Responses_11-18-15.pdf

RFP-NIAID-NIHOA2015025, NIAID/DCR Technical and Administrative Management Services

Questions:

1. RFP Section M Evaluation Factors for Award, page 100, e. HIV Antiviral Treatment Trials indicates: The offeror's proposal must address a plan to have host countries authorities and/or other stakeholders identify sources available, if any, to provide antiretroviral treatment to HIV affected populations that have participated in the contract funded HIV antiretroviral treatment trial, OR describe why the offeror believes that there are no such sources available.

Given the sample task order is for an observational trial, what documentation is the offeror expected to provide?

While this sample task order describes an observational trial, it is feasible that a treatment trial could be implemented. In anticipation of a treatment trial, NIAID is requesting a description of offeror’s plan for either maintain the treatment or justification for halting the treatment post study.

2. RFP Attachment 3, Task Area 2.2, page Att 3-6: Last sentence in this paragraph reads: “Note that Contractor shall be responsible for all associated costs of providing personnel including, A recruitment costs:”

Please verify if this sentence is complete as written or provide additional details. Correction made it should read,” including, recruitment costs”.

3. RFP Attachment 3a, page Att 3a-1, Statement of Work, I. Background and Introduction: indicates the collaboration started in 2013. Attachment 3b, Sample Study 1 for the IDIQ RFP, page 2 indicates clinical work began in 2004 and page 7 indicates collaboration was established in 2003.

Please clarify for assumption purposes, which year the sample collaboration began and when enrollment began or is expected to begin per site (if enrollment start was different among the sites). At what stage of clinical conduct is the Sample Task Order Study 1? Should the offeror/contractor assume the study is ongoing?

Correction – This is a start-up.

4. RFP Attachment 3a, page Att 3a-2, Statement of Work, includes a table of projected enrollment by site (6,291 participants). However, Att 3-b, page 3 states that the protocol estimates recruitment up to 50,000 eligible participants. Therefore, please clarify what these projected enrollment numbers refer to. Is this current enrollment as of the RFP date, 2015 enrollment projections, 2016 enrollment projections, etc.?

For the purpose of this task order offeror should bid against the 6,291

Please clarify the gap between the sum of the projected enrollment per 6 sites and the 50,000 enrollment goal.

Number of participants to enroll by site, ignore 50,000 for this exercise.

5. Attachment 3a-1, Sample Task order 1, Study 1: Should the offeror assume that additional sites will be brought onto the study in order to meet the enrollment projections of 50,000?

No

6. RFP Attachment 3a, page Att 3a-2, Statement of Work, indicates “Subject remuneration per visit totals $15 with exception of initial visit whereby no remuneration is paid.” However, Att 5 does not provide technical cost assumptions for remuneration.

Should the offeror include subject remuneration costs in cost proposal? If already started, please provide information on which visits have been completed. Yes, not ongoing this is a start-up.

7. Attachment 3-b states that the sample task order study will be 5 years. However, Attachment 5-1 states study will continue under this contract for 7 years. Please clarify. This will be 7 year contract.

8. When is the last anticipated follow up visit of the Last Patient Enrolled for the sample task order?

By end of year 4

9. RFP Attachment 5, Technical Cost Assumptions, page Att 5-1, 7. Meetings & Conference Support Services in San Jose, Colombia; includes Four training meetings ~ 100 attendees and five meetings of the institutional review board.

Are these meetings annually or over the 7 year task order period? Please clarify if the 100 attendees are per training meeting or cumulative for the 4 training meetings.

Assume a total of 7 for 7 year period

10. RFP Attachment 5, Technical Cost Assumptions, page Att 5-1, 8. Data Management & Information Technology Services: Must maintain supplies & equipment for six clinical sites necessary to support clinical research and Contractor pays telecom usage fee to carrier.

Is the offeror responsible for providing data management support to the SALVAR VIDAS Data Management Coordinating and Operations Centre other than noted in the Technical Cost Assumptions? If yes, please define which additional data management and IT services the Contractor will be supporting, such as CRF design, database design, and query resolution.

Yes, the Government expects the offeror to provide.

11. For the Sample Task Order, should the offeror assume that the database is already built? How many pages is the CRF?

No, this is a start-up.

12. RFP Attachment 5, Technical Cost Assumptions, page Att 5-1, 9. Administrative, Management, and Clinical Staff, Current staffing levels:

Please define the current staffing positions, titles or descriptions and levels of effort that the offeror must include in cost proposal.

This is a start- up.

13. RFP Attachment 5, Technical Cost Assumptions, page Att 5-2, 2) Travel: there are no travel assumptions for the 2 monitoring visits to each site per year and the four training meetings noted on page Att 5-1.

Please provide travel assumptions for the monitoring visits and training meetings.

2 days.

14. Attachment 5, page Att 5-1, Section 3, Uniform Cost Assumptions, 9. Administrative, Management, and Clinical Staff, under 2), Travel:

For budgeting purposes, please provide the departure location for the 200 attendees traveling to the annual conference in San Jose, Colombia.

