Notice Number: NOT-AI-05-032
Release Date: April 5, 2005
Receipt Date: June 7, 2005
The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS), plans, sponsors, and directs national and international extramural research programs testing vaccines, therapeutics, and preventive modalities. Through these programs, DAIDS supports more than 125 trials in over 40 countries at over 900 sites with 50,000 volunteers. DAIDS is seeking organizations capable of providing a clinical research product management center to support the DAIDS clinical research programs. The work is currently being carried out by McKesson BioServices under contract N01-AI-85352. We are recompeting this contract. The support to be provided under the resultant contract will provide a central location to receive, store, repackage, label and distribute investigational agents used in clinical trials performed by DAIDS clinical trials networks and programs. The management of clinical products must be in accordance with Federal regulations governing investigational agents. Work to be performed includes: 1) initial transition from the incumbent contractor (if required); 2) cognitive pharmaceutical services including assessment of clinical protocols for pharmaceutical issues; evaluation of clinical protocols for quantities of pharmaceutical products; review of site pharmacy monitoring visits reports and charting of critical issues; provision of storage and stability information on pharmaceutical products; conference with the DAIDS Pharmaceutical Affairs Branch regarding pharmacy related protocol implementation issues; provision of assistance and training to research pharmacists in order to establish a quality assurance program; inspection of manufacturing facilities for current Good Manufacturing Practices; and evaluation of the appropriateness of requests for pharmaceutical products; 3) receipt and storage of study products; 4) labeling, packaging and repackaging of study products; 5) development of validated shipping practices to protect the integrity of study products during shipment; 6) shipment and distribution of study products domestically and internationally; 7) ensuring that all shipping documents and permits are developed or obtained for international shipments; 8) provision of inventory control and quality assurance; 9) maintenance of an environment that is clean and sanitary and that meets current Good Manufacturing Practices criteria; 10) development and implementation of security and safety measures for the storage of study products; 11) provision of internal training with sufficient frequency to ensure all staff are trained in critical procedures 12) recall capability for study products from sites, and the process and disposal of returned drugs; 13) maintenance of a dedicated computerized tracking system for the range of product inventory services; 14) administrative support; 15) purchase of a limited number of drugs as directed;16) management and oversight of international clinical research product management centers; and 17) facilitation of an orderly transition to a subsequent contractor. Offerors should demonstrate expertise in: 1) support to various networks and groups that may have as many as 125 active studies at any given time that the number of clinical sites will range from 1 to 250 per study with as many as 700 of these sites located in South America, the Caribbean, Asia, and Africa; 2) support to an estimated 40 different study products per year that will require repackaging; and 3) an estimated 400 different products with 70,000 individual units requiring labeling. Offerors shall demonstrate related ability and experience for providing pharmaceutical services; support for receipt, storage and inventory maintenance of domestic and international shipping of clinical trial study products; available qualified personnel; organizational background and experience; and documented availability of facility, equipment and other required resources to be dedicated to this project. It is estimated that 14 to 15 FTEs at the prime contractor site will be required with expertise consistent with the operations of a project of this size and complexity. This solicitation also includes MANDATORY QUALIFICATION CRITERIA that must be met at the time of the original proposal submission. These criteria are: 1) Offeror(s) must meet all applicable U.S. Food and Drug Administration current cGMP requirements, as specified in Title 21, Code of Federal Regulations, Parts 210 and 211. If a subcontractor(s) is proposed, it (they) must also meet the cited requirements; 2) Offeror(s) must possess current licenses to distribute drugs and other agents, including controlled substances and ethanol-containing products, in its jurisdiction; 3) Offeror(s) proposed Principal Investigator and staff pharmacists must be licensed to practice pharmacy in the offeror's jurisdiction; and 4) Offeror(s) must possess a current U.S. Environmental Protection Agency toxic waste generator permit and the necessary local and state permits for transportation of toxic wastes.
It is anticipated that up to one cost-reimbursement, completion type contract will be awarded for a period of 7 years, beginning approximately February 28, 2006. RFP NIH-NIAID-DAIDS-06-05 was available electronically on March 28, 2005 and may be accessed at http://www.fedbizopps.gov/ or http://www.niaid.nih.gov/contract/rfps.htm. Only electronic copies of the solicitation will be available. All information required for the submission of an offer will be contained in the solicitation. Responses to this RFP will be due approximately June 7, 2005.
Any reasonable offeror may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract. No facsimile transmissions will be accepted. No collect calls will be accepted. See Government-Wide Numbered Note 26.
For questions or further information, contact:
Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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