15-223-SOL-00077.pdf

Solicitation No. 15-223-SOL-00077

Section B Continuation of Standard Form (SF) 1449

B-1 Continuation of SF 1449, Blocks 19-24 – Item No., Schedule of Supplies or Services, Quantity, Unit, Unit Price and Amount.

Firm-Fixed Price Contract for Transfusion-Transmissible Infections Monitoring System (TTIMS) – Laboratory and Risk Factor Database Coordinating Center (LRCC) for a base period with up to four (4) option periods meeting the performance requirement in Section D, Attachment #1.

CLIN Description Quantity Unit Unit Price Total Price

1 TTIMS-LRCC duties to be performed including all labor, facilities, materials and travel in accordance with requirements as identified in Attachment #1, Transfusion-Transmissible Monitoring System (TTIMS) Laboratory and Risk Factor Database Coordinating Center (LRCC) Statement of Work (SOW) dated July 10, 2015 (9 Pages) and appendices thereto in Section D.

Period of Performance (POP) 09/21/2015 – 9/20/2016

1 Dollars U.S.

$1.00

The below items are optional and may be exercised in accordance with the applicable FAR Clause 52.217-9 in Section C below.

CLIN Description Quan tity Unit

Unit Price Total Price

2 Option Period 1- Same as Item 0001 description.

POP 09/21/2016 –

9/20/2017

1 Dollars U.S. $1.00 $

3 Option Period 1- Same as Item 0001 description.

POP 09/21/2017 –

9/20/2018

1 Dollars U.S. $1.00 $

4 Option Period 1- Same as Item 0001 description.

POP 09/21/2018 –

9/20/2019

1 Dollars U.S. $1.00 $

5 Option Period 5- Same as Item 0001 description.

POP 09/21/2019 –

1 Dollars U.S. $1.00 $

CLIN Description Quan tity Unit

Unit Price Total Price

9/20/2020

TOTAL $

Section C- Contract Clauses-

C-1 FAR Clause 52.212-4 Contract Terms and Conditions-Commercial Items (Refer to SF-1449, Block 27a) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (MAY 2015), applies to this acquisition. Addenda to this clause are as follows:

C-1.1. Additional Clauses Incorporated by Reference This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. The full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far http://farsite.hill.af.mil/vfhhsara.htm

FAR Clause No. Title Date 52.203-3 Gratuities APR 1984 52.203-12 Limitation on Payments to Influence Certain Federal Transactions OCT 2010 52.203-16 Preventing Personal Conflicts of Interest DEC 2011 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform

Employees of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper MAY 2011 52.217-8 Option to Extend Services

NOV 1999

52.217-9 Option to Extend the Term of the Contract “(a)…thirty (30) calendar day before the contract expires;…60 calendar…

(c) five (5) years (exclusive of any extensions under FAR Clause 52.217-8).”

MAR 2000

52.223-2 Affirmative Procurement of Biobased Products Under Service and Construction Contracts

JUL 2012

52.223-6 Drug-Free Work Place MAY 2001 52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.227-1 Authorization and Consent DEC 2007 52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement DEC 2007

52.227-14 Rights in Data – General Alt II dtd Dec 2011 may apply if any limited data is identified in provision 52.227-15

MAY 2014

52.227-16 Additional Data Requirements JUN 1987 http://www.acquisition.gov/far http://farsite.hill.af.mil/vfhhsara.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_000.htm#P450_67440

FAR Clause No. Title Date 52.227-23 Rights to Proposal Data JUN 1987

52.232-40 Providing Accelerated Payments to Small Business Subcontractors DEC 2013

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

HHSAR Clause No.

Title Date

352.201-70 Paperwork Reduction Act JAN 2006

352.202-1 Definitions JAN 2006

352.203-70 Anti-Lobbying JAN 2006 352.219-70 Mentor-Protégé Program Reporting Requirements JAN 2010 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

OCT 2009

352.223-70 Safety and Health JAN 2006 352.224-70 Privacy Act JAN 2006 352.227-70 Publications and Publicity JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.237-70 Pro-Children Act JAN 2006 352.237-71 Crime Control Act – Reporting of Child Abuse. JAN 2006 352.237-72 Crime Control Act – Requirement for Background Checks. JAN 2006 352.239-70 Standard for Security Configurations JAN 2010 352.239-71 Standard for Encryption Language JAN 2010 352.239-72 Security Requirements for Federal Information Technology Resources JAN 2010 352.242-71 Tobacco-Free Facilities JAN 2006 352.270-1 Accessibility of Meetings, Conferences, and Seminars to Persons with

Disabilities

JAN 2001

352.270-6 Restrictions on Use of Human Subjects JAN 2006 352.270-8 Prostitute and Related Activities JAN 2010

C-1.2. HHSAR 352.242-70 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 CO 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 CO. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The individuals cited below are key personnel:

Name:

Title: Project Manager

Email:

Telephone:

Name(s):

Title: Principal/Co-Principle Investigators Email(s):

Telephone(s):

C-1.3 Observance of Federal Holidays & Other Government Closings No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below.

1. New Year’s Day January 1st

2. Martin Luther King Day Third Monday in January

3. President’s Day Third Monday in February

4. Memorial Day Last Monday in May

5. Independence Day July 4th

6. Labor Day First Monday in Sept.

7. Columbus Day Second Monday in Oct.

8. Veteran’s Day November 11

9. Thanksgiving Day Fourth Thursday in November

10. Christmas Day December 25

C-1.4. Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this contract:

(To be completed at time of award) Name:

Email Address: @fda.hhs.gov Phone: 240-402- Mailing Address: 10903 New Hampshire Ave, Silver Spring, MD 20993

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (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 CO for this contract is Jerry W. Martin.

All communications pertaining to contractual and/or administrative matters under the contract shall be addressed to the Contract Specialist (CS) at the following address: Attention: Crystal McCoskey, FDA/OAGS, 3900 NCTR Rd, Building 50, Room 426, Jefferson, AR. 72079 Phone (870) 543-7267 or electronically at crystal.mccoskey@fda.hhs.gov

C-1.5. Contractor’s Point of Contact

(To be completed at time of award) Name:

Phone:

Email:

C-1.6. Inspection and Acceptance

The Contracting Officer’s Representative (COR), as a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services provided and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the

COR.

The contractor shall submit deliverables that are complete, concise, and conform to the format that shall be agreed upon in advance between the Contractor and the COR. Per the summary deliverables table in Section C-1.8, certain types of deliverables shall be submitted initially in draft form, allowing the COR to review and provide additional clarification and comments, which shall be included in the final deliverable. In the event of the rejection of any deliverable, the Contractor shall be notified in writing by the COR, giving the specific reason(s) for rejection. The Contractor shall respond to the rejected deliverable and return the corrected deliverable to the COR. The delivery of corrected deliverables shall be no later than ten (10) calendar days.

All deliverables shall be submitted electronically to the COR using the Microsoft Office tool suite (i.e.

Microsoft Word and Excel) and Adobe PDF.

C-1.7. Invoices

Upon Government acceptance of deliverables, the Contractor shall submit no more than one (1) invoice monthly in arrears to the Contracting Officer identified in C-1.4. above.

Invoices shall contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.

To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable;

(vi) Terms of any discount for prompt payment offered, if applicable;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order; and

(xii) Any other information or documentation required by the purchase order/award.

C-1.8. Reporting Requirements/Deliverable and Activity Schedule

All deliverables required by this contract shall be delivered to the COR except where indicated that both the CO and the COR receive copies. All deliverables shall be subject to the inspection and acceptance by the COR. All reports required under this contract shall be submitted in Microsoft Word or Microsoft Excel compatible format. All deliverables shall be submitted electronically to the COR/CO, as specified in the table, at the address(s) located in Section C-1.4.

Task Deliverable/Work Product Title Due Date Delivered To

Solicitation Section C-

1.14

Associate Contractor Agreement

Within thirty (30) calendar days after identification of joint participate requirement

CO

Solicitation Section C-

1.12

FDA Data Disclosure Clearance Procedures (Attachment 2)

As identified throughout the contract CO

Solicitation Section C-

1.13

Organizational Conflicts of Interest

Immediately upon discovery of an organizational conflict of interest throughout the contract

CO

Solicitation Section C-

2 (FAR

52.219-9)

Subcontracting Plan Annually 30 calendar days after the end of the Government’s fiscal year

CO

SOW 2.1 LRCC TTIMS Protocol 2 months after contract award date COR

SOW 2.1

LRCC Sections/Input to the Manual of Procedures (MOP)

3 months after contract award date COR

SOW 2.1

Centralized Bio-Specimen Repository

30 calendar days from contract award date COR, Committee

SOW 2.2 Risk Interview Survey Within 45 calendar days after Contract award date COR, Committee

