RFP_2016-N-17821.pdf

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Influenza Free Ferret Supply for Improving Public Health
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2016-N-17821-CDCFerretsSupply
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PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 58

2. CONTRACT NO.

3. SOLICITATION NO.

2016-N-17821

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/03/2016

6. REQUISITION/PURCHASE

NO.

00HCVGDE-2016-94709

7. ISSUED BY CODE 2543 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention

Office of Acquisition Services (OAS)

2920 Brandywine Rd, RM 3000

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 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time 07/06/2016

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

Thaddeus Rollins

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-1971

C. E-MAIL ADDRESS

tnr6@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 26

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 33

X D PACKAGING AND MARKING 9 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 11 X K OTHER STATEMENTS OF OFFERORS 34

X G CONTRACT ADMINISTRATION DATA 12 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 47

X H SPECIAL CONTRACT REQUIREMENTS 17 X M EVALUATION FACTORS FOR AWARD 57

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 calendar days (60 calendar days unless a different 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

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 2543 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Office of Acquisition Services (OAS)

2920 Brandywine Rd, RM 3000,Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Solicitation RFP 2016-N-17821

Section A – Solicitation/Contract Form (Continued)

EXECUTIVE SUMMARY

1. Description of the supplies being procured:

The Statement of Work (SOW – Section C) establishes the requirements for Contractor provided services to include the coordination of activities. The purpose of this contract is to ensure a stable supply of ferrets that are seronegative for influenza

A and B viruses so that the Influenza Laboratories at CDC can produce and distribute strain specific serum for influenza diagnostic purposes, for testing of pandemic vaccine candidates and for antigenic characterization of currently circulating influenza strains including avain strains. Ferrets shall be provided in accordance with the specifications included in Section C, and as ordered (delivery orders) by the Government at the prices stated herein.

NOTE: The quantities shown are estimates only. CDC will purchase a minimum of 1392 prebleeds and 1392 ferrets from any CLIN.

2. Type of Contract:

Firm-Fixed Price Indefinite Delivery Indefinite Quantity (IDIQ) supply contract

3. Format of the Contract:

This contract will have a base year for twelve (12) months and four (4) one (1) year option periods. NOTE: This requirement will be funded by issuing delivery orders to the contractor. It is Government’s decision as to whether or not any of the option years will be executed and the contract extended beyond the base year.

4. The North American Industry Classification System (NAICS):

The NAICS code for this acquisition is 112930. The small business size standard is $7.0 million.

5. Contract Administration:

Please submit any and all questions in writing to Thaddeus Rollins, email address: tnr6@cdc.gov. All questions must be submitted in writing by e-mail NLT June 16, 2016. See Section L, clause L.7.

6. Additional information:

See Section L for important information as to what is required to be submitted in response to this request for proposal (RFP).

mailto:Thaddeus%20Rollins%20email:%20tnr6@cdc.gov

Section B - Supplies Or Services And Prices/Costs

Base Year Items

Period of Performance: 9/19/2016-9/9/18/2017

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT

PRICE

EXTENDED PRICE

0001 Ferret Prebleeds

MAX: 1392

0002 Ferrets 3-6 mths old

0003 Delivery Fee

12/Trips

Total: $____________

Option 1 YEAR 2 Items

Period of Performance: 9/19/2017-9/18/2018

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

1001 Ferret Prebleeds

1002 Ferrets 3-6 mths old

1003 Delivery Fee

Option 2 YEAR 3 Items:

Period of Performance: 9/19/2018-9/18/2019

Option 3 YEAR 4 Items:

Period of Performance: 9/19/2019-9/9/18/2020

3001 Ferret Prebleeds

3002 Ferrets 3-6 mths old

3003 Delivery Fee

2001 Ferret Prebleeds

2002 Ferrets 3-6 mths old

2003 Delivery Fee

Option 4 YEAR 5 Items:

Period of Performance: 9/19/2020-9/9/18/2021

4001 Ferret Prebleeds

4002 Ferrets 3-6 mths old

4003 Delivery Fee

TOTAL AGGREGATE PRICE (BASE AND ALL OPTION YEAR) $________________

Section C - Description/Specification/Work Statement

STATEMENT OF WORK

Title of Project: Influenza-free Ferret Supply for Improving Public Health

C.1 Background and Need: The Influenza Division at CDC requires access to healthy ferrets that are serologically negative against all influenza virus strains. These animals are needed for i) the production of strain-specific immune sera for use as a diagnostic reagent and to monitor antigenic drift of circulating influenza viruses which is necessary to assist with influenza vaccine composition recommendations ii) the safety and efficacy testing of vaccine candidates against influenza viruses with the potential to cause a pandemic and iii) the evaluation of the virulence, transmissibility and antiviral resistance of emerging influenza viruses that pose a threat to public health. Pursuing these critical missions of the Influenza

Division is dependent on a constant and reliable supply of influenza-free ferrets.

