SOURCES SOUGHT
A -- On-Site Toxicologic Pathology and Related Investigative Research Services
- Notice Date
- 4/16/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA-1056360
- Archive Date
- 5/22/2009
- Point of Contact
- Regina R. Williams,, Phone: (870) 543-7012, Priscella T. Sullivan,, Phone: 214-253-5274
- E-Mail Address
-
regina.williams@fda.hhs.gov, priscella.sullivan@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE for market research purposes to determine the availability and capability of potential small businesses (including HUBZone firms, certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses). This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. PLEASE DO NOT INCLUDE PRICE OR COST INFORMATION WITH YOUR SUBMISSION. The National Center for Toxicological Research, Jefferson, Arkansas, has a requirement for On-Site Toxicologic Pathology and Related Investigative Research Services. Qualified professional, technical, and administrative staff will be required to perform fourteen (14) major services and functional support areas of responsibility in the following: 1) Toxicologic Pathology comprising Necropsy (inclusive of routine and special tissue harvest and fixation), Routine and Specialized Histology and Histopathology; 2) Immunopathology to include cell proliferation and methods development to support an expanding array of advanced Immunoenzyme and Immunofluorescent Immunohistochemistry (IHC) assays; 3) Molecular Pathology Techniques including the development of emerging methods, apoptosis assays, non-radioactive In Situ Hybridization with RNA and oligonucleotide probes, and broadened use of Laser Capture Microdissection, RNA isolation from microdissected material, polymerase chain reaction (PCR), and genetic monitoring of rodent strains; 4) Biomarker relevant specialty techniques comprised of Laser Capture Microdissection, Tissue Microarrays and methods development of complimentary technologies; 5) Digital Pathology/Image Analysis including remote viewing and image sharing technologies, quantitative digital imaging methods development, and the standardization and work flow integration of emerging Critical Path-relevant Computer Assisted Pathology System (CAPS) smart imaging technology; 6) Clinical Pathology consisting of Clinical Chemistry, Hematology, and Urinalysis as well as special ELISA- and enzymatic-based assays and research methods development to include cellular mitochondrial assays; 7) Teratology/Fertility/Reproductive System Assessment to include automated sperm motility analysis, manual and computerized assisted spermatogenesis staging and vaginal cytology; 8) Digital Imagery (Macro and Micro Photography); 9) Translational Toxicology, Critical Path Investigative Research Support and Pathology-related Collaboration Services to support NCTR’s new core-technology facilities; 10) Research and Publication, and Professional Services to include investigative consultation and research collaboration with NCTR Study Director/Principal Investigators during the review, planning, development, and conduct of NCTR approved research protocols, (2) collaborative development, application and standardization of new emerging technologies, in particular those supporting NCTR’s contribution to the Critical Path Initiative, and (3) the preparation of scientific manuscripts and participation in NCTR approved symposium, workshops and technology-specific meetings. In general, the Contractor must provide the total toxicologic pathology and related investigative research technology expertise for the Center and, thus, represents NCTR on these matters. Consultation with recognized experts shall be on an ad hoc basis. Contractor shall participate in seminars, works; 11) Administrative Services and Management; 12) Health and Safety of Contract Employees and Laboratory Environment Protection; 13) Repository Services comprised of archiving of pathology specimens, electronic data and digital image files; and 14) Quality Control of Pathology Activities, Data and Case Accountability with comprehensive Quality Assurance oversight of designated contract activities to ensure complete regulatory compliance with FDA and EPA Good Laboratory Practices (GLPs and OECD Guidelines for designated studies and procedures) as they pertain to the 14 major services and functional support areas. Each area of work outlined above involving receipt of animals, tissues, or other samples, and the subsequent processing and collecting of data will be governed by Standard Operating Procedures (SOPs) written and maintained by the contractor. These SOPs are a requirement of the Good Laboratory Practices (GLP) regulations and must reflect in content the requirements of those regulations. All companies responding to this synopsis must demonstrate their experience and capability by submission of qualification statements, including references directly related to the requirement. Qualification statements will be evaluated on the basis of (1) demonstrated ability to provide on-site personnel with the requisite skills and training to provide the toxicologic pathology and related investigative research services in the stated areas, (2) experience to satisfactorily manage and accomplish on-site toxicologic pathology and related investigative research services in the stated areas and (3) knowledge of GLP regulations and experience with GLP studies. Firms responding to this request for qualification statements should indicate whether they are, or are not, certified by the Small Business Administration as an 8(a) firm. This information will be used to determine if a National Buy for 8(a) firms, or a set-aside for small business firms or HUBZone firms, is appropriate. The applicable North American Industry Classification (NAICS) code is 541711 - Research and Development in Biotechnology. The small business size standard is 500 employees. Qualification statements are due by postal mail, email or fax on or before May 7, 2009 by 1:00 pm (Central Standard Time – Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration OC/OSS/OFFAS, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502, email: regina.williams@fda.hhs.gov, (870) 543-7012 ph, (870) 543-7990 fax. Qualification statements shall be limited to 25 pages and should reference Sources Sought No. FDA-1056360. Seven copies of the qualification statement (original plus six copies) must be submitted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1634010b24c6ed587228e16b699d8635&tab=core&_cview=1)
- Place of Performance
- Address: National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN01794958-W 20090418/090416221858-1634010b24c6ed587228e16b699d8635 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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