NHLBI-CSB-HB-2016-03-JT_-_Amendment_1.pdf

SOLICITATION: NHLBI-CSB-HB-2016-03-JT

AMENDMENT: One (1)

TITLE: Maintenance of the NHLBI Biologic Specimen Repository

ISSUED BY:

National Heart, Lung, and Blood Institute, NIH Office of Acquisitions, CSB, OM 6701 Rockledge Drive, Room 6140, MSC 7902 Bethesda, Maryland 20892-7902

Point of Contact: John Turner, Contracting Officer [E-mail – john.turner@nih.gov]

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. 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 email which includes a reference to the solicitation and amendment number.

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

I. REFERENCE: Section L, item 2 “Instructions to Offerors”, paragraph a.6 “Page and Formatting Limitations” (Page 51) is revised to read as follows:

The Technical Plan (objectives, approach, methods and procedures) of the technical proposal shall not exceed 30 single-sided pages or 15 double-sided pages. 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. Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

II. REFERENCE: Section L, item c “Business Proposal Instructions”, paragraph 11.d “Adequate Accounting System” (Page 84) is revised to read as follows:

FAR Part 16 sets forth the requirements and limitations for consideration of contract type. The offeror's/contractor's accounting system and practices must be adequate and suitable for accumulating costs under government contracts.

III. RESPONSE TO QUESTIONS:

1. Item 2. Task Area B, on page 1 of Attachment 15, indicates that “biospecimens are typically received as bulk relocations at the end of the clinical study.” Also, Section C, part 1 on the following page asks for a price proposal on the transfer of 50,000 samples as described under Section 2.2.2. of the SOW. Please clarify whether this means the samples will be transferred in their current storage units (which will then become Repository equipment inventory maintained by the contractor), or whether samples will be transferred in cryoboxes/shippers and freezer space must be made available at the repository to receive the samples.

Answer: For budgetary purposes assume that the biospecimens will be transferred in freezers that will become Repository equipment.

2. Item 2. Task Area B, on page 1 of Attachment 15, indicates that “biospecimens are typically received as bulk relocations at the end of the clinical study.” Also, Section C, part 1 on the following page asks for a price proposal on the transfer of 50,000 samples as described under Section 2.2.2. of the SOW. In order to provide the most accurate pricing for these transfers, can NHLBI provide a standard geographical reference point for the transfer of study specimen collections to the biorepository? Would NHLBI consider using Chicago as a standard generic reference point?

Answer: Offerors should use Chicago as a reference.

3. Item a, on page 3 of Attachment 15, requests pricing for the retrieval of 50,000 samples, of which 20 percent (10,000 samples) will be aliquoted. Please clarify whether the remaining 40,000 samples (plus 10,000 of the generated aliquots) will be shipped.

Answer: The 40,000 retrieved vials that were not aliquoted plus the 10,000 vials that were aliquoted will be distributed. The 20,000 new aliquots would be returned to inventory. The cost proposal should include all materials and effort to accomplish the retrieval and distribution activities described in the SOW Task Area C. As indicated in the SOW Task Area C, item 2bii, the cost to ship the packaged specimens is generally borne by the requestor.

4. Item b, on page 3 of Attachment 15, requests pricing for the retrieval of 80,000 vials for destruction. Please clarify whether destruction should be priced at the individual vial level (requiring vial-level inspection) or at the box level (requiring only box-level inspection).

Answer: For budgetary purposes assume 60,000 vials stored in 1000 boxes will be a box level destruction and 20,000 vials stored in 400 boxes will be individual vial-level inspection. .

5. Expansion of biological materials is mentioned in Article B.1., page 4 of the Solicitation, in Items 8.b and 2)a. on pages 3 and 7 of Attachment 3 (SOW), and in Item 3 (Task Area C-Withdraw Biospecimen) on page 1 of Attachment 15. Please provide additional detail on the potential expansion of cell cultures. In particular:

5.a. What types of cells/cell lines would be involved?

5.b. How many passages would be performed per expansion?

5.c. How large are the expansions (for instance, splitting a single plate 1:3, 1:10, etc.)?

5.d. Will expanded cultures be frozen down for additional storage? Frozen down and then shipped? Shipped out as plated cultures?

5.e. How frequently are such requests made?

Answer: A budget for cell/cell line expansion should not be included in the sample Task Order for Task Area C-Withdraw Biospecimen. Expansion of biological materials has been limited in the current contract to a QC activity of fewer than 100 vials of Epstein-Barr Virus (EBV) transformation of cells. It is anticipated that as the Biorepository acquires new collections that there will be collections with a variety of material types that may need to be expanded. The offeror should demonstrate their experience and knowledge in expanding a variety of biological material and their ability to provide this service, or have this service provided, if requested by the NHLBI.

