Amendment No 3.pdf

Amendment #3 Solicitation Number

RFP-NIAID-DMID-NIHAI2011122

AMENDMENT Three (3)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID) 6700-B Rockledge Drive, Room 3220, MSC7612 Bethesda, MD 20892-7612

Solicitation Number: RFP-NIAID-DMID-NIHAI2011122

Date of Solicitation Issuance: 05/31/2012

Date of Amendment No.3 Issuance: 08/16/2012

Number of Pages 11

NIAID Point of Contact: PRIMARY:

Alexandra J. Buck, Contract Specialist Email: alexandra.buck@nih.gov Phone: 301-402-9396

SECONDARY:

George W. Kennedy, Contract Specialist Email: kennedyg@mail.nih.gov Phone: 301-451-2607

Purpose of Solicitation Amendment: The above numbered Solicitation is amended as set forth below.

The hour and date specified for receipt of proposals remains unchanged – until 4:00 PM Eastern Prevailing Time on August 23, 2012.

Offerors must acknowledge receipt of this Amendment (as well as the other amendments) on each copy of the proposal submitted. Failure to receive your acknowledgement of this Amendment may result in rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The Purpose of Amendment No. 3 is to respond to questions received regarding this solicitation.

Below is the Government’s response to questions received regarding this solicitation:

1. Question 1 – Is it permissible to be a subcontractor on proposals submitted by different organizations?

Answer 1 – Yes.

2. Question 2 - Does the IDIQ Contractor have to be a clinical site, or can the IDIQ contractor provide all clinical sites through subcontracts?

Answer 2 - The contractor must serve as the overall party responsible for conduct of the clinical trial. In most instances, the contractor would be anticipated to be a clinical site.

However, given the technical nature of the work, it may be done through subcontracts. Please refer to Section M, Item 5. “Technical Evaluation Criteria,” of the solicitation for further details regarding technical proposal evaluation.

3. Question 3 - Can HIV infected individuals with STI co-infections be included as a population to the study?

Answer 3 – Yes, as long as the STI is the focus of the study.

4. Question 4 - Attachment 7, Section 4; 3) “Storage,” states that offerors should include uniform assumption of the following on a yearly basis and address 1500 clinical specimens and 250 investigational products. Can the government specify if they are seeking central facilities for this storage and the duration of this storage?

Answer 4 - The offeror should propose how they would store the samples needed for and generated by the clinical trial being proposed. The timeframe is determined by the length of the proposed trial.

5. Question 5 - In Attachment 7 page 1 (page 131 of the RFP): “Additional Business Proposal

Instructions and Uniform Cost Assumptions,” we note the following statement: “The Government’s requirement for the work set forth in the Statement of Work for Task Area 1, Task Order 1 is 3,224 direct labor hours” and wondered if we were misreading the text or if there might be a typographical error in this portion of the Attachment.

Answer 5 – The solicitation is correct. The requirement for Task Area 1, Task Order 1, which has a 12 month period of performance, is 3,224 direct labor hours.

6. Question 6 - Pg.55, 2.a.2. states that proposals should be “printed/copied double-sided, on at least 30% post consumer fiber paper;” however, Attachment 1, III.A.5. (p. 3 of 3) says to submit “single sided on standard…paper.” Which is correct?

Answer 6 – The Government recognizes that these two statements are in conflict; therefore, proposals that meet either provision will be considered compliant.

7. Question 7a - Pg. 51, L.1.c.2. states that Task Orders “will be fixed-price/cost reimbursement, term/completion.” P.96, 11.d. says “the resultant contract will not be Firm Fixed Price.” Which is correct?

Answer 7a - Any contract awards resulting from this solicitation will be Indefinite Delivery/Indefinite Quantity (IDIQ). The type of Task Orders issued under the resulting IDIQ contracts will be determined at the time each Order is issued.

Question 7b - If there are to be Firm Fixed Price task orders, should Task Order 1 and the Sample Task Order for Task Area 2 be prepared as cost reimbursement or Firm Fixed Price?

Please specify the type of Task Order pricing to submit for each of the two Task Orders.

Answer 7b – Cost reimbursement pricing should be submitted for the two task orders.

8. Question 8 - In the previous question, what does “term/completion” mean?

Answer 8 – A completion contract describes the scope of work by stating a definite goal or target and specifying an end product. A term contract describes the scope of work in general terms and obligates the contractor to devote a specified level of effort for a stated time period

9. Question 9 - Attachment 1, Page 2 – II.B.2.a&b. requires inclusion of “Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.” There is no such schedule shown in Section J. Please provide this document or a link.

