Document ID: FDA-2010-N-0492-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Posted Date: 2010-10-05T04:00Z

[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]               
[Page 61494-61495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc10-108]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0492]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices: 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 written or electronic comments on the collection of 
information by December 6, 2010.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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

[[Page 61495]]

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.

Medical Devices: 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 will help to ensure 
that IVD users will 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
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 Section 502 of the FD&C Act/Section 351 of the                          Annual Frequency       Total Annual          Hours per
                     PHS Act                       No. of  Respondents     per Response           Responses           Response           Total Hours
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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.

    The glossary activity is inclusive of both domestic and foreign IVD 
manufacturers. FDA receives submissions from approximately 689 IVD 
manufacturers annually. The number of hours per response for the 
glossary and educational outreach activities were derived from 
consultation with a trade association and FDA personnel. 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.

    Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25008 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S