Solicitation_DNA_Plating_cg_edit.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2015-N-17644

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

09/18/2015

6. REQUISITION/PURCHASE NO.

000HCPCG-2016-89712

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 1 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in 2920 Brandywine Road, Atlanta, GA 30341 until 2:00p local time 10/17/2015 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

Arrange Receipt of 50,000+ DNA Samples (approximately 544 boxes of samples and 144 boxes of normalized samples)

(FAR 52.217-6 Option of Increased Qty. included, Section I ifqty. increases)

POP: 11/01/2015-03/31/2016

SEVERABLE

MIN: 0/ Box

MAX: 700/ Box

Inventory samples (approximately 50,000 samples need to be individually scanned (approximately 544 boxes), also 144 boxes of normalized samples).

(FAR 52.217-6 Option of Increased Qty. included, Section I if qty. increases)

POP: 11/01/2015-03/31/2016

SEVERABLE

MIN: 0/ Box

MAX: 700/ Box

For NHANES III Concentrations

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0/ Box

MAX: 78/ Box

For NHANES 2011-2012 Samples

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0/ Box

MAX: 92/ Box

Store samples in seven freezers; this cost includes maintenance of the freezers

POP: 11/01/2015-10/31/2016

nonSEVERABLE MIN: 7/ Each

MAX: 7/ Each

Normalize DNA Samples (1 plate of 92) as requested by researcher (estimated at 100 plates per researchers) - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0/Each

MAX: 500/ Each

Create a Quality Control Sample (5% of master set of 100 plates per researcher) (1 plate of 92) - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Each

MAX: 25 Each

Prepare 96-well aliquot plates of a normalized set (1 plate of 92) and QC plates as requested by researchers - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Each

MAX: 510 Each

Prepare 96-well aliquot plates of a normalized custom set (1 plate of 92) with QC plates - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Each

MAX: 100 Each

Ship DNA as requested - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Box

MAX: 400 Box

Receive unused DNA from researcher - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Box

MAX: 100 Box

POP: 11/01/2015-10/31/2016

NonSEVERABLE 1 Job

Provide end-of-year report

POP: 11/01/2015-10/31/2016

1 Job

Disposal of DNA samples as needed - to be funded as needed

POP: 11/01/2015-10/31/2016

SEVERABLE

MIN: 0 Box

MAX: 10 Box

Store DNA Samples in 7 freezers (includes maintenance of freezers)

POP: 11/01/2016-10/31/2017

NonSEVERABLE MIN: 7 Each

MAX: 7 Each

Normalize DNA Samples (1 plate of 92) to be funded as needed based on researcher requests (estimated at 100 per researcher)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Each

MAX: 500 Each

Create a QC Sample (5% of master set) (1 plate of 92) (to be funded as needed)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates normalized set - (1 plate of 92) with QC plates (to be funded as needed)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates of normalized custom set - 1 plate of 92 and QC plates (to be funded as needed)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Each

Ship DNA samples (to be funded as needed)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Box

Receive unused DNA from researcher (to be funded as needed)

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Box

Maintain inventory

POP: 11/01/2016-10/31/2017

1 Job

Prepare/provide end-of-year report

POP: 11/01/2016-10/31/2017

1 Job

Disposal of DNA Samples as needed - to be funded as needed

POP: 11/01/2016-10/31/2017

SEVERABLE

MIN: 0 Box

Store DNA Samples in 7 freezers (includes maintenance of freezers)

POP: 11/01/2017-10/31/2018

NonSEVERABLE MIN: 7 Each

Normalize DNA Samples - 1 plate of 92 (to be funded as needed based on researcher requests)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Each

Create QC Samples (5% of master set) - 1 plate of 92 (to be funded as needed)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates of normalized sets - 1 plate of 92 - with QC plates (to be funded as needed)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates of normalized custom sets - 1 plate of 92 - and QC plates (to be funded as needed)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Each

Ship DNA Samples (to be funded as needed)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Box

Receive unused DNA samples from researcher (to be funded as needed)

