[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65036-65037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22492]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0325]


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 (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 19, 2007.

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: 202-395-6974, 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.

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: 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--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, FDA published a 
notice of availability of the final 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 FFD&C Act and section 351 of 
the PHS Act.
    In the Federal Register of August 31, 2007 (72 FR 50373), FDA 
published a 60-day notice soliciting public comment on the proposed 
collection of information provisions. No comments were received.
    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:

[[Page 65037]]



                                      Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section 502 FFD&C
 Act/Section 351         No. of        Annual Frequency     Total Annual        Hours per         Total Hours
     PHS Act          Respondents        per Response        Responses           Response
----------------------------------------------------------------------------------------------------------------
Glossary                       1,742                  1              1,742                  4           6,968\2\
----------------------------------------------------------------------------------------------------------------
Educational                    1,742                  1              1,742                 16             27,872
 Outreach
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     34,840
----------------------------------------------------------------------------------------------------------------
\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: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22492 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S