SOURCES SOUGHT
R -- Drug Development Support for Cancer Therapy Evaluation Program (CTEP)
- Notice Date
- 6/18/2014
- Notice Type
- Sources Sought
- 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, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-ETSB-41007-27
- Archive Date
- 7/24/2014
- Point of Contact
- Charlotte L. McCormack, Phone: 240-276-5409, Lisa A. Hill, Phone: 2402765418
- E-Mail Address
-
mccormackc@mail.nih.gov, hilll1@mail.nih.gov
(mccormackc@mail.nih.gov, hilll1@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $7 Million per annum. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the administration and coordination of most of the extramural therapeutic clinical trials supported by the DCTD. CTEP, DCTD has sponsored from 100 to 200 active Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA) at one time. The current CTEP portfolio encompasses the development of approximately 65 investigational agents on which the Division sponsors approximately 120 active INDs. The sources of investigational agents are typically internally developed NCI agents and those co-developed with pharmaceutical industry collaborators. There are currently approximately 600 clinical studies conducted under these INDs that run the gamut from pilot studies through licensing studies. In addition to single-agent trials, CTEP sponsors multi-agent trials, with either combinations of investigational drugs or biomarker-driven strata of unique agents. Oftentimes, CTEP-sponsored studies contain supporting investigational in vitro diagnostic assays or investigational imaging agents. CTEP-sponsored studies span the purview of Office of Cell and Gene Therapy (CBER), Office of Hematology and Oncology Products (CDER), and Office of In Vitro Diagnostics and Radiological Health (CDRH), requiring expertise in investigational drugs, biologics and assays. Two previous contracts awarded competitively and entitled, "Drug Development Support for Cancer Therapy Evaluation Program," have provided support. These include contract N02-CM-27022 and the current contract N02-CM-81000 (2008-2015). The Contractor in all cases has been Technical Resources International., Bethesda, MD. Purpose and Objectives: The CTEP must prepare, file and manage INDs for the investigational agents it sponsors in clinical trials, including the agents from the NCI's intramural clinical programs and pharmaceutical collaborators. As sponsor of these IND trials, DCTD must design a plan for the efficient evaluation and development of these investigational agents and monitor the safety, efficacy and distribution of the agents, tracking the progress of the studies both administratively and scientifically. CTEP must also submit amendments to the INDs it sponsors including new protocols, protocol amendments, adverse events, preclinical data, updated chemistry and manufacturing information, special exceptions, investigator brochures and responses to FDA communications. Project Requirements: Organization must provide support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a wide range of services as described below. The organization will also provide similar support for the Cancer Imaging Program, Division of Cancer Treatment and Diagnosis (DCTD). Your Organization shall furnish services, qualified personnel, material, equipment, including secure computers, high speed-high capacity data link to NCI servers, computer support, and facilities, including maintenance of appropriate software and licenses as needed to perform the clinical research support tasks set forth below. All of the aspects of this in-depth tracking of investigational agent information shall require frequent face-to-face, one-on-one meetings to discuss strategies and tasks and to review and analyze data. The Organization will be required to: 1) Provide support for the preparation, tracking, submission and distribution of CTEP drug development related documents and FDA submissions. 2) Monitor and Support Adverse Event Reporting. 3) Track information regarding investigational anti-cancer agents. 4) Provide general technical and administrative support for investigational agent development and regulatory activities. 5) Maintain a Quality Control Program 6) Assist in the transition of this contract to a successor contract through a 3 month Phase Out transition period. Anticipated Period of Performance: It is anticipated the services will be acquired through full and open competitive procedures. It is anticipated that a cost reimbursement contract will be awarded with a one (1) year base plus six (6) one (1) year option periods beginning on or about April 1, 2015. Information Sought: To be deemed capable of providing services that meet the CTEP requirements, please submit a written capability statement demonstrating your ability and experience. Submission Information: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Charlotte McCormack, Contracting Officer, at charlotte.mccormack@nih.gov in MS Word or Adobe Portable Document Format (PDF) by July 3, 2014 4:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. 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. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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