Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 23, 2008 FBO #2462
DOCUMENT

A -- Testing of drug and placebo formulations in BALB/c mice with experimental cutaneous Leishmania major infections. - Amendment 1

Notice Date

8/21/2008
 

Notice Type

Amendment 1
 

NAICS

561990 — All Other Support Services
 

Contracting Office

Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, Maryland, 21702-9203
 

ZIP Code

21702-9203
 

Solicitation Number

N62645-08-R-0020
 

Response Due

9/3/2008 2:00:00 PM
 

Archive Date

9/18/2008
 

Point of Contact

Tameka N Davis, Phone: 301-619-1677, Burzie C Baker III,, Phone: 301-619-0707
 

E-Mail Address

tameka.davis@med.navy.mil, burzie.baker@med.navy.mil
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information included in this notice. Also, this acquisition is being conducted under FAR 13.5, Test Program Procedures for commercial items. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is N62645-08-R-0020 The solicitation is issued as a request for proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 05-24 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: www.acqnet.gov/far and www.acq.osd.mil/dpap/dfars/index.htm. The NAICS code is 541990, with a small business size of $7 million. This is a 100% small business set-aside; all qualified vendors are encouraged to submit a proposal. The Naval Medical Logistics Command requests responses from qualified small business sources capable of providing animal study on NIDBR Drug Formulation with the following Statement of Work: Background - The Naval Institute for Dental and Biomedical Research (NIDBR) requires contract services for testing of drug and placebo formulations in BALB/c mice with experimental cutaneous Leishmania major infections. To date, NIDBR has conducted in vitro experiments on Leishmania major promastigotes and host cells. For parasite cultures, we have generated data to illustrate a dose dependent toxic effect of the active drug on Leishmania major. The LD50 for this drug was estimated to be 0.06 ug/ml and 0.03 ug/ml for administration of one and two doses, respectively. To ensure that the active drug is not toxic to host cells, human skin flbroblasts have been used as controls. In these experiments, administration of 62 ug/ml did not exert a cytotoxic effect to host cells over a 24-hour period. 1.Statement of Work. 1.1. Objective. Determine the efficacy of NIDBR's drug formulations for the topical treatment of cutaneous leishmaniasis in BALB/c mice. NIDBR's proprietary drug and placebo formulation will be applied topically onto the rump of mice, which have been infected with Lmajor. Efficacy of tine treatment will be assessed through a number of parameters, including: 1) measurement of lesion; 2) physical signs; and 3) recovery time. During the course of the experiments the animals will be monitored for indicators of drug toxicity by documenting body weight, food and water consumption, and activity levels of infected adults. 1.2. Technical Tasks/Requirements. As detailed in the Paragraph 3, Requirements, the animal experiments would include: 1)inducing experimental cutaneous infections in BALB/c mice 2)applying topical application of NIDBR's drug or placebo formulation 3)monitoring animals and recording data The contractor will be required to communicate with NIDBR, on a monthly basis, to provide a summary of progress and to identify any difficulties or shortcomings. If problems arise, a teleconference or site visit (if necessary) will be held to promptly address and resolve the concern. Animal research is to be conducted within a facility that is accredited by AAALAC. If the contractor handles large animals within their facility, then the USDA inspection requirements must be satisfied. As a cooperative effort, NIDBR and Contractor will prepare applications and protocols that are required by all Institutional Animal Care and Use Committees (IACUC) authorities (i.e., Contractor's and Navy Surgeon General Oversight office (BUMED)). Experiments will not commence unless IACUC approval is obtained. If needed, the Contractor will make accommodations to allow a site visit to the animal facility. 1.3. Deliverable: With the information detailed in the addendum, NIDBR expects to receive a report (hard and electronic copies) of all materials/methods employed and data resulting from this contract. Blood collected at necropsy will be processed for plasma. Immediately thereafter, the plasma will be aliquoted into 0.15 ml volumes and frozen (£ -20°C). Within a mutually agreed upon time, the frozen plasma aliquots will be shipped to NIDBR with an adequate amount of dry ice to maintain frozen samples. If abnormal tissue is identified at necropsy, the tissue will be placed in a standard histology fixative and provided to NIDBR at a mutually agreed upon time. 1.4. Order Details 1.4.1 Period of Performance - The contract period is one year from date of award of contract. 1.4.2 Place of Performance - Work will be performed at the Contractor's facilities. 1.4.3 Government Furnished Resources (GFR) - Leishmania major cultures and drug formulations will be provided by NIDBR within a mutually agreed upon time. The parasites and drug formulations provided by NIDBR will only be utilized for this contract. Excess of the parasite suspension will be autoclaved (1 bar pressure, 121 °C for 20 min) and discarded. 