14-223-SOL-00077_(FINAL).pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DCSC

ROOM 2129, HFA-500

5630 FISHERS LANE

ATTN: DAN FELDMAN

DHHS/FDA/OAGS

CODE 16. ADMINISTERED BYCODE

X

X

541712

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDCSC

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

08/25/2014 1630 ET 240-402-7577 DANIEL FELDMAN

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

14-223-SOL-00077

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 75 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

ROCKVILLE MD 20857

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

ROCKVILLE MD 20857

ROOM 2129, HFA-500

5630 FISHERS LANE

ATTN: DAN FELDMAN

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

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27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDEND

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

14-223-SOL-00077

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SECTION 1 – SUPPLIES AND SERVICES AND PRICES

1.1 SOLICITATION DESCRIPTION

The U.S. Food and Drug Administration’s (FDA), Center for Tobacco Products (CTP) has a need for in vivo toxicology of tobacco and related products. The Contractor shall furnish all necessary facilities, materials, and personnel and shall perform non-personal professional services and program support to complete all tasks related to this requirement entitled, “In Vivo Toxicology of Tobacco and Related Products.”

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation is a Request for Proposal (RFP) under FAR Part 12, Acquisition of Commercial Items, and Part 15, Contracting by Negotiation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-76. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), which has an associated Small Business Size Standard of 500 employees. This is a full and open competition requirement; there are no set-asides.

1.2 CONTRACT TYPE

This is an Indefinite Delivery/Indefinite Quantity (ID/IQ) multiple award requirement with the ability to issue firm-fixed-price and labor hour task orders. The period of performance is a one year base period with four one year option periods.

1.3 CONTRACT CEILING

The ID/IQ guaranteed minimum amount will be $1,000 over the five year period of performance, inclusive of the four one year options. The contract maximum ceiling amount will be $9,000,000 over the maximum period of performance of the contract, inclusive of all option periods.

1.4 PRICING

Labor Hour:

The pricing chart below lists the labor categories that are anticipated to be required throughout the maximum period of performance of the contract, inclusive of all option periods.

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The Contractors shall provide all necessary services in accordance with a task order’s Statement of Work at the following fully burdened fixed hourly rates, inclusive of all direct and indirect costs, such as wages, fringe, overhead, general and administrative, and profit.

Labor Rate Pricing Chart:

Labor Categories Estimated Annual Hours

Base Year Fully Loaded Labor Rate

Option Year 1 Fully Loaded Labor Rate

Option Year 2 Fully Loaded Labor Rate

Option Year 3 Fully Loaded Labor Rate

Option Year 4 Fully Loaded Labor Rate

Project Director 375 Senior Scientist 410 Subject Matter Expert

Statistician 125 Data Manager 375 Research Assistant 1000 Laboratory Technician

Writer/Editor 200 Total Price

Note: Reference Section 2 for a full description of each labor category.

Firm-Fixed-Prices:

Base Year:

Animal Prices:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for FDA Animal Care and Use Committee (ACUC) approval and ordering, housing, handling, and maintaining cells and animals for four dose groups, one vehicle control group, one control group with five males and five females per group, and a plethysmography group with two males and two females (64 total animals) is the following:

Compound Class* 3 Day PK** Unit Price for the Inhalation Route***

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route***

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

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Ingredients/Additives

Electronic Cigarette Solutions

Combustible Whole Tobacco Products

Smokeless Whole

Essential Oils

Resins

Herbal Extracts

Highly Volatile Variable Gases

Acyclic Amines

Epoxides

Acyclic Hydrocarbons

Nitro-Containing Compounds

Phenols

Polycyclic Aromatic

Heterocyclic Aromatic Amines

Carbonyls

Nitrosamines

Furans

Tobacco Specific Alkaloids

Aromatic

Polychlorinated Dibenzodioxins/Fura ns

Nitrosoamines

FDA Harmful and Potentially Harmful Constituent (HPHC)

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Metals

FDA HPHC

Radioactive Metals

Quantity 3 3 3 1 1 1

*This is a non-exclusive list of possible compounds that may be tested under this contract.

** PK refers to pharmacokinetic analyses throughout the RFP.

***All inhalation route exposure shall be Nose-Only Inhalation Exposure (NOIE) throughout the RFP.

****IV refers to intravenous and IP refers to intraperitoneal methods throughout the

RFP.