6. Item 14, page 4 of Attachment 3 (SOW) states: “Have the capability to perform assays for DNA and RNA integrity, cell viability and viral, serologic, cell surface phenotype and biomarker assays.” Specifically, 6.a. What types of material would the viral, serologic, cell surface and biomarker assays be performed on?

6.b. Can specific examples of the types of markers to be analyzed be provided?

6.c. How frequently are such requests made?

Answer: RNA integrity, viral, serologic, cell surface and biomarker assays have not been performed under the current contract. These assays may be needed in the future to determine specimen integrity. Currently, approximately 300 DNA samples/year are assayed to determine the concentration and integrity of the DNA. The offeror should demonstrate their experience and ability to perform these assays, or have these assays performed, if requested by the NHLBI. The material tested would be the cryopreserved samples stored in the Biorepository.

7. With respect to Attachment 4, GFP, does the NHLBI prefer to own all of their equipment (e.g., direct-cost purchases for freezers) or can the equipment be purchased/owned by the contractor and depreciated against the contract?

Answer: The NHLBI prefers to own their freezers.

8. Please clarify the page limitations in item 6 on page 51 of the Solicitation. Does “substudy” refer to Task Orders A-D, and is each Task Order limited to eight pages, or are all task orders to be discussed in eight pages? Would NHLBI consider limiting the Technical Plan to 30 pages without additional restrictions within the given 30 pages?

Answer: The term “substudy” was incorrectly inserted into this solicitation. No proposal for a “substudy” is required. The proposal should address each item in each Task Area (A thorugh D) within the 30 page limit. There are no page requirements for an individual Task Area. Item 6 on page 51 has been revised.

9. We are requesting clarification on contract type for each task area (A, B, C, D).

• Section L, page # 48, paragraph C2 states: It is anticipated that the award from this solicitation will result in an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with an ordering period of five years. Depending on the specific requirement Task Orders may be:

o Cost Reimbursement or Firm Fixed Price.

o Term or Completion.

o Single Year or Multiple-Year.

(See Section L.2.c. Business Proposal Instructions).

• On the same page, paragraph D then states in part:

o The following performance incentive will be used in any contract awarded from this SOLICITATION:

Cost-Plus-Award-Fee (CPAF)

• Section L, page #50, paragraph 2A1 then states: It is contemplated that an indefinite delivery indefinite quantity (IDIQ) type contract with cost-reimbursement and firm fixed price type task orders will be awarded.

What contract type has the government selected for each task area (A, B, C, D)?

Answer: Cost-Plus-Award-Fee is a type of Cost Reimbursement contract. The base IDIQ contract serves to outline all potential contract types available for future task orders, as the requirements for all future task orders are not yet defined. The IDIQ will consist primarily of cost reimbursement (Cost-Plus-Award-Fee) task orders. However, Firm-Fixed-Price is included under the IDIQ as an allowable contract-type for future, yet to be defined, task orders that may be more appropriately suited for Firm-Fixed-Price. An example Firm-Fixed-Price task order may be a large equipment purchase. Page 48, paragraph D is “Applicable on a Task Order basis”.

Task Area’s A, B, C, and D will be Cost-Plus-Award-Fee.

10. Page 41, Section J, Business Proposal Attachments, lists Attachment 12 the Breakdown of Proposed Estimated Costs w/Excel Spreadsheet as a required attachment. If Firm Fixed Price is the contract type selected for the task orders, what level of cost detail is required to justify our price and is the Breakdown of Proposed Estimated Costs w/Excel Spreadsheet then not applicable?

Answer: All Cost Estimates shall be based on a Cost-Plus-Award-Fee contract type.

11. Will a proposal be deemed non-responsive if it only proposes a firm fixed-price for one or more Tasks and does not also provide proposed costing on a cost-reimbursement basis for such Tasks?

Answer: All proposals shall be based on a Cost-Plus-Award-Fee contract type.

12. Page 55, number 16 provides requirements for Information and Physical Access

Security. Please confirm that if BSI is used, the contractor is not responsible for submitting all components of an ISSP, only items associated with access control, and that 508 compliance is not required?

Answer: Correct, if BSI is used, the contractor is only responsible for submitting the access control components of the ISSP.

Section 508 compliance is only required for electronic Reports/Deliverables submitted in electronic format, per Section C.2 of the solicitation.

