Combined_Synopsis_SB1341-13-RQ-0095_FBO.pdf

CLASSIFICATION CODE: 65 Medical, Dental and Veterinary Equipment and Supplies.

TITLE: Combined Synopsis – SRM 3949 Folate Vitamers in Frozen Human Serum

SOLICITATION NUMBER: SB1341-13-RQ-0095

RESPONSE DATE: February 8, 2013

CONTACT POINTS: Michael Szwed, Contract Specialist, (301) 975-6330

Andrea Parekh, Contracting Officer, (301) 975-6984

DESCRIPTION:

The National Institute of Standards and Technology (NIST) has a requirement for Standard

Reference Material of SRM 3949 Folate Vitamers in Frozen Human Serum

The Government intends to award a firm-fixed price purchase order as a result of this solicitation.

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL

ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION

FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY

SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A SEPARATE

WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THE SOLICITATION IS

BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES UNDER THE

AUTHORITY OF FAR 13.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-62

1352.215-72 INQUIRIES (APR 2010)

Offerors must submit all questions concerning this solicitation in writing to michael.szwed@nist.gov. Questions should be received no later than 7 calendar days after the issuance date of this solicitation. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325413 with a size standard of 500 employees.

This acquisition is set aside 100% for small business.

All offerors shall provide a quotation for the following line items:

CLIN 0001: Candidate SRM 3949 Level 1 (1000 units per concentration level), Price per ampoule and total price of CLIN.

CLIN 0002: Candidate SRM 3949 Level 2 (1000 units per concentration level), Price per

CLIN 0003: Candidate SRM 3949 Level 3 (1000 units per concentration level), Price per

STATEMENT OF WORK

Preparation of SRM 3949 Folate Vitamers in Frozen Human Serum

I. BACKGROUND

Standard Reference Material (SRM) 1955 Homocysteine and Folate in Frozen Human Serum was issued by NIST in 2005 and was developed in collaboration with the Centers for Disease

Control and Prevention (CDC). SRM 1955 consists of three pools with varying concentrations of folate species (vitamers). In the age of folic acid fortification in the U.S., there is continued interest in monitoring the folate status of both individuals and populations because adverse health effects could occur from inadequate folate intake and excessive intake of folic acid. In addition, concentrations of the folate species 5-methyltetrahydrofolate (5-methylTHF) and folic acid (PGA) currently detected in serum may exceed the highest concentration of these species found in SRM 1955 (≈ 37 nmol/L for 5-methyltetrahydrofolate and ≈ 1 nmol/L for folic acid).

Also, other folate species, such as tetrahydrofolic acid (THF), 5-formyltetrahydrofolic acid (5-formylTHF), and 5,10-methenyltetrahydrofolic acid (5,10-methenylTHF) as well as an oxidation product of 5-methylTHF called MeFox may also be present in serum samples. SRM 1955 does not have certified values for these folate species. There is currently less than a five year supply of SRM 1955, and SRM 3949 Folate Vitamers in Frozen Human Serum will be developed as a replacement for SRM 1955.

II. SCOPE OF WORK

The Contractor shall provide 1,000 sales units of this SRM, and each unit consists of three vials of serum (1 mL) at each of three different folate vitamer concentration levels. The Contractor shall acquire approximately 3.3 L human serum to prepare the three pools required. The specific target values for each pool are listed below. Unless otherwise noted, all concentrations must be achieved through blending of donor units of human serum. Fortification (spiking) of serum to achieve the target concentrations will not be considered for Levels 1 and Level 2, but will be considered to achieve the target concentrations of 5-formylTHF and 5,10-methenylTHF for

Level 3. Dilution of serum with phosphate-buffered saline (PBS) may be required to achieve the target concentration of 5-methylTHF in Level 1. Supplementation of donors with folic acid

(i.e., a multivitamin containing 400 µg/tablet) approximately 1 hr prior to blood draw may be required to achieve the target concentration of folic acid in Level 2. Ascorbic acid (0.5% w/v) must be added to the serum as early as possible to minimize oxidation of folate species. The ascorbic acid must be added to serum as soon as the serum is prepared from whole blood to stabilize folates.

