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Added: Jun 30, 2011 12:39 pmThis 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 National Cancer Institute (NCI), National Institutes of Health (NIH) project is for the renewal of contract HHSN261201000085I, with CCS Associates, Inc. (CCSA) that was awarded for a one year period. Freedom of Information Act (FOIA) requests regarding the current contract with CCS Associates, Inc. should be directed to Suzy Milliard at firstname.lastname@example.org. This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI).
A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government.
Interested parties are expected to review this Notice, the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk.
The National Cancer Institute (NCI) Center for Strategic Scientific Initiatives (CSSI) Office of the Director (CSSI-OD or the Office) has as its mission the task of planning, developing, executing, and implementing rapid strategic scientific and technology initiatives that keep the Institute ahead of the scientific curve with respect to potential new highly productive areas and discoveries. This may involve the development and application of advanced technologies, synergy of large scale and individual initiated research, and/or forging novel partnerships that emphasize innovation, trans-disciplinary teams and convergence of scientific disciplines to enable the translation of discoveries into new interventions, both domestically and in the international arena, to detect, prevent and treat cancer more effectively.
Purpose and Objectives:
The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns including 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 that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.
As a result of this SBSS Notice, the NCI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.
If an RFQ is issued, the NCI anticipates that one (1) award may result from the issuance of the RFQ.
The intent is to procure this requirement as a commercial item purchase order.
Independently, and not as an agent of the Government, the Contractor shall perform the services described in the attached Draft Statement of Work (SOW). The Contractor shall provide qualified personnel, material, equipment and facilities not otherwise provided by the Government during the performance of this contract.
Anticipated Period of Performance:
The period of performance for this requirement is five (5) years, consisting of a one-year base period plus four (4) one-year options. The anticipated start date is September 30, 2011.
Draft Statement of Work:
A copy of the draft Statement of Work (SOW), which is subject to revisions, is attached to this sources sought announcement or may be accessed on the NCI Office of Acquisitions Website at URL: http://rcb.nci.nih.gov once there, click on Current Requests for Proposals.
In the event an RFQ is issued, North American Industry Classification System (NAICS) code 541690with a size standard of 7.0 million dollars is being considered.
Capability Statement/Information Sought:
Tailored Capability Statements shall demonstrate a clear understanding of all tasks specified in the draft Statement of Work (SOW). Tailored Capability Statements for this requirement shall address the following areas:
In support of Task Area 1:
a. Design and perform background research, participate in planning, develop relational databases and prepare draft white papers on topics relevant to the research and business needs of the initiatives and collaborations of the Director and Deputy Director of CSSI.
b. Identify, qualify, and convene key participants for scientific workshops and conferences relevant to these initiatives; draft meeting agendas; participate in the meetings; draft meeting reports for internal use in project planning and for publication. Parties involved may include NCI, other NIH entities, FDA, academia, and industry.
c. Develop and maintain research and business plans for projects undertaken by the Director and Deputy Director of CSSI. These plans shall emphasize the use of best practices and shall include:
i. Definition of what will be measured and calculated;
d. Develop and review research protocols and analysis plans for projects carried out under the auspices of the Director and Deputy Director of CSSI. It is anticipated that many of the protocols will have novel and complex designs (e.g., adaptive randomization, multiple investigational agents and/or devices) aimed at advancing the sciences of oncology drug development and management of cancer patients.
4. Develop science-based regulatory strategy and provide regulatory affairs support for studies sponsored by the Office of the Director of CSSI and its collaborators. Develop, submit and maintain regulatory documentation (e.g., investigational device exemption (IDE) applications, 510(k) applications, investigational new drug (IND) applications and Master INDs, imaging charters, briefing documents, biomarker qualification packages). Manage safety data and reporting and Data and Safety Monitoring Board (DSMB) activities.
5. Manage operations for sponsored studies. For example, qualify sites for carrying out the studies; ensure manufacturing, tracking, and delivery of study materials to appropriate locations; assist in development of data management/bioinformatics systems; monitor study progress; and carry out quality assurance audits of study data and processes.
