RFP_FDA_16_Tissue.doc

FDA-16-TISSUE RESIDUE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 – Schedule of Prices A.

The Contractor shall perform the work as described in Section C, C.1, “Scope of Work”, as required below for the basic contract and option year periods outlined below:

B.

9/1/2016 through 8/31/2017 (Base Year)

TBD

9/1/2017 through 8/31/2018 (Option Year 1)

TBD

B.2 – Pricing Terms A.

The loaded rate proposed for each tissue residue inspection is a firm fixed price (FFP) rate. This includes all applicable labor, overhead, general, and administrative expenses. Any travel or training negotiated will be treated as a cost reimbursement item and will be treated as a separate line item.

B.

For training/travel, the total expenditures for domestic travel (transportation, lodging, meals, and incidental expenses) not to exceed $TBD incurred in direct performance of this contract shall be allowed based on the Federal Travel Regulations and HHS Travel Regulations.

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

C.

For Firm Fixed Price (FFP) priced inspections issued under this contract, the unit prices are listed in Article B.1 above for the time period in which the services are estimated to be performed, as agreed to by the Government and the contractor. Price(s) specified under this contract are fixed and only subject to adjustment prior to the options being exercised in accordance with 52.216-5 Price Redetermination Prospective (OCT 1997).

D.

The Government will issue a modification for any quantities above the minimum amount ordered once the basic contract is issued.

B.3 - Minimum and Maximum Quantities

A.

As referred to in Section I, FAR clause 52.216-22 Indefinite Quantity (OCT 1995), paragraph (b), the contract minimum will be funded by the issuance of the basic contract. The maximum quantity is TBD.

B.4 – Modifications A.

This is a Firm Fixed Price (FFP) Indefinite Quantity contract. A modification for inspections above the minimum quantity will be issued and funded separately, based on program needs. Additional funds may be provided for travel/training on a cost reimbursement basis and will be negotiated prior to their occurrence. Services are purchased solely by the award of this contract. The contractor shall not perform or deliver any services above the minimum ordered unless and until the Contracting Officer orders such services as specified in a modification to the contract.

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, and otherwise do all things necessary for or incident to the performance of the work as described below.

If the contracting State has not adopted all applicable sections of Title 21 of the Code of Federal Regulations or demonstrated equivalent State requirements, the contractor shall conduct tissue residue inspections using State officials who have been commissioned as officers of the Department of Health and Human Services, Food and Drug Administration, under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under commission, conformance with the procedural requirements of the Federal FD&C Act is required including use of credentials, issuance of Form FDA 482 (Notice of Inspection), Form FDA 483 (Inspectional Observations), and Form FDA 484 (Receipt for Samples), or equivalent State forms as negotiated in the individual contract. Commissioned officials shall use current credentials and the appropriate FDA forms during an inspection.

If the contracting 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. If necessary, a legal review may 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 shall discuss and verify compliance with the above delineated regulatory authority requirements with the District prior to commencing contract inspection work.

The PAC is 71S006 for tissue residue inspections performed under contract.

The objective of this contract is to obtain assistance from State regulatory authorities to protect consumers from potentially harmful residues in food derived from animals. It is important that inspections are conducted to determine the source and root cause of illegal drug residues. The use of compounds not approved for use in the U.S., or misuse of FDA-approved new animal or new human drugs, can have an impact on the safety of food derived from animals for consumers.

The principal activity shall be to conduct inspections to follow‑up on reports of violative (illegal) drug residues in order to document the cause of the residue(s) and prevent future violations. For additional guidance see Attachment A (located in C. Method of Coverage) – CPGM 7371.006, Illegal Residues in Meat, Poultry, Seafood and Other Animal Derived Foods.

The presence of violative levels of drugs in the food from food producing animals is a health concern. The specific objectives of the program are:

· To minimize consumers’ exposure to food adulterated with illegal drug residues.

· To eliminate the illegal use of drugs in food producing animals.

· To obtain compliance through voluntary and/or regulatory actions.

· To conduct inspections to determine and document the cause of illegal drug residues and/or shipment of adulterated food and/or drugs(s).

