SOLICITATION NOTICE
R -- Drafting of Clinical Trials Agreements (CTAs), Cooperative Research and Development Agreements (CRADAs) and Materials Transfer Agreements (MTAs)
- Notice Date
- 5/5/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-60062-NV
- Response Due
- 5/23/2006
- Archive Date
- 6/7/2006
- Description
- This is a combined synopsis/solicitation for commercial services prepared in accordance with the 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. This solicitation RFQ-NCI-60062-NV includes all applicable provisions and clauses in effect through FAR FAC 2005-09. The National Cancer Institute (NCI), Cancer Therapy Evaluation Program plans to enter into a contract for the drafting of Clinical Trials Agreements (CTAs), Cooperative Research and Development Agreements (CRADAs) and Materials Transfer Agreements (MTAs). The North American Industry Classification code is 541990, and the business size standard is $6M. This solicitation is set-aside for small businesses. Background The mission of the Cancer Therapy Evaluation Program (CTEP) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. Purpose The Agreement Coordination Group of the Regulatory Affairs Branch of CTEP is responsible for the preparation and execution of all agreements for the non-clinical and clinical development of agents that are in the CTEP portfolio. This includes all clinical collaborative agreements such as Clinical Trials Agreements (CTAs) and Cooperative Research and Development Agreements (CRADAs) as well as all Material Transfer Agreements (MTAs) for non-clinical studies. A high priority program within CTEP is the Pediatric Preclinical Testing Program and this Group is responsible for negotiating and executing all of the MTAs to support this Program with the pharmaceutical companies and the participating institutions. The Group also negotiates and executes the confidentiality agreements for the initial meetings with potential collaborators and is responsible for coordinating all collaborator interactions with CTEP. Statement of Work Education and Experience The contractor shall have a Ph.D. in a biomedical scientific field, and experience in the drafting of the agreements used by the NIH to facilitate collaborations with pharmaceutical companies and academic institutions. Tasks: The contractor shall provide draft agreements to support the Cancer Therapy Evaluation Program. Confidentiality Agreement drafts based on the model agreements provided by CTEP will be expected to be returned within 1-2 days. The timeline will be established at the time the contractor receives the agreement. The drafts will be reviewed by the Coordinator and revisions and corrections will be expected within 2 days. Following further review by the Coordinator, additional corrections and revisions will be expected 1 day later. For all other agreements, the contractor will be given the timeline based on the complexity of the agreement at the time the work is assigned. CRADA Research plans would be expected to take at least 2-3 weeks to complete the initial draft because of the detailed information that must be researched for inclusion in the research plan. Material Transfer Agreements would be expected to take about a week to draft. Revisions would be expected within 2 days of receiving corrections from the Coordinator. The contractor will also provide guidance and recommendations to the Coordinator to assist in the preparation of agreements. An outline of the clinical studies will be provided to the contractor who will then provide recommendations on the appropriate agreement. The Coordinator will review the recommendations provided and assign the agreement based on the recommendations. The above timelines would be followed for the drafting and revision of all agreements assigned. The contractor shall recommend appropriate wording to the Coordinator, Research and Development Agreements for the NCI Confidential Disclosure Agreements (CDAs) with potential pharmaceutical collaborators for exchange of information; CDAs for CTEP staff to attend advisory meetings and CDAs with companies interested in agents that DCTD is no longer developing. The contractor shall have good understanding of CTEP policies and procedures in order to appropriately draft the required agreement. The contractor will also be responsible for drafting all of the CDAs to support the participation of the Investigational Drug Steering Committee (IDSC) members as described by the Clinical Trials Working Group in the review of CTEP drug development plans. The contractor will review the Conflict of Interest forms for the IDSC members and make recommendations to the Coordinator regarding which members should participate for a given meeting. The review will be expected within a week of receiving all of the completed forms. The contractor shall be responsible for supporting the Pediatric Preclinical Testing Program (PPTP). The contractor must attend the PPTP Drug Development Group meetings in order to provide recommendations on the feasibility of working with the proposed companies. The contractor will establish a timeline for drafting