SOURCES SOUGHT
R -- Support Services for the Pharmaceutical Management Branch
- Notice Date
- 7/8/2016
- Notice Type
- Sources Sought
- 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
- Archive Date
- 8/9/2016
- Point of Contact
- James J. Horkan, Phone: 240-276-7803
- E-Mail Address
-
james.horkan@nih.gov
(james.horkan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541611 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $15.0 Million per annum. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: 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. This acquisition is a re-competition of contract HHSN261201200009C awarded to the EDJ Associates, Inc. Previous contracts for this requirement include: contract HHSN261200722000C (March 1, 2007 to April 30, 2012) and N02-CM-27023 (August 1, 2002 to April 30, 2007). Purpose and Objective: 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. Project Requirements: Activities will include, but are not limited to the following: • The contractor will be responsible for collecting and reviewing all documents related to investigator/associate registration and CTEP delegation of tasks logs. • During business hours, the contractor will answer PMB phone lines and triage incoming calls to efficiently direct callers to the appropriate staff to address their questions. This personal interaction (with the receptionist and other contract staff) is frequently the only contact that our sites have with the NCI and continues to play an important role in our ability to provide high levels of customer support to our clinical trials. • The contractor will process electronically submitted agent orders for PMB supplied agents (CTEP IND, DCP, CIP and select non-CTEP IND studies) on open-label and blinded clinical trials. The latter requiring increased attention to ensure appropriate safeguards are in place to prevent unblinding that could compromise data integrity and trial outcome. • The contractor will review and process agent orders allowing appropriate agent to get to the appropriate location in time to treat patients on our clinical trials. The contractor will also support the other responsibilities related to IND agent maintenance, such as stock recovery, agent transfer and local destruction of IND agent. • The contractor will maintain the annual registration documents (1572, Financial Disclosure Form, Supplemental Investigator Data Form and Biosketch/CV) for all investigators and Non-Physician Investigators and Associates participating on CTEP sponsored trials in accordance to CTEP procedures. The number of registered investigators eligible to enroll patients onto NCI sponsored clinical trials is expected to be between 23,000 and 28,000. • The contractor will maintain the IAM accounts for all Investigators, Non-Physician Investigators, Associate-Plus, Associate and Associate Basic. Approximately 23,000 to 28,000 Investigators and 50,000 to 60,000 Associates will have records in the IAM system that will be used to control access to NCI application. • The contractor will be responsible for staffing helpdesks for the ECM and IAM (internal CTEP systems) which maintain records for persons and organizations and associated accounts within CTEPs clinical research program. • Contract staff will also be dedicated to the administrative support of the NCI's Treatment Referral Center, which assists customers with locating appropriate ongoing clinical trials or potential alternate mechanisms for access to investigational agents (i.e., single-patient protocol, Treatment Referral Center protocol, treatment use protocol, and company sponsored programs). • The contractor will provide support to CTMB in the form of agent distribution reports for the purpose of auditing agent records at the site level. Anticipated Period of Performance: It is anticipated that one (1) cost reimbursement contract will be awarded with a one (1) year base period plus four (4) one (1) year option periods beginning on or about May 01, 2017. Other Important Information: The offeror must be able to demonstrate past performance and expertise in (1) Personnel, (2) Technical Approach, and (3) Organizational Experience. Capability Statement/Information Sought: To be deemed capable of providing services that meet the CTEP's requirements, please submit a written capability statement demonstrating your ability and experience. Submission Information: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address), as well as the eligible small business concerns name, point of contact, address and DUNS number. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to James Horkan, at james.horkan@nih.gov in MS Word or Adobe Portable Document Format (PDF) by July 25, 2016 2:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CM71012-14/listing.html)
- Place of Performance
- Address: NCI Shady Grove Building, 9609 Medical Center Drive, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN04175884-W 20160710/160708234312-ba2705a8368b8df1d8a82b0caa94a576 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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