ATTACHMENT C-Pricing Model.xlsx
XLSX spreadsheet 43 KB Posted
- Solicitation number
- W911QY20R0007
About this file
This document contains an attachment to a solicitation for regulatory consulting services on a multiple award indefinite delivery/indefinite quantity contract. The government requires senior regulatory experts to provide consultation and reporting on projects related to FDA regulations, quality auditing, FDA package submissions and other areas. The attachment includes fully burdened labor rates for labor categories including Senior Executive Consultant, Senior Regulatory Affairs Analyst/Manager, Senior Subject Matter Expert, Project Manager, Medical Writer, and Scientist. It also includes templates for pricing models with rate tables for evaluation purposes and for the first task order. Responses are due by November 30th, 2020 to the Army Contracting Command Aberdeen Proving Ground for consideration.
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Other files
| File | Type | Posted |
|---|---|---|
| ATTACHMENT A-PastPerformanceInformation_Revised.docx | DOCX document | |
| ATTACHMENT F-Responses to Contractor Questions.xlsx | XLSX spreadsheet | |
| ATTACHMENT D-BotPlagueRegAsmnt_InitialTaskOrderPWS_Revised.docx | DOCX document | |
| W911QY21R00070002.pdf | ||
| W911QY21R00070001.pdf | ||
| ATTACHMENT A-PastPerformanceInformation.docx | DOCX document | |
| ATTACHMENT B-Past Performance Questionaire.docx | DOCX document | |
| W911QY21R0007.pdf | ||
| ATTACHMENT D-BotPlague_InitialTaskOrderPWS.docx | DOCX document | |
| ATTACHMENT E-48 CFR 19.704 Subcontracting Plan.PDF |
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Text version
Tab A Contract Rates
| ORDERING PERIOD | Base Year | Option Yr 1 | Option Yr 2 | Option Yr 3 | Option Yr 4 |
| Dec 2020-December 2021 | Dec 2021-December 2022 | Dec 2022-December 2023 | Dec 2023-December 2024 | Dec 2024-December 2025 | |
| Labor Category | Fully Burdened Rate | Fully Burdened Rate | Fully Burdened Rate | Fully Burdened Rate | Fully Burdened Rate |
| Senior Executive Consultant | |||||
| Senior Regulatory Affairs Analyst/Manager | |||||
| Senior Subject Matter Experts | |||||
| Project Manager | |||||
| Medical Writer | |||||
| Scientist |
| *Instructions/notes: This sheet will become Attachment 2 to any resulting contract, and will be used to negotiate |
| FFP Task Orders or modifications to Task Orders for ID/IQ requirements* |
| Insert fully burdened labor rates for each labor category shown in YELLOW above. |
| Identify by Company name, any Subcontractor being proposed. Subcontractor rates shall be fully burdened. |
| This form must be returned as an EXCEL SPREADSHEET. Any other format will be deemed unacceptable. |
| There is no guarantee that requirements will exist for all labor categories listed herein!! |
| Note - the one year periods above are just for the contractor to insert rates for that period |
Offerors rates for the last ordering period will remain the same for up to a 3 month period based on actual contract award date!!!
| ATTACHMENT 2 - PMSP PRICING MODEL, TAB "A" | &"Times New Roman,Bold"&11 |
| &"Times New Roman,Bold"&11 |
Use or disclosure of the data contained on this page is subject to the restriction on the title page of this proposal
Tab B Evaluation Purposes
| Loaded Rates on this worksheet shall be used by the Government for evaluation purposes to determine the Proposed Price. |
| Insert fully burdened labor rates for each labor category (and for each location) shown in YELLOW below. |
| Identify by Company name, any Subcontractor being proposed. Subcontractor rates shall be fully burdened. |
| This form must be returned as an EXCEL SPREADSHEET. Any other format will be deemed unacceptable. |
| There is no guarantee that requirements will exist for all labor categories listed herein!! The Government may order a full year or any part thereof. |
| The values portrayed in this spreadsheet have no representation of the IDIQ ceiling |
| Include Price of yearly Manpower Reporting and CDRLs where indicated below. |
| FREDERICK, MARYLAND | ||||||||||||||||
| Dec 2020-December 2021 | Dec 2021-December 2022 | Dec 2022-December 2023 | Dec 2023-December 2024 | Dec 2024-December 2025 | Subcontractor | |||||||||||
| Labor Category | Fully Burdened Rate | Hours | Total | Fully Burdened Rate | Hours | Total | Fully Burdened Rate | Hours | Total | Fully Burdened Rate | Hours | Total | Fully Burdened Rate | Hours | Total | |
| Senior Executive Consultant | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | |
| Senior Regulatory Affairs Analyst/Manager | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | $ - 0 | 312 | $ - 0 | |
| Senior Subject Matter Experts | $ - 0 | 1,872 | $ - 0 | $ - 0 | 1,872 | $ - 0 | 1,872 | $ - 0 | $ - 0 | 1,872 | $ - 0 | $ - 0 | 1,872 | |||
| Project Manager | $ - 0 | 312 | 312 | 312 | 312 | 312 | ||||||||||
| Medical Writer | $ - 0 | 156 | 156 | 156 | 156 | 156 | ||||||||||
| Scientist | $ - 0 | 156 | 156 | 156 | 156 | 156 |
TOTAL LABOR YEAR 1: $ - 0 TOTAL: LABOR YEAR 2 $ - 0 TOTAL: LABOR YEAR 3 $ - 0 TOTAL: LABOR YEAR 4 $ - 0 TOTAL: LABOR YEAR 5 $ - 0 TOTAL: ALL YEARS $ - 0
TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S for all Locations (NTE): $ 6,000.00 TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S for all Locations (NTE): $ 12,000.00 TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S for all Locations (NTE): $ 15,000.00 TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S for all Locations (NTE): $ 15,000.00 TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S for all Locations (NTE): $ 15,000.00 TOTAL TRAVEL AND ODCS FOR ALL YEARS ALL LOCATIONS $ 63,000.00
