RFP 75N93022R00012 Amendment 002 (SF30).pdf
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- Solicitation number
- 75N93022R00012
About this file
This document contains questions and answers regarding a solicitation for clinical research data management and systems support services. The National Institutes of Health National Institute of Allergy and Infectious Diseases is seeking proposals to implement, operate, and maintain systems and workflows supporting clinical research studies. The goal is to enhance and modernize foundational tools for project management, infrastructure, user support, and clinical research information system design, development, and implementation. The period of performance begins December 1, 2022. Systex, Inc. is the incumbent. Offerors should prepare proposals according to the instructions in Attachment 6 and limit past performance submissions to relevant examples.
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Other files
| File | Type | Posted |
|---|---|---|
| Amendment 3 (75N93022R00012).pdf | ||
| Pricing Template (75N93022R00012).xlsx | XLSX spreadsheet | |
| ATTACHMENT 19 - Packaging and Delivery of Proposal.pdf | ||
| RFP_75N93022R00012 8.9.22.pdf | ||
| CRIMSON SOW_07.27.2022 (Final).docx | DOCX document | |
| RFP_75N93022R00012 8.9.22.pdf |
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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE
2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)
7. ADMINISTERED BY (If other than Item 6) CODE
STANDARD FORM 30 (REV. 11/2016)
Prescribed by GSA FAR (48 CFR) 53.243
FACILITY CODE
9A. AMENDMENT OF SOLICITATION NUMBER
9B. DATED (SEE ITEM 11)
10A. MODIFICATION OF CONTRACT/ORDER NUMBER
10B. DATED (SEE ITEM 13)
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.
12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
NUMBER IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority)
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15C. DATE SIGNED
15A. NAME AND TITLE OF SIGNER (Type or print)
16C. DATE SIGNED
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
PAGE OF PAGES
6. ISSUED BY CODE
8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)
CODE
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
16B. UNITED STATES OF AMERICA
(Signature of Contracting Officer)
Previous edition unusable
Mary Muir
The purpose of amendment 2 is to answer Offeror questions related to RFP# 75N93022R00012
NIAID
National Institutes of Health National Institute of Allergy and Infectious Diseases 9000 Rockville Pike Bethesda, MD 20892-7612
TO ALL POTENTIAL OFFERORS
National Institutes of Health National Institute of Allergy and Infectious Diseases Bethesda, MD 20892-7612
RFP 75N93022R00012
1 10
08/30/2022
Mary E. Muir -S Digitally signed by Mary E. Muir -S Date: 2022.08.30 15:40:46 -04'00'
1. Attachment 6 identifies 3 key personnel positions and Section 4 of the Statement of Work identifies 5 key personnel positions. Can NIH please clarify which is correct?
There are 5 key personnel positions per the Statement of Work. Please follow what you see on the Statement of Work.
2. Attachment 6 requires that we lay out the proposal in accordance with the instructions contained within (which clearly maps to the evaluation criteria). However, Section L provides an entirely different set of proposal content requirements (which do not clearly map to the evaluation criteria), many of which appear to be oriented towards scientific research work typically associated with grants. Can NIH please clarify the precise proposal requirements? It is currently difficult to determine which set of proposal instructions should be followed.
Please prepare your proposal in accordance with Attachment 6
3. Is there an incumbent? Yes, Systex, Inc.
4. Will this be Multiple Award? No. This will be a stand-alone contract.
5. What vehicle will this use? Stand-alone contract, as per the solicitation, CPFF.
6. Is there a dollar value for this opportunity?
In order to establish the need, an IGCE was established to determine price reasonableness. The
IGCE is an internal document that cannot be shared with Offerors.
7. Will the data be available from the Agency (NIH)? There is not enough information in this question to provide a substantive response.
8. Are we able to meet with the Program Managers and Stakeholders for a demo?
No, there are no oral presentations, nor pre-award meetings scheduled for this requirement.
9. Will the government, to the extent they are able, provide the specific architecture of the
CRIMSON and STORM systems? Additionally, will the government describe the underlying technologies (specific databases, middleware, and/or data visualization tools used, etc.)?
The underlying technologies are described in the SOW.
Here are the specific systems:
STORM
LabKey
Windows
PostgreSQL
Apache/Tomcat
Python
R
Java
JavaScript
CRIMSON
Solaris
SQL Server
4D
Java
PERL
UNIX Shell
Python
Ruby
Visual Studio C#
10. Will the government require letters of commitment for key resumes?
No, the govt will not require letters of commitment but if any key personnel are changed, someone as qualified or better has to be the replacement. Also, the replacement’s resume must be submitted to the govt for review and approval before the change is made.
