[Federal Register: August 5, 2004 (Volume 69, Number 150)]
[Notices]               
[Page 47448-47450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au04-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0383]

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

[[Page 47449]]


ACTION: Notice.

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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 (the PRA).

DATES: Fax written comments on the collection of information by 
September 7, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA 250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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.

Recommended Glossary and Educational Outreach to Support Use of Symbols 
on Labels and in Labeling of In Vitro Diagnostic Devices Intended for 
Professional Use

    This document provides guidance on the voluntary use of selected 
symbols in place of text to convey some of the information required for 
in vitro diagnostic devices (IVDs) intended for professional use under 
Sec.  809.10 (21 CFR 809.10) (FDA's labeling requirements for IVDs) and 
parts 610 and 660 (21 CFR parts 610 and 660) (FDA's labeling 
requirements for biologics (including IVDs)) that are licensed under 
the Public Health Service Act. Use of these symbols will not result in 
a new collection of information but is a means of fulfilling underlying 
labeling requirements that are subject to OMB clearance. Under section 
502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
352), 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.
    This 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, this guidance recommends an educational 
outreach effort to enhance the understanding of newly introduced 
symbols. Both the glossary and the educational outreach help to ensure 
that IVD users will have enough general familiarity with the symbols, 
as well as quick reference materials available, to be likely to 
understand the symbols used in IVD labeling, further ensuring that such 
labeling satisfies the requirements of section 502(c) of the act.
    Respondents: The likely respondents are IVD manufacturers who plan 
to use the selected symbols in place of text on the labels and/or 
labeling of their IVDs.
    In the Federal Register of October 28, 2003 (68 FR 61449), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received one comment regarding information 
collection from a manufacturer. This comment stated ``We believe no 
additional educational outreach is needed for the symbols contained 
within the draft guidance document. A user comprehension study was 
conducted showing acceptance of these symbols and an explanation is 
provided in the glossary.'' FDA disagrees with this comment. The 
educational outreach will enhance the understanding of the newly 
introduced symbols among the intended audience.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                    Annual Frequency        Total Annual
                 Activity                    No. of Respondents       per Responses           Responses        Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary                                         1,742                     1                 1,742                     4                6,9681
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Educational outreach                             1,742                     1                 1,742                    16                27,872
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 would be carried 
out by domestic and foreign IVD manufacturers. The Center for Devices 
and Radiological Health Information Retrieval System's Registration and 
Listing Information database provided the number of IVD manufacturers 
as 1,742; 1,206 are domestic IVD manufacturers and 536 are 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, as shown in the draft guidance, 
for the specific symbols used in labels or labeling for the IVDs they 
manufacture. The 16-hour estimate for educational outreach includes 
activities manufacturers will use to educate the various professional 
users of IVDs about the meaning of the IVD symbols. This estimate is 
based on FDA 's expectation that IVD manufacturers will jointly sponsor 
many educational outreach activities.
    The draft guidance document also refers to labeling requirements, 
annual reporting requirements, and other information collections 
established under existing regulations. The collections of information 
described in section III of the guidance that result from Sec.  809.10 
were approved under OMB control number 0910-0485. The collections of 
information described in

[[Page 47450]]

section III of the guidance that result from Sec. Sec.  610.60, 610.61, 
and 610.62 were approved under OMB control number 0910-0338. In 
accordance with section 3506(c)(2)(A) of the PRA, a 60-day notice 
soliciting public comment on the collections of information described 
in section III of the guidance that result from part 660 (Sec. Sec.  
660.2, 660.28, 660.35, 660.45, and 660.55) published in the Federal 
Register of July 22, 2003 (68 FR 43359). The collections of information 
described in section X of the guidance, regarding annual reports, were 
approved under OMB control numbers 0910-0231 and 0910-0315. The 
collections of information described in section X of the guidance, 
regarding adverse event reporting, were approved under OMB control 
numbers 0910-0437 and 0910-0291.

    Dated: July 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17879 Filed 8-4-04; 8:45 am]

BILLING CODE 4160-01-S