Level 1: Human serum containing 10 nmol/L ± 5 nmol/L 5-methylTHF and 1 nmol/L ± 0.5 nmol/L PGA

Level 2: Human serum containing 50 nmol/L ± 5 nmol/L 5-methylTHF and 10 nmol/L ± 4

Level 3: Human serum containing 30 nmol/L ± 5 nmol/L 5-methylTHF; 5 nmol/L ± 3 nmol/L

PGA; 5 nmol/L ± 3 nmol/L THF; 5 nmol/L ± 3 nmol/L 5-formylTHF; 5 nmol/L ± 3 nmol/L

5,10-methenylTHF; and 5 nmol/L ± 3 nmol/L MeFox

III. SPECIFIC TASKS

The Contractor shall collect 5 serum units along with pilot tubes containing a minimum of 1 mL serum for three (3) concentration levels (total of 15 serum units). These pilot tubes shall be provided to NIST for measurement of folate vitamer content by liquid chromatography-tandem mass spectrometry. NIST will specify a blending protocol to achieve target concentrations in each of the three levels. The Contractor shall acquire a total of approximately 3.3 L of human serum containing appropriate levels to blend into the three pools. The target concentrations for the three human serum pools are listed below:

Level 1: Human serum containing 10 nmol/L ± 5 nmol/L 5-methylTHF and 1 nmol/L ± 0.5

Level 2: Human serum containing 50 nmol/L ± 5 nmol/L 5-methylTHF and 10 nmol/L ± 4

Level 3: Human serum containing 30 nmol/L ± 5 nmol/L 5-methylTHF; 5 nmol/L ± 3 nmol/L

PGA; 5 nmol/L ± 3 nmol/L THF; 5 nmol/L ± 3 nmol/L 5-formylTHF; 5 nmol/L ± 3 nmol/L

5,10-methenylTHF; and 5 nmol/L ± 3 nmol/L MeFox

The Contractor shall thoroughly blend and filter (2 micrometer) the serum. The Contractor shall test the serum pools for biosafety. All sera shall be demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus, and human immunodeficiency virus antigen 1 by tests licensed by the U.S. Food and Drug Administration.

The Contractor shall prepare 1,000 bottles of each of Levels 1, 2, and 3 of SRM 3949. Each bottle shall contain nominally 1 mL of serum (1.1 mL dispensed with accuracy better than 0.1 mL). Prior to filling, the Contractor shall label vials with labels that are appropriate for use at low temperature; these labels will be provided by NIST. Bottles shall be amber glass, and be capable of withstanding ultra-cold temperatures. Bottles shall be sealed with a butyl rubber stopper, and a color-coded aluminum crimp cap shall be applied. Bottles will be transferred, in fill order, from the bottling equipment to a box in a "Z" pattern, filling each row left to right.

The location of the first bottle in each box shall be noted on each side of the outside corner of the box, and boxes will be numbered sequentially.

IV. DELIVERABLES AND DELIVERABLE DUE DATES

Provide 15 serum units along with pilot tubes containing a minimum of 1 mL serum for each donor unit. These pilot tubes shall be provided to NIST for measurement of folate vitamer content by liquid chromatography-tandem mass spectrometry no later than 60 days after award of this requirement.

The Contractor shall provide NIST with details of the steps involved in material preparation not later than 120 days after award of this requirement to ensure documentation of any deviations as well as to provide information that will be utilized in the NIST acquisition Report of Analysis and SRM certificate. Documentation indicative of biosafety shall be required with shipment of the final material not later than 120 days after award of this requirement to ensure all sera were demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus, and human immunodeficiency virus antigen 1 by tests licensed by the U.S. Food and Drug Administration.

The Contractor shall provide NIST with 1,000 bottles of each of the three materials

(CLINs 0001-0003) as described above. Each bottle shall contain 1 mL of serum.

