SOLICITATION NOTICE
R -- Statistical Expertise and Administrative Support
- Notice Date
- 1/21/2010
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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-(HG)-2010-065-DLM
- Archive Date
- 2/9/2010
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items 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. The solicitation number is NHLBI-PB-(HG)-2010-065-DLM and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-38 (1/11/2010). Period of performance: The proposed performance for this service will consist of one (12) month basic contract period (February 1, 2010 – January 31, 2011) and will include two (2) options to renew for a twelve month period. The North American Industry Classification (NAICS) Code is 541711 and the business size standard is 500 Employees. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisition (OA), for the National Institute of Human Genome Research (NHGRI) Intramural Research Program, Office of the Clinical Director requires statistical and administrative support. The statistical expert should be a senior level expert in the development and execution of clinical research protocols. The Office of the Clinical Director also requires administrative support assistant for the Data Safety and Monitoring Board (DSMB) and will provide written reports to the Director, NHGR and to NHGRI, Institutional Review Board (IRB) as required by the DSMB charter. Background Information: The NHGRI Intramural Research Program, through the OCD, conducts natural history studies and therapeutic drug trials on rare diseases; statistical expertise is essential to determine the number of patients needed to discern a difference among groups and to choose an appropriate study design. Scope of Project/Work: The Office of the Clinical Director (OCD), NHGRI, seeks contract assistance for two areas crucial to the mission of the Institute. The first involves senior level statisticians to assist in the development and execution of clinical research protocols. Issues to be addressed include power analyses, sample size, group analyses, trends, and stopping rules, as well as more complex topics. The NHGRI Intramural Research Program, through the OCD, conducts natural history studies and therapeutic drug trials on rare diseases; statistical expertise is essential to determine the number of patients needed to discern a difference among groups and to choose an appropriate study design. This work is especially critical for trials involving investigational drugs (e.g., nitisinone for alkaptonuria and pirfenidone for pulmonary fibrosis in Hermansky-Pudlak syndrome), since these require an Investigational New Drug exemption for which annual reports to the FDA are obligatory. The Investigational New Drug exemptions are held by a member of the NHGRI faculty. In addition, future clinical trials are planned for rare diseases such as Hereditary Inclusion Body Myopathy and Autosomal Recessive Polycystic Kidney Disease; these studies will require extensive statistical consultations. Some pre-clinical studies also require statistical expertise provided by this contract. The second area of support required by the NHGRI OCD involves administrative assistance for the Institute’s Data Safety and Monitoring Board (DSMB). This committee serves the NHGRI Institutional Review Board (IRB) by reviewing clinical protocols in which there is an intervention, especially if a placebo is involved. The DSMB advises on issues such as study design, power estimates, stopping rules, interim analyses, and adverse event reporting. Members of the DSMB also assess objectively the seriousness of unexpected adverse events. The DSMB provides statistical, clinical research, and medical expertise on an essentially volunteer basis, except for expenses. Contract support is needed for arranging meetings, recording minutes, and communicating with and reimbursing members of the DSMB. The contract agency also provides formal, written reports to the Director, NHGRI, and to the NHGRI IRB, as required by the DSMB charter. This is a notice of intent to negotiate with EMMES CORP., 401 N Washington Street, Suite 700, Rockville, Maryland 20850-1737 to provide statistical expertise and administrative support. This group has been providing this exact support to the NHGRI for the past 6 years, and has performed in an exemplary fashion, with excellent statistical consultations and timely and accurate documentation of DSMB proceedings and correspondence. EMMES Corp. has extensive experience in statistical consultation and IRB/DSMB administration for NIH institutes and other biomedical entities. The company is local and can respond to requests for assistance in a timely fashion. In addition, the Clinical Director of NHGRI has experience working with this company through protocol 86-EI-0062. EMMES also supports the NEI IRB and DSMB. For statistical work, initial and follow-up meetings will be held at the NHGRI offices of the investigators seeking consultation. Much of the data analysis and planning, however, will be performed at the EMMES Corporation offices in Rockville. For administrative support to the DSMB, the work will be performed at the EMMES Corporation offices, except for the annual meeting of the DSMB, which is held on the NIH campus in Bethesda. For statistical consulting, reports of sample size, power analysis, stopping rules, etc., are required to be delivered by the Contractor to the NHGRI physician or scientist seeking the consultation. For administrative assistance to the DSMB, the deliverables consist of the arranging of DSMB meetings and conference calls, and the preparation of minutes of the meetings, agendas, certificates of compliance with Conflict of Interest rules, and reports of deliberations. These must be certified by the Director of NHGRI and delivered to the NHGRI Institutional Review Board and the NHGRI Clinical Director, in a timely fashion as stipulated by the DSMB Manual of Operations. The Offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors Commercial; 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; 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 Statues or Executive Orders Commercial Items, Contract Terms and Conditions 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 Offeror must include in their quotation the unit price, the list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. Note: In order to receive an award, offerors must have a valid registration in the Central Contractor Registration (CCR) www.ccr.gov and Online Representations and Certifications Application (ORCA) www.bpn.gov. The clauses are available in full text at http://www.arnet.gov/far. Interested parties capable of furnishing the Government with the item specified in this synopsis should submit their quotation to the below address. Quotations will be due five (5) calendar days from the publication date of this synopsis or by January 25, 2010 7:30am, Eastern Standard Time. The quotation must reference Solicitation number NHLBI-PB-(HG)-2010-065-DLM. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Heart, Lung, and Blood Institute, 6701 Rockledge Blvd., Room 6149, Bethesda, Maryland 20892, Attention: Dorothy Maxwell. Emails will be accepted at maxwelld@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HG)-2010-065-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20, United States
- Record
- SN02047161-W 20100123/100121235621-aeadc1afc28566e808306304f7a217e0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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