Fisheries in the Western Pacific; Community Development Program Process, 68199-68200 [2010-28075]
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Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations
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frequency of performance drills
regarding operation of exits in the
normal and emergency modes on that
type aircraft.
(D) The substitute pilot or flight
engineer is in possession of all items
required for duty.
(E) The substitute pilot or flight
engineer is located in the passenger
cabin.
(F) The substitute pilot or flight
engineer is identified to the passengers.
(G) The substitution of a pilot or flight
engineer for a required flight attendant
does not interfere with the safe
operation of the flight.
(H) The airplane engines are shut
down.
(I) At least one floor-level exit remains
open to provide for passenger egress.
(b) During passenger deplaning, on
each airplane for which more than one
flight attendant is required by § 121.391,
the certificate holder may reduce the
number of flight attendants required by
that paragraph provided:
(1) The airplane engines are shut
down;
(2) At least one floor level exit
remains open to provide for passenger
egress; and
(3) The number of flight attendants on
board is at least half the number
required by § 121.391, rounded down to
the next lower number in the case of
fractions, but never fewer than one.
(c) If only one flight attendant is on
the airplane during passenger boarding
or deplaning, that flight attendant must
be located in accordance with the
certificate holder’s FAA-approved
operating procedures. If more than one
flight attendant is on the airplane during
passenger boarding or deplaning, the
flight attendants must be evenly
distributed throughout the airplane
cabin, in the vicinity of the floor-level
exits, to provide the most effective
assistance in the event of an emergency.
(d) The time spent by any
crewmember conducting passenger
boarding or deplaning duties is
considered duty time.
Issued in Washington, DC, on October 28,
2010.
J. Randolph Babbitt,
Administrator, Federal Aviation
Administration.
[FR Doc. 2010–28056 Filed 11–4–10; 8:45 am]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
15 CFR Part 902
50 CFR Part 665
[Docket No. 0907211157–0522–04]
RIN 0648–AX76
Fisheries in the Western Pacific;
Community Development Program
Process
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule; effectiveness of
collection-of-information requirements.
AGENCY:
In this rule, NMFS announces
approval by the Office of Management
and Budget (OMB) of collection-ofinformation requirements contained in
regulations implementing Amendment 1
to the Fishery Ecosystem Plans for
American Samoa, Hawaii, the Mariana
Archipelago, and Western Pacific
Pelagic Fisheries, relating to the
community development plan process.
The intent of this final rule is to inform
the public that OMB has approved the
associated reporting requirements.
DATES: New 50 CFR 665.20(c),
published at 75 FR 54044 (September 3,
2010), has been approved by OMB and
is effective on December 6, 2010. The
amendment to 15 CFR part 902 in this
rule is effective December 6, 2010.
ADDRESSES: Written comments
regarding the burden-hour estimates or
other aspects of the collection-ofinformation requirements contained in
this final rule may be submitted to
NMFS, attention Michael D. Tosatto,
1601 Kapiolani Blvd., Honolulu, HI
96814, and to OMB by e-mail to
OIRA_Submission@omb.eop.gov or fax
to 202–395–7285.
FOR FURTHER INFORMATION CONTACT:
Jarad Makaiau, NMFS Pacific Islands
Region (PIR), Sustainable Fisheries, tel
808–944–2108.
SUPPLEMENTARY INFORMATION: A final
rule for Amendment 1 was published in
the Federal Register on September 3,
2010 (75 FR 54044). The requirements
of that final rule, other than the
collection-of-information requirements,
were effective on October 4, 2010.
Because OMB had not approved the
collection-of-information requirements
by the date that final rule was
published, the effective date of the
associated permitting and reporting
SUMMARY:
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68199
requirements in that rule was delayed.
OMB approved the collection-ofinformation requirements contained in
the final rule on September 22, 2010.
Under NOAA Administrative Order
205–11, dated December 17, 1990, the
Under Secretary for Oceans and
Atmosphere has delegated authority to
sign material for publication in the
Federal Register to the Assistant
Administrator for Fisheries, NOAA.
Classification
This final rule has been determined to
be not significant for purposes of
Executive Order 12866.
Notwithstanding any other provision
of the law, no person is required to
respond to, and no person shall be
subject to penalty for failure to comply
with, a collection of information subject
to the requirements of the Paperwork
Reduction Act (PRA), unless that
collection of information displays a
currently valid OMB control number.
