SOURCES SOUGHT
B -- Central Data Collection Center (CDCC) - Draft Statement of Work
- Notice Date
- 7/28/2015
- 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-SBSS-PCPSB-55004-26
- Archive Date
- 10/12/2015
- Point of Contact
- Kathleen Y. Sears, Phone: (240) 276-5435
- E-Mail Address
-
kathleen.sears@nih.gov
(kathleen.sears@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work 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. 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. This requirement is assigned North American Industry Classification System (NAICS) 541990 - Other Professional, Scientific, and Technical Services which has a size standard of $15,000,000. 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. Background: The National Cancer Institute's (NCI) Board of Scientific Counselors approved the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial in January 1991. Contracts were awarded in September 1992. Ten Screening Centers (SCs), a Coordinating Center (CC), and a Laboratory (Lab) were competitively selected for award. Screening began upon Office of Management and Budget (OMB) approval of study forms in November 1993. The NCI Executive Committee approved Special Studies to investigate research topics using questionnaire and biological data on October 8, 1996. In 2009, the NCI Director approved the continuation of follow-up of PLCO participants beyond the originally planned 13-year follow-up period. In March 2011, a new contract to a Centralized Data Coordinating Center (CDCC) was awarded permitting centralized follow-up of all PLCO participants who consented to continuation in the study as either active (transfer to CDCC for follow-up activities as previously done at SCs) or passive (remain as PLCO participant through linkages conducted only by the SCs). In 2000, the PLCO contracts with the six of the ten SCs were modified to permit the conduct of a feasibility study in which a relatively small number of individuals were recruited, randomized to either low-dose CT or chest radiography, and screened at baseline and a year later, subsequently referred to as the Lung Screening Study (LSS) Feasibility Phase. Based on the findings from this feasibility study, in September 2002, the National Lung Screening Trial (NLST), a multi-institutional trial was launched at all ten PLCO SCs and the American College of Radiology Imaging Network (ACRIN). Design, Participants and Procedures The PLCO Cancer Screening Trial is a large-scale, randomized study designed to determine whether certain screening tests will reduce the number of deaths from these cancers. PLCO follow up was being conducted at ten sites, geographically and demographically disparate, around the U.S. The Trial enrolled 154,906 male and female participants between the ages of 55 and 74 from 1993 to 2001. Lifestyle, dietary and risk factor information was collected from participants. The intervention arm received posterioanterior (PA) chest x-ray annually for four screens (except never smokers who received three annual screens), flexible sigmoidoscopy at enrollment and again during the fourth or sixth annual screening interval depending on time of enrollment. Men were screened for prostate cancer with PSA for six annual screens and with digital rectal exams for four annual screens. Women were screened for ovarian cancer with CA-125 for six annual screens and with transvaginal ultrasound for four annual screens. Participants randomized to the usual care arm were advised to receive regular health care from their primary care provider. Whole blood, sequential serum samples and multiple plasma samples were collected from the intervention arm. Aliquots from these samples are stored in the PLCO Biorepository through collaboration with the NCI's Division of Cancer Epidemiology and Genetics (DCEG). The usual care arm provided buccal cell DNA samples; these specimens are also stored in the PLCO Biorepository. PLCO completed enrollment in July 2001 with participants randomly assigned to either the intervention or usual care arm. PLCO has a nearly equal number of men and women. The majority of participants are non-Hispanic whites although several centers had initiatives to recruit minority participants. The population is relatively well educated, with over half of the participants having a college education. The smoking history of participants at entry was as follows: 47% never smokers, 43% former smokers and 11% current smokers. The screening phase of PLCO ended in September 2006 for the last enrollees. The participants are followed for at least 13 years from the time of enrollment. NLST is a multi-institutional trial to determine if increased detection of apparently early-stage lunch cancers by computerized tomography screening ultimately resulted in decreased lung cancer-specific mortality. The Trial followed 53,456 subjects through the end of 2009, resulting in an average follow-up period of 6.5 years. Incident lung (and other) cancers and deaths during this period were ascertained through an active follow-up process at all ten PLCO SCs and 23 ACRIN institutions; participants were mailed annual questionnaires and reported cancers were confirmed through medical record abstracting. Deaths were ascertained through vital status updates with death certificates obtained for participants known to have died; this was supplemented by National Death Index (NDI) linkages. Serial specimens of blood, urine, and sputum were collected at 15 NLST-ACRIN SCs from a total of 10,208 subjects. In addition, paraffin blocks from resected lung tumors were collected. NLST completed enrollment in April 2004 with participants randomly assigned to either the intervention or usual care arm. NLST has slightly more number of men than women. The majority of participants are non-Hispanic whites although several centers had initiatives to recruit minority participants. PLCO/NLST Biorepository The Biorepository (maintained in Frederick, MD) contains approximately 2.8 million biologic specimens collected during the six screening years. These specimens are an invaluable resource for cancer research. Some of the characteristics that make the uniquely valuable include: • Large sample size allows ample statistical power to address many molecular epidemiologic questions • Specimens are collected prospectively • Serial specimens were collected annually during the screening visits • Detailed demographic, epidemiologic and clinical data are available Pathology specimens have also been collected for many prostate, lung, colorectal, ovarian, breast, and bladder tumors. Pathology collection was routed through laboratories where tissue microarrays (TMAs) are constructed and cores are removed from tumors for DNA and RNA extraction. Both trials have a competitive application review process for investigators interested in utilizing specimens collected from the trials. Continued Follow-up of Participants The PLCO and NLST Trial is a