SOURCES SOUGHT
A -- United States Renal Data System - Special Study Centers
- Notice Date
- 3/27/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- 06-02
- Response Due
- 4/5/2006
- Point of Contact
- Marlene Mireles, Contract Specialist, Phone 301-594-8831, Fax 301-480-4226, - Marlene Mireles, Contract Specialist, Phone 301-594-8831, Fax 301-480-4226,
- E-Mail Address
-
MirelesM@extra.niddk.nih.gov, MirelesM@extra.niddk.nih.gov
- Description
- The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases is conducting a market survey to determine the availability and technical capability of qualified small business, veteran-owned small business, service-disabled veteran-owned small business or HUBZone small businesses capable of serving Similarly, the NIDDK is seeking organizations or institutions to carry out special studies of biomedical importance to the Institute and the Nephrology community as USRDS Special Studies Centers. Each SSC shall perform existing data studies in three major areas; and design, pilot, and conduct one special study during the contract period. These studies will be carried out in collaboration with the NIH, the USRDS Coordinating Center, and the Centers for Medicare and Medicaid Services (CMS). This request is for interested firms with the capablitiy of providing the required services to submit a capability statement along with projected pricing, to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurment will be classified under North American Industrial Classification (NAICS) code 541710 with a size standard of 500 employees. All respondents are requested to identify their firm's size and type of business. Each SSC Contractor shall perform all tasks set forth in the Statement of Work and shall be involved in all aspects of the project. The work shall be performed according to the following defined ten tasks: a. TASK ONE: Three-Month Transition Period b. TASK TWO 1) The Contractor shall work in collaboration with the CC, the other SSCs, the DKUHD NIDDK, CMS OCSQ and OSP, the CMS Network Forum, and the Steering Committee to coordinate all functions pertaining to all aspects of the project, including: 2) The Contractor shall have responsibility for developing and implementing systems for intra-program communications between the SSC and the NIDDK, other SSCs, the CC, the HCFA, and the general community. The Contractor shall actively elicit and maintain cooperation, interest and communication between the organizational components of the USRDS database. c TASK THREE The Contractor shall design and implement a structure and a system within the Special Studies Center that shall provide effective biostatistical and analytical expertise, and data management. 1) The Contractor shall provide the technical expertise and computer facilities to maintain, update their SSC database, and to conduct NIDDK-directed analyses. The Co-Project Officers will direct these analyses. 2) The Contractor shall have a system design for data storage and maintenance that is compatible with the CC=s format for the data system. The Contractor shall coordinate the implementation of their data storage and maintenance system with the CC. 3) The Contractor shall maintain confidentiality and security of all registry information. d. TASK FOUR – Contribute to the Annual Data Report (ADR) The contractor shall work with the Coordinating Center to produce analyses appropriate for inclusion in the ADR. It is expected that each special study center will contribute a chapter or part of a chapter in each ADR. e. TASK FIVE – Conduct Special Studies The Contractor shall obtain and utilize an appropriately selected national or regional sample of patients for each existing data study or special focused study. The Government requires that the clinical studies be designed so as to lead to generalizable conclusions. 1) At this time, it is anticipated that the broad topical areas listed below will be included among the topics to be addressed by the SSCs under this solicitation. However, at the discretion of the Government and in response to emerging issues, the topical areas of these special data collection studies may be changed or modified by the Co-Project Officers in consultation with CMS and with its various advisory committees and consultants. One special study for the term of the contract and two existing data studies per year are anticipated to be completed by each SSC. o Nutrition/Malnutrition o Cardiovascular Diseases o Quality of Life, Rehabilitation and Psychological Impact of ESRD o Other/Emerging Issues Each special study and existing data study shall include economic/cost analysis and pediatric components in their analyses as appropriate. To the extent possible, the SSCs and the Co-Project Officers shall work to integrate individual special studies from the separate SSCs into combined data collection strategies. 2) The Contractor shall submit a proposal for each existing and special study topic for peer review through the Co-Project Officers. No special or existing data study shall be initiated without the direction and prior written approval of the Project Officer. 