N02CM37002-05_Synopsis_posted_08232012.pdf

Shelf Life Evaluation of Investigational Dosage Forms

RFP No: NCI-CM-37002-05

Synopsis

Program Objectives

The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment, and Diagnosis (DCTD), National Cancer Institute (NCI), is seeking a contractor to evaluate shelf life of samples of investigational clinical drug formulations. The products may include parenteral, oral, and other types of dosage forms. The results of such testing and evaluations will be provided promptly to the PRB.

These reports will be used for:

$ providing NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation, $ determine continued conformance to the assigned specifications, and $ to support NCI's Investigational New Drug Applications (INDs) filed with the Food and Drug Administration (FDA).

Background

Currently there are approximately 20 lots of NCI drug products on stability testing, including both injectable and oral products. These will require approximately 20-25 separate evaluations per year. It is anticipated that there will be approximately 10 new clinical lots each year requiring shelf life determination. The contractor shall store, and properly evaluate quality of each one of these products, insuring that no scheduled time points are missed or overlooked.

The analytical instrumentation shall include sufficient capability to perform high performance liquid chromatography, ultraviolet and infrared spectroscopy, gas liquid chromatography, moisture determinations, pH determination, and particle size determination.

Uniform Assumptions

For the purpose of estimating costs, offerors should assume the required space for the NCI inventory of samples is given as an example in the following Table.

Storage Condition Approximate Capacity

(sq. ft.)

Elevated Temperature

(40EC, 75%RH)

Controlled Room Temperature (22-25EC)

Refrigeration (2-8EC) 300

Freezer (-10 to -20EC) 50

Deep Freeze (-70 to -80EC) 20

The Contractor shall furnish services, qualified personnel, materials, and a complete and fully operational facility. The facility shall include all necessary equipment and instrumentation adequate to conduct all aspects of the shelf life evaluation of the clinical drug products. Such facility and equipment shall conform to and be maintained in accordance with FDA prescribed current Good Manufacturing Practices (cGMPs).

Issues relating to intellectual properties and confidentiality refers to the clauses described in DHHS policy and regulation.

The services will be acquired through full and open competitive procedures under NAICS 325412. It is anticipated that one award of cost-reimbursement, completion-type contracts will be made for a period of one year with four option years beginning on or about February 1, 2013 as a result of the RFP. Each increment for these contracts will be for a period of 12 months. The proposed contract project represents a recompetition of the following current contract:

HHSN261200700021C with Midwest Research Institute

The RFP will be available electronically on or about September 10, 2012 and may be accessed through the FedBizOpps at www.fbo.gov. All responsible sources may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO

MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE

SOLICITATION AND ANY AMENDMENTS.