[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Pages 39498-39499]
[FR Doc No: 2012-16227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0503]

Guidances for Industry and Food and Drug Administration Staff:
Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Notification (510(k)) Submissions; and
Clinical Performance Assessment: Considerations for Computer-Assisted
Detection Devices Applied to Radiology Images and Radiology Device
Data--Premarket Approval and Premarket Notification (510(k))
Submissions; 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 two related guidance documents. The first guidance,
entitled ``Computer-Assisted Detection Devices Applied to Radiology
Images and Radiology Device Data--Premarket Notification (510(k))
Submissions'' (CADe 510(k) guidance), provides recommendations
regarding premarket notification (510(k)) submissions of certain
computer-assisted detection (CADe)\1\ devices applied to radiology
images and radiology device data. The second guidance, entitled
``Clinical Performance Assessment: Considerations for Computer-Assisted
Detection Devices Applied to Radiology Images and Radiology Device
Data--Premarket Approval (PMA) and Premarket Notification (510(k))
Submissions'' (CADe clinical performance assessment guidance), provides
recommendations on the design and conduct of clinical performance
studies for CADe devices applied to radiology images and radiology
device data.
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    \1\ The use of the acronym CADe for computer-assisted detection
may not be a generally recognized acronym in the community at large.
It is used here to identify the specific type of devices discussed
in this document.

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

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Computer-Assisted Detection Devices Applied to
Radiology Images and Radiology Device Data--Premarket Notification
(510(k)) Submissions'' or the guidance document entitled ``Clinical
Performance Assessment: Considerations for Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data--
Premarket Approval (PMA) and Premarket Notification (510(k))
Submissions'' 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 these guidances.
    Submit electronic comments on the guidances 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: Nicholas Petrick, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, rm. 4118, Silver Spring, MD 20993, 301-796-
2563, and Mary Pastel, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G310,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    CADe devices are computerized systems that incorporate pattern
recognition and data analysis capabilities (i.e., combine values,
measurements, or features extracted from the patient radiological data)
intended to identify, mark, highlight, or in any other manner direct
attention to portions of an image, or aspects of radiology device data,
that may reveal abnormalities during interpretation of patient
radiology images or patient radiology device data by the intended user
(i.e., a physician or other health care professional).
    The CADe 510(k) guidance provides recommendations on documentation
and performance testing to be part of a 510(k) submission for class II
CADe devices applied to radiology images and radiology device data. The
CADe clinical performance assessment guidance provides recommendations
regarding clinical performance studies

for both class II and class III CADe devices applied to radiology
images and radiology device data. These clinical performance studies
may be part of a premarket submission to FDA, whether it is a 510(k)
submission, an application for PMA, an application for a humanitarian
device exemption, or an application for an investigational device
exemption.
    In the Federal Register of October 21, 2009 (74 FR 54053), FDA
announced the availability of the draft guidance documents. Interested
persons were invited to comment by January 19, 2010. Six comments were
received with multiple recommendations about changes to the content of
the documents. FDA also received comments during the public meetings of
the Radiology Devices Panel, an FDA advisory committee, on March 4-5,
2008, and November 17-18, 2009. In response to all of these comments,
FDA revised both guidance documents to clarify the level of detail the
Agency would like to see regarding the description and operation of the
CADe device and about test data reuse. In response to the comments, the
new guidance documents also clarify that digitized film is within the
scope of radiological data and that FDA intends to create new product
codes as necessary to identify and track new types of CADe products.
    FDA's revisions, based on comments on the CADe 510(k) guidance,
also include updated recommendations on the scoring process and when a
clinical performance assessment may be necessary. The Generalizability
Testing subsection was extensively modified, including removing
recommendations on algorithm stability testing. In response to comments
on the CADe clinical performance assessment guidance, FDA limited the
postmarket section to outlining the basic postapproval study process.

II. Significance of Guidance

    These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the Agency's current thinking on premarket notification (510(k))
submissions of certain CADe devices applied to radiology images and
radiology device data and on clinical performance studies for CADe
devices applied to radiology images and radiology device data. The
guidance documents do not create or confer any rights for or on any
person and do not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of either 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
``Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Notification (510(k)) Submissions,''
or ``Clinical Performance Assessment: Considerations for Computer-
Assisted Detection Devices Applied to Radiology Images and Radiology
Device Data--Premarket Approval (PMA) and Premarket Notification
(510(k)) Submissions,'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number (1697) to identify the CADe 510(k) guidance or the
document number (1698) to identify the CADe clinical performance
assessment guidance.

IV. Paperwork Reduction Act of 1995

    These guidance documents refer to currently 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 801 have been approved under
OMB control number 0910-0485; 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 part 812 have been
approved under OMB control number 0910-0078; and the collections of
information in 21 CFR part 814 have been approved under OMB control
numbers 0910-0231 and 0910-0332.

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. 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: June 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16227 Filed 7-2-12; 8:45 am]
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[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Page 44965]
[FR Doc No: 2011-19131]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Federal Register Citation of Previous Announcement: [76 FR 44057,
July 22, 2011].

STATUS: Open meeting.

PLACE: 100 F Street, NW., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: July 26, 2011 at 11 a.m.

