FBO_FDA1081735.pdf

Subject: Copy Testing of Messages in Direct-to-Consumer (DTC) Promotion of Prescription Drugs

Solicitation Number: FDA1081735

PART 1 – DESCRIPTION

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE

WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND

SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION;

QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE

ISSUED. THIS SOLICITATION IS BEING ISSUED USING FAR PART 13.5 PROCEDURES.

This solicitation is a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-49.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541910.

This is an RFQ for Marketing Research and Public Opinion Polling services. The requirement is set-aside for an 8(a) competitive acquisition as a result of this combined synopsis/solicitation that will include the terms and conditions that are set in PART 3.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

2. DESCRIPTION OF SUPPLIES & SERVICES

The FDA has a requirement for consultants to perform marketing research and public opinion polling services which includes analytical, evaluation and statistical analysis. The role of FDA’s Center for Drug Evaluation and Research (CDER) Division of Drug Marketing, Advertising and Communications (DDMAC) is to protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.

FDA has responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. The FDA engages in a variety of tasks to perform this responsibility, including, but not limited to: providing written comments to pharmaceutical sponsors on proposed promotional materials; reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are false or misleading; and acting as a liaison between the Center for Drug Evaluation and Research (CDER) and other divisions within FDA on promotional issues.

The purpose of this FDA acquisition is to acquire contractor support to assist with the copy testing studies that will provide FDA with the means to obtain, on an as-needed basis, reactions and interpretations regarding questions of immediate concern to the CDER.

2.1. It is anticipated that an indefinite delivery/indefinite quantity (IDIQ) contract will be awarded

2.2. Contract Type

2.2.1. IDIQ contract vehicle with the issuance of Fixed-Price task orders. Base year contract with four option years.

2.3. Pricing Terms

2.3.1. The pricing break-down is by the type of copy test (low to medium prevalence) for print and TV ads.

2.4. Minimum Amount Commitment

2.4.1. The IDIQ contract includes an initial obligation of funds in the amount of $10,000.00 to the awardee to cover the minimum order guarantee over the aggregate 5 year period.

2.5. Maximum Contract Ceiling

2.5.1. This is a single award; IDIQ Contract will have an overall ceiling price of $5.5 Million.

The maximum aggregate dollar value of the task orders awarded to the Contractors can not exceed the established contract ceiling.

CLIN Description of Services Quantity Unit Price Amount

Base Contract

1 Copy Tests: print ads, medium prevalence medical conditions 3 $ 2 Copy Tests: print ads, low prevalence medical conditions 3 $ 3 Copy Tests: TV ads, medium prevalence medical conditions 2 $ 4 Copy Tests: TV ads, low prevalence medical conditions 2 $

Total Amount for the base $

Option Year 1

5 Copy Tests: print ads, medium prevalence medical conditions 3 $ 6 Copy Tests: print ads, low prevalence medical conditions 3 $ 7 Copy Tests: TV ads, medium prevalence medical conditions 2 $ 8 Copy Tests: TV ads, low prevalence medical conditions 2 $

Total Amount for Option Year 1 $

Option Year 2

9 Copy Tests: print ads, medium prevalence medical conditions 3 $ 10 Copy Tests: print ads, low prevalence medical conditions 3 $ 11 Copy Tests: TV ads, medium prevalence medical conditions 2 $ 12 Copy Tests: TV ads, low prevalence medical conditions 2 $

Total Amount for Option Year 2 $

Option Year 3

13 Copy Tests: print ads, medium prevalence medical conditions 3 $ 14 Copy Tests: print ads, low prevalence medical conditions 3 $ 15 Copy Tests: TV ads, medium prevalence medical conditions 2 $ 16 Copy Tests: TV ads, low prevalence medical conditions 2 $

Total Amount for Option Year 3 $

Option Year 4

17 Copy Tests: print ads, medium prevalence medical conditions 3 $ 18 Copy Tests: print ads, low prevalence medical conditions 3 $ 19 Copy Tests: TV ads, medium prevalence medical conditions 2 $ 20 Copy Tests: TV ads, low prevalence medical conditions 2 $

Total Amount for Option Year 4 $ Total Amount for the Aggregate $

2.6. Definitions

2.6.1. The purpose of this section is to provide clarity in the usage with FDA words or terms that may have conflicting meanings in the commercial sector. The following words or terms will have the same meaning throughout this solicitation.

A code book provides information about the variables in a dataset, such as the type (for example, numeric), variable labels, and value labels.

Coding involves converting responses to open-ended questions into numbers that can be more easily counted and tabulated.

Confidentiality involves the protection of individually-identifiable data from unauthorized disclosures.

