Notice2024-30224
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 244 (Thursday, December 19, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#69393b283a1d080f0f290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="68383a293b1c090e0e280e0c094600001b460f071e">[email protected]</span></a>.
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:
<bullet> Obtaining useful, valid, and reliable information for the
development of variables and measures for formulating the basic
objectives of social and behavioral research and
<bullet> 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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