Test Materials:

The Contractor’s unit firm-fixed-prices per compound on a rodent for in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for ordering and preparing products, chemicals, and mixtures for assessment is the following:

Compound Class* 3 Day PK Unit Price for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

FDA HPHC Metals

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Testing and Analysis:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for administering test products and constituents, including all necessary analytical measurement is the following:

for the Inhalation

3 Day PK Unit Price for the Oral

3 Day PK Unit Price for the IV/IP

14 Day Unit Price for the Inhalation

28 Day Unit Price for the Inhalation

90 Day Unit Price for the

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Route Route Route Route Route Route

Herbal Extracts

Furans

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*This is a non-exclusive list of possible compounds that may be tested under this contract.

Base Year Total Price (i.e. summation of labor and compound total prices):

Option Year 1:

Animal Prices:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for FDA ACUC approval and ordering, housing, handling, and maintaining cells and animals for four dose groups, one vehicle control group, one control group with five males and five females per group, and a plethysmography group with two males and two females (64 total animals) is the following:

for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

Potentially HPHC

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Test Materials:

The Contractor’s unit firm-fixed-prices per compound on a rodent for in vivo toxicology for the

3 Day PK Unit Price for the

3 Day PK Unit Price for

14 Day Unit Price for the

28 Day Unit Price for the

90 Day

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Oral Route the IV/IP Route

Inhalation Route

Inhalation Route

Inhalation Route

Ingredients/Additives

Herbal Extracts

Furans

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*This is a non-exclusive list of possible compounds that may be tested under this contract.

Testing and Analysis:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Option Year 1 Total Price (i.e. summation of labor and compound total prices):

Option Year 2:

Animal Prices:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for FDA ACUC approval and ordering, housing, handling, and maintaining cells and animals for four dose groups, one vehicle control group, one control group with five males and five

Compound Class* 3 Day PK 3 Day PK 3 Day PK 14 Day 28 Day 90 Day

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Inhalation Route

Unit Price for the Oral Route

Unit Price for the IV/IP Route

Unit Price for the Inhalation Route

Unit Price for the Inhalation Route

Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

Furans

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*This is a non-exclusive list of possible compounds that may be tested under this contract.

Test Materials:

The Contractor’s unit firm-fixed-prices per compound on a rodent for in vivo toxicology for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Testing and Analysis:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

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Herbal Extracts

Furans

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Option Year 2 Total Price (i.e. summation of labor and compound total prices):

Option Year 3:

Animal Prices:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for FDA ACUC approval and ordering, housing, handling, and maintaining cells and animals for four dose groups, one vehicle control group, one control group with five males and five for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Test Materials:

The Contractor’s unit firm-fixed-prices per compound on a rodent for in vivo toxicology for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the

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Herbal Extracts

Furans

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Total Price

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Testing and Analysis:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Option Year 3 Total Price (i.e. summation of labor and compound total prices):

Option Year 4:

Animal Prices:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for FDA ACUC approval and ordering, housing, handling, and maintaining cells and animals for four dose groups, one vehicle control group, one control group with five males and five for the Inhalation

3 Day PK Unit Price for the Oral

3 Day PK Unit Price for the IV/IP

14 Day Unit Price for the Inhalation

28 Day Unit Price for the Inhalation

90 Day Unit Price

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Route Route Route Route Route Route

Herbal Extracts

Furans

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*This is a non-exclusive list of possible compounds that may be tested under this contract.

Test Materials:

The Contractor’s unit firm-fixed-prices per compound on a rodent for in vivo toxicology for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

Herbal Extracts

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Furans

*This is a non-exclusive list of possible compounds that may be tested under this contract.

Testing and Analysis:

The Contractor’s unit firm-fixed-prices per compound on a rodent for complete in vivo toxicology testing and analysis for all necessary facilities, materials, and labor for for the Inhalation Route

3 Day PK Unit Price for the Oral Route

3 Day PK Unit Price for the IV/IP Route

14 Day Unit Price for the Inhalation Route

28 Day Unit Price for the Inhalation Route

90 Day Unit Price for the Inhalation Route

Ingredients/Additives

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Herbal Extracts

Furans

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Option Year 4 Total Price (i.e. summation of labor and compound total prices):

Grand Total Price (i.e. summation of the Base and Option Years 1, 2, 3, and 4’s total prices):________________________

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

CTP’s mission is to protect the public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco use, including understanding the harms and risks of the usage of tobacco products at both the individual and population level. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). The Tobacco Control Act granted FDA new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health. The FDA needs Contractors to provide scientific support to assist in the implementation of the Tobacco Control Act through in vivo analysis of tobacco and related products.

