Attachment_1_-_SOW.pdf

Statement of Work

Purpose The National Institute of Nursing Research (NINR) Division of Intramural Research (DIR) has a need for specialized Biostatistics and Bioinformatics support in support of the mission of the Biobehavioral Branch.

Scope The NINR DIR has a project that involves the collection and analysis of human microbiome, host genetic and transcriptomic profiles, as well as behavioral and clinical measures to examine the transcriptomic profiles study participants to study individualized profiles, interaction and predictor of patient-related outcomes (e.g., obesity and eating behavior).

The project will require statistical and bioinformatics support in two essential data processing and analysis components:

Data Processing and Standard Statistical Analyses This project will generate dense complex data sets, which include clinical-, psychometric, host-molecular, and microbiome data. Individual data sets require highly specialized individualized data processing, especially in the case of molecular and microbiome data for which bioinformatics support will be required. Post processing analysis of the data sets will be conducted using standard statistical approaches appropriate to each data set. These approaches allow for limited integration between data sets and are often exploratory in nature and are complex, especially when data sets are integrated. Experienced statistical support is required to handle these analyses.

Personalized Predictive Models: Machine Learning Algorithms The principle goal of the project is to build predictive models which integrate behavioral (eating-behavior), metabolic characteristics, genetic and microbiome profiles. The most effective way to integrate these “Big Data” data/ high dimension data in order to derive personalized, rather than aggregative based models, is through custom designed machine learning algorithms. In order to design, optimize and implement a machine learning algorithm specialized bioinformatics support is required. Machine learning based analysis of the data is an essential component of the project to generate personalized predictive models. Experienced machine learning programming support is therefore also essential.

Tasks

Task 1 – Direct Research Support This data analysis component of this project should take place over a 1 year time period for a total of 342 contracted hours. Tasks include:

• Data processing , normalization, and quality control and batch correction (human microbiome, transcriptome and genotype data)

• Standard analysis of research and clinical data

• Integrated multivariate analysis of data sets

• Personalized predictive models using machine learning algorithms

• Deliverables will include all results of data analysis and bioinformatics, visual representation of results for publication purposes

• Provide study design documentation prior to the internal analysis requested by a NINR/DIR Investigator

• Provide figures, diagrams and power analyses and summary of analysis as agreed based on approved study design

Task 2 – Project Management and Reporting Support

• Medical writing support (e.g., writing up of data analysis and bioinformatics methods, protocols)

• Provide verbal and written status updates as requested by the project officer.

Government Responsibilities The Government will:

• Provide the raw data at one time, within two weeks following date of contract award

• Follow instruction for data collection

• Inform any critical changes in data collection

Responsibilities of the Contractor The Contractor will:

• Weekly meetings to provide updates, discussion and progress projects

• Availability during normal business hours to address critical issues in data analyses and interpretation as needed

• Supply all necessary computer infrastructure including statistical programs to analyze data

• Provide oversight to NINR fellows to meet training needs in regards to data analyses in genomics. Didactic teaching analyses methods when required. This will include on-site overseeing of data analyses, as well as more formal teaching as needed.

Duty Station Vendor will perform services from their own facilities

Contract Type This is a firm fixed-price type order.

Period of Performance Twelve months with two optional years

Deliverables

Deliverables/Reports Due (within the following timeframes after contract award)

Processed, quality reviewed Data Within 12 weeks following data submission Standard data analysis Within 15 weeks following data submission Integrated Multivariate Analysis Within 32 weeks following data submission Personalized predictive models using machine learning algorithms

Within 48 weeks following data submission

Finalized results report, figures and tables Within 52 weeks following data submission Methods write up for publication Within 52 weeks following data submission

Section 508

This language is applicable to Statements of Work (SOW) or Performance Work Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that Federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow Federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors11) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below.

Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005):

http://www.hhs.gov/od/Final_Section_508_Policy.html HHS Section 508 Web site: http://508.hhs.gov/ HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm

Management Requirements The Contractor shall guarantee strict confidentiality of the information/data that is provided by the Government during the performance of this contract. The Contractor must commit to protecting non-public Departmental information and data. The Contractor and any subcontractors performing under this contract shall not release, publish, or disclose non-public Departmental information to unauthorized http://www.hhs.gov/od/Final_Section_508_Policy.html http://508.hhs.gov/ http://www.hhs.gov/web/policies/index.html http://www.section508.gov/index.cfm personnel and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information:

• 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)

• 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

• Public Law 96-511 (Paperwork Reduction Act)

Disclosure of the information/data, in whole or in part, by Contractor can only be made after Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the Contract, the Contractor shall obtain a written determination from the NINR Project Officer. The Contractor is not allowed to incur local travel costs associated with traveling to and from NIH's facilities.

All computer code, data and information obtained during this project will be the property of NINR.

Privacy and Security Requirements All personnel and activities must conform to all Federal, HHS, NIH and NCI policies and guidelines regarding security, confidentiality and privacy.

Information Security is applicable to this SOW. The SOW requires the contractor to perform one, or any combination, of the following on behalf of the Government:

1. Develop, have the ability to access, and maintain a Federal information system(s).

2. Access or use of sensitive information or Personally Identifiable Information (PII).

3. Remotely access federal information or physically remove sensitive federal information or PII beyond agency premises or control.

Pursuant to Federal and HHS Information Security Program Policies the following requirements apply to this task order:

Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002); http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

Security Categories and Levels The security level for this task order is:

a) Confidentiality Level: [ x] Low [ ] Moderate [ ] High

b) Integrity Level: [ x] Low [ ] Moderate [ ] High

c) Availability Level: [ x] Low [ ] Moderate [ ] High Overall Level: [X] Low [ ] Moderate [ ] High

Position Sensitivity Designations The following sensitivity level(s), clearance type(s), and investigation requirements apply to this contract:

a) Level 1: NACI.

b) The Contractor shall submit a roster by name, position, e-mail address, phone number, and responsibility of all staff (including subcontractor staff) working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a federal information http://csrc.nist.gov/drivers/documents/FISMA-final.pdf system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at http://ocio.nih.gov/docs/public/Suitability-roster.xls

Suitability investigations are required for contractors who will need access to NIH information systems and/or to NIH physical space. However, contractors who do not need access to NIH physical space will not need an NIH ID Badge. Each contract employee needing a suitability investigation will be contacted via e-mail by the NIH Office of Personnel Security and Access Control (DPSAC) within 30 days. The DPSAC e-mail message will contain instructions regarding fingerprinting as well as links to the electronic forms contract employees must complete. Additional information can be found at the following website:

http://idbadge.nih.gov/background/index.asp.

All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

Personnel Security Responsibilities The Contractor shall perform and document the following actions:

The contractor shall notify the Contracting Officer, the NINR Project Officer, and the Security Investigation Reviewer within five working days before a new employee assumes a position that requires a suitability determination or when an employee with a suitability determination or security clearance stops working under this acquisition. The Government will initiate a background investigation on new employees requiring suitability determination and will stop pending background investigations for employees that no longer work under this acquisition.

• New employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability determination level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate suitability level.

• Departing employees: Provide the name, position title, and suitability determination level held by or pending for the individual.

All documentation shall be made available to the Project Officer and/or Contracting Officer upon request.

All documentation shall be made available to the Project Officer and/or Contracting Officer upon request.

Information Security Training Contractors/subcontractors shall receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements.

http://ocio.nih.gov/docs/public/Suitability-roster.xls http://ocio.nih.gov/docs/public/Suitability-roster.xls http://idbadge.nih.gov/background/index.asp

The Contractor shall ensure that each contractor/subcontractor employee has completed: following training at http://irtsectraining.nih.gov/ prior to performing any task order work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of this acquisition:

1. Information Security Awareness Training course (including agreement to NIH Rules of Behavior),

2. Securing Remote Computers and

3. Privacy Awareness Course

The Contractor shall maintain a list by name and title of each Contractor/Subcontractor employee working under this acquisition who has completed the NIH required training. The list (along with any subsequent updates to the list) shall be provided to the Project Officer. Any additional security training completed by Contractor/Subcontractor staff shall be included on this list. [The list of completed training shall be included in the first technical progress report. Any revisions to this list as a result of staffing changes shall be submitted with the next required technical progress report.]

