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General Information Short Title: Case-control study of early-life residential exposure to tetrachloroethylene and risks of childhood cancers, congenital anomalies and fetal death Document Type: Notice... General Information Short Title: Case-control study of early-life residential exposure to tetrachloroethylene and risks of childhood cancers, congenital anomalies and fetal death Document Type: Notice of Intent Solicitation Number: 75N91021R00025 Posted Date: 2/23/2021 Response Date: 3/2/2021 Classification Code: B599 – Special Studies NAICS Code: 541990 – All Other Professional, Scientific and Technical Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), intends to procure services on a sole source basis from Health Research, Inc. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. Only one award will be made as a result of this solicitation. This will be awarded as a Severable firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND Tetrachloroethylene (perchloroethylene, or “perc”) is a widely used solvent in the dry-cleaning industry. The International Agency for Research on Cancer (IARC) has classified perc as a probable human carcinogen based on sufficient evidence in experimental animals and limited human evidence, primarily from occupational studies. Perc is also recognized as an environmental pollutant, released mainly from commercial and industrial sources, and may be harmful to children; maternal exposures during pregnancy have been associated with increased risk of childhood leukemia, as well as excess risks of selected congenital anomalies and fetal death. Environmental perc exposure is of particular concern for residents in buildings with a co-located dry-cleaning facility, with perc concentrations in residential air and blood at least 10 to 100 times higher than for residents of buildings without a co-located facility. However, no epidemiologic studies to date have investigated cancer risks associated with residential exposures from co-located dry-cleaning facilities. The mission of the Occupational and Environmental Epidemiology Branch (OEEB) of the National Cancer Institute Division of Cancer Epidemiology and Genetics (DCEG) is to investigate occupational and environmental exposures suspected to cause cancer. Occupational perc exposure has been a longstanding research focus of the branch. To investigate the risks of childhood cancer and other events from early-life environmental perc exposure, OEEB investigators propose to conduct a record linkage-based case-control study using New York State (NYS) health databases to examine the association between early-life residential exposure to perc (from residence in a New York City (NYC) building with a ground-floor dry cleaning facility) and risks of childhood cancers, congenital anomalies and fetal death. OBJECTIVE To investigate whether early-life residential perc exposure (defined as maternal residence at the child’s birth in a building with a ground-floor dry-cleaning facility using perc) is associated with elevated risk of childhood cancers, congenital anomalies and fetal death. SCOPE To perform this study, the Contractor will conduct data linkage of records from the NYC vital statistics database, the NYS Cancer Registry and the NYS Congenital Maladies Registry (CMR), select cases and controls for the study in consultation with the National Cancer Institute (NCI), and coordinate assessment of early-life residential perc exposure through linkages of dry cleaning facility addresses and maternal addresses on birth certificates. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The Contractor shall perform the following tasks: Participate in monthly conference calls with NCI to discuss project issues. Receive data file containing vital statistics records (births and fetal deaths) dated between 1985 and 2016 from the NYC Department of Health and Mental Hygiene. Extract from NYS Cancer Registry records of incident cancers diagnosed between the ages of 0 and 19 between 1985 and most recent year with complete registry data. Extract from NYS CMR incident records of congenital anomalies diagnosed between 1985 and most recent year with complete registry data. Link the NYS Cancer Registry and CMR records to the NYC birth records through probabilistic linkage using selected identifiers (birth certificate number, date of birth, sex, name, maternal residence zip code). Select eligible cases for the three case groups (childhood cancers, congenital anomalies, fetal deaths) on the basis of maternal residence in NYC on the birth certificate (or fetal death record). Select study controls from among NYC live births between 1985 and 2016 with a maternal address in NYC on the birth certificate. Controls shall be frequency matched to the overall case distribution (at a ~1:1 ratio to fetal deaths) by child sex and year of birth (or fetal death). Link maternal residence address from birth certificate (and, where available, case address info at diagnosis from cancer cases) to geocoded dry cleaning facility addresses from DEC using geocode coordinates and NYC building identification numbers. Prepare a report summarizing the final methods used to design the case-control study. Deliver a study data set (stripped of personally identifiable information) to NCI containing information regarding the following: case-control status; disease type and diagnosis date (if applicable), birth certificate data regarding the delivery, newborn, mother and father; and exposure data. Data dictionary definine the variable labels and codes in the dataset (MS Word or Adobe PDF). TYPE OF ORDER This will be issued as a Severable Firm Fixed Price Purchase Order. The services acquired under this contract are severable services. Funds are only available for use for the contract line item number (CLIN) to which they are obligated. Unused funds from one CLIN or option period may not rollover for use in other periods or CLINs. PERIOD OF PERFORMANCE The period of performance is from March 15, 2021 to March 14, 2022. PLACE OF PERFORMANCE All work shall be performed at the Contractor’s facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All deliverables shall be sent electronically (unless approved by the COR) per the following deliverable schedule: DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE #1 (Task 4.1) Monthly teleconference with NCI to discuss project issues First week of every month (times TBD) #2 (Tasks 4.2, 4.3, 4.4) Extract the specified records from the NYC vital statistics database, NYS Cancer Registry and NYS CMR. 3 months from date of award #3 (Tasks 4.5, 4.6, 4.7) Link the vital statistics records to the cancer registry and CMR records, and select eligible cases and controls 6 months from date of award #4 (Task 4.8) Link maternal residence address from birth certificate (and, where available, case address info at diagnosis from cancer cases) to geocoded dry cleaning facility addresses from DEC using geocode coordinates and NYC building identification numbers. 9 months from date of award #1 (Task 4.9) Report summarizing the final methods used to design the case-control study (MS Word or Adobe PDF format). 30 days prior to end of period of performance #2 (Task 4.10) Study data set (stripped of personally identifiable information) to NCI containing information regarding the following: case-control status; disease type and diagnosis date (if applicable), birth certificate data regarding the delivery, newborn, mother and father; and exposure data (MS Excel or tab-delimited text format). 30 days prior to end of period of performance #3 (Task 4.11) Data dictionary definine the variable labels and codes in the dataset (MS Word or Adobe PDF). 30 days prior to end of period of performance The planned study will involve linking together cancer registry records (to identify childhood cancer cases diagnosed in NYC), congenital anomalies records (to identify childhood anomalies diagnosed in NYC) and vital statistics records (to identify cases of fetal deaths in NYC, select a study control group of NYC live births, and obtain for all selected subjects the mother’s address at birth for exposure assessment). The NYSDOH/HRI collects and manages several registries and databases capturing different types of health records and health events in the state, including the NYS cancer registry, NYS congenital maladies registry and vital statistics database (capturing birth and death certificates). NYSDOH/HRI is uniquely qualified for this acquisition because it is the only organization with access to the complete records including personal identifiable information. It would be impossible to carry out this study without NYSDOH/HRI. In order to carry out this research it is essential to work with complete NYS health records including personally identifiable information like name, date of birth, address etc. Such records with personal identifiers are not accessible to researchers outside of NYSDOH/HRI for reasons of data privacy. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on March 2, 2021. All responses and questions must be emailed to David Romley, Contract Specialist via electronic mail at david.romley@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91021R00025 on all correspondence.