Attachment_A_-_Data_Disclosure_Procedure_and_Forms.pdf

10-223-SOL-00226

Data 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 (Appendix D) identifying 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 the personal information of the queried or surveyed individual removed (e.g., names, addresses, and dates of birth), so that any user or audience cannot purposefully or inadvertently discover a participating consumer’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 (Appendix

D 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.

2. For each proposed disclosure, FDA shall submit a Clearance Request Form

(Appendix E is a blank copy), a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

3. FDA shall identify Contractor as the data source when disclosing Aggregated

Limited Rights Data or Limited Rights Data.

4. 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.

5. 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:

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

b. 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;

c. 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

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

6. 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.

7. 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.

Data Disclosure Forms (Third Party)

i. COVER SHEET

Date: __________

Contractor's Address: Client’s Address:

Food and Drug Administration

5100 Paint Branch Parkway College Park, MD 20740

Contact Name: Contact Name:

Telephone: Telephone:

E-mail: E-mail:

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:

Clearance requested for (check one): Date of this Clearance

Request:

Public Release of Aggregated Limited

Rights Data by FDA (complete project description and Section I)

Request form completed by:

Disclosure of Limited Rights Data to a third party (complete project description and Section II)

Phone number of requestor:

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:

Publication Research Presentation Other, please specify:

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):

Food Additive, Color Additive, or GRAS Substance 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].

FDA THIRD PARTY

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:

Note on obtaining copies of proprietary software from contractors

If FDA may wish to receive from a data provider copies of associated proprietary software that was not developed with FDA funds:*

(1) In addition to cross-referencing FAR 52.227-14, the data access agreement should--

a. cross-reference FAR 52.227-14 Alt. III (1987) regarding access to

"restricted computer software"; and

b. include the following statement, explaining that such software constitutes "restricted computer software" for purposes of the agreement:

Restricted Computer Software -- For purposes of [Agreement], the definition of Restricted Computer Software provided at FAR 52.227-14 is understood to include any proprietary computer software the development of which FDA did not fund.

(2) The Contractor should provide a Restricted Rights Notice to FDA with the software as provided for at FAR 52.227-14 Alt. III (1987). The content of the notice can be specified in the agreement. Contact legal counsel if the parties wish to use language in the notice that is different from the model language provided at FAR 52.227-14 Alt. III (1987).

*If FDA paid for development of the software, the software would not be "restricted computer software" and these special provisions and procedures would not apply.