[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Notices]
[Pages 50373-50374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17217]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0325]


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 information 
collection, 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 October 30, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or 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: Denver Presley, Jr., Office of Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

[[Page 50374]]

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--Section 502 of the Federal Food, 
Drug and Cosmetic Act/Section 351 of the Public Health Service Act (OMB 
Control Number 0910-0553)--Extension

    Section 502 of the Federal Food, Drug and Cosmetic Act (FFD&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 FFD&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 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 for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  Section 502 of
  the FFD&C Act/         No. of        Annual Frequency     Total Annual        Hours per
  Section 351 of      Respondents        per Response        Responses           Response         Total Hours
   the PHS Act
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Glossary                       1,742                  1              1,742                  4           6,968\2\
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Educational                    1,742                  1              1,742                  6             27,872
 Outreach
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Total                                                                                                    34,840
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One time burden.

    The glossary and educational outreach activities are inclusive of 
both domestic and foreign IVD manufacturers. The Center for Devices and 
Radiological Health's ``Information Retrieval System's Registration and 
Listing Information'' database listed the total number of IVD 
manufacturers as 1,742. From this total, 1,206 of the IVD manufacturers 
were listed as domestic and 536 were listed as foreign manufacturers. 
Consequently, FDA has based its burden estimate on the maximum possible 
number of manufacturers choosing to implement the use of symbols in 
labeling. 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. The 16-hour estimate for educational outreach is 
inclusive of activities manufacturers used to educate the various 
professional users of IVDs regarding the meaning of the IVD symbols. 
Further, this estimate is based on FDA's expectation that IVD 
manufacturers will jointly sponsor many more educational outreach 
activities.

    Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17217 Filed 8-30-07; 8:45 am]
BILLING CODE 4160-01-S