SOLICITATION NOTICE
A -- Multiple Data Coordinating Center for the Division of Epidemiology, Statistics and Prevention Research (DESPR)
- Notice Date
- 5/2/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- NIH-NICHD-DESPR-2013-15
- Archive Date
- 7/3/2013
- Point of Contact
- Theresa Koomson, Phone: 301-435-6957, Elizabeth Osinski, Phone: 301-435-6947
- E-Mail Address
-
koomsont@nih.gov, eo43m@nih.gov
(koomsont@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Division of Epidemiology, Statistics and Prevention Research (DESPR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NIHCD) proposes to establish a Data Coordinating Center (DCC) with management capabilities to support the original research projects conducted by its intramural investigators. This is a 100% SMALL BUSINESS SET-ASIDE, NAICS 541712 with a size standard of 500 employees or less. It is anticipated that the resultant contract will be an Indefinite Delivery Indefinite Quantity (IDIQ), cost reimbursement contract to be awarded for a 5-year period with performance beginning on or about September 26, 2013. The Division encompasses three branches: 1) Epidemiology Branch; 2) Biometry Branch and 3) Prevention Research Branch. ]. Central to the Division's mission is to design, implement, and conduct epidemiologic, behavioral and biostatistical research. This includes reproductive, perinatal and pediatric epidemiologic research, as well as research addressing gravid women, and child and adolescent health and behaviors. Original biostatistical and bioinformatics methodology is developed based on analytic problems encountered in the design and/or conduct of the epidemiologic or behavioral research. As an intramural entity, the Division is charged with research aimed at filling critical data gaps within its mission by utilizing state-of-the­art methodologies and technologies. In addition, Division investigators are charged with the timely communication of research findings to both professional and lay audiencesThe Division typically will implement one to three new major studies annually with the DCC through the task order mechanism on the Government fiscal year calendar, subject to funding. Each major study lasts from approximately two to five years; smaller studies of one to two years that may require support, mostly building on or expanding earlier work, may also be undertaken in the course of any year should Division funds permit. This includes both epidemiologic and behavioral research within the following broad domains and as described below: etiologic research; clinical prediction; clinical efficacy or intervention trials; and behavioral intervention trials. As an added dimension, most of the studies involve collection and/or laboratory analysis of biospecimens, including specimens from diverse biological media, such as blood, serum, urine, placental tissue, fat, hair, and saliva, to name just a few. The objectives of this contract are for the NICHD to obtain on behalf of DESPR: 1) state-of-the-art, web-based data coordination and management systems and support that offer access to all aspects of the data for each study with real-time (24/7) surveillance capability; 2) the capability of the web-based data management system to track biospecimens or other types of data, such as photographs or other images (e.g., DXA scans, radiographs, ultrasound images), that may be collected from research sites or in study participants' homes; 3) the capability for production of fully documented data files, imaging or digital archives, supporting data files which include quality assurance documentation, and analytic files or other requirements as needed; 4) the ability to provide or subcontract for specific biostatistical methologic expertise and/or laboratory analyses as required for each study; 5) the ability to "report back" or communicate research findings to study participants; and 6) the ability to provide other essential logistical support such as scheduling conference calls, steering committee meetings or data safety and monitoring boards (DSMBs) meetings along with the preparation of minutes for all such activities. The Division's Epidemiology and Prevention Research Branches typically conduct research that utilizes one of two types of designs. First is the prospective cohort design for the longitudinal collection of questionnaire data (particularly during critical or sensitive windows within human reproduction and development), biospecimens, electronic data (e.g., using fertility monitors, peak flow meters or other PDA-type devices), and, increasingly, digital data (e.g., x-rays, MRIs, ultrasound images, operative photographs, video from camera-outfitted motor vehicles). The sampling frameworks for such studies may be from targeted clinics, research sites or geographic areas, and may include convenience and population-based sampling. Sampling may be on the individual, population or group level. Further complicating and impacting database design and management of the longitudinal studies is that approaches are often on units other than just the individuals of interest. For example, a couple-dependent approach for collection of reproductive data. That is, investigators may take a couple-dependent approach to fertility, a family approach for follow-up of children born after maternal gravid complications, a classroom-based approach for surveying children, or multi-generational approaches to the genetics of diseases. Hence, the ability of the Offeror to support individual or higher order units of analysis is essential. In addition, study covariates are frequently time­varying which further dictates