RFP No-12-223-SOL--00080-final.pdf

12-223-SOL-00080

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 36

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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

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

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

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

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

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

04/03/2012 X

DSCI

DHHS/FDA/OAGS/DSCI

ATTN: Vivian Lucas

5630 FISHERS LANE

ROOM 2095, HFA-500

ROCKVILLE MD 20857

1300 ET 05/03/2012

VIVIAN L LUCAS 301

VIVIAN.LUCAS@FDA.HHS.GOV

827-0359

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X

X

X

X

X

X

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PAGE(S)

VIVIAN L. LUCAS

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

2-4

4-6 6-7 7-8 8-13 13-14

14-18

18-24

25-28

28-34

34-36

RFP No. 12-223-SOL-00080

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 CONSIDERATION AND PAYMENT

The Contractor shall provide the services described in Section C, Description/Specifications/Work Statement. Except as otherwise specified in the contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein. The Contractor shall be paid the estimated cost amount shown in the schedule below:

A. Base Period – (dates shall be inserted at award)

The estimated cost of the contract for the Base Period is _*shall be inserted at award. The cost is subject to the provision of Limitation of Cost and Allowable Cost and Payment clause in Section I.

B. Option Period I – (dates shall be inserted at award)

The estimated cost of the contract for Option Period I is _*shall be inserted at award. The

C. Option Period III - (dates shall be inserted at award)

The estimated cost of the contract for Option Period II is _*shall be inserted at award. The

D. Option Period IV - (dates shall be inserted at award)

The estimated cost of the contract for Option Period II is _*shall be inserted at award. The

B.2 PROVISIONS APPLICABLE TO DIRECT COSTS

Notwithstanding Clause 52.216-7 "Allowable Cost and Payment" and Clause 52.244-2 "Subcontracts", of the Federal Acquisition Regulation, unless otherwise expressly provided elsewhere in the contract or in any modification thereto, the cost of the following items or activities shall be unallowable as direct costs:

1. Acquisition by purchase or lease, of any interest in real property;

2. Special rearrangement or alteration of facilities;

3. Purchase or lease or rental of any item of general purpose; office furniture or office equipment (including data tapes);

4. Travel to foreign countries; and

5. Food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations.

B.3 TRAVEL AND OTHER COSTS

1. The Contractor shall be reimbursed, not to exceed $*shall be inserted at award for the base period; $__________ for option period I; and $_________ for option period II for all domestic travel as described below, incurred directly and specifically in the performance of this contract, claimed by the Contractor and accepted by the Contracting Officer/Specilaist.

Domestic travel expenses incurred by the Contractor in direct performance of the contract shall be reimbursed provided such travel is necessary for the performance of this contract and the cost does not exceed:

a. The lowest customary standard, coach, or equivalent airfare offered during normal business hours for air travel except when such accommodations: 1) require circuitous routing, 2) require travel during unreasonable hours, 3) excessively prolong travel, 4) result in increased costs that would offset transportation savings, 5) are not reasonably adequate for the physical or medical needs of the traveler, or 6) are not reasonably available to meet mission requirements. In order for costs in excess of customary standard or coach airfare to be considered allowable, the applicable exception must be documented and justified.

b. Costs of rail travel by most direct route, coach-class accommodations.

c. The prevailing mileage rate set forth in the Federal Travel Regulation (FTR) or reasonable actual expenses for travel by motor vehicle in effect on date of travel. Travel by motor vehicle, including rented automobile, shall be reimbursed on a reasonable actual expense basis, or at the Contractor’s option, on a mileage basis at the prevailing FTR rate, plus any toll or ferry charges.

d. The prevailing rates set forth in the FTR for lodging, meals and incidental expenses.

2. Travel claims shall be submitted and included with the quarterly invoices for approval. Listed below is a description of receipts required as attachments to the invoice to support travel claims:

a. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

b. Lodging receipt;

c. Parking/tolls receipt;

d. Rental car receipt including receipts for gasoline;

e. Receipts for taxi travel.

3. Any equipment having a unit acquisition cost in excess of $3,000, the cost of which the Contractor is to be reimbursed as a direct item of cost, shall not be acquired by the Contractor without the specific advance written approval of the Contracting Officer/Specialist.

B.4 CONSULTANTS

If consultants are utilized in the performance of this contract, then the consultant fees or other payments made to them shall not exceed the daily rate of $* shall be inserted at award, if applicable, exclusive of travel costs without the written approval of the Contracting Officer/Specialist.

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

C.1 BACKGROUND

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which became law on June 22, 2009, gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. In order to achieve its mission to protect the American public from tobacco-related disease and death, the FDA requires comprehensive information on the sale and marketing of tobacco products in the United States.

FDA will use this data to monitor trends in tobacco sales and marketing to both inform the development of polices and regulatory actions and evaluate their impact. To better understand consumer choices and the impact of FDA actions, FDA requires comprehensive data for the full range of tobacco products including cigarettes, cigars, smokeless tobacco, roll-your-own tobacco, pipe tobacco, e-cigarettes, hookah tobacco, dissolvable tobacco products and tobacco accessories.

The Agency needs to know the size and nature of tobacco product sales in the United States and how these sales change in response to FDA actions. Monitoring consumer purchases of tobacco products is one way to measure the effectiveness of FDA actions to protect the public from tobacco related death and disease. Retail sales scanner data is the most readily available, complete, representative and accurate source for sales information. We also need information on the demographic characteristics of purchasers. Retail sales data will also permit FDA to analyze the cost impact of various policy options and actions. This will permit FDA to balance the costs and public health benefits of current and future efforts to regulate tobacco. In particular, the data will permit analyses that evaluate how current and future policy options could impact tobacco product manufacturers, retailers, distributors, importers or other relevant entities.

In addition to retail sales data, FDA seeks information on tobacco product pricing, promotional activities and advertising expenditures to assess trends in the factors that influencing the sale and consumption of tobacco products. Data on the size and characteristics of tobacco marketing expenditures, including promotion over the Internet and through social media, are important to provide the Agency with the tools needed to develop effective policies and actions to regulate tobacco products.

To carry out the statutory mandate to protect the American public from tobacco related death and disease; FDA must measure the sale and consumption of tobacco products and understand the marketing and promotion methods used to sell tobacco products. The purpose of this project is to provide FDA with access to retail sales and marketing data describing the past, present and future volumes, nature and composition of consumer tobacco purchases.

C.2 PURPOSE/OBJECTIVE

The objective of this contract shall be the purchase of desktop access to current and historical datasets of commercially available tobacco products sales data, including pricing and promotional information in a form that can be downloaded by FDA for further analysis using software such as Excel or SAS.

C.3 SCOPE OF WORK

Data Access:

1) The Contractor shall provide FDA with nationally representative, currently existing, commercially available tobacco products sales data, pricing, and promotional information.

Tobacco products include, but are not limited to: cigarettes, smokeless tobacco, pipe tobacco, roll-your-own tobacco, cigars, e-cigarettes, hookah tobacco, dissolvable tobacco products, and tobacco accessories. The data should be collected using scientifically sound methodologies. Data should also be in a form that can be downloaded by FDA for further analysis in software such as Excel or SAS. Data should be available by brand, sub-brand, UPC code, and carton, pack or other unit measure. Additional characteristics of interest include product attributes (such as flavors) and use of promotions (e.g., buy 1 get 1 free), and any other marketing information that is available. The Contractor shall provide;

a) Immediate, direct, multi-user, desktop access to currently existing, commercially available data with a maximum of a 6-month lag time, i.e., time between the date of purchase and date of data availability for FDA use.

b) Access to at least five years of historical tobacco product data.

c) Information on the emergence of new types of tobacco products by brand, or sub-brand, attributes, and type of tobacco product including information on when and where these products are introduced into the market (including test marketed products).

d) Data that can be analyzed on a national, regional, and/or state level.

e) Any available demographic information about purchasers including but not limited to age, race/ethnicity, gender, income, and education. This information may come from data collection other than from scanner data. Sales data should also be available by type of retail outlet and should be in a form that can be downloaded by FDA for further analysis in software such as Excel or SAS.

f) Allow FDA to share aggregate findings from reports or data analysis with other government agencies, non-governmental organizations and/or publish findings.

