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FBO DAILY ISSUE OF APRIL 25, 2008 FBO #2342
SOLICITATION NOTICE

R -- Low-Acid and Acidified Canned Foods (LACF) Computer Data Entry and Administrative Support

Notice Date

4/23/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541513 — Computer Facilities Management 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-08-00633
 

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, 541513 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 Low-Acid Canned Food (LACF) Data Entry Electronic Support for the Center for Food Safety and Applied Nutrition (CFSAN). 1. Objective: The requirement services will coordinate firm registration and food process filings for low-acid canned food and acidified food as required. This encompasses the establishment and maintenance of records of all commercial food processors engaged in the manufacture, processing, and/or packing of acidified or thermally processed low-acid foods in hermetically sealed containers to include domestic as well as all foreign firms which export these products to the United States. 2. Background Several food spoilage outbreaks with public health significance associated with commercially packed low acid canned foods and acidified foods occurred in the early to mid 1970's. To provide consumer protection from such incidents, the Food and Drug Administration (FDA) has promulgated three regulations (Attachment 1). Two of these are Good Manufacturing Practice (GMP) regulations: 21 CFR Part 113 Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers, and 21 CFR Part 114 Acidified Foods. The third regulation is 21 CFR Part 108 Emergency Permit Control. The Emergency Permit Control regulation sets forth definitions and administrative procedures, and provides the mechanism for enforcement under Section 404 of the Act. It establishes requirements and conditions for exemption from or compliance with Section 404. Specifically, 21 CFR Part 108 requires, among other things, that affected processors, both foreign and domestic, register their firms with FDA and file their scheduled processes using appropriate forms (Refer to Forms FDA: 2541 http://www.cfsan.fda.gov/~acrobat/frm2541.pdf 2541a http://www.cfsan.fda.gov/~acrobat/frm2541.pdf 2541c http://www.cfsan.fda.gov/~acrobat/frm2541c.pdf and related instructions). By means of these forms, regulated firms register their establishment(s), disclose the low acid canned foods and acidified foods produced in each, and state the technical information for each scheduled process. From the completed forms (source documents), FDA prepares and maintains a computerized LACF/AF database which contains all the submitted information. After being transcribed into the database, the source documents are manually filed in the event of litigation and to confirm information in the database. Registration of a processing establishment is required to be completed only once. When an establishment relocates, registration of the new location is required which nullifies the previous registration. Submission of process data, however, is an on going activity. All changes to process parameters or addition of a new product to a manufacturer's line of products require submission of appropriate process filing forms. Presently, FDA receives annually approximately 400 new registration forms (FDA 2541) this includes initial registrations and plant relocations. FDA is currently receiving approximately 11,100 process filing forms (FDA 2541a and 2541c) per year. The information contained on these forms is entered into a computerized data base which can be used by FDA headquarters and field personnel to determine industry compliance with the process filing requirement, selectively evaluate processing parameters, or generate and report classification totals. The hardcopy file is maintained as backup. 3. Scope of Work Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials and services and otherwise do all things necessary for, or incident to the performance of the work as described below. work. The contractor shall provide staff (contract staff) to be cross-trained in multiple tasks to facilitate quality control and distribution of work. The contract staff shall coordinate firm registration and food process filings for low-acid canned food and acidified food as required under Federal 21 CFR parts 108.25 and 108.35. This record encompasses the establishment and maintenance of records of all commercial food processors engaged in the manufacture, processing and or packing of acidified or thermally processed low-acid foods in hermetically sealed containers to include domestic as well as all foreign firms which export these products to the United States. The necessity of this activity is based on the fact that improperly processed canned foods which have a pH greater than 4.6 may support the outgrowth and toxin production of the food borne bacteria Clostridium botulinum which causes the sometimes fatal disease botulism. The contract staff must apply substantial skill and knowledge of governing agency policies and regulations in the day-to-day dealing with representative of the food industry and representatives of other governments and their agency representatives as well as providing guidance to FDA field offices in matters which pertain to firm registration and process filings. The contractor shall perform data entry tasks using the Low-Acid Canned Foods (LACF) Web application to help the Food and Drug Administration (FDA) personnel to access, update, and track food process filing compliance with regards to the production of Low-Acid Canned Foods/Acidified Foods (LACF/AF). The data entered into the LACF Web application by the contractors will provide the FDA personnel with access to the system for viewing registration information and production processes and also will provide easy access to computerized data