Clinical Research Products Management Center (CRPMC)

Description

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. 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. Description 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 regulation or guidance. Anticipated Period of Performance It is anticipated that a cost reimbursement, term/level of effort (LOE) type contact will be awarded as a result of this solicitation. 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) per year for the base period (Year 1) and 27 FTEs per year for Options 1-6 (Years 2-7), including consultant and subcontractor effort for years 1 through 7. 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 through 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 through 7. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about March 27, 2026, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."