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United States Food and Drug Administration

Generic Clearance for Qualitative Data to Support 
Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and 
Animal Food and Feed

OMB Control No. 0910-0891

SUPPORTING STATEMENT

Part A:  Justification:

    1. Circumstances Making the Collection of Information Necessary
This generic information collection supports research conducted by the Food and Drug Administration (FDA, the Agency), 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)).  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 Paperwork Reduction Act of 1995 (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 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.

This generic clearance is necessary to enable HFP to understand stakeholders’ perceptions, attitudes, motivations, and behaviors.  To ensure that communications activities have the highest effect, we will conduct research and studies relating to the control and prevention of disease and the safety and health of the public.  We intend to collect qualitative information that will be used to inform the regulatory science knowledge base, as well as to explore areas of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency.  The information gathered may also be used to help develop communications and educational messages related to public health. 

We therefore request extension of approval for the generic collection as discussed in this supporting statement, and administered in accordance with methodologies described in our supporting statement part B.

    2. Purpose and Use of the Information Collection 
Consistent with OMB communication on flexibilities under the PRA1 and the use of Generic Clearance, individual submission requests will be those we believe are low in burden, similar in nature, and do not raise any substantive or policy issues.  In conducting studies relating to the control and prevention of diet-related disease, foodborne illness and other adverse events related to food, dietary supplements, cosmetics, and animal food and feed, FDA will need to employ qualitative research to assess knowledge and perceptions about topics in the above-mentioned areas with specific target audiences.

Therefore, FDA will collect, analyze, and interpret information gathered through this generic clearance in order to: (1) gain an in-depth understanding of a pertinent research area and topic; (2) better understand characteristics of the target audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, and materials directed to consumers and industry; (3) more efficiently and effectively design survey/research questions and study stimuli; and (4) more efficiently and effectively design experimental studies; and 
FDA will only submit a collection for approval under this generic clearance if it meets the following conditions:   
    • The collections are voluntary;
    • 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;
    • The collections are noncontroversial; 
    • Personally identifiable information (PII) is collected only to the extent necessary2 and is not retained;
    • Information gathered will not be used for substantially informing influential policy decisions;3 and
    • 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. 
 
To obtain approval for a 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).
The types of collections that this generic clearance covers include, but are not limited to:
    • Individual in-depth interviews (IDIs)
    • Focus Groups 
    • Small Group Discussions 
    • Observations 

    3. Use of Improved Information Technology and Burden Reduction
Consideration will be given to collecting information electronically or using online collaboration tools to reduce burden.  Therefore, approximately 85 percent of these information collections will be completed electronically.  To facilitate interpretation, discussions are recorded and videotaped (when appropriate) so that both a visual record and written transcript of the discussion are available for review.
    4. Efforts to Identify Duplication and Use of Similar Information 
As each new research study is developed, FDA will review existing literature and databases, including pretesting reports on existing messages and materials.  FDA will also consult with outside experts to evaluate available information on similar messages with comparable audiences.  FDA will work with other HHS agencies responsible for communicating about food, dietary supplements, cosmetics, and animal food and feed with the general public. 
However, because communications to consumers, surveys, and studies about food, dietary supplements, cosmetics, and animal food and feed will be diverse and vary by target audience, new data collection instruments generally will be prepared for each qualitative study.  
Therefore, data collected by FDA is unique.  Coordination with other agencies ensures that duplicative data is not being gathered.  Further, with each new qualitative data collection, FDA will ensure that no similar data are gathered or maintained by FDA or are available from other sources known to FDA.  We are unaware of duplicative information collection.
    5. Impact on Small Businesses or Other Small Entities
Small businesses, or other small entities, may be involved in efforts related to collections of information approved under this clearance.  However, FDA will minimize the effect and burden on them by sampling appropriately.
    6. Consequences of Collecting the Information Less Frequently
Qualitative information is often used as a first step to explore concepts of interest and assist in the development of quantitative study proposals.  The collection of timely data will be important to the development and conduct of ongoing and future research efforts at the Agency.  Without feedback about consumer knowledge and perceptions, FDA will not have timely information to adjust its survey/research questions, study stimuli, and draft communication messages. 
Qualitative research methods may also be used to help develop materials directed at consumers and industry.  FDA is using a variety of messages and materials to inform and educate the public about food, dietary supplements, cosmetics, and animal food and feed.  Communicating effectively on these topics involves conveying complex concepts, and without detailed data from qualitative testing, FDA cannot fully ensure that these messages and materials directed at consumers are serving their intended purpose.  Thus, without qualitative testing, FDA could spend a large amount of money on communications, surveys, or other studies that are ineffective in achieving the intended purpose of reducing costs to people’s lives and to the government.
    7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.  The information collected will be voluntary and will not be used for statistical purposes.
    8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment on the proposed collection of information in the Federal Register of April 17, 2026 (91 FR 20693).  No comments were received. 
    9. Explanation of Any Payment or Gift to Respondents
It is standard practice in commercial market research to offer recruited participants some form of remuneration for the time they spend engaged in a personal interview activity.  Instances for offering a small incentive will be determined on a case-by-case basis (depending on the information collection design).  Incentive amounts will vary by type of qualitative method, the market rate of the geographic location for in-person research, and the difficulty of the recruitment.  Incentive amounts for information collections with general consumers submitted under this generic will typically not exceed $75, though more may be requested for difficult-to-recruit populations.  Details and justification on each incentive request will be included in each individual submission.
    10. Assurance of Confidentiality Provided to Respondents
Privacy Act

