SOURCES SOUGHT
A -- Evaluation of single dose protection afforded by the prophylactic HPV vaccines
- Notice Date
- 5/17/2016
- 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, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SBSS-ETSB-1010-59
- Archive Date
- 6/8/2016
- Point of Contact
- Corwin Stephens, Phone: 2402765362
- E-Mail Address
-
corwin.stephens@nih.gov
(corwin.stephens@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. I. Background: Since 2004, Fundacion Inciensa (FUNIN) has been recruiting, enrolling, vaccinating and following a cohort of women in the Guanacaste province of Costa Rica in which the link between the Human Papillomavirus (HPV) and cervical 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. A follow-up contract was awarded in 2012. The Costa Rica HPV Vaccine Trial showed similar HPV vaccine efficacy over four years among women who received one, two and three doses of the HPV16/18 vaccine, and stable antibody responses have been observed throughout the seven years of follow-up studies accrued to date. Continuing to investigate these discoveries and further document the protection afforded by fewer doses could result in a monumental, global public health breakthrough. II. Purpose and Objectives: The NCI is seeking to support a prospective clinical trial aimed at evaluating the non-inferiority of 1 versus 2 doses of the HPV vaccines. The contract will also permit an additional extension to the follow-up of women in our ongoing Costa Rica Vaccine Trial (CVT), which initially followed women for 10 years and will now extend that follow-up out to 15 years among a subset of participants. CVT showed similar HPV vaccine efficacy over four years among women who received one, two and three doses of the HPV16/18 vaccine, and stable antibody responses have been observed throughout the seven years of follow-up accrued to date in CVT, following up on these discoveries and further documenting the protection afforded by fewer doses could result in a monumental, global public health breakthrough. Thus, this new trial that will directly evaluate the protection afforded by single-dose and two-dose regimens of the prophylactic HPV vaccines. Continuation of the current cohort will document durability of antibody titers among women who received fewer doses. III. Capability Statement/Information Sought: 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: a) 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. We encourage all responsible sources, particularly small businesses, to submit detailed concise information which will be considered by the agency. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the size standard for such requirements is 1,000 employees. IV. Submission Information: Interested and qualified organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. For small businesses, statements should 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 concerns 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 Corwin Stephens, Contracting Officer, corwin.stephens@nih.gov in Adobe Portable Document Format (PDF), by May 24, 2016 5:00 PM EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. V. 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. VI. 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/HHS-NIH-NCI-SBSS-ETSB-1010-59/listing.html)
- Record
- SN04118990-W 20160519/160517234404-890c82e10038529a1371406eeeb7b329 (fbodaily.com)
- Source
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