· To identify on-farm husbandry practices and animal drug use practices to prevent future residues, identify educational needs, and aid in policy development.

A. Coverage

1. The FDA District Office will assign establishment inspection assignments to be completed by the contractor. The FDA District Office will assign establishment inspections based upon risk categorization and other factors such as District resources (Section C.1., part B.2, Inspection Assignments).

B. Inspections

1. Purpose: The contractor shall conduct inspections to determine and document the responsibility of those individuals/firms causing illegal drug residues, and/or shipping adulterated food, which is offered for sale. The contractor shall:

· Identify the practices and procedures at the firm that may have contributed to the illegal drug residue(s);

· Document the source of the animal that contained the illegal drug residue, the ownership of the animal and all parties involved in the sale, slaughter and transportation of the animal in interstate commerce;

· Document the extra label use of animal drugs and the adulteration of animal drug(s) by providing affidavits and documentation of interstate commerce for the drugs involved; and,

· Document, via the use of affidavits, the drug use practices and record keeping practices of the entity responsible for the adulteration of food and/or drug adulteration

2. Inspection Assignments: Assignment of specific firms to be inspected by the contractor will be generated by the FDA District office.

a. Risk Based Inspections: Limited resources dictate that inspections for all violations be based upon risk. The Center for Veterinary Medicine (CVM) has developed a risk ranking system. The Risk Score is calculated based upon likelihood of exposure, residue toxicity, and exposure level. The FDA District Office will issue assignments to the contractor requesting an on‑site inspection based upon the illegal residue. Assignment priority will be given to residues with the highest risk score

b. Non-Drug Residue Inspections: While drug residues will comprise most of the assignments under this contract, reports of other residues may be assigned for follow‑up. Illegal residues of pesticides, industrial chemicals, mycotoxins, or microbiological contamination may be reported to FDA, or information may be obtained from other sources, and inspections may be requested.

c. Inspection of Producers: The inspections shall be conducted at the animal producer/owner, buyer/dealer, and/or transporter as identified by FSIS on their reports. The primary objective of the inspections will be to determine and document the cause of the illegal residue. The inspection shall obtain information on the producer's operations, drug usage, animal husbandry practices, feed delivery systems, responsibility for the violation, and disposition of any remaining animals.

d. Time Requirements: The contractor shall initiate the establishment inspection within twenty (20) business days after receiving the inspection assignment from the FDA District Office. The FDA District Office will make assignments throughout the period of performance, as needed. The contractor shall complete the inspection within twenty (20) business days after initiating the inspection. The FDA District Office may grant an extension to the contractor for individual inspections due to inspection complexity or other circumstances in the inspection. The FDA District Office shall document any time extension approvals via email or physical copy.

The Establishment Inspection Report (EIR) shall be completed and submitted to the FDA District Office within ten (10) business days after the completion of the inspection, when significant observations are made or State regulatory action is taken. The EIR shall be completed and submitted to the FDA District Office within twenty (20) business days after the completion of the inspection without significant violations and not requiring State regulatory actions (generally rated as “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”). See Section F, Deliveries or Performance.

e. Further Investigations to Determine Responsible Source: If the owner identified by FSIS is determined not to have caused the violation, further investigation shall be conducted to determine the responsible source of the residue. Illegal residues may be caused by the grower/feedlot, a veterinarian, animal technician, by the dealer, buyer, hauler, auction barn, or slaughterhouse.

Inspection of any of these parties, including a veterinarian, should be made to identify the practices resulting in the residue. Information, including affidavits, photo copies, photos and documents obtained during these investigations shall be included with the EIR.

C. Method of Coverage:

1. General: Activities under the contract shall be conducted using the procedures, techniques, and reporting methods specified by FDA in the FDA Compliance Program Guidance Manual(CPGM 7371.006) ‑ Illegal Residues in Meat, Poultry, Seafood and Other Animal Derived Foods http://www.fda.gov/animalveterinary/safetyhealth/animalfeedsafetysystemafss/ucm357243.htm.

It describes the program, priorities, inspectional procedures, etc., and is included as Attachment A. All activities under this contract shall be done in accordance with CPGM 7371.006.

