SOLICITATION NOTICE
B -- Average Treatment Effect Estimation Accounting For Covariate Measurement Error New Casual Model Technique with Medical Device Application: Impact of Breast Pump Use on Mother's Breast-Feeding Practice and Infant's Health
- Notice Date
- 6/21/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1073527
- Archive Date
- 7/14/2010
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-30. 30. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 541690, is to notify contractors that the government intends to issue a Firm Fixed Price Contract in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This action is designated as Full and Open The performance period is on or about May 1, 2010 to August 30, 2011. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotes (RFQ). The Food and Drug Administration (FDA) intends to award a firm fixed price contract for The Average Effect Estimation Accounting Covariate Measurement Error New Casual Model Technique with Medical Device Application. The Impact of Breast Pump Use on Mother's Breast Feeding Practice and Infant Health Specifications in reference to this solicitation are listed as follows: Statement of Work Title: Average Treatment Effect Estimation Accounting for Covariate Measurement Error - New causal model technique with a medical device application: the Impact of Breast Pump Use on Mother's Breast-Feeding Practice and Infant's Health Background From a methodological point of view, ignoring measurement error in covariates (a fairly common issue) may lead to misleading inferences on average treatment or exposure effects evaluation in non-randomized studies. Although an analysis based on a carefully conducted, randomized and controlled clinical trial is still the gold standard in obtaining valid causal effects of medical products, such designs can be either impractical or too burdensome to conduct in pre-market and post-market studies. For example, for medical devices, it is not uncommon to have a non-randomized design for the Investigational Device Exemption (IDE) study in the premarket phase; and very frequently a prospective, controlled cohort design is used for the Post-approval Study (PAS) of medical devices at the post-market phase. Average causal effect (ACE) estimation methods for these non-randomized studies have typically relied on standard propensity scoring techniques under the traditional causal framework, which assumes all covariates are measured accurately and no unobserved factors influence the treatment and outcome (Rosenbaum and Rubin, 1983,1984; Dehejia and Wahba, 1999). However, covariates are often measured with unobservable error, which violates the critical assumption underlying the current causal framework. Since ignoring the error often leads to significant biased results, extending the standard causal inference framework allowing covariate measurement error and developing appropriate estimation methods are of critical importance for a valid assessment of the safety and efficacy of medical products (including devices, drugs, and biologics) in both the pre-market and post-market phases. From an application point of view, the breast pump is a medical device regulated by CDRH and broadly used in US. A study has shown that 85% of mothers who breastfed infants that were 1.5-4.5 months old used a breast pump. However, little is known about how mothers' experiences with breast pumps, including both benefits and adverse events, impact their breast feeding practice. The American Academy of Pediatrics recommends that infants receive breast milk throughout the first year of their life. Therefore, it is important to know how the mother's breast feeding practice associated with the use of a breast pump and how the breast pump usage influences the infant's health. However, some important confounders, e.g. household social economic status and mother's post-natal health status, are either unobservable or liable to measurement error. The presence of measurement error in covariates violates the critical assumption underlying the current causal framework, which need new causal methods to address these two important questions. In this project, we plan to use IFPS II data (Infant Feeding Practices Study II) (Fein, 2008), a major longitudinal study conducted by FDA in collaboration with CDC, NIH, DHHS/OWH, and the Maternal and Child Health Bureau. The data have been analyzed for presentation at the annual meetings of the American Public Health Association in November 2007 and were published in a journal supplement in 2008. Purpose The purpose of this requisition is to procure appropriate source to: (1) develop a causal inference framework to allow covariate measurement error; (2) develop a new causal inference model for average treatment effect estimation accounting for the measurement error structure under non-randomized clinical trials and observational studies; and (3) apply this new causal model on the evaluation of the health impact of breast pump usage using IFPS II data. Scope of Work The contractor shall: • develop a new statistical methodology to: o create a causal inference framework to allow for covariate measurement error. o develop an average treatment effect (ATE) estimation model under the new causal framework that accounts for covariate measurement error, based on existing propensity score methodology. o conduct simulation studies to demonstrate the advantages of the new method over the currently used propensity score-based causal inference method. • participate in developing and writing manuscripts describing the extended causal framework and the proposed new estimation methods. • conduct the data analysis, using IFPS II data, to evaluate the health impact of breast pump usage on mother's breast feeding behavior and infants' health status using the newly developed causal inference model and conventional propensity score-based causal inference method. • participate in writing manuscripts describing the impact of breast pump use on Mother and infant health. • submit the final report/documentation of the developed new Causal Inference Methodology. Timeline with Major Milestones and Deliverables The contractor shall submit the following: (all submissions shall be electronic) 1) Statistical plan of developing a new causal inference methodology to allow covariate measurement error, and the documentation for the development of estimation methods. 2) Manuscript for the development of average treatment effect (ATE) model under the proposed causal framework accounting for covariate measurement error. 3) Data analysis results for the evaluation of the impact of breast pump usage on mother and infant health using IFPS II data. 4) The SAS or statistical programs used to analyze the data, and an interpretation of the results. 5) Final report and documentation of new Causal Inference Methodology and its application on the study of Breast Pump Use. Schedule of Deliverables Scheduled item Due Date 1) Statistical plan of developing a new causal inference methodology to allow covariate measurement error, and the documentation for the development of estimation methods 10-30-2010 2) Manuscript for ATE estimation 12-31-2010 3) Data analysis results for the evaluation of breast pump usage 03-30-2011 4) Interpretation of results for the drafting of manuscript 05-30-2011 5) Final report and documentation of new Causal Inference Methodology and its application on the evaluation of Breast pump Use 08-30-2011 Place of Performance The work shall be performed at the contractor's site. Evaluation Criteria The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Personnel (35 points) The offeror shall name the participating personnel and identify their qualifications and experience. The offeror shall provide personnel who have education in statistics, biostatistics, or a field that includes statistical training such as epidemiology. The personnel shall have formal training in longitudinal data analysis and causal inference methodology. Relevant Experience (40 points) The offeror shall provide personnel who are familiar with the IFPS II study and dataset, have demonstrated professional knowledge of developing causal inference methodology modeling and longitudinal data analysis. Overall Price (15 points) The offeror shall provide the best overall value for the FDA in terms of cost, relevant experience and approach. Project Management (10 points) The offeror shall provide information on the administration of the project. This should include management plans, methods for achieving data analysis and manuscript writing, and quality control procedures. ***Responses to this solicitation should not exceed 10 pages.*** The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible offerors within the competitive range. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest priced. Relative importance and trade-offs. The Government will base the determination of best value on performance and evaluation factors as identified above. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to maryrose.nicol@fda. no later than June 24, 2009 5:00 pm EST. QUOTATIONS DUE: All quotations are due, via email to: maryrose.nicol@fda.hhs.gov no later than 5:00 pm, EST on June 29, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33, FAR 52.217-9 Option to Extend the Term of the Contract. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to maryrose.nicol@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1073527/listing.html)
- Place of Performance
- Address: Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN02182997-W 20100623/100621234557-e1bf67880049929c824118dead9f3365 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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