1.4.4 Facilities. Supplies and Services - All facilities, supplies (exception stated in paragraph 1.4.3), and personnel required to perform the tasks outlined in the Statement of Work will be the responsibility of the Contractor. 1.4.5 Information. All Government unique information related to this requirement necessary for Contractor performance will be made available to the Contractor. The Contracting Officer's Representative (COR) will be the point of contact for identification of any required information to be supplied by the Government. 1.4.6 Federal Ownership of Intellectual Property. Unless otherwise noted in advance, all materials and data resulting from this effort are understood to be the property of the Federal Government. To protect the Government's interest, control and safety, prior written approval will be obtained for any changes or replacement of the contractor's scientists who are involved in research under the auspices of this contract. 1.4.7 Documentation: All existing documentation relevant to this task's accomplishment will be made available to the Contractor. 2.Security Requirements 2.1 Requirements. This is a non-classified project. Contractor is required to safeguard the information labeled as proprietary. 2.2. Privacy Act. All Contractor personnel assigned to this task will have access to information that may be subject to the Privacy Act of 1974. The Contractor is required to ensure the proper safeguarding of such information to prevent unauthorized release. 2.3. Nondisclosure Agreement. In the course of its work, the selected Contractor may be required to execute a Nondisclosure Agreement (NDA). Each employee of the successful Offeror may be required to sign a Non-Disclosure Agreement (NDA) prior to commencing work under this Order. The supervisor/manager of the proposed personnel may also be required to sign the NDA on behalf of the Contractor. 2.4. Organizational Conflict of Interest. The parties acknowledge that, during performance of the contract resulting from this Order solicitation, the Contractor may require access to certain proprietary and confidential information (whether in its original or derived form) submitted to the Government Such information includes, but is not limited to, business practices, proposals, designs, mission or operation concepts, sketches, management policies, cost and operating expense, technical data and trade secrets. The Contractor shall take appropriate steps not only to safeguard such information, but also to prevent disclosure of such information to any party other than the Government. The Contractor agrees to indoctrinate company personnel who will have access to or custody of the information concerning the nature of the confidential terms under which NIDBR received such information and shall stress that the information shall not be disclosed to any other party or to Contractor personnel who do not need to know the contents thereof for the performance of the contract. Contractor personnel shall also be informed that they shall not engage in any other action, venture, or employment wherein this information will be used for any purpose by any other party. 3. Requirements 3.1 Inducing experimental cutaneous infections in BALB/c mice As indicated (paragraph 3.3), NIDBR will provide the Leishmania major promastigotes. Prior to inoculating the animals, the contractor must confirm the viability of the parasites, using light microscopy (400X magnification). If > 95% of the parasites are motile, the experiment will be initiated by subcutaneously inoculating five-week-old female BALB/c mice in the shaved skin over the sacrum on the dorsal line at the base of the tail (referred to as the rump) with 5 X105 metacyclic Leishmania major promastigotes. If insufficient parasites are viable, then arrangements will be made for another shipment from NIDBR. The animals will be housed individually for the duration of the experiment. As dictated by the approved animal use protocol, routine animal husbandry, euthanasia, and disposal of carcasses will be followed. 3.2 Applying topical application of NIDBR's drug or placebo formulation Mice will be divided into three groups. For the first two groups, three different drug doses will be tested (see attached table). Each group of mice will be treated on 6 or 12 weeks post-infection (wpi), respectively. Within the designated treatment period, the animals will be treated twice a day for five consecutive days. Topical applications will be given by rubbing (small circular motions) the drug or placebo emulsion on the lesion for 1 minute. Efforts will be made to prevent grooming of the treatment site for 10 minutes after the application of the drug or placebo formulation by one of the following methods: 1) administration of a low dose of medetomidine (0.03 to 0.05 mg/kg SQ) for short-term sedation. (This can then be reversed by atipamezole (1 mg/kg IP or SQ)); 2) administration of isoflorane inhalant; or 3) use of plastic rodent restraint cylinder. The duration of this experiment will be 14 weeks. Mice within group three will serve as normal controls or as infected untreated controls. Dosage# MiceAdminister Drugs Experiment (4 Consecutive Days) Group 1 Control56 WPI 6 necropsied A56 WPI 6 necropsied B56 WPI 6 necropsied Control56 WPI 6 necropsied Group 2 Control512 WPI 6 necropsied A512 WPI 6 necropsied B512 WPI 6 necropsied Control512 WPI 6 necropsied Group 3 Control5no infection/no treat6 necropsied No Drug5infected/no treat6 necropsied (WPI indicates week post-infection) 3.3) Monitoring animals and recording data The following will be monitored and documented for each animal a) mortality (daily) b)physical appearance and signs (daily) c)body weight (weekly and prior to euthanasia) d)food and water consumption (weekly) e) measure length and width of lesion (weekly) At necropsy: a)exsanguination- process blood for plasma b)determine weight of liver, kidneys, and spleen c)document general pathology of all tissues at necropsy. If abnormal tissue is observed, the tissue will be placed in a standard histology fixative and provided to NIDBR. 