Attachment 6.docx data disc clear forms.pdf

Attachment 6 – Data Disclosure Clearance Forms

I. COVER SHEET

Date: __________

Contractor's Address: Client’s Address:

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993-0002

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:

q Public Release of Aggregated Limited Rights Data by FDA (complete project description and Section I)

Request form completed by:

q 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:

q Publication q Research q Presentation q 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):

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? q Yes q 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.