SOL_18150.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.

2017-N-18150

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

O4/05/2017

6. REQUISITION/PURCHASE NO.

000HCCCC-2017-07127

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

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 handcarried, in the depository located in 2:00pformtext until

EST

local time 5/19/2017 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

Desiree Harris

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(301) 458-4629

C. E-MAIL ADDRESS

Huq9@cdc.gov

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

See Section B

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

Acquisition & Assistance Field Branch-Hyattsville

3311 Toledo Road

Hyattsville, MD 20782-2064

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

To In-Vivo Biotinetic, Cariovascular, and other targeted Organ Studies

1 Job

1 Lot

Section C - Description/Specification/Work Statement

Title of Project: Phase 2: Case study of printer-emitted engineered nanoparticles (PEPs) specific to- in vivo biokinetic, cardiovascular, and other targeted organ studies, The services contemplated under this contract are considered to be an “Other Functions” as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.

C.1 Background and Need – In FY2016, the Phase 1 study consisted of the following research conducted by the servicing agency: particle generation, characterization and fractionation, in vitro dosimetric determination, in vitro toxicity investigation in multiple cell lines, pilot study in in vivo evaluation of PEP-induced cardiovascular effects via inhalation. In the proposed Phase 2 study, emphasis will be given on biokinetics of inhaled PEPs, other PEP-targeted organ toxicity, and prolong PEP exposure-induced cardiopulmonary responses studies.

The unique physicochemical properties of engineered nanomaterials (ENMs) are being exploited for use in a growing variety of commercial NEPs, including electronics, cosmetics, and structural materials, as well as a wide variety of products for medical applications. Numerous in vitro and in vivo studies have investigated the possible adverse effects of inhalation exposure to pristine ENMs during synthesis and handling by workers and consumers. However, human exposure is not limited to pristine ENMs, but also includes a wide variety of particles released from NEPs across their life cycle, including consumer use and disposal. Therefore, these results cannot be correlated to exposures at consumer level since the test particles used are not representative of the “real world” exposure of consumers to PEPs. Indeed, the potential for exposure from such life cycle particulate matter (“LCPM”) may exceed that of pristine engineered nanoparticles (“ENPs”). Moreover, the physico-chemical properties and toxicological profiles of LCPM may differ greatly from those of pristine ENPs. Despite the potential for LCPM exposure, most nanotoxicological studies have focused on pristine ENPs, and toxicological evaluation of LCPM has been limited. NIOSH and the EPA have therefore recommended life cycle analyses in their nanotechnology research programs. Most importantly, the servicing agency need to develop a methodology that can link real world LCPM exposures to toxicology and cardiopulmonary risk. This study will specifically address this important research gap.

Numerous epidemiologic studies have shown strong associations between inhalation of ambient particulate matter (“PM”) and cardiovascular mortality and morbidity, with mortality from cardiovascular causes exceeding that from respiratory causes. Animal studies also indicate that the cardiovascular system may be more sensitive to pulmonary exposure to PM than the lung. To date, however, most nanotoxicology studies have focused primarily on the pulmonary effects of ENP exposure. This contract will address the cardiopulmonary effects of ENP exposure.

This Phase 2 study will use state-of-the-art PEP exposure generation systems and in vivo bioassays combined with traditional pathological analysis and advanced computational genomic modeling to assess mechanisms of potential PEP-induced cardiopulmonary and other organ diseases and predict potential disease implications in humans. The integrated approach will identify mechanistic pathways predictive of LCPM-induced cardiopulmonary diseases in animal models, and by extrapolation, in humans. In addition, this Phase 2 study will identify biomarkers of early response and potential treatment targets. The recently developed particle generation and exposure methods will still be applied to create and characterize real-world PEP exposures for the assessment of cardiopulmonary effects. In vivo inhalation experiments will be performed to assess cardiopulmonary effects and biokinetics of inhaled PEPs and validate as well as extend the in vitro findings of Phase 1. Particularly, the toxicological effects of PEPs will be measured in the preexisted cardiovascular conditions, such as myocardial infarction (MI). Histopathological analysis will be performed for those PEP-targeted other organs. Moreover, this Phase 2 study will identify PEP-induced gene signatures from the cultured cells (Phase 1), lung and blood samples from in vivo models and determine whether these signatures predictively match those for known pathways of cardiopulmonary and other organ diseases in humans. This multi-disciplinary screening approach, linking in vitro (Phase 1) and in vivo PEP exposures to in vitro and in vivo toxicological evaluation, as well as computational modeling results will provide a robust and useful framework for risk assessment of engineered nanomaterials released across the life cycle of NEP. The development of genomic-based non-invasive diagnostic blood tests of cardiopulmonary and other targeted organ diseases will provide valuable predictive biomarkers for surveillance and early risk assessment of engineered nanomaterial exposures.