3) SSC Investigators may collaborate with other interested investigators, as long as there is no conflict of interest in such collaborations. The primary results of the studies performed by the SSCs shall constitute deliverables to the Government, and may, at the direction of the Co-Project Officers, be included in the ADRs. 4) The Contractor shall actively participate in the identification and solicitation from the renal scientific, academic and voluntary organizations as well as renal patient groups, ideas for research, and opportunities of significant public health importance that could be developed into intervention strategies to improve care, within the approved general topic areas. 5) The Contractor shall design special study data collection instruments in collaboration with NIDDK, CMS and the CMS ESRD Networks to support the focused special studies done by that center. 6) The Contractor will have 12 months after data entry is complete to exclusively use the data for development of manuscripts and reports. After this time, the primary patient identifiable data from the special studies shall be provided by the SSCs to the CC, to be incorporated by the CC into the master USRDS database, and made available in encrypted SAF format to the research community. f) TASK SIX The Contractor shall be responsible for preparing all background and necessary forms to obtain OMB and/or Aclinical exemption@ clearance from the OMB or the Clinical Exemption Review Committee (CERC) of the NIH, for use of the data collection instruments for their special studies, in accordance with the Paperwork Reduction Act. This information shall be given to the Co-Project Officers to submit to the CERC or OMB. The information packets to be prepared by this SSC shall include statement of justification, descriptions of the survey, data analysis plans, tabulation and publication plans, and the time schedule for data collection, analysis and publication. The number of consultants to be used, an estimation of response reporting burden, and an estimation of cost to the Federal Government shall also be included in the package. Each SSC should assume 10 percent of the OMB/CERC package may require rework and resubmittal to the CERC or OMB. g) TASK SEVEN The Contractor shall provide special studies patient data to the CC in a SAS or other format compatible with the master USRDS database. The data must be provided in an organized fashion that allows incorporation of the special study data with the rest of the USRDS Database to proceed in a smooth and timely fashion. h) TASK EIGHT At the direction of the Co-Project Officers, the Contractor shall aggregate, analyze and release data from the existing data study or special study being performed by their institution, for the use of the Government. Such data requests may require greater than two hours of combined computer and personnel time. No more than 3 such requests are expected per year. Reports required as deliverables under the terms of this contract are not considered to be data requests. In all instances of data release, each SSC shall strictly adhere to all provisions of the Publication Policy and the NIDDK Data Request Policy. i) TASK NINE No commitments to represent the USRDS shall be made by a SSC to any society or organization without the prior written approval of the Co-Project Officers. The Co-Project Officers may call on SSC staff to deliver all or part of such presentations. j) TASK TEN The Contractor shall prepare manuscripts (deliverables of data analysis) for publication in collaboration with the NIDDK and CMS staff, describing the research findings from the existing data and the special focused studies. A minimum of one manuscript is expected from each existing data study, and approximately two manuscripts from each special focused data collection study. All manuscripts shall be prepared in accordance with the USRDS Publication Policy. The estimated required resources and the time required to prepare each manuscript shall be provided to the Project Officer prior to initiation of the manuscripts. k) TASK ELEVEN The Contractor shall maintain appropriate database and data files. In addition, each SSC=s data system shall have the ability to transmit and receive data electronically to and from CMS and the CMS ESRD Networks. Interested firms responding to this market survey msut provide (a) capablity statment demonstrating their experience, skills and capability to fulfill the Government's requirements for the above. The capablity statment shall be in sufficient enough detail, but not to exceed 10 pages, so that the Government can determine the experience and capability of your firm to provide the requirements above. Your capablity statement, not to excced 10 pages, should include references, key personnel and teaming arrangements. A copy of the capablilty statement must be received at the address identified in this synopsis by no later than close of business (5:00pm local time at designated location) on April 5, 2006. Responses by fax or e-mail WILL NOT BE ACCEPTED. This synopsis is for information and planning purposes and is not to be construed as a committment by the Government, nor will the Government pay for information solicited. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (27-MAR-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 24-APR-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NIDDKD/06-02/listing.html)
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20817
- Country: USA
- Zip Code: 20817
- Record
- SN01034391-F 20060426/060424221932 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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