Attachment 3_CDRL_Syringe and Needle Final-1500.pdf

CONTRACT DATA REQUIREMENTS LIST

(2 Data Items)

Form Approved OMB No. 0704-0188

The public reporting burden for this collection of information is estimated to average 220 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 the Department of Defense, Executive Services Directorate (0704-0188). 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 organization. Send completed form to the Government Issuing Contracting Officer 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 Acquisition Document No.) 5. CONTRACT REFERENCE 6. REQUIRING OFFICE

7. DD 250 REQ 9. DIST STATEMENT

REQUIRED

10. FREQUENCY 12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION

b. COPIES

8. APP CODE

16. REMARKS

11. AS OF DATE 13. DATE OF SUBSEQUENT

SUBMISSION

a. ADDRESSEE Draft

Final

Reg Repro

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

15. TOTAL

4. AUTHORITY (Data Acquisition Document No.)

7. DD 250 REQ

8. APP CODE

9. DIST STATEMENT

REQUIRED

10. FR

11. AS

16. REMARKS

G. PREPARED BY

DD FORM 1423-2, AUG 96 PREVIOUS EDITION MAY BE USED. Page of Pages Adobe Professional 8.0

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

Reset

3. SUBTITLE

5. CONTRACT REFERENCE 6. REQUIRING OFFICE

QUENCY 12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION

OF DATE 13. DATE OF SUBSEQUENT a. ADDRESSEE

SUBMISSION

b. COPIES

Draft Final

Reg Repro

15. TOTAL

H. DATE I. APPROVED BY J. DATE

E

CONTRACT DATA REQUIREMENTS LIST

(2 Data Items)

Form Approved OMB No. 0704-0188

The public reporting burden for this collection of information is estimated to average 220 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 the Department of Defense, Executive Services Directorate (0704-0188). 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 organization. Send completed form to the Government Issuing Contracting Officer 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 Acquisition Document No.) 5. CONTRACT REFERENCE 6. REQUIRING OFFICE

7. DD 250 REQ 9 DIST STATEMENT

REQUIRED

10. FREQUENCY 12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION

b. COPIES

8. APP CODE

16. REMARKS

11. AS OF DATE 13. DATE OF SUBSEQUENT

SUBMISSION

a. ADDRESSEE Draft

Final

Reg Repro

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

15. TOTAL

4. AUTHORITY (Data Acquisition Document No.)

7 DD 250

REQ

9 DIST STATEMENT

REQUIRED

11. AS

16. REMARKS

G. PREPARED BY

DD FORM 1423-2, AUG 96 PREVIOUS EDITION MAY BE USED. Page of Pages Adobe Professional 8.0

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

Reset

3. SUBTITLE

5. CONTRACT REFERENCE 6. REQUIRING OFFICE

FREQUENCY 12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION

OF DATE 13. DATE OF SUBSEQUENT a. ADDRESSEE

SUBMISSION

b. COPIES

Draft Final

Reg Repro

15. TOTAL

H. DATE I. APPROVED BY J. DATE

8. APP CODE

INSTRUCTIONS FOR COMPLETING DD FORM 1423

(See DoD 5010.12-M for detailed instructions.)

FOR GOVERNMENT PERSONNEL

Item A. Self-explanatory.

Item B. Self-explanatory.

Item C. Mark (X) appropriate category: TDP - Technical Data Package; TM - Technical Manual; Other - other category of data, such as "Provisioning,""Configuration Management," etc.

Item D. Enter name of system/item being acquired that data will support.

Item E. Self-explanatory (to be filled in after contract award).

Item F. Self-explanatory (to be filled in after contract award).

Item G. Signature of preparer of CDRL.

Item H. Date CDRL was prepared.

Item I. Signature of CDRL approval authority.

Item J. Date CDRL was approved.

Item 1. See DoD FAR Supplement Subpart 4.71 for proper numbering.

Item 2. Enter title as it appears on data acquisition document cited in Item 4.

Item 3. Enter subtitle of data item for further definition of data item (optional entry).

Item 4. Enter Data Item Description (DID) number, military specification number, or military standard number listed in DoD 5010.12-L (AMSDL), or one-time DID number, that defines data content and format requirements.

Item 5. Enter reference to tasking in contract that generates requirement for the data item (e.g., Statement of Work paragraph number).

Item 6. Enter technical office responsible for ensuring adequacy of the data item.

Item 7. Specify requirement for inspection/acceptance of the data item by the Government.

Item 8. Specify requirement for approval of a draft before preparation of the final data item.

Item 9. For technical data, specify requirement for contractor to mark the appropriate distribution statement on the data (ref.

DoDD 5230.24).

Item 10. Specify number of times data items are to be delivered.

Item 11. Specify as-of date of data item, when applicable.

Item 12. Specify when first submittal is required.

Item 13. Specify when subsequent submittals are required, when applicable.

Item 14. Enter addressees and number of draft/final copies to be delivered to each addressee. Explain reproducible copies in Item 16.

Item 15. Enter total number of draft/final copies to be delivered.

Item 16. Use for additional/clarifying information for Items 1 through 15. Examples are: Tailoring of documents cited in Item 4; Clarification of submittal dates in Items 12 and 13;

Explanation of reproducible copies in Item 14.; Desired medium for delivery of the data item.