SECTION D - PACKAGING AND MARKING

D.1. PACKAGING

All deliverables shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier including that which is necessary to prevent deterioration and damages due to the hazards of shipping, handling, and storing.

If the Contractor submits deliverables electronically, the title of the document and contract number shall be identified in the subject line of the email.

D.2. MARKING

Each package/container shall be delivered to the COR at the address in Section G.1.2 and shall be clearly marked as follows:

A. Name of Contractor;

B. Contract Number;

C. Description of Items Contained Therein; and

D. Consignee’s Name, Address, telephone number, and email address.

SECTION E - INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

The COR, as a duly authorized representative of the Contracting Officer/Specialist, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided and performing the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the Contracting Officer/Specialist and COR.

E.2. FAR 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/Specialist will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far.

SECTION F – DELIVERIES OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE

The period of performance for this contract shall be a base period of one (1) year with two (4), One (1) year option periods. The terms of the options are:

Option Period I: *shall be completed at contract award Option Period II: *shall be completed at contract award Option Period III: *shall be completed at contract award Option Period IV: *shall be completed at contract award

The options may be exercised unilaterally in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000).

F.2 REPORTING REQUIREMENTS/DELIVERABLE AND ACTIVITY SCHEDULE

All deliverables required by this contract shall be delivered to the COR except where indicated that the Contracting Officer/Specialist (CO/CS) and the COR receive copies. All deliverables shall be subject to the inspection and acceptance of the COR. All deliverables shall be submitted electronically to the COR (*COR email address shall be inserted at award) and Vivian.Lucas@fda.hhs.gov.

Schedule and Deliverable Items:

Task/Deliverable Schedule On-line access to database with both current and

Within two weeks of contract approval

F.3 PLACE OF DELIVERY

See addresses located identified in Section G.1.1 and G.1.2.

F.4. FAR 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/Specialist will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far.

FAR Clause No. Title Date

52.242.15 Stop Work Order (AUG 1989)

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government's points of contact during performance of the contract:

G.1.1 Contracting Officer/Contract Specialist

The Contracting Officer for this contract is Dawn Rabunsky. The Contract Specialist is Vivian Lucas. Ms. Lucas can be reached at (301) 827-______or electronically at Vivian.Lucas@fda.hhs.gov . All communications pertaining to contractual and/or administrative matters under the contract should be addressed to the Contract Specialist at the following address: Attention: Vivian Lucas, FDA/OAGS, 5630 Fishers Lane, Room 2095, HFA-500, Rockville, Maryland 20857.

G.1.2 COR Appointment and Authority

The COR assigned to this contract is:

*shall be identified at contract award.

(a) Performance of work under this contract must be subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

(2) Constitutes a change as defined in the clause entitled “Changes”;

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor's employees.

(c) Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer/Specialist.

(d) The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer/Specialist no later than the beginning of the next Government work day.

(e) Failure of the contractor and the Contracting Officer/Specialist to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled

“Disputes.” The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the Contracting Officer/Specialist of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor at the time of the contract award setting forth in full the responsibilities and limitations of the COR.

G.2 HHSAR 352.242-70 KEY PERSONNEL (JAN 2006)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer/Specialist and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer/Specialist. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The individuals cited below are key personnel:

Name: ____________________________

Title: ___________________________

Email Address: ______________________

Telephone: ( )_____________________

G.3. INVOICE SUBMISSION INSTRUCTIONS

The Contractor shall submit invoices monthly/ quarterly after receipt and acceptance of all contractual deliverables scheduled for submission during the period have been submitted to and accepted by the COR or appointed designee. Vouchers/Invoices shall not be approved without submission of the Quarterly Report. The invoice shall be submitted on Standard Form 1034 and 1035 and may include an attachment detailing the cost information outlined in Section G.5 and G.6.