The FDA District Office will provide guidance, interpretation, and training as appropriate. The contractor shall conduct these inspections to determine compliance with the Federal Food, Drug, and Cosmetic Act, State law, or both. The inspections shall be conducted under the authority of State law, if applicable.

The Compliance Program includes Attachment C the “Tissue Residue Evaluation Form” and Attachment G the “Drug Inventory.” These forms shall be used for each inspection and submitted to FDA along with the endorsed Establishment Inspection Report and legible copies of the FSIS Violation Notification Letter and Laboratory Report (See the Reports/Deliverables section of this contract for detailed reporting requirements).

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

D. Quality Control FDA will evaluate contractor performance throughout the contract period. This will be accomplished by a variety of techniques, including: review of reports and joint inspections (included as contract inspections). Joint inspection EIR’s will be provided to the contractor.

(1.) Contract Performance Standard: In accordance with contract requirements, the contractor shall conduct the assigned initial inspections, necessary re-inspections, and necessary visits (within the contractor’s jurisdiction) within twenty (20) business days of assignment by the District. The contractor shall complete the inspection within twenty (20) business days after initiating the inspection. The District shall be notified within three (3) business days, after completion of the inspection via email and/or telephone if significant violations are encountered during an inspection and/or State action is planned by the contractor.

The Establishment Inspection Report (EIR) shall be completed and submitted to the FDA District Office within ten (10) business days after the completion of the inspection, when significant observations are made or State regulatory action is taken. The EIR shall be completed and submitted to the FDA District Office within twenty (20) business days, after completion of the inspection without significant violations and not requiring State regulatory actions (generally rated as “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”). See Section F, Deliveries or Performance.

At least 90% of all submitted inspection reports shall be timely, accurate, completed and acceptable for data entry, analyses, and processing.

(2.) Contract Performance Measurement: The Government will measure compliance with contract inspection requirements by reviewing inspection records and conducting audits or joint inspections. Refer to Field Management Directive (FMD)-76, http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM384257.pdffor the joint audit inspection requirements. Results of all FDA quality assurance reviews will be furnished to the contractor. The FDA District Office will review each EIR to verify that the required information is complete and accurate.

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

E. Training

It is the responsibility of the contractor to assess the training and expertise of its personnel. The contractor shall assign personnel with the requisite training and experience to conduct contract inspection work.

The contractor personnel should successfully complete the VM201 (Tissue Residue) course and a joint audit inspection. The contractor personnel shall read and be familiar with CPGM 7371.006 (Illegal Residues in Meat, Poultry, Seafood and Other Animal Derived Foods) and other relevant guidance documents.

The contractor shall receive prior approval from the FDA District Office to assign contract inspections to contractor personnel that have not received the recommended training.

All travel requests under this contract to participate in FDA-approved training courses shall be negotiated and pre-approved by the Office of Partnerships (OP) and Office of Acquisition and Grants (OAGS). All travel shall be in compliance with the Federal Travel Regulations and HHS Travel Regulations (See Section I). Reimbursement for training cannot exceed the cost estimate approved by the Contract Specialist. If your travel costs increase, a modified cost estimate shall be approved prior to attending the course or you will not be reimbursed for the additional costs. All travel arrangements shall be accomplished under State travel authorities and reimbursed to the contractor through the contract voucher/invoice. The Contractor shall submit receipts with their training invoice(s) or they will not be reimbursed.

F. Work Plan Meeting A work plan meeting between the appropriate FDA District Office and State contractor personnel shall occur no later than sixty (60) days after the start of the contract period of performance. This meeting may occur in-person or remotely.

The goals of the meeting are to:

· Confirm understanding of key contract deliverables, reporting requirements, schedules, and process for contract modifications

· Scheduling of joint audit inspection(s) to meet the requirements of FMD-76 and other measures to monitor the performance of the contract.

· Confirm that State regulatory authorities are equivalent to Federal requirements, or the State officials are Commissioned.

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

· Confirm training requirements are met by contractor personnel to perform inspections and other work obligated under the contract.

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

· Review the utilization of Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF) and data entry requirements.

