Statement_of_Work.pdf

FDA -- 2017 – MEDICAL DEVICES

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 – Background and Objectives

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

a. Background Information

Section 510 (h) of the Federal, Food, Drug and Cosmetic Act states, “Every establishment in any state registered with the Secretary pursuant to this section shall be subject to inspection pursuant to Section 704 and every such establishment engaged in the manufacture, propagation, compounding or processing of a drug or drugs or of a device or devices classified in Class II or III shall be so inspected by one or more officers or employees duly designated by the secretary at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter.”

In 1978, when Section 510 (h) was amended to include medical devices, the Food and Drug Administration (FDA) established its current policy that the biennial inspection requirements of Section 510(h) shall be satisfied only by the conduct of Good Manufacturing Practice (GMP) inspections. This policy was established because it was believed that the intent of Congress was that all 510(h) inspections were to entail an in-depth coverage of the inspection processes.

In October 1996, the final rule for the new Quality System (QS)/GMP Regulation was promulgated. This final rule revised the requirements in Part 820 of Title 21 of the Code of Federal Regulations. The requirements of this new regulation now include a detailed design control sub-system that has added to the complexity of the inspection process and the need for a reengineered inspection approach. This new approach known as the Quality System Inspection Technique (QSIT) was implemented at the beginning of Fiscal Year 2000. Under the QSIT approach to inspections, two different levels of inspection, Level 1 and Level 2, can be performed.

b. Objectives

Because of the large number of Class I and II firms in FDA’s Official Establishment Inventory (OEI), the purpose of this contract shall be to obtain state assistance in the inspection of Class I and Class II medical devices manufacturers to determine compliance with the QSIT/GMP regulations.

B-2 – Compensation

a. The Contract Type is Firm Fixed Price.

b. As consideration for full performance of the work stated in Part I, Section C, C-1 – Scope of

Work, the Government shall pay the Contractor the firm fixed price of $________ for QSIT Level 1 medical device inspections, $_________ for QSIT Level 2 medical device inspections, $_________ and not to exceed $_________ for cost reimbursement travel for training, for a total contract amount of $___________. (Does not include Visits).

The period of performance shall be from date of award to twelve (12) months after the date of award.

c. 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 Part I, Section F, F-1 – Reports / Deliverables and Section G, G-3, Invoice Submission and in accordance with the following schedule:

Base Period Period of Performance : From 9/30/2017 To 9/29/2018

Inspection Type Inspection # Unit Price Total

QSIT Level 1 $ $

QSIT Level 2 $ $

Training $

Period Total $

Option Year 1 Period of Performance : From 9/30/2018 To 9/29/2019

Inspection Type Inspection # Unit Price Total

QSIT Level 1 $ $

QSIT Level 2 $ $

Option Year 2 Period of Performance : From 9/30/2019 To 9/29/2020

Inspection Type Inspection # Unit Price Total

QSIT Level 1 $ $

QSIT Level 2 $ $

Option Year 3 Period of Performance : From 9/30/2020 To 9/29/2021

Inspection Type Inspection # Unit Price Total

QSIT Level 1 $ $

QSIT Level 2 $ $

Option Year 4 Period of Performance : From 9/30/2021 To 9/29/2022

Inspection Type Inspection # Unit Price Total

QSIT Level 1 $ $

QSIT Level 2 $ $

Contract Total (base plus options): $___________________

SECTION C – DESCRIPTION / SPECIFICATIONS / WORK STATEMENT

C-1 - Scope of Work

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

Inspection Obligations:

1. Upon award of this contract, the appropriate FDA District Office shall supply to the Contractor a list of Class I and /or Class II medical device manufacturers that are valid for the Contractor to inspect under this contract. The list shall use firms identified by the Center of Devices and Radiological Health (CDRH)/ FDA. This list shall indicate the level of inspection to be performed at each manufacturer’s location. These manufacturers are those that FDA believes are active and suitable for inspection under this contract.

Questions regarding the guidance contained in the Compliance Program may be discussed with the FDA Contracting Officer Representative (COR) and the FDA’s District Officer.