50 domestic and 50 international.

15. RFP, page 48, Technical Proposal Attachments:

Please confirm that Attachment 5, Planned Enrollment Report, PHS-398/2590, (Rev. 08/12) is to be completed by the enrolling site, not by the offeror/contractor as part of its technical proposal.

To be completed by the Offeror

16. For the sample task order, please confirm the following:

a. Will the offeror/contractor be responsible for receipt and follow-up on SAEs?

Yes for this task order

b. If the offeror/contractor will not hold the safety database, will the offeror/contractor be responsible for writing SAE narratives?

Yes

c. Will the offeror/contractor be responsible for SAE review?

Yes, in conjunction with NIAID delegate safety group

d. Will the offeror/contractor be responsible for Expedited Reporting in Ex-US countries?

Contingent on IRB’s requirements of Country

17. In Att 5, it states that a uniform cost assumption of 25,000 of clinical specimens per year to be labeled, packaged and shipped.

Is this in addition to or including the 52 domestic and/or 24 international shipments? If it is an addition, please specify the frequency of shipments and final destination.

Including the 52 domestic and/or 24 international shipments.

18. In regard to Att 5, it states that the offeror should include a uniform assumption of 52 domestic and 24 international shipments per year.

Please clarify the specimen type and quantity of specimens per shipment for domestic and international. Please indicate the final destination of the international shipments. Please specify the destination of the domestic shipment.

Please reference sample study and assume all samples will be stored.

50 international and 50 domestic International destination: Bethesda, MD and Frederick, MD Domestic destination: Colombia

19. Attachment 5, section 3 states 100,000 new serum and plasma specimens to be labeled, stored and inventoried each year.

a. For purposes of costing the sample task order, study 1, should this number be followed exactly or should this be broken out per volunteer population and dependent on whether or not samples are collected every 6 months or every 12 months?

1. Attachment 3 states: For all volunteers, an aliquot of serum and plasma from 20 ml of blood will be sampled and stored every six months for HIV positive patients for future virologic and immunologic research, and future resistance genotyping (based on additional informed consent as appropriate). It is collected every 12 months for HIV negative patients.

Follow exactly.

20. Does NIAID have any existing cloud infrastructure (e.g. hosting) that can be utilized? If so, can the Government provide details regarding host environment, tools, and security construct?

NIAID does support an existing AWS federal deploy, however the preference is the utilization of the NIAID data center for projects of this type.

21. For Sample Study 1: Can the offeror assume that the infrastructure (e.g., facility, pharmacy, designated waiting areas, power supply, and hot water) of the investigational sites can be used?

Assume that you will establish and build capacity

- If so, will the Government need to provide a fee for the services to the sites?

- Is there an existing data entry system that the Government needs deployed? Can the offeror propose alternative solutions to data entry from paper based CRFs? No/Yes

22. Task Area 4.3, c:

Is there an estimate on the amount of data to be generated/transmitted per hour/day/week. No 2 – Is there a current VTC product to tie into with NIAID? No 3 – Is there a requirement for servers/hosting to be on-site? Yes, at one central location Yes at 1 central location.

4 – Are backup requirements available? Are they the same requirements that NIAID has for other data (i.e. frequency, retention period)? No 6 – What is the amount of pages to be printed per day/week? Unknown.

6 - For imaging, will there be a need for automated paper feeders for large quantities of scanning?

Yes 7 – Are there any prohibitions against using wireless networking? No, as long as secure.

7 - Approximately how many networked devices would be present at each site?

Offeror is expected to review list of personnel and provide best estimate.

8 – Please clarify “data management” software. Would this be something similar to SAS?

Offeror is expected to make recommendation.

9 – Does this collaboration server also one of the “web presences” mentioned in 4.3 c 15 (such as items c., d., e., and/or f.)? Yes.

10 – Is there a need to do application development at the clinical site or will it be done at program headquarters? Offeror is expected to make recommendation.

12 – Assume that it is preferable to use a satellite connection vs. either an ISP or wireless provider at the remote site both for a more stable/reliable connection and a consistent network configuration. Assume that the need for public IP is only needed to communicate with the program office and other clinical sites, and that the clinical sites themselves could be on a private network (10.x, 172.16.x, 192.168.x). Offeror is expected to make recommendation.

13 – Is there a need for desktop computer or could they all be notebooks, laptops, or other portable devices? Offeror is expected to make recommendation.

23. Task Area 4.4

Does NIAID have any existing cloud infrastructure (e.g. hosting) that can be utilized? If so, can the Government provide details regarding host environment, tools and security construct?

See question 21.

24. Task Area 4.5, a

For all equipment, will there be any physical sanitization procedures performed should the equipment come into contact with any deadly pathogens? If so, please describe these procedures.

If there is no procedure in place or if it would ruin the equipment, is destruction of the equipment (once all data is retrieved/backed up) an option?

The decontamination of electronics is routinely accomplished through gas phase agents and there exist well established methods that can be adopted for equipment size and operational situation

What other computer-connected equipment may be used at a clinical site? Barcode scanners, microscopes, ultrasounds, etc.…?