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Box

Maintain inventory

POP: 11/01/2017-10/31/2018

1 Job

Prepare and provide end-of-year report

POP: 11/01/2017-10/31/2018

1 Job

Disposal of DNA Samples as needed - to be funded as needed

POP: 11/01/2017-10/31/2018

SEVERABLE

MIN: 0 Box

Store samples in seven freezers (includes maintenance of freezers)

POP: 11/01/2018-10/31/2019

NonSEVERABLE MIN: 7 Each

Normalize DNA samples (1 plate of 92) based on researcher request - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Each

Create quality control (5% of master set of 100 plates) (plate of 92) - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates - normalized set (1 plate of 92) with quality control - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates - normalized custom set (1 plate of 92) and QC plates - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Each

Ship DNA per request - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Box

Receive unused DNA from researchers - to be funded as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Box

Maintain inventory

POP: 11/01/2018-10/31/2019

1 Job

Provide end-of-year report

POP: 11/01/2018-10/31/2019

1 Job

Dispose DNA samples as needed - fund as needed

POP: 11/01/2018-10/31/2019

SEVERABLE

MIN: 0 Box

Store samples in seven freezers (includes maintenance of freezers)

POP: 11/01/2019-10/31/2020

NonSEVERABLE MIN: 7 Each

Prepare normalized DNA samples at request - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Each

Create QC samples (5% of master set) - 1 plate of 92 - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Each

Prepare 96-well aliquot plates of normalized set with quality control (1 plate of 92) as requested - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Each

Prepare 96-well alilquot plates of normalized custom set (1 plate of 92) and QC plates - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Each

Ship DNA as needed - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Box

Received unused DNA from researcher - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Box

Maintain inventory

POP: 11/01/2019-10/31/2020

1 Job

Provide end-of-year report

POP: 11/01/2019-10/31/2020

1 Job

Dispose DNA samples as needed - to be funded as needed

POP: 11/01/2019-10/31/2020

SEVERABLE

MIN: 0 Box

SECTION C – DESCRIPTION/SPECIFICATION/WORK STATEMENT

I. BACKGROUND

The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. NHANES is a major program of the National Center for Health Statistics (NCHS). NCHS is part of the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (DHHS) and has the responsibility for producing vital and health statistics for the Nation. NHANES is overseen by the Division of Health and Nutrition Examination Surveys (DHANES). In 1991, a DNA biorepository was developed to maintain DNA specimens for future research studies that would allow genetic information to be combined with other NHANES data.

As part of the NHANES physical exam, blood is collected from participating sample persons. Beginning with the NHANES III survey (1991-1994) and in certain subsequent NHANES survey cycles (1999-2002, 2007-2012), a blood sample was collected from participants for extracting DNA. The DNA from the NHANES III participants was extracted from immortalized cells (transformed with EBV) created from a blood sample not from whole blood as in subsequent survey cycles. For subsequent survey cycles two tubes of blood were collected from participants and DNA isolated from each primary and secondary tube. DNA sets were established as follows: 1999-2002 (combines NHANES survey cycles 1999-2000 and 2001-2002), 2007-2008, 2009-2010, 2011-2012. Since 2012 there has not been further collection of blood for DNA extraction.

To ensure continued quality, 1% of samples from the NHANES 1999-2002, 2007-2008, 2009-2010 and 2011-2012 were recently run on agarose gels to assess DNA degradation. All samples had high molecular DNA present and none showed any significant signs of degradation. These samples were normalized based on their measured concentrations prior to electrophoresis and the DNA band intensities were similar indicating accurate concentrations. In addition, an assay that detects short tandem repeat (STR) from 8 regions of the genome was run on the same 1% of NHANES 1999-2012 samples to test for contamination. None of the samples showed any evidence of contamination with a 5% limit of detection.

After a hiatus the stored DNA samples are available again for genetic research. NCHS will no longer have the capability to continue storing or processing existing DNA samples. This capability is required for genetic research to be conducted on existing NHANES DNA samples. This Statement of Work (SOW) is part of an acquisition plan for the government to acquire these services.