2. Prior to conducting QSIT inspections, the Contractor shall follow the pre-announced inspection procedures set forth in the FDA Investigations Operations Manual (IOM), “510 Pre-Inspectional Activities”, website address: / and annotation of observations on the List of Inspectional Observations, Form FDA-483 in accordance with IOM 512.3, Annotation of the FDA 483 at website address:

http://www.fda.gov/ICECI/Inspections/IOM http://www.fda.gov/ICECI/Inspections/ucm250720.htm

3. If the pre-announcement procedure indicates that the firm may no longer be active, the

Contractor shall notify the FDA’s District Office in writing (e-mail is preferred) as soon as possible and await further guidance.

4. From among the list verified by the FDA District Office of active Class I and Class II finished medical device manufacturers; the FDA shall direct the Contractor to perform QSIT Level I or QSIT Level 2 inspections.

Tasks (Inspection Coverage):

1. The Contractor shall conduct Level 1 QSIT inspections and Level 2 QSIT inspections of verified, active, Class I / Class II finished device manufacturers selected from the list provided to the Contractor by the FDA’s District Office.

2. During the inspection, the Contractor shall determine manufacturer compliance with the

Medical Device Reporting (MDR) Regulation, 21 CFR, Part 803. Instructions for the inspection procedures are contained in the program entitled: “Inspection of Medical Device Manufacturers” which is located at websites:

http://www.fda.gov/ICECI/Inspections/IOM http://www.fda.gov/ICECI/Inspections/ucm250720.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

3. The Contractor shall conduct inspections of these establishments using state officials who have been commissioned as officers of the U.S. Department of Health and Human Services, Food and Drug Administration, under the authority of the Federal Food, Drug, and Cosmetic Act. Under commission, conformance with the procedural requirements of the act is required, including use of credentials, issuance of Notice of Inspection (FDA- 482), Inspection Observations (FDA-483), affidavit (FDA-463a) and Receipt for Sample (FDA-484) forms. These forms shall be provided by the FDA’s District Office. Each FDA-483 form shall include the following statements: “The observations noted in this form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.” This statement is contained in FDA Compliance Program Guidance Manual: CP 7382.845 located at website:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/UCM244277.pdf

4. Note: FDA maintains the right to decommission contractor personnel in performance of this contract at any time.

5. The Contractor shall verify registration and product listing information submitted by the manufacturer and submits any corrected information to the FDA’s District Office with the inspection report. Verification and product listing shall be verified in accordance with FDA Compliance Program (CP7382.845) entitled: "Inspection of Medical Device Manufacturers".

6. The Contractor shall determine manufacturer compliance with the Corrections and

Removals (CAR) Regulation in accordance with 21 CFR, Part 806 and FDA Compliance Program (CP7382.845) entitled: "Inspection of Medical Device Manufacturers.”

Instructions for quality audit procedures are contained in the program entitled:

“Inspection of Medical Device Manufacturers” located under “Quality Audits” at website:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114945.htm#9.%20Quality

7. The Contractor shall complete an Establishment Inspection Report (EIR) for each establishment inspected in accordance with IOM 510 – Narrative Report, located at website along with related FDA-supplied forms. The Contractor shall input complete inspection information into the Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF).

http://www.fda.gov/ICECI/Inspections/IOM/default.htm

8. Compliance actions are not provided for under this contract. However, it is anticipated that the Contractor shall pursue vigorously any necessary compliance follow-up to any violations encountered during inspections made under this contract by using State laws.

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM244277.pdf http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM244277.pdf http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114945.htm#9.%20Quality

The Contractor shall notify and coordinate such State actions with the FDA District Offices.

Performance Standard: In accordance with contract requirements, all inspection requirements shall be completed prior to the end of the contractual period of performance.

Accurately completed Establishment Inspection Reports shall be forwarded to the appropriate FDA District Office no later than thirty (30) business days after completion of the inspection.

Reports shall be considered to be accurate and complete after FDA District staff enter all data from the reports into the Field Accomplishments Compliance Tracking System (FACTS).

The above time frames shall not apply for inspections conducted in September of each year as those inspections shall be entered into the FDA data system prior to October 15th to be counted in the FDA's fiscal year data. As a result, State contract inspections completed in September shall be entered into eSAF and the reports received by the District office no later than October 10th of each year.

All State inspectors shall be audited during the contract period of performance. State inspectors may be audited more than once per contract period of performance in order to meet the minimum audit rate according to the latest version of Field Management Directive (FMD)-76 State Contracts – Evaluation of Inspectional Performance (see Attachment 3).

FMD-76.doc http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm

Within twelve (12) months of contract award, the Contractor shall complete all inspections referenced in Section B, B-2, paragraph b.

