Attachment G - Contract Data Requirements List (CDRL) (03 Apr 24).pdf

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

PREVIOUS EDITION MAY BE USED.

Form Approved OMB No. 0704-0188

The public report ing burden for this collect ion of information is est imated to average 110 hours per response, including the t ime for review ing instruct ions, searching exist ing data sources, gathering and maintaining the data needed, and complet ing and review ing the collect ion of information. Send comments regarding this burden est imate or any other aspect of this collect ion of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notw ithstanding any other provision of law , no person shall be subject to any penalty for failing to comply w ith a collect ion of information if it does not display a currently valid OMB control number. Please do not return your form to the above organizat ion. Send completed form to the Government Issuing Contract ing Off icer for the Contract/PR No. listed in Block E.

A. CONTRACT LINE ITEM NO. B. EXHIBIT C. CATEGORY:

TDP ________ TM _______ OTHER

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

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

4. AUTHORITY (Data Acquisit ion Document No.) 6. REQUIRING OFFICE

7. DD 250 REQ

8. APP CODE

9. DIST STATEMENT

REQUIRED

10. FREQUENCY

13. DATE OF SUBSEQUENT

SUBMISSION

14. DISTRIBUTION

a. ADDRESSEE

b. COPIES

Draft Final

Reg Repro

15. TOTAL

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

G. PREPARED BY H. DATE I. APPROVED BY J. DATE

Page of Pages

0 0 0

Adobe Professional 7.0

16. REMARKS

Block 4: Data Items Description (DID) is included as a reference to this RPP and can be found at: https://quicksearch.dla.mil/qsSearch.aspx Block 7: Acceptance and Inspection of described technical data will be performed by AOR. Comments on the Data Deliverables will be provided within 10 days. AOR will have 10 days to respond to any questions. All final Data Deliverables with incorporated changes shall be submitted 10 days after receipt of government comments.

Block 9: The Technical Data purchased under this pOTA will not be distributed outside the Government for other than Government purposes unless, pursuant to the terms of the agreement, the Government exercises its unlimited rights therein.

Block 11,12 & 13: Performer shall submit all Data Deliverables in accordance with the IMS. This includes:

1. Regulatory strategy (Deliverable 9): See DI-TCSP-82040 Section 3a for content. Initial due with proposal; final after pre-IDE meeting with FDA.

2. FDA Interactions (Deliverables 8-10 & 20): See DI-TCSP-82040 Section

3b for comprehensive list of communications to be provided to the AOR.

3. Reports of Assay Verification, Validation, Accelerated Study

(Deliverable 11).

4. Final Clinical Specimen Study Execution & Report (Deliverable 15): The investigation study of RDS performance will conform to FDA requirements for in vitro diagnostics and use of human samples. Report format will conform to ICH E3.

5. RDS Stability Study (Deliverable 16): Execution of the study and study report will conform to applicable ISO standards (e.g., ISO 23640:2011), ICH guidelines (Q1 series) and FDA guidance for in vitro diagnostics.

6. Device Instructions for Use & Technical Manuals (Deliverable 17):

Device labeling, instructions for use and technical manual shall conform with the regulations at 21 CFR 809 for in vitro diagnostic devices.

7. Establish Commercial Manufacturing Capacity for RDS (Deliverable 18):

See DI-TCSP-82040 Section 3e for information that the Government may ask to review. Manufacturing shall conform to the FDA device quality system regulations (21 CFR 820.30) applicable to in vitro diagnostics.

8. CLIA Waiver Study Execution & Report (Deliverable 20): If the RDS qualifies for a CLIA waiver, the study may be combined with 510(k) clearance studies or as a separate study. Study design shall conform to FDA guidance (Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; and Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.) The final report will conform to FDA guidance for in vitro diagnostic CLIA waiver studies.

x

TBDRapid Donor Screening Development

1 Technical Data Package

DI-TCSP-82040 USAMMDA

See Block 16

12. DATE OF FIRST

SUBMISSION

See block 16 See block 16

1 2

1AOR 1

N/AN/A

TBD

5. CONTRACT REFERENCE

XX

11. AS OF DATE

See block 16

See Block 16 not separately priced (NSP)

III

AOR SupervisorUSAMMDA AOR

N/A

SOO Section 10.0

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

A. CONTRACT LINE ITEM NO. B. EXHIBIT C. CATEGORY:

TDP ________ TM _______ OTHER

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

16. REMARKS (Continued)

DD FORM 1423-1, FEB 2001 Page of Pages2 2