SOLICITATION NOTICE
B -- Multi-Disciplinary Research Efforts
- Notice Date
- 6/24/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1119148
- Archive Date
- 7/10/2013
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is 1119148 and this solicitation is issued as a Request for Quote (RFQ). RESPONSE DATE: 07/08/2013 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66 effective April 1, 2013. The associated North American Industry Classification System (NAICS) Code is 541990- All Other Professional, Scientific, and Technical Analysis; FSC Code is B504. Small Business Size Standard is $14.0 Million. Acquisition is unrestricted. Contract Type: Commercial Item-Firm Fixed Price. REQUIREMENTS: Part I: General Information Background: The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Systems Biology, Innovative Safety and Technologies Branch requires collaboration on multi-disciplinary research efforts in nationally recognized research programs in support of FDA's mission. Bladder cancer is the fourth most common cancer in the United States and cigarette smoking is the leading risk factor for the development of bladder cancer. Recent epidemiological studies have strengthened the association of cigarette smoking with bladder cancer. Objective: The FDA's hypothesis is that microRNA (miRNA) may be a reliable biomarker to identify patients with bladder cancer and potentially distinguish between bladder cancer that occurs in smokers vs. NEVER smokers. Since some miRNAs are expressed in a tissue-specific manner, they may also be more specific than existing biomarkers of bladder cancer. It is hypothesized that miRNA expression patterns found in blood and/or urine could mirror the miRNA changes in bladder tumors and be potentially used as noninvasive biomarkers for bladder cancer diagnosis. Part II: Work Requirements Scope: The main research aspect is to determine if biofluids miRNA can serve as early molecular biomarkers for tobacco smoking-induced bladder cancer. The researcher shall hold a Ph.D. degree in Physiology and Biophysics or Oncology. Contractor activities shall include, but not be limited to: • Isolation of RNA from human tissues, analysis of Next-Generation Sequencing data, use of bioinformatics tools to elucidate the mechanisms and confirm miRNA biomarkers using Real-Time Polymerase Chain Reaction (qRT-PCR). • Development of circulating miRNA biomarkers for smoking-related bladder cancer, analysis of miRNA profiling in body fluid by qRT-PCR array. Deliverables and Milestones: The following are deliverables/milestones for the base period: 1. RNA extraction: Extraction of serum, urine and tissue samples for miRNA profiling analysis. An estimated total of one-hundred and twenty (120) RNA samples, including miRNA fraction, shall be isolated by Trizol method. The quality and quantity of the RNA shall be assessed by Nanodrop with data results submitted to the Contracting Officer's Representative (COR) electronically in spreadsheet format. Due Date: Within 30 business days from start of the period of performance. 2. microRNA profiling: An estimated sixty (60) tissue RNA samples shall be provided to external vendors for Next-Generation sequencing analyze. An estimated sixty (60) urinary microRNA samples shall be analyzed using qRT-PCR array. The microRNA expression data shall be submitted to the COR electronically in spreadsheet format to include threshold cycles (Ct) values. Due Date: Within 60 business days from date of milestone 1 completion. 3. Processing and storage of miRNA-seq results. The estimated sixty (60) sample Next-Generation sequencing data shall be uploaded to ArrayTrack. Upon completion, the COR shall be notified in order to verify the data input into ArrayTrack. Due Date: Within 60 business days from date of milestone 2 completion. 4. Analysis of miRNA-seq results. Once the data is uploaded to ArrayTrack, comparisons between the cancer, an estimated thirty (30) samples, and control, an estimated thirty (30) samples shall be made to identify miRNA changes that associated with bladder cancer. Contractor shall provide a complete list, electronically to the COR, of all miRNA checked for changes. Due Date: Within 90 business days from date of milestone 3 completion. 5. Confirmation of miRNA biomarkers. Once the list of biomarkers has been identified from Next-Generation sequencing and/or qRT-PCR array, secondary confirmation of the results shall be conducted. Specifically, qRT-PCR single reaction confirmation of the biomarker changes shall be conducted for existing samples. miRNA targets and the related biological pathway shall be predicted using different computational algorithms. A final results report shall be submitted to the COR. Due Date: Within 120 business days from date of milestone 4 completion. The contractor shall use the same technical approach as the base period to provide similar deliverables/milestones in the option period. The sample type may change, i.e. to human lung RNA. Period of Performance: Base year: July 1, 2013 through June 30, 2014 Option Year1: July 1, 2014 through June 30, 2015 Place of Performance: U.S. Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road, Bldg 5B (Laboratory) Jefferson, AR 72079 Security and Privacy: It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained with performance of this contract, unless made public by FDA or upon written approval by NCTR. The Contractor shall complete the following steps for badging/access to the NCTR Facility: Step 1: Complete the Office of Personnel Management Electronic Questionnaire for Investigations Processing Initiation (e-QIP) form which will be provided by the COR. Step 2: When completed, the form shall be e-mailed to the COR. Step 3: Within 24 hours, the contractor will be contacted by an FDA Security Specialist with instructions on granting access to the appropriate e-QIP Web pages for completion of background investigation forms. Step 4: Once the contractor completes the online forms, they will be prompted to print out signature pages. These signature