AMENDMENT #02 OF SOLICITATIONS FOR SUBCLINICAL CARDIOVASCULAR DISEASE STUDY, NHLBI HC-98-07, NHLBI HC-98-08, NHLBI HC-98-09, NHLBI HC-98-10, NHLBI HC-98-11, NHLBI HC-98-12 ------------------------------------------------------------------ 1. AMENDMENT OF SOLICITATION NUMBERS: NHLBI HC-98-07, NHLBI HC-98-08, NHLBI HC-98-09, NHLBI HC-98-10, NHLBI HC-98-11, NHLBI HC-98-12 2. AMENDMENT #02 3. AMENDMENT DATE: DECEMBER 11, 1997 4. RFP ISSUE DATE: NOVEMBER 4, 1997 5. ISSUED BY: National Institutes of Health National Heart, Lung, and Blood Institute Contracts Operations Branch Rockledge Building, MSC 7902 6701 Rockledge Drive Bethesda, MD 20892-7902 6. NAME AND ADDRESS OF CONTRACTOR: To all recipients of RFP Numbers: NHLBI HC-98-07, NHLBI HC-98-08, NHLBI HC-98-09, NHLBI HC-98-10, NHLBI HC-98-11, NHLBI HC-98-12 7. This amendment revises various sections of the RFPs as shown below: ******************************************************************* Clarifications for questions regarding exam components and schedule 1. Question: Clarify carotid and brachial arteries in examinations not to exceed 30 minutes each of participants' time (examination time). Does this mean a total of 60 minutes; 30 minutes for the carotid, and 30 minutes for the brachial. Answer: The combined examination time for carotid imaging and brachial artery flow assessments using ultrasonography should not exceed 60 minutes. Technician and participant efficiencies in developing and executing the protocols for each examination should be anticipated by potential contractors. 2. Question: Does the time schedule allow for a comprehensive exam and 6 follow-up exams or 6 follow-up exams? It appears that it would take from 9/1/2001 through 8/31/2007 to complete 5 follow-up exams given the fact that the comprehensive exams are completed over a two year period from 9/1/2000 through 8/31/2002. This also assumes that follow-up exams are spaced one year apart. (Also) If the ninth year of follow-up ends 3/31/2007 instead of 8/31/2007 should we assume an accelerated schedule of follow-ups for that one year. Please clarify. Answer: Following the comprehensive examination beginning in September of 2000, five annual follow-up examinations each focusing on repeated measures of "endothelial function and vascular stiffness" should be anticipated for each participant beginning one year after the comprehensive examination. One of the annual examinations will also be devoted to either of a repeat EBCT, carotid ultrasound, or MRI examination for each participant as described in the original RFP and Amendment #01. Participant revisits will also occur every 6 months solely for the purpose of blood specimen collection in the time periods between annual examinations. The first of these annual follow-up examinations will overlap the end of the comprehensive examination period. All follow-up examinations shall be concluded by February of 2007. Given the expected loss to follow-up is over time, the final follow-up examinations should be able to be conducted in a shorter time frame. Modifications in the timing and components of follow-up examinations may be proposed and may occur during protocol development. 3. Question: Clarify the use of cohorts from existing cohort studies. Answer: Existing cohort studies may be proposed for inclusion in this study, but requirements for age, gender, and race/ethnicity representation as specified elsewhere in the RFP, would need to be adhered to. ****************************************************************** 8. The hour and date specified for receipt of offers is NOT extended. Receipt is January 28, 1998 at 4:30 EST. If you submit a proposal, please acknowledge that your proposal is based on the original RFP and this amendment. Failure of this acknowledgment in your proposal may result in rejection of your offer. 9A. NAME AND TITLE OF CONTRACTING OFFICER (type or print): Cheryl A. Jennings, Contracting Officer 9B. UNITED STATES OF AMERICA BY (Signature of Contracting Officer) /signed/ 9C. DATE SIGNED: December 11, 1997 END OF AMENDMENT