Herpes H1-H2 Data Collection

Sources Sought Sources Sought This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open competitive procedures should be utilized. This is strictly market research and the Government will not entertain any questions. Background The National Health and Nutrition Examination Survey (NHANES) is a program of studies conducted by the National Center for Health Statistics (NCHS) designed to provide national statistics on the health and nutritional status of the civilian, non-institutionalized U.S. population through household interviews, standardized physical examinations, and the collection of biologic samples in special mobile examination centers (MEC). The survey oversamples the largest race/ethnic minority groups, including Hispanics, non-Hispanic blacks, and non-Hispanic Asians, along with other subgroups of the population. It is estimated that approximately 20,000 individuals ages one year and older will be examined during the period of performance of this contract. This Statement of Work (SOW) seeks to obtain laboratory measurements on biologic samples for Herpes Simplex Virus Types (HSV) 1 and 2. These tests will be performed on participants aged 14 - 49 years old. Blood samples are collected in morning, afternoon and evening sessions. These tests will be measured on all participants 14-49 years old in all sessions. Biological samples will be collected on a regular basis throughout the year and shipped to the testing laboratory on a weekly basis, with the exception of two weeks for a summer break and two weeks over the holiday season at the end of the year. The contractor shall provide any and all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements. These tests must be batched as a single award. However, the government retains the right to only fund a portion of the tests each year. Data collection for the NHANES 2021-2026 survey cycles will commence in 2021 and conclude in 2026. Prior to the commencement of data collection, all data management, programming, quality control and reporting system changes must be developed. Objective and Scope Objective The purpose of the NHANES sexually transmitted infection (STI) data collection and testing, specifically for HSV Types 1 and 2 in serum, is to monitor national trends in HIV and STIs in the United States. NHANES is unique in that the laboratory data can be linked to NHANES sexual behavior questions, which allow for a better understanding of risk factors and trends. The availability of sexually transmitted infection and risk factors data in a national sample over time is a unique and invaluable resource for evaluation of national HIV/STD risk-reduction efforts and for risk-based modeling of the burden and trends of sexually transmitted infections. HSV is categorized by two types: HSV-1 and HSV-2. HSV-1 is a common chronic infection that is the cause of most oral herpes or cold sores. HSV-2 is a sexually transmitted infection and can be used as a marker for sexual transmission of other infectious agents. HSV-2 infections are rarely life threatening, but morbidity due to painful genital ulcerations is significant. HSV-2 infection is one of the best markers of sexual risk factors leading to sexually transmitted infections, because: (a) HSV-2 infections are common and, thus, HSV-2 rates are a measure of sexual risk in the broader population beyond high risk groups; (b) HSV-2 infection is almost always a result of sexual transmission and, thus, a specific measure of sexually transmitted infection; (c) HSV-2 infections are not curable and, thus, HSV-2 risk is not influenced by health care-seeking factors; and (d) sensitive, specific, and relatively inexpensive tests for HSV-2 antibody are available. HSV-2 is a very important marker for monitoring the impact of large national efforts, motivated by the HIV epidemic, to reduce risky sexual behaviors. 1.2.2 Scope This technical approach involves five primary tasks: 1) submit current Clinical Laboratory Improvement Amendments (CLIA) certificate, review the NHANES Contract Laboratory Manual, develop and test systems for testing and reporting NHANES HSV Types 1 and 2 samples for length of the contract, submit NHANES Initial Requirements Laboratory Checklist, and perform HSV Type 1 and 2 testing on 150-200 samples provided by NHANES; 2) perform HSV Type 1 and 2 antibody testing on serum and submit results in a base year, and four potential option years, submit quarterly reports, provide updated CLIA certificate as needed and store NHANES samples for at least one year; 3) Development and delivery of laboratory procedure manual(s). This work shall provide laboratory measurements for HSV Type 1 and 2. Specifically, this effort will allow the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC) to provide HSV Type 1 and 2 data for public use. The CDC is conducting this Sources Sought to identify contractors who possess the capabilities to provide services as specified in the objectives above and to determine their availability and capability. If your firm may be interested in this requirement and has performed similar projects, please submit your response in accordance with the submission instructions below. Based on the responses to this Sources Sought Notice, this requirement may be set-aside for small business or procured through full and open competition. Submission Instructions: Respondents who believe that they possess the expertise and experience to meet the government's needs as described above are invited to submit technical and management capabilities addressing those requirements. These may include but are not limited to: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Respondent must indicate in your capability statement: Organization name, Address, DUNS number, Business size Classification (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code of 621511 size standard which is $35.5 million. Points of contact, Email, Telephone number, Page Limitation: No more than fifteen (15) pages, 8 - x 11. Response Due Date: Submit information above to Cynthia Mitchell, Contracting Officer CMItchell@cdc.gov. Responses are due on or before 2:00 pm, Eastern Time Local, June 25th. Any information received by the government will not be returned.