13. Attachment 3, section 2.2.1, 8 indicates that personnel with the experience and training to receive and distribute specimens, aliquot and expand, provide panels, withdraw biospecimens, and perform assays must be provided. Under which Task Order will routine small shipments or aliquoting requests be covered? Will separate task orders be issued for these activities or should these be included in one of the listed Task Areas, A, B, or C?

Answer: Routine small shipments and aliquoting activities are covered under Task Area C.

Estimates for the number of routine small shipments and the aliquoting needs within a set period of time will be provided to the contractor and a Task Order will be awarded based on these estimates. For example, a Task Order could cover the routine shipping and aliquoting tasks that are anticipated over a twelve month period. Individual Task Orders would, therefore, not be issued for each individual shipping and aliquoting request. Of note, a Task Order could include activities from different Task Areas.

As directed in Attachment 15, for evaluation purposes offerors must include an executable cost/price proposal for an initial task order, Task Order 001 - Task Area A. Only the activities in the SOW Task Area A should be included. Attachment 15 also requests submission of a cost proposal for the acquisition of one study (C. 1. Task Area B) and retrieval activities (C. 2. Task Area C). For evaluation purposes separate cost proposals for C.1. and C2. should be prepared.

14. Attachment 3, SOW and Attachment 15, Additional Technical & Business Proposal Instructions—Should project management time needed for adjusting personnel levels and overseeing activities such as Task Areas B and C be included in those task orders, or should it be placed in overall Biorepository management in Task Area A?

Answer: Project management time needed for adjusting personnel levels and overseeing activities such as Task Areas B and C should it be placed in the overall Biorepository management, Task Area A.

15. Attachment 3, page 4, number 11 states that the Biorepository contractor will “maintain a secure and validated electronic inventory system…” Would you please confirm that there will be no costs for maintenance of the system under this contract if the BSI is used?

Answer: As stated in Attachment 3, page 4, number 11, the Biorepository contractor shall “maintain the secure and validated electronic inventory system”. Regardless of whether the BSI system, or an equivalent system, is used, the cost of maintaining the inventory system and the cost of providing direct access to the inventory should be budgeted in the proposal.

16. What are the specific requirements for aliquoting/expanding/sectioning, customized biospecimen panels, and biomarker assays? More specifically what is the frequency, volume (average number of samples), and applications that have and will be deployed from NHLBI for the repository? A high level estimate is fine. Referencing SOW Attachment 03 page section 2.2.1 #8b, #8c, #14

Answer: Responses # 5 and 6 provide information on the expanding and aliquoting needs.

Customized biospecimen panels are only prepared under this contract in extraordinary circumstances and at the request of the NHLBI. The offeror should demonstrate that they have the expertise and capability to provide customized panels. Similarly, sectioning has not been performed under the current contract but this activity is anticipated as a future need as new collections are acquired. It is anticipated that sectioning requirements would not exceed 300 sections/year. The offeror should also demonstrate their experience and ability to perform this activity, or have this activity performed, if requested by the NHLBI.

17. What is the make and model of all government owned equipment and/or the dimensions of every make/model? Referencing Attachment 04.

Answer: Attachment 04 – List of GFP has been updated to include the manufacturer, model, size in cubic feet, size required in square feet, size of freezer only in square feet, and a breakdown of size requirements according to the type of freezer (Mechanical Chest, Mechanical Upright, or Liquid Nitrogen).

In addition the NHLBI Biorepository has some materials that are not currently stored in government furnished freezers. These materials include biological reagents that require refrigeration and paraffin blocks and dried blood spots on filter paper that are stored at ambient temperatures. Offerors should propose purchasing equipment for these materials that require refrigeration under Task Area A or providing space in non-NHLBI owned equipment that is currently available at their facility. A rough estimate of the space required for each temperature condition is as follows:

Condition CuFt Total +4 60 Total -20 1 Ambient 50

18. There is conflicting information on the type of contract to be awarded within the RFP. Is this considered a cost-plus reimbursement or a fixed fee contract? See RFP p. 48 Type of Contract and Number of Awards, pg. 50 It is contemplated that an IDIQ type contract with cost-reimbursement and firm fixed price type task orders will be awarded, and page 84 as stated in Section L.1, General Instructions of this solicitation, the resultant contract will not be Firm-Fixed Price.

Answer: The base IDIQ contract serves to outline all potential contract types available for future task orders, as the requirements for all future task orders are not yet defined. The IDIQ will consist primarily of cost reimbursement (Cost-Plus-Award-Fee) task orders. However, Firm- Fixed-Price is included under the IDIQ as an allowable contract-type for future, yet to be defined, task orders that may be more appropriately suited for Firm-Fixed-Price. The language on page 84 has been revised.