SOURCES SOUGHT
A -- Human Papillomavirus (HPV) Type 16/18 Vaccine Trial in Costa Rica
- Notice Date
- 5/24/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02CP11015-SBSS
- Archive Date
- 6/18/2011
- Point of Contact
- Seena Mathews, Phone: 3014353814
- E-Mail Address
-
mathewss@mail.nih.gov
(mathewss@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the size standard for such requirements is 500 employees. The National Institute of Cancer (NCI), Division of Cancer Epidemiology and Genetics (DCEG), is anticipating to award a 5-year non-competitive contract to Fundacion Inciensa (FUNIN) in Costa Rica to continue follow-up of women enrolled in studies regarding HPV infection and cervical neoplasia among vaccinated and unvaccinated women. This trial follows a large-scale NCI sponsored cohort investigation of women in the Guanacaste province of Costa Rica in which the link between HPV and cervival neoplasia was investigated under a previous NCI contract. This study was highly successful and achieved an overall participation rate of >90% which made it an attractive population to evaluate the efficacy of vaccine development to prevent HPV infections. Since 2004, FUNIN has been recruiting, enrolling, vaccinating and following a subset of these women. The requirements of the new award will permit NCI to evaluate the long-term vaccine effects and will enable evaluation of numerous questions regarding HPV vaccine immunology and the epidemiology of HPV and associated disease. Follow-up will allow for the evaluation of the HPV-16/18 vaccine among women through their early to mid-30s, therefore extending follow-up through the peak years of pre-cancer diagnosis among well-screened women. A more comprehensive evaluation of vaccine impact will therefore be possible, and larger numbers of pre-cancer outcomes (particularly pre-cancers caused by HPV types other than HPV-16/18) will be accrued for the various analyses envisioned. Some of the major activities of the contract include: 1) Obtain all other necessary approvals and clearances for the study from the collaborating institutions and appropriate agencies within each community in which the investigation is planned; 2) Institute procedures to maximize study participation and retention. These efforts shall include but not be limited to informational campaigns to inform the community about the study, mailings to participants, home visits by outreach workers, provision of transportation to and from the study clinics; 3) Assist in the development of forms and materials to be used in the study. This shall include informational brochures, questionnaires, and other study forms; 4) Ship and track study materials and biological specimens to the United States. This will include shipments at room temperature and in frozen states; 5) Collect data (interviewing, biologic specimen collection and processing); 6) Perform active follow-up and monitoring of all participants. Active follow-up of participants shall include at least one visit every two years, and more frequently if clinically indicated; 7) Provide for the treatment of minor conditions diagnosed at the time of a clinical examination; 8) Maintain quality control and standardization so that appropriate and valid data result can be reported. To be deemed capable of providing the current need for the study the offeror must submit a written capability statement. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: 1. Personnel/Experience: a) Proven organizational and past experience in conducting and managing large scale international longitudinal studies involving the recruitment and interview of study participants, the performance of clinical examinations including a pelvic examination and colposcopy, and the collection and processing of varied biological specimens. b) The offeror shall provide the name of the principal investigator, his/her professional qualifications and specific experience as a key investigator in HPV research and possessing sufficient authority to assure access to facilities and records required for the project c) The offeror shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein. 2. Facilities: Adequacy of clinical facilities for performing clinical exams, as well as facilities for data entry and management, and for the processing and storage of biospecimens prior to shipment to the United States. If any responsible source believes it can perform the requirements they may submit their capability statements via email (PDF format; 15 Page Limit, these pages exclude resumes) for consideration by NCI to Seena Ninan, Contracting Officer, at the e-mail address provided by the response date. No collect calls or facsimile transmissions will be accepted. Respondents must include DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the applicable NAICS code. 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(s). 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP11015-SBSS/listing.html)
- Record
- SN02455315-W 20110526/110524234415-6cf2a631cb67061230891eeca4d06882 (fbodaily.com)
- Source
-
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