FDA-RFP-1146395.pdf

PART I- THE SCHEDULE

SECTION A. SOLICIATION/CONTRACT FORM

Solicitation and Offer- Negotiated Acquisition, or Standard Form (SF 33) (see attachment

A)

SECTION B - SUPPLIES AND PRICES

B.1 SOLICITATION DESCRIPTION

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-83. The associated North American Industrial Classification System (NAICS) code for this procurement is 541910- Market Research and Public Opinion Polling.

B.2 CONTRACT TYPE

The government intends make award a Firm-Fixed Price Contract to no more than one (1) awardee.

B.3 PRICING

The Contractor shall provide services in accordance with the Statement of Work and Work Requirements at fixed rates.

Pricing Chart:

TASK Description Quantity Unit Price

Total Price

0001 Final Research Protocol 1

0002 Quarterly Reports 4

2001 Option Year 1: Quarterly Reports 4

2002 Option Year 1: Data Analysis 1

Total Firm Fixed Price

SECTION C – STATEMENT OF WORK

C.1 BACKGROUND

The Food and Drug Administration’s (FDA) Division of Nonprescription Drug Products (DNDP) is responsible for review of over-the-counter (OTC) drug products introduced both through new drug applications and the monograph process. DNDP works in collaboration with the Division of Medication Error Prevention and Analysis (DMEPA) around proprietary naming of new nonprescription drug products and assumes responsibility for approval of the final product package labeling that appears on them.

Particular concern has emerged with the practice of “umbrella branding,” a term that refers to commercial brand extensions common in over-the-counter drug applications. Umbrella branding provides a regulatory challenge for FDA because the application of well-known proprietary names may create safety issues when new products have different ingredients or changes to dosing, creating risk and benefit profiles that differ from those associated with the product consumers typically associate with the established name.

DNDP and DMEPA are interested in timely, expert research that will inform the best regulation of proprietary names and OTC package labeling. The needed research would provide secure evidence to inform ongoing regulatory action and future guidance development around OTC proprietary drug naming and principal display panel (PDP) presentation. Better evidence will aid in formulating policies and regulatory decisions that reduce consumer medical errors with OTC products. The generation of systematically collected and robust information on consumer reactions to labeling is also of broader interest to risk communication scientists across the Agency.

C.2. SCOPE OF WORK

This contract will provide for the conduct of health sciences research for Year 1 of a proposed two-year project. This research was designated as a priority by the Safety Research Interest Group (SRIG), a subcommittee within the Center for Drug Evaluation and Research tasked with the identification of drug-safety related research areas and allocating resources under the Critical Path Initiative. SRIG has guaranteed support for one year of study, with continuation of the project contingent on reporting and re-application for continued support. The contractor will interact with a research team led by social scientists and physicians in the Divisions noted above.

C.3. WORK REQUIREMENTS

C.3.1 STATEMENT OF WORK

Independently, and not as an agent of the Federal Government, the contractor shall provide all stated to include the following:

TASK 1: The Contractor shall conduct research investigating consumer understandings, comprehension, and choice carrying potential implications for medication use outcomes.

TASK 2: The work will test consumer performance on comprehension tasks, comparing a broad range of OTC labels and packaging in a branded condition with labels and packaging that carry no such identification.

TASK 3: The research design will incorporate formal testing procedures that provide rigorous, quantifiable measures of consumer performance with qualitative work that explores the meaning of consumer understandings and response, and investigates the context and dimensions of consumer performance and decision making.

TASK 4: The research will take into account variations in health literacy, ethnicity, socioeconomic status, age, and other variables that might condition motivation or ability to obtain information.

SECTION D - 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 via e-mail to:

[TBD]

The Contractor shall mark each shipment with the company name, the contract number, the item identification, quantity of items, and notice of partial or final delivery.

SECTION E - INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

This contract incorporates one or more provisions 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 Clause Description Date 52.246-4 Inspection of Services—Fixed-Price (Aug 1996)

SECTION F - DELIVERIES OR PERFORMANCE

All deliverables shall be delivered F.O.B Destination to the COR for acceptance.

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

52.242-15 STOP-WORK ORDER (AUG 1989)

F.1 ANTICIPATED DELIVERABLES/ DELIVERY SCHEDULE

Deliverables Task Due Date Final Research Protocol Finalize protocol for research, including plans for statistical and textual data analyses and all needed materials for Human Subjects review, aligning with existing FDA proposal and draft materials.

30 days ARO.

