Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies such as the Food and Drug Administration (FDA) must obtain approval from the Office of Management and Budget Review (OMB) for each collection of information they conduct or sponsor. A “collection of information” includes an Agency’s request or requirement that members of the public submit reports, keep records, or provide information to a third party. The PRA requires Agencies to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment before submitting the proposed collection of information to OMB for review and clearance.
FDA announced in the July 6, 2020 Federal Register that it has asked OMB for a Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed. Techniques that would fall under the generic clearance include individual in-depth interviews, small group discussions, focus groups, and observations for collecting data on consumers’ perceptions, attitudes, motivations, and behaviors regarding food and cosmetic products, dietary supplements, and animal food and feed. The techniques are expected to yield information from stakeholders that will assist FDA in developing quantitative study proposals and will complement other research efforts. FDA proposes to submit a collection for approval under this generic clearance only if it meets the following conditions:
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The collections are voluntary;
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The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government;
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The collections are noncontroversial;
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Personally identifiable information (PII) is collected only to the extent necessary (for example, collections that collect PII to provide remuneration for participants of focus groups and cognitive laboratory studies) and is not retained;
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Information gathered will not be used for the purpose of substantially informing influential policy decisions; and.
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Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistical data or used as though the results are generalizable to the population of study.
FDA proposes to submit individual qualitative collections to the OMB for approval under this generic clearance with an abbreviated supporting statement and supporting documentation (e.g., a copy of the interview or moderator guide, screening questionnaire). Additionally, individual qualitative collections would also undergo review by FDA’s institutional review board, senior leadership in the Center for Food Safety and Applied Nutrition (CFSAN), and PRA specialists.
© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 188