Cooperation rates measure the proportion of all respondents who participated in the study of all eligible units ever contacted.

Copy tests are simple experiments conducted with altered versions of existing print and television ads to test the messages in the ads.

Non-response bias occurs when the observed value deviates from the population parameter due to differences between respondents and non-respondents. Non-response bias may occur as a result of not obtaining 100 percent response from the selected cases.

Prevalence of a medical condition is the total number of people with the medical condition in the population at a given time.

Print format includes static versions of ads such as magazine ads, pamphlets, email solicitations, and internet pages. For example, these materials may be original hard copies, scanned copies, or JPEG files.

A survey pretest involves experimenting with different components of the questionnaire or survey design prior to full-scale implementation.

Programming involves the manipulation of questionnaires and stimuli into a format that is amenable to web survey use.

Random assignment involves using procedures to ensure that each respondent has the same opportunity to be assigned to any of the experimental conditions (in copy tests, any version of the ad).

Response rates measure the proportion of the sample frame that is represented by the respondents in each copy test.

Stimuli are the different versions of the ads that participants will view in copy tests.

Stock footage consists of existing photographs and videos that may be purchased for use.

The target audience is a group of individuals for whom a given advertisement would be relevant. For example, those at risk for or who have been diagnosed with high cholesterol would be the target audience for a prescription drug that lowers bad cholesterol.

The target population is any group of potential sample units or persons.

Video format includes non-static versions of ads such as TV ads and embedded website videos. For example, these materials may be DVD or MPEG files.

Weights are the inverse of the probability of selection in most probabilistic surveys and represent the probability that a respondent was selected into the sample from a population. Weights may be adjusted for non-response.

PART 3 – STATEMENT OF WORK

OBJECTIVES

FDA’s objective is to provide the FDA with the required resources to conduct copy tests of promotional materials with consumers that will meet the study objectives and specifications detailed below, and to do so within narrow time frames.

3. Technical Requirements:

3.1. Technical Approach

3.1.1. The contractor shall furnish the personnel, services, except as provided in the schedule, required for or incident to the performance of the work as described below. The contractor shall be prepared to develop a response to individual requests for task order proposals as set forth in PART 3.3 below.

3.2. Basic Requirements for All Copy Tests

3.2.1. The Contractor shall provide up to ten studies which shall be conducted as needed over a period of one year. We estimate that three will be print ads with medium prevalence medical conditions, three will be print ads for low prevalence medical conditions, two will be TV ads for medium prevalence medical conditions, and two will be TV ads for low prevalence medical conditions; however, the exact breakdown will depend on FDA needs identified throughout the year. The timing of the copy tests will be dictated by the needs of

FDA.

3.2.2. The Contractor shall provide studies that shall focus on target audience’s reactions to advertising materials provided by FDA. Consumer copy tests will use an internet testing methodology with a sample projectable to the target populations. In cases in which FDA is interested in testing consumers who have a lower prevalence medical condition, a screening mechanism may be needed.

3.2.3. The Contractor shall provide the following: stimuli construction, sample selection, and data collection on a national basis (with the capability of collecting data via internet administration), statistical analysis, and interpretation. The contractor shall pretest and field up to ten copy tests over the one year contract period, using questionnaires developed by FDA. As copy tests shall be conducted in response to irregularly-occurring FDA needs, it shall be necessary for the contractor to have the capability to conduct tests on short notice, at the same time, and at irregularly-occurring intervals. At a minimum, the FDA project officer will provide two calendar days notice of the requirement to commence work on a new copy test.

3.2.4. Stimuli construction

3.2.4.1. FDA will provide a pretest version of the questionnaire and stimuli for each copy test. The stimuli will be provided either in print format (for example, scanned copies or hard copies) or video format (for example, DVD or MPEG format). The original provided by FDA will be similar to materials that are available after publication or broadcast. The Contractor shall make the best representation of the materials possible to ensure that respondents view the stimuli as close as possible to the manner it is actually viewed when disseminated from the advertiser. The Contractor shall be responsible for making the questionnaire and stimuli internet-ready. The Contractor shall incorporate changes based on the pretest to produce the final copy test version of the questionnaire. A link to the final copy test version of the questionnaire shall be provided to FDA prior to fielding the copy test.

3.2.4.2. The Contractor shall be responsible for editing existing ads or creating new ads to be used for stimuli based on criteria set forth by FDA. The Contractor shall utilize stock photos or footage, computer graphics, and/or new photos or footage to create versions as specified by discussions with FDA. The set of basic tasks required includes creating or editing of sound and video tracks and graphics such as superimposed text (SUPERs). Following pretesting, the Contractor shall be responsible for editing these advertisements to emphasize or play down certain elements in the advertisements, such as adding or removing SUPERs, audio, or video.

