SOLICITATION NOTICE
R -- Scientific Services for Support of NCRR Clinical Research Study Oversight and Monitoring
- Notice Date
- 3/3/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB(RR)-2010-089-MKL
- Archive Date
- 3/27/2010
- Point of Contact
- Melissa K. Lombardo, Phone: (301) 435-0370
- E-Mail Address
-
ml363x@nih.gov
(ml363x@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format specified in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is NHLBI-PB(RR)-2010-089/MKL and is issued as a Request for Proposal (RFP). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-38. The acquisition will be made pursuant to the authority in FAR Part 13 to use simplified procedures for commercial requirements. The procurement is being conducted on a competitive basis, as a total small business set-aside. The North American Industry Classification System (NAICS) Code is 541690 - Other Scientific and Technical Consulting Services, and the associated small business size standard is $7.0 million. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), for the National Center for Research Resources (NCRR), proposes to procure the services of a well-trained scientific medical professional to provide recommendations that shall be advisory in nature and to provide technical and medical support for clinical research study oversight and monitoring of NCRR sponsored studies and trials. The technical and medical support services shall include, but not be limited to the following: provide expertise to NCRR staff on specific studies and serve as Executive Secretary of NCRR Data and Safety Monitoring Boards, Protocol Review Committees, or as a Medical Review Officer for NCRR sponsored studies. Overview/Background of Project This project resides within the Office of the Director of the National Center for Research Resources (NCRR), specifically in support of the Senior Advisor for Informatics and Clinical Research. The NCRR provides clinical research infrastructure for medical scientists (including both NIH-supported investigators and those investigators supported by funds provided by other federal, state, and local agencies and the private sector) who conduct clinical research and supports career development of investigators who have made a commitment to focus their research endeavors on clinical research. The Office of the Director provides advice and resources to assist program staff across Divisions in their responsibilities for monitoring and overseeing clinical research studies and trials. In some cases, the studies require oversight by NCRR managed Data and Safety Monitoring Boards, Protocol Review Committees, and Medical Review Officers that are independent of the programs or Divisions that manage the studies. Contractor Requirements This position requires experience in clinical research and protocol design/development, as well as highly developed scientific and administrative skills. Timely handling of responsibilities is required as tight timelines are in place for the scientific review of materials, protocols, and adverse events to assure the safety of the participants in NCRR sponsored studies. Significant administrative skills are required for establishment, management, and tracking of monitoring boards and committees. This may include emergency reviews or meetings to address emerging safety concerns or occurrence of serious adverse events. Thus, the time commitment must allow flexibility. The number of studies within the NCRR is variable, but can be significant, requiring careful planning and attention to monitoring schedules even in the absence of need for emergency review. Significant skill in the management of groups and individuals is required to assure the smooth functioning of any committee. Careful documentation of identified conflicts of interest and management is required to prevent contamination of the independent review process. Meticulous recording of actions is required as well as timely implementation. The Contractor shall prepare and submit Technical Progress Reports on a monthly basis. The Technical Progress Reports shall include a listing of activities inclusive of, but not limited to, significant advances achieved, modifications, problems, and recommended solutions enacted, that occur within the contractor's assigned portfolio of responsibilities. This should be presented in sufficient detail that the Contracting Officer's Technical Representative (COTR) can evaluate the effectiveness of the contractor's effort. The level of effort, for this requirement, is based on an hourly rate of a scientific medical professional to provide the services described above. The number of hours shall not exceed 1,040 hours over a twelve (12) month period. The total effort, in labor hours, will be reported monthly and serve as the basis for payment. The proposed period of performance for these services will consist of one twelve (12) month basic contract period, and shall include options to renew for four (4) successive twelve (12) month periods. It is anticipated that work, under the proposed contract, will begin on or about March 31, 2010. The Government will provide web-based access (only to designated sites required to perform the services of this position) to the Government databases required for performance of the proposed contract responsibilities, including library resources, NCRR Program sites, and others as needed at the discretion of the Government. The NIH will provide conference call services for