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, 1169-1170 [2011-74]
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1169
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
intended to gauge and track consumer
attitudes, awareness, knowledge, and
behavior regarding various topics
related to health, nutrition and physical
activity. The authority for FDA to
collect the information derives from
FDA’s Commissioner of Food and Drugs
authority provided in section 903(d)(2)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)).
The survey consists of two
independent data collection activities.
One collection, entitled ‘‘Health and
Diet Survey—General Topics,’’ tracks a
broad range of consumer attitudes,
awareness, knowledge, and self-reported
behaviors related to key diet and health
issues. The other collection, entitled
‘‘Health and Diet Survey—Dietary
Guidelines Supplement,’’ will provide
FDA with updated information about
consumer attitudes, awareness,
knowledge, and behavior regarding
various elements of nutrition and
physical activity based on the key
recommendations of the Dietary
Guidelines for Americans, which are
jointly issued by the Department of
Health and Human Services and the
U.S. Department of Agriculture every
5 years.
The information to be collected with
the Health and Diet Survey—General
Topics will include: (1) Awareness of
diet-disease relationships, (2) food and
dietary supplement label use, (3) dietary
practices including strategies to lose or
maintain weight, and (4) awareness and
knowledge of dietary fats. This survey
has been repeated approximately every
3 years over the course of the past
several years for the purpose of tracking
changes and trends in public opinions
and consumer behavior, with some new
questions added or omitted or partially
modified each iteration in response to
current events. In the next 3 years, FDA
plans to field the Health and Diet
Survey—General Topics in 2012 and
anticipates that it might have the need
for additional iterations in 2014. The
information to be collected with the
Health and Diet Survey—Dietary
Guidelines Supplement will include: (1)
Awareness and sources of information,
(2) attitudes toward diet and physical
activity, and (3) practice and knowledge
related to recommended behaviors. The
survey will also ask about perceptions
and use of Federal nutrition
information, special diet, weight status,
health status, and demographics. In the
next 3 years, FDA anticipates to field
the Health and Diet Survey—Dietary
Guidelines Supplement in 2011–2012.
FDA and other Federal Agencies will
use the information from the Health and
Diet Survey to evaluate and develop
strategies and programs to encourage
and help consumers adopt healthy
lifestyles. The information will also
help FDA and other Federal Agencies
evaluate and track consumer awareness
and behavior as outcome measures of
their achievement in improving public
health.
Description of Respondents: The
respondents are adults, age 18 and
older, drawn from the 50 States and the
District of Columbia. Participation will
be voluntary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
General Topics: Pretest .......................................................
General Topics: Screener ....................................................
General Topics: Survey .......................................................
Dietary Guidelines Supplement: Screener ..........................
Dietary Guidelines Supplement: Survey ..............................
27
10,000
3,000
4,000
1,200
1
1
1
1
1
27
10,000
3,000
4,000
1,200
0.25
0.02
0.25
0.02
0.22
7
200
750
80
264
Total ..............................................................................
........................
........................
........................
........................
1,301
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of the number
of respondents and the hours per
response on its experience with
previous Health and Diet Surveys. Prior
to the administration of the Health and
Diet Survey—General Topics, the
Agency plans to conduct a pretest to
identify and resolve potential problems.
The pretest will be conducted with 27
participants; we estimate that it will
take a respondent 15 minutes (0.25
hours) to complete the pretest, for a total
of 6.75 hours, rounded to 7. The Agency
will use a screener to select an eligible
adult respondent in each household to
participate in the survey. For the Health
and Diet Survey—General Topics data
collection activity, a total of 10,000
individuals in the 50 States and the
District of Columbia will be screened by
telephone. We estimate that it will take
a respondent 1.2 minutes (0.02 hours) to
complete the screening, for a total of 200
hours. We estimate that 3,000 eligible
adults will participate in the survey,
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each taking 15 minutes (0.25 hours), for
a total of 750 hours. For the Health and
Diet Survey—Dietary Guidelines
Supplement data collection activity,
4,000 individuals in the 50 States and
the District of Columbia will be
screened by telephone. We estimate that
it will take a respondent 1.2 minutes
(0.02 hours) to complete the screening
questions, for a total of 80 hours. Of
these respondents, 1,200 will complete
the survey. We estimate that it will take
a respondent 13 minutes (0.22 hours) to
complete the entire survey, for a total of
264 hours. Thus, the total estimated
burden is 1,301 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
HHS.
[FR Doc. 2011–85 Filed 1–6–11; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2010–N–0492]
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:
ACTION:
Food and Drug Administration,
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:
E:\FR\FM\07JAN1.SGM
07JAN1
1170
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February 7,
2011.
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 e-mailed to
oira_submission@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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–5156, e-mail:
Daniel.Gittleson@fda.hhs.gov.
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—
(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.
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.
In the Federal Register of October 5,
2010 (75 FR 61494), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Section 502 of the FD&C Act/Section 351 of the PHS Act
Glossary ...............................................................................
1 There
689
Total annual
responses
1
689
Hours per
response
Total hours
4
2,756
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–74 Filed 1–6–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0610]
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jdjones on DSK8KYBLC1PROD with NOTICES
Annual
frequency per
response
Draft Guidance for Industry on
Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Postmarketing
Adverse Event Reporting for Medical
Products and Dietary Supplements
During an Influenza Pandemic.’’ The
draft guidance discusses FDA’s
intended approach to enforcement of
adverse event reporting requirements for
drugs, biologics, medical devices, and
dietary supplements during an
influenza pandemic. The agency makes
recommendations to industry for
focusing limited resources on reports
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1169-1170]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-74]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0492]
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
[[Page 1170]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Fax written comments on the collection of information by
February 7, 2011.
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 e-mailed to oira_submission@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:
Daniel Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, e-mail: Daniel.Gittleson@fda.hhs.gov.
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--(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.
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.
In the Federal Register of October 5, 2010 (75 FR 61494), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Section 502 of the FD&C Act/ Number of frequency per Total annual Hours per Total hours
Section 351 of the PHS Act respondents response responses response
----------------------------------------------------------------------------------------------------------------
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: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-74 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P
