Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 62541-62543 [2019-24804]
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62541
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
in brackets in the heading of this
document.
Q-Submission Program for Medical
Devices
FOR FURTHER INFORMATION CONTACT:
OMB Control Number 0910–0756—
Extension
The guidance entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ (https://www.fda.gov/media/
114034/download) provides an
overview of the mechanisms available to
submitters through which they can
request feedback from or a meeting with
FDA regarding certain potential or
planned medical device submissions
reviewed by the Center for Devices and
Radiological Health (CDRH) and the
Center for Biologics Evaluation and
Research (CBER). The guidance
provides recommendations regarding
certain types of Q-Submissions, such as
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Pre-Submissions, Submission Issue
Requests, Study Risk Determinations,
Informational Meetings, and other QSubmissions Types and other uses of
the Q-Submission Program.
For clarity and consistency with the
guidance that describes the program, we
are requesting that the title of the
information collection request, OMB
control number 0910–0756, be changed
to ‘‘Q-Submission Program for Medical
Devices.’’
In the Federal Register of August 13,
2019 (84 FR 40069), 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
Number of
respondents
FDA Center
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
CDRH ...................................................................................
CBER ...................................................................................
3,502
91
1
1
3,502
91
137
137
479,774
12,467
Total ..............................................................................
........................
........................
........................
........................
492,241
1 There
are no capital costs or operating and maintenance cost associated with this of information.
Respondents are medical device
manufacturers subject to FDA’s laws
and regulations. FDA’s annual estimate
of 3,593 submissions is based on
experienced recent trends. FDA’s
administrative and technical staffs, who
are familiar with Q-Submissions,
estimate that an average of 137 hours is
required to prepare a Q-Submission.
Our estimated burden for the
information collection reflects an
overall increase of 143,713 hours. We
attribute this adjustment to an increase
in the number of submissions we
received based on FY18 data.
Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24803 Filed 11–14–19; 8:45 am]
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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 on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 communication
studies involving medical devices and
radiation-emitting products regulated by
FDA. This information will be used to
explore concepts of interest and assist in
SUMMARY:
PO 00000
Frm 00040
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the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 14,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 14, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is 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
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62542
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
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:
• 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 on Medical Devices
and Radiation-Emitting Products.’’
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.
• 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
VerDate Sep<11>2014
16:58 Nov 14, 2019
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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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 on Medical
Devices and Radiation-Emitting
Products
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
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiation
emitting products will involve many
research methods, including individual
in-depth interviews, mall-intercept
interviews, focus groups, selfadministered 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 medical device and
radiation-emitting product use.
Knowledge of consumer and health care
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using medical devices and
radiation-emitting products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their 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
E:\FR\FM\15NON1.SGM
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Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
Annually, FDA projects conducting
about 30 studies using a variety of
research methods and lasting an average
of 0.17 hours each (varying from 0.08 to
1.5 hours). FDA estimates the burden of
this collection of information based on
prior experience with the various types
62543
of data collection methods described
earlier. FDA is requesting this burden so
as not to restrict the Agency’s ability to
gather information on public sentiment
for its proposals in its regulatory and
communications programs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Individual In-Depth Interviews .....................................
General Public Focus Group Interviews .....................
Intercept Interviews: Central Location .........................
Intercept Interviews: Telephone ..................................
Self-Administered Surveys ..........................................
Gatekeeper Reviews ...................................................
Omnibus Surveys ........................................................
360
144
200
4,000
2,400
400
1,200
1
1
1
1
1
1
1
360
144
200
4,000
2,400
400
1,200
0.75 (45 minutes) ...
1.5 ..........................
0.25 (15 minutes) ..
0.08 (5 minutes) .....
0.25 (15 minutes) ...
0.5 (30 minutes) .....
0.17 (10 minutes) ...
270
216
50
320
600
200
204
Total (General Public) ..........................................
Physician Focus Group Interviews ..............................
8,704
144
........................
1
8,702
144
................................
1.5 ..........................
1,860
216
Total (Physician) ...................................................
144
........................
........................
................................
216
Total (Overall) ...............................................
8,848
........................
........................
................................
2,076
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, we have made no
adjustments to our burden estimate.
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Dated: November 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: January 12–14, 2020.
Time: 6:00 p.m. to 12:00 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Lorna W. Role, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, 35A Convent Drive,
MSC 3716, Bethesda, MD 20892, lorna.role@
nih.gov.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: March 22–24, 2020.
Time: 6:00 p.m. to 12:00 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Lorna W. Role, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, 35A Convent Drive,
MSC 3716, Bethesda, MD 20892, lorna.role@
nih.gov.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: June 21–23, 2020.
Time: 6:00 p.m. to 12:00 p.m.
[FR Doc. 2019–24804 Filed 11–14–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
The meetings will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKE, including consideration of
personnel qualifications and
performance, and the competence of
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Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Lorna W. Role, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, 35A Convent Drive,
MSC 3716, Bethesda, MD 20892, lorna.role@
nih.gov.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: October 4–6, 2020.
Time: 6:00 p.m. to 12:00 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Lorna W. Role, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, 35A Convent Drive,
MSC 3716, Bethesda, MD 20892, lorna.role@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: November 7, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–24775 Filed 11–14–19; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62541-62543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24804]
-----------------------------------------------------------------------
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 on Medical Devices and
Radiation-Emitting Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 communication studies involving medical
devices and radiation-emitting products regulated by FDA. 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: Submit either electronic or written comments on the collection
of information by January 14, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 14, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 14, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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
[[Page 62542]]
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:
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 on Medical
Devices and Radiation-Emitting Products.'' 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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 on Medical Devices and Radiation-Emitting
Products
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 relating to the safety of regulated
medical devices and radiation-emitting products. FDA must conduct
needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation emitting products will involve many research
methods, including individual in-depth 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 medical device
and radiation-emitting product use. Knowledge of consumer and health
care professional decision-making processes will provide the better
understanding of target audiences that FDA needs to design effective
communication strategies, messages, and labels. These communications
will aim to improve public understanding of the risks and benefits of
using medical devices and radiation-emitting products by providing
users with a better context in which to place risk information more
completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their 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
[[Page 62543]]
messages in either individual or group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
Annually, FDA projects conducting about 30 studies using a variety
of research methods and lasting an average of 0.17 hours each (varying
from 0.08 to 1.5 hours). FDA estimates the burden of this collection of
information based on prior experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the Agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual In-Depth Interviews............... 360 1 360 0.75 (45 minutes)........................ 270
General Public Focus Group Interviews........ 144 1 144 1.5...................................... 216
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 0.5 (30 minutes)......................... 200
Omnibus Surveys.............................. 1,200 1 1,200 0.17 (10 minutes)........................ 204
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Total (General Public)................... 8,704 .............. 8,702 ......................................... 1,860
Physician Focus Group Interviews............. 144 1 144 1.5...................................... 216
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Total (Physician)........................ 144 .............. .............. ......................................... 216
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Total (Overall)...................... 8,848 .............. .............. ......................................... 2,076
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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, we have made no adjustments to our burden
estimate.
Dated: November 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24804 Filed 11-14-19; 8:45 am]
BILLING CODE 4164-01-P