Answer 9 - A hyperlink found in Attachment 1, page 2 – II.B.2.a provides a blank schedule to be filled in by the offerors.

10. Question 10a – For Attachment 14 (Tech Proposal Cost Summary), does the Government require a separate Tech Proposal Cost Summary for each Task Oder or should the direct costs for each Task Order be combined?

Answer 10a - The direct costs for each task order should be combined, and presented on a single Technical Proposal Cost Summary sheet.

Question 10b - This attachment covers a 7-year period. We assume we should edit this to match the periods of the Task Orders?

Answer 10b – The 7 year period reflects the 7 year ordering period duration of resulting IDIQ contract awards.

Question 10c - Please confirm the only cost information to be included in the technical proposal is the direct cost information related to the two task orders in Attachments 5 and 6. If not, please clarify.

Answer 10c – Yes, including labor-hours and categories and applicable rates, materials, subcontracts, travel and associated costs. Please also refer to pages 55-56 of the solicitation.

11. Question 11 - Will the contractor be required to obtain any necessary permits for sending international shipments of samples/blood products (specimens/tissue samples)?

Answer 11 - Yes, if samples/blood products are shipped internationally.

12. Question 12a - The Business Proposal instructions, in the Basic Cost/Price Information section

(p. 85), provide a list of the cost element items which must be discussed, including fee and profit. For CPFF proposals, does the Government distinguish between fee and profit? If so, please clarify?

Answer 12a – There is no distinction.

Question 12b - For Firm Fixed Price proposals, either during this RFP stage or in later Task Order Proposals after award, does the Government require that contractors discuss the element of profit in their FFP proposal?

Answer 12b – The Task Orders contained in the immediate solicitation (Attachment 5: Task Area 1 – Task Order 1, and Attachment 6: Task Area 2 – Sample Task Order) are cost-reimbursement. Provisions pertaining to future task orders will be determined at that time.

13. Question 13 - In Section L, on Page 53, in the section defining the Competitive Ordering

Process, it states that all Contractors within a technical area will receive an email notification of the task order requirement. Can the Government expand on this process, and define what is meant by “within a technical area?”

Answer 13 – For this solicitation, the technical areas are “Task Area 1” and “Task Area 2” found on page 2 of Attachment 4, Statement of Work. Competitively awarded task orders will be solicited from all Contractors within these technical areas.

14. Question 14 - Please confirm that the Salary Rate Limitation requirements on page 89 do not apply to Consultants.

Answer 14 - Correct. The salary rate limitation does not apply to consultants.

15. Question 15 - Does the Government require any pricing documentation from any proposed teaming subcontractors that are not used under Task Order 1 or Sample Task Order 2 (but who would likely be used on future task orders)?

Answer 15 – No, pricing documentation related to future task orders will be requested for submission at that time.

16. Question 16 - Given this is a Multiple Award vehicle, has the Government designated the number of, or range of, awards it plans to issue?

Answer 16 – Although multiple awards are anticipated, the Government has not designated a specific number of awards, or range of awards, that it plans to issue.

17. Question 17- Will the requirement for certified cost or pricing data be removed from the RFP as required in FAR 15.403-1 when there is adequate, independent price competition?

Answer 17 – Certified cost or pricing data is not required by this solicitation. However, “Data Other than Certified Cost or Pricing Data” is required. Please refer to page 86 of the solicitation.

18. Question 18a - The Cost instructions at the bottom of page 88 of the RFP state: “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 b. 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.” Will there be any need for a table matching FAR Table 15-2 if all cost information is contained in the NIH provided spreadsheets?

Answer 18a - As long as all the cost information is contained in the NIH generated spreadsheets, there is no need to create a separate table.CK AP - As stated in the RFP, other than certified cost or pricing is required.

Question 18b - Is the reference to subparagraph b. meant to point to paragraph L.2.c.3.b?

Does the NIH RFP-provided cost spreadsheet meet these requirements when properly completed?

Answer 18b - Yes, the reference pertains to L.2.c.3.b. The NIH-RFP provided cost spreadsheet fulfills the requirements. Please refer to page 86.

19. Question 19a - The current performance of work involves concepts being presented by the contractors. Is this still anticipated?

Answer 19a - Yes.