11. Regarding proposal delivery, can the proposal be emailed to the contracting officer, or will the government require a hardcopy for delivery?
The proposals will be emailed to the following Contracting Specialists: Matt Lear (matt.lear@nih.gov) and Uju Obii-Obioha (uju.obii-obioha@nih.gov)
12. Per RFP page 60, is the government requesting the last 5 contracts performed by the offeror regardless of applicability to the statement of work? No, to clarify, as stated on page 60 of the RFP, please only submit past performance experience that are similar in nature to the solicitation work scope. Please submit all past performance that is relevant mailto:matt.lear@nih.gov mailto:uju.obii-obioha@nih.gov to the scope of work delineated in the SOW. For instance, if the Offerors only has two
(2) relevant contracts, that is sufficient; just include the number of relevant contracts you have therefore it could be less than 5.
13. Per RFP page 60, is the government requesting ALL contracts currently performed by the offeror related to this effort, in addition to past performance performed by subcontractors, key personnel, or predecessor companies without limitation? Please refer to response to question #12. Additionally, does the government define a "major subcontract" as $500,00 as indicated in the RFP or does that indicate $500,000? To clarify, the dollar threshold for a major subcontract is $500,000. The “$500.00” was a typo.
14. The Technical Proposal has an overall Page Limit of 125 pages, including attachments.
Since different vendors may have different attachment sizes, do you have any other Page Limit for the Technical Proposal which does not include the attachments?
No, the page limit for the technical proposal will be limited to 125; however, the page limit excludes the cover sheet, CVs, biosketches, resumes, references, preliminary data, references to published materials and all appendices and attachments.
15. Does the government anticipate that there will be any Other Direct Costs (ODCs) required on the part of the contractor for this effort? If so, can the government describe the total anticipated value of these ODCs?
Yes, it is anticipated that there will be Other Direct Costs such as software licenses and materials.
We will not provide the total anticipated value.
16. Can the government provide the current breakdown of Labor Categories/FTEs/personnel supporting this effort by Task Area?
Please refer to the Pricing Template sheet (attached in SAM.GOV) for more details. If your proposed labor category and hours are different from the Pricing Template, please provide an explanation and assumptions.
17. Reference: The RFP states “The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request (CCR) database.”
Question: As the DUNS is now retired, will the Government permit submission of the UEI number instead? Yes, please submit your UEI as the DUNS numbering system has been retired.
18. Reference: The Statement of Work has the file name including the date 7/27/2022 and within the file is dated 6/28/22. The RFP is dated 8/9/2022 and includes the SOW dated 6/28/2022.
Question: Please confirm the Statement of Work with the file name including the date 7/27/2022 is the most current and the RFP dated 8/9/2022 is the most current which also includes the SOW dated 6/28/2022. Yes, the Statement of Work dated 6/28/2022 and the RFP dated 8/9/2022 are the most current.
19. Reference: The RFP states “The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See SECTION J, Attachment entitled, TECHNICAL PROPOSAL COST
SUMMARY.) However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs”
Question: Please confirm the Technical Proposal is not to include any cost information or labor hours. Please do not include any cost data in the technical proposal. Please utilize the Summary of
Proposed Cost Excel spreadsheet (Attachment 8) OR the spreadsheet titled “Pricing Template” to provide all cost proposed. If you decide to use the Proposed Cost Excel spreadsheet, please ensure that you list all the labor categories on the “Pricing Template” in your sheet. This spreadsheet is to be submitted as supporting documentation with your business proposal. Please see Attachment 8
(https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx) of the solicitation.
20. Reference: The SOW and RFP indicate 5 Key Personnel roles as: Program Manager, Principal
System Engineer, Clinical Implementation Lead, System Security and Privacy Officer, and Senior
Clinical Data Manager.
The Technical Criteria for Evaluation indicates “The Appropriateness and adequacy of the education, training, experience, qualifications and effort for proposed key personnel to perform the requirements of the SOW.
A. Lead System Engineer- Appropriateness and adequacy of the education, training experience, expertise, qualifications and effort of the proposed Lead System Engineer.
B. Clinical Implementation Lead- Appropriateness and adequacy of the education, training, experience, expertise and qualifications of the Clinical Implementation Lead.
C. System Security and Privacy Officer – Appropriateness and adequacy of the education, training, experience, expertise, qualifications and effort of the proposed System Security and Privacy Officer.”
Question: Please confirm if the Program Manager and Principal System Engineer will be evaluated as part of the Technical Proposal evaluation process.
The five key personnel roles will be evaluated as part of the Technical Proposal evaluation process: Program Manager, Principal System Engineer, Clinical Implementation Lead, System
Security and Privacy Officer, and Senior Clinical Data Manager.