Delivery of the 1,000 bottles of the three materials is required within 120 days after the requirement is awarded.

PERIOD OF PERFORMANCE AND PLACE OF PERFORMANCE

The period of performance shall be 120 days after award for delivery of the requirements with a performance period of 150 days from the contract award date.

All work shall take place at the Contractor’s facility.

VII. GOVERNMENT-FURNISHED PROPERTY, DATA, AND/OR INFORMATION

No later than seven (7) days from contract award, NIST will provide the Contractor with:

Labels appropriate for use at the low temperature at which NIST will store the material upon receipt.

No later than thirty (30) days from receipt of serum pilot tubes, NIST will provide the Contractor with:

Blending protocol to enable the contractor to achieve target concentrations in each of the three levels.

VIII. PERFORMANCE REQUIREMENT SUMMARY

Required Supply

Production of 1,000 bottles of each of Levels 1, 2, and 3 of SRM 3949.

Performance Standard

1. Materials will be prepared and packaged as described in the SOW and meet all specifications set forth in the SOW.

2. A minimum of 1,000 bottles of each of the three materials must arrive intact and unbroken.

Acceptable Quality Level

The units of Level 1, Level 2, and Level 3 SRM 3949 with the associated physical and chemical properties specified in section III of this Statement of Work shall be suitable for use as a certified reference material (CRM). If deficiencies or inconsistencies between the material and the documentation (defined in sections IV and V) are found, or if less than the stated number of units are received intact, the contractor has 30 days to correct the deficiency at no additional cost to the Government.

Monitoring Method

The NIST Contracting Officer’s Representative (COR) will verify the SRMs were successfully prepared and acceptable when they are analyzed as part of NIST SRM certification process. This will be completed no later than 30 days after receipt and acceptance of the ampoules. SRMs will be tested by established analytical methods for determining folates in human serum and SRM

1955 Homocysteine and Folate in Frozen Human Serum will be utilized as a control material in these analyses to ensure the quality of measurements.

IX. TRAVEL: None

X. DELIVERY

Delivery shall be FOB DESTINATION.

At the time of shipment, the contractor shall notify the COR by email, providing the date the deliverables are shipped, shipping method, tracking number, method of delivery and the anticipated delivery date it will arrive at NIST.

XI. SHIPPING:

Boxes shall be labeled to indicate their contents. Materials shall be stored frozen (-80 °C) prior to overnight shipment on dry ice to NIST. Delivery is expected within 120 days after receipt of labels by the contractor.

Delivery Address:

National Institute of Standards and Technology

Attention: TBD

100 Bureau Drive

Gaithersburg, MD 20899

XI. MINIMUM CONTRACTOR QUALIFICATIONS

The Contractor must provide documentation that he is currently certified for ISO 13485:2003, “Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes” and has experience analyzing the compounds in section III of this SOW in human serum. Documentation may be a certificate from ISO or from a certification organization or a letter authorizing the Contractor to use the ISO logo.

Alternatively, the Contractor may provide not less than three (3) each of the following records for each of the analytes (i.e., 5-methylTHF, PGA, THF, 5-formylTHF, 5,10-methenylTHF, and

MeFox) in section III of this SOW for a total of 90 records:

· Calibration records

· Quality control (QC) blank results

· QC spike amounts

· QC spike recovery

· Minimum detection limit determination data

The records shall be no older than three (3) years from the date of the solicitation. The Offerors shall provide the above records in hardcopy or as a pdf file.

XII. PAYMENT

One payment will be made for the final deliverables in CLINs 0001-0003 which is the total value of the contract. NIST will test and accept the final deliverables no later than 30 days from receipt of the total quantity of 3,000 ampoules of Blood Serum. The contractor will invoice for the total price of the contract upon written acceptance from the COR.

(End of Statement of Work)

INSTRUCTIONS:

Addendum to FAR 52.212-1, Quotation Preparation Instructions

Central Contractor Registration

In accordance with FAR 52.212-4 (t) the awardee must be registered in the Central Contractor

Registration (www.sam.gov) prior to award. Refusal to register shall forfeit award.

All Offeror's quotations shall cite the RFQ Order Number and project title. The quotation shall also list the Offeror's point of contact for this project including name, title, address, phone number, and email address on the title page.

All Offerors must submit with their quotes a completed Offeror Representations and

Certifications - Commercial Items (FAR 52.212-3) form. If the Offeror's Representations and

Certifications are registered on the SAM website, it must be indicated in the quote.

All quotes must be signed.

Due Date for Quotation

Venders shall submit their quotations electronically via Federal Business Opportunities thru the FBO Bid Module for this requirement not later than 1:00 p.m. Eastern Time on

Friday, February 8, 2013. FAX quotations shall not be accepted. E-mail quotations shall not be accepted. Quotations shall not be deemed received by the Government until the quotation is entered into the FBO Bid Module set forth above.

1) Price Quotation: The contractor shall propose a firm-fixed-price, FOB Destination, for

CLIN. 0001 - 0003. Price quotations shall remain valid for a period of 60 days from the date quotations are due.

2) Technical Quotation: The contractor shall submit technical information with pricing information. The technical quotation shall address the following:

(1) Minimum qualifications stated in section XI of the statement of work.

(2) The Contractor must provide with their Quote the following information regarding

Human Subjects. This information is in addition to CAR provision 1352.235-70

Protection of human subjects

(a) The Contractor shall provide documentation of compliance with the Common

Rule for the Protection of Human Subjects (15 C.F.R. Part 27) as follows:

http://www.sam.gov/

i. If the Contractor purchases previously drawn blood from a source/vendor/contractor without the collection of identifying information from the donors, or without providing identifying information to the contractor, the use of human subjects may be exempt from the requirement of review by an

Institutional Review Board (IRB).

(1.) If the Contractor does not have a cognizant IRB, NIST can determine if the research activity is exempt or is not considered to be research as defined under the Common Rule. In this case, the Contractor must submit a written justification of their determination that the use of human subjects meets the requirements for one of the exemptions found at 15 C.F.R. 27.101(b), or why the activity is not research as defined at 15 C.F.R. 27.102(e). THE WRITTEN JUSTIFICATION

MUST ACCOMPANY THE QUOTE. An official determination as to whether the research is exempt, or is not research under the Common

Rule will be made by NIST as part of the review process for the quote.

(2.) If the Contractor has a cognizant IRB, then the Contractor’s IRB must approve the exemption, or approve that the activity is not considered to be research as defined under the Common Rule. In this case the Contractor must provide to NIST copies of the documentation provided to the IRB, and a copy of the IRB approval memorandum. THE DOCUMENTATION MUST

ACCOMPANY THE QUOTE. NIST reserves the right to review the IRB’s determination of the exemption, or that the activity is not research under the

Common Rule based on the documentation provided from the IRB, per 15

CFR 27.112, and this will be made by NIST as part of the review process for the proposal.

If the contractor proposes to draw the blood themselves or obtain the blood via a custom collection specifically for this project, then the activity is likely non-exempt research under the Common Rule, if the activity is research under the Common Rule. Therefore, approval of the protocol, questionnaires, surveys, recruitment materials and informed consent forms for blood collection must be reviewed and approved by an appropriate IRB. Contractor must submit a copy of the protocol, questionnaires, surveys, recruitment materials and informed consent forms approved by the IRB, documentation of the IRB’s approval of the activity, and the Contractor’s Federal-wide assurance number linked to the cognizant IRB’s registration number with OHRP.

QUOTATION EVALUATION:

Evaluation Factors

Award shall be made to the contractor whose product meets or exceeds the technical specifications and is the lowest price.

Award will be made, if at all, to the responsible contractor whose offer conforming to the requirements of the solicitation and meets the minimum qualification requirements.