SECTION D – PACKAGING AND MARKING

This section is not applicable to this solicitation/contract.

SECTION E – INSPECTION AND ACCEPTANCE

E.1 - Inspection and Acceptance

Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at:

Food and Drug Administration, State Contracts and Compliance,HFA-500

5630 Fishers Lane, Room 2129 Rockville, Maryland 20857 E.2 - FAR 52.252-2, Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES

FAR 52.246.4, Inspection of Services – Fixed Price. (AUG 1996)

SECTION F - DELIVERIES OR PERFORMANCE

F.1 - Reports/Deliverables A. Inspection Reports- In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the contractor’s jurisdiction. Communication of inspectional findings to the District Office shall be achieved with the following guidance:

(1) For any inspection that has significant violations and/or State regulatory action is planned, the State shall NOTIFY the District Office via email and/or telephone within three (3) business days after completion of the inspection and submit the complete inspection report, including any State regulatory action taken and status, within ten (10) business days of 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 State shall submit the inspection reports within twenty (20) business days of the completion of the inspection.

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

i. Background

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

The eSAF system automates the issuance of work requests to the contractor and allows the contractor to enter and update inspection results electronically. Additionally, the contractor will have access to the firm’s data that FDA has maintained in FACTS for the past several years. This data will enable the contractor to obtain information about past inspections and violations for firms within their jurisdictional area.

Guidance on FDA product codes and OEI development and maintenance procedures may be found in FMD-130 http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm.

ii. eSAF

The contractor shall use eSAF to submit inspection data. The FDA District Office will assign establishment inspections in eSAF. The use of eSAF is mandatory under this contract. Training may be obtained through FDA/ORM/DHRD or by the FDA District Office.

iii. eSAF Support

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

iV. Changes 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.

NOTE: The above time frames will 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, contract inspections conducted in September shall be entered into eSAF and be in the District Office no later than the 10th day of October. The contractor shall complete the assigned inspections before the end of the contract period of performance in order to receive payment.

At least 90% of all notifications and submitted inspection reports shall be timely, accurate, completed and acceptable for data entry, analyses, and processing.

The PAC is 71S006 for tissue residue inspections performed under contract.

B. Sample Reports- SUBMIT TO THE FDA DISTRICT OFFICE

Copies of State sample analysis reports shall be submitted to the FDA District office together with the inspection report.

C. Quarterly Summary Reports (QSR)- SUBMIT VIA EMAIL NO LATER THAN TWENTY (20) BUSINESS DAYS AFTER THE END OF EACH 90 DAY REPORTING PERIOD TO THE DISTRICT FOR APPROVAL. A courtesy copy should also be submitted via email to the COR.

For each 90 day period of the contract, a QSR shall be prepared on the contractor’s letterhead. It shall include the contract number, reporting period, date submitted, and the name, telephone number, and email address of the person who prepared the report.

The QSR shall also specify the following:

· FEI# (if applicable), name, address, and city of the firm inspected

· Inspection date

· Inspection number

· Details of any unusual findings and State actions

· Other work performed and authorized by the contract

NOTE (1): In those periods where no inspections were performed, a report showing no inspections is required.

NOTE (2): Invoices cannot be approved without the District approved QSR. Therefore, timely submission to the District is critical to expedite voucher/invoice processing and payment.

Approval of the QSR by the District is required prior to submission of the invoice. Invoices will not be paid without District approval of the QSR. Documentation of District approval of the QSR shall be submitted with the invoice and QSR to OAGS and the COR.

Review of the QSR will be conducted by the District and a notification provided to the State on the acceptability of the QSR within ten (10) business days of receipt. If questions exist regarding the QSR, the State shall have ten (10) business days to respond to the District by providing additional information or submitting a corrected QSR.

Once the QSR is approved by the District, the QSR (including the approval from the District) and invoice may be submitted for payment to OAGS and the COR.

Copies of the District approved QSR,District approval and invoice shall be provided as follows:

1. One copy to:

Food and Drug Administration

ORA/Office of Partnerships

Jocelyn Ramos, Contracting Officer Representative (COR) jocelyn.ramos@fda.hhs.gov

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

2. One copy to:

Food and Drug Administration/OAGS/DASG

State Contracts and Compliance

ATTN: Contract Specialist

5630 Fishers Lane, HFA-500

Rockville, MD 20857

Fax: 301-827-7106

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

Travel for contract purposes

All travel requests under this contract for FDA–approved training courses, contract meetings with FDA field office(s), etc. shall be negotiated and pre-approved by OP and OAGS. Reimbursement for training cannot exceed the cost estimate approved by the Contract Specialist. If your travel costs increase, a modified cost estimate shall be approved prior to attending the course or you will not be reimbursed for the additional costs. All travel arrangements shall be accomplished under State travel authorities and reimbursed to the contractor through the contract voucher/invoice. The contractor shall submit receipts with their training invoice(s) or they will not be reimbursed.

F.2 - Period of Performance Performance of this base contract will be for 12 months from the effective date.

SECTION G – CONTRACT Administrative Data G.1 – Government Administrative Personnel

The Government may unilaterally change its Contracting Officers Representative (COR) and District Technical Advisor designations.

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

The COR and District Technical Advisor are responsible for monitoring the contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in the requirement.

Action taken by the COR or District Technical Advisor to resolve technical problems encountered during performance of the contract shall be documented and a copy of the documentation shall be furnished to the Contracting Officer. This documentation also includes site visit reports and minutes of all meetings held in connection with this contract. The Contracting Officer shall also be notified in advance of all meetings or any site visit to the Contractor’s facility.

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

The following will represent the Government as Technical Representatives for the purpose of this contract:

COR (Headquarters):

Jocelyn Ramos

ORA/Office of Partnerships

510-337-6894 jocelyn.ramos@fda.hhs.gov

District Technical Advisor (District Office):

Name

Phone No.

E-Mail Address

G.2 – Project Director

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

Name: _________________

Title: _________________

Email: _________________

Phone: _________________

G.3 – Invoice Submission Fixed Price - Quarterly

A.

The Contractor shall submit all invoices, District approved Quarterly Summary Reports, training receipts, and documentation of other work to all addressees in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

Attn: Contract Specialist

5630 Fishers Lane

Room 2129, HFA-500

Rockville, MD 20857

Fax: 301-827-7106

**Acceptable methods of delivery include mail, hand delivery, fax, and email.**

(II)

One courtesy copy to the Contracting Officer Representative (COR) and District Technical Advisor:

Food and Drug Administration

ORA/Office of Partnerships

Jocelyn Ramos, COR

Email: jocelyn.ramos@fda.hhs.gov ** Acceptable method of delivery is via email.**

B.

Invoices submitted under this contract shall comply with the requirements set forth in FAR Clauses 52.232-25 “Prompt Payment” and 52.232-33 “Payment by Electronic Funds Transfer – Central Contractor Registration” and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice shall be submitted on company letterhead and include each of the following:

(I) Name and address of the Contractor;

(II) Invoice date and invoice number;

(III) Award Number;

(IV) Description, Quantity, Unit of measure, Unit price, and extended price supplies delivered or services performed, including:

(a) Period of performance for which costs are claimed;

(b) Itemized travel costs, including origin and destination;

(c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discounted for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

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

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

(XII) Any other information or documentation required by the award;

(XIII) Contractor is □ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject award, including the following:

(1) Invoice number, amount and date submitted

(2) Corresponding payment amount & date received

(b) Total amount of all payments received to date under the subject contract or order

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance

C.

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

D.

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

FDA/OC/OA/OFO/OFS

ATTN: DIVISION OF PAYMENT SERVICES

Office of Financial Services Food and Drug Administration Attn: Vendor Payments

10903 New Hampshire Avenue

Bldg. 32, Room 2162, Mail Hub 2145

Silver Spring, MD 20993-0002 fdavendorpaymentsteam@fda.hhs.gov E. In addition, one informational copy of all vouchers shall be submitted to the District Technical Advisor in the District Office designated in Section G.1.

G.4 – POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

A.

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

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor 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 will be referred to an individual one level above the Contracting Officer, whose decision will be final.

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

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.csd.disa.mil/.

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

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 - Confidentiality

The clauses below are mandatory to ensure compliance with information disclosure laws.

A. Definitions:

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.

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.

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.

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

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

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

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.)

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.

B. Authorities; Breach of Contract. Federal statutes and regulations govern FDA's handling of the nonpublic information it receives from the Contractor or wishes to share with the Contractor, and the Contractor's handling of the nonpublic information the Contractor creates or obtains for use in the Contractor's work for FDA. The relevant statutory provisions include the Freedom of Information Act (5 U.S.C. § 552(b)), the Privacy Act (5 U.S.C. § 552a), the Trade Secrets Act (18 U.S.C. § 1905), provisions of the FD&C Act including 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), and 21 U.S.C. § 379, as well as applicable regulatory provisions such as 21 C.F.R. §§ 20.62, 20.63, 20.64, 20.88, and 20.90, governing protecting nonpublic information from disclosure.

The Contractor understands that its unauthorized disclosure of nonpublic information created or obtained under this Contract may result in a violation of federal laws and may subject the Contractor to criminal penalties. Unauthorized disclosure also will constitute a breach of the terms of this Contract.

C. FDA’s Disclosure of Nonpublic Information to Contractors. FDA may disclose data and information otherwise exempt from public disclosure to the Contractor for use only in its work for FDA (21 C.F.R. § 20.90).

The Contractor understands that the information FDA provides is the property of FDA and that FDA may take steps, including the initiation of judicial proceedings, at any time to prevent disclosure of the information, or if further disclosed, to retrieve the information.

D. Contractor’s Handling of Nonpublic Information. As evidenced by its signature on this Contract, the Contractor certifies to FDA that it has and will maintain the legal authority to protect nonpublic information from disclosure, and agrees:

(1) Not to disclose to anyone outside its organization, including subcontractors, vendors, suppliers, or non-government agencies, any nonpublic information created or obtained by carrying out this Contract without the written consent of the submitter of this information (confidential commercial or trade secret), the written consent of the individual who is the subject of the information or that individual’s authorized legal representative (personal privacy), or a written statement from FDA that the information no longer has nonpublic status, unless law otherwise permits that disclosure,

(2) To inform FDA within 48 hours of any effort made to obtain the information by subpoena, court order, or other compulsory process, including a request under the Freedom of Information Act, and to take appropriate legal measures to resist the disclosure of such information. The Contractor shall not disclose the information until FDA has had the opportunity to take appropriate legal measures to resist the disclosure of such information, has determined whether it shall take such measures and has notified the agency of its determination, which determination shall be made in a timely fashion. The Contractor may disclose the nonpublic information to comply with the order of a court of competent jurisdiction (see “*”) receiving such disclosure. However, the Contractor agrees to seek a protective order or take other appropriate legal measures to preserve the confidentiality of the information to the greatest extent possible consistent with the Court’s order. [“*” NOTE: The current Foods “streamline” commitments have the following clause rather than the prior sentence: “if the court ordered such disclosure, the Contractor has taken the legal measures in an effort to ensure that nonpublic information will be disclosed in a manner that maintains the confidentiality of the information, and the Contractor has notified FDA but failed to receive a timely determination of FDA actions,”] and

(3) To maintain appropriate safeguards and procedures, and to take necessary precautions to protect the confidentiality of nonpublic information. Precautions include, but are not limited to, physically safeguarding the nonpublic information; training personnel to maintain the confidentiality of the information and to properly handle and account for the data and information; limiting the reproduction, transmission, and disclosure of the data and information; destroying by means of shredding or other effective methods or returning to FDA the nonpublic information at the conclusion of the purpose for which FDA provided the information; and providing to all recipients of the information written procedures about safeguarding nonpublic information, including procedures when the Contractor employs time-shared computer operations (see 21 C.F.R. § 20.90 (b)).

H.2 - FDA 1350 Access To Non-Public Informationtc " H-[ FDA 1350 Access to Non-Public Information " \l 2 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. 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 Contracting Officers Representative (COR) and Contracting Officer. Any new contractor and subcontractor employees assigned to this contract shall sign the form, and the contractor shall deliver it (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 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 their 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.

If this is an automated data processing/telecommunications (ADP/TC) contract, in addition to the above briefings, the FDA COR and the FDA Center/Office Information Systems Security Officer (ISSO) will brief contractor and subcontractor personnel and consultants on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate contractor and subcontractor personnel and consultants shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length; and attendance at one (1) course is sufficient. This training will be provided at no cost to the contractor.

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.

The contractor shall be required to submit a physical security plan with their proposal. The plan shall provide written procedures which detail the instructions issued to contract employees on the following:

1.

safeguarding material during use;

2.

safeguarding material at all other times;

3.

accounting for material

a. tracking procedures,

b. created in-process;

4.

storage control;

5.

key control;

6.

area security;

7.

visitor control;

8.

receipt and transmittal of material;

9.

reproduction of material;

10.

destruction of material;

11.

recording logs;

12.

response to emergency situations;

13.

compromise of information; and, 14.

administrative controls.

This clause applies to the contractor, any subcontractors, and any consultants. Non-public information shall be released to only those persons who will be using the contractor's approved facility unless the off-site facility has been reviewed by the FDA Physical Security Staff and approved in writing by the FDA Physical Security Office.

For transmittal of documents the contractor shall adhere to the following:

1.

Documents to be transmitted internally shall be transmitted on a person-to-person basis between approved employees only.

2.

Documents to be transmitted outside the contractor's facility shall be double-wrapped with the inner wrapping marked "FDA Privileged Information - Access Controlled". The names and addresses of the sender and addressee shall be typed on both the inner and outer wrappings.

3.

Documents to be transmitted back to the FDA or to another address designated by the FDA shall be transmitted by an approved employee or by U. S. Registered mail (return receipt requested). It shall be double-wrapped or wrapped by such a method as specifically approved in writing by the FDA Physical Security Office.

4.

A receipt log shall be maintained for all external transmittals.

5.

The contractor shall follow up all transmittals in order to obtain signed receipt within five (5) business days of transmittal. Failure of recipient to furnish such receipt shall be reported to the FDA Physical Security Office within ten (10) business days of transmittal.

Non-public information shall not be released to the contractor unless all required security precautions have been met [as demonstrated during an inspection by the Food and Drug Administration (FDA) Physical Security Staff], and written procedures for enforcing them have been provided by the contractor and approved in writing by the Physical Security Staff. The FDA Physical Security Office will notify the contractor of the approval.

When the contractor facilities have a current certification from the Defense Contract Administration Services/Defense Logistics Agency (DCAS/DLA) as a "Secret" or higher classification, such rating will satisfy the FDA security requirements for the contractor's facility. Loss of such certification during the period of the contract will be cause for a possible issuance of a Stop Work Order pending review by the FDA's Physical Security Staff of the contractor's facility. The contractor shall notify the FDA Physical Security Office in the event their DCAS/DLA rating is expected to be terminated.

Pending the outcome of any subsequently required investigation, additional requirements on the contractor shall include, but not be limited to, the following: restrictions on access to data by contractor employees, subcontractor employees, and consultants; special storage requirements; restrictions on transmission and disclosure of information; changes in periods of retention and in methods of destruction of source documents or related material; and disclosure statements for all contractor employees, subcontractor employees, and consultants.

The FDA Physical Security Staff will review the contractor's facility and assess the contractor's compliance. Recommendations for bringing noncompliant areas into compliance will be provided to the contractor by the FDA Physical Security Office.

The Contractor shall make any changes necessary within thirty (30) days after written notice from the FDA Physical Security Office in order to comply with FDA security requirements. When appropriate changes have been made the Contractor shall contact the FDA Physical Security Office to request further review by the FDA. The FDA Physical Security Office will notify the Contractor in writing of the outcome of the second inspection. Failure of the contractor to satisfy FDA security requirements within thirty (30) days after the first written notification from the Contracting Officer may be cause for termination of the contract.

The contractor shall designate a Security Representative to act as liaison between the contractor and the FDA on all security-related matters. This includes personnel changes, personnel terminations, disciplinary actions, etc.