bases containing information for all previously registered domestic and foreign LACF/AF processors. The contractors shall in the absence of the Coordinator as requested be responsible for performing work to: •Add a Registration Form •Update a Registration Form •Search for a Registration Form •Create a Batch (mail submissions) •Add a Process Filing Form to a Batch •Assign a Batch to a Food Technologist •Update a Batch •Track a Process Filing •Add/Correct a Process Filing Form(s) in Data Entry Process •Update Process Filing Form(s) to Master File •Correct Process Filings in Master file •Search for Process Filing Form(s) •Manage Batches •Move Process filings from one FCE to another •View an Import Alert •Generate Reports •Discontinue/replace old forms •Attach Support Documentation The contractor also shall proofread and correct (as necessary) all backlogged and subsequent process filing forms and provide other administrative support services to ensure a timely, accurate and complete LACF/AF database and hardcopy files. The accuracy rate at this point shall be 99.5% error free transactions. The contractor, at no cost to the Government, will correct contractor errors identified by the Government. The contractor shall in the absence of the LACF Coordinator, as needed manage the day-to-day activities of the Low-Acid/Acidified Foods Plant Registration/Process Filing System. These activities include registration of new canning plants as well as the receipt, tracking, and computer data entry/validation and storage of information filed with the Food and Drug Administration on active canning processes submitted by industry. The work includes the establishment and implementation of Quality Control for Registration and Process Filings, checking for accuracy of information being placed in the Tracking file by LACF coordinators and technical editing by editors prior to giving the forms to the contract staff for data entry. The Lead will perform Quality Control checks of data entry performed by the contract staff. The contract staff shall operate the help desk telephone lines and as requested the LACF e-mail account, which are the primary agency contact points for all registration and filing by industry. These contacts are used to explain FDA regulatory requirements for firm registration and filing, to assist individual firms in completing their filing forms, and to distribute appropriate forms and accompanying instructions. In many instances, the contract staff must demonstrate tact and diplomacy in communicating effectively with individuals, including individuals who do not fluently speak English or who have difficulty understanding English. In addition, these contacts often are adversarial as a result of FDA action taken or contemplated for their product. These contract staff’s tasks include: •Assist FDA field offices concerning the compliance status of domestic and foreign acidified and low acid canned food establishments and processes. They will provide FDA field offices with current information on establishment registrations and process filings on which regulatory decisions are based. The records maintained by the contract staff determine whether seizure of domestic manufacturer’s products or automatic detentions of foreign manufacturer’s products are warranted. As requested, they will notify FDA field offices when firms have subsequently met registration filing requirements so that detentions may be lifted. •Assist and respond to inquiries from manufacturers, importers, trade associations, foreign embassies, consultants, attorneys, other Government agencies, and private citizens concerning the status of establishment registration and process filings. They will provide guidance on requirements of 21 CFR 108, for completion of required forms, labeling requirements, and status of foreign firms from which importers may consider making purchases. The contract staff will independently determine which inquiries should be referred to supervisory or technical experts. •Answer questions regarding the new online filing system and as requested, provide the means for industry to access this system to include: address verification, mailing the Primary Authorized Representative letters to the facilities, and notification when access has been granted. In addition, when Firms have problems logging on the FURLS website with a valid username and password the contractor will refer them to the FURLS help desk for assistance to establish a link with the online system. As requested the contractor will provide instructions and guidance to firms needing to: •Edit registration information •View status of filing forms •Access current and previously submitted filings •Add new filing forms •Resubmit returned filing forms The contractor shall maintain a myriad of detailed accurate computerized data. The contract staff must be familiar with thermal processing nomenclature and management of a major computerized file to permit accurate classification of documents. The contractor shall be responsible for monitoring and maintaining the LACF/AF computer data bases that contain data which is critical to the effectiveness of FDA’s LACF regulatory activities to include domestic and foreign inspections, the surveillance of imported products, heat sterilization process evaluations, and other compliance and regulatory activities. The contractor shall perform file cleanup projects to remove outdated and erroneous materials from LACF files, including separation and removal of all out of business firms that are now filed in the FDA’s file room, this will require the contract staff to pull outdated folders and send to the records section for further handling. The contractor shall remove duplicate process filings that are in the master file with errors that need to be corrected that would result in inaccurate data being disseminated to the field. 