SOURCES SOUGHT
B -- Development of a Continuous Quality Improvement Plan for the FDA Center for Tobacco Products
- Notice Date
- 11/19/2014
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- 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-RFI-1139902
- Archive Date
- 12/25/2014
- Point of Contact
- Juana Quinteros, Phone: 240.402.7624
- E-Mail Address
-
Juana.Quinteros@fda.hhs.gov
(Juana.Quinteros@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Small Business Sources Sought Release Date: November 19, 2014 Response Date: December 10, 2014 at 4:30pm ET via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration (FDA), Juana Quinteros Contract Specialist Juana.Quinteros@fda.hhs.gov Description: Development of a Continuous Quality Improvement Plan for the FDA Center for Tobacco Products, Office of Compliance and Enforcement This is a Small Business Sources Sought to identify the capabilities of the marketplace of small business interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this small business sources sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: (i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, non-developmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or non-developmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs can be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: The following statement of work outlines the need and requirements of the Development of a Continuous Quality Improvement Plan for the FDA Center for Tobacco Products, Office of Compliance and Enforcement RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the Sources Sought number; FDA-RFI-1139902  no more than five (5) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: Can you provide the following: 1. Work with office leadership to evaluate and report on the current procedures used by the nearly 150 employees to conduct the daily work of the office. The evaluation should include, but is not limited to: understanding of statutorily mandated responsibilities, review of current procedures and outcomes, and consultation with Division and Branch supervisors. A quality assessment which identifies the strengths and areas for improvement shall be performed and reported on for each of the following OCE components, their respective responsibilities are also provided: a. Division of Promotion, Advertising, and Labeling (Approximately 29 employees) • Perform surveillance, investigation, and case development regarding advertising and labeling provisions in effect. • Responsible for approving Smokeless Warning Plan and performing Tobacco Product Marketing Reviews. • Enforce statutory and regulatory requirements involving promotion, advertising, and labeling. b. Division of Enforcement and Manufacturing (Approximately 38 employees) • Perform compliance review of tobacco product submissions. • Coordinate with FDA Office of Regulatory Affairs for inspections of manufacturers and distributors. • Responsible for registration and listing database. c. Division of Business Operations (Approximately 29 employees) • Coordinates FDA Tobacco Retailer Inspection Contracts. • Performs final review, in conjunction with FDA Office of Chief Counsel, on Civil Money Penalty Cases and performs follow-up, on all retail cases which go toward hearing. • Coordinates all administrative, human resource, and information technology activities. • Serves as primary point-of-contact to provide technical assistance in conjunction with subject matter experts for small tobacco product businesses. d. Front Office (Approximately 8 employees) • Provides oversight of OCE, interacts with other CTP offices, and reports to CTP leadership. 2. Review and provide any recommended updates and suggested implementation strategies to an already established quality plan. CTP will provide a copy of the quality plan after award. The review should focus on the areas of the plan which cover the following Division and its respective responsibilities: a. Division of State Programs (Approximately 41 employees). • Provides training for inspectors and other contractors under the FDA Tobacco Retailer Inspection contracts. • Reviews inspection results from State enforcement program; issues warning letters and civil money penalties. 3. Based on the quality assessment evaluation described in section C1, after meeting with OCE representatives, the Contractor shall develop a quality improvement plan that reflects the goals identified in OCE's and CTP's strategic plans and enhances OCE's efficiency, effectiveness, and productivity. The plan shall incorporate the results of the quality assessment of OCE's current performance, identify challenges and obstacles encountered in the execution of the office's work and set performance objectives that identify opportunities to improve processes and outcome. Additionally, the plan shall incorporate the recommendations and suggestions related to the Division of State Programs review described in section C2. The plan shall highlight best practices for developing and implementing quality improvement programs. In addition to areas the Contractor identifies, the quality improvement plan should concentrate on the following items: a. An internal and external stakeholder focus; b. Leadership Involvement; c. Developing and maintaining a data informed practice; d. Developing, implementing, and utilizing statistical tools to promote knowledge and understanding; e. Quality Improvement Process Development with an emphasis on long term goals for the QI program and the objectives to accomplish these goals; and f. Continuous Quality Improvement Activities. 4. After OCE acceptance of the quality improvement plan, the Contractor shall present the plan to senior OCE management during a one-hour presentation. This presentation should focus on possible way to implement the recommendations provided in the final plan. The meeting will also provide an opportunity for discussion and further clarification on the recommended implementation. 5. The contractor will also provide up to 2 follow-up sessions with OCE management to discuss the activities conducted by OCE related to the recommended implementation of the plan. The contractor shall provide a review of the activities already conducted and provide recommendations on ways to continue the implementation. Part B. Size of Business The Government is seeking small business opportunities. State whether your company is a small business (and also state your under socioeconomic status), College/University, large business or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $150K Over $150K but under $250K Over $250K
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1139902/listing.html)
- Place of Performance
- Address: 10903 New Hamphshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03576574-W 20141121/141119234056-3885575a51e124ab273ac0c9d40bb5f9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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