data structure. The second typical study design is the randomized trials. The Epidemiology Branch conducts both randomized clinical trials aimed at assessing clinical efficacy and intervention trials. The Prevention Research Branch typically conducts intervention trials involving individuals, families, or schools as the randomization unit. Unlike, the longitudinal or cohort studies, the trials require the capability of the Offeror to support all trial activities, including, for example, randomization, outcome tracking, compliance assessment, and independent monitoring by a DSMB. General Notes to Offerors: * The state-of-the-art, web-based data coordination and management systems should be able to accommodate up to three major new studies annually, with each lasting from two to five years. Smaller studies in scope and commitment, such as pilot studies or add-ons to an existing project, are also likely and will arise on an ad hoc basis, depending on Division funding, so that flexibility in overall capability is expected. Studies largely involve prospective (observational) cohort designs or randomized trials. Longitudinal capture of data from multiple sources and varying types of biospecimens is typically a part of the Division's research portfolio. *The web-based data management system shall accommodate each project but ensure the flexibility to meet specific needs tailored to studies' protocols. The web-based system should have the following characteristics: 1) flexible data collection including the ability to upload files from multiple sites or sources (e.g., laboratories, clinical facilities, study participants homes); 2) ability to track biospecimens from collection to participating study laboratories and the NICHD's biospecimen repository, and the online notification of research sites about receipt of biospecimens in a timely manner; 3) ability to accommodate multiple remote users (e.g., study participants entering data from homes) including flexibility in accommodating varying browsers; 4) ability to accommodate varying types of data including electronic medical data and digital files; 5) ability to provide or subcontract of expert biostatistical, information technological, or laboratory services as requested by the Government to meet the study's needs; 6) ability to provide logistical support for the scheduling, hosting and minute taking of Steering Committee meetings, DSMBs, and similar activities; and 6) ability to deliver interim and final databases and supporting documentation in formats requested by the Government. *The first task is in support of an observational cohort study to evaluate predictors of asthma control variability during pregnancy accounting for changes in lung function and markers of inflammation associated with pregnancy in non-asthmatics. A total of 400 women with asthma (200 with good asthma control and 200 with sub-optimal asthma control) and 150 women without asthma will be recruited at a clinical center (sought under another solicitation). Longitudinal collection of data from multiple sources (e.g., mobile devices, self-administered questionnaires, blood pressure measurements) is planned along with the collection of biospecimens (e.g., blood, urine) at repeated intervals timed to gestation. Subcontracting for laboratory research is also anticipated this project. *DESPRs research focuses exclusively on people and, as such, the Offeror must have proven expertise in the preparation of study materials needed for obtaining (often multiple) institutional review boards, Office of Management & Budget (OMB) applications, certificates of confidentiality, investigational new drug (IND) applications, and other necessary documentation. In addition, proven expertise in the development and maintenance of manual of procedures (MOP) is required. Changes to the MOP are expected to be documented in real time within the web based data management structure and to remain as a part of the official audit trail. *Key personnel shall be designated specifically for each Task and may include the Principal Investigator, Study Manager, Biostatistician, Web Programmer and/or Data Manager. The purpose of this announcement is to inform interested organizations of a planned Request for Proposals (RFP). This announcement is NOT an RFP. This is a 100% Small Business Set-Aside. It is anticipated that one award indefinite delivery / indefinite quantity (IDIQ), cost reimbursement contract will be awarded for a 5-year period with performance beginning on or about September 26, 2013. RFP-NIH-NICHD-DESPR-2013-15 will be available electronically on or about May 17, 2013, with a closing date tentatively set for June 18, 2013 and may be accessed through the FedBizOpps website: www.fbo.gov. Offerors are responsible for routinely checking this website for any amendments to the solicitation. Any questions concerning this announcement must be submitted in writing to Theresa Koomson, Contracting Officer, at tk12w@nih.gov or addressed to Ms. Theresa Koomson, Office of Acquisitions, NICHD, Executive Blvd., Suite 7A07, MSC 7510 Bethesda, Maryland 20892-7510. If sending by overnight carrier, use Rockville, Maryland 20852. The secondary point of contact is Ms. Elizabeth Osinski, Contracting Officer, at eo43m@nih.gov at the same address as above. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIH-NICHD-DESPR-2013-15/listing.html)
- Place of Performance
- Address: To be determined, United States
- Record
- SN03051699-W 20130504/130502235207-b0dc86f08b4772e9771c4799dbe2873c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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