THIS IS A N0TICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Epidemiology Branch within the Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate a new contract entitled, "Impact of Diet, Exercise and Lifestyle on Fertility: The IDEAL Fertility Study" on a sole source basis to the University of Utah under the authority of 41 U.S.C. 253(c)(1), FAR 6.302-1(a)(2). The Epidemiology Branch is an intramural research group within the Division of Intramural Population Health Research (DIPHR), of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) that conducts research to identify risk factors for adverse outcomes in reproductive and perinatal epidemiology (http://science.nichd.nih.gov/confluence/display/despr/home). Human fecundity and related impairments are a particular area of interest for the Branch as are interventions that may improve fecundity at the population level. An area of particular interest is assisted reproductive technology (ART); how outcomes of fertility treatment can be improved and whether treatment affects maternal and child outcomes. The Epidemiology Branch conducts much of its research via contracts, collaborating scientifically with the contractors, but under the guidance and direction of NICHD. The purpose of this proposed study is to evaluate the impacts of modifiable lifestyle factors on fertility in the context of a couple-based approach across a spectrum of fertility and treatment. Female partners of Folic Acid and Zinc Supplementation Trial (FAZST) participants provide a unique and valuable resource, bringing about an opportunity to follow a large, prospective cohort of women undergoing fertility treatment, while leveraging precious resources to create a rich data source for future studies. In the proposed IDEAL study, the contractor shall extend follow-up of approximately 1200 of the female FAZST participants to 12 months post randomization of the male partner and complete additional detailed assessments and bio specimens collection. The Epidemiology Branch and Division intend to invite female partners of participants in the Folic Acid and Zinc Supplementation Trial (FAZST), to participate in a study (the Impact of Diet, Exercise and Lifestyle on Fertility [IDEAL] study) that includes specific and detailed follow-up for the female partners to address these important research questions. The FAZST trial is a multi-site double-blind block-randomized placebo-controlled clinical trial to evaluate the effect of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes among male partners of couples seeking fertility treatment. Currently, female partners are only minimally involved in FAZST, with a single baseline visit and short monthly web-based questionnaires to track pregnancy outcomes, along with medical chart abstraction to assess fertility treatments and verify reported pregnancy outcomes. Female partners of FAZST couples create a potential cohort of women from whom to study the effects of dietary and lifestyle factors on pregnancy outcomes among couples seeking fertility treatment. This proposed initiative includes additional detailed follow-up for questionnaires and biospecimen collection for the female partners of the FAZST trial. The FAZST trial is currently under contract with the University of Utah under Contract No. HHSN275201200007C . The University of Utah (UU) has several unique qualifications: 1) UU is the only source with the complete infrastructure in place for recruitment and follow-up of the FAZST participants (complete data and follow-up of male partners to enable assessment of couple-based lifestyle factors when paired with IDEAL, as well as established clinic based recruitment and technical support for the trial); 2) No other organization has comparable data or experience with the couple based recruitment and consent procedures currently in place; 3) UU has extensive knowledge of and experience with reproductive health protocols and the anthropometric and dietary assessments used in similar populations, including large multi-site clinical trials with the extensive follow-up at multiple time points during pregnancy including collection of placenta samples. This is not a request for proposals. However, if any responsible source believes it can perform this requirement, they must submit an electronic capability statement by 3:00 p.m., Eastern Standard Time, on or before September 24, 2014 for consideration by the NICHD to Megan Gnall, Contracting Officer to megan.gnall@nih.gov. All responses must contain material in sufficient detail to allow the NICHD to determine if the party can perform this requirement. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. The reference number to be used for this announcement is RFP-NIH-NICHD- DIPHR-RFP-2015-06 which must be cited in the subject line of your email response.