Instrumentation interfaces may include laboratory analyzers or other diagnostic equipment leveraging standard interface messaging (e.g. ASTM, HL7 or file based parsing) ii – Is there a need to have test and/or development servers on site?

No iii – Is there a requirement to maintain backups on site? For any on-site backups, how “rugged” must they be (able to handle being dropped from a certain height, waterproof/water-resistant, tapes, and external drives)?

On site backup may be limited to practical RAID approach, a plan for offsite backup and recovery through a hardened data center will be expected.

25. Task Area 4.5, c

For general maintenance, is the expectation that there will be a technician/engineer deployed at remote clinical sites to perform maintenance/troubleshooting or will equipment be returned to headquarters or another location for these activities to be performed?

Yes, contractor should propose best solution for maintaining equipment.

26. in relation to page 88 – Small Business Plan

Do offerors need to submit a small business plan for the ceiling contract value in the business proposal submission? Yes

27. (in relation to page 88 – Small Business Plan)

Do offerors need to submit a small business plan for the sample task order even though it is not intended for award in the business proposal submission? No

28. (in relation to – Form 2043)

Do the offerors need to populate Form 2043 with the un‐awardable sample task order pricing or do we leave the price portion blank?

Leave the price portion blank.

29. In attachment 3 it states on pp. 3‐1 through 3‐2 that Performance Requirements would need to be addressed in each Task Order response.

We are not locating the Performance Requirements for the sample task order. Can you please provide the applicable Performance Requirements for the sample task order or comment on the reason for their omission.

Reference page 127, Attachment 3a‐1, Roman numeral III – TECHNICAL REQUIREMENTS. The requirement describes the four task areas defined in the base SOW.

1. Reference: Solicitation pgs. 1 and 2 Question: There appears to be two different RFP/Solicitation numbers:

Section A – Solicitation/Contract Form (pg. 1): RFP-NIAID-NIHOA2015025 Header (starting pg. 2): RFP-NIAID-NIHAO2015025

Can the Government Please clarify/amend? Please use RFP-NIAID-NIHAO2015025

2. Reference: Section J-List of Attachments, pg. 47; Section J-List of Attachments (following Section M),

pg. 105 Question: There appears to be two Section J’s with conflicting attachment numbers. Can the Government please clarify these attachments?

Section J – pg. 47 Section J – pg. 105 Attachment 5: Planned Enrollment Report, PHS-398/2590 (Rev. 08/12)

Attachment 8: Planned Enrollment Report, PHS-398/2590 (Rev. 08/12)

Attachment 6: Technical Proposal Cost Summary

Attachment 9: Technical Proposal Cost Summary

Attachment 7: Summary of Related Activities Attachment 10: Summary of Related Activities Attachment 8: Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310)

Attachment 11: Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310)

Attachment 9: HHS Section 508 Product Assessment Template

Attachment 12: HHS Section 508 Product Assessment Template

Formatting error, offeror should still be able to navigate document to propose against this RFP

3. Reference: Section L, 2. Instructions to Offerors, a. General Instructions, 13. Past Performance

Information, pg. 64:

a. Offerors shall submit the following information as part of their Business proposal.

A list of the last 3 contracts completed during the past Three years and [ALL CONTRACTS/THE LAST 1 CONTRACTS AWARDED] currently being performed that are similar in nature to the solicitation workscope.

Question: Can the Government please clarify this requirement? Does the Government require:

Current or completed contracts?

Both current and completed contracts?

Three of each (six total)?

A list of three contracts awarded during the past three years that are similar in nature to the solicitation.

4. Reference: Section L, 4. Human Subjects, pgs. 69-81; Section M, Human Subjects Evaluation, pgs. 97- 101; Attachment 3b, Sample Study, 12.0 Human Subjects Protection, pgs. 20-21 Question: Is the Offeror to write in response to the Sample Study or provide a general response (to the Base IDIQ)?

General response to IDIQ

5. Reference: Section M, 1. GENERAL, pg. 97:

The major evaluation factors for this solicitation include technical (which encompasses experience and past performance factors), and cost/price factors.

Question: Can the Government please confirm that the Past Performance section belongs in the Business Proposal Business Proposal

6. Reference: Section M, 4. Evaluation of Data Sharing Plan and 5. Evaluation of Data Sharing Plan, pg.

Question: Should this be a single evaluation factor? Yes

7. Reference: Attachment 1, pg. Att 1-3 Question: Do Resumes count towards the overall 100 page limit for the Technical Proposal? Yes

8. Reference: Attachment 3, 3. General Task Requirements, pgs. Att 3-1 – 3-2 Question: C and D appear to be missing. Can the Government please clarify/provide the missing requirement? There is no section C and D.

9. Reference: Attachment 3, Task Order Deliverables, 2. Other Reports and Deliverables (Delivery Schedule), c. Protocol SOPs, & Manual of Procedures, pg. Att 3-14

First draft is due 30 days after Task Order award.