2.2 OBJECTIVE

The objective of this contract is to support the FDA’s implementation of the Tobacco Control Act through in vivo analysis of tobacco and related products.

2.3 SCOPE OF WORK

Activities under the proposed contract shall include, but are not limited to, assessing tobacco products in in vivo genetic toxicology nonclinical studies utilizing the inhalation route, which shall include pharmacokinetic analyses (PK) by varying routes, in addition to inhalation. The Contractor shall conduct acute, sub-acute, and chronic inhalation (3-day to 90-day) toxicology studies on aerosolized tobacco product components, such as constituents (including chemicals currently on the FDA’s HPHC list), ingredients, byproducts (e.g. smoke, aerosols, etc.), and additives, including other constituents, flavors, humectants, essential oils, resins, and herbal extracts, from traditional tobacco products (cigarettes, cigars, cigarillos, etc.), electronic cigarettes, electronic cigarette solutions, and other nicotine delivery systems in an appropriate animal model. The Contractor shall evaluate the pharmacokinetics of the test products following inhalation exposure for up to 48 hours (which may vary based on the half-life of the selected compound) and additional routes of administration, including oral, intravenous or intraperitoneal, for comparative pharmacokinetics.

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2.4 STATEMENT OF WORK

The Contractor shall provide the following tasks and deliverables related to in vivo genetic toxicology nonclinical studies. The FDA will delineate particular tasks and deliverables in task orders:

• Develop scientific protocols and methodologies and execute the protocols and methodologies.

• Select research facilities.

• Develop documentation for FDA Animal Care and Use Committee (ACUC) approval and provide animal subjects protection.

• Order, house, handle, and maintain cells and animals.

• Conduct validation of inhalation systems prior to executing short- and long-term toxicology studies for each chemical and/or mixture to confirm uniform distribution in an inhalation chamber and/or stability of an administered dose.

• Administer test products and constituents, including exposing laboratory animals, such as rats, to test articles (e.g. tobacco product smoke and aerosolized tobacco constituents incorporated into or emitted from traditional tobacco products (cigarettes, cigars, cigarillos, etc.), electronic cigarettes, electronic cigarette solutions, and other nicotine delivery systems) by inhalation and other administered routes, such as orally and intravenously. Chemicals may be constituents (e.g. HPHC constituents), byproducts (e.g. smoke, aerosols, etc.), additives, or other ingredients, such as flavors, humectants, essential oils, resins, and herbal extracts.

• Collect toxicological and pharmacokinetic data and performing data analyses in SAS transport (.xpt) and Microsoft Excel (.xlsx) format, including verification and chemical analysis of concentration/dose levels of tobacco products and tobacco product constituents, such as particle size. For example, the Contractor may conduct pharmacokinetic analyses, including pharmacokinetics using the tobacco specific nitrosamine, N-nitrosonornicotine NNN, following inhalation exposure to tobacco constituents, by pharmacokinetically comparing various exposure routes in addition to inhalation.

• Conduct chronic studies (i.e. 90-day studies) on single chemicals and/or mixtures from traditional tobacco products, electronic cigarettes, electronic cigarette solutions, and other nicotine delivery systems.

• Write scientific reports on data and findings, including periodic progress reports, interim and final data analysis, and scientific manuscripts for peer-review journals.

• Conduct scientific literature reviews.

• Provide comprehensive written minutes of all meetings and conference calls.

• Perform quality assurance assessments.

• Comply with Good Laboratory Practices (GLP) (see Facilities Section below).

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Facilities:

All work shall be performed off-site at Contractor facilities. The Contractor shall conduct animal testing at facilities that are appropriately certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

Facilities must have a current AAALAC accreditation at the time of award of a contract and throughout the life of the contract.

