Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2026-07501 · Docket No. FDA-2026-N-2917

Summary

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information which allows the submission of individual generic requests for obtaining qualitative data to support social and behavioral research for food, dietary supplements, cosmetics, and animal food and feed.

Dates

Either electronic or written comments on the collection of information must be submitted by June 16, 2026.

Supplementary Information

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed OMB Control Number 0910-0891—Extension OMB's Office of Information and Regulatory Affairs (OIRA) has issued memoranda that provides an overview of administrative flexibilities available to assist agencies in complying with their statutory obligations under the PRA. Among these flexibilities is use of a generic clearance for certain information collection activities. A generic clearance may be appropriate when (1) the need for the data collection can be evaluated in advance, as part of the review of the proposed plan, but (2) the Agency cannot determine the details of the specific individual collections until a later time. Generic clearances cover collections that are voluntary, low-burden, and uncontroversial. This generic clearance for certain information collection activities supports research conducted by FDA, as authorized under section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(D)), and is intended to help FDA's Human Foods Program (HFP) understand stakeholders' perceptions, attitudes, motivations, and behaviors. Understanding these perceptions, attitudes, motivations, and behaviors plays an important role in improving FDA's communications which impact various stakeholders and assists in the development of quantitative study proposals to complement other important research efforts in the Agency. To ensure that regulatory actions and communications activities have the highest potential to be received, understood, and accepted by those for whom they are intended, HFP and related FDA offices conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act (42 U.S.C. 241(a)). To ensure that communications activities have the highest effect, we conduct research and studies relating to the control and prevention of disease and the safety and health of the public. FDA is requesting OMB approval for the use of this generic collection of information that allows FDA to use qualitative social/behavioral science data collection techniques ( i.e., individual in-depth interviews (IDIs), small group discussions, focus groups, and observations) to better understand stakeholders' perceptions, attitudes, motivations, and behaviors regarding various issues associated with food, dietary supplements, cosmetics, and animal food and feed. Understanding these consumers', manufacturers', and producers' perceptions, attitudes, motivations, and behaviors plays an important role in improving FDA's communications that impact these various stakeholders and in assisting in the development of quantitative study proposals, complementing other important research efforts in the Agency. To obtain approval for an individual generic submission collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation ( e.g., a copy of the interview or moderator guide, screening questionnaire). Selection for potential respondents is done via a screening process to match the best possible respondent to each individual generic submission. Respondents to individual requests made under the generic clearance, once approved by OMB, may include a wide range of consumers and other FDA stakeholders, such as producers and manufacturers who are regulated under FDA-regulated food, dietary supplements, cosmetics, and animal food and feed. Participation is voluntary. We estimate the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Individual In-Depth Interview Screening 2,400 1 2,400 .08 (5 minutes) 192 Individual In-Depth Interviews 200 1 200 1 200 Focus Group/Small Group Participant Screening 5,400 1 5,400 .08 (5 minutes) 432 Focus Groups/Small Group Discussion 1,800 1 1,800 1.5 2,700 Observation Screening 720 1 720 .08 (5 minutes) 58 Observations 144 1 144 2 288 Total 10,664 3,870 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on both historical numbers of participants from past projects as well as estimates for projects to be conducted in the next 3 years. Based on a review of the information collection since our last request for OMB approval, we have adjusted our burden estimate based on actual usage of this collection of information and have decreased the number of responses and hours by half for these items, as listed in the first four rows in table 1. We have reduced our estimate for the number of responses from 19,600 to 9,800 responses (a decrease of 9,800 responses) and reduced the number of hours from 7,048 to 3,524 hours (a decrease of 3,524 hours) based on our experience conducting these collections of information. The total reduction in burden, therefore, is estimated as 9,800 responses and 3,524 hours. The new burden is estimated at 10,664 responses and 3,870 hours. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-07501 Filed 4-16-26; 8:45 am]