This final rule contains new
collection-of-information requirements
subject to the PRA under OMB Control
Number 0648–0612. The public
reporting burden for developing and
submitting a development plan is
estimated to average six hours per
response, including the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
information. Send comments regarding
these burden estimates or any other
aspect of this data collection, including
suggestions for reducing the burden, to
NMFS (see ADDRESSES) and to OMB by
e-mail to
OIRA_Submission@omb.eop.gov or fax
to 202–395–7285.
List of Subjects in 15 CFR Part 902
Reporting and recordkeeping
requirements.
Dated: November 2, 2010.
Samuel D. Rauch III,
Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service.
For the reasons set out in the
preamble, 15 CFR part 902 is amended
as follows:
■
PART 902—NOAA INFORMATION
COLLECTION REQUIREMENTS UNDER
THE PAPERWORK REDUCTION ACT:
OMB CONTROL NUMBERS
1. The authority citation for part 902
continues to read as follows:
■
Authority: 44 U.S.C. 3501 et seq.
2. In § 902.1, amend the table in
paragraph (b), under the entry ‘‘50 CFR’’
■
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68200
Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Rules and Regulations
§ 902.1 OMB control numbers assigned
pursuant to the Paperwork Reduction Act.
by adding the entry for § 665.20 in
numerical order to read as follows:
*
*
*
*
(b) * * *
*
CFR part or section where the information collection requirement is located
Current OMB control No.
(all numbers begin with 0648–)
*
*
*
*
*
50 CFR ............................................................................................................................................................
*
*
............................................................
*
*
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*
665.20 ..............................................................................................................................................................
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[FR Doc. 2010–28075 Filed 11–4–10; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
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Mary Pastel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G304,
Silver Spring, MD 20993–0002, 301–
796–6887; or
Kyle J. Myers, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 62, rm. 3118,
Silver Spring, MD 20993–0002, 301–
796–2533.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA–2008–N–0273]
Medical Devices; Radiology Devices;
Reclassification of Full-Field Digital
Mammography System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is announcing the
reclassification of the full-field digital
mammography (FFDM) system from
class III (premarket approval) to class II
(special controls). The device type is
intended to produce planar digital x-ray
images of the entire breast; this generic
type of device may include digital
mammography acquisition software,
full-field digital image receptor,
acquisition workstation, automatic
exposure control, image processing and
reconstruction programs, patient and
equipment supports, component parts,
and accessories. The special control that
will apply to the device is the guidance
document entitled ‘‘Class II Special
Controls Guidance Document: FullField Digital Mammography System.’’
FDA is reclassifying the device into
class II (special controls) because
general controls along with special
controls will provide a reasonable
assurance of safety and effectiveness of
the device. Elsewhere in this issue of
the Federal Register, FDA is
announcing the availability of the
guidance document that will serve as
the special control for this device.
DATES: This rule is effective December 6,
2010.
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SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Statutory Framework for Device
Classification
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et
seq.), as amended by the Medical Device
Amendments of 1976 (Pub. L. 94–295),
the Safe Medical Devices Act of 1990
(Pub. L. 101–629), the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115), and
the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), among other amendments,
established a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of
devices, depending on the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
FDA refers to devices that were in
commercial distribution before May 28,
1976 (the date of enactment of the 1976
amendments), as ‘‘preamendments
devices.’’ FDA classifies these devices
after the Agency has taken the following
steps:
1. Receives a recommendation from a
device classification panel (an FDA
advisory committee);
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*
–0612
*
*
2. Publishes the panel’s
recommendation for comment, along
with a proposed regulation classifying
the device; and
3. Publishes a final regulation
classifying the device type.
FDA has classified most
preamendments devices under these
procedures.
FDA refers to devices that were not in
commercial distribution before May 28,
1976, as ‘‘postamendments devices.’’
These devices are classified
automatically by statute (section 513(f)
of the FD&C Act) into class III without
any FDA rulemaking process. These
device types remain in class III and
require premarket approval, unless and
until:
1. FDA reclassifies the device type
into class I or II;
2. FDA issues an order classifying the
device type into class I or II in
accordance with section 513(f)(2) of the
FD&C Act, as amended by FDAMA; or
3. FDA issues an order finding the
device to be substantially equivalent,
under section 513(i) of the FD&C Act, to
a predicate device that does not require
premarket approval. The Agency
determines whether new devices are
substantially equivalent to predicate
devices by means of premarket
notification procedures in section 510(k)
of the FD&C Act (21 U.S.C. 360(k)) and
21 CFR part 807 of the regulations.
Reclassification of classified
postamendments devices is governed by
section 513(f)(3) of the FD&C Act. This
section provides that FDA may initiate
the reclassification of a device classified
into class III under section 513(f)(1) of
the FD&C Act, or the manufacturer or
importer of a device may petition the
Secretary of Health and Human Services
(the Secretary) for the issuance of an
order classifying the device into class I
or class II. FDA’s regulations in 21 CFR
860.134 set forth the procedures for the
filing and review of a petition for
reclassification of these class III devices.