In accordance with the Code of Federal Regulations (CFR) Title 21, Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58), at all times during the life of the contract, the Contractor must be able to provide to the FDA Contracting Officer’s Representative (COR) at his request a self-certifying statement concerning their GLP showing their facilities and operations meet all of the GLP requirements pursuant to Title 21, Part 58.

2.5 LABOR CATEGORIES DESCRIPTIONS

The Contractor shall expect to utilize personnel for orders with the following knowledge, skills, experience, and abilities. The labor categories below are not necessarily an inclusive list of all labor required for all task orders and is written in singular form for ease of delineation of the descriptions and not for the quantity of personnel required to complete the work ordered under this contract. The Contractor shall provide all necessary labor to successfully complete all work ordered under this contract.

Project Director: The Project Director shall plan, conduct, and manage task orders utilizing integrated business information technology services. The Project Director shall have advanced knowledge of the relevant science and the ability to apply new and unique methods and procedures to meet the FDA’s requirements. Preferably, the Project Director shall have at least about six years of recent and relevant toxicology experience.

Senior Scientist: The Senior Scientist shall serve as a principal investigator and lead person for protocol development and order completion. The Senior Scientist shall provide technical and subject matter expertise on an order. Preferably, the Senior Scientist shall have at least about five years of toxicology experience and have a PhD in Toxicology.

Subject Matter Expert: The Subject Matter Expert shall provide technical knowledge, analysis, and advice on exceptionally complex problems that need extensive knowledge of the subject matter for effective implementation. The Subject Matter Expert shall develop innovative and creative technical solutions to problems, questions, and issues, using or extending state-of-the-art methods and technology. Preferably, the Subject Matter Expert shall have at least about six years of toxicology experience and a PhD in Toxicology.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58

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Statistician: The Statistician shall analyze data and compile reports, charts, and tables based on established statistical methods. The Statistician shall perform empirical quantitative analysis and develop empirical tests including, but not limited to, goodness of fit, inferences of central tendency or dispersion, general distribution, association analysis, and randomness or trend. The Statistician shall support experimental project design, perform hypothesis testing, and provide analysis of experimental results.

Preferably, the Statistician shall have at least about five years of toxicology experience and have at least a Bachelor’s Degree in Statistics.

Data Manager: The Data Manager shall manage all aspects of data collection, including establishing and maintaining policies and procedures for gathering, coding, analyzing, and reporting data. Preferably, the Data Manager shall have at least about one year experience performing these data management activities.

Research Assistant: The Research Assistant shall execute research tasks under supervisory direction, such as collecting quantitative data, supporting protocol development, producing routine reports, and assisting with administrative tasks.

Preferably, the Research Assistant shall have at least about two years of experience performing these Research Assistant type tasks.

Laboratory Technician: The Laboratory Technician shall provide administrative, clerical, and laboratory support. The Laboratory Technician shall execute routine tasks, such as maintaining files and ordering and managing supplies. The Laboratory Technician shall execute research tasks under the direction of senior scientific staff.

Preferably, the Laboratory Technician shall have at least about one year of experience performing these Laboratory Technician type tasks.

Writer/Editor: The Writer/Editor shall support the collection and organization of information required for analyses, studies, guides, reports, training materials, and other documents. The Writer/Editor shall draft text based on source material or input from professional staff and provides conceptual and editorial review services to senior staff, including suggested revisions to improve clarity and editing and formatting documents to ensure readability and conformance with applicable standards. Preferably, the Writer/Editor shall have at least about two years of experience performing these Writer/Editor type tasks.

SECTION 3 - PACKAGING AND MARKING

All deliverables under this contract shall be packed and marked in accordance with best commercial practices to ensure safe and timely delivery.

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: Food and Drug Administration offices located in the Washington, DC

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Mark for: TBD

The Contractor shall mark each shipment with their company name, contract number, identification of the item, quantity of items, and notice of partial or final delivery. For electronic deliverables, the Contractor shall identify the title of the document and contract number in the subject line of the email.

SECTION 4 - INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance decisions for all materials, documents, and services provided under this contract.

For the purpose of this Section, the FDA COR is the authorized representative of the Contracting Officer.

SECTION 5 - DELIVERIES OR PERFORMANCE

Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B. Destination to the COR for acceptance.

