[Federal Register: November 19, 2007 (Volume 72, Number 222)]
[Notices]
[Page 65036-65037]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no07-58]
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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.
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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.
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 baguilar@omb.eop.gov. 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\
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Section 502 FFD&C
Act/Section 351 No. of Annual Frequency Total Annual Hours per Total Hours
PHS Act Respondents per Response Responses Response
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Glossary 1,742 1 1,742 4 6,968\2\
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Educational 1,742 1 1,742 16 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: 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