"RECOVERY" The National Standard for Normal Fetal Growth: Clinical Centers

This Project is an American Recovery and Reinvestment Act (ARRA) action. Receipt of award is contingent upon the offeror's meeting the requirements of Section 1512 (reports of use of funds) of the Recovery Act.



Solicitation Number: RFP-NICHD-DESPR-10-24

Amendment Number: One (1)

Amendment Issue Date: April 1, 2010

Proposal Due Date: April 5, 2010 at 4:00PM, local time (UNCHANGED)



The purpose of this amendment is to provide a response to a technical question and to respond to a question concerning proposal preparation instructions.



Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.



QUESTION 1: The technical proposal page limit is 20 pages. I know the resumes and references are NOT part of the 20 pages. Are the technical attachments in Section J included in the 20 pages or NOT included in the 20 pages? These attachments from Section J include Attachment 5: Targeted/Planned Enrollment Table, Attachment 6: Technical Proposal Cost Summary, Attachment 7: Summary of Related Activities, and Attachment 8: Protection of Human Subject Assurance Identification.

RESPONSE: These attachments are not included in the 20-page limit.

QUESTION 2: inclusion/exclusion criteria, the maternal age group for singletons is 18-40 but the maternal age group for twins is 18-45. I wanted to confirm that this correct that there are two separate age brackets for the singletons versus twins?

RESPONSE: These age inclusion/exclusion criteria are stated correctly.

This Project is an American Recovery and Reinvestment Act (ARRA) action. Receipt of award is contingent upon the offeror's meeting the requirements of Section 1512 (reports of use of funds) of the Recovery Act.



The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to solicit proposals form qualified organizations to conduct a multicenter prospective, observational study: The primary goals of this study are to acquire reliable and valid data to: (1) establish a U.S. national standard for normal fetal growth (velocity) and size for gestational age; (2) create an individualized standard for optimal fetal growth and size; (3) improve accuracy of fetal weight estimation based on ultrasound measures; and (4) construct an individualized standard for fundal height.

The secondary goals of this study are to: (1) recruit a cohort of women with a higher risk of gestational diabetes mellitus because of pregravid obesity and collect blood samples for etiologic research; (2) recruit a cohort of twin pregnancies with a similar number of monochorionic and dichorionic twins; (3) obtain blood samples for a prediction study of fetal growth restriction and/or overgrowth; and (4) obtain placental tissues and cord blood in selected cases and controls for studies on etiology of idiopathic fetal growth restriction, and in all twin gestations.



The Government is currently conducting a multicenter prospective study to establish a U.S. national standard for normal fetal growth. The study aims to recruit (1) 2,400 low risk women with an equal number of White, Hispanic, African American and Asian race/ethnicity; (2) 600 obese women; and (3) 250 monochorionic and 250 dichorionic twin pregnancies. Women will be recruited in the first trimester and followed up through pregnancy. Each woman will receive 5 scheduled ultrasound exams, which include 2-dimensional (2D) and 3 dimensional (3D) fetal anthropometric measurements. Uterine artery and fetal Doppler studies will be performed at selected gestational weeks. After delivery neonatal anthropometic measures will be carefully taken. Obstetric and neonatal information will be extracted from medical charts. Blood samples will be collected at enrollment, at 16 to 18 weeks, 24 to 28 weeks in all subjects and at 6 weeks postpartum in selected subjects. Placental tissues will be collected in selected subjects.



The purpose of this acquisition is to recruit up to four additional clinical centers in the U.S. to participate in the ongoing study. Currently the following four sites were awarded contracts in 2008: Columbia University, Medical University of South Carolina, Northwestern University and University of California at Irvine.



The NICHD anticipates award of up to four cost reimbursement completion form contracts with a two year period of performance beginning on or about September 30, 2010. RFP-NIH-NICHD-DESPR-10-24 will be available electronically within 10 days from this notification. You can access the RFP through the FEDBIZOpps (URL: https://www.fbo.gov)



Please note that the NICH does not intend to release hard copies of the RFP. Responses to the RFP will be due on or about March 16, 2010. NICHD will consider proposals submitted by any responsible offeror. The advertisement does not commit the government to award a contract. The NICHD also reserves the right to cancel the requirement at any time prior to contract award. No collect calls will be accepted. No facsimile or e-mail transmissions will be accepted.



This acquisition has been designated as a full and open competition under the North American Classification System (NAICS) code 541712. Any questions concerning this announcement must be submitted in writing to Elizabeth Shanahan, Contracting Officer at eshanahan@mail.nih.gov. The secondary point of contact is Lisa Coleman at lcoleman@mail.nih.gov. The RFP No. is NIH-NICHD-DESPR-10-24. All correspondence must cite the RFP Number.