SOURCES SOUGHT
A -- NHLBI Production Assistance for Cellular Therapies (PACT) – Cell Processing Facilities
- Notice Date
- 10/31/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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-SBSS-HB-16-09
- Archive Date
- 12/2/2014
- Point of Contact
- Justin M. Borden, Phone: 3014350348, Jeffrey A Williams, Phone: (301) 402-1677
- E-Mail Address
-
justin.borden@nih.gov, jeffrey.williams@nih.gov
(justin.borden@nih.gov, jeffrey.williams@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Contracting Office Address 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 RKL2/6125A, MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Introduction 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 NAICS code 541712 should not submit a response to this notice. Background The objective of this program is to continue to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, biologic systems, and targeted treatments for serious diseases without effective therapies. The current segment of the Production Assistance for Cellular Therapies (PACT) program (2010-2015) includes five Cell Processing Facilitates (CPFs) and one Coordinating Center (CC). The five CPFs provide production assistance in areas ranging from translational development to the scale-up of a product to the manufacture and delivery of clinical grade cellular therapy products for animal safety studies and Phase I/II clinical trials. Applications for product manufacture were received via a web portal and managed by the CC. Applications that are found to be of programmatic interest to the Institute and associated with a funded clinical study were considered for manufacture by the program. In addition, the CPFs and the CC provide education and regulatory support through active assistance with product regulatory materials, cell processing workshops, presentations at scientific meetings, peer reviewed publications, and educational web seminars. For more information on the 2010-2015 PACT programs, see http://www.pactgroup.net/ The National Heart, Lung, and Blood Institute (NHLBI) is planning a competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the development of clinical manufacturing protocols and production of novel somatic (biological) cell therapies for use in pre-clinical studies to be used in support of Investigational New Drug (IND) applications. This program will fund up to eight (8) geographically dispersed Cell Processing Facilities (CPFs) and one (1) Coordinating Center (CC) within the U.S. with the capacity to provide consulting, manufacturing, preclinical study, administrative, and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung, and blood cellular therapy research. The PACT CPFs shall be established to serve investigators as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. The CC shall be the monitor and coordinator for organizational and regulatory aspects of the PACT Program. (Refer to Sources Sought Notice HHS-NIH-NHLBI-SBSS-HB-16-08 for the PACT CC) The services of the PACT renewal were identified as essential for the advancement of cellular therapy research by the previous PACT External Advisory Panel, investigators using PACT services, NIH working groups, and NHLBI staff. These services shall include support for IND-enabling translational research and diversifying the cell therapy expertise within the program by increasing the number of manufacturing CPFs up to eight. The PACT program shall no longer provide cellular products for Phase I/II clinical trials; however, it shall reflect operational changes in the review and selection of applications for services. Project Requirements The NHLBI is seeking small businesses with the ability to serve as a CPF for a five-year renewal of the NHLBI PACT program. The CPF is expected to fulfill the following: 1. In conjunction with the CC and the other CPFs, participate in developing and maintaining a manual of procedures (MOP). 2. Participate as a member of the Steering Committee and subcommittees as necessary to achieve program objectives. 3. Work with the CC to implement procedures for evaluating and prioritizing requests for service. 4. Establish and implement a plan to work with institutional technical transfer offices to facilitate the development of a PACT material transfer agreement (MTA) template and other program specific contract templates. 5. Work cooperatively with the PACT CC to develop educational activities and partnerships with professional societies related to advancing cellular therapies. 6. Establish and maintain working relationships with relevant NIH/NHLBI programs. 7. Provide written reports to NHLBI on program activities. 8. Provide investigators with requested translational study support or cellular therapy products to: 8.1. Work in close partnership with the investigator and the PACT CC to establish project milestones. 8.2. Work in close partnership with the investigator to complete the desired milestones. 8.3. Develop and implement all necessary technology transfer and supply agreements between the requesting investigator and the contractor's institutions. 8.4. For each initiated approved project to manufacture cell product or provided service to: 8.4.1. Provide project work scope including project milestones to the CC prior to initiating work. 8.4.2. Provide technical reports on project progress to the NHLBI COR and the CC and when project milestones or decision points are reached. 8.4.3. Participate in the analysis and writing of study manuscripts and reports for publication and presentation. 8.5. Implement and maintain quality control and quality assurance plans for all products and services requested. 8.6. Process, store, ship, and analyze products produced. 8.7. Maintain a laboratory that meets all requirements for the production of clinical grade products. 8.8. Comply with all relevant Office of Human Research Protections (OHRP) and Office of Laboratory Animal Welfare (OLAW) regulations. 8.9. Provide regulatory consultation services and assist in the preparation of the Chemistry, Manufacturing, and Controls (CMC) section of the Investigational New Drug (IND) application as needed for the conduct of the projects. 9. Participate in site visits to be conducted by the CC. 10. Ensure an orderly close-out of the program or transition of PACT resources to a successor contractor upon contract expiration. Anticipated Period of Performance March 1, 2016 - February 28, 2021 Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement and any furnished documents shall clearly address each of the following items separately and demonstrate: 1. Staff expertise, availability, experience, and formal and other training; 2. Management experience and capability to perform similar work; 3. Organizational capability and capacity to perform similar work. Potential Offerors shall include a description of the organizational structure, facilities, and equipment; 4. Successfully completed projects of a similar nature. Potential Offerors shall include references and other related information for any Government and non-Government projects. 5. The firm's status as a small business under NAICS Code 541712. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Jeffrey Williams, Contracting Officer, at Jeffrey.Williams@nih.gov and Justin Borden, Contract Specialist, at Justin.Borden@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate up to eight Indefinite Delivery and Indefinite Quantity contract with both fixed price and cost reimbursement task orders, for a period of five years with an approximate award date of March1, 2016. Original Point of Contact Jeffrey Williams, Contracting Officer, NHLBI Extramural Contracts Branch, Phone (301) 435-0335, Fax (301) 480-3338, Email: Jeffrey.Williams@nih.gov Justin Borden, Contract Specialist, NHLBI Extramural Contracts Branch, Phone (301) 435-0348, Fax (301) 480-3338, Email: Justin.Borden@nih.gov 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 RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES.
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