SOLICITATION NOTICE
R -- Administrative Assistance for the SSIRB
- Notice Date
- 1/6/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-30019-NV
- Archive Date
- 2/5/2003
- Point of Contact
- Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - David Keefer, Contracting Officer, Phone (301) 435-3801, Fax (301) 480-0309,
- E-Mail Address
-
dm170b@nih.gov, dk63h@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial service, prepared in accordance with the format 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, No. RFQ-NCI-30019-NV includes all applicable provisions and clauses in effect through FAR FAC 2001-10. The acquisition is being made in accordance with the test program for using simplified procedures for certain commercial services authorized in FAR 13.6. The North American Industry Classification code is 541990, and the business size standard is 6M. This solicitation is set-aside for small business. Background: The Special Studies Institutional Review Board (SSIRB) is one of two institutional review boards (IRBs) at the National Cancer Institute. In accordance with 45 CFR 46, the NCI IRBs provide prospective review and approval of all human subject research activities to protect the rights and welfare of humans who are the subjects of the research. The SSIRB primarily reviews NCI intramural epidemiologic studies, behavioral research, and cancer prevention clinical trials which do not involve treatment of patients diagnosed with cancer. As specified in the NIH Multiple Project Assurance (MPA), the NCI IRBs meet on a monthly basis to review new protocols for approval of implementation; requests for changes or amendments to ongoing protocols; and (annually) ongoing studies for approval for continuation. Principal investigators for the intramural projects interact with IRB chairs and membership to meet the stipulations and recommendations resulting from the IRB deliberations, to assure protections of participants from research risks and ethical conduct of research. According to federal regulations 45 CFR 46 and requirements of the MPA for the NIH Intramural Program, minutes of the SSIRB meetings must accurately record all IRB actions and must include details of discussions leading to the IRB?s descisions. Minutes are prepared by the SSIRB Administrative manager, approved by vote of the SSIRB membership, and signed by both the Administrative manager and the SSIRB Chair. The minutes serve as the official document of reference for all SSIRB actions. Purpose and Objectives for this procurement: A Contractor with an in depth knowledge of the federal IRB process is needed to support the SSIRB Chair. The duties of this position are detailed below. Statement of Work: The SSIRB holds regularly scheduled meetings on the third Monday of each month. If the third Monday falls on a Federal holiday, the meeting is scheduled the following day (Tuesday). Meetings convene at 1:00pm -5:00pm. This meeting requires onsite participation of the contractor. On a monthly basis, in collaboration with the SSIRB Chair, the Contractor shall: 1) Review the agenda for the monthly SSIRB meeting and all supporting documents (new protocols, continuing review applications, follow-up and information items) prior to the scheduled SSIRB meeting; 2) Prepare draft minutes of the scheduled meetings (or special functions) from personal notes and/or other sources of documentation (e.g. audio recordings, videotapes) to record accurately and in a detailed manner all actions of the SSIRB and discussions relevant to these actions, in accordance with federal regulations (45 CFR 46) and requirements of the MPA for the NIH Intramural Program; 3) Attend the SSIRB meeting and draft minutes for the SSIRB Chair and membership in a timely manner (one week) for review and formal approval; make corrections in the draft minutes as required by the SSIRB membership for formal approval; and provide a final copy of the corrected and approved minutes to the SSIRB Chair for signature and retention in SSIRB records; and 4) Provide similar organizational support for special SSIRB meetings or projects on an ad hoc basis, as requested by the Chair. Deliverables: 1) The contractor shall prepares draft minutes of SSIRB meetings and special functions from personal notes and/or other sources of documentation (e.g., audio recordings, videotapes), to record accurately and in a detailed manner all actions of the SSIRB and discussions relevant to these actions, in accordance with federal regulations (45 CFR 46), requirements of the NIH MPA, and guidelines developed by OHSR. The contractor shall submit the draft minutes to the SSIRB Chair and membership within a week of the meeting for review and formal approval, make corrections to the draft minutes as required by the SSIRB membership for formal approval, and provides a final copy of the corrected and approved minutes to the SSIRB Chair for signature and retention in SSIRB records. 