SOURCES SOUGHT
A -- Drug Formulation and Manufacturing Program
- Notice Date
- 1/19/2018
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Acquisition, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- NIHOD-CMSSDA-SSN-2018001-SB
- Archive Date
- 2/12/2018
- Point of Contact
- Robert Burdette, Phone: 3015948028
- E-Mail Address
-
robert.burdette@nih.gov
(robert.burdette@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Responses from organizations that are not considered a small business under NAICS code 325412 will not be accepted or reviewed as part of this market research. Please note this Small Business Sources Sought Notice is associated with the initiative outlined in NIHOD-CMSSDA-SSN-2018001. Small Business Entities that have responded to the previous notice need not submit an additional response. BACKGROUND: The National Institutes of Health (NIH) Clinical Center (CC), Pharmacy Department, Investigational Drug Service (IDS) is responsible for the procurement and management of investigational drugs for Phase I, Phase II, and Phase III clinical studies. The Drug Manufacturing and Formulation Program (DMFP), a component of the IDS, will conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The NIH Office of Logistics and Acquisition Operations (OLAO) Category Management, Strategic Sourcing, and Data Analysis (CMSSDA) branch's mission is to encourage the utilization of government-wide contract solutions and advocate for smarter leveraged buying. As part of its mission CMSSDA establishes and manages an array of NIH-wide strategic sourcing vehicles for commodities and services not managed on a Government-wide level. IDS and CMSSDA are partnering to establish a suite of multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts that, together, will constitute the DMFP. Contractors will conduct process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies, drug product manufacturing, packaging, labeling, storage, and distribution of the drug products. The work will be conducted in accordance with Current Good Manufacturing Practices (cGMP) regulations as required and where appropriate in accordance with Good Laboratory Practice (GLP) regulations. Data and documentation will be prepared in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). PURPOSE AND OBJECTIVES: The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for IDS compounds. Throughout the period of performance of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. Additionally, unless otherwise requested any assigned research must be performed in compliance with, all current FDA, World Health Organization (WHO), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to good laboratory practices (GLP) and current good manufacturing practices (cGMP) as may be applicable. A general overview of the tasks that may be potentially required under this contract is identified here: • Technical Support The primary duties under these taskings may include maintaining up-to-date GLP and cGMP standard operating procedures, providing technical expertise and input in terms of designing experiments for projects/programs, customizing protocol development, analyzing manufacturing processes, reviewing and analyzing data with regard to manufactured products, and participating in project planning. • API Development, Scale Up and Manufacture The primary duties under these taskings may require the Contractor to develop, perform scale up, and manufacturing of API from small scale (≈25 g) up to large scale (10 kg) in accordance with the current ICH Quality Guidelines on Development and Manufacture of Drug Substances (Q11) and Quality Risk Management (Q9). • Drug Product Formulation and Manufacture The primary duties under these taskings may require the Contractor to conduct preformulation studies, formulation development, process development, scale-up, and GMP manufacture of clinical trial material (CTM). Targeted drug products may include, but are not limited to, solid- and liquid-oral (by mouth), parenteral (sterile injection), transdermal (across skin), transmuscosal (across mucous membranes), and inhalation (lung delivery), while the type of dosage form may include, but not be limited to tablets, capsules, powder-in-capsule, powder-in-bottle, creams, ointments, gels, pastes, sachets, lyophilized powder in a vial, sterile or preserved liquids in a vial, suspensions, and suppositories. ANTICIPATED PERIOD OF PERFORMANCE: The resultant IDIQ contracts will consist of a basic ordering period of 60 months for a total of a five (5) year ordering period. Task Orders under each contract will be placed as needed by NIH. Specific performance dates, locations, and task areas, will be specified on Task Orders. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement will be classified under the NAICS code 325412; "Pharmaceutical Preparation and Manufacturing" with a size standard of 1,250 Employees. ANTICIPATED CONTRACT TYPE: The types of orders anticipated for use under the resultant IDIQ contract include firm-fixed price, time and materials, Labor hour, and cost reimbursement. CAPABILITY STATEMENT/INFORMATION SOUGHT: Capability statements should include the following information: • Company name and address; • Clear and convincing documentation of their capability of providing and ability to provide the services specified in this notice; • Examples of prior completed Government contracts, references, and other related information; - Respondents' DUNS number, organization name, address, point of contact, size and type of business (e.g., 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); • Point of contact, including telephone number and email address for representative from interested business; and • Interested Vendors are encouraged to address the following in the response: o Quality Assurance capabilities, structure, and processes; o cGMP documentation; o Drug Product formulation and manufacturing capacity (forms and batch sizes); o Experience manufacturing for Phase I trials; and o Experience with:  Investigational New Drugs;  Chemistry Manufacturing Controls;  Dissolution/Disintegration Assays;  Interpretation of chromatogram;  Microbiological testing of non-sterile products; and o High-risk or Hazardous Compounding. 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). DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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. Interested parties may identify their interest and capability to respond to the requirement. Written responses to this synopsis shall contain sufficient documentation to establish their capability to fulfill this requirement. NIH OLAO will not be responsible for any costs incurred by interested parties in responding to this notice. Please email, with the sources sought notice number in the subject line to the Contracting Officer listed below.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIHOD-CMSSDA-SSN-2018001-SB/listing.html)
- Place of Performance
- Address: Approved contractor manufacturing facilities and National Institutes of Health facilities as required., United States
- Record
- SN04794402-W 20180121/180119230831-5c6b0fcecf3c753c85dfec5b312fd14b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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