C.2 Project Objective – The purpose of this contract is to secure a stable supply of healthy ferrets that are sero-negative against influenza A and B viruses so that the Influenza Division at CDC can provide accurate and reliable assessments of influenza surveillance, safety and efficacy of vaccine candidates and risk assessments of emerging influenza viruses that pose a threat to public health.

C.3 Scope of Work –

The contractor will provide the CDC with a monthly inventory of ferrets available for purchase. This inventory must include at least 50 healthy, male ferrets that are 3-6 months of age and are sero-negative against influenza A and B viruses. The contractor will provide up to 116 ferret pre-bleeds per month selected by the CDC based on the provided inventory list. Sera will be tested by the CDC to confirm sero-negativity. The contractor will deliver up to 116 ferrets per month in a single delivery each month based on the testing results and projected needs of the CDC. All ferrets will be transported in sealed, HEPA-filtered containers and in a climate controlled environment.

C.4 Technical Requirements –

Ferret Inventory Maintenance:

All CDC-bound ferrets at the contractor’s facility will be maintained inside of a HEPA-filtered enclosure.

All staff entering the enclosure will wear appropriate personal protective equipment, including respirator to protect the animals from potential exposure to influenza virus. Any staff experiencing influenza-like illness will not enter the ferret housing enclosure. An up to date inventory account of available ferrets will be provided to the Contracting Officer’s Representative (COR) at the CDC via email by the 1st day of each month and will include the dates of birth for each lot of animals. The ferret inventory will be maintained so that at least 50 healthy, male ferrets that are sero-negative to influenza A and B viruses will be available on any given month. The age of these ferrets will be restricted to 3-6 months at the time of inventory assessment. Each month the CDC will select up to 116 ferrets from the inventory to screen for potential purchase; the COR will communicate this selection to the contractor in an email.

Delivery of Ferret Prebleeds:

The contractor will collect blood samples from each of the selected ferrets and will isolate approximately

0.2-0.5 mL of serum from each sample. This will be accomplished by centrifugation of whole blood and transfer of the separated top layer of serum to a fresh, sterile vial that is labeled with the corresponding ferret ear tag number. Within 3 business days of the CDC’s request for prebleeds, the contractor will ship the frozen serum samples via overnight delivery to the CDC so that they arrive on a non-holiday, business day. The contractor will also email the COR a list of the prebleeds (itemized by ferret ID) with each ferret’s date of birth included. The sera will be tested for the presence of influenza antibody by the CDC and, based on the results, the COR will communicate via email which ferrets should be delivered to the

CDC.

Delivery of Ferrets:

Up to 12 deliveries per year (1 per month) will be scheduled between the contractor and the COR at the

CDC. Each delivery will be scheduled within two weeks of the COR’s communication of screening results to the contractor. All ferrets will be housed in sealed, HEPA-filtered animal transport containers and transportation will occur in a climate-controlled environment. Transport containers will be positioned so that ample airflow is maintained during transport. Ferrets are extremely sensitive to elevated temperatures. Anyone loading or unloading the ferrets should wear personal protective equipment including a respirator to protect the animals from potential exposure to influenza during transport to the

CDC. If ferrets are transported via ground, a back-up vehicle will be available in case the primary transport vehicle malfunctions.

Replacement Prebleeds and Ferrets:

Any ferret prebleed found to be sero-positive will be replaced with another from a ferret chosen by the

COR at no cost to CDC. Any ferrets that die in transit will be replaced by the contractor at no cost to the

CDC. Any ferret identified as sero-positive after being tested upon arrival at the CDC will be replaced by the contractor at no cost to the CDC.

C.5 Reporting Schedule –

An inventory of available animals, including the quantity per lot and the dates of birth of each lot of animals, will be provided to the COR at the CDC via email by the 1st day of each month.

Each shipment of prebleeds will contain the vials of serum labeled with the corresponding ferret ear tag number. At the time of pre-bleed shipment, the contractor will provide the COR with an itemized list of ferret IDs and their corresponding dates of birth.

If the contractor becomes aware of any potential problems related to ferret well-being, sero-positivity or availability, the COR at the CDC is to be notified immediately.

C.6 Special Considerations –

Ferrets are to be housed as prescribed in chapter three, “Environment, Housing and

Management,” in the 2011 National Research Council’s Guide for the Care and Use of

Laboratory Animals. When using this guide, refer to the requirements described for cats, as they are closest to ferrets in regards to care, feeding and housing.

Personnel caring for ferrets should be appropriately trained and provided with clearly defined procedures for conducting their duties including but not limited to personal hygiene, zoonoses, chemical safety, microbiologic and physical hazards (2011, National Research Council, page 20).

All staff in direct contact with these ferrets must wear personal protection equipment that includes respirators, gloves, and hair and shoe covers at all times when in the facility. Street clothes and shoes are not to be worn in animal enclosure at any time.

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires that institutions receiving PHS support for activities involving animals base their programs of animal care and use on the 2011 National Research Council’s Guide for the Care and

Use of Laboratory Animals and comply, as applicable, with the Animal Welfare Act and other

Federal statutes and regulations relating to animals.

C.7 Government Furnished Property- N/A

C.8 References –

National Research Council, Guide for the Care and Use of Laboratory Animals, 2011, National Academy

Press, Washington D.C.

Code of Federal Regulations, Title 9--Animals and Animal Products, Chapter 1, Part 3, revised January1, Deliverables –

An inventory of available animals, including the quantity per lot and the dates of birth of each lot of animals, will be provided to the COR at the CDC via email by the 1st day of each month.

Each month the contractor will provide up to 116 prebleeds at the request of the COR at the CDC from the inventory list. Prebleeds will be shipped via overnight delivery to the CDC within 3 business days of the request. At the time of pre-bleed shipment, the contractor will provide the

COR with an itemized list of ferret IDs and their corresponding dates of birth.

After CDC has screened the prebleeds, the COR will communicate by email to the contractor which ferrets to ship. The contractor will schedule delivery of the ferrets within 2 weeks of this notification.

Any replacement prebleeds or ferrets will be delivered as requested by the COR.

Section D - Packaging And Marking

D.1 Packaging Requirements (Nov 2003)

Ferrets are to be shipped in hepa-filtered containers (containers are to be air conditioned in summer).

Ferrets are to be shipped in such a manner as to assure safe arrival at destination.

(End of Clause)

D.2 Marking Requirements (May 1998)

Shipping containers will be marked indicating that live animals are inside and that ferrets are to remain in hepa-filtered containers until ferrets are removed from the hepa-filtered containers at final CDC destination.

Also, the contractor must mark/stencil all shipping containers with the following information:

Agency

Description of Contents

CDC Contract Number

Contractor’s Name and Address

Section E - Inspection And Acceptance

E.1 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.arnet.gov/far http://farsite.hill.af.mil/VFFARa.htm or VFFAR1.htm

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 Project Officer) at the destination of the articles, services or documentation.

FAR SOURCE TITLE AND DATE

52.246-2 Inspection of Supplies – Fixed-Price (Aug 1996)

52.246-16 Responsibility for Supplies (Apr 1984) http://www.arnet.gov/far http://farsite.hill.af.mil/VFFARa.htm%20or%20VFFAR1.htm

Section F - Deliveries Or Performance

F.1 Place of Delivery (May 1998)

Deliveries shall be made F.O.B. Destination to the following address:

Receiving – Building 11

1600 Clifton Road, N.E.

Atlanta, GA 30033

F.2 Period of Performance (Jul 1999)

Base Period: 09/19/2016 – 09/18/2017

Option Year 1: 09/19/2017 – 09/18/2018

Option Year 2: 09/19/2018 – 09/18/2019

Option Year 3: 09/19/2019 – 09/18/2020

Option Year 4: 09/19/2020 – 09/18/2021

F.3 Deliverable(s) Schedule (Jul 1999)

TO BE ESTABLISHED ON INDIVIDUAL DELIVERY ORDERS

The Contractor shall deliver within the time frames specified in the SOW.

52.211-17 Delivery of Excess Quantities (Sep 1989)

52.242-15 Stop-Work Order (Aug 1989)

52.242-17 Government Delay of Work (Apr 1984)

52.247-34 F.O.B3. Destination (Nov 1991)

Section G - Contract Administration Data

G.1 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.2 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.3 Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)

(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-System for Award

Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) ) In addition to System for Award Management, 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 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

G.4 Invoice Submission (Mar 2006)

CDCAG001 – Invoice Submission (Mar 2006)

(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 30333

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

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall e-mail a copy of the invoice/voucher to the cognizant contracting office previously identified in this contract. The Contractor is , is not [ ] required to email a copy of each invoice directly to the Contracting Officer Representative concurrently with submission to the

Contracting Officer.

