AMENDMENT NO. 1;RFP-NIH-NHLBI-HC-99-14

"Study of Coronary Revascularization And Therapeutics Evaluations (SOCRATES)" Clinical Data Coordinating Center (CDCC).
AMENDMENT OF SOLICITATION NO.: RFP-NHLBI-HC-99-14
AMENDMENT NO.: 1 (One)
AMENDMENT DATE: December 29, 1998
RFP ISSUE DATE: December 03, 1998
ISSUED BY: William M. Stevens, Contracting Officer
National Heart, Lung, and Blood Institute
Contracts Operations Branch, DEA
Rockledge 2, Room 6118
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902
NAME AND ADDRESS OF OFFERORS: To all recipients of RFP No. NHLBI-HC-99-14
1.This amendment extends the receipt date of the proposals and clarifies sections of the RFP No. NHLBI-HC-99-14.

The date specified for receipt of offers is extended to April 30, 1999.

Block 9. is amended to read as follows:

Sealed offers in original and 25* copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in [Block 8] *But see page 14 until (hour) 4:30 PM local time (Date) 04/30/1999.

SECTION L--INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, SECTION I. SPECIFIC RFP INSTRUCTIONS AND PROVISIONS, Part D. NUMBER AND TYPE OF AWARD is amended to read as follows:

It is anticipated that ONE award will be made as an incrementally funded cost-reimbursement contract for a Clinical Data Coordinating Center (CDCC) .

E. Level of Effort. The Government considers that the personnel and estimated levels of effort listed below will be required for successful completion of the study. Effort is shown as a percentage of FTE (full time equivalent) labor. The effort is listed below as information only and is not to be considered restrictive for proposal purposes.

It is expected that a completion, cost-reimbursement type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the effort below to be approximate. This information is furnished for the offerors's information only and is not to be considered restrictive for proposal purposes. The following FTE's are based on a per year total.



Labor Category Phase 1 Phase 2 Phase 3 Phase 4
Investigator FTE's 0.95 1.65 0.9 0.9
Staff FTE's 1.38 5.5 3.5 3
Total: 2.33 7.15 4.4 3.9


SECTION M--EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA is amended to read as follows:

SECTION M--EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA

GENERAL

Proposals submitted in response to this RFP will be reviewed by (1) a primary technical review group using peer review procedures under the auspices of Review Branch, DEA and (2) a secondary review group composed primarily of members of the DHVD, NHLBI professional staff.

Technical factors will be paramount in the decision to award a contract. Although technical factors are paramount in the decision to award a contract, price will be considered a factor in the source selection decision. If two or more offerors are approximately equal in technical ability, then price may become paramount. In any event, the Government reserves the right to make an award to the best advantage of the Government, price and other factors considered.

This research project involves human subjects. NIH Policy requires that women, members of minority groups and their subpopulations, and children must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research.

The factors to be evaluated are as follows:
No. Criterion Points
1. Personnel - Qualification and availability of the CDCC staff: specific competence and prior experience of professional, technical, and administrative staff pertinent to the operation of a CDCC in multicenter randomized clinical trials in cardiovascular disease similar in complexity to SOCRATES. Suitability and specific staff competence and prior experience of the proposed core laboratories and central interpretation units and monitoring their performance. Suitability of on-site medical and scientific expertise in cardiovascular medicine and therapy, management of side effects and adverse reactions to proposed therapies, and data analyses. Ability to take appropriate leadership in scientific data publication and preparation of scientific reports and manuscripts. 35
2. Technical Qualifications of the CDCC: Adequacy of the proposed methods to coordinate and manage a complex trial consisting of a large network of clinical sites/investigators and core laboratories, including organizing and monitoring recruitment and follow-up of study patients from multicenter network systems. Suitability of the proposed central units. Ability to implement study protocol in a standardized fashion in both clinical units (CNCs) and central units. Adequacy of the proposed plans for central data acquisition, management, and analysis, including randomization of patients, quality control measures. Adequacy of the proposed plan to provide for central interpretation of AECG, resting ECG, and angiographic, and health care costs and detailed quality of life data. 35
3. Knowledge and understanding of scientific issues: Adequacy of knowledge and understanding of scientific issues related to rationale and design of the trial, treatment strategies, including the proposed manual of operations to meet the requirements of the Statement of Work. 20
4. Institutional Support, Corporate Facilities and resources: Adequacy of organizational and administrative structure of the proposed CDCC. Demonstrated ability to participate in a long-term cardiovascular multicenter randomized trial of similar complexity to SOCRATES, both in central data management and coordination of protocol-mandated study activities. Adequacy of the institutional commitment to the program, and of the proposed facilities, equipment, and space for accomplishing the statement of work. 10

Total:

100



The date specified for receipt of offers is extended to April 30, 1999. Please acknowledge receipt of this amendment by sending an electronic mail to:

ws69s@nih.gov.

Failure of your acknowledgment to be received prior to the hour and date specified for receipt of proposals may result in rejection of your offer.

Sincerely,
/s/
William M. Stevens
Contracting Officer





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