II. PURPOSE

The purpose of this performance-based work statement (PBWS) is to store DNA samples from approximately 20,000 NHANES participants, process as needed and prepare and ship DNA plates to researchers. Additionally, inventory management and reporting, QA/QC reporting, receiving returned DNA sample, and destruction of unneeded or unusable sample as requested are required.

III. JUSTIFICATION

NHANES DNA samples are the only nationally representative collection of stored DNA specimens and genetic data obtained from testing and can be combined with NHANES data on the health, nutritional status, health behaviors and environment. Consequently, genetic research of NHANES DNA samples allows for the possibility of generalizations of analytic conclusions to the national level. Furthermore, NHANES data are stratified by race, sex, age, and income.

IV. SCOPE OF WORK

The contractor shall perform all work necessary to receive, store, process, plate, inventory, record, ship, and/or dispose of NHANES DNA samples in a manner that preserves their research value and allows the DNA to be used for research purposes. The contractor shall implement procedures to ensure high quality laboratory practices.

V. WORK BREAKDOWN STRUCTURE

BASE PERIOD –Twelve(12) Months

1. Arrange for receipt of about 50,000 DNA samples from the CDC stored specimen facility, including ensuring that proper shipping procedures and regulations are complied with.

Contracting lab will receive:

Complete assembled master set of crudely extracted DNA of unknown concentrations from survey participants in NHANES III (1991-1994).

Complete assembled master set plus incomplete secondary set of highly purified DNA from NHANES 1999-2002, 2007-2008, 2009-2010.

Normalized DNA (at 50 ng/ul) from NHANES 1999-2002, and 2007-2008.

DNA stocks from NHANES 2011-2012.

2. Inventory samples (scan tube barcodes to match inventory manifest) on a freeze table or comparable method to avoid thawing and provide DHANES with inventory report. Notify Project Officer of receipt and inventory of sample when shipped sample arrive.

3. Measure DNA concentration of the NHANES III crude master stocks and assess DNA quality.

Contracting lab will:

Measure DNA concentrations in each sample using a method that does not require highly purified DNA (eg. Real Time PCR of a human housekeeping gene such as RNAseP or Picogreen)

Assess quality using methods to detect presence of high molecular weight DNA, potential DNA degradation, and sample purity (eg. gel electrophoresis, human short tandem repeat (STR) analysis)

4. Measure the concentration of NHANES 2011-2012 DNA stocks. Assemble a master set for distribution. Provide DHANES with the concentrations.

Measure DNA concentrations in each sample measuring the A260 by spectrophotometer and confirming DNA purity by measuring A280 and evaluating A260/A280 ratio.

Assemble master set with maximum number of participants utilizing secondary stock if necessary to ensure each participant sample has a concentration of at least

50 ug/ml, volume near 1 ml, and appropriate A260/A280 ratio. If criteria are not met by either primary or secondary stock that individual can be removed from the

DNA repository

5. Store DNA samples in -70 or -80 degree Celsius freezer or in liquid nitrogen (for samples in cryovials capable of liquid nitrogen storage). Maintain freezers as necessary to meet this requirement.

6. Normalize DNA sets to a concentration and volume specified by NCHS as needed and store appropriately for long term storage.

7. Assemble a set of quality control (QC) samples for NHANES sets. The QC set will consist of 5% of duplicate samples from the master or secondary set which will be blinded to the researchers receiving DNA samples. The identity of these samples will be provided to the contractor by NCHS. Normalize the QC samples to a concentration and volume specified by NCHS as needed and store appropriately for long term storage

8. Prepare 96-well aliquot plates of the normalized set and QC sets to ship to researcher(s), with an option to create more than one set at a time, as requested by the Project Officer (according to the specifications of the research protocol).

9. Prepare 96-well aliquot plates of a normalized partial set (custom set) from the appropriate NHANES DNA collection and QC sets to ship to researcher(s) as requested by the Project Officer (according to the specifications of the research protocol).

10. Ship DNA sets and complete shipping manifest to researcher as directed using standard secure shipping methods in accordance with all applicable regulations for biological materials. The contractor shall provide receipt and inventory of DNA specimens electronically. Notification of inventory and shipping must be sent to the Project Officer as soon as the plated DNA ships. See Appendix A for shipping procedures.

