MODIFICATION
B -- Continuation of Follow-up of DES-Exposed Cohorts - Solicitation 1
- Notice Date
- 5/8/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP51012-58
- Point of Contact
- Rosa M. Lopez, Phone: 2402765426, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
rosa.lopez@nih.gov, jill.johnson2@nih.gov
(rosa.lopez@nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation of Continuation of Follow-up of DES-Exposed Cohorts - N02CP51012-58 The Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) intends to re-compete contracts HHSN261201000120C with Trustees of Dartmouth College, HHSN261201000128C with Trustees of Boston University, HHSN261201000129C with Tufts Medical Center, HHSN261201000137C with Methodist Hospital Research Institute and HHSN261201000145C with the University of Chicago. The purpose of the contracts will be to continue follow-up of established DES cohorts (mothers, daughters, sons, and granddaughters) to measure cancer incidence and mortality, especially cancer of the breast and the reproductive system as the offspring enter a period of increasing cancer rates. Major activities of the Contractors include: (1) Conduct one questionnaire follow-up to ascertain disease outcome and risk factor information. The questionnaire will have already been developed under a separate contract. Mail questionnaires to all surviving daughters and sons, and encourage the use of an online questionnaire. The online questionnaire will be developed by a separate coordinating center identified by the Government. Conduct telephone interviews with subjects who did not complete a mailed or online questionnaire; (2) assist in development of a questionnaire to be administered to a third generation cohort. Conduct one questionnaire follow-up of DES-granddaughters to ascertain disease outcome and risk factor information. Contact the mothers of granddaughters who have reached 18 years of age and request consent to allow contact with them. Mail granddaughters the study questionnaire. Conduct telephone interviews with subjects who did not respond to the mailed questionnaire; (3) continue tracing efforts of cohort members who have been lost to follow-up through the use of, but not limited to, credit bureaus, motor vehicle bureaus, town listings, web sites, previously known contact persons, and searches of the NDI and state cancer registries. Keep addresses up-to-date, within one year, for recently contacted cohort members; (4) maintain quality control procedures to ensure standardization and high quality of data collection, including maintaining a written log or record book documenting any changes affecting study conduct or analysis for DCEG, NCI informational purposes, verifying the completeness and accuracy of data sent to the coordinating center, training study personnel to follow study procedures, and strictly supervise their work and monitoring the performance of field activities, by tracking response rates, workload, and completeness and accuracy of data collection; (5) collect medical records and pathology reports for questionnaire reports of melanoma and cervical cancer, but not for reports of other cancers that have been shown to be reported accurately by the study participants. Collect slides for reports of cervical disease (CIN2+); (6) provide data from completed questionnaires and medical record validation to the coordinating center, as identified by the Government. Determine causes of death for cohort members, including mothers, who have died. Contractor Investigators shall provide identifiers to the coordinating center for centralized determination of cause of death, either through use of the NDI Plus system or through acquisition and coding of death certificates; (7) agree to the pooling of non-identified data with other participants in this effort and to be involved in analyses approved by the Steering Committee. Meet one to two times during the year by phone with Contracting Officer Representative (COR), other collaborators, and members of the Steering Committee to discuss analysis of pooled data and to decide upon procedures for dissemination of data after the completion of the manuscripts prepared from the pooled data. Participate in conference calls to discuss progress on the study as needed; and (8) assist in developing a newsletter to maintain contact with the study participants and advise them of study findings. Mail two newsletters or letters to cohort members during the five-year period. The newsletters will be formatted and printed by a coordinating center under a separate contract. The project will require a contractor to continue follow-up of surviving members of an existing cohort of at least 500 women, men and their grandchildren who were exposed to diethylstilbestrol (DES) in utero. Prospective offerors must be able to provide demonstrated evidence of their ability to follow an existing cohort of at least 500 DES-exposed daughters, sons, and granddaughters. This would include describing the cohort as follows: (1) demonstrating access to the personal identifiers and appropriate medical records of the cohort participants; (2) detailing the initial requirements for inclusion in the cohort, including the basis for determining that DES exposure occurred; (3) extent of data on the regimen of DES given to individual cohort members or to the typical member; (4) total number of subjects initially eligible, losses to follow-up (by time), deaths (by time), and survivors; (5) total number of exposed and unexposed daughters, sons and granddaughters to be followed, and number of questionnaires to be mailed; (6) proportion of subjects in number 4 expected to respond to the questionnaire and anticipated proportion that will require telephone interviews; (7) occurrence of neoplasms in the cohort as measured to date and expected number that will occur over the next 5 years; (8) extent of clinical data on cohort members from first and subsequent exams, if applicable; and (9) extent of other data on cohort members from medical records, interviews or questionnaires, if applicable. Prospective offerors must additionally provide information characterizing the cohort, the study base, and data including: (1) a description of a cohort of unexposed subjects selected to be comparable to men or women who were exposed in utero; (2) special resources for confirming reported neoplasms; and (3) information on the accuracy and completeness of the study database. The Government anticipates that five (5) contracts will be awarded with a base period of one year and four one year option periods. The NAICS Code is 541990. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.
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-
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- Record
- SN03725709-W 20150510/150508235401-365e8b04d533db62cc660caa8417bbb2 (fbodaily.com)
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