Notice2022-24693
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
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Published
November 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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 87 Issue 218 (Monday, November 14, 2022)</title>
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[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68173-68174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24693]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2683]
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 or Agency) 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 December 14, 2022.
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#d383819280a7b2b5b593b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="b2e2e0f3e1c6d3d4d4f2d4d6d39cdadac19cd5ddc4">[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 methods to
achieve these goals: (1) individual indepth interviews, (2) general
public focus group interviews, (3) intercept interviews, (4) self-
administered surveys, (5) gatekeeper surveys, and (6) 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 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).
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the
[[Page 68174]]
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.
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.
In the Federal Register of August 10, 2022 (87 FR 48665), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received. The first
comment was not responsive. The second comment requested that
participants be informed that participation is voluntary and can
withdraw at any time. Prior to beginning the interview and several
times throughout, participants are informed that their participation is
voluntary and that they can withdraw at any time. We believe no further
clarification to the survey instruments are necessary. The third
comment expressed concerns regarding the potential misuse of
information from the collection. We have previously outlined the scope
and purpose of the information collection, and we do not believe
further elaboration is necessary. Further, as outlined in the
supporting statement, all information collections must be non-
controversial, must not retain Personally Identifiable Information, and
``will not be used for substantially informing influential policy
decisions.''
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........ 109,470 1 109,470 0.25 (15 27,368
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 35,886 responses with a
corresponding increase of 8,972 hours. We attribute this adjustment to
an increase in funding and need to obtain additional information in
specific areas, particularly substance abuse (for example, opioids and
stimulants) and COVID-19. In addition, we attribute the increase in the
number of respondents (from 7,298 to 109,470) and decrease in the
number of responses per respondent (from 15 to 1) to an inadvertent
administrative error reflected in the 60-day notice. These changes,
however, do not impact the estimated total annual responses or burden
hours.
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24693 Filed 11-10-22; 8:45 am]
BILLING CODE 4164-01-P
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