Commercial RFP.doc

Clinical Data Interchange Standards Consortium (CDISC) FDA-SOL-08-00570

Study Data Tabulation Model (STDM) Training Standard Form 1449

TABLE OF CONTENTS

FDA-SOL-08-00570

Solicitation/Contract/Order for Commercial Items

PART A:

Addendum – Continuation of SF-1449

PART B:

Addendum to FAR Clause 52.212-4 – Contract Terms and Conditions – Commercial Items (By Reference)

PART C:

FAR Clause 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items

PART D:

ATTACHMENTS

1. Statement of Work

2. Wage Determination Under the Service Act

3. Contractor’s Non-Public Information (NPI) Agreement

PART E:

Addendum to FAR Clause 52.212-1 – Instructions to Offerors – Commercial Items

PART F:

FAR Clause 52.212-2 – Evaluation-Commercial Items, Or Other Description of Evaluation Factors for Award, If Used

PART G:

PART A:

Continuation of SF-1449, Prices/Performance/Cost Addendum

PRICING SCHEDULE

Base Period: 12 Months from Contract Award CDISC STDM Training

Total

Total

Training Sessions

Training Sessions

Option Year One (1): 12 Months from Exercise of Option CDISC STDM Training

Total

Total

Training Sessions

PART B:

FAR 52.212-4 – Contract Terms and Conditions- Commercial Items Addendum

FAR CLAUSES

B.1

CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE, as provided herein. See FAR 52.252-2 for an Internet address (if specified) for electronic access to the full text of a clause.

NUMBER

TITLE

DATE

52.212-2

EVALUATION – COMMERCIAL ITEMS

JAN 1999

52.212-4

CONTRACT TERMS AND CONDITIONS

FEB 2007

– COMMERCIAL ITEMS

52.217-5

EVALUATION OF OPTIONS

JUL 1990

B.2

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days of the end of the contract.

B.3

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

B.4

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

http://www.AGENCY.gov http://www.AGENCY.gov/offices/cpo/AGENCYar.cfm http://www.arnet.gov/far/loadmainre.html

Health and Human Services Agency Clauses

B.5

INSURANCE REQUIREMENTS

A.

The Contractor shall, at his own expense, procure and maintain, during the entire performance period of this contract, insurance of at least the kinds and amounts set forth below:

1.

Worker's Compensation and Employer's Liability:

Contractors are required to comply with applicable Federal and State worker's compensation and occupational disease statutes. Employer's liability coverage of at least $100,000 shall be required except in states with exclusive or monopolistic funds that do not permit worker's compensation to be written by private carriers.

2.

General Liability:

Contractors are required to have bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

3.

Automobile Liability:

The Contractor is required to have automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operated in the United States shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

B. At all times during performance, the Contractor shall maintain with the Contracting Officer a current Certificate of Insurance showing at least the insurance required by the Schedule, and providing for thirty (30) days written notice to the Contracting Officer by the insurance company prior to cancellation or material change in policy coverage.

B.6 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT AND VEGETATION (APR 1984) (FAR 52.237-2)

The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the Government installation. If the Contractor's failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the Contracting Officer directs. If the Contractor fails or refuses to make such repair or replacement, the Contractor shall be liable for the cost, which may be deducted from the contract price.

[This space intentionally left blank] B.7 Reporting Matters Involving Fraud, Waste, and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

For the latest information regarding fraud and abuse, please visit the HHS Inspector’s General web site at http://oig.hhs.gov/.

B.8 Definitions (January 2006) (HHSAR 352.202-1)

(a) The term "Secretary" or "Head of the Agency" (also called "Agency Head") means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term "his/her duly authorized representative" means any person, persons, or board authorized to act for the Secretary."

(b) The term "Project Officer" means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract."

B.9 Withholding of Contract Payments (January 2006) (HHSAR 352.232-9)

Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays’’ or ‘‘Default’’, as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

B.10 Excusable Delays (January 2006) (HHSAR 352.249-14)

(a) Except with respect to failures of subcontractors, the Contractor shall not be considered to have failed in performance of this contract if such failure arises out of causes beyond the control and without the fault or negligence of the Contractor.

(b) Such causes may include, but are not restricted to, acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Contractor. If the failure to perform is caused by the failure of a subcontractor to perform, and if such failure arises out of causes beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either of them, the Contractor shall not be deemed to have failed in performance of the contract, unless:

(1) The supplies or services to be furnished by the subcontractor were obtainable from other sources,

(2) the Contracting Officer ordered the Contractor in writing to procure such supplies or services from such other sources, and

(3) the Contractor failed to comply with such order.

Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of such failure and if the Contracting Officer determines that any failure to perform was caused by circumstances beyond the control and without the fault or negligence of the Contractor, the delivery schedule shall be revised accordingly, subject to the rights of the Government under the termination clause contained in this contract. (As used in this clause, the terms ‘‘subcontractor’’ and ‘‘subcontractors’’ mean subcontractor(s) at any tier.)

B.11 Pricing of Adjustments (Jan. 2001) (HHSAR 352.270-4)

When costs are a factor in determination of a contract price adjustment pursuant to the "Changes" clause or any provision of this contract, such costs shall be determined in accordance with the applicable cost principles and procedures set forth below:

B.12 Anti-Lobbying (January 2006) (HHSAR 352.270-10)

Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

B.13 Privacy Act (January 2006) (HHSAR 352.270-11)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term ‘‘system of records’’ means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as HHS employees. These provisions also apply to all subcontracts awarded under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work to be performed by the Contractor; and (b) specifies the disposition to be made of such records upon completion of contract performance.

B.14 Tobacco-Free Facilities (January 2006) (HHSAR 352.270-13)

In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with this policy.

B.15 Crime Control Act of 1990-Reporting of Child Abuse (January 2006) (HHSAR 352.270-17)

Public Law 101-647, also known as the Crime Control Act of 1990 (Act), imposes responsibilities on certain individuals who, while engaged in a professional capacity or activity, as defined in the Act, on Federal land or in a federally-operated (or contracted) facility, learn of facts that give the individual reason to suspect that a child has suffered an incident of child abuse. The Act designates "covered professionals" as those persons engaged in professions and activities in eight different categories including, but not limited to, physicians, dentists, medical residents or interns, hospital personnel and administrators, nurses, health care practitioners, chiropractors, osteopaths, pharmacists, optometrists, podiatrists, emergency medical technicians, ambulance drivers, alcohol or drug treatment personnel, psychologists, psychiatrists, mental health professionals, child care workers and administrators, and commercial film and photo processors.

The Act defines the term "child abuse" as the physical or mental injury, sexual abuse or exploitation, or negligent treatment of a child. Accordingly, any person engaged in a covered profession or activity under an HHS contract or subcontract, regardless of the purpose of the contract or subcontract, shall immediately report a suspected child abuse incident in accordance with the provisions of the Act. If a child is suspected of being harmed, the appropriate State Child Abuse Hotline, local child protective services (CPS), or law enforcement agency should be contacted. For more information about where and how to file a report, the Childhelp USA, National Child Abuse Hotline (1-800-4-A-CHILD) should be called. Any covered professional failing to make a timely report of such incident shall be guilty of a Class B misdemeanor.

By acceptance of this contract or order, the Contractor agrees to comply with the requirements of the Act. The Act also applies to all applicable subcontracts awarded under this contract. Accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with the provisions of the Act.

[This space intentionally left blank]

FDA TERMS AND CONDITIONS ADDENDUM

Contract Administration Data

B.16 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 (JUN 2003), 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 Management, Systems Accounting Branch, HFA-720, 12345 Parklawn Drive, Rockville, MD 20857 no later than 14 days prior to submission of the first invoice:

1. Routing transit number of the financial institution receiving payment.

2. Number of account to which funds are to be deposited.

3. Type of depositor account ("C" for checking, "S" for savings).

B.

Upon delivery and acceptance of the deliverable outlined in the negotiated award, one original and two (2) copies shall be submitted to the Office of Financial Management at the following address:

ORIGINAL INVOICE:

Department of Health and Human Services

Food and Drug Administration

Attn: Office of Financial Management

Systems Accounting Branch, HFA-720

12345 Parklawn Drive

Rockville, MD 20587

CC COPIES:

Attn: Roberta Richardson, HFA-500

5630 Fishers Lane

Rockville, MD 20857-0001

Attn: Project Officer 5600 Fishers Lane

Rockville, MD 20857 B.17 Government Furnished Property

· FES, GSSG (SGEG), or other existing FDA standardized evaluation forms

· FDA guides and position classification standards or supplements applicable to particular units of work.

· The program will provide information regarding the missions and functions of organizational elements or blocks of work.

· Office space, PC, printing capability, telephone, and office supplies.

FDA can and will utilize the contract by contacting the contractor project manager and informing him/her of the nature of the need and services required.

The contractor(s) will work Monday through Friday on site at 5600 Parklawn Drive, Rockville, MD, 20857 from 8:30-5:00, excluding federal holidays, not to exceed a total of 1,664 hours for the performance period. FDA and the contractor will determine labor category(ies) based on specific task requirements.

Any government furnished property shall be safeguarded from theft or release in keeping with existing regulations.

B.18 Control of Property In addition to the applicable "Government Property" the Contractor shall comply with the provisions of DHHS publication "Contractor's Guide for Control of Government Property," which is hereby incorporated by reference. The guide is available on the HHS website: http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm. All references in the Guide to the acquisition cost threshold for accountable property are changed to $5,000, and the Sensitive Item List in Appendix C is replaced by the following list:

Central Processing Units (CPU) Assemblies

Weapons (including tranquilizer guns)

Additionally all references to HHS 565 in the Guide are deleted. The form is obsolete. The Contractor shall inventory of all accountable Government property and submit a list of that property to the Contracting Officer on commencement of the contract, usually concurrent with transfer of the property, annually on the anniversary of contract award, and within 90 days after completion or termination of the contract.

The inventory list, reflecting each item of accountable property as a separate line item, should contain the following data elements:

1. Barcode/tag number

2. Item name/description

3. Manufacturer's name

4. Manufacturer's model number

5. Manufacturer's serial number

6. Unit cost

7. Date received/inventoried

8. Contract number

9. Remarks (optional)

B.19 Key Personnel

HHSAR 352.270-5 Key personnel (Jan 2006)

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.

B.20 Privileged Data Protection

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

B.21 Non-Disclosure of Non-Public Information

All contractor personnel shall submit a signed FDA 3398 – Commitment to Protect Non-Public Information prior to commencement of any work under any individual task.

The contractor shall not release any information concerning individual task orders or any information gained due to such work or anticipated work on any task order without the advance, written consent of the contracting officer. Much of the work performed will be considered management confidential and may at times be subject to the Privacy Act, including reports that may contain information about pending personnel actions or recommendations to management for remedial interventions. All contractor work product produced by the contractor while under contract with the FDA shall be considered the property of the Federal Government.

B.22 Travel Expenses

The contractor has no authority to incur travel costs without the advance written consent of the contracting officer. If travel is approved, the funding for travel shall be invoiced as a separate line item and shall be reimbursed in accordance with FAR 31.205-46.

B.23 CONFLICT OF INTERESET: FDA 1338 Individual Conflict of Interest As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

DEFINITION of Conflict of Interest

Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

CONTRACTOR’S CONFLICT OF INTEREST RESPONSIBILITIES

The individual contractor must be free of interest prior to performing under this contract.

Anytime prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the project officer. The project officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the project officer.

CONFLICT OF INTERSET SCREENING

An individual offeror /contractor submitting a proposal in response to this solicitation must submit the following information (if no relevant information exists, please provide a statement to that effect).

1. A list of any stock holdings and investments for you, your spouse and minor children.

2. Any positions, either compensated or not, that you currently hold (or have under negotiation).

3. Any contracts, grants, or cooperative research and development assignments that you are working on or have under negotiation;

4. Any other sources of income (not mentioned above)

5. Any other relevant information concerning any past, present, or planned interests that may have a bearing on the responsibilities described in the Statement of Work.

The project officer shall conduct a review if the information submitted and determine if a conflict of interest exists prior to forwarding any documents to the contractor. Prior to submitting new work assignments, the project officer will follow-up with the contractor to determine if any changes to his/her financial interest have occurred.

CONFLICT OF INTEREST AGREEMENT

In executing this contract, the individual contractor agrees:

1. To report to the proper authority within the FDA (the Project Officer), any situation or event that may constitute a conflict of interest, whether actual or potential.

2. To act impartially and not give preferential treatment to any individual or organization which has submitted applications, information, and or data.

3. Not to solicit any gift or other item, nor accept any gift or other item, of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with or conducting activities related to the evaluations and work performed under this contract. Aggregate market value of individual gifts should not exceed $50.00 in a calendar year.

4. Not to disclose any information and/or data within his or her purview, or to which he/she has access as a result of performing work under this contract.

5. Not to participate in any matter involving specific parties who are likely to or can directly affect the financial interest of a member of his household or a relative with whom they have a close personal relationship; and

6. To disqualify himself from participating in particular matters involving former employees or their representatives, with whom they have worked within the past one (1) year and who might represent a conflict of interest.

[This space intentionally left blank] B.24 Estimate of Effort It is expected that a LABOR HOUR type contract will be awarded as a result of this RFP.