4. Customer Service The contract staff shall operate the help desk. This work requires them to interact with various headquarters personnel (food technologist, compliance officers, and computer programmers), FDA District office personnel (inspectors, investigators, and compliance officers), contract personnel, industry personnel, trade association, and foreign government representatives for the purpose of obtaining or disseminating information on the status of plant registrations/process filings. This assures that field units have data required to perform their surveillance and regulatory functions. The contractor shall be responsible for designating batches of forms ready for computer master file update. The contractor shall not permit a backlog of process forms, due to contractor delays, to exceed two average week's receipts (approximately 400 forms). The contractor shall as requested, open, date stamp, and sort incoming mail. This shall include retrieving Missing Data file copies of forms returned to firms for clarification and attaching file copies to forms resubmitted by firms. The contractor shall maintain hardcopy files by manually filing source documents after computer database updates. The contractor will facilitate user access to hardcopy files by physically separating and spreading documents, as cabinets become crowded. The contractor will keep the LACF file cabinets locked at all times, except when they are working in a particular cabinet. As requested, the contractor shall mail FDA forms and instructions upon receipt of written or telephone requests and will photocopy, mail and file already formulated requests for missing data or clarification. The contractor shall ensure that employees become familiar with and follow the guidelines provided for in FDA Staff Manual Guide 3140.1, FDA Policy on Use of Government Electronic Equipment and Systems. In the event that the contractor fails to meet any one of these requirements, the Government shall notify the contractor by describing the specific deficiency (ies) in writing. The contractor shall correct any described deficiency within five (5) working days after receipt of the above notice at no additional cost to the Government. Government Space and Equipment Available to the Contractors: 5. Period of Performance The period of performance will be June 1, 2008 and ending May 30, 2009, with four (4) one (1) year options. 6. Hours of Operation The data entry contract staff shall work forty (40) hours per week, while maintaining at least two (2) employees on duty during normal operating hours of Monday through Friday from 8:00 a.m. to 4:30 p.m. The contract staff shall conform to the norm of CFSAN for monitoring time and attendance and follow the schedule for Federal employees in not working on Federal holidays and any other special closing of the facilities (e.g., Inauguration, closing due to weather, etc.) The contractor is responsible for making certain that vacation schedules result in a minimum of two team members supporting the office on a regular basis during the normal operating hours. 7. Security Guidelines All contractor staff with access to any sensitive FDA information either electronically or on paper must have an FDA Level 5 clearance at no additional cost to the government. The contractor shall submit in writing any proposed additional staff (name, resume, title, category, hourly rate, and the FDA clearance status) to FDA/CFSAN. A Level 1 clearance must be requested and submitted within 10 working days if needed. Proof of clearance must be provided to FDA/CFSAN when received and prior to admittance for work. The information contained in FDA forms 2541a and 2541c is privileged, confidential information and considered by regulations to be trade secrets, therefore, these task must be performed by a contractor who is not engaged or connected with the commercial processing of canned low acid or acidified foods. 8. Release of Information Due to the nature of LACF operations, telephone inquiries are routinely made to the desk of the LACF Registration Coordinator (HFS-618) from industry, state, local, federal, and foreign governments, and academia concerning the status and regulatory compliance of Food Canning Establishment (FCE) registered manufacturers and submitted and technically reviewed FCE Process Filing forms (FDA 2541a and FDA 2541c). These calls are most likely related to importation of related products or FDA and/or state inspections. As a precaution of security as dictated by 5 U.S.C. § 552, the Freedom of Information Act (FOIA), some LACF/ACF database information is considered to be trade secret information and must be kept confidential except to the parties who are authorized to receive it. Before releasing any information, if the caller can not be identified as an FDA or other federal employee, through the database, the identity and authority of the caller must be verified. To check to see if a person is authorized in the data base go to the AR screen, if name does not appear, do not give any information other than form. At the close of the contract, the contractor shall, after obtaining FDA approval, destroy all information of a confidential or trade secret nature (including), but not limited to, computerized data and computer printouts. Furthermore, after the closeout of the contract, the active files and equipment are to be located in room 3C041. The inactive files are located in Beltsville, Maryland 20740. During the course of this contract the Government is preparing to implement a new electronic filing system. Upon the implementation of this new system, the government will provide training and written procedures for data entry. Daily operations as referenced in the SOW may also change and the procedures will be documented and provided with training to contract staff. This type of change does not require a new SOW. If changes are deemed to be a significant change from items identified in this Statement of Work a revised Statement of Work will be provided. 