4. SPECIAL CONTRACT REQUIREMENTS 4.1 Information Security Plan (a) The contractor shall prepare and maintain an information security plan, which promotes information protection and systems security appropriate to the environment in which it will be executed. This plan should address confidentiality and privacy, integrity and backup of data and systems, access, continuity of operations, and all other relevant considerations. The contractor is responsible for ensuring that the project complies with relevant federal and other jurisdictional regulations. Before developing the security plan, the contractor should review the considerations included in federal regulations, guidance, and information security standards. (b) In addition to developing and maintaining a security plan as described above, the contractor shall be responsible for continuously assessing and assuring information security for the project and for updating the security plan as needed throughout the duration of the contract. 4.2. Information Security Training The contractor shall be responsible for ensuring that all contractor employees receive employment screening and information security training appropriate to their responsibilities, prior to the start of their work on the contract. This would be provided at the contractor's expense and would be the contractor's responsibility to plan and arrange. 4.3. Non-Disclosure Agreement for Contractor and Contractor Employees (a) Contractor employees may be required to sign a written non-disclosure agreement and submit the original(s) to the Contracting Officer before data, government furnisher property, or information otherwise exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them. A sample disclosure statement is provided (b) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with (NIDBR). (c) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement. PERIOD OF PERFORMANCE The contract period is one year from date of award. The estimated contract award date is 30 September 2008. DELIVERY AND ACCEPTANCE: Results shall be sent electronically and via hard copy to the National Institute for Dental and Biomedical Research (NIDBR), Great Lakes, IL. EVALUATION FACTORS FOR AWARD: Offerors shall provide in sufficient detail a technical proposal that shall meet or exceed each of the requirements of the Statement of Work. The Contracting Officer may request clarifying information from an offeror without conducting discussions in accordance with FAR 15.306. If the Government decides to determine a competitive range and conduct discussions, oral and/or written discussions will be conducted with all offerors in the competitive range. The offeror’s initial proposal shall contain the offeror’s best terms from a price and technical standpoint. The Government intends to evaluate offers and award a contract without discussions, but reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to award to other than the lowest offeror if the Government determines that a price premium is warranted due to technical merit. The Government reserves the right to award to other than the highest rated offeror. The Government reserves the right to make no award as a result of this solicitation. In addition, the RFP may be amended or canceled as necessary to meet NIDBR requirements. The Government intends to award a firm fixed price contract resulting from this solicitation to the responsible offeror whose offer is the Best Value, price and other factors considered. The technical factors below are significantly more important than price and past performance, and are listed in descending order of importance. Price is more important than past performance. Technical Factors A-C will be evaluated individually on a pass/fail basis. If an offeror’s technical proposal is judged to have failed any one of the Factors A-C the firm’s offer will receive no further consideration for award. If an offeror’s technical proposal is judged to have passed all Factors A –C (Minimum Technical Qualifications), then the offeror will subsequently be evaluated on Price and Past Performance. However, past performance may become a critical factor in the event that two or more offerors are determined to be essentially equal following the evaluation of technical and price factors. Evaluation of price will be based on the offeror’s total price. Minimum Technical Qualifications. To be qualified for this award, offers must meet all of the following A-C: (A) Facility accreditations: i. Contractor shall be Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accredited ii. Contractor shall meet U.S. Department of Agriculture (USDA) inspection requirements (if large animals are handled at facility) (B) IACUC program: i. Contractor shall have an institutional animal care and use committee (IACUC) that ensures that all Federal laws, regulations, and policies are followed when investigators perform animal research. ii. Contractor shall facilitate applications and protocols that are required