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IFED Information

AMENDMENT 1

AMENDMENT 2

AMENDMENT 3

Social & Scientific Systems, Inc. (SSS), in support of its logistical support services contract with the Epidemiology Branch of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), U.S. Department of Health and Human Services (Contract No. HHSN291200555546C), invites potential offerors to submit a proposal to participate in the Infant Feeding and Early Development (IFED) study as collaborating research institutions. SSS anticipates issuing up to two cost plus fixed fee type–subcontracts pursuant to proposals received in response to this RFP.

STUDY SUMMARY 

Evidence suggesting that soy formula has the potential to modify the hormonal milieu of infants during their first year of life is accumulating and provides support for an investigation into the longer term effects on early childhood development.

SSS is soliciting proposals to conduct the IFED study, an observational cohort study investigating critical endpoints during infancy and toddlerhood. The study will focus on the natural history of estrogen activity in full-term infants, enrolling infants in each of three primary feeding regimens (breastfed, soy-formula fed, and cow’s milk–formula fed) from birth through the age of 7 months (boys) to 9 months (girls) with the goal of having complete data on 300 infants (50 boys, 50 girls per feeding group). Infants of mothers recruited during pregnancy will be followed through infancy (7 months for boys, 9 months for girls) and may be eligible to continue into the Toddler phase of the study. Additional new participants around the ages of 10–12 months will be screened using a retrospective assessment of feeding methods during infancy, and if eligible, will be enrolled into the Toddler phase as well.

Each collaborating site will recruit, screen, and enroll mothers into the study during their third trimester of pregnancy, and collect a sample of her blood and urine as well as a diet history. At birth, the infant will undergo a physical examination (e.g., anogenital distance, breast bud, and testicle size and position), specimen collection (urine and blood), and ultrasonography (ovaries, testes, uterus, and breast). To document changes in estrogen responsive tissues, the site will repeat the physical examination and specimen collections during 10 visits over 7 months in boys and 12 visits over 9 months in girls; ultrasounds will be conducted at alternate visits.

Infant participants who are maintained on their initial feeding regimen for their first year of life will be invited to continue in the Toddler phase of the IFED study as they approach their first birthday. In addition, each site will recruit and screen a new pool of mothers of infants approaching their first birthday to enroll in the Toddler phase. Those who retrospectively report consistent feeding regimens during their infancy will be eligible to participate. In total, approximately 1,500 children (250 boys and 250 girls per feeding group) will be recruited with the goal of having 1,200 children (200 boys and 200 girls per feeding group) complete the following assessments at 12 and 24 months: 1) language acquisition with hearing assessment, 2) toy preference, 3) persistent palpable breast tissue, and 4) bone density. By following both infants in the study whose mothers have prospectively documented feeding histories through 11 months of age, as well as 11-month olds whose mothers retrospectively report consistent feeding histories, the results of the language, toy, and bone tests can be compared among children with prospectively and retrospectively reported simple feeding histories to validate outcomes. 

As the Coordinating Research Center, SSS intends to identify up to two collaborative sites, each to conduct the study protocols for both the Infant and Toddler phases. Each site will be responsible for recruitment, screening, and enrollment as well as completion of all measurements on approximately half (n=224 for the Infant phase, n=750 for the Toddler phase) the targeted study population.

LINKS

IFED RFP

Attachment A.  Contract Provisions

Attachment B.  Ultrasound Protocol

Attachment C.  Schedule of Tests for Infant Phase

Attachment D.  Schedule of Tests for Toddler Phase

Attachment E.  RFP Cover Page (choose "save" after clicking)

Attachment F.  RFP Budget Template (choose "save" after clicking)

Attachment G.  Representations and Certifications

Amendment 1

Amendment 2

Amendment 3

IMPORTANT DATES

QUESTIONS ABOUT IFED

Written questions regarding the RFP can be submitted to Jim Burke at This e-mail address is being protected from spambots. You need JavaScript enabled to view it . Responses to all questions will be posted on the SSS Web site: www.s-3.com/ifed. Questions submitted after September 19, 2008, will not be addressed. SSS will post the responses to all questions on the Web site no later than September 26, 2008. Please check the Web site periodically for updates.

SUBMISSION PROCEDURES

Please submit an electronic version of the proposal to Jim Burke at This e-mail address is being protected from spambots. You need JavaScript enabled to view it   by 5:00 p.m. Eastern Standard Time, November 3, 2008. Appropriate formats of electronic files include *.pdf, *.doc, and *.xls. Also, please submit one original plus 7 copies of the proposal and all supporting materials to the address below within 24 hours of the electronic submission. Proposals should be no more than 30 pages (e.g., single-spaced, 12 pt. font, 1-inch margins) in length (not including attachments). Please send proposals to: 

Jim Burke, Director of Contracts
Social & Scientific Systems, Inc.
8757 Georgia Avenue, 12th Floor
Silver Spring, MD 20910