21. Reference: The SOW and RFP indicate the position of Principal System Engineer as a Key role.
Under the Technical Evaluation Criteria, the role is titled “Lead System Engineer”.
Question: Please confirm these two roles are the same one role with the same requirements for experience.
Yes, they are the same role.
22. Reference: The RFP states on page 77: “The following information shall be provided on the first page of your pricing proposal: ……9. Name, title, and signature of authorized representative.”
AND The RFP states on pages 79 & 80: “A. You must provide the following information on the first page of your pricing proposal. ……11. Name, title and signature of authorized representative.
Question: The RFP instructions for the Business Proposal Cover Sheet presents different sets of instructions. Please confirm the required list of elements for the Business Proposal Cover Sheet.
The required list of elements is stated on page 77 of the RFP should be listed on the NIH-2043 form
(Attachment 7). Please disregard the elements on pages 79 and 80.
23. Reference: The RFP states “The locations of where the contract will perform the work are
Frederick MD, Bethesda MD, Rockville MD, and remote.”
Question: Please provide the estimated number of trips between locations or historical data (not including the height of COVID-19) for travel. Please indicate if foreign travel or travel to locations other than those listed here is likely.
There will be no reimbursement for any travel related cost between local sites in Maryland. All non-local travel will follow Government travel reimbursement policies and regulations.
24. Reference: The RFP indicates “The contractor shall begin to provide technical and application support for software and infrastructure problems within one hour of notification or outage during duty hours (currently 0700-1530, Monday-Friday) and within four hours during non-duty hours. Technical support must be documented to industry standards and reported.”
Question: Please provide historical information on previous outages and on the average number of calls/issues with software and infrastructure.
No historical information can be provided.
25. RFP Number : 75N93022R00012 Reference: Page 91, 3. EVALUATION OF DATA SHARING PLAN The offeror's plan for the sharing of final research data shall be assessed for appropriateness and adequacy. If your proposal does not include a plan or if the plan in your proposal is considered
"unacceptable," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your data sharing plan during discussions and in your Final Proposal Revision (FPR). If your data sharing plan is still considered "unacceptable" by the Government after discussions, your proposal may not be considered further for award.
Is this applicable to this proposal? Yes, as this is an IT procurement with data sharing requirements, this is relevant to this proposal.
26. RFP Number : 75N93022R00012 Reference: Page 74, b. Personnel, 1. Principal Investigator/Project Director and 2. Multiple Principal Investigators
Are these applicable to this proposal? No, please disregard as this is not applicable to this requirement.
27. Past Performance Information
a. Offerors shall submit the following information as part of their Business proposal. A list of the last five contracts completed during the past three years and ALL CONTRACTS currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a
"major subcontract" is defined as a subcontract in excess of $500,00..
Is there a limit to the number of past performances required? Please see response to question 12
28. On Page 60: A list of the last five contracts completed during the past three years and ALL
CONTRACTS currently being performed that are similar in nature to the solicitation work scope.
Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns.
On Page 131 and 138 of the package: (in Attachment 6) Past performance descriptions may be of active work or work completed within the last five years.
Clarification: Please clarify whether Past Performances need to be with the past 3 or 5 years? Please see response to question 12.
29. Attachment 1 : Attachment 1 indicates that the System Security and Privacy Officer will obtain and maintain a certification equivalent to DoD 8140 Information Assurance Level 1 certification during the period of the contract and that the certification must have a grounding in FISMA. Is there a particular category of DOD equivalent certificates that the certification must come from (For example there is an IAT Level I, IAM Level I, IASAE Level I, etc. ) and/or can you provide a list of acceptable certifications? Any relevant or requirement FISMA artifacts equivalent to DoD 8140 Information Assurance Level 1 certification will be determined and obtained post award.
30. Attachment 6 and Section L.2.14.a: Attachment 6 requests "Past Performance" as part of the technical proposal however Section L.14.a (pg. 60 of the RFP) requires past performance as part of the business proposal. Can NIH please advise which is the correct location for past performance information? Please submit past performance information with your business proposal.
31. Attachment 6 and Section L.14.a: If the answer to the preceding question is "technical proposal", are offerors to provide all the information in Section L.14.a (pg. 60-61) in the technical proposal section 6? Please see response to question 30.
32. Section L.2.b.a: Does Section L.2.b.a requirements correspond with the Attachment 6, Section 3 requirements? Can the government please conform these two different sets of instructions for Technical Approach so offerors can better understand how to organize our offer? While the requirements delineated in section 32. The requirements in Section L.2.b.a are to be submitted with your technical proposal, please also submit any information in Attachment 6, section 3 that is required as supplemental information in your technical proposal.