Quarterly Report(s) Report informing activities and progress made on the research project via written reports and teleconference with the COR. Upon agreement with PO, 2nd and 3rd Quarter reporting documents may be abbreviated to complement teleconferences.

3 months and 15 days ARO and every three months thereafter.

Addendum to reporting for Year 2 resubmission

Submission to complement 1st quarterly reporting, providing preliminary observations regarding feasibility of design and any needed modifications, unanticipated challenges or issues, and other perspectives to accompany preliminary submission for Year 2 funding.

With submission of first quarterly report.

Year 1 final report Report informing first year of study. This can may be incorporated in 4th Quarterly Report

One (1) Year ARO, with submission of final quarterly report.

Option Year One Quarterly Report(s) Reports informing activity, which may be abbreviated to accompany a meeting upon agreement with PO and investigators.

One Year 3 months

ARO.

Data analysis Completion of preliminary quantitative and One Year, 9 months http://www.acquisition.gov/far/index.html qualitative data analyses ARO.

Final Reporting Final reporting on study, providing recommendations regarding existing guidance on OTC display panels, proprietary naming and labeling. The report will include sections that anticipate draft manuscripts for publication including a report on quantitative testing, the qualitative component of research, and a policy or commentary piece on packaging, labeling, and proprietary naming.

Two (2) Years ARO, with final quarterly report.

F.2 PERIOD OF PERFORMANCE

The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.

The period of performance for Option Year 1, if exercised, shall begin one (1) year following the date of contract award.

F.3 LOCATION, WORK SCHEDULE AND TRAVEL

Unless otherwise directed, contractors will adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays.

F.4 SECURITY AND PRIVACY

It is not anticipated that the contractor will be exposed to sensitive Agency information or data.

But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer.

F.5 CONTRACTOR CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS,

POLICIES AND STANDARDS

The Contractor shall be responsible for knowledge of and compliance with all applicable federal laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo.

SECTION G - CONTRACT ADMINISTRATION DATA

G.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

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

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; 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: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

James Chestnut 5630 Fishers Lane Rockville, MD 20857 James.Chestnut@fda.hhs.gov

Tel: (240) 402-7570

The contact information for the Contract Specialist is:

Christopher McGucken

5630 Fishers Lane Rockville, MD 20857 Christopher.McGucken@fda.hhs.gov Tel: (240) 402-7599

G.3 INVOICE SUBMISSION

A. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Christopher McGucken, Contracting Specialist 5630 Fishers Lane Room 2130, HFA-500 Rockville, MD 20852

Email: Christopher.mcgucken@fda.hhs.gov

****Acceptable methods of delivery include: mail, hand delivery and email*****

(II) One copy to the contracting officer technical representative (COR), clearly marked “Courtesy Copy Only”:

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

10903 New Hampshire Ave Silver Spring, MD 20993-0002

Email: XXXXX@fda.hhs.gov

*****Acceptable methods of delivery include: mail, hand delivery and email*****

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price 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 purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of 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 Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

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

mailto:XXXXX@fda.hhs.gov

(a) List of all invoices submitted to date under the subject award, including the following: 1) Invoice number, Amount and Date Submitted; 2) Corresponding payment amount and date received.

(b) Total amount of all payments received to date under the subject contract or order.

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current active period of performance.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Office of Financial Services Food and Drug Administration W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

Final payments will occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of each task.

Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms. Payment will be made on a task order basis.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with Federal Acquisition Regulation (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 prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

mailto:fdavendorpaymentsteam@fda.gov

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) 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 IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 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, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by 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 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

PREPAID TRANSPORTATION/POSTAGE (OCT 1997) (IAW FAR 13.403(a)) "FAST PAY" items shall be shipped transportation or postage prepaid.

CONSIGNEE'S NOTIFICATION TO PURCHASING ACTIVITY OF NON-RECEIPT,

DAMAGE, OR NONCONFORMANCE (OCT 1997) (IAW FAR 13.403(c)) The consignee shall notify the purchasing office promptly after the specified date of delivery of supplies not received, damaged in transit, or not conforming to specifications of the purchase order. Unless extenuating circumstances exist, the notification should be made not later than 60 days after the specified date of delivery.

