[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]


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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.

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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.

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 [email protected]. 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, [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.

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\
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                                                                                         Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Glossary...........................................................             689                1              689                4            2,756
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\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