SOLICITATION NOTICE
R -- Professional Services
- Notice Date
- 8/5/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541611
— Administrative Management and General Management 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-08-1045996
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541611, is to notify contractors that the government is seeking competition in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26. This is a total 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. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. STATEMENT OF WORK: Background: The Food and Drug Administration (FDA) announced in August 2003 its intention to make the agency’s animal feed safety program more comprehensive and risk-based. The modernized Animal Feed Safety System (AFSS), which has a 2009 target completion date, will instill preventive control measures for ensuring the safety of animal feed and human food derived from animals (i.e., meat, milk and eggs). FDA with State assistance is developing the AFSS Framework, the third draft of which was placed on the Center for Veterinary Medicine’s (CVM) web site in April 2008. This document describes in detail the current processes, guidance, regulations and policy documents used by the FDA and the products that should be developed to meet the objective of having a more comprehensive, preventative and risk-based animal feed safety program in the United States. Education and Outreach is an important component of the AFSS. Developing “guidance” documents for use by our stakeholders (those impacted by changes in agency procedures, policies and regulations) is a key activity of the AFSS Team, the agency group working on the project. Duties: The Contractor will provide advisory and consultative services to CVM on critical issues regarding those segments of the AFSS project that deal with the work products contemplated under the Process Control and Education and Outreach components. Specifically, the Contractor will prepare guidance for industry (GFI) documents for three feed manufacturing types, ingredient, mixed feed and mixer-feeder. Each GFI will explain what each establishment type will be required to perform to be in compliance with the requirements of the new process control regulations, which are being prepared by the AFSS Team for the Federal Register proposal step of the comment and rulemaking process. Further, the Contractor will complete the paperwork impact section for the proposed regulation. The contractor will be responsible for the timely drafting of documents, and their efficient revision based on comments from the AFSS Team. The Contractor should have extensive experience with the policies and procedures of the FDA, the legal processes within FDA, and voluntary compliance approaches. Also, the Contractor needs wide-ranging knowledge of the regulatory and stakeholder groups that could be impacted by the guidance. Furthermore, the Contractor must have a working knowledge of the feed industry as it currently exists and operates, as well as the goals, objectives and premises of the AFSS. The Contractor will need to be available to travel on occasion. Location: The work will take place at the Contractor’s office and occasionally at CVM, 7519 Standish Place, Rockville, MD. Equipment Use: No government equipment will be provided. TECHNICAL EVALUATION FACTORS Area 1 - Personnel 65 Points Factors to be considered: I. Knowledge and experience of the contractor with regard to the regulation of the animal feed industry. This is evidenced by specific narrative examples describing recent experience in the following: a. developing guidance and program documents that address regulation of the animal feed industry; b. writing regulations to ensure safety of animal feed; and, c. how implementation of FDA’s animal feed safety system impacts safety of animal feed. II. The availability of contractor personnel to commit to the contract. This is evidenced by: a. the amount of time the offeror has available to complete the project and the amount of time committed to competing work; and, b. whether the offeror can rapidly ramp up to begin work on the project Area 2 - Technical Understanding and Approach 35 Points Provide a comprehensive statement of the scope and purpose of the project to demonstrate complete understanding of the intent and requirements. This understanding indicates a clear comprehension and awareness of the contract’s objectives, specifically the development of the Paperwork Impact Assessment and the three guidance documents. Objectives: State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and the relationship to comparable work in progress elsewhere. Approach: Use as many subparagraphs as needed to outline clearly the general plan of work that specifically addresses the services in the Statement of Work (Attachment 1). Methods: Describe in detail the methodologies that would be used for the project, indicating level of experience with each. Schedule: Describe on-site staff scheduling approach to the requirements to be performed during the business hours. The contractor may propose alternate schedules such as staggering workday schedules to minimize overtime paid for weekend and holiday workers to develop more cost efficient methods for providing service. Factors to be considered: i. Knowledge and understanding of the Scope of Work is demonstrated by the clarity, practicality, and appropriateness of the offeror’s proposal and plan to accomplish the effort. ii. Recognition by the offeror of potential difficulties in the performance of the project and plan to overcome such problems. Period of Performance: Twelve months from the date of award. Work Hours No specific work hours. SECURITY REQUIREMENTS: The Contractor shall obtain FDA security clearance prior to beginning work. Contractor shall sign a confidentiality agreement prior to beginning work under this contract. Objectives include: To generate guidance documents and paperwork impact assessment for a proposed progress control regulation for animal feed. Offerors are advised that award will be made to that offeror whose quotation provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors. BILLING: The contract will be set up as an invoice. 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. QUESTIONS DEADLINE: All questions are to be submitted via email to karen.petty@fda.hhs.gov no later than August 11, 2008, 3:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: karen.petty@fda.hhs.gov, no later than 3:00pm, EST on Thursday, August 14, 2008. 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. Responses to this notice must be sent via email to Karen.petty@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1322479cfafae5d7912342f021ee44e6&tab=core&_cview=1)
- Record
- SN01631363-W 20080807/080805221923-1322479cfafae5d7912342f021ee44e6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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