Medical_Device_RFP_2015.doc

FDA-15-Devices

Request for Proposal

THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

1 | 36

2.

CONTRACT NUMBER

3.

SOLICITATION NUMBER

FDA-15-Devices

4.

TYPE OF SOLICITATION

SEALED BID (IFB)

[ X]

NEGOTIATED (RFP)

5.

DATE ISSUED

April 30, 2015

6.REQUISITION/PURCHASE NUMBER

7. ISSUED BY CODE

8.

ADDRESS OFFER TO (If other than Item 7)

Type of Contract: Firm-Fixed Price

DHHS/FDA/OAGS/DASG/State Contracts Branch

5630 Fishers Lane, Room 2024, HFA-500

Rockville, MD 20857 Period of Performance: TBD to TBD

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder"

SOLICITATION

9.

Sealed offers in original and 1 copy for furnishing the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in 5630 Fishers Lane, Rm 2024, Rockville, MD 20857 until 1:00 PM EASTERN local June 12, 2015.

(Hour) (Date)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR NFORMATION CALL:

NAME: Yared Girmai

E-MAIL ADDRESS

yared.girmai@fda.hhs.gov

AREA CODE

NUMBER

402-7581

EXT.

11. TABLE OF CONTENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions in 52.214-16, Minimum Bid Acceptance Period.

12.

In compliance with the above, the undersigned agrees, if this offer is accepted within 90 calendar days from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13.

DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause 52-232-8)

1. ACKNOWLEDGMENT OF

AMENDMENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

15A. NAME AND

CODE

FACILITY

16.

NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER (Type or print)

ADDRESS OF

OFFEROR

CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE

17.

SIGNATURE

18.

OFFER DATE

AWARD (To be completed by Government)

19.

ACCEPTED AS TO ITEMS NUMBERED

20.

AMOUNT

21.

ACCOUNTING AND APPROPRIATION

22.

AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

[ ] 10 U.S.C. 2304(c)( ) [ X ] 41 U.S.C. 253(c)( 5 )

23.

SUBMIT INVOICES TO ADDRESS SHOWN IN

(1 copy unless otherwise specified)

ITEM

G-4

24.

ADMINISTERED BY (If other than item 7)

CODE

25.

PAYMENT WILL BE MADE BY

CODE

Office of Financial Services

10903 New Hampshire Avenue

WO32 Second Floor, MAIL HUB 2145

Silver Spring, MD 20993-0002

26.

NAME OF CONTRACTING OFFICER (Type or print)

27.

UNITED STATES OF AMERICA

(Signature of Contracting Officer) 28.

AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

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, $_________ for three (3) joint 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:

QSIT Level 1

QSIT Level 2

Joint Inspection

QSIT Level 1

QSIT Level 2

Joint Inspection

Contract Total (base plus options):

d. Training: Total expenditures for domestic travel (transportation, lodging, meals, and incidental expenses) and other allowable costs associated with Government approved training not to exceed $__________ incurred in direct performance of this contract shall be allowed based on the contractor’s travel policy. All travel/training must be approved prior to attendance by the contracting officer’s representative (COR) and the contracting officer.

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

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:

Identification of 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. This list shall identify the level of inspection to be performed at each manufacturer’s location. These manufacturers, other than manufacturers of critical devices and significant risk devices identified in the QS/GMP Compliance Program, 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: http://www.fda.gov/ICECI/Inspections/IOM/default.htm 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/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 of verified and 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/InspectionGuides/ucm074899.htm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=803

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/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/ucm094529.htm

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: http://www.fda.gov/ICECI/Inspections/IOM/ucm122529.htm along with related FDA-supplied forms.

8. Compliance actions are not provided for under this contract. However, it is anticipated the Contractor shall pursue vigorously any necessary compliance follow-up to volatile conditions encountered during inspections made under this contract by using State laws. The contractor shall notify and coordinate such State actions with the FDA District.

Performance Standard: In accordance with contract requirements, all inspection requirements shall be completed no later than fifteen (15) days 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 (ten) 10 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). All State inspectors must be audited during the contract period of performance if the required number of audits exceeds the number of State inspectors. State inspectors may be audited more than once per contract period of performance in order to meet the minimum audit rate according to the Field Management Directive (FMD)-76 State Contracts – Evaluation of Inspectional Performance (released January 2014, Version 1.0) (Attachment 3).

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.

