[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50373-50374]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au07-110]
-----------------------------------------------------------------------
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
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Glossary 1,742 1 1,742 4 6,968\2\
----------------------------------------------------------------------------------------------------------------
Educational 1,742 1 1,742 6 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: 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