Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 13813-13814 [2017-05106]
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Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
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
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 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
13813
hours). FDA estimates the burden of this
collection of information based on prior
recent 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.
In the Federal Register of October 28,
2016 (81 FR 75134), 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
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
.75 (45 minutes) ....
1.5 .........................
.25 (15 minutes) ....
.08 (5 minutes) ......
.25 (15 minutes) ....
.5 (30 minutes) ......
.17 (10 minutes) ....
270
216
50
320
600
200
204
Total (general public) ............................................
8,704
........................
........................
...............................
1,860
Physician focus group interviews .................................
144
1
144
1.5 .........................
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.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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: Fax written comments on the
collection of information by April 14,
2017.
[FR Doc. 2017–05097 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
[Docket No. FDA–2013–N–1089]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommended
Glossary and Educational Outreach To
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
(202) 395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0553. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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:
Recommended Glossary and
Educational Outreach To Support Use
of Symbols on Labels and in Labeling
of In Vitro Diagnostic Devices Intended
for Professional Use
OMB Control Number 0910–0553—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device to avoid
misbranding. Section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262) establishes requirements
that manufacturers of biological
products must submit a license
application for FDA review and
approval prior to marketing a biological
product for introduction into interstate
commerce.
E:\FR\FM\15MRN1.SGM
15MRN1
13814
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:
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
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
Fmt 4703
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
Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13813-13814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1089]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recommended Glossary
and Educational Outreach To Support Use of Symbols on Labels and in
Labeling of In Vitro Diagnostic Devices Intended for Professional Use
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: Fax written comments on the collection of information by April
14, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: (202) 395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0553.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Recommended Glossary and Educational Outreach To Support Use of Symbols
on Labels and in Labeling of In Vitro Diagnostic Devices Intended for
Professional Use
OMB Control Number 0910-0553--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 352), among other things, establishes requirements for
the label or labeling of a medical device to avoid misbranding. Section
351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)
establishes requirements that manufacturers of biological products must
submit a license application for FDA review and approval prior to
marketing a biological product for introduction into interstate
commerce.
[[Page 13814]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[FR Doc. 2017-05106 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P