RFP for Capacity Bldg.doc

10-223-SOL-00169

TABLE OF CONTENTS

PART I- THE SCHEDULE

Pages

SECTION A-

STANDARD FORM 33

1-2

SECTION B-

SUPPLIES OR SERVICES PRICES/COSTS

SECTION C-

DESCRIPTION/SPECIFICATIONS 4-10

/STATEMENT OF WORK

SECTION D- PACKAGING AND MARKING

SECTION E- INSPECTION AND ACCEPTANCE

SECTION F- DELIVERIES OR PERFORMANCE

SECTION G- CONTRACT ADMINISTRATION DATA

12-15

SECTION H- SPECIAL CONTRACT REQUIREMENTS

16-27

PART II - CONTRACT CLAUSES

SECTION I- CONTRACT CLAUSES

28-36

PART III - LIST OF DOCUMENTS, EXHIBITS,

AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS 37

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K- REPRESENTATIONS, CERTIFICATIONS, AND OTHER 38

STATEMENTS OF OFFERORS OR RESPONDENTS

SECTION L- INSTRUCTIONS, CONDITIONS, AND

38-48

NOTICES TO OFFERORS AND RESPONDENTS

SECTION M-

EVALUATION FACTORS FOR AWARD

49-52

SECTION B–

SUPPLIES OR SERVICES PRICES/COSTS

B-1 Description of Services The Food and Drug Administration (FDA) has a requirement for the performance of a comprehensive assessment to determine capability of educational and training in the international arena that is in alignment with the FDA’s mission areas, where overlaps in capacity building training exist, and where current and future gaps in capacity building training may exist.

The Contractor shall provide fixed-pricing for the deliverables below for each description :

· See SOW C.4.1. through C.4.5. (pps. 3-6)

· See Deliverable 1-8 (pps. 9-10)

· See SOW C.4.1. [p. 3](ongoing Project Management), C.4.7 [p. 7], and C.4.8. [p. 8].

· See Deliverable 1 (monthly project reports) 9-10 [p.10]

· See SOW C.4.1.[p3] (ongoing Project Management), C.4.7 [p. 7], and C.4.8 [p.8]

· See Deliverable 1 (monthly project reports), and 11-15 [p. 10]

SECTION C- DESCRIPTIONS/SPECIFICATIONS

C.1 Background

The U.S. Food and Drug Administration (FDA) through its Office of International Programs (OIP) is performing a comprehensive capacity assessment of existing education and training programs and an analytical evaluation of these programs that are taking place around the globe primarily for government regulatory personnel and industry in areas that align with FDA’s mission and regulatory remit. With this information and data, FDA expects to better understand what educational and training efforts exist, what educational and training strategies work well, which methods and modalities work best for what circumstances, and what are the costs associated with the various trainings.

FDA’s responsibilities have increased greatly in recent years, as globalization, emerging areas of science, and evolving technologies present the Agency with unprecedented challenges and opportunities. As FDA increases its global engagement, requests for education and training – seminars, workshops, technical/scientific conferences, teaching forums, lectures, web-based courses and other learning mechanisms – will increase significantly in those areas that relate directly to FDA’s mission and goals.

C.2 Objectives The objective of this assessment is to clearly understand the range and scope of the current capacity of educational and training environments around the globe in areas that align well with FDA’s mission to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food and feed supply, cosmetics, products that emit radiation and tobacco products. As part of increasing FDA’s understanding of the global capacity of the educational and training landscape, the Agency also needs to understand what works well (and less well) to improve the global public health, which learning methodologies and modalities work best for what circumstances, and the associated costs for each.

To gain this understanding, the Government is performing a comprehensive assessment to determine capacity of educational and training in the international arena that is in alignment with the FDA’s mission areas, where overlaps in capacity building training exist, and where current and future gaps in capacity building training may exist.

C.3 Scope C.3.1 Services

The scope of this contract includes the full range of technical, engineering and management services required to conduct a comprehensive assessment and report on the international capacity of educational and training programs.

C.3.2 Supplies

The scope of this contract does not include the delivery of supplies, hardware, or software to the Government.

C.3.3 Development and Delivery

The scope of this contract includes the development, configuration, and delivery of data and information within standard industry document, spreadsheet, database, formats.

The scope of this contract does not include the development of software or hardware.

C.3.4 Testing / Independent Verification and Validation (IV&V)

The scope of this contract does not include testing or IV&V.

C.3.5 Compliance with Standards (Security, Privacy, Testing)

This contract requires the Contractor pursuant to Federal and HHS Information Security Program Policies, and any subcontractor performing under this contract to comply with the following requirements:

C.3.5.1 Contractor-Employee Non-Disclosure Agreements

Each Contractor/Subcontractor employee who may have access to non-public Department information under this contract shall complete the Commitment to Protect Non-Public Information - Contractor Agreement:

http://nitaac.nih.gov/downloads/ciosp2/Contractor_Employee_Non-Disclosure.doc.

A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer prior to performing any work under the contract.

C.3.5.2 Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of this contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the task order is of a sensitive or of pre-decisional nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer or designee (e.g., COTR). Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer or designee (e.g., COTR).

C.3.5.3 Contractor and Subcontractor Staff

The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) performing work under this contract. The roster submitted to FDA shall be submitted to the COTR, with a copy to the Federal Contracting Officer, within two business weeks of the effective date of this contract.

C.4 Detailed Tasks / Activities

C.4.1 Project Planning

The assessment of the international capacity of educational and training in the international arena that is in alignment with the FDA’s mission areas shall be performed in three stages to be completed in nine months. The Contractor shall develop and deliver an Education and Training Capacity Building Global Assessment (ETCBGA) Project Plan. This plan shall include:

· Stage 1: The Contractor shall identify and deliver to the FDA for approval:

· Contractor’s organizational structure and responsibilities for key members of the organization.

· Schedule of all required activities (tasks) and deliverables with adequate time allotted for Government review and comment for deliverables.

· Resources required to accomplish each task, including an estimate of the funding required and expected government furnished equipment (GFE), property (GFP), and information (GFI).

· The draft assessment population assessment matrices (other government, multilateral organizations, and-non-government organizations, (e.g. United Nations technical agencies, etc.), academia, for-profit sector, and other (e.g. mixed sector organizations, etc.) see Section 4.3

· The Contractor’s strategy for leveraging internet portals for data collection and knowledge repository (internet portal for organizations to submit learning programs for inclusion in the ETCBGA)

· Draft matrix of areas of investigation (e.g. organization, location, funding, curriculum modality, types of trainees, etc.)

· Draft evaluation criteria assessment matrix (e.g. cost, effectiveness, duration, etc.)

· Draft matrix of potential risks and issues that may impact the successful completion of the ETCBGA and the Contractor’s recommended mitigation plan

· Contractor’s approach for conducting the ETCBGA including an outline of the Contractor’s proposed ETCBGA Report

· Contractor’s approach for the electronic delivery the ETCBGA to allow the FDA to search/assess ETCBGA data (e.g. searchable database delivered on a stand-a-lone DVD, development of a web-based knowledge repository or portal), see Section 4.6.5.

· Stage 2: The Contractor shall deliver to the FDA for approval:

· Contractor’s draft ETCBGA Report.

· Contractor’s draft electronic ETCBGA allowing the FDA to search/assess ETCBGA data

· Update report on ETCBGA risks and issues the Contractor encounter that may impact the ETCBGA and the Contractor’s recommended mitigation plan

· Stage 3: The Contractor shall deliver to the FDA for approval:

· Education and Training Capacity Building Global Assessment Report

· Contractor’s delivery of the electronic ETCBGA allowing the FDA to search/assess ETCBGA data

· Final report on ETCBGA risks and issues the Contractor encountered that influenced the ETCBGA and lessons learned during the assessment project.

· As necessary, support to FDA users on how to use the electronic ETCBGA.

C.4.2 Define Scope of Education and Training Capacity Building Global Assessment Report (ETCGBAR) Project The Contractor shall provide the scope of the International Education and Training Capacity Building Global Assessment (ETCBGA) Project. The Contractor’s assessment shall include the following FDA mission areas and address FDA stakeholder needs and priorities. The Contractor shall document the scope of the assessment in the ETCBGA Report.

The FDA has identified the following mission areas where international capacity education and training would be most relevant in terms of its own global engagement, and where FDA expects overlap to exist:

· Good Practices. “Good” agricultural practices, manufacturing practices, clinical practices, laboratory practices, pharmacovigilance practices for human and animal drugs, aquacultural practices, and veterinary practices, good review practices and good regulatory practices, etc.

· Inspection Practices and Methodologies. Education and training that targets strengthening an inspectorate and inspection practices within a country, in the areas of foods, feeds, medical products, vaccines/biologics, and medical devices.

· Labeling. Proper food, feed, and nutrition labeling as well as medical product labeling.

· Supply Chain Management Systems. Protect against counterfeit and contaminated foods, feeds and medical products, and ensure safety and efficacy throughout product lifecycle.

· Quality and Risk Management. The various elements that underpin quality management systems and risk management frameworks within the context of FDA-regulated products.

· Standards and Guidelines. FDA standards and guidance (e.g., ICH, VICH, OIE and Codex guidelines) that are pertinent to FDA’s regulatory mission.

· Data Quality. The verification and validation of performance data and related data issues, including the completeness and reliability of the data.

· Preclinical Study Design. Clinical trial design, data integrity and data interpretation.

C.4.3 Identify Sources

The Contractor shall identify potential suppliers around the globe of acceptable capacity education and training in alignment with the previously defined scope, priorities, and stakeholder needs. The Contractor shall document the sources for the assessment in the ETCBGA Report.

The Government has identified the following potential sources as examples; however, the Contractor is not limited to these sources.

There are governments, multi-country consortia, international and other organizations, FDA-regulated industry sectors and academia that are performing similar types of training within the foods/feed/medical and veterinary products/biologics/cosmetics regulatory context, resulting in a duplication of efforts and dilution of scarce resources. In terms of governments, this includes the large donor governments such as the United States, United Kingdom, Canada, the European Union, Australia, and Japan, among others.

Regarding organizations, there are a number of multilateral organizations, multi-country consortia, scientific societies, non-governmental organizations, and foundations that provide training as part of their overall mission, in areas that align closely with FDA’s regulatory portfolio. Examples include, but are not limited to, the World Health Organization and its regional offices, including the Pan American Health Organization; the Food and Agriculture Organization (FAO), the World Animal Health Organization (OIE); the Asia Pacific Economic Cooperation (APEC); the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S); International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medical Products (VICH); U.S. Pharmacopeia, the Drug Information Association, and the World Trade Organization (WTO’s), e.g., WTO’s Standards Development and Trade Facility, among others. Sectors of industry provide some training at the country level, and in some sub-areas of the globe, e.g., Central America, it is not uncommon for academia or mixed sector organizations to play a role in training in areas where FDA has equities, as many governments may lack the capacity.

C.4.4 Survey the Suppliers

The Contractor shall conduct a survey of the previously identified suppliers for international capacity building education and training.

At a minimum, the Contractor’s survey shall include the application of a comprehensive, analytical, systematic review that would identify the current education and training activities and programs that are taking place around the globe in areas that align well with FDA’s mission, identify types of person (s) being trained or educated, would assess what works well, would describe which learning methods and modalities work best for what circumstances, and would provide information about the associated costs for providing the training.

At a minimum, the Contractor’s methodology shall include surveys, references, mailings, telephone outreach, literature searches, Internet searches, other types of reviews/analyses, and other forms of engagement with relevant stakeholders.

The contractor shall provide a written description of the methodology(ies) to be applied in this systematic review in the ETCBGA Report prior to the initiation of the review itself and FDA must concur with the approach.

At the conclusion of the supplier survey, the Contractor shall document the initial findings in the ETCBGA Report.

C.4.5 Check References

The Contractor shall contact current users of candidate international capacity building learning programs and methodologies to provide a better understanding of quality and performance of the programs with respect to the supplier’s claims and documentation.

The Contractor shall document the references used and the results of the references check in the ETCBGA Report.

C.4.6 Evaluate Candidates

Based on the information gathered from the previous assessment activities, the Contractor shall apply the previously approved methodology to complete the assessment.

C4.7 ETCBGA Report

The Contractor shall document the results of the evaluation in the ETCBGA Report. At a minimum, the report shall contain a detailed and comprehensive situational analyses of the training that currently exists globally, and offer options for FDA’s consideration on ways, in concert with other learning stakeholders, FDA stakeholders can work together to address and cover its collective educational/training programs and their impact, in a sustainable, measurable way, in support of the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the global food and feed supply, cosmetics, products that emit radiation and tobacco products.

The report shall contain a description of an evidence-based approach and methodology (ies) applied for data collection, including collection of the following types of data elements.

a) Broad situational analyses (with appropriate citations) that describe (a) current learning needs, (b) the modalities and methods that work well/less well for which circumstances, (c) current learning environment and (d) types of persons being trained or educated;

b) Major stakeholders that are involved in education and training and their purpose for engagement;

c) Resources that contribute to current learning programs (e.g., human and financial resources);

d) Types and modalities of learning provided (e.g. education vs. training; classroom vs. distance learning; etc.);

e) Trends in gaps and duplication of efforts, and

f) Analyses of where other learning efforts either align well or intersect with FDA priorities.

g) Any information that assesses the effectiveness of any of the education and training activities and programs.

The report shall identify current education and training efforts and investments in capacity building around the globe, and based on these, should provide an analysis of gaps and duplicated efforts, identification of entities best positioned or suited to perform specific types of learning modalities, especially for sustainability over time. Data sources and methodologies used for analyses, options, and recommendations shall be clearly identified.

The Report shall identify frameworks/situations in which learning needs emanate from the country level and an organization that works to help country(ies) meet their identified learning needs. For example, this modality is applied through the InterAmerican Cooperation on Agriculture’s performance, vision and strategy (PVS), a strategy that assists countries in the Americas to establish their education and training priorities, e.g., the PVS for national food safety.

Based on the data, the Contractor’s report shall also present options and recommendations on ways the FDA, in concert with other major stakeholders in the area of building education and training capacity (in the regulatory areas described above), can best address the needs and challenges of building learning capacity for government regulators and industry globally that would best meet FDA’s public and animal health missions and goals while improving global regulatory learning capacity overall.

The Contractor shall provide recommendations as to how FDA, in concert with other education stakeholders, can work together to address and cover its collective learning reach and impact -- in a sustainable, measurable way -- in support of assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food and feed supply, cosmetics, products that emit radiation and tobacco products.

Based on the Contractor’s review and knowledge of FDA regulatory equities, the Contractor shall identify possible niche role(s) for FDA to build education and training capacity around the globe.

C.4.8. Electronic ETCBGA Report ~ Searchable Data

The Contractor shall provide the ETCBGA Report electronically to allow the FDA to search/assess ETCBGA data in an industry-standard searchable format. At a minimum, the information provided shall include but not be limited to:

a) Name of Organization

b) Address of Organization

c) Primary Person Contacted, including Name, Person’s Title and Organizational Unit, Phone, Fax, and E-mail.

d) Organization’s Areas of Education and Training (that intersects or aligns with FDA priorities as described in this SOW)

e) Date of Contact

f) Date of information updates (last date of data insertion)

g) Geographic areas of focus where training is performed, including city, country, and geographic coverage area

h) Number/frequency of training performed

i) Learning types and area(s) of focus (pertinent to FDA areas as described above)

j) Types of participants, e.g., what types of attendees are targeted, and their educational level, their professional experience, their position of responsibility and employment, etc.

k) Numbers of persons participating in the learning event (with an ability to tally by organization and compute overall totals)

l) Types of learning faculty; e.g., their educational background and experience, their position of responsibility and employment, etc.

m) Types of evaluation (e.g. Kirkpatrick Level 1, 2 and 3 evaluations)

n) Learning Investment – by learning costs (human and financial resources) C.5 Schedule and Deliverables The timeline for the nine-month project deliverables are shown in Table 2:

Updates will be included in Contractor’s monthly report Electronic Delivery

Microsoft Word & Project Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Updates will be included in Contractor’s monthly report Electronic Delivery

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Microsoft Word Yes

Format based on approved method proposed in project plan Yes

Microsoft Word

Microsoft Project Yes

Support not to exceed the end of the period of performance.

C.6 Acronym List

[SPACE INTENTIONAL LEFT BLANK]

SECTION D- PACKAGING AND MARKING

D.1 Marking Instructions for Reports The Contractor shall use the instructions in C.4.8 for submitting all reports.

SECTION E- INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at the U.S. Food and Drug Administration, Division of Operations Contracts, 5630 Fishers Lane, Room 2129, HFA-500, Rockville, Maryland 20857-0001.

52.252-2 Clauses incorporated by Reference (Feb 1998)

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

http://www.acqnet.gov/ 52.246-3 Inspection of Services- Fixed Price (Aug 1996)

[SPACE INTENTIONALLY LEFT BLANK]

SECTION F- DELIVERIES OR PERFORMANCE

F.1. Reports/Deliveries

The Contractor shall submit the reports/deliverables found in the table in Section C.5 of this solicitation:

Unless otherwise specified, all reports or copies of reports shall be delivered to:

Department of Health and Human Services

U.S. Food and Drug Administration

Division of Operations Contracts

Attn: London Johnson

5630 Fishers Lane, Room 2129, HFA-500

Rockville, Maryland 20857

F.2. Period of Performance

Performance of this contract shall begin on (TBA) and shall not extend beyond nine months.

F.3. 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es):

http://www.acqnet.gov/ 52.242-15 Stop Work Order (Aug 1989)

52.242-16 Government Delay of Work (Apr 1984)

SECTION G- CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer’s Technical Representative (COTR)

The following COTR will represent the Government for the purpose of this contract: [TO BE NAMED AT THE TIME OF AWARD]

The COTR is responsible for the following:

1) Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements

2) Interpreting the Statement of Work and any other technical performance requirements

3) Performing technical evaluation as required

4) Performing technical inspections and acceptances required by this contract

5) Assisting in the resolution of technical problems encountered during performance

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to; (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contract or any costs incurred during the performance of this contract; and (5) change any terms and conditions of this contract The Government may unilaterally change its COTR designation.

G.2. FDA 1137 Invoice Submission (F-P)

The Contractor shall submit vouchers or invoices in accordance with the following FAR Clauses: 52.232-25 Prompt Payment (Oct 2008) and 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003); in accordance with the following instructions.

A. In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration, Office of Financial Services, Systems Accounting Branch, HFA-720, 12345 Parklawn Drive, Rockville, MD 20857 no later than 14 days prior to submission of the first invoice:

A.

THE CONTRACTOR SHALL SUBMIT ALL INVOICES TO ALL ADDRESSEES IN THE MANNER SPECIFIED BELOW:

(I) ONE ORIGINAL AND ONE COPY TO THE APPROVING OFFICIAL:

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS AND GRANTS SERVICES

ATTN: LONDON JOHNSON, COTR

5630 FISHERS LANE

ROOM 2101

ROCKVILLE, MARYLAND 20857

E-mail: LONDON.JOHNSON@FDA.HHS.GOV

*** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, AND E-MAIL

(II) ONE COPY TO THE CONTRACTING OFFICER TECHNICAL REPRESENTATIVE (COTR) OR OTHER PROGRAM CENTER/OFFICE DESIGNEE, CLEARLY MARKED “COURTESY COPY ONLY”:

*****TO BE ANNOUNCED UPON AWARD***

*** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, OR E-MAIL

B.

INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER – CENTRAL CONTRACTOR REGISTRATION) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN. TO CONSTITUTE A PROPER INVOICE, THE INVOICE MUST BE SUBMITTED ON COMPANY LETTERHEAD AND INCLUDE EACH OF THE FOLLOWING:

(I) NAME AND ADDRESS OF THE CONTRACTOR;

(II) INVOICE DATE AND INVOICE NUMBER;

(III) PURCHASE ORDER/AWARD NUMBER;

(IV) DESCRIPTION, QUANTITY, UNIT OF MEASURE, UNIT PRICE, AND EXTENDED PRICE SUPPLIES DELIVERED OR SERVICES PERFORMED, INCLUDING:

(a) PERIOD OF PERFORMANCE FOR WHICH COSTS ARE CLAIMED;

(b) ITEMIZED TRAVEL COSTS, INCLUDING ORIGIN AND DESTINATION;

(c) ANY OTHER SUPPORTING INFORMATION NECESSARY TO CLARIFY QUESTIONABLE EXPENDITURES;

(V) SHIPPING NUMBER AND DATE OF SHIPMENT, INCLUDING THE BILL OF LADING NUMBER AND WEIGHT OF SHIPMENT IF SHIPPED ON GOVERNMENT BILL OF LADING;

(VI) TERMS OF ANY DISCOUNT FOR PROMPT PAYMENT OFFERED;

(VII) NAME AND ADDRESS OF OFFICIAL TO WHOM PAYMENT IS TO BE SENT (MUST BE THE SAME AS THAT IN THE PURCHASE ORDER/AWARD, OR IN A PROPER NOTICE OF ASSIGNMENT);

(VIII) NAME, TITLE, AND PHONE NUMBER OF PERSON TO NOTIFY IN EVENT OF DEFECTIVE INVOICE;

(IX) TAXPAYER IDENTIFICATION NUMBER (TIN);

(X) ELECTRONIC FUNDS TRANSFER (EFT) BANKING INFORMATION, INCLUDING ROUTING TRANSIT NUMBEROF THE FINANCIAL INSTITUTIONRECEIVIN PAYMENT AND THE NUMBER OF THE ACCOUNT INTO WHICH FUNDS ARE TO BE DEPOSITED;

(XI) NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER TECHNICAL REPRESENTATIVE (COTR) OR OTHER PROGRAM CENTER/OFFICE POINT OF CONTACT, AS REFERENCED ON THE PURCHASE ORDER;

(XII) ANY OTHER INFORMATION OR DOCUMENTATION REQUIRED BY THE PURCHASE ORDER/AWARD.

(XIII) CONTRACTOR IS □ IS NOT □ REQUIRED TO ATTACH AN INVOICE LOG ADDENDUM TO EACH INVOICE WHICH SHALL INCLUDE, AT A MINIMUM, THE FOLLOWING INFORMATION FOR CONTRACT ADMINISTRATION AND RECONCILIATION PURPOSES:

(a) LIST OF ALL INVOICES SUBMITTED TO DATE UNDER THE SUBJECT AWARD, INCLUDING THE FOLLOWING:

(1) INVOICE NUMBER, AMOUNT, & DATE SUBMITTED

(2) CORRESONDING PAYMENT AMOUNT & DATE RECEIVED

(b) TOTAL AMOUNT OF ALL PAYMENTS RECEIVED TO DATE UNDER THE SUBJECT CONTRACT OR ORDER

(c) AND, FOR DEFINITIZED CONTRACTS OR ORDERS ONLY, TOTAL ESTIMATED AMOUNTS YET TO BE INVOICED FOR THE CURRENT, ACTIVE PERIOD OF PERFORMANCE

C.

AN ELECTRONIC INVOICE IS ACCEPTABLE IF SUBMITTED IN ADOBE ACROBAT (PDF) FORMAT. ALL ITEMS LISTED IN (I) THROUGH (XII) OF THIS CLAUSE MUST BE INCLUDED IN THE ELECTRONIC INVOICE. ELECTRONIC INVOICES MUST BE ON COMPANY LETTERHEAD AND MUST CONTAIN NO INK CHANGES AND BE LEGIBLE FOR PRINTING.

D.

QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA PAYMENT OFFICE AT:

FDA/OC/OA/OFO/OFS

ATTN: DIVISION OF PAYMENT SERVICES

12345 PARKLAWN DRIVE, HFA-720

301.827.3742 OR 866.807.3742

fdavendorpaymentsteam@fda.gov

ROCKVILLE, MARYLAND 20857

G.3. Technical Direction A. Performance of the work under this contract shall be subject to the technical direction of the COTR. The term “technical direction is defined to include the following:

1. Technical directions to the Contractor which shift work emphasis between work areas or tasks require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work

2. Providing information to the Contractor for assistance in the interpretation of drawings, specifications, or technical portions of the work description

3. Review and where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

B. Technical Direction must be within the scope of work stated in the contract. The COTR does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled “Changes” (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the COTR or shall be confirmed by him or her in writing within five (5) working days

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the COTR in the manner prescribed by this clause and within his or her authority under the provisions of this clause E. If, in the opinion of the Contractor, any instruction or direction issued by the COTR is within one of the categories as defined in B.(1) through B.(4) above, the Contractor shall not proceed but shall notify the Contracting Office, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his or her opinion, the technical directions are within the scope of this clause and do not constitute a change under the “Changes” clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled “Disputes”.

G.4. Key Personnel

The individuals cited below are key personnel. (See “Key Personnel” clause in Part II, Section I):

Name:

Title

(To be announced)

(To be announced)

SECTION H- SPECIAL CONTRACT REQUIREMENTS

H.1. FDA 1335 Personnel Security Clearance Requirements FDA 1335 Personnel Security Clearance Requirements (Aug 2006)

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b.. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 1.

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed:

a. Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who will work in a field office will submit fingerprints to:

Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

1. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

· Review of prior Government/military personnel records;

· Review of FBI records and fingerprint files;

· Searches of credit bureaus;

· Personal interviews; and

· Written inquiries covering the subject's background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Project Officer.

3 PRELIMINARY CHECK (NCIC AND CREDIT BUREAU CHECK)

Prior to commencement of work, the Government will perform, at a minimum, an inquiry through the National Crime Information Center (NCIC) and a credit check through an appropriate credit bureau entity for all contractor employees identified in the contract.

Personnel Security Staff will notify the Contracting Officer, in writing, of the results of the preliminary check. Notification will be given by the Contracting Officer to the contractor to commence work with those individuals who have been cleared. Individuals who receive an unfavorable preliminary report shall not perform work under this contract, unless FDA determines that a background investigation will be conducted and the Contracting Officer has notified the contractor in writing of this determination. Within 10 calendar days of this notification the contractor will be required to submit the additional security forms specified in Chart A for those individuals.

An individual who receives an unfavorable report may, upon written request to Personnel Security Staff, obtain a copy of the report.

4. NON-PUBLIC DATA PROTECTION

The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

CHARTS A & B ARE APPENDED TO THIS CLAUSE

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE POSITIONS - LEVEL 1

FROM

TO

DATE REQUIRED

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

in contract file Ten (10) calendar days prior to commencement of work

temporary *Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

(301) 796-4601, -4597, -4595 Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 796-4607

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

(301) 796-4598, -4762 Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201

Silver Spring, MD 20993

Hours 8:00 a.m. -11: a.m. and

1:00 p.m.-3:00 p.m. Mon-Fri

No appointment necessary

(301) 796-4607

CHART B

Public Trust Positions - Levels 5 or 6

FROM

TO

DATE REQUIRED

SF 85P - Questionnaire for Public Trust Positions

Online via OPM’s e-QIP system

of work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 796-4607

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

(301) 796-4598, -4762 Ten (10) calendar days prior to commencement of work

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

10903 New Hampshire Ave.

Bldg 1, Room 1201 HFA 630

Silver Spring, MD 20993

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.