SOURCES SOUGHT
A -- Preclinical Development Services for AIDS Therapeutics
- Notice Date
- 1/15/2013
- 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
- HHS-NIH-NIAID(AI)-SBSS-13170
- Archive Date
- 2/13/2013
- Point of Contact
- Craig D. Heggestad, Phone: 301-496-0612, Michelle L Scala, Phone: 301-496-0612
- E-Mail Address
-
heggestadcd@niaid.nih.gov, mscala@niaid.nih.gov
(heggestadcd@niaid.nih.gov, mscala@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 there 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 Division of Acquired Immunodeficiency Syndromes (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), maintains a portfolio of contracts to support the development of (1) therapies for HIV infection and its complications and co-infections, and (2) microbicides for preventing the sexual transmission of HIV. Services provided under these contracts assist investigators in academic settings and small pharmaceutical firms in filling specific gaps in their drug development plan as they advance their product towards clinical investigation. Information about these contract resources can be found at the following NIAID website: http://www.niaid.nih.gov/labsandresources/resources/atrg/Pages/default.aspx The NIAID anticipates awarding an Indefinite Delivery Indefinite Quantity 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 base contract. This is a recompetition of two existing contracts, "Pharmaceutical and Chemical Resource for AIDS Drug Development" with SRI International under contract number HHSN266200700024C, and "Safety Evaluation of Anti-Infective Agents" with SRI International under contract number HHSN272200700043C. Purpose and Objectives The purpose of the proposed contract is to provide a suite of product development services. These services are provided to investigators on a case-by-case basis for a wide variety of product candidates, rather than to advance a single product candidate through an entire preclinical development pathway. These services have helped investigators obtain critical data and products needed to acquire additional funding, gain prospective partnerships, fulfill regulatory requirements, and complete studies needed before entering clinical trials. 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: 1)Administrative and Technical Support: This task area includes general administrative and technical activities to support all future Task Orders awarded under the contract. 2)Formulation and Dosage Form Manufacture: Under this task area, the Contractor shall conduct studies in compliance with current Good Manufacturing Practice (cGMP) to support the development of formulations of potential therapeutic agents and Microbicides. Targeted formulations shall include tablets, capsules, lyophilized powders, solutions, suspensions, aerosols, gels, films, or rings for vaginal or rectal delivery. 3)Pharmacology and Toxicology: Under this task area, the Contractor shall conduct studies to assess the pharmacology and toxicology of potential therapeutic agents and Microbicides. Testings shall be conducted in vitro or in relevant animal species. Studies shall be performed in compliance with Good Laboratory Practice (GLP) guidelines (21 CFR 58) when requested. Additionally, the Contractor shall conduct all animal studies in a facility accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) or its equivalent. Performance Requirement and Anticipated Period of Performance The anticipated period of performance is for seven years beginning May 9, 2014 through May 8, 2021. Capability Statement/Information Sought 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 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; 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 will 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 4:00 PM, January 29, 2013 Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Craig Heggestad, Contract Specialist. He can be emailed at the address provided below. 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-13170. A paper copy can be sent via regular mail to the address provided below. If sending a paper copy, please send an original and one copy. Craig Heggestad Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 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: Craig Heggestad Email Address: heggestadcd@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID(AI)-SBSS-13170/listing.html)
- Place of Performance
- Address: Place of Performance is unknown at this time, United States
- Record
- SN02965699-W 20130117/130115234424-efec32cd87515e06f2d39d5c5b2a0f28 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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