Final_Amendment_2_Package_CL-B.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

Solicitation No. NHLBI-ECB-HB-2014-06-AC, Amendment No. 002 Page 2 of 5

This amendment provides important information, including changes to the instructions for proposal submission. Please read it carefully.

1. The proposal due date is hereby extended. RFP Attachment 1, Packaging and Delivery of Proposals, is replaced with the version contained herein.

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of Proposals," until 3:00 pm local time on July 3, 2013. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043."

2. Since the proposal due date is extended, the deadline for all technical and business questions will be extended.

Forward all technical and business questions to Allison Cristman at allison.cristman@nih.gov. All questions must be received, via email, by 3:00 PM local time on June 14, 2013. Questions submitted after this date and time may not be answered.

3. Attachment 2 – Past Performance Questionnaire desired response date is extended until June 19, 2013.

4. Questions and Responses

a. At what frequency will samples be transferred to the permanent storage location?

It is anticipated that one bulk transfer will occur between years four and six and one bulk relocation will occur at the end of the contract.

b. Can the applicant propose to be the long term storage and biosample distribution provider?

The applicant cannot propose to be the long term storage and distribution provider under this RFP. Long term storage for the biospecimens will be provided by the NHLBI Biologic Specimen Repository and requests for biospecimens will be managed by the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC). These resources are funded under separate contracts and this RFP does not solicit proposals to do this work.

c. There is no suggested list of biosample processing services, can a suggested list be provided?

A suggested list cannot be provided. The Technical Proposal should include the offerors technical approach to building a biospecimen resource for the National MDS Study.

d. Please confirm if the only primary time sample being collected and submitted for processing is whole blood?

The biospecimens material types and the collection time points will be determined during development of The National MDS Study protocol. Responses to the “Request for Information (RFI): Building a National Resource to Study Myelodysplastic Syndromes (MDS) – The MDS Cohort Natural History Study” (NOT-HL-12-147 or FBO Notice Number HHS-NIH-NHLBI-RFI-12-147; https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RFI-12- 147/listing.html) identified the following as important material types to collect: bone marrow aspirates, peripheral blood, skin punches, and cells from buccal brushes/mouth wash. Cryopreserved unfractionated bone marrow aspirates, peripheral blood derivatives, such as plasma, serum, viable cells (lymphocytes, monocytes), RNA and DNA, were also suggested as important material types to consider.

e. Some biomaterial fractionation protocols may require pre-processing and aliquoting at the collection site. Will this be an option that can be pursued in the application?

The Technical Proposal should describe the collection and processing requirements the offeror determines appropriate to build a biospecimen resource for The National MDS Study collection.

mailto:allison.cristman@nih.gov

Solicitation No. NHLBI-ECB-HB-2014-06-AC, Amendment No. 002 Page 3 of 5

f. What is the projected number of new samples per year and what year of the proposal is sample collection scheduled to begin?

It is estimated that 2500 participants will be accrued over a sixty month period beginning in Year 2 of the program. The following phased accrual goals in years 2-6 will likely be used to meet the target: 200, 400, 600, 800, and 500. Responses to the “Request for Information (RFI): Building a National Resource to Study Myelodysplastic Syndromes (MDS) – The MDS Cohort Natural History Study” (NOT-HL-12-147 or FBO Notice Number HHS-NIH-NHLBI-RFI-12-147; https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RFI-12- 147/listing.html) suggested that participants should undergo two to four clinical assessments per year.

g. Are there any guidelines for sample storage vessels and environmental conditions (i.e.: temperature) that should be followed?

The CL/B will follow all State and Federal regulations necessary to collect, process, store and distribute a quality biospecimen collection. The biospecimen resource should be designed to support current and future research in MDS and should be established following the NCI Best Practices for Biospecimen Resources at http://biospecimens.cancer.gov/practices/2011bp.asp.

h. Is a GLP facility required to perform this work?

The CL/B is a research resource and the facilities should meet current best practices for building a biospecimen resource for the scientific community.

i. Does the work need to be completed in a manner consistent with supporting an FDA audit?

See response to Question h.

j. Is this a fixed fee or cost plus contract?

As stated in Section L.1.c., Type of Contract and Number of Awards (RFP page 48), the anticipated contract type is an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The resulting task orders will likely be cost reimbursement, and may include fee, depending on the offeror.

k. Is the software used for lab service tracking and sample management required to be 21 CFR part 11 compliant?

The contractor must provide a validated electronic biospecimen and laboratory management system that provides a secure environment for managing the biospecimen inventory and hematologic samples. The adequacy of the proposed electronic laboratory data system is a Technical Evaluation Factor.

l. Will awardees need to be FISMA compliant and if so at what level?

The Security Level is 5 (Moderate Risk)—See Page 72 of the RFP.

m. What is the projected number of assays that will be performed per sample?

See response to Question f.

n. Will the sample collection kits be the same for every study participant?

Sample kits will be designed to meet the needs of The National MDS Study protocol. See the responses to Questions c. and d. for additional information.

o. By way of background, I manage several small patient specimen repositories for academic research use, and am curious whether that experience would correspond with this RFP, or whether this is more suited/designed for a commercial enterprise.

