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, 50373-50374 [E7-17217]
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Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Notices
beneficiaries on a mandatory basis into
managed care entities without section
1115 or 1915(b) waiver authority;
Frequency: On occasion; Affected
Public: State, local, or tribal
government; Number of Respondents:
56; Total Annual Responses: 10; Total
Annual Hours: 100.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on October 30, 2007.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto, Room
C4–26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
conducting of adolescent pregnancy
approaches. They are the only research
group currently conducting a study of
size and scope that provides for access
to schools and study participants for the
collection of additional data needed.
Building on the existing study already
underway saves the cost of initiating a
study from the ground up.
FOR FURTHER INFORMATION CONTACT: Stan
Koutstaal, Ph.D., Director, Division of
Abstinence Education, Family and
Youth Services Bureau, ACYF, ACF,
DHHS. Portals Building, Suite 800, 1250
Maryland Avenue, SW., Washington,
DC 20024; 202–401–6959.
Dated: August 24, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–17351 Filed 8–30–07; 8:45 am]
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
BILLING CODE 4120–01–P
Administration on Children,
Youth, and Families (ACYF), ACF,
DHHS.
ACTION: Notice.
AGENCY:
sroberts on PROD1PC70 with NOTICES
Food and Drug Administration
[Docket No. 2007N–0325]
ACTION:
Notice of Award of Non-Competitive
Grant
CFDA No.: 93.010, Community-Based
Abstinence Education.
Legislative Authority: Title XI, Section
1110 of the Social Security Act.
Amount of Award: $2,500,000.
Project Period: September 30, 2007–
March 30, 2009 (18 months).
Justification for the Exception to
Competition: ACYF will award service
grant funds without competition to the
Prevention Research Center at the
University of Texas Health Science
Center at Houston to build on a
longitudinal study they are currently
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
Administration for Children and
Families
00:43 Aug 31, 2007
BILLING CODE 4184–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Aug<31>2005
Dated: August 24, 2007.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. E7–17216 Filed 8–30–07; 8:45 am]
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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
50373
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or 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.
ADDRESSES:
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.
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.
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\31AUN1.SGM
31AUN1
50374
Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Notices
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 BURDEN1
Section 502 of the FFD&C Act/Section 351 of the 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
6
27,872
Total
34,840
1 There
sroberts on PROD1PC70 with NOTICES
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
VerDate Aug<31>2005
00:43 Aug 31, 2007
Jkt 211001
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0330]
Presidential Interagency Working
Group on Import Safety; Public
Meeting
Food and Drug Administration,
HHS.
PO 00000
Frm 00053
Fmt 4703
SUMMARY: The Interagency Working
Group on Import Safety (Working
Group) is announcing a public meeting
to identify actions the public and
private sectors can take to promote the
safety of products imported into the
United States. The Working Group was
created by the Executive order on July
18, 2007.
The public meeting will be held
on October 1, 2007, from 8 a.m. to 6
p.m. Persons interested in attending the
meeting in person or by teleconference
must register by September 17, 2007.
See section III.B of the SUPPLEMENTARY
INFORMATION section of this document
for details on how to register. Submit
written or electronic comments by
October 1, 2007.
DATES:
BILLING CODE 4160–01–S
AGENCY:
Notice of public meeting;
request for comments.
ACTION:
Sfmt 4703
The public meeting will be
held in the Jefferson Auditorium, U.S.
Department of Agriculture, 1400
Independence Ave., SW., South Bldg.,
Washington, DC 20090. The public may
ADDRESSES:
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Notices]
[Pages 50373-50374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17217]
-----------------------------------------------------------------------
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: https://www.fda.gov/dockets/ecomments or 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: 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
