Amendment #2
to RFP-NIH-NIAID-DAIT-99-26

"STATISTICAL AND CLINICAL COORDINATING CENTER (SACCC): COLLABORATIVE NETWORK FOR CLINICAL RESEARCH ON IMMUNE TOLERANCE AND AUTOMIMMUNITY CENTERS OF EXCELLENCE"

Amendment to Solicitation No. :

NIH-NIAID-DAIT-99-26

Amendment No.:

2

Amendment Issue Date:

March 15, 1999

RFP Issue Date:

December 10, 1998

Proposal Due Date:

April 9, 1999, 4:00 P.M. EST (Unchanged)

Issued By:

Carl Henn
Contracting Officer
NIH/NIAID
Contracts Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard, MSC 7610
Bethesda, Maryland 20892-7610

Point of Contact:

Jacqueline C. Holden, Contracting Officer

Name and Address of Offeror:

To All Offerors

 

The above numbered solicitation is amended as set forth below: The hour and date specified for receipt of offers is NOT extended. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram, letter or e-mail, provided each telegram, letter or e-mail makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.


PURPOSE: To correct errors noted in Amendment #1 to this RFP-NIH-NIAID-DAIT-99-26 as follows:

Title of Statement of Work for Part A is changed from: "Kidney and Islet Transplantation" to "Kidney and Islet Transplantation for the Collaborative Network and Pilot Clinical Trials and Mechanistic Studies in Multiple Autoimmune Diseases for the Autoimmunity Centers of Excellence."

Under the Statement of Work for Part A, two excerpts from RFP 99-26 were provided and they are modified to read as follows: EXCERPT FROM RFP 99-30: Best available current data indicate that: (1) approximately eight clinical sites will participate in conducting clinical trials in the first year of the contract for ~40 kidney transplant study participants and ~30 islet transplant study participants; (2) in the second year of the contract, approximately 12 clinical sites will participate in conducting clinical trials for ~80 kidney transplantation study participants and ~45 islet transplant study participants; (3) in the third and subsequent years of the contract, approximately 15 clinical sites will participate in clinical trials for ~180 kidney transplant study participants and ~55 islet transplantation study participants; (4) in FY 2000, the Centers will initiate four single-site pilot clinical trials involving approximately 100 total study participants, and two multi-site clinical trials involving a total of six clinical sites and 100 study participants; and (5) in the second and subsequent years of the Center program, three single-site pilot clinical trials will be initiated each year, involving approximately 100 total study participants, and three multi-site clinical trials per year, involving approximately three hundred (300) total study participants and a total of ten clinical sites.

EXCERPT FROM RFP 99-30: Best available current data indicate that: (1) approximately five mechanistic study sites will participate in investigations of underlying mechanisms in the first year of the contract; (2) in the second and subsequent years of the contract, approximately six mechanistic study sites will participate in investigations of underlying mechanisms; (3) for the Center program, three sites will be involved in the design and conduct of mechanistic studies throughout the life of this research program; and (4) at least one and often two mechanistic studies will be conducted in conjunction with Center single-site pilot clinical trials, and at least two and often three mechanistic studies will be conducted in conjunction with Center multi-site clinical trials.

The first sentence of number 7.a. of the Statement of Work for PART A is modified to read as follows:

"a. Site establishment visits for all Network and Center clinical sites in FY 2000 and,..."


Except as provided herein, all terms and conditions of the RFP document NIH-NIAID-DAIT 99-26 remain unchanged and in full force and effect.

Offerors must acknowledge reeipt of this Amendment #2 prior to the offer/proposal due date and time specified in the solicitation or as amended, by one of the following methods:

  1. By acknowledging receipt of the amendment on each copy of the offer submitted; or
  2. By sending an electronic mail message to Jacqueline C. Holden, Contracting Officer, at jh55b@nih.gov which includes a reference to the solicitation and amendment number; or
  3. By sending the Contracting Officer a separate letter or telegram which includes a reference to the solicitation and amendment number.

Failure to receive your acknowledgment of this amendment prior to the hour and date specified for proposal receipt may result in the rejection of your offer.


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