3.2.5. Sample Selection

3.2.5.1. Respondents: The Contractor shall provide for the selection of participants to ensure that participants are representative of the appropriate populations. FDA will provide for each copy test a list of screening criteria for respondent selection—such as age group, gender, race, and education level as well as screener questions to ensure participants are able to read. Selected participants shall be randomly assigned to a test condition.

3.2.6. Data Collection

3.2.6.1. The Contractor shall conduct the experiment by randomly assigning the respondents to the test conditions, using the same questionnaire for all respondents.

Each copy test should last no more than fifteen minutes. The Contractor shall be responsible for acquiring reliable measurements of the time spent by participants in milliseconds on any particular screens as required by FDA. The questionnaire shall contain open-ended (for example, no more than 25% of questionnaire) and closed-ended questions. The Contractor shall have at least two (2) people manually code the responses to open-ended questions.

3.2.7. Confidentiality

3.2.7.1. The Contractor shall ensure the confidentiality for all respondents, and notification of anonymity of responses shall be provided to respondents. Once response editing and validation procedures are completed, respondents’ names and other identifying information shall be permanently dissociated from their responses before data for both the pretests and the full experiment are sent to FDA.

3.2.7.2. See Part 8 for Confidentiality Agreement.

3.2.8. Response Rate

3.2.8.1. The Contractor shall ensure a high response rate (for example, 80%). Response rate shall be calculated based upon standards as described in Standards and Guidelines for Statistical Surveys (OMB September 2006; available at http://www.whitehouse.gov/sites/default/files/omb/inforeg/statpolicy/standards_stat_s urveys.pdf). The contractor shall also perform a non-response bias analysis and provide the cooperation rate.

3.2.9. Weight adjustment

3.2.9.1. The Contractor shall be prepared to construct a weight for each completed interview so the total sample resembles the aggregate characteristics of the relevant population in (1) gender, (2) age, (3) education, and (4) race/ethnicity. The Contractor shall provide the population characteristics of the internet panel to FDA for each copy test.

3.2.10. Quality Control

3.2.10.1. The Contractor shall put in place procedures to ensure quality control, including quota tally sheets, random validation interviews, and daily feedback to identify problems and their resolution. The Contractor shall notify the project officer via email within 24 hours of any significant problems encountered.

3.2.11. Copy Test Procedures

3.2.11.1. The Contractor shall pretest and field the copy test with an FDA approved sample of target audience consumers. FDA will provide the criteria for the target audience with each copy test. Each copy test may have between two (2) to four (4) ads. Up to two (2) pretests shall be conducted for each copy test at the request of FDA. Each pretest shall include 25 target audience members per ad tested. Each of the copy tests shall require completed interviews from 100 target audience members per ad tested. People who participate in the pretest cannot participate in the copy test.

3.2.11.2. As discussed above, the Contractor shall:

3.2.11.3. Identify and select samples of target audience respondents appropriate to the topic of each specific copy test;

3.2.11.4. Develop internet-ready materials and program questionnaire for internet data collection (including editing stimuli provided by FDA);

3.2.11.5. Pretest and field the copy test via the internet with an FDA approved sample of target audience consumers from a panel approved by FDA;

3.2.11.6. Code and enter data, including manual coding of open-ended questions;

3.2.11.7. Document sample selection procedures, response rates, cooperation rates, and other methodologies undertaken.

3.2.11.8. Conduct statistical analyses (for example, frequencies, t-tests, ANOVAs) in consultation with FDA and with analysis plans provided by FDA;

3.2.11.9. Interpret and write up reports summarizing the methods and results of each copy test.

3.2.11.10. After base contract award, all Contractor clarifications at the task order level shall be addressed with the COTR prior to Contractor task order bilateral acceptance.

3.3. Staffing and Key Personnel

3.3.1. The key personnel specified in this contract are considered to be essential to work performance. At least 120 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 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. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

Project Manager

Task Responsibility

Manages multiple aspects of a single project and multiple projects at one time, including overseeing quality control. Communicates clearly and articulately in written and oral form. Assesses complex research questions, applies appropriate statistical and analysis plans, and interprets data.

Years of Experience Minimum requirements: A PhD in psychology, statistics, research methods, or related field or equivalent and extensive experience managing research projects similar to the statement of work.

Statistician

Task Responsibility

Plans data collection; analyzes and interprets numerical data from experiments, studies, surveys, and other sources; and applies statistical methodology to provide information for scientific research and statistical analysis. Presents results of statistical analyses in written reports.