FAR 52.252-2, Clauses Incorporated by Reference (February 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:

www.acquisition.gov/far/index.html.

FAR 52.247-34, F.O.B. DESTINATION (NOV 1991)

Electronic Submission:

The Contractor shall submit all required reports electronically in Microsoft Word 2007 compatible format with 12 point font to the COR. The Contractor shall submit all data to the COR in SAS transport (.xpt) and/or Microsoft Excel (.xlsx) format. The Contractor shall confirm all electronic documents submitted to the FDA are virus free before transmittal to the

FDA.

5.1 ANTICIPATED TASKS AND DELIVERABLES

NOTE: The FDA will delineate actual tasks and deliverables and their schedules with the issuance of each task order. The following are illustrative examples of anticipated tasks and deliverables for a task order:

Kickoff Meeting: Within 10 business days of the effective date of a task order, the http://www.acquisition.gov/far/index.html

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Contractor shall conduct a kickoff meeting with the COR and other appropriate FDA staff and within two business days after the kickoff meeting provide the COR with meeting notes, including a summary of discussions, action items, and due dates.

Study Protocol: Within 45 business days of the kickoff meeting, the Contractor shall provide complete study protocol documents to the COR and provide revised study protocol materials within 10 business days of the FDA providing feedback on the draft materials.

Biweekly Teleconferences: The Contractor shall conduct teleconferences with the COR and other appropriate FDA staff every two weeks and within two business days after each teleconference provide the COR with meeting notes, including a summary of discussions, action items, and due dates.

Monthly Progress Reports: The Contractor shall provide the COR with a monthly progress report by the 10th day of each month for the prior month’s reporting period, which shall include a clear account of the work performed during the reporting period; an outline of the work to be accomplished during the next reporting period; for labor hour order, hours expended during the reporting period and an account of total hours worked throughout the period of performance of the order; and a description of any problems encountered or anticipated that will affect the completion of any work within the agreed upon time and fiscal constraints, together with recommended solution(s) to such problem(s); or, a statement that no problems were encountered or anticipated.

Scientific Reports: The Contractor shall provide the COR a scientific report on the order’s data, findings, analysis, and results 30 business days before the end of the period of performance of the task order.

PUBLICATIONS AND PRESENTATIONS:

The Contractor shall not present, publish, or otherwise release any information arising out of their contract without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions.

RIGHTS IN DATA AND REPORTS:

Property rights, including data first produced under this contract, source code, and publication rights, arising out of this contract shall rest with the Government and the Contractor, in accordance with FAR 52.227-14, Rights in Data - General (MAY 2014), Alternate V (DEC 2007), and FAR 52.227-16, Additional Data Requirements (JUN 1987).

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5.2 ORDERING PERIOD

The FDA may issue task orders up to the final day of the contract, and the contract shall remain in force to allow for the completion of all task orders. The FDA will not issue, and the Contractor shall not accept, any new task orders issued after expiration of the contract’s period of performance.

5.3 PERIOD OF PERFORMANCE

The contract’s period of performance is one year from the effective date of the contract with four one year option periods.

5.4 OPTION PERIODS

The FDA has a unilateral right to exercise the following four one year option periods under the same terms and conditions agreed to in the base period.

The optional periods of performance, if exercised, shall commence as follows:

OPTION PERIOD FROM THE EFFECTIVE DATE OF THE

CONTRACT

Option Year 1 One Year (approximately September 1, 2015 to August 31, 2016) Option Year 2 Two Years (approximately September 1, 2016 to August 31, 2017) Option Year 3 Three Years (approximately September 1, 2017 to August 31, 2018) Option Year 4 Four Years (approximately September 1, 2018 to August 31, 2019)

FAR 52.217-9, Option to Extend the Term of the Contract (March 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years and six months.

(End of clause)

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FAR 52.217-8, Option to Extend Services (November 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of this contract.

(End of Clause)

SECTION 6 - CONTRACT ADMINISTRATION

6.1 ORDERING PROCEDURES

All task orders issued under this contract must conform to the following procedures and terms, in addition to the ordering procedures and terms stated in Section 8 below.

