W81XWH18R0025ExhibitC.pdf

DD FORM 1423-1, FEB 2001

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

PREVIOUS EDITION MAY BE USED.

Form Approved OMB No. 0704-0188

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 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

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

15. TOTAL

16. REMARKS

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

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

Page of Pages

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 Pages

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 1423-1 (BACK), FEB 2001

Section F - Deliveries or Performance

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

DI-TCSP-82040, section 1, & section 2.b.

2.b.FDA Interactions – provide copies of the plan and processes that will ensure the government has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement documentation.

(1) Meetings – provide FDA meeting documentation that includes, but is not limited to the copies of all meeting request letters, meeting briefing package submissions, meeting communications, and formal meeting minutes prepared by FDA and/or the contractor, and any other meeting correspondence (formal or informal).

(2) Communications – FDA Communications documentation shall include, but is not limited to copies of sponsor FDA contact reports, informal and email communications, official communication letters; all communications during the review of drug/biologic submissions.

(3) Submission Packets – FDA regulatory submission packages (including cover letters and required forms) shall include, but are not limited to applications such as Investigation New Drugs (21 CFR §312), New Drug Applications (21 CFR §314), Biologics License Applications (BLAs) (21 CFR §600-680), and Emergency Use Authorization (21 USC 360bbb-3))along with any applicable product master files. Provide an electronic copy of submissions to the FDA; supporting documentation, including submissions provided in electronic (in compliance with FDA’s guidance regarding electronic common technical document format) and paper format as applicable. Provide copy of submission date, acknowledgement letters, communications related to the application, filing letters, decision letters, post-marketing commitments, and any applicable approval letters. Provide submission tracking list as applicable for the product development effort/project.

(4) Inspections and Enforcement – provided information on inspections and enforcement including, but not limited to, the following:

(a) Notification of FDA Inspections – Pre-announced inspections, PAI, quality systems (QS) inspections (International Conference of Harmonisation (ICH)-Quality), team inspections, foreign inspections, and third-party inspections.

(c) Disqualification of clinical investigators by the FDA, clinical research organization (CRO), or Institutional Review Boards (IRBs).

(d) Inspection responses and correction plans – Notification of outstanding actions as result of inspections. Prior FDA Form 483s, as applicable to the project, may be redacted if necessary if this doesn’t impact readability.

(e) Establishment Inspection Report (EIR), prior EIRs as applicable.

(5) Registration and Listing – the contractor shall provide a copy of the establishment registration and listing documentation.