Sol_Doc_75F40125R00037_Attachment 4 - Data Disclosure Clearance Forms.docx
DOCX document 199 KB Posted
- Attached to
- Access to Outpatient Longitudinal Data IDIQ Federal contract opportunity
- Solicitation number
- 75F40125R00037
About this file
The file is a Data Disclosure Clearance Form for the FDA's Access to Outpatient Longitudinal Data Indefinite-Delivery Indefinite-Quantity (IDIQ) contract (Solicitation Number 75F40125R00037). The form provides a structured template for requesting clearance to either publicly release aggregated limited rights data or disclose limited rights data to third parties, with separate sections for each type of request.
The associated federal contract opportunity involves a multiple-award IDIQ contract anticipated to issue two awards, with a specific reservation for a small business concern. The contract is under NAICS code 541519 with a small business size standard of $34 million or 150 employees. The solicitation is unrestricted but requires active SAM.gov registration, and notably, offerors must submit proposals for both the IDIQ and Task Order #1 concurrently to be considered eligible for award. The contracting agency is the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services.
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Text version
Access to Outpatient Longitudinal Data IDIQ 75F40125R00037 Attachment 4
ATTACHMENT 4: 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):
image1.emf
Data Disclosure Clearance Form.docx-2.pdf
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 Description" 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."
Data Disclosure Clearance Form
CLEARANCE TYPE/REQUESTOR INFORMATION:
(Public Release of Aggregated Limited Rights Data by FDA (complete project description and Section I )
( Disclosure of Limited Rights Data to a third party (complete project description and Section II )
Clearance Request Date: Requestor's Name:
Phone Number: Email Address:
PROJECT DESCRIPTION:
Name(s) and description(s) of FDA project associated with the use of the data:
FDA contacts (s) for the project (s):
SECTION I: (Public Release of Aggregated Limited Rights Data by FDA)
Purpose of Aggregated Limited Rights Data use:
Publication
Other (please specify):
Research Presentation
Name of publication, presentation or forum:
Date(s) of publication, presentation or forum (if known):
Drug File Name:
SECTION II: (Disclosure of Limited Rights Data to a third party) Description of third party:
Company or Agency Name:
Address:
City: State: Zip Code:
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 procedures? Yes No
The requesting parties hereby agree to the terms and conditions set forth in the clearance procedure and submit this request to Insert Company or LLC Name
FDA THIRD PARTY
By:
Name (print):
Title:
Date:
By:
Name (print):
Title:
Date:
Data Disclosure Clearance Form
PROJECT DESCRIPTION:
SECTION I: (Public Release of Aggregated Limited Rights Data by FDA)
SECTION II: (Disclosure of Limited Rights Data to a third party)
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