
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10100-10101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05133]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0549]


Agency Information Collection Activities; Proposed Collection; 
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 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 product labeling regulations to explicitly 
allow for the optional inclusion of graphical representations of 
information, or symbols, in labeling (including labels) without 
adjacent explanatory text (referred to in this document as ``stand-
alone symbols'') if certain requirements are met.

DATES: Submit either electronic or written comments on the collection 
of information by May 20, 2019.

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 May 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 20, 2019. 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 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-0549 for ``Use of Symbols in Labeling.'' 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: 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: 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

[[Page 10101]]

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.

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.
    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
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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\
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                                                                                         Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures      per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary...........................................................           3,000                1            3,000                4           12,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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: March 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05133 Filed 3-18-19; 8:45 am]
BILLING CODE 4164-01-P


