MODIFICATION
B -- Breeding, Care and Support of Transgenic Mouse Colony of Mammary Cancer
- Notice Date
- 3/24/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-RC-57003-74
- Response Due
- 4/4/2005
- Archive Date
- 4/19/2005
- Small Business Set-Aside
- Total Small Business
- Description
- Amendment 1 As a result of the combined synopsis solicitation below the following questions were received in the contracts office. The due date for responses is unchanged. The questions and answers are as follows: Question 1: Will "replacement" FVB/N wild type (+/+)females be provided as needed by the Government, or will a colony breeding replacements need to be maintained? Answer 1: The Government shall replace wild-type females to contractor as needed or requested. It is important to point out that these are commercially available wild-type C57BL/6 (B6) mice, not FVB/N mice. Question 2: It is not clear whether the Government wants only hemizygous (T/+) females retained/produced for research use, or if they want hemizygotes of both sexes. Answer 2: The Government wants only hemizygous females retained/produced for research use. Hemizygous males will only be maintained and used for breeding. Question 3: The Government refers to producing non-transgenic mice. Does it mean FVB/N wild type (+/+) animals, or animals produced by breeding found to be non-transgenic during PCR analysis? Answer 3: Non-transgenic mice refer to female progeny that do not express the transgene by PCR analysis. Question 4: Does the Government intend to set a specific production quota by gender? Answer 4: For male transgenic mice, this will be based on establishing breeding pairs and setting aside a small reserve for replacement. For female mice (transgenic and non-transgenic), this will be based on numbers specified in the contract. Question 5: The RFP states that one to one breeding is how the breeders should be paired but does not clarify what sex and ages of progeny are needed. Answer: Breeding shall be conducted using young (> 8 week), healthy hemizygous male transgenic mice with young (> 8 week), healthy female wild-type mice. Once weaned, female offspring will be maintained as part of the stock colony and used experimentally at the discretion of the Government. Male transgenic mice will be maintained for the expressed purpose of colony breeding. Question 6: Will the Government specify a requirement to cull litters to a certain number before weaning? Answer 6: Male offspring can be culled once a sufficient reserve is established for breeding and future replacement of breeders due to low production or health reasons. (Male transgenic mice also develop mammary tumors.) Female transgenic and non-transgenic progeny shall be maintained at the discretion of the Government. Question 7: Will the supplies needed to perform the technical manipulations be provided by the Government or by the contractor? This information is needed for preparing the cost proposal. Answer 7: The Government shall provide primers for PCR reactions and arrange for normal B6 female mice for breeding purposes to be delivered directly to the contract facility, as needed. The contractor shall procure all other supplies for technical work. Question 8: The solicitation states that the breeding colony must not suffer due to cross contamination. For example, previous RFPs of aging mouse colonies request that there must be two separate and distinct colonies. Does the Government intend that this colony be established in a similar manner? Answer 8: No. Question 9. The solicitation states that some animals may be returned to the contract facility after certain interventions. Does the Government want these animals returned to the primary colony of origin or placed in a separate location upon return? Answer 9: After experimental manipulations, animals may b e placed in a separate location, as long as it is dedicated to mice and there is no evidence of contamination in that room. This is a combined synopsis solicitation for commercial services, prepared in accordance with the format in FAR Part 12.6, as supplemented with additional information included in this notice. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This solicitation includes applicable provisions and clauses in effect through FAR FAC 2001-26 (01/2005). The North American Industry Classification System Code is 451710 and the business size standard is 500 employees. This is a 100% Small Business Set-Aside. BACKGROUND INFORMATION: The Laboratory of Tumor Immunology and Biology of the Center for Cancer Research of the National Cancer Institute has undertaken the experimental evaluation of numerous immunotherapy strategies for neoplastic disease of solid tumors, including recombinant viral-based vaccines and adoptive T cell transfer. The purpose of this acquisition is to establish and maintain a mouse transgenic breeding colony to be used as a pre-clinical animal model to investigate mechanistic questions in tumor progression and antitumor therapy. We have a unique mouse model termed "MTAG" that develops primary and metastatic mammary cancer (as a consequence of mammary gland specific-transgene expression) in which to study host-tumor interactions. The nature of tumor development in these mice better mirrors what occurs in human neoplasia. The overall goals of these studies may thus have important conceptual and practical implications for the immunotherapy of patients with neoplastic disease. The offeror will provide animal care and maintenance for approximately 200 mice (per month) for experimental procedures, and the necessary breeding colonies to produce, replenish and maintain the mouse colony. Because the female transgenic mouse of interest will be hemizygous, it will also be necessary to screen the offspring via polymerase chain reaction to identify the appropriate transgene-positive mice. The experimental procedures will integrate both cellular and molecular biological techniques to study characteristics of the host-tumor interaction, as well as the design and analysis of immune-based therapeutic approaches to potentially intervene with malignant progression. The immune studies require dedicated laboratory space to minimize any known contaminants, which may compromise the activity of the immune cells. Therefore, a dedicated mouse facility is required to house and breed these transgenic mice, to provide screening of the offspring and to identify offspring expressing the transgene. CONTRACT REQUIREMENTS: 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 provide the Line Items below: Line Item 1. Maintenance of Mouse Breeding Colonies. The Government's requirement is for a minimum of 25 pairs and a maximum of 30 pairs. Priced by Breeding Pair Cage per Day. Units is 10,950 (365 days x 30 cages) x proposed unit price _______ = proposed extended price _______. The Contractor shall breed and maintain transgenic mouse colonies in accordance with AAALAC guidelines and DHHS Publication No. NIH 85-23 Guide for the Care and Use of Laboratory Animals. The contractor shall possess an approved Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH, as required by Section 1-43-30 of the Public Health Service Policy on Human Care and Use of Laboratory Animals. The Contractor shall also ensure that all mice, including transgenic and non-transgenic progeny, are pathogen-free, including but not necessarily limited to: PVM, REO3, GDVII, POLY, Parvo, MHV, LCM, SEND, ECTRO, and LDH. If an outbreak is detected, the Contractor shall ensure that no cross-contamination occurs in order to avoid loss of the transgenic colony. The Contractor shall: a ) Establish breeding colonies for transgenic mice supplied by the Government. b) Monitor and report on the performance (productivity) of individual breeding pairs, as well as provide an inventory of the transgene-positive and transgene-negative progeny mice, on a monthly basis. c) Develop and optimize assays to test progeny mice for the presence of the desired transgene, based on the collection of tissues and/or blood samples from wailing mice. d) Remove animals from inventory and assign them to study protocols, as identified by the Project Officer or investigator. e) Ensure about 200 progeny mice are available each month for experimental purposes, as described in Line Item 2. Line Item 2. Animal Care and Maintenance. The Government's requirement is for a minimum of 30 cages and a maximum of 50 cages. Priced by Animal Cages per Day (5 Animals per Cage). Units is 14,600 (365 x 40 cages) x proposed unit price _________ = proposed extended price__________. The Contractor shall: a) Maintain and expand the breeding colony, as specified in Task 1, in order to produce and deliver approximately 200 progeny per month, including transgenic and non-transgenic mice as requested by the Project Officer for experimental purposes. b) Ensure that all progeny, including transgenic and non-transgenic progeny, are pathogen-free, as specified in Task 1. If an outbreak is detected, the Contractor shall ensure that no cross-contamination occurs in uninfected mice in order to avoid loss of the transgenic colony. c) House all mice in microisolator cages, and all cages, feed and water autoclaved prior to use. This procedure will also be important to minimize spread of any potential infection. The Contractor shall practice the industry standards set forth by AAALAC guidelines and DHHS Publication No. NIH 85-23 Guide for the Care and Use of Laboratory Animals in order to ensure pathogen-free health status. d) Provide adequate lab space to perform technical manipulations and an adjacent area for NCI investigators to gown and enter the lab space. e) Provide refrigerator and freezer (-20 degrees C and -70 degrees C) storage of materials and work products. Provide a BSL I/II hood for use as needed. LINE ITEM 3. Technical Support. The Government's requirement is for a minimum of 400 hours and a maximum of 680 hours. Priced by Technical Support Hour. Units is 540 hours x proposed unit price_________ = proposed extended price __________. The Contractor shall: a)The Contractor shall inject temperature-sensitive or biologically delicate (labile) materials, as defined by the specified experimental protocol, within 30 minutes of arrival to the Contract facility. The Contractor shall a) Perform experimental procedures as outlined in experimental protocols that will be provided by LTIB investigators. b) Perform inoculations of tumors, lymphocytes or other reagents and biological materials via diverse routes in mice, including footpad, tail scarification, intraperitoneal, intradermal, subcutaneous, intramuscular and intravenous, as requested by the LTIB researcher. Collect blood samples via retro-orbital bleeding, tail vein or cardiac puncture, as defined by the experimental protocol. c) Palpate and