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the services being ordered. Only duly warranted Contracting Officers in the FDA’s Office of Acquisitions and Grants Services (OAGS) are authorized to issue task orders against this contract and modifications to the task orders.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract’s terms and conditions shall control in the event of conflict with any task order’s terms and conditions. In the event there is a conflict between the requirements of a task order and the Contractor’s proposal, the task order’s terms shall prevail. A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for issuing individual task orders is as follows:

a) An OAGS Contract Specialist will issue a Request for Task Order Proposals

(RTOP) to a pool of IDIQ stakeholders, which will include, at a minimum, a Statement of Work (SOW) with the following elements:

1. Description of the work required in terms of its purpose(s) or objective(s);

2. Description of how work performance will be assessed relative to objectives, goals, and/or outcomes;

3. Tasks and deliverables required and how and when they shall be required.

4. Period and place of performance; and

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5. The type of order, i.e. whether it will be fixed-price, labor hour, or a hybrid/combination type task order, and pricing and payment terms.

Task Orders issued under this contract may be labor hour, fixed-price, or a hybrid/combination type order depending on the nature of the work requested and the FDA Contracting Officer’s determination.

b) The Contractors shall prepare and submit task order proposals in accordance with the RTOP proposal instructions, addressing all areas of the requirement delineated in the RTOP. The Contractors shall submit the task order proposals within the time period specified in the RTOP and shall adhere to any applicable ceiling rates established in their contract. No separate payment will be made to Contractors for the cost to prepare, submit, or negotiate a task order proposal.

The FDA will evaluate task order proposals and made order award decisions based on technical acceptability, price reasonableness, and past performance, including any specific evaluation criteria stated in the RTOP.

6.2 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following COR will represent the FDA for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for the following: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the FDA Contracting Officer changes in requirements; (2) interpreting Statement of Works and any other technical performance requirements; (3) performing technical evaluations;

(4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to direct or negotiate any changes in a contract or task order, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of their contracts.

The contact information for the FDA Contracting Officer is the following:

James Chestnut U.S. Food and Drug Administration

Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 James.Chestnut@fda.hhs.gov

Telephone: (240) 402-7570

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The contact information for the FDA Contract Specialist is the following:

Dan Feldman

Office of Acquisitions and Grants Services

5630 Fishers Lane Rockville, MD 20857 Daniel.G.Feldman@fda.hhs.gov Telephone: (240) 402-7577

The contact information for the FDA Ombudsman is the following:

Walter Harris

WO 1, Room 2314 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Walter.Harris@fda.hhs.gov Telephone: (301) 796-4700

In accordance with FAR 16.505(b)(8), Mr. Harris is the FDA’s task order ombudsman for reviewing complaints from Contractors and ensuring Contractors are given a fair opportunity to be considered for orders under this ID/IQ procurement.

6.3 INVOICE SUBMISSION

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) One original to the Contract Specialist:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Dan Feldman, Contract Specialist 5630 Fishers Lane Room 2129, HFA-500 Rockville, MD 20857

Email: Daniel.G.Feldman@fda.hhs.gov

(II) One copy to the COR clearly marked as a “Courtesy Copy Only:”

U.S. Food and Drug Administration ATTN: (To be determined upon contract award); COR Address:

Email: XXXXX@fda.hhs.gov mailto:XXXXX@fda.hhs.gov

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Acceptable methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

B. Invoices submitted under these contracts must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein.

The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on company letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Contract and task order numbers;

(IV) Description, quantity, unit of measure, unit price, and extended price for supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the contract, task order, or in a proper notice of assignment) (VIII) Name, title, and phone number of person to notify in event of a defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA COR; and (XII) Any other information or documentation required by the contract or task order.

The Contractor shall attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject order, including the following: (1) invoice number, amount, and date submitted to the Contract Specialist; and (2) corresponding payment amount and date received payment.

(b) Total estimated amounts yet to be invoiced under the task order.

D. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

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Office of Financial Services

10903 New Hampshire Avenue W032, Second Floor Mail Hub 2145 Building 32, Room 2162 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

Payment is only authorized upon successful completion of tasks and/or deliverables in accordance with the payment and pricing terms of each task order and upon receipt and acceptance of a proper invoice. Proper invoice submission includes following the invoice instructions herein and the terms of the task order. Payment will be made on a task order basis. Final payment of a task order will occur upon verification by the FDA COR there is successful completion of the task order.

