RFP_FDA-FY16_Egg.docx

FDA-16-EGG-RFP

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 - Background and Objectives

In performing the work as described in detail in Section C-1 Scope of Work, the contractor shall consider the following:

a. Background

On July 9, 2009 FDA published a final rule requiring shell egg producers to implement certain measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation. The rule requires producers with 3,000 or more laying hens on a farm to implement SE prevention measures including procurement of chicks from SE-monitored breeder flocks, having a biosecurity program and a rodent and pest control program, testing the layer house environment at certain time points and testing eggs following a positive environmental test. Producers are also required to comply with cleaning and disinfection requirements if a layer house environment or eggs from that house test positive for SE. Additionally, producers are required to comply with registration and recordkeeping requirements.

FDA took this action because SE is among the leading bacterial causes of foodborne illness in the United States and shell eggs are a primary source of human SE infections. The correlation between eggs and SE has been confirmed through epidemiological and laboratory data collected by the Center for Disease Control (CDC). This link has been further substantiated through data collected by various surveillance networks overseen by CDC. It is well accepted that shell eggs are the predominant source of SE-related cases of salmonellosis in the United States where a food vehicle is identified.

Many states participate in voluntary state run egg quality assurance programs (EQAP). These EQAP’s all having similar requirements, however there is significant variation in how these requirements are implemented from state to state. Although similar to FDA’s final rule, state run EQAP’s are voluntary, vary in their requirements between states, and not all states have an EQAP.

This final rule is the most recent in a series of farm-to-table egg safety efforts begun by FDA and Food Safety and Inspection Service (FSIS) in the 1990’s. Although there are currently several Federal regulations related to food safety at the food service level, this is the first and only federal rule that addresses the introduction of SE into the egg during production.

Although the incidence of SE declined from the mid to late 1990’s, it has remained relatively stable the last several years. This makes interventions at the production level of particular importance. Since eggs remain one of the primary source of SE infections, continued actions to improve egg safety are the most effective way to reduce the overall number of SE infections and outbreaks. FDA believes the additional preventive measures required by this rule will further reduce the incidence of egg-associated SE illnesses and meet the agency’s published health goals.

The final rule, which is codified in 21 CFR 118, was implemented in a staggered fashion with larger producers required to come into compliance before smaller producers. Producers having between 49,999 - 3,000 layers were required to be in compliance by July 9, 2012 while producers with more than 50,000 layers were required to be in compliance by July 9, 2010.

b. Objectives

This contract is designed to acquire state assistance for the inspectional coverage of egg producing facilities covered by FDA’s final SE egg rule, specifically:

1. To conduct inspections of egg layer farms to assess compliance with 21 CFR 118: Production, Storage and Transportation of Shell Eggs, the “Egg Rule”.

2. To monitor or inspect persons involved in holding or transporting eggs for shell egg processing or egg product facilities in order to verify compliance with refrigeration requirements during storage and transport.

3. To encourage voluntary corrective action by the facility when appropriate and document deficiencies to take additional action.

4. To furnish the FDA with reports of inspections accomplished under the contract. Reports on any compliance follow-up, sample results and corrections achieved by the contractor under its own program will also be submitted.

B-2 – Compensation

a. As consideration for full performance of the work stated in Section C-1 Scope of Work, the Government shall pay the contractor a total fixed price of $________ for # inspections and not to exceed $_______ for travel/training, for a total contract amount of $________ .

b. Payment up to the full amount of this contract shall be contingent upon receipt and acceptance by the Government of inspection and acceptance E 1, inspection reports and proper invoices as required by Section F-2 Reports/Deliverables and Section G-3 Invoice Submission, and in accordance with the following schedule referenced in section E1.

c. Inspection Visits:

An inspection visit is defined as when an inspection is attempted and the establishment is found to be:

1. Out of Business (OOB)- OOB is defined as a firm that is no longer in business for reasons other than having moved.

2. Not an official establishment (NOE) – NOE is defined as an establishment that is no longer engaged in activities or manipulates products subject to FDA regulation, but still remains in business.

Reasonable efforts to verify a firm is OOB/Visit shall include a physical visit and records research. After performing a reasonable effort to locate the possible new site or conduct the inspection, an establishment inspection report (or other form as directed by the District) will be submitted to the FDA District Office. Additional guidance may be found in Field Management Directive (FMD-130). Reasonable efforts to conduct a complete inspection must be approved by the District prior to invoicing for an inspection. Visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm.

d. Training and Travel

Total expenditures for domestic travel (transportation, lodging, meals, and incidental expenses) and training not to exceed $________ incurred in direct performance of this contract, shall be allowed based on the Federal Travel Regulation. All travel/training must be approved prior to attendance by the contracting officer’s representative (COR) and the contracting officer. All travel needs to be in accordance with Federal Travel Regulations and HHS Travel Regulations needs to be in accordance with Federal Travel Regulations and HHS Travel Regulations.

e. Schedule

Base Year

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 1

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 2

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 3

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 4

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Select one:

Option 1: Inspection OOB/Visits are included as a separately priced line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above.

Option 2: Inspection OOB/Visits are excluded and not reimbursed under this contract. If this is selected, the contractor shall not be reimbursed for any visits/OOBs under this contract.

Note: The award for number of inspections will be based on the FDA’s inventory and the recommendation of District Office.

Section C – Description/Specifications/Work Statement

C-1 Scope of Work

a. Scope

Independently and not as an agent of the Government the contractor shall furnish the necessary personnel, materials, services, facilities, except as provided in the schedule, and otherwise do all things necessary for or incident to the performance of the work as described below:

The contractor shall conduct farm inspections of those egg production farms subject to the Egg Rule. At a minimum, the contractor shall:

· Evaluate the firm's written SE prevention plan, and implementation

· Evaluate the firm's Biosecurity measures and implementation

· Evaluate the firm's implementation and records of their rodent and pest control programs

· Evaluate the firm’s records documenting compliance with the cleaning and disinfection procedures

· Evaluate the firm’s implementation and records for refrigeration requirements (transportation and holding records to be included, if applicable)

· Verify the firm’s registration status with the FDA, which is separate from Bio-Terrorism Act of 2002 (BT). A firm is required to register under the BT Act (Food Facilities Registration rule) if they ever pack eggs from any farm that is not under their ownership

· Verify the firm’s personnel that is responsible for ensuring compliance with each farm’s SE prevention plan qualifies to perform the assigned duties

· Verify the firm's procurement of SE-monitored pullets and chicks

· Evaluate the firm's environmental testing procedures, records, and results of the test and egg sampling programs

· Determine if environmental testing was conducted at required time periods and if positive samples were found, whether or not appropriate actions were taken in accordance with the Egg Rule;

· Conduct an environmental assessment (walk-through) of a minimum of four layer houses (chosen by the investigator)

· Issue a form FDA-483 to cover any significant objectionable conditions observed during the inspections and prepare the Establishment Inspection Report (EIR) in accordance with established procedures

· Contact their Food and Drug Administration (FDA) district office immediately if during an inspection egregious conditions are observed (conditions would be considered egregious, and appropriate for more in-depth follow-up by FDA if the firm failed to implement the SE prevention plan and operate in an environment that presents a strong likelihood of SE contamination in shell eggs)

b. Coverage

· The establishments to be inspected by the contractor include those egg producers required to register with FDA under 21 CFR 118.11 of FDA’s Egg Rule. Specifically, those egg producers with 3,000 or more laying hens at a particular farm that do not sell all of their eggs directly to consumers and that produce shell eggs for the table egg market will be subject to inspection. Individuals who transport or hold shell eggs for shell egg processing or egg products facilities will also be subject to inspection to verify compliance with the registration and refrigeration requirements in 21 CFR 118.11 and 118.4(e).

c. Work planning Sessions

An annual work planning session(s) between appropriate FDA Region, District, and State contractor personnel shall take place within sixty (60) days of awarded contract. The goals of the session(s) are to:

· Coordinate an inspection schedule that will avoid duplication of inspections to be accomplished by FDA and state personnel

· Develop a consensus of the priority in the selection of firms to inspect

· Discuss and ensure clarity in regards to the definition of an inspection visit per the contract, criteria for considering a firm Out of Business (OOB), and reporting requirements

· Confirm that state regulatory authorities are equivalent to Federal requirements, or the state officials are Commissioned, and the contractor has the contractual obligations to accomplish the inspection schedule

· Establish and exchange primary contact information. Along with program management, it is recommended that senior management from the state and district are also part of the process

· Confirm understanding of key contract deliverables and schedules specifically for quarterly reporting and invoicing -

· Discuss training needs, sharing of resources, and other collaborative efforts

· Discuss and coordinate audit requirements. The minimum audit rate for the egg contract is one(1)joint inspection per program

· Identify point of contact at the District level for notification in the event that egregious violations of the rule are observed during the contracted inspection to ensure timely notification of the FDA District office to advise the district of the inspection findings and the need for expedited response from the FDA District office A minimum of one additional meeting shall be held with the District and State during the second or third quarter of the contract performance period to review the progress of the State and verify the contract deliverables are being satisfactorily met.

C-2 Detailed Tasks

a. General Requirements for Conducting Inspections

1. Food Safety Modernization Act of 2011

The Food Safety Modernization Act (FSMA), signed into law January 2011, authorized FDA to collect new user fees for specific domestic and foreign food re-inspections. FSMA authorizes FDA to assess and collect re-inspection fees to capture 100% of the costs related to certain domestic and foreign food facility re-inspections. The user fee for re-inspection is to cover re-inspection-related costs when the initial inspection, initiated on or after October 1, 2011, has a final OAI classification supported by “violations materially related to food safety requirements.” The re-inspection must be conducted specifically to determine whether compliance has been achieved.

Egg processing facilities which receive any egg(s) from a company/farm under different ownership are subject to FSMA re-inspection fees. To assist FDA in communicating the Re-Inspection Fee requirement to industry, the contractor shall print and hand out the attached FSMA User Fee Information Sheet to the most responsible individual at the inspected establishment during the opening meeting. The information sheet provides the statutory authority granted to FDA to collect user fees for re-inspections by FSMA, who will be assessed re-inspection fees and the rates. Please see the links below for FSMA guidance and the rates of fees information (Attachment 5).

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257982.htm#intro

2. Bio-Terrorism Act of 2002 Food Defense Security Preventative Measure Guidance During the inspection, the inspector shall determine if the facility is aware of food defense security preventative measures. If the facility is not aware of these measures.

Inform the establishment management of the appropriate security preventive Measure Guidance or information on how to obtain the guidance from FDA. Guidance related to Food Defense and Emergency Response efforts are available on FDA/CFSAN’s web site:

http://www.fda.gov/Food/FoodDefense/default.htm

3. Documentation

The fact that the discussion regarding the firm’s security prevention measures took place and, if applicable, guidance documents were provided should be recorded in the Summary section of the inspection report. The details of inspectional findings regarding security should NOT be recorded.

The contractor shall document that the re-inspection fee information sheet was provided to the firm in the summary section of the inspection report.

4. Abbreviated Inspections

The state agency (Contractor) shall conduct inspections to gain information regarding the firm’s compliance with the Egg Rule focusing on facilities identified by FDA for coverage under state contract. No environmental sampling will be conducted by the Contractor. If conditions present that would warrant environmental sampling, a referral/assignment will be made by the FDA District Office.

5. Registration

During the inspection of farms covered by the Egg Rule, the contractor shall make sure the firm’s management or person(s) responsible for administering the SE prevention plan are aware of the registration requirements in section 118.11 of the rule. The firm’s management or individual(s) responsible for administering the SE prevention plan also shall be informed that information regarding the Egg Rule, including a link to the rule itself can be found at the following website:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/default.htm

Registered egg producers shall submit an update to a registration within 60-calendar days of any change to any of the information previously submitted. For facilities that are required to register, but have not as of yet done so, the contractor shall encourage electronic registration at the following website:

https://www.access.fda.gov/

6. Registration Documentation

The contractor shall document the registration status of the shell egg farm and document discussions which occurred with firm management or the individual(s) in charge of administering the SE prevention plan in the summary section of the inspection report. Observations about failure to register are NOT to be placed on the FDA Form 483 or equivalent form. If a facility is not registered and they do not intend to register, contractors are required to notify the local FDA District office.

7. Enforcement Compliance actions are not provided for under this contract. However, the Contractor may wish to pursue any necessary compliance follow-up to violative conditions under the state's program. Any state actions shall be coordinated with the FDA district. The warning letter for an Official Action Indicated (OAI) classification must be signed by the FDA District Director and must contain the specific language stated in the Compliance Program.

If an inspection conducted under contract results in a final district classification of “OAI” and details violations that are “materially related to food safety”, the State will be notified by the District and any re-inspection of the firm will be conducted by the FDA District office.

b. Inspections

(a.) Farm Inspections (Priority 1): Inspections of those farms covered by the Egg Rule should include the following:

1. Confirm that a written SE prevention plan is in place at the specific farm and located on site either in a hard or electronic copy and identify the individual(s) responsible for administering and revising the plan.

2. Review records to ensure chicks were procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan standards for “US Salmonella Enteritidis Clean” status and/or that pullets were raised under SE monitored conditions.

3. Review ALL records required under the Egg Rule to ensure compliance.

4. Ensure that SE prevention measures are in place, including:

5. Conduct a walk-through of the farm’s facilities and assess a minimum of four (4) houses, selected by the contractor based on on-site observations. The contractor must visually inspect for gross non-compliance with the rule (e.g. excessive rodent activity, stray animals in layer house, and lack of biosecurity measures) and implementation of the SE prevention plan.

6. Verify rodent and pest control activity through review of records, assuring proper placement of bait stations and visual observation for rodent and pest activity including harborage areas during the walk-through.

7. Verify on farm cooler temperatures through visual observation and review of temperature logs or temperature recorder charts to ensure compliance with refrigeration requirements.

8. Verify registration of the farm as required by the rule.

9. If applicable, review records indicating diversion of eggs to treatment (as defined in the rule) noting dates eggs were diverted and where they were sent for treatment.

