Amendment_2_-_RFP_NHLBI-CSB-DE-2014-09-CM_.docx.pdf

SOLICITATION: NHLBI-CSB-DE-2014-09-CM

AMENDMENT: Two (2)

TITLE: Clinical Research and Operations Management Support (CROMS)

EFFECTIVE DATE: February 6, 2014

ISSUED BY:

National Heart, Lung, and Blood Institute, NIH Office of Acquisitions, CSB, DERA 6701 Rockledge Drive, Suite 6042, MSC 7902 Bethesda, Maryland 20892-7902

Point of Contact: Cornelius Moore, Contracting Officer [E-mail – Cornelius.Moore@nih.gov]

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged.

No additional questions will be accepted.

Offerors must acknowledge receipt of the amendment prior to the hour and the date specified for receipt of proposals, by one of the following methods:

A. By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

B. By separate letter or email which includes a reference to the solicitation and amendment number.

All other terms and conditions of the solicitation remain unchanged.

DESCRIPTION OF AMENDMENT

PURPOSE: To revise Section J. of the solicitation and answer questions submitted in response to the Request for Proposals (RFP).

I. REFERENCE: Section J., Attachment 11 is revised to replace the link to the document. Please use the link attached below to access the Certificate of Current Cost or Pricing Data form:

http://oamp.od.nih.gov/DGS/FORMS/cert-current-cost.pdf

II. REFERENCE: Responses to Questions (Attachment 1 of Amendment 2)

END OF AMENDMENT

http://oamp.od.nih.gov/DGS/FORMS/cert-current-cost.pdf

Clinical Research and Operations Management Support (CROMS) Attachment 1 RFP Number: NHLBI-CSB-DE-2014-09-CM Questions and Responses – Amendment 2

1. The RFP contains FAR clause 52.215-20 regarding the Requirements for Certified Cost or Pricing Data.

a. Does the Government expect to receive at least two or more proposals from responsible offerors competing independently?

We are unable to determine at this point the number proposals that will be received.

b. If yes, please confirm that there will be no requirement to submit certified cost or pricing data per FAR 15.403-1(b)(1) and (c)(1)?

2. On page 84 of the RFP, section M.5.3.e, the RFP states that the Offeror will be evaluated on the “suitability of proposed plans for start up and for orderly transition to a successor Contractor.” Is this evaluation criterion referencing 1) both the initial start-up phase of this new contract and the transition phase at the end of the contract (in 5 years), or 2) is the start up referenced here in relation to the suitability of the Offerors to start up of the statement of work tasks and an evaluation of the proposed transition plans to transition work from the current incumbent (at the beginning of this contract)?

Offerors will need to be prepared to transition and incorporate existing work and data into their systems. Evaluation criteria will be amended to read:

e) Suitability of proposed plans for start-up and for orderly transition from incumbent Contractor and at start-up to a successor Contractor at the end of the contract period.

3. On Page 47 of the RFP, Instructions to Offerors in paragraph 2.a.6-Page and Formatting Limitations, the RFP indicates that the page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources.... The RFP requirements include resumes of key personnel (L.2.b.1.b.4) and a description of the experience and qualifications of personnel who will be assigned for direct work on this program (L.2.b.1.b.). Can the Government clarify whether these personnel related requirements are to be included in the page count?

The Technical Proposal should include information so that adequacy and feasibility of the proposed staff can be evaluated as described in the Technical Evaluation Factors (page 83-84).

No, personnel related requirements will not be included in the page count.

4. The RFP also specifies that the Offeror will be evaluated on Facilities. Due to the restricted page limitations, are the description of facilities required to be included in the page count?

Please refer to page 47 paragraph 6 Page and Formatting Limitations. ” This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.”

5. Would the government provide further specification on the sample Standard Operating Procedure (SOP) requirements defined on page 68 of the RFP: Specifically for the "Study document preparation and review" SOP, does the Government intend this SOP to address the review of Essential Documents or the preparation of study materials for the conduct of the study?

The text on page 68 of the RFP “Study document preparation and review” refers to study material for the conduct of the study, such as a protocol, consent and associated documents.

6. On page 79 of the RFP, Uniform Cost Assumptions, section 1a-e, can the Government define what is meant by “study duration?” Is this the study time period from start-up through study close-out and submission of the final Clinical Study Report? If not, please clarify the intended duration for each?

Uniform Cost Assumption # 1 is to provide Study Design, Clinical Study Preparation/ Operational Assistance to work with NIDCR clinical sites in the coordination of their studies. Other uniform cost assumptions (# 2-14) pertain to data management, regulatory support, etc. A Clinical Study Report is not included in the uniform cost assumptions.

7. On page 79 of the RFP, Uniform Cost Assumptions, section 1a-d, can the Government confirm that it intends the Offeror’s effort should include activities from study design/protocol development through study close-out and submission of the final Clinical Study Report, and not just operational project oversight of others?