PART II- CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I.1 HHSAR CLAUSES INCORPORTATED BY REFERENCE

http://www.ppirs.gov/ http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm

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:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.201-70, PAPERWORK REDUCTION ACT (JAN 2006)

352.202-1, DEFINITIONS (JAN 2006)

352.203-70, ANTI-LOBBYING (JAN 2006)

352.215-70, LATE PROPOSALS AND REVISIONS (JAN 2006)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.223-70, SAFETY AND HEALTH (JAN 2006)

352.224-70, PRIVACY ACT (JAN 2006)

352.227-70, PUBLICATIONS AND PUBLICITY (JAN 2006)

352.228-7, INSURANCE—LIABILITY TO THIRD PERSONS (Dec 1991)

352.242-71, TOBACCO-FREE FACILITIES (JAN 2006)

352.242-73, WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

352.270-1, ACCESSIBILITY OF MEETINGS, CONFERENCES, AND SEMINARS TO PERSONS WITH

DISABILITIES (JAN 2001)

352.270-10 ANTI-LOBBYING (JAN 2006)

I.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html.

I.3 FAR CONTRACT CLAUSES

52.202-1 DEFINITIONS (NOV 2013)

(IAW FAR 2.201)

52.203-3 GRATUITIES (APR 1984)

(IAW FAR 3.202)

52.203-5 COVENANT AGAINST CONTINGENT FEES (MAY 2014)

(IAW FAR 3.404)

52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT (SEP 2006)

(IAW FAR 3.503-2)

http://www.hhs.gov/policies/hhsar/subpart301-1.html http://www.acquisition.gov/far/index.html

52.203-7 ANTI-KICKBACK PROCEDURES (MAY 2014)

(IAW FAR 3.502-3)

52.203-8 CANCELLATION, RESCISSION, AND RECOVERY OF FUNDS FOR ILLEGAL OR

IMPROPER ACTIVITY (MAY 2014)

(IAW FAR 3.104-9(a))

52.203-10 PRICE OR FEE ADJUSTMENT FOR ILLEGAL OR IMPROPER ACTIVITY (MAY 2014)

(IAW FAR 3.104-9(b))

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS

(OCT 2010)

(IAW FAR 3.808(b))

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO

INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)

(IAW FAR 3.908-9)

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON RECYCLED PAPER (MAY 2011)

(IAW FAR 4.303)

52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT

AWARDS (JUL 2013)

(IAW FAR 4.1403(a))

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (NOV 2014)

(IAW FAR 4.1804(c), FAR 12.301(d))

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS

(DEC 2014)

(IAW FAR 4.1202(b))

52.209-6 PROTECTING THE GOVERNMENT'S INTEREST WHEN SUBCONTRACTING WITH

CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT

(AUG 2013)

(IAW FAR 9.409)

52.215-2 AUDIT AND RECORDS--NEGOTIATION (OCT 2010)

(IAW FAR 15.209(b)(1))

52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZone SMALL BUSINESS

CONCERNS (OCT 2014)

(IAW FAR 19.1309(b))

(c) Waiver of evaluation preference.

__ Offeror elects to waive the evaluation preference.

52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS (MAY 2014)

(IAW FAR 19.708(a))

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013)

(IAW FAR 19.309(c))

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.222-3 CONVICT LABOR (JUN 2003)

(IAW FAR 22.202)

52.222-21 PROHIBITION OF SEGREGATED FACILITIES (APR 2015)

(IAW FAR 22.810(a)(1))

52.222-26 EQUAL OPPORTUNITY (APR 2015)

(IAW FAR 22.810(e))

52.222-35 EQUAL OPPORTUNITY FOR VETERANS (JUL 2014)

(IAW FAR 22.1310(a)(1), DFARS 222.1310(a)(1))

(a) Definitions. As used in this clause-- “Active duty wartime or campaign badge veteran,” “Armed Forces service medal veteran,” “disabled veteran,” “protected veteran,” “qualified disabled veteran,’ and “recently separated veteran” have the meanings given at FAR 22.1301.

(b) Equal opportunity clause. The Contractor shall abide by the requirements of the equal opportunity clause at 41 CFR 60-300.5(a), as of March 24, 2014. This clause prohibits discrimination against qualified protected veterans, and requires affirmative action by the Contractor to employ and advance in employment qualified protected veterans.

(c) Subcontracts. The Contractor shall insert the terms of this clause in subcontracts of $100,000 or more unless exempted by rules, regulations, or orders of the Secretary of Labor. The Contractor shall act as specified by the Director, Office of Federal Contract Compliance Programs, to enforce the terms, including action for noncompliance.

Such necessary changes in language may be made as shall be appropriate of identify properly the parties and their undertakings.