33. Section L.2.b.a.2: The Approach section appears to be geared to a discrete project with a finite "end". This project is a development, modernization, enhancement and operations & maintenance effort. Can NIH please identify the "research" identified in this section that is to be performed? To clarify, this requirement is non- Research and Development in nature;
therefore, this section is not applicable.
34. Section L.2.b.a.4: This section also implies delivery of discrete products. While there are objectives and work to be completed in performance of the SOW, there is not a finite "end" to this work. Can NIH please clarify as this appears to be instructions oriented to a research type.
project, not a development, modernization, enhancement and operations & maintenance effort contract? To clarify, this requirement is non Research and Development in nature;
therefore, this section is not applicable.
35. Section L.2.b.b and Attachment 6, Section 5: These two requirements are in conflict. Section L implies information on all personnel must be provided while Attachment 6, Section 5 only identifies three positions that information should be provided for. Please confirm that Attachment 6 is correct. Please see response to question 33.
36. Section L.2.b.b and SOW Section 4 and Attachment 6, Section 5: Section L makes mention of a "Principal Investigator" and also notes that multiple Principal Investigators may be proposed. However SOW Section 4 "Key Personnel" and Attachment 6, Section 5 "Key Personnel" make no mention of a Principal Investigator/Project Director. Can the Government please clarify which key personnel role is the "Principal Investigator/Project Director"? Please see response to question #26.
37. Section L: As a whole, Section L requirements for the technical proposal appear to be geared towards a grant funded research or scientific type project. This is a development, operations and sustainment effort. Would the government please consider directing offerors to respond exclusively to the requirements set for in Attachment 6, which also align to the evaluation factors? Yes, please respond and tailor your proposal to Attachment 6 as applicable.
38. Section L.2.c.4, Section L.2.c.2, and Attachment 11: Section L.2.c.4 and Section L.2.c.2 provide different information on what is to be included on the cover sheet and Attachment 11 states that offerors are to use NIH 2043 as the cover sheet which does not have space to include the information required by the Section L instructions. Can the government please confirm that use of NIH 2043 is sufficient for the business proposal cover sheet? Yes, this is sufficient;
however, please ensure that all information required is included in the cover sheet.
39. Section L.2.c.8.a: This section states that offerors are to clearly list all government property that will be in use as well as why the contractor needs it. This contract is performed at the government site utilizing government equipment exclusively. Does the government require this detail? If an Offeror proposes specific equipment in their technical proposal, please include any relevant specifications for the equipment proposed. Please refer to Attachment 2:
Government Furnished Property, to see a list of the equipment that will be provided to the resultant Contractor.
40. Section L.2.c.9.a-e: This information is also generally required in the technical proposal. Can the government confirm it wants this information in the Business Proposal as well? Please submit all relevant information in your technical proposal, not business proposal
41. Information Security And/Or Physical Access Security, Paragraph E: On page 65, it is noted that a security control assessment must be conducted by a FedRAMP third-party assessment organization (3APO) for the initial ATO and annually thereafter…" It is our understanding that 3PAO is only required if the provider was planning on providing a cloud based service, which is not part of the requirements for this program. Would the government consider removing the requirement for a FEDRamp 3PAO to conduct the security assessment since CRIMSON is not a cloud based system?
Please refer to the clause below instead of the clause in the RFP
A security control assessment must be conducted for the initial ATO and annually thereafter or whenever there is a significant change to the system’s security posture in accordance with the Continuous Monitoring Plan.
42. L.2.a.14 and Attachment 6: Section L states that offerors should provide a list of five contracts completed in the last three years and all contracts currently being performed should be submitted for past performance. Attachment 6 states past performance descriptions may be of active work or work completed within the last five years. Can the government please clarify the discrepancy between Attachment 6 (five years) and Section L (three years)? Please see response to question 12.
43. Section L.2.a.4: This section of the RFP states that the "technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See Section J, Attachment entitled, Technical Proposal Cost Summary). However, in review of Section J, the attachment referenced is not provided. Does the government in fact want price information to be included and, if yes, please advise as to where offerors can find the attachment that is not provided in Section J as well as please identify which section of the proposal it is to be included as Attachment 6 does not make any reference to providing price information in the technical proposal? Please see response to question. Please disregard the Section J referenced sheet. There should be no price information in the Technical Proposal. All cost information should be included in the Pricing Template
(Attached on SAM.GOV) or Summary of Proposed Cost spreadsheet (Attachment 8:
https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx)
44. There is a discrepancy in the period of performance in 2 separate pages. Does the period of performance start in December 2022 or December 2023?
The period of performance starts on December 1, 2022. December 1, 2023 is when Option 1 period of performance starts.
45. Has there been any incumbent awardee for this proposal in the past?
Yes, the incumbent is Systex Inc.
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