measure tumors as requested by LTIB researcher, and contact the Project Officer or investigator if any tumor approaches the ethical limit so that the mouse or mice in question can be arranged for appropriate delivery to the NIH. d) Harvest tissues, such as tumors, spleens, lymph nodes, and supply them either in medium or snap-frozen in liquid nitrogen. e) Routine viral testing every two months on sentinel animals. Testing shall include Orphan OPV, MHV, etc., as outlined in Task 1 and directed by AAALAC practices, policies and protocols. Positive reports shall be transmitted to the Project Officer within 72 hours after the testing has been completed. LINE ITEM 4. Delivery Service Priced By Delivery. The Government's requirement is for a minimum of 40 deliveries and a maximum of 75 deliveries. Units is 75 deliveries x proposed unit price ________= proposed extended price ________. The contractor shall pick up and deliver mice, mouse products and reagents between the contractor and Building 10, NIH campus in Bethesda, MD. Mouse products shall be delivered within time frames specified in individual protocols. All materials picked-up or delivered, must be stored for transit under conditions outlined in the experimental protocols. Many protocols require fresh tissue or blood products that must be delivered within 30 minutes of collection. Delivery of mice, reagents and other mouse products not specific to a protocol shall be delivered within 2 hours of receipt of request unless the requester approves a delivery time frame of longer duration. DELIVERIES: Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in Article C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule: a) The items specified below as described in SECTION C, ARTICLES C.1. and C.2. will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below: 1) Mice and other Mouse Products (as ordered) shall be delivered within 2 hours of request or as specified; 2) Monthly Activity Reports (3 copies) shall be delivered on the 5th calendar day following the reporting period. b) The originals of Item 2, above, shall be addressed and delivered to the Contracting Officer. c) Item 1 and two (2) copies of Item 2, above, shall be addressed and delivered to the Project Officer. d) Unless otherwise specified, deliveries shall be made Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day. REPORTING REQUIREMENTS: In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERIES of this contract: a) Monthly activity reports with the following specific information: (i) Status reports on all technical tasks performed, such as immunizations and bleedings, and quality control typing of mice. (ii) Report on any veterinarian problems and the steps undertaken to address these problems. (iii) Inventory summary which lists the following: total animals held by strain, sex, tag number, room number; all breeding pairs and their progeny including the number of animals of each strain and sex, age and source of mice of each inbred strain entering the quarantine facility. This summary shall also include the number and size of litters of each strain borne and the number and size of litters of each strain weaned each month, and the number of mice of each strain delivered to NIH. b) The Contractor shall also provide a notification report to the Project Officer about breeding or health problems that threaten any of the mice or the maintenance of the strain, within 24 hours of detection of the problem. Phone or email notification shall be followed up with a written report to the Contracting Officer and the Project Officer within 5 working days. SPECIAL SHIPPING AND PACKAGING REQUIREMENTS: All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specification. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. Packaging: All mice assigned for delivery to the LTIB, NIH shall be housed in microisolator cages (up to 5 mice/cage) to ensure rodent pathogen-free health status during transportation. These conditions will also be followed by the LTIB if any mice are to be returned to the contract facility for subsequent maintenance and evaluation following experimental procedures. All reagents prepared for transit from the contract facility to the LTIB, NIH are to be maintained in sterile tubes containing buffer, medium, etc., as specified in the individual experimental protocols. Marking: All mice shall be individually ear-tagged with a unique ID number for unambiguous identification. All specimens (e.g., tissues) derived from mice thereof shall be clearly marked using the ear-tag ID number of the respective mouse. Shipping: All mice shall be delivered in cages (up to 5 mice/cage) under AAALAC standards for the transport of mice, and packaged as described above. All reagents shall be stored for transit under the physical (e.g., temperature, etc.) conditions specified in the experimental protocols. If any reagents are delivered to the Contractor for injection, these materials must be administered into the designated mice within 30 minutes of arrival to the contract facility. Evaluation-Commercial Items (Jan 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical Capability of the items offered to meet the Government Requirement as stated in the Technical Evaluation Criteria, Price, and Past Performance. Technical and past performance, when combined, are more important, when combined, when compared to price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. TECHNICAL EVALUATION CRITERIA: 1) (30 points) Evidence of the qualifications of the personnel directly involved in the services required under the proposed contract. Evidence that these employees have: a) a thorough understanding of breeding and maintaining mice for laboratory research, b) a thorough knowledge of the equipment and supplies used to maintain and produce mice for laboratory research, c) a thorough knowledge and experience of handling pox-virus based vaccines and in injecting mice, bleeding and storage of serum form animals, passaging ascites tumors, maintaining pedigree records, and quality control typing of mice for the presence of a particular transgene. 