CHANGE IN THE MEETING: Deletion of an Item.
    The following item will not be considered during the Commission's
Open Meeting on July 26, 2011 at 11 a.m.
    The Commission will consider whether to adopt rule and form
amendments under the Securities Exchange Act of 1934 and the Investment
Company Act of 1940 to require an institutional investment manager that
is subject to Section 13(f) of the Securities Exchange Act to report
annually how it voted proxies relating to executive compensation
matters as required by Section 14A of the Securities Exchange Act,
which was added by the Dodd-Frank Wall Street Reform and Consumer
Protection Act.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

     Dated: July 25, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19131 Filed 7-25-11; 4:15 pm]
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[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Page 72961]
[FR Doc No: 2011-30458]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3343-EM; Docket ID FEMA-2011-0001]

Massachusetts; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the Commonwealth of Massachusetts (FEMA-3343-EM), dated
November 1, 2011, and related determinations.

DATES: Effective Date: November 1, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 1, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the Commonwealth of Massachusetts resulting from a severe storm
during the period of October 29-30, 2011, are of sufficient severity
and magnitude to warrant an emergency declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the Commonwealth of Massachusetts.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Mark H.
Landry, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the Commonwealth of Massachusetts have been
designated as adversely affected by this declared emergency:

    The counties of Berkshire, Essex, Franklin, Hampden, Hampshire,
Middlesex, Norfolk, and Worcester for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-30458 Filed 11-25-11; 8:45 am]
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[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41366-41367]
[DOCID:fr18jy08-100]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2008-0204]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Numbers: 1625-0015

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
an Information Collection Request (ICR), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of their approval
for the following collection of information: 1625-0015, Bridge Permit
Application Guide (BPAG). Our ICR describes the information we seek to
collect from the public. Review and comments by OIRA ensure we only
impose paperwork burdens commensurate with our performance of duties.

DATES: Please submit comments on or before August 18, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2008-0204] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission.
    (a) To Coast Guard docket at http://www.regulation.gov.
    (b) To OIRA by e-mail to<EMAIL_ADDRESS>    (2) Mail or Hand delivery.
    (a) DMF (M-30), DOT, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC 20590-0001. Hand deliver between
the hours of 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The telephone number is<PHONE_NUMBER>.
    (b) To OIRA, 725 17th Street, NW., Washington, DC 20503, to the
attention of the Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in time, mark the fax to the
attention of the Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this notice. Comments and
material received from the public, as well as documents mentioned in
this notice as being available in the docket, will become part of this
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find this docket on the Internet
at http://www.regulations.gov.
    A copy of the complete ICR is available through this docket on the
Internet at http: //www.regulations.gov. Additionally, copies are
available from Commandant (CG-611), U.S. Coast Guard Headquarters,
(Attn: Mr. Arthur Requina), 2100 2nd Street, SW., Washington, DC 20593-
0001. The telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:
    The Coast Guard invites comments on whether this information
collection request should be granted based on it being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the collections; (2) the accuracy of the estimated burden of
the collections; (3) ways to enhance the quality, utility, and clarity
of information subject to the collections; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. Comments to Coast Guard must contain the docket number of
this request, [USCG 2008-0204]. For your comments to OIRA to be
considered, it is best if they are received on or before the August 18,
2008.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
paragraph on DOT's ``Privacy Act Policy'' below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2008-0204], indicate

the specific section of the document to which each comment applies,
providing a reason for each comment. We recommend you include your
name, mailing address, an e-mail address, or other contact information
in the body of your document so that we can contact you if we have
questions regarding your submission. You may submit comments and
material by electronic means, mail, fax, or delivery to the DMF at the
address under ADDRESSES; but please submit them by only one means. If
you submit them by mail or delivery, submit them in an unbound format,
no larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit them by mail and would like to know that they
reached the Facility, please enclose a stamped, self-addressed postcard
or envelope. We will consider all comments and material received during
the comment period. We may change the documents supporting this
collection of information or even the underlying requirements in view
of them. The Coast Guard and OIRA will consider all comments and
material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this notice as being available in the
docket. Enter the docket number [USCG-2008-0204] in the Search box, and
click, ``Go>>.'' You may also visit the DMF in room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act Statement of DOT in the Federal Register published on April 11,
2000 (65 FR 19477), or by visiting http://DocketsInfo.dot.gov.

Previous Request for Comments.

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (73 FR 19084, April 8,
2008) required by44 U.S.C. 3506(c)(2). That notice elicited no
comments.

Information Collection Request.

    1. Title: Bridge Permit Application Guide (BPAG).
    OMB Control Number: 1625-0015.
    Type of Request: Extension of currently approved collection.
    Affected Public: The public and private owners of bridges over
navigable waters of the United States.
    Abstract: The collection of information is a request for a bridge
permit request. The application is submitted to the Coast Guard for
approval of any proposed bridge project. A letter of application must
be submitted along with letter-size drawings (plans) and maps showing
the proposed project and its location. Sections 401, 491, and 525 of 33
U.S.C. authorize the Coast Guard to approve plans and locations for all
bridges and causeways that go over navigable waters of the United
States. Bridge permit application regulations are contained in 33 CFR
115.50.
    Burden Estimate: The estimated burden has increased from 2,240 to
3,315 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 9, 2008.
D.T. Glenn,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
 [FR Doc. E8-16420 Filed 7-17-08; 8:45 am]

BILLING CODE 4910-15-P