Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Use of Symbols in Labeling-Glossary To Support the Use of Symbols in Labeling, 47306-47308 [2019-19351]
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47306
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
These records are maintained in paper
and/or electronic form.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
These records are retrieved by the
name or other programmatic identifier
assigned to the individual about whom
they are maintained.
In accordance with the National
Archives and Records Administration
General Records Schedule 2.8 Employee
Ethics Records, these records are
generally retained for a period of six
years after filing, or for such other
period of time as is provided for in that
schedule for certain specified types of
ethics records. In cases where records
are filed by, or with respect to, a
nominee for an appointment requiring
confirmation by the Senate when the
nominee is not appointed and
Presidential and Vice-Presidential
candidates who are not elected, the
records are generally destroyed one year
after the date the individual ceased
being under Senate consideration for
appointment or is no longer a candidate
for office. However, if any records are
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in the investigation. Destruction is by
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authentication and password protection.
Access to the systems is controlled
based on user roles and responsibilities.
Executive branch agencies control their
users’ access to information in Integrity
and are responsible for properly
safeguarding the records maintained in
their systems.
jbell on DSK3GLQ082PROD with NOTICES
RECORD ACCESS PROCEDURES:
Individuals wishing to request access
to their records should contact the
appropriate office as shown in the
Notification Procedure section.
Individuals must furnish the following
information for their records to be
located and identified:
a. Full name.
20:43 Sep 06, 2019
Jkt 247001
1990) and subsequently amended by the
following notices: 68 FR 3097 (Jan. 22,
2003); 68 FR 24744 (May 8, 2003); 76 FR
24489 (May 2, 2011); 77 FR 45353 (July
31, 2012); 78 FR 73863 (Dec. 9, 2013).
Approved: September 4, 2019.
Emory Rounds,
Director, U.S. Office of Government Ethics.
[FR Doc. 2019–19372 Filed 9–6–19; 8:45 am]
BILLING CODE 6345–03–P
CONTESTING RECORD PROCEDURES:
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
VerDate Sep<11>2014
b. Department or agency and
component with which employed or
proposed to be employed.
c. Dates of employment.
d. A reasonably specific description of
the record content being sought.
Individuals requesting access to
records maintained at OGE must also
follow OGE’s Privacy Act regulations
regarding verification of identity and
access to records (5 CFR part 2606).
Because the information in these
records is updated on a periodic basis,
most record corrections can be handled
through established administrative
procedures for updating the records.
However, individuals can obtain
information on the procedures for
contesting the records under the
provisions of the Privacy Act by
contacting the appropriate office shown
in the Notification Procedure section.
NOTIFICATION PROCEDURES:
Individuals wishing to inquire
whether this system of records contains
information about them should contact,
as appropriate:
a. For records filed directly with OGE
by non-OGE employees, contact the
General Counsel, Office of Government
Ethics, Suite 500, 1201 New York
Avenue NW, Washington, DC 20005–
3917;
b. For records filed with a Designated
Agency Ethics Official (DAEO) or the
head of a department or agency, contact
the DAEO at the department or agency
concerned; and
c. For records filed with the FEC by
candidates for President or Vice
President, contact the FEC General
Counsel, Federal Election Commission,
999 E Street NW, Washington, DC
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Individuals wishing to make such an
inquiry must furnish the following
information for their records to be
located and identified:
a. Full name.
b. Department or agency and
component with which employed or
proposed to be employed.
c. Dates of employment.
Individuals seeking to determine if an
OGE system of records contains
information about them must also
follow OGE’s Privacy Act regulations
regarding verification of identity (5 CFR
part 2606).
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
HISTORY:
This system of records was originally
published in full at 55 FR 6327 (Feb. 22,
Frm 00074
Food and Drug Administration
[Docket No. FDA–2019–N–0549]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Use of Symbols in Labeling—Glossary
To Support the Use of Symbols in
Labeling
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by October 9,
2019.
