[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 862-863]
[FR Doc No: 2013-31611]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form ABS-15G, OMB Control No. 3235-0675, SEC File No. 270-620.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Form ABS-15G (17 CFR 249.1300) is used for reports of information
required under Rule 15Ga-1 (17 CFR 240.15Ga-1) of the Exchange Act of
1934 (``Exchange Act''). Exchange Act Rule 15Ga-1 requires asset-backed
securitizers to provide disclosure regarding fulfilled and unfulfilled
repurchase requests with respect to asset-backed securities. The
purpose of the information collected on Form ABS-15G is to implement
the disclosure requirements of Section 943 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act to provide information
regarding the use of representations and warranties in the asset-backed
securities markets. We estimate that approximately 810 securitizers
will file Form ABS-15G annually at estimated 311.223 burden hours per
response. In addition, we estimate that 75% of the 311.223 hours per
response (233.417 hours) is carried internally by the securitizers for
a total annual reporting burden of 189,068 hours (233.417 hours per
response x 810 responses).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    Please direct your written comment to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: December 31, 2013.
Elizabeth M. Murphy,
 Secretary.
[FR Doc. 2013-31611 Filed 1-6-14; 8:45 am]
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DATE][NOTICES]


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31128-31129]
[DOCID:fr30my08-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0275]

Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Full Field Digital
Mammography System; 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 draft guidance entitled ``Class II Special Controls
Guidance Document: Full Field Digital Mammography System.'' This draft
guidance document describes a means by which the full field digital
mammography (FFDM) system may comply with the requirement of special
controls for class II devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed rule to reclassify the FFDM
system device type from class III (premarket approval) into class II
(special controls). This draft guidance is neither final nor is it in
effect at this time.

DATES:  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 written or electronic comments on this draft guidance
by August 28, 2008.

ADDRESSES:  Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Full Field Digital Mammography System'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. 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 written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    An FFDM system is a device intended to be used to produce full
field digital x-ray images of the breast. This generic type of device
may include one or more of the following: digital mammography software,
full field digital image receptor, acquisition workstation, and signal
analysis programs. Mammographic x-ray producing equipment (x-ray
generator, x-ray control, x-ray tube, collimator, beam filter, and
breast compression system) and display accessories are regulated under
21 CFR 892.1710, 21 CFR 892.2040, and 21 CFR 892.2050 as class II
devices (special controls). The FFDM system device is currently in
class III and subject to premarket approval requirements (section 515
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360e)).
    At a public meeting on May 23, 2006, the Radiological Devices Panel
(the Panel) unanimously recommended that the FFDM system be
reclassified from class III to class II (special controls). The Panel
also recommended that class II with a special controls guidance
document would provide reasonable assurance of the safety and
effectiveness of the device. FDA considered the Panel's
recommendations, and elsewhere in this issue of the Federal Register,
FDA is proposing to reclassify the FFDM system into class II. If the
reclassification rule is finalized, FDA intends that this draft
guidance document will serve as the special control for this device.
    Following the effective date of any final reclassification rule
based on the proposal, any firm submitting a premarket notification
(510(k)) for an FFDM system would need to address the issues covered in
the special controls draft guidance document. However, the firm need
only show that its device meets the recommendations of the draft
guidance document or in some other way provides equivalent assurances
of safety and effectiveness.

II. Significance of Guidance

    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, if
finalized, will represent the agency's current thinking on the FFDM
system. It does not create or confer any rights for or on any person
and does 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 the draft guidance may do
so by using the Internet. To receive ``Class II Special Controls
Guidance Document: Full Field Digital Mammography System,'' 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 hard copy. Please use the document number (1616) to
identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance document 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, 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), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments and submissions will be accepted by FDA
only through FDMS at http://www.regulations.gov.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12119 Filed 5-29-08; 8:45 am]

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[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Page 6362]
[FR Doc No: 2013-01938]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

    Extension:
    Form N-8F; OMB Control No. 3235-0157, SEC File No. 270-136.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form N-8F (17 CFR 274.218) is the form prescribed for use by
registered investment companies in certain circumstances to request
orders of the Commission declaring that the registration of that
investment company cease to be in effect. The form requests information
about: (i) The investment company's identity, (ii) the investment
company's distributions, (iii) the investment company's assets and
liabilities, (iv) the events leading to the request to deregister, and
(v) the conclusion of the investment company's business. The
information is needed by the Commission to determine whether an order
of deregistration is appropriate.
    The Form takes approximately 5.5 hours on average to complete. It
is estimated that approximately 142 investment companies file Form N-8F
annually, so the total annual burden for the form is estimated to be
approximately 781 hours. The estimate of average burden hours is made
solely for the purposes of the Paperwork Reduction Act and is not
derived from a comprehensive or even a representative survey or study.
    The collection of information on Form N-8F is not mandatory. The
information provided on Form N-8F is not kept confidential. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently-valid OMB
control number.
    Written comments are requested on: (i) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (ii) the accuracy of the Commission's estimate of the burdens
of the collection of information; (iii) ways to enhance the quality,
utility, and clarity of the information collected; and (iv) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312, or send an
email to<EMAIL_ADDRESS>
    Dated: January 24, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01938 Filed 1-29-13; 8:45 am]
BILLING CODE 8011-01-P