11. Arrange for receipt of remaining unused DNA samples from researcher at the completion of their study, including ensuring that proper shipping procedures and regulations are complied with. Notify Project Officer of receipt and inventory of sample when shipped sample arrive.

12. Prepare and provide end-of-year report on inventory, including start and final inventory.

13. Maintain accurate inventory of DNA specimens at all times and perform periodic quality assurance checks as requested by the Project Officer. Depending on the volume of research, assess specimen degradation when appropriate.

14. Dispose DNA samples in approved manner as requested by DHANES.

*The services described in Line 5 – 14 are repeated for each option year. Four (4) Option Years are anticipated.

Performance-based Matrix – Firm Fixed Price – Genetic Plating

Incentives/Payment-Quality Link

Arrange for receipt of about 50,000 DNA samples. Store DNA samples in -70 or -80 degree freezer or in liquid nitrogen

Delivery of initial inventory file and operations manual

Prepare 96-well aliquot plates of normalized DNA samples and QA/QC and ship as required.

Yearly report including sample inventory, sample receipt, sample shipment, and freezer usage (e.g. number of freezers operating, surplused, etc.)

Proper shipping procedures and regulations are followed. Thawing does not occur. Freezers are maintained to meet the necessary requirements at all times.

Completed inventory report and operations manual.

Proper QA/QC specifications are met. Proper shipping procedures and regulations are followed. Thawing does not occur.

Accuracy & Timeliness

Operational settings for safety and security of DNA samples in a secured environment.

Inventory of samples complete one month after delivery of specimens

QA/QC specifications. Operational settings for safety and security of DNA samples in a secured environment.

One month after end of the annual Period of Performance.

Continuous electronic system monitoring with notification capability, e.g. alarm.

Surveillance system will be primarily NCHS observations.

1. Positive incentives:

a. Payment of contract labor rate for satisfactory service.

b. Contractor performance evaluated using the automated Contractor Performance Assessment Reporting System (CPARS). The evaluation will be considered when future AGENCY contract selections are made.

2. Payment is linked to quality through FAR 52.246-4 Inspection of Services—Fixed-Price.

SECTION D – PACKAGING AND MARKING

Packing and shipping of NHANES DNA sample must comply with Federal regulations (Federal Register, Vol. 45, No. 141-Monday, July 21, 1980, Part 72 – Interstate Shipment of Etiologic Agents). Non-infectious DNA and RNA are “Not Restricted in the U.S., even if genetically modified.

Shipping material typically includes:

Insulated Foam Shipping Kit

Tab locking literature mailers for the secondary receptacle

Dry Ice Labels

“This Side Up” labels

Dry ice

Absorbent material under pad

Ziploc bags

Bubble wrap

Definitions:

Primary Receptacle: A labeled, primary, watertight, leak-proof receptacle containing the specimen. The receptacle is wrapped in enough absorbent material to absorb all fluid in case of breakage. (Examples: 96 well plate, cryovial, micro packaging vial, etc.)

Secondary Receptacle: A second durable, watertight, leak-proof receptacle to enclose and protect the primary receptacle(s). Several wrapped primary receptacles may be placed in one secondary receptacle. Sufficient additional absorbent material must be used to cushion multiple primary receptacles. (Examples: Ziploc bag, shipping canister, etc.)

Outer Shipping Package: The secondary receptacle is placed in an outer shipping package which protects it and its contents from outside influences such as physical damage and water while in transit. (Examples: Cardboard box, Styrofoam box, etc.)

SECTION E. - INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the COR/Project Officer) at the destination of the articles, services or documentation.

(End of Clause)

E.2 Acceptance:

Final acceptance will be based on the completion of each deliverable.

(End of Clause)

SECTION F – DELIVERIES OR PERFORMANCE

FAR SOURCE

TITLE AND DATE

52.242.15

Stop-Work Order (Aug 1989)

52.242.17

Government Delay of Work (Apr 1984)

F.1 DELIVERY SCHEDULE

The Contractor shall deliver, within the time frames specified, to the Project Officer at the address shown in Section G, and copies of Item(s) to the Contracting Officer at the address shown on the face page of the contract.

Specific deliverables and dates to be accomplished are listed below:

Deliverables

Due by

1. Provide inventory report after

30 days after receipt of DNA

DNA samples are received samples

2. Yearly inventory files

30 days after End of each yearly POP to include start and final yearly inventory.

F.2 PERIOD OF PERFORMANCE

The period of performance for this contract shall be from Date of Award through 10/31/2020 subject to the availability of funds for each Fiscal Year and the Optional Years being exercised.

F.3 Place(s) of Performance

All work is to be performed at the Contractor’s facility.

(End of Clause)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 Contracting Officer

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered for deviation from any stipulation of this contract. (End of Clause)

G.2 Contracting Officers Representative (COR) Technical Guidance

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.3. Contracting Officer’s Representative (COR)

NCHS COR/George W. Zipf

Division of Health and Nutrition Examination Surveys

National Center for Health Statistics

Centers for Disease Control and Prevention

3311 Toledo Road, Room 4313

Hyattsville, MD 20782

Telephone: 301-458-4289

G.4.

Government Property The government shall provide DNA samples in the appropriate receptacles. No other government furnished materials are required for or shall be provided on this contract.

(a) Government-Furnished Property (GFP). The Government reserves the right to supply the Contractor, as Government-furnished property, any additional supplies, equipment, and materials determined by the Contracting Officer to be necessary and in the best interest of the Government in the performance of this contract provided the property is furnished, or the Contractor is notified of the Government’s intent to furnish it, prior to the Contractor’s commitment to acquire such items.

(b) Contractor-Acquired Property (CAP). Regardless of the place of performance, when the costs of such items will be charged to the contract, the Contractor must receive written consent from the Contracting Officer prior to purchase of any item which requires such consent under FAR 52.244-2 (see Section I, FAR 52.244-2, paragraphs (c), (d) and (e)).

(c) If performance of this contract is within and on Government facilities, and the Government-furnished property or contractor-acquired property is for use only within or on the Government facilities, the control and accountable record keeping for such property shall be retained by the Government (see FAR 52.245-1, Property Records). The Contractor shall remain accountable for loss or damage, but will not be required to submit an annual inventory or place its own bar codes on the items. The Government will provide property labels and other identification for contractor-acquired Government property under this paragraph.

(d) If performance of this contract is not within Government facilities, and there is either Government-furnished property or contractor-acquired property being used in performance of the work, the Contractor shall be responsible for the control and accountable record keeping for such property in accordance with FAR Subpart 45.5 as supplemented by HHS Publication (OS) 74.115 entitled "Contractor’s Guide for Control of Government Property," a copy of which will be provided upon request.

(e) The Chief of Material Management Branch, PGO, Centers for Disease Control and Prevention (CDC), is hereby designated as the Property Administrator for this contract. The Contractor agrees to furnish information regarding the Government property under this contract to the Property Administrator, an authorized representative, or a duly designated successor(s). The Contractor shall identify each item of equipment furnished by the Government to the Contractor or acquired by the Contractor using contract funds, with a suitable decal, tag, or other marking, as prescribed by the Property Administrator, and shall follow the guidance set forth in the “Contractor’s Guide for Control of Government Property.”

(End of Clause)

CDC42.0001 Contractor Performance Assessment Reporting System (CPARS) Requirements (April 2013) In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

Provide the current CPARS representative information below.

PRINT OR TYPE NAME

EMAIL ADDRESS AND PHONE NUMBER

[End of Provision] G.5 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to:

HYPERLINK "http://www.cpars.gov" www.cpars.gov

For details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

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G.6 Contract Communications/Correspondence

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

G.7 Payment by Electronic Funds Transfer

The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050.