Question 19b - If it is a mix of contractor generated and NIAID generated, what is the split that is anticipated?

Answer 19b – An exact split isn’t indicated at this time. Please refer to Attachment 5 regarding the requirements for Concepts as it pertains to Task Order 1.

20. Question 20 - If there will be concepts presented, what is the review and approval process?

Answer 20 – Under Task Order 1 Concept review is a requirement of the Contractor. Please refer to Attachment 5, Task Area 1 – Task Order 1.

21. Question 21 - Might a task order be for a concept only, or would the task order be for the concept and the trial?

Answer 21 – As defined in Attachment 4, Statement of Work, Task Orders involving concept development will be solicited under Task Area 1, while task orders involving clinical trials will be solicited under Task Area 2.

22. Question 22 - Does the Government anticipate any of the Task Orders will require contractors to provide personnel to work on Government work sites or at other contractor sites? If yes, approximately what percent of tasks will require this type of activity?

Answer 22 - No, the Government does not anticipate this.

23. Question 23a - If a contractor develops a concept independent of a task order, will there be a way under the contract to capture the concept development costs?

Answer 23a – All work required under this IDIQ contract will be solicited via Task Order Request.

Question 23b - Do Contractors have to wait for a concept-development task order?

Answer 23b - Yes, all work required under this IDIQ contract will be solicited via Task Order Request, thus work will not begin without a Task Order being awarded.

24. Question 24 - Is there a mechanism for paying to maintain infrastructure while awaiting task orders, such as a basic Task Order to allow contractors to perform basic program activities? This will help organizations retain staff members without need to ramp up and down as Task activity goes up and down.

Answer 24 – Task Orders will be solicited and issued in Task Area’s indicated in Attachment 4, Statement of Work.

25. Question 25 - Will investigator initiated protocols be considered?

Answer 25 - Please refer to pages 1 and 2 of Attachment 5: Task Area 1 – Task Order 1 for the requirements of this Task Order.

26. Question 26 -Will contractors who perform the Phase I portion be given preference as the trial moves to Phases II and III?

Answer 26- The requirements for future task orders will be determined at that time.

27. Question 27 - What is the average number of specific tasks offerors should assume to perform each year under the contract?

Answer 27- Work required under this IDIQ contract will be solicited as the need arises.

28. Question 28 - What is the range of period of performance of task orders? For instance, will protocol implementation Task Orders have a standard period of performance or will this be determined on a case-by-case basis as Task Orders are competed? Will there be a minimum time period?

Answer 28 – The periods of performance for task orders will be determined on a case-by-case basis.

29. Question 29 - Will the Contractor be permitted to submit concept proposals for review by the Government?

Answer 29 - Please refer to Attachment 5 for the requirements of Task Area 1 – Task Order 1.

30. Question 30 - Will protocol implementation Task Orders be allowed to include PK/PD Laboratory services by the Contractor or its subcontract teammates? Or will these related services be obtained under a different contract vehicle? Will the awardee of the Contract be working with DMID Phase I Unit Contractor(s) in any manner?

Answer 30 – Please see Attachment 5: Task Area 1 – Task Order 1; and Attachment 6: Task Area 2 – Sample Task Order for the requirements of the task orders solicited in this RFP. The requirements of future Task Orders will be developed at that time.

31. Question 31 - Does the Government have preferred sites or pre-established sites (either CONUS or OCONUS) that they want contractors to use for some or all of the task orders?

Answer 31 – No.

32. Question 32 - What is the estimated level of effort for Task Area 2 Sample Task Area?

Answer 32 - Task Area 2 is Completion type task order. Contractors should use their professional judgment in developing their proposal.

33. Question 33 - Page 57, Selection of Offerors states that the “business portion of each contract proposal will be subjected to a cost and price analysis, management analysis, etc.” Can the Government provide further detail about the requirements of the management analysis to be included in the business portion of the contract proposal, as Section M does not make clear reference to this?

Answer 33 – This is to differentiate from the technical review committee’s evaluation. The business portion of each contract proposal will be subjected to appropriate analyses.

34. Question 34 - The Business Proposal Instructions, specifically the section describing Data Other than Certified Cost or Pricing Data, define the detail to which this data should be submitted. Please confirm that this level of detail is also expected for each of the Offeror’s subcontractors.

Answer 34 - This is a correct statement regarding the level of detail for subcontractors. Please refer to page 87 of the solicitation.

