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, 61494-61495 [2010-25008]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
effectiveness review prevented
marketing of the product. The length of
the patent term extension is generally
limited to a maximum of 5 years, and
is calculated by PTO based on a
statutory formula. When a patent holder
submits an application for patent term
extension to PTO, PTO requests
information from FDA, including the
length of the regulatory review period
for the patented product. If PTO
concludes that the product is eligible for
patent term extension, FDA publishes a
notice that describes the length of the
regulatory review period and the dates
used to calculate that period. Interested
parties may request, under § 60.24 (21
CFR 60.24), revision of the length of the
regulatory review period, or may
petition under § 60.30 (21 CFR 60.30) to
reduce the regulatory review period by
any time where marketing approval was
not pursued with ‘‘due diligence.’’ The
statute defines due diligence as ‘‘that
degree of attention, continuous directed
effort, and timeliness as may reasonably
be expected from, and are ordinarily
exercised by, a person during a
regulatory review period.’’ As provided
in § 60.30(c), a due diligence petition
‘‘shall set forth sufficient facts, including
dates if possible, to merit an
investigation by FDA of whether the
applicant acted with due diligence.’’
Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates
whether any change in the regulatory
review period is necessary. If so, the
corrected regulatory review period is
published in the Federal Register. A
due diligence petitioner not satisfied
with FDA’s decision regarding the
petition may, under § 60.40 (21 CFR
60.40), request an informal hearing for
reconsideration of the due diligence
determination. Petitioners are likely to
include persons or organizations having
knowledge that FDA’s marketing
permission for that product was not
actively pursued throughout the
regulatory review period. The
information collection for which an
extension of approval is being sought is
the use of the statutorily created due
diligence petition.
Since 1992, 12 requests for revision of
the regulatory review period have been
submitted under § 60.24. For 2007,
2008, and 2009, a total of three, or one
per year, have been submitted under
§ 60.24. Two regulatory review periods
have been altered. During that same
time period, two due diligence petitions
were submitted to FDA under § 60.30,
for an average of fewer than one per
year. There have been no requests for
hearings under § 60.40 regarding the
decisions on such petitions; however,
for purposes of this information
collection approval, we are estimating
that we may receive one submission
annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
60.24(a)
1
100
1
100
100
60.30
1
50
1
50
50
60.40
1
100
1
10
10
Total
160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25010 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2010–N–0492]
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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
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 collection of
information, 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.’’
Submit written or electronic
comments on the collection of
information by December 6, 2010.
DATES:
Submit electronic
comments on the collection of
information to https://
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.
ADDRESSES:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05OCN1.SGM
05OCN1
61495
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
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.
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
(OMB Control Number 0910–0553)—
Extension
Section 502 of the Federal Food, Drug
and Cosmetic Act (the FD&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 FD&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 FD&C 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 of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Section 502 of the FD&C
Act/Section 351 of the PHS
Act
No. of
Respondents
Glossary
mstockstill on DSKH9S0YB1PROD with NOTICES
1 There
Annual Frequency
per Response
689
Total Annual
Responses
1
Hours per
Response
689
Total Hours
4
2,756
are no capital costs or operating and maintenance costs associated with this collection of information.
The glossary activity is inclusive of
both domestic and foreign IVD
manufacturers. FDA receives
submissions from approximately 689
IVD manufacturers annually. 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2010–25008 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
Food and Drug Administration
[Docket No. FDA–2010–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Food and
Drug Administration Regulated
Products: Export Certificates
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
4, 2010.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0498. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
E:\FR\FM\05OCN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61494-61495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0492]
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 collection of
information, 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 December 6, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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
[[Page 61495]]
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.
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 (OMB Control Number 0910-0553)--
Extension
Section 502 of the Federal Food, Drug and Cosmetic Act (the FD&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 FD&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 FD&C 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 of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 502 of the FD&C Act/Section 351 of the Annual Frequency Total Annual Hours per
PHS Act No. of Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary 689 1 689 4 2,756
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The glossary activity is inclusive of both domestic and foreign IVD
manufacturers. FDA receives submissions from approximately 689 IVD
manufacturers annually. 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.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25008 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