2) The Contractor shall maintain a notebook file with a section for each SSIRB meeting at which usual business is conducted.. The materials filed for each meeting include the agenda, a copy of the approved minutes of the meeting with original signatures of the Chair and a formal attendance record signed by each member at the meeting. 3) A separate notebook file shall be developed and maintained for each special meeting or investigation conducted by the SSIRB. Each notebook includes a Table of Contents and/or meeting agenda, minutes of the meeting(s) relevant to the problem or investigation, and copies of all supporting documents and relevant information. Period of Performance: It is anticipated that award will be for a one year base period plus3 one year option periods if exercised by the Government. FAR Clause 52.217-9 Option to Extend the Term of the Contract (March 2000) shall apply to any award made from this solicitation. Level of Effort: It is anticipated that 594 hours of effort will be required for the base year and each option year that is exercised. Evaluation Criteria: Award will be based on an evaluation of proposals against three factors. The factors in order of importance are: Technical Evaluation Criteria (based on 100 points): 1) Experience in accurately documenting IRB committee actions and recording relevant details of committee deliberations including minutes from personal notes and/or other sources of documentation (e.g., audio recordings, videotapes) in accordance with federal regulations (45 CFR 46), requirements of the NIH MPA, and guidelines developed by OHSR. (50); 2) Experience in working on federal requirements and procedures for assuring human subject protection in biomedical research including the preparation of clinical protocols, informed consent forms and patient interactions (30); and 3) Knowledge and understanding of NIH and Clinical Center guidelines and procedures for IRBs.(20) Provisions and Clauses: This solicitation incorporates the provisions at FAR 52.212-1, INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS, and at FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS. The latter provision includes the DUNS Number Addendum. The resulting contract will incorporate the requirements of the clause at FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS, and the requirements contained in paragraphs (a) and (d) of the clause at FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS - DEVIATION FOR SIMPLIFIED ACQUISITIONS. The contract will also incorporate the following FAR clauses cited in paragraphs (b) and (c) of the latter clause: FAR 52.222-26, EQUAL OPPORTUNITY; FAR 52.222-35, AFFIRMATIVE ACTION FOR SPECIAL DISABLED AND VIETNAM ERA VETERANS; FAR 52.222-36, AFFIRMATIVE ACTION FOR HANDICAPPED WORKERS; FAR 52.222.37, EMPLOYMENT REPORTS ON SPECIAL DISABLED VETERANS AND VETERANS OF VIETNAM ERA; and FAR 52.225-3, BUY AMERICAN ACT - SUPPLIES. Offers are due January 21, 2003 at 1:00 p.m. EST. Facsimile submission are not authorized. Offers must be in writing and should be submitted one original and two copies of the follows: (1) completed SF 1449, signed by an individual authorized to bind the organization; (2) a Schedule of Offered Supplies/Services containing pricing for the system being offered, published price lists (if applicable), and a delivery schedule; (3) completed Representations and Certifications - Commercial Items, with DUNS Number addendum; (4) descriptive literature indicating that the offer meets the stated requirements; (5) acknowledgment of amendments, if any. The Representations and Certifications must be signed by an authorized representative of the offeror. Full text copies of the Representations and Certifications or other cited provisions and clauses may be obtained from Debbie Moore, Purchasing Agent, on (301) 402-4509 or by fax on (301) 402-4513. Offers and related materials must be submitted to Debbie Moore at the listed address. Offers that fail to furnish the required information or reject the terms and conditions of the solicitation may be excluded from consideration. Please cite the solicitation number on your offer. Any questions must be submitted in writing and may be e-mailed to dm170b@nih.gov or faxed to 301-402-4513. It is the vendors responsibility to call 301-402-4509 to insure questions have been received. No collect call will be accepted.
- Record
- SN00234212-W 20030108/030106213201 (fbodaily.com)
- Source
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