FDA_LAW_RFP_(Ver_4).doc

MASTER --- TABLE OF CONTENTS

PART I – The Schedule

PART II – Contract Clauses

PART III – List of Documents, Exhibits and Other Attachments

PART IV – Representations and Instructions

SECTION B. SCHEDULE OF SUPPLIES/SERVICES

1. As consideration for performance of the work stated in Section C, C.2 “Scope of Work”, the Government shall pay the Contractor a firm fixed price per course as outlined in the schedule below.

2. Payment under this contract shall be contingent upon receipt and acceptance by the Government of reports and proper invoices as required in Section F.1, “Reports/Deliverables” and Section G.5, “Invoice Submission”, and in accordance with the following schedule:

Contract Line Item Number (CLIN) 01: ORA Basic Food and Drug Law Course

$5,000

1 For evaluation purposes only

Funds Available- CLIN 01: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 02: CTP Basic Food and Drug Law Course

$5,000

Funds Available- CLIN 02: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 03: CVM Basic Food and Drug Law Course

$5,000

Funds Available- CLIN 03: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 04: CFSAN Basic Food and Drug Law Course

$5,000

Funds Available- CLIN 04: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 05: ORA Compliance Law Course

$5,000

Funds Available- CLIN 05: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 06: ORA Practical Compliance Applications Course

$5,000

Funds Available- CLIN 06: The total amount presently available for performance of this CLIN is ($[allocated for training courses] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 07: ORA Advanced Import Investigations Course

$5,000

Funds Available- CLIN 07: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

Contract Line Item Number (CLIN) 08: ORA Regulatory Science Course

$5,000

Funds Available- CLIN 08: The total amount presently available for performance of this CLIN is ($[allocated for training course] and $[allocated for travel] to be completed at time of contract award). It is specifically agreed and understood that the contractor shall only be paid for training courses and travel authorized by a properly placed order in accordance with Section I Clause entitled “52.216-18 Ordering, Clause H.1 entitled “Placing and Processing Orders,” and which has been satisfactorily performed. The notice shall state the total number of courses delivered by the Contractor.

3. TRAVEL: Reimbursement for travel shall be submitted and included with applicable invoice for approval. Listed below is a description of receipts that may be required as attachments to the invoice to support travel claims:

1.

Copy of common carrier ticket reflecting class of travel, dates of travel, and amount of fare;

2.

Lodging receipt;

3.

Parking/tolls receipt;

4.

Rental car receipt including receipts for gasoline;

5.

Receipts for taxi travel.

4. Orders will be priced using the fixed unit prices and estimated unit costs listed in the above pricing tables. The unit prices listed for the Base year shall apply to orders issued within the first year of the contract. Orders issued during the second year of the contract period of performance will utilize option year 1 rates. Orders issued during the third year of the contract period of performance will utilize option year 2 rates. Orders issued during the fourth year of the contract period of performance will utilize option year 3 rates. Orders issued during the fifth year of the contract period of performance will utilize option year 4 rates.

5. Total expenditures for domestic travel (ground transportation, lodging, meals, and incidental expenses) incurred in direct performance of this contract, shall be allowed based on the Federal Travel Regulations.

6. Minimum and Maximum Quantities: The minimum quantity under this contract is 12 courses. The maximum contract quantity is 275 courses. The minimum and maximum amounts apply to the base and all options years in the aggregate.

SECTION C. DESCRIPTION/SPECIFICATIONS

C.1 - Background The Food and Drug Administration (FDA) has a continuing need to train its field and headquarters operational personnel in the basic legal aspects of the Food, Drug and Cosmetic (FD&C) Act and related regulations. A clear and consistent understanding of the laws, regulations, and legal precedents is essential to assure appropriate and uniform application of the administrative and compliance guidelines of the Agency.

The Office of Regulatory Affairs (ORA) staff is the field component of FDA and is engaged in investigative, scientific and compliance activities in support of the Agency’s consumer safety protection mission.

