FDA. DC Contract.pdf

FDA DOCUMENT CONTROL ROOM PROGRAM FDA-SOL-08-00653

SF 1449

i

TABLE OF CONTENTS

FDA-SOL-08-00653

1. TOPIC

PAGE

Solicitation/Contract/Order for Commercial Items 1 Standard Form (SF) 1449

PART A:

Addendum – Continuation of SF-1449

Prices/Performance/Costs

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 35

2. Glossary of Terms and Acronyms 111

3. Wage Determination Under the Service Act 116

4. Contractor’s Non-Public Information (NPI) Agreement 121

5. Program Facility Listing 123

6. Map of Facility Locations 124

7. Data Entry Requirements for Document Types/Work 125

8. Facility File Storage & Work Area Listing 126

9. Base Projected Hours 128

10. Pre-Proposal Instructions

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

1. Past Performance Questionnaire

PART G:

FAR Clause 52.204-8 – Annual Representations and Certifications (Jan 2006) 149

PART A:

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

SUPPLIES OR SERVICES AND PRICES/COSTS

A BACKGROUND AND OBJECTIVES

A-1 BACKGROUND:

As part of the Federal Government, the Food and Drug Administration (FDA) provides an essential role in the protection of the well-being of the citizens of the United States.

One of the many important components of FDA is the responsibility for the safety and effectiveness of drugs intended for use by humans.

This contract period of performance is designed to meet the Government’s Paperwork Reduction Act (GIPA) through management and development of strategic processing including increase in quantity and range/type of electronic submissions while maintaining a high level of security during the review process and post-marketing product life.

The Contractor shall be required to provide services and support resources capable for evaluating, processing and managing paper and electronic drug documents (applications and submissions).

The Contractor must be able to provide support in a dynamic and changing environment, ideas to improve the receipt and handling process, offering innovative approaches that result in time and cost efficiencies.

A major objective is to reduce paper usage thus relieving document storage space, document distribution cost, distribution time to reviewers and document maintenance necessary in managing drug application as well as giving expanded flexibility to the FDA review and possible outside reviews.

FDA is involved in a major effort to enhance drug reviewer’s productivity and quality of work by requiring submissions to be received electronically. It is anticipated that this will result in a decreasing dependency on paper processing activity during application review.

The Contractor shall also need to be able to manage documents in a timely and secure manner during day-to-day planned activities and facility relocation.

A-2 OBJECTIVES:

The goal of this acquisition is to provide assistance to the FDA Document Control Rooms.

A.3 CONTRACT VEHICLE / TASK ORDERS

As requirements are identified by FDA, the Contracting Officer (CO) shall issue Individual Task Orders (ITOs) against the Master Contract. The ITOs shall be issued with a specific Statement of Work (SOW), funding document, and will have a designated Project Officer (PO).

The Master Contract period of performance shall have a base period of one (1) year and four (4) option periods (one year each). Use of this contract vehicle implies that all participating individual task order project Officers will work cooperatively with the designated Project Officer (PO), the Office of Acquisitions and Grants Services, follow all applicable laws and regulations, and only request services that are within the scope of this contract.

The ITO PO shall be responsible for obtaining consent for use of this contract vehicle from the designated PO.

The CO shall be responsible for negotiating all ITOs, issuing all ITOs, receiving reports, approving invoices, overseeing all financial transactions, and implementing all Master Contract and ITO modifications, as needed.

It is anticipated that the ITOs issued against this contract vehicle will be a hybrid Indefinite Delivery Indefinite Quantity, Firm-Fixed-Price (FFP). However, other types of individual task orders may also be placed under this contract, such as a Time and Materials /Labor Hour (T&M) Task Orders. All deliverables shall be clearly identified, complete with clear descriptions, due dates, and at a predetermined, agreed-upon price. If practicable, the ITOs shall be performance based with specific, measurable performance standards that shall be clearly identified, logical, and practicable.

A period of performance will be specified for each ITO. The SOW for each ITO shall specify any special acceptability standards for each deliverable, and all payments shall be made subject to the ITO PO’s acceptance. The ITO PO shall have full project oversight responsibility for the work completed under the respective ITO. However, all ITO requirements and subsequent modifications shall be provided to the “Lead PO” to ensure compatibility with the existing scope of work.

The CO shall be the only Government Representative authorized to make any changes which either decrease or increase the Master Contract or ITO SOW or price. In addition, the CO is the only Government Representative authorized to change any terms or conditions of the Master Contract or any respective ITO. Any proposed revisions shall be referred to the CO and shall require the submittal of a modification request, as well as concurrence from the designated PO.

The ITO POs shall submit a written report to the designated PO and CO at the completion of each ITO. The report shall include the following information: any changes made to the original SOW, any respective changes to ITO price with a complete breakdown of price allocation, and a complete contractor performance evaluation.

The requirements of this contract are broken down into a Fixed Price portion (Base) and an Indefinite Delivery Indefinite Quantity portion as follows:

A-4 COMPENSATION FOR BASE FIXED PRICE

a. The Base contract is a Firm-Fixed Price (FFP).

b. Payment will be made on a monthly basis wit the receipt of a proper voucher/invoice.

c. As consideration for performance of the work stated in D-1, “Statement of Work” in Section D, the Government will pay the Contractor at the firm fixed price of $___________________ per month, for an annual total of $____________________.

d. As consideration for the services using Attachment 9 – Base Projected hours for the FDA Document Control Room (Including Technical Exhibits 4 through 7).

A.4.1 Contract Schedule Modifications Effected by Option One Exercise

a. Upon execution of each option, an additional twelve (12) months will be added to the contract period of performance.

b. The following payment schedule(s) will be effective for the optional year(s) of performance.

c. By the addition of Option Year 1, the Government will pay to the contractor:

$_________________ per month, for an annual amount of $_____________________.

A.4.2 Contract Schedule Modifications Effected by Option Two Exercise

a. Upon execution of each option, an additional twelve (12) months will be added to the contract period of performance.

b. The following payment schedule(s) will be effective for the optional year(s) of performance.

c. By the addition of Option Year 2, the Government will pay to the contractor:

$_________________ per month, for a annual amount of $______________________.

A.4.3 Contract Schedule Modifications Effected by Option Three Exercise

a. Upon execution of each option, an additional twelve (12) months will be added to the contract period of performance.

c. By the addition of Option Year 3, the Government will pay to the contractor:

A.4.4 Contract Schedule Modifications Effected by Option Four Exercise

a. Upon execution of each option, an additional twelve (12) months will be added to the contract period of performance.

c. By the addition of Option Year 4, the Government will pay to the contractor:

A.5 INDEFINITE QUANTITY INDEFINITE DELIVERY (IDIQ) PORTION

a. Payment will be made in accordance with the pricing schedule set forth in each ITO and receipt of a proper voucher/invoice.

b. Firm Fixed Unit Price Labor Categories (see Pricing Schedule IDIQ Portion, page 7) provided shall be applicable for the duration of this contract.

c. As consideration for performance of the work stated in the individual task order SOW, the Government will pay the Contractor base on the type of contract awarded.

A.5.1 INSTRUCTIONS FOR PLACING AND NEGOTIATING INDIVIDUAL TASK ORDERS

When the Government anticipates issuing an ITO for services, the Government will provide the contractor with an ITO SOW and request that the contractor submit a written work plan. Within 14 calendar days after receipt of a request and a task description from the Government, the contractor shall submit one (1) copy of a written work plan to the CO. Alternatively, the Government may require an oral proposal/work plan covering any or all of the written work plan requirements listed below. The format and content of the work plan shall be substantially the same as the work plan that the contractor submitted with its original proposal. The work plan shall include:

• A work schedule including the estimated date of commencement of work after issuance of the task order by the CO

• A detailed price proposal, utilizing the rates in the contractor’s proposed cost/pricing schedule for the Master Contract, in addition to the total estimated price

• Specific plans for dealing with anticipated problems that may be encountered

Offers shall remain valid for at least 60 days from date of submission.

A.6 MINIMUM AND MAXIMUM QUANTITIES

As referred to in paragraph (b) of the “Indefinite Quantities” clause of this contract, the contract guaranteed minimum is satisfied with the award of the contract. The maximum of all orders issued and awarded under this contract will not exceed $90,000,000.

A.7 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.

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PRICING SCHEDULE IDIQ PORTION

A.8 Base Year: August 1, 2008 – July 31, 2009

DOCUMENT CONTROL ROOMS

Labor Categories Hourly Rate

Program Manager Project Team Manager Project Team Supervisor

Senior Task Leader IT Technician IV IT Technician II Records Mgmt Spec-I Records Mgmt Spec-II

A.8.1 Option Year One (1): August 1, 2009 – July 31, 2010

DOCUMENT CONTROL ROOMS

IT Technician II

A.8.2 Option Year Two (2): August 1, 2010 – July 31, 2011

DOCUMENT CONTROL ROOM

IT Technician II

* All pricing must be supported through backup documentation, which should include overhead, profit, and ODCs.

A.8.3 Option Year Three (3): August 1, 2011 – July 31, 2012

IT Technician II

A.8.4 Option Year Four (4): August 1, 2012 – July 31, 2013

IT Technician II

* All pricing must be supported through backup documentation, which should include overhead, profit, and ODCs.

Note: Additional labor categories can be added as necessary and the rate will be negotiated at the time of inclusion.

PART B:

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

52.211-11 LIQUIDATED DAMAGES – SUPPLIES, SEP 2000

SERVICES, OR RESEARCH AND DEVELOPMENT

52.228-5 INSURANCE – WORK ON A GOVERNMENT JAN 1997

INSTALLATION

52.232-7 PAYMENT UNDER TIME-AND-MATERIAL AND FEB 2007

LABOR-HOUR CONTRACTS

52.242-15 STOP-WORK-ORDER AUG 1989

52.243-3 CHANGES – TIME-AND-MATERIALS OR SEPT 2000

LABOR-HOURS

52.244-2 SUBCONTRACTS JUN 2007

52.245-1 GOVERNMENT PROPERTY JUN 2007

52.245-9 USE AND CHARGES JUN 2007

52.248-1 VALUE ENGINEERING FEB 2000

52.253-1 COMPUTER GENERATED FORMS JAN 1991

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

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.

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

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

B.4 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from (to be negotiated) through (to be negotiated).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

B.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1,000,000.000;

(2) Any order for a combination of items in excess of $1,000,000; or

(3) A series of orders from the same ordering office within 60 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 15 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

B.6 FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995)

a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in http://acquisition.gov/far/current/html/52_216.html#wp1115057 the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after expiration date of the contract.

B.7 52.219-11 SPECIAL 8(A) CONTRACT CONDITIONS (FEB 1990)

The Small Business Administration (SBA) agrees to the following:

(a) To furnish the supplies or services set forth in this contract according to the specifications and the terms and conditions hereof by subcontracting with an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(b) That in the event SBA does not award a subcontract for all or a part of the work hereunder, this contract may be terminated either in whole or in part without cost to either party.

(c) Except for novation agreements and advance payments, delegate to the Food and Drug Administration the responsibility for administering the subcontract to be awarded hereunder with complete authority to take any action on behalf of the Government under the terms and conditions of the subcontract; provided, however, that the Food and Drug Administration shall give advance notice to the SBA before it issues a final notice terminating the right of a subcontractor to proceed with further performance, either in whole or in part, under the subcontract for default or for the convenience of the Government.

(d) That payments to be made under any subcontract awarded under this contract will be made directly to the subcontractor by the Food and Drug Administration.

(e) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the Contracting Officer cognizable under the “Disputes” clause of said subcontract.

