89 FR 244 pgs. 103841-103842 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Type: NOTICEVolume: 89Number: 244Pages: 103841 - 103842
Pages: 103841, 103842Docket number: [Docket No. FDA-2024-N-1055]
FR document: [FR Doc. 2024-30224 Filed 12-18-24; 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-2024-N-1055]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA, us, or we) 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 January 21, 2025.
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 OMB control number for this information collection is 0910-0847. 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.
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
OMB Control Number 0910-0847-Extension
This information collection is intended to support FDA-conducted research. Understanding patients, consumers, and healthcare professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decision-making processes and communications that affect various stakeholders. FDA uses the following methodology to achieve these goals: (1) creation and validation of survey instruments; (2) use of techniques to evaluate sampling and recruitment methods; (3) evaluation of the validity and reliability of survey instruments; (4) individual in-depth interviews, (5) general public focus group interviews, (6) intercept interviews, (7) self-administered surveys, (8) gatekeeper surveys, and (9) focus group interviews. These methods serve the narrowly defined need for direct and informal opinion on a specific topic and serve as a qualitative and quantitative research tool having two major purposes:
• Obtaining useful, valid, and reliable information for the development of variables and measures for formulating the basic objectives of social and behavioral research and
• Successfully communicating and addressing behavioral changes with intended audiences to assess the potential effectiveness of FDA communications, behavioral interventions, and other materials.
[top] While FDA will use these methods to test and refine its ideas and help develop communication and behavioral strategies research, the Agency will generally conduct further research before making important decisions (such as adopting new policies and allocating or redirecting significant resources to support these policies).
FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research, Office of the Commissioner, and any other Centers will use this mechanism to test communications and social and behavioral methods about regulated drug products on a variety of subjects related to consumer, patient, or healthcare professional perceptions, beliefs, attitudes, behaviors, and use of drug and biological products and related materials. These subjects include social and behavioral research, decision-making processes, and communication and behavioral change strategies.
Further, in addition to overseeing the safety of drug products when used according to approved drug labeling or as directed by a healthcare provider, CDER conducts studies on topics related to the safe and effective use of drug products, and emerging safety issues in areas such as: (1) nonmedical use of approved drug products; (2) use of unapproved and falsified ( i.e., counterfeit, fake) drug products; (3) use of botanical substances ( e.g., cannabis derived products); (4) controlled substance prescribing decisions; (5) bystander response to drug overdoses; and (6) potentially false or misleading information about drug products. Reliable data on these and related topics are a critical first step to understanding whether further studies or action is needed to protect public health.
Because often data on these topics are not collected as part of routine healthcare delivery or via established Federal surveys, FDA requires the development and validation of novel instruments ( i.e., interview and focus group guides, questionnaires) and approaches to gathering data on emerging safety issues the methods used to create and validate these instruments may include interviews, focus groups, small group discussions, pilot and test/re-test survey launches, and external validation against benchmark surveys. In conducting research in these areas, FDA will need to employ the following validation methodology: (1) research to assess knowledge, perceptions, and experiences related to topics in the above-mentioned areas with specific target populations; (2) techniques to evaluate sampling and recruitment methods; and (3) evaluations of the validity and reliability of survey questionnaires in target populations.
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 23, 2024 (89 FR 30381). Although one comment was received, it was not responsive to the four collection of information topics solicited and therefore will not be discussed in this document.
Annually, FDA projects about 25 social and behavioral studies using the variety of test methods listed in this document. FDA is revising this burden to account for the number of studies we have received in the last 3 years and to better reflect the scope of the information collection.
FDA estimates the burden of this collection of information as follows:
| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Interviews and Surveys | 126,770 | 1 | 126,770 | 0.25 (15 minutes) | 31,693 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on a review of the information collection since our last request for OMB approval, our burden estimate for this information collection reflects an overall increase of 17,300 responses with a corresponding increase of 4,325 hours. We attribute this adjustment to the need to validate information in specific areas.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30224 Filed 12-18-24; 8:45 am]
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