Correct.

a. We are seeking a little further clarity to help flesh-out the full range of activities to include.

Are we to apply all elements of SOW Task 1 and 2 to these Uniform Cost Assumptions?

Yes. The uniform cost assumptions are provided to assist offerors in proposing cost on the specified tasks.

8. On page 79 of the RFP, Uniform Cost Assumptions, section 1e, can the Government provide additional detail with regard to:

a. What “operational assistance activities” are required? (i.e., should the Offeror’s effort include activities from study design/protocol development through study close-out and submission of the final Clinical Study Report, and not just operational project oversight of others?) Please provide additional clarification as to the breadth of “operational assistance?”

No further details can be provided. The offeror should propose based on information in the RFP and past experience.

b. What are the scopes and Phases of the anticipated 20 additional study sites involved in the conduct of on-going clinical studies?

Assume various stages and scopes for the 20 additional clinical studies. NIDCR studies are posted on www.ClinicalTrials.gov for examples of types of clinical research being conducted.

9. We would like to include a Cross Reference Matrix with our proposal response that maps the RFP sections to the relevant locations in our proposal in order to assist the reviewers and which will not contain any substantive information – just proposal location references.

a. Can the Government confirm that this would be treated like other administrative areas such as the cover sheet, abstract, table of contents, etc., and not count towards the page limit?

The suggested section will not be counted towards the page limitation.

10. On page 62 of the RFP under paragraph b.1.a.4-Schedule: The RFP indicates that Offerors must “Provide a schedule for completion of the work and delivery of items specified in the statement of work.” Because the actual work to be performed is not currently known, we assume we are to apply this requirement to some or all of the Uniform Cost Assumptions. Many of the Uniform Cost http://www.clinicaltrials.gov/

Assumptions do not contain enough information to submit a realistic schedule given the lack of study specific details. Please clarify which parts of the Uniform Cost Assumptions we should apply this requirement to, or please provide further clarification?

Please provide a description of how you intend on submitting the tasks outlined in the Statement of Work along with the deliverables listed in Article F.2. Deliveries of the RFP.

11. Can the original and 13 copies of the Technical Proposal and the original and 3 copies of the Business Proposal be submitted in individual 3 ring binders?

Yes.

12. The last paragraph in Attachment #1 states “Please be aware that the U.S. Postal Service’s “Express Mail” DOES NOT deliver to the Rockville, Maryland address AND delivery to the Bethesda, Maryland address will result in a delayed delivery to our office in Rockville, MD (up to 3

– 5 days). If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.” Only Bethesda addresses are given for both the courier delivery service and U.S. Postal Service. Is there another address for the office in Rockville, MD to send proposal by a courier delivery service (i.e. FedEx, UPS, etc.)?

The final paragraph is referring to the “Express Mail” option. Please send all proposals to the address listed and please take into the consideration the note provided, so any possible delays can be accounted for.

13. Although the Appendices section has been expanded, our question about "Technical Plan" remains: “For example, it includes “Objectives, approach, methods and procedures, and substudy proposal” but it does not reference organizational experience, facilities, and resources – which constitutes 30% of the technical evaluation criteria (RFP pg. 84). Is the discussion of experience to be included within the 30 pages, or part of the (now 100)-page Appendices (or provided as an Attachment that does not count toward any page limitation)?

Discussion of experience will not be included in the Technical Plan but will be included in the Appendices of the Technical Proposal.

14. Under Section L.2.b.4.b – “Sharing of Model Organisms for Biomedical Research” (RFP pg. 65) -offerors must include in the “technical proposal a specific plan for sharing and distributing unique model organism research resources…” Based on the statement of work (SOW), we assume this is not applicable to this RFP. Please confirm.”

Correct.

15. Under Section L.2.b.6 Additional Technical Proposal Instructions – in the subsection for “Clinical Site Monitoring and Quality Assurance Implementation Plan” (RFP pg. 68) –please clarify if this is two separate documents”- a Clinical Site Monitoring Plan and a Quality Assurance Implementation Plan. Additionally, should these be provided as an Attachment(s) not counting toward any page limitation?

They are to be in the appendices which are not to exceed 100 pages. The RFP requests that offerors provide SOPs on clinical Site Monitoring and Quality Assurance. These may or may not be separate documents, depending on the offerors’ SOP.

See responses to questions 10 and 11 in Amendment 1.

16. Under Section L.2.b.6 Additional Technical Proposal Instructions - please clarify if the requested QA Implementation Plan is for the contractor’s processes (i.e. a QA plan for our data management, monitoring, reporting, etc.) or the sites’ processes (i.e. a clinical quality management plan).”

Quality assurance pertains to ensuring quality of the data of clinical studies being conducted. It may cover ensuring the clinical site’s quality management and the contractor’s process for ensuring quality of data and study conduct.

