Population Assessment of Tobacco and Health (PATH) Study
Added: Mar 10, 2015 3:59 pm
The National Institute on Drug Abuse (NIDA), in partnership with the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) (collectively, the Government), plans to solicit proposals under full and open competition procedures from qualified organizations having the knowledge, expertise, experience, and capability to continue collection of behavioral data and biospecimens among new participants, aged-up participants, and continuing participants in a national longitudinal study.In brief, the Government plans to include performance of the following through this contract:(1) Develop and implement a national, probability-based sampling design to replenish the Population Assessment of Tobacco and Health (PATH) Study cohort to achieve the baseline sample size of at least 45,987 persons ages 12 years and older;(2) Implement procedures to ensure high rates of cohort retention and response over four biennial waves of behavioral and biospecimen collection;(3) Establish and maintain a sample of shadow youth for continual replenishment of the youngest age groups at each biennial wave;(4) Establish and maintain the youth cohort for continual replenishment of the youngest age groups in the adult cohort at each biennial wave;(5) Design, coordinate, and conduct cognitive testing with specified samples to enrich the PATH Study's development of assessment instruments for each wave;(6) Design, coordinate, and conduct methodological substudies with specified samples to enhance the PATH Study's data collection, including use of web-based data collection;(7) Develop assessment instruments in English and Spanish for youth and adults that minimize respondent burden and maximize respondent cooperation and confidentiality;(8) Develop and implement protocols for the collection and handling of biospecimens among youth and adults;(9) Arrange to requisition, process, track, and ship biospecimens from the repository for laboratory analysis; to track and ship residual biospecimens from the laboratory to the repository; and to link laboratory analytical results with behavioral data;(10) Establish a Biospecimen Access Committee (BAC) to evaluate applications by independent researchers for biospecimens; arrange to requisition, process, track, and ship biospecimens from the repository to researchers; and as necessary, arrange for the shipment of residual biospecimens from researchers to the repository;(11) Hire, train, retain, and motivate a team of field managers, supervisors, and interviewers to carry out the PATH Study's data and biospecimen collection with professionalism, courtesy, and rapport;(12) Set and maintain high standards of data quality and control over the entire data collection process, with use of such procedures as random data audits, ongoing data verification, Global Positioning System (GPS) tracking of PATH Study laptops, and spot checks of interviewer-participant interactions by monitoring Computer Assisted Recorded Interviews (CARI);(13) Plan, coordinate, and develop Information Clearance Requests (ICRs) for on-time submission through NIDA/NIH to the U.S. Office of Management and Budget (OMB) for review and approval of each biennial wave of data and biospecimen collection;(14) Design and develop one or more nested studies with random or targeted subsamples of the PATH Study cohort to conduct during and/or after a wave of data and biospecimen collection;(15) Plan, coordinate, and conduct analytical substudies, ranging from short-turnaround analyses on time-sensitive issues and high-priority questions to in-depth analyses that produce research papers and analytic reports for publications and/or presentations;(16) Create de-identified, cleaned data for analytic data files and data tables, with associated codebooks, for both restricted and public use;(17) Develop draft deliverables for review, revision, and resubmission that meet NIDA's requirements for the acceptance of final deliverables as specified herein and in the contract's schedule of deliverables;(18) Secure and protect Personally Identifiable Information (PII) of all participants;(19) Obtain security certification and accreditation under the Federal Information Management Security Act of 2002;(20) Continuously monitor security controls and update system documentation on the study's information system to inform the NIDA Authorizing Official's decision on whether to authorize operations; and(21) Link personal identifiers of consenting participants to cancer registries and archival medical records for purposes of validating data on behavioral health outcomes.Additional option quantities may include performance of one or more of the following tasks:(1) Plan substudies on topics selected by the Government and coordinate substudy teams to analyze data and prepare research papers on findings;(2) Analyze data and develop in-depth analytic reports on topics selected by the Government;(3) Perform short-turnaround analyses of varying types to address high-priority, time-sensitive questions and issues as determined by the Government;(4) Conduct formative developmental nested studies to prepare for one or more larger nested studies during and/or after a data-collection wave;(5) Perform small nested studies, which involve data collection from subgroups of cohort participants, during and/or after a data-collection wave;(6) Conduct medium-size nested studies, which involve data collection from a larger number of cohort participants than small nested studies, during and/or after a data-collection wave; and(7) Perform large nested studies, which involve data collection from larger samples of cohort participants than either small or medium-size nested studies, during and/or after a data-collection wave.Mandatory Criteria: The successful offeror must possess an approved Federal Wide Assurance (FWA) issued by the National Institutes of Health Office for Human Research Protections (OHRP) in order to conduct clinical research in humans. Offerors that do not possess this certification must demonstrate their submitted requisite documentation to OHRP for the issuance of an FWA by time of award. Award will not be made to any offeror who has not obtained the specified FWA.NIDA anticipates to award one cost-reimbursement completion type contract with a base period of eight months plus eight one-year option periods and potential option quantities. This award is a competitive renewal of HHSN271201100027C, titled "The Population Assessment of Tobacco and Health (PATH) Study."RFP No. N01DA-16-5582 will be available electronically on or around March 30, 2015. You may access the RFP through FedBizOpps (URL: http://fedbizopps.gov), the NIDA website (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps), or the NIH Guide. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA anticipates a December 2015 award date. NIDA will consider proposals submitted by any responsible offeror.Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.This advertisement does not commit the Government to award a contract.
N01DA-16-5582 Department of Health and Human Services National Institutes of Health
3/10/15, 3:59 PM