the Material Transfer Agreements for the PPTP based on the discussions at the meeting about the testing timelines for the agents. The contractor will send the Coordinator reviewed and approved drafts to the company for the company?s review and answer any questions the company may have about the content of the agreement. The contractor shall recommend acceptable wording to address any issues raised by the company during its review of the agreement. There will be at least 24-30 agreements per year in support of this program. The contractor shall draft Cooperative Research and Development Research Agreement (CRADA) research plans to support DCTD development activities. This will require the contractor to be present for meetings with the pharmaceutical company in order to understand the scope of the work to be covered in the research plan. The contractor will receive from the Coordinator specific scientific documents such as the Drug Development Group summary, the Investigator?s Brochure and the draft clinical solicitation for use in the preparation of the research plan. The contractor may be required to search the scientific literature for additional background information as well as contact the company for its background data. The contractor shall review all NCI technology abstracts to ensure that technology advertised is consistent with DCTD obligations and agreements. The Coordinator will furnish the Operating Committee list and Anticipated IND filing list to the contractor on a monthly basis to assist with this task. The contractor shall recommend wording for NCI Material Transfer Agreements and other CTEP collaborative agreements as needed to support DCTD program activities. This would include RAID MTAs, DTP screening agreements and MCRADAs. The Coordinator will provide these documents to the contractor when input is sought and provide the timeframe that recommendations are needed in. The contractor will work independently and not as an agent of the government and shall furnish all the required services to perform the work. Prior to obtaining or accepting any other position the contractor shall coordinate with the Project Officer and/or the Contracting Officer to assure there is not a conflict of interest. Deliverables The contractor will attend meetings as necessary to perform the work. The contractor shall draft 120 Confidentiality Agreements, 25-30 Material Transfer Agreements, 15-20 CRADA Research Plans and to review 600 abstracts during the contract period. The contractor will provide all documents in electronic format that is compatible with Microsoft word. Period of Performance Period of performance shall be from June 1, 2006 or date of award whichever is later for twelve months. Evaluation criteria: Offers will be evaluated based on the following technical criteria. The technical portion of the proposal will receive paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. Technical evaluation will be performed by an NCI technical review committee. The below technical evaluation criteria will be used by the Government when reviewing the technical portion of the quotation. The criteria below are listed in the order of relative importance. 1) Technical Knowledge and Understanding ? 30%. 2) Technical Capability ? 30%. 3) Past Performance? 15%. 4) Personnel Qualifications ? 15%. 5) Writing Samples - 10%. 6) Price ? is a consideration but not scored. 1. Technical Knowledge and Understanding (30 points): The offeror shall demonstrate the techniques, methods, and processes the offeror plans to use to successfully accomplish the major tasks specified in the Statement of Work (SOW). In addition the offeror?s proposal shall demonstrate their understanding of the SOW by expressing the concept of the technical approach that clearly shows a grasp of the range and the complexity of the work, to include, but not be limited to, demonstrating knowledge and understanding of specified tasks within the SOW. The offeror should also demonstrate a clear knowledge of the Cancer Therapy Evaluation Program mission and goals and how the SOW contributes to those goals. 2. Technical Capability (30 points) The proposed technical solution, shall include, but is not limited to the following: Contractor shall have a minimum of 3 years experience within the last 5 years writing CRADA research plans for the preclinical and clinical development of anticancer agents, writing Material Transfer Agreements and Confidentiality agreements for anticancer agent development for a scientific audience. 3. Past Performance (15 points) The past performance shall demonstrate the contractor?s background and experience. The contractor shall provide: A minimum of three (3) references to include organization name, address, telephone number, a point of contact, a description of services provided, and the contract value (if appropriate). These references should be directly linked to experience writing about cancer prevention/early detection and/or other public health/ science/medical writing experience. 