Notice Number: NOT-AI-12-032

Key Dates

Release Date: May 24, 2012

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this contract is for the continued operation of Clinical Research Products Management Center (CRPMC) to support the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) clinical research trials networks and programs in HIV/AIDS and its comorbidities, as well as tuberculosis and hepatitis C, in the United States and international locations. The CRPMC will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy audits, 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 cGMP audits of manufacturing facilities. Additionally, the CRPMC will provide technical expertise for the receipt of study products; storage under GMP; validate containers for the shipment of study products; evaluate orders, distribute study products; design and label of study products and product kits; package and repackage of study products under GMP; monitor product inventories and expiration dates; recall and process of study product returns, and maintain a database to track study product activities. The CRPMC will train staff in critical procedures and under limited circumstances, purchase drugs. The CRPMC must have the capabilities 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.

It is anticipated that one cost reimbursement, term type contract will be awarded for a 1-year Base period plus six 1-year options for a possible total period of performance of 7 years beginning on or about May 1, 2013. The performance requirement will be for the delivery of 24 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Years 2 through 7), which may be unilaterally exercised by the Government.  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 2.25 FTEs per option that may be exercised up to two times in a performance year, 2) increased level of effort to support pharmacy oversight responsibilities in the amount of 2.25 FTEs per option that may be exercised up to two times in a performance year; and 3) increased level of effort to provide limited study product management functions to AIDS Malignancy Consortium (AMC) in the amount of 2 FTEs per option that may be exercised one time each performance year.  Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume as stated above.

The NAICS Code is 541712 with a size standard of 500 employees.

The anticipated period of performance is May 1, 2013 through November April 30, 2014 with 1 year options to extend the period for six additional years through April 30, 2020. 

Any responsible offeror may submit a proposal which will be considered by the Agency.  This RFP will be available electronically on/about May 15, 2012, and may be accessed through the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract and through FedBizOpps http://www.fedbizopps.gov/.  This notice does not commit the Government to award a contract.  No collect calls will be accepted.  No facsimile transmissions will be accepted.

Inquiries

Please direct all inquiries to:

Kishan Patel, Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612 (Express mail:  Use Zip Code 20817)
Phone: 301-594-0983
Fax: 301-480-4675
patelki@niaid.nih.gov

Michelle L. Scala, Contracting Officer
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612 (Express mail:  Use Zip Code 20817)
Phone: 301-451-3693
Fax: 301-480-4675
mscala@niaid.nih.gov

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