Researchers at Harvard Public Health’s Center for Nanotechnology and Nanotoxicology developed an exposure generation system, Printer Exposure Generation System (“PEGS”), to monitor and assess nanoparticle emissions during use of printer. NIOSH and Harvard have been working together for the last four years to study the presence of ENMs in toner formulations currently in use in laser printers and assess safety implications during consumer use. In this study, researchers at Harvard will study emitted PEP-induced cardiovascular and other organ effects resulting from the use of laser printers and the biokinetics of inhaled PEPs.

C.2 Project Objective – This study will employ “real world” exposure systems to generate and characterize PEPs during use and investigate their cardiopulmonary effects in rats via whole-body inhalation. Moreover, the biokinectic studies will be performed to analyze the clearance and translocation of PEPs in rats through intratracheal instillation C.3 Scope of Work – In the proposed Phase 2 study, emphasis will be given to cardiopulmonary responses, biokinetics of inhaled PEPs, and other PEP-targeted organ toxicity. A novel exposure-generation system to produce real-world PEPs exposure atmospheres will be employed (Fig. 1). Contractor will purchase a common printer based on their previous research, which uses a toner formulation containing nano metals which improves image clarity. A Printer Exposure Generation System (PEGS) will be used to house the printer and monitor the generated aerosol (Fig. 2). Size fractionated samples will be collected for physicochemical and morphological characterization (size, shape and composition) using state-of-the-art analytical methods. This study will focus on the PM0.1 size fraction of PEPs particles. In vivo inhalation experiments will be performed to assess cardiopulmonary effects and biokinetics of inhaled PEPs and validate as well as extend the in vitro findings of Phase 1.

Sprague-Dawley rats will be exposed for 21 consecutive days (105 total hours) at 5 hours/day to both PEPs and gaseous co-pollutants released by the laser printer using the generation platform described in Aim 1. Toxicological assessments will be performed on the following exposure days: 1, 5, 9, 13, 17 and 21 to evaluate the potential toxicological effects of the emissions from the tested laser printer. Particle concentration (mass/m3), total particle (count/m3), size distribution, and gases within the animal exposure chambers will be monitored in real time throughout the study. Respiratory and cardiovascular function data will be collected continuously during the 21 days of exposure, and for 4-hour intervals for 5 consecutive days before and after the 21-day exposure.

C.4 Technical Requirements –

Scientific consultation in aerosol science and toxicology in support of an Interagency Agreement with Consumer Product Safety Commission (CPSC) shall be for end products and the following tasks to be completed and deliverables:

Tasks to be completed:

1. Generation, characterization, and fractionation of PEP aerosols. This will include the use of real time instrumentation for particles, offline organic speciation using GC-MS, ICP-MS, NMR;

2. Clearance and Translocation- biokinetic studies. The PEPs will be neutron activated in order to measure their biopersistence and the potential of the particles or some of their constituents to translocate to other organs. A set of aliquots of the sampled PEPs will be neutron-activated. Samples will be irradiated with a thermal [slow] neutron flux of 5 x 1013n/cm2s for up to 120 hours. Long neutron activation of these particles will be necessary because the concentration of metals is relatively low. Depending on composition, the particles brought back from MIT will have the same physical and chemical properties, but will now contain such radioactive gamma emitting metals as Fe, Mn, Cr, Zn, V and others. The specific activity will depend on the % of that metal as well as the nuclear cross-section [the probability that an atom of that metal will capture a neutron] of that element . These radioisotopes have good gamma energies and reasonable half-lives. For example, neutron irradiation of Zn-containing PEPs particles will produce 65Zn, which decays with a half-life of 244.26 days and emits gamma energies of 345, 770 and 1115 keV. The radioactive particles will be used in physiologically and geochemically based in vitro extractions and in pharmacokinetic studies in intact rats. The particles will be given by intratracheal instillation and the rats will be sacrificed from 2 hour, 1 day and 7 days post-exposure. The lungs and other organs and tissues will be analyzed for gamma activity. These data will let us assess the solubility/retention of PEP particles in the lungs and the potential of metal constituents or intact particles to enter other organs of interest, e.g. brain, blood, liver, heart, kidney and other tissues. Pitfall: If neutron activation does not result to a strong gamma radiation signal due to limited metal content, chemical tracing will be pursued using ICP-MS and Organic signatures on PEPs and will follow them in organs using LC-MS;