pages shall be brought to the Regulatory Compliance and Risk Management Office in Building 50 when fingerprinting is scheduled. Step 5: Upon arriving at NCTR, the contractor shall complete the computer-based New Employee Safety Orientation Program. When the orientation program is completed, an e-mail is generated to the Security Specialist. Step 6: The Contractor shall present two forms of acceptable identification in accordance with the Homeland Security Presidential Directive 12 (at least one form of ID must be a photo ID). Step 7: The Contractor will be escorted by the COR until their fingerprint results return with a favorable designation [the timeframe varies depending on the workload of the FDA Security Office (usually 2 to 4 weeks). At that time, a permanent badge is requested. Step 8: The Contractor will not obtain a computer network account until a favorable fingerprint is received. Contractor Conformance with Applicable Laws, Regulations, Polices and Standards: The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, polices and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be found at or through Federal CIO Council website at : http://www.cio.gov. HHS documents are found at : http://www.cdc.gov. List of Government Furnished Property: - Samples - Real-time qPCR Instrument - Nanodrop Spectrophotometer - Lab computer with Internet access - The contractor will be provided with a Personal Identification Verification (PIV) Card for both the physical (building) and logical (computer) access to FDA facilities and information systems. Although the Government will provide the Contractor with the items, the Contractor is responsible for accurate analysis results. The COR shall be notified immediately in the event of equipment failure or inaccuracy. All items will remain the property of the Government and shall be returned in the same condition as received upon project completion. Schedule of Items Base Period tiny_mce_marker____________ Option Year 1 tiny_mce_marker____________ Total tiny_mce_marker____________ FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (FEB 2012) applies to this solicitation. Addendums to this provision are as follows: The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: (i) Scientific/Technical Approach of the services offered to meet the Government requirement; (ii) Past Performance/Experience; (iii) Price Scientific/Technical Approach and Past Performance/Experience, when combined, are more important when compared to price. The Government will evaluate offers for award purposes by adding the total price for all options, including additional 6 month extension option found in FAR 52.217-8, Option to Extend Services, to the total price for the basic requirement. For evaluation purposes, the 6 month extended price will be based on the Option Year 1 pricing provided by the offeror. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Technical capability will be determined by review of information submitted by the Offeror which must provide a description in sufficient detail to show that the service quoted meets the Government's requirement and demonstrate successful performance of the service requested with the specific equipment stated in the requirements. The government is not responsible for locating or securing any information, which is not identified in the quote. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures, and other information corresponding to each minimum required service, which demonstrates the capabilities of the Offeror. Furthermore, evidence of education achievements, exposure to ArrayTrack, proven publication records in scientific journals (to include first author research with high impact factor), and experience with carcinogenesis, especially cancer-related biomarkers, relative work completed in molecular biology, including RNA isolation and work with a qRT-PCR shall be included with offer. The Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (DEC 2012), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2012), applies to this acquisition. Addendums to this clause are as follows: Other Terms and Conditions Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Invoice Submission Payment terms net 15 days after government acceptance of the supplies/services. Invoices shall be submitted to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The following clauses are incorporated by reference: • FAR 52.217-8, Option to Extend Services is applicable, "...within 10 calendar days prior to contract expiration." • FAR 52.217-9, Option to Extend the Term of the Contract is applicable, (a) "...by written notice to the Contractor within one (1) day of contract expiration;...preliminary written notice of its intent to extend at least 30 days before the contract expires." (b) "...shall not exceed 2 years and 6 months from the date of award." • FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (DEVIATION) is applicable. • HHSAR Clauses: 352.222-70, 352.231-71 352.242-71 are applicable to this solicitation. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b) 52.204-10, 52.209-6, 52.219-4, 52.219-28, 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.223-18, 52.225-3, 52.225-13 and 52.232-33 Additional Information It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation. Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 8, 2013 to crystal.mccoskey@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502. When appropriate, offerors should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Crystal G. McCoskey by e-mail at crystal.mccoskey@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 09:00 AM CST on July 3, 2013. Please reference solicitation number 1119148 in subject line of all correspondence. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the Place of Performance section above.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1119148/listing.html)
- Record
- SN03098178-W 20130626/130624234918-b8505385c74c4bfa43ab5eb5bbb456bd (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 |