Amendment_A001.pdf

Offers 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 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 THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

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

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY 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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

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

CHECK ONE 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 date, 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)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

NHLBI-CSB-(DE)-2013-22-DEL / AMENDMENT #A001 / PAGE 2

The purpose of this amendment #A001 is as follows:

1. ARTICLE C.2. Reporting Requirements, b. Other Reports/Deliverables, is revised to add item

12. Multiple Principal Investigator Leadership Plan as follows:

12. Multiple Principal Investigators Leadership Plan

The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting

Officer.

2. Section H-SPECIAL CONTRACT REQUIREMENTS is revised to add ARTICLE H.16 as follows:

ARTICLE H.16. MULTIPLE PRINCIPAL INVESTIGATORS

The NIH awarded this contract as a multiple Principal Investigators project. The Key Personnel

Article in SECTION G of this contract designates the Contact Principal Investigator and all other

Principal Investigators.

Contracts designating multiple Principal Investigators require a current Leadership Plan with updates as needed. The Contractor's Leadership Plan, dated ___TBD_______, (and as modified thereafter, in accordance with the Reporting Requirements Article in SECTION C of this contract), is hereby incorporated by reference.

3. Section L, INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, 2.

INSTRUCTIONS TO OFFERORS, b. TECHNICAL PROPOSAL INSTRUCTIONS, 1.

Technical Discussion, b. Personnel, is revised to add item 5. Multiple Principal Investigators as follows:

5. Multiple Principal Investigators

The NIH now provides offerors the opportunity to propose a multiple Principal Investigator (PI) model on research and development contracts. The multiple PI model is intended to supplement, and not replace, the traditional single PI model. The NIH chose this RFP as a candidate for the multiple PI model. Ultimately, the decision to submit a proposal using the multiple PI versus single PI is the decision of the investigators and their institutions. The decision should be consistent with and justified by the scientific goals of the project.

It is essential that organizations consider all aspects of this approach before submitting a proposal. While there are some projects that clearly are appropriate for the multiple PI model, the "fit" of other projects may not be so clear. Offerors should base the selection of either the single PI or multiple PI option on the research proposed, to ensure optimal facilitation of the science. Projects suitable for the multiple PI model could include as few as two PIs who are jointly responsible for the scientific and technical direction of the project. The multiple PI option is based on the proposed project, not on the number of performance sites or the number of participating institutions.

NHLBI-CSB-(DE)-2013-22-DEL / AMENDMENT #A001 / PAGE 3

Multiple PIs under research contracts shall use the Subcontract Model. In this approach, offerors submit a single proposal, and a single award is made to the prime contractor. The prime contractor, when appropriate, will award subcontracts to fund the components of the project at the other institutions. The relationship between the contractor and subcontractors must be designed to support all components of the project.

To facilitate communication with the NIH, the offeror must designate a Contact PI at the time of proposal submission. The Contact PI must be employed at the prime contractor's organization. The designation of the Contact PI may rotate on an annual basis. However, this rotation is restricted to PIs located at the prime contractor's organization. The Contact PI is responsible for: relaying communications between all of the PIs and the NIH, and coordinating progress reports for the project. Being named Contact PI does not confer any special authority for the project.

Leadership Plan Offerors proposing multiple PIs will need to submit a Leadership Plan as part of the Technical Proposal. The Leadership Plan shall describe the governance and organizational structure of the research project including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts.

The Leadership Plan shall follow the Table of Contents provided below:

I. Rationale Include a discussion of how the project will be enhanced by the multiple PI approach.

II. Identification of all proposed PIs Identify the proposed PIs, their point of contact information and affiliated organizations, and the percentages of time proposed for this project. Identify the Contact PI and plans for rotation of that role, if any.

III. Roles and Responsibilities Identify both the scientific and administrative roles and responsibilities of all named PIs.

IV. Approach to Fiscal and Management Coordination Describe how the project will be performed and monitored from a fiscal and management perspective. Discuss organizational administrative coordination and support.

V. Project Direction and Resource Allocation Address how decisions will be made regarding scientific direction, and, how resources will be allocated and redistributed if needed during performance.

Address plans for shared resources such as IT or other shared data considerations.

If joint standard operating procedures will be developed, describe this process.

VI. Communication and Lines of Authority Address communication and lines of authority within and among PIs and within and among organizations.

VII. Data sharing, Intellectual Property, Publication, and other Proprietary Considerations Data sharing plans, intellectual property considerations, publication agreements, NHLBI-CSB-(DE)-2013-22-DEL / AMENDMENT #A001 / PAGE 4 and any other proprietary or confidential information sharing should be addressed in this section.

VIII. Conflict Resolution Address how conflicts will be avoided, identified, and resolved.

IX. Other Address any other information relative to the leadership approach to Multiple PI projects.

Offerors submitting single PI proposals do not need to submit a Leadership Plan.

4. Provide the following response to the question asked by potential offerors:

QUESTION #1: 1) Can the dual PI format be used for this RFP if an explicit leadership plan is included, since this model worked very well for other contracts that are relevant to the current RFP?

RESPONSE #1: Yes, please refer to the amended items 1 though 3 listed above. When Multiple

Principal Investigators are named, the "Contact PI" MUST be specified. Please note, offerors submitting single PI proposals do not need to submit a Leadership Plan.

QUESTION #2: The RFP states: “For proposal purposes offerors should assume that 30 requests will be received/evaluated per year and 20 shipments of specimens and accompanying clinical data will be processed per year. Offerors should also assume that shipping and processing costs for 15 of the 20 shipments will be borne by the requesting investigator.” Will this mechanism apply to the data analysis also? i.e., should the contractor budget to perform analyses pertaining to about 20 requests per year, with about 15 such analyses charged to the requestor (and credited to the contract following the same mechanism as the one used for the biospecimen processing and shipping)?

RESPONSE #2: Analytical and statistical support will vary depending on the request. In cases where the SICCA Biorepository contractor provides data analysis, all costs should be borne by the contractor.

QUESTION #3: At the time of the proposal, are offerors expected to provide a budget for the base period only or for all subsequent option periods?

RESPONSE #3: The offeror must provide a budget for the base period and all four option periods at the time of proposal. The Technical and Cost proposals must encompass the base period and all four options.

QUESTION #4: Is it allowable to include a copy of Standard Operating Procedures (SOPs) as an

Appendix?

RESPONSE #4: Yes.

QUESTION #5: Is it allowable to refer to a website (provide an URL) that is relevant to our proposal in the technical proposal?

RESPONSE #5: Yes.

QUESTION #6: Is there any guidance on what government owned storage units would be transferred with the initial migration of samples?

NHLBI-CSB-(DE)-2013-22-DEL / AMENDMENT #A001 / PAGE 5

RESPONSE #6: It is anticipated that all items identified in attachment #4, Government Furnished

Property, of the RFP will be transferred with the initial migration of samples.

QUESTION #7: What is the estimated number of samples (starting number to be migrated or yearly inflow of new samples)?

RESPONSE #7: Please refer to the SICCA Biorepository Specimen Inventory chart below for details about the initial migration of samples. Note that all samples will be transferred to the new contractor during the initial migration and no additional inflow of samples will occur after the initial migration.

QUESTION #8: Is there any information on storage conditions needed (mechanical freezers; LNO2)?

RESPONSE #8: Please refer to the following chart regarding storage conditions.

SICCA Biorepository Specimen Inventory – as of February 2013

Item Unit Storage Condition Quantity

Serum Milliliter (ml) -80o 31940

Whole Blood # of 15 ml tubes -80o 10,221

DNA # of vials 4o 4248

PFR-R Milliliter (ml) -80o 2788.14

PFR-L Milliliter (ml) -80o 2736.97

Whole Saliva Milliliter (ml) -80o 2448.83

Tears-L # of vials -80o 3808

Tears-R # of vials -80o 3796

Paraffin slides Slides Room temperature 13403

H&E Slides Slides Room temperature 7090

Frozen Glands Each Liquid Nitrogen 10447

RNA Imprints-L Each -80o 2633

RNL Imprints-R Each -80o 2565

Plasma Milliliter (ml) -80o 7440.5

PBMCs # of vials Liquid Nitrogen 2604

Oragene (extracted) # ABgene tubes -80o 444

Whole Blood (relative) Milliliter (ml) -80o 255

6701 Rockledge Drive, Rockledge 2, Room 6135 Bethesda, MD 20892 Attn: Evanthia Bouzis, Contracting Officer

6701 Rockledge Drive, Rockledge 2, Room 6135 Bethesda, MD 20892 Attn: Evanthia Bouzis, Contracting Officer