The Contractor shall submit one (1) original of the invoice with required supporting documentation in hard copy to the Contract Specialist at the address below. In addition, an electronic copy may also be submitted to Vivian.Lucas@fda.hhs.gov:

Contract Specialist: Vivian Lucas U.S. Department Health and Human Services Food and Drug Administration Office of Acquisitions and Grants Services (OAGS) 5630 Fishers Lane Room 2095, HFA-500 Rockville, MD 20857

(301) 827-_________

The Contractor agrees to include the following information on and/or with its invoice:

Contractor’s name, point of contact, phone number, email and address Signature of Contractor official to authorize invoice is proper and correct Invoice Date, Invoice Number, Invoice Period Contract Number which authorizes supplies or services Payment terms Bank Name of Financial Institution receiving payment Routing transit number of financial institution receiving payment Name, email, telephone number of person to notify in the event of defective invoice Taxpayer Identification Number (TIN) DUNS Number COR Name, telephone number, and email address

G.3.1 PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Contractor shall submit vouchers or invoices in accordance with the FAR 52.232-25 "Prompt Payment (OCT 2008)," and FAR 52.232-33 “Payments by Electronic Funds Transfer – Central Contractor Registration” (Oct. 2003). The Contractor is responsible for registering and remaining active in the Central Contractor Registration database at www.ccr.gov. Payment shall be made to the Contractor’s financial institution designated in the Contractor’s CCR.

The Contractor shall designate a financial institute for receipt of electronic funds transfer payment. The designation shall be submitted in writing to the finance office at the following address:

FDA/Office of Financial Services (OFS) 12345 Parklawn Drive Rockville, Maryland 20857

(301) 827-3745 Email address: FDAVendorPaymentsTeam@fda.gov

Questions regarding invoice payments shall be directed to FDA/OFS at FDAVendorPaymentsTeam@fda.gov or call (301) 827-3745.

G.4 MINIMUM COST INFORMATION

The Contractor’s monthly/quarterly invoice must be submitted in a format showing expenditures for that period, as well as contract cumulative for each contract period of performance. Funds obligated for the base contract cannot be carried over to an option period exercised under this contract. The detailed invoice supporting information can be submitted as an attachment to the invoice cover page (SF-1034).

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Fringe Costs - show rate, base and total amount;

3. Overhead or Indirect Costs - show rate, base and total amount;

4. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

5. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

6. Subcontractors (if applicable) - include, for each subcontractor, the same data as is being provided for the prime contractor;

7. Information Technology/Data Processing - include all non-labor costs, i.e., computer time;

8. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, storage, postage;

9. G & A - show rate, base and total.

The Contractor shall maintain documentation (receipts/invoices) to substantiate costs incurred for the invoice reporting period and shall be available upon the Contracting Officer’s/Specilaist’s request.

G.5 NEGOTIATED OVERHEAD RATES

Pursuant to the provisions of FAR 52.216-7, ”Allowable Cost and Payment”, indirect costs under this contract shall be obtained by applying the final rate or rates negotiated, subject to the approval of the Contracting Officer/Specialist. Reimbursement for indirect costs shall be made on the basis of the following rates:

Type of Provisional Ceiling Rate Rate Rate Base

Fringe % % Direct Labor

Indirect Cost % % All direct costs

It is further agreed that, unless the prior approval of the Contracting Officer/Specialist is obtained, the Contractor shall not change its methods of accounting under this contract in such a manner as to account for any item of cost on a direct-cost basis if such item of cost was previously considered as an indirect charge.

G.6 GOVERNMENT FURNISHED PROPERTY (GFP)

This award does not include any government furnished property.

G.7 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

During the life of this order, the Contractor’s performance shall be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The evaluation shall be conducted utilizing the Department of Defense (DOD) Contractor Performance Assessment Reporting System (CPARS). The Contractor shall register in the CPARS upon contract award. The CPARS may be accessed by the Contractor at http://www.cpars.disa.mil/.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 FDA 1350 ACCESS TO NON-PUBLIC INFORMATION

All persons authorized by FDA to work under this contract (contractor, subcontractors, consultants) are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form (see Section J – Attachment 1). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the contractor shall notify the COR and Contracting Officer/Specialist. Any new contractor, subcontractor, or consultant assigned to this contract shall sign the form and shall submit to the Contracting Officer/Specialist and COR within ten (10) days prior to commencement of any work under this contract.

The contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted by the Contracting Officer/Specialist.

The disclosure of any confidential information in violation of the agreement may be subject to civil or criminal sanctions.

Briefings

A FDA representative (typically, the COR) shall conduct an orientation briefing for the contractor/contractor employees. The briefing shall stress: (I) the importance of protecting non-public information; (2) specified computer/ADP requirements as outlined in the DHHS Automated Information Systems Security Program Handbook (copy of handbook available upon request); and (3) the consequences of unauthorized disclosure of non-public information.

Briefing updates shall be conducted annually.

The Contractor shall brief all employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of the responsibility to protect it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The Contractor shall conduct an updated briefing annually and shall submit a report to the COR within ten (10) days after the briefing which includes: an outline of the briefing, a copy of any briefing materials, date briefing was conducted and the names of the attendees.

H.2 HHSAR 352.270-10 - ANTI-LOBBYING (JANUARY 2006)

Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

SECTION I - CONTRACT CLAUSES

I.1 FAR 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/Specialist will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR – http://www.acquisition.gov/far and HHSAR - http://www.hhs.gov/oamp/policies/hssar.doc.

1. Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses

Reg Clause Date Clause Title

FAR 52.202-1 Jan-12 Definitions FAR 52.203-3 Apr-84 Gratuities FAR 52.203-5 Apr-84 Covenant Against Contingent Fees

FAR 52.203-6 Sep-06 Restrictions on Subcontractor Sales to the Government

FAR 52.203-7 OCT 2010 Anti-Kickback Procedures

FAR 52.203-8 Jan-97 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

FAR 52.203-10 Jan-97 Price or Fee Adjustment for Illegal or Improper Activity

FAR 52.203-12 Oct-10 Limitation on Payments to Influence Certain Federal Transactions

FAR 52.203-13 Apr-10 Contractor Code of Business Ethics and Conduct

FAR 52.203-14 Dec-07 Display Hotline Poster(s)

FAR 52.204-4 May-11 Printed or Copied Double-Sided on Recycled Paper

FAR 52.204-7 Feb-12 Central Contractor Registration

FAR 52.204-10 Feb-12 Reporting Executive Compensation and First-Tier Subcontract Awards

FAR 52.209-6 Dec-10

Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

FAR 52.215-2 Oct-10 Audit and Records – Negotiation

FAR 52.215-8 Oct-97 Order of Precedence - Uniform Contract Format

FAR 52.215-10 Aug-11 Price Reduction for Defective Cost or Pricing Data

FAR 52.215-12 Oct-10 Subcontractor Cost or Pricing Data

FAR 52.215-15 Oct-10 Pension Adjustments and Asset Reversions

FAR 52.215-18 Jul-05 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

FAR 52.215-19 Oct-97 Notification of Ownership Changes

FAR 52.215-20 Oct-10 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data

FAR 52.215-21 Oct-10 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications

FAR 52.216-5 Oct-97 Price Redetermination - Prospective

FAR 52.216-7 Jun-11 Allowable Cost and Payment modify paragraph (a) The words 31.2 and substitute 31.6

FAR 52.216-11 Apr-84 Cost Contract-No Fee

FAR 52.219-8 Jan-11 Utilization of Small Business Concerns

FAR 52.219-9 Jan-11 Small Business Subcontracting Plan

FAR 52.219-16 Jan-09 Liquidated Damages - Subcontracting Plan

FAR 52.222-2 Jul-90 Payment for Overtime Premiums FAR 52.222-3 Jun-03 Convict Labor FAR 52.222-21 Feb 99 Prohibition of Segregated Facilities FAR 52.222-26 Mar-07 Equal Opportunity

FAR 52.222-35 Sep-10

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

FAR 52.222-36 Oct-10 Affirmative Action for Workers with Disabilities

FAR 52.222-37 Sep-10

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

FAR 52.222-40 Dec-10 Notification of Employee Rights Under the National Labor Relations Act