Additional security training requirements commensurate with the position may be required as defined in NIST Special Publication 800-16, Information Technology Security Training Requirements (http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf). This document provides information about information security training that may be useful to the Contractor.

Contractor/subcontractor staff may be required to complete additional training prior to performing any work under this acquisition as directed by the NINR ISSO, CIO, or Executive Officer.

Contractor Employee Non-Disclosure Agreement Each Contractor/subcontractor employee who may have access to non-public Department information under this task order shall complete the Commitment to Protect Non-Public Information – Contractor Employee Agreement at: http://irtsectraining.nih.gov/. It is also the contractor’s responsibility to upload the non-disclosure agreements to irtsectraining.nih.gov. A copy of each Agreement shall be submitted to the NINR Project Officer prior to performing any work under the contract. Other copies are retained/submitted as stated in the Agreement.

Loss and/or Disclosure of Personally Identifiable Information (PII) – Notification of Data Breach The Contractor shall be responsible for reporting all incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH CISO thru the NINR ISSO within one hour of discovering the incident by using one of the following two forms:

• NIH PII Spillage Report http://ocio.nih.gov/security/sec_policy.html (PII Procedures)

• NIH Lost or Stolen Assets Report http://ocio.nih.gov/security/sec_policy.html (PII Procedures)

The notification requirements do not distinguish between suspected and confirmed breaches.

The Contractor will have access to PII due to administrative privileges and/or maintenance and troubleshooting responsibilities. The contractor is not expected to nor is the contractor authorized to access PII except as required for installation, maintenance and customer support duties. In the event the contractor discovers PII that is not in compliance with HHS/NIH policy the PII information must be identified and brought to the attention of the COTR and ISSO immediately in order to ensure adequate protections are put in place. PII shall not be removed from the NIH perimeter without written permission from the Data Owner, COTR, NINR CIO and ISSO even on Government provided laptops or USB drives. PII http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf http://ocio.nih.gov/security/sec_policy.html http://ocio.nih.gov/security/sec_policy.html should never be included in any logs or other troubleshooting material that may need to be communicated to a vendor for troubleshooting. PII is not authorized to be collected, transmitted or stored on contractor equipment.

Data Encryption The following applies to all Contractor/subcontractor laptop computers containing HHS data at rest and/or HHS data in transit:

1. All laptop computers used on behalf of the government shall be secured using a Federal Information

Processing Standard (FIPS) 140-2 compliant whole-disk encryption solution. The cryptographic module used by an encryption or other cryptographic product must be tested and validated under the Cryptographic Module Validation Program to confirm compliance with the requirements of FIPS PUB 140-2 (as amended). For additional information, refer to http://csrc.nist.gov/cryptval.

2. All mobile devices, including non-HHS laptops and portable media, that contain sensitive HHS information shall be encrypted using a FIPS 140-2 compliant product. Data at rest includes all HHS data regardless of where it is stored.

3. A FIPS 140-2 compliant key recovery mechanism shall be used so that encrypted information can be decrypted and accessed by authorized personnel. Use of encryption keys which are not recoverable by authorized personnel is prohibited. Key recovery is required by “OMB Guidance to Federal Agencies on Data Availability and Encryption”, November 26, 2001, http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf

4. Encryption keys shall comply with all HHS and NIH policies http://intranet.hhs.gov/infosec/docs/guidance/hhs_standard_2007.pdf and shall provide adequate protection to prevent unauthorized decryption of the information.

5. All media used to store information shall be encrypted until it is sanitized or destroyed accordance with NIH procedures. Contact the NIH Center for Information http://www.cit.nih.gov/ServiceCatalog/SERVICES.HTM?SERVICE=MEDIA%20SANITIZATION%20SERVI

CE.

6. Link to NIH Web Page Privacy Policy (NIH Manual Chapter 2805): http://www3.od.nih.gov/oma/manualchapters/management/2805

7. NIH Manual 1745 - NIH Information Technology (IT) Privacy Program:

http://www3.od.nih.gov/oma/manualchapters/management/1745/

8. Information Security Program Policy:

http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pd f

9. Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002) http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

Using Secure Computers to Access Federal Information

1. The Contractor shall configure its computers that contain HHS data with the applicable United States government Configuration Baseline, USGCB (http://USGCB.NIST.gov), (formerly Federal Desktop Core Configuration, FDCC, http://nvd.nist.gov/fdcc/index.cfm) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level.

2. The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements.

The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with USGCB http://csrc.nist.gov/cryptval http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf http://intranet.hhs.gov/infosec/docs/guidance/hhs_standard_2007.pdf http://www.cit.nih.gov/ServiceCatalog/SERVICES.HTM?SERVICE=MEDIA%20SANITIZATION%20SERVICE http://www.cit.nih.gov/ServiceCatalog/SERVICES.HTM?SERVICE=MEDIA%20SANITIZATION%20SERVICE http://www3.od.nih.gov/oma/manualchapters/management/2805 http://www3.od.nih.gov/oma/manualchapters/management/1745/ http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf http://csrc.nist.gov/drivers/documents/FISMA-final.pdf http://usgcb.nist.gov/

Scanner capability to ensure its products operate correctly with USGCB configurations and do not alter USGCB settings – see http://nvd.nist.gov/validation.cfm. The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest USGCB major version and subsequent major versions.

3. The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause.

4. As needed, the Government shall provide logical access to NIH resources via a terminal server solution to the Contractor.

5. A Privacy Act Notification Statement (NS) and NINR disclaimer must be posted on all websites, paper and electronic forms which collect information in identifiable form (IIF), that is, information that is personal in nature and which may be used to identify an individual. NOTE: The acronyms IIF and PII (personally identifiable information) mean the same thing.

NIH Physical Access Security In accordance with OMB Memorandum M-05-24, background investigations must be completed for all contractor/subcontractor personnel who have (1) access to sensitive information, (2) access to Federal information systems, (3) regular or prolonged physical access to Federally-controlled facilities, or (4) any combination thereof.

The SOW requires the Contractor to have regular or prolonged physical access to a Federally-controlled facility and/or have access to Federal Information systems, thereby requiring compliance with the following regulations/policies:

1. HHS Information Security Program Policy:

http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Polic y.pdf

2. Homeland Security Presidential Directive/HSPD-12, Policy for a Common Identification Standard for Federal Employees and Contractors (08-27-04):

3. http://www.dhs.gov/xabout/laws/gc_1217616624097.shtm#1

4. OMB Memorandum M-05-24, Implementation of Homeland Security Presidential Directive

(HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors (08-05-05): http://www.whitehouse.gov/omb/memoranda/fy2005/m05-24.pdf

5. Federal Information Processing Standards Publication (FIPS PUB) 201-1 (Updated June 26, 2006):

http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf

6. HHS Interim Policy: Contractual Implementation of Homeland Security Presidential Directive (HSPD) 12, Policy for a Common Identification Standard for Federal Employees and Contractors [Draft]

7. HHS Office of Security and Drug Testing, Personnel Security/Suitability Handbook (02-01-05):

http://www.hhs.gov/ohr/manual/pssh.pdf

Privacy Act This Statement of Work requires the Contractor to have incidental or administrative access to data covered under the following but not all inclusive Privacy Act System of Records.

The Contractor agrees to comply with the policies and practices defined in the System of Records listings for this data and any other Privacy Act system the contractor may have access to, and to the Privacy Act clauses for FAR 52.224.1 and 52.224-2, herein incorporated by reference.

http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf http://www.dhs.gov/xabout/laws/gc_1217616624097.shtm#1 http://www.whitehouse.gov/omb/memoranda/fy2005/m05-24.pdf http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf http://www.hhs.gov/ohr/manual/pssh.pdf

Proposal Requirements This is a Firm Fixed Price contract. The offeror shall submit a detailed breakdown by labor category and task of an estimated number of hours and the loaded hourly rate for the work to be completed as outlined in the Statement of Work. This business proposal will include:

Costs Direct Labor Costs Direct Labor

Category Hourly Rate Number of Hours Total Amount

Other Costs (List all other costs not otherwise included in the Direct Labor category and provide bases for pricing)

Specify cost category

Total Amount

Proposal Instructions The offeror shall submit its proposal in two volumes, a Technical Proposal (with CPARS information, if included, in appendices that will not count towards the page total) not to exceed 15 pages, and a Business Proposal not to exceed 7 pages. Past Performance Questionnaires should be sent to the attention of the individual identified in the instructions (please see Attachment 2 – Past Performance Questionnaire).

Evaluation Criteria The Government will make one award to the most responsive and responsible vendor that offers NIH the “best value” price and technical factors considered. Since this “best value” approach contains price/technical tradeoffs, award will not necessarily be made to the lowest price vendor or to the most technically qualified vendor. Note: Vendors that take exception to any term or condition of the Request for Proposal (RFP) could make the offer unacceptable.

Vendors do not have the option to respond to select requirements and must be able to provide all requirements to be considered for this engagement.

The award may be made without discussions; therefore vendors are encouraged to submit proposals that are responsive and most advantageous. If NIH deems discussions necessary, NIH will conduct discussion only with those vendors determined to be within the competitive range for an efficient award. In this RFP, personnel qualifications and past performance are significantly more important than price. However, as proposals become more equal in technical merit, price will become more important.

The evaluation factors are used by the evaluation panel when reviewing proposals. The factors below are listed in the order of relative importance.

No. Criteria 1 Personnel Qualifications

Adequacy and feasibility of the proposed professional staff to conduct the services and meet research goals and objectives; including:

No. Criteria

• Microbiome data processing and analysis

• Genomic data processing and analysis

• Clinical data processing and analysis

• Behavioral data processing and analysis

• Specialist knowledge with ICH E9 (statistical principles for clinical trials), clinical data analysis and end point analysis

• Integration of multiple data sets and types for multivariate modeling - Expertise in big data analysis and bioinformatic interpretation

• Modeling of highly dimensional data

• Machine learning

• Visualizing complex data and results

• Experience in the field of genomics related to the research conducted within the DIR/NINR

• Based locally and assigned specifically to NIH

• Experience in working with IC’s throughout the NIH in the fields of structural bioinformatics and proteomics and genomics

• Able to train personnel on bioinformatics of next generation sequencing

• Able to assemble genomes, annotate genes and proteins and carry out Pathway analysis and Gene Ontology

• Able to customize bioinformatics analysis for DNA-seq, RNA-seq, and CHIP-seq 2 Management and Quality Control

Adequacy and feasibility to establish and maintain the animal project;

including:

• Plans to maintain a quality assurance and quality control program

• Plans to make adjustments to address unanticipated changes

3 Past Experience

• Similar experience within the Government INIH and/or NINR experience preferred).

• Analytical support leading to publication

4 Past Performance

• See instructions below

5 Price

• The government anticipates issuing a firm-fixed price award for this

RFQ. The price analysis will take place after the non-price review.

All non-price factors, when combined, are more important than price factors.

Past Performance

The Past Performance Factor evaluation will assess the relevance and breadth of the Offeror’s experience and the quality of the Offeror’s past performance. The Government is seeking to determine whether the Offeror has experience that will enhance its technical capability to perform and whether the Offeror consistently delivers quality services in a timely and cost effective manner. In evaluating past performance, HHS/NIH will only take into consideration the relevant experience and past performance assessments from the Offeror's customers, from projects similar in Size and Scope. However, the HHS/NIH reserves the right to use other relevant past performance information it obtains through other sources including other agency databases and information contained in trade literature.

Relevance of Experience: The Offeror’s experience will be evaluated on the degree of relevance to the requirement on the basis of similarity in size, scope, complexity, technical difficulty, contract type, and period of performance. Only recent experience will be evaluated. Evaluations may include interviews with previous clients of the prime contractor and subcontractors and may include interviews with previous clients of proposed personnel. The Offeror’s experience with and knowledge of issues and problems of large organizations will be evaluated.

Past Performance Assessments: The Offeror’s past performance will be evaluated on the basis of information contained in the Offeror's proposal and the information that the Government obtains through other means. The offeror shall submit Past Performance Questionnaires to their relevant experience, and annotate the offerors they have submitted to in their proposal. The offeror can substitute CPARs or other online reviews for the questionnaires. The past performance evaluation will assess the Offeror’s record of providing high quality services of a similar nature in a manner that ensures maximum accuracy, throughput, cost effectiveness and overall client satisfaction.

If some of the Offeror’s experience is relevant and the rest is not, only the relevant experience will be evaluated for purposes of past performance. If no experience is relevant or the experience that is relevant cannot be evaluated due to a reference’s failure to respond, a rating of neutral will be assigned.

Contract Clauses

52.212-4 Contract Terms and Conditions – Commercial Items (May 2015)

Addendum to 52.212-4 Invoicing Guidance

Mail the original itemized invoice to:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquires regarding payment call:

Chief, Accounts Payable Section, OFM

(301) 496-6088

Additionally, please email a courtesy copy of the invoice to the Contract Specialist for the official contract file.

The following Invoice and Payment Terms is applicable to all purchase orders, task/delivery orders and BPA Calls:

I. Invoice Requirements

A. An invoice is the Vendor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in bullets 1 through 12 below. If the invoice does not comply with these requirements, it can result in an invoice being considered improper and returned to the vendor.

1. Name and Address of the Vendor

2. Invoice date (Date Invoice Submitted)

3. Order number and where applicable, main agreement (e.g., BPA and Contract #)

4. Description, quantity, unit of measure, unit price, and extended price of supplies delivered or service performed

5. Shipping and payment terms (e.g., shipment number and date of shipment, prompt payment discount terms)

6. Name and complete mailing address where payment is to be sent per ACH information on record

7. Name (where practicable), title, telephone number and mailing address of person to be notified in the event of a defective invoice

8. DUNS number or DUNS+4, as registered in CCR

9. Vendor Identification Number (VIN)

10. NOTE: This only applies to new purchase orders, task/delivery orders and BPA Calls awarded on/after June 4, 2007. The VIN is a 7 digit number that appears after the vendor's name on the face page of the award document in the block where the contractor's name and address appear. Inclusion of the VIN on the invoice is not required if the invoice identifies the contractor's DUNS or DUNS+4

11. Any other information or documentation required by the order (e.g., evidence of shipment)

12. Unique Invoice Number which can only be used one time regardless of the number of contracts or orders held by an organization (or business unit identified by a separate DUNS or DUNS+4 number), regardless if the invoices are being issued out of separate locations

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase

Order. If authorized, shipping costs must be itemized.

II Invoice Payment

A. Except as indicated in paragraph B below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice

2. The 30th day after Government acceptance of supplies delivered or services performed

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically if payment is not made by the due date and the conditions listed below are met, if applicable

1. A proper invoice was received by the designated billing office;

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition;

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

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

As prescribed in 12.301(b)(4), insert the following clause:

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL ITEMS (JUNE 2016)

(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 and 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:

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_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 (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (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. (Oct 2015) (31 U.S.C. 6101 note).

__ (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.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (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] _X _ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (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.

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

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637(d)(4)).

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

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

__ (iv) Alternate III (Oct 2015) 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)).

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

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

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

_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 (Dec 2015) (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 (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2016) (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).

__ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

__ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

_X_ (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 (OCT 2015). (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.)

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

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

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.

13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (E.O. 13423 and 13514).

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

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C.

8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT

2015) (E.O. 13423 and 13514).

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

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG

2011) (E.O. 13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (45) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (46)(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.

__ (47) 52.225-5, Trade…