Question: In order to provide a draft, the protocol must be approved. Should the draft be due 30 days after protocol approval as opposed to 30 days after task order award?

30 days after protocol approval.

10. Reference: Attachment 3, Task Order Deliverables, 2. Other Reports and Deliverables (Delivery Schedule), f. Training Material, pg. Att 3-15 Question: Can the Government please clarify/expand upon what is meant by Training Material?

We expect the offeror to provide what is appropriate for training materials.

11. Reference: Attachment 3a, pg. Att 3a-1 Question: Section A appears to be missing. Can the Government please this section?

There is no section A

12. Reference: Attachment 5, Section 3 – Uniform Cost Assumptions, 1) Technical Cost Assumptions, pg.

Att 5-1 Question: The listed assumptions appears to be missing #6. Can the Government please clarify/provide the missing requirement?

6. The number of volunteers per year shown in the following table;

Baseline Follow‐up

HIV+ve Not on cART

HIV+ve on cART

HIV‐ve

Hospital Pablo Tobon Uribe

Hospital Universitario San Jorge

Hospital El Tunal

Universitario San Jose ese

Naval de Cartagen

Fundacin Hospital de la Misericordia

13. Reference: Attachment 5, Section 3 – Uniform Cost Assumptions, pg. Att 5-2 Question: Can the Government please clarify/provide the missing requirement?

Same as #12

14. Reference: 508 Compliance Question: Does the Offeror’s proposal (Technical and Business) have to be 508 compliant? No

15. Reference: Executive Summary Question: The RFP does not mention an overall proposal Executive Summary. Should the Offeror include one, will be included in the 100 page limit? Does the Government consider the "Overview" to serve as the Executive Summary? Yes

16. Reference: Hardware Cost Question: The SOW requires the acquisition of hardware (desktops, notebook computers, mobiles devices, printers) for program staff at all of the sites. Will the Government pay directly for these expenses or will the vendor be reimbursed after buying the equipment on behalf of the Government?

Vendor will be reimbursed.

17. Reference: Software Licenses Questions: Software licenses may be needed to implement data systems (laboratory systems, clinical trials data management, database license, hosting fees) to support the DCR program. Are software licenses fees reimbursable under this contract? Yes

18. Reference: Cloud-based Systems Question: Are secured cloud-based systems acceptable under this contract?

See PPD 3rd set of questions Q.23

19. Reference: Personnel Question: Can the government provide Labor Categories against which the Offeror can propose? Can the Government also provide the Estimated Staffing for the Task Order Proposal?

No not beyond what is in the UCA. Program expects Offeror to assess personnel needs.

20. Reference: Sample Study Task Order Questions:

Are there site investigators identified to run this study at the six study sites under SALVAR VIDAS for this protocol? Will they be required to be hired by the contractor winning this bid?

No, this is a start-up. Yes

Are there site investigators identified to run this study at the six study sites under SALVAR VIDAS for this protocol? Will they be required to be hired by the contractor winning this bid?

Duplicate Will this task order supply the SALVAR VIDAS Yes

Is there be a central repository for subject samples, or is there a repository at each location? Does the repository exist for samples or will this be part of the proposal, setting up a repository central, or individual at each site? No this is a start-up. Offeror expected to establish a central repository.

Is there an existing database that the data will be reported to? Will a database need to be created, or any modules of existing database need updated or added for this study? No, Yes

Study sites will be collecting forms and sending them to Salvar Vidas HQ Data Section for incorporation into the database, will the contractor be staffing any of the positions at the HQ Data Section or will the contractor only be responsible for staffing the sites with clinical research staff?

Yes and No.

Is there an expected staffing table, or guidance on where staff are expected to be placed? No Regarding the table on pg. Att 3a-2, are the expectant enrollments for the entire study length or is it annual? Does the government expect to reach the 50,000 subjects outlined in the protocol? If yes, will the same ratio of expected enrollment be the same for the total of 50,000 subjects?

Entire study length and No

21. Reference: Attachment 3 – Base SOW. Section 4.3 Communication Support Services and 4.5 Data Management and IT Service Question: Both sections seem to have repetitive requirements as follows. Can the Government please clarify?

3. Production and Test/development database/application servers.

4. Data Backup.

5. Equipment rack and uninterruptible power supply.

6. Network printing and imaging.

7. Network hardware for Local Area Network (LAN).

8. Data management software.

9. Collaborative server.

10. Management and security software and applications development software.

11. Productivity software including a server-based email, and Microsoft Office applications.

12. Internet connectivity and LAN are needed at all clinical sites, as well as the program headquarters to allow public IP addresses for worldwide bi-directional communications and the ability to establish secure connections to the research sites through the public internet.

13. Desktop and notebook computers for the program staff at all of the sites. General maintenance and life cycle acquisitions as necessary.

14. Any e-mail transmissions that include project information will include the appropriate identification and disclaimer. Contractor shall submit proposed disclaimer language to the COR for approval prior to implementation.