participation at meetings. The Contractor shall be responsible for the management, set-up, and programming of conference calls required under this proposed contract. The Government shall furnish work space, computer, telephone, and other electronic equipment, as necessary for the performance of services under this proposed contract. It is anticipated that a fixed price type contract will be awarded. FAR provisions and clauses that apply to this acquisition are: 1) FAR Clause 52.212-1, Instructions to Offerors-Commercial Items; 2) FAR Clause 52.212-2, Evaluation--Commercial Items. As stated in FAR Clause 52.212-2 (a), The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The merits of each proposal will be evaluated carefully, based on responsiveness to the requirements set forth in this combined synopsis/solicitation and the thoroughness and feasibility of the technical approach taken. A best buy analysis will be performed taking into consideration technical approach, past performance, and price. You are advised that, in the selection of the contractor for this acquisition, paramount consideration shall be given to the evaluation of technical proposals, rather than cost or price. All evaluation factors, other than cost or price, when combined, are significantly more important than cost/price. Mandatory Qualification Criteria: In order to be considered a responsive offer, the offeror must possess a Medical Degree and have clinical research and review experience. Responses to this notice will be reviewed and evaluated in accordance with the following criteria: a) Technical Approach - demonstrated knowledge and expertise in clinical research study oversight and monitoring; demonstrated understanding of the requirements described above; demonstrated skill in effectively managing board and committee meetings; and demonstrated ability to effectively prepare technical and scientific written communication (40 points); b) Appropriate qualifications, skills, and expertise - lack of conflict of interest, relevant personal qualifications (30 points); and c) Demonstrated medical and scientific knowledge of rare diseases clinical research and administration (30 points). The Government intends to evaluate the proposals and award the contract without discussions with Offerors. Therefore, the initial offer should contain the Offerors best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions, request product samples or demonstrations, if later determined by the Contracting Officer to be necessary. The Government may reject any and all offers if such action is deemed necessary. The Government may also waive informalities and minor irregularities in the offers received; 3) FAR Clause 52.212-3, Offeror Representations and Certifications--Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions Required To Implement Statutes or Executive Orders--Commercial Items; and 5) FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items Deviation for Simplified Acquisitions. The clauses are available in full text at http://www.arnet.gov/far. The Contractor shall be required to comply with the applicable Federal and HHS Information Security Program Policies. The requirements of Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002); http://csrc.nist.gov/drivers/documents/FISMA-final.pdf will be incorporated into the resultant contract. In addition, the following FAR Clauses are applicable to this acquisition and will be incorporated, in full text, in the resultant contract. 52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within [ to be completed at contract award ]. (End of clause) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within [ to be completed at contract award ]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least sixty (60) days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed sixty (60) months or five (5) years. (End of clause) In order to be considered for an award, an offeror must have completed the online electronic Representations and Certifications located at http://orca.bpn.gov/ in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR at www.ccr.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchase agreement resulting from this solicitation. NOTE: lack of registration in the CCR will make an offeror ineligible for award. Interested offerors capable of furnishing the Government with the scientific and technical services specified in this synopsis should submit their proposal to the below address. Proposals will be due ten (10) calendar days from the publication date of this synopsis or by March 12, 2010 at 3:00 p.m., Eastern Standard Time. Please submit one original and two (2) copies of your proposal. All responsible sources may submit a proposal, which if timely received, shall be considered by the agency. The external package marking of the print copies shall be marked as follows: RFP No. NHLBI-PB(RR)-2010-089/MKL. Proposals shall be delivered to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Room 6148, Bethesda, Maryland 20892-7902, Attention: Melissa K. Lombardo. Responses may be submitted electronically to lombardm@nhlbi.nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. Faxed copies will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB(RR)-2010-089-MKL/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02081587-W 20100305/100303234622-0b4380785c6b85ed795c7d829481ab56 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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