FAR 52.222-50 Feb-09 Combating Trafficking in Persons FAR 52.222-54 Jan-09 Employment Eligibility Verification FAR 52.223-6 May-01 Drug-Free Workplace FAR 52.223-14 Aug-03 Toxic Chemical Release Reporting FAR 52.225-1 Feb-09 Buy American Act - Supplies

FAR 52.225-13 Jun-08 Restrictions on Certain Foreign Purchases

FAR 52.227-1 Dec-07 Authorization and Consent

FAR 52.227-2 Dec-07 Notice and Assistance Regarding Patent and Copyright Infringement

FAR 52.227-14 Dec-07 Rights in Data - General FAR 52.229-3 Apr-03 Federal, State and Local Taxes FAR 52.232-1 Apr-84 Payments FAR 52.232-8 Feb-02 Discounts for Prompt Payment

FAR 52.232-9 Apr-84 Limitation on Withholding of Payments

FAR 52.232-11 Apr-84 Extras FAR 52.232-17 Oct-10 Interest FAR 52.232-20 Apr-84 Limitation of Cost FAR 52.232-23 Jan-86 Assignment of Claims FAR 52.232-25 Oct-08 Prompt Payment

FAR 52.232-33 Oct-03 Payment by Electronic Funds Transfer--Central Contractor Registration

FAR 52.233-1 Jul-02 Disputes FAR 52.233-3 Aug-96 Protest After Award FAR 52.233-4 Oct-04 Applicable Law for Breach of Contract

Claim FAR 52.242-1 Apr-84 Notice of Intent to Disallow Costs

FAR 52.243-2 Aug-87 Changes – Cost Reimbursement Alternate II (Apr 1984)

FAR 52.245-1 Aug 10 Government Property FAR 52.246-25 Feb-97 Limitation of Liability - Services

FAR 52.249-4 Apr-84 Termination for Convenience of the Government (Services) (Short Form)

FAR 52.249-8 Apr-84 Default FAR 52.253-1 Jan-91 Computer Generated Forms

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR) (48 CFR Chapter 3) Contract Clauses

HHSAR 352.201-70 Jan-06 Paperwork Reduction Act

HHSAR 352.202-1 Jan-06 Definitions HHSAR 352.203-70 Jan-06 Anti-Lobbying

HHSAR 352.216-70 Jan-06 Additional Cost Principles

HHSAR 352.222.70 Jan-10 Contractor Cooperation in Equal Employment

HHSAR 352.233-71 Jan-06 Litigation and Claims

HHSAR 352.239-72 Jan-10

Security Requirements for Federal Information and Technology Accessibility

HHSAR 352.242-73 Jan-06 Withholding of Contract Payments

HHSAR 352.242-74 Apr-84 Final Decisions on Audit Findings

I.2 FAR CLAUSES IN FULL TEXT

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 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/Specialist may exercise the option by written notice to the Contractor prior to the expiration of the contract.

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor prior to expiration of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend 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 (5) years.

SECTION J - LIST OF ATTACHMENTS

The following attachments are attached to solicitation. They will not be re-issued with the resultant contract.

Attachment 1 Contract Pricing Format Attachment 2 SF LLL Disclosure of Lobbying Activities

Attachment 3 Invoice Request Information for FDA Cost Reimbursement Type Contracts

Attachment 1

Contractor’s Commitment To Protect Non Public Information (NP) Agreement

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

FOOO AND DRUG ADMINISTRATION

CONTRACTOR'S COMMITMENT TO PROTECT

NON-PUBLIC INFORMATION (NPI) AGREEMENT

Whereas access to non-public information (NPI) from the files of the Food and Drug Administration

(FDA) is required in the performance of my official duties, under Contract Number________________, and between FDA and my employer, ____________________________________________________

I, __________________________________, hereby agree that I shall not further release, publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U.S.C. § 3310),21 U.S.C. § 3600), 18 U.S.C, § 1905, as well as other applicable statutory and regulatory provisions.

Further, I agree to:

1. Store NPI in the secured offices of the FDA or in FDA approved contractor facility containers if work is performed off an FDA site.

