[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Pages 1169-1170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-74]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.


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

[[Page 1170]]

(OMB) for review and clearance under the Paperwork Reduction Act of 

DATES: Fax written comments on the collection of information by 
February 7, 2011.

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 e-mailed 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.

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

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)--

    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 
    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.
    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.
    In the Federal Register of October 5, 2010 (75 FR 61494), 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 

                                 Table 1--Estimated Annual Reporting Burden \1\
  Section 502 of the FD&C Act/       Number of     frequency per   Total annual      Hours per      Total hours
   Section 351 of the PHS Act       respondents      response        responses       response
Glossary........................             689               1             689               4           2,756
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-74 Filed 1-6-11; 8:45 am]