SOURCES SOUGHT
B -- Continuation of Follow-up of DES-Exposed Cohorts
- Notice Date
- 12/22/2014
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NCI-SS-ETSB-1012-58
- 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
- Title: Continuation of Follow-up of DES-Exposed Cohorts Type of Notice: This is a Support Services Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential Support Services requirement. Background: The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) research focuses on discovering genetic and environmental determinants of cancer and identifying new approaches to cancer prevention. This project is for the re-competition of contracts HHSN261201000120C with Trustees of Dartmouth College, HHSN261201000128C with Trustees of Boston University, HHSN261201000129C with Tufts Medical Center, HHSN261201000137C with the Methodist Hospital Research Institute, and HHSN261201000145C with the University of Chicago, which were awarded on a competitive basis for a five year period. Purpose and Objectives: The purpose of this project is to continue to monitor the individuals participating in studies of DES for cancer risk, particularly among daughters as they approach menopause and among DES-exposed sons; assess the impact of and the risks associated with exposure to other hormones such as hormone replacement therapy in DES-exposed mothers and daughters; and study whether DES-exposed women and men will develop non-reproductive conditions, as required by congressional mandate under the DES Research and Education legislation. The NCI, in collaboration with five field centers assembled in the early 1990s, is following cohorts of DES exposed and unexposed mothers, daughters, sons, and more recently, granddaughters. The NCI has linked this exposure to increased breast cancer risk in mothers, increased risk of 12 serious adverse outcomes, including three malignancies, in exposed daughters, and urogenital anomalies and possibly testicular cancer in sons. The major objectives of the project are the following: •Monitor the cancer incidence among the DES exposed daughters, sons and granddaughters compared with external and internal rates, with particular focus on cancers of the breast, uterus, ovary, prostate and colon and rectum. •Monitor the mortality of mothers, daughters and sons. •Monitor the incidence of validated diagnoses of cardiovascular disease, and reported diagnoses of diabetes, osteoporosis, fractures, hypertension and high cholesterol comparing DES exposed with unexposed sons and daughters. •Monitor the incidence of preneoplastic events (in particular, CIN2+) and the incidence of benign lesions of the breast and urogenital tract among the exposed and unexposed daughters and granddaughters. •Continue to evaluate differences in reproductive experience among the granddaughters. •Compare mammographic densities between DES exposed and unexposed daughters. •Maintain a resource for biologic specimen collections to pursue underlying biological mechanisms for DES-related morbidities. Project Requirements: 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. Disease outcomes will be ascertained by means of questionnaires, medical record review, and tissue samples as appropriate. The work will include but not be limited to, mailing questionnaires to cohort members, conducting telephone interviews with study participants who did not respond to the questionnaire, validating certain outcomes reported on the questionnaire, analysis of resulting data, and development of a questionnaire for follow-up beyond the contract period. In addition, the work will include conducting searches of the National Death Index (NDI) (or providing death certificates) and relevant state cancer registries. Tracing efforts and keeping addresses up to date will occur throughout the contract period. Specific tasks to be performed by the Contractor include the following: 1)Conduct one questionnaire follow-up to ascertain disease outcome and risk factor information. The questionnaire will be developed under an existing 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 questionnaire to be administered to 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) Use quality control procedures to ensure standardization and high quality of data collection, including: •Maintain a written log or record book documenting any changes affecting study conduct or analysis for DCEG, NCI informational purposes. •Verify the completeness and accuracy of data sent to the coordinating center. •Train study personnel to follow study procedures, and strictly supervise their work. •Monitor 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. 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. 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 (the Steering Committee will consist of one (1) member from each Center, a representative from the Division of Cancer Epidemiology and Genetics (DCEG) and any consumer advocates and external advisors that provide general oversight to the study.) Meet one to two times during the year by phone with the Project Officers, 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. 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 the coordinating center. Anticipated Period of Performance: The anticipated period of performance for this requirement is one year, with four one-year options. Other Important Considerations: Only the Trustees of Dartmouth College, Trustees of Boston University, Tufts Medical Center, the Methodist Hospital Research Institute, and the University of Chicago hold the personal identifiers required for the surviving members of the existing cohorts. Capability Statement/Information Sought: We encourage all responsible sources, particularly small businesses, to submit a capability statement which will be considered by the agency. Organizations that submit capability statements in response to this notice will be evaluated against the following criteria: 1.Documented access to this unique cohort population consisting of at least 500 women, men and their grandchildren who were exposed to diethylstilbestrol (DES) in utero. This includes holding the personal identifiers for DES cohort participants that NCI requires. 2.Documented ability to obtain the necessary IRB approvals for the studies related to the DES cohort. 3.Documented ability to conduct tracing efforts of cohort participants. 4.Documented ability and experience in conducting cohort participant follow-up through the mailing of questionnaires, telephone interviews, and the collection of medical records. Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number. All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Rosa Lopez, Contract Specialist, at rosa.lopez@nih.gov in MS Word or Adobe Portable Document Format (PDF), by January 2, 2014, 2:00PM, EST. All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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