[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55724-55725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1089]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 the reporting requirements for 
the collection ``Recommended Glossary and Educational Outreach to 
Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic 
Devices Intended for Professional Use.''

DATES: Submit either electronic or written comments on the collection 
of information by November 12, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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 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.

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 so that it is not misbranded. 
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.
    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 guidance 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. Under section 502(c) of the FD&C Act, a drug or device is 
misbranded, ``. . . If any word, statement, or other information 
required by or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such conspicuousness 
(as compared with other words, statements, designs, or devices, in the 
labeling) and in such terms as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.''
    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.

[[Page 55725]]

    FDA estimates the burden of this collection of information as 
follows:

                                                 Table 1--Estimated Annual Third-Party Disclosure Burden
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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: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22110 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P