SOURCES SOUGHT
B -- Technical Support in the Interaction of Dietary Supplements on the Liver Toxicity
- Notice Date
- 7/3/2012
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1106397
- Archive Date
- 7/11/2012
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for technical expertise on various studies. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is seeking capability statements from manufacturing businesses capable of meeting the performance requirements. Draft Performance Work Statement (PWS): The U.S. Food and Drug Administration (FDA), the National Center for Toxicological Research (NCTR) has a requirement for technical expertise in the (1) interaction of dietary supplements on the liver toxicity caused by acetaminophen, (Tylenol), (2) Expertise in biomarker discovery of liver toxicity using state-of -the -art ‘Omics technologies, (genomics, Metabolomics and proteomics) and (3) assessment of the cardiovascular risk posed by methylphenidate (Ritalin) in non-human primates. 1. Background: The FDA's Commissioner has highlighted the need for Regulatory Science to underpin the FDA's decision-making. Solid scientific studies and communications arising from such are critical to support this mission. The work at NCTR embraces the needs of the multiple regulatory agencies within the FDA and these have very different focuses (e.g., dietary supplements, tobacco regulation). The Center of Innovative Safety and Technologies conducts research in biomarker discovery of liver toxicity, the interaction of dietary supplements on the liver toxicity caused by various drugs (presently studying the interaction with acetaminophen (Tylenol), and cardiovascular research within NCTR, across FDA Centers and in the larger toxicology community. Ultimately the goal is to publish the results in scientific journals to help inform the public and other scientists. 2. Objective: There is a need for additional personnel to assist the Center for Innovative Safety and Technologies researchers to provide technical expertise in the interaction of dietary supplements on the liver toxicity caused by acetaminophen (Tylenol). Expertise in biomarker discovery of liver toxicity using state-of -the -art ‘Omic technologies, (genomics, metabolomics and proteomics). Must be able to assess the cardiovascular risk posed by methylphenidate (Ritalin) in non-human primates. 3. Scope: Working in close coordination with the Division of Systems Biology Center for Innovative Safety and Technologies at the FDA's National Center for Toxicological Research at Jefferson, Arkansas the contractor shall provide scientific advice, direction, and support staff conducting basic and applied research to answer questions of FDA importance. The contractor shall communicate via e-mail, phone calls and /or visits to the NCTR campus with the Division Director to make recommendations. This is further detailed in Paragraph 4, Specific Tasks. 4. Specific Tasks and deliverables: 4.1 Assist the Center of Innovative Safety and Technologies researchers in toxicogenomics and toxicology studies. The contractor will provide toxicology/pharmacology expertise for the interaction of dietary supplements with drugs on liver toxicity. The specific deliverable will be drafting one or more scientific papers for submission to a peer-reviewed journal that summarizes the results of the recently completed studies assessing the interaction of black cohosh, kava, and ginkgo biloba on the hepatotoxicity caused by acetaminophen. In addition, the contractor will help design and oversee additional studies to determine if some dietary supplement exposure scenarios result in lower blood levels of acetaminophen. The contractor will also assist in the discovery of new biomarkers in liver toxicity by coordinating the processing and contracting of liver mRNA from recently completed biomarkers of hepatotoxicity studies in rats. The contractor will assist in the publication of these findings once the mRNA Next-Generation sequencing results are obtained from the sequencing provider (being outsourced to a 3rd party vendor). The contractor will be required to visit the NCTR campus lab one to two days a week. Based on the research results provide the Division Director with draft of proposed additional studies that may be needed. 4.2 The Contractor shall assist the Division to achieve biological qualification and public acceptance of biomarkers that require expert assistance. In achieving biological qualification the contractor will ensure that no erroneous results are produced in the data and that the research follow scientific protocol. The contractor will be responsible for analyzing gene expression experiments, and other raw data reports with relevance to each experiment. Gene expression data, including miRNA levels, are being generated in several different studies. The contractor will be responsible for ensuring that the first set of samples are processed and then sent to a 3rd party vendor for Next-Generation sequencing. 4.3 Draft a paper describing the cardiovascular assessments that were conducted in non-human primates chronically exposed to methylphenidate (Ritalin). As part of this process, coordinate with the University of Miami on the data they analyzed for inclusion in the paper. 5. Deliverable Schedule: The written tasks need to be completed within 90 calendar days after award including Director Review and contractor incorporating comments into final report. The draft publications for submission to peer-reviewed journals will be reviewed by the Division Director and the NCTR publication review process for acceptability. Contracting of Next-Generation sequencing will hinge on sample availability and success will be measured by coordinating the processing of the samples and sending them to the vendor for analysis. The contractor will provide a weekly report to the Division Director outlining the progress made in coordinating studies and 3rd party work, writing papers, and general oversight of the projects. Place of Performance Off-site at Contractor's facility and on-site at: 3900 NCTR Road Jefferson, AR 72079 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offeror is capable of performing the required services identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offeror has the experience capability at providing these services. • Desired qualifications for proposed key personnel: • Project Management Certification (PMP), for overseeing complex projects involving the conduct and coordination of many different toxicology studies. • Documented ability in preparing a research protocol. • Proven publication record on potential biomarkers of hepatotoxicity including miRNA. • Experience as a Study Director of regulatory toxicology studies in either a pharmaceutical or contract research organization. • Expertise in preclinical toxicology studies in species including rodents and non-human primates. • Experienced Toxicologist with a DABT, (Diplomat of the American Board of Toxicology). • Documented knowledge in gene expression profile and database mining • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide comments on drafts statement of work and if any of these specifications are too restrictive or vague. The government would like comments to address what questions one might like include in the PWS. No response will be considered that the PWS is sufficient for a competitive acquisition. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Suggestions on applicable NAICS code for this requirement. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $14.0 million. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 9, 2012 by 10:00 A.M. (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1106397. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1106397/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02793673-W 20120705/120703235854-3c352107d77d7ec73ad028dda8c0e3e8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |