FDA-14-223-SOL-00005_Section_1-2_thru_Amendment_0007.doc

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FDA-14-223-SOL-00005/0007

On-Site Records Information Management (RIM) RFP

NOTICE TO OFFERORS

This solicitation is being processed under a Partnership Agreement (PA) between the Department of Health and Human Services (HHS) and the Small Business Administration (SBA), under which the SBA has delegated to HHS, authority to enter into 8(a) contracts directly with eligible 8(a) firms. The PA implements innovative and effective methodology designed to streamline the acquisition process for awards under the 8(a) program. The Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS), is a designated pilot agency under the PA.

Any solicitation and subsequent award processed under the referenced PA shall be made by the FDA/OAGS. SBA shall, however, retain responsibility for 8(a) certification, administer other eligibility related issues under the 8(a) program, and be available to 8(a) firms for counseling and assistance.

If you have any questions pertaining to this PA, please contact OAGS, 5630 Fishers Lane, Rockville, MD 20857, Elvis Colbert, 301-827-6791, or via email at aaron.glazier@fda.hhs.gov.

HHS/SBA PA 1 (SEP 2007)

Servicing Small Business Administration Field Office

It is requested that the 8(a) participant submitting this offer/bid provide the following information regarding the firm’s cognizant servicing Small Business Administration (SBA) office.

Servicing SBA Officer: ______________________________________________

Address ______________________________________________

Cognizant SBA Business Opportunity Specialist Name:

Phone:

TABLE OF CONTENTS

Standard Form (SF) 1449

PART A:

Addendum – Continuation of SF-1449

PART B:

Prices/Performance/Costs

PART C:

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

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

PART D:

IDIQ ATTACHMENTS

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:

FAR Clause 52.212-3 – Annual Representations and Certifications- Commercial Items (NOV 2013)

SECTION 2: RFP LIST OF ATTACHMENTS

PART H: RFP FORMS

SECTION 3: CDER TASK ORDER LIST OF ATTACHMENTS & APPENDICES

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PART I: CDER TASK ORDER STATEMENT OF WORK

PART J: CDER REFERENCE DOCUMENTS (APPENDICES)

PART A: Addendum- Continuation of SF-1449

INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ) CONTRACT/ DELIVERIES OR PERFORMANCE

A.1 A.1

CONTRACT TYPE

The Government intends to issue one (1) single award Indefinite Delivery-Indefinite Quantity (IDIQ) contract resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation and offers a sound technical approach that meets the requirements identified in the Statement of Work At the discretion of the Contracting Officer, the Government may use a variety of contract types under this contract for each task order, including: Firm-Fixed-Price (FFP), Labor-Hour (LH), Time-and-Materials, or a combination thereof. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of task order type.

Requirements tailored for a specific Center’s program needs will be the focus of each Request for Task Order Proposal (RFTOP) issued under the contract, including specific deliverables and schedules for the deliverables. Each RFTOP will include the specific Center requirements, performance standards, and a quality assurance approach. The period of performance of each task order will be established upon the issuance of the order. Deliverables are to be determined upon the issuance of each task order.

A.1.1

MINIMUM AND MAXIMUM CONTRACT VALUE

(a) Award of the base period of the initial task order shall be considered the guaranteed minimum. If a base task order is not issued at issuance of the contract award, a minimum guarantee of $25,000 will be obligated.

(b) The IDIQ ceiling for this contract is $103 Million.

a.1.2

OVERVIEW OF PRICING SCHEDULES

The agreed upon negotiated Labor Rates shall be fixed for the duration of this contract (See Sections B.1 – B.5). These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. Labor Rates proposed for Task Orders issued against this IDIQ contract must be in accordance with agreed upon IDIQ Labor Categories and Fixed Labor Rates. If a task order is extended, as a result of a direct action or inaction by the Government, which delays the Contractor from completing the task order within the Period of Performance identified, the Contractor may use the Labor Rates associated with the applicable contract year for the extension. However, in no event shall the Contractor perform, or be paid for any work which exceeds the not-to-exceed dollar amount of a task order.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort, fixed labor rate for labor mix proposed, allowable other direct costs and indirect cost, and timeframe in which the services are estimated to be performed. The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Labor-Hour or Time-and-Materials task order will contain a ceiling price. The Contractor shall comply with FAR 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (Aug 2012), in regards to the ceiling price for the individual task order(s).

A.2

DELIVERIES OR PERFORMANCE

A.2.1 ORDERING PERIOD

The ordering period is five years from the effective date of the A.2.2

PERIOD OF PERFORMANCE FOR TASK ORDERS

The Period of Performance for task orders will be as specified in individual task orders. Two constraints apply to the period of performance for task orders. First, individual task orders may not exceed 5 years (inclusive of option periods). Second, individual task orders may not extend further than 6 months beyond the IDIQ Ordering Period end date.

A.2.3

NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

A.2.4

DELIVERABLES

Deliverables will be specified in the task orders issued under this contract. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures according to FAR 52.212-4 (a) Inspection/Acceptance.

A.2.5

PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this contract prior to being assigned to task orders awarded. Please see Part D.1.21: Description of Labor Categories.

A.2.6

PLACE OF PERFORMANCE

The Contractor will primarily work on site at FDA facilities. The Program Manager will be the only Position that will be available to work off site and paid at contractor site rates, however, Government data shall remain on the Government site. Location information will be specified in each task order. Most FDA Centers and Offices operate predominantly in the Washington, DC Metropolitan area with concentrations in the FDA's Maryland locations of Bethesda, College Park, Laurel, Rockville, and Silver Spring.

PART B: Addendum- SUPPLIES OR SERVICES/PRICE/PERFORMANCE /COSTS

B.1 Contract Year 1:

B.2 Contract Year 2:

B.3 Contract Year 3:

B.4 Contract Year 4:

B.5 Contract Year 5:

B.6 Materials Handling Fee The Contractor may charge a handling fee of (TBD)% of the direct cost of materials for materials under Time and Materials task orders.

PART C: CONTRACT CLAUSES

B.1 C.1

FAR CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions – Commercial Items

(Sept 2013)

52.212-4 Contract Terms and Conditions – Commercial Items (Alt I) (Aug 2012)

52.227-14 Rights in Data – General

(Dec 2007) 52.227-17 Rights in Data – Special Works

52.227-18 Rights in Data – Existing Works

C.2

FULL TEXT FAR CLAUSES

C.2.1 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JAN 2014)

(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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 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).

_x_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

_x_ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note).

_x_ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

_x_ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved]

__ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (13)(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.

_x_ (14) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (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.

__ (iv) Alternate III (Jul 2010) of 52.219-9.

_x_ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

_x_ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (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.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (21) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

_x_ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_x_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_x_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

_x_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_x_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_x_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

_x_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_x_ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

_x_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_x_ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

_x_ (37)(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.

_x_ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Nov 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

__ (ii) Alternate I (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Nov 2012) of 52.225-3.

_x_ (41) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_x_ (42) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (43) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (44) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (45) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (46) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (47) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_x_ (48) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (49) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (50) 52.232-36, Payment by Third Party (Jul 2013) (31 U.S.C. 3332).

__ (51) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (52)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

_x_ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

_x_ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

_x_ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

_x_ (7) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) C.2.2 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 designates, in the Schedule. Such orders may be issued from the date of award through the five (5) year ordering period.

(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.

(End of clause)

C.2.3 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 $3,000, 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 $25,000,000;

(2) Any order for a combination of items in excess of $25,000,000;

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

(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) above.

(d) Notwithstanding paragraphs (b) and (c) above, 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 30 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

C.2.4 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 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 6 months after the end of the ordering period.

(End of clause)

C.2.5 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 prior to the end of the period of performance.

(End of Clause)

C.2.6 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 at any time within the period of performance, provided that the Government gives the Contractor a preliminary written notice of its intent to extend 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 five (5) years and six (6) months.

(End of clause)

C.2.7 52.219-18 -- Notification of Competition Limited to Eligible 8(a) Concerns.

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 in connection with construction or service contracts.

(2) Company XX will notify the FDA’s Contracting Officer, James G. Whitt, in writing at James.Whitt@fda.hhs.gov 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.

(End of Clause)

C.2.8 52.224-2 -- Privacy Act (Apr 1984)

(a) The Contractor agrees to --

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies --

(i) The systems of records; and

(ii) The design, development, or operation work that the contractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a system of records on individuals that is subject to the Act; and

(3) Include this clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a system of records.

(b) In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency.

(c)

(1) “Operation of a system of records,” as used in this clause, means performance of any of the activities associated with maintaining the system of records, including the collection, use, and dissemination of records.

(2) “Record,” as used in this clause, means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and that contains the person’s name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint or voiceprint or a photograph.

(3) “System of records on individuals,” as used in this clause, 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.

(4) “Personally Identifiable Information (PII)” means information that can be used to distinguish or trace a person's identity, such as his or her name, social security number, or biometric records, that alone, or when combined with other personal or identifying information which is linked or linkable to a specific person, such as date and place of birth, or mother’s maiden name, etc.

PII encompasses a broader range of records inclusive of those which are subject to the Privacy Act. The Privacy Act applies to records about “individuals” defined in that statute as citizens of the United States or aliens lawfully admitted for permanent residence.

PII covers all human persons, regardless of whether the person is a citizen of the United States, legal permanent resident, or a visitor to the United States.

(5) “Breach” and “Privacy Incident” mean the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, unauthorized access, or any similar situation where persons other than authorized users, and for other than authorized purpose, have access or potential access to Personally Identifiable Information, whether physical or electronic. These terms will both carry this meaning when used within this section.

(End of Clause)

C.2.9 FAR 52.237-2 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT AND VEGETATION (APR 1984)

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.

C.2.10 52.237-3 Continuity of Services (Jan 1991)

(a) The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to—

(1) Furnish phase-in training; and

(2) Exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor.

(b) The Contractor shall, upon the Contracting Officer’s written notice, (1) furnish phase-in, phase-out services for up to 90 days after this contract expires and (2) negotiate in good faith a plan with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities for each division of work described in the plan, and shall be subject to the Contracting Officer’s approval. The Contractor shall provide sufficient experienced personnel during the phase-in, phase-out period to ensure that the services called for by this contract are maintained at the required level of proficiency.

(c) The Contractor shall allow as many personnel as practicable to remain on the job to help the successor maintain the continuity and consistency of the services required by this contract. The Contractor also shall disclose necessary personnel records and allow the successor to conduct on-site interviews with these employees. If selected employees are agreeable to the change, the Contractor shall release them at a mutually agreeable date and negotiate transfer of their earned fringe benefits to the successor.

(d) The Contractor shall be reimbursed for all reasonable phase-in, phase-out costs (i.e., costs incurred within the agreed period after contract expiration that result from phase-in, phase-out operations) and a fee (profit) not to exceed a pro rata portion of the fee (profit) under this contract.

(End of clause)

C.2.11 52.239-1 -- Privacy or Security Safeguards (Aug 1996)

(a) The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

(b) To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

(c) If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

(End of Clause) C.2.12 52.222-42 Statement of Equivalent Rates for Federal Hires. (May 1989) In compliance with the Service Contract Act of 1965, as amended, and the regulations of the Secretary of Labor (29 CFR Part 4), this clause identifies the classes of service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332.

This Statement is for Information Only:

It is not a Wage Determination

General Clerk I 14.88

General Clerk II 16.24

General Clerk III 18.74

Data Entry Operator I 14.38

Data Entry Operator II 15.69

Document Preparation Clerk 14.21

Computer Operator I 18.92

Computer Operator II 21.18

Computer Operator III 23.60

Computer Operator IV 26.22

Computer Operator V 29.05

Messenger Courier 13.62

(End of clause) c.3 HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS (HHSAR) Clauses:

HHSAR Clauses Incorporated By Reference (IBR)

For Clauses in full text, go to: http://farsite.hill.af.mil/vfhhsara.htm 352.201-70 Paperwork Reduction Act (2006) 352.202-1 Definitions (January 2006)

352.203-70 Anti-lobbying (January 2006) 352.222-70 Contractor cooperation in equal employment opportunity investigations (2010)

352.223-70 Safety and health (January 2006) 352.224-70 Privacy Act (January 2006)

352.227-70 Publications and Publicity (January 2006)

352.231-71 Pricing of adjustments (January 2001)

352.232-72 Limitation of Government’s obligation (January 2010)

352.237-71 Crime Control Act—reporting of child abuse (January 2006)

352.237-72 Crime Control Act—requirement for background checks (January 2006) 352.242-73 Withholding of Contracts Payments (January 2006) 352.249-14 Excusable Delays (January 2006)

352.203–70 Anti-Lobbying (January 2006)

352.222-70 Contractor cooperation in equal employment opportunity investigations (January 2010)

352.232-9 Withholding Payments (January 2006))

352.232-99 Providing Accelerated Payment to Small Business Subcontractors (Deviation) (AUG 2012) 352.239-70 Standard for security configurations (January 2010) 352.239-71 Standard for encryption language (January 2010)

352.239-72 Security requirements for Federal information technology resources (January 2010) 352.239-73 Electronic information and technology accessibility (January 2010)

352.242-70 Key Personnel (January 2006) 352.242–71 Tobacco Free Facilities (January 2006)

352.224-70 Confidentiality of Information (January 2006) 352.270-1 Accessibility of meetings, conferences, and seminars to persons with disabilities (January 2001) 352.270-8 Prostitution and related activities (January 2010) 352.270-9 Non-discrimination for conscience (January 2010)

352.270-10 Anti-Lobbying (January 2006) 352.270-11 Privacy Act (January 2006) C.4

FDA TERMS AND CONDITIONS/CLAUSES:

C.4.1 CONTRACTOR ADVERTISING OF CONTRACT AWARD (SEP 2012)

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205–1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

C.4.2 Contract Administration Data

C.1 FDA INVOICE REQUIREMENTS

The Contractor shall submit invoices as specified in each task order.

C.4.2.1 CONTRACTING OFFICER

The Contracting Officer for the IDIQ contract is:

James G. Whitt

5630 Fishers Lane

Rockville, MD 20857

Phone: 301-827/1022

Email: James.Whitt@fda.hhs.gov

C.4.2.2 IDIQ CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) For the IDIQ Contract (To be identified at award of contract) The IDIQ COR will be responsible for the following:

Receiving the IDIQ Monthly Report

Tracking compliance with Limitations on Subcontracting clause across task orders

Tracking and monitoring contract ceiling

Tracking and monitoring staff allocation across task orders

Reviewing changes to staffing matrix

Secondary point of contact for issues that need to be escalated

Reviewing Task Order SOWs for scope compliance

Receiving and archiving all task orders issued against the contract For each individual task order, a Task Order COR will be assigned. The TO COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The TO COR does not have authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

Technical Leads may assist the Task Order COR. The Technical Leads will not have the authority to provide technical direction in accordance with the paragraphs above; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and…