The National MDS Study will establish a research resource for the wider scientific community and the CL/B will play a major role in the program (see Question p.). Any organization that can meet the requirements of the solicitation can submit a proposal.

https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RFI-12-147/listing.html https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RFI-12-147/listing.html http://biospecimens.cancer.gov/practices/2011bp.asp

Solicitation No. NHLBI-ECB-HB-2014-06-AC, Amendment No. 002 Page 4 of 5

p. This is a contract arrangement, not a grant, and it appears much of the decision-making authority will reside within the Data Coordinating Center (DCC) committee. Thus, final determination of how the Repository will operate and collect/store the specimens, which type of research assays are performed on the specimens, when and to whom samples will be distributed, etc. will be managed through that committee. Is that correct?

As described in Attachment 17, Additional Proposal Instructions, Sections B (Description of Technical Requirements) and C (Organization and Committees), overall coordination of the National MDS Study will be performed by the DCC and the CL/B will play a major role in designing the biospecimen collection, developing and implementing procedures to establish the biospecimen collection, performing research assays specified in the protocol. The CL/B PI will also be a voting member of The National MDS Study Steering Committee and participate in all subcommittees.

q. Only specimens collected as part of the National MDS study will be covered under this contract, any pre-existing repository samples we already have in our freezers or future collections would have to be maintained completely separately. Is that correct?

Yes.

r. The research assay portion of the Central Repository proposal should be focused on assessing specimen integrity/stability, not on disease-focused characterization (e.g. flow cytometry, molecular tests, etc.). Is that correct?

As stated in the Statement of Work, the CL/B will provide the facilities, validated operating procedures, and quality assurance programs necessary to establish and maintain a quality biospecimen collection of hematological samples.

Research assays will be developed by the Protocol Team and will be included in the protocol. The CL/B will perform the research assays, interpret the research assays results, and transfer the data to the DCC for inclusion in The National MDS Study data set.

s. The central laboratory will need to have capabilities to perform flow cytometry/molecular characterization assays, but the exact specifications for those types of assays will be determined at a later point in the project?

See the response to Question r.

t. As far as the database IT component, the Central laboratory will be responsible for only specimen tracking and associated specimen characterization results (e.g. flow cytometry), the merging with patient clinical measurements/outcomes will be managed through the DCC?

The CL/B will provide and maintain an electronic validated biospecimen and laboratory management system and maintain the IT interface that will electronically and securely transfer the biospecimen data to the DCC. The DCC will be responsible for centralizing and linking the CL/B data to the clinical measurement and outcome data collected by participating sites.

u. Should the past performance questionnaire be provided to the prime awardee or the contracting officer of the prime awardee for completion in cases where we were/are a subcontractor?

The past performance questionnaire should be provided directly to the Contracting Officer (see Attachment 2).

v. Can the past performance questionnaire be sent to agencies/companies for evaluation of our performance on current/on-going contracts or should it only be sent to agencies/companies for evaluation of our performance on completed contracts?

The past performance questionnaire may be from either current/on-going or completed contracts.

w. Article B.2 on page 5 of the solicitation indicates that the contract period is July 1, 2014 through June 30, 2022, a period of 8 years. However, the Additional Proposal Instructions, Attachment 17, included in the amendment dated 4/18/2013, indicate that the study close-out period is expected to occur over a period of 12 months in year 7. In addition, the estimate of effort and meeting assumptions do not include year 8. Can

Solicitation No. NHLBI-ECB-HB-2014-06-AC, Amendment No. 002 Page 5 of 5 you please confirm that our technical proposal should propose activities for the entire 8 year contract period? Or should we propose a 7 year contract period to agree with the additional proposal instructions?

The 8th year has been provided for any delays in this period. Your technical proposal should be based and submitted on the entire contract period as described in the SOW. The business proposal format is described in Attachment 17; the business proposal should only be for Task Order 001.

x. Regarding our business proposal for this contract and Task Order 001, Attachment 17, Section G estimates the period of performance to be 15 months. Are we to submit a budget solely for the first 15 months of the contract period only? Should we prepare and submit a single-column budget with one period that is 15 months long? Or should we prepare a budget with costs broken down into two periods, the first being 12 months and the second at 3 months?

The budget for Task Order 001 should be a single budget for the first 15 months.

y. We are instructed to include costs for developing and validating the assays for the proposed immunophenotyping panel and research assay using study samples (Attachment 17, p.6). Should we assume that those tasks will be completed during the first 15 months so that all costs can be included on our Task Order 001 budget? If these activities are expected to occur over a period that is greater than 15 months, how do we reconcile that with the task order 001 budget period?

Per the RFP’s Statement of Work, Task Area 001 (Task Area A) these tasks are to be completed during the first 15 months (see Page 2 of the Statement of Work).

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

RFP Number: NHLBI-ECB-HB-2014-06-AC

– 1 – Attachment 1

PACKAGING AND DELIVERY OF PROPOSALS

DUE DATE: 3:00 P.M. local time on Wednesday, July 3, 2013.

Proposals not received at the place and time specified in the solicitation will be considered late and will be handled in accordance with FAR 52.215-1, subparagraph (c)(3). Your proposal shall be organized as specified in SECTION L.2, General Instructions. Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

NUMBER OF COPIES

Technical Proposal: Original and twenty-one (21) copies

Business Proposal: Original and five (5) Copies

Technical & Business Proposal: One (1) electronic copy of each as searchable PDF files on CD

THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

If courier delivery service:

Office of Scientific Review Division of Extramural Research Activities National Heart, Lung and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR, MSC 7924

BETHESDA, MD 20817

If using U.S. Postal Service:

Office of Scientific Review Division of Extramural Research Activities National Heart, Lung and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR, MSC 7924

BETHESDA, MD 20892-7924

RFP No. NHLBI-ECB-HB-2014-06-AC: The National MDS Study Central Lab & Biorepository

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY