RFP_(FINAL).doc

FDA-15-FEED

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 – Background and Objectives In performing the work as described in Section C1-

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT, the contractor shall review and consider the following:

The Medicated Feeds Program has been implemented with the assistance of the States under contract since 1973. For the last several years, States have accomplished surveillance inspections to determine whether firms manufacturing medicated feeds were in compliance with key good manufacturing practices (GMP) regulations.

The Second Generation Medicated Feed Regulations, published by the FDA in 1986, set forth revised requirements concerning approval procedures for the manufacture of animal feeds containing new animal drugs. These regulations focus on high-risk drugs, i.e., carcinogens and drugs requiring withdrawal times at their lowest use level. Firms using Category II Type medicated articles to make medicated feeds are required to register with FDA and hold approved licenses. The inspection of these facilities shall be performed on a risk-based schedule, but not more frequently than once every two years.

The previous medicated feeds program is now officially titled the Feed Manufacturing Compliance Program. With the passage of the Animal Drug Availability Act of 1996, the Federal Food, Drug and Cosmetic Act was amended and replaced the requirement for feed mills to have an approved medicated feed application (MFA) for the manufacture of each medicated feed with the need for medicated feed mills to be licensed with FDA. FDA's Center for Veterinary Medicine (CVM) uses the Current Good Manufacturing Practices (CGMP) inspection classification to determine the approval decisions for pending medicated feed mill license applications. Classification of Official Action Indicated (OAI) shall result in recommendations to refuse license approvals, while No Action Indicated (NAI) and Voluntary Action Indicated (VAI) classifications shall not. An OAI classification for a licensed firm may start the process to withdraw the license.

On June 5, 1997, FDA published its first rule prohibiting the use of certain animal-origin materials in the feed of ruminant animals. A second rule was published on April 25, 2008, prohibiting the use of certain cattle origin materials in the food and feed of all animals. These actions were taken to prevent the spread of bovine spongiform encephalopathy (BSE) in the United States; and we commonly refer to the phrase "BSE rule" to describe these rules. The original rule, which is codified in 21 CFR 589.2000, provides for labeling, record keeping and clean out requirements for renderers, feed manufacturers, haulers of feed, and livestock producers. The new rule, codified in 21 CFR 589.2001, became effective April 27, 2009, and prohibits the use of certain cattle-origin materials as ingredients in all animal feed.

B. Objectives This contract is designed to obtain State assistance in the inspectional coverage of feed establishments, specifically:

1. To conduct inspections of licensed and non-licensed feed establishments to determine compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) or State feed law (if the contractor's State feed law has incorporated the provisions of the current Association of American Feed Control Officials (AAFCO) Uniform State Feed Bill or Ruminant Feed Ban), or both.

2. Assuring compliance with 21 CFR 589.2000 and 21 CFR 589.2001 by licensed and non-licensed medicated feed manufacturers, ingredient manufacturers such as rendering facilities, and other types of operations engaged in the manufacturing, distribution, retail, and use of animal feed.

3. To encourage voluntary corrective action by the establishment when appropriate.

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

B-2 – Compensation A. The Contract Type is Firm Fixed Price.

B. As consideration for full performance of the work stated in Section C, “Scope of Work”, the Government shall pay the contractor $________ for Feed CGMP Licensed inspections, $________ for BSE Only Manufacturing Inspections, $________ for Visits/Out of Business (OOB), $________ for BSE Non-Manufacturing Inspections, $________ for Feed CGMP Non-Licensed Inspections, $________ for Samples, $________ for Animal Feed Regulatory Program Standards (AFRPS), and $________ for travel/ training, for a total contract amount of $_________________. The period of performance shall be from _______ through ________. (12 months) C. Payment

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

D. Travel/ Training

Total expenditures for domestic travel (such as transportation, lodging, meals, and incidental expenses) and training not to exceed $ ________ incurred in direct performance of this contract, shall be allowed based on Federal Travel Regulations and the Health and Human Services (HHS) Travel Regulations. All travel/training must be approved prior to attendance by the Contracting Officer Representative (COR) and the Contracting Officer (CO).

Domestic Travel allowance for training under this contract shall be paid on a cost reimbursement basis. The estimated travel and training costs are subject to FAR Clause 52.216-7 “Allowable Cost and Payment” and FAR Clause 52.232-20 “Limitation of Cost”. These FAR clauses are included by reference in Section I of the contract.

E. Schedule

Base Year: $____________________________________ Period of Performance: ____________ to _____________ Basic Work

Feed CGMP Licensed Inspections

BSE Only Manufacturing Inspections

Visits/OOB

Visits/OOB The contractor is required to select one of the two options below.

If Option 1 is selected, the contractor must provide a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

If Option 2 is selected, the contractor will not be reimbursed for any Visits/OOB conducted under this contract.

Select one:

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

During the contract period of performance, the Contractor shall not perform nor will be paid for any Visit/OOB that exceed 20% of the total number of all inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

The contractor must submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

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

Elective Work

BSE Non-Manufacturing Inspections

Feed CGMP Non-Licensed Inspections

Samples

OEI Improvement

Animal Feed Regulatory Program Standards (AFRPS)

Travel/ Training

Option Year 1: $________________________________ Period of Performance: ____________ to _____________ Basic Work

Feed CGMP Licensed Inspections

BSE Only Manufacturing Inspections

Visits/OOB

If Option 1 is selected, the contractor must provide a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

If Option 2 is selected, the contractor will not be reimbursed for any Visits/OOB conducted under this contract.

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

During the contract period of performance, the Contractor shall not perform nor will be paid for any Visit/OOB that exceed 20% of the total number of all inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

The contractor must submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

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

The Government reserves the right to bilaterally increase the number of inspections as stated above.

Elective Work

BSE Non-Manufacturing Inspections

Feed CGMP Non-Licensed Inspections

Samples

OEI Improvement

Animal Feed Regulatory Program Standards (AFRPS)

Travel/ Training

Option Year 2: $________________________________ Period of Performance: ____________ to _____________ Basic Work

Feed CGMP Licensed Inspections

BSE Only Manufacturing Inspections

Visits/OOB

If Option 1 is selected, the contractor must provide a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

If Option 2 is selected, the contractor will not be reimbursed for any Visits/OOB conducted under this contract.

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

During the contract period of performance, the Contractor shall not perform nor will be paid for any Visit/OOB that exceed 20% of the total number of all inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

The contractor must submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

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

The Government reserves the right to bilaterally increase the number of inspections as stated above.

Elective Work

BSE Non-Manufacturing Inspections

Feed CGMP Non-Licensed Inspections

Samples

OEI Improvement

Animal Feed Regulatory Program Standards (AFRPS)

Travel/ Training

E. As consideration for full performance of the work stated in Section C-1 Scope of Work, the Government shall pay the contractor a fixed price of $________ for Feed CGMP Licensed inspections, $________ for BSE Only Manufacturing Inspections, $________ for Visits/Out of Business (OOB), $________ for BSE Non-Manufacturing Inspections, $________ for Feed CGMP Non-Licensed Inspections, $________ for Samples, $________ for Animal Feed Regulatory Program Standards (AFRPS), and $________ for travel/ training, for a total contract amount of $_________________.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C-1 SCOPE OF WORK

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 may conduct a combination of CGMP (licensed and non-licensed feed establishments) and “BSE Rule” only inspections at feed establishments. The CGMP inspection of licensed and non-licensed feed manufacturing facilities is to include BSE coverage (note: BSE coverage during CGMP inspections of licensed and non-licensed facilities is not to be considered as a separate contract inspection for the purpose of contract reimbursement). The Contractor shall record the corrective actions taken by the firm in response to identified significant violations, including the firm’s response to the Contractor, in the summary of findings section of the inspection report and electronic State Access to FACTS (eSAF). If requested by the District, the contractor shall also follow-up on any open complaints or corrective actions taken due to a recall that would fall under the scope of the contract.

As referenced below, the Contractor’s establishment inspections shall comply with the General Requirements for Conducting Inspections. The State and District will agree upon the specific requirements for conducting and reporting inspections and other work performed as part of the work planning meeting. The Contractor may refer to the Investigations Operations Manual 2014 (or most recent version when notified by FDA), Chapter 5 – Establishment Inspections (specifically, Sections 5.9.3, 5.9., and 5.10.1) for guidance on conducting inspections, collecting evidence, and writing Establishment Inspections Reports (EIRs).

(http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf).

All information collected during the performance of this contract shall be considered to be confidential commercial information, including the Establishment Inspection Report (EIR), FDA 483, or equivalent forms, evidence collected, and all supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. The Contractor shall notify the District within three (3) business days after receipt of a public records request for information obtained during the performance of the contract is received. The Contractor is not authorized to release confidential commercial information. Refer to Section H – Special Contract Requirements for additional requirements for maintaining confidential commercial information.

A.

COVERAGE

The establishments to be inspected by the contractor as a CGMP inspection shall be those required to register with FDA because they manufacture medicated feeds from Category II, Type A Medicated Articles (21 CFR 207), or certain liquid and free-choice feed using Category I, Type A medicated articles to make medicated feeds are required to register with FDA and hold approved licenses. These establishments are included in FDA's active Official Establishment Inventory (OEI). Non-registered establishments (establishments which do not have a medicated feed mill license from the FDA) may be inspected as a follow-up to a tissue residue investigation that implicates a feed mill as the source of the contaminant or for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001. These manufacturing sites are required to comply with a different set of CGMP regulations (i.e., 21 CFR 225. 120 et. seq.). Both licensed and non-licensed establishments have the same requirements with regard to the “BSE rule”.

General Requirements for Conducting Inspections

The contractor shall comply with the following requirements when conducting inspections under this contract:

1. Food Safety Modernization Act of 2011

i. Information Sheet – Assessment of Re-inspection and Recall User Fees by the FDA

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 user 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.

To assist FDA in communicating the User Fee requirement to industry, the contractor shall print and hand out the attached FSMA User Fee Information Sheet (or most recent version when notified by FDA) 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 user fees and the rates.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm325614.htm

ii. Documentation

The contractor shall document that the user fee information sheet was provided to the firm in the Summary section of the inspection report

2. BioTerrorism Act of 2002

i. Food Defense Security Preventative Measure Guidance

During the inspection, the contractor should determine if the facility is aware of food defense security preventative measures. If the facility is not aware of these measures, the inspector should facilitate an exchange of information to heighten awareness of the subject of food defense. Inform the establishment management of the appropriate security preventive guidance or provide 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

ii. Registration

As assigned by the District Office, the contractor shall make sure that the firm’s management is aware of the BioTerrorism Act (BT Act) registration requirements and any updates to that information. The firm’s management shall also be informed that information regarding food security, the BT Act, facility registration, required and optional information, definitions, exemptions, and penalties for failure to register, etc., is available at the following website: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm

All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA biennially. The contractor shall inform the firm that changes to the BT Act require food facilities to submit registrations to FDA containing information previously considered optional. Additional information regarding Registration Renewal may be found at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm314178.htm#n w .

The FDA Unified Registration and Listing System (FURLS) was built to electronically register all domestic and foreign facilities that distribute food to the U.S. Contractors must establish user accounts for at least two (2) key personnel in the FDA Unified Registration and Listing System (FURLS within the first 60 calendar days of the contract period of performance. Key personnel should have direct responsibility for meeting the obligations of the contract. In addition, at least two (2) key personnel must attend a training session not to exceed two (2) hours on the use of FURLS. Contractors are encouraged to access FURLS to determine the registration status of the firm prior to conducting an inspection.

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/

iii. Documentation

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

The contractor shall document the registration status of the firm and registration discussions with firm management in the “Summary of Findings and Discussion with Management” sections in their inspection report.

Observations about failure to register or implement food defense measures are NOT to be placed on the FDA 483 or equivalent form. If a facility is not registered and they do not intend to register, the contractor is to notify the local FDA District office.

B.

METHOD OF COVERAGE

1. GENERAL

The activities under the contract shall be conducted using the procedures, techniques, and reporting forms specified by FDA in the current Feed Manufacturing Compliance Program (CP 7371.004) and BSE/Ruminant Feed Ban Inspection Compliance Program (CP 7371.009).

EMBED AcroExch.Document.7 The applicable sections of these regulations are incorporated by reference. The Government shall furnish updated copies to the contractor or provide reference to the online location. The FDA Regional/District office shall provide guidance and interpretations as necessary.

As referenced in C-1 Scope of Work, the Contractor shall conduct establishment inspections based on the plans and requirements established during the Work Planning meetings and indicated in the General Requirements for Conducting Inspections section of this contract.

If the contract State has adopted all applicable sections of Title 21 of the Code of Federal Regulations, or can demonstrate equivalent State requirements, the contracting agency can conduct the inspections under State credentials.

It is the responsibility of the Contractor to determine whether the State regulatory requirements are equivalent to the Federal requirements. A legal review should be conducted by the State agency’s counsel to determine if the State regulatory requirements are equivalent in effect to the current Federal requirements.

If the contracting State has not adopted all applicable sections of Title 21 of the Code of Federal Regulations or demonstrated equivalent State requirements, the Contractor shall conduct inspections under this contract using State officials who have been commissioned and credentialed as officers of the Department of Health and Human Services, Food and Drug Administration, as set forth in section 704(a) (1) of the FD&C Act. Commissioned officials shall use current credentials and use FDA forms as necessary during an inspection.

The Contractor shall discuss and verify compliance with the above delineated regulatory authority requirements with the District prior to commencing contract inspection work. The contractor should also provide the appropriate Guidance for Industry documents to the firm during the inspection found at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm.

2. ENFORCEMENT

Compliance actions are not provided for under this contract. However, it is anticipated the Contractor shall vigorously pursue any necessary compliance follow-up to violative conditions encountered during inspections made under this contract by using State laws. Such actions may include stop-sales, administrative plant closures or orders, warnings, license revocations, court actions, etc. The contractor shall notify and coordinate such State actions with the FDA District. Where appropriate correction has not been achieved by the Contractor, FDA may initiate compliance actions under the FD&C Act.

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 FDA District office shall notify the State and shall conduct any re-inspection of the firm. The warning letter for an OAI classification must be signed by the FDA District Director and must contain the specific language stated in the Compliance Program. However, if the State report contains adequate evidence and other documentation, a warning letter may be based on a State inspection.

C.

INSPECTIONS

1. PRIORITIES

(a.)

BSE INSPECTIONS (PRIORITY 1)

Conduct inspections (and re-inspections, as approved by the District) of both licensed and non-licensed feed establishments for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001. Similar inspections are to be conducted when inspecting all establishments under this contract subject to the BSE Rule, including CGMP inspections at licensed and non-licensed medicated feed mills and BSE inspections at non-manufacturing establishments.

Personnel performing BSE inspections are required to complete the web-based courses: "Bovine Spongiform Encephalopathy (BSE01) and BSE Inspectional Approach (BSE02)" and review Compliance Program Guidance 7371.009, “BSE/Ruminant Feed Ban Inspections”.

These courses can be found at: http://www.fda.gov/Training/ForStateLocalTribalRegulators/default.htm

As options to the web-based courses, "BSE Inspectional Approach (BSE02)", the State may view CVM “BSE Inspection Training, 7 Modules” video or attend VM 213 BSE Inspection Training. The State shall maintain and make available to the District documentation demonstrating that all inspectors conducting contract BSE inspections have successfully completed the training requirements.

After completing these courses and reviewing the Compliance Program Guidance, inspectors shall be familiar with the BSE inspection checklist and with the requirements for labeling and recordkeeping. Finally, they shall be able to determine a firm’s status for compliance with the BSE feed regulation.

(b.) MEDICATED FEED PRE-APPROVAL INSPECTIONS (PRIORITY 2) Conduct pre-approval inspections of all firms submitting feed mill license applications for the first time. This inspection is required to take place before a license application can be approved and should take place within 60 days of the filing of license application. FDA has a 90-day statutory obligation to act on a license application. If the inspection is not made, CVM is obligated by the Act to approve the license application. New applicants may be newly constructed or acquired facilities, or active feed mixers that wish to secure a license. A new facility does not have to be in operation to demonstrate capability and obtain license approval. The investigator must determine the applicant’s knowledge of the CGMP requirements and preparedness to comply.

(c.) MEDICATED FEED BIENNIAL INSPECTIONS (PRIORITY 3) Conduct biennial CGMP inspections of licensed firms whose most recent CGMP inspection was classified NAI or VAI.

New personnel performing Medicated Feeds inspections are strongly encouraged to complete ORA U classroom course, Medicated Feed (VM206) before conducting medicated feed mill CGMP inspections.

The State shall maintain and make available to the District documentation demonstrating that all inspectors conducting contract Medicated Feeds inspections have successfully completed VM206. After completing this course, they shall be familiar with medicated feed GMP’s, critical control points pertaining to the manufacturing of quality medicated feeds, and proper reporting of significant deviations from GMP’s during medicated feed inspections.

WORKPLANNING SESSION(S)

An annual work planning session(s) between the appropriate FDA District Office and State contractor personnel shall occur no later than thirty (30) business days after the start of the contract period of performance. The District Technical Advisor will draft the work planning session(s) minutes for review by the State within thirty (30) business days. Corrections must be agreed upon by both the State and District. The goals of the session(s) are to:

i. Coordinate an inspection schedule that shall avoid duplication of inspections to be accomplished by FDA and State personnel. The inspection schedule should be risk-based taking into account the inspection requirements in the Food Safety Modernization Act (FSMA) and public health priorities of FDA.

For contracts with periods of performance that start on or before September 1:

· A minimum of twenty (20%) of the assignments required to meet the contract obligation will be made during the work planning session.

· All remaining assignments will be issued by the start of the 2nd quarter of the contract period of performance.

· At the discretion of the State and District, an additional work planning meeting may be necessary.

ii. Develop a consensus of the priority in the selection of firms to inspect. Firms with the highest priority for inspection should be agreed upon.

iii. Discuss and ensure clarity in regards to the definition of a “visit” per the contract, criteria for considering a firm “OOB” or Out of Business, and reporting requirements.

iv. Review FDA and State firm inventories for the identification of new firms and updating firm information, such as operational status, products being manufactured or stored, distribution of products, name, address, etc. In addition, FDA shall provide the Firm Establishment Identification (FEI) numbers for all firms on the inspection schedule. For States conducting BSE Non-Manufacturing Establishment inspections, the State shall provide the District with a list of proposed firms for inspection. By an agreed upon method, the State will notify the District of any new firms identified after an inspection and will provide all information required by the District in order to enter the firm into FDA inventory and to assign an FEI.

v. Develop an audit schedule when assigning the firms to be inspected under contract. Firm selection should be based on the inspection priorities listed in the “Statement of Work” section of the contract and contractual obligation of the contractor.

vi. 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.

vii. Review the utilization of eSAF and data entry requirements.

viii. 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.

ix. Confirm understanding of key contract deliverables and schedules. The requirements and critical elements of the establishment inspection reports or other reporting forms will be agreed upon by the State and District. Target completion goals for meeting the contract obligation in established limits shall be also agreed upon by the State and District. Target completion goals may include either a certain percentage or specific firms that must be inspected or audited by a specified date. The target completion goals should take into account the availability of the firms for inspection (such as seasonal firms), District performance goals, and State resources.

x. Discuss training needs, sharing of resources, and other collaborative efforts. State inspectors are encouraged to attend courses offered by FDA, including ORAU on-line courses and classroom training, including but not limited to, VM101 (Grain and Feed Mill Operations), VM206 (Medicated Feed), and VM213 (BSE Inspection).

xi. Confirm training requirements are met by State officials to perform inspections and other work obligated under the contract.

xii. Discuss samples collected under the contract (if applicable).

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.

2.

TYPES OF INSPECTIONS (BASIC WORK)

(a.) BSE FEED MANUFACTURING ESTABLISHMENT INSPECTIONS The contractor shall conduct "BSE Rule" compliance inspections at both licensed and non-licensed feed manufacturing establishments. The “BSE Rule” only inspections may include initial inspections and re-inspections, as assigned by the District.

Follow the directions attached, "Inspections for Compliance with 21 CFR 589.2000 and 589.2001" and complete the form, "Report of Inspection for Compliance with 21 CFR 589.2000/2001". The appropriate FDA Guidance for Industry documents should be given to the medicated feed establishment that is being inspected. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm The PAC code for all contract BSE Inspections is PAC 71S011, BSE State Contract Inspections/All Firm Types.

(b.) CGMP INSPECTIONS FOR LICENSED MEDICATED FEED FIRMS Routine CGMP inspections are applicable to establishments that have undergone an inspection and have received NAI or VAI status. The inspections shall not be made more frequently than once every two years to satisfy the statutory biennial requirement for licensed medicated feed manufacturing firms. Re-inspections as a follow-up to non-OAI violative practices may be made under this contract when assigned by the FDA District. Re-inspections of firms with a final FDA classification of OAI will be performed by the FDA District.

The contractor shall verify the firm has completed the annual licensed mill and drug registration requirements and document the registration status in the inspection report.

Pre-approval inspections are surveillance CGMP inspections of medicated feed firms submitting a feed mill license application for the first time or for firms whose workload obligation has been set to “no”. The contractor may be assigned firms for pre-approval inspections by the District based on a request from the Center for Veterinary Medicine (CVM). As the Center has statutory 90-day timeframe to act on the application of the license, these inspections should be completed as soon after assignment as possible.

The appropriate FDA Guidance for Industry documents should be given to the establishment that is being inspected. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm Compliance with the “BSE Rule” shall also be confirmed and form, "Report of Inspection for Compliance with 21 CFR 589.2000/2001" completed.

The PAC code for CGMP inspections for contract Licensed Medicated Feed Facilities is 71S004, State Contract Medicated Feed Inspection – Licensed Facilities. Time shall be split appropriately between PAC codes 71S004 and 71S011.

(c.) INSPECTION VISITS

An Inspection Visit is defined as when an inspection is attempted as assigned by the District and the establishment is found to be: “Out Of Business” (OOB), not an official establishment (NOE) as defined by FDA, not subject to coverage under the feed contract, relocated outside of the contractor’s geographical jurisdiction, or when a complete inspection cannot be accomplished during the contract period of performance for unforeseen circumstances. Investigational contractor activities completed under the OEI Improvement elective are not considered a visit, even if the result is a finding of OOB or NOE.

A visit shall be documented by providing the District with an establishment inspection report or other form as directed by the District. The report shall document all efforts made by the Contractor to conduct a full inspection and research performed to verify the operational status, location, and activities of the firm. The Contractor will request a replacement assignment or inspection within twenty (20) business days of a visit being encountered, if necessary.

OOB is defined as a firm that is no longer in business for reasons other than having moved. Reasonable efforts to verify a firm is OOB shall include a physical visit, contacting the local US Postal Service for a forwarding address, and records research.

The contractor shall perform all reasonable efforts to locate firms that have moved or relocated. If a firm has relocated to a new location within the contractor’s geographical jurisdiction, a complete inspection shall be conducted at the new location and a visit shall not be charged. If a firm has relocated to a new location out of the contractor’s jurisdiction, a visit may be charged and documented as indicated below.

NOE is defined as an establishment that is no longer manipulates product or is engaged in activities subject to FDA regulation, but still remains in business. The activities performed by an NOE firm shall be fully documented in the report to allow for a correct determination of the firm’s status by FDA. Additional guidance may be found in Field Management Directive (FMD)-130 OEI Development and Maintenance Procedures (Date Revised July 17, 2006), http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm Due to errors in the FDA inventory, firms that are not subject to contract inspection may still engage in activities under FDA jurisdiction. While the firm may not be considered OOB or NOE by FDA, the contractor may charge for a visit if the firm is determined by the District to not be eligible for inspection under the contract and the origin of the assignment is not the OEI Improvement Elective.

Reasonable efforts to conduct a complete inspection must be approved by the District.

D.

ELECTIVE WORK

1. BSE NON-MANUFACTURING FEED INSPECTIONS

Elective work may be performed to conduct additional BSE Inspections at Non- Manufacturing Feed Establishments that are not listed as part of Official Establishment Inventory (OEI). Options for inspections may include inspection of a farm’s feed operations, transportation of feeds (trucks, etc.), feed establishments that salvage foods for use in animal feeds, and feed retailers.

The contractor shall provide the District Technical Advisor an inventory list of proposed establishments to be inspected under this elective during the work planning session. The inventory list shall contain the firm name, location, and type of facility. The list of firms will assist the FDA District in entering the firms into eSAF for the State and provide an understanding of the work that will be accomplished under this elective.

The appropriate FDA Guidance for Industry documents should be given to the establishment that is being inspected.

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm

The PAC code for all contract BSE Inspections is PAC 71S011, BSE State Contract Inspections/All Firm Types.

2. CGMP NON-LICENSED FEED MANUFACTURING INSPECTIONS

Elective work may be performed to conduct CGMP Inspections at Non

Licensed Feed Manufacturing Establishments. The firm must be a manufacturer of a medicated feed that does not require a license. While these facilities are not required to be registered as a drug establishment, the firms may be part of the Official Establishment Inventory (OEI). Options for inspections may include: inspection of a farm’s feed manufacturing operations, integrators, and commercial feed establishments that are not required to register as a drug establishment.

Non-Licensed Feed manufacturer must comply with the requirements of 21 CFR 225.120 - 225.202; these sections of the CGMPs are sometimes referred to as the ‘less stringent CGMPs’. The Non-Licensed facilities will be inspected using a systematic approach to identify and verify compliance with various aspects of the CGMPs. This will allow inspections to focus on the specific issues related to the manufacture of a safe medicated feed and identify significant CGMP concerns or deviations.

Compliance with the “BSE Rule” shall also be confirmed and the form, "Report of Inspection for Compliance with 21 CFR 589.2000/2001" shall be completed. Contractors may elect to use the model form found in the Association of American Feed Control Officials (AAFCO) Official Publication (OP) to record the non-licensed medicated feed inspection.

The appropriate FDA Guidance for Industry documents should be given to the establishment that is being inspected.

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm

The PAC code for contract CGMP inspections at Non-Licensed Medicated Feed Facilities is 71S012, State Contract Medicated Feed Inspection – Non-Licensed Facilities. Time shall be split between PAC codes 71S012 and 71S011. The appropriate medicated animal feeds product code(s) covered during the inspection should be used in eSAF.

3. SAMPLES

Types of samples (a.) GENERAL/ROUTINE

Elective work may be performed to collect animal feed and feed ingredients produced, imported, or distributed within the State. The State should use discretion and inspectional findings to guide sampling. Surveillance samples should give priority to coverage of locally grown or produced animal feed and feed ingredients. Samples collected should be based on past violative samples, current analytical findings, and on information obtained through intelligence gathering activities, such as inspections, complaints, adverse events, and recalls. Animal feed for food-producing animals, especially lactating dairy cows and laying hens, should have priority over feeds for non-food producing animals.

Physical samples should not normally be collected during surveillance CGMP or BSE inspections. An exception occurs under the circumstances detailed in the Feed Compliance Program where cross contamination with specific drugs could occur. If there is a likelihood that the State laboratory analysis could confirm cross contamination using appropriate methodology, samples should be collected. Information on the sample collection and analysis shall be reported on State forms.

Samples shall consist of sufficient units, size, etc., necessary for the official laboratory methodology to be used. FDA shall make appropriate Sample Schedules (IOM Chapter 4, http://www.fda.gov/ICECI/Inspections/IOM/ucm123267.htm) available to the contractor upon request. Samples shall be collected in accordance with current testing methodologies and techniques as specified by the FDA/ORA/Office of Regulatory Science or other recognized testing methodologies and techniques. Such samples shall be collected to demonstrate violations to Federal Law through laboratory analysis. The contractor may also be requested to collect interstate documentation on a sample if FDA is considering pursuing regulatory action based upon the State’s sample results.

Types of sample analyses that may be performed:

· Toxins (such as mycotoxins)

· Potency or cross-contamination of samples during medicated feed mill inspections for compliance or cause

· Presence of animal tissue

· Pesticides/industrial chemicals

· Elements

· Microbes

· Dioxins

When developing the sampling plans, the contractor and District should take into consideration:

· Inspectional findings and observations

· FDA performance goals, priorities, and sampling assignments

· Investigations Operations Manual (IOM)

· Relevant Compliance Program Guidance Manuals, such as 7371.003, 7371.004, 7371.005, and 7371.009

· Products or firms with a history of being associated with illness, injury, compliance issues, or regulatory actions being pursued by FDA or the State, including recalls, seizures, injunctions, import alerts, and consumer complaints

· Firms assigned for inspection under contract

· State laboratory capabilities (b.) SPECIAL NON-ROUTINE SAMPLES

This request is limited to 10 non-routine sample requests over the performance of the contract. The Government may request that the Contractor collect samples to protect the public health under the auspices of this contract for emergencies and other special purposes. At the direction of FDA Headquarters, the FDA District may request that a non-routine sample be collected.

(i) PURPOSE

The reason for the collection may be, but not limited to, special sampling assignments as a result of: targeting of specific commodities as a result of intelligence (BT surveillance), the result of possible contamination, other violations of the FD&C Act, or other extraordinary circumstances.

(ii) PROCESS

The sample would normally be collected during an inspection of an assigned firm. However, the sample could be requested as a result of specific project or intelligence regarding a specific commodity and may not be associated with an inspection. The sample shall be collected in accordance with FDA procedures, forms, and sample sizes in accordance with procedures outlined in the FDA Inspectors Operations Manual (IOM). The Contractor shall contact the FDA District Office for instructions on maintaining “chain of custody”, location of the testing laboratory and other special instructions.

In addition to domestic samples, import samples may also be collected at the direction of the FDA.

(iii) REIMBURSEMENT

The cost of collecting, preparing, and shipping the sample shall be vouchered as a cost reimbursable item. The contract shall be modified to cover the cost of special samples. These special sample collection requests do not affect routine sample collections that are currently available as an elective under the contract.

4. ANIMAL FEED REGULATORY PROGRAM STANDARDS

The Animal Feed Regulatory Program Standards (AFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of animal feed. Through implementing the AFRPS, a State program shall be better able to achieve and maintain programmatic improvements that help ensure the safety and integrity of the U.S. animal feed supply. A State’s implementation of the AFRPS also helps to ensure a uniform and consistent approach to feed regulation among jurisdictions such as the sharing of information and the coordination of resources.

The AFRPS are composed of eleven standards that serve as an objective framework to evaluate and improve components of a State feed program. The feed standards cover the State feed program’s regulatory foundation, training, inspection program, auditing, feed-related illness or death and emergency response, enforcement program, outreach activities, budget and planning, laboratory services, sampling program, and assessment and improvement of standard implementation.

In the first year of implementation, the State program uses the self-assessment worksheet for each standard to complete a baseline evaluation of its program.

After completing the baseline evaluation, the State program must develop an improvement plan for requirements of the standards that are either partially or not fully met. The improvement plan includes the following:

· The individual element or documentation requirement for the standard that was not met,

· Improvements needed to meet the program element or documentation requirement(s) of the standard,

· Lists of individual tasks that shall be used to address the improvement, and

· A projected completion date for each task.

Appendix 9.1, or a comparable form, must be used to develop an improvement plan for each standard with the exception of Standard 9: Assessment and Improvement.

Appendix 9.2, or a comparable form, must be used to track implementation status of all of the standards. The self-assessment worksheets and Appendix 9.1: Assessment and Improvement Plan should be used to complete this appendix.

In subsequent years, the Contractor shall implement their improvement plans. If the elements of a program standard are not met, the improvement plan shall contain specific strategies and timeframes for achieving implementation and maintaining an acceptable level of performance. The improvement plan shall also contain reviews of the State program’s progress in implementing the plan. Continued funding will be based on the subsequent self-assessments and improvement plans that will track the State program’s progress toward meeting and maintaining implementation with the program standards.

Contractors receiving funds under the Implementation with the Animal Feed Regulatory Program Standards (AFRPS) Cooperative Agreement are NOT eligible to enroll in this option.

To receive reimbursement for participation, the Contractor must complete and submit the following:

1. Appendix 9.1: Assessment and Improvement Plan, or an equivalent form, for each standard (with the exception of Standard 9)

2. Appendix 9.2: Implementation Status of Animal Feed Regulatory Program Standards, or an equivalent form.

The Appendices must be emailed to AFRPS@fda.hhs.gov for review and acceptance prior to invoicing. Technical assistance, such as webinars, conference calls, meetings, and on-site visits, shall be made available to State programs.

If FDA provides a State program with financial assistance to implement the AFRPS, FDA shall conduct verification audits of the State program’s progress towards AFRPS implementation. FDA shall conduct the initial verification audit within six (6) months after the end of the contract period of performance, or first year of implementation, for State programs electing to participate in the AFRPS elective.

5. Elective Work to Advance Establishement inventory (OEI) Improvement

i. Introduction This OEI Improvement Elective encourages collaboration to improve the data in the FDA inventory database and to increase consistency between FDA District Offices and state regulatory partners. The goal of this elective investigational work is to improve the accuracy of FDA Official Establishment Inventory (OEI) by implementing standardized criteria for verifying that a firm is no longer subject to FDA jurisdiction and should be removed from the database or is recorded with erroneous data. This will reduce the number of attempted inspections of firms that have closed, moved, or are no longer engaged in FDA regulated activities to enhance the utilization of Government resources.

ii. Scope

The Contractor will be assigned firms that the FDA District Offices suspect are no longer subject to FDA jurisdiction and are erroneously listed in the Official Establishment Inventory (OEI).

The following types of firms may be assigned:

· Firms with a workload status of Bioterrorism (B) or Potential (P)

· Firms that have moved without proper notification to FDA

· Firms with other inaccurate registration information

· Operational firms with no inspectional history

· Firms that are no longer operational (OOB), subject to FDA inspection (NOE), or no longer considered a workload obligation

If a firm is found to be operational and subject to inspection under the contract, a complete inspection should not be performed until approval from the District is obtained. The firm may be assigned at a later date for inspection under the contract.

This elective work shall be documented on the form provided by the FDA.