Inactive

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:... 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 National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) plans, sponsors, and directs extramural research programs involving evaluation of the safety and efficacy of vaccines, therapeutics, and prevention modalities. Through these programs, clinical trials at more than 145 clinical research sites are supported. NIAID is required to provide oversight and management of investigational study product for clinical trials to ensure compliance with all applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312 and Human Subjects Protection Title 45 CFR Part 46. Investigational study product management includes the receipt, storage, handling, and distribution of investigational product. These activities are mission critical functions and high priority in ensuring the integrity of study products used in human clinical trials. The Clinical Research Products Management Center contract was initially awarded in 1988. The current contract number 75N93020C00032 is with Fisher BioServices, Inc., Rockville, Maryland. Purpose and Objectives This contract is for the continuation of a Clinical Research Products Management Center (CRPMC) that provides investigational study product management expertise and pharmaceutical services that adhere to current Good Manufacturing Practice (cGMP), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP), the Food and Drug Administration (FDA), Code of Federal Regulations (CFR), and all applicable regulations in support of NIAID supported clinical trials networks and programs. This contract is for the management and operation of the CRPMC to support NIAID sponsored clinical research trials, with a core focus of HIV/AIDS and its co-morbidities. The Contractor shall provide cGMP-compliant facilities for the receipt, storage, handling, shipping, and disposition of study products. All functions must be conducted in accordance with all federal, local and other applicable regulations governing study product including but not limited to, the CFR, ICH GCP, cGMP, Good Distribution Practices (GDP), Good Documentation Practices and all applicable regulations or guidance. Project Requirements This contract is to continue to provide a broad range of pharmaceutical and investigational study product management services to the current and evolving clinical research portfolio, including adult, pediatric, vaccine and prevention trials. For the purposes of this contract, study product is defined as investigational product (IP) or investigational medicinal product (IMP). The CRPMC securely ships study products to clinical research sites to ensure the timely continuation of NIAID supported studies. The CRPMC also plays an essential role in the management of study product documents of the regulatory trial master file (TMF) for NIAID sponsored, IND studies and is responsible for maintaining a readily accessible, validated and compliant electronic system for document management. The Contractor provides regulatory guidance and expertise regarding study product management as it pertains to ICH, CFR and other critical regulations. The contract will emphasize improving adaptability and use cutting edge forecasting models and conservative study product distribution models. Anticipated Period of Performance It is anticipated that a cost reimbursement, term/level of effort (LOE) type contract will be awarded. The period of performance will be for one-year (Base Period) plus six (6) one-year Options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately March 16, 2027. The requirement will be the delivery of 27 full-time equivalents (FTEs) for the base period (Year 1) and 27 FTEs per year for Options 1-6 (Years 2-7), including consultant and subcontractor effort. In addition to the services outlined above to be provided in the base requirement, options for additional services under the contract may be exercised at the discretion of the Government as follows: Options 7 through 34: Increased level of effort to accommodate significant increases in work in the amount of 2 FTEs per option that may be exercised up to four times per year in Years 1-7. Options 35 through 48: Increased level of effort to accommodate significant increases in work in the amount of .5 FTE per option that may be exercised up to two times per year in Years 1-7. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above. 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 (eight 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. Page Limitations Interested qualified small business organizations should submit a tailored Capability Statement, not to exceed 8 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 Each response should include the following Business Information: DUNS Company Name Company Address Company Points 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 located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferably placed under the eligible small business concern’s name and address). Number of copies All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Shawnice Williams, Contracting Officer, at shawnice.williams@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS75N93026R00003. Facsimile responses will not be accepted. Common Cut-off Date Electronically submitted Capability Statements are due no later than January 23, 2026, at 3:00 p.m., EST. Capability Statements will not be accepted after the due date and time stated. Capability Statements will not be returned. 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. Respondents will be added to the prospective offerors list for any subsequent solicitation. 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.