Years of Experience Minimum requirements: A Master degree in statistics or equivalent and extensive professional experience providing statistical analysis support for projects similar to the statement of work.

PART 4 – DELIVERABLES

4. Deliverables shall be specified at the Task Order level.

4.1. Copy Test Type 1: Print Ad, Medium Prevalence Medical Condition

4.1.1. The Contractor supplied participants in this type of copy test will have medium prevalence medical conditions. Medium prevalence medical conditions are defined as those that are present in 5% to 10% of the US population. The particular characteristics of the respondents to be included in each study will be specified by FDA at the beginning of each copy test.

4.1.2. FDA will provide copies of the materials in print format, from which the contractor will make edits or changes as appropriate. The contractor is responsible for converting original materials into a format suitable for internet administration that maintains the integrity of the original materials.

4.1.3. See Part 3.2 for the procedures to be followed for each copy test.

4.1.4. The following timetable shall be observed for the completion of each copy test.

Table 1: Due dates for copy tests involving print ads and medium-incidence populations.

Deliverable/Action Due Date

Complete Package from FDA1 Day 1 Stimuli creation/editing complete Within 6 calendar days of complete package Internet programming complete Within 6 calendar days of complete package Pretest 1 data to FDA Within 4 calendar days of stimulus and programming completion FDA approval of revisions

Within 4 calendar days of data submission

Pretest 2 data to FDA2 Within 6 calendar days of FDA approval of revisions

FDA approval of revisions2

Final data Within 12 calendar days of FDA approval of pretest revisions

Draft report including methods, analyses, and interpretation in APA3 format

Within 24 calendar days of FDA approval of pretest revisions

Final report Within 5 calendar days of FDA response to draft report

4.1.5. Reports and Deliverables:

4.1.5.1. Stimuli: at least one electronic copy of all print stimuli created for the copy test.

1 Complete package from FDA includes 2 copies of print stimulus materials and electronic copy of questionnaire(s).

2 If necessary 3 American Psychological Association

4.1.5.2. Draft and Final Report: at least one electronic copy of a draft report and one electronic copy of the final report electronically in MS Word in APA (American Psychological Association) style (http://www.apastyle.org/) that includes:

4.1.5.2.1. Brief introduction to the experimental question.

4.1.5.2.2. Internet-panel description;

4.1.5.2.3. Sampling and weight report: Sampling procedures employed;

confidentiality/anonymity steps taken; incentives procedures; weight construction procedures (including SPSS syntax of the weight construction procedures as well as any other pertinent documentation);

4.1.5.2.4. Final dispositions of the sample including participation, response rate, and non-response bias analysis of refusers according to OMB standards as described in Standards and Guidelines for Statistical Surveys (OMB September 2006; available at:

http://www.whitehouse.gov/sites/default/files/omb/inforeg/statpolicy/standards_sta t_surveys.pdf), demographic data on non-responders, and population characteristics of the internet panel;

4.1.5.2.5. Questionnaire development and modification;

4.1.5.2.6. Data collection techniques, including randomization of assignment to experimental condition;

4.1.5.2.7. Any significant problems encountered during the project and solutions applied;

4.1.5.2.8. Data preparation and processing procedures;

4.1.5.2.9. Analysis plan

4.1.5.2.10. Analyses

4.1.5.2.11. Interpretation of the analyses

4.1.5.3. Data: Data files shall be prepared and delivered according to the following specifications for each pretest and main copy test:

4.1.5.3.1. One copy in SPSS format (compatible with FDA’s current version of SPSS;

currently FDA uses version 16) and one copy in ASCII format, to be delivered electronically and on compact disks (CDs) via mail to the project officer at FDA’s White Oak Campus, Silver Spring, MD;

4.1.5.3.2. Each record shall be uniquely identified and shall correspond to one respondent’s data;

4.1.5.3.3. All data values shall be numeric rather than character;

4.1.5.3.4. One (1) electronic copy of a finalized code book of variable names and definitions that match across pretest and copy test respondents.

4.2. Copy Test Type 2: Print Ad, Low Prevalence Medical Condition

4.2.1. Contractor supplied participants in this type of copy test will have low prevalence medical conditions. Low prevalence medical conditions are defined as those that are present in 1% to 5% of the US population. The particular characteristics of the respondents to be included in each study will be specified by FDA at the beginning of each copy test.

4.2.2. The FDA will provide copies of the materials in print format, from which the contractor will make edits or changes as appropriate. The contractor is responsible for converting original materials into a format suitable for internet administration that maintains the integrity of the original materials.

4.2.3. See Part 3.2 for the procedures to be followed for each copy test.

4.2.4. The following timetable shall be observed for the completion of each copy test.

Table 2: Due dates for copy tests involving print ads and low-incidence populations.

