Federal contract opportunity HHS-NIH-NCI-SS-TSB-47002-11 for pharmaceutical preparation manufacturing at National Institutes of Health National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, response was due Jan 17, 2014.

Solicitation Number
Contract Number(s)
None listed
Additional Info Link
None listed
No Set-Aside Used
Synopses View

Notice Number: HHS-NIH-NCI-SS-TSB-47002-11
Title: "Development and/or Production of Parenteral Dosage Forms for Clinical Studies"

This is Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and(3) their size classification relative to North American Industry Classification System (NAICS) code for the proposed acquisition. The NAICS code for this acquisition is 325412 Pharmaceutical Preparation Manufacturing, which has a size standard of 750 employees.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

This National Cancer Institute (NCI), National Institutes of Health (NIH) project is a recompetition of an existing requirement, and any new contract awards will be added to an existing pool of IDIQ contract awardees. Production capabilities of are particular interest, as the NCI wants to increase capacity in this area. Therefore, a capability statement that only addresses production capabilities will be considered responsive to this inquiry. This Sources Sought notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute. Interested parties are expected to review this Notice and the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk.

Purposes and Objectives:
The National Cancer Institute is seeking qualified businesses to produce and/or develop pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. 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 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.

Capability Statement/Information Sought:
Capability Statements shall demonstrate an understanding of and experience with the production and development of pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer in humans. If a Request for Proposals (RFP) is issued following this Sources Sought announcement, offerors will need to demonstrate, at the time of proposal submission, that they have recent prior experience 1) manufacturing and delivering batches of sterile injectable drugs for human use, and 2) handling, manufacturing and/or developing cytotoxic drugs. The Capability Statements for this requirement shall address the following four (4) areas: 1) technical approach, 2) personnel; 3) facilities and equipment and 4) corporate experience with similar projects.

1. Respondents must provide a detailed Technical Approach that demonstrates a clear understanding of the draft SOW with discussions of the following relative to cytotoxic agents for human use: a) formulation development; b) production of parenteral dosage forms; c) quality control and assurance; and d) packaging and labeling of finished products. Standard Operating Procedures used in the preparation and manufacture of dosage forms should be described, as well as Standard Operation Procedures for protecting personnel from cytotoxic agents being formulated and quality control tested.

2. Personnel described must have experience with parenteral product development, especially freeze-drying, as well as expertise in the areas of sterile emulsions, liposomes and microdispersions. In addition, staff should possess experience with a variety of analytical instrumentation and the development of stability indicating assays.

3. A description of the facility that will be directly utilized and available for this proposed project, including laboratory, equipment and storage areas, should be provided

4. The description of your firm's corporate experience with similar projects should include your firm's general background, experience, and qualifications particularly with projects involving development and production of specialty parenteral formulations. A special notation should be made of similar or related programs performed for the Government including docu¬mentation with reference to the applicable contract numbers and the supervising agencies.

A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, may be accessed online.

Anticipated Period of Performance:
The period of performance for this requirement would be approximately five years. The anticipated start date is June 15, 2014. Multiple awards are anticipated.

Information Submission Instructions:
1. Page Limitations:
Interested qualified organizations should submit a tailored capability statement for this requirement not to exceed twenty-five (25) single-sided pages including attachments, resumes, charts, etc. (single-spaced, 12 point font minimum) that clearly details the firms ability to perform aspects of the notice described above and the draft Statement of Work. Tailored capability statements should also include point of contact, address, and DUNS number.
2. Number of Copies/Delivery Point:
All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via e-mail) to Brenda Oberholzer, Contracting Officer, at oberholzerb@mail.nih.gov in MS Word, or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NCI-SS-TSB-47002-11. Facsimile responses will not be accepted.

3. Common Cut-off Date:
Electronically submitted tailored capability statements are due no later than 12:00 PM (EST) on January 17, 2014. CAPBILITY STATEMENT RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses is received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALLY: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).


Package File Description
Statement of Work STATEMENT_OF_WORK_12.16.2013.pdf Statement of Work
Place of Performance