SOURCES SOUGHT
A -- SYNTHESIS OF THERAPEUTIC AGENTS FOR TREATMENT OF INFECTIOUS DISEASES
- Notice Date
- 12/26/2013
- 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-2013177
- Archive Date
- 1/24/2014
- Point of Contact
- Craig D. Heggestad, Phone: 3014438175, Michelle L. Scala, Phone: 301-451-3693
- 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 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. Background The Division of Acquired Immunodeficiency Syndrome (DAIDS), The National Institute of Allergy and Infectious Diseases (NIAID), NIH, supports research to identify therapeutic agents for the prevention and treatment of infections with the human immunodeficiency virus (HIV) and co-infections with opportunistic pathogens, including Mycobacterium tuberculosis. Most experimental agents require chemical resynthesis, pharmaceutical analysis, and dosage formulation to ensure they are of sufficient quantity and quality to permit evaluation in clinical trials in humans. This solicitation will support the synthesis of therapeutic agents in small and large scale amounts, including synthesis of limited compounds according to current Good Manufacturing Practice (cGMP) regulations of the Food and Drug Administration (FDA). In the last 5 years an average of 25-30 compounds have been synthesized per year. Compounds assigned for synthesis include heterocycles (typically containing nitrogen, oxygen, and sulfur), carbocycles, carbohydrates, nucleosides and peptides. The majority of synthesized compounds have been used for enzymatic, in vitro, and in vivo studies. Small quantities of metabolites have been synthesized for use in mechanism of action and metabolism studies and larger, bulk quantities of compounds have been synthesized for animal studies and clinical trials. The current contractor is Starks Associates, Inc., 1280 Niagara Street, Buffalo, New York 14213. Purpose and Objectives The scope of this effort is small scale synthesis of compounds in quantities required for testing in either in vitro or in animals, and large scale synthesis of compounds for early Phase I clinical studies. Some compounds will require synthesis in compliance with cGMP regulations. This contract will provide resources for the synthesis of promising compounds for the treatment of HIV, TB and other infectious diseases of relevance to the research agenda of NIAID. Project requirements This Sources Sought notice is seeking small businesses that possess relevant experience and knowledge in organic synthesis of therapeutic reagents. The Contractor shall comply with all relevant Federal, State, and local health and safety guidelines and regulations. The Contractor must also be registered with the United States FDA as a manufacturer of bulk drugs. Specifically, the Contractor shall: A. Synthesize Compounds 1. The Contracting Officer's Representative (COR) will identify the target compounds, size of batch, need for cGMP compliance (21 CFR Parts 210-211) and provide synthetic methods when available. When no synthetic route or specific procedure is provided, the Contractor shall furnish the synthetic route or specific procedures for the COR's approval prior to starting the synthesis. Prior to proceeding with scale-up synthesis, the Contractor shall provide a written synthetic method and cost estimate for the COR's approval. 2. The Contractor shall perform the following functions for each approved synthesis assignment: a) Synthesize, purify and characterize small-scale (10mg - 10g/batch) or large scale (10-1000 g/batch) target compounds of high purity; b) Characterize compounds for purity by a chromatographic method, and for chemical identity and purity by nuclear magnetic resonance (NMR), infrared (IR), ultraviolet (UV), mass spectroscopy (MS) and elemental analysis; c) Provide data sheets and preparative methods for all compounds sent to NIAID; d) Provide Material Safety Data Sheets (MSDS) for all compounds; in accordance with (see MSDS attachment); e) Ship synthesis targets, intermediates or acquired compounds, samples of intermediates and characterized byproducts under appropriate safety conditions to the location designated by the COR. Provide to the COR as requested; B. Acquire and Prepare Compounds On specific assignment from the COR: 1. Acquire, through purchase or donation (e.g., from a pharmaceutical company), and further characterize compounds. 2. Extract pure materials from marketed drugs and provide a certificate of analysis (COA) for the extracted pure materials. 3. Perform solubility determinations on compounds identified by COR. C. Project Management 1. Overall Project Management Provide for the overall management, integration and coordination and communication of contract activities. Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation and timely completion of all projects carried out under this contract. 