YEARLY CONTRACT MANPOWER REPORTING - PROVIDE YEARLY PRICE PRICE FOR 1 EACH:
| TOTAL ALL YEARS, | |
| ALL LOCATIONS: | ERROR:#REF! |
ATTACHMENT 2 - PMSP PRICING MODEL
Tab C Labor Categories
| Government Labor Category | |
| Typical Duties and Qualifications | |
| Program/Project Management Services | |
| Senior Executive Consultant | Provides expertise, advises, and leads personnel across functional regulatory disciplines. Consultants will normally be recognized as authorities in their field of expertise as technical experts on drugs, vaccines, biologics, and devices. Typical consultant personnel may have provided regulatory and quality consultation to senior leaders at the highest levels within a pharmaceutical company, and/or the U.S. Food and Drug Administration. Fifteen (15) plus years in a Senior Project Manager/Leader Role at a pharmaceutical/biotechnology United States company that has brought at least one product to market. |
| Senior Regulatory Affairs Analyst/Manager | Experience, 10+ years with the development of regulatory strategies and communicating with the FDA in written submissions, regulatory meetings, and may have served as a panel member. Experience developing internal processes and procedures for the execution/oversight of sponsor responsibilities identified in 21 CFR, writing/reviewing/editing work objectives for clinical research organizations, developing/executing/overseeing clinical protocols. Experience with developing and providing consultation in the execution of regulatory strategies for vaccines, orphan drugs, new mechanisms of action, and rare diseases. Experience with regulatory approaches to support feasibility of emergency use regulatory mechanisms |
when appropriate a plus.
Senior Subject Matter Experts Expert level, 10+ years of relevant experience in areas such as animal model development, clinical development and oversight of Clinical Research Organizations, current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP), Pharmaceutical Chemistry, Manfuacturing, and Controls (CMC), medical device expertise - design capability, design controls, design verification, device history files, Human Factors studies, reliability as determined by Fault Tree analysis/tolerance interval methods and others to achieve five-nines reliability. Experience with Quality Management Systems. In-depth knowledge of health care research and analysis, policy, legislation and military regulations in the area of quality, as well as health care risk management. PhD in biology, or pharmacology, or chemistry or equivalent, or Veterinarian, or MD, RN or equivalent clinical degree with extensive medical product and clinical trial development experience.
| Project Manager | Serves as a project manager for task order or contracts in coordination with the contract-level Contracting Officer's Respresentative (COR), and Government technical leads. Responsible for the management of specific task order(s) and ensuring that requirments are understood. Bachelor or Masters degree with at least 10 years of experience. |
| Medical Writer | Experience (5+ years) working independently to draft executive summaries, situational reports white papers, information papers, memorandums, scientific papers and/or journals as well as cover letters, prefaces to manufacturing, non-clinical, and clinical sections intended for FDA submissions. Proficient with Microsoft Office applications. |
| Scientist | Experience in the areas of science and technology, research, technology maturity, and applicability of CBRN prophylactic and therapeutic drugs, biologics, and devices through advanced development, production, and fielding. Experience reviewing medical literature and databases for technical information to substantient technical assessments. Experience in a science and technology is preferred (10+ years), with a completion of a full course of study in an accredited college or university leading to a PhD is required. |
ATTACHMENT 2 - PMSP PRICING MODEL
Tab D Pricing for Task Order 01
| Fully Burdened Rates on this worksheet shall be used by the Government for evaluation purposes to determine the Proposed Price of Task Order 01. |
| Insert fully burdened labor rates for each labor category (and for each location) shown in YELLOW below. |
| Identify by Company name, any Subcontractor being proposed. Subcontractor rates shall be fully burdened. |
| This form must be returned as an EXCEL SPREADSHEET. Any other format will be deemed unacceptable. |
| The values portrayed in this spreadsheet will establish the price of the initial Task Order |
| Include Price of Manpower Reporting where indicated below. |
| Task Order 01 | Subcontractor | |||
| Labor Category | Fully Burdened Rate | Hours | Total | |
| Senior Executive Consultant | $ - 0 | $ - 0 | ||
| Senior Regulatory Affairs Analyst/Manager | $ - 0 | $ - 0 | ||
| Senior Subject Matter Experts | $ - 0 | $ - 0 | ||
| Project Manager | $ - 0 | $ - 0 | ||
| Medical Writer | $ - 0 | $ - 0 | ||
| Scientist | $ - 0 | $ - 0 |
TOTAL LABOR: $ - 0
TOTAL TRAVEL (CONUS and OCONUS) AND ODC'S (NTE): $ - 0
CONTRACT MANPOWER REPORTING $ - 0
| TOTAL TASK | |
| ORDER PRICE | $ - 0 |
ATTACHMENT 2 - PMSP PRICING MODEL
File details come from the government source that posted it. Updated .