DD Form 1423 CDRLA007.pdf

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Attached to
Warfighter Health, Performance and Evacuation Project Management Office, Transport Telemedicine Systems Automated IV Pressure Infuser for MEDEVAC
Solicitation number
W81XWH20R0021
Issued by

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This document package includes a Contract Data Requirements List (CDRL) and a federal contract opportunity notice. The CDRL outlines regulatory submission requirements for an automated intravenous pressure infuser system. It requires the contractor to submit documentation to the FDA for approval or clearance as necessary, including study reports, communications, and other regulatory exchanges. The contractor must provide copies to the government of all FDA submissions and communications, and allow the government to reference the regulatory findings.

The related federal contract opportunity is seeking proposals to develop an automated IV pressure infuser that achieves Technology Readiness Level 8. It must function properly under expected operating conditions. Offerors must submit a statement of work outlining design, development, testing, approval, production, training and fielding activities. The statement of work will be reviewed by the Warfighter Health, Performance and Evacuation Project Management Office. The opportunity is issued by the Department of the Army Medical Command.

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Other files

File Type Posted
W81XWH-20-R-0021 IV Pressure Infuser Questions and Answers 5-18-20.pdf PDF
20-R-0021-P00001 Conf Copy 5-4-20.pdf PDF
20-R-0021-P00001 Amendment 1 5-4-20.pdf PDF
A07_W81XWH-20-R-0021_Attch-4_Key-Personnel-Template_draft1.docx DOCX document
20-R-0021 IV Pressure Infuser 4-27-20.pdf PDF
A07_W81XWH-20-R-0021_Attch-1_Small-Business-Utilization_draft1(SSP).docx DOCX document
DD Form 1423 CDRLA003.pdf PDF
DD Form 1423 CDRLA005.pdf PDF
DD Form 1423 CDRLA001.pdf PDF
DD Form 1423 CDRLA002.pdf PDF
DD Form 1423 CDRLA004.pdf PDF
A07_W81XWH-20-R-0021_Attch-5_Cost-Proposal_Spreadsheet_draft1.xls XLS spreadsheet
A07_W81XWH-20-R-0021_Attch-2_OCI-Certification_draft1.docx DOCX document
A07_W81XWH-20-R-0021_Attch-3_Proposed-Level-of-Effort-Template-draft1.docx DOCX document
DD Form 1423 CDRLA006.pdf PDF
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G. PREPARED BY

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

16. REMARKS

C. CATEGORY:

TDP ________ TM _______ OTHER _________________________

Form Approved OMB No. 0704-0188

15. TOTAL

PREVIOUS EDITION MAY BE USED.DD FORM 1423-1, AUG 96 (EG) Page ____ of ____ Pages

A. CONTRACT LINE ITEM NO. B. EXHIBIT

D. SYSTEM/ITEM E. CONTRACT/PR NO. F. CONTRACTOR

1. DATA ITEM NO. 2. TITLE OF DATA ITEM 3. SUBTITLE

4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE 6. REQUIRING OFFICE

7. DD 250 REQ

8. APP CODE

9. DIST STATEMENT

REQUIRED

10. FREQUENCY

11. AS OF DATE

12. DATE OF FIRST SUBMISSION

13. DATE OF SUBSEQUENT

SUBMISSION

14. DISTRIBUTION

a. ADDRESSEE

b. COPIES

Draft Final

Reg Repro

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

H. DATE J. DATEI. APPROVED BY

The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports (0701-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please DO NOT RETURN your form to the above address. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.

Designed using Perform Pro, WHS/DIOR, Aug 96

B EXHIBIT: A
TDP:
TM:
OTHER: N/A
E CONTRACTPR NO: W81XWH-20-R-TBD
F CONTRACTOR: TBD
2 TITLE OF DATA ITEM: Regulatory Approvals and FDA Submission
3 SUBTITLE: N/A
6 REQUIRING OFFICE: USAMMDA-WHPE
9 DIST STATEMENT REQUIRED: N/A
11 AS OF DATE: SEE BLK 16
H DATE:
a ADDRESSEERow1: USAMMDA-WHPE
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Draft15 TOTAL: 0
Reg15 TOTAL: 3
Repro15 TOTAL: 0
J DATE: 23 SEP 2019
17 PRICE GROUP:
18 ESTIMATED TOTAL PRICE: INSERT IN SECT. B
Text1: CLINS
Text2: Automated IV Pressure Infuser
Text3: A007
5 CONTRACT REFERENCE: N/A
Text 4: DI-TCSP-82040
Text5: Contractor will submit the IND/IDE, and/or pre-EUA, and other required documentation in accordance with the Statement of Objectives (SOO) to the FDA. Contractor shall provide the Government copies of all FDA submissions generated by the contractor prior to and during performance of contract necessary to pursue FDA approval, and /or pre-EUA, and notify the Government of FDA decisions. Data includes but is not limited to study reports, communications with and from the FDA, and any other pertinent report or regulatory exchange. The contractor shall also deliver to the government (i.e. Department of Defense) the right to cross reference regulatory findings to support government purpose (i.e. EUA or treatment INDs/IDE). All written communication to and/or from the FDA will be provided to the Government at the time of submission or at time of receipt form FDA. Government review is 15 days after receipt of first submittal and will not impede submission of documents to FDA by Contractor.
2019-08-27T16:03:56-0400
WANG.JAY.YUAN.1379211905
2019-09-23T23:35:56-0400
MILANO.MAUREEN.COSTA.1229254070
Text8: 1
Text9: 1
Combo Box3:
0:
0: [LT]
Combo Box4: [A]
Combo Box5: [AS REQUIRED]
Combo Box6: [SEE BLK 16]
Combo Box7: [SEE BLK 16]

File details come from the government source that posted it. Updated .