SOW 2.2 Risk Factor Interviews Within in 21 calendar days of triggered event COR

SOW 2.2

Tracking of Follow-Up Investigations

Within in 21 calendar days of triggered event COR

SOW 2.2 Analytical Plan Within 3 months after contract award date COR, Committee

SOW 2.3 Risk Factor Data Surveillance Results

7th calendar day of the month COR, Committee

SOW 2.3

Sequencing Data Quarterly Report

By 7th calendar day of the following quarter

COR

SOW 2.3 Testing Quarterly Report By 7th calendar day of the following quarter

COR

SOW 2.4

Committee/Subcommittee Conference Calls Meeting Minutes

By 10th calendar day following the meeting COR, Committee

SOW 2.4

Committee/Subcommittee Agendas

5 calendar days prior to the meeting COR, Committee

SOW 2.4

Central Electronic Repository of Meeting Minutes/ Calls/Action Items

Last business day of the month COR, Committee

SOW 2.4 Draft Technical Report Draft due 30 calendar days before the last day of the

COR

contract’s period of performance

SOW 2.4 Final Technical Report Final due at the end of contract’s period of performance

COR

SOW 5.4 Abstracts and Presentations 5 business days prior to submission or presentation COR

SOW 2.4 Manuscripts for publication 30 calendar days prior to the agreed date COR

SOW 2.5 Written Site Visit Report 30 calendar days after site visit COR, Committee

SOW 2.5

Written External Collaboration Requests

Prior to the 5th 5 calendar days of each month COR, Committee

SOW 2.6 Kick Off Meeting Minutes Within 10 calendar days after contract award date COR, Committee

SOW 2.6 Monthly Status Report 5th calendar day of the month (for the prior month report)

COR, Committee

SOW 2.6 Transition-Out Plan 30 calendar days prior to the agreed date COR

C-1.9. 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 Generals 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 email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W.

Washington, D.C. 20201

Information regarding procedural matters is contained on the HHS/OIG website at http://oig.hhs.gov/hotline.html

C-1.10 Period of Performance Contract Period – 1 year from date of contract award followed by up to four (4) additional one (1) year option periods for a total of five (5) years.

C-1.11 Post Award Evaluation of Contractor Performance

During the life of this order, the Contractor’s performance shall be evaluated on an interim and final basis

Task Meeting / Activity Title Location(s) Estimated

Occurrences Receiving

Organization

SOW 2.5 Committee Monthly Meeting

FDA White Oak Campus, Bldg 71 or teleconference One per Month Committee

SOW 2.5

Semi-Annual On-Site Meeting (to include PIs and some Committee Members)

FDA White Oak Campus, Bldg 71 Two per year Committee

SOW 2.5

Committee Conference Call Teleconference Minimum

Monthly Committee

SOW 2.5

Sub-Committee Conference Call Teleconference Minimum

Monthly Committee

SOW 2.6 Contract Kick-Off Meeting

FDA White Oak Campus, Bldg 71 One COR

SOW

2.6.4 and

FAR

52.237-3

Transition-Out Plan 90 calendar days prior to contract expiration One/Once CO, COR mailto:HHStips@oig.hhs.gov http://oig.hhs.gov/hotline.html pursuant to FAR Subpart 42.15. The evaluation shall be conducted utilizing the Department of Defense (DOD) Contractor Performance Assessment Reporting System (CPARS). The Contractor shall register in the CPARS upon contract award. The CPARS may be accessed by the Contractor at http://www.cpars.gov/.

C-1.12 FDA Data Disclosure Clearance Procedures

1. PURPOSE:

As part of its regulatory activities, FDA may require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures (Attachment 2).

In the event the contractor identifies Limited Rights Data in provision 52.227-15, this Limited Rights Notice authorizes FDA to disclose these Limited Rights Data for public health, safety, and regulatory purposes, provided that the disclosures of these data are made subject to prohibition against their further disclosure.

In accordance with the Limited Rights Notice, the purpose of this document is to establish timely clearance procedures for the FDA and contractor to follow when FDA seeks either (1) to make Aggregated Limited Rights Data (see definition below) publicly available, or (2) to disclose actual Limited Rights Data to specific third parties subject to prohibition against their further disclosure.