(f) To notify the Food and Drug Administration Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

B.8 52.219-12 SPECIAL 8(A) SUBCONTRACT CONDITIONS (FEB 1990)

(a) The Small Business Administration (SBA) has entered into Contract No. TBD with the Food and Drug Administration to furnish the supplies or services as described therein. A copy of the contract is attached hereto and made a part hereof.

(b) The TBD, hereafter referred to as the subcontractor, agrees and acknowledges as follows:

(1) That it will, for and on behalf of the SBA, fulfill and perform all of the requirements of Contract No. TBD for the consideration stated therein and that it has read and is familiar with each and every part of the contract.

http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

(2) That the SBA has delegated responsibility, except for novation agreements and advance payments, for the administration of this subcontract to the Food and Drug Administration with complete authority to take any action on behalf of the Government under the terms and conditions of this subcontract.

(3) That it will not subcontract the performance of any of the requirements of this subcontract to any lower tier subcontractor without the prior written approval of the SBA and the designated Contracting Officer of the Food and Drug Administration.

(4) That it will notify the Food and Drug Administration Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock or other ownership interest to any other party.

(c) Payments, including any progress payments under this subcontract, will be made directly to the subcontractor by the Food and Drug Administration.

B.9 52.219-17 SECTION 8(A) AWARD (DEC 1996)

(a) By execution of a contract, the Small Business Administration (SBA) agrees to the following:

(1) To furnish the supplies or services set forth in the contract according to the specifications and the terms and conditions by subcontracting with the Offeror who has been determined an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(2) Except for novation agreements and advance payments, delegates to the Food and Drug Administration the responsibility for administering the contract with complete authority to take any action on behalf of the Government under the terms and conditions of the contract; provided, however that the contracting agency shall give advance notice to the SBA before it issues a final notice terminating the right of the subcontractor to proceed with further performance, either in whole or in part, under the contract.

(3) That payments to be made under the contract will be made directly to the subcontractor by the contracting activity.

(4) To notify the Food and Drug Administration Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

(5) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the cognizant Contracting Officer under the “Disputes” clause of the subcontract.

(b) The offeror/subcontractor agrees and acknowledges that it will, for and on behalf of the SBA, fulfill and perform all of the requirements of the contract.

(c) The offeror/subcontractor agrees that it will not subcontract the performance of any of the requirements of this subcontract to any lower tier subcontractor without the prior written approval of the SBA and the cognizant Contracting Officer of the Food and Drug Administration.

http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

B.10 52.219-18 NOTIFICATION OF COMPETITION LIMITED TO ELIGIBLE 8(A) CONCERNS (JUNE 2003)

(a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA’s 8(a) Program and which meet the following criteria at the time of submission of offer—

(1) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan; and

(2) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by the SBA.

(b) By submission of its offer, the Offeror represents that it meets all of the criteria set forth in paragraph (a) of this clause.

(c) Any award resulting from this solicitation will be made to the Small Business Administration, which will subcontract performance to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.

(d)(1) Agreement. A small business concern submitting an offer in its own name shall furnish, in performing the contract, only end items manufactured or produced by small business concerns in the United States or its outlying areas. If this procurement is processed under simplified acquisition procedures and the total amount of this contract does not exceed $25,000, a small business concern may furnish the product of any domestic firm.

This paragraph does not apply to construction or service contracts.

(2) The TBD will notify the Food and Drug Administration Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock or other ownership interest to any other party.

Alternate I (Apr 2005). If the competition is to be limited to 8(a) concerns within one or more specific SBA regions or districts, add the following paragraph (a)(3) to paragraph (a) of the clause:

(3) The offeror's approved business plan is on the file and serviced by TBD.

[End of clause]

Alternate II (Dec 1996). When the acquisition is for a product in a class for which the Small Business Administration has determined that there are no small business manufacturers or processors in the Federal market in accordance with 19.502-2(c), delete paragraph (d)(1).

B.11 52.227-23 RIGHTS TO PROPOSAL DATA (TECHNICAL) (JUN 1987)

It is agreed that as a condition of award of this contract, and notwithstanding the conditions of any notice appearing thereon, the Government shall have unlimited rights (as defined in the "Rights in Data--General" clause contained in this contract) in and to the technical data contained in the proposal dated (to be determined at time of award) upon which this contract is based.

http://acquisition.gov/far/current/html/Subpart 19_5.html#wp1086841

Health and Human Services Agency Clauses

B.13 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.14 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.

B.15 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/.

http://oig.hhs.gov/

B.16 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.17 CONFIDENTIALITY OF INFORMATION (JANUARY 2006) (HHSAR 352.224-70)

(a) Confidential information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the ‘‘Disputes’’ clause.

(c) If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a (New Window), and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

(d) Confidential information, as defined in paragraph (a) of this clause, shall not be disclosed without the prior written consent of the individual, institution, or organization.

(e) Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this clause, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

(f) Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

(g) The provisions of paragraph (d) of this clause shall not apply to conflicting or overlapping provisions in other Federal, State, or local laws.

B.18 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.

http://www4.law.cornell.edu/cgi-bin/htm_hl?DB=uscode5&STEMMER=en&WORDS=552+&COLOUR=Red&STYLE=s&URL=/uscode/5/552.html

The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

B.19 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.20 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.21 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.22 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.

B.23 352.270-5 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. (End of clause)

Pursuant to HHSAR Clause 352.270-5, Key Personnel, incorporated in this contract, the following individual(s) is considered to be essential to the work being performed hereunder:

Name Title

[To be specified in Award]

FDA TERMS AND CONDITIONS CLAUSES

Contract Administration Data

B.23 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 Services, Systems Accounting Branch, HFA-720, 12345 Parklawn Drive, Rockville, MD 20857 no later than 14 days prior to submission of the first invoice:

The Contractor shall furnish the following information on each invoice:

1. Bank name

2. Routing transit number of the financial institution receiving payment

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

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

5. Period of Performance for which costs are claimed

6. Labor hours separated by labor category

7. Itemized material costs

8. Travel costs, itemized and identified including origin and destination

9. Any other supporting data that will clarify unusual expenditures

10. Contract Number

11. Project officer Name and telephone number

12. Contractor contact person and telephone number

The Contractor shall include the costs for the current period and the cumulative costs for the total contract according to the categories shown above.

B. Upon delivery and acceptance of the deliverable outlined in the negotiated award, one original and two

(2) copies shall be submitted to the following addresses:

ORIGINAL:

Department of Health and Human Services Food and Drug Administration Attn: Office of Financial Services

Systems Accounting Branch, HFA-720 12345 Parklawn Drive Rockville, MD 20587

CC COPIES:

Department of Health and Human Services Food and Drug Administration Attn: Contracting Officer, HFA-500 5630 Fishers Lane Rockville, MD 20857-0001

Department of Health and Human Services Food and Drug Administration Attn: Project Officer

5630 Fishers Lane Rockville, MD 20857

Invoice submissions: Will be specified in the ITO’s

B.24 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR

42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

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

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

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

B.25 GOVERNMENT FURNISHED PROPERTY

The Government will provide facilities, equipment, materials, and services required to manage and operate the document control rooms, excluding other direct cost needed by the contractor used in performance of the contract. However, the Government will be prepared to provide an off-site facility to process and store applications and materials that meet the security, safety, and accessibility standards for Government facilities.

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

All Government furnished supplies will be replenished by the Government.

Government Furnished Supplies:

Special Supply Items

Regulatory Folder Jackets Internal Tracking/Transmittal Forms

Folder Dividers Acco Binder Clips Manila Folders Storage Boxes Copier Paper FRC Boxes

Copier Ink Toner Plastic Mail Storage Tubs Shrink Wrap BarCode Labels

Masking Tape Date Stamps Compact Disks DLT Tapes

Standard Office Supply Items

Writing Tablets Color Paper Pens / Pencils Erasers

Highliters Permanent Ink Markers Paper Clips Binder Clips Envelopes Rubber Bands Staplers Staple Clips / Various sizes

Electric & Manual Hole Punch Calculators

[this space intentionally left blank]