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES (JUL 2014)

(IAW FAR 22.1408(a))

(a) Equal opportunity clause. The Contractor shall abide by the requirements of the equal opportunity clause at 41 CFR 60.741.5(a), as of March 24, 2014. This clause prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by the Contractor to employ and advance in employment qualified individuals with disabilities.

(b) Subcontracts. The Contractor shall include the terms of this clause in every subcontract or purchase order in excess of $15,000 unless exempted by rules, regulations, or orders of the Secretary, so that such provisions will be binding upon each subcontractor or vendor. The Contractor shall act as specified by the Director, Office of Federal Contract Compliance Programs of the U.S. Department of Labor, to enforce the terms, including action for noncompliance. Such necessary changes in language may be made as shall be appropriate to identify properly the parties and their undertakings.

52.222-37 EMPLOYMENT REPORTS ON VETERANS (JUL 2014)

(IAW FAR 22.1310(b))

52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL LABOR

RELATIONS ACT (DEC 2010)

(IAW FAR 22.1605)

52.222-50 COMBATING TRAFFICKING IN PERSONS (MAR 2015)

(IAW FAR 22.1705(a)(1))

52.223-6 DRUG-FREE WORKPLACE (MAY 2001)

(IAW FAR 23.505)

52.223-18 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE

DRIVING (AUG 2011)

(IAW FAR 23.1105)

52.225-13 RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUN 2008)

(IAW FAR 25.1103(a))

52.227-1 AUTHORIZATION AND CONSENT (DEC 2007)

(IAW FAR 27.201-2(a)(1))

52.227-2 NOTICE AND ASSISTANCE REGARDING PATENT AND COPYRIGHT

INFRINGEMENT (DEC 2007)

(IAW FAR 27.201-2(b))

52.232-17 INTEREST (MAY 2014)

(IAW FAR 32.611(a), FAR 32.611(b))

52.232-23 ASSIGNMENT OF CLAIMS (MAY 2014)

(IAW FAR 32.806(a)(1))

52.232-25 PROMPT PAYMENT (JUL 2013)

(IAW FAR 32.908(c))

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the **** day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision. If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013)

(IAW FAR 32.706-3)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

(IAW FAR 32.009-2)

52.233-1 DISPUTES (MAY 2014)

(IAW FAR 33.215)

52.233-3 PROTEST AFTER AWARD (AUG 1996)

(IAW FAR 33.106(b))

52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM (OCT 2004)

(IAW FAR 33.215(b))

52.242-13 BANKRUPTCY (JUL 1995)

(IAW FAR 42.903)

52.244-5 COMPETITION IN SUBCONTRACTING (DEC 1996)

(IAW FAR 44.204(c))

52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS (APR 2015)

(IAW FAR 44.403)

52.246-25 LIMITATION OF LIABILITY--SERVICES (FEB 1997)

(IAW FAR 46.805(a)(4))

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

(IAW FAR 52.107(b)) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/dfars/dfartoc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/af_afmc/affars/affar1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference (hyperlink).

52.253-1 COMPUTER GENERATED FORMS (JAN 1991)

(IAW FAR 53.111)

PART III

SECTION J - LIST OF ATTACHMENTS

Attachment A: SF33

PART IV

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS OR QUOTERS

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (DEC 2014)

(IAW FAR 4.1202(a)) (a)(1) The North American Industry Classification System (NAICS) code for this acquisition is .

(2) The small business size standard is .

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in the System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[ ] (i) Paragraph (d) applies.

[ ] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless— http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/dfars/dfartoc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/af_afmc/affars/affar1toc.htm

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—Representation.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(viii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(ix) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(x) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xi) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xii) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternate I, II, and III) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $79,507, the provision with its Alternate II applies.

(D) If the acquisition value is $79,507 or more but its less than $100,000, the provision with its Alternate III applies.

(xviii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification.

This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transaction Relating to Iran—Representation and Certifications. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

_____ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(see note) (iii) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment -- Certification. ). (Note: If this clause is applicable it will be listed in the appropriate clause section of this document.)

__ (iv) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

(see note) (v) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only). (Note: If this clause and it’s Alternate I are applicable they will be listed in the appropriate clause section of this document.)

(vi) 52.227-6, Royalty Information.

__(A) Basic.

__ (B) Alternate I.

__(vii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM Web site accessed through https://www.acquisition.gov . After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause # Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (NOV 2014)

(IAW FAR 4.1804(b))

(b) The Offeror represents that it [ ] has or [ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates “has” in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code:________________________________________ Immediate owner legal name:_________________________________________ (Do not use a “doing business as” name) Is the immediate owner owned or controlled by another entity?:

[ ] Yes or [ ] No.

