Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey, 13814-13815 [2017-05103]
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Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
In the Federal Register of November
30, 2004 (69 FR 69606), FDA published
a notice of availability of the guidance
entitled ‘‘Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.’’
The document provides guidance for the
voluntary use of selected symbols in
place of text in labeling. It provides the
labeling guidance required for: (1) In
vitro diagnostic devices (IVDs),
intended for professional use under 21
CFR 809.10, FDA’s labeling
requirements for IVDs; and (2) FDA’s
labeling requirements for biologics,
including IVDs under 21 CFR parts 610
and 660.
The guidance document recommends
that a glossary of terms accompany each
IVD to define the symbols used on that
device’s labels and/or labeling.
Furthermore, the guidance recommends
an educational outreach effort to
enhance the understanding of newly
introduced symbols. Both the glossary
and educational outreach information
help to ensure that IVD users have
enough general familiarity with the
symbols used, as well as provide a quick
reference for available materials, thereby
further ensuring that such labeling
satisfies the labeling requirements under
section 502(c) of the FD&C Act and
section 351 of the PHS Act.
The likely respondents for this
collection of information are IVD
manufacturers who plan to use the
selected symbols in place of text on the
labels and/or labeling of their IVDs.
The glossary activity is inclusive of
both domestic and foreign IVD
manufacturers. FDA receives
submissions from approximately 689
IVD manufacturers annually. The 4-hour
estimate for a glossary is based on the
average time necessary for a
manufacturer to modify the glossary for
the specific symbols used in labels or
labeling for the IVDs manufactured.
In the Federal Register of December 5,
2016 (81 FR 87570), 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 THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Glossary ...............................................................................
689
1
689
4
2,756
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
solicits comments on the Safety
Communication Readership Survey.
DATES: Submit either electronic or
written comments on the collection of
information by May 15, 2017.
ADDRESSES: You may submit comments
as follows:
[FR Doc. 2017–05106 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Safety Communication
Readership Survey
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
SUMMARY:
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18:19 Mar 14, 2017
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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
PO 00000
Frm 00027
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Sfmt 4703
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2009–N–0360 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food and
Drug Administration Safety
Communication Readership Survey.’’
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
Division of Dockets Management
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
E:\FR\FM\15MRN1.SGM
15MRN1
13815
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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.
FDA Safety Communication Readership
Survey
OMB Control Number 0910–0341—
Extension
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
375(b)) gives FDA authority to
disseminate information concerning
suspected or imminent danger to public
health by any regulated product. Section
1701(a)(4) of the Public Health Service
Act (42 U.S.C. 300u(a)(4)) also
authorizes FDA to conduct research
relating to health information.
FDA’s Center for Devices and
Radiological Health (CDRH) carries out
FDA’s regulatory responsibilities
regarding medical devices and
radiological products. CDRH must be
able to effectively communicate risk to
health care practitioners, patients,
caregivers, and consumers when there is
a real or suspected threat to the public’s
health. CDRH uses safety
communications to transmit information
concerning these risks to user
communities. Safety communications
are released and available to
organizations such as hospitals, nursing
homes, hospices, home health care
agencies, manufacturers, retail
pharmacies, and other health care
providers, as well as patients,
caregivers, consumers, and patient
advocacy groups. Through a process for
identifying and addressing postmarket
safety issues related to regulated
products, CDRH determines when to
release safety communications.
FDA seeks to evaluate the clarity,
timeliness, and impact of safety
communications by surveying a sample
of recipients to determine the impact of
safety communications on the
knowledge of the recipients.
Understanding how the target audiences
view these publications will aid in
determining what, if any, changes
should be considered in their content,
format, and method of dissemination.
The collection of this data is an
important step in determining how well
CDRH is communicating risk. The
results from this survey will emphasize
the quality of the safety
communications and customer
satisfaction. This will enable us to better
serve the public by improving the
effectiveness of safety communications.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Public Health Notification Readership Survey .............
300
3
900
0.17 (10 minutes) ..
153
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the Safety
Communication program, it is estimated
that an average of three collections will
be conducted per year. The total burden
of response time is estimated at 10
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18:19 Mar 14, 2017
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minutes per survey. This was derived by
CDRH staff completing the survey.
PO 00000
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05103 Filed 3–14–17; 8:45 am]
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Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13814-13815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0360]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Safety Communication
Readership Survey
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 the Safety Communication Readership Survey.
DATES: Submit either electronic or written comments on the collection
of information by May 15, 2017.
ADDRESSES: You may submit comments 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 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2009-N-0360 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food and Drug Administration
Safety Communication Readership Survey.'' 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 Division of Dockets Management 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
[[Page 13815]]
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
Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.
FDA Safety Communication Readership Survey
OMB Control Number 0910-0341--Extension
Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 375(b)) gives FDA authority to disseminate information
concerning suspected or imminent danger to public health by any
regulated product. Section 1701(a)(4) of the Public Health Service Act
(42 U.S.C. 300u(a)(4)) also authorizes FDA to conduct research relating
to health information.
FDA's Center for Devices and Radiological Health (CDRH) carries out
FDA's regulatory responsibilities regarding medical devices and
radiological products. CDRH must be able to effectively communicate
risk to health care practitioners, patients, caregivers, and consumers
when there is a real or suspected threat to the public's health. CDRH
uses safety communications to transmit information concerning these
risks to user communities. Safety communications are released and
available to organizations such as hospitals, nursing homes, hospices,
home health care agencies, manufacturers, retail pharmacies, and other
health care providers, as well as patients, caregivers, consumers, and
patient advocacy groups. Through a process for identifying and
addressing postmarket safety issues related to regulated products, CDRH
determines when to release safety communications.
FDA seeks to evaluate the clarity, timeliness, and impact of safety
communications by surveying a sample of recipients to determine the
impact of safety communications on the knowledge of the recipients.
Understanding how the target audiences view these publications will aid
in determining what, if any, changes should be considered in their
content, format, and method of dissemination. The collection of this
data is an important step in determining how well CDRH is communicating
risk. The results from this survey will emphasize the quality of the
safety communications and customer satisfaction. This will enable us to
better serve the public by improving the effectiveness of safety
communications.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Health Notification Readership Survey 300 3 900 0.17 (10 minutes)..................... 153
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the Safety Communication program, it is
estimated that an average of three collections will be conducted per
year. The total burden of response time is estimated at 10 minutes per
survey. This was derived by CDRH staff completing the survey.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05103 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P