Development and Production of Parenteral Dosage Forms for Clinical Trials

Amendment No.: 2



OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE



REQUEST FOR PROPOSAL NUMBER: N02-CM-77021-39



Amendment No.: 2



Date of Issuance: April 30, 2008



The above numbered Request For Proposal (RFP) is amended as set forth below.



The hour and date specified for receipt of Offerors is changed to May 13, 2008, 3:00 pm local time.



Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.



FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.



This Amendment revises the RFP as stated below:



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ARTICLE B.2. Estimated Cost and Fixed Fee - is amended as follows:



b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.





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Section I.2., Authorized Substitutions of Clauses - is amended to delete the following:





Alternate 1 of FAR Clause 52.233-1, Disputes, is hereby deleted.







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Section J - List of Attachments - is amended to delete the following:



Attachment 15, Disclosure of Lobbying Activities, OMB Form SF-LLL, is hereby deleted as this attachment is a duplicate of Attachment 11.







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13. Proposer's Annual Financial Report - is amended to delete the following:



A copy of the organization's most recent annual report must be submitted as part of the business proposal.







15: Travel Costs/Travel Policy - is amended to delete the following:



One copy of the offeror's (and any proposed subcontractor's) written travel policy shall

be included in the business proposal (original only). If an offeror (or any proposed

subcontractor) does not have a written travel policy, the offeror shall so state.







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2. Mandatory Evaluation Criteria - is amended to include the following:



The Contractor SHALL show proof (FDA form 483) of routine FDA inspection(s) within the last two years. This requirement shall be met at the time of proposal submission.

RFP Number : N02CM77021-39

Amendment 1



- 1 -

OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N02CM77021-39

Amendment No.: 1

Date of Issuance: April 10, 2008



The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors is changed to: May 6, 2008, 3:00 pm local time.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or

as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.



FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.



This Amendment revises the RFP as stated below:



The due date and time for submission of proposals is changed to May 6, 2008 at 3:00 pm local time.



ALL QUESTIONS RELATED TO THIS SOLICITATION SHALL BE SUBMITTED ELECTRONICALLY NO LATER THAN APRIL 24, 2008 TO THERESA H. SHROFF, CONTRACTING OFFICER, AT THE FOLLOWING E-MAIL ADDRESS: SHROFFT@MAIL.NIH.GOV

ELECTRONIC RFP ANNOUNCEMENT

The Pharmaceutical Research Branch (PRB), Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI)is seeking a contractor to provide services for developing and producing pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTD Cancer Operating Committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small batches (less than 100 units) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch sizes (1 - 10,000 or more units) for advanced Phase II/III trials is also possible. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenterals, sterile emulsions, liposomes and sterile micro-dispersions) is desirable but not essential.



Data obtained from any contract that may be awarded will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agencies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting.



Offerers must meet the following Mandatory Evaluation Criteria in order to be considered for an award: The Contractor must be registered with the FDA as a pharmaceutical manufacturing facility for sterile products. The Contractor should show proof (FDA form 483) of routine FDA inspection(s) within the last two years. This requirement shall be met at the time of proposal submission. Moreover, the Contractor must be in compliance with FDA requirements during the course of the contract performance. All chemicals and drugs handled during the contract should be regarded as potentially toxic and should be handled accordingly. Offerors will be instructed to descibe their safety program and proposed approach to handling toxic agents. Proposals will be evaluated as to the adequacy of the facilites and the proposed methods for handling these agents.



It is anticipated that one (1) cost reimbursement, completion-type, options contract will be awarded for a base period of five (5) years plus two (2) option years for a potential period of performance of seven (7) years. The North American Industry Classification System (NAICS) code is 541711. The proposed solicitation represents a recompetition of Ben Venue Laboratories, Inc., contract N02-CM-37005. The solicitation will be released ELECTRONICALLY approximately March 15, 2008.



The RFP will only be available electronically and may be accessed through the National Cancer Institute, Office of Acquisitions homepage at: http//rcb.nci.nih.gov/ Once at the Office of Acquisition homepage select Current Requests for Proposals. All information required for the preparation and submission of a proposal will be contained in the electronic RFP package. POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND ANY AMENDMENTS. FURTHER, ALL QUESTIONS REGARDING THE RFP SHALL BE SUBMITTED ELECTRONCIALLY TO CONTRACTING OFFICER THERESA H. SHROFF AT ts144t@nih.gov.



This announcement does not commit the Government to award a contract.