Development and Production of Parenteral Dosage Forms for Clinical Studies
Awarded Award Notice Posted
- Solicitation number
- N02CM37007-11
- Agency
- National Institutes of Health Department of Health and Human Services
- Awarded
- to Piramal Pharma Solutions Inc.
- Set-aside
- Partial Small Business
Opportunity facts
- Contract number
- HHSN261201300031I Federal IDV award
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- Not on record
- Place of performance
- Contractor Site, United States
Notice details come from SAM.gov. Updated .
Notice text
4 versions
Update #4 · Latest ·
Added: May 01, 2013 3:01 pm
Amendment 2
The following questions and responses are provided for clarification.
1.Part IV. Section L2.c.5 "Small Business Subcontracting Plan" Paragraph a. states THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS. If a qualified small business plans to subcontract any work to another small business, is a Small Business Subcontracting Plan required?
CO RESPONSE: A small business subcontracting work to another small business is not required to provide a Small Business Subcontracting Plan. Only large businesses need to submit a Small Business Subcontracting Plan.
2.The RFP and various attachments provide multiple and different requirements for reporting. Please clarify.
CO RESPONSE: Although worded differently, the reporting requirements in the RFP and various attachments are the same. For clarification purposes, ARTICLE C.2.a(1) has been revised as shown below.
Final Task Order Reports
The Contractor shall provide a Final Task Order Report upon completion of the Task Order Statement of Work. These reports shall include 1) summation of the work performed and results obtained for the entire period of performance. This report shall be in sufficient detail to comprehensively describe the results achieved.
Final reports for development Task Orders shall include a study summary that describes the findings of the development work including all tests performed, accelerated stability data of the pilot batch, a draft master batch record reflecting the findings and recommendations from the development study, product specific methods and specifications, provide specific recommendations for production methods that could be distributed by the Government for manufacturing, and tentative specification for vial and closure to be used.
Final reports for production Task Orders must be completed and accurate including all procedures and tests performed. The report for the first batch of each new drug manufactured shall include certain parts to be used in the NCI's Investigation New Drug Application to the FDA as directed by the Contracting Officers Representative. The project report shall inlcude the following along with other pertinent sections depending on the project: manufacturer's quality control of the active drug substance, manufacturing instructions and/or executed batch record, calculations, in-process assay, manufacturing records, component certificates (e.g. for vials, stoppers, excipients), quality control of formulated product, final vial and label accounting, and description of facilities or reference to a Drug Master File.
This report is due at the time of drug shipment to NCI. No monthly report is due when the final report is due.
Additionally, The Sample Task Orders (for both development and Production have been corrected and attached to this modification to list the reporting requirements as "Monthly Task Order Reports" and "Final Task Order Report".
3. Attachment 1 "Package and Delivery of the Proposal" requires one (1) original and eight (8) copies of the Technical Proposal. Attachment 6 "Additional Technical Proposal Instructions" Part IV.C (page 8), last paragraph states, "Please provide 3 copies of your safety manual." Please clarify.
CO RESPONSE: Please provide one (1) original and eight (8) copies of the Technical Proposal, as well as three (3) copies of the Safety Manual. Only three copies of the Safety Manual are requested to reduce the burden on the Offeror as the reviewers will have to access the manuals and do not need individual copies.
4. The RFP specifies a Cost-Plus-Fixed-Fee basis for the Development task; would it be permissible to submit a proposal for development work as fixed price?
CO RESPONSE: Yes. Costs for either the Development or the Production may be proposed as either Cost-Plus-Fixed-Fee or Fixed Price.
Update #3 ·
Added: Apr 29, 2013 2:18 pm
This amendment extends the RFP due date by one week as described below.
Additionally, this amendment answers the following question as received:
"Can you please describe the next steps of the acquisition process and what is expected from an Offeror?"
The solicitation/Request for Proposal (RFP) that was posted 4/17/2013 outlines what the terms of any potential contract(s) will be and what should be included in a proposal (SECTION L), an how the proposal will be evaluated (SECTION M). After proposals are received the following key steps will occur:
1. Technical Evaluation of Proposals
2. Establishment of Competitive Range
3. Notice to Offerors (Notices are sent to those included in the Competitive Range, and those that will not be considered further)
4. Negotiations (with those in the Competitive Range)
5. Final Proposal Revisions are due (with those from the Competitive Range)
6. Source Selection
7. Award and Award Notice
Update #2 ·
Added: Apr 17, 2013 1:28 pm This Modification/Amendment is posting the Solicitation as previously scheduled. Please see the following Attachments: RFP N02CM37007-11, Attachments 1 through 8, and Attachments 9 through 19
Update #1 ·
Added: Apr 02, 2013 12:53 pm
SYNOPSIS
N02CM37007-11
"Development and Production of Parenteral Dosage Forms for Clinical Studies"
The Development Therapeutics Program (DTP) of the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is soliciting organizations to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTD will be as¬signed for development and production as parenteral products. Batch sizes shall range from small batches (100 - 200 units) to intermediate size batches to be used in Phase I and II trials (1,000 - 5,000 or more units). The capability to develop and manufacture other pharmaceutical dosage forms (i.e. sterile emulsions, liposomes and sterile micro-dispersions) is desirable.
Data obtained from resulting contract(s) may 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 agen¬cies, 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.
The contract type is multiple award, five (5) year, Indefinite Delivery Indefinite Quantity (IDIQ) type contracts. Task Orders will be either cost reimbursement completion or fixed price completion. Offerors will be invited to submit proposals for approximately 4 Development Task Orders and 4 Productions Task Orders as described in the Statement of Work (SOW). As discussed in the Statement of Work, offerors will need to demonstrate, at the time of proposal submission, that they have recent prior experience 1) manufacturing and delivering batches of pharmaceutical clinical product for human use, and 2) handling, developing, and manufacturing cytotoxic drugs.
The NAICS code for this acquisition is 325412. The size standard for this NAICS Code is Number of Employees - 750. This acquisition will be a partial set aside.
The solicitation is scheduled for electronic release on or about April 18, 2013. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/. It is the offeror's responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITION, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO FAX SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED.
Point of Contact:
Brenda Oberholzer
oberholzerb@mail.nih.gov
Riverside Five, Suite 400, Room 4025
8490 Progress Drive
Frederick, MD 21701
Phone: 301-624-8750
Attachments
| File | Type | Posted |
|---|---|---|
| REVISED_Sample_Production_Task_Order.pdf | ||
| REVISED_Sample_Development_Task_Order.pdf | ||
| RFPN02CM37007-11.pdf | ||
| Attachments_9_through_19.pdf | ||
| Attachments_1_through_8.pdf | ||
| STATEMENTOFWORK3182013.pdf |
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