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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 12, 2014 FBO #4491
SOURCES SOUGHT

B -- Cortisol Saliva Analysis and Saliva Collection Supplies - Statement of Work

Notice Date
3/10/2014
 
Notice Type
Sources Sought
 
NAICS
621511 — Medical Laboratories
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
 
ZIP Code
21702
 
Solicitation Number
HHS-NIH-NCI-SBSS-TSB-44410-11
 
Archive Date
4/1/2014
 
Point of Contact
Brenda Oberholzer, Phone: 301-624-8750
 
E-Mail Address
oberholzerb@mail.nih.gov
(oberholzerb@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
Statement of Work 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 621511 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $30 Million. A. Background In clinical protocol 14-AT-0054, we are measuring group differences in baseline salivary cortisol levels over time, as well as salivary cortisol levels in response to experimental tasks. Both measures are important for understanding hypothalamo-pituitary axis function in yoga practitioners versus control subjects. For this project, we will collect 35 saliva samples/person for the baseline cortisol measure and 7 saliva samples/person during the experimental task. We will be testing a maximum of 98 subjects, and therefore will collect and analyze up to a total of 4116 saliva samples. In the event that our primary outcome reaches significance before all 98 participants have been tested, we may terminate the study early. The National Center of Complementary and Alternative Medicine (NCCAM) is anticipating to award a firm-fixed price competitive purchase order for the necessary supplies and cortisol saliva analysis of 4,116 samples over a two-year period. B. Purpose and Objectives of the Procurement Provide a source of clinical grade supplies and equipment and provide a qualified testing facility capable of analyzing a large volume of samples (4,116) over a period of 2 years while maintaining a high level of accuracy in testing and reliable and repeatable analysis. The contractor shall be required to; 1. Provide supplies (swabs, storage tubes with coded labels, cryogenic storage boxes and dry-ice shipment boxes). Swabs are preferred over passive drool sampling as the latter often leads to under-sampling and inaccuracies. Passive sampling is particularly problematic when the samples are acquired at home, like most of the samples in the current study, as the researcher cannot correct the participant if under-sampling has occurred. 2. Be able to perform testing on samples received in multiple shipments, as the samples can be altered if frozen for long periods of time. Saliva samples will be stored at the NIH in -80 C freezers. Collection tubes can only survive in the freezer for 6 months, therefore it is extremely important that we have flexibility in how many samples we can send for out testing services at a time. 3. Provide the highest accuracy in testing: Cortisol is assayed using a highly sensitive enzyme immunoassay and the samples should be assayed in duplicate for at least part of the sampling to determine accuracy. We need the samples tested at least to include 85% singlet testing and 15% in duplicate testing (i.e. two test results per sample), (see attached Granger paper, Incorporating Salivary Biomarkers Into Nursing Research: An Overview and Review of Best Practices). We need the company to provide an average intra-assay coefficient of variation <5%, and because testing of 4,116 samples will require numerous assays, we need the company to provide an average inter-assay coefficient of variation <6%. The higher the coefficients the less accurate the testing. 4. Provide a CLIA (Clinical Laboratory Improvement Amendments) certified testing facility. U.S. regulations created to provide quality standards for laboratory testing to ensure accuracy, reliability and timeliness of test results. C. Contractor Requirements To be deemed capable of providing the current need the organization must submit a written tailored capability statement. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: Personnel/Experience: a. Proven organizational and past experience in salivary cortisol analysis. b. The organization shall provide the name of the Principal Investigator, his/her professional qualifications and specific experience as a key investigator in cortisol saliva analysis. c. The organization shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein. Facilities: Adequacy of facilities for performing the Statement of Work. The organization shall provide evidence of CLIA certification and testing accuracy standards. 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 Brenda Oberholzer, Contracting Officer, at oberholzerb@mail.nih.gov by the 12 pm ET, March 17, 2014. 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. 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/FCRF2/HHS-NIH-NCI-SBSS-TSB-44410-11/listing.html)
 
Place of Performance
Address: Contractor location, United States
 
Record
SN03306861-W 20140312/140310235237-2ab96a865b88c43ba6d4cb44663cbd13 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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