17. “Information Management Systems (RFP pg. 69): should this description be included as a separate Attachment (not page limited), an Appendix (part of the (now 100) page limit), or as part of the Technical Plan write-up for SOW Task Area 10 (part of the 30 page limit)?

The description should be provided with the appendices of the RFP.

18. The Statement of Work (Attachment 3) - Task 12 (pg. 14): references transition for a subsequent contract (but not the incoming contract). Is a transition plan for the current incumbent contractor available? If not, how should offerors address transition into a new contract resulting from this RFP (e.g. timelines, cost)?”

A transition plan from the incumbent contractor is not available at this time. A transition period for the awardee is anticipated to occur over approximately 90 days. Offerors will need to be prepared to transition and incorporate existing work and data into their systems.

19. For UCA #4 (RFP pg. 80) – it states that assessment visits will be made to 10 sites each year, including one initial site assessment visit plus one follow-up interim monitoring visit (2 visits/year). Typically, initial site assessment visits occur once per site; for proposal purposes, please confirm that the initial site assessment visits are to be proposed each year. That is, for this UCA, there will be 2 visits x 10 sites = 20 visits per year for each of the 5 years.

Yes.

20. Please re-confirm or clarify the Government’s response to Q&A #22 contained in Amendment

1. The response does not appear to be in line with current HHS Department guidance regarding Salary Rate Limitation. Please see the following HHS reference, particularly Q&As no. 11 and 12, stipulating that the cap pertains to the total annual direct salary: http://www.hhs.gov/asfr/ogapa/acquisition/salary-rate-limitation-qa.html Based on that, it appears that the scenario in Q&A #22 of an employee being paid $9,615 per year would not be a violation, because the annual amount is well below the salary limitation of $179,700 of direct salary per employee on a given contract. Please clarify or confirm.

The response is in line with the HHS Department guidance. In your previous question you stated:

“If a prime contractor or subcontractor employee has a normal gross annual salary of $200,000 (which would exceed Executive Level II if the employee worked full-time for a year under the contract) and only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal approximately $9,615 ($200,000/2080 = $96.15 * 100 = $9,615). “

If the salary rate for an individual employee is less than $179,700 or $179,700/2080 = $86.39/hour then they would not be in violation of the Salary Rate Limitation. This is based on http://www.hhs.gov/asfr/ogapa/acquisition/salary-rate-limitation-qa.html the total amount of salary paid during a year (base pay). The amount of salary payment under the contract allowed would be $86.39 * 100 = $8,639. If the contractor wishes to augment this amount through their own funds they may pay for the $976 difference but the amount that is invoiced under the contract is limited to $8,639.

21. My question concerns Section L of the Solicitation under article 2 "Instructions to Offerers", page 78, item 7, lined. What is meant by “Information on their cognizant field audit offices" , and how can it be rephrased? Also, if the offerers' sub-contractors do not have a negotiated agreement with the federal government, can that item be excluded?

Information on the audit office is requested. If they do not have a rate agreement, indicate that in your proposal and discuss how you will evaluate the reasonableness of their rates.

22. Are we able to use a Financial Report from 2012?

Yes.

23. In Attachment 1 of the RFP (Packaging and Delivery of Proposals) what is meant by "originals must be readily accessible for date stamping purposes"?

When packaging the shipment, please place the original Technical and Business Proposals on the top labeled “original”, so they can be time stamped easily.

24. Article C.2. Reporting Requirements (Page 6) section a. 1: What are these reports and do they need to be part of the cover letter?

The listed reports are provided for proposal preparation purposes only and do not need to be part of the cover letter. The reports would be required if a contract was awarded to the offeror.

25. Page 10 section D., What is meant be "deliverables", do the outside of packaging need to be labeled with contractor # and name?

Refer to the paragraph under Part 1 – The Schedule on page 4 of the RFP. “The contract schedule set forth in section B through H, herein, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract that will be awarded as a result of this solicitation.”

26. Does the Submission cover letter need to be attached to each copy of the Technical and Business Proposal?

Yes.

27. Section L.2.b (page 47 of the RFP) states that “The substudy proposal section of the Technical Plan (included within the 30 page limit) shall not exceed 8 single-sided or 4 double-sided pages.” This is the only mention of a substudy proposal throughout the entire RFP. Can you confirm that offerors are not required to produce a substudy proposal?

A sub-study is not required in this RFP. Examples given in section 6, Page and Formatting Limitation, are standard examples, but not expected.

28. Item 8 of the Uniform Cost Assumptions (page 80 of the RFP) states that offerors should “assume

5 domestic shipments are to be made…” and then the sentence ends. Can you confirm that the assumption is 5 domestic shipments per year for a total of 25 shipments over the 5-year contract period?