15. Establish and maintain a web presence (using commercial software) and maintain website(s) necessary to support:

a. Activities outlined in the Statement of Work including internal /operational procedural information such as CRF’s, manual of operations, policies & guidance, etc.

b. Information for the general public.

c. Assistance to DCR-funded investigators.

d. Sharing of information between sites and/or multiple collaborative partners.

e. Sharing of information between the Contractor and DCR staff via a “restricted-access” site.

f. Protocol-specific and program communication(s) that shall be implemented with appropriate secured access working with IT staff as necessary.

As stated.

No. Solicitation Section Question 1 L.2.a.13.a Past

Performance Information Please clarify if “ALL CONTRACTS” or “THE LAST 1 CONTRACTS AWARDED” are to be provided as part of this section of the proposal. A list of three contracts awarded during the past three years that are similar in nature to the solicitation.

2 M.4/M.5 Evaluation of Data Sharing Plan

These two sections are titled the same. Are they separate sections or should one be titled differently.

Error in formatting, offeror should be able to find needed information to propose.

3 Attachment 3, (3) General Task Order Requirements

Can you confirm there is not a section C or D under Section (3)?

Confirmed

4 Attachment 3, (3).E.

Personnel

For the Associate Researcher, would the government consider changing key behaviors i, x, and xi to the following:

i. Assist in designing, developing, implementing, monitoring, and analyzing clinical research trials

ii. Assist in developing clear and accurate materials for clinical protocols, IND applications, operational guidance, study reports, training materials, and summaries of site visit findings

iii. Assist in preparing written summaries of analyses for publication, presentations, grant applications, and/or review by regulatory agencies

Also, can you confirm the role of the Associate Researcher? The overall description of the Associate Researcher presents more like a Clinical Trial Monitor, however, the majority of the key behaviors are indicative of a Clinical Research Coordinator who would perform those activities versus overseeing them for compliance.

If Offeror would like to expand scope of duties, please feel free to do so.

Offeror should focus on function of Associate Researcher and explain if you are adding oversight.

5 Attachment 3, (3).F.2.2 It appears that the last sentence of this section is incomplete. Can the government confirm/correct the content of this sentence? Correction made it should read,” including, recruitment costs”.

6 Attachment 3, (3).F.4.3 Can the government confirm what site(s) the communication support services will be provided to? Not at this time.

7 Attachment 3, F – Deliveries or Performance

Task Order Reporting Requirements states that “All reports required herein shall be submitted in electronic format.” Under Technical Reports, item 2 Report of Government Property, requests hard copies to be submitted to the COR and the Contracting Officer. Can you confirm that the government requires hard copies versus electronic copies for this deliverable? All electronic copies.

8 Attachment 3b, Annexure G: Time and Event Schedule

Please clarify the HIV+ve on cART follow up visits for samples Hep B, RPR for syphilis, and urine NAT.

Are the samples to be drawn at 1 month and then every 6 months or only once at 12 months?

Greatly dependent on protocol but 6 months for these samples.

9 Attachment 5, 3.(1) The list of assumptions states that “cART will be supplied and shipped at no charge to this contract.” Can you confirm that supplying and shipping of cART is covered under a separate agreement and that the contractor is not responsible for those costs? Confirmed.

10 Attachment 5, 3.(1).9 Administrative, Management, and Clinical Staff

Please provide the current staff positions and staffing levels being provided on this ongoing study.

Offeror decides. Program apologizes for the mistake, this is a start-up not an ongoing study.

11 Attachment 5, 3.(1).8 Data Management & Information Technology Services

Should the offeror assume that all supplies, equipment, and infrastructure/communication are in place and currently in working order at the six (6) clinical sites?

Please provide a list of supplies and equipment that the offeror will maintain.

Please provide the current telecom usage fee and carrier unless it is expected for the offeror to propose a new carrier to be used. Program apologizes for the mistake, this is a start-up not an ongoing study.

12 Attachment 5, 3.(2) Travel

Should the offeror assume the number of days listed in A-C do not include travel days?

Yes

13 Attachment 5, 3.(3).A and D

Can the government confirm that values listed in A and D are US dollar amounts versus number of specimens? Number of specimens.

14 Attachment 5, 3.(3).B and C

Can the government provide an estimated size of each shipper?

No

15 Attachment 5, 3.(4).A Can the government confirm that the value listed in A is US dollar amount versus number of specimens?

Same as #13

16 Attachment 5, 3.(5) Government Furnished Property

Please provide a list of Government Furnished Property that the offeror will be responsible for.