Training:

• It is the responsibility of the Contractor to assess the training and expertise of its staff, maintain training records, and determine that inspectors meet the requisite training and experience to conduct the various contract inspections, provide remedial training and other activities performed under this contract. The Contractor shall communicate training needs to the Office of Partnerships (OP) and the FDA district office during work planning or when information related to training is requested, such as through the FDA Division of Human Resource Development (DHRD) training needs survey.

State inspectors are strongly encouraged to utilize device-related distance learning material available through ORA University (DHRD), as well as attend courses offered by FDA, including DV210 (Core Medical Device Investigator, Blended Learning), when the opportunity arises.

• The FDA shall provide training for medical device inspections to state investigators having thirty (30) credit hours of college-level courses in the natural sciences (e.g., biology, chemistry, physics, etc) or engineering and having conducted inspections and issued notices of findings in the medical device area.

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

• All travel requests under this contract to participate in FDA-approved training courses shall be negotiated and pre-approved by the OP and Office of Acquisitions and Grants Services (OAGS). The travel request shall be in compliance with the Federal Travel Regulations (FTR) and Health and Human Services (HHS) Travel Policy Manual.

Reimbursement for training cannot exceed the cost estimate approved by the Contracting Officer. If Contractor travel costs increase, a modified cost estimate shall be approved prior to attending the course or the traveler/s shall not be reimbursed for the additional costs. All travel arrangements shall be accomplished under State travel authorities and reimbursed to the State through the contract voucher/invoice process.

The Contractor shall submit receipts with their training invoice(s) or they shall not be reimbursed.

Quality Control

FDA shall evaluate Contractor performance throughout the contract period. This shall be accomplished by a variety of techniques, including but not limited to: review of reports, joint inspections (included as contract inspections), and audits. Joint inspections shall be provided to the Contractor for review and information. For comprehensive information regarding the FDA Audit Program, refer to Field Management Directive (FMD)-76 (Attachment 3) or most recent version when notified by FDA).

1. Audit Requirements

The auditing requirements detailed in FMD-76 shall be used to meet the number of required audits for a performance period.

2. Inspector Performance Standard

All Contractor inspectors shall be audited at the frequency described in FMD-76.

3. Inspector Performance Measurement

All Contractor inspectors shall successfully pass audit requirements with an acceptable rating.

For audit requirements, refer to FMD 76.

4. Inspector (Individual) Performance Deficiencies and Correction

All Contractor inspectors who receive an overall score of “Needs Improvement” shall receive remedial training in deficient areas as agreed upon by the FDA district office and contracted state program. The FDA district office shall document and notify the contracted state program when individual inspector performance deficiencies as described in FMD-76 are identified. The completion of a Corrective Action Plan for Program and Individual Performance Deficiencies (Appendix J) shall be required. The Contractor inspector shall discontinue conducting contract inspections until remedial training is completed and audits performed by the contracted state program and FDA district office verifying that the deficiency has been corrected. The contracted state program may be required to absorb the costs of the training.

5. Contract Program Audit Performance Evaluation and Correcting Deficiencies

The FDA district office shall coordinate with the Contractor to take appropriate action when the Audit Program identifies deficiencies in the program’s performance of the contract inspections as described in FMD-76. An unacceptable audit shall not cause a contract to be altered or unpaid, nor shall payment for the contract inspection be withheld.

The Contractor shall be evaluated on its overall work performance and all audits conducted during the contract year, not the outcome of one contract audit. Audit findings may indicate an overall program deficiency or a deficiency with a specific performance element.

Program performance deficiencies shall require the completion of a Corrective Action Plan for Program and Individual Performance Deficiencies (Appendix J). The Contractor may be required to absorb the costs of the training. It is at the FDA District Office’s discretion if additional audit and/or joint inspection/s is/are needed for state inspectors in addition to the required audit indicated in FMD – 76. Contractor is required to lead any joint inspections that occur in order to receive payment.

6. Contract Performance Standard

In accordance with contract requirements, the Contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the State and report all completed inspection results to the FDA district office no later than thirty (30) business days after completion of the inspection. Inspections are defined as completed when the inspectional activity at the firm has concluded, the Form FDA 483 (or equivalent form) has been issued to the firm (if appropriate), and the close out discussion has been held. The inspection results shall be entered in eSAF and submitted to the FDA district office within thirty (30) business days. Responses received from the firm detailing corrective actions in response to a contract inspection shall be submitted to the FDA district office within thirty (30) business days of receipt. In addition, the Contractor shall notify the FDA district office via email within three (3) business days upon determination that significant violations are identified during the inspection or State regulatory action is being considered or planned.

The above time frames shall not apply for inspections conducted in September of each year as those inspections shall be entered into the FDA data system prior to October 15th to be counted in the FDA's fiscal year data. As a result, State contracted inspections completed in September shall be entered into eSAF and the reports received by the District office no later than October 10th of each year.

7. Contract Performance Measurement

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

8. Corrective Action Plan

The Contractor shall submit a corrective action plan if 90% of the deliverables do not successfully meet any given requirement as stated in this contract or presented during the workplanning meeting. The Contract Officer Representative (COR) shall provide notification to the Contractor upon determination of the need for a corrective action plan.

The corrective action plan shall identify the responsible parties, actions required, dates of completion, and other information needed to ensure the contract requirements and obligation shall be met during the contract period of performance. The Contractor shall submit the corrective action plan as described in Section F of this contract to the COR, District Technical Advisor, and Contracting Officer. The inability to meet the requirements of the contract may result in adverse actions, including termination of the contract.

9. Delay in Contract Payments

If FDA finds an inspection record, sample report, quarterly report, or invoice to be unacceptable, the Contractor shall be advised and given an opportunity to correct and/or resubmit the required documentation. Each instance whereby the Contractor fails to submit or correct the required report shall result in the delay of invoice payment until the corrected document(s) are received and accepted by the FDA.

ELECTRONIC STATE ACCESS TO FIELD ACCOMPLISHMENTS AND

COMPLIANCE TRACKING SYSTEM (eSAF)

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

The eSAF system shall allow FDA to automate the issuance of work requests to the State medical devices firm Contractors and shall allow the Contractors to enter and update inspection results electronically. Additionally, the Contractors shall have access to the firm’s data that FDA has maintained in FACTS for the past several years. This data shall enable the States to obtain information about the firm including past inspections, consumer complaints, and violations for firms within their jurisdictional area. All Contractors shall input complete inspection information into the eSAF system. Inspections should be classified using the guidance found in FMD-86 (Attachment 4 or most recent version when notified by

FDA).

Inspection conclusions found in eSAF may transfer differently into FACTS. The table below summarizes the eSAF classifications that may be chosen and the final inspection conclusion found in FACTS. Guidance from the FDA district office on the proper use of eSAF inspection classification may be provided to the Contractor.

eSAF Classification eSAF Code

Transfer Code

FACTS

Code

FACTS

Classification

Definition excerpted from

FMD-86

No action indicated

NAI N NAI No Action Indicated

(NAI)

No objectionable conditions or practices were found during the inspection, or the objectionable conditions found do not justify further action.

No action/follow-up inspection

NFI N NAI No Action Indicated

(NAI)

Voluntary action indicated

VAI E VAI Voluntary Action Indicated

(VAI)

Significant objectionable conditions and practices were observed, but the District is not prepared to take or recommend any regulatory action.

Violation/follow-up inspection

VFI E VAI Voluntary Action Indicated

(VAI)

Action referred to FDA

RAI A OAI Official Action Indicated

(OAI)

Significant, objectionable conditions or practices warrant a Warning Letter, seizure, injunction, recall or other regulatory actions listed in FMD-86.

State/Title action indicated

SAI

I RTS Refer to State

(RTS)

Significant objectionable conditions or practices are present, but the Agency either does not have jurisdiction over the apparent violation in question or it is determined that state action is the most efficient method of obtaining the establishment’s compliance with applicable federal laws, regulations or administrative requirements.

RTC Refer to Center only

Significant objectionable conditions or practices appear to warrant regulatory action, but the apparent violations noted constitute a compliance area for which no clear policy has been established or there are significant technical issues which require Center review and decision.

eSAF All Contractors are required to enter inspection information into the eSAF system.

Contractors shall use an Internet browser that is compatible with eSAF and have the other resources required for eSAF usage. Training may be obtained through FDA/ORM/DHRD or by the District.

eSAF Support The Contractor shall contact the ORA Applications Helpdesk for technical assistance via e-mail at APPSDESK@fda.hhs.gov or at 866-807-3742. The Helpdesk operates 24hrs/daily.

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

mailto:APPSDESK@fda.hhs.gov mailto:APPSDESK@fda.hhs.gov

SECTION D - PACKAGING AND MARKING

This section is not applicable to this solicitation/contract.

SECTION E - INSPECTION AND ACCEPTANCE

Inspection and Acceptance

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

52.246-4 Inspection of Services – Fixed Price (Aug. 1996)

(a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

(g) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

SECTION F – DELIVERIES OR PERFORMANCE

F-1 – Period of Performance

The period of performance of this contract shall be for one (1) year commencing with the effective date of the contract. The Government may extend the period of performance for up to Four (4) additional option years in accordance with 52.217-9 Option to Extend the Term of the Contract (MAR 2000).

F-2 – Reports/Deliverables

Establishment Inspection Report No significant violations: Submitted to the District within thirty (30) business days after completion of the inspection.

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

Electronic Reporting: Using the Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF)

Contractor is responsible to enter the inspection information into eSAF.

Audit forms, memorandums, and other documents required for the audit program

Refer to FMD – 76 (most recent version) for the reporting requirements.

Quarterly Summary Reports

Submit no later than thirty (30) business days after the end of each ninety (90) day reporting period to the District for approval with a courtesy copy to the COR.

Invoices Shall be accompanied by an approved quarterly summary report and district approval email confirmation.

A. Establishment Inspection Reports

In accordance with contract requirements, the Contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the State. The Establishment Inspection Report (EIR) and form FDA 483 (Inspectional Observations), or equivalent forms, shall detail the conditions found by the Contractor with sufficient narrative and evidence to enable an FDA assessment of the significance of any objectionable conditions or practices. The Contractor should also refer to the Investigations Operations Manual for guidance (Attachment 5).

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 section of the inspection report and eSAF.

The Contractor shall submit inspection findings to the FDA district office as follows:

1. For any inspection conducted under contract that has violations, or a State regulatory action (or both) has been conducted or is being considered, the Contractor shall NOTIFY the FDA district office via email within three (3) working days after completion of the inspection and provide updates on the status of the firm. The Contractor shall submit the complete inspection report (hard copy and through eSAF), including the Compliance Action Report and compliance documents (e.g., warning letters, embargo forms, license revocation, etc.), within thirty (30) business days after completion of the inspection.

2. For inspections without significant violations and not requiring State regulatory actions

(generally rated as “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”), the Contractor shall submit the inspection reports (hard copy and through eSAF) to the District office within thirty (30) business days after completion of the inspection.

NOTE: The above time frames shall not apply for inspections conducted in September of each year as those inspections shall be entered into the FDA data system prior to October 15th to be counted in the FDA's fiscal year data. As a result, State contract inspections completed in September shall be entered into eSAF and the reports received by the District office no later than October 10th of each year.

At least ninety percent (90%) of all notifications and submitted inspection reports shall be timely, accurate, complete and acceptable for data entry, analyses, and processing.

Inspection time should be charged against the following PAC codes, as appropriate:

82S008 – Level 1 82S009 – Level 2

B. Sample Reports

Routine physical samples shall not be collected during inspections, except as noted in the relevant Compliance Program. In the event samples are indicated, the Contractor shall contact the FDA district office or COR for guidance. FDA shall bear the cost of sample shipment to an FDA laboratory.

C. Compliance Action Reports

Reports of compliance or enforcement actions shall be submitted to the FDA District Office upon completion. Copies of the documents used by the Contractor to record compliance actions shall be furnished to the appropriate FDA District office within thirty (30) business days after completion.

D. Electronic Reporting

The Contractor shall input complete inspection information into the eSAF system within thirty (30) business days after completion of the inspection.

NOTE: The above time frames shall not apply for inspections conducted in September of each year as those inspections shall be entered into the FDA data system prior to October 15th to be counted in the FDA's fiscal years data. As a result, State contract inspections conducted in September shall be entered into eSAF and the reports received by the District office no later than October 10th of each year.

At least ninety percent (90%) of all notifications and submitted inspection reports shall be timely, accurate, complete and acceptable for data entry, analyses, and processing.

F-3 -- Quarterly Summary Reports

Included with the report shall be an electronic document (i.e. Word or Excel, as agreed to by the District) of the establishments inspected and any regulatory actions, specifying the following information:

1. Facilities Inspected – A list of the facilities inspected during the reporting period, including:

• Facility Name

• Facility Identification Number (FEI) and Facility Registration Number

• Date of Inspection

• Level of QSIT inspection performed (Level 1 or Level 2)

• Inspector Name

• Date Inspection Submitted to FDA

• Summary of Findings

2. Cumulative Inspection Performed – a cumulative total of the number of inspections, audits and/or joint inspections performed since the beginning of the contract period of performance.

3. Facility Status Changes- A list of the facilities with status or address changes discovered by the Contractor, including:

• Facility name

• Address

• Facility Identification Number (FEI) and Facility Registration Number

• Date inspected

• Inspector Name

• Change(s)

4. State Adverse Actions – The Contractor shall report any actions taken at the state level against facilities for medical device violations. If there was no adverse action taken, the Contractor shall check “none”.

5. Inspections / Work to Be Performed – A brief description of the inspections and work to be scheduled and performed during the next ninety (90) days.

6. Changes to Point of Contact / Inspector Information – A brief description of changes in Point of Contact / Inspector status, business phone numbers, business mailing addresses, e-mail addresses, and/or names.

7. Current Problems – Provide a brief synopsis of problems encountered and proposed corrective action, as well as point of contact and e-mail address or telephone number.

8. Pursuant to the clauses set forth in Section H, the Contractor shall submit to the Contracting Officer any changes or updates to its security plan accepted by FDA. The Contractor shall also submit the State’s approved confidentiality form (Attachment 1) Form FDA 3398, for any new inspectors under the contract during the period of performance.

9. Quarterly summary report approved by the FDA district office shall be submitted via email within thirty (30) business days after the end of each ninety (90) day. Submit the report to:

A. FDA Contracting Office

Anthony Webb Food and Drug Administration State Contracts and Compliance, HFA-500 5630 Fishers Lane, Room 2109 Rockville, Maryland 20857

(240) 402-7549 anthony.webb@fda.hhs.gov

AND

B. COR

Office of Partnerships (OP) Attn: Meiying Li 12420 Parklawn Drive

ELEM-3019

Rockville, MD 20857 Meiying.Li@fda.hhs.gov (301)796-5903 mailto:anthony.webb@fda.hhs.gov

*IMPORTANT NOTE: Vouchers/Invoices shall not be paid without the QSIT Quarterly Report and FDA District approval. Therefore, timely submission and obtaining District approval is critical to expedite voucher/invoice processing.

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 – Administrative/Technical Personnel

The following personnel will represent the Government for the purpose of this contract:

1. Contracting Officers Representative (COR):

CDR Meiying Li

ORA/Office of Partnerships 12420 Parklawn Drive Rockville, MD 20857 Email: Meiying.Li@fda.hhs.gov Phone: 301-796-5903

a. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the contract.

b. The responsibilities and limitations of the COR are as follows:

• The COR is responsible for monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Office changes in the requirement. The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor.

• The COR is not authorized to make any commitments or otherwise obligate the

Government or authorize any changes which may affect the cost, period of performance, or terms and conditions of the contract. Any Contractor request for changes shall be referred to the Contracting Officer (CO) directly or through the COR. No such changes shall be made without the expressed prior authorization of the CO. The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

2. District Technical Advisor: TBD by the FDA District

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

b. The responsibilities and limitations of the District Technical Advisor are as follows:

• The District Technical Advisor is responsible for the final inspection and acceptance of all reports and such other responsibilities as may be specified in the contract.

• Communication and collaboration with State management

• Meet with State management twice a year with one meeting dedicated to work planning

• Ensure information provided by states is properly entered into FDA systems

• Review and provide feedback to state management on work products submitted to FDA

• Verify information on Quarterly Summary Reports within 10 working days of report receipt

• Work with OP to address discrepancies and to ensure work is completed in accordance with the contract

G-2 – Key Personnel (HHSAR 352.242-70)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the State), the State shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The State shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the State or Government.

The individual cited below is key personnel:

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

Project Director

Name: ____________________________

Title: ____________________________

Email Address: ______________________

Telephone: ( ) _____________________

G-3 – Quarterly Invoice Submission

1.Invoice Type

Fixed Price – Quarterly

2. Method of Submission

The Contractor shall combine all invoices; District approved Quarterly Summary Reports (with approval email/memo), training receipts, and documentation of other work in one PDF document. The completed PDF document should be submitted to all addressees in the manner specified below:

• One copy to:

Food and Drug Administration/OAGS/DSAAG State Contracts Branch ATTN: Contract Specialist 5630 Fishers Lane, HFA-500 Rockville, MD 20857

• One copy to the Contracting Officers Representative (COR):

ORA/ Office of Partnerships ATTN: Meiying Li, COR 12420 Parklawn Drive Rockville, MD 20857 Email: Meiying.Li@fda.hhs.gov

**Acceptable method of delivery is via email. **

• One courtesy copy to the District Technical Advisor (TBD by the FDA District)

3. Invoices

Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 “Prompt Payment” and 52.232-33 “Payment by Electronic Funds Transfer – System for Award Management” and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead, SF1034 or the FDA recommended invoice form and include each of the following:

a. Name, address and program of State;

b. Invoice date and invoice number;

c. Award Number;

d. Period of performance, Description (type of inspection, samples, MFRPS, etc.), Quantity, Unit price, and Line item number.

e. Name, title and phone number of person to notify in event of defective invoice;

f. Taxpayer Identification Number (TIN);

mailto:Meiying.Li@fda.hhs.gov

g. Electronic Funds Transfer (EFT) Banking information, including bank name, routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

h. Name and telephone number of the FDA contracting officer representative (COR) or other program center/ office point of contact, as referenced on the award;

i. Any other information or documentation required by the award (District approved quarterly summary report email/memo, District approval, etc.);

4. Electronic Invoices

An electronic invoices submitted in adobe acrobat (PDF) format is acceptable. All items listed in (I) through (XIII) of this clause must be included in the electronic invoice.

5. Questions regarding Invoice payments

Questions regarding invoice payments should be directed to the FDA Payment Office at:

FDA/OC/OA/OFO/OFS

ATTN: Office of Financial Services Food and Drug Administration Attn: Vendor Payments 10903 New Hampshire Avenue WO32, Second Floor, Mail Hub 2145 Silver Spring, MD 20993-0002 fdavendorpaymentsteam@fda.gov

G-4 – Government Furnished Materials

All reporting forms required for use in the performance of the services required hereunder shall be furnished by the Government. Delivery shall be made in a timely manner to the Contractor’s facility, such that the required services can be performed within the effective dates of the contract.

The following forms required for use in the performance of the services required hereunder will be made available to Contractors upon request.

FDA-482 Notice of Inspection FDA-483 Inspectional Observations FDA-484 Receipt of Samples

G-5 – Post Award Evaluation of Contractor Performance

A. Contractor Performance Evaluations mailto:fdavendorpaymentsteam@fda.gov

Interim and final evaluations of Contractor performance shall be prepared on this contract in accordance with FAR 42.15. The final performance evaluation shall be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

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

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

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

The registration process requires the Contractor to identify an individual that shall serve as a primary contact and who shall be authorized access to the evaluation for review and comment. In addition, the Contractor shall be required to identify an alternate contact that shall be responsible for notifying the FDA contracting official in the event the primary contact is unavailable to process the evaluation within the required 14-day time frame.

http://www.cpars.gov/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H-1 – Confidentiality Definitions

a. Confidential Commercial Information:

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

b. Disclosure:

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

c. Nonpublic information:

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

d. Contractor:

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

e. Personal privacy information:

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

f. Pre-decisional information:

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

g. Sponsor/ submitter:

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

h. Trade secret information:

A trade secret is information that may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort.

There must be a direct relationship between the trade secret and the productive process. Trade secret information might be found in the same records that contain confidential commercial information.

H-2 – FDA 1350 Access to Non-Public Information

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form provided as an attachment to this contract (Attachment 1). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA COR and Contracting Officer. Any new Contractor and subcontractor employees assigned to this contract shall sign the form, and the Contractor shall submit ten (10) days prior to commencement of work to the Contracting Officer.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted.

Briefings:

A FDA representative (typically, the COR or District Technical Advisor) will conduct an orientation briefing for the Contractor/Contractor’s employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/ADP requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of the responsibility to protect

it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA COR within ten (10) days after the briefing which includes: an outline of the briefing, a copy of any briefing materials, date briefing was conducted and the names of the attendees.

H-3 – FDA 1354 Physical Security Requirements for Releasing Non-Public Information

Under the provisions of Title 21, United States Code, Section 331(j), the Contractor shall establish and maintain comprehensive security measures for controlling access to non-public information released under a contract involving the processing of such information.

This clause applies to the Contractor, any subcontractors, and any consultants. Non-public information will be released to only those persons authorized under this contract.

For transmittal of documents the Contractor shall adhere to the…