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.

(c) 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 mailto:FMOAPINV@CDC.GOV

G.5 COR & Technical Monitor (Jul 1999)

(a) Performance of the work hereunder shall be subject to the technical directions of the designated

Contracting Officer’s Technical Representative (COR) for this contract. Dr. Taronna Maines is hereby designated as the COR for this contract. The COR mailing address is: Centers for Disease Control and

Prevention (CDC), Attn: Dr. Taronna Maines – M/S G16, 1600 Clifton, Atlanta, GA 30333. The

Technical Monitor for this contract is Dr. Taronna Maines. The Technical Monitor’s mailing address is

Centers for Disease Control and Prevention (CDC), Attn: Dr. Taronna Maines – M/S G16, 1600 Clifton

Road, Atlanta, GA 30333.

(b) 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 and adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

© The Government Project Officer 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.

G.6 Contractor Performance Assessment Reporting System (CPARS) Requirements

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS).

The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment

Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of

FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

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

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

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

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

Provide the current CPARS representative information below.

PRINT OR TYPE NAME

EMAIL ADDRESS AND PHONE NUMBER

[End of Provision]

G.7 Online Representations and Certification Application (ORCA) (Dec 2006)

(a) All potential Contractors are required to complete electronic annual representations and certifications at http://orca.bpn.gov in conjunction with registration in the Central Contractor Registration (CCR) database per FAR 4.1102 and FAR 4.1201. Certifications in ORCA are required prior to the submission of contract proposals.

(b) Contractors shall update the representations and certifications submitted to ORCA as necessary, but at least annually, to ensure they are kept current, accurate, and complete. All Contractors with current contracts shall notify the Contracting Officer in writing when changes are made to ORCA. The representations and certifications are effective until one year from date of submission or update to ORCA.

G.8 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.

http://orca.bpn.gov/

(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.9 Electronic Subcontracting Reporting System (eSRS)

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 System for Award

Management database. The eSRS is a World Wide Web based application available at:

htttp://www.esrs.gov. The eSRS website provides training and instruction for data submission.

Section H - Special Contract Requirements

H.1 Health and Safety Requirements (Oct 2007)

The Contractor shall be responsible for implementing the appropriate controls for protection to the life and health of employees and other persons in the performance of the contract. The contractor shall comply with all applicable federal, state and local environmental, health and safety regulations and standards, nationally recognized guidelines, and any specific requirements specified by the Government, such as, but not limited to 1) 29 CFR part 1910 – Occupational safety and health standards, including the requirements for hazard assessments, personal protection equipment selection, training of employees and other persons in the recognition of hazards and specific procedures implemented to protect from exposure, such as appropriate work practices, emergency procedures, proper use and limitations of personal protective equipment, and medical management, including immunizations, medical surveillance and incident reporting procedures, and medical evaluation and follow-up; 2) 40 CFR parts 1 – 799, Environmental protection Agency; 3) 10 CFR parts 0 – 199, Nuclear Regulatory Commission; 4)

Biosafety in Microbiological and Biological laboratories, U.S Department of Health and Human Services, HHS Publication No. CDC93-8395; 5) Biosafety in the Laboratory: Prudent Practices for Handling and

Disposal of Infectious Materials; 6) Prudent Practices for Handling Hazardous Chemicals in the

Laboratory; and 7) Prudent Practices for the Disposal of Chemicals from the Laboratory.

H.2 HHSAR 352.270-9 Care of Laboratory Animals.

(a) The following provision shall be included in solicitations expected to involve vertebrate animals:

Notice to Offerors of Requirement for Adequate Assurance of Protection of Vertebrate Animal Subjects

(SEP 1985)

The PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions establishes a number of requirements for research activities involving animals. Before award may be made to an applicant organization, the organization shall file, with the Office of Laboratory Animal Welfare

(OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance which commits the organization to comply with the provisions of the PHS Policy on Humane Care and Use of Laboratory

Animals by Awardee Institutions, the Animal Welfare Act, and the Guide for the Care and Use of

Laboratory Animals prepared by the Institute of Laboratory Animal Resources. In accordance with the

PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities and procedures. No award involving the use of animals shall be made unless the Animal Welfare Assurance has been approved by OLAW. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The Contracting Officer will request that OLAW negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, OLAW may be contacted at NIH, Bethesda, Maryland 20892 (301-496-7041).

