B08-Exhibit_-CDRL_A001_Regulatory_Strategy.pdf

PDF 76 KB Posted May 21, 2019

Attached to: Analgesic Ketamine Federal contract opportunity
Solicitation number: W81XWH19R0032
Issued by: Department of the Army Medical Command

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Solicitation-W81XWH-19-R-0032-CDRL A001

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B08-W81XWH-19-R-0032_Attch-3_Cost-Template.xls	XLS spreadsheet	May 21, 2019

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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: A001

TDP:

TM:

OTHER: x

DSYSTEMITEM: Reports

E_CONTRACTPR_NO:

FCONTRACTOR:

1_DATA_ITEM_NO: A001

2_TITLE_OF_DATA_ITEM: Regulatory Strategy

3_SUBTITLE:

4_AUTHORITY_Data_Acquisit: DI-TCSP-82040

5_CONTRACT_REFERENCE:

6_REQUIRING_OFFICE: CBMS-MITS

7_DID_250_REQ: Yes

8_APP_CODE:

DIST_STATEMENT: A

10_FREQUENCY: Semi-Annually

11_AS_OF_DATE: Award Date

12_DATE_OF_FIRST_SUBMISSI: Award Date

13_DATE_OF_SUBSEQUENT_SUB: see Blk 16

addressee1: see address in

draft1: 1

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16_REMARKS: BLK 4. DID can be obtained from http://assist.daps.dla.mil/quicksearch.

Target product profile following the FDA “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool.” A Regulatory strategy detailing engagement with and licensure by FDA for both the base effort and Optional Task (f) should also be described. This should include details of IND filing path(s) and all regulatory actions necessary to achieve FDA approval.

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: LTC Nanette Patton

JPM MITS

J_DATE:

Page:

of_pages:

Reset:

reg38t: 1

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