SOURCES SOUGHT
B -- The Influence of Brand and Principle Display Panel for Safe Consumer Use of Over the Counter Drugs - Sources Sought Notice
- Notice Date
- 4/24/2015
- Notice Type
- Sources Sought
- NAICS
- 541910
— Marketing Research and Public Opinion Polling
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1146395
- Archive Date
- 5/16/2015
- Point of Contact
- Christopher R. McGucken, Phone: (240) 402-7599
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- FDA-SS-1146395: Sources Sought Notice, PDF. The 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1146395/listing.html)
- Record
- SN03710696-W 20150426/150424235258-ecde0754390d532460f920edb011f2e6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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