Complete Package from FDA4 Day 1 Stimuli creation/editing complete Within 6 calendar days of complete package Internet programming complete Within 6 calendar days of complete package Pretest 1 data to FDA Within 8 calendar days of stimulus and

Pretest 2 data to FDA5 Within 10 calendar days of FDA approval of

FDA approval of revisions4

Final data Within 18 calendar days of FDA approval of pretest revisions

Draft report including methods, analyses, and interpretation in APA6 format

Within 28 calendar days of FDA approval of pretest revisions

4.2.5. Reports and Deliverables:

4.2.5.1. Stimuli: at least one electronic copy of all print stimuli created for the copy test.

4.2.5.2. Draft and Final Report: at least one electronic copy of a draft report and one electronic copy of the final report electronically in MS Word in APA (American Psychological Association) style (http://www.apastyle.org/) that includes:

4.2.5.2.1. Brief introduction to the experimental question.

4.2.5.2.2. Internet-panel description;

4.2.5.2.3. Sampling and weight report: Sampling procedures employed;

confidentiality/anonymity steps taken; incentives procedures; weight construction procedures (including SPSS syntax of the weight construction procedures as well as any other pertinent documentation);

4.2.5.2.4. Final dispositions of the sample including participation, response rate, and non-response bias analysis of refusers according to OMB standards as described in Standards and Guidelines for Statistical Surveys (OMB September 2006; available at:

http://www.whitehouse.gov/sites/default/files/omb/inforeg/statpolicy/standards_sta t_surveys.pdf), demographic data on non-responders, and population characteristics of the internet panel;

4.2.5.2.5. Questionnaire development and modification;

4.2.5.2.6. Data collection techniques, including randomization of assignment to experimental condition;

4.2.5.2.7. Any significant problems encountered during the project and solutions applied;

4.2.5.2.8. Data preparation and processing procedures;

4.2.5.2.9. Analysis plan

4.2.5.2.10. Analyses

4.2.5.2.11. Interpretation of the analyses

4.2.5.3. Data: Data files shall be prepared and delivered according to the following

4 Complete package from FDA includes 2 copies of print stimulus materials and electronic copy of questionnaire(s).

5 If necessary 6 American Psychological Association

4.2.5.3.1. One copy in SPSS format (compatible with FDA’s current version of SPSS;

currently FDA uses version 16) and one copy in ASCII format, to be delivered electronically and on compact disks (CDs) via mail to the project officer at FDA’s White Oak Campus, Silver Spring, MD;

4.2.5.3.2. Each record shall be uniquely identified and shall correspond to one respondent’s data;

4.2.5.3.3. All data values shall be numeric rather than character;

4.2.5.3.4. One (1) electronic copy of a finalized code book of variable names and

4.3. Copy Test Type 3: TV Ad, Medium Prevalence Medical Condition

4.3.1. Contractor supplied participants in this type of copy test will have medium prevalence medical conditions. Medium prevalence medical conditions are defined as those that are present in 5% to 10% of the US population. The particular characteristics of the respondents to be included in each study will be specified by FDA at the beginning of each copy test.

4.3.2. The FDA will provide copies of the materials in video format, from which the contractor will make edits or changes as appropriate. The contractor is responsible for converting original materials into a format suitable for internet administration that maintains the integrity of the original materials.

4.3.3. See Part 3.2 for the procedures to be followed for each copy test.

4.3.4. The following timetable shall be observed for the completion of each copy test.

Table 3: Due dates for copy tests involving TV ads and medium-incidence populations.

Complete Package from FDA7 Day 1 Stimuli creation/editing complete Within 12 calendar days of complete package Internet programming complete Within 12 calendar days of complete package Pretest 1 data to FDA Within 4 calendar days of stimulus and

Pretest 2 data to FDA8 Within 6 calendar days of FDA approval of

FDA approval of revisions2

Final data Within 12 calendar days of FDA approval of pretest revisions

Draft report including methods, analyses, and interpretation in APA9 format

Within 24 calendar days of FDA approval of pretest revisions

4.3.5. Reports and Deliverables:

4.3.5.1. Stimuli: at least one copy on compact disk (CD) of all video stimuli created for the copy test.

7 Complete package from FDA includes 2 copies of video stimulus materials and electronic copy of questionnaire(s).

8 If necessary 9 American Psychological Association

4.3.5.2. Draft and Final Report: at least one electronic copy of a draft report and one electronic copy of the final report electronically in MS Word in APA (American Psychological Association) style (http://www.apastyle.org/) that includes:

