[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30381-30383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1055]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a generic clearance to collect 
information to support social and behavioral research used by FDA about 
drug products.

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 24, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 24, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 30382]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2024-N-1055 for ``Agency Information Collection Activities; Proposed 
Collection; Comment Request; Data To Support Social and Behavioral 
Research as Used by the Food and Drug Administration.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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).
    FDA's Center for Drug Evaluation and Research, 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.

[[Page 30383]]

    Further, in addition to overseeing the safety of drug products when 
used according to approved drug labeling or as directed by a healthcare 
provider, the Center for Drug Evaluation and Research (CDER) conducts 
studies on topics related to the safe and effective use of drug 
products, and emerging safety issues in areas such as nonmedical use of 
approved drug products, use of unapproved and falsified (i.e., 
counterfeit, fake) drug products, use of botanical substances (e.g., 
cannabis derived products), controlled substance prescribing decisions, 
bystander response to drug overdoses, and 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.
    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
                                      Number of     responses     Total annual     Average burden per     Total
             Activity                respondents       per         responses            response          hours
                                                   respondent
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Interviews and Surveys............      126,770             1          126,770   0.25 (15 minutes)....   31,693
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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: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08655 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P