Field personnel are the first line in gathering and reviewing evidence, maintaining its integrity, and recognizing its significance with respect to the laws enforced by FDA. For a number of years, the ORA staff has coordinated the formalized basic food and drug law training of field and headquarters personnel and, as the coordinating unit, will assure continuity of effort in both training and performance. “Training in food and drug law is a major segment of a developmental program for newly hired investigators, inspectors, and analysts in the field. Continuation of this quality training is essential in order for FDA to maintain a cadre of field and headquarters personnel sufficiently acquainted with FDA laws and regulations to enforce Agency policies and statutes in a uniform manner.”

FDA has a need to offer more advanced training for FDA staff of varying duration and complexity. For example, expertise needs to be presented in the import and compliance areas, advanced applications of the FD&C Act and expertise pertaining to commodity assets that the FDA regulates, such as veterinary medicine, drugs, device, foods, and regulatory actions pertaining to the law such as seizures and injunction actions, etc.

C.2 - Scope of Work

The contractor shall supply necessary qualified personnel to provide instructional courses. The estimated number of courses for each FDA Center is as follows:

Base Year Maximum Number of Courses Base Year

Content covered includes: food and drug law, basic and advanced import regulations, courtroom testimony, injunction, seizure, and aspects of the law pertaining to a particular commodity area, for example; device, drug, foods, biologics, veterinary medicine, etc.

These courses will be held at multiple government selected sites for approximately 40 – 60 FDA employees per course. The government reserves the right to record any course delivered under this contract.

Courses to be instructed under this contract include:

The Basic Food and Drug Law Course: Presentations will be conducted Monday through Thursday 8:00am to 5:00pm with a Thursday review session from 5:30pm to 7:30pm. On Friday, the contractor shall provide an additional course instruction and opportunity for review and final clarifications from approximately 8:00am 2pm, followed by a two hour test and time allotted for test review. As a result of participating in this course, the participant will be able to:

· Recognize the structure of the FD & C Act.

· Determine what are food, drug, cosmetic, device, food additive, dietary supplement and biological products under the applicable statutes.

· Recognize how relevant cases are presented in federal court and how precedent decisions impact Agency actions.

· Differentiate between FDA Policy, Regulation and Law.

· Identify the enforcement tools provided for under the statutes enforced by FDA.

· Recognize the basic elements that must be developed to initiate import actions, seizure, injunction, criminal penalties and license suspension or revocation for various violations of the statutes enforced by FDA.

· Recognize how products may be violative under the statutes enforced by FDA.

· Identify the statutory basis for inspectional and sampling authority.

Compliance Law course: Presentations will be conducted Monday through Friday 8:00am to 5:00pm with Thursday review session from 5:30pm to 7:30pm.

This course is a review of the FD&C Act and the new statutory obligations, amendments and updates as well as general discussions regarding court versus administrative actions. Case studies will reinforce the principles and concepts taught in the lecture. This is a dynamic learning experience designed to build upon the knowledge and experience of the participants. One optional review session is offered in the evening but is not mandatory for FDA participants.

Objectives: Upon completion of the course, participants will be able to:

· Explain the statutory structure of the FD&C Act and determine the elements that can be used in court to support legal actions.

· Identify which statutory sanctions might be applicable to different situations from both a theoretical and practical standpoint.

· Determine what are food, drug, cosmetic and devices under the statute and distinguish the differences between a food additive, an added substance, a drug and a dietary supplement.

· Explain the various statutory provisions for adulteration and misbranding of food, food additives, dietary supplements, drugs and devices, establishment inspections, sample collections, etc.

· Identify the statutory foundation for legal action recommendations.

· Identify prohibited acts and the criteria for assessing liability.

· Identify the role that FDA enforcement policy and practical considerations play in the selection of appropriate regulatory options.

· Explain precedent decisions that have impacted, may impact, or will impact Agency actions.

· Explain the introduction and conduct of FDA lawsuits through the Federal court system and how the various features of the lawsuit affect FDA activities.

· Identify the context in which a complaint for forfeiture, complaint for injunction, information, and indictment relate to regulatory options.

· Identify major legislative changes to statutes enforced by FDA since 1990.

· Identify applicable federal rules which apply to seizures and injunction.

Practical Compliance Applications course: This is a two week course. Both weeks the course runs Monday through Friday 8:00am to 5:00pm.

This course is designed for Directors of Compliance Branch (DCB) and compliance officers (CO) who perform compliance (domestic or import) work to provide them with the “practical applications” of selecting and processing certain regulatory actions. The course is designed in two parts: the first part will focus on the decision making process involved in selecting an appropriate course of action and the second part will focus on providing the practical, hands-on experience in processing seizure and injunction actions, including but not limited to: preparation, monitoring, and trial/post-trial activities. The instructional strategies will be through lectures, demonstrations, “hands-on” exercises and case studies as follows:

· Identify and analyze violations;

· Identify policy considerations;

· Consider regulatory options to arrive at a desired outcome;

· Assess jurisdiction, interstate commerce and responsibility;

· Prepare seizure and injunction recommendations and determine type and scope of seizure/ injunction; and,

· Identify the compliance officer’s role in monitoring seizure and injunction actions.

Objectives: At the end of the course, each participant will be able to…

· Select the appropriate regulatory course of action in accordance with agency guidelines and policies;

· Prepare and process seizure action; and,

· Prepare and process injunction action.

The contractor shall be requested to instruct on the following topics:

· Responsibility

· Interactions with Office of Chief Counsel

· Post Seizure Activities

· Trial and Post - Injunction Advanced Import Investigations course: Monday through Friday 8:00am to 5:00pm. Currently presentations are conducted Monday 12:15pm to 5:00pm and Tuesday 8:00am to 11:30am, however, the government reserves the right to change these times.

This course is designed to provide those who work in imports with specific skills and tools needed to make effective and equitable regulatory decisions of FDA and Customs penalty actions on violative imported products. Some of the specific skills and tools include: coverage of FDA and Customs laws and regulations, customs operations, evidence development, applied thinking, import investigations, overview of legal issues that impact imports, FDA/Customs collaborative issues and office of criminal investigations activities. Instructional strategies will be through lectures, interactive group discussions, and classroom exercises.

Objectives: At the end of the course, each participant will be able to:

· Identify available sanctions under the FD&C Act and investigate & develop evidence to support a broad range of enforcement action(s) against import violator;

· Identify available sanctions under Title 19 (US CBP administrative penalties) and investigate & develop evidence to support a broad range of enforcement action(s) against import violators; and,

· Identify and apply the principles of critical thinking to solve local import issues and problems.

The contractor shall supply instructional services as follows:

· Overview of Legal Issues that Impact Imports

· Section 801 of the Act, including the recent BTA changes

· Evidence Development

· Law and Practice; Civil vs. Criminal (Title 18 USC 2, 542, 545, 2320, 371, 1001);

· Obstruction of Justice (Title 18 USC 1505);

· Elements of Crime/Standards of Proof/Criminal Intent;

· Food and Drug Related Law

· Domestic sanctions applicable to imports, Definitions, Adulterations, Misbranding, and Prohibited Regulatory Science course: Contract services will be needed for 2 hours of presentation. Contractor shall be given 3 hours to prepare for presentation. The presentation will be conducted on Friday, approximately 8:30am to 10:30am.

The objectives of the LB236 Regulatory Science training course are to generate accurate and defensible worksheets for regulatory sample analysis; locate, comprehend, and utilize compliance programs, reference guidance documents and assignments; identify the regulatory significance of sample accountability: integrity and chain-of-custody; and apply the appropriate concepts of method selection, verification, or validation to a particular analytical situation.

The contractor shall supply instructional services as follows:

· Prepare a presentation and accompanying “mock trial” exercise that would prepare the new hire analyst for courtroom testimony in defense of analytical findings. The presentations should be approximately 1 hour in length. The classroom exercise should also be 1 hour in length.

· Deliver the PowerPoint presentation to the training officer of the course so that it can be reproduced into the training course manual.

· The contractor shall have correspondence via phone or e-mail with an analyst that will participate in the mock trial exercise at the training course. The contractor shall prepare the analyst for the exercise using mock worksheets that will be created by the contractor and provided to the analyst and the training officer at least two (2) weeks prior to the course.

· Present the 1 hour long presentation on analyst courtroom testimony and the 1 hour long mock trial exercise at the Regulatory Science course.

FDA instructors/resource persons will be used as monitors and proctors and only participate in the program where their expertise is considered necessary by FDA to fully explain current and precedent Agency policy and procedures.

a. Each course shall cover the fundamental aspects of the Food, Drug and Cosmetic (FD&C) Act and its implementing regulations, significant guidance documents, major judicial guidelines and opinions in this field, legal consequences of administrative actions and decisions, study of the government’s burden of proof in court cases, and case development. Content for some courses shall be more specific and geared to the audience needs. Example content includes: Untitled and Warning letters, Seizure, Injunction, Post Filing Activity/Coordinate Trial Preparations, Consent Decree/Order, Import Regulation, Veterinary Laws and Regulations. There shall also be summary analyses of other acts enforced by the FDA including, but not limited to:

· Public Health Security and Bioterrorism Preparedness and Response Act

· Dietary Supplement Health and Education Act

· Safe Medical Devices Act

· Generic Drug Enforcement Act

· Prescription Drug Marketing Act

· Nutritional Labeling Education Act

· Radiological Control for Health and Safety Act

· Title 18, Section 1001 Section 2 and Section 372

b. The majority of courses will be directed to students from field units who will need diversified rather than specific coverage of the FD&C Act. Some courses, however, will be conducted for specific group disciplines, i.e., students working primarily in foods, medical devices, radiological health, drugs, biologics, or veterinary medicine. The Contractor will be expected to appropriately adjust the agenda to accommodate the needs of the student audience. Times for presentation will also vary depending on the audience and material to be covered.

c. All courses outlined in this contract shall be designed by the contractor with approval of the Training Officer for the course, and the use of an updated course outline/materials provided by the Government that addresses our training needs through the use of the Government’s textbook/workbook and course materials, i.e., pre-course reading materials, quizzes and final testing mechanisms. These courses must be developed to include:

· A set of pre-course reading materials that shall be distributed by the government to the students prior to the course. The pre-course materials shall be reviewed once every six (6) months and updated and /or re-designed as appropriate by the contractor. All updates and/or re-designs must be approved by the COR. The materials should provide the students with a basic understanding of the legal concepts within which FDA’s enforcement policies and activities are framed.

· A complete course outline which shows the learning objectives established for each time module, and the identification of workshops and precedent cases to be discussed during lecture/seminar sessions.

· A complete Instructor’s Guide for each course referenced above to include: All referenced cases and case background including as much detail as possible; presentation delivery times per topic/per day; time estimates for students to complete in-class work shops including review time; etc.

· Lectures, workshops, or seminar discussion to illustrate application of the principles of the law explained during lecture presentation and plenary sessions to assure, as much as possible, a better understanding of the course content and goals through active involvement of all participants.

· An updated textbook/workbook will incorporate all information in the Governments textbook/workbook. An additional record of learning/reference material for the participants may include actual and hypothetical cases and case situations discussed or used as workshop exercises during the course. Additional information maybe added by the contractor at the discretion of the training officer and/or COR.

· Copies of multimedia aids to be used as reference material by participants.

· A testing mechanism for last day of the course, designed to measure how effectively the learning objectives established for the course have been accomplished through the administration of written questions.

· A test map that clearly indicates what material a student will need to review for the test. The test map should be clearly linked to course objectives.

· A retesting mechanism to be used in the event the student fails the test.

· A CD for each course containing all training materials to be used during the course.

d. **Note**: All course materials shall not include copyright material and will be copied and distributed for the government. All materials created will become property of the U.S. Government. All materials should be provided in Microsoft Office 2010 format (i.e. Excel, Word, PowerPoint, etc...) or using the current Government standard software products.

e. Course materials will be designed by the Contractor to meet FDA needs. The Contractor shall update these materials as directed by the Training Officer/Project Officer to reflect Agency regulations and policies and when such changes are necessitated by new Agency regulations and policies or changes affecting existing Agency regulations and policies. These changes could occur as frequently as on a monthly basis or course-to-course.

f. Each time course materials are changed the Contractor shall provide the Training Officer/Project Officer a new master copy of the materials in hard copy and on CD.

g. A review of the final test to reinforce learning objectives and clarify misunderstanding. This review will take place on Thursday evening for the Basic Food and Drug Law and Compliance Law courses. Any other necessary reviews will be scheduled at the Training Officer/Project Officer’s discretion.

h. Course content will be targeted to a specific audience, e.g. imports, veterinary medicine, medical devices, drugs; advanced applications of the Basic Food and Drug Law will be presented to the contractor at least two (2) months in advance in order for the contractor to prepare lectures and exercises based on defined objectives. The Training Officer/Project Officer will send the contractor the course agenda listing times and days of presentation. The number of hours may vary depending on course content.

i. Time spent preparing accreditation materials will be considered as part of course preparation and will not be reimbursed separately.

j. The contractor shall update all named courses semi-annually to reflect changes required by judicial rulings, agency policy changes, or other substantial development in terms of the effectiveness of the learning experience of the students as identified by evaluations and critiques.

k. FDA employees are called upon to defend regulatory actions taken against a firm in a court of law. To prepare the employees for the types of questions that may be asked of an investigator, compliance officer or laboratory analyst, the contractor shall be called upon to present a mock cross examination. The cross-examination may be filmed by FDA so that employees may have access when needed to prepare for cross examination in a trial. FDA employees will be used as trial participants. The cross-examination may be part of a course and filmed during the course or may be filmed independently to provide maximum film production.

l. The Contractor shall make his/her own transportation/reservations including hotel and rental car as authorized by the Training Officer/Project Officer (COR). Receipts and invoice must be provided to the Contracting Officer for payment.

m. Contractor shall not previously or presently be involved in lawsuits against the federal government.

n. Course content needs to be delivered using materials we have already created and is the property of the FDA. (Current MP101 course manual and most current copy of the Basic Food, Drug Law and Cosmetic Act).

SECTION D. PACKAGING AND MARKING

D.1 – Marking Instructions for Reports/Deliverables The Contractor shall mark each shipment with its organization name, contract number; item number and quantity (indicate partial or final shipment). As appropriate, Government should note on the face page of the report/deliverable and when feasible on the binding (1) “one volume only” or (2) “volume 1 of 2, volume 2 of 2” etc.

D.2 – Delivery Instructions for Reports/Deliverables Unless otherwise specified, all reports/deliverables or copies of reports/deliverables shall be delivered to:

ORA/ORM/DHRD

Attn: COR 11919 Rockville Pike

Rockville, MD 20852

SECTION E. INSPECTION AND ACCEPTANCE—N/A

F. DELIVERIES OR PERFORMANCE

F.1 Period of Period Performance

The period of performance of this contract shall be for 12 months commencing with the effective date of the contract. The Government may extend the term of this contract for an additional four-12 month option periods pursuant to Clause 52.217-9.

F.2 - Reports/Deliverables The following shall be submitted by the Contractor to the Contracting Officer’s Representative (COR), and vice versa, at the time specified.

(a) Not later than six (6) weeks prior to the start of any class:

· The contractor shall submit to the COR two (2) electronic copies of the instructor’s draft course outline that follows the agenda already provided by the government.

· The outline shall include a synopsis of any lectures of FDA cases to be discussed by the principal instructor during lecture periods, and examples of multimedia aids which the instructor prepares to illustrate focus points.

(b) Not later than four (4) weeks prior to the start of the first course:

· The approved draft outline and/or comments, synopsis, and multimedia materials shall be returned to the Contractor by the government. NOTE: The contractor shall use an appropriate method of delivery to the government to assure the timely receipt of all written material and reports.

(c) The contractor shall supply to the COR a copy of the presentation materials required to support at least two (2) weeks prior to the date of the presentation.

(d) Quarterly Report: The contractor shall provide the Contracting Officer and COR with a Quarterly Report.

The Contractor shall submit by the 10th day of the 3rd month of each contract period a Quarterly Report. The Report shall provide a description of overall progress and applicable supporting data in sufficient detail to comprehensively explain progress to date. Topics shall include:

1. Contract Number and Title, Contractor’s Name and Address, date of report

2. Number of courses delivered during quarterly reporting period.

3. Number of courses delivered for the contract period.

4. Funds expended during the current reporting period

5. Total funds remaining.

6.

Issues, concerns or recommendations that the contractor may have to offer.

SECTION G. CONTRACT ADMINISTRATION DATA

G.2 - Time of Delivery for Individual Orders The performance period/delivery dates for supplies/services ordered under this contract shall be specified on each Task Order.

G.3 - Contracting Officer’s Representative The following COR will represent the Government for the purpose of this contract:

TBD at Time of Award.

FDA

Street 1 Street 2 City/State/Zip Code

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

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

(1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

G.4 - Key Personnel HHSAR- 352.242-70, Key Personnel (JAN 2006) The performance of the work required by this contract will be conducted under the direction of:

Name

Email address

Telephone number

The following instructor(s) are designated to accomplish the training under this contract.

Instructor(s):

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

G.5

INVOICE INSTRUCTIONS

A.

Invoice Submission The Contractor shall submit invoices after receipt and acceptance of all contractual deliverables scheduled for submission during the period. Vouchers/Invoices shall not be approved without submission of the report.

The Contractor shall submit one (1) electronic copy of the invoice with required supporting documentation to the COR and CS at ______TBD________fda.hhs.gov and ____TBD_______@fda.hhs.gov. If the supporting documentation is too large for email transfer, the Contractor shall notify the COR and CS of such and send the supporting documentation to the CS at:

Contract Specialist: *(Shall be inserted at Contract award) U.S. Department Health and Human Services Food and Drug Administration Office of Acquisitions and Grants Services (OAGS) 5630 Fishers Lane, RM ___TBD_____

Rockville, MD 20857, HFA-500

(301) 827-___TBD______

The Contractor agrees to include the following information on and/or with its invoice:

· Contractor’s name, point of contact, phone number, email and address

· Signature of Contractor official to authorize invoice is proper and correct

· Invoice date, invoice number, invoice period

· Contract Number which authorizes supplies or services

· Payment terms

· Bank name of financial institution receiving payment

· Routing transit number of financial institution receiving payment

· Name, email, telephone number of person to notify in the event of defective invoice

· Taxpayer Identification Number (TIN)

· DUNS Number

· COR Name, telephone number, and email address B.

Payment by Electronic Funds Transfer

The Contractor shall submit vouchers or invoices in accordance with the FAR 52.232-25, Prompt Payment, and FAR 52.232-33, Payments by Electronic Funds Transfer – System for Award Management. The Contractor is responsible for registering and remaining active in the Central Contractor Registration database at www.ccr.gov. Payment shall be made to the Contractor’s financial institution designated in the Contractor’s System for Award Management Registration.

The Contractor shall designate a financial institution for receipt of electronic funds transfer payment. The designation shall be submitted in writing to the finance office at the following address:

Office of Financial Services

Food and Drug Administration

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

(301) 827-3745

Email address: FDAVendorPaymentsTeam@fda.gov

Questions regarding invoice payments shall be directed to FDA/OFS at FDAVendorPaymentsTeam@fda.gov or call (301) 827-3745.

G.6 - Government-Furnished Equipment, Facilities, and Materials Each FDA Center using this contract is responsible for all these duties to support their own courses.

a) Provide necessary equipment such as flip charts, overhead projector, large projection screen and lavaliere microphone.

b) Provide each student copy of the most current FD&C Act as amended: as designated by the Contractor for reference during classes.

c) Copy all course related materials such as: pre-course reading materials, course agenda, textbook/workbook (learning/reference material, workshop/class exercises, copies of multimedia aids, glossary of terms), testing mechanisms, and all other handouts required.

d) Ship all the course related materials to the course site prior to the start of the course.

e) Distribute: set of pre-course materials to students prior to course.

f) Arrange for training facility: To accommodate approximately 40-55 FDA personnel per course.

g) Arrange a block of lodging rooms: for Contractor and FDA personnel during courses which are conducted at ORA U, but may be at locations across the country.

h) Arrange for FDA instructors/resource persons to participate in the course when necessary. They can be expected to fully explain current and precedent FDA case decisions and policies.

i) The ORA Training Officer/Project Officer or coordinating office (CDRH, CVM, CTP, CFSAN, etc) will coordinate and assist with the following travel related arrangements for the Contractor.

(1) Discuss arrival and departure times with the contractor prior to the course.

(2) The Training Officer/Project Officer or the coordinating office must authorize rental car use.

(3) The contractor may use personal vehicle and claim mileage at government rates as long as it does not exceed the government airfare to the training location.

(4) The Training Officer/Project Officer will include the Contractor’s name on the hotel rooming list, when applicable, but Contractor will be responsible for making his/her own hotel reservations and confirmations.

SECTION H. SPECIAL CONTRACT REQUIREMENTS

H.1 Placing and Processing Orders FAR 12.6-03 (a) 2(iii)

1. All work shall be initiated by issuance of fully executed orders issued by the Contracting Officer. The work to be performed under these orders must be within the scope of the contract. The Government is only liable for services expended under the terms and conditions of this contract to the extent that a fully executed order has been issued and covers the required work and costs. Charges for any work not authorized shall be disallowed.

2. Content of Order: Each order placed under this contract will include the following minimum information:

· The contract number, order number, and date of order.

· Applicable accounting and appropriation data and special invoicing instructions where applicable.

· Item number and description, quantity and unit price.

· Delivery or performance date.

· Place of delivery or performance.

· Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

3. For each order under the contract, the Contracting Office shall send a request for proposal to the contractor. The request will contain a detailed description of the courses required.

4. The contractor shall submit a proposal confirming their acceptance to deliver the identified courses and defining the travel estimate required to complete the order.

5. Within 10 business days after receipt of each order, or as otherwise indicated by the Contracting Officer for each order, the Contractor shall sign and return one copy of the order to the Contracting Officer.

6. Task orders will be considered fully executed upon signature of the Contracting Officer. The contractor shall begin work on the order in accordance with the effective date of the order.

7. The contractor shall notify the Contracting Officer of any instructions or guidance given that may impact the cost, schedule or deliverables of the order. A formal modification to the task order must be issued by the Contracting Officer before any changes can be made.

8. Orders may be placed during the period of performance of the contract. Prices applicable to performance of an order will be the contract prices in effect at the time the order is issued.

H.2 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

H.3 FDA Holidays

FDA personnel observe the following days as holidays:

New Year’s Day

Martin Luther King’s Birthday

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans’ Day

Thanksgiving Day

Christmas Day

Any other day designated by Federal statue

Any other day designated by Executive Order

Any other day designated by the President

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract.

Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor will direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies.

H.4 System for Award Management Registration

In accordance 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.

(5) Definitions.

“Registered in the SAM database” means that-

(5) 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, “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-

(5) 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 nonprocurement 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-

(5) 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/ H.5 Organizational Conflict of Interest

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and…