Animal_Food_RFP_Final.docx

FDA-18-FEED

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 – Background and Objectives

In performing the work as described in Section C: DESCRIPTION/ SPECIFICATIONS/ STATEMENT OF WORK, the Contractor shall review and consider the following:

A. Background

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

Published by the FDA in 1986, the Second-Generation Medicated Feed Regulations 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 A medicated articles to make medicated feeds are required to register with FDA as drug establishments and hold an approved license. 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 Medicated Feed Manufacturing Compliance Program and the contract shall be referred to as Animal Food Safety Inspection contract. 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 obtain an approved medicated feed application (MFA) for the manufacture of each medicated feed with the requirement for medicated feed mills to be licensed with FDA. FDA's Center for Veterinary Medicine (CVM) uses the 21 CFR Part 225 Current Good Manufacturing Practices (Part 225 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 based on egregious objectionable conditions found during the firm’s inspection.

On June 5, 1997, FDA published its first rule prohibiting the use of certain animal-origin materials in the feed of ruminant animals. On April 25, 2008, a second rule was published prohibiting the use of certain cattle-origin materials in the food of all animals. These actions were taken to prevent the spread of bovine spongiform encephalopathy (BSE) in the United States which is commonly referred to as the "BSE rule". 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 the food of all animals.

The FDA Food Safety Modernization Act (FSMA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (also referred to as the Preventive Controls for Animal Food rule or PCAF rule) is now final and effective with compliance dates for businesses other than small or very small businesses which began in September 2016. This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, territorial, and tribal regulatory counterparts, academia and other stakeholders. FSMA embraces preventing food safety problems as the foundation of a modern food safety system and recognizes the need for a global approach to animal food safety.

The PCAF rule establishes for the first-time requirements for Current Good Manufacturing Practice (Part 507 CGMP) that specifically address the manufacturing, processing, packing, and holding of all animal food (21 CFR Part 507, subpart B and related requirements in subparts A and F). It is important to establish Part 507 CGMPs for animal food to ensure that these products are manufactured under conditions and practices that protect against contamination. The rule also establishes requirements for Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (PCAF PC) (21 CFR Part 507, subpart C and E and related requirements in subparts A, D, and F).

With some exceptions, the PCAF rule requirements, including requirements for Part 507 CGMPs and PC, for animal food applies to facilities that manufacture, process, pack, or hold animal food and are required to register as a food facility under section 415 of the FD&C Act. This rule does not apply to farms that manufacture food for their own animals or other food facilities not required to register under section 415 of the FD&C Act (such as food facilities regulated by USDA FSIS). The PCAF rule requirements apply to domestic and imported animal food, including food for pets and livestock, as well as raw materials and other ingredients used in animal food.

B. Objectives

This contract is designed to obtain State and local assistance in the inspectional coverage of feed establishments, specifically:

1. To conduct inspections of licensed and non-licensed medicated feed establishments to determine compliance with 21 CFR Part 225, the Federal Food, Drug, and Cosmetic Act (FD&C Act), and/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) Model Bill and Regulations, or FDA’s Ruminant Feed Ban Regulations), or both.

2. To verify compliance with the Veterinary Feed Directive (VFD) regulations in 21 CFR 558.6 by feed manufacturers, distributors, veterinarians, and animal producers involved in the distribution of VFD drugs, the manufacture or distribution of VFD feeds, the issuance of VFD orders and the feeding of VFD feeds, respectively.

3. To verify 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.

4. To conduct inspections and verify compliance with 21 CFR Part 507 as it relates to Part 507 CGMP requirements (subpart B and related requirements of subparts A and F) and/or PCAF PC requirements (subparts C and E and related requirements of subparts A, D, and F) for animal food facilities that are registered with FDA to manufacture, process, pack or hold food for animals in the United States or State feed law (if the Contractor’s State feed law has incorporated the provisions into their law), or both.

5. To collect samples that shall be used for contaminant surveillance, to determine compliance with applicable regulations, and/or for other possible situations, when mutually agreed.

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

7. To prepare and submit reports of assigned inspections and sample collections, as well as, reports on any compliance follow-up and corrections achieved by the Contractor under its own program.

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 the not to exceed price of $______________ based on the schedule in paragraph E. below. The Government shall have no obligation to make payment in the excess of the ceiling price. The Government may increase the ceiling price of the contract. If this occurs, a bilateral contract modification will be required.

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

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 required in the performance of work in Section C-1 shall be approved prior to attendance by the Contracting Officer Representative (COR) and written approval by the Contracting Officer (CO).

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 NTE: $____________________________________

Period of Performance: ___________ to ____________

Basic Work

Elective Work

Quantity

NTE

Visits/OOB

Select one:

Option 1: Inspection 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.

The Contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 20% of the total number of all inspections stated above, including all Elective 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 shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

Option 2: Inspection Visits/OOBs 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.

Option Year 1 NTE: $________________________________

Period of Performance: ___________ to ____________

Basic Work

Quantity

Select one:

Option 1: Inspection 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.

The Contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 20% of the total number of all inspections stated above, including all Elective 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 shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

Option 2: Inspection Visits/OOBs 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.

Option Year 2 NTE: $________________________________

Period of Performance: ___________ to ____________

Basic Work

Quantity

Select one:

Option 1: Inspection 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.

The Contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 20% of the total number of all inspections stated above, including all Elective 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 shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

Option 2: Inspection Visits/OOBs 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.

Option Year 3 NTE: $________________________________

Period of Performance: ___________ to ____________

Basic Work

Quantity

Select one:

Option 1: Inspection 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.

The Contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 20% of the total number of all inspections stated above, including all Elective 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 shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

Option 2: Inspection Visits/OOBs 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.

Option Year 4 NTE: $________________________________

Period of Performance: ___________ to ____________

Basic Work

Quantity

Select one:

Option 1: Inspection 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.

The Contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 20% of the total number of all inspections stated above, including all Elective 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 shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

Option 2: Inspection Visits/OOBs 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.

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 incidental to the performance of the work as described below.

The medicated feed inspection of licensed and non-licensed feed manufacturing facilities and other feed manufacturers shall include BSE coverage if the feed manufacturing facility uses proteins prohibited from use in ruminant feeds (known hereafter as “prohibited materials”) in their facilities.

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). The Contractor shall also conduct follow-up to any open consumer complaints, corrective actions taken due to a recall, or other significant, identified animal health issue.

The Contractor’s establishment inspections shall comply with the General Requirements for Conducting Inspections of this contract. The Contractor and District shall 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 (IOM) (Attachment 1, or most recent version when notified by FDA), for guidance on conducting inspections, collecting evidence, and writing Establishment Inspections Reports (EIRs).

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA greatly expands FDA’s authority to regulate the U.S. animal food supply by focusing on preventing animal food safety problems, developing new prevention-focused standards and new enforcement tools, establishing a clear regulatory framework, and enhancing partnerships with Federal, State, local, territorial, and tribal agencies. The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) rule (21 CFR Part 507) became final on September 17, 2015. All firms were given at least one year to achieve compliance with the CGMP portion of the requirements. Businesses other than small or very small were subject to compliance by September 2016 for implementation of Part 507 CGMP requirements and September 2017 for PCAF PC requirements, respectively. Compliance dates for the PC portion of the requirements were extended an additional year for all firm sizes. Small businesses (generally those with fewer than 500 full time equivalent employees) shall comply with Part 507 CGMP requirements in September 2017, and with the PC requirements in September 2019. Very small firms (less than $2.5 million total sales annually) shall comply with the CGMPs by September 2018 and the PC requirements (if applicable) by September 2020. As discussed in the Part 507 CGMP Inspections and the PCAF PC Inspections elective, inspectional assignments for firms that are subject to the PCAF rule requirements may become available as each business size becomes subject to its specific compliance dates. In preparation for future contract opportunities, attendance of specific FSMA training (Food Safety Preventive Controls Alliance course, regulator training, and training inspections) focused on the PCAF rule requirements, which includes provisions for both Part 507 CGMP and PCAF PC is strongly encouraged by the Contractor’s inspectional personnel. The Part 507 CGMP and PCAF PC training inspections can be performed with a qualified FDA or State instructor. As specific training information and dates become available, the details shall be provided to the Contractor.

All information collected during the performance of this contract shall be considered 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 and/or after the performance of the contract. 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

Medicated feed inspections are to be conducted by the Contractor at licensed medicated feed manufacturing sites which are required to have an FDA Feed Mill License, to annually register with FDA as a drug establishment, and comply with 21 CFR 225.10 through 225.115. Additionally, feed mills that are making medicated feeds, but which are not required to have an FDA Feed Mill License, are required to comply with 21 CFR 225.120 through 225.202. Most of these facilities are also required to be registered with FDA as food facilities. These establishments are included in FDA's active Official Establishment Inventory (OEI).

Both licensed and non-licensed medicated feed mills may be inspected for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001 if they use prohibited material in their manufacturing.

All feed manufacturing facilities shall comply with the same set of BSE rules.

General Requirements for Conducting Inspections The Contractor shall comply with the following requirements when conducting inspections under this contract:

1. Bioterrorism Act of 2002

i. 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. (Attachment 2, or most recent version when notified by FDA).

All food facilities that are required to register with FDA under section 415 of the FD&C Act shall renew their registrations with FDA biennially. Food facility registration renewal takes place in even number years, and shall next take place in 2018. The Contractor shall inform the firm that changes to the BT Act requires food facilities to submit registrations to FDA containing information previously considered optional.

The FDA Unified Registration and Listing System (FURLS) was built to electronically register all domestic and foreign facilities that export food to the U.S. Contractors shall 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 shall attend a training session not to exceed two (2) hours on the use of FURLS. Contractors are required 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 yet done so, the Contractor shall encourage electronic registration at the following website: https://www.access.fda.gov/

ii. Documentation

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 FDA District.

2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) rule and the Sanitary Transportation of Human and Animal Food (Sanitary Transport) rule under the Food Safety Modernization Act (FSMA) of 2011

i. The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (also referred to as the Preventive Controls for Animal Food rule or PCAF rule) became final on September 17, 2015. The new rule established Current Good Manufacturing Practice (Part 507 CGMP) requirements for all registered food facilities that manufacture, process, pack, or hold animal food (21 CFR Part 507, subpart B and related requirements in subparts A and F). The PCAF rule also established Hazard Analysis and Risk-Based Preventive Control (PCAF PC) requirements for registered animal food facilities (21 CFR Part 507, subparts C and E and related requirements in subparts A, D, and F). Under the PCAF PC provisions, animal food production facilities are required to establish a food safety system that includes an analysis of hazards and implements risk-based preventive controls for the animal food manufactured, processed, packed, or held by the facility. Businesses shall be in full compliance with Part 507 CGMP requirements by September 17, 2018 and by September 17, 2020 shall comply with the PCAF PC requirements. The compliance dates are based on the size of the business. For example, businesses that are not small or very small businesses shall need to comply with Part 507 CGMP requirements by September 19, 2016, and the PCAF PC requirements by September 18, 2018. Small businesses (generally those with less than 500 full time equivalent employees, but more than $2.5 million in animal food sales over a three-year period adjusted for inflation) shall need to comply with the Part 507 CGMP requirements by September 18, 2017.

To assist FDA in communicating the PCAF rule, the Contractor shall print or electronically distribute the FSMA Fact Sheet on the PCAF Final Rule (Attachment 3 or the most recent version when notified by FDA) to the most responsible individual at the inspected establishment The Contractor when educating the facility on the CGMP requirements of the PCAF Final Rule shall print or electronically distribute Final Guidance for Industry #235, Current Good Manufacturing Practice (CGMP) Requirements for Food for Animals, to assist in gaining compliance at a facility that has been found to have objectionable conditions during an inspection (Attachment 4).

ii. The goal of the proposed rule on Sanitary Transportation of Human and Animal Food (Sanitary Transport) under FSMA is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles and failure to properly protect food during transportation. Specifically, the rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. The rule also establishes requirements for vehicles and transportation equipment, transportation operations, records, trainings and waivers. The rule was published April 6, 2016. Small businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts) have two years after publication to comply (April 6, 2018). Other businesses (a business that is not small and is not otherwise excluded from coverage) have one year after publication to comply (April 6, 2017).

To assist FDA in communicating the Sanitary Transport final rule, the Contractor shall print or electronically distribute the FSMA Fact Sheet (Attachment 5 or most recent version when notified by FDA) addressing the Sanitary Transport rule to the most responsible individual at the inspected establishment. The fact sheet explains key requirements. An updated fact sheet on the final rule shall be provided once it is available.

iii. Documentation

The Contractor shall document if the PCAF, Sanitary Transport Fact Sheet, and Final Guidance for Industry #235: CGMP Requirements for Food for Animals were provided to the firm in the summary section of the inspection report.

3. Risk Assessment of Animal Food Firms

Risk-informed work planning is a fundamental element in the implementation and execution of an effective public health and regulatory program. Historically, animal food firms in the FDA inventory were not categorized by risk and several pieces of data needed to determine a firm’s risk are not currently captured in the FDA inventory.

Through a collaborative effort, ORA and the Center for Veterinary Medicine (CVM) developed a simple nine-item questionnaire and formula to calculate a risk score for animal food firms based on data collected during an inspection. Over time, the collection of this risk data shall facilitate a more uniform approach to animal food work planning as animal food firms shall be continually evaluated based on risk data following State contract and ORA inspections.

The risk data consists of eight weighted questions, each having two possible responses (yes/no), and one text-only question that is not weighted. To promote consistency in responses, additional guidance regarding how to answer some of the questions is provided.

The Animal Food Risk Data Form shall be completed at the time of all firm inspections.

ORA is seeking to automate this risk data by developing a data entry portal in eSAF. Completion of the Animal Food Risk Form shall be required when the data entry portal in eSAF or other system is made available.

The PAC code for collecting risk data during an inspection is 71S894, State Contract Animal Food Risk Data Form.

Work performed covering another program, such as medicated feed (licensed – 71S004 or non-licensed – 71S012), VFD State Contract Inspections – 71S023 or BSE – 71S011, time shall be split appropriately between the represented PAC codes and PAC code 71S894, State Contract Animal Food Risk Data Form.

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 Medicated Feed Manufacturing Compliance Program (Attachment 6, or most recent version when notified by FDA) and BSE/Ruminant Feed Ban Inspection Compliance Program (Attachment 7, or most recent version when notified by FDA). The Contractor shall be notified by FDA as additional Compliance Programs become effective that address the PCAF rule requirements. The applicable sections of these documents are incorporated by reference. The Government shall furnish updated copies to the Contractor or provide reference to the online location. The FDA Program Division/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 appropriate handouts to the firm during the inspection.

The greatest inspection priority is placed on “High Risk” firms, Performance Goals (PGs), and meeting mandatory inspection frequency mandates established by FSMA as identified by the FDA District. To meet FDA mandated inspection frequencies, assignments shall include a “cover-by” date. The State shall complete the inspection by the cover-by date as mutually agreed upon during the work planning session.

2. ENFORCEMENT

Follow-up on previous objectionable conditions noted on a FDA-483, Inspectional Observation form, discussion items, or State actions shall be documented in the Establishment Inspection Report to explain what measures the firm has taken to fix or correct the condition(s). If the condition(s) have not been fixed or corrected, document a timeframe the firm shall perform the necessary correction to address the condition(s) for further consideration to confirm the conditions(s) are no longer an issue. 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 using State authorities. 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 Contractor. Any re-inspection of the firm classified as OAI shall be performed by FDA.

A deficiency letter may be issued by FDA to the firm as a result of an inspection performed during a Part 507 CGMP or PCAF PC inspection. Per request of the District, the Contractor may be asked to perform a follow up inspection of the facility. In this case, the Contractor shall invoice FDA for conducting the follow up inspection at the unit price of a Part 507 CGMP inspection or PCAF PC inspection, as appropriate.

C. INSPECTIONS

1. BSE INSPECTIONS

BSE inspections may be conducted at any establishment subject to the BSE rule, such as feed mills, renderers, protein blenders, feed distributors (retail facilities) and on-farm at ruminant feeders. Priority is given to facilities that manufacture versus facilities that do not manufacture. BSE inspections shall also be performed with other types of inspections (medicated feed, PCAF CGMP, etc.) when appropriate.

The Contractor shall conduct a BSE inspection for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001 only at those manufacturing establishments which are using prohibited materials.

Personnel performing BSE inspections are required to complete the web-based courses: Bovine Spongiform Encephalopathy (BSE01) and BSE Inspectional Approach (BSE02) or attend VM 213 BSE Inspection Training in-person or via online webinar. These courses can be found at: http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm119016.htm. As an alternative to the web-based courses, the State may view the “BSE Inspection Training, 7 Modules” video produced by and available from CVM. 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.

Regardless of the training material used, State inspection personnel shall also review Compliance Program Guidance Manual (CPGM) 7371.009 (Attachment 6). State inspectors shall be familiar with the BSE inspection checklist, the requirements for labeling and recordkeeping, and able to determine a firm’s status for compliance with the BSE feed regulation.

2. MEDICATED FEED PRE-APPROVAL INSPECTIONS

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 sixty (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 shall determine the applicant’s knowledge of the medicated feed manufacturing regulations and whether the firm is prepared and able to comply. VFD issues shall be addressed consistently with other medicated feed inspections. However, conducting a pre-approval inspection with any other type of inspection (BSE or PCAF) is not automatic, and shall only be done in consultation with the District, CVM, and OP.

3. MEDICATED FEED INSPECTIONS

Conduct licensed medicated feed inspections of firms’ subject to 21 CFR Part 225 whose most recent medicated feed inspection was classified NAI or VAI. The Part 225 CGMP inspection shall be conducted using FDA’s Form 2481via fillable PDF or on paper. The inspection is to cover the firm’s compliance with CGMPs for all types of medicated feeds, including those medicated feeds which may contain VFD drugs. For a medicated feed CGMP inspection, there is no difference between VFD and non-VFD drugs.

Coverage of compliance with the VFD regulations in Part 558.6 is expected for all medicated feed mill inspections. This would include routine review of VFD orders and reporting of VFD coverage using the VFD inspection tool.

The Contractor shall also perform trace-back/trace-forward investigations at 30% of the total number of assigned medicated feed inspections (referred to as the 30% Directive*). The Contractor shall select VFD order(s) written by a local (in-state) veterinarian for a local (in-state) livestock producer and conduct a trace-back to the veterinarian and a trace-forward to the producer. The selection shall be within the Contractor’s area of inspection coverage.

New State personnel performing Medicated Feed inspections are required to complete the FDA training course Medicated Feed Inspection (VM206) before conducting medicated feed mill Part 225 CGMP inspections. This requirement is applicable only to new State personnel. Current State inspectors who have successfully passed a contract audit are not required to complete VM206, but are still strongly encouraged to complete the course. When State personnel attend VM206, the State shall maintain and make available to the District documentation demonstrating their attendance and completion of the course. Regardless of the specific training method used, personnel shall be familiar with medicated feed regulations that apply to licensed medicated feed mills, typical feed manufacturing operations, the manufacturing of quality medicated feeds, and proper reporting and documentation of significant deviations from the regulations identified during medicated feed inspections.

*Only States that are prohibited by State law or policy to conduct VFD inspections on farms may select the option to omit the 30% directive. The State shall provide documentation of the law or policy. These states would still be expected to complete the distributor portion of the VFD tool when conducting medicated feed mill inspections.

4. PCAF CGMP and Preventive Controls Inspections

PCAF inspections covering the CGMPs and/or Preventive Controls shall only be conducted at facilities subject to those rules which are facilities required to register as food facilities.

By September 2018, firms of all sizes that are subject to the CGMP requirements in 21 CFR Part 507 (specifically, subpart B and the related requirements in Subparts A and F) are eligible to be inspected. Compliance was phased-in based on firm size.

Contractor shall conduct inspections to ensure compliance with 21 CFR Part 507, subpart B and the applicable sections of subparts A and F. Facilities shall be selected during a joint work-planning meeting. Any forms, data collection, or inspection protocols shall be provided to the Contractor when available.

The appropriate FDA Guidance for Industry documents shall be given to the establishment that is being inspected. Those documents were listed earlier in the SOW.

The PAC code for Part 507 CGMP inspection is 71S014, State Contract PCAF CGMP inspections.

If work is performed covering another program, such as medicated feed (licensed – 71S004 or non-licensed – 71S012) or BSE – 71S011, time shall be split appropriately between the represented PAC codes and PAC code 71S014, State Contract PCAF CGMP inspections.

FDA has developed in-classroom training and inspection protocols to perform Part 507 CGMP inspections. State personnel are required to attend the training course, VM102, Current Good Manufacturing Practice (CGMP) for Animal Food Regulators, before conducting the Part 507 CGMP inspections under the contract.

As additional details regarding inspections and training become available, States shall be invited to propose upon this elective.

5. PCAF PREVENTIVE CONTROL (PC) INSPECTIONS AT FIRMS SUBJECT TO THE REQUIREMENTS IN 21 CFR 507.

Inspections at firms subject to the Preventive Control requirements in 21 CFR Part 507 shall be phased-in based on business size starting in October 2018 as were the CGMP requirements, but delayed from the CGMP requirements for one year. The first year of PCAF PC inspections shall have a relatively small number of firms’ subject to the PC requirements in 21 CFR part 507, subparts C and E and related requirements in subparts A, D, and F.

Contractor shall conduct PCAF PC inspections to ensure compliance with 21 CFR 507, subparts C and E and the related requirements in subparts A, D, and F. Facilities shall be selected during a joint work-planning meeting held between the Contractor and the FDA District Office. Any forms, data collection, or inspection protocols shall be provided to the Contractor when available.

The appropriate FDA Guidance for Industry documents should be given to the establishment that is being inspected. Those documents were listed earlier in this contract.

The PAC code for FSMA PCAF PC inspection is 71S015, State Contract PCAF inspections.

If work is performed covering other inspection types, such as, Part 507 CGMP (71S014), Part 225 medicated feed CGMP (licensed – 71S004 or unlicensed – 71S012) or BSE – 71S011, time shall be split appropriately between the represented PAC codes and PAC code 71S015, State Contract PCAF inspections.

FDA is currently developing the inspection protocols and training required to perform PCAF PC inspections. The first inspections for these requirements shall begin in October 2018. Training shall be required before conducting PCAF PC inspections. FDA and State regulatory staff shall take FDA’s PCAF PCs Animal Food Regulators course, VM220. The “regulator training” may be provided through a combination of webinars, in-person classroom training, and online modules.

As additional details regarding inspections and training become available, States shall be invited to propose upon this elective.

WORKPLANNING SESSION(S)

An annual work planning session(s) between the appropriate FDA District Office and Contractor personnel shall occur no later than thirty (30) business days after the start of the contract period of performance. The District Technical Advisor shall draft the work planning session(s) minutes for review by the State within thirty (30) business days. Corrections shall 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 inspection work to be accomplished by FDA and State personnel and ensure that the work obligated under the contract is aligned with anticipated work assignments. The inspection schedule should be risk-based considering the inspection requirements in the Food Safety Modernization Act (FSMA), the individual programs covered under the contract, and public health priorities of FDA.

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

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

· All remaining assignments shall 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. To meet FDA mandated inspection frequencies, assignments may include a cover-by date. The inspection shall be completed by the cover-by date.

iv. 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.

v. 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 or VFD inspections at distributors that do not manufacture, the State shall provide the District with a list of proposed firms for inspection. By an agreed upon method, the State shall notify the District of any new firms identified after an inspection and shall provide all information required by the District to enter the firm into FDA inventory and to assign an FEI number.

vi. 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, including the current audit phase.

vii. 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.

viii. Review the utilization of eSAF and data entry requirements (Attachment 9, or newest version when notified by FDA).

ix. 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.

x. Confirm understanding of key contract deliverables and schedules. The requirements and critical elements of the establishment inspection reports or other reporting forms shall be agreed upon by the State and District.