35. Question 35 - Attachment 4: The Background and Introduction states that all awardees will be required to coordinate and collaborate on STI CTG research program activities. Are these specific activities allowed to be charged to the contract, and if so, what is the contract mechanism that will be used as the vehicle for invoicing.

Answer 35 - All work required under this IDIQ contract will be issued as Task Orders.

36. Question 36 - Section L, 2. a. 4, the section on Separation of Technical and Business Proposals states that the technical proposal must include direct cost information. Can the Government specify exactly what information they would like in terms of direct cost in the technical proposal?

Answer 36 – Please refer to Item 4 in the Instructions to Offerors section of the solicitation located on page 55 for information regarding the content of cost information in the technical proposal.

37. Question 37 - The section Information Required for ALL Clinical Research Proposals includes the requirement for “the proposed dates of enrollment (beginning to end).” Can the Government confirm that this is a reasonable requirement without knowledge of study design or a protocol.

Answer 37- Please refer to page 66 of the solicitation and use your professional judgment.

38. Question 38 - In the section, Task Orders Under Multiple Award IDIQ contracts, it states that the “Contracting Officer shall consider price and cost under each order as one of the factors in the selection decision.” Can the Government explain what consideration they are making when asking for both?

Answer 38- Price or cost will be considered in the selection decision as applicable for each task order.

39. Question 39- In the Selection of Offerors section on page 58, it states that NIAID reserves the right to make a single award to the RFP. If this should occur will the requirement for proposals to TORFPs remain? (TORFPs = Task Order RFP)

Answer 39 - Yes, all work required under any resulting contract will be solicited via Task Order Rdequest.

40. Question 40 - In the Technical Proposal Instructions on page 60, in the Statement of Work:

Objectives sections; Does the review of pertinent work already published relevant to this project need to be work published by the Offeror?

Answer 40- No.

41. Question 41 - In the Technical Proposal Instructions on page 60, in the Statement of Work, the Government asks for both approach and methods to be defined. Can examples be provided to enhance the distinction between approach and methods?

Answer 41 - Please use your professional judgment.

42. Question 42a - In reference to Attachment 7, Page 1, “Uniform Cost Assumptions,” Task Area

1, Task Order 1 – the Government’s requirement for the work set forth in the Statement of Work for Task Area 1, Task Order 1 is 3,224 direct labor hours. Is the expectation that the Uniform Cost Assumptions for this task would include the activities in Attachment 5, Task Area 1, Task Order 1-Item A2 which includes: “Maintain a public website that a) provides general information about the overall scientific goals of the STI CTG, b) describes how concepts can be submitted for consideration, and c) indicates the nature and subject of planned clinical protocols. This site shall provide capability for each protocol team to interact with and store study documents.”

Answer 42a - Yes, those hours are inclusive of maintaining the public website.

Question 42b - If yes, can the government provide an estimate of the amount of time it is likely to take to maintain this website as opposed to the effort required for other aspects of Task 1?

Answer 42b – Please use your professional judgment in developing your proposal.

Question 42c - Will all companies receiving an award under the STI RFP be asked to coordinate a public website, or will only one company operate a single website for the entire program?

Answer 42c – The requirements set forth in the Attachment 5: Task Area 1 – Task Order 1, Statement of Work will apply to all resulting Task Orders awarded.

43. Question 43a - Attachment 5: Task Area 1 states that the contractor shall maintain a public website. Is the Government requiring Vulnerability Scanning Requirements to be routinely conducted and reported for this website?

Answer 43a - Yes.

Question 43b - Does the Government require the contractor to install software/hardware patches and upgrades to protect automated federal information assets as part of this requirement?

Answer 43b - Yes

Question 43c - Is the website to be maintained the existing STICTG.ORG website currently in existence or a new site?

Answer 43c - A new site, that is required to be Section 508 compliant.

Question 43d – Please confirm the requirement that the website have the capability to share documents.

Answer 43d - Confirmed.

Question 43e - Is the required website to utilize the domain name STICTG.ORG? Is the domain name owned by the government? Is the domain name transferrable?

Answer 43e - The required website will utilize the domain name STICTG.ORG. The domain name is owned by the Government and is non-transferrable.

Question 43f - If the site is to be a new site, will this site reside in a government data center or one provided by the Contractor?

Answer 43f - Government data center.

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

ALL OTHER TERMS AND CONDITIONS OF THIS SOLICITATION REMAIN

UNCHANGED.