(b.) Transportation and/or Holding Facility Inspections (Priority 2): Individuals involved in transportation or holding of eggs for shell egg processing or egg products facilities are required to comply with refrigeration requirements of the rule. These inspections should verify that transportation vehicles and holding facilities are maintained at temperatures at or below that required by the rule (i.e. 45 F).

C. Method of Coverage

1. General

The activities under the contract shall be conducted using the procedures, techniques, and methodologies specified by FDA in the Egg Rule. While conducting inspections, contractors should follow biosecurity measures enforced by the specific farm where the inspection is being conducted in addition to following general biosecurity measures listed in FDA’s Investigations Operations Manual (IOM). FDA’s Investigations Operations Manual, the primary source regarding Agency policy and procedures for field investigators and inspectors, discusses biosecurity measures for FDA inspectors in Chapter 5.2.10 “Routine Biosecurity Procedures for Visits to Facilities Housing or Transporting Domestic or Wild Animals” and is available at:

http://www.fda.gov/ICECI/Inspections/IOM/ucm122530.htm#5.2.10.2

The general procedures are listed below:

· The contractor is responsible to have their inspectors be respirator fitted and certified or follow their state requirements for respiratory protective gear.

· The inspectors must NOT be a bird and/or reptile owner in their own home or have been in any other poultry facility up to 72 hours before an inspection.

· The inspectors should not have contact with birds for 72 hours prior to an inspection, including visits to aviaries, tending backyard feeders, etc.

· Disposable personal protective clothing (e.g., tyvek suits, booties, and gloves) must be changed between poultry houses on the farm to avoid cross-contamination of not just Salmonella Enteritidis but other infectious bird diseases such as avian influenza (AI) and exotic Newcastle disease (END).

· Wear rubber boots or other suitable footwear, which you disinfect upon arriving at the site and prior to departure. It is preferable to also place disposable foot coverings over your footwear, regardless of the type, after you have disinfected them. If the firm has footbaths, use them. Boots and footwear should be disinfected with any of the agents identified at the end of this subsection using a good brush. Clean and disinfect the brush(es) and bucket you use for these activities.

· Wash your hands with soap and water. Use of hand sanitizers is encouraged. If you are visiting a facility where a known animal disease is present or the firm's biosecurity protocol requires, wear disposable gloves.

· Wear disposable or freshly laundered coveralls, when appropriate. Some facilities may provide disposable coveralls and require visitors to shower in and shower out at their facilities. If requested by the firm and facilities are provided, you should follow those requests.

· Wear appropriate head coverings, as necessary. If you wear a head covering, clean and disinfect between facilities or use disposable head coverings.

· Minimize any materials you carry with you such as notebooks, flashlights, etc. to what is required. Consider keeping these things in clean plastic bags or containers between uses. Disinfect any of these types of items as best you can between visits to facilities or between different animal-housing areas.

· If you are visiting production units with animals of multiple ages, always work from the youngest to the oldest.

· Avoid direct contact with livestock or wild animals, bodily fluids or animal byproducts when visiting facilities.

· Vehicles to be used for transport to egg farms must be cleaned and disinfected prior to arrival. Prior to leaving the farm location the vehicle should be cleaned and disinfected, including the car, tires and wheel wells.

· Contractors shall ensure that any waste generated during egg farm inspections is not disposed on the farm.

In the absence of the contracting State agency responsible for egg inspection having adopted 21 CFR Part 118, the contractor shall conduct inspections of these establishments using state officials who have been commissioned and credentialed as officers of the Department of Health and Human Services, Food and Drug Administration, under the authority of the Federal FD&C Act. This includes the use of credentials, and issuance of Notice of Inspection, Inspectional Observations and Receipt for Sample forms. If the contracting state has adopted 21 CFR Part 118 or can demonstrate State authority that is equivalent in effect, the agency can conduct the inspections under State credentials and use reporting forms equivalent to FDA or as required by state law.

2. Compliance Documents The activities under the contract shall be conducted using procedures, techniques, and reporting forms equivalent to FDA or as required by state law. The contract inspections shall be conducted in accordance with the applicable sections of the following current FDA Compliance Programs. The FDA regional/district offices will provide technical guidance to the Contractor.

3. Training

The State inspectors shall complete and pass the Egg Safety training course (FD107) available through FDA. It is the responsibility of the Contractor to assess the training and expertise of its staff and determine contracted inspections are conducted by staff with the requisite training and experience. Training needs must be communicated to the Office of Partnerships (OP) and the District during work planning or when information related to training is requested.

