RFP No. NIH-NHLBI-HB-00-01

"Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)--Clinical Center

Request for Proposal No.: NIH-NHLBI-HB-00-01
Amendment No.: One (1)
Amendment Date: August 16, 1999
RFP Issue Date: July 2, 1999
Issued By: Joann Ciufolo
Contracting Officer
NIH/NHLBI
BDR Contracts Section, Contracts Operations Branch
6701 Rockledge Drive, MSC 7902
Bethesda, Maryland 20892-7902
Original Proposal Due Date August 30, 1999, 4:30 PM (EST)
Amended Proposal Due Date: September 30, 1999, 4:30 PM (EST)


The above numbered solicitation is amended as set forth below. The hour and date specified for Receipt of Offers IS EXTENDED as specified above.

STATEMENT OF WORK, PHASE II - Patient Entry and Follow-up, paragraph (1), first sentence, is revised to read as follows: "Enroll at least 20 infants in the United States and Canada with sickle cell anemia (HbSS) between the ages of 6 months and 2 years whose parents or legal guardians would consent to have their children participate in this clinical trial of hydroxyurea to prevent chronic end organ damage."

Section L. SPECIAL REQUIREMENTS - is amended to add the following paragraph:

"A consortium may be formed to conduct this clinical trial at a site. A consortium is defined as a group of pediatric sites within a locality which refer study subjects to the clinical center Principal Investigator for study participation. Costs associated with investigator travel, patient tests and patient care are to be proposed with the understanding that the clinical center Principal Investigator will be responsible for oversight and coordination of all trial subjects enrolled at that center. Travel meeting costs are to be proposed for one principal investigator per clinical center."

Please include an acknowledgement of receipt of amendment #1 in your original business proposal.

Sincerely,

          /s/
Joann A. Ciufolo
Contracting Officer, NHLBI


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