Minimum requirement: Evaluation of minimum requirement shall be based on the information provided in the quotation. NIST will evaluate whether the contractor has demonstrated that its proposed quotation meets or exceeds all minimum requirements. Quotations that do not demonstrate they meet the Scope of Work on all requirements will not be considered further for award. If a contractor does not indicate whether its quotation meets a certain minimum requirement, NIST will determine that it does not.

Price: The Government will evaluate price for reasonableness.

Acceptance of Terms and Conditions: This is an open-market solicitation for the service and supply of Human Serum as defined herein. The Government intends to award a Purchase Order as a result of this solicitation that will include the clauses set forth herein.

“The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

The contractor must state any exceptions to the terms of this purchase order clearly stated on the quotation.

Note: This procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If a contractor submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price.

However, the terms and conditions stated herein will be included in any resultant Purchase

Order, not the terms and conditions of the contractor’s FSS or GWAC contract, and the statement required above shall be included in the quotation.

PROVISIONS AND CLAUSES:

The following provisions and clauses apply to this acquisition and are hereby incorporated by reference. All FAR clauses may be viewed at http://acquisition.gov/comp/far/index.html.

http://acquisition.gov/comp/far/index.html

FAR Provisions that apply to this solicitation

52.212-1, Instructions to Offerors-Commercial Items

52.212-3 Offeror Representations and Certifications-Commercial Items

Addendum to 52.212-3

Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a

Felony Conviction Under Any Federal Law (Class Deviation) (March 2012)

1) In accordance with Sections 543 and 544 of Public Law 112-55 Commerce, Justice, Science, and Related Agencies Appropriations Act 2012, Title V (General Provisions) none of the funds made available by that Act may be used to enter into a contract with any corporation that-

a) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, unless the agency has considered suspension or debarment of the corporation and made a determination that this further action is not necessary to protect the interests of the Government.

b) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, unless the agency has considered suspension or debarment of the corporation and made a determination that this further action is not necessary to protect the interests of the Government.

2) The Offeror represents that, as of the date of this offer-

a) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

b) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreements with the authority responsible for collecting the tax liability.

(End of provision)

Offerors shall complete annual representations and certifications on-line at http://SAM.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items.

If paragraph (j) of the provision is applicable, a written submission is required.

FAR Clauses by Reference that apply to this solicitation

52.212-4 Contract Terms and Conditions—Commercial Items

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—

Commercial Items (APR 2010)

52.203-6, Restrictions on Subcontractor Sales to the Government

52.204-10 – Reporting Executive Compensation and First-Tier Subcontract

Awards.

2.223-18, Contractor Policy to Ban Text Messaging while Driving-

52.219-6 Notice of Total Small Business Set-Aside

52.219-8, Utilization of Small Business Concerns

52.222-3, Convict Labor;

52.222-19 Child Labor – Cooperation with Authorities and Remedies;

52.222-21, Prohibition of Segregated Facilities;

52-222-26, Equal Opportunity;

52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.222-36, Affirmative Action for Workers with Disabilities;

52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.223-18, Contractor Policy to Ban Text Messaging while Driving

52.225-1, Buy American Act-Supplies

52.225-13 Restriction on Certain Foreign Purchases;

52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration.

52.232-99, Providing Accelerated Payment to Small Business Subcontractors

(DEVIATION)

52.245-1 Alternate I. Government Property

52.247-34 F.O.B. Destination

FAR Clauses - Full text

52.252-1 Solicitation Provisions Incorporated by Reference.

SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137568]

(End of provision)

52.252-2 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 Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137568

52.232-99, Providing Accelerated Payment to Small Business Subcontractors

(DEVIATION)

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS

(DEVIATION)(AUG 2012)

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012.

(a) Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.

(b) Include the substance of this clause, including paragraph (b), in all subcontracts with small business concerns.

(c) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

Commerce Acquisition Regulation (CAR) Provisions and Clauses – Full Text

The following provisions and clauses apply to this solicitation:

1352.235-70 Protection of human subjects.

Protection of Human Subjects (APR 2010)

(a) Research involving human subjects is not permitted under this award unless expressly authorized in writing by the Contracting Officer. Such authorization will specify the details of the approved research involving human subjects and will be incorporated by reference into this contract.

(b) The Federal Policy for the Protection of Human Subjects (the “Common Rule”), adopted by the Department of Commerce at 15 CFR part 27, requires contractors to maintain appropriate policies and procedures for the protection of human subjects in research. The Common Rule defines a “human subject” as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The term “research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule also sets forth categories of research that may be considered exempt from 15 CFR part 27. These categories may be found at 15 CFR 27.101(b).

(c) In the event the human subjects research involves pregnant women, prisoners, or children, the contractor is also required to follow the guidelines set forth at 45 CFR part 46 subpart B, C and

D, as appropriate, for the protection of members of a protected class.

(d) Should research involving human subjects be included in the proposal, prior to issuance of an award, the contractor shall submit the following documentation to the Contracting Officer:

(1) Documentation to verify that contractor has established a relationship with an appropriate

Institutional Review Board (“cognizant IRB”). An appropriate IRB is one that is located within the United States and within the community in which the human subjects research will be conducted;

(2) Documentation to verify that the cognizant IRB possesses a valid registration with the United

States Department of Health and Human Services' Office for Human Research Protections

(“OHRP”);

(3) Documentation to verify that contractor has a valid Federal-wide Assurance (FWA) issued by

OHRP.

(e) Prior to starting any research involving human subjects, the contractor shall submit appropriate documentation to the Contracting Officer for institutional review and approval. This documentation may include:

(1) Copies of the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB;

(2) Documentation of approval for the human subjects research protocol, questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB;

(3) Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually; and/or

(4) Documentation to support an exemption for the project from the Common Rule [ Note: this option is not available for activities that fall under 45 CFR part 46 subpart C].

(f) In addition, if the contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed consent form approved by the cognizant IRB, the contractor shall submit a copy of all modified material along with documentation of approval for said modification by the cognizant IRB to the Contracting Officer for institutional review and approval. The contractor shall not implement any IRB approved-modification without written approval by the Contracting Officer.

(g) No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged to the project, until the Contracting Officer approves the required appropriate documentation in writing.

(End of provision)

1352.201-70 Contracting Officer's Authority.

CONTRACTING OFFICER'S AUTHORITY.

The Contracting Officer is the only person authorized to make or approve any changes in any of the requirements of this contract, and, notwithstanding any provisions contained elsewhere in this contract, the said authority remains solely in the Contracting Officer. In the event the contractor makes any changes at the direction of any person other than the Contracting

Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract terms and conditions, including price.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.201-72 Contracting Officer's Representative (COR).

CONTRACTING OFFICER'S REPRESENTATIVE (COR) (APR 2010)

(a) (TBD ) is hereby designated as the Contracting Officer's Representative (COR). The

COR may be changed at any time by the Government without prior notice to the contractor by a unilateral modification to the contract. The COR is located at:

Phone Number:

E-mail:

(b) The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the contract and serves as technical liaison with the contractor. The COR is also responsible for the final inspection and acceptance of all deliverables and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the

Government or authorize any changes which affect the contract price, terms or conditions. Any contractor request for changes shall be referred to the Contracting Officer directly or through the

COR. No such changes shall be made without the express written prior authorization of the

Contracting Officer. The Contracting Officer may designate assistant or alternate COR(s) to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the contractor.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.208-70 Restrictions on printing and duplicating.

RESTRICTIONS ON PRINTING AND DUPLICATING (APR 2010)

(a) The contractor is authorized to duplicate or copy production units provided the requirement does not exceed 5,000 production units of any one page or 25,000 production units in the aggregate of multiple pages. Such pages may not exceed a maximum image size of 10 ⁄4 by 14 ⁄4 inches. A “production unit” is one sheet, size 8

⁄2 x 11 inches (215 x 280 mm), one side only, and one color ink. Production unit requirements are outlined in the Government Printing and Binding Regulations.

