[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43690-43691]
[FR Doc No: 2011-18390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0149] (Formerly 2007D-0309)

Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Electrocardiograph
Electrodes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Electrocardiograph Electrodes.'' The special
controls identify the following risks to health associated with
electrocardiograph electrodes: Adverse tissue reaction to the skin-
contacting electrode materials and misdiagnosis. The guidance document
provides information on how to mitigate these risks and recommends
testing and labeling for these devices. This guidance document
describes a means by which electrocardiograph electrodes may comply
with the requirement of special controls for class II devices.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Electrocardiograph Electrodes'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the

Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments
with the docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1238, Silver Spring, MD 20993-0002, 301-
796-6322.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance describes a means by which electrocardiograph
electrodes may comply with the requirement of special controls for
class II devices. In the Federal Register of October 4, 2007 (72 FR
56771), and Docket No. FDA-2007D-0309, FDA proposed to classify
electrocardiograph electrodes, intended to acquire and transmit the
electrical signal at the body surface to a processor that produces an
electrocardiogram (ECG) or vectorcardiogram, into class II. FDA also
proposed to exempt this device from premarket notification requirements
and issued a draft guidance document to describe the special control
requirements. FDA invited interested persons to comment on the proposed
regulation and the draft guidance document by January 8, 2008. FDA
received seven comments on the proposed rule. These comments addressed
issues pertaining to labeling, the scope of the devices subject to the
classification rule, and testing. In response, FDA has revised the
labeling section of the guidance, has clarified the scope of the
guidance, and has clarified the information regarding testing for shelf
life. Elsewhere in this issue of the Federal Register, FDA is
publishing a final rule to classify electrocardiograph electrodes into
class II (special controls) and to exempt the device from 510(k)
premarket notification procedures.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of
electrocardiograph electrodes classified under Sec.  870.2360 (21 CFR
870.2360). In order to be classified as a class II device under Sec.
870.2360, an electrocardiograph electrode must comply with the
requirements of special controls; manufacturers must address the issues
requiring special controls as identified in the guidance document,
either by following the recommendations in the guidance document or by
some other means that provides equivalent assurances of safety and
effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.
    To receive ``Class II Special Controls Guidance Document:
Electrocardiograph Electrodes,'' you may either send an e-mail request
to<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a paper copy. Please use
the document number (1597) to identify the guidance you are
requesting.

IV. Paperwork Reduction Act

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130; the collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18390 Filed 7-20-11; 8:45 am]
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[Federal Register: April 1, 2008 (Volume 73, Number 63)]
[Notices]
[Page 17369-17370]
[DOCID:fr01ap08-66]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG 2008-0190]

Chemical Transportation Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of meetings.

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SUMMARY: The Chemical Transportation Advisory Committee (CTAC); its
Subcommittees on Outreach, National Fire Protection Association (NFPA)
472 Standard, Hazardous Cargo Transportation Security (HCTS), and
International Maritime Solid Bulk Cargoes (IMSBC) Code; as well as its
Working Group on Barge Emissions and Hazard Communication will meet in
Washington, DC, to discuss various issues relating to the marine
transportation of hazardous materials in bulk. These meetings will be
open to the public.

DATES: The Subcommittee on Outreach will meet on Tuesday, April 22,
2008, from 8 a.m. to 9:30 a.m. The Barge Emissions and Hazard
Communication Working Group will meet Tuesday, April 22, 2008, from
9:30 a.m. to 10:30 a.m. The Subcommittee on NFPA 472 Standard will meet
on Tuesday, April 22, 2008, from 1 p.m. to 2 p.m. The Subcommittee on
HCTS will meet on Tuesday, April 22, 2008, from 2:15 p.m. to 4 p.m. The
new Subcommittee on IMSBC Code will meet Wednesday, April 23, 2008,
from 8 a.m. to 3 p.m. The coordinator for the U.S. Coast Guard's
``Homeport'' will conduct training on the application of the Web site
for use by CTAC members on Wednesday, April 23, 2008, from 1 p.m. to 4
p.m. CTAC will meet on Thursday, April 24, 2008, from 9 a.m. to 3:30
p.m. These meetings may close early if all business is finished.
Written material and requests to make oral presentations should reach
the U.S. Coast Guard on or before April 18, 2008. Requests to have a
copy of your material distributed to each member of the committee
should

reach the U.S. Coast Guard on or before April 18, 2008.

ADDRESSES: CTAC and its Subcommittees and Working Group will be meeting
at U.S. Coast Guard Headquarters, 2100 Second Street, SW., Washington,
DC. Send written material and requests to make oral presentations to
Commander Rick Raksnis, Commandant (CG-5223), U.S. Coast Guard
Headquarters, 2100 Second Street, SW., Washington, DC 20593-0001. This
notice and documents identified in the Supplementary Information
section as being available in the docket may be viewed in our online
docket, USCG-2008-0190, at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Commander Rick Raksnis, Designated
Federal Officer (DFO) of CTAC, or Sara Ju, Assistant to the DFO,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).

Agendas of Meetings

    Chemical Transportation Advisory Committee (CTAC). The agenda
includes the following:
    (1) Progress report from the Outreach Subcommittee and its Barge
Emissions and Hazard Communication Working Group.
    (2) Status report on the HCTS Subcommittee.
    (3) Status report on the NFPA 472 Subcommittee.
    (4) Progress report on the IMSBC Code Subcommittee.
    (5) Presentation on U.S. Coast Guard Web site ``Homeport''.
    (6) Presentation on Transportation Security Administration (TSA) on
surface transportation security within the railroad industry.
    (7) Presentation on Hazardous Materials First Responder training
offered by the International Association of Fire Fighters.
    (8) Status report on the implementation of the Transportation
Worker Identification Credential (TWIC).
    (9) Presentation on the National Response Center (NRC).
    The Outreach Subcommittee. The Subcommittee will discuss the
application of the U.S. Coast Guard's Web site ``Homeport'' to help
advance its outreach activities.
    The Barge Emissions and Hazard Communication Working Group. The
Working Group will discuss emergency response contact numbers on barges
and various outreach efforts for first responders.
    The NFPA 472 Standard Subcommittee. The Subcommittee will review
its task statement and identify any outstanding items.
    The HCTS Subcommittee. The Subcommittee will discuss the status of
the Transportation Worker Identification Credential (TWIC) and proposed
changes to the Advanced Notice of Arrival (ANOA) process.
    The IMSBC Code Subcommittee. The Subcommittee will discuss the
following topics:
    (1) Adoption of the IMSBC Code and the requirements contained in
SOLAS Chapter VI for international shipments of solid bulk cargoes;
    (2) Harmonization of U.S. regulations with the IMSBC Code and SOLAS
Chapter VI; and
    (3) Incorporation of requirements and best practices for the safe
transport of solid bulk cargoes contained in Coast Guard policy,
guidelines, and previously issued special permits.
    The Subcommittee will develop recommendations to Title 46 Code of
Federal Regulations (CFR) Part 148, taking into account the IMSBC Code,
for CTAC to review and approve. This is the first in a series of
meetings anticipated for this Subcommittee. Working groups and/or
correspondence groups will be established to facilitate the work of
this Subcommittee.

Procedural

    These meetings are open to the public. At the Chairman's
discretion, members of the public may make oral presentations during
the meeting. If you would like to make an oral presentation, please
notify the DFO no later than April 18, 2008. Written material for
distribution at this meeting should reach the Executive Director no
later than April 18, 2008. If you would like a copy of your material
distributed to each committee member in advance of the meeting, please
submit 25 copies to the Executive Director no later than April 18,
2008.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at this meeting, contact
the Executive Director as soon as possible.

    Dated: March 21, 2008.
J. Lantz,
Director of Commercial Regulations and Standards.
 [FR Doc. E8-6618 Filed 3-31-08; 8:45 am]

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