SOLICITATION NOTICE
R -- Follow-On Statistical and Administrative Services
- Notice Date
- 2/28/2013
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2013-103-DLM
- Archive Date
- 3/20/2013
- 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
- INTRODUCTION : THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. FOLLOW-ON REQUIREMENT : This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive award to the National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to EMMES CORP., 401 N Washington Street, Suite 700, Rockville, Maryland 20850-1737 to continue providing statistical expertise and administrative support. BACKGROUND : The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The National Human Genome Research Institute (NHGRI), 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. The Office of the Clinical Director (OCD), NHGRI, needs contract assistance for statistical expertise. PROJECT DESCRIPTION: EMMES Corporation has been providing continued support to the NHGRI for the past 9 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, NHGRI has experience working with Emmes Corp. through protocol 86-EI-0062. Emmes Corp. also provides support for NIH, National Eye Institute (NEI) IRB and DSMB. The Contractor shall provide consultation by senior level statisticians to assist in the development and execution of clinical research protocols. Some pre-clinical studies also require statistical expertise provided by this contract. Issues to be addressed include power analyses, sample size, group analyses, trends, and stopping rules, as well as more complex topics. Finally, the Contractor shall provide OCD administrative assistance to run 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. Continued contract support is needed for arranging meetings, recording minutes, and communicating with and reimbursing members of the DSMB. The Contractor provides formal, written reports to the Director, NHGRI, and to the NHGRI IRB, as required by the DSMB charter. A member of the contract agency serves as Executive Secretary of the DSMB. JUSTIFICATION Statement of Work : Contractor Requirements : 1. The Contractor shall provide consultation by senior level statisticians to assist in the development and execution of clinical research protocols. Statistical expertise is essential to determine the number of patients needed to discern a difference among groups and to choose an appropriate study design. 2. The Contractor shall also provide the NHGRI OCD with administrative assistance for the Institute's Data Safety and Monitoring Board (DSMB). Desired Results/Functions/End Items : 1. 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. 2. 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. Contract support is needed for arranging meetings, recording minutes, and communicating with and reimbursing members of the DSMB. PERIOD OF PERFORMANCE : Base with four (4) options (12 Months each year) Base: March 2013 through 2014 Option Year 1: March 2014 through 2015 Option Year 2: March 2015 through 2016 Option Year 3: March 2016 through 2017 Option Year 4: March 2017 through 2018 Government Requirements : • For statistical consultations, 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 contractor's office. For administrative support to the DSMB, the work will be performed at the contractor's offices, except for the annual meeting of the DSMB, which is held on the NIH campus in Bethesda. Reporting Requirements and Deliverables : • The Contractor shall provide 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. Inspection and Acceptance Requirements : • The Contractor shall provide minutes, agendas, which 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. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth under FAR Part 13.106-1 (b) (1), Soliciting from a single source not exceeding the simplified acquisition threshold, and is exempt from the requirements of FAR Part 6, Competition Requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541990, All Other Professional, Scientific and Technical Services and the Small Business Size Standard is $14.0M. The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-65 (January 29, 2013). The determination by the Government to award a follow-on purchase order on a sole source on competitive basis for continued statistical and administrative services to Emmes Corportation a small business is based upon a previous synopsis published in FedBizOpps for a base and two option years [HHS-NIH-NHLBI-CSB-(HG)-2010-080-DLM, February 19, 2010], issued under HHSN268201000147P, March 17, 2010. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. The determination by the Government to award a purchase order on a sole source noncompetitive basis for continued statistical and administrative services. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. This notice of intent is not a request for competitive proposals. If you have any questions, please submit to the National Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2013-103-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02998461-W 20130302/130228234706-dd9d08d0c4ff7a803866b5bbfa08d8e9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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