SOLICITATION NOTICE
R -- ASSISTANCE SERVICES FOR LACF TEAM IN PROCESS REVIEW
- Notice Date
- 4/28/2008
- 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-08-00647
- Point of Contact
- ZetherineGore ,, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@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 purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-24. 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 Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. 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. 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. This solicitation is issued as a Request for Proposal (RFP) The Food and Drug Administration (FDA) intends to award a purchase order for Assistance Services for Low-Acid Canned Food (LACF) Team Process Review. 1. STATEMENT OF WORK Independently and not as an agent of the Government, 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. The contractor shall have access to the FDA On-Line LACF Database and shall regularly access the database and review low acid process filing submissions. This review shall be conducted in accordance with commonly accepted practices for the calculation and evaluation of thermal process and in a manner consistent with FDA policies and procedures. Each filing will be evaluated and classified as either “accepted” or returned to the filer for additional information or explanation. The contractor shall make a timely disposition of each filing that is reviewed. The contractor shall respond to filer inquiries and comments in a timely manner. If necessary, the contractor will generate a letter detailing process adequacy concerns for a specific submission and send to the Project Officer. The Project Officer will review and accept the letter prior to its being issued. The Contractor shall also provide expert technical opinions on thermal processing issues on an as needed basis, as determined by the Project Officer The Contractor shall be fully competent and knowledgeable in the application of the current Good Manufacturing Practice Regulations (GMP’s) for low-acid canned foods (21 CFR 113) and the GMP’s for acidified foods (21 CFR 114). The Contractor shall be completely familiar with at least the following: •Nomenclature for studies in thermal processing; •Protocol for carrying out heat penetration studies; •Temperature distribution protocol for processing in all types of retorts; •Protocol for conducting temperature distribution; •Application of HACCP to LACF and AF processing; •FDA import procedures. NOTE: Services must be obtained from a contractor that does not perform similar services for the regulated industry thus avoiding a conflict of interest. 2. ESTIMATE OF LEVEL OF EFFORT 833.3 hours of review 3. PERIOD OF PERFORMANCE Base Year: May 17, 2008 – May 16, 2009 Option Period 1: May 17, 2009 – November 16, 2009 4. DELIVERABLES The contractor shall regularly review filing submissions using the FDA LACF On-Line database and make definitive dispositions of those filings in a timely manner. It is expected that approximately ten (10) filing submissions will be reviewed per hour of review time, although the review time needed for each filing is variable. 5. PRICING The offeror’s fixed price should be provided for the base year and the option period and list the labor hours and hourly rate for period of performance. 6. EVALUATION FACTORS FOR AWARD A. BEST VALUE CRITERIA - BASIS FOR AWARD The Offeror should demonstrate in 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 offerors proposal submission based on Technical Elements, Price, and Past Performance as described below. Technical, Past Performance, and Price are of equal importance. 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 OF OPTIONS It is anticipated that any purchase order awarded from this RFQ will contain option provision(s) and period(s). In accordance with FAR Clause 52.217-5, Evaluation of Options (July 1990), the Government will evaluate offers for award purposes by adding the total price for the option to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests. Evaluation of the option will not obligate the Government to exercise the option. C. EVALUATION CRITERIA The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the Statement of Work as set forth in the RFQ. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Offerors should provide information on all of the following criteria. (1) Technical Solution The proposal must demonstrate a thorough understanding of the requirements of the Statement of Work and describe an approach which will demonstrate the achievement of timely and acceptable performance as describe in the Statement of Work and the Specifications therein. The proposal shall present a comprehensive statement of the problem, scope, and purpose of the project to demonstrate an understanding of the requirements from a management and technical standpoint. Detailed plan of work/program management, complete with quality control, including start-up service and follow-up service provisions and a detailed time line of commencement. (2) Qualifications and Availability of Personnel Offerors must demonstrate evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff. Personnel proposed to be assigned and available for work under the project shall be evaluated on their demonstrated, documented, and relevant expertise, education, availability, and experience. Supporting documentation about the experience, training, and education (e.g., resumes) of proposed personnel must be provided. (3) Past Performance Evaluation FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. (4) Price FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered). 7. PAYMENT SCHEDULE Payment will be made in monthly installments based on level of effort (hours worked). 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 are to be submitted via email to Zetherine.Gore@fda.hhs.gov no later than May 1, 2008, 2:00pm EST. 10. OFFERS DUE Two (2) copies of offeror’s proposals must be delivered no later than 2:00 p.m. local time on May 6, 2008. Food and Drug Administration Attn: Zetherine Gore Food and Drug Administration 5630 Fishers Lane, Room 2075, HFA-500 Rockville, MD 20857 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
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=0a46ac1281d131c3133dea22e5497ac9&tab=core&_cview=1)
- Place of Performance
- Address: FOOD AND DRUG ADMINISTRATION, COLLEGE PARK, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN01561945-W 20080430/080428214939-0a46ac1281d131c3133dea22e5497ac9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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