Agency Information Collection Activities; Proposed Collection; 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, 55724-55725 [2013-22110]
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55724
Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices
Explanation of Recordkeeping Burden
Estimate. FDA expects that at least some
of the manufacturers will be able to
satisfy the PS requirement using
information or data they already have.
For purposes of calculating burden,
however, FDA has assumed that each PS
order can only be satisfied by a 3-year
clinically based surveillance plan, using
three investigators. These estimates are
based on FDA’s knowledge and
experience with postmarket
surveillance.
Dated: September 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22013 Filed 9–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013-N–1089]
Agency Information Collection
Activities; Proposed Collection;
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.
ACTION:
Notice.
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 either electronic or
written comments on the collection of
information by November 12, 2013.
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
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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16:50 Sep 10, 2013
Jkt 229001
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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
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.
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)
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
(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
help to ensure that IVD users 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.
The glossary activity is inclusive of
both domestic and foreign IVD
manufacturers. FDA receives
submissions from approximately 689
IVD manufacturers annually. 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.
E:\FR\FM\11SEN1.SGM
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Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices
55725
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Activity
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure
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.
Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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:
[FR Doc. 2013–22110 Filed 9–10–13; 8:45 am]
BILLING CODE 4160–01–P
Evaluation of FDA’s General Market
Youth Tobacco Prevention
Campaigns—(OMB Control Number
0910–New)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0717]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Food and Drug Administration’s
General Market Youth Tobacco
Prevention Campaigns
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 11,
2013.
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–New and
title ‘‘Evaluation of FDA’s General
Market Youth Tobacco Prevention
Campaigns’’. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amends
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to grant FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health and to
reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21
U.S.C. 393(d)(2)(D)) supports the
development and implementation of
FDA public education campaigns
related to tobacco use. Accordingly,
FDA is currently developing and
implementing youth-targeted public
education campaigns to help prevent
tobacco use among youth and thereby
reduce the public health burden of
tobacco. The campaigns will feature
televised advertisements along with
complementary ads on radio, on the
Internet, in print, and through other
forms of media.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use by minors, FDA requests
OMB approval to collect information
needed to evaluate FDA’s general
market youth tobacco prevention
campaigns. Comprehensive evaluation
of FDA’s public education campaigns is
needed to ensure campaign messages
are effectively received, understood, and
accepted by those for whom they are
intended. Evaluation is an essential
organizational practice in public health
and a systematic way to account for and
improve public health actions.
FDA plans to conduct two studies to
evaluate the effectiveness of its youth
tobacco prevention campaigns: (1) An
outcome evaluation study consisting of
a youth experimenter and non-trier
initiative and a male only youth rural
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smokeless initiative and (2) a media
tracking survey. The timing of these
studies will be designed to follow the
multiple, discrete waves of media
advertising planned for the campaigns.
• Outcome Evaluation Study. The
outcome evaluation study consists of an
initial baseline survey of youth aged 11
to 16 before the campaigns launch. The
baseline will be followed by three
longitudinal followup surveys of the
same youth, aged 11 to 16, at
approximate 8-month intervals after the
campaigns launch. As the cohort will be
aging over this time period, the data
collected throughout the study will
reflect information from youth aged 11
to 18. Information will be collected
about youth awareness of and exposure
to campaign advertisements and about
youth knowledge, attitudes, and beliefs
related to tobacco use. In addition, the
surveys will measure tobacco use
susceptibility and current use.
Information will also be collected on
demographic variables including age,
sex, race/ethnicity, grade level, and
primary language. Finally, a baseline
survey will also be conducted with the
parent or legal guardian of each youth
baseline survey participant in order to
collect data on household
characteristics and media use.
• Media Tracking Survey. The media
tracking survey consists of assessments
of youth aged 13 to 17 conducted at 4
months, 12 months, and 20 months post
launch. The tracking survey will assess
awareness of the campaigns and
receptivity to campaign messages. These
data will provide critical evaluation
feedback to the campaigns and will be
conducted with sufficient frequency to
match the cyclical patterns of media
advertising and variation in exposure to
allow for mid-campaign refinements.
All information will be collected
through in-person and Web-based
questionnaires. Youth respondents will
be recruited from two sources: (1) A
probability sample drawn from 90 U.S.
media markets gathered using an
address-based postal mail sampling of
U.S. households for the outcome
evaluation study and (2) an Internet
E:\FR\FM\11SEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55724-55725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22110]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1089]
Agency Information Collection Activities; Proposed Collection;
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.
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 either electronic or written comments on the collection
of information by November 12, 2013.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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 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.
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 help to ensure that
IVD users 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.
The glossary activity is inclusive of both domestic and foreign IVD
manufacturers. FDA receives submissions from approximately 689 IVD
manufacturers annually. 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.
[[Page 55725]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary................................................. 689 1 689 4 2,756
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22110 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P