(d) If the Offeror indicates “yes” in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest level owner CAGE code:________________________________________ Highest level owner legal name:_________________________________________

(Do not use a “doing business as” name)

PART IV- REPRESENTATIONS AND INSTRUCTIONS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR

RESPONDENTS

52.204-7 SYSTEM FOR AWARD MANAGEMENT (JUL 2013)

(IAW FAR 4.1105(a)(1)) https://www.acquisition.gov/

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (NOV 2014)

(IAW FAR 4.1804(a), FAR 12.301(d))

52.215-1 INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION (JAN 2004)

(IAW FAR 15.209(a))

52.216-1 TYPE OF CONTRACT (APR 1984)

(IAW FAR 16.105)

The Government contemplates award of a (see individual line item) contract resulting from this solicitation.

52.233-2 SERVICE OF PROTEST (SEP 2006)

(IAW FAR 33.106(a))

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from (See page 1 Issuing Office).

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the

GAO.

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

(IAW FAR 52.107(a)) This solicitation incorporated one or more solicitation provisions 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.

The full text of a clause may be accessed electronically at this/these address(es): Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/dfars/dfar1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/af_afmc/affars/affar1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page conduct a search for the desired regulation reference, using your browser's FIND function. When located, click on the regulation reference (hyperlink).

L.1 OFFEROR RESPONSE DATES AND TIME

RFP Due Date: All proposals and revisions shall be submitted via email to Christopher.McGucken@fda.hhs.gov before 3:00PM Eastern Time on 30 July 2015.

Note: Late proposals will not be evaluated.

L.2 PROPOSAL INSTRUCTIONS

Note: Pursuant to FAR 52.215-1 (JAN 2004), subparagraph (f)(4), the Government intends to evaluate proposals and make awards without discussion with Offeror’s. Therefore, the Offeror’s initial proposal should contain the Offeror’s best terms from a price and technical standpoint.

However, the Government reserves the right to conduct discussions if the Contracting Officer determines they are necessary.

Format

Cover Letter http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/dfars/dfar1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/af_afmc/affars/affar1toc.htm mailto:Christopher.McGucken@fda.hhs.gov

The cover letter shall include; a POC (name and telephone number); a statement from the offeror verifying that they are SAM.GOV Registered.

Proposals shall be submitted in three separate volumes:

Volume I: Technical Volume II: Relevant Past Performance Volume III: Price

VOLUME I: TECHNICAL

The format of the technical volume should include the following sections, with maximum page limits as indicated:

Face Page – 1 Page Table of Contents – 1 Page Performance Sites -- 1 Page Research and Related – Other Project Information – 1 Page Project Summary / Abstract – 1 Page Public Health and Regulatory Science Relevance 1- Page Facilities and Other Resources – 2 Pages Equipment – 1 Page Biographical Sketches for Investigators and Staff (with Personal Statement, Positions and Honors, and Selected Publications)— As Needed; Individual Sketches should not exceed 5 Pages

Research Plan – 15 Pages Bibliography and References – As Needed

Letters of Support / Institutional Commitments – As Needed Additionally, the Offeror’s technical proposal must include information on the following evaluative criteria for technical capabilities, key personnel/facilities, and delivery.

Criterion 1: Technical Capabilities

1.1 Design, conduct, analyze, and report research. The offeror must demonstrate the capability to effectively design, conduct, analyze, and report health sciences research. The offeror should be capable of carrying out research of sufficient quality and rigor to inform FDA policy around issues of OTC labeling, packaging and proprietary naming. Offerors should also have the capacity to produce independent research that can withstand critical scrutiny from all stakeholders. Although the proposed work will not involve administration of active drug products, we expect the scientific level of the design, conduct, analysis, and presentation to meet the standards for peer-reviewed, clinical and health services studies. We encourage, but do not insist, that research be conducted in medical or health care facilities.

The offeror must include any examples of similar work experience and that demonstrate this capability, including any federal experience.

1.2 Develop complete protocol, schedule and budget. The proposal must demonstrate capability to develop a research plan taking into consideration all tasks, processes, and dimensions essential to carrying out a high-quality research project. The protocol, including schedule and budgeting, will describe research that can falsify hypotheses related to the effects of product branding and package presentation on consumer decisions about product choice, including tests of how varying presentations of pharmacologically equivalent products effect comprehension of labeled safety information. The protocol must also describe qualitative interviews and/or other elicitations that lead to a better understanding of consumer rationale for and cognition about choices and performance on study tests. The proposal must include examples of similar work experience demonstrating this capability, including any federal experience.

