Document ID: FDA-2016-N-2683-0012
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-11-14T05:00Z

[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68173-68174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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:
     Obtaining useful 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).
    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