[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]


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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.

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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 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.

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.

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
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                                                                                         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
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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