2. Provide for tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines. 3. Meetings and Teleconferences a) Contract Initiation Meeting Within 60 calendar days after the effective date of the contract, participate in a one-day Contract Initiation Meeting with the COR, the Contracting Officer and other NIAID personnel designated by the COR, to be held at the Contractor's site. The purpose of the Contract Initiation Meeting shall be to orient the Contractor to NIAID contract procedures. b) Monthly Meetings Plan and conduct monthly meetings by telephone conference call of the Contractor's Key Personnel with the COR and Contracting Officer, to review the status of projects and to discuss any matters relevant to the scientific and financial administration of the contract and future activities. Two days in advance of the meeting prepare and distribute the agenda and meeting materials to all participants. Provide a summary of all meetings in the Semi-Annual Progress Reports. c) Annual Site Visits Arrange Annual Site Visits at the contractor's site for NIAID contract and program staff, designated by the COR, to review and discuss the following: project progress and costs; problems, obstacles and approaches to overcoming them; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the Principal Investigator, the Project Manager, other Contractor staff and, as needed, the Contractor's business representative. D. INITIAL AND FINAL TRANSITION 1. Initial Transition In the event of transition to a new contractor, ensure an orderly, secure, and efficient transition of activities from the predecessor contractor, as follows; Within thirty (30) calendar days of the contract award, the Contractor shall submit for COR review and written approval, an Initial Transition Plan and timetable for the receipt, storage, and transfer of all items in the incumbent Contractor's Final Transition Plan. The Plan should also include a summary of the current availability of all staff assigned to the contract. This Initial Transition Plan shall include transfer of laboratory notebooks, equipment and property, including drug samples, chemicals and other supplies purchased with contract funds or otherwise furnished by the Government. Upon receipt of written approval from the COR, the Contractor shall implement the Initial Transition Plan to complete the tasks associated with transition within thirty (30) calendar days. 2. Final Transition The Contractor shall ensure an orderly, secure, and efficient transition of contract-related materials and activities to the successor contractor or to the Government. A description of transition activities, timelines, and assigned staff shall be provided in a Draft and Final Transition Plan, which will be reviewed and approved by the COR. The Draft Transition Plan shall be submitted three (3) months prior to the completion date of the contract, and the Final Transition Plan (approved by the COR and Contracting Officer) shall be submitted two (2) months prior to the completion date of the contract. a) Implement the Final Transition Plan as approved by the COR and the Contracting Officer for the transfer of equipment and property, including drug samples, chemicals, and other supplies purchased with contract funds or otherwise furnished by the Government. b) Provide the successor contractor with documents and electronic files necessary for the continuation of this contract including protocols detailing ongoing studies anticipated not to be completed by the expiration date. E. OPTIONS: In addition to the services outlined above to be provided for the Base Period, the Government may unilaterally exercise, at its discretion, options for additional services as follows: Options to Extend the Term of the Contract (Options 1-6): The Government may unilaterally exercise options to extend the period of performance beyond the base period, annually, for a total period of performance of up to 7 years. If Options 1-6 are exercised, the services required will be the same as provided during the Base period.1. Anticipated period of performance The National Institute of Allergy and Infectious Diseases (NIAID) anticipates that one cost reimbursement, term (level-of-effort) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) 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 February 13, 2015. Other important considerations The requirement will be for the delivery of 6.14 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). Capability statement / information sought Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, 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. In order to be deemed capable, small business organizations must submit capability statements that include: 1) Demonstrated expertise and experience in organic synthesis, purification, and identification of intermediate target compounds; 2) Capabilities to generate and interpret spectroscopic data; 3) Ability to comply with Federal, state and local regulations and guidelines regarding safety and handling of chemicals; 4) Competency in literature searching; 5) Demonstrated experience with contracts of similar size and scope to this proposed effort. Contract projects listed may include those entered into by the US Federal Government, agencies of state or local governments, for-profit and non-profit entities; 6) Proposed key personnel that demonstrate that your organization has the necessary expertise to perform the requirements of the project; 7) Sufficient corporate qualifications needed to perform the requirements of the project; and 8) A statement identifying the offeror as a small business firm. Any organization responding to this SOURCES SOUGHT notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform this work. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone and Email address • Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) 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) located at http://www.ccr.gov/index.asp. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Craig Heggestad, Contract Specialist at heggestadcd@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The email subject line must specify Sources Sought Reference Number HHS-NIH-NIAID(AI)-SBSS-2013177. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM (E.S.T.), January 9, 2014. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT 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 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). 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
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