There is no GFP as this is a start-up

17 Attachment 1, IV.2 Will the government include resumes as exempt from the page limitation for the Technical Proposal? Yes 18 Attachment 9 Please confirm that Attachment 9 Technical Proposal Cost Summary should be completed for Sample Task

Order 1 and included in the Technical Proposal. Confirmed 19 Attachment 10 Please confirm that Attachment 10 Summary of Related Activities should be completed for each key personnel position proposed for Sample Task Order 1. Confirmed 20 Attachment 11 Please confirm that Attachment 11 Protection of Human Subjects Assurance Identification/IRB

Certification/Declaration of Exemption should be completed for Sample Task Order 1. Confirmed 21 Attachment 12 Please confirm that Attachment 12 HHS Section 508 Product Assessment Template should be included in the

Technical Proposal and, if so, what product should the offeror be assessing? Confirmed 22 Attachment 15 Please confirm that Attachment 15 should be completed for the Sample Order only and that no additional cost spreadsheets should be completed for the base IDIQ. Confirmed

23 Attachment 5,3.(1)

Technical Cost Assumptions

The protocol does outline subject stipends and the amounts, however there is no mention of taking over site contracts and the continuation of site payments for completed enrollments/visits. Should we assume that we will not be responsible for these in this sample task order response? Offeror responsible.

1. Attachment 3- 3E1c – Associate Researcher – is described as an individual who will “oversee and monitor clinical trials.” However, Section 3F – Description of Individual Task Areas – does not describe the task of conducting clinical site monitoring.

Will clinical site monitoring be within the scope of this IDIQ?

Yes

2. Kindly elaborate on the requirements for Infrastructure Support (Attachment 3, Section 4,4) that the offeror will be expected to provide and to whom.

As depicted in SOW our collaborations are in sites that are research compromised therefore build-up of items listed for resource. Network collaborators.

3. Attachment 5, Section 3 – Uniform Cost Assumptions, part 1) Technical Cost Assumptions:

a. Assumption 3. “2 monitoring visits to each site per year.”

Should we assume this is 2 site visits per site per year? Monitoring is not included in the tasks areas in the contract SOW.

b. Assumption 7.e “Meetings & Conference Support Services in San Jose, Colombia.”

However, San Jose is not a large city in Colombia. (It refers to a number of remote areas in Colombia.) It the reference to San Jose correct?

4. The scope of the Sample Task Order 1 includes “supporting continuation of the active protocol known as Study 1.”

For our technical response, at what point in the progress of this study should we assume our work will begin? (e.g., after 5,000 participants have been enrolled.)

We are deleting the highlighted terms, this is a start-up.

5. Cognizant Officer- In Article G.6, the solicitation references a cognizant Contracting Officer representative that is responsible for negotiating provisional and/or final indirect cost rates and provides the Director, Division of Financial Advisory Services and address.

Will the cognizant Contracting Officer listed in G.6 accept the offeror’s current approved NICRA if the offeror’s cognizant agency is USAID, and the offeror has a Negotiated Indirect Rate Agreement (NICRA) that is approved through USAID. If USAID is the cognizant agency for a company we would accept that rate agreement, as there would only be one federal agency issuing a NICRA at one time. However, for NIH purposes the rates may need to be adjusted if the company has R&D expenses as HHS handles these costs differently. We usually can get the information from the company and compute any necessary adjustment.

6. In PART II – CONTRACT CLAUSES, Article I.2. Authorized Substitutions of Clauses: Under

(b) the proposal document indicates that FAR clause 52.215-21, Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data—Modifications (October 2010) is added.

Is certified cost or pricing data required when in Subpart 15.403 (c) the Contracting Officer is not required to obtain certified cost or pricing data when a determination of fair and reasonable prices are based on adequate price competition? This is a proposal that is highly visible and is highly likely to obtain more than two offerors competing independently. Additionally, FHI 360 has a reasonable expectation that at least one other offeror is capable of submitting a meaningful offer and FHI 360 has no reason to believe that other potential offerors will not submit an offer. In light of these facts and circumstances please confirm that FHI 360 will not be required to certify cost or pricing data.

Delete Section 3 page 84‐88. Replace with the following: Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010)

(a) Exceptions from certified cost or pricing data.

(1) In lieu of submitting certified cost or pricing data, offerors may submit a written request for exception by submitting the information described in the following subparagraphs. The Contracting Officer may require additional supporting information, but only to the extent necessary to determine whether an exception should be granted, and whether the price is fair and reasonable.

(i) Identification of the law or regulation establishing the price offered. If the price is controlled under law by periodic rulings, reviews, or similar actions of a governmental body, attach a copy of the controlling document, unless it was previously submitted to the contracting office.

(ii) Commercial item exception. For a commercial item exception, the offeror shall submit, at a minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include

(A) For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

(B) For market priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market;

(C) For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item.

(2) The offeror grants the Contracting Officer or an authorized representative the right to examine, at any time before award, books, records, documents, or other directly pertinent records to verify any request for an exception under this provision, and the reasonableness of price. For items priced using catalog or market prices, or law or regulation, access does not extend to cost or profit information or other data relevant solely to the offeror's determination of the prices to be offered in the catalog or marketplace.

(b) Requirements for certified cost or pricing data. If the offeror is not granted an exception from the requirement to submit certified cost or pricing data, the following applies:

(1) The offeror shall prepare and submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in accordance with the instructions contained in Table 15-2 of FAR 15.408, which is incorporated by reference with the same force and effect as though it were inserted here in full text. The instructions in Table 15-2 are incorporated as a mandatory format to be used in this contract, unless the Contracting Officer and the Contractor agree to a different format and change this clause to use Alternate I.