Government Furnished Equipment:

Equipment Type Make Model

DR1/DDMAC

Barcode Machine Datamax DMX - 1 - 4208

Printer HP LaserJet 4000TN Printer HP Laserjet 4200 Printer HP LaserJet 4350dtn Printer HP LaserJet 4100 Printer HP LaserJet 4100N Printer Samsung ML-3561ND

Photocopier Canon Imagerunner 3300G Photocopier Canon Imagerunner 105 Photocopier Canon Imagerunner 600 Photocopier Canon Color Imagerunner C5185 Photocopier Canon Imagerunner 8070 Photocopier OCE 3155 Fax Machine Brother Intellifax1270 Fax Machine HP 1040 Power Jacks Vestil EPT-2547-030 Power Jacks Multiton EME 3026x47

Stock Chaser and Trailer Notrec E-266

Equipment Type Make Model

OGD

Equipment Type Make Model Barcode Machine Datamax I Class

Printer HP LaserJet 4350dtn Printer HP LaserJet 4000TN Printer HP LaserJet 4350N Printer HP LaserJet 4100

Printer HP Laserjet 4200/4300

Series Photocopier Canon Imagerunner 3300G Photocopier Canon Imagerunner 3300G Photocopier Canon Imagerunner 5020 Fax Machine Ricoh 5510L Fax Machine HP 1040 Fax Machine HP 1240

Equipment Type Make Model

CDR

Equipment Type Make Model Barcode Machine Datamax DMX I-4208

Printer HP LaserJet 4350dtn Printer HP LaserJet 4200 Printer HP LaserJet 4300 Printer HP LaserJet 4350tn Printer HP LaserJet 4100tn Printer HP LaserJet 4250tn Printer HP LaserJet 4100 Printer HP LaserJet 4000tn Printer HP LaserJet P3005X Printer Samsung ML-2151N

Photocopier Canon Imagerunner 330S Photocopier Canon Imagerunner 8500 Photocopier Canon Imagerunner 5020 Photocopier Canon Imagerunner 3300G Photocopier Canon Imagerunner C3200 Photocopier Canon Imagerunner C6800 Fax Machine Brother Intellifax FAX4750E Fax Machine HP 1240 Fax Machine Panasonic UF990 Power Jack Multiton EME AC 3026x47 Power Jack Vestil EPT - 2547 - 30 Manual Jack Crown N/A Manual Jack Liftrite N/A

Barcode Scanner (handheld) Opticon PHL1600

X Ray Machine Heimannn

System HS-7555i Wave Machine Crown WAV50-84

Lift Cart Dandy

Southwork A-850W

B.26 PROTECTION OF FEDERAL GOVERNMENT PROPERTY AND BUILDINGS

The contractor assumes full responsibility for repair and/or replacement value for all Federal Government owned property and shall indemnify the Federal Government for any and all losses or damage of any nature to any and all Federal Government property that is proximately caused by an act or failure to act on behalf of the contractor.

Contractor liability extends to the unauthorized retention, dissemination, and/or sharing of confidential material or information that the contractor may gain access to in the performance of the services required under this contract.

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:

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm

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.26.1 BUILDING PROTECTION

Any property damage that results from the contractor’s activities shall be the responsibility of the contractor.

The contractor shall be required not to damage in any way the corridors, walls, doorways, elevators, or landscaped areas along its authorized service routes.

B.26.2 MITIGATION OF FACILITY DAMAGE

The contractor is solely responsible for damage to facilities resulting from its activities. This shall include cleaning and repairs of walls, floors, corridors, elevators, and any other part of the buildings, if requested by the FDA. Any materials used for said purpose of cleaning or repair shall be approved in advance by FDA.

B.26.3 MITIGATION OF FURNITURE, MATERIAL AND EQUIPMENT DAMAGES

If, due to any fault of the contractor, its employees, agents, or sub-contractors, Government owned property or property controlled by FDA is lost or damaged during the performance of this contract, the contractor shall be responsible to FDA for such loss or damage.