Performance Measurement: Contractor performance shall be evaluated by the FDA throughout the contract period of performance. FDA shall review reports, conduct joint State/Federal inspections (included as contract inspections) or independent re-inspections. Independent re-inspections (audits) are made by FDA to evaluate the overall performance of the contractor. Findings of the independent FDA re-inspections shall be provided to the Contractor for review and information. Inspection reports shall be reviewed by FDA to verify that the required data and information are accurate and complete. Inaccurate or incomplete forms shall be considered unacceptable and returned to the Contractor for correction and re-submission. All State inspectors must successfully pass joint audit requirements with an overall "acceptable" rating. Such inspections shall be scheduled by the FDA District Office in concert with the Contractor. For comprehensive information regarding the FDA Audit Program, refer to FMD-76.

Payment Withholding: If FDA finds an inspection report, form 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 documentation shall result in withholding of invoice payment until the Contractor submits or corrects the required document. All State inspectors who receive an overall score of "needs improvement" shall receive remedial training in deficient areas or as agreed upon by the FDA District Office prior to resuming inspection duties.

Training and Joint Inspection:

1. 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 inspection inspections and other activities performed under this contract.

2. 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. State inspectors shall participate in minimum of one (1) Level 1 and one (1) Level 2 QSIT joint inspections of manufacturers of Class I/II devices with FDA investigators within that State, prior to conducting any independent inspections required by this contract. If significant changes are made in the FDA medical device regulations, FDA shall provide any necessary training based on those changes for State contract personnel.

3. The initial, formal training course for new inspectors shall be extensive and thorough. FDA shall present guidelines consisting of detailed information on requirements of the GMP, MDR, CAR and other FDA regulations pertinent to this contract; associated procedures and reporting requirements; information regarding liaison activities with the appropriate FDA District Office and familiarization with applicable FDA forms, manuals. QSIT training shall be computer based. Successful completion of the computer based QSIT training course and Update Video on Quality Auditing is a prerequisite to conduct inspections under this contract. A follow-up training course shall be scheduled as needed. (Note: The FDA shall reimburse contractors only for personnel who successfully complete training courses.)

Samples

1. 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-Field COR for guidance. FDA shall bear the cost of sample shipment to an FDA laboratory.

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 with 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 – Reports/Deliverables

The contractor shall submit the following reports/deliverables:

a. Quarterly Summary Report approval:

A review of the Quarterly Summary Report (QSR) shall be conducted by the District and a notification provided to the contractor on the acceptability of the Quarterly Summary Report within ten (10) business days of receipt. If questions exist regarding the Quarterly Summary Report, the State shall have ten (10) business days from receipt of the QSR questions to respond to the District by providing additional information or submitting a revised Quarterly Summary Report. Following the review and confirmation of acceptance of all work detailed on the Quarterly Summary Report, the District shall provide the contractor (via email with copy to the COR) approval of the Quarterly Summary Report.

Approval of the Quarterly Summary Report by the District is required prior to submission of the invoices. Invoices shall not be submitted to OAGS nor shall invoices be paid without District approval of the Quarterly Summary Report. Documentation of District approval of the Quarterly Summary Report shall be submitted with the invoice and Quarterly Summary Report to OAGS and the COR.

b. Reporting Summary:

Quarterly Reports shall be submitted to the FDA Contract Office, FDA COR and FDA District Office via e-mail, fax, or mail (e-mail is preferred). Quarterly Reports and any submitted supporting documentation shall be submitted no later than thirty (30) business days after the end of each 90 day reporting period to the District for approval with a courtesy copy to the COR.

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.

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.

The QSIT Quarterly Reports shall include the following information:

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

· Facility Name

· Facility Identification 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 inspection 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

· Date inspected

· Inspector

· Change

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”.

The following information for each medical device facility shall be transmitted in the QSIT Quarterly Report:

· Name and address of the medical device facility,

· Facility Identification Number

· Summary of the problems that initiated the State action, including the date of inspection(s), violations cited, and other pertinent information.

· Description of the State action (including copies of orders or letters) to the facility that were used to inform them of the action.

5. Inspections / Work to Be Performed – A brief description of the inspections and work to be scheduled and performed during the next 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 being encountered (or were encountered) proposed corrective action, as well as point of contact and e-mail address or telephone number.

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

b. Property Inventory shall be submitted annually if applicable.

c. Confidentiality/Security Requirements

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 must be submitted via email within thirty (30) business days after the end of each ninety (90) day. Submit the report to:

A. COR

Food and Drug Administration

Office of Partnerships (OP) Attn: Meiying Li

12420 Parklawn Drive

ELEM-3019

Rockville, MD 20857

Meiying.Li@fda.hhs.gov

(301)796-5903

B. FDA Contracts Office Food and Drug Administration

State Contracts and Compliance, HFA-500

Attn: Yared Girmai 5630 Fishers Lane, Room 2024 Rockville, Maryland 20857 yared.girmai@fda.hhs.gov

(240) 402-7581 C. FDA District Office

TBD

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

F-2 – Period of Performance

The contract will be from the effective date of award for 12 months plus one option year. The Government may extend the period of performance for one additional option year in accordance with clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000).

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 – Administrative/Technical Personnel

a. The Government administrative and technical personnel assigned responsibilities for this contract are as follows:

COR:

Meiying Li

(301)796-5903

MeiYing.Li@fda.hhs.gov

The FDA District Office: TBD

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

The COR and the FDA’s District Office 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 and the FDA’s District Office 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 and/or the FDA’s District Office Representatives 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.

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 Address: ______________________

Telephone: ( )_____________________ G-3 – Quarterly Invoice Submission

The Contractor shall submit vouchers or invoices quarterly in accordance with the FAR 52.232-25 "Prompt Payment (OCT 2008)," and FAR 52.232-33 “Payments by Electronic Funds Transfer – Central Contractor Registration (Oct. 2003).

A. In accordance with the above clauses, your invoices should include the following:

-Name and address of the Contractor

-Invoice date and Invoice Number

-Contract or Purchase Order Number which authorizes supplies/services

-Shipping and Payment terms

-Name and address of Contractor Official to whom payment is sent

-Bank Name of the financial institution receiving payment, -Routing transit number of the financial institution receiving payment, -Name and phone number of the person to notify in the event of a defective invoice

-Tax Identification Number

-DUNS

All payments will be made by Electronic Funds Transfer (EFT) and the Contractor shall be responsible for providing any changes to the Central Contractor Registration (CCR) database.

*IMPORTANT NOTE: Quarterly invoices shall not be approved without Inspection Reports. Therefore, timely submission is critical to expedite invoice payment processing.

B. Travel for contract purposes – All travel negotiated and agreed to under this contract for training, contract meetings with FDA field office(s), etc. will be accomplished under state travel authorities and be reimbursed to the contractor through the contract voucher/invoice.

Invoices with reimbursable travel costs must include a list of expenditures or receipts for associated costs, such as incurred per diem, airfare, ground transportation costs, etc.

C. An original and one (1) copy of invoices shall be submitted to the attention of the designated Contracting Officer at the following address:

-DHHS/FDA/OAGS

-State Contracts and Compliance

-5630 Fishers Lane, HFA-500

-Rockville, Maryland 20857

D. In addition, one informational copy of all vouchers shall be submitted to the COR designated in Section G.

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.

G-5 – Post Award Evaluation of Contractor Performancetc \l 3 "ARTICLE G. . POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE" A. Contractor Performance Evaluations

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 30-day time frame.

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 13). 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 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 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.

If 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 the 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 may 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. The name of the Security Representative shall be provided in the offeror's proposal.

H-4 – Commissioning of Inspectors

The Government may require that the Contractor be commissioned by the Government to enable the Contractor to conduct activities under this contract including, but not limited to, undertaking examinations, inspections, and investigations, and related activities to protect the public health in accordance with Federal law, such as the provisions of “Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (Public Law 107-188). The Government has an established procedure to commission the Contractor’s employee to perform certain functions pursuant to the Federal Food, Drug, and Cosmetic Act, such as conducting FDA examinations, inspections, and investigations, collecting and obtaining samples, copying and verifying records, and receiving and reviewing official FDA documents (see Government’s Regulatory Procedures Manual, Chapter 3).

H-5 – Representations, Certifications and Other Statements of Offerors

System for Award Management Registration

In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the – Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance.

If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account.

(1) Definitions.

"Registered in the SAM database" means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor's CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

"System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the non-procurement common rule by agencies, Government corporations , or by the Government Accountability Office.

(2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM.

If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number-

(i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or

(ii) If located outside the United States, by contacting the local Dun and Bradstreet office.

The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office.

(3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206-7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/

SECTION I - CONTRACT CLAUSES

I-1 – 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):

https://www.acquisition.gov/far/ http://www.hhs.gov/policies/hhsar/ Federal Acquisition Regulation (FAR)(48 CFR Chapter 1) Clauses