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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103841-103842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30224]

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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.

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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, 
[email protected].

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.
    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).

[[Page 103842]]

    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:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Interviews and Surveys........         126,770               1         126,770  0.25 (15                  31,693
                                                                                 minutes).
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\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]
BILLING CODE 4164-01-P
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