SOURCES SOUGHT
A -- Manufacture and Characterization Services (MCS) for Vaccines and other Biologics for Infectious Diseases
- Notice Date
- 4/28/2011
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DMID-AI2010107
- Archive Date
- 5/28/2011
- Point of Contact
- Nicole Gordon, Phone: (301) 402-4925, Deborah Anderson, Phone: 301-402-2234
- E-Mail Address
-
gordonn@niaid.nih.gov, andersonj@niaid.nih.gov
(gordonn@niaid.nih.gov, andersonj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 the applicable NAICS code should not submit a response to this notice." The information from this market research will help the DMID, NIAID, NIH, and DHHS, plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. Background: Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to study control and prevent diseases caused by all infectious agents (except HIV). Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services. (http://www3.niaid.nih.gov/research/resources/dmid). The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a product development-oriented program to provide preclinical development support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources. The suite of services will encompass those activities commonly associated with the development of vaccine and biologic products for infectious disease required for Investigational New Drug (IND) application and/or Biologic License Application (BLA). Consequently, DMID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. The Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order. NIAID anticipates award an Indefinite Delivery Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements of the solicitation, providing a guaranteed minimum award. Task orders for specific tasks requiring specialized expertise will be issued after the award of the IDIQ contract. Purpose and Objectives: The purpose of this solicitation is to establish a NIAID resource entitled "Manufacture and Characterization Services (MCS) for the Development of Vaccines and Other Biologics for Infectious Diseases" that provides a suite of product development preclinical services from early feasibility studies through manufacture and release of Phase I/II material. While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II trials. Project Requirements: The Contractor shall provide DMID with a broad and flexible range of development-oriented capabilities to provide preclinical development support for multiple vaccine and biologic products when such products emerge from investigator-initiated research studies or other sources identified by DMID Program staff. These capabilities span early feasibility studies through manufacture of Phase I/II material to more rapidly and efficiently close development and production gaps, increase the government's response to emerging disease threats, and improve surge manufacturing capabilities. The Contractor shall also provide appropriate documentation and support for pre-IND and IND submissions for Phase I and II clinical testing. DMID will issue a Task Order Request for Proposal after determination of a specific need that is appropriate to the Statement of Work. The Contractor shall be prepared to develop a response in which the Contractor specifies the methods it will employ in accomplishing the key components of each Task Order and the associated costs. The needs, funding, product maturity and timelines of the product as specified in the Task Order establishes requirements for compliance with current Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) [21 CFR Parts -11, -58, -210, -211, -600]. For the purposes of this contract, the following definitions shall apply: •Vaccines - An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy. Vaccine product include but are not limited to synthetic peptides, recombinant proteins, nucleic acids, viral-like particles, vector-based vaccines, as well as live, modified, and/or attenuated organisms. •Vaccine Components - An antigen-enhancing substance (i.e. adjuvant) or a delivery system (i.e. needle free dermal patch) that is used during dose administration to enhance the immune response of a vaccine. •Other Biologics - Therapeutic preparations made from living organisms or the components of living organisms and are most likely regulated by CBER. Biologics include but are not limited to allergenics; antitoxins; blood and blood products; and cellular and gene therapy products. For the purposes of this contract, challenge material for non-clinical, preclinical, and clinical trials will also be added to the definition of biologics. The services shall be directed at the following: •diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (NIAID) Category A, B, and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx) •emerging and re emerging infectious diseases; •antimicrobial resistant and multi drug resistant infections; •other bacterial infections; •fungal infections; •viral infections; and •parasitic diseases. The Contractor shall be required to carry out the Scope and Activities defined in the following five Task Areas: (1) Administrative, Management and Technical Support: One Task Order will be assigned under this Task Area. The Task Order will be a cost-reimbursement, term (level of effort) type contract with a Base Period of 12 months and multiple Options to extend the Base Period of Performance in 12-month increments up to a total of 10 years to continue the same requirement. The contractor is REQUIRED to provide a total level of effort of 307 total direct labor hours per year based on a Work Year of 1920 productive work hours (excluding vacation, holiday, sick leave) for a period of performance of 10 years (Base period plus nine, one-year Options). The scope of this Task Area's activities includes the ability to facilitate ad hoc meetings and provide ad hoc reporting as part of general administrative, management, and technical support activities that are not Task Order specific. (2) cGMP Manufacture and Related Activities: The scope of Task Area 2 includes producing cGMP vaccine and biologic products in accordance with relevant FDA guidelines and the performance and documentation of all other related activities including product release assays required for human clinical use. The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of the activities. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations. (3) Process Development and Related Activities: The scope of Task Area 3 includes development and performance of production and purification processes amendable to scale-up for the manufacture of vaccine and biologic products; the production of research-grade products and cGMP materials; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials; developing and performing animal immunogenicity and potency assays; and perform non-clinical animal testing. Activities may also include technology transfer of processes to/from other facilities. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations. (4) Feasibility Assessments and Audits: The scope of Task Area 4 includes assessing and advising via documented communications (e.g., reports) on products for feasibility of design, development, manufacture, assay development and stability for the development of Phase I and II clinical trial materials; developing and writing Preclinical and/or Product Development Plans for specified products; performing risk/gap analysis for incoming projects and materials; and conducting, reviewing and evaluating audits of potential vendors. Audit types include technical and/or facilities audits. (5) Regulatory Activities and Documentation: The scope of Task Area 5, for products produced and/or tested for use in NIAID-sponsored research in collaboration with the product supplier, includes developing a Manufacturing Report; Chemistry, Manufacturing and Controls (CMC) Information; a Master File; and other regulatory documents appropriate for submission to the U.S. Food and Drug Administration (FDA). [Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (www.fda.gov/cber).] The Contractor shall obtain and compile, in consultation with the COTR, product sponsors, subcontractors and/or consultants, the nonclinical data, CMC, and other appropriate documentation for submission to either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), FDA, or non-domestic regulatory authorities, as applicable. Task Order(s) may be comprised of only one Task Area or may be a combination of multiple Task Areas. Agency Contracting Officer's Technical Representative (COTRs) and scientists will collaborate with the Contractor in all awarded Task Orders. Technical Requirements will be defined in the individual Task Orders. The list below represents the maximum number of specific tasks offerors should assume to perform each year under the contract. This list is provided to indicate the general scope of work of this contract. Assume that the period of performance of task orders may range from less than one year to multiple years. 1 task order/year -- Administrative, Management, and Technical Support (Area 1) 6 task orders/year -- cGMP Manufacture and Related Activities (Area 2) 6 task orders/year -- Process Development and Related Activities (Area 3) 8 task orders/year -- Feasibility Assessments and Audits (Area 4) 6 task orders/year -- Regulatory Activities and Documentation (Area 5) Capability Statement/Information Sought: Capability Statements should clearly convey information regarding the respondent's capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; (4) corporate experience and management capability; and (5) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) demonstrated ability to carry out the work; (6) adequacy of the documented experience with, and appropriateness of plans for: (a) receiving, formatting, storing and shipping compounds and biological agents; (b) technology transfer processes; (c) shipping, handling and storing compounds and formulated vaccine and biologic products; (d) providing and evaluating preclinical and/or product development plans; (e) experience working with potential biohazards, toxic chemicals, and radioisotopes; and (f) adequacy of the plan for training, implementation, and monitoring of safety procedures; (7) availability of adequate facilities, equipment, and resources with sufficient capacity necessary to safely and efficiently accomplish the work described in the Statement of Work in a timely manner, to include documented access to BSL-2, BSL-3, and BSL-4 facilities; (8) perform work in accordance with the following guidelines: "Biosafety in Microbiological and Biomedical Laboratories", Centers for Disease Control and Prevention and the National Institutes of Health, Fifth Edition 2007 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm); Federal Guidelines for Research involving Recombinant DNA molecules at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html);and Recommendations for the Safe Handling of Cytotoxic Drugs, NIH Publication No. 92-2621 and the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385. Each response should include the following Business Information: •DUNS. •Company Name. •Company Address. •Company Point of Contact, Phone and Email address •Current GSA Schedules appropriate to this Sources Sought. •Do you have a Government approved accounting system? If so, please identify the agency that approved the system. •Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp Teaming Arrangements: All teaming arrangements should also include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors or consultants. Page Limits and Number of Copies: Capability Statements are limited to between 5 and 20 pages (excluding resumes). Resumes should be limited to 2 pages each. Responses must be submitted not later than May 13, 2011. Capability statements will not be returned and will not be accepted after the due date. E-mail and facsimile transmissions will be accepted. Electronic submissions should be submitted in.pdf format. In the subject line of the e-mail transmission, please reference: Sources Sought Capability Statement for RFP NIAID-DMID-NIHAI2010107. A paper copy may be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy. 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(s)."
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