Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications by the Food and Drug Administration's Center for Devices and Radiological Health, 18556-18557 [2023-06434]
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ddrumheller on DSK120RN23PROD with NOTICES1
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Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
recorded through an online
teleconferencing platform. The
committee will discuss new drug
application (NDA) 214697, for
epinephrine nasal spray, submitted by
ARS Pharmaceuticals Inc., for the
proposed indication of emergency
treatment of allergic reactions (Type I)
including anaphylaxis in adults and
children ≥30 kilograms.
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than 2 business days before the meeting.
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meeting, the background material will
be made publicly available on FDA’s
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committee meeting. Background
material and the link to the online
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available at https://www.fda.gov/
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allow the presentation of materials in a
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Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
April 27, 2023, will be provided to the
committee. Oral presentations from the
public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m.
Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 19,
2023. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 20, 2023.
For press inquiries, please contact the
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FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
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If you require accommodations due to a
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19:20 Mar 28, 2023
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disability, please contact Takyiah
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INFORMATION CONTACT) at least 7 days in
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FDA is committed to the orderly
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AdvisoryCommittees/AboutAdvisory
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06481 Filed 3–28–23; 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; Submission for Office of
Management and Budget Review;
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) 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 April 27,
2023.
SUMMARY:
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 0910–0678. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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 Center for
Devices and Radiological Health (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
E:\FR\FM\29MRN1.SGM
29MRN1
Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
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.
In the Federal Register of November
2, 2022 (87 FR 66192), FDA published
a 60-day notice requesting public
18557
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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
200
4,000
2,400
400
1,200
1
1
1
1
1
1
1
420
288
200
4,000
2,400
400
1,200
Total (general public) ...................................................................
........................
........................
0.75
1.50
0.25
0.08
0.25
0.50
0.17
(45 minutes) ............
(1 hour, 30 minutes)
(15 minutes) ............
(5 minutes) ..............
(15 minutes) ............
(30 minutes) ............
(10 minutes) ............
315
432
50
320
600
200
204
........................
..........................................
2,121
Healthcare Professional
Healthcare professional individual indepth interviews ........................
Healthcare professional focus group interviews .................................
72
144
1
1
72
144
0.75 (45 minutes) ............
1.50 (1 hour, 30 minutes)
54
216
Total (healthcare professional) ....................................................
Total (overall) ...............................................................................
........................
........................
........................
........................
........................
........................
..........................................
..........................................
270
2,391
1 There
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: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06434 Filed 3–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
ddrumheller on DSK120RN23PROD with NOTICES1
Meeting of the National Advisory
Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Council on Migrant Health
SUMMARY:
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19:20 Mar 28, 2023
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(NACMH) scheduled a public meeting.
Information about NACMH and the
agenda for this meeting can be found on
NACMH’s website at https://
www.hrsa.gov/advisory-committees/
migrant-health.
DATES: May 24–25, 2023, 9:00 a.m.–5:00
p.m. Eastern Time.
ADDRESSES: This meeting will be held
in-person at Hyatt Place Tampa Wesley
Chapel, 26000 Sierra Center Boulevard,
Lutz, Florida 33559 with an option to
join virtually. For information about the
meeting, visit NACMH’s website 30
business days before the meeting date,
where instructions to join the meeting
will be posted.
FOR FURTHER INFORMATION CONTACT:
Esther Paul, NACMH, Designated
Federal Official, Strategic Initiatives
Division, Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 5600 Fishers Lane,
Rockville, MD 20857; 301–594–4300; or
epaul@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH
provides advice and recommendations
to the Secretary of Health and Human
Services on policy, program
development, and other matters of
significance concerning the activities
under section 217 of the Public Health
Service Act, as amended (42 U.S.C.
218). Specifically, NACMH provides
recommendations concerning the
organization, operation, selection, and
funding of migrant health centers, and
PO 00000
Frm 00046
Fmt 4703
Sfmt 9990
other entities under grants and contracts
under section 330 of the Public Health
Service Act (42 U.S.C. 254b). NACMH
meets twice each calendar year, or at the
discretion of the Designated Federal
Official in consultation with the
NACMH Chair.
During the May 24–25, 2023, meeting,
NACMH will discuss issues related to
migratory and seasonal agricultural
worker health. Agenda items are subject
to change as priorities dictate. Refer to
the NACMH website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to NACMH
should be sent to Esther Paul,
Designated Federal Official, using the
contact information above at least 3
business days prior to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Esther Paul at the address and
phone number listed above at least 10
business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–06502 Filed 3–28–23; 8:45 am]
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18556-18557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0796]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 April 27, 2023.
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 0910-0678. 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.
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 Center for Devices and
Radiological Health (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
[[Page 18557]]
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.
In the Federal Register of November 2, 2022 (87 FR 66192), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/survey Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Public
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual indepth interviews............... 420 1 420 0.75 (45 minutes)......................... 315
General public focus group interviews....... 288 1 288 1.50 (1 hour, 30 minutes)................. 432
Intercept interviews: central location...... 200 1 200 0.25 (15 minutes)......................... 50
Intercept interviews: telephone............. 4,000 1 4,000 0.08 (5 minutes).......................... 320
Self-administered surveys................... 2,400 1 2,400 0.25 (15 minutes)......................... 600
Gatekeeper reviews.......................... 400 1 400 0.50 (30 minutes)......................... 200
Omnibus surveys............................. 1,200 1 1,200 0.17 (10 minutes)......................... 204
-----------------------------------------------------------------------------------------------------------
Total (general public).................. .............. .............. .............. .......................................... 2,121
--------------------------------------------------------------------------------------------------------------------------------------------------------
Healthcare Professional
--------------------------------------------------------------------------------------------------------------------------------------------------------
Healthcare professional individual indepth 72 1 72 0.75 (45 minutes)......................... 54
interviews.
Healthcare professional focus group 144 1 144 1.50 (1 hour, 30 minutes)................. 216
interviews.
-----------------------------------------------------------------------------------------------------------
Total (healthcare professional)......... .............. .............. .............. .......................................... 270
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: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06434 Filed 3-28-23; 8:45 am]
BILLING CODE 4164-01-P
