Pre-Solicitation Notice: NIAID Clinical Research Products Management Center

Notice Number: NOT-AI-19-039

Key Dates
Release Date : February 01, 2019

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), plans, sponsors, and directs national and international extramural research programs involving the testing of vaccines, therapeutics and prevention modalities. Through these programs, clinical trials in over 28 countries at more than 300 clinical research sites are supported.

NIAID places a high priority on ensuring the integrity of study endpoint and safety data. The quality and integrity of study products is a cornerstone of patient safety and study data. This contract is for the continuation of a Clinical Research Products Management Center (CRPMC) that provides pharmaceutical services and study product management expertise and 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) guidelines, the Food and Drug Administrations (FDA), Code of Federal Regulations (CFR), European Medicines Agency (EMA) and any applicable local or international regulation in support of NIAID supported clinical trials networks and programs.

NIAID Division of AIDS (DAIDS), has a requirement for the management and operation of a Clinical Research Products Management Center (CRPMC) to support NIAID sponsored clinical research trials both domestically and internationally, with a core focus of HIV/AIDS and its co-morbidities. The Contractor will provide pharmaceutical services and study product management by providing a cGMP-compliant facility, receipt, storage, labeling, packaging, repackaging, shipping, acquiring, and disposition of study products. Through the exercise of Options, the contract may provide for additional clinical site pharmacy oversight responsibilities, as well as support for other high-priority, NIAID sponsored clinical trials on a limited, as-needed basis. All functions must be conducted in accordance with federal, local and international regulations governing study product including but not limited to, the CFR ICH, EMA, GCP, cGMP, Good Distribution Practices (GDP), Good Documentation Practices and all applicable regulation or guidance.

This contract will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy monitoring reports and maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting Current Good Manufacturing Practice (cGMP) audits of manufacturing facilities. Additionally, the Contractor will provide technical expertise for the receipt and distribution of study products; storage under cGMP; validation and qualification of containers for the shipment of study products; evaluate orders and distribute study products; design and labeling of study products and product kits; packaging and repackaging of study products under cGMP; to monitor product inventories and expiration dates; for the recall and process of study product returns and maintain a database to track study product activities. This contract also plays an important role in the regulatory management of the study products section of the Trial Master File (TMF) for NIAID sponsored, DAIDS held IND studies and is responsible for maintaining a readily accessible, organized and current electronic system for document management. The Contractor will also be able to provide regulatory guidance and expertise as it pertains to ICH, CFR and international regulations with regards to the study product management. The Contractor will train staff in critical procedures and under limited circumstances, acquire study products and ancillary supplies.

The Contractor must have the capability to provide a cGMP facility to carry out the scope of work both domestically within the United States (U.S.) and internationally, including countries in Africa, Asia, South America, the Caribbean, and Europe. All functions must be conducted in accordance with federal, local and international regulations governing study products. For the purposes of determining your related capabilities, your organization must have the capabilities to support over 80 clinical trials, conducted at more than 300 clinical research sites in over 28 countries. The organization must provide a broad range of pharmaceutical and study product management services to the current and evolving clinical research portfolio, including adult, pediatric, vaccine and prevention trials. A capable organization must securely ship these products successfully to various countries with varying climates at all times of the year. This ensures the timely continuation of NIAID supported studies. The organization must also play an important role in the regulatory management of the study products section of the Trial Master File (TMF) for NIAID sponsored, DAIDS held IND studies and will be responsible for maintaining a readily accessible, organized and current electronic system for document management. The Contractor must be able to provide regulatory guidance and expertise as it pertains to ICH, CFR and international regulations with regards to the study product management and distribution.

Anticipated Period of Performance

It is anticipated that a cost reimbursement, term/level of effort, type contact 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 15, 2020. 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).

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: 1) 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 in each performance year (Options 7 through 34, years 1-7); and 2) increased level of effort to support increased level of effort in the amount of .5 FTEs per option that may be exercised up to two times in a performance year (Options 35 through 48, years 1-7). 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 February 15, 2019, and may be accessed through the FedBizOpps website at: http://www.fbo.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 via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website at https://ecps.nih.gov and then click on "How to Submit." Submission of proposals by facsimile or e-mail is not acceptable.

Inquiries

Please direct all inquiries to:

Kishan Patel 
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
Telephone: 240-669-5157
Email: 32Tpatelki@niaid.nih.gov