In preparing this supporting statement, we consulted our Privacy Office to ensure appropriate identification and handling of information collected. 

This ICR will collect personally identifiable information (PII).  PII collected typically consists of name and contact information.  PII is collected on behalf of the FDA by a contractor or vendor who conducts surveys.  Only the contractor conducting the research will have access to PII.  Information collected by the vendor or contractor will be summarized into aggregate form, sent in aggregate to FDA (no PII will be included), and destroyed after the study or interview has been completed.  Collected PII is used for scheduling and renumeration purposes.  All information collected will be kept secure by the vendor or contractor.  FDA and any vendor or contractor will disclose identifiable information only to the extent authorized by the individual or required by law.  Contractors or vendors maintaining information will destroy it in accordance with applicable records retention and other requirements per contract terms after the aggregate information has been provided to FDA and the survey has been completed.  In keeping with IRB/Human Subjects Research protocols, the FDA clearance process ensures that study data is appropriately secured (e.g., housed on the contractor’s servers, password protected, separate storage areas for each study, access controlled).

FDA determined that although PII is collected, it is not subject to the Privacy Act of 1974, and the particular notice and other requirements of the Act do not apply.  Specifically, the contractor does not use name or any other personal identifier to retrieve records from the information collected.

Freedom of Information Act (FOIA)

Under FOIA (5 U.S.C. 552), the public has broad access to government documents.  However, FOIA provides certain exemptions from mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9)).  FDA will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information. 

    11. Justification for Sensitive Questions
There are no expectations that the individual projects will contain sensitive questions, but if they do, we will include a justification for them in the individual submission.

    12. Estimates of Annualized Burden Hours and Cost
12a.  Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden1
Type of Interview
No. of Respondents
No. 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 the first four rows in Table 1 with the other rows remaining the same.  For the first four rows, 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.

12b.  Annualized Cost Burden Estimate

The general public will complete the majority of data collections.  The average hourly compensation rate for the general public is estimated to be equivalent to a Federal Government employee at the GS-9, step-1 level in the locality pay area of Washington-Baltimore in 2026, which is $33.84.  To account for any overhead, we have doubled the wage rate to $67.68 to determine the cost to the potential respondents.  The estimated annualized cost for the general public for 3,870 hours of reporting time is $261,921.60 ($67.68 × 3,870 hours).  The number of participants and length of response are based on FDA prior experience with communications testing and an estimate of the communication needs of HFP.  The actual cost will vary depending upon the topic of interest.

