SOLICITATION NOTICE
R -- Support Services for the Cancer Therapy Evaluation Program (CTEP) Pharmaceutical Management Branch (PMB)
- Notice Date
- 11/4/2016
- Notice Type
- Presolicitation
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CM71012-14
- Point of Contact
- James J. Horkan, Phone: 2402767803, Rukshani Levy,
- E-Mail Address
-
james.horkan@nih.gov, rukshani.levy@nih.gov
(james.horkan@nih.gov, rukshani.levy@nih.gov)
- Small Business Set-Aside
- Woman Owned Small Business
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the management and distribution of agents used on the majority of NCI sponsored treatment trials, as well as agent distribution support for select Division of Cancer Prevention (DCP) and non-NCI sponsored treatment trials. In accordance with being a regulatory sponsor of clinical trial research, the PMB is responsible for maintaining NCI registration and credentialing information for its investigators and associates, which allows them to participate in sponsored trials. Maintenance includes, but is not limited to, annual collection and storage of FDA Form 1572, Investigator Data Form, Financial Disclosure Form and Curriculum Vitae for all investigators and a subset of this data for registered associates. The PMB manages the Treatment Referral Center (TRC) for handling special CTEP clinical agent initiatives, referrals to high priority clinical trials and the coordination, authorization, and processing of all requests for Special Exception and Treatment Referral Center protocol agent use. The PMB is responsible for assuring that authorization and distribution of agents to only eligible NCI investigators. In order to accomplish this, the PMB pharmacists prepare agent forecasting, agent acquisitions, and perform inventory management of all IND agents distributed by CTEP for open-label and blinded clinical trials. The PMB staff coordinates distribution of NCI agents to investigators for non-human (preclinical) use. The PMB pharmacists also provide pharmaceutical reviews of all applicable CTEP trials. The Government is seeking a Contractor to provide support of PMB functions (http://ctep.cancer.gov/branches/pmb/default.htm), mainly in support of drug distribution (e.g., all processes surrounding agent management - order processing, transfers, local destruction, investigator brochure distribution, stock recovery notice distribution, etc.), investigator/associate registration processing and maintenance, curation of database containing NCI list of organizations associated with NCI trials, as well as helpdesks for managing the investigator, associate and organizations databases. The NCI seeks continuation of services to be acquired through competitive Women-Owned Small Business (WOSB) set-aside procedures under NAICS 541611. It is anticipated that a cost-reimbursement, completion-type contract with a base period of one year and four one-year option periods may be awarded beginning on or about April 30, 2017. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE WOMEN-OWNED SMALL BUSINESS (WOSB) SOURCES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS' RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CM71012-14/listing.html)
- Record
- SN04321044-W 20161106/161104234111-ad63e3bf5773108966de4055bf8665ad (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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