SOURCES SOUGHT
U -- Reviewer Education in State of the Art Pharmaceutical Manufacturing
- Notice Date
- 6/2/2009
- Notice Type
- Sources Sought
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1055855-09
- Archive Date
- 6/24/2009
- Point of Contact
- Patricia Wright, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
(patricia.wright@fda.hhs.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; women owned small businesses; or small disadvantaged businesses; and 3 their size classification relative to 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The project title: Reviewer Education in State of the Art Pharmaceutical Manufacturing Background: A goal of Office of Pharmaceutical Science is to help establish common approaches to the manufacture and formulation of drugs among pharmaceutical manufacturers. OPS is an umbrella organization over the activities of Chemistry, Manufacturing, and Controls (CMC) review (also referred to as the Product Quality Review) in CDER. This includes assessment of product and process design and evaluation of product quality in light of established standards and setting and maintaining new quality standards. The level of assessment required by OPS Staff is becoming more challenging as the Agency begins to see the submission of novel and complex dosage forms resulting in added complexity in science-based regulatory decision making. OPS oversees the review process for CDER’s New Drug (NDA) and Abbreviated New Drug Applications as well as Investigational New Appliations (INDs) and some Biologic License Applications (BLAs) which is conducted by the Offices of New Drug Quality Assessment, Generic Drugs, and Biotechnology Products with support from the Office of Testing and Research and the Immediate Office. The staff working in these programs has backgrounds in chemistry, biology, biopharmaceutics, clinical pharmacology, immunology, pharmaceutical science, microbiology, pharmacology/toxicology, labeling and statistics. OPS is faced with the challenge to ensure that the entire staff attains the necessary level of understanding across the various technical and scientific elements of the product assessment. Further, OPS engages in scientific research to support decision making for application review, standard setting, and for technology development which establishes an expectation and requirement in awareness and understanding of current pharmaceutical and manufacturing science. Purpose The purpose of this contract is to deliver a professional development program to ensure reviewers are current in state-of-the-art pharmaceutical manufacturing and technology. Accomplishing this objective requires delivery of a well-structured educational program based on the needs of OPS staff that review and evaluate the chemistry, manufacturing, and controls (i.e., CMC or product quality information) for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologic License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs). Project Requirement The delivery of contractor services and products to CDER should contribute directly to the accomplishment of expectations in the following task areas: •Providing recommendations for a structured professional development program in state-of-the-art pharmaceutical manufacturing and technology •Identifying the needs and competencies of OPS staff who review or contribute to the scientific assessments of INDs, NDAs, BLAs, and ANDAs •Designing the scientific training program based on the needs of the CDER review programs and knowledge requirements for state-of-the-art pharmaceutical manufacturing and technology •Developing goals and objectives for a professional development program based on the reviewers' needs and competencies, •Delivering the professional development program, •Evaluating the training program to ensure it met the stated goals and objectives, and •Identifying a designated project manager to facilitate the contract goals, objectives, timelines, and resource management. Responses to this notice shall be limited to 15 pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS xxxxxx (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received to the attention: Patricia Wright, email: patricia.wright@fda.hhs.gov not later than 4:30 PM Eastern Standard time on June 9, 2009 for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
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