2024-00221. Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 qualitative data on tobacco products and communications.

DATES:

Either electronic or written comments on the collection of information must be submitted by March 11, 2024.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 11, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA–2014–N–0987 for “Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–3794, [e-mail].

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 the Collection of Qualitative Data on Tobacco Products and Communications

OMB Control Number 0910–0796—Extension

This information collection supports Food and Drug Administration (FDA, us, or we) programs. Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs.

In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research including but not limited to focus groups, usability and/or psychometric testing, indepth interviews (IDIs), cognitive interviews and asynchronous qualitative discussions ( e.g., online journaling or web-based discussion boards), naturalistic observation and ethnographic studies to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve four major purposes. First, foundational research will provide critical knowledge and insights about intended audiences. FDA must first understand people's knowledge of, perceptions of, and reactions to tobacco related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, formative research will provide information about people's responses, thoughts, and feelings regarding potential creative messaging, or stimuli. Third, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to communicate with intended audiences around tobacco prevention and cessation. Fourth, cognitive testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the intended audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, and interpret information gathered through this generic clearance to: (1) better understand characteristics of the intended audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies.

FDA is requesting approval of an extension of this generic clearance for collecting information using qualitative methods ( e.g., interviews, focus groups, asynchronous discussion boards, etc.) for studies involving all tobacco products regulated by FDA. This information will be used to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Qualitative research plays an important role in gathering information because it allows for an indepth understanding of individuals' attitudes, beliefs, motivations, and feelings. Qualitative research serves the narrowly defined need for direct and informal public opinion on a specific topic.

The number of respondents to be included in each new study may vary, depending on the nature of the study ( e.g., foundational, formative, etc.), approach (synchronous vs. asynchronous, or virtual vs. in person) and the intended audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the “Average Burden per Response” figures. FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Type of Interview	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
In-Person Individual Indepth Interviews	4,500	1	4,500	1	4,500
Indepth Interview Screener	22,500	1	22,500	0.083 (5 minutes)	1,875
Focus Group Screener	56,000	1	56,000	0.25 (15 minutes)	14,000
Focus Group Discussion	252,000	1	252,000	1.5	378,000
Discussion Board Screener	8,000	1	8,000	0.083 (5 minutes)	667
Discussion Board Participation	100	1	100	1.5	150
Total					399,192
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated burden for the information collection reflects an overall increase of 384,258 hours and a corresponding increase of 314,926 responses. We attribute this adjustment to the number of study responses used during the current approval and now estimated for the next 3 years. A greater number of qualitative studies will be conducted over the next 3 years due to the need to develop new creative messages and content. Recent years have seen a dramatic change in media. With the shift to digital media, FDA must adapt to communicate effectively in a digital environment. As digital tobacco use prevention/interventions are still in their infancy, we must better understand the types of digital channels available. To impact public health outcomes, we need to understand how to reach our intended audience. New foundational studies are needed (including those on digital metrics, measurement, and implementation). As a result, we have adjusted our burden estimate and revised the number of respondents to the information collection.

Dated: January 4, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.