To change the classification of the
device, the proposed new class must
E:\FR\FM\05NOR1.SGM
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Agencies
[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Rules and Regulations]
[Pages 68199-68200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28075]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
15 CFR Part 902
50 CFR Part 665
[Docket No. 0907211157-0522-04]
RIN 0648-AX76
Fisheries in the Western Pacific; Community Development Program
Process
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Final rule; effectiveness of collection-of-information
requirements.
-----------------------------------------------------------------------
SUMMARY: In this rule, NMFS announces approval by the Office of
Management and Budget (OMB) of collection-of-information requirements
contained in regulations implementing Amendment 1 to the Fishery
Ecosystem Plans for American Samoa, Hawaii, the Mariana Archipelago,
and Western Pacific Pelagic Fisheries, relating to the community
development plan process. The intent of this final rule is to inform
the public that OMB has approved the associated reporting requirements.
DATES: New 50 CFR 665.20(c), published at 75 FR 54044 (September 3,
2010), has been approved by OMB and is effective on December 6, 2010.
The amendment to 15 CFR part 902 in this rule is effective December 6,
2010.
ADDRESSES: Written comments regarding the burden-hour estimates or
other aspects of the collection-of-information requirements contained
in this final rule may be submitted to NMFS, attention Michael D.
Tosatto, 1601 Kapiolani Blvd., Honolulu, HI 96814, and to OMB by e-mail
to OIRA_Submission@omb.eop.gov or fax to 202-395-7285.
FOR FURTHER INFORMATION CONTACT: Jarad Makaiau, NMFS Pacific Islands
Region (PIR), Sustainable Fisheries, tel 808-944-2108.
SUPPLEMENTARY INFORMATION: A final rule for Amendment 1 was published
in the Federal Register on September 3, 2010 (75 FR 54044). The
requirements of that final rule, other than the collection-of-
information requirements, were effective on October 4, 2010. Because
OMB had not approved the collection-of-information requirements by the
date that final rule was published, the effective date of the
associated permitting and reporting requirements in that rule was
delayed. OMB approved the collection-of-information requirements
contained in the final rule on September 22, 2010.
Under NOAA Administrative Order 205-11, dated December 17, 1990,
the Under Secretary for Oceans and Atmosphere has delegated authority
to sign material for publication in the Federal Register to the
Assistant Administrator for Fisheries, NOAA.
Classification
This final rule has been determined to be not significant for
purposes of Executive Order 12866.
Notwithstanding any other provision of the law, no person is
required to respond to, and no person shall be subject to penalty for
failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act (PRA), unless that
collection of information displays a currently valid OMB control
number.
This final rule contains new collection-of-information requirements
subject to the PRA under OMB Control Number 0648-0612. The public
reporting burden for developing and submitting a development plan is
estimated to average six hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection information. Send comments regarding these burden estimates
or any other aspect of this data collection, including suggestions for
reducing the burden, to NMFS (see ADDRESSES) and to OMB by e-mail to
OIRA_Submission@omb.eop.gov or fax to 202-395-7285.
List of Subjects in 15 CFR Part 902
Reporting and recordkeeping requirements.
Dated: November 2, 2010.
Samuel D. Rauch III,
Deputy Assistant Administrator for Regulatory Programs, National Marine
Fisheries Service.
0
For the reasons set out in the preamble, 15 CFR part 902 is amended as
follows:
PART 902--NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE
PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS
0
1. The authority citation for part 902 continues to read as follows:
Authority: 44 U.S.C. 3501 et seq.
0
2. In Sec. 902.1, amend the table in paragraph (b), under the entry
``50 CFR''
[[Page 68200]]
by adding the entry for Sec. 665.20 in numerical order to read as
follows:
Sec. 902.1 OMB control numbers assigned pursuant to the Paperwork
Reduction Act.
* * * * *
(b) * * *
------------------------------------------------------------------------
CFR part or section where the
information collection requirement Current OMB control No. (all
is located numbers begin with 0648-)
------------------------------------------------------------------------
* * * * * * *
50 CFR.............................. ..................................
* * * * * * *
665.20.............................. -0612
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2010-28075 Filed 11-4-10; 8:45 am]
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