Table 2.--Estimated Annual Cost Burden
Type of Interview
Total Burden Hours
Average Rate
Total Participant Cost
Individual In-Depth Interview Screening
192
$67.68
$  12,994.56
Individual In-Depth Interviews
200
$67.68
$  13,536.00
Focus Group/Small Group Participant Screening
432
$67.68
$  29,237.76
Focus Groups/Small Group Discussion
2,700
$67.68
$182,736.00
Observation Screening
58
$67.68
$    3,925.44
Observations
288
$67.68
$  19,491.84
Total
$261,921.60

    13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs 

There are no capital, start-up, operating, or maintenance costs associated with this information collection.

    14. Annualized Cost to the Federal Government
FDA incurs costs to conduct qualitative research, including potentially hiring a contractor to provide a facilitator/moderator, rent meeting space, travel to conduct the groups, and provide participants with minimum payment cost in the form of a token stipend.  
Costs will include contractor expenses for designing and conducting information collection activities, specifically, drawing samples, training interviewers, collecting and analyzing information, and reporting findings.  Contractor expenses may vary from $20,000-$250,000 depending on the size of the study.  Therefore, in a given year, it is anticipated that approximately $1 million in contractor expenses will be expended to fund at least two large-scale studies and eight smaller-scale studies.

In addition, government staff costs may be incurred for monitoring by the government Project Officer and Senior Analyst, projected to be about 25 percent of the FTEs’ time per year (522 hours).  Given FDA personnel cost for a GS-13, step 1 in the locality pay area of Washington-Baltimore for 2026 is $ 58.35 per hour and doubling this to $116.70 per hour to account for overhead, $60,917.40 would be spent annually on government staff salaries ($116.70 × 522 hours).

The total estimated annual cost to the government for this collection of information is $1,060,917.40, which is equal to the total of contractor expenses ($1 million) plus FDA government staff personnel cost ($60,917.40).

    15. Explanation for Program Changes or Adjustments
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 the first four rows in Table 1 with the other rows remaining the same.  For the first four rows, 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 over the past three years.  The new burden is estimated at 10,664 responses and 3,870 hours.

Table 3.--Changes or Adjustments to Burden Estimates
Activity
Previously Approved Annual Burden Hours
Proposed Annual Burden Hours
Difference (Hours)
(+/-)
Rationale for Change
(Estimate Revision/Programmatic)
Individual In-Depth Interview Screening
384
192
-192
Adjustment based on past usage.
Individual In-Depth Interviews
400
200
-200
Adjustment based on past usage.
Focus Group/Small Group Participant Screening
864
432
-432
Adjustment based on past usage.
Focus Groups/Small Group Discussion
5,400
2,700
-2,700
Adjustment based on past usage.
Total
7,048
3,524
-3,524


    16. Plans for Tabulation and Publication and Project Time Schedule
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be statistically generalized to the overall population.  Findings will be used to inform experimental research, public education, or communication activities.
Although FDA does not intend to publish its findings, FDA may receive requests to release the information (e.g., congressional inquiry, FOIA requests).  FDA will disseminate the findings when appropriate, strictly following FDA’s “Guidelines for Ensuring the Quality of Information Disseminated to the Public,” and will include specific discussion of the limitation of the qualitative results discussed above.
It is not appropriate to treat focus group data as quantifiable.  FDA will disseminate focus group findings only when appropriate and will include specific discussion of the limitations of focus group results with regard to being non-quantitative.  Information quality encompasses (1) utility, the usefulness of the information to its intended users, including the public; (2) objectivity, whether information is being presented in an accurate, clear, complete, and unbiased manner; and (3) integrity, the information is protected from unauthorized access or revision.  FDA uses a number of mechanisms to ensure the quality of the information we disseminate.  FDA reviews the quality of information before it is disseminated and treats information quality as integral to every step of the development of information, including its creation, collection, maintenance, and dissemination.
    17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not requesting an exemption from this requirement.  The OMB expiration date will be displayed.
    18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.