2. PROCEDURES

These clearance procedures do not apply to disclosure of information, including of Limited Rights Data and/or Aggregated Limited Rights Data, made in response to an authorized request of Congress or any other government body of competent jurisdiction.

a. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (located within Attachment

2) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party. Each party must update the Cover Sheet any time any of its contact information or its Contact changes.

b. For each proposed disclosure, FDA shall submit a Clearance Request Form, a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

c. FDA shall identify contractor as the data source when disclosing Aggregated Limited Rights Data or Limited Rights Data.

d. Within 24 hours of receipt by the contractor's contact of the Clearance Request Form, contractor shall provide a clearance decision for the requested Public Release of Aggregated Limited Rights Data.

e. Within 48 hours of receipt by the contractor's contact of the Clearance Request Form, the Contractor shall provide a clearance decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

(1) The third party must be actively engaged in a project initiated by FDA;

(2) Clearance to share the data with the third party shall be granted only for purposes of the FDA initiated http://www.cpars.gov/ project and shall not extend beyond the duration of the third party's active engagement in that project;

(3) The third party must execute in a timely manner the required contractor Third Party Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing;

and

(4) The third party must agree in writing not to release the Limited Rights Data to any additional party.

f. If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files relied upon to FDA for submission to Contractor for clearance approval.

g. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools.

This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

h. Notwithstanding any of the above provisions, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the information will be shared in a manner intended to protect the information from public disclosure.

Contractors submitting proposals to perform work under this contract must assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.

C-1.13 Organizational Conflicts of Interest (Simplified)

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

C-1.14 Associate Contractor Agreement

(a) The Contractor shall enter into Associate Contractor Agreements (ACA) for any portion of the contract requiring joint participation in the accomplishment of the Government’s requirement. The agreements shall include the basis for sharing information, data, technical knowledge, expertise, and/or resources essential to the integration of the DDCC, which shall ensure the greatest degree of cooperation for the development of the program to meet the terms of the contract. ACA Agreements shall be completed and provided to the CO within thirty (30) calendar days of identification of joint participate requirement. Associate contractors are listed in (h) below.

(b) ACAs shall include the following general information:

(1) Identify the associate contractors and their relationships.

(2) Identify the program involved and the relevant Government contracts of the associate contractors.

(3) Describe the associate contractor interfaces by general subject matter.

(4) Specify the categories of information to be exchanged or support to be provided.

(5) Include the expiration date (or event) of the ACA.

(6) Identify potential conflicts between relevant Government contracts and the ACA; include agreements on protection of proprietary data and restrictions on employees.

(c) A copy of such agreement shall be provided to the Contracting Officer for review before execution of the document by the cooperating contractors.

(d) Nothing in the foregoing shall affect compliance with the requirements of the Organizational Conflict of Interest clause at C-1.13.

(e) The Contractor is not relieved of any contract requirements or entitled to any adjustments to the contract terms because of a failure to resolve a disagreement with an associate contractor.

(f) Liability for the improper disclosure of any proprietary data contained in or referenced by any agreement shall rest with the parties to the agreement, and not the Government.

(g) All costs associated with the agreements are included in the negotiated cost of this contract.

Agreements may be amended as required by the Government during the performance of this contract.

(h) The following contractors are associate contractors with whom agreements are required:

CONTRACTOR ADDRESS PROGRAM/CONTRACT

C-1.15 Wage Determination

This contract is subject to the Service Contract Labor Standards statute, and the place of performance was unknown when the solicitation was issued. The following Wage Determination is incorporated into this contract as Attachment #3:

TBD based on information submitted with offers

C-2. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAY 2015) (Reference block 27a of SF 1449)

(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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(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) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(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:

__X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C.

3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 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) [Reserved]

_X__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

_X__ (8) 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 - if offeror selects “b” in FAR 52.209-7)__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

_X__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (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__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

_X__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)).

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

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

___ (iv) Alternate III (Oct 2014) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

_X__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 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__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

____ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O.

13126).

_X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X__ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

_X__ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

_X__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

_X__ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X__ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

_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) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Jun 2014) of 52.223-13.

___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.

8259b).

___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X__ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (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 (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (45) 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).

___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X__ (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (54) (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:

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

_X__ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

Employee Class Monetary Wage -- Fringe Benefits

Medical Records Technician (SCA Occupational Code

18.96 hourly* + 23%**

12190)

Medical Assistant (SCA Occupational Code 12100)

Laboratory Technician (SCA Occupational Code 30210)

Computer Systems Analyst II (SCA Occupational Code 14102)

13.68 hourly* + 23%**

17.06 hourly* + 23%**

28.06 hourly* + 23%**

*Hourly rates based on Washington-Baltimore-Northern

Virginia locale

**Fringe Benefits for federal hires at NCTR are calculated at an average of 23% of rate of pay

_X__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

_X_ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C.

chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

_X__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 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) (41 U.S.C.

3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

(viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

(ix) 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.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

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

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O.

13658).

(xvi) 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).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 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)

Section D- Contract Documents, Exhibits or Attachments

The following attachments are incorporated into this solicitation.