The text should read “…shipments are to be made each year….” Assume shipping costs for 1 product to the following 5 locations: Birmingham, Boston, Houston, Minnesota and Seattle.

a. That section also states that 1 shipment will require re-labeling and packaging – is that 1 shipment per year that requires re-labeling and packaging?

One of the 5 shipments each year will require re-labeling and packaging.

b. Approximately how many units (to be re-labeled) does the shipment consist of?

This is not known at this time. For specific details not known, the offeror should propose based on information in the RFP and past experience.

c. Are these bulk shipments or small shipments to the clinical sites? Can you provide the approximate weight range of these shipments?

Weight of shipments is not known at this time.

d. Can you provide more detail on the formulations (e.g. tablets, capsules, liquid, injectable, ointments, etc.) of the product agents?

Formulation of product is not known at this time.

e. Can you specify the cold chain requirements (e.g. refrigerated, frozen, ultra-low, other shipping condition, etc.) for the product/agent shipments in order to produce more accurate cost projections?

Assume refrigerated, 2°- 8° C

29. Under Section L.2.c.10. – “Additional Business Proposal Instructions” – subsection on Uniform Cost Assumptions (RFP pg. 79), Item #1.e) – references “operational assistance for 20 additional study sites” – please clarify the location to be assumed for these sites. For example, can we assume the same locations as noted in Item 4 – Site Operational Assessments?

Yes

30. Under the same Section – Item #9 (RFP pg. 80): states that 20% of the sites are at NIH; please clarify the location of the other 80%?

Refer to Uniform Cost Assumption 1 for potential domestic site locations (i.e., Minnesota, Boston, Birmingham and Seattle).

31. The RFP instructions require the inclusion of the following three types of documents:

• Completed Section 508 Product Assessment Templates (page 66)

• Sample offeror Standard Operating Procedures (page 68)

• Curricula vitae for key personnel (page 63)

Due to the length of these documents, can they be considered exempt from the appendix page limitations on page 47?

Please supply the Completed Section 508 Product Assessment Template as a separate “attachment” to your proposal that will not be counted towards the page limitation.

The Sample offeror Standard Operating Procedures will be included in the in appendices section.

Please refer to Amendment 1 – Question 10 on instructions. “The page limitation for the appendices has been increased to not to exceed 100 pages. If the required information cannot be accommodated within this limitation, it is acceptable, to provide the first few pages or the amount that might be needed to give a clear indication of the information while staying within the limitation.”

Curricula Vitae for Key Personnel will be included in the personnel section which is excluded from the Page limitation. Please refer to the response to question 4 above. ” This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.”

32. Section J – Technical Proposal Attachment (page 37 of the RFP): Though not listed as attachments, will you also require the use of the NIH form 1688 “Project Objectives” and the “Government Notice for Handling Proposals”? If yes, will these forms also be exempt from the page limitations listed on p. 47?

The NIH form 1688 “Project Objectives” has not been requested. The “Government Notice for Handling Proposals”, if added, would not be counted in the page limitations.

33. Under Article F 2 Deliveries on Page 12 of the RFP Item 30. Establish Websites and Databases from ongoing systems, the delivery schedule is "Within 90 calendar days after contract award".

However, in the SOW (attachment 3) on page 4 under Task 3. Data Collection, Management, and Quality control, the last sentence of the first paragraph has a different delivery schedule "...These systems shall be in place, along with having contract personnel available to assist with data collection efforts, within 30 days of contract award."

For consistency, plan for a 90 calendar day transition period.

34. In Attachment 3 (Statement of Work), p 8 for Task 6, Item C., please clarify the extent of toxicity testing for the "Preclinical product testing". Does toxicity testing include in vivo animal testing as well as in vitro testing?

It is not known what types of preclinical testing might be needed in the future.

35. In Uniform Cost Assumption (UCA) 8 (on page 80 of the RFP) regarding Specialized Operational Support, the second bullet of the instructions indicates that offerors should “assume annual costs of $100,000 for the provision of specimen storage/shipping, pre-clinical testing and/or pilot lot production.” The first bullet in UCA 8 provides assumptions regarding “Product/Agent and associated costs” but does not specify a dollar value to use for proposal purposes. May we assume the $100,000 plug value in the second bullet applies to all costs associated with UCA 8?

The $100,000 applies to the second bullet: specimen storage/shipping, preclinical testing and or pilot lot production only.

a) If not, please clarify whether we should include additional costs for the provision of product/agent shipments for one of the studies in UCA 1 (e.g., for 1.d), or if we should assume this is required for all studies?

It is not necessary to assume product shipment for Uniform Cost Assumption 1.d.

b) If the Government wants additional costs specifically for product/agent shipments, will you provide a plug value so that all offerors can assume the same value?

The government has not provided an assumed value for product/agent shipment. See response to question 3.i in Amendment #1 of this RFP