2) (25 points) Possession of adequate facilities. a) evidence of availability of adequate facilities, current programs of animal care and specific plans for attention to the maintenance, care and management of the animals to be involved in this project, with particular respect for mouse holding rooms, air handling equipment, storage areas, laboratory work area, and physical isolation from other animal facilities. b) evidence of the facilities being accredited by the American Association of Accreditation of Laboratory Animal Care or ability of being eligible for accreditation (application paper, etc.) 3) (20 points) Disease prevention. Evidence of disease prevention and health status program for the proposed contract. Evidence of quality veterinary care. 4) (15 points) Evidence of qualifications and previous experience of the organization in animal care, breeding and handling as required in the Specifications/Statement of Work. 5) (10 points) Evidence of capability to transport mice to a new facility without harm to mice or their ability to breed, or evidence that the mice do not require a move. If possible, prior experience in successfully transporting such a colony should be documented. Period of Performance: Base Year: July 2005 through July 2006 plus four one-year options. It is intended to be a Cost Reimbursement Contract with not to exceed line items. FAR Clauses 52.217-8, Option to Extend Services and 52-217-9 Option to Extend the Term of the Contract apply. Payment: The contractor shall invoice monthly for services provided. FORMAT AND INFORMATION FOR SUBMITTING A PROPOSAL: Please submit one (1) original and four (4) copies of both the technical and business proposals and one (1) completed and signed Representations and Certifications (Commercial Items). The technical proposal should clearly and fully demonstrate the offeror's capabilities, knowledge and experience regarding the technical requirements. The business proposal should clearly demonstrate the proposed cost with documentation such as the offeror's commercial price schedule to support those costs. The offeror shall provide a minimum of two (2) references for whom they have or are currently providing similar services. EVALUATION PROCESS: The Government will award a contract resulting from this solicitation to the responsible offeror conforming to the solicitation whose proposal is the most advantageous to the government, price and other factors considered. FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS AND FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS?COMMERCIAL ITEMS, along with the DUNS NUMBER ADDENDUM. The resulting contract will incorporate FAR 52.212-4, CONTRACT TERMS AND CONDITIONS?COMMERCIAL ITEMS and FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS?COMMERCIAL ITEMS. The following FAR Clauses cited in paragraph (b) of the clause at 52.212-5 are applicable to this acquisition. FAR Clause 52.216-18 Ordering : paragraph (a) period of performance July 1, 2005 through June 30, 2006. FAR Clause 52.216-19 Order Limitation: paragraph (A) minimum 40 animals will be maintained, 30 breeding pairs, 540 hours and 100 deliveries. FAR 52.222-19Child Labor/ Cooperation with Authorities and Remedies; FAR 52.222-21 Prohibition of Segregated Facilities; FAR 52.222-26 Equal Opportunity; FAR 52.222-35, Affirmative Action for Workers with Disabilities; FAR 52.222-37 Employment Records on Disabled Veterans and Veterans of the Vietnam Era, and Other Eligible Veterans; FAR 52.232.32, Payment by Electronic Funds Transfer/Central Contractor Registration. Note: Contractor must be registered with the Central Contractor Registration (CCR) in order to receive an award. Interested offerors may obtain the forms and FAR Clauses via the acquisition web site at http://www.arnet.gov/far. Technical and price quotations, along with a completed Offeror Representations and Certifications-Commercial Items with DUNS number addendum, must be received in the contracting office no later that 3:30 p. m. on March 25, 2005. Please cite the solicitation number RFPN02-RC-57003-74 on all correspondence. Proposals can be mailed to 6120 Executive Blvd., Room 6060, Rockville, Maryland 20852, attention: Odessa S. Henderson. If you have any questions pertaining to this solicitation, they must be in writing via electronic mail or fax to oh4o@nih.gov or 301-402-6699. No collect calls will be accepted. No faxed copies or electronic quotations will be accepted.
- Place of Performance
- Address: National Cancer Institute, Bethesda, Maryland
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00775415-W 20050326/050324211923 (fbodaily.com)
- Source
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