6. Prepare draft manuscripts, critical reviews, news releases, PowerPoint presentations and other graphics, etc., as requested for publication of research results and plans. Ensure that the required Government clearances/approvals are obtained prior to starting work and/or releasing/publishing these items.
7. Perform coordination activities. Maintain contact information for working groups, committees, project teams, etc.; assist in planning business meetings and teleconferences; prepare agendas and minutes for same; maintain files of correspondence and other documentation as directed.
8. Facilities, staff, equipment and processes in place at start of contract. Including a relevant data management system that is caBIG capatible, and supports regulatory submissions, including preclinical and clinical data management, safety data, regulatory document tracking and background materials for IND/IDE maintenance.
9. The Contractor shall be readily available to attend meetings in person in Bethesda with one hour advance notice and respond to requests after normal business hours and on weekends.
In support of Task Area 2
1. Conduct literature/media research and prepare written summaries for specific CSSI initiative(s) steering committees in support of high-priority initiatives.
2. Provide scientific literature research and review (including written summaries and databases) for selection of biomarkers, laboratory technologies and imaging modalities along with clinical settings providing the best possible opportunities for development of biomarkers, nano-based moieties and technologies, and proteomics-based technologies useful in oncologic drug development and improving the care of cancer patients; include information to address both scientific and economic criteria for qualifying candidate biomarkers.
3. Develop priority ranking of research efforts within CSSI initiative(s) by drafting criteria for determining their utility for developing new oncology therapies or new uses of approved therapies or other intended uses.
4. Prepare and maintain documentation for justifying CSSI initiatives and assisting with implementation with all stakeholders (e.g. academia, patient advocates, FDA, industry).
Support grantees and other stakeholders in the initiatives of CSSI. It is anticipated that this support shall include tasks such as:
1. Assist in implementation of research plans. Activities include:
a. Prepare draft documentation of the definitions and standards for review by CSSI and individual initiative committees, including review and assurance of standards adequate for data sharing among protocols.
Examples of specific tasks include preparation of a clinical development plan for a nano-based drug or drug delivery system; development and maintenance of specific clinical protocols and regulatory documentation (e.g., IND, IDE, 510(k)) for the nano-based product in support of the clinical development plan or for proteomics assay; and assisting in preparation of briefing documents and data packages for FDA validation and qualification of proteomics assays.
2. Prepare draft manuscripts, news releases, PowerPoint presentations, etc. Assist in publication via a dedicated website, (Government, if available, contractor, if not) as well as by preparing draft presentations for relevant scientific and trade association meetings, articles in the scientific and trade association literature, and news releases directly to the public or via other interested parties. Ensure that the required Government clearances/approvals are obtained prior to starting work and/or releasing/publishing these items.
3. Perform literature/media research and prepare written summaries to keep CSSI and the individual initiatives abreast of complementary research initiatives, both in the U.S. and worldwide.
Information Submission Instructions:
1. Page Limitations:
Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm's ability to perform the aspects of the notice described above and in the draft SOW. Tailored capability 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 (preferably placed under the eligible small business concern's name and address) as well as the eligible small business concern's name, point of contact, address and DUNS number.
All capability Statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to C. Timothy Crilley, Contracting Officer, at email@example.com or Contract Specialist, Kimberly Goetz, at firstname.lastname@example.org in MS Word, WordPerfect or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NCI-SBSS-TSB-110088-04. Facsimile responses will not be accepted.
3. Common Cut-off Date:
Electronically submitted tailored capability statements are due no later than 2:00PM (Eastern Prevailing Time) on July 7, 2011. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.
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(s).
Bldg 244, Room 112
Frederick, Maryland 21702
Kimberly M. Goetz
C. Timothy Crilley,
June 30, 2011
Jul 07, 2011 2:00 pm Eastern
Original Set Aside:
R -- Professional, administrative, and management support services
541 -- Professional, Scientific, and Technical Services/541690 -- Other Scientific and Technical Consulting Services