All travel requests under this contract to participate in FDA-approved training courses must be negotiated and pre-approved by OP and the Contracting Officer. Reimbursement for training cannot exceed the total cost. (See B2 d Funds Available). If your travel costs increase, a modified cost estimate must be approved prior to attending the course or you will not be reimbursed for the additional costs. All travel arrangements will be accomplished under State travel authorities and reimbursed to the State through the contract voucher/invoice. The Contractor shall submit receipts with their training invoice(s) or they will not be reimbursed.

d. Samples

Environmental or egg samples will not be collected during farm inspections. In situations where conditions may warrant sample collection, the contractor shall immediately contact their FDA district office.

e. Quality Control

FDA will evaluate contractor performance throughout the contract period. This will be accomplished by a variety of techniques, including: review of reports, joint inspections (included as contract inspections), and audits. Joint inspections will be provided to the Contractor for review and information. For comprehensive information regarding Audit program, refer to Field Management Directive 76(Attachment 7):

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm

1. Inspector Performance Standard: All contractor inspectors shall be audited at the frequency described in FMD-76(Attachment 7) or the link:

2. Inspector Performance Measurement: All contractor inspectors must successfully pass audit requirements with an acceptable rating. For audit requirements refer to FMD 76.

3. Inspector Performance Deduction: All contractor inspectors who receive an overall score of “needs improvement” shall receive remedial training in deficient areas as agreed upon by the District and State program. The State may be required to absorb the costs of the training. The State inspector will discontinue conducting contract inspections until remedial training is completed. Refer to FMD-76 for additional details.

4. Contract Inspection Audit Performance Evaluation The District will coordinate with the State to take appropriate action when the Audit Program identifies deficiencies in the performance of contract inspections as described in FMD-76.

An unacceptable audit will not cause a contract to be altered or unpaid, nor will payment for the contract inspection be withheld. The contractor will be evaluated on its overall work performance during the contract year, not the outcome of one contract audit. A single audit may give an indication of a problem, but may not prove sufficient to determine its scope. If this occurs, it may indicate an area in the Contractor’s inspection program that may be improved.

5. Contract Performance Standard: In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the state and report all completed inspection results no later than thirty (30) days after completion of the inspection. At least 90% of all submitted inspection reports shall be timely, accurate, completed and acceptable for data entry, analyses, and processing. Payment could be withheld for delayed submission.

6. Contract Performance Measurement: The Government will measure compliance with contract inspection requirements by reviewing inspection records and conducting audits or joint inspections. Results of all FDA quality assurance reviews will be furnished to the contractor. A sample of inspection records will be reviewed by FDA to verify that the required data and information are complete and accurate.

7. Payment Withholding: If FDA finds an inspection record quarterly report or invoice to be unacceptable, the Contractor will be advised and given an opportunity to correct or submit a new inspection record. Each instance whereby the Contractor fails to submit or correct the required report shall result in withholding of invoice payment until the corrected report(s) are received and accepted by the FDA.

f. Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF)

The FDA has an automated Field Accomplishment and Tracking System (FACTS) in which all firm/facility/farm inspection data is captured and tracked. In an effort to automate some processes and to streamline communications between the States and FDA, the eSAF concept was developed.

The eSAF system allows FDA to automate the issuance of work requests to the State egg facility contractors and will allow the state contractors to enter and update inspection results electronically. Additionally, the states will have access to the firm’s data that FDA has maintained in FACTS for the past several years. This data will enable the States to identify firms considered to be “high risk” and to obtain information about past inspections and violations for firms within their jurisdictional area (Attachment 2), “Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF),” represents the requirements associated with eSAF. The state contractor shall consult the FDA District Office regarding the eSAF training.

Following completion of FDA eSAF training, and in accordance with eSAF Requirements Document, the contractor shall input complete inspection information into the eSAF system.

1. eSAF Support

After training has been successfully completed, the Contractor shall contact the ORA Applications Helpdesk for technical assistance via e-mail at APPSDESK@fda.hhs.gov or at telephone number, 866-807-3742. The Helpdesk operates 24hrs/daily.

2. Change in eSAF Users

The Contractor shall notify APPSDESK@fda.hhs.gov with a courtesy copy to the District Technical Advisor at least twenty-four (24) hours prior to an eSAF user departing from State employment or transferring/reassignment to a position that does not require the use of eSAF.

g. Confidentiality of Information: The contractor shall protect non-public information in accordance with (list FDA/HHS standards).

The contractor shall develop and provide a physical security plan to detail how sensitive and private information will be protected.

The contractor’s inspectors shall complete and submit Form FDA 3398, “Contractor’s Commitment to Protect Non- Public Information (NPI) Agreement,” prior to performing any work under this contract. (See List of Attachments)

SECTION D – PACKING AND MARKING

This section is not applicable to this solicitation/contract.

SECTION E – INSPECTION AND ACCEPTANCE

E-1 – Inspection and Acceptance Pursuant to the appropriate inspection clause as referenced below, inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at the Food and Drug Administration, State Contracts and Compliance, HFA-500, 5630 Fishers Lane, Rockville, Maryland 20857.

FAR 52.246-4 Inspection of Services (AUG 1996)

SECTION F – DELIVERIES OR PERFORMANCE

F-1 – Period of Performance

The contract will be from the effective date of award for 12 months. There will be 4, 12 month option periods for a total 5 year period of performance.

F2 - Reports/Deliverables

Significant violations and/or State regulatory action has been conducted or is being considered: District shall be notified within three (3) business days and the report submitted within thirty (30) business days after the completion of the inspection.

Significant violations and/or State regulatory action have been conducted or are being considered: Submitted within three (3) business days after the completion of the inspection.

Quarterly Reports Submit no later than thirty (30) business days after the end of each ninety (90) day reporting period.

a. Establishment Inspection Reports: In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections and visits within the state.

The contractor shall complete a detailed Establishment Inspection Report for the appropriate industry. The Contractor shall use the FDA Product Code List to complete the appropriate sections of eSAF or the Coversheet, including Part C: Products Covered, where the products inspected will be recorded. Also, corrective action shall be reported and coded on Part E of the coversheet or equivalent form under the newly revised Compliance Achievement Reporting System, which replaces the Voluntary Correction Reporting System. If eSAF is utilized by the States corrective action information, it shall be submitted with a hard copy Establishment Inspection Report, or equivalent form. The Government will furnish the necessary FDA forms.

The Contractor shall submit inspection findings to the District Office as follows:

1. For any inspection that has significant violations, the State shall NOTIFY the District Office via email within three (3) days after completion of the inspection, and submit the complete inspection report, within thirty (30) business days.

2. For inspections without significant violations and not requiring state regulatory actions (generally rated as “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”), the State shall submit the inspection reports within thirty (30) business days.

NOTE: The above time frames will not apply for inspections conducted in September of each year as those inspections must be entered into the FDA data system prior to October 15th to be counted in the FDA’s fiscal year data. As a result, state contract inspections conducted in September must be entered into eSAF no later than October 10th of each year. At least 90% of all notifications and submitted inspection reports shall be timely, accurate, complete and acceptable for date entry, analyses and processing.

b. Electronic Reporting: Upon completion of the FDA eSAF training, the contractor shall henceforth input complete inspection information into the eSAF system within thirty (30) business days after the completion of the inspection.

c. Quarterly Summary Report: SUBMIT VIA EMAIL NO LATER THAN THIRTY (30) BUSINESS DAYS AFTER END OF EACH NINETY (90) DAY REPORTING PERIOD.

For each 90-day period of the contract (based upon the performance period), a Quarterly Summary Report (Form FDA2684a) on the inspections, samples, and actions shall be prepared.

The contractor must submit a Quarterly Summary Report (Form FDA 2684; Attachment 6) to the District for approval with a courtesy copy to the COR. The report must be submitted via email no later than thirty (30) business days after the end of each ninety (90) day reporting period of the contract. In those periods where no inspections were performed, a report showing no inspection IS REQUIRED.

Included with the Quarterly Summary Report shall be the contract number, a list of the establishments inspected specifying the name and address of the firm inspected, FEI#, inspection date, and type of inspection. Where visits were encountered, they should also be noted.

d. Quarterly Summary Report Approval: A review of the Quarterly Summary Report will be conducted by the District and a notification provided to the contractor on the acceptability of the Quarterly Summary Report with ten (10) business days of receipt. If questions exist regarding the Quarterly Summary Report, the State will have ten (10) business days to respond to the District by providing additional information or submitting a revised Quarterly Summary Report. Following the review and confirmation of acceptance of all work detailed on the Quarterly Summary Report, the District will provide the contractor (via email with copy to the COR) approval of Quarterly Summary Report.

Approval of the Quarterly Summary Report by the District is required prior to submission of the invoices. Invoices cannot be submitted to OAGS nor will invoices be paid without District approval of the Quarterly Summary Report. Documentation of District approval of the Quarterly Summary Report shall be submitted with the invoice and Quarterly Summary Report to OAGS and the COR.

Copies of the District approved Quarterly Summary Report shall be provided as follows:

1. One copy to:

Food and Drug Administration Office of Partnerships ATTN: Mei Ying Li Meiying.li@fda.hhs.gov 12420 Parklawn Drive, Room 3019 Rockville, MD 20857

** Preferred method of delivery is via email**

2. One copy to:

Rockville, Maryland 20857 Julia.savage@fda.hhs.gov

**Acceptable and preferred method of delivery is via email**

SECTION G – CONTRACT ADMINISTRATION DATA

G-1 - Administrative Personnel

a. The Government administrative and technical personnel assigned responsibilities for this contract are as follows:

Contracting Officers Representative (COR):

Mei Ying Li MeiYing.li@fda.hhs.gov 12420 Parklawn Drive Rockville, MD 20857 Meiying.li@fda.hhs.gov 301 796 5903

District Technical Advisor (FDA District Office):

State Contract Monitor or designee at the District Office assigned to the contract (please contact the FDA District Office).

b. The COR and District Technical Advisor are authorized to correspond and hold conferences with the Contractor on matters of a technical nature; conduct inspections and perform evaluations permitted by the contract; approve technical data required by the contract; and maintain the official technical file.

The COR and District Liaison are responsible for monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Office changes in the requirement. Actions taken by the COR or District Technical Advisor to resolve technical problems encountered during performance of the contract shall be documented and a copy of the documentation shall be furnished to the Contracting Officer. This documentation also includes site visit reports and minutes of all meetings held in connection with this contract. The Contracting Officer shall also be notified in advance of all meetings or any site visits to the Contractor’s facility.

The COR or District Technical Advisor are not empowered to issue or approve changes; enter into any agreement or contract modification, or any other matter which may affect the cost, period of performance, or terms and conditions of the contract.

G-2 - Project Director

The performance of the work required by this contract will be conducted for the State under the direction of:

Name:

Title:

E-mail:

Phone:

G-3 – Invoice Submission

Fixed Price – Quarterly Submission

FDA TWO-WAY-MATCHING INVOICE CLAUSE

a. THE CONTRACTOR SHALL SUBMIT ALL INVOICES TO ALL ADDRESSEES IN THE MANNER SPECIFIED BELOW:

1. ONE ORIGINAL AND ONE COPY TO THE APPROVING OFFICIAL:

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS AND GRANTS SERVICES

ATTN: Julia A. Savage

5630 FISHERS LANE

ROOM 2005 HFA-500

ROCKVILLE, MARYLAND 20857

E-mail: julia.savage@FDA.HHS.GOV

2. ONE COURTESY COPY TO THE CONTRACTING OFFICER REPRESENTATIVE (COR) and District Technical Advisor:

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF PROGRAM OPERATIONS

ATTN: MeiYing Li, COR 12420 Parklawn Dr.

ROOM 3019

Rockville, MARYLAND 20857 E-mail: meiying.li@FDA.HHS.GOV

(Preferred method of delivery is via email)

b. INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER – CENTRAL CONTRACTOR REGISTRATION) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN. TO CONSTITUTE A PROPER INVOICE, THE INVOICE MUST BE SUBMITTED ON COMPANY LETTERHEAD AND INCLUDE EACH OF THE FOLLOWING:

1. NAME AND ADDRESS OF THE CONTRACTOR;

2. INVOICE DATE AND INVOICE NUMBER;

3. PURCHASE ORDER/AWARD NUMBER;

4. DESCRIPTION, QUANTITY, UNIT OF MEASURE, UNIT PRICE, AND EXTENDED PRICE SUPPLIES DELIVERED OR SERVICES PERFORMED, INCLUDING:

(a) PERIOD OF PERFORMANCE FOR WHICH COSTS ARE CLAIMED;

(b) ITEMIZED TRAVEL COSTS, INCLUDING ORIGIN AND DESTINATION;

(c) ANY OTHER SUPPORTING INFORMATION NECESSARY TO CLARIFY QUESTIONABLE EXPENDITURES;

5. SHIPPING NUMBER AND DATE OF SHIPMENT, INCLUDING THE BILL OF LADING NUMBER AND WEIGHT OF SHIPMENT IF SHIPPED ON GOVERNMENT BILL OF LADING;

6. TERMS OF ANY DISCOUNT FOR PROMPT PAYMENT OFFERED;

7. NAME AND ADDRESS OF OFFICIAL TO WHOM PAYMENT IS TO BE SENT (MUST BE THE SAME AS THAT IN THE PURCHASE ORDER/AWARD, OR IN A PROPER NOTICE OF ASSIGNMENT);

8. NAME, TITLE, AND PHONE NUMBER OF PERSON TO NOTIFY IN EVENT OF DEFECTIVE INVOICE;

9. TAXPAYER IDENTIFICATION NUMBER (TIN);

10. ELECTRONIC FUNDS TRANSFER (EFT) BANKING INFORMATION, INCLUDING ROUTING TRANSIT NUMBEROF THE FINANCIAL INSTITUTIONRECEIVIN PAYMENT AND THE NUMBER OF THE ACCOUNT INTO WHICH FUNDS ARE TO BE DEPOSITED;

11. NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER TECHNICAL REPRESENTATIVE (COTR) OR OTHER PROGRAM CENTER/OFFICE POINT OF CONTACT, AS REFERENCED ON THE PURCHASE ORDER;