3. Electrocardiographic (ECG) data acquisition and analysis. A subgroup of rats will undergo open heart surgery and have implanted a radio telemetry transmitter (DSI PhysioTel® Transmitter ETA-F20; Data Sciences International, Inc., Saint Paul, MN) for measurement of the ECG. Electrodes will be implanted subcutaneously in a Lead II configuration. At least 2 weeks post-implantation, left-ventricular myocardial infarction (MI) is induced by thermocoagulation. Real-time ECG waveforms will be continuously displayed and recorded using a PC-based system (Dataquest ART, Data Sciences International, Inc.). Offline, electrocardiogram (ECG) signals will be reviewed and analyzed using customized software scripts in Matlab (Mathworks, Inc., Natick, MA). Premature ventricular beats (PVBs) will be identified and annotated by an investigator blinded to the exposure status of each animal and the number of PVBs for each exposure hour recorded. A normal control exposed group of rats will be included in this study. If there are >50 PVBs in a given hour, the total number for that hour will be estimated based on review of three 1-min windows positioned at 5, 30, and 55-min into that hour.

Heart rate (HR) and heart rate variability (HRV) assessment. Normal sinus beats will be automatically labeled and subsequently verified by an investigator. The investigator will calculate heart rate as the reciprocal of the 3-min mean normal beat-to-beat interval, SDNN, a measure of total HRV, as the standard deviation of all normal beat-to-beat intervals within a 3-min interval, and RMSSD, a measure of HRV that reflects parasympathetic nervous system activity, as the root-mean-square of successive differences among all normal beat-to-beat intervals within a 3-min interval. HR and HRV will be assessed at 0, 60, 120, 180, and 240 min after the start of the exposure. If the ECG within 10 min of each time point could not be automatically labeled by the software or was otherwise of insufficient quality, no value will be reported for that time point for that rat.

ECG intervals will be estimated every 10 sec using Ponemah Physiology Platform version 4.8 (DSI Ponemah, Valley View, OH). Statistical analyses will be based on the mean PR interval and P wave duration for each rat for each hour.

Respiratory data collection: Briefly, rats will be exposed to PEPs or HEPA-filtered air (FA) in individual plethysmography chambers for 21 days. Continuous respiratory measures will be collected using an automated acquisition system (Buxco/Ponemah, DSI). Data will be reduced to 10 min. averages of the following parameters: frequency (f), tidal volume (TV), inspiratory time (Ti), expiratory time (Te), enhanced pause (Penh), accumulated volume (AV), minute volume (MV), peak inspiratory flow (PIF), peak expiratory flow (PEF), relaxation time (RT), end inspiratory pause (EIP), end expiratory pause (EEP), expiratory flow at 50 % (EF50), and pause (PAU). Other derived parameters will be calculated, including inspiratory duty cycle (IDC) and minute ventilation (Vi).

Lung injury and inflammation: BALF will be analyzed on day(s) 1, 5, 9, 13, 17 and 21 of exposure to assess cytotoxic lung injury (acellular LDH), neutrophil degranulation (myeloperoxidase, MPO) air-blood barrier damage (albumin and hemoglobin), and markers of inflammation and fibrogenesis (total and white blood cell differential counts, cytokine and chemokine concentrations). BALF collected on day(s) 1, 5, 9, 13, 17 and 21 of exposure will also be used to determine whether ROS production will be induced by the PEP exposure. The induction of oxidative stress will be measured by evaluating changes in the cellular content of glutathione (GSH), an important cellular antioxidant. In addition, at 24 hr after the final exposure, BALF will be collected and analyzed for neurotrophic factors, nerve growth factor (NGF) and Brain-derived neurotrophic factor (BDNF) using an ELISA assay. This will confirm the previous in vitro studies. At day(s) 1, 5, 9, 13, 17 and 21 of exposure, lung, heart and tracheobronchial lymph nodes tissue will be examined histologically for inflammation and fibrosis, and collagen deposition in lung tissue will be measured to further assess fibrogenesis. Chemiluminescence will be performed to assess ROS activity in both the heart and the lung. The rats will undergo the procedure immediately after the end of the exposure on day(s) 1 and 5 to quantify the levels of in vivo chemiluminescence using a photon counter of the cardiac and pulmonary tissue for both PEPs and HEPA-filtered air (FA) exposed groups.

Neurogenic pathway monitor: 10 days prior to PEP exposure, a 5% solution of the fluorescent neural tracer Fast Blue will be instilled into the trachea. This intravital marker permeates the airway wall, is taken up by sensory nerve fibers in the airway epithelium and mucosa, and is transported to nerve cell bodies located in the nodose and jugular ganglia. One day post-exposure, nodose and jugular ganglia will be removed, dissociated using enzymatic digestion and enriched by removing non-neuronal components with centrifugation through 15% albumin. The enriched neuronal pellet will be resuspended in culture medium. Using fluorescence microscopy, fast blue labeled airway neurons will be collected using a cell picker. Non-airway neurons (unlabeled) will be collected as an internal control. The isolated airway neurons will be transferred to tubes and processed for quantitative RT-PCR measurement of trkA, trkB and TRRPV1 receptor and SP mRNA. Evaluate the cardiopulmonary activity of PEPs upon extended rat exposures (21 day inhalation study). This includes the characterization of animal exposures during the study and use on implanted by surgery telemeters to monitor in real time cardiovascular function of the animals. Analysis of the cardiovascular data will also be performed at Harvard (Systemic blood pressure (BP), left ventricular pressure (LVP), ECG, heart rate (HR) and core temperature, etc). In addition, BAL fluid will be collected in various exposure time points and analyzed to asses cytotoxic lung injury (acellular LDH), air-blood barrier damage (albumin), and markers of inflammation and fibrogenesis (total and differential cell counts, cytokine and chemokine concentrations);

4. Collect lung and heart tissues of rats exposed to PEPs and send them to NIOSH for histopathological assessment and genomic studies. Blood samples will also be collected and send to West Virginia University for genetic analysis.

5. Analysis of data;

6. Delivery of an initial report detailing the research design and plan

7. Delivery of a mid-term report detailing the project progress

8. Delivery of a final project report which include a statement of the problem, a list of project aims, description of methods used, summary of results, and conclusions.

9. Any presentation in scientific conferences and any publications of the work under this contract should be published in peer-reviewed scientific journals within three years of the end of the period of performance of this contract.

10. Harvard University scientists will travel to NIOSH in Morgantown, WV up to three times to discuss the progress of the PEPs study.

This contract shall be conducted in compliance with the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals, the Animal Welfare Act and Regulations, the current edition of the “Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state, or federal regulations.

C.5 Reporting Schedule/Deliverables –

of Copies

In addition, the investigators will provide informal reports as to progress or unanticipated technical issues on a bio-monthly basis by oral communication with NIOSH scientists C.6 Travel

Harvard University scientists will travel to NIOSH in Morgantown, WV up to three times to discuss the progress of the PEPs study.

C.7 Payment Milestone Schedule

Payment will be made in accordance with the payment milestone schedule below:

of Copies Delivery Date

Delivery Date

Amount

C.8. Data Management Plan

HHS/CDC policy requires that contract award recipients make research resources including data readily available after publication to qualified individuals within the scientific community for research purposes. CDC requires that all new collections of public health data include a Data Management Plan (DMP). For purposes of this statement of work, “public health data” means digitally recorded factual material commonly accepted in the scientific community as necessary to validate research findings including datasets used to support scholarly publications. Only new awards, as of the date of issue of this policy and all continuations thereafter, are subject to this policy. The CDC AR-25 outlines the components of a Data Management Plan (DMP) and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation. This new requirement ensures that CDC is in compliance with the following; Office of Management and Budget (OMB) memorandum titled “Open Data Policy–Managing Information as an Asset” (OMB M-13-13); Executive Order 13642 titled “Making Open and Machine Readable the New Default for Government Information”; and the Office of Science and Technology Policy (OSTP) memorandum titled “Increasing Access to the Results of Federally Funded Scientific Research” (OSTP Memo).

Investigators, upon award of a NIOSH contract that will generate “public health data” must provide a data management plan for how they will collect, analyze, store, use and make available the data collected for the proposed project or activity. If data sharing is not possible, applicants need to provide a justification explaining the reasons for not sharing their data. The costs of sharing or archiving data may be included as part of the total budget requested for first-time or continuation awards. Awardees for CDC funds should incorporate data release into their study designs and should do the following: (a) set up procedures for protecting personal or proprietary information, (b) ensure data quality, and (c) include appropriate documentation (e.g., data dictionary, codes, etc.) for reuse of data. The CDC AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

The contractor should address the following questions in their DMP:

What types of data do you plan to generate include the size, file formats, number of files?

Who will find your data useful?

Are there limitations on the secondary research use of data, if the study involved human data?

What transformations will be necessary to prepare data for preservation and sharing?

What metadata documentation will be submitted with the data?

Will a data sharing agreement be required?

Describe whether data will be provided directly to the researchers, or if access will be provided to a restricted online database or at a CDC-controlled site (e.g., the National Center for Health Statistic’s Research Data Center)?

Which archive/repository/central database have you identified as a place to deposit?

