FDA-SS-1163032.pdf

FDA-SS-1163032

Notice of Intent to Award a Sole Source Contract to Harvard School of Public Health (HSPH) for United States Population Longitudinal Data and Specialized Analytic Support

The Food and Drug Administration intends to make a sole source award to Harvard School of Public Health to acquire U.S. population longitudinal data and specialized analytic support to help address FDA’s needs for scientific evidence on dietary intake exposures and chronic health outcomes in accordance with FAR 6.302-1. Only one responsible source and no other supplies or services will satisfy agency requirements.

The FDA intends to contract without competition because the HSPH prospective cohort studies are the only ongoing U.S. longitudinal investigations of their sizes and duration collecting dietary intake exposure and chronic health outcome data.

The HSPH is the only source running the following longitudinal studies:

− Nurses’ Health Study original cohort (NHS1: ~122,000 participants, since 1976) − Nurses’ Health Study II (NHS2: ~116,000 participants, began in 1989) − Nurses’ Health Study III (NSH3: ~100,000 participants, began in 2010)− Health

Professionals Follow-Up Study (HPFS: ~100,000 men, since 1986) − Growing Up Today Study (GUTS1: children of NHS participants, including 16,882 girls and boys; since 1996) − Growing Up Today Study 2 (GUTS2: children of NHSII participants, including 10,923 girls and boys; since 2004)

The period of performance will be for 24 months. The NAICS code for this action is 541712.

This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements.

This is a notice of intent to issue this solicitation on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item, or submit a proposal within 15 days to the individual listed. A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government.