SOURCES SOUGHT
39 -- NCI ARC Consolidated Repository Services
- Notice Date
- 8/6/2014
- Notice Type
- Sources Sought
- NAICS
- 493120
— Refrigerated Warehousing and Storage
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02CO57001-02
- Archive Date
- 8/27/2014
- Point of Contact
- Nicole Belanger, Phone: 3016248754
- E-Mail Address
-
belangern@mail.nih.gov
(belangern@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) issued solely for information-gathering and planning purposes. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. The National Cancer Institute (NCI), National Institutes of Health (NIH) is seeking to identify vendors capable of providing storage facilities and freezers, including back-up power supplies and freezers as well as regular maintenance and labor for the storage, acquisition and distribution of biological specimens. Responses to this RFI will not affect a potential vendor's ability to respond to any RFP that may or may not follow, nor will not responding limit participation in any future RFP. Please ensure that any sensitive or protected information is marked as such. Small businesses are encouraged to respond and should indicate their small business status and any set-aside with their capability statements. By submitting a response, each respondent agrees that any and all costs incurred in generating the RFI response or in support of activities associated with it shall be the sole responsibility of the respondent. The Government shall incur no obligations or liabilities to anyone for any costs or expenses incurred by the respondents in preparing the RFI response. Responses to this RFI are solicited to the best acquisition strategy, and to determine the commercial market pricing structure for these services. Statement of Work A.Scope The contractor shall provide storage facilities and freezers, including back-up power supplies and back-up freezers as well as regular maintenance and labor for the storage, acquisition and distribution of biological specimens. The contractor shall be registered with the Food and Drug Administration (FDA) for the storage of clinical drugs and biological specimens and provide evidence of this registration. B.Purpose The purpose of this requirement is to allow the National Cancer Institute (NCI) Administrative Resource Center (ARC) managers to be able to order freezer space by task. The contractor is also responsible for providing informational interface with NCI and external investigators that are submitting or requesting research compounds; for updating of the chemical database which includes chemical, inventory, receiving and shipping information; systematic file and record keeping of both current and archival information related to repository activities; and reacquisition of samples for continued chemical and biological studies. C.Freezer Maintenance and Storage The contractor shall provide regular preventative maintenance for all freezers used for storage of biological specimens consistent with the manufacturer's guidelines provided to them for the specific freezers in use. Samples stored under this contract can/cannot be stored in shared -80 freezers. Accurate clinical-grade, Good Manufacturing Procedures (cGMP) inventory records must be kept and an inventory report must be submitted with each monthly bill. The contractor shall maintain back-up power supplies/generators to the freezers where these specimens will be stored, in the event of a power failure. The contractor shall have available "back-up" freezer storage in case of a specific freezer breakdown. The contractor shall maintain freezers at the appropriate temperature range given the specimen type, monitor the storage facilities and adhere to GMP record keeping requirements on the status of specific specimens while the specimens are in the possession of the contractor during storage and transit. The contractor shall provide FDA certification as a cGMP storage facility for clinical reagents. The contractor facility shall adhere to U.S. Food and Drug Administration (FDA) GMP storage guidelines as described at http://www.fda.gov/cder/dmpq, have limited access to these stored specimens and must be able to deliver them to their required destination. D.Emergency Service Emergency repair services shall be provided by qualified contractor staff on an unlimited basis seven days a week, 24 hours a day during the term of this contract at no additional cost to the government. E.Personnel Qualifications Personnel shall have the knowledge, training and experience or any combination thereof to enable them to perform the functions required herein. Qualifications apply particularly to working with/under Good Manufacturing Procedures GMP regulations and to the handling GMP reagents and maintaining material at the specified temperatures when the specimens are out of the freezer chamber and/or are in transit. F.Specific Tasks Independently and not as an agent of the government, the contractor shall furnish all the necessary services, qualified personnel, material equipment and facilities, not otherwise provided by the government as needed to perform the Statement of Work. 1.Acquisition/Documentation a. Execute registration policies and procedures developed by DTP for the submission of structures, associated chemical data and compound samples using the DTP website: http://dtp.nci.nih.gov/. These procedures may be revised and updated over time. This includes the assignment of NSC registration numbers to chemical structures and other entities (e.g. biologics, creams, investigational, ethical and OTC drug products) using polices and procedures developed by DSCB. b. Maintain and execute procedures for the non web-based manual submission and registration of structures, associated chemical data and the compounds. c. Act as primary point-of-contact between DSCB and compound submitters. d. Assist investigators on structure and sample submission, and website registration procedures. e. Input chemical structures and chemical data into the NCI chemical database. The majority of structures are submitted by investigators requesting anti-cancer testing. f. Check the chemical accuracy of structures and chemical data entered into the database. g. Maintain permanent files of all supplier correspondence related to submission of structures, chemical data and physical compound samples. This includes a file of legal confidentiality agreements between NCI and investigators. h. Reacquire compounds from submitters as requested by the COR. Generally, this material will be used for additional in vitro/in vivo evaluation. i. Acquire, through purchase order process, additional quantities of commercial compounds as requested by the COR. j. Distribute copies of requested documentation to NCI staff and external investigators as directed by the COR. These may be as hard copies or in electronic form. k. Maintain relevant, accurate, and current records such as identity, inventory and shipping history, for all registered compounds. 