Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 30381-30383 [2024-08655]
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Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
FOR FURTHER INFORMATION CONTACT:
Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5367, Silver Spring,
MD 20993–0002, 301–796–0700; or
James Myers, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
ddrumheller on DSK120RN23PROD with NOTICES1
Section 506B(c) of the FD&C Act (21
U.S.C. 356b(c)) requires FDA to publish
an annual report on the status of
postmarketing studies that applicants
are required to, or have committed to,
conduct and for which annual status
reports have been submitted. Under
§§ 314.81(b)(2)(vii) and 601.70 (21 CFR
314.81(b)(2)(vii) and 601.70), applicants
of approved drug products and licensed
biological products are required to
submit annually a report on the status
of each clinical safety, clinical efficacy,
clinical pharmacology, and nonclinical
toxicology study or clinical trial either
required by FDA (PMRs) or that they
have committed to conduct (PMCs),
either at the time of approval or after
approval of their new drug application,
abbreviated new drug application, or
biologics license application, as
applicable. The status of PMCs
concerning chemistry, manufacturing,
and production controls and the status
of other studies or clinical trials
conducted on an applicant’s own
initiative are not required to be reported
under §§ 314.81(b)(2)(vii) and 601.70
and are not addressed in this report.
Furthermore, section 505(o)(3)(E) of the
FD&C Act (21 U.S.C. 355(o)(3)(E))
requires that applicants report
periodically on the status of each
required study or clinical trial and each
study or clinical trial ‘‘otherwise
undertaken . . . to investigate a safety
issue . . .’’
An applicant must report on the
progress of the PMR/PMC on the
anniversary of the drug product’s
approval 1 until the PMR/PMC is
completed or terminated and FDA
determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either
1 An applicant must submit an annual status
report on the progress of each open PMR/PMC
within 60 days of the anniversary date of U.S.
approval of the original application or on an
alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
granted by FDA alternate annual reporting dates to
facilitate harmonized reporting across multiple
applications.
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no longer feasible or would no longer
provide useful information.
II. Fiscal Year 2022 Report
With this notice, FDA is announcing
the availability of the Agency’s annual
report entitled ‘‘Report on the
Performance of Drug and Biologics
Firms in Conducting Postmarketing
Requirements and Commitments.’’
Information in this report covers any
PMR/PMC that was established, in
writing, at the time of approval or after
approval of an application or a
supplement to an application and
summarizes the status of PMRs/PMCs in
fiscal year 2022 (i.e., as of September 30,
2022). Information summarized in the
report reflects combined data from the
Center for Drug Evaluation and Research
and the Center for Biologics Evaluation
and Research and includes the
following: (1) the number of applicants
with open PMRs/PMCs; (2) the number
of open PMRs/PMCs; (3) the timeliness
of applicant submission of the annual
status reports (ASRs); (4) FDA-verified
status of open PMRs/PMCs reported in
§ 314.81(b)(2)(vii) or § 601.70 ASRs; (5)
the status of closed PMRs/PMCs; and (6)
the distribution of the status by fiscal
year (FY) of establishment 2 (FY2016 to
FY2022) for PMRs and PMCs open at
the end of FY2022, or those closed
within FY2022. Additional information
about PMRs/PMCs is provided on FDA’s
website at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryI
nformation/Post-marketingPhaseIV
Commitments/default.html.
Dated: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08649 Filed 4–22–24; 8:45 am]
BILLING CODE 4164–01–P
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.
2 The establishment date is the date of the formal
FDA communication to the applicant that included
the final FDA-required (PMR) or requested (PMC)
postmarketing study or clinical trial.
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30381
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.
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by June
24, 2024.
DATES:
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.
ADDRESSES:
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’’).
E:\FR\FM\23APN1.SGM
23APN1
30382
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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-201509-18/pdf/2015-23389.pdf.
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
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, PRAStaff@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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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 decisionmaking 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, decisionmaking processes, and communication
and behavioral change strategies.
E:\FR\FM\23APN1.SGM
23APN1
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
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
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
30383
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
Interviews and Surveys ...............................................
1 There
I
126,770
I
1
I
Total annual
responses
Average burden
per response
Total
hours
126,770
0.25 (15 minutes) ........................................................
31,693
are no capital costs or operating and maintenance costs associated with this collection of information.
Food and Drug Administration
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will take place
virtually on May 23, 2024, from 9:30
a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee
meetings, including information
regarding special accommodations due
to a disability may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm408555.
htm.
[Docket No. FDA–2024–N–0008]
FOR FURTHER INFORMATION CONTACT:
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Molecular and Clinical Genetics Panel
of the Medical Devices Advisory
Committee; Notice of Meeting—
Guardant Shield Blood Collection Kit
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses
per
respondent
Number of
respondents
Activity
Notice.
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Molecular and Clinical Genetics Panel
of the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
SUMMARY:
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Jarrod.Collier@
fda.hhs.gov, 240–672–5763, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On May 23,
2024, the committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application for the Shield test
by Guardant Health, Inc. The proposed
indication for use statement is as
follows: The Shield test is a qualitative
in vitro diagnostic test intended to
detect colorectal cancer derived
alterations in cell-free DNA from blood
collected in the Guardant Blood
Collection Kit. Shield is intended for
colorectal cancer screening in
individuals at average risk of the
disease, age 45 years or older. Patients
with an ‘‘Abnormal Signal Detected’’
may have colorectal cancer or advanced
adenomas and should be referred for
colonoscopy evaluation. Shield is not a
replacement for diagnostic colonoscopy
or for surveillance colonoscopy in highrisk individuals. The test is performed
at Guardant Health, Inc.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total annual Average burden per Total
Activity respondents per responses response hours
respondent
----------------------------------------------------------------------------------------------------------------
Interviews and Surveys............ 126,770 1 126,770 0.25 (15 minutes).... 31,693
----------------------------------------------------------------------------------------------------------------
\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
