B08-Exhibit-CDRL_A002_TDP.pdf
PDF 76 KB Posted
- Attached to
- Analgesic Ketamine Federal contract opportunity
- Solicitation number
- W81XWH19R0032
- Issued by
- Department of the Army Medical Command
About this file
Solicitation-W81XWH-19-R-0032-CDRL A002
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Solicitation_Questions_and_Answers.docx | DOCX document | |
| B08-Solicitation-W81XWH-19-R-0032-0001.docx | DOCX document | |
| B08-W81XWH-19-R-0032_Attch-1-Small_Business_Utilization.docx | DOCX document | |
| B08-W81XWH-19-R-0032_Attch-2_OCI-Certification.docx | DOCX document | |
| B08-Solicitation-W81XWH-19-R-0032.docx | DOCX document | |
| B08-Exhibit_-CDRL_A001_Regulatory_Strategy.pdf | ||
| B08-W81XWH-19-R-0032_Attch-3_Cost-Template.xls | XLS spreadsheet |
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Text version
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 and Communications 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
| A_CONTRACT_LINE_ITEM_NO: |
| B_EXHIBIT: A002 |
| TDP: X |
| TM: |
| OTHER: |
| DSYSTEMITEM: Reports |
| E_CONTRACTPR_NO: |
| FCONTRACTOR: |
| 1_DATA_ITEM_NO: A002 |
| 2_TITLE_OF_DATA_ITEM: Technical Data Package (TDP) |
| 3_SUBTITLE: |
| 4_AUTHORITY_Data_Acquisit: |
| 5_CONTRACT_REFERENCE: |
| 6_REQUIRING_OFFICE: USAMMDA |
| 7_DID_250_REQ: Yes |
| 8_APP_CODE: |
| DIST_STATEMENT: |
| 10_FREQUENCY: One Time |
| 11_AS_OF_DATE: see Blk 16 |
| 12_DATE_OF_FIRST_SUBMISSI: see Blk 16 |
| 13_DATE_OF_SUBSEQUENT_SUB: see Blk 16 |
| addressee1: see address in |
| draft1: |
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| 16_REMARKS: The contractor shall prepare and maintain currency of a Technical Data Package (TDP) that includes all necessary documentation and technical data and reports collected and prepared during the development effort funded by the Government. The TDP shall include all necessary documentation and data for the Government, or its designee, to continue the development or production of the product. The Contractor shall assist in the technical transfer as determined by the Government. Contractor will provide copies of TDP content as requested by Government. The contractor shall provide copies of manufacturing documents, reports, etc. associated with the TDP within seven (7) business days of the Government’s request. |
The TDP shall be transferred to the Government immediately if at any time the Contractor defaults and fails to remedy said default before or after approval, or within three (3) months of FDA licensure.
Blk 12. Submit at conclusion of contract.
Blk 14 & Blk 15. Submit via e-mail in Microsoft Office format to:
Government COR as assigned in Section G of the contract.
Electronic submissions are preferred.
Address to: U.S. Army Medical Materiel Development Activity (USAMMDA) 1430 Veterans Dr.
Fort Detrick, MD 21702
| 17_PRICE_GROUP: |
| ESTIMATED_TOTAL_PRICE: |
| G_PREPARED_BY: LTC Carl Soffler |
Product Manager, USAMMDA-PSPMO
| H_DATE: |
| 1_APPROVED_BY: |
| J_DATE: |
| Page: |
| of_pages: |
| Reset: |
| reg38t: 1 |
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