Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications by the Food and Drug Administration's Center for Devices and Radiological Health, 66192-66194 [2022-23781]
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Federal Register / Vol. 87, No. 211 / Wednesday, November 2, 2022 / Notices
use of investigational drugs for
treatment of patients with serious or
immediately life-threatening diseases or
conditions who lack therapeutic
alternatives. FDA issued a guidance in
2016 (updated in 2017) in a questionand-answer format to respond to the
most frequently asked questions on
various provisions of the regulation
regarding expanded access.
The Cures Act added section 561A to
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360bbb–0) to
include new requirements regarding
expanded access. Under section 561A of
the FD&C Act, a manufacturer or
distributor of one or more
investigational drugs for the diagnosis,
monitoring, or treatment of one or more
serious diseases or conditions is
required to make its policy for
evaluating and responding to expanded
access requests (expanded access
policy) readily available to the public,
such as by posting the policy on a
publicly available website. In addition,
FDARA (Pub. L. 115–52) amended the
FD&C Act to require that the expanded
access policy for an investigational drug
be posted by the earlier of (1) the first
initiation of a phase 2 or phase 3 study
with respect to such investigational
drug or (2) within 15 days after the drug
receives a fast track, breakthrough, or
regenerative advanced therapy
designation.
This revised draft guidance includes
responses to stakeholder questions
received since publication of the
updated final guidance in 2017 and
includes the Agency’s recommendations
related to new requirements of the Cures
Act and FDARA that are related to
expanded access. This guidance revises
the guidance for industry of the same
title issued in June 2016 and updated in
October 2017. Significant changes to the
2017 version of the guidance include
additional recommendations related to
institutional review board review,
informed consent, and new
requirements established by the Cures
Act and FDARA.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Expanded
Access to Investigational Drugs for
Treatment Use: Questions and
Answers.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the of the applicable
statutes and regulations.
VerDate Sep<11>2014
16:38 Nov 01, 2022
Jkt 259001
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information under the Expanded Access
regulations (21 CFR 312.300 through
312.320) have been approved under
OMB control number 0910–0814; and
the collections of information in 42 CFR
part 11 have been approved under OMB
control number 0925–0586.
III. Electronic Access
Persons with access to the internet
may obtain the revised draft guidance at
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23785 Filed 11–1–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications by the Food and
Drug Administration’s Center for
Devices and Radiological Health
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 studies regarding
communications by FDA’s Center for
Devices and Radiological Health
(CDRH). This information will be used
to explore concepts of interest and assist
in the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
January 3, 2023.
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
January 3, 2023. 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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
E:\FR\FM\02NON1.SGM
02NON1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 211 / Wednesday, November 2, 2022 / Notices
• 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 the Docket No. FDA–
2013–N–0796 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Testing
Communications Regarding Products
Regulated by FDA’s Center for Devices
and Radiological Health.’’ 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.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
VerDate Sep<11>2014
16:38 Nov 01, 2022
Jkt 259001
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.
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.
Testing Communications by FDA’s
Center for Devices and Radiological
Health
OMB Control Number 0910–0678—
Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
66193
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs. FDA
must conduct needed research to ensure
that such programs have the highest
likelihood of being effective. Improving
communications by FDA’s CDRH
involves many research methods,
including individual indepth
interviews, mall-intercept interviews,
focus groups, self-administered surveys,
gatekeeper reviews, and omnibus
telephone surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about product use.
Knowledge of consumer, caregiver, and
healthcare professional decision-making
processes will provide a better
understanding of target audiences that
FDA needs to design effective
communication strategies, messages,
and labels.
Second, as initial testing, the
collected information will allow FDA to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with
intended audiences. Testing messages
with a sample of the target audience
will allow FDA to refine messages while
still in the developmental stage.
Respondents will be asked to give their
reaction to the messages in either
individual or group settings.
Third, as evaluative research, the
collected information will allow FDA to
ascertain the effectiveness of the
messages and the distribution method in
achieving the objectives of the message
campaign. Evaluation of message
campaigns is a vital link in continuous
improvement of communications at
FDA.
FDA expects to conduct studies under
this generic information collection using
a variety of research methods. We
estimate that the burden to respondents
will average 16 minutes each (varying
from 5 minutes to 90 minutes). FDA
estimates the burden of this collection
of information based on prior
experience with the various types of
data collection methods described
earlier.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\02NON1.SGM
02NON1
66194
Federal Register / Vol. 87, No. 211 / Wednesday, November 2, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
responses per
respondent
Number of
respondents
Type of respondent/survey
Total annual
responses
Average burden per response
Total hours
General Public
Individual indepth interviews .............
General public focus group interviews.
Intercept interviews: central location
Intercept interviews: telephone .........
Self-administered surveys .................
Gatekeeper reviews ..........................
Omnibus surveys ..............................
420
288
1
1
420
288
200
4,000
2,400
400
1,200
1
1
1
1
1
200
4,000
2,400
400
1,200
Total (general public) .................
........................
........................
........................
0.75 (45 minutes) .............................
1.50 (1 hour, 30 minutes) ................
315
432
0.25
0.08
0.25
0.50
0.17
(15 minutes) .............................
(5 minutes) ...............................
(15 minutes) .............................
(30 minutes) .............................
(10 minutes) .............................
50
320
600
200
204
...........................................................