FOR THE CONTRACTOR

Item 17. Specify appropriate price group from one of the following groups of effort in developing estimated prices for each data item listed on the DD Form 1423.

a. Group I. Definition - Data which is not otherwise essential to the contractor's performance of the primary contracted effort (production, development, testing, and administration) but which is required by DD Form 1423.

Estimated Price - Costs to be included under Group I are those applicable to preparing and assembling the data item in conformance with Government requirements, and the administration and other expenses related to reproducing and delivering such data items to the Government.

b. Group II. Definition - Data which is essential to the performance of the primary contracted effort but the contractor is required to perform additional work to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, or quality of the data item.

Estimated Price - Costs to be included under Group II are those incurred over and above the cost of the essential data item without conforming to Government requirements, and the administrative and other expenses related to reproducing and delivering such data item to the Government.

c. Group III. Definition - Data which the contractor must develop for his internal use in performance of the primary contracted effort and does not require any substantial change to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, and quality of the data item.

Estimated Price - Costs to be included under Group III are the administrative and other expenses related to reproducing and delivering such data item to the Government.

d. Group IV. Definition - Data which is developed by the contractor as part of his normal operating procedures and his effort in supplying these data to the Government is minimal.

Estimated Price - Group IV items should normally be shown on the DD Form 1423 at no cost.

Item 18. For each data item, enter an amount equal to that portion of the total price which is estimated to be attributable to the production or development for the Government of that item of data.

These estimated data prices shall be developed only from those costs which will be incurred as a direct result of the requirement to supply the data, over and above those costs which would otherwise be incurred in performance of the contract if no data were required. The estimated data prices shall not include any amount for rights in data. The Government's right to use the data shall be governed by the pertinent provisions of the contract.

DD FORM 1423-2 (BACK), AUG 96

DD FORM 1423-2 (BACK), AUG 96

DD FORM 1423-2 (BACK), AUG 96

9. Distribution Statement C: Distribution authorized to U.S. Government agencies and their Contractors (Administrative or Operational Use). Determination made 20 May 2020. Distribution guidance is included in DOD Instruction 5230.24.

12. & 13. Submit within 5 calendar days after conduct of meeting.

14. Submit as electronic file in Microsoft Office (i.e.,Word, Excel, Power Point) via email to the Contracting Officer's Representative (COR), MAJ Andrea Mountney (andrea.mountney.mil@mail.mil); the BARDA representative, Joseph Figlio (Joseph.Figlio@hhs.gov; the SRS Representative, Ronald Ottem (rco9@cdc.gov); the Contract Specialist* (KS), Tyler N. Gates (tyler.n.gates2.civ@mail.mil); and, the Contracting Officer* (KO), Aaron Skinner (aaron.d.skinner.civ@mail.mil).

http://quicksearch.dla.mil/. Only paragraphs 10.2.2.a, b, d, e, and f apply, and a Senior Official's signature for verification. The contractor shall include 510(k) letters as appendices to the Certificates of Analysis.

9. Distribution Statement C: Distribution authorized to U.S. Government agencies and their Contractors (Administrative or Operational Use). Determination made 20 May 2020. Distribution guidance is included in DOD Instruction 5230.24.

12. & 13. Initial Submission: Concurrent with proposal. Subsequent submissions: Provide a paper copy od Certificae of Analysis with each shipment. Provide 510(k) Approval Letters Updates if any information from the initial 510(k) Approval Letters is changed/needs to be updated.

14. Distribution copies shall be submitted as electronic files in Microsoft Office (i.e.,Word, Excel, Power Point) via email to the Contracting Officer's Representative, MAJ Andrea Mountney (andrea.mountney.mil@mail.mil); the BARDA representative, Joseph Figlio (Joseph.Figlio@hhs.gov; the SRS Representative, Ronald Ottem (rco9@cdc.gov); the Contract Specialist* (KS), Tyler N. Gates (tyler.n.gates2.civ@mail.mil); and, the Contracting Officer* (KO), Aaron Skinner (aaron.d.skinner.civ@mail.mil).

http://quicksearch.dla.mil/. Only paragraphs 2 and 3.g apply. Provide the following information on the Packing Slip: (1) Contract number, (2) Storage, (3) Item description, (4) Part number, (5) Lot numbers; and (6) Quantities.

9. Distribution Statement C: Distribution authorized to U.S. Government agencies and their Contractors (Administrative or Operational Use). Determination made 20 May 2020. Distribution guidance is included in DOD Instruction 5230.24.

12. & 13. This deliverable (paper copy) shall be provided upon each product delivery to each designated shipping location(s).

14. Distribution copies shall be submitted as electronic files in Microsoft Office (i.e.,Word, Excel, Power Point) via email to the Contracting Officer's Representative, MAJ Andrea Mountney (andrea.mountney.mil@mail.mil); the BARDA representative, Joseph Figlio (Joseph.Figlio@hhs.gov; the SRS Representative, Ronald Ottem (rco9@cdc.gov); the Contract Specialist* (KS), Tyler N. Gates (tyler.n.gates2.civ@mail.mil); and, the Contracting Officer* (KO), Aaron Skinner (aaron.d.skinner.civ@mail.mil).