4.3.5.2.1. Brief introduction to the experimental question.

4.3.5.2.2. Internet-panel description;

4.3.5.2.3. Sampling and weight report: Sampling procedures employed;

confidentiality/anonymity steps taken; incentives procedures; weight construction procedures (including SPSS syntax of the weight construction procedures as well as any other pertinent documentation);

4.3.5.2.4. Final dispositions of the sample including participation, response rate, and non-response bias analysis of refusers according to OMB standards as described in Standards and Guidelines for Statistical Surveys (OMB September 2006; available at:

http://www.whitehouse.gov/sites/default/files/omb/inforeg/statpolicy/standards_sta t_surveys.pdf), demographic data on non-responders, and population characteristics of the internet panel;

4.3.5.2.5. Questionnaire development and modification;

4.3.5.2.6. Data collection techniques, including randomization of assignment to experimental condition;

4.3.5.2.7. Any significant problems encountered during the project and solutions applied;

4.3.5.2.8. Data preparation and processing procedures;

4.3.5.2.9. Analysis plan

4.3.5.2.10. Analyses

4.3.5.2.11. Interpretation of the analyses

4.3.5.3. Data: Data files shall be prepared and delivered according to the following

4.3.5.3.1. One copy in SPSS format (compatible with FDA’s current version of SPSS;

currently FDA uses version 16) and one copy in ASCII format, to be delivered electronically and on compact disks (CDs) via mail to the project officer at FDA’s White Oak Campus, Silver Spring, MD;

4.3.5.3.2. Each record shall be uniquely identified and shall correspond to one respondent’s data;

4.3.5.3.3. All data values shall be numeric rather than character;

4.3.5.3.4. One (1) electronic copy of a finalized code book of variable names and

4.3.6. Copy Test Type 4: TV Ad, Low Prevalence Medical Condition

4.3.6.1. Contractor supplied participants in this type of copy test will have low prevalence medical conditions. Low prevalence medical conditions are defined as those that are present in 1% to 5% of the US population. The particular characteristics of the respondents to be included in each study will be specified by FDA at the beginning of each copy test.

4.3.6.2. The FDA will provide copies of the materials in video format, from which the contractor will make edits or changes as appropriate. The contractor is responsible for converting original materials into a format suitable for internet administration that maintains the integrity of the original materials.

4.3.6.3. See Part 3.2 for the procedures to be followed for each copy test.

4.3.6.4. The following timetable shall be observed for the completion of each copy test.

Table 4: Due dates for copy tests involving TV ads and low-incidence populations.

Complete Package from FDA10 Day 1 Stimuli creation/editing complete Within 12 calendar days of complete package Internet programming complete Within 12 calendar days of complete package Pretest 1 data to FDA Within 8 calendar days of stimulus and

Pretest 2 data to FDA11 Within 10 calendar days of FDA approval of

FDA approval of revisions4

Final data Within 18 calendar days of FDA approval of pretest revisions

Draft report including methods, analyses, and interpretation i

APA

n 12 format

Within 28 calendar days of FDA approval of pretest revisions

4.3.6.5. Reports and Deliverables:

4.3.6.6. Stimuli: at least one copy on compact disk (CD) of all video stimuli created for the copy test.

4.3.6.7. Draft and Final Report: at least one electronic copy of a draft report and one electronic copy of the final report electronically in MS Word in APA (American Psychological Association) style (http://www.apastyle.org/) that includes:

4.3.6.7.1. Brief introduction to the experimental question.

4.3.6.7.2. Internet-panel description;

4.3.6.7.3. Sampling and weight report: Sampling procedures employed;

confidentiality/anonymity steps taken; incentives procedures; weight construction procedures (including SPSS syntax of the weight construction procedures as well as any other pertinent documentation);

4.3.6.7.4. Final dispositions of the sample including participation, response rate, and non-response bias analysis of refusers according to OMB standards as described in Standards and Guidelines for Statistical Surveys (OMB September 2006; available at:

http://www.whitehouse.gov/sites/default/files/omb/inforeg/statpolicy/standards_sta t_surveys.pdf), demographic data on non-responders, and population characteristics of the internet panel;

4.3.6.7.5. Questionnaire development and modification;

4.3.6.7.6. Data collection techniques, including randomization of assignment to experimental condition;

4.3.6.7.7. Any significant problems encountered during the project and solutions applied;

4.3.6.7.8. Data preparation and processing procedures;

4.3.6.7.9. Analysis plan

10 Complete package from FDA includes 2 copies of video stimulus materials and electronic copy of questionnaire(s).

11 If necessary 12 American Psychological Association

4.3.6.7.10. Analyses

4.3.6.7.11. Interpretation of the analyses

4.3.6.8. Data: Data files shall be prepared and delivered according to the following

4.3.6.8.1. One copy in SPSS format (compatible with FDA’s current version of SPSS;

currently FDA uses version 16) and one copy in ASCII format, to be delivered electronically and on compact disks (CDs) via mail to the project officer at FDA’s White Oak Campus, Silver Spring, MD;

4.3.6.8.2. Each record shall be uniquely identified and shall correspond to one respondent’s data;

4.3.6.8.3. All data values shall be numeric rather than character;

4.3.6.8.4. One (1) electronic copy of a finalized code book of variable names and definitions that match across pretest and copy test respondents.

