LTRC_DCC_Amendment_003.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID NO. PAGE OF PAGES

1 3

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable)

003 See Block 16C. N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (if other than Item 6) CODE National Institutes of Health National Heart, Lung, and Blood Institute Rockledge II Building, Room 6016 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

See Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) () 9A. AMENDMENT OF SOLICITATION NO.

NHLBI-HR-16-04

9B. DATED (SEE ITEM 11)

December 18, 2014

10A. MODIFICATION OF CONTRACT/

ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offerors must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

TITLE: Lung Tissue Research Consortium – Data Coordinating Center

PURPOSE: The purpose of this amendment is to answer questions received in response to the solicitation.

See the continuation page for questions and answers.

Except as prov ided herein, all items and conditions of the document ref erenced in Item 9A or 10A, as heretof ore changed, remains unchanged and in f ull f orce and ef f ect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Scott Bredow Contracting Officer, Extramural Contracts Branch

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

BY 02/09/2015 (Signature of person authorized to sign.) (Signature of Contracting Officer)

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105 STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

Solicitation No. NHLBI-HR-16-04, Amendment No. 003

Questions received on February 2, 2015:

1. Who will be conducting the –omics assays?

Response: Omics assays will be performed by the DCC contractor or subcontractor(s) to the DCC. See Attachment 1, Page 13, Item 7.

2. Who decides what kind of assay will be used (is this case-by-case decision of each PI or is this decided by the LTRC

COTR)?

Response: The –omics analyses to be performed will be recommended by the steering committee after contract awards are made. Based on this scientific advice, technical and cost estimates provided by the DCC, and recommendations from the COR, the contracting officer will make a final decision regarding acquisition of –omics analyses and will authorize performance of those assays.

3. What specific types of -omics assays shall the DCC support? How many datasets will be expected for each?

Response: The number and types of –omics analyses are yet to be determined. Based on other investigator recommendations in similar studies this work is likely to involve 1-2 platforms and up to 2,000 subjects to be analyzed. The types of assays are not known, but RNA sequencing and panels of proteins are popular choices in other studies.

4. Which -omics assays will not need to be supported?

Response: See previous answer.

5. What levels of analysis shall the DCC support for generating -omics datasets and what levels will be carried out by the PI’s team once they download the data from the web portal? For example, for RNA-seq transcriptomics analyses, the process can be partitioned into four levels :

Level I: Reference genome alignment Level II: Gene/transcript expression quantification, data QC, and normalization Level III: Detection of differential genes/transcripts Level IV: Gene set enrichment analysis

Response: Levels I and II are likely to be performed by the DCC. Levels II and IV are likely to be performed by users who receive data sets from the LTRC.

6. At what level will the assay subcontractor provide the data to the DCC ? Will the subcontractor, for example, carry out parts of Level I data preprocessing or will they share the raw data?

Response: These details will be negotiated by the DCC and the subcontractor.

7. Does NHLBI expect to generate genomic LTRC datasets that will require data submission to NIH-designated repositories as specified in the NIH GDS (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html)?

Response: NHLBI intends to require data sharing similar to that outlined in the NIH GDS.

8. The current website appears to be using SAS v 9.3 on the public website allowing anyone to access and use SAS to create reports. Does NHLBI have an agreement with SAS that allows a third party vendor to use SAS in this manner without being subject to typical SAS license fees for multiple users outside an organization?

Response: The LTRC public website is simple HTML and CSS. It is hosted on a windows internal information services server. The stat view portion of the website requires ASP, base SAS, and SAS/Internet, but this is not transferrable under the current contract.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

Solicitation No. NHLBI-HR-16-04, Amendment No. 003

9. Are offerors able to bid outside the roles prescribed in Attachment 1 Section L.d? Will they be penalized for doing so?

Response: The labor categories and hours stated in Attachment 1, Section L.d., Estimated Level of Effort, are for information purposes only and are not to be considered restrictive for proposal purposes as stated in the RFP.

Additionally, the hours are the Government estimate for Task Area A.

10. On page #77 of the RFP, under Business Proposal Instructions, it states “The offeror should propose costs for one year of Task Area A and provide supporting cost documentation. For Task Areas B and C, only provide estimated costs in the Cost Proposal Template for one year of Task Area B and one year of Task Area C. Supporting cost documentation is not required for Task Areas B and C. The Task Areas are described within Attachment 1 of this RFP. Furthermore, on page #4 of the RFP, it stated “This is an Indefinite Quantity contract as contemplated by FAR

16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $500 (minimum) nor more than a total of $3,500,000 (maximum) for successful performance of this contract.”

Our question is, with the above instructions in mind, how does the government calculate the total cost proposed by the contractor? Is the total (cost for Task A for all 4 years + cost of Task B for 30 months + cost of Task C for 12 months)? And if yes, does the total need to be less than the $3,500,000 max stated in the RFP?

Response: As stated on Page 3 of Attachment 1 to the RFP under Task Area A, it says that this Task Area will include Task Order 001, which will be awarded concurrently with the base IDIQ contract. It is anticipated that each task order under Task Area A will be for twelve (12) months so Task Order 001 is expected to be twelve (12) months and it will be awarded with the base IDIQ, which is the reason for the requirement of supporting cost documentation. The reason for providing estimated costs for Task Areas B and C is for information purposes only..

- An offerors total cost proposed will be based on the costs proposed for Task Order 001. However, the costs proposed for one year of Task Areas B and C will be used for information purposes.

- As stated in the RFP, the Government intends to award an IDIQ contract with a minimum task order amount of $500 and a maximum of $3,500,000.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.