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 0910–0740. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
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:
None.
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fmt 4703
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09SEN1
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
Medical Devices; Use of Symbols in
Labeling—Glossary To Support the Use
of Symbols in Labeling
OMB Control Number 0910–0740—
Extension
In the Federal Register of June 15,
2016 (81 FR 38911), FDA issued a final
rule revising medical device and certain
biological product labeling regulations
by explicitly allowing for the optional
use in medical device labeling of standalone symbols established in a Standard
Development Organization (SDO)developed standard. In particular, FDA
will allow the use of stand-alone
graphical representations of
information, or symbols, in the labeling
for the medical devices, if the symbols
are established in a standard developed
by an SDO as long as: (1) The standard
is recognized by FDA under its
authority under section 514(c) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360d(c)) and the
symbol is used according to the
specifications for use of the symbol set
forth in FDA’s section 514(c)
recognition, or alternatively, (2) if the
symbol is not included in a standard
recognized by FDA under section 514(c)
of the FD&C Act or the symbol is in a
standard recognized by FDA but is not
used according to the specifications for
use of the symbol set out in the FDA
section 514(c) recognition, the device
manufacturer otherwise determines that
the symbol is likely to be read and
understood by the ordinary individual
under customary conditions of purchase
and use and uses the symbol according
to the specifications for use of the
symbol set forth in the SDO-developed
standard. In addition, in either case, the
symbol must be explained in a written
or electronic symbols glossary that is
included in the labeling for the medical
device. Furthermore, the labeling on or
within the package containing the
device must bear a prominent and
conspicuous statement identifying the
location of the glossary that is written in
English or, in the case of articles
distributed solely in Puerto Rico or in a
Territory where the predominant
language is one other than English, the
predominant language may be used. The
use of such symbols must also comply
with other applicable labeling
requirements of the FD&C Act, such as
section 502(a) and (f) (21 U.S.C. 352(a)
and (f)).
The respondents for this collection of
information are domestic and foreign
device manufacturers who plan to use
stand-alone symbols on the labels and/
or labeling for their devices marketed in
the United States.
In the Federal Register of March 19,
2019 (84 FR 10100), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received the following
comments:
• Comment supporting the use of the
existing rule to continue the use of
symbols without explanatory text, and
including additional instructions, as
needed, in the symbols glossary.
• Comment suggesting the
development or use of the symbol for
electronic instructions for use be
included.
• Comment suggesting adding
requirements regarding education on the
meaning of symbols in devices.
• Comment requesting future support
on the use of ‘‘homegrown’’ or
proprietary symbols not contained in a
standard from a recognized SDO to
reduce burden on space limited areas.
• Several comments requesting that
we not mandate the inclusion of the title
and designation number in the glossary
because the commenters believe they
are not necessary for the user of the
medical device to understand the
symbol. The commenters assert that
removing the requirement for title and
47307
designation number may permit more
symbols glossaries to be included in a
paper Instructions for Use (IFU) versus
needing to be on a website due to the
amount of information needed. The
commenters assert this is beneficial in
that it may permit more users to see the
glossary more easily than going to a
web-based glossary. The comments also
assert that information such as the title
and designation number could be part of
the submission content, rather than part
of the labeling/IFU.
• Comment suggesting the use of the
International Standards Organization
(ISO) Symbol 1641 (Consult IFU) to
replace the requirement to bear a
prominent and conspicuous statement
identifying the location of the symbols
glossary. The comment asserts that use
of ISO Symbol 1641 is believed to be
globally well understood to indicate any
information needed to understand the
proper use of the device is in the IFU.
Use of ISO symbol 1641 will also reduce
burden and costs as the statement in
English requires translation for use in
other countries, whereas the symbol is
universal.
FDA has reviewed and continues to
consider comments to the extent that
they relate to this information
collection. We note that we
continuously evaluate ways to improve
stakeholder understanding of the
symbols rule. We have made no changes
to the information collection at this time
as a result of the comments. Based upon
comments received, FDA also notes that
existing symbols contained within
standards for an electronic IFU exist,
which are intended to indicate on
product or product packaging that
relevant information for use of the
product is available in electronic form
rather than, or in addition to, printed
paper form.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Glossary ...............................................................................
3,000
1
3,000
1
3,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
jbell on DSK3GLQ082PROD with NOTICES
TABLE 2—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 ...............................................................................
3,000
1
3,000
4
12,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
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09SEN1
47308
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
The estimated burden is based on the
data in a similar collection for
recommended glossary and educational
outreach approved under OMB control
number 0910–0553 (‘‘Use of Symbols on
Labels and in Labeling of In Vitro
Diagnostic Devices Intended for
Professional Use’’). As such, the PRA
also covers the requirements of the final
rule to submit the symbols glossary to
FDA in otherwise required submissions
during the premarket review process
and to disclose it to third parties in
otherwise required device labeling,
which means adding to such submission
or labeling a compiled listing of each
SDO-established symbol used in the
labeling for the device; the title and
designation number of the SDOdeveloped standard containing the
symbol; and the title of the symbol and
its reference number, if any, in the
standard; and the meaning or
explanatory text for the symbol as
provided in the FDA recognition or, if
FDA has not recognized the standard or
portion of the standard in which the
symbol is located or the symbol is used
not in accordance with the
specifications for use of the symbol set
out in the FDA section 514(c)
recognition, the explanatory text as
provided in the standard.
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: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19351 Filed 9–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3840]
Electronic Submissions; Data
Standards; Support for Unified Code
for Units of Measure
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing its adoption of the most
current set of the Unified Code for Units
of Measure (UCUM) codes. The UCUM
is a terminology standard that contains
a system of coding units of measure
used in science and medicine. UCUM
offers a single coding system for units of
measure that does not contain
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
ambiguities amongst electronic
communication, and assigns a concise
semantics to each defined unit. FDA is
encouraging sponsors and applicants to
use UCUM standard for drug
establishment registration and drug
listing, as well as for content of product
labeling provided in regulatory
submissions to the Center for Biologics
Evaluation and Research and the Center
for Drug Evaluation and Research.
ADDRESSES: You may submit either
electronic or written comments at any
time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
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–
2019–N–3840 for ‘‘Electronic
Submissions; Data Standards; Support
for Unified Code for Units of Measure.’’
Received comments will be placed in
the docket and, except for those
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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 laws.
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:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: On May
23, 2005, the Secretary of the
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47306-47308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19351]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0549]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices; Use
of Symbols in Labeling--Glossary To Support the Use of Symbols in
Labeling
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 (PRA).
DATES: Fax written comments on the collection of information by October
9, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0740.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: 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,
[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.
[[Page 47307]]
Medical Devices; Use of Symbols in Labeling--Glossary To Support the
Use of Symbols in Labeling
OMB Control Number 0910-0740--Extension
In the Federal Register of June 15, 2016 (81 FR 38911), FDA issued
a final rule revising medical device and certain biological product
labeling regulations by explicitly allowing for the optional use in
medical device labeling of stand-alone symbols established in a
Standard Development Organization (SDO)-developed standard. In
particular, FDA will allow the use of stand-alone graphical
representations of information, or symbols, in the labeling for the
medical devices, if the symbols are established in a standard developed
by an SDO as long as: (1) The standard is recognized by FDA under its
authority under section 514(c) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used according to
the specifications for use of the symbol set forth in FDA's section
514(c) recognition, or alternatively, (2) if the symbol is not included
in a standard recognized by FDA under section 514(c) of the FD&C Act or
the symbol is in a standard recognized by FDA but is not used according
to the specifications for use of the symbol set out in the FDA section
514(c) recognition, the device manufacturer otherwise determines that
the symbol is likely to be read and understood by the ordinary
individual under customary conditions of purchase and use and uses the
symbol according to the specifications for use of the symbol set forth
in the SDO-developed standard. In addition, in either case, the symbol
must be explained in a written or electronic symbols glossary that is
included in the labeling for the medical device. Furthermore, the
labeling on or within the package containing the device must bear a
prominent and conspicuous statement identifying the location of the
glossary that is written in English or, in the case of articles
distributed solely in Puerto Rico or in a Territory where the
predominant language is one other than English, the predominant
language may be used. The use of such symbols must also comply with
other applicable labeling requirements of the FD&C Act, such as section
502(a) and (f) (21 U.S.C. 352(a) and (f)).