Criterion 2: Key Personnel and Facilities

2.1 Personnel The offeror’s research effort should be led by a principal investigator or investigators with demonstrated expertise in research on nonprescription drug labeling, patient and consumer safety issues in OTC drug use, and the social dimensions of drug safety, including but not limited to expert knowledge of issues surrounding health literacy.

Because this research will inform regulatory judgments that may be controversial, investigators with national and international standing in the specified domains of expertise would be highly desirable. The lead investigator for the contractor shall have attained a doctoral degree and the research team will be also be led or advised by a medical doctor with experience related to the specific research concerns.

The offeror must demonstrate a prudent allocation of staff resources to accomplish the research project and include examples of work experience substantiating this capability, including if the experience is related to a federal project. If any subcontractor is proposed, the proposal must provide the same information for the subcontractor. The offeror must also produce a letter of agreement with the subcontractor.

The offeror must give key personnel’s names, positions/titles, number of hours and percent of time to be spent on the research, describe the minimum qualifications required to work on the task, and demonstrate that the key personnel possess adequate professional qualifications to perform assigned functions. The proposal must include key personnel’s resumes indicating their experience and achievements, particularly related to projects similar to theproposed studies. If any subcontractor is proposed, the proposal must provide the same information as stated above for the subcontractor.

The offeror must also describe the availability, accessibility, or both of necessary personnel to facilitate pre-task consultations between the Government and the offeror and to ensure work on the task can begin within the time frame specified. If any subcontractor is proposed, the proposal must provide the same information as stated above for the subcontractor.

2.2 Facilities The offeror must provide documentation showing the offeror has access to facilities to ensure that work on the task can begin within a reasonable amount of time after an award. If any subcontractor is proposed, the proposal must provide the same information as stated above for the subcontractor.

The offeror must also provide documentation showing the offeror owns or has access to all equipment, communication facilities, hardware, and software needed to complete the research, including their type, general specifications, quantity, and availability. The proposal must include any examples of similar work experience demonstrating the availability, allocation, and use of such facilities. If any subcontractor is proposed, the proposal must provide the same information as stated above for the subcontractor.

The offeror must also describe the procedures and standards to ensure anonymity of participants and data confidentiality during data collection, transmission, and storage.

VOLUME II: REVELVANT PAST PERFORMANCE

The Offeror’s proposal shall include the following:

A minimum of three academic or corporate references from contracts with a similar scope and nature completed within the last three years will be evaluated.

VOLUME III: PRICE

Offeror’s shall provide pricing in section B.

The format of the Price Volume is suggested to include:

Budget – 5 Pages or Electronic Spread Sheet Personnel Justification – 1 Page Consortium, Sub-Contractor, or Advisory Justification – 1 Page

SECTION M - EVALUATION FACTORS FOR AWARD

EVALUATION CRITERIA FOR AWARD (OCT 1997) (IAW FAR 13.106-2(b), FAR 14.201-5(c), FAR 15.204-5(c))

M.1 EVALUATION CRITERIA

The Government’s source selection decision will be based on a Best Value Tradeoff process which incorporates the following factors: Technical, Relevant Past Performance and Price.

The Government will evaluate the Technical Proposal using the following adjectival rating. The Technical Proposal will receive an overall rating based on the criterion of technical capabilities, key personnel/facilities, and delivery weighted in descending order.

Adjectival Description

Exceptional Greatly exceeds all minimum requirements of the criteria; has a high probability of success; contains no weaknesses or deficiencies.

Good Exceeds all the minimum requirements of the criteria; has an above average probability of success; contains no significant weaknesses and only minor, correctable weaknesses exist.

Acceptable Meets all the minimum requirements of the criteria; has an average probability of success; no significant weaknesses and any deficiencies can be readily corrected.

Unacceptable Fails to meet any of the minimum requirements of the criteria; proposal needs major revisions; very low probability of success.

CRITERIA 2 – RELEVANT PAST PERFORMANCE .

Each reference will be evaluated against the information included in the past performance offeror.

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

Relevance of Experience: The Offeror’s experience will be evaluated on the degree of relevance to the requirement on the basis of similarity in size, scope, complexity, technical difficulty, contract type, and period of performance. Only recent experience will be evaluated.