section I."

- For requests to share Limited Rights Data with specific third parties, complete "Section II."

CLEARANCE TYPE/REQUESTOR INFORMATION:

E-mail address of requestor:

PROJECT DESCRIPTION:

Name(s) and description(s) of FDA project associated with the use of the data:

FDA contact(s) for the project(s):

SECTION I: (Public Release of Aggregated Limited Rights Data by FDA)

Purpose of Aggregated Limited Rights Data use:

Audience and name of publication(s), presentation(s), or forum(s):

Date(s) of publication(s), presentation(s), or forum(s) (if known):

The following items must be provided electronically by FDA with this Clearance Form (if practicable):

Drug file name:

Query file name (if applicable):

Contractor shall provide clearance by e-mail for the release(s) identified in this Section I.

SECTION II: (Disclosure of Limited Rights Data to a third party) Description of third party:

Company or Agency

Name:

Address:

Contact for project:

Describe third party association with FDA (e.g., contractor, research partner, etc.):

How will the limited rights data be used?

Has the third party read and agreed to all the conditions set forth in the clearance? ( Yes ( No

The requesting parties hereby agree to the terms and conditions set forth in the clearance procedure and submit this request to [Contractor].

Signature:

Name (print):

Title:

Date:

Signature:

Name (print):

Title:

Date:

[Contractor] hereby grants data disclosure clearance for the purpose(s) identified in this Section II.

CONTRACTOR

Signature:

Name (print):

Title:

Date: