SOURCES SOUGHT
A -- Folic Acid Supplementation & Semen Quality Trial (FASST)
- Notice Date
- 3/17/2011
- 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 Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-DESPR-SBSS-2011-02
- Archive Date
- 4/11/2011
- Point of Contact
- Lynn L Salo, Phone: 301-435-6962, Elizabeth D Osinski, Phone: 301-435-6947
- E-Mail Address
-
ls59u@nih.gov, eo43m@nih.gov
(ls59u@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Business Sources Sought (SBSS): Folic Acid Supplementation & Semen Quality Trial (FASST) Notice Number: Sources Sought NIH-NICHD-DESPR-SBSS-2011-02 Announcement Type: Small Business Sources Sought (SBSS) Agency/Office: National Institutes of Health Location: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Key Dates: Response Date: 10 days after issuance Purpose of this Announcement: 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; 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 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees or less. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks a clinical trial coordinating center to coordinate and monitor a multi-center, double-blinded, randomized controlled clinical trial to assess the effects of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes among males of couples seeking fertility treatment. The proposed research study aims to increase the current understanding of the effects of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes, as well as the capacity of semen parameters to predict outcomes of fertility treatment. First, we want to investigate the effect of folic acid and zinc sulfate supplementation on semen quality parameters, including (but not limited to) concentration, motility, morphology, and sperm DNA fragmentation. Second, as the effects of folic acid and zinc sulfate supplementation are expected to improve not only semen quality, but also outcomes of fertility treatment, we want to investigate the effects of supplementation on fertilization rates, embryo quality, implantation, and clinical pregnancy. Lastly, we want to determine the predictive value of semen quality parameters and DNA integrity to predict fertilization, embryo quality, and clinical pregnancy. The contractor should be capable of managing and monitoring the proposed research study and provide oversight and quality control for recruitment and data collection. It is anticipated that any resultant contract(s) will be a cost reimbursement contract with options. Project Requirements: The proposed acquisition will involve the following types of activities: 1. Serve as the trial coordinating center for management and monitoring of a randomized clinical trial of folic acid and zinc sulfate supplementation among men of couples undergoing fertility treatment. 2. Serve as a clinical site or subcontract with clinical sites with large patient volumes of couples undergoing fertility treatment. 3. Procure folic acid and zinc sulfate and placebo medications for randomization. 4. Oversee recruitment and randomization of men of couples undergoing fertility treatment. 5. Handling and shipment of biospecimens for laboratory analysis and storage (e.g., semen, blood, urine). 6. Conduct (or subcontract for) the following assays that are anticipated: semen analysis, DNA fragmentation, hCG, serum folate test, anti-mullerian hormone, Inhibin B, estradiol, progesterone, luteinizing hormone, follicle-stimulating hormone. 7. Serve as the coordinating center for developing procedures and instruments used in conducting the survey/study/clinical trial and analyzing data. 8. Coordinate clearance procedures such as Office of Management and Budget (OMB) and Institutional Review Board (IRB) approvals, and maintain regular reporting as required by these organizations. 9. Conduct the survey/study using techniques such as paper and pencil, internet-based, personal interviews, telephone interviews, mail or Internet questionnaires, and/or abstracting data from existing sources. For some studies, physical measurement and the collection and analysis of biological specimens may be necessary. 10. Oversight of quality control for medication and biospecimen storage and analysis. 11. Assure protection of human subjects and confidentiality of information. Anticipated Period of Performance: The anticipated period of performance is five years from September 2011 through September 2016. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. 1) Approach-Does the Offeror have the infrastructure in place to coordinate and monitor a randomized clinical trial which either will be performed by the Offeror or subcontracted to several high volume fertility clinics with numbers sufficient to support study implementation and completion in a timely fashion? Does the Offeror have the capacity to identify an appropriate patient population and to provide the appropriate health care personnel? 2) Personnel and Experience-Does the Offeror have in place a research team that will be involved in the design, development, and organization of a randomized clinical trial and data management? Does the team include scientists and clinicians with expertise in this area? Respondents must provide, as part of their responses, information concerning (a) staff experience, including their availability, experience, and training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capabilities; and (e) examples of prior completed Government contracts, references, and other related information. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to 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(s). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies (e-mail to ls59u@nih.gov) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mail to Lynn Salo at the address listed below). Please limit responses to 15 pages or less. These pages exclude resumes. Written capability statements should be received by the Contracting Officer by 3:00PM ten (10) days after publication of this notice. Capability statements must identify the business status of the organization. No collect calls will be accepted. Inquiries should be directed to: Ms. Lynn Salo, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6962, FAX 301-402-3676, e-mail ls59u@nih.gov. OR, Ms. Elizabeth Osinski, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6947, FAX 301-402-3676, e-mail eo43m@nih.gov.
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