Holidays: The Contractor is not required to provide service on the following days:

New Years Day

Labor Day

Martin Luther Kin Jr. Birthday

Columbus Day

President’s Day

Veteran’s Day

Memorial Day

Thanksgiving Day

Independence Day

Christmas Day

Occasionally, Executive orders are issued closing Federal departments and agencies for part or all of a workday. The Contractor is excused from duty during such periods, and will not be paid for those closures/Executive Orders.

Work under this contract may be performed at the location indicated below. The Project Office may also authorize work to be performed off site.

5600 Fishers Lane

Rockville, MD 20857

This information is furnished for the offeror’s information only and is not to be considered restrictive for proposal purposes.

B.25 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

Personnel Security Staff, OSO

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

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.

4. 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

OSO/Office of Security Operations

Attn: Personnel Security Staff

5600 Fishers Lane, PKLN 15A-22, HFA-640

Rockville, MD 20857

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.

6. 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

1.1.1 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

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

**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

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

(301) 827-5502, -5521, -5507, -5508 Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-9527

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

(301) 827-5502, -5521, -5507, -5508 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

5600 Fishers Lane

PKLN 12A-43, HFA 630

Rockville, MD 20857

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

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

No appointment necessary

(301) 827-9615

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) 827-9527

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

(301) 827-5502, -5521, -5507, -5508 Ten (10) calendar days prior to commencement of work

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

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

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch

5600 Fishers Lane

PKLN 15A-22, HFA-640

Rockville, MD 20857

(301) 827-5502, -5521, -5507, -5508 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

5600 Fishers Lane

PKLN 12A-43, HFA 630

Rockville, MD 20857

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

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

No appointment necessary

(301) 827-9615

Fair Credit Reporting Act of 1970, as amended PLEASE TAKE NOTICE THAT ONE OR MORE CONSUMER CREDIT REPORTS MAY BE OBTAINED FOR EMPLOYMENT PURPOSES PURSUANT TO THE FAIR CREDIT REPORTING ACT, AS AMENDED, 15 U.S.C., 1681, ET. SEQ. SHOULD A DECISION TO TAKE ANY ADVERSE ACTION AGAINST YOU BE MADE, BASED EITHER IN WHOLE OR IN PART OF THE CONSUMER CREDIT REPORT, THE CONSUMER REPORTING AGENCY THAT PROVIDED THE REPORT PLAYED NO ROLE IN THE AGENCY’S DECISION TO TAKE SUCH ADVERSE ACTION.

Information provided by you on this form will be furnished to the consumer reporting agency in order to obtain information in connection with an investigation to determine your (1) fitness for Federal employment, (2) clearance to perform contractual service for the Federal Government, and/or 93) security clearance or access. The information obtained may be re-disclosed to other Federal agencies for the above purposes and in fulfillment of official responsibilities to the extent that such disclosure is permitted by law.

I hereby authorize the Food and Drug Administration, to obtain such report(s) from any consumer credit reporting agency for employment purposes.

(Print Name)

(SSN)

(Signature)

(Date)

Your Social Security Number is needed to keep records accurate, because other people may have the same name. Executive Order 9397 also asks Federal agencies to use this number to help identify individuals in agency records.

PART C

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items C.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (FEB 2008)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(2) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78)

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

__ (2) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a).

__ (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (4) [Reserved]

__ (5)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-6.

__ (iii) Alternate II (Mar 2004) of 52.219-6.

__ (6)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (7) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)).

__ (8)(i) 52.219-9, Small Business Subcontracting Plan (Nov 2007) (15 U.S.C. 637(d)(4).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (9) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

__ (10) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (11)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Sept 2005) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (12) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Oct 1999) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (13) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (14) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f).

X (15) 52.219-28, Post Award Small Business Program Representation (June 2007) (15 U.S.C. 632(a)(2)).

X (16) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X 17) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2008) (E.O. 13126).

X (18) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

X (19) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

X (20) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

X 21) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

__ (22) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

X (23) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201).

X (24)(i) 52.222-50, Combating Trafficking in Persons (Aug 2007) (Applies to all contracts).

__ (ii) Alternate I (Aug 2007) of 52.222-50.

__ (25)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Aug 2000) (42 U.S.C. 6962(c)(3)(A)(ii)).

__ (ii) Alternate I (Aug 2000) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

__ (26) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (27)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

__ (ii) Alternate I (Dec 2007) of 52.223-16.

__ (28) 52.225-1, Buy American Act—Supplies (June 2003) (41 U.S.C. 10a-10d).

__ (29)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Aug 2007) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L 108-77, 108-78, 108-286, 109-53 and 109-169).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__ (30) 52.225-5, Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (31) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2006) (E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (32) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (33) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

X (34) 52.232-29,…