2,121
Healthcare Professional
Healthcare professional individual indepth interviews.
Healthcare professional focus group
interviews.
Total (healthcare professional) ..
Total (overall) ......................
1 There
72
1
72
0.75 (45 minutes) .............................
54
144
1
144
1.50 (1 hour, 30 minutes) ................
216
........................
........................
........................
........................
........................
........................
...........................................................
...........................................................
270
2,391
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Over the next 3-year approval period,
we anticipate increasing our capability
to conduct more communication
surveys, which aligns with CDRH’s
strategic priorities. We have adjusted
our burden estimates accordingly.
Additionally, we have added an
estimated hour burden for ‘‘healthcare
professional individual indepth
interviews.’’ These changes reflect an
overall increase of 315 burden hours
and a corresponding increase of 276
responses annually.
Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23781 Filed 11–1–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2336]
khammond on DSKJM1Z7X2PROD with NOTICES
Assessing User Fees Under the Overthe-Counter Monograph Drug User Fee
Program; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
VerDate Sep<11>2014
16:38 Nov 01, 2022
Jkt 259001
‘‘Assessing User Fees Under the Overthe-Counter Monograph Drug User Fee
Program.’’ This guidance provides
stakeholders with information regarding
FDA’s implementation of the Over-theCounter Monograph Drug User Fee
Program authorized under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
DATES: Submit either electronic or
written comments on the draft guidance
by January 3, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidances at any time as follows:
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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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’’).
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 the Docket No. FDA–
2022–D–2336 for ‘‘Assessing User Fees
Under the Over-the-Counter Monograph
Drug User Fee Program.’’ Received
comments 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
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66192-66194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23781]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0796]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications by the Food and Drug
Administration's Center for Devices and Radiological Health
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 studies regarding
communications by FDA's Center for Devices and Radiological Health
(CDRH). This information will be used to explore concepts of interest
and assist in the development and modification of communication
messages and campaigns to fulfill the Agency's mission to protect the
public health.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.
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 January 3, 2023. 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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
[[Page 66193]]
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 the Docket No.
FDA-2013-N-0796 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Testing Communications Regarding
Products Regulated by FDA's Center for Devices and Radiological
Health.'' 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.
Testing Communications by FDA's Center for Devices and Radiological
Health
OMB Control Number 0910-0678--Extension
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs. FDA must conduct needed research to
ensure that such programs have the highest likelihood of being
effective. Improving communications by FDA's CDRH involves many
research methods, including individual indepth interviews, mall-
intercept interviews, focus groups, self-administered surveys,
gatekeeper reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about product use.
Knowledge of consumer, caregiver, and healthcare professional decision-
making processes will provide a better understanding of target
audiences that FDA needs to design effective communication strategies,
messages, and labels.
Second, as initial testing, the collected information will allow
FDA to assess the potential effectiveness of messages and materials in
reaching and successfully communicating with intended audiences.
Testing messages with a sample of the target audience will allow FDA to
refine messages while still in the developmental stage. Respondents
will be asked to give their reaction to the messages in either
individual or group settings.
Third, as evaluative research, the collected information will allow
FDA to ascertain the effectiveness of the messages and the distribution
method in achieving the objectives of the message campaign. Evaluation
of message campaigns is a vital link in continuous improvement of
communications at FDA.
FDA expects to conduct studies under this generic information
collection using a variety of research methods. We estimate that the
burden to respondents will average 16 minutes each (varying from 5
minutes to 90 minutes). FDA estimates the burden of this collection of
information based on prior experience with the various types of data
collection methods described earlier.
FDA estimates the burden of this collection of information as
follows:
[[Page 66194]]
Table 1--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/survey Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
General Public
----------------------------------------------------------------------------------------------------------------
Individual indepth interviews. 420 1 420 0.75 (45 315
minutes).
General public focus group 288 1 288 1.50 (1 hour, 30 432
interviews. minutes).
Intercept interviews: central 200 1 200 0.25 (15 50
location. minutes).
Intercept interviews: 4,000 1 4,000 0.08 (5 minutes) 320
telephone.
Self-administered surveys..... 2,400 1 2,400 0.25 (15 600
minutes).
Gatekeeper reviews............ 400 1 400 0.50 (30 200
minutes).
Omnibus surveys............... 1,200 1 1,200 0.17 (10 204
minutes).
---------------------------------------------------------------------------------
Total (general public).... .............. .............. .............. ................ 2,121
----------------------------------------------------------------------------------------------------------------
Healthcare Professional
----------------------------------------------------------------------------------------------------------------
Healthcare professional 72 1 72 0.75 (45 54
individual indepth interviews. minutes).
Healthcare professional focus 144 1 144 1.50 (1 hour, 30 216
group interviews. minutes).
---------------------------------------------------------------------------------
Total (healthcare .............. .............. .............. ................ 270
professional).
Total (overall)....... .............. .............. .............. ................ 2,391
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
Over the next 3-year approval period, we anticipate increasing our
capability to conduct more communication surveys, which aligns with
CDRH's strategic priorities. We have adjusted our burden estimates
accordingly. Additionally, we have added an estimated hour burden for
``healthcare professional individual indepth interviews.'' These
changes reflect an overall increase of 315 burden hours and a
corresponding increase of 276 responses annually.
Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23781 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P