(End of Provision)

H.3 Care of Live Vertebrate Animals (JAN 2001)

(a) Before undertaking performance of any contract involving animal related activities, the

Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7

U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the

Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care and use of any live vertebrate animals used or intended for use in the performance of this contract will conform with the PHS Policy on Humane Care of Use of

Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of

Laboratory Animals prepared by the Institute of Laboratory Animal Resources and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR

Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall be used.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved PHS Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.

(End of Clause

H.4 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.

(End of clause)

H.5 Representations and Certifications (Sep 2009)

The Representations, Certifications and Other Statements of Offerors submitted by __________ dated

____________ are hereby incorporated by reference, with the same force and effect as if they were given in full text. The on-line Representations and Certifications is located at https://orca.bpn.gov/.

H.6 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006)

(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 NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and

NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC)

Contractor Non-Disclosure Agreement

I. Non-public Information

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

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

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized

Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the CDC.

II. Procurement-Sensitive Information

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized

Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee’s responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for

Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data;

contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personal involved in the solicitation; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

Contractor understands and agrees that employee access to any procurement-sensitive information may create a conflict of interest which will preclude contractor from becoming a competitor for any acquisition(s) resulting from this information. Therefore, if an employee participates in any discussions relating to procurement-sensitive information, assists in developing any procurement-sensitive information, or otherwise obtains any procurement-sensitive information during the course of performing duties at the CDC, contractor understands and agrees that contractor are be excluded from competing for any acquisition(s) resulting from this information.

III. Identification of Non-Government Employees

Contractor understands that its employees are not agents of the Government. Therefore, unless otherwise directed in writing by the CDC, contractor agrees to assist and monitor employee compliance with the following identification procedures:

A. At the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor’s work with the CDC), contractors’ employees will identify themselves as an employee of a contractor.

B. Contractors’ employees will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages, in connection with contractual duties to the CDC:

Employee’s name

Name of contractor

Center or office affiliation

C. At the beginning of telephone conversations or conference calls, contractors’ employees will identify themselves as an employee of a contractor.

D. Contractors should not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises. The only other exception is when a CDC management official has granted permission to use the CDC logo.

E. Contractors’ employees will program CDC voice mail message to identify themselves as an employee of a contractor.

I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. Contractor acknowledges that contractor has read and fully understands this agreement.

Name of contractor: ___________________________________

Signature of Authorized Representative of Contractor:_________________________________

Date:________________

Copies retained by: contracting official and contractor

EXHIBIT II

Centers for Disease Control and Prevention (CDC)

Contractors’ Employee Non-Disclosure Agreement

I. Non-Public Information

I understand that in order to fulfill my responsibilities as an employee of [Name of CDC contractor], I will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public.

Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

I [Name of Employee], agree to use non-public information only in performance of my responsibilities to the CDC. I agree further that I will not 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 I may obtain in connection with the performance of my responsibilities to the CDC.

II. Procurement-Sensitive Information

I further agree that unless I have prior written permission from the CDC, I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any procurement-sensitive information gained in connection with the performance of my responsibilities to the CDC. I specifically agree not to disclose any non-public, procurement-sensitive information to employees of my company or any other organization unless so authorized in writing by the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract

(RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors;

non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data;

contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

I understand and agree that my access to any procurement-sensitive information may create a conflict of interest which will preclude me, my current employer, or a future employer from becoming a competitor for any resulting government acquisition derived from this information. Therefore, if I participate in any discussions relating to procurement-sensitive information, assist in developing any procurement-sensitive information, or otherwise obtain any procurement-sensitive information during the course of performing my duties at the CDC, I understand and agree that I, my current employer, and any future employer(s) are excluded from competing for any resulting acquisitions.

III. Special Non-Disclosure Clause for Contractors with Access to CDC Grants Management and

Procurement-Related Information Technology Systems

In addition to complying with the non-disclosure requirements and safeguards stated above, I understand that my authorization to use CDC’s grants management and procurement systems is strictly limited to the access and functions necessary for the performance of my responsibilities to the CDC and which have been approved in advance by the CDC. I understand that I am not authorized to enter procurement requests for any requirements pertaining to contracts or subcontracts held by me or my employer.

IV. Identification as a Non-Government Employee

I understand that as an employee of a government contractor, I represent an independent organization and

I am not an agent of the Government. Therefore, I agree that unless I have prior written authorization from the CDC, I will, at the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor’s work with the CDC), identify myself as an employee of a contractor. I further agree to use the following identification procedures in connection with my work at the CDC:

A. I will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages:

Employee’s name

Name of contractor

Center or office Affiliation

B. I will identify myself as an employee of a contractor at the beginning of telephone conversations or conference calls;

C. I will not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises; the only other exception is when a CDC…

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