Attachment #1, Transfusion-Transmissible Infections Monitoring System (TTIMS) Laboratory & Risk Factor Database Coordinating Center (LRCC) Statement of Work (SOW) (9 Pages) with Appendix 1:

Appendix A, Quality Assurance Surveillance Plan (8 Pages)

Attachment #2, Data Disclosure Clearance Procedures (4 Pages)

Attachment #3, RESERVED FOR WAGE DETERMINATIONS (__Pages)

Attachment #4, Small Business Subcontracting Plan (12 Pages)

Section E- Solicitation provisions

E-1. FAR PROVISION 52.212-1 (Ref. Block 27A of SF 1449) The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (Apr 2014), applies to this solicitation. Addenda to this provision are as follows:

E-1.1 Offer Electronic Submission Instructions

(b)(4) Provide written narrative aligned to the statement of work tasks that describes the technical approach, methodology, program/project management, resources (i.e., facilities, staff, subcontractors, etc.), quality control, communications and outreach that will be utilized to satisfy all of the requirements;

detail how the approach will further ensure the overall minimum program objectives. Offeror’s shall provide a management plan demonstrating the knowledge, capability, and experience that will enable the Offeror to serve as the biostatistical and analytical center for evaluation and monitoring of HIV, HCV, and HBV positive blood donors supporting analysis, integration, and storage of TTI risk factor data and disease marker surveillance information. Identify personnel key to the success of the proposed approach, which at a minimum shall include program/project manager(s) and principal investigators/co-principal investigators, discuss their roles and responsibilities as well as their experience in performing same or near-same services, and provide resumes/curriculum vitae for each.

(b)(6) Pricing - Offerors shall complete Section B-1. Additionally, Offerors shall provide a payment plan inclusive of associative percentages of work to be completed in accordance with milestone achievement within each contract period.

(b)(10) Recent is defined as within the last three (3) years. Provide at least three (3) relevant past performance references for same or near-same services, describing the work performed and who it was performed for, the inclusive periods of performance for that work, the program/project managers and principal/co-principal investigators responsible for that work, and client name, point of contact name and email address/phone number(s).

Wage Determinations – Offerors shall provide wage determination numbers for all locations of work to be performed by any non-exempt SCA employees. Offeror shall provide any Collective Bargaining Agreements in place, if applicable.

Subcontracting Plan - Large business Offerors shall submit a Small Business Subcontracting Plan to include any existing HHS Office of Small and Disadvantaged Business Utilization (OSDBU)-approved mentor-protégé agreement in accordance with Attachment #4.

E-1.2 Inquiries Questions concerning this solicitation must be received no later than 27 July 2015, 1:00 p.m. Central Time. All questions shall be submitted electronically to Crystal McCoskey at crystal.mccoskey@fda.hhs.gov. Government responses to the questions will be posted as amendments to the solicitation and will be available to all interested parties at https://www.fbo.gov. All related solicitation information and amendments will be posted to the Federal Business Opportunities website at www.FBO.gov. Contractors are responsible for monitoring the FBO.gov site for changes.

E-1.3 Additional Provisions Incorporated by Reference This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. The full text of provisions may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far https://www.fbo.gov/ http://www.fbo.gov/ http://www.acquisition.gov/far

FAR Provision No. Title Date

FAR 52.209-7 Information Regarding Responsibility Matters,

(b) “The offeror [_] has [_] does not have current active Federal contracts and grants with total value greater than $10,000,000.”

Jul 2013

52.227-15 Representation of Limited Rights and Restricted Computer Software “[ ] (1) None of the data proposed for fulfilling the data delivery requirements qualifies as limited rights data or restricted computer software; or[ ] (2) Data proposed for fulfilling the data delivery requirements qualify as limited rights data or restricted computer software and are identified as follows:________________________”

(Dec 2007)

HHSAR

Provision No.

Title Date

352.219-70 Mentor-Protégé Program Jan 2010 352.270-4 Protection of Human Subjects JAN 2006 352.270-9 Non-discrimination for Conscience JAN 2010

E-2. FAR 52.212-2 Evaluation-Commercial Items

The provision at FAR 52.212-2 Evaluation-Commercial Items (Oct 2014), is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

(i) Technical Capability;

(ii) Relevant Past Performance

(iii) Price

Technical Capability and Relevant Past Performance, which are of equal importance, when combined, are more important, when compared to price.

E-3. FAR PROVISION 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS –

COMMERCIAL ITEMS

The provision at FAR 52.212-3, Offeror’s Representations and Certifications-Commercial Items, (Mar 2015) applies to this acquisition.

http://farsite.hill.af.mil/test/regs/far2afmcfars/fardfars/Far/52_000.htm#52.209-7