(2) As soon as practicable after agreement on price, but before contract award (except for unpriced actions such as letter contracts), the offeror shall submit a Certificate of Current Cost or Pricing Data, as prescribed by FAR 15.406-2.

(End of provision) Alternate I (October 2010) of FAR Clause 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other than Cost or Pricing Data (October 2010). As prescribed in 15.408(l)(and see 15.403- 5(b)(1)), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:

(b)(1) The offeror shall submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in the following format:

The format specified in paragraph L.2.c.4. Certified Cost or Pricing Data, subparagraph 3. formats for Submission of Line Item Summaries shall be used for the submission of cost data. Submission of all other Certified cost or pricing data shall be in accordance with Table 15-2 in FAR 15.408.

Page Number in

RFP

Section Question

1 102‐103 Section 6 – Technical Evaluation Factors

The RFP outlines four technical evaluation factors with weights.

How are these weights being applied to the IDIQ response versus the sample task order response?

The response to the sample task order is a reflection of the offeror’s ability to meet the requirement of the RFP. This is one collective response.

2 Att 3‐5 Section 2.1.b Is the contractor expected to procure Federal Wide Assurance (FWA) or advise clinical research staff on the need for site specific

FWA?

This is not something that is procured, we advise the offeror to gain an understanding of FWA

3 Att 3‐6 Section 2.1.i The government states “assist sites with operations implementation..” – is there an expectation that the contractor will work directly with clinical staff to execute clinical research versus advising on clinical research design and overall management?

Yes

4 N/A N/A As a prime contractor, do all subcontractor need to be identified at the time of RFP submission, or is there the ability to secure new subcontractors based on the scope of individual task orders?

No/Yes

5 64 Section 12 – Past Performance

The RFP states “A list of the last 3 contracts completed during the past Three years and [ALL CONTRACT/THE LAST 1 CONTRACTS AWARDED] currently being performed that are similar in nature to the solicitation workscope”. Can the government clarify if submitting the last 3 contracts completed during the past three years will meet past performance information requirements? A list of three contracts awarded during the past three years that are similar in nature to the solicitation.

6 Att 4‐1 Table of Contents Within Section 3, is the government looking for an integrated response for both the IDIQ and sample task order, or clearly separated responses (e.g., Section 3.1 – IDIQ response; Section 3.2

– Sample Task Order technical response)? Separated Responses

7 Att 4‐3 Section 4 Scientific and Technical Personnel

Page 4‐3 lists Program Manager, Project Manager, Associate Researcher and Training Associate as roles, and pages 66‐68 list Single PI/Project Director, Multiple PIs, Other Investigators and Additional Personnel as roles. Which set of roles apply for the IDIQ versus the sample task order? Program Manager for IDIQ and all other roles for T.O.

8 97 & Att 3a‐1

Section M.2 & Attachment 3a

Please confirm that Offeror(s) total evaluated price will consist solely of the estimated price for Sample Task Order 1.

Confirmed

9 84‐85 Business Proposal Instructions

The Government states that Certified Cost or Pricing Data is required and a Certificate of Current Cost or Pricing Data is required to be submitted before award. However, in accordance with FAR 15.403‐1(b)(1), certified cost or pricing data should not be required if the prices agreed upon are based on adequate price competition.

As this is a competitive acquisition, will the Government consider removing the requirement for certified cost or pricing data in its entirety? Delete Section 3 page 84‐88. Replace with the following:

RFP

Section Question

Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010)

(a) Exceptions from certified cost or pricing data.

(1) In lieu of submitting certified cost or pricing data, offerors may submit a written request for exception by submitting the information described in the following subparagraphs. The Contracting Officer may require additional supporting information, but only to the extent necessary to determine whether an exception should be granted, and whether the price is fair and reasonable.

(i) Identification of the law or regulation establishing the price offered. If the price is controlled under law by periodic rulings, reviews, or similar actions of a governmental body, attach a copy of the controlling document, unless it was previously submitted to the contracting office.

(ii) Commercial item exception. For a commercial item exception, the offeror shall submit, at a minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include

(A) For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted.

Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

(B) For market priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market;

(C) For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item.

(2) The offeror grants the Contracting Officer or an authorized representative the right to examine, at any time before award, books, records, documents, or other directly pertinent records to verify any request for an exception under this provision, and the reasonableness

RFP

Section Question of price. For items priced using catalog or market prices, or law or regulation, access does not extend to cost or profit information or other data relevant solely to the offeror's determination of the prices to be offered in the catalog or marketplace.

(b) Requirements for certified cost or pricing data. If the offeror is not granted an exception from the requirement to submit certified cost or pricing data, the following applies:

(1) The offeror shall prepare and submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in accordance with the instructions contained in Table 15-2 of FAR 15.408, which is incorporated by reference with the same force and effect as though it were inserted here in full text. The instructions in Table 15-2 are incorporated as a mandatory format to be used in this contract, unless the Contracting Officer and the Contractor agree to a different format and change this clause to use Alternate I.

