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The National Children’s Study –Vanguard Centers

Solicitation Number: NIH-NICHD-NCS-SS-10-22
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Child Health and Human Development
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July 1, 2011
University of Utah
200 South Presidents Circle
Salt Lake City, Utah 84112
United States
Added: Jul 13, 2010 1:15 pm
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in continuing data collection in the seven original locations in the National Children's Study (NCS) Vanguard Study. This study serves as a platform to test acceptability and costs of the study for use in planning the main study. This announcement is not a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this small business sources sought is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, 8(a), SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $7 million.

The NCS is a longitudinal cohort study that will examine the effects of environmental influences on the health and development of approximately 100,000 children enrolled from 105 distinct geographic areas across the country to form a nationally representative sample. Environment is broadly defined to include biological, physical, chemical, and social/cultural influences on children’s health and development. Priority outcomes include obesity, diabetes, and physical development; injuries; asthma; pregnancy-related outcomes; child development and mental health; and identifying beneficial health effects.

The Vanguard Study was launched in 2009 at seven Centers. The overall study design of the NCS is to enroll women who are pregnant, or likely to become pregnant, during an approximate four-year enrollment period. To be eligible the women must reside in designated geographic areas. Children enter the study when they are born to an enrolled mother. Each child in the study will be followed from before birth until 21 years old. Accordingly, participants enrolled in the pilot (Vanguard) cohort will continue to be followed as a pilot cohort until the child is 21 years of age. Enrollment into the pilot cohort is expected to continue through December 2011 with a goal of beginning enrollment into the main study in January 2012. The NCS Main Study has an accrual target of 100,000 children from 105 study locations.

An early step of the original Vanguard Study includes canvassing designated neighborhoods, going door to door to identify women who are potentially eligible for enrollment. Once a woman is identified as eligible she is invited to participate in the Study. Women who are pregnant as well as those who have a high probability of becoming pregnant are invited to enroll in the study. Enrolled participants are followed with a series of home and clinic based data collection visits. Additionally women, who are not pregnant at the time of the initial household screening but have a moderate or low probability of pregnancy, are followed with phone calls from the Study Center every 3 to 6 months.

To be deemed capable of providing the current need for the study the small business offeror must submit a written capability statement that clearly demonstrates capacity in the following areas:

1. Experience: The offeror shall demonstrate previous successful experience based on studies of the relevant size and breadth, providing specific detail related to each appropriate task.

2. Personnel: The offeror shall provide the name of the principal investigator, his/her professional qualifications and specific experience as a key investigator in large studies similar the current study. The offeror shall demonstrate that the proposed investigation team and staff have previous experience in carrying out such a prospective study.

3. Facilities: The offeror shall have the necessary dedicated office space and accommodations. Space should be available, as necessary, for other activities such as testing, training, collaborative planning, meetings, etc. Capacity for primary data collection activities shall also be described.

4. Access to study population: The offeror shall demonstrate their ability to follow-up and conduct study visits with women, men and children already enrolled in the study. Study visits could include collection of interview data, physical measurements, biological specimens and environmental samples. Women and children enrolled in the pilot study must be followed longitudinally to meet study goals. The offeror should be capable of performing already scheduled data collections with participants. Offerors must also be capable of following a large number of women by telephone to identify new pregnancies. Once a pregnancy is identified the offeror must be capable of enrolling expectant mothers as new participants.

5. Relationships with the community: The offeror shall demonstrate the existence or ability to rapidly form working relationships with important entities within Study Locations e.g. hospitals, providers of prenatal care and members of the community such that they (the research team) are recognized and trusted within the community.

If any responsible source believes it can perform the requirements they may submit three (3) hard copies of their capability statements (15 Page Limit, these pages exclude resumes) for consideration by NICHD to Seena Mathews, Contracting Officer, at the mailing and e-mail address provided by the response date.

Overnight deliveries should be mailed to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, Suite 7A07, Rockville, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit their capability statements via email (PDF format) in addition to 3 hard copies.

Respondents must include DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the applicable NAICS code.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation(s).

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.

Contracts Management Branch
6100 Executive Blvd., Suite 7A07, MSC7510
Bethesda, Maryland 20892-7510
Howard Cyrus,
Contracting Officer
Phone: 301-435-6963
Fax: 301-402-3676