The respondents for this collection of information are domestic and
foreign device manufacturers who plan to use stand-alone symbols on the
labels and/or labeling for their devices marketed in the United States.
In the Federal Register of March 19, 2019 (84 FR 10100), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received the following comments:
Comment supporting the use of the existing rule to
continue the use of symbols without explanatory text, and including
additional instructions, as needed, in the symbols glossary.
Comment suggesting the development or use of the symbol
for electronic instructions for use be included.
Comment suggesting adding requirements regarding education
on the meaning of symbols in devices.
Comment requesting future support on the use of
``homegrown'' or proprietary symbols not contained in a standard from a
recognized SDO to reduce burden on space limited areas.
Several comments requesting that we not mandate the
inclusion of the title and designation number in the glossary because
the commenters believe they are not necessary for the user of the
medical device to understand the symbol. The commenters assert that
removing the requirement for title and designation number may permit
more symbols glossaries to be included in a paper Instructions for Use
(IFU) versus needing to be on a website due to the amount of
information needed. The commenters assert this is beneficial in that it
may permit more users to see the glossary more easily than going to a
web-based glossary. The comments also assert that information such as
the title and designation number could be part of the submission
content, rather than part of the labeling/IFU.
Comment suggesting the use of the International Standards
Organization (ISO) Symbol 1641 (Consult IFU) to replace the requirement
to bear a prominent and conspicuous statement identifying the location
of the symbols glossary. The comment asserts that use of ISO Symbol
1641 is believed to be globally well understood to indicate any
information needed to understand the proper use of the device is in the
IFU. Use of ISO symbol 1641 will also reduce burden and costs as the
statement in English requires translation for use in other countries,
whereas the symbol is universal.
FDA has reviewed and continues to consider comments to the extent
that they relate to this information collection. We note that we
continuously evaluate ways to improve stakeholder understanding of the
symbols rule. We have made no changes to the information collection at
this time as a result of the comments. Based upon comments received,
FDA also notes that existing symbols contained within standards for an
electronic IFU exist, which are intended to indicate on product or
product packaging that relevant information for use of the product is
available in electronic form rather than, or in addition to, printed
paper form.
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 Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary........................................................... 3,000 1 3,000 1 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--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........................................................... 3,000 1 3,000 4 12,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 47308]]
The estimated burden is based on the data in a similar collection
for recommended glossary and educational outreach approved under OMB
control number 0910-0553 (``Use of Symbols on Labels and in Labeling of
In Vitro Diagnostic Devices Intended for Professional Use''). As such,
the PRA also covers the requirements of the final rule to submit the
symbols glossary to FDA in otherwise required submissions during the
premarket review process and to disclose it to third parties in
otherwise required device labeling, which means adding to such
submission or labeling a compiled listing of each SDO-established
symbol used in the labeling for the device; the title and designation
number of the SDO-developed standard containing the symbol; and the
title of the symbol and its reference number, if any, in the standard;
and the meaning or explanatory text for the symbol as provided in the
FDA recognition or, if FDA has not recognized the standard or portion
of the standard in which the symbol is located or the symbol is used
not in accordance with the specifications for use of the symbol set out
in the FDA section 514(c) recognition, the explanatory text as provided
in the standard.
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: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19351 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P