Amend 1 - SF30.doc

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT CONTINUATION PAGE

RFP NHLBI-HB-11-02

Amendment No: 01

1.

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

REQUEST FOR PROPOSAL NUMBER NHLBI-HB-11-02

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:

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

II. 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 Attachment 1, Packing and Delivery of Proposals (1); (2) revise Section J, List of Attachments, Attachment 3 – Statement of Work; (3) modify Section L.1. GENERAL INFORMATION, paragraph “c” Type of Contract and number of awards; (4) modify Section L.2. INSTRUCTIONS TO THE OFFEROR, paragraph “a” GENERAL INFORMATION, Item 1- Contract Type and General Clauses; and (5) provide questions and answers.

A) This amendment revises the RFP as stated below.

1) Section J- List of Attachments, Attachment, Packing and Delivery of Proposals, the address for delivery of 20 copies of the Technical proposal to the Review Branch is revised to correct the room number from 7124 to 7195. The Correct address is shown below:

If courier delivery service If using U.S. Postal Service

Review Branch Review Branch

Division of Extramural Research Activities Division of Extramural Research Activities

National Heart, Lung, and Blood Institute, NIH National Heart, Lung, and Blood Institute, NIH

Rockledge II, Room 7195 Rockledge II, Room 7195

6701 Rockledge Drive, MSC 7924 6701 Rockledge Drive, MSC 7924

Bethesda, MD 20817 Bethesda, MD 20892-7924 2) SECTION J - List of Attachments, Attachment 3 - Statement of Work, page 5 the second paragraph of the section entitled "REDS-III Infrastructure Data Coordinating Center ", is revised to read as follows. Changes are in bold print.

The DCC shall compile donor and donation data from each international site in a centralized cumulative donor/donation database and shall be responsible for providing all statistical/analytical support for the analysis of these data. 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. Analysis of all data compiled in the database shall be conducted by the DCC. Additionally, the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated three large epidemiological and/or survey studies and about three laboratory studies [which may or may not be component(s) of the large epidemiological studies] conducted at each of the REDS-III international collaborative programs.

*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.

3) Section J, Attachment 3 – Statement of Work, Page 9, “d” Statement of Work, Task 5: Coordinate and participate in the development and finalization of REDS-III study protocols and develop corresponding Manuals of Operations, revised to include the following language under the NOTE TO OFFERORS:

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.

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

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.

5) The 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.

B) QUESTIONS: RFP NO. NHLBI-HB-11-02

Recipient Epidemiology and Donor Evaluation Study – III (REDS-III) - DCC

1) Are the FTE estimates for each phase as stated in Section L.1.d. Estimate of Effort intended to be per year?

Yes, the estimates are per year for each phase.

Thus, effort for personnel at the DCC is estimated to be about 9 FTEs per year for years 1 and 2; 11 FTEs per year for years 3, 4, 5, and 6; and 9 FTEs for year 7.

2) How much assistance is the DCC expected to provide to the international sites with respect to setting up the data management systems? Should the DCC budget for any hardware, applications, information technology support, and/or internet connectivity for each of the international Centralized data Collection Centers?

The DCC is responsible for all data management activities for international sites that are not identified as being international sites’ responsibilities. Please refer to RFP No NHLBI-HB-11-04, REDS-III International sites, Attachment 3-Statement of Work, #7, for a description of international sites’ data management responsibilities.

3) The RFP states that the overall system security level will be moderate and each of the three categories (confidentiality, integrity, and availability) will be moderate. Based on the description of the systems and data that will be hosted by the DCC, particularly the statement that the DCC will not receive any identifiers, please clarify why the systems developed for receiving, managing, processing, etc. the data need to be hosted in a NIST moderate system security environment given the significant additional cost of operating in this environment.

As noted, the determination of an overall system security level is based on assessment of the following three categories: confidentiality, integrity, and availability. The confidentiality impact level is the effect of unauthorized disclosure of health care research and practitioner education on the ability of responsible agencies to foster advancement in health discovery. Although identifiers should not be collected in REDS-III, errors in data collection may unfortunately occur, and the security level should take into account worst case scenarios; thus a moderate security level. The integrity impact level which is the major driver of the “moderate” level assigned to the REDS-III project reflects the need to have excellent data management practices to guarantee the integrity of the data. Integrity of data is paramount to REDS-III because unreliable data leads to inaccurate results which could misinform regulatory agencies charged with defining policies for blood safety and availability. REDS and REDS-II data have often informed policy decision making and the same will be expected of REDS-III data. It is therefore critical that the data collected by REDS-III be of high integrity. Timely availability of data and the ability to rapidly respond to new questions that are critical to blood safety and availability are also important to the mission of REDS-III.

4) The RFP states that Contractors will submit a Self-Assessment with their proposal and update and resubmit it annually. Will Contractors also be required to complete a security Certification and Accreditation (C&A) package as described in HHS Standard for FISMA Inventory Management (http://www.hhs.gov/ocio/policy/20080006001s.html) leading to an Authority to Operate (ATO)?

No, a C&A package and ATO are not required.

5) The RFP states that the DCC will develop and implement secure and robust data collection, tracking, management, and storage procedures for all data compiled by the REDS-III program. This suggests that the REDS-II DCC will not transfer systems, data, and other system and data management related information to the REDS-III DCC for use on REDS-III. If that is the case, please confirm that the REDS-III DCC is not required to use the same tools and technologies as were used by the DCC on REDS-II and can select the tools and technologies it deems most appropriate for use on REDS-III.

The tools and technologies that are deemed most appropriate should be proposed.

6) Is it expected that any other materials and/or resources would be transitioned from the REDS-II DCC?

No

7) The RFP states that the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated five large epidemiological and/or survey studies and about ten laboratory studies [which may or may not be component(s) of the large epidemiological studies] during the course of the domestic program. For budgeting purposes, how may of the ten laboratory studies should we assume will be components of the epidemiological studies and how many will be stand alone studies?

See Item A. RFP revision number 3 above.

8) The RFP states that the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated three large epidemiological and/or survey studies and about three laboratory studies [which may or may not be component(s) of the large epidemiological studies] conducted at each of the REDS-III international collaborative programs. Based on the above requirement, the DCC could be responsible for anywhere from 3-24 separate studies depending on whether studies involve more than one country/region and whether the laboratory studies are components of the epidemiological studies. For budgeting purposes, please provide further guidance on the total number of epidemiological/survey studies and laboratory studies we should plan for, including how many of the laboratory studies we should assume will be components of the epidemiological studies.

See Item A. RFP revision number 3 above.