2. Grant access to NPI only to known employees of the FDA or to other persons designated in writing by the FDA.

3. Return all NPI and any pertinent notes to the FDA Project Officer I am assigned to upon completion of the contract, or at any time upon the FDA's request.

4. Report in writing to the FDA Project Officer I am assigned to, all incidents in which unauthorized persons may have gained access to any NPI entrusted to me.

I understand the provisions of 21 U.S,C. § 331(j), 21 U.S.C. § 3600), 18 U.S.C. § 1905 and that I am subject to criminal penalties prescribed by law for any violation thereof.

Signature: ________________________________________ Date: _________________________

Type or Print Name: ________________________________________

Witnessed by: _____________________________________ Date: __________________________

Type or Print Name: ____________________________________________

Attachment 2 Contracting Pricing Format

CONTRACT PRICING FORMAT (example format)

(complete for each contract period of performance and a total for all periods, base and options)

NAME OF OFFEROR

HOME OFFICE ADDRESS

SUPPLIES AND/OR SERVICES TO BE FURNISHED

DIVISION(S) AND LOCATION(S) WHERE WORK IS TO BE

PERFORMED

TOTAL AMOUNT OF PROPOSAL

GOVERNMENT SOLICITATION NO.

DETAIL DESCRIPTION OF COST ELEMENTS

1. DIRECT MATERIAL (Itemize on separate sheet) EST.

COST($)

TOTAL

EST. COST

REFERENCE

a. PURCHASED PARTS

b. SUBCONTRACTED ITEMS

c. OTHER – (1) RAW MATERIAL

(2) YOU STANDARD COMMERCIAL ITEMS

(3) INTERDIVISIONAL TRANSFERS (AT OTHER THAN COST)

TOTAL DIRECT MATERIAL

2. MATERIAL OVERHEAD ( RATE %X$ BASE= )

3. DIRECT LABOR (Specify) ESTIMATED

HOURS

RATE/HOUR EST. COST ($)

TOTAL DIRECT LABOR

4. LABOR OVERHEAD (Specify Department or Cost Center) O.H. RATE X BASE= EST COST ($)

TOTAL LABOR OVERHEAD

5. SPECIAL TESTING (Including field work at Government installations) EST COST ($)

TOTAL SPECIAL TESTING

6. SPECIAL EQUIPMENT (If direct charge) (Itemize on separate sheet)

7. TRAVEL (If direct charge) (Give details on separate sheet) EST COST ($)

a. TRANSPORTATION

b. PER DIEM OR SUBSISTENCE

TOTAL TRAVEL

8. CONSULTANTS (Identify-purpose-rate) EST COST ($)

TOTAL CONSULTANTS

9. OTHER DIRECT COSTS (Itemize on separate sheet)

10. TOTAL DIRECT COST AND OVERHEAD

11. GENERAL AND ADMINISTRATIVE EXPENSE (Rate % of cost element Nos. )

12. ROYALTIES

13. TOTAL ESTIMATED COST

14. FEE OR PROFIT

15. TOTAL ESTIMATED COST AND FEE OR PROFIT

Attachment 3 SF LLL Disclosure of Lobbying Activities

DISCLOSURE OF LOBBYING ACTIVITIES Approved by OMB Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352 0348-0046 (See reverse for public burden disclosure.) 1.

Type of Federal Action: 2. Status of Federal Action: 3. Report Type: a. contract a.

bid/offer/application a. initial filing b. grant b. initial award b. material change c. cooperative agreement c.

post-award For Material Change Only: d. loan year _________ quarter _________ e. loan guarantee date of last report ______________ f. loan insurance 4. Name and Address of Reporting Entity: 5. If

Reporting Entity in No. 4 is a Subawardee, Enter Name and Address of Prime: Tier ______, if known: Congressional District, if known: Congressional District, if known: 6. Federal

Department/Agency: 7. Federal Program Name/Description: CFDA Number, if applicable:

_____________ 8. Federal Action Number, if known: 9. Award Amount, if known: $ 10. a. Name and

Address of Lobbying Registrant b. Individuals Performing Services (including address if (if individual, last name, first name, MI): different from No. 10a) (last name, first name, MI): 11. Signature:

