SOURCES SOUGHT
B -- Analysis of Bulk Drugs & Pharmaceutical Formulations - Statement of Work
- Notice Date
- 12/9/2016
- Notice Type
- Sources Sought
- 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
- N02CM77004-16
- Archive Date
- 1/14/2017
- Point of Contact
- Nicole Belanger, Phone: 3016248754, C. Timothy Crilley, Phone: 301/228-4224
- E-Mail Address
-
belangern@mail.nih.gov, tcrilley@mail.nih.gov
(belangern@mail.nih.gov, tcrilley@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work SMALL BUSINESS SOURCES SOUGHT NOTICE Notice Number: N02CM77004-16 Title: Analysis of Anti-Cancer Chemicals & Pharmaceutical Formulations Introduction: This is a Small Business 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 small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The NAICS code for this acquisition is 325412, which has a size standard of 1,250 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this SBSS Notice, the NCI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. Interested parties are expected to review this Notice and the draft Statement of Work (SOW) to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk. Background: The analytical contract services constitute a program resource responsible for evaluating the identity and purity of active pharmaceutical ingredients and formulated drug products. Completed analytical reports on bulk drug substances and dosage forms provide the basis for assessing their suitability for use in advanced anti-tumor screening, toxicological studies, formulation studies and clinical trials. These data are also submitted to the Food and Drug Administration (FDA) as a required portion of the NCI's Investigational New Drug (IND) filings for investigational anti-tumor agents. Historical summaries of the analytical data are used in preparing specifications of various active pharmaceutical ingredients for procurement actions and routine quality control of these materials. The methods and data are also provided to other contract projects for implementing shelf-life monitoring, facilitating formulation development, and supporting the analytical aspects of pharmacological and toxicological testing. The potential active pharmaceutical ingredients to be studied will be selected by the NExT program at DCTD, NCI. The attached draft Statement of Work (SOW) document outlines the purpose, requirements and scope of the Analysis of Bulk Drugs & Pharmaceutical Formulations. Purpose and Objectives: The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small business concerns that are interested in and capable of performing the work described herein. The objective of this project is to obtain services, personnel, equipment, and facilities as required to perform analytical method development and analyses of bulk drug substances and formulated drug products under cGMP conditions. Project Requirements: The Contractor shall possess the necessary labor, services, equipment, materials, supplies and facilities, except as otherwise specified herein, as needed to perform the work as set forth in the attached Statement of Work (SOW): Anticipated Period of Performance: The anticipated period of performance for this requirement is five (5) years. The anticipated start date is on/or about August 1, 2017. A multi-award IDIQ is anticipated. Capability Statement/Information Sought: Sources are expected to have the personnel, facilities, equipment and experience to meet requirements for all tasks in the draft SOW. Respondents must be qualified and prepare capability statements for all of the Task Areas in the draft Statement of Work. The Capability Statements will be evaluated based on the information provided in relation to the project requirements and the current capability and capacity to: 1. Perform work in the Task Areas in the attached draft Statement of Work; 2. Staff education, training, experience, expertise and knowledge; 3. Corporate experience and management capabilities; and 4. Facilities, Equipment and Systems. Information Submission Instructions: 1. Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm's ability to perform the aspects of the notice described above and in the draft SOW. Tailored capability statements should also include an indication of current certified small business status and subtype(s); this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible small business concern's name, point of contact, address and DUNS number. 2. Number of Copies/Delivery Point: All capability statements in response to this Small Business Sources Sought Notice shall be submitted electronically (via e-mail) to Nicole Belanger, Contracting Officer, at belangern@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify N02CM77004-16. Facsimile responses will not be accepted. 3. Common Cut-off Date: Electronically submitted, tailored capability statements are due no later than 2:00 PM (Eastern Standard Time) on December 30, 2016. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME MAY 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 sufficiently detailed to allow the Government to determine the organization's 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 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. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02CM77004-16/listing.html)
- Record
- SN04347964-W 20161211/161209233944-c07ba5899b40362803234a05210cd3fa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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