6.4 KEY CONTRACTOR PERSONNEL

The above named individuals are designated as key personnel for this contract and are considered essential for its successful performance. In the event any of the key personnel are unable to perform as proposed for any reason during the performance of the contract, the Contractor shall immediately notify the COR and Contacting Officer in writing. Such notice shall include an explanation for lack of performance, a proposed replacement by someone of equal or better qualifications and experience, and shall explain the impact on performance. The Contractor shall provide the Contracting Officer and the COR the same personnel information (e.g. resumes) for replacement personnel as the Contractor provided for the initial personnel. Replacement personnel shall have at least the same or equivalent knowledge, skills, and abilities that are necessary to complete the work on this contract as the original assigned personnel. All replacements are subject to the prior approval of the Contracting Officer.

The following labor categories are considered key: Project Director and Senior Scientist.

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

7.1 CONTRACTOR PERFORMANCE EVALUATIONS

In accordance with FAR 42.15, FDA will complete annual and final Contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be mailto:fdavendorpaymentsteam@fda.gov

Page - 38 - of 75 prepared at the FDA’s Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon expiration of the contract.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at the following address: https://cpars.cpars.gov/. FDA will register the Contractor in CPARS upon receipt of the names and email addresses of two individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the Contractor in CPARS, the Contractor will receive an automated CPARS email message which contains user identification information and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contacts will receive an email instructing them to access CPARS to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, the Contractor shall submit rebuttal comments via CPARS within 14 days from the date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

Evaluations will also be stored for a three year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

The Contractor may obtain CPARS training material and register for on-line training at the following website: https://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of CPARS.

7.2 SECTION 508 STANDARD REQUIREMENTS

The Contractor shall ensure all deliverables are in compliance with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended (508 standards), which requires electronic and information technology (EIT) to be accessible to people with disabilities.

Information about Section 508 compliance is available at http://www.section508.gov/.

7.3 SECURITY AND PRIVACY

To ensure adequate security and privacy protections, the Contractor shall follow the following terms (see also Subsection 5.1, PUBLICATIONS AND PRESENTATIONS).

Unless otherwise indicated below, the Contractor shall submit all security and privacy forms and other documentation to the COR or his or her designee for review and approval.

http://www.ppirs.gov/ http://www.section508.gov/

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• Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. Contractor personnel assigned to this contract are required to complete and undergo a National Agency Check Inquiry (NACI) before a Contractor employee may be issued an identification badge for access to FDA facilities or networks. Unfavorable information security check results will be reported to the appropriate personnel and action may be taken.

• Because of the sensitivity of FDA data, Contractor personnel having access to FDA facilities or networks shall also undergo a Level 5 Public Trust Security Clearance, including finger printing, performed under the auspices of the

FDA.

• Except as may otherwise be permitted by a data owner, Contractor personnel agree not to use, disclose, or reproduce proprietary data, other than as required in performance of the contract; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the Contractor without such limitation.

• Each Contractor or subcontractor personnel who may have access to non-public HHS information under this contract shall complete and submit a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement. A copy of each signed and witnessed 3398 form shall be submitted to the COR or his or her designee prior to performing any work under this contract. The Contractor shall hold all discussions and deliberations under their contract as confidential and shall limit public access and distribution of the work resulting from their contract. The Contractor shall secure facilities and communications to limit the access and distribution of any materials, documents, data, findings, analysis, or conclusions arising out of their contract. The Contractor agree Contractor personnel shall not divulge or release data or other information developed or obtained in connection with the performance of their contract to anyone, unless made publically available by the FDA or upon written approval of the COR or his or her designee.

• The U.S. Department of Health and Human Services (HHS) policies require contractors, including subcontractors, receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The Contractor shall ensure that all of its personnel and subcontractor personnel anticipated to work under this contract have completed all requisite training, including the FDA Computer Security Awareness Training course, prior to performing any work under their contract that requires FDA network access and that these personnel complete this course again annually during performance under their contract. HHS may change, add, or modify computer security awareness training requirements to enhance and protect the HHS computer security program.

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• To ensure compliance with Federal laws, rules, procedures, policies, and regulations related to privacy and security, the COR or his or her designee may require other forms or training for Contractor personnel before or during their performance under their contract.

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