Print Name: Title: Telephone No.: _______________________ Authorized for Local Reproduction Standard Form

LLL (Rev. 7-97) Information requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure of lobbying activities is a material representation of fact upon which reliance was placed by the tier above when this transaction was made or entered into. This disclosure is required pursuant to 31 U.S.C. 1352. This information will be available for public inspection. required disclosure shall be subject to a not more than $100,000 for each such failure. Prime Subawardee

Federal Use Only: Date: who fails to file the Any person $10,000 and than civil penalty of not less

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreementto make paymenttoanylobbyingentityforinfluencingorattemptingtoinfluenceanofficeroremployeeofanyagency,aMemberof Congress,anofficer oremployeeof Congress,oranemployeeofaMemberofCongressinconnectionwithacoveredFederalaction.Completeallitemsthatapplyforboththeinitialfili ng andmaterial change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.

1. Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

2. Identify the status of the covered Federal action.

3.

Identify the appropriateclassification of this report. If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

4.

Enterthefullname,address,city,Stateandzipcodeofthereportingentity.IncludeCongressionalDistrict,ifknown.Checktheappropriateclassif ication ofthereportingentitythatdesignatesif itis, orexpectstobe,aprimeorsubawardrecipient.Identifythetierof thesubawardee,e.g.,thefirst subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.

5. If the organization filing the report in item 4 checks "Subawardee," then enter the full name, address, city, State and zip code of the prime Federal recipient. Include Congressional District, if known.

6. Enter the name of the Federal agency making the award or loan commitment. Include at least one organizationallevel below agency name, if known. For example, Department of Transportation, United States Coast Guard.

7. Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

8.

Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number;

the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., "RFP-DE-90-001."

9. For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

10. (a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.

(b) Enter the full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (MI).

11. The certifying official shall sign and date the form, print his/her name, title, and telephone number.

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.

Attachment 4

Invoice Request Instructions for FDA Cost Reimbursement Type Contracts

General: The contractor shall submit claims for reimbursement in the manner and format described herein and as illustrated in the sample invoice request.

Format: Stand Form 1034, Public Voucher for Purchase and Services Other than Personal; and Standard Form 1035, Public Vouchers for Purchase and Services Other Than Personal—Continuation Sheet.

Number of Copies: As indicated in the Invoice Submission clause in the contract, an original and one copy.

Frequency: Invoices requests submitted in accordance with the payment clause shall be submitted monthly unless otherwise authorized by the Contracting Officer.

Cost Incurrence Period: Costs incurred must be within the contract performance period.

Preparation and Itemization of the Invoice Request: The Contractor shall furnish the information set forth in the notes below.

(a) Payor’s Name and Address: The paying office and address, identified in the Invoice Submission clause of the contract, shall be entered on all copies of the invoice request.

(b) Invoice/Financing Request Number: Insert the appropriate serial number of the invoice/financing request.

(c) Date Invoice/Financing Request Prepared: Insert the date the invoice/financing request is prepared.

(d) Contract Number and Date: Insert the contract number and the date of the contract.

(e) Payee's Name and Address: Show the Contractor's name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.

(f) Total Estimated Cost of Contract: Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount currently obligated and available for payment.

(g) Billing Period: Insert the beginning and ending dates (day, month, and year) of the period in which costs were incurred and for which reimbursement is claimed.

(h) Amount Billed for Current Period: Insert the amount billed for the major cost elements, adjustment and adjusted amounts for the period.

(i) Cumulative Amount from Inception to Date of this Billing: Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract.

(j) Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled Costs Requiring Prior Approval on page 1 of these instructions.

(1) Direct Labor: This consists of salaries and wages paid (or accrued) for direct performance of the contract.

(2) Fringe Benefits: This represents fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be identified here.

(3) Accountable Personal Property: This category of cost includes permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more and having an expected service life of more than two years, and sensitive property regardless of cost (see the DHHS Contractor's Guide for Control of Government Property.)

(4) Materials and Supplies: This category includes equipment with unit costs of less than $500 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

(5) Premium Pay: This is remuneration in excess of the basic hourly rate.

(6) Consultant Fee: Fees paid to…