9. Labor Categories “Data Entry/Administrative Technician” and “Senior Data Analyst” is the labor identified as required to successfully complete the tasks identified in the work breakdown. 8. Pricing The offeror’s fixed price should be provided for the base year and each option year and list the labor hours and hourly rate for period of performance. 9. Evaluation Factors for Award A.GENERAL You are advised that an award of a delivery order will be made to the GSA vendor whose offers is determined by the Government to represent the best value and results in the lowest overall cost alternative (i.e., price, special features, administrative costs) to meet the Government’s needs. B.EVALUATION OF OPTIONS It is anticipated that any task 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 all options 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 options will not obligate the Government to exercise the option(s). C.EVALUATION CRITERIA In determining which offer represents the best value (i.e., labor hours, special features, administrative costs) to meet the Government’s needs, the Government shall evaluate responses using the following evaluation criteria that are listed in descending order of priority: The technical proposal will receive paramount consideration in the selection of the offerorr for this acquisition. In the event that the technical evaluation reveals that two or more offerors are approximately equal in the technical ability, then cost may become a significant factor in determining award. In any event, the government reserves the right to make an award based on a best value determination, cost and other factors considered. Offerors who merely propose to provide a service in accordance with the statement of work will not be eligible for award. The offeror must include a comprehensive plan for meeting the needs of the Government, addressing each of the requirements of the statement of work and explaining the proposed technical approach to be used. Failure to provide the information required to evaluate the offer may result in the rejection of the offer without further consideration. 1) Understanding the Requirements and Technical Approach45 Points 2) Qualifications and Availability of Proposed Personnel35 Points 3) Past Performance 20 Points Total Possible Points: 100 points 1) Understanding the Requirements and Technical Approach (Points: 45) 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. Proposal will be evaluated on the following: (a)Understanding of the purpose and scope and work to be accomplished (b)Methodology to accomplish the objectives of the given task. (c)Quality control and quality assurance methods (d)Identification and use of appropriate technologies (LACF data base system, Microsoft Outlook, Word and Excel) to accomplish the objective (e)Management structure for the contract (f)Adequacy of strategies for coordination, interaction, and communication with the Government Project Manager to ensure that the work is accomplished in a timely and efficient manner, particularly as these strategies relate to keeping the Government Project Manager informed and up-to-date about customer service, technical or administrative operational issues (g)Methods to resolve problems and (h)Warranties provided with product 2) Qualifications and Availability of Personnel (Points: 35) Offerors must demonstrate evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff. Qualification statements for any proposed key personnel listed. 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 (Points: 20) The government is seeking to determine whether the offeror has consistently demonstrated a commitment to customer satisfaction and timely delivery of high quality products and services. (a) Offerors shall submit a list and description of the last 3 contracts completed during the past three years and all contracts currently in process. Offerors shall be evaluated on (1) record of conforming to specifications and to standards of good workmanship; (2) adherence to contract schedules, including the administrative aspects of performance; (3) reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and (4) business-like concern for the interests of the customer. b) Offerors shall furnish documentation of corporate experience in the technical portion of their offer that addresses the technical aspects specified as part of the Business Management Past Performance Questionnaire, e-mail Zetherine Gore at <zetherine.gore@fda.hhs.gov> for a copy of the questionnaire. Corporate experience will be evaluated based upon the offeror's prior experience with similar activities.. 10. Payment Schedule Payment will be made in monthly installments based on level of effort (hours worked). 11. Facilities And Equipment Contractor shall conduct perform services in space provided by FDA. FDA will also provide appropriate equipment. 12. 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. 13. Questions Deadline: All questions are to be submitted via email to Zetherine.Gore@fda.hhs.gov no later than April 28, 2008, 2:00pm EST. 14. Offers Due Two (2) copies of offeror’s proposals must be delivered no later than 2:00 p.m. local time on May 2, 2008. Proposals shall not exceed 10 pages and be in 12 font format. Food and Drug Administration Attn: Zetherine Gore Food and Drug Administration 5630 Fishers Lane, Room 2075, HFA-500 Rockville, MD 20857 15. 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=2756e58b8ce9e642bff13ca7cf799a9e&tab=core&_cview=1)
 

Place of Performance

Address: Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland, 20740, United States

Zip Code: 20740
 

Record

SN01559263-W 20080425/080423215103-2756e58b8ce9e642bff13ca7cf799a9e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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