SOLICITATION NOTICE
R -- Strategic Planning and Industry Reviewer Training in Pharmaceutical Product Quality
- Notice Date
- 4/12/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- FDA-SOL-10-1068436
- Archive Date
- 5/12/2010
- Point of Contact
- Zetherine Gore, Phone: (301) 827-5093, Vida - Niles, Phone: 301-827-2476
- E-Mail Address
-
zetherine.gore@fda.hhs.gov, vida.niles@fda.hhs.gov
(zetherine.gore@fda.hhs.gov, vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant contract order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-40. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code (541690) is to notify contractors that the government intends to issue a contract in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total 100% small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that discussions after initial offer(s) is/are provided are not necessary. This announcement is issued as a Request for Proposal (RFP). The Food and Drug Administration (FDA) intends to award a contract for expert consultant services to assist the Office of Pharmaceutical Science (OPS) with Strategic Planning and Industry/Reviewer Training in Pharmaceutical Product Quality. This requirement is identified as FDA-SOL-10-1068436 for the following statement of work: 1. BACKGROUND AND OBJECTIVE In August 2002, the Food and Drug Administration (FDA or the Agency) announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality and bring a 21st century focus to this critical FDA responsibility. Contractor assistance is needed to advise OPS management and assess current practices in regulating product quality to create a new framework for the regulatory oversight of manufacturing quality based on quality systems and risk management approaches. 2. SCOPE OF WORK The contractor shall furnish the necessary services and personnel, and otherwise do all things necessary for or incident to the performance of the work as described below: Statement of Work A. The contractor shall advise the OPS Director and management on current practices in regulating product quality; B. The contractor shall assist in developing a plan to address the specific concepts of the regulatory processes to ensure that the regulatory strategies are based on the degree to which an application reflects a manufacturer's understanding of manufacturing process, process control, and quality systems; C. The contractor shall facilitate OPS' efforts to provide consistent direction to staff and/or regulated industry; D. The contractor shall develop training programs for OPS staff on quality by design (QbD) and process analytical technology (PAT). This includes: 1. Recommending aspects of training to ensure future understanding of the new regulatory processes and how the processes will be applied across the entire Office. 2. Providing OPS program offices with training plans and developing training course agendas for the science staff. 3. Providing support for the logistics of the training program (determining appropriate venue, working with presenters, registering and tracking attendees). 3. DELIVERABLES A. Provide advise OPS Director and management on current practices in regulating product quality and assist in development of strategic plans; B. Written memos on regulatory and review strategies that reflect the degree at which an application reflects a manufacturer's understanding of manufacturing process, process control, and quality systems; C. Memos and recommendations on OPS's review and CGMPs and practices that are of mutual interest to the Office of Compliance and the Office of Regulatory Affairs; D. Development of training course plans and agenda related to pharmaceutical manufacturing quality, process control, and quality systems. 4. LEVEL OF EFFORT It is estimated that one consultant is required at a level of effort of approximately 333 hours per year. This estimate is provided for informational purposes only and should not be considered restrictive. 5. PAYMENT SCHEDULE Payments under any resultant contract will not be made more than monthly. 6. PERIOD OF PERFORMANCE The period of performance shall be for one (1) base year with four (4) option years. It is anticipated that contract performance will begin in May 2010. 7. BASIS FOR AWARD Provision 52.212-1 Instructions to Offerors-Commercial Items(Nov 2007) is incorporated by reference. 52.212-2 Evaluation-Commercial Items (Jan 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. (b) Proposals received will first be evaluated from a technical standpoint without regard to proposed cost. Those proposals considered to be technically acceptable will then be evaluated from a financial and management standpoint. (c) Technical factors are significantly more important than cost or price. It is pointed out, however, that should technical competence between offerors be considered approximately the same, then cost or price could become primary. Evaluation Factors for Award A. Best Value Criteria - Basis for Award The Offeror should demonstrate the statement of work is understood and offer a logical approach to its achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offeror's proposal submission based on the evaluation criteria described below. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a task order on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint. B. Evaluation Criteria The proposal must demonstrate a thorough understanding of the requirements of the Statement of Work and describe an approach which demonstrates that achievement of timely and acceptable performance as describe in the Statement of Work. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below: Technical Approach The proposal must demonstrate the offeror's understanding of the technical requirements and the ability to apply knowledge and experience of CDER's review practices and the regulatory changes necessary to implement CGMPs. This includes application of pharmaceutical manufacturing quality, process control, and quality systems.. Qualifications The proposal must demonstrate the offeror's qualifications and ability to assess pharmaceutical manufacturing processes, process controls, and quality systems; and the offeror's a) knowledge of regulatory and review practices related to manufacturing product quality; b) knowledge of FDA regulatory authority; c) knowledge of OPS and CDER missions and business practices; d) knowledge of FDA Plain Language guidelines; e) knowledge of CDER drug review process; f) knowledge of CGMPs Experience The offeror must demonstrate its experience with CDER's Office of Pharmaceutical Science, and experience working with Offices involved in with manufacturing science. Offeror's demonstrated ability to work with CDER and external partners for developing training. The offeror must demonstrate its experience and knowledge of FDA's principles of Quality by Design (QbD); Design Space and Process Analytical Technology (PAT). Price FDA will evaluate the offeror's proposal on their ability to provide support at a reasonable and realistic price. Past Performance FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. 8. CCR Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. 9. QUESTIONS DEADLINE: All questions pertaining to this solicitation must be received at zetherine.Gore@fda.hhs.gov no later than April 15, 2010, 2:30 p.m. 10. OFFERS DUE: Proposals submissions must be provided electronically in Adobe pdf format and are restricted to a limitation of fifteen (15) pages. Submit proposals to zetherine.gore@fda.hhs.gov 11. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. No telephone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-10-1068436/listing.html)
- Place of Performance
- Address: Food and Drug Administration, 10993 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02118660-W 20100414/100412234223-408a26e35ac912a4328bdc36cb8d8dee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |