RFP FINAL.docx

FY 21 Animal Food 75F40121R00023

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 (i.e. Animal Food) 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

Training and domestic travel for training are not provided for in this contract. The Contractor is responsible for ensuring staff is trained in accordance with the State’s Training Plan as identified under the Animal Feed Regulatory Program Standards (AFRPS), in addition to meeting the training requirements specified in the contract.

E. Schedule

Base Period NTE: $____________________________________

Period of Performance: ___________ to ____________

Basic Work

Elective Work

Quantity

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 Period 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 Period 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 Period 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.

52.217-8 Up to Six Months Option Period 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

The Contractor shall furnish the necessary personnel, materials, services, facilities, except as provided in the schedule and otherwise do all the things needed for or incidental to the work's performance as described below.

The Contractor's establishment inspections shall comply with the General Requirements for Conducting Inspections of this contract. The Contractor and FDA Program Division Director or designee will determine the specific requirements for conducting and reporting inspections and other work performed as part of the work planning meeting. The Contractor shall use the Investigations Operations Manual (IOM) (Attachment 1, or most recent version from the FDA) for guidance on conducting inspections, collecting evidence, and writing Establishment Inspection Reports (EIRs). The Contractor shall also adhere to FDA/CVM’s Compliance Programs, most current version of CVM’s COVID-19 priorities, assignment memorandums (as applicable), and additional guidance specific to each program area as provided. Specific training requirements for conducting contract inspection types are in the Animal Food Contract Training Requirements document (Attachment 23, or most recent version from the FDA).

During the inspection, the Contractor shall obtain the name, title, physical, mailing, and email addresses of the firm's top management official. When an inspection is "closed" under 21 CFR 20.64(d)(3), FDA will release a copy of the EIR to the inspected establishment per Field Management Directive (FMD) 145, Procedure for Release of Establishment Inspection Report to the Inspected Establishment. The Contractor shall provide the firm with any State inspection reports as approved by the FDA Program Division Director or designee.

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) or an equivalent FDA platform. 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 or animal food that may pose a significant animal or human health concern.

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 enforcement tools, establishing a clear regulatory framework, and enhancing partnerships with Federal, State, local, territorial, and tribal agencies. The FSMA Current Good Manufacturing Practice (CGMP) 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 had at least one year to achieve compliance with the CGMP portion of the requirements. In preparation for future contract opportunities, attendance of specific FSMA courses (Food Safety Preventive Controls Alliance (FSPCA), FDA online prerequisite, and FDA Regulator trainings) focused on the PCAF regulation requirements, that include provisions for both Part 507 CGMPs and PCs, which is required in order to conduct any inspections under 21 CFR Part 507 by the Contractor’s inspectional personnel. After completing the classroom training and before conducting inspections, the Contractor is strongly encouraged to perform Part 507 CGMP and PC training inspections with qualified FDA or State personnel as available. FDA shall provide details regarding training information and dates as they become available.

All information collected under this contract shall be considered confidential commercial information, including the Establishment Inspection Report (EIR), Form FDA 483 or equivalent State forms, evidence collected, and all supporting documentation. Evidence and supporting documentation may include but is not limited to; suppliers, receiving of incoming animal food and ingredients, distribution records, photographs, affidavits, complaint records, laboratory results, and other documents collected by the Contractor. The Contractor shall notify the FDA Program Division Director or designee within three (3) business days after receipt of a public records request for information obtained during and 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.

I. COVERAGE

CVM's requirement is for both FDA and States to perform comprehensive animal food inspections that cover all applicable PACs (as determined by the facility's activities) during a single visit. A comprehensive inspection covers all of the following animal food program regulations that are applicable to that facility based on the facility's activities, including: 21 CFR part 507 (PCAF CGMPs and PCs), 21 CFR part 225 (Licensed or Non-licensed Medicated Feed Mill CGMPs), 21 CFR §§589.2000-2001 (BSE), 21 CFR §558.6 (VFD), and 21 CFR part 1, subpart O (Sanitary Transportation – DIRECTED ONLY). All inspections conducted under this contract shall adhere to the comprehensive inspection model as described above. This inspectional approach improves field staff efficiency, provides a complete picture of compliance at a facility, eliminates facilities receiving more than one routine surveillance inspection in a fiscal year, and ensures that facilities have a thorough understanding of their compliance with all applicable regulations at the close of an inspection. FDA Program Division Director or designee is responsible for returning work to the Contractor if the work fails to cover all PAC codes applicable to a facility. Refer to Attachment 8 for a list and description of all PAC codes.

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 FDA Program Division Director or designee, the Contractor shall ensure that the firm’s management is aware of the Bioterrorism Act (BT Act) registration requirements and any updates to that information. The Contractor shall also inform the firm’s management about animal food security, the BT Act, food facility registration, required and optional information, definitions, exemptions, and penalties for failure to register. (For additional information see Attachment 2, or most recent version from the FDA).

All animal food facilities required to register with the FDA under section 415 of the FD&C Act shall renew their food facility registrations with the FDA biennially, in even number years, from October to December (For additional information See Attachment 2, or most recent version from the FDA). The Contractor shall inform the firm that changes to the BT Act require animal food facilities to submit food facility registrations to FDA containing information previously considered optional. Beginning October 1, 2020, facilities are required to submit a Unique Facility Identifier (UFI) when they renew or create an initial food facility registration. The FDA has currently recognized Dun & Bradstreet’s (D&B) Data Universal Numbering System (DUNS number) as the only acceptable UFI for submitting a UFI during the 2020 biennial food facility registration. The DUNS number is available free of charge to animal food facilities and can be obtained by contacting D&B by phone at 866-705-5711 or via email at govt@dnb.com, or by visiting D&B’s Web sites at http://www.dnb.com/duns-number.html or https://fdadunslookup.com. Normally obtained within a few business days, the process to obtain a DUNS number may take up to 45 days or more in some circumstances.

The FDA Unified Registration and Listing System (FURLS) electronically registers all domestic facilities and foreign facilities that export human and animal food to the United States. Contractors can access FURLS to determine:

1) The registration status of the firm

2) The entry of the facility’s DUNS number

3) If the firm has submitted a Qualified Facility Attestation before conducting an inspection

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. Those key personnel shall attend a training session not to exceed two (2) hours on using FURLS.

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 firm's registration status and registration discussions with firm management in the "Summary of Findings” and “Discussion with Management" sections in their inspection report.

Contractors should not include observations about the firm's failure to register or implement food defense measures on the Form FDA 483 or equivalent State form. If a facility is required to register but has not and has no intentions to do so, the Contractor is to notify the FDA Program Division Director or designee.

2. Qualified Facility Attestation

i. Firm’s Attestation:

A firm that attests to meeting the definition of a "qualified facility" can become subject to the modified requirements by:

1) submitting their attestation, Form FDA 3942b (Animal Food), through FURLS at least biennially in conjunction with their food facility registration

2) attesting that either the facility implements preventive controls to address hazards associated with its animal food or is in compliance with non-Federal food safety laws.

As assigned by the FDA Program Division Director or designee, the Contractor shall make sure that they are aware of the firm’s attestation status as a qualified facility before inspecting so that the firm is inspected under 21 CFR Part 507.7 requirements based on the firm’s submitted attestation. The firm can attest to one of two sections within the PCAF regulation. The firm can attest to 507.7(a)(2)(i) that states the firm has identified the potential hazards associated with the animal food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are adequate. Or the firm can attest to 507.7(a)(2)(ii) that states the firm complies with State, local, county, tribal, or other applicable non-Federal food safety law. Attestation information can be accessed within FURLS when the Contractor verifies a valid food facility registration for the firm.

All animal food facilities required to register with FDA under section 415 of the FD&C Act shall renew their registration with FDA biennially. During the food facility registration process in even number years from October to December, each firm must complete and submit an attestation. The Contractor shall inform the firm to submit an updated attestation to continue operating as a qualified facility beginning October 2020. Renewal of the attestation will occur on a biennial basis thereafter (every even fiscal year).

The facility’s status may change prior to the biennial food facility registration based on their annual determination to either meeting the definition of a qualified facility or no longer meet the definition of a qualified facility. For either case, the facility must submit a Form FDA 3942b (Animal Food), through FURLS. If the facility is now meeting the definition of a qualified facility, the facility would submit a new attestation. If no longer meeting the definition of a qualified facility, the facility would update a change in status of the existing attestation.by accessing their FURLS account. Additionally, if the facility is no longer a qualified facility, the facility must comply with all requirements found in subparts C and E of 21 CFR part 507 no later than December 31 of the calendar year declaring they are no longer a qualified facility.

ii. Documentation

If the firm does not meet the definition of a qualified facility found in 21 CFR part 507.3 of the PCAF regulation and has submitted an attestation with the FDA, the Contractor will contact the FDA Program Division Director or designee to notify them of the discrepancy discovered. Additionally, the Contractor will document the findings within the discussion with firm management in the "Summary of Findings” and “Discussion with Management" sections in their inspection report. Do not put observations related to a discrepancy of not meeting a qualified facility's definition on the Form FDA 483 or equivalent State form.

During an inspection at a facility with a current attestation that has been verified as meeting the definition of a qualified facility, the Contractor will document violations based on the requirements within the qualified facility section of the regulation on the Form FDA 483 or equivalent State form based on the paragraph chosen by the firm to attest, either 507.7(a)(2)(i) or 507.7(a)(2)(ii). The Contractor can also cite additional observations found during the inspection under the Part 507 CGMP requirements.

If the Contractor finds that the firm does meet the definition to become a qualified facility and has not submitted an attestation, inspect the firm under all applicable requirements within the PCAF regulation. The inspector shall cite any significant observations found during the inspection on the Form FDA 483 or equivalent State form. To assist in determining significance, refer to the Citation Spreadsheet available in the Resource Library on FoodSHIELD via this link: FoodSHIELD Site.

A firm that does not meet the definition to become a qualified facility and has not submitted an attestation, may not follow modified requirements and is not exempt from subpart C and E (unless other exemptions apply). The firm is subject to inspection under all applicable provisions within the PCAF regulation.

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

i. PCAF Regulation

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. It 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 regulation 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). The PCAF PC requirements stipulate animal food facilities to establish a food safety system that includes an analysis of hazards and implements risk-based preventive controls identified by the facility for the animal food manufactured, processed, packed, or held by the facility.

ii. Sanitary Transport Regulation

NOTE: Sanitary Transport inspections are DIRECTED at this time.

The Sanitary Transportation of Human and Animal Food Rule (Sanitary Transportation or ST Regulation) (21 CFR Part 1, Subpart O) became final on April 6, 2016. The goal of the Sanitary Transportation regulation is to prevent practices that create food safety risks, such as failure to refrigerate food, inadequate cleaning of vehicles, and failure to properly protect food during transportation. Specifically, the regulation establishes requirements for vehicles and transportation equipment, transportation operations, information exchange, training, records, and waivers.

To assist FDA in communicating the requirements of the Sanitary Transportation Regulation and its implementation, the Contractor shall distribute handouts, links, or electronic versions of the Key Requirements: Final Rule on Sanitary Transportation of Human and Animal Food information sheet to the most responsible individual at the firm if not previously provided or if the facility is unaware of the Sanitary Transportation requirements (Attachment 3, or most recent version from the FDA). Additional information may be found via the link below: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm.

iii. Documentation

The Contractor shall record in the summary section of the report which guidance documents they gave to the firm: The Sanitary Transportation information sheet, Final Guidance for Industry #235: CGMP Requirements for Food for Animals, or a link to the Draft Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (if a PC inspection was performed), for example. Furthermore, the Contractor will determine if information about the DUNS number needs to be given to the firm so the firm can create and submit this number when completing their biennial food facility registration. The Contractor will use the summary section of the inspection report to record this discussion with the firm.

Refer to the following Q&A regarding food facility registration, DUNS and attestation: https://www.fda.gov/animal-veterinary/animal-food-feeds/animal-food-facility-registration-and-qualified-facility-attestation-frequently-asked-questions

4. Risk Assessment of Animal Food Firms

Risk-informed work planning is a fundamental element in implementing and executing effective public health and regulatory programs. In the past, FDA did not categorize animal food firms in its inventory by risk because the Agency did not have enough information to determine a firm’s risk. Section 201 of the FSMA law mandates the need to categorize the facility’s risk into one of two categories, high-risk and non-high-risk.

Through a collaborative effort, the Office of Regulatory Affairs (ORA) and the Center for Veterinary Medicine (CVM) developed a questionnaire and formula to calculate a relative-risk score for animal food firms based on data collected during an inspection and deployed it in eSAF as a module in February 2019. In September 2020, FDA updated the questionnaire to capture risk associated with pet food to include treats and chews. Over time, this data will facilitate a uniform approach to work planning as animal food firm activities are updated regarding their compliance with regulations, ingredients used in the production of products, and processes used to manufacture products.

The revised risk data consists of weighted questions, each having two possible responses (yes/no), one weighted question that when answered ‘Yes’ activates two additional weighted questions, and one text-only question that is not weighted. CVM provides guidance to assist with responding to additional questions. This risk data will be combined with other factors such as compliance history, recalls, complaints, etc., to obtain an overall relative risk for an animal food facility.

The Contractor shall complete the Animal Food Risk Data Form during all inspections. The results must be entered electronically into the revised automated module in eSAF (or an equivalent FDA platform) to complete an applicable inspection assignment under this contract. The form and instructions are stored in FoodSHIELD and is available to States via this link FoodSHIELD Site.

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

5. METHOD OF COVERAGE

a. GENERAL

The activities under the contract shall be conducted using the procedures, techniques, and reporting forms specified by FDA in the Comprehensive Animal Food Inspection CPGM 7371.000. This document will be available in FoodSHIELD after March 15, 2021, via this link: FoodSHIELD Site. 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 Director or designee shall provide guidance and rely on CVM to provide 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. The Contractor should maintain a memo from their counsel explaining the scope and findings of the legal review.

If the contracting State has not adopted all applicable sections of Title 21 of the Code of Federal Regulations for each Part of regulations under consideration for inspections 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) of the FD&C Act. Commissioned officials shall use current credentials and use FDA forms as necessary during an inspection. Refer to Attachment 13, or most recent version from the FDA.

The Contractor shall discuss and verify compliance with the above delineated regulatory authority requirements with the Division prior to commencing contract inspection work. The Contractor should also provide hardcopies, links, or electronic versions of appropriate handouts to the firm during the inspection if not provided to the firm during previous inspections.

FDA is in the process of risk-ranking our inventory to identify high-risk and non-high-risk animal food firms. While that effort is underway, States should prioritize facilities that meet the criteria for facilities that are “high regulatory priority” as identified in the program management instructions of the Comprehensive Animal Food Program Compliance Program. The contractor shall work with the FDA Program Division Director or designee to ensure that the correct inventory is chosen during the work planning process to allow for a comprehensive inspection.

b. ENFORCEMENT

Follow-up on previous objectionable conditions noted on a Form FDA 483, Inspectional Observations, discussion items, or State actions, shall be documented in the EIR to ex plain what measures the firm has taken to correct the condition(s). If the condition(s) have not been corrected, document a timeframe the firm shall perform the necessary correction to address the condition(s) for further consideration to confirm the condition(s) no longer persists.

However, it is anticipated the Contractor shall 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 compliance actions with the FDA Program Division Director or designee while the inspection is still open (prior to closing out the inspection) as outlined in the Comprehensive Animal Food Inspection CPGM 7371.000. Where appropriate correction has not been achieved by the Contractor, FDA may initiate compliance actions under the FD&C Act or under animal food regulations within 21 CFR.

If an inspection conducted under contract results in a final Division classification of Official Action Indicated (OAI) and details violations that are “materially related to animal and/or human food safety”, the FDA Program Division Director or designee shall notify the Contractor. Any reinspection of the firm classified as OAI will usually be performed by FDA. However, the Contractor could conduct the reinspection, after receiving concurrence from the Division and CVM. For reinspection where FDA takes the lead, States will be invited to participate, but reimbursement under the contract will not be made.

A compliance action may be taken against the firm by FDA as a result of an inspection performed during any contracted inspection. Per request of the FDA Program Division Director or designee, 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 based on the regulation(s) needing the follow up inspection, as appropriate.

Contractor shall notify the Program Division Director or designee as soon as possible if the inspectional findings reveal violative conditions which may warrant an OAI classification. Please refer to Part II.2.G.(2).(a) Animal Feed Regulatory Control Officials in the Comprehensive Animal Food Inspection Compliance Program 7371.000.

When contacted, Divisions must follow inspectional procedures as required by the Agency and Center. For additional information refer to Part II.2.H.(1) Notification of CVM-Violative Conditions in the Comprehensive Animal Food Inspection Compliance Program 7371.000.

States should contact CVM via the rTAN when: violative conditions are observed, subsequent follow-up is required, or if questions regarding inspectional approach arise as outlined in Part II.2.H(1) Notification of CVM-Violative Conditions in the Comprehensive Animal Food Inspection Compliance Program 7371.000. See Part II.2.H.(3) Regulator Technical Assistance Network (rTAN) and Inspectional Support in the Comprehensive Animal Food Inspection Compliance Program 7371.000 for specifics.

c. REGULATION COMMUNICATIONS

During inspections, where FDA or State inspectors did not previously distribute regulation communications to the firm, the Contractor shall distribute handouts, links, or electronic versions of the following documents to the most responsible person at the firm:

· FDA Food Facility Registration: https://www.fda.gov/animal-veterinary/animal-food-feeds/animal-food-facility-registration-and-qualified-facility-attestation-frequently-asked-questions (Attachment 2, or most recent version from the FDA)

· FSMA Fact Sheet on the PCAF Final Rule: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM461884.pdf (Attachment 4, or most recent version from the FDA)

· Final Guidance for Industry (GI) #235 Current Good Manufacturing Practice Requirements for Food for Animals: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf (Attachment 14, or most recent version from the FDA)

· Sanitary Transportation Regulation: https://www.fda.gov/media/97317/download (Attachment 3, or most recent version from the FDA)

· Fact Sheet on Enforcement Discretion for Certain FSMA Provisions (Attachment 6)

· BSE Guidance for Industry: https://www.fda.gov/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/default.htm (Attachment 9, or most recent version from the FDA)

· Guidance for Industry #120 Veterinary Feed Directives: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf (Attachment 17, or most recent version from the FDA)

· BSE Guidance of Industry #195 Small Entities Compliance Guide: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052449.pdf (Attachment 10, or most recent version from the FDA)

· Draft Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-245-hazard-analysis-and-risk-based-preventive-controls-food-animals (Attachment 5, or most recent version from the FDA)

· FSMA Rules and Guidance for Industry: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry (Attachment 7 or most recent version from the FDA)

d. PROGRAM/ASSIGNMENT CODE (PAC) FOR CONTRACT INSPECTIONS AND INVESTIGATIONS

The PAC is one of FDA’s critical data elements to track operational activities accomplished by FDA and States. The PAC is used to identify the specific Compliance Program, Field Assignment, or a group of work directed towards a particular regulation. When reporting the outcome of contract work assigned as inspections or investigations in eSAF or an equivalent FDA platform, the Contractor shall use the following PACs (Attachment 8, or most recent version via this link: FoodSHIELD Site):

· 71S004, State Contract Inspection: Licensed Medicated Feed Facilities

· 71S011, State Contract Inspection: Facilities handling materials prohibited in ruminant animal food (BSE)

· 71S012, State Contract Inspection: Non-Licensed Medicated Feed Facilities

· 71S014, State Contract Inspection: Food Facilities subject to PCAF Part 507 CGMP requirements

· 71S015, State Contract Inspection: Food Facilities subject to both Part 507 CGMP and PC requirements

· 71S016, State Contract Inspection: Food Facilities required to register and submitted a qualified facility attestation

· 71S017, State Contract Inspection: Food Facilities required to register and subject to modified requirements for solely engaging in the storage of unexposed packaged animal food that requires time/temperature controls for safety

· 71S018, State Contract Inspection: Facilities subject to the Sanitary Transportation requirements (DIRECTED ONLY)

· 71S023, State Contract Inspection: Facilities subject to Veterinary Feed Directive requirements

· 71S876, State Contract Investigation: OEI Improvement Animal Feeds

· 71S894, State Contract Inspection: Animal Food Risk Data Form

6. WORK PLANNING

Annual work planning session(s) between the appropriate FDA Division Office and Contractor personnel shall occur no later than thirty (30) business days after the start of the contract period of performance. The FDA Program Division Director or designee 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 FDA Program Division Director or designee. The goals of the session(s) are to:

a. 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 aligns with the Animal Food Compliance Program. The inspection schedule should be risk-based considering the inspection requirements in FSMA, the individual programs covered under the contract, and the FDA's public health priorities.

For contracts with periods of performance that start on or before September 1, the Division Director or designee shall:

· Make a minimum of twenty percent (20%) of the assignments required to meet the contract obligation during the work planning session.

· Issue all remaining assignments by the start of the 2nd quarter of the contract period of performance.

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