In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

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G.8 Invoice Submission

(a) The Contractor shall submit the original contract invoice/voucher to the shown below:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 3033

(b) Please do not forget to submit a copy of each invoice directly to the Project Officer and Contracting Officer or Contract Administrator concurrently with submission to the Financial Management Office (FMO). It saves time, postage, and speeds up the payment processing by emailing the invoices to the 3 listed email addresses below:

Financial Management Office (FMO):

Email to:FMOAPINV@CDC.GOV, Fax: 404-638-5324

Contracts Specialist: Nina Waters, 770-488-2933

Contracting Officer’s Representative (COR) George W. Zipf (301)458-4289

(c) The Contractor is required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Contract Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c) (1).

(13) DUNS + 4 Numbers

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SECTION H – SPECIAL CONTRACT REQUIREMENT

H.1 Type of Contract

The Government anticipates awarding a Firm-Fixed Price/Indefinite Delivery-Indefinite Quantity (IDIQ) Task Order contract to be awarded for this requirement.

H.2 Government Rights in Data

All data, software and supporting materials acquired under this contract become the property of the U.S. Government. Under no circumstances shall an offeror place a copyright that will in any way limit the Government’s use of any of the materials for which the vendor develops, provides and/or receives payment under this contract.

The Contractor shall not provide any government documents, information, or licensed material in any form to sources not authorized by NCHS without written approval during the period of performance of this requirement and any time afterwards. Execution of non-disclosure statements will be required.

H.3 Review of Data

The following persons may review the data: NCHS Project Officer and Contracting Officer Representative; NCDC&P Project Representative, NIH Project Representative, the NHANES Data collection contractor, and outside consultants as requested by the Project Officer or Alternate Project Officer.

H.4 Identification and Disposition of Data

The Contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the Contracting Office and the Project Officer. The Contractor will release all tabulations and reports solely to the Project Officers or their designee. Copies of quality control data may be maintained in the contracting laboratory. If method development is done as part of this project, the Contractor may keep that data. All biologic specimens must be returned to the Project Officer and may not be used for other purposes unless approved by the Project Officer.

H.5 Smoke Free Working Environment

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities.

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H.6 Privacy Act

(a) Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.

(b) The COTR is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

(c) The Contractor shall follow the Privacy Act guidance as outlined in the Privacy Act of 1974 (5 USC 552a) and Section 308(d) of the Public Health Service Act.

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H.7 Dissemination of Information

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR.

(End of Clause)

H.8 Data Subject to Confidentiality Requirements

The type(s) of data subject to the Clause at 352.224-70, Confidentiality of Information, which has been incorporated by reference in Section I, are as follows:

All Data generated by this procurement, including personally identifying information.

Following are the requirements for handling these data:

The Contractor is prohibited from publicizing or disseminating information without the prior review and comment of the Project Officer. All data and products developed under this contract shall become and remain the property of the Government.

H.9 Issuance of Task/Delivery Orders

The Contractor shall be capable of providing the staff necessary to conduct the required work. The timing, magnitude, and scope of each requirement cannot be predicted until the Government determines the specific work to be performed. The Contractor should expect a fluctuating workload throughout the performance period of this contract and will provide the technical, professional, managerial, and clerical support required to complete the task order successfully.

Performance hereunder shall be accomplished by task orders issued under this contract in accordance with the following procedure.

As the Government identifies specific requirements for work to be performed under this contract, a Task Delivery Order will be issued unilaterally. The Order will detail the requirements and associated funding. The NCHS program official will subsequently provide a predetermined delivery schedule for those requirements. If the Contractor does not accept the Task/Delivery Order and cannot reach agreement on an individual task order basis, it shall be considered a dispute and handled according to the provision of the contract in Section I, FAR 52.233-01 Disputes – Alternate I” (Oct 1995).

H.10 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006)

The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

The NDA made part of this clause, exhibit I and II , is required in service contracts where positions and/or functions proposed to be filled by contractor’s employees will have access to non-public and procurement-sensitive information. The NDA also requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with the CDC), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC)

Contractor Non-Disclosure Agreement

I. Non-public Information

[Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the contracting official. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the contracting official could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the contracting official.

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the CDC.

II. Procurement-Sensitive Information

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee’s responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’…