(b) This clause does not preclude writing, editing, preparation of manuscript copy, or preparation of related illustrative material as a part of this contract, or administrative duplicating/copying (for example, necessary forms and instructional materials used by the contractor to respond to the terms of the contract).

(c) Costs associated with printing, duplicating, or copying in excess of the limits in paragraph (a) of this clause are unallowable without prior written approval of the Contracting

Officer. If the contractor has reason to believe that any activity required in fulfillment of the contract will necessitate any printing or substantial duplicating or copying, it shall immediately provide written notice to the Contracting Officer and request approval prior to proceeding with the activity. Requests will be processed by the Contracting Officer in accordance with FAR

8.802.

(d) The contractor shall include in each subcontract which may involve a requirement for any printing, duplicating, and copying in excess of the limits specified in paragraph (a) of this clause, a provision substantially the same as this clause, including this paragraph (d).

1352.209-73 Compliance with the laws.

COMPLIANCE WITH THE LAWS (APR 2010)

The contractor shall comply with all applicable laws, rules and regulations which deal with or relate to performance in accord with the terms of the contract.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.209-74 Organizational conflict of interest.

ORGANIZATIONAL CONFLICT OF INTEREST (APR 2010)

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The restrictions described herein shall apply to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest

(hereinafter collectively referred to as “contractor”) in the activities covered by this clause as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

For the purpose of this clause, affiliation occurs when a business concern is controlled by or has the power to control another or when a third party has the power to control both.

(c) Warrant and Disclosure. The warrant and disclosure requirements of this paragraph apply with full force to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the

Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement at any tier expected to exceed the simplified acquisition threshold. The terms “contract,” “contractor,” and

“Contracting Officer” shall be appropriately modified to preserve the Government's rights.

(f) Prime Contractor Responsibilities. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507-1, and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting

Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the

Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk.

(g) Waiver. The parties recognize that this clause has potential effects which will survive the performance of this contract and that it is impossible to foresee each circumstance to which it might be applied in the future. Accordingly, the contractor may at any time seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting

Officer, including a full written description of the requested waiver and the reasons in support thereof.

1352.233-70 AGENCY PROTESTS (APR 2010)

(a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate agency Protest Decision Authority. See 64

Fed. Reg. 16,651 (April 6, 1999)

(b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: Andrea Parekh, CONTRACTING OFFICER

100 Bureau Drive, MS 1640

(c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: HEAD OF THE CONTRACTING OFFICE (HCO)

(d) A complete copy of all agency protests, including all attachments, shall be served upon the Contract Law Division of the Office of the General Counsel within one day of filing a protest with either the Contracting Officer or the Protest Decision Authority.

(e) Service upon the Contract Law Division shall be made as follows:

U.S. Department of Commerce

Office of the General Counsel

Chief, Contract Law Division

Room 5893

Herbert C. Hoover Building

14th Street and Constitution Avenue, N.W.

Washington, D.C. 20230.

FAX: (202) 482-5858

1352.233-71 GAO and Court of Federal Claims protests.

(a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate agency Protest Decision Authority. See 64 Fed. Reg.

16,651 (April 6, 1999)

(b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: Andrea Parekh, CONTRACTING OFFICER

(c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: HEAD OF THE CONTRACTING OFFICE (HCO)

(d) A complete copy of all agency protests, including all attachments, shall be served upon the Contract Law Division of the Office of the General Counsel within one day of filing a protest with either the Contracting Officer or the Protest Decision Authority.

(e) Service upon the Contract Law Division shall be made as follows:

U.S. Department of Commerce

Office of the General Counsel

Chief, Contract Law Division

Room 5893

Herbert C. Hoover Building

14th Street and Constitution Avenue, N.W.

Washington, D.C. 20230.

FAX: (202) 482-5858

1352.246-70 Place of acceptance.

PLACE OF ACCEPTANCE (APR 2010)

(a) The Contracting Officer or the duly authorized representative will accept supplies and services to be provided under this contract.

(b) The place of acceptance will be:

National Institute of Standards and Technology

100 Bureau Drive

Gaithersburg MD 20899