SOURCES SOUGHT
A -- COMPREHENSIVE RESOURCES FOR HIV MICROBICIDES AND BIOMEDICAL PREVENTION
- Notice Date
- 1/16/2015
- 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, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-15029
- Archive Date
- 2/17/2015
- Point of Contact
- Robert J. Corno, Phone: 2406695151, John R. Manouelian, Phone: 2406695152
- E-Mail Address
-
robert.corno@nih.gov, manouelj@niaid.nih.gov
(robert.corno@nih.gov, manouelj@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; women-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. Background The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. These services are currently being provided under two NIAID contracts entitled, "Non-human Primate Models to Evaluate Therapeutic Strategies and Topical Microbicides for HIV" (under Contract No. HHSN272200800020C with Advanced BioScience Laboratories) and "Comprehensive Resources for HIV Microbicides and Biomedical Prevention" (under Contract No. HHSN272201000001C with Advanced Bioscience Laboratories). However, the Government intends to consolidate these services into one requirement under one contract. The Government intends to award multiple-award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts in order to continue these support services. Task Orders will be issued in the following areas: • Preclinical gap-filling services (Task Area A) • HIV animal models supporting product development (Task Area B) • Product manufacturing (Task Area C) • Scientific and quality/regulatory support services (Task Area D) It is anticipated that NIAID will award base contract awards to multiple contractors for Task Areas A, B, and C; however, based on the need for centralized support services, NIAID anticipates awarding a base contract to a single contractor for Task Area D. In order to ensure the independence and objectivity required for the functions carried out under Task Area D, the contractor who is selected for the award of Task Area D will not be awarded a base contract for Task Areas A, B, and/or C. This includes both the prime contractor as well as any potential subcontractor. Purpose and Objectives The purpose of the proposed contract is to provide NIAID with preclinical product development services for candidate products that emerge from investigator-initiated research studies or from collaborations with outside companies or organizations. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. More specifically, these development services may be used to support a product at any point along the product development pathway, from discovery to IND, Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use this contract to more rapidly and efficiently fill critical development gaps and advance promising nBP products and MPTs into clinical testing. Although the focus of this contract will be development of nBP products, contract resources, at the discretion of NIAID, may be used to advance HIV vaccines, antivirals, or other HIV preventive or therapeutic strategies. Throughout this contract, these candidate products and/or strategies will collectively be referenced as "products." Project Requirements Offerors should have the qualifications, experience and capability to perform this requirement. The Contractor will carry out tasks in the following three areas: A. Preclinical Gap-Filling Services: Under this task area, the Contractor shall conduct the following types of activities: 1) In vitro/ex vivo assays or methods; 2) Small and large animal safety models; 3) Analytical method development, method transfer and validation, and/or performance of the method; and 4) Other specific activities in support of this task area as required by NIAID to advance products into clinical testing. B. HIV Animal Models Supporting Product Development: Under this task area, the Contractor shall conduct pharmacokinetic (PK), safety, and efficacy studies in animal models of mucosal HIV/SIV/SHIV transmission in order to characterize promising products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent animal or human studies. These models may include nonhuman primates (NHP), humanized mice, or other animal models of HIV infection or pathogenesis as they become available. When applicable, other activities (e.g., immunology, histopathology, etc.) as specified in the Task Order SOW shall be performed. C. Product Manufacturing: Under this task area, the Contractor shall conduct the following types of activities: 1) Product manuafacturing and/or characterization to support both preclinical and clinical product indications.; and 2) Other specific activities in support of this task area as required by FDA to advance prducts into clinical testing. D. Scientific and Quality/Regulatory Support Services: Under this task area, the Contractor shall perform the following types of activities to advise and support the COR, other NIAID staff, and/or product sponsors, or support the general development of products through provision of resources to the HIV prevention field: 1) Provide additional expertise; 2) Develop and support programmatic meetings in specific regulatory requirements or other topics; 3) Provide Quality Assurance/Quality Control (QA/QC) coordination support; 4) Conduct audits; 5) Prepare regulatory documentation; 6) Convene scientific groups related to non-vaccine biomedical prevention (nBP) products in support of this contract; and 7) Provide centralized storage for contract materials. Anticipated Period of Performance It is anticipated that multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts will be awarded on or about June 15, 2016, for a period of 7 years, through June 14, 2023. Task Orders to be issued against the base contract will primarily be cost-reimbursement type, both term and completion form. The Government reseves the right, however, to issue fixed-price type Task Orders, when appropriate. Upon award of the base contract, the Government anticipates awarding a Task Order as follows: 1) Task Order #D-1, Coordination of Quality Assurance/Quality Control Support. The period of performance will be for a one (1) year (Base Period), plus six one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about June 15, 2016. The requirement will be for the delivery of 2.05 full time equivalents (FTEs) per year, for the base period (Year 1), and 2.05 FTEs per year for Options 1-6 (Years 2-7). Capability Statement/Information Sought Capability statements submitted as a result of this announcement should demonstrate the Offeror's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort, which 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, which 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; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including that performed by any subcontractors and consultants. The Contractor shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 3:00 PM (E.S.T.), February 2, 2015 Capability statements will not be returned and will not be accepted after the due date. These statements shall be submitted by e-mail to Robert Corno, Contract Specialist. He can be emailed at cornorj@niaid.nih.gov. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID(AI)-SBSS-15029. 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 Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Robert Corno Email Address: cornorj@niaid.nih.gov Contracting Officer: John R. Manouelian Email Address: manouelj@mail.nih.gov 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.
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