long-term screening trial monitoring cancers with long natural history. In such a situation, it takes many years for data accrual to reach the critical mass necessary for meaningful analyses. Participants have finished the screening and more than half of them have been followed for at least 13 years. As a result, research activities utilizing PLCO and NLST biospecimens have begun to gain momentum. The number of EEMS applications has increased steadily. It is likely that this trend will continue and the usefulness of the biorepository should increase as the data continues to accumulate. Extending follow-up of PLCO and NLST participants will add more important data to this rich scientific resource. PLCO follow-up efforts were centralized in 2011 and following the consenting process, eligible participants were transferred from PLCO SCs to the CDCC in August 2014 for a total of approximately 85,000 active participants (those who transferred to the CDCC) and 16,500 passive participants (those who remained at the SCs). Purpose and Objectives: The purpose of this contract is to increase the value of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and National Lung Screening Trial (NLST) resources by 1) continuing the follow-up of PLCO and NLST participants for an additional 5-year period (2016-2021); 2) updating key exposure data and collecting additional data; and 3) collecting additional biospecimens. This contract will enhance the value of the PLCO and NLST resources by 1) substantially increasing the number of accrued incident cancer; 2) strengthening the trials' ability to evaluate the long-term effects of screening on cancer mortality; and 3) allowing for a continued opportunity to collect additional exposure data and biospecimen. Project Requirements: 1. Project Management 2. Computer Programming 3. PLCO/NLST Passive Follow-Up 4. PLCO/NLST Active Follow-Up 5. Special Studies/Additional Projects A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The period of performance for this ID/IQ contract would be 5 years. The anticipated start date is March 1, 2016. A single award is anticipated. Other Important Considerations: Draft Statement of Work: A copy of the draft Statement of Work (SOW), which is subject to revisions may be assessed at the end of this document. Capability Statement/Information Sought: Sources are expected to have the expertise, personnel, and systems to meet requirements of the draft Statement of Work (SOW). Tailored Capability Statements shall demonstrate a clear understanding of all tasks specified in the attached draft SOW. Tailored Capability Statements for this requirement shall also address the following: Technical Approach o Demonstrated soundness, appropriateness, adequacy and feasibility of the technical approach to all tasks in the Statement of Work and referencing the Sample Task Order Statement of Work. o Appropriate compliance with FISMA security at Moderate/Moderate/Low for databases, documentation, related software, and all necessary elements. o Demonstrated understanding of the technical, scientific and operational problems and solutions associated with accomplishing the Statement of Work. o Methodology for successful accomplishment of the Statement of Work; including management, coordination, and data collection. o Suitability and feasibility of the technical approach. o Suitability and feasibility plan to ensure confidentiality of information. o Adequacy of Sample Task Order proposed. Personnel: Project Director: o Appropriateness and adequacy of the education, training, experience, expertise, knowledge and effort of the proposed Project Director to carry out the proposed task area(s) with respect to the following: o Managing and coordinating the efforts of personnel required to perform the functions described in the Statement of Work and Sample Task Order Statement of Work. Other Personnel: o Suitability and adequacy of the training, qualifications, and experience of other personnel and subcontractors with respect to: medical record abstracting, computer programming, and data collection. Organizational Experience and Capabilities o Demonstrated organizational experience and ability to carry out the specific tasks and requirements of the Statement of Work including:Documentation and demonstration of the quality of the organization's experience in the management of large-scale epidemiologic and clinical research data and the quality assurance and control of such data. o Documentation and demonstration of the quality of experience in providing broad quality assurance, auditing, data collection and data management tasks identified in the Statement of Work. o Managerial approach to providing corporate support to Project Management o Stability of the workforce and ability to recruit and retain staff. o Capability to perform the proposed Sample Task Order Statement of Work. o Adequacy and suitability of staffing plan delineating lines of authority and areas of responsibility for proposed Sample Task Order Statement of Work. Facilities and Equipment o Documented availability and adequacy of facilities, equipment, and databases to perform the Statement of Work, including all computers, hardware and software, computer equipment and servers and dedicated space for staff and equipment. o Adequacy and suitability of the secure environment for confidential storage of information. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION 508 o Offerors capability to ensure Section 508 compliance SUSTAINABILITY ACQUISITION PLAN o Offerors capability to ensure compliance with Sustainable Acquisition Policy and the interim rule entitled "Sustainable Acquisition" at http://www.gpo.gov/fdsys/pkg/FR-2011-05-31/pdf/2011-12851.pdf (FAR case 2010-001, FAC 2005-52). Information Submission Instructions: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed fifteen (15) total single-spaced pages including all attachments, resumes, charts, etc. ( 12 point font size at a minimum), that clearly details the firm's ability to perform and that addresses the specific requirements described above and the draft Statement of Work (SOW). Tailored capability statements should also include an indication of current certified small business status. Please provide your DUNS number, organization name, address, point of contact, including names, titles, addresses, telephone, fax numbers, email addresses, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code on the first page of your capability statement. 2. Number of Copies/Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Kathleen Sears, Contracting Officer at searsky@mail.nih.gov either in MS Word, or Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SBSS-PCPSB-55004-26. Facsimile and telephone responses will not be accepted. 3. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 4:00PM EST on August 12, 2015. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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