Amendment 1 to NHLBI-11-01.doc

SEQ CHAPTER \h \r 1NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

REQUEST FOR PROPOSAL NUMBER NHLBI-HB-11-01

REDS-III CENTRAL LABORATORY

AMENDMENT NO. 1

DATE OF ISSUANCE: December 24, 2009 SEQ CHAPTER \h \r 1The 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 in the solicitation or as amended, by one of the following methods:

1) By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

2) By separate letter or email which includes a reference to the solicitation and amendment number.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF PROPOSALS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR PROPOSAL. If by virtue of this amendment you desire to change a proposal already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

PURPOSE: The purpose of this amendment is to: (1) revise Section J, List of Attachments, Attachment 3 – Statement of Work; (2) modify Section L.1. GENERAL INFORMATION, PARAGRAPH “c” Type of Contract and Number of Awards; (3) modify Section L.2. INSTRUCTIONS TO OFFERORS, paragraph “a”- General Instructions, item “1” Contract Type; and (4) provide questions and answers.

This amendment revises the RFP as stated below.

1) SECTION J - List of Attachments, Attachment 3 - Statement of Work, page 5 of 10, the first paragraph of the section entitled "REDS-III Infrastructure Requirements for International Sites ", is revised to read as follows. Changes are in bold print.

REDS-III Infrastructure Requirements for International Sites The infrastructure of the REDS-III international component shall consist of U.S. blood centers which have ongoing collaborative research arrangements with blood centers in low or middle income countries impacted by the HIV/AIDS epidemic. The blood centers participating in each international program must collect a total of at least 250,000 blood donations annually from at least three collaborating foreign collection sites within the same country or region*. The foreign collection sites should be geographically dispersed within the same country or region*, and, whenever possible, be representative of the varying prevalence of HIV in the region(s)/country of interest. Each foreign blood collection site must collect a minimum of 25,000 donations annually. The infrastructure shall include a centralized data collection center (CCC) responsible for compiling donor/donation data and protocol specific data from participating blood centers within each country or region* before being submitted to the REDS-III DCC.

*The foreign collection sites may be located in two or more countries that are part of an alliance or a consortium, and represent a particular geographic region of the world struggling with the HIV epidemic. In total, the participating blood centers representing two or more countries shall collect 250,000 or more blood units per year and there shall be strong evidence of previous successful collaborations between these countries as well as a clear description of the alliance or consortium infrastructure.

2) Section J, Attachment 3 – Statement of Work, Pages 7-8, paragraph 1- is revised to include the following language:

NOTE TO OFFERORS:

For budgeting purposes, the offeror should assume that five of ten laboratory studies will be components of large epidemiological studies and five laboratory studies will be stand alone studies.

For budgeting purposes, the offeror should assume that for each of up to 4 International sites, 2 of 3 laboratory studies will be components of large epidemiological studies and one laboratory study will be a stand alone study.

3) Section L.1. - GENERAL INFORMATION, paragraph “c” TYPE OF CONTRACT AND NUMBER OF AWARDS is modified to read as follows:

(Changes are in bold print) It is anticipated that one award will be made from this solicitation and that the award will be made on/about January 14, 2011.

It is anticipated that the award from this solicitation will be a multiple-year Cost-Reimbursement type Completion contract with a Period of Performance of seven years, and that incremental funding will be used (See Section L.2.”c”- Business Proposal Instructions). There is a possibility that the contract will be a different type of contract, including, but not limited to, a Multi-year contract or an Options type contract. Offerors will be notified if the contract type changes prior to award.

4) Section L.2. –INSTRUCTIONS TO OFFERORS, Paragraph “a” GENERAL INSTRUCTIONS, Item 1 - Contract Type and General Clauses is modified to include the following language:

There is a possibility that the contract will be a different type of contract, including, but not limited to, a Multi-year contract or an Options type contract. Offerors will be notified if the contract type changes prior to award.

QUESTIONS AND ANSWERS: RFP NO. NHLBI-HB-11-01 - Recipient Epidemiology and Donor Evaluation Study – III (REDS-III) – Central Laboratory

1) The technical proposal pages 58-59 request specific information that can only be estimated and not defined until after individual research projects are defined by the REDS study participants. How should an applicant address issues asking for statements of specific personnel, subcontractors, shipment of samples (within USA and from unspecified other countries), percent effort of personnel, data transmissions, etc?

The information requested under section 14 (Additional Technical Proposal Instructions, pages 58-59) are generic and apply to any laboratory research that may be conducted to address blood product safety and availability research questions in the U.S. and internationally.

The offeror should assume that five of ten laboratory studies estimated to be conducted in the Domestic Program will be components of large epidemiological studies and that five laboratory studies will be stand-alone studies. The offeror should also assume that for each of up to 4 International sites, 2 of 3 laboratory studies will be components of large epidemiological studies and one laboratory study will be a stand alone study. Please refer to RFP No NHLBI-HB-11-03, REDS-III Domestic Sites, Attachment 3- Statement of Work for information on Domestic Sites responsibilities, RFP No NHLBI-HB-11-02, REDS-III Data Coordinating Center, Attachment 3- Statement of Work for information on Data Coordinating Center responsibilities, and RFP No NHLBI-HB-11-04, REDS-III International Sites, Attachment 3- Statement of Work for information on International Sites’ responsibilities.

It is also suggested that offerors use the information provided in the Statement of Work (RFP No NHLBI-HB-11-01, REDS-III Central Laboratory, Attachment 3- Statement of Work) to develop the information that needs to be provided in response to section 14, Additional Technical Proposal Instructions, pages 58-59.

2) In the Business Proposal, how should issues of cost/profit/fees etc, total expense and substantiation of specific elements, etc, be addressed? Only after the specific research studies are formulated, will a central laboratory be able to provide very specific responses; however, a framework can be presented before the specific research studies are confirmed by the REDS-III study participants.

As stated in Section L.C Business Proposal Instructions, paragraph 2; you do not need to submit cost and pricing data with the initial proposal. Information to substantiate your proposed costs (such as vendor quotes) may be requested after the establishment of the competitive range. However, cost breakdowns should be provided to show how you arrived at your proposed costs as required in Attachment 9 – Breakdown of Proposed Estimated Costs (Plus Fixed Fee) with Excel Spreadsheets. A narrative to explain how you estimated your proposed costs shall also be provided.

3) For the specific technical research proposals, can study-related blood samples be collected at multiple time points from transfusion recipients?

The number of blood samples collected from transfusion recipients will depend on the scientific question being addressed and the recipient population being studied. Blood samples may need to be collected at multiple time points from transfusion recipients.

4) Do we need to have our own BSL-3 facility, or can this be contracted out by the central lab?

If work requires a BSL-3 facility, the work can either be done in house if a BSL-3 facility is available or contracted out.

5) Do you have any advice or guideline for estimation of the effort required of the PI of the central lab in REDS-II or desirable for REDS-III PI or support scientific personnel?

The proposed effort needs to be commensurate with the ability to conduct all elements of the statement of work. Please refer to Section L.1, subsection e. Estimate of Effort for the estimated total required. The percent effort for the Principal Investigator or support scientific personnel is to be determined by the offeror.

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