B -- Copy Testing of Promotional Materials Directed to Consumers and Healthcare Professionals

This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide Copy Testing of Promotional Materials Directed to Consumers and Healthcare Professionals for the Food and Drug Administration (FDA).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. DDMAC 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 Division engages in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion; reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between DDMAC and other divisions within the FDA on promotional issues. The purpose of the contract is to provide DDMAC with the means to obtain, on an as-needed basis, reactions and interpretations regarding questions of immediate concern to the Division. Copy Test Studies 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 US population. Note that simple projection from a small panel sample is not sufficient. The contractor shall have the means to include individuals who may be economically or socially disadvantaged. In cases in which FDA is interested in testing consumers who have a relatively rare condition, a screening mechanism may be needed. Healthcare professional copy tests will use an Internet testing methodology with a sample projectable to the US population of the particular medical specialty of interest (e.g., family practitioners, OB-GYNs). The services required of the contractor are essentially those of sample selection, screening, and data collection on a national basis, with the capability of data collection via Internet administration. The contractor shall pretest and field up to an anticipated five copy tests per year over the five year contract period, using questionnaires developed by DDMAC. As copy tests shall be conducted in response to irregularly-occurring Agency needs, it shall be necessary for the contractor to have the capability to conduct tests on short notice and at irregularly-occurring intervals. The contractor will be required to: 1) identify and select samples of target audience respondents appropriate to the topic of each specific copy test; 2) develop Internet-ready materials, stimuli, and programming. Stimuli may be in audio, video or print format, as needed. This process may take multiple iterations before final work is approved.; 3) pretest and field the copy test via the Internet with a sample of target audience consumers or healthcare professionals to be approved by FDA; 4) code and enter data, including coding of open-ended questions; 5) deliver electronically to FDA a complete and edited data file compatible with SPSS version 16, including variable titles and value labels as well as other details to ease interpretation, and a methods report describing the sample, weighting, and other variables as needed. Contractors must submit a capability statement (five pages maximum) describing their company?s experience and ability to: 1. Conduct internet based experimental research, 2. Identify and select appropriate samples of consumers and healthcare professionals, including socially and economically disadvantaged consumers, 3. Produce internet-ready questionnaires and stimuli, 4. Provide data in SPSS compatible format, and 5. List prior experience with experimental research design and study implementation. An indefinite delivery indefinite quantity type contract is expected with a base year with four one year options. The NAICS code for this effort is 541990 with a size standard of $6.5 million. Interested offerors must provide (1) company?s name, mailing address, e-mail address, telephone and fax numbers, website address, and point of contact (2) a summary list of similar work previously performed or being performed; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel should be included; (4) if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages) (submit copies of any documentation such as letters or certificates to indicate the firm?s status); (5) DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). (6) Companies must be registered in the Central Contractor Registry (CCR at www.ccr.gov) to be considered as a potential source; (7) identification of the firm?s GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are requested and (8) if the company has a government approved accounting system, identify the agency that approved the system. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or indication the Government will contract for the work contained in this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow-up information requests. Responses to this announcement will not be returned, nor will there be any discussions or debriefings of any responses. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Responses must be sent to this notice no later than 4:00 p.m. eastern standard time on April 7, 2008 submitted by email, courier or U.S. Postal Service to the attention of Megan Gnall, Contracting Officer at the above stated address.