12. ANY OTHER INFORMATION OR DOCUMENTATION REQUIRED BY THE PURCHASE ORDER/AWARD.

13.) CONTRACTOR IS □ IS NOT □ REQUIRED TO ATTACH AN INVOICE LOG ADDENDUM TO EACH INVOICE WHICH SHALL INCLUDE, AT A MINIMUM, THE FOLLOWING INFORMATION FOR CONTRACT ADMINISTRATION AND RECONCILIATION PURPOSES:

a. LIST OF ALL INVOICES SUBMITTED TO DATE UNDER THE SUBJECT AWARD, INCLUDING THE FOLLOWING:

b. TOTAL AMOUNT OF ALL PAYMENTS RECEIVED TO DATE UNDER THE SUBJECT CONTRACT OR ORDER

c. AND, FOR DEFINITIZED CONTRACTS OR ORDERS ONLY, TOTAL ESTIMATED AMOUNTS YET TO BE INVOICED FOR THE CURRENT, ACTIVE PERIOD OF PERFORMANCE

c. AN ELECTRONIC INVOICE IS ACCEPTABLE IF SUBMITTED IN ADOBE ACROBAT (PDF) FORMAT. ALL ITEMS LISTED IN (I) THROUGH (XII) OF THIS CLAUSE MUST BE INCLUDED IN THE ELECTRONIC INVOICE. ELECTRONIC INVOICES MUST BE ON COMPANY LETTERHEAD AND MUST CONTAIN NO INK CHANGES AND BE LEGIBLE FOR PRINTING.

d. QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA PAYMENT OFFICE AT:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments fdavendorpaymentsteam@fda.gov

G-4 - Government Furnished Materials and Information

The following forms that may be required for use in the performance of the services required hereunder will be furnished by the Government. Delivery will be made in a timely manner to the Contractor’s facility, such that the required services can be performed within the effective dates of the contract. The forms may be obtained from the local District Office.

The offeror shall identify Government-owned property in your possession and/or property acquired from Federal funds, for which you have title and is proposed to be used in the performance of the prospective contract.

The management and control of any Government property shall be in accordance with DHHS Publication entitled, “Contractor’s Guide for Control of Government Property,” dated 1990, a copy of which will be provided upon request. The HHS handbook is available on the HHS website http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%30Q_HHS%30Contracting%30Guide.pdf G-5 Contractor Performance Evaluations Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

a. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through the Contractor Performance Assessment Reporting System (CPARS) web site, which is managed by the Department of Defense (DOD). Details regarding CPARS training and on-line registration can be found at https://www.cpars.gov/.

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the FDA contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H-1 – Confidentiality Definitions

a. Confidential Commercial Information:

Confidential commercial information is valuable data or information which is used in one's business and, if voluntarily submitted by the information's owner to FDA, is of a type customarily not disclosed to the public by the person to whom the information belongs or, if not voluntarily submitted, is information which, if disclosed by FDA would be likely to cause substantial harm to the competitive position of the person to whom the information belongs or impair the agency's ability to obtain similar data in the future. Examples of records that may fall within the definition of confidential commercial information either in part or in their entirety include information in an application to market an unapproved product, or in an Establishment Inspection Report containing the results of an inspection of a regulated company.

b. Disclosure:

Disclosure means releasing, transferring, providing access to, or otherwise divulging to the public nonpublic information by any means of communication--including photographic, written, oral, electronic (including databases), or mechanical.

c. Nonpublic information:

Nonpublic information includes but is not limited to trade secret, confidential commercial, predecisional, or other information, such as personal privacy information about an individual, information provided by a confidential informant, techniques and procedures for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, information that could reasonably be expected to endanger the life or physical safety of an individual, or information, which if disclosed, could reasonably be expected to interfere with enforcement proceedings (“open investigatory”). Information includes oral information, documents, photographs, data, and other records, in written (paper) or electronic form or other medium, that are either created or obtained by FDA and under FDA's control at the time the information is shared with the Contractor.

d. Contractor:

For purposes of this Contract, the term “Contractor” means a state or local government organization and includes an employee of the Contractor.

e. Personal privacy information:

Information about an individual, which, if disclosed, would constitute a clearly unwarranted invasion of personal privacy.

f. Predecisional information:

Predecisional information refers to information that is created by FDA in the course of its decision-making process and is not available to the general public. Predecisional information includes non-factual information contained in inter- or intra-agency records prepared during the process of FDA's deliberations and proposed policies before final adoption. A document that FDA considers to be predecisional may include confidential commercial or trade secret information.

g. Sponsor/submitter:

A sponsor/submitter is an individual, partnership, corporation, or association that owns or submitted the nonpublic confidential commercial or trade secret information that is submitted to FDA. (Often a sponsor/submitter is the manufacturer of a product.)

h. Trade secret…