(2) As soon as practicable after agreement on price, but before contract award (except for unpriced actions such as letter contracts), the offeror shall submit a Certificate of Current Cost or Pricing Data, as prescribed by FAR 15.406-2.

(End of provision) Alternate I (October 2010) of FAR Clause 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other than Cost or Pricing Data (October 2010). As prescribed in 15.408(l)(and see 15.403-5(b)(1)), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:

(b)(1) The offeror shall submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in the following format:

The format specified in paragraph L.2.c.4. Certified Cost or Pricing Data, subparagraph 3. formats for Submission of Line Item Summaries shall be used for the submission of cost data. Submission of all other Certified cost or pricing data shall be in accordance with Table 15-2 in FAR 15.408.

10 Att 3 Business Proposal For the IDIQ statement of work, please confirm that no pricing is required to be submitted for the IDIQ statement of work?

Confirmed.

11 N/A N/A Based on the UCA’s provided, it appears the government is only expecting short‐term travel to Colombia. Please confirm if this is correct? Correct. The UCA ensures that the offerors are proposing with the same data set.

12 88‐90 Small Business Subcontracting Plan

The subject plan requires offerors to include a “statement of total dollars planned to be subcontracted” and similar requirements in which offerors must express specific dollar amounts in relation to subcontracted dollars. This cost/price information requirements

RFP

Section Question specified by the Government do not include any basis for pricing at the IDIQ level. As an alternative, will the Government permit offerors to propose these goals as percentages rather than as fixed dollar amounts? Yes, this is the offeror’s choice.

13 84 L 2.c.2.i 1. Please confirm if all offerors shall use Department of State Standardized Regulations for estimating any applicable travel and ODC costs for Sample Task Order 1. . GSA Per Diem Travel Costs.

14 48 and 105 Section J (48) and Section J list of Attachments (105)

The two cited Section J references number attachments differently.

For example, Section J on page 48 lists the Breakdown of Proposed Estimated Costs as Attachment 11, while Section J on page 105 lists this as Attachment 15. Please clarify. Program mistake, but offeror should be able to find needed information.

15 112‐121, 172‐173

J. Attachment 3 J. Attachment 5

Please confirm that Attachment 3, Sections E and F, and the Attachment 5, Section 3, represents all items we are required to price for the sample task effort. Program encourages Offeror to propose against everything. Closely review all aspect of SOW including anything that has a cost implication and include such in your proposal; as it stands you have excluded specific data found in

RFP.

16 172 J. Attachment 5 In order to provide the most accurate price for the sample task, can the Federal Government provide additional details on the supplies, equipment, and telecom services for all study sites OR in the absence of this detail, provide an estimated standard cost for these items? No, this is the Offeror’s responsibility to propose.

17 172 J. Attachment 5 In order to satisfy the Federal Government’s requirement to estimate staff levels, can the Federal Government provide current staffing levels as mentioned in Universal Cost Assumption #9? Sorry this is our mistake, this is not ongoing but a start‐up, so no.

18 Attachment

Section J – Attachment 12

The Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet provided by Government shows a start date of 1/1/2007, will the Government clarify the Period of Performance Offerors’ should assume for pricing Sample Task Order

1. This varies dependent upon task, approximately 6 weeks after award so approximately June 2016 – May 2021.

Question

Page Number in

RFP

Section Question

1 125 J. Attachment 3 (3‐ 14)

Please confirm that the Delivery Schedule listed for Training Needs Assessment Report and Training Material (“First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments.” and “First draft is due 30 working days after Task Order award. Final due is due five business days after receipt of Government comments.”, respectively.) are accurate?

Confirmed.

2 117 J. Attachment 3 (3‐ 7)

Please confirm whether the Offeror anticipates that partner sites receiving training will fall under the Institutional Review Board of NIAID/DCR or whether they will be expected to stand up their own IRB structure (e.g. Steering Committee)?

Both.

3 Att 5‐1 Section 3 Technical Cost Assumptions

Can the government provide a list of assumptions on activities and expenses that will be supported by the Colombian Ministry of Health and Social Protection (e.g., payment for patient participation in research cohorts)?

Assume that Government will pay all costs.

4 Att 5‐1 Section 3 Technical Cost Assumptions

Within the sample task order, are the staff who are currently engaging with patients in initial study and continuous monitoring being provided by the CMHSP and their associated professional fees should not be included in the contractor’s estimated budget?

No, not provided/ Yes include in cost proposal.

5 Att 5‐1 Section 3 Technical Cost Assumptions

In the sample task order, is primary electronic data capture already being supported and not the responsibility of the contractor?

No/Yes it is the responsibility of the contractor.

6 Att 4‐2 Section 3; Training (b)

“Describe capabilities, plans, procedures, and past experience for needs assessment and training of Program staff.” Is it the government’s expectation that other than…