by all IACUC authorities (i.e., Contractor’s and Navy Surgeon General Oversight office (BUMED). (C) Facility equipment/capabilities: i. Contractor shall have Biosafety Level 2 (BL-2) facility with adequate laboratory facilities, containment equipment, and personal protective equipment. ii. Protocols for working with/handling BL-2 pathogens are in place. The Factors identified below will be the evaluation factors used to evaluate all offers passing all Minimal Technical Evaluation Factors A-C. Price Evaluation Factors (i)Completeness. The offeror has submitted a total price, completed all required representations and certifications, and acknowledgement of any amendments. (ii) Reasonableness. The Government's determination that the proposed price is fair and reasonable based on price analysis. (iii) Realism. The offeror's prices shall be examined to identify unusually low pricing and potential misunderstanding of the requirements Past Performance Evaluation Factors (i) Provide dates of contracts, both government and commercial, for the same work of similar size and complexity performed in the past three year period as follows: Name, address, and telephone number of the contracting organization; contract number and dollar value; date of contract and period of performance; and brief description of contract. For Government contracts, identify the name and telephone number of the procuring and administrative Contracting Officer(s). Past performance evaluation may consider the following: timeliness of results, Experience working with animal species in study, Experience performing skin studies or infectious disease studies, Ability to compete required pathology studies, and/or history of animal study publications. INSTRUCTIONS TO OFFERORS: Offerors shall provide sufficient technical documentation (including but not limited to: product literature, specifications, certifications) to allow for thorough evaluation of proposal. Additionally, the vendor shall fully explain their ability to meet the requirements above. Proposals shall be no more than twenty pages with 12 point, Times new Roman font. Margins shall be no less than one inch on all sides. Shipping shall be FOB Destination. Proposal shall specify the Total Price. Adequate competition is anticipated for this acquisition. The government anticipates award of a Firm Fixed Price contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any Federal Supply Schedule (FSS) numbers and pricing. Include any applicable discounts to the Government. Other Administrative Instructions: Central Contractor Registration (CCR). Offerors shall be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov; provide DUNS number; Cage Code and TIN. FAR Provisions & Clauses: FAR 52.212-1, Instructions to Offerors---Commercial Items FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions---Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. In compliance with said clause, the following FAR clauses apply: 52.219-8, Utilization of Small Business Concerns; 52.222-3, Convict Labor; 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers with disabilities; FAR 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). 52.233-3, Protest After Award FAR 52.222-41 Service Contract Act of 1965 FAR 52.223-3 Hazardous Material Identification and Material Safety Data FAR 52.227-1 Authorization and Consent FAR 52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement FAR 52.227-11 Patent Rights-Ownership by the Contractor FAR 52.227-14 Alt V Rights in Data-General FAR 52.245-4 Government Furnished Property Offerors are reminded to include a completed copy of 52.212-3 with RFP response. All clauses shall be incorporated by reference in the order. DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items; DFARS 252.212-7001, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders---Commercial Items, In compliance with said clause, following additional DFARS clauses apply: 52.203-3, Gratuities 252.227-7015, Technical Data—Commercial Items; 252.232-7003, Electronic Submission of Payment Requests; 252.243-7002, Requests for Equitable Adjustment; 252.247-7024, Notification of Transportation of Supplies by Sea. 252.247-7023, Transportation of Supplies by Sea DFARS 252.227-7039 Patents-Reporting of Subject Inventions DFARS 252.232-7003 Electronic Submission of Payments DFARS 252.235-7011 Final Scientific or Technical Report DFARS 252.235-7010 Acknowledgment of Support and Disclaimer. Proposals are due by 2:00pm Eastern Time on 03 September 2008. Proposals shall be submitted by email only as a MS Word or Adobe PDF attachment to: tameka.davis@med.navy.mil. Any questions shall be addressed to tameka.davis@med.navy.mil by email only NLT 28 August 2008. No phone calls accepted.
 

Web Link

FedBizOpps Complete View
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Document(s)

Amendment 1
 

File Name: Amendment 01 (Amendment 01 to Solicitation N626465.doc)

Link: https://www.fbo.gov//utils/view?id=91bacb674ac7951f497e3731b23006aa

Bytes: 21.00 Kb
 

File Name: Chart detailed in Paragraph 3.2 (Chart.doc)

Link: https://www.fbo.gov//utils/view?id=74b701d3c8505f72e51765679eb1defe

Bytes: 33.50 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Naval Medical Logistics Command, Frederick, Maryland, 21702, United States

Zip Code: 21702
 

Record

SN01647315-W 20080823/080821222343-f89284acb45658f3603b1a690d4fc1ef (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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