PART 5 – INSPECTION AND ACCEPTANCE

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

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

5.2. Inspection and acceptance will be performed at the location identified in Part 6. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or the COTR within 30 days of receipt.

5.3. Inspection of all stimuli will be conducted by the COTR or Alternative COTR.

5.3.1. Inspection of pretest data will take place within 4 calendar days of submission. For all other deliverables, inspection will take place within 7 calendar days of submission. If issues are discovered, the Contractor will have 5 calendar days to make corrections. All deliverables should be good quality work submitted on time and should meet all the requirements set forth in the Statement of Work. Major requirements for each deliverable are listed below.

5.3.2. Stimuli: For acceptance, stimuli should look and sound professional and each version should correspond to the requirements of the copy test.

5.3.3. Program: For acceptance, the program should display stimuli in such a way that participants can view it easily, include the full questionnaire with no errors, and capture all data necessary, including timing measures where indicated.

5.3.4. Pretest and final data: For acceptance, the pretest and final datasets should be SPSS data files, include all data from all participants, include coded responses to open-ended questions, and include clear and correct variable and value labels.

5.3.5. Draft and final report: For acceptance, the draft and final reports should be well-written (i.e., free of spelling and grammatical mistakes and typos, logical and clear) and include all of the sections (under “Reports and Deliverables”) set forth in the Statement of Work. The information contained within (e.g., response rates) should be accurate and verifiable.

PART 6 – DELIVERIES OR PERFORMANCE

6. DELIVERIES

6.1.1. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work in PART 3 of this contract and upon delivery and acceptance by the Contracting Officer, or the COTR, of the services, plans and reports required at the dates specified within PART 3 of this contract.

6.1.2. Deliveries of the reports are to be sent via email to the COTR’s address listed below:

Name.lastname@fda.hhs.gov

6.2. PERIOD OF PERFORMANCE

6.2.1. The period of performance for this contract shall be the effective date of contract for a base and four option years.

6.3. PLACE OF PERFORMANCE

6.3.1. The place of performance for this contract shall be at the contractor’s site.

PART 7 – CONTRACT ADMINISTRATION DATA

7. CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR)

7.1. The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award)

7.1.1. The COTR 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.

7.1.2. 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 the RFQ; (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.

7.1.3. The contact information for the Contracting Officer is:

David Kordel

5630 Fishers Lane Rockville, MD 20857

David.kordel@fda.hhs.gov

7.2. INVOICE SUBMISSION

7.2.1. In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration no later than 14 days prior to submission of the first invoice:

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

(I) One original to the Contracting Officer:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: David Kordel, Contracting Officer 5630 Fishers Lane Room 2095, HFA-500 mailto:David.kordel@fda.hhs.gov

Rockville, MD 20857 E-mail: david.kordel@fda.hhs.gov

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

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

U.S. Food and Drug Administration

ATTN: [INSERT NAME], COTR

10903 NEW HAMPSHIRE AVENUE

ROOM XXXX

Silver Spring, MD 20993 Email: xxxx.xxxx@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 other 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 high costs claimed;

(b) Itemized travel costs, including origin and destination;

(c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped to 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 the person to notify in the event of a defective invoice;

(IX) Taxpayer identification number (TIN);

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

(XI) Name and telephone number of the FDA Contracting Officer Technical Representative (COTR), as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is □ is not □ 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:

(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 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:

FDA/OC/OA/OFO/OFS

ATTN: Division of Payment Services 12345 Parklawn Drive, HFA-720 Rockville, MD 20857

301.827.3742 OR 866.807.3742

fdavendorpaymentsteam@fda.gov

7.2.2. Final payments will occur upon verification by the FDA COTR, noting acceptance of the work.

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

7.2.3.1. Payment will be made on a task order basis in accordance with the pricing matrix.

7.3. GOVERNMENT FURNISHED PROPERTY

7.3.1.1. If required, the FDA will provide any Government Furnished Property to the

Contractor at the Task Order level.

