MODIFICATION
B -- Development and Production of Parenteral Dosage Forms for Clinical Studies - Revised Attachments 7 & 8
- Notice Date
- 5/1/2013
- Notice Type
- Modification/Amendment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02CM37007-11
- Response Due
- 5/17/2013 12:00:00 PM
- Archive Date
- 5/30/2013
- Point of Contact
- Brenda Oberholzer, Phone: 301-624-8750
- E-Mail Address
-
oberholzerb@mail.nih.gov
(oberholzerb@mail.nih.gov)
- Small Business Set-Aside
- Partial Small Business
- Description
- Revised Attachment 8 Revised Attachment 7 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02CM37007-11/listing.html)
- Place of Performance
- Address: Contractor Site, United States
- Record
- SN03049952-W 20130503/130501234635-c1bae2cc0ef480eecaea080329650c16 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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