2.Receipt and Storage a. Store chemicals, biological specimens, purified natural products and bulk compounds. This includes approximately 500,000 - 600,000 individual samples in current long-term storage. The majority of compounds are in amount ranging from 5 mg to 20 g, with a few samples of bulk drug up to 50 kg. b. Receive weekday shipments and related documentation and safely store until registered and moved to permanent storage or shipped to researchers. c. Store chemicals, biological specimens, drugs and plated sets under their recommended storage conditions. For instance, this includes capabilities for temperature storage at controlled ambient, 0-5 deg C., -15 to -20 deg C., and -70- to -80 deg C; under nitrogen or argon atmosphere; protected from light; under controlled humidity conditions. d. Provide sufficient monitoring of storage conditions to guarantee continuous proper storage including, for a limited number of bulk API samples, adequate monitoring and documentation to meet cGMP guidelines. e. Notify the Contracting Officer's Representative (COR) immediately when physical changes in chemical samples are noticed. f. Provide safe storage and security measures to conform to all pertinent drug/chemical regulations. This includes an adequate waterless fire suppression system to protect staff, the chemical inventory and storage infrastructure. g. Prepare Material Safety Data Sheets for specific compounds as directed by COR. h. Maintain the current computerized inventory of compounds of interest and bulk drugs in the repository. In addition, infrequently requested drugs shall be inventoried for accuracy at the time an order request is filled. i. Provide for the safe and proper disposal of items to be eliminated from the inventory stock as the result of decomposition or for other reason at the request of the COR. No samples should be disposed without authorization of the COR. j. Receive returned chemicals and drugs and return to inventory or dispose. k. All work shall be performed utilizing good laboratory techniques in accordance with accepted industry standards. The below is a list of individual/generic tasks that can be ordered under this contract. The above responsibilities shall be standard duties for each task: a.Frozen Storage of Biological Specimens/Materials b.Frozen Storage of Biological Treatment Cells for NIH Clinical Trial in-patient treatments c.Frozen Storage of Vaccines d.Frozen Storage of Monoclonal Antibodies e.Multi-temperature Storage and Distribution of drug products for NCI clinical trials f.Multi-temperature Storage and Distribution of chemotherapeutic agents for NCI testing g.Other G.Shipping and Distribution a. Weigh, package and ship chemicals and drugs as approved by the COR to NCI screening laboratories and external research investigators. These may be located domestically or internationally (e.g. Europe, Asia, and Australia). b. Provide special handling and packaging for heat and/or light sensitive and labile chemicals and drugs. The shipments shall conform to all laws and regulations, both domestic and international, governing the shipping of hazardous substances and other regulated substances. c. Furnish shipping cartons, cushioning materials, labels, containers, insulating material, dry ice and any other supplies to insure the safe, intact arrival of the contents of each package shipped. d. Update inventory transactions, document the shipment of compounds, and associated data to the NCI chemical database. e. Provide for regular (3-4/week) overnight shipments of samples to the NCI testing and screening laboratories. Include provisions for 1-day turnaround for a limited number of expedited shipments. H.Security and Safety a. The Contractor shall not divulge any information concerning the suppliers, chemicals and drugs received, stored, or shipped except to authorized personnel as indicated by the COR. All other inquires should be directed to the COR (See Article H). b. The Contractor shall comply with all pertinent security and safety requirements required by applicable Federal, State and local government regulations. c. Personnel assigned to the project shall be bonded. d. The chemical storage areas shall be protected from fire damage by systems other than water sprinklers. e. The Contractor shall be the authorized waste disposal agent for work performed under this contract and comply with all local, State and Federal regulations. f. The Contractor shall provide appropriate and adequate safeguards to insure for the safety and security of all Government-owned property including but not limited to, chemical inventory, laboratory equipment, computers and hard copy, film and electronic information. The Contractor shall also maintain all Government-owned equipment in good working order. g. The Contractor shall provide appropriate and adequate safeguards to insure for the safety and security of all Government-owned property which is removed by the Contractor's employees from the Contractor' facility (e.g. hard copy documents, laptops, compact discs, flash memory devices). h. The Contractor shall conform to all applicable NIH policies in regards to Internet and computer security and training (e.g. firewalls, virus protection, password protection, encryption, etc.). If any responsible source believes it can perform the requirements they may submit their capability statements via email (PDF format; 15 Page Limit, these pages exclude resumes) for consideration by NCI to Nicole Belanger, Contracting Officer, at the e-mail addresses belangern@mail.nih.gov by 1:00 PM ET, August 12, 2014. No collect calls or facsimile transmissions will be accepted. Respondents must include DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the applicable NAICS code. 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation(s).
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