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, 87570-87572 [2016-29104]
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Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2896 for ‘‘Public Meeting on
Pre-Market Evaluation of AbuseDeterrent Properties of Opioid Drug
Products; Extension of Comment
Period.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Silver Spring, MD 20993, 301–796–
4714, Michelle.Eby@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the
Federal Register of October 6, 2016 (81
FR 69532), FDA published a notice
announcing a public meeting and
requesting comments on the approach to
testing FDA recommended in its draft
guidance ‘‘General Principles for
Evaluating the Abuse Deterrence of
Generic Solid Oral Opioid Drug
Products’’ 1 and FDA’s efforts to develop
standardized in vitro testing
methodologies for evaluating the abuse
deterrence of opioid drug products. The
comment period ends on December 1,
2016. Because the Agency has received
requests for an extension to allow
interested persons additional time to
submit comments, FDA is extending the
comment period until January 3, 2017.
Additional comments specific to the
draft guidance ‘‘General Principles for
Evaluating the Abuse Deterrence of
Generic Solid Oral Opioid Drug
Products’’ should be submitted to the
docket for the draft guidance (FDA–
2016–D–0785) in lieu of, or in addition
to, the docket for the public meeting.
Although you can comment on any
guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 1,
2016. Other comments should be
submitted to this docket by January 3,
2016. FDA has committed to taking
steps to address the epidemic of opioid
abuse transparently and in close
cooperation with stakeholders and will
provide other opportunities to
comment, as appropriate. For example,
FDA intends to issue a general guidance
for public comment describing the
Agency’s recommendations for
standardized in vitro testing to evaluate
purported abuse-deterrent properties
and considerations for a potential
applicant as it develops an abusedeterrent formulation of an opioid drug
product.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29097 Filed 12–2–16; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Michelle Eby, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6184,
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@fdagov-drugs-gen/documents/document/
ucm492172.pdf.
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[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
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 February 3, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–1089 for ‘‘Recommended
Glossary and Educational Outreach To
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
VerDate Sep<11>2014
19:12 Dec 02, 2016
Jkt 241001
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
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87571
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 to avoid
misbranding. 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 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.
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
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Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
the specific symbols used in labels or
labeling for the IVDs manufactured.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
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: November 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
collection of information to OMB for
review and clearance.
Medical Device: Current Good
Manufacturing Practice Quality System
Regulations— OMB Control Number
0910–0073—Extension
[FR Doc. 2016–29104 Filed 12–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device:
Current Good Manufacturing Practice
Quality System Regulations
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 January 4,
2017.
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 0910–0073. 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, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Under section 520(f) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360j(f)), the
Secretary of the Department of Health
and Human Services has the authority
to prescribe regulations requiring that
the methods used in, and the facilities
and controls used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a device, but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to Current Good Manufacturing
Practice (CGMP), as described in such
regulations, to assure that the device
will be safe and effective and otherwise
in compliance with the FD&C Act.
The CGMP/Quality System (QS)
regulation implementing authority
provided by this statutory provision is
found under part 820 (21 CFR part 820)
and sets forth basic CGMP requirements
governing the design, manufacture,
packing, labeling, storage, installation,
and servicing of all finished medical
devices intended for human use. The
authority for this regulation is covered
under sections 501, 502, 510, 513, 514,
515, 518, 519, 520, 522, 701, 704, 801,
and 803 of the FD&C Act (21 U.S.C. 351,
352, 360, 360c, 360d, 360e, 360h, 360i,
360j, 360l, 371, 374, 381, and 383). The
CGMP/QS regulation includes
requirements for purchasing and service
controls, clarifies recordkeeping
requirements for device failure and
complaint investigations, clarifies
requirements for verifying/validating
production processes and process or
product changes, and clarifies
requirements for product acceptance
activities quality data evaluations and
corrections of nonconforming product/
quality problems.
Requirements are compatible with
specifications in the international
standards ‘‘ISO 9001: Quality Systems
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Model for Quality Assurance in Design/
Development, Production, Installation,
and Servicing.’’ The CGMP/QS
information collections will assist FDA
inspections of manufacturers for
compliance with QS requirements
encompassing design, production,
installation, and servicing processes.
Section 820.20(a) through (e) requires
management with executive
responsibility to establish, maintain,
and/or review the following topics: (1)
The quality policy, (2) the
organizational structure, (3) the quality
plan, and (4) the quality system
procedures of the organization. Section
820.22 requires the conduct and
documentation of QS audits and reaudits. Section 820.25(b) requires the
establishment of procedures to identify
training needs and documentation of
such training.
Section 820.30(a)(1) and (b) through
(j) requires, in respective order, the
establishment, maintenance, and/or
documentation of the following topics:
(1) Procedures to control design of class
III and class II devices and certain class
I devices as listed therein; (2) plans for
design and development activities and
updates; (3) procedures identifying,
documenting, and approving design
input requirements; (4) procedures
defining design output, including
acceptance criteria, and documentation
of approved records; (5) procedures for
formal review of design results and
documentation of results in the design
history file (DHF); (6) procedures for
verifying device design and
documentation of results and approvals
in the DHF; (7) procedures for validating
device design, including documentation
of results in the DHF; (8) procedures for
translating device design into
production specifications; (9)
procedures for documenting, verifying,
and validating approved design changes
before implementation of changes; and
(10) the records and references
constituting the DHF for each type of
device.
Section 820.40 requires manufacturers
to establish and maintain procedures
controlling approval and distribution of
required documents and document
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]]>Agencies
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87570-87572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29104]
-----------------------------------------------------------------------
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 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 February 3, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you
[[Page 87571]]
do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-1089 for ``Recommended Glossary and Educational Outreach To
Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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 to avoid misbranding. 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 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.
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
[[Page 87572]]
the specific symbols used in labels or labeling for the IVDs
manufactured.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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Glossary...................................................... 689 1 689 4 2,756
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29104 Filed 12-2-16; 8:45 am]
BILLING CODE 4164-01-P
