88 FR 20 pgs. 6261-6262 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Monthly Monitoring Study
Type: NOTICEVolume: 88Number: 20Pages: 6261 - 6262
Pages: 6261, 6262Docket number: [Docket No. FDA-2022-N-0863]
FR document: [FR Doc. 2023-01978 Filed 1-30-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0863]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Monthly Monitoring Study
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by March 2, 2023.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The title of this information collection is "Monthly Monitoring Study." Also include the FDA docket number found in brackets in the heading of this document.
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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Monthly Monitoring Study
OMB Control Number 0910-NEW
This information collection supports the development and implementation of FDA public education campaigns related to tobacco use. To reduce the public health burden of tobacco use in the United States and educate the public-especially young people-about the dangers of tobacco use, FDA's Center for Tobacco Products (CTP) is developing and implementing multiple public education campaigns.
FDA launched "The Real Cost" in February 2014, seeking to reduce tobacco use among at-risk youth ages 12 to 17 years old in the United States who are open to smoking cigarettes and/or using electronic nicotine delivery systems (ENDS) products, or have already experimented with cigarettes and/or ENDS products. Given the rapidly evolving tobacco landscape in the United States, frequent and nimble data collection strategies are needed to keep pace and provide relevant information to FDA to inform its tobacco prevention media campaign development about changes in tobacco use and emerging products among youth and young adults.
In an effort to inform specified recommendations around "The Real Cost" and FDA's other public education programs to reduce tobacco-related death and disease, more research is needed to understand the trends in use and perceptions of novel and emerging tobacco products, as well as awareness and preferences related to emerging tobacco products and specific brands and device types so that FDA can develop new media campaign messages that resonate with youth and young adults. The purpose of the Monthly Monitoring Study is to collect primary data from youth and young adults, ages 15 to 24 years old, in the United States to monitor perceptions and use of emerging and novel tobacco products and emerging trends in brand and device awareness and use.
The study will be conducted using web-based surveys that are self-administered on personal computers or web enabled mobile devices. The study will use an online survey to collect data from up to 27,000 youth and young adults ages 15 to 24 years to monitor perceptions about and trends in use of ENDS and other emerging tobacco products. Participants will be recruited through social media advertisements. To achieve the required pace of data collection, the study will not contact parents of youth under 18 years old for parental permission and will obtain a waiver of parental permission from the institutional review board. The study will include questions about marijuana use to allow the study team to differentiate between use of current and emerging tobacco products and marijuana, which can be used in tobacco products such as ENDS and little cigar/cigarillos. The survey will take approximately 20 minutes to complete per participant. This survey will ask participants to provide feedback on tobacco use and quitting behavior, as well as brand and device preferences, tobacco information sources, peer influence and perceptions, and marijuana use.
The aim of the Monthly Monitoring Study is to answer the following questions:
• What are the trends in brand and device use for ENDS products and other emerging tobacco products among youth and young adults ages 15 to 24 years in the United States? What are their perceptions of these products?
• How is respondent tobacco use affected by environmental factors, including peer influence and other external factors such as COVID-19?
• What are the primary sources of new product information and where are these products purchased/acquired?
• What are the primary sources of health information for ENDS and other emerging tobacco products?
[top] In support of the provisions of the Family Smoking Prevention and Tobacco Control Act that require FDA to protect the public health and to reduce
In the Federal Register of July 26, 2022 (87 FR 44405), FDA published a 60-day notice requesting public comment on the proposed collection of information. One PRA related comment was received.
(Comment) The commenter stated that they believed the study should include children as young as age 10 years.
(Response) The age range for inclusion of this study (15 to 24 years) is based on the target audience for CTP/Office of Health Communication and Education's campaigns, which are adolescents and young adults. Additionally, we are limited by the social media mode of data collection (platforms generally do not allow children younger than 13 years old to have accounts) and by the Children's Online Privacy Protection Rule, which does not allow us to contact youth 13 years old and under without parental permission. Furthermore, lowering the age range would greatly increase the time needed to field the survey, as well as the costs. Given that parental permission is not feasible for the social media-based recruitment, we must be granted a waiver of parental permission from our institutional review board. Our institutional review board has not historically granted a waiver of parental permission for respondents younger than 15 years old.
FDA estimates the burden of this collection of information as follows:
| Type of respondent/activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Youth Screener | 135,000 | 1 | 135,000 | 0.04167 (2.5 minutes) | 5,625 |
| Youth Assent | 27,000 | 1 | 27,000 | 0.04167 (2.5 minutes) | 1,125 |
| Youth Online Survey | 27,000 | 1 | 27,000 | 0.33333 (20 minutes) | 9,000 |
| Young Adult Screener | 135,000 | 1 | 135,000 | 0.04167 (2.5 minutes) | 5,625 |
| Young Adult Consent | 27,000 | 1 | 27,000 | 0.04167 (2.5 minutes) | 1,125 |
| Young Adult Online Survey | 27,000 | 1 | 27,000 | 0.33333 (20 minutes) | 9,000 |
| Total | 31,500 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
We expect the screening process (2.5 minutes per response) to yield a 5 to 1 ratio of eligible participants. We will need to screen approximately 270,000 potential participants (135,000 youth and 135,000 young adults) over the study period. Participants determined to be eligible through the screener will complete a youth assent or young adult consent (2.5 minutes per response) and the online survey (20 minutes per response).
Over the course of the study period, we intend to survey approximately 1,500 youth ages 15 to 17 years old, and young adults ages 18 to 24 years old, every 1 to 2 months. The survey will be repeated with a new cross-sectional sample approximately every month or every other month over a period of 18 months. We will obtain a final sample size of 54,000 youth and young adults (27,000 youth and 27,000 young adults) over the course of the study period. Respondents will be allowed to complete an additional, cross-sectional survey after 6 months.
We made the following changes between the 30-day and 60-day publications: In reviewing recruitment metrics for two similar CTP studies, we found an average of 5:1 screening to survey completion ratio. Therefore, we adjusted the number of required screeners and burden hours accordingly.
Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01978 Filed 1-30-23; 8:45 am]
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