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, 65036-65037 [E7-22492]
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65036
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
610, 660, 803, and 807 (21 CFR parts
201, 207, 211, 600, 601, 606, 607, 610,
660, 803, and 807). The collections of
information in §§ 606.121, 606.122, and
610.40 have been approved under OMB
Control No. 0910–0116; § 610.2 has been
approved under OMB Control No. 0910–
0206; §§ 600.12(e) and 600.80 have been
approved under OMB Control No. 0910–
0308; §§ 601.2(a), 601.12, 610.60,
610.61, 610.62, 610.67, 660.2(c),
660.28(a) and (b), 660.35(a), (c) through
(g), and (i) through (m), 660.45, and
660.55(a) and (b) have been approved
under OMB Control No. 0910–0338;
§§ 803.20, 803.50, and 803.53 have been
approved under OMB Control No. 0910–
0437; and §§ 600.14 and 606.171 have
been approved under OMB Control No.
0910–0458. The current good
manufacturing practice regulations for
finished pharmaceuticals (part 211)
have been approved under OMB Control
No. 0910–0139; the establishment
registration regulations (parts 207, 607,
and 807) have been approved under
OMB Control Nos. 0910–0045, 0910–
0052, and 0910–0387; and the labeling
regulations (part 201) have been
approved under OMB Control Nos.
0910–0340 and 0910–0370.
In the Federal Register of July 23,
2007 (72 FR 40157), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received
on the information collection.
Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–22489 Filed 11–16–07; 8:45 am]
BILLING CODE 4160–01–S
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,
rwilkins on PROD1PC63 with NOTICES
HHS.
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
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
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\19NON1.SGM
19NON1
65037
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
ESTIMATED ANNUAL REPORTING BURDEN1
Section 502 FFD&C Act/Section 351
PHS Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Glossary
1,742
1
1,742
4
6,9682
Educational Outreach
1,742
1
1,742
16
27,872
Total
34,840
1 There
2 One
are no capital costs or operating and maintenance costs associated with this collection of information.
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]
rwilkins on PROD1PC63 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Animal Drug User Fees and Fee
Waivers and Reductions–21 CFR Part
740 (OMB Control Number 0910–
0540)—Extension
[Docket No. 2007N–0219]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Drug User
Fees and Fee Waivers and Reductions
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0540. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of the 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Public Law 108–130), amended the
Federal Food, Drug, and Cosmetic Act
and requires FDA to assess and collect
user fees for certain applications,
products, establishments, and sponsors.
It also requires the agency to grant a
waiver from, or a reduction of, those
fees in certain circumstances. Thus, to
implement this statutory provision of
ADUFA, FDA developed a guidance
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees.
Further, this guidance also describes the
types of fees and fee waivers and
reductions, what information FDA
recommends be submitted in support of
a request for a fee waiver or reduction,
how to submit such a request, and
FDA’s process for reviewing requests.
Requests for waivers or reductions may
be submitted by a person paying any of
the animal drug user fees assessed—
application fees, product fees,
establishment fees, or sponsor fees.
In the Federal Register of June 14,
2007 (72 FR 32851), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents to this collection of
information are new animal drug
sponsors.
FDA estimates the burden for this
collection of information as follows:
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65036-65037]
From the Federal Register Online via the Government Printing 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 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\
----------------------------------------------------------------------------------------------------------------
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
