SOLICITATION NOTICE
B -- A Randomized Trial of the Effect of Exercise Participation on Estrogen Exposure and Metabolism
- Notice Date
- 8/10/2014
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02CP42633-57
- Archive Date
- 9/9/2014
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442, Terry L. Galloway, Phone: 240-276-5384
- E-Mail Address
-
reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov
(reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Nutritional Epidemiology Branch (NEB), plans to procure on a sole source basis services to evaluate the ability of 12-months of exercise to influence circulating estrogen levels and estrogen metabolism in postmenopausal women from Craft Technologies, Inc., 4344 Frank Price Church Road, Wilson, NC 27893. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The National Cancer Institute (NCI) has developed a stable isotope dilution liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay for measuring concurrently all 15 estrogens and estrogen metabolites (EM) in human serum, in both unconjugated+conjugated and unconjugated only forms, with high sensitivity, validity, and reproducibility (Xu X et al, Anal Chem 2007 79:7813-21). The specific EM include the parent estrogens (estrone and estradiol); metabolites in the 2-hydroxylation pathway (2-hydroxyestrone, 2-methoxyestrone, 2-hydroxyestradiol, 2-methoxyestradiol, and 2-hydroxyestrone-3-methyl ether); metabolites in the 4-hydroxylation pathway (4-hydroxyestrone, 4-methoxyestrone, and 4-methoxyestradiol); and metabolites in the 16-hydroxylation pathway (16a-hydroxyestrone, estriol, 17-epiestriol, 16-ketoestradiol, and 16-epiestriol). Laboratory and clinical studies have suggested that specific estrogen metabolism profiles and/or specific estrogen metabolites may play a role in breast cancer etiology. Development of the LC-MS/MS assay allowed for the first time robust tests of these hypotheses about estrogen metabolism in population studies. The Nutritional Epidemiology Branch proposes to conduct the first study of exercise and estrogen metabolism in postmenopausal women using a comprehensive serum-based measure of all 15 EM. The Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial randomized 320 postmenopausal women to either 12 months of aerobic exercise or a control group. Study retention was excellent (96% completion) and exercise adherence was exceptional (exercisers averaged 178.5 min/week of aerobic exercise). Women in the exercise condition increased cardiorespiratory fitness by 14%, lost 2.4 kg of body fat, and had lower circulating estradiol and higher sex hormone-binding globulin at 12 months. The Contractor shall: 1) Assay total (conjugated+unconjugated) concentrations of 15 estrogens/estrogen metabolites (EM) in 688 serum (sample volume=0.3 mL) samples from postmenopausal women participating in the randomized ALPHA Trial. Results from each batch of 43 samples (40 unknowns + 3 blinded quality control materials) shall be transmitted to the Contracting Officer's Representative (COR) within three working days of completion of the assays. To the DCEG's knowledge, Craft Technologies, Inc. is the only laboratory that has developed an assay for the 15 circulating estrogens and estrogen metabolites (EM) in serum samples with 1) sensitivity adequate to measure all 15 EM in postmenopausal women, 2) high reproducibility (≤ 10% coefficients of variation, including all steps of the procedure, for estrone, estradiol, and most of the estrogen metabolites), 3) demonstrated accuracy, based on calibration of the estradiol measurements with the Centers for Disease Control Hormone Standardization Program, and 4) low sample volume requirements (≤ 0.3 mL for each assay). This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11 AM EST, on August 25, 2014. All responses and questions must be in writing and faxed 240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@nih.gov. A determination by the Government not to compete this proposed requirement 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02PC42633-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02CP42633-57/listing.html)
- Place of Performance
- Address: Contractor's Site, United States
- Record
- SN03459153-W 20140812/140810233255-c3dcecebe13fc07a34f8ecb574f63c26 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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