B08 Pricing Sheet - Attachment 4.xlsx

XLSX spreadsheet 17 KB Posted

Attached to
Food and Drug Administration (FDA) Regulatory Compliance Training
Solicitation number
HT9425-25-R-0050
Issued by

About this file

The document is a comprehensive Pricing Sheet for a Food and Drug Administration (FDA) Regulatory Compliance Training contract solicited by the U.S. Army Medical Research and Development Command (USAMRDC). The pricing sheet covers a base year and four option years (May 2025 - April 2030), with multiple Contract Line Item Numbers (CLINs) for training courses in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR). These courses include both introductory and refresher training levels, with some sessions specified as face-to-face at Fort Detrick, MD.

The underlying contract objective is to provide competency training for personnel involved in FDA-regulated research activities, ensuring compliance with federal regulations in pharmaceutical and medical device development. The training is specifically designed for USAMRDC personnel to meet FDA regulatory requirements outlined in Title 21 Code of Federal Regulations. The solicitation (HT9425-25-R-0050) is managed by the Defense Health Agency, with the long-term goal of maintaining high standards of competency and regulatory compliance in product development efforts supporting U.S. Military medical research. Notably, all pricing line items in the document are currently listed at $0.00, suggesting this may be a preliminary or template pricing document.

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PRICE SHEET

Pricing Sheet
Food and Drug Administration Regulatory Compliance Training Non-personal services in support of ORA
Period of PerformanceBase Year (approximately 01 May 2025 - 30 April 2026)
CLINSDescriptionCLIN TYPEQuantityUnit of IssueUnit PriceTotal
0001Introductory GCPFFP1Each$0.00
0002Refresher GCPFFP1Each$0.00
0003Introductory GMPFFP1Each$0.00
0004Refresher GMPFFP1Each$0.00
0005Introductory QSRFFP1Each$0.00
0006Refresher QSRFFP1Each$0.00
TOTAL VALUE$0.00
Period of PerformanceOption Year 1 (approximately 01 May 2026 - 30 April 2027)
CLINSDescriptionCLIN TYPEQuantityUnit of IssueUnit PriceTotal
1001Introductory GCP (Face to Face At Fort Detrick, MD)FFP1Each$0.00
1002Refresher GCP (Face to Face At Fort Detrick, MD)FFP1Each$0.00
1003Refresher GCPFFP1Each$0.00
1004Introductory GLPFFP1Each$0.00
1005Refresher GLPFFP1Each$0.00
1006Introductory GMPFFP1Each$0.00
1007Refresher GMPFFP1Each$0.00
TOTAL VALUE$0.00
Period of PerformanceOption Year 2 (approximately 01 May 2027 - 30 April 2028)
CLINSDescriptionCLIN TYPEQuantityUnit of IssueUnit PriceTotal
2001Introductory GCPFFP1Each$0.00
2002Refresher GCPFFP1Each$0.00
2003Introductory GLPFFP1Each$0.00
2004Refresher GLPFFP1Each$0.00
2005Introductory GMPFFP1Each$0.00
2006Refresher GMPFFP1Each$0.00
TOTAL VALUE$0.00
Period of PerformanceOption Year 3 (approximately 01 May 2028 - 30 April 2029)
CLINSDescriptionCLIN TYPEQuantityUnit of IssueUnit PriceTotal
3001Introductory GCP (Face to Face At Fort Detrick, MD)FFP1Each$0.00
3002Refresher GCP (Face to Face At Fort Detrick, MD)FFP1Each$0.00
3003Introductory QSRFFP1Each$0.00
3004Refresher QSRFFP1Each$0.00
TOTAL VALUE$0.00
Period of PerformanceOption Year 4 (approximately 01 May 2029 - 30 April 2030)
CLINSDescriptionCLIN TYPEQuantityUnit of IssueUnit PriceTotal
4001Introductory GCPFFP1Each$0.00
4002Refresher GCPFFP1Each$0.00
4003Introductory GLPFFP1Each$0.00
4004Refresher GLPFFP1Each$0.00
4005Introductory GMPFFP1Each$0.00
4006Refresher GMPFFP1Each$0.00
4007Introductory QSRFFP1Each$0.00
4008Refresher QSRFFP1Each$0.00
TOTAL VALUE$0.00

SUPPLEMENTAL PRICE SHEET

Supplemental Pricing Sheet
Food and Drug Administration Regulatory Compliance Training in support of ORA
Period of Performance
Labor Category (Introductory GCP)HoursSubtotal
Period of Performance
Labor Category (Refresher GCP)HoursSubtotal
Period of Performance
Labor Category (Introductory GLP)HoursSubtotal
Period of Performance
Labor Category (Refresher GLP)HoursSubtotal
Period of Performance
Labor Category (Introductory GMP)HoursSubtotal
Period of Performance
Labor Category (Refresher GMP)HoursSubtotal
Period of Performance
Labor Category (Introductory QSR)HoursSubtotal
Period of Performance
Labor Category (Refresher QSR)HoursSubtotal

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