SOURCES SOUGHT
Q -- Human Papillomavirus Virus Testing
- Notice Date
- 2/17/2016
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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
- RFI-N02CP62532-24
- Archive Date
- 3/8/2016
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Jolomi Omatete, Phone: 2402766561
- E-Mail Address
-
kimesha.leake@nih.gov, jolomi.omatete@nih.gov
(kimesha.leake@nih.gov, jolomi.omatete@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Key Dates: Capability Statement Due Date: February 22, 2016, 2016 1:00 pm Eastern Time Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ General Information: This Request for Information (RFI) is to obtain knowledge and information for project planning purposes. The information gleaned for this RFI will allow the NCI to develop acquisition specifications/requirements as it pertains to the study entitled "Prospective Evaluation of HPV Prior to Diagnosis of Incident Head and Neck Cancer and Anogenital Cancer." It should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the NCI. The NCI does not intend to award a cooperative agreement, grant, or contract on the basis of responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Purpose: Based on the response to this RFI, the NCI may issue a solicitation at an undetermined time in the future or use the information to guide purchases of equipment, adaptation of specific methodologies or conduct specific methodological research. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME, no basis for claims against NCI shall arise as a result of a response to this Request for Information notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. This notice is for market research only. The NCI is specifically interested in determining the types of organizations available in the marketplace that provide these technologies. In particular, the NCI is seeking qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB] which provide these technologies. Based on the responses received from this announcement, an acquisition may be solicited as a Total Small Business Set-Aside. NAICS Code and Size Standard: In the event an RFQ is issued, North American Industry Classification System (NAICS) code 541380 with a size standard of $14.0 million is being considered. Background: Human papilloma virus (HPV) is the cause of cervical cancer, as well as subsets of cancers at other anatomic sites, including the oropharynx, vulva/vagina, penis, and anus. We recently reported that HPV16 E6 seropositivity was present in prediagnostic samples for 34.8% of oropharyngeal cancer cases and 0.6% of controls. The increased risk of oropharyngeal cancer among HPV16 E6 seropositive participants was independent of time between blood collection and diagnosis and was observed more than 10 years before diagnosis. NCI now aims to confirm its initial finding by testing additional samples from other studies, and to expand its research to anogenital cancers, in order to understand whether this potential cancer biomarker is unique to HPV-driven oropharyngeal cancer, or also predicts risk at other anatomic sites where HPV is known to be a causal factor. Purpose and objectives: The purpose of the procurement is to provide HPV laboratory testing to support this NCI-IARC (International Agency for Research on Cancer) collaborative case-control study. This study has 4 aims: Confirm the main effects of HPV on cancer at several anatomic sites of the head and neck Expand evaluation to cancers of the anogenital region Investigate the specificity of the marker in people without cancer Evaluate the sensitivity of the marker by comparing it to the gold-standard of HPV in corresponding tumor samples. Information Requested: The Contractor shall perform HPV testing of serum samples from cases and controls, and tumor samples from cases from multiple cohort studies. The Contractor shall perform testing and provide the following deliverables. The data files formats are described below. Tasks: HPV testing in samples: The contractor shall perform HPV testing of formalin-fixed paraffin-embedded (FFPE) tumor samples tissues from cases using the same HPV testing platforms (described below) used in the Europe cohort studies (EPIC). It is necessary that the tumors from the US-based PLCO study be tested using the exact same methodology and platforms as those used for the European cohort so that the same results are interpretable across the studies. Further, pathology archive samples from these cohort studies do not have access to fresh frozen tissue-instead, only FFPE is available. The testing approaches include DNA and RNA detection (including the necessary extraction step), as well as p16 immunohistochemistry specifically: P16 IHC (approximate quantity 61 samples) HPV 16 RNA (approximate quantity 61 samples) HPV x RNA (approximate quantity 30 samples) Period of Performance The period of performance should will be one base year, starting from the date of award and one option year. Reporting requirements and deliverables HPV test results will be delivered to the NCI Contracting Officer Representative (COR) annually. The deliverables shall include a data file based on the results of the specified testing. The data files shall be provided as Excel files. The files shall be provided to the COR by email. The deliverables will be provided at the end of the year. The Principal Investigator (PI) and the contractor will be in communication throughout the process to assure quality control. Communication will consist of conference calls and emails. Inspection and acceptance criteria The government shall have 30 days for inspection and acceptance of each deliverable. The government will issue payment for the deliverable following acceptance of the deliverable. Additional comments relevant to this RFI, and addressing issues that are not specifically mentioned above, are also encouraged. How to Submit a Response: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single space, 12 point font minimum) that clearly details the ability to perform the aspects of the notice described above. Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. All proprietary information should be marked as such. 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 (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NCI personnel and will be held in a confidential manner. Due Date: Capability statements are due no later than February 22, 2016 1:00 pm Eastern Time Delivery Point: All capability statements sent in response to the Request for Information must be submitted electronically (via e-mail) to Kimesha Leake at kimesha.leake@nih.gov in MS Word, WordPerfect or Adobe Portable Document Format (PDF). All responses must be received at NCI by the specified due date and time in order to be considered. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and emailed to Kimesha Leake, Contract Specialist at kimesha.leake@nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) www.sam.gov. No collect calls will be accepted. Please reference solicitation number RFI-N02CP62532-24 on all correspondences. Point of Contact: Inquiries concerning this Notice may be directed to: Kimesha Leake, Contract Specialist 9609 Medical Center Drive, room 1E626 Rockville, MD 20850 kimesha.leake@nih.gov
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