7.4. SECTION 508

7.4.1. Pursuant to the HHSAR clause at 352.270-19 incorporated into PART 3 of the underlying contract. The complete text of Section 508 Final Standards can be accessed at http:// www.access-board.gov/sec508/standards.htm. The standards applicable to this requirement will be identified in individual Task Order Statements of Work. The contractor must have knowledge of the 508 Standard when performing the work. The standards that may apply to the requirements are:

7.4.1.1. § 1194.21 Software applications and operating systems

7.4.1.2. § 1194.22 Web-based intranet and internet information and applications & notes.

7.4.1.3. § 1194.24 Video and multimedia products

7.4.1.4. § 1194.25 Self-contained, closed products

7.4.1.5. § 1194.26 Desktop and portable computers.

7.4.1.6. § 1194.31 Functional performance criteria

7.4.1.7. § 1194.41 Information, documentation, and support

PART 8 – SPECIAL CONTRACT REQUIREMENTS

8.1. This research is exempt from Office of Management and Budget (OMB) review, per the Paperwork Reduction Act 44 U.S.C. 35 § 3518:

‘‘§ 3518. Effect on existing laws and regulations ‘‘(a) Except as otherwise provided in this chapter, the authority of an agency under any other law to prescribe policies, rules, regulations, and procedures for Federal information resources management activities is subject to the authority of the Director under this chapter.

‘‘(b) Nothing in this chapter shall be deemed to affect or reduce the authority of the Secretary of Commerce or the Director of the Office of Management and Budget pursuant to Reorganization Plan No. 1 of 1977 (as amended) and Executive order, relating to telecommunications and information policy, procurement and management of telecommunications and information systems, spectrum use, and related matters.

‘‘(c)(1) Except as provided in paragraph (2), this chapter shall not apply to the collection of information— mailto:fdavendorpaymentsteam@fda.gov http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm

‘‘(A) during the conduct of a Federal criminal investigation or prosecution, or during the disposition of a particular criminal matter;

‘‘(B) during the conduct of— ‘‘(i) a civil action to which the United States or any official or agency thereof is a party; or ‘‘(ii) an administrative action or investigation involving an agency against specific individuals or entities;

‘‘(C) by compulsory process pursuant to the Antitrust Civil Process Act and section 13 of the Federal Trade Commission Improvements Act of 1980; or ‘‘(D) during the conduct of intelligence activities as defined in section 3.4(e) of Executive Order No. 12333, issued December 4, 1981, or successor orders, or during the conduct of cryptologic activities that are communications security activities.

‘‘(2) This chapter applies to the collection of information during the conduct of general investigations (other than information collected in an antitrust investigation to the extent provided in subparagraph (C) of paragraph (1)) undertaken with reference to a category of individuals or entities such as a class of licensees or an entire industry.

‘‘(d) Nothing in this chapter shall be interpreted as increasing or decreasing the authority conferred by Public Law 89–306 on the Administrator of the General Services Administration, the Secretary of Commerce, or the Director of the Office of Management and Budget.

‘‘(e) Nothing in this chapter shall be interpreted as increasing or decreasing the authority of the President, the Office of Management and Budget or the Director thereof, under the laws of the United States, with respect to the substantive policies and programs of departments, agencies and offices, including the substantive authority of any Federal agency to enforce the civil rights laws.

8.2. This research has been reviewed by FDA’s Research Involving Human Subjects Committee (RIHSC) and has received exemption (RIHSC# 10-125D).

8.2.1. Protection of Human Subjects (APR 2005)

A. All research conducted, supported, or regulated by any U.S. Government Agency is subject to certain uniform requirements of the Federal Policy for the Protection of Human Subjects including Institutional Review Board (IRB) membership, IRB review and approval criteria, IRB operations and record keeping, and informed consent. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees that research involving human subjects and funded by the FDA shall receive approval from FDA’s Research Involving Human Subjects Committee (RIHSC) prior to enrolling human subjects. The Contractor shall understand and comply with ethical principles and regulatory requirements involving human subjects research as specified in the Federal regulations for the Protection of Human Subjects, 45 CFR 46. The Contractor shall remain in compliance with the Health and Human Services (HHS) policies and procedures that concern the conduct of human subjects research.

B. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract in a proper manner and as safely as is feasible. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of FDA. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of FDA for acts of the Contractor or its employees.

C. If at any time during performance of this contract, the Contracting Officer determines, in consultation with FDA’s RIHSC, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing by the Contracting Officer. If the Contractor fails to complete the corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with FDA’s RIHSC, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved Department of Health and Human Services Human Subject Assurances.

PART 9 – CONTRACT CLAUSES

9. FAR CLAUSES INCORPORATED BY REFERENCE

9.1.…