SOURCES SOUGHT
A -- Infertility Treatment, Child Growth and Development through Age Three Years
- Notice Date
- 10/5/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NICHD-DESPR-EB-SS-2007-02
- Response Due
- 10/23/2006
- Archive Date
- 11/6/2006
- Description
- Background The National Institute of Child Health and Human Development (NICHD) is interested in identifying whether there are any interested Small Business Concerns with the requisite capabilities to undertake a longitudinal study to determine empirically if infertility treatments, such as ovulation-stimulating medications and the various assisted reproductive technologies (ART), adversely affect the growth, motor and social development of children from birth through age three years. This is a new requirement. The period of performance is 4 years, and it is anticipated that a cost-reimbursement completion contract will be awarded for this requirement. A growing body of scientific evidence suggests that infertility treatment may impact human health and development. The number of children conceived with the help of infertility treatments currently comprises approximately 1-2% of live births in the United States, but the proportion is expected to continue to increase and the characteristics of the women undergoing treatment to change as more States begin to mandate health insurance coverage for infertility and ART procedures and as the efficacy of these therapies continues to improve. A recent report of the U.S. President?s Council on Bioethics called for: (a) improved monitoring of infertility treatments and outcomes, (b) long-term longitudinal studies to assess child health concerns, and (c) improved/expanded decision-making for parents and practitioners. Moreover, the Council called attention to the fact that virtually no data exist for populations of such children with regard to their growth and neurodevelopment during infancy and childhood. Given that a notable portion of children conceived with the help of infertility treatment are born early or growth-restricted, they are a subgroup of children at risk for developmental disabilities including subtle differences in perception, cognition, vision, or motor skills. These endpoints are in need of systematic, empirical, and longitudinal investigation. Choice of comparison population remains an issue for children conceived by infertility treatment or ART, given that the preponderance of literature has relied upon naturally-conceived children (assumed or otherwise). More appropriate comparison groups, particularly for long-term outcomes among singletons infants, might be children of subfecund couples who become pregnant without ovulation-induction agents or ART. To ensure sufficient power for a longitudinal follow-up, to have access to a large enough sample of women and outcomes (for comparison at various levels of fertility), and to avoid a lack of generalizability due to the specialized treatment regimens employed at individual clinics, any study attempting to answer questions (i.e., differential loss to follow-up, longitudinal trends, choice of controls) about the long-term consequences of fertility treatment needs to be population-based. A population-based study is now possible because the revised U.S. Standard Certificate of Live Birth that is being phased in nationally includes a question about the use of infertility treatment in the Prenatal Tests and Procedures section, and that question can be used to identify appropriate children for follow-up. Objectives A population-based sampling strategy will be used to recruit in a ratio of 1:3 a matched-exposure cohort of infants identified from pregnancies conceived with the help of infertility treatment, as noted on birth certificates, and children who were conceived without such therapies. For the primary cohort, a total of 1,500 infants identified on birth certificates as having been conceived by infertility treatment (exposed) are to be enrolled as study subjects at three to five months of age (gestation-corrected, if necessary) and followed longitudinally for three years (until age 36 months), along with the cohort of 4,500 unexposed children, matched for maternal age, zip code of residence, and plurality of birth. All co-twins (or triplet siblings) of study subjects are also to be enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality), or they are to be followed (secondary cohort) on the same schedule as study subjects. Assuming that approximately a third of the birth outcomes from infertility treatment are twins or higher order multiples, the secondary cohort is expected to number 2,000 (500 twin siblings of exposed and 1,500 twin siblings of unexposed infants). The period of recruitment for the cohorts is expected to last 10 months to one calendar year. The sampling frame for the study is expected to be either a State or consortium of States that have real-time access to birth certificates and adequate numbers of births from infertility treatment to meet study requirements. Parents will be asked to participate in the study for three years by: (a) completing an initial questionnaire about the pregnancy, including, for example, confirmation of infertility treatment, time-to-pregnancy, infant feeding, and other demographic and socio-economic factors (i.e., maternal education, occupation) and confounders associated with motor and social development; (b) completing a standardized screening instrument that addresses their child?s motor and social development at chronologic or gestation-corrected ages 4, 8, 12, 16, 20, 24, 30, and 36 months; and (c) providing information on the child?s growth and medical history (e.g., illnesses, diagnoses of birth defects, major impairments). Whenever possible, records will be linked to other pertinent health records (e.g., early intervention programs, WIC, birth defect or cancer registries). Depending upon State requirements, screening results will be communicated to parents, and parents expressing concern about their children will be given contact information for State-approved developmental assessment centers and early intervention programs. Requirements To be deemed capable to implement the longitudinal study, a Small Business Concern must submit a written capability statement that clearly demonstrates their ability to: 1. Have demonstrated real-time (electronic submission) access to birth certificates to identify and recruit parents for follow-up; 2. Have access to birth certificates from State(s) or regions that have had mandated reported of infertility treatment for at least one year; 3. Have demonstrated feasibility for achieving recruitment goals based on number of birth certificates positive for infertility treatment and be able to implement a plan for sampling; 4. Have affirmative support from State health officials and the State administration for publicity and recruiting; 5. Design a tracking system reactive to the State vital statistics system to ensure timely follow-up of infants and children through the 3 years of enrollment; 6. Implement a plan for contacting, recruiting and enrolling the cohorts of study subjects who are identified from birth certificates and implement the longitudinal protocol; 7. Assist in the development and implementation of a web-based data entry system provided by the NICHD and compile all data collected in the course of the study; and 8. Provide final data sets with both primary and secondary cohorts also linked to other pertinent health registries (e.g., early intervention programs, WIC, birth defect or cancer registries). AT THIS TIME THE NICHD IS ONLY REQUESTING CAPABILITY STATEMENTS FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The applicable North American Industry Classification System (NAICS) code for this requirement is 541710. Therefore, the small business size standard for this announcement is 500 employees or less. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates number of employees. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit three (3) copies of their written Capability Statement to the attention of Jennifer J. Awkard, Contracting Officer, at the address provided by 3:00 PM Local Time on October 23, 2006. Overnight deliveries should be mailed to National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, Rockville, Maryland 20852. See numbered note 25. No collect calls will be accepted. No facsimile transmissions will be accepted. The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals may be set-aside for small businesses. Point of Contact Jennifer J. Awkard, Contracting Officer, Phone: 301-435-6957, Fax: 301-402-3676, Email: awkardje@mail.nih.gov
- Record
- SN01161903-W 20061007/061005220213 (fbodaily.com)
- Source
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