4. Personnel Qualifications (15 points): The offeror shall demonstrate the ability and competency of personnel, quantity and type of required training and experience, and which personnel are identified to perform the various aspects of the work. The offeror?s proposal should include a summary of each individual?s background, education, and his/her proposed responsibility. The offeror shall include a verification of current employment or a letter of commitment signed by that individual. Resumes of staff shall reflect not only academic qualifications but length and variety of experience in similar and relevant tasks. 5. Writing Samples (10 Points) The offeror shall provide at least one writing sample demonstrating experience in writing a CRADA research plan in the area of preclinical/ clinical development of anticancer agents. A minimum of four (4) writing samples related to cancer prevention or cancer early detection topic areas (clinical trials, other research, etc). 6. Price (Price will be evaluated but will not be scored.) Technical proposal: Proposals shall contain information regarding the technical approaches of the Offerors / Vendors, including the capabilities and plans of the Offerors / Vendors for provision of all of the services and products described in the aforementioned contractor requirements. Information submitted will be used in the evaluation of your quotation. Therefore, your response to this solicitation should be complete, as it must stand on its own and be responsive to all technical evaluation criteria. Evaluation Process: The Government will award a contract resulting from this RFQ to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. Provisions and clauses: The following FAR provisions and clauses apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS FOR SIMPLIFIED ACQUISITION; FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS ? COMMERCIAL ITEM ? WITH DUNS NUMBER ADDENDUM; FAR 52.212-4, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES, OR EXECUTIVE ORDERS-COMMERCIAL ITEMS-FOR SIMPLIFIED ACQUISITION. Clause 52.219-6, NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE. The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR 52.222-26; EQUAL OPPORTUNITY; FAR 52.222.35, AFFIRMATIVE ACTION FOR DISABLED VETERANS AND VETERANS OF THE VIETNAM ERA; FAR 52.222-36, AFFIRMATIVE ACTION FOR WORKERS WITH DISABILITIES; FAR 52.222-37, EMPLOYMENT REPORTS ON DISABLED VETERANS AND VETERANS OF VIETNAM ERA; FAR 52.225-3, BUY AMERICAN ACT SUPPLIES; AND 52.232-34, PAYMENT BY ELECTRONIC FUNDS TRANSFER-OTHER THAN CENTRAL CONTRACTING REGISTRATIONS. Full text copies of the FAR Terms and Conditions and other cited provisions may be obtained on line at the NCI website at http://amb.nci.nih.gov or from Deborah Moore, Contract Specialist at dm170b@nih.gov or (301) 402-4509. Please note: All contractors must be registered in the Online Representations and Certifications Applications (ORCA) in order to receive an award. Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. HHSAR 352.224-70 Confidentiality of Information (Apr. 1984) (a) Confidential information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. (b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. (c) If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. (d) Confidential information, as defined in paragraph (a) of this clause, that is information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization, shall not be disclosed without the prior written consent of the individual, institution, or organization. (e) Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this clause, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. (f) Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. (g) The provisions of paragraph (e) of this clause shall not apply when the information is subject to conflicting or overlapping [[Page 4257]] provisions in other Federal, State or local laws. a. CONFIDENTIALITY OF INFORMATION The following information is covered by HHSAR Clause 352.224-70, Confidentiality of Information (MARCH 2005): ALL ITEMS LISTED IN THE STATEMENT OF WORK b. Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Offers are due May 23, 2006 at 1:00 p.m. EDT. Facsimile and email submission are NOT authorized. Offers must be in writing and should be submitted as follows: (1) one original and three copy of a completed SF 1449, signed by an individual authorized to bind the organization; (2) one original and three copies of the technical proposal; (3) copy of the contractor ORCA validation/registration; (4) acknowledgment of amendments, if any. Offers and related materials must be submitted in writing to Debbie Moore at the listed address. Offers that fail to furnish the required information or reject the terms and conditions or statement of work of the solicitation may be excluded from consideration. Please cite the solicitation number RFQ-NCI-60062-NV on your offer. Any questions must be submitted in writing and may be e-mailed to dm170b@nih.gov or faxed to 301-402-4513. It is the vendor?s responsibility to call 301-402-4509 to verify questions have been received.
- Record
- SN01042644-W 20060507/060505221540 (fbodaily.com)
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