What is the expected timeline from data collection to release or anticipated date of release?

Data Management Plan Progress Reporting Routine reviews and reports specified within the contract terms and conditions will be used to monitor awardee progress. Awardees should justify changes from the original DMP, and these changes should be concurred by the funding program.

At the end of the contract funding period, the awardee will submit a final DMP. The final DMP will include the location of each dataset, any restriction to access, and changes to the plans for long term preservation of the data. The final DMP should also indicate that all laws, regulations, and rights regarding the data have been complied with.

Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance consistent with 45 CFR 74.62 or other authorities as appropriate. Such procedures include, but are not limited to, reduction in funding, restriction of funds, or contract termination. The DMP is not intended to replace other contract reporting requirements.

Section D - Packaging And Marking Section E - Inspection And Acceptance

E.2 Inspection and Acceptance (Jul 1999)

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 Contracting Officer’s Representative) at the destination of the articles, services or documentation.

Section F - Deliveries Or Performance F.1. Clauses

F.2 Deliverable(s) Schedule (Jul 1999)

The Contractor shall deliver to the Contracting Officer's Representative (COR), Contract Specialist and the Contracting Officer any reports or deliverables as may be specified in the contract within the time frames specified. See Sample below for Deliverable Schedule structure:

F.3 Period of Performance (Contract and Task Orders) (Jul 1999) 24 months

F.4 Place(s) of Performance (Jul 1999)

The Contractor’s Facility Section G - Contract Administration Data G.1 Contract Communications/Correspondence (Jul 1999)

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.

G.2 Contracting Officer Representative (COR)

a) A Contracting Officer Representative (COR) will be assigned to the contract. A COR will be assigned to each contract issued under the contract. The Contracting Officer will provide under separate cover the duties and responsibilities of the COR. The COR is not authorized to alter the requirements of this contract or contract without written approval of the Contracting Officer. The COR is not authorized to obligate any funds.

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

c) 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.

d) 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.

e) 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.

G.3 Contracting Officer (Jul 1999)

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 grounds for deviation from any stipulation of this contract.

G.4 Subcontracting Program Reports (May 1998)

a) The Contractor shall submit the reports listed below in accordance with the instructions and within the time periods specified on the report forms:

(1) Standard Form 294, Subcontracting Report for Individual Contracts.

(2) Standard Form 295, Summary Subcontract Report.

b) In addition to the reporting information specified on the report forms, the Contractor shall provide, in the “Remarks” block on each Standard Form 294 submitted, a narrative of the progress made in fulfilling the small business and small disadvantaged business subcontracting goals contained in its approved plan.

c) The Contractor shall report to the Contracting Officer any difficulties encountered in achieving the goals and shall describe the action being taken to overcome the difficulties.

G.5 CDCAG001 Invoice Submission

Note. While multiple options for invoices are provided, the preferred method of invoicing is a single email to FMOAPINV@CDC.GOV, also addressed to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR).

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

Or – The Contractor may submit the original invoice/voucher via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations.

b) The contractor shall submit 2 copies of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer.

c) The Contractor is , is not 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 Task Order 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 Number

G.6 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: 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.

G.7 CDC37.0001 Non-Personal Services (April 2013)

a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. . The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

G.8 Electronic Subcontracting Reporting System (eSRS) (Dec 2005)

The contractor shall register with the Electronic Subcontracts Reporting System (eSRS) for the submission of its Individual Subcontract Report (SF 294) and the Annual Summary Reports (SF 295). Before registering in eSRS, the contractor information must be correct in Central Contractor Registration database. The eSRS is a world wide web-based application available at: http://www.esrs.gov. The eSRS website provides training and instruction for data submission.

G.9 Payment by Electronic Funds Transfer (Dec 2005)

a) 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.

b) 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.

c) 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 Section H - Special Contract Requirements

H.1. HHSAR 352.211-3 Paperwork Reduction Act.

Paperwork Reduction Act (DEC 2015)

(a) This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer's Representative shall be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.

(b) The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.

(End of clause)

H.2 HHSAR 352.203-70 Anti-Lobbying (Dec 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

The Contractor shall ensure all its subcontractors which perform work under this contract (at all tiers) comply with the above requirements.

H.3. HHSAR 352.237-75 Key Personnel.

Key Personnel (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

H.4 Non-Disclosure Agreement for Contractor and Contractor Employees (May 2009)

a) 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.

b) 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.”

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

d) 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.

e) 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.

f) The Contractor shall prepare and maintain a current list of employees working under NDA's 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 can

HYPERLINK "http://www.hyperdictionary.com/dictionary/not" not 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…