[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Proposed Rules]
[Page 28401]
[FR Doc No: 2018-12708]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-ORD-2018-0280; FRL-9977-78]
RIN 2080-AA13

Notification of Submission to the Secretary of Agriculture;
Harmonization of Regulations Safeguarding Human Test Subjects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of submission to the Secretary of Agriculture.

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SUMMARY: This document notifies the public as required by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA
Administrator has forwarded to the Secretary of the United States
Department of Agriculture (USDA) a draft regulatory document concerning
``Harmonize 40 CFR 26 Subparts C, D, and K with Subpart A (the Common
Rule)''. The draft regulatory document is not available to the public
until after it has been signed and made available by EPA.

DATES: See Unit I. under SUPPLEMENTARY INFORMATION.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-ORD-2018-0280, is available at http://www.regulations.gov or at the Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Greg Susanke, Office of the Science
Advisor, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    Section 25(a)(2)(A) of FIFRA requires the EPA Administrator to
provide the Secretary of USDA with a copy of any draft proposed rule at
least 60 days before signing it in proposed form for publication in the
Federal Register. The draft proposed rule is not available to the
public until after it has been signed by EPA. If the Secretary of USDA
comments in writing regarding the draft proposed rule within 30 days
after receiving it, the EPA Administrator shall include the comments of
the Secretary of USDA and the EPA Administrator's response to those
comments with the proposed rule that publishes in the Federal Register.
If the Secretary of USDA does not comment in writing within 30 days
after receiving the draft proposed rule, the EPA Administrator may sign
the proposed rule for publication in the Federal Register any time
after the 30-day period.

II. Do any statutory and Executive Order reviews apply to this
notification?

    No. This document is merely a notification of submission to the
Secretary of USDA. As such, none of the regulatory assessment
requirements apply to this document.

List of Subjects in 40 CFR Part 26

    Environmental protection, Administrative practice and procedures,
Human research, Pesticides and pests.

    Dated: June 4, 2018.
Richard P. Keigwin,
Director, Office of Pesticide Programs.
[FR Doc. 2018-12708 Filed 6-18-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Rules and Regulations]
[Pages 6897-6899]
[FR Doc No: 2015-02407]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0087; Directorate Identifier 2014-NM-234-AD;
Amendment 39-18098; AD 2015-03-02]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A319-115, A319-133, A320-214, A320-232, and A320-233
airplanes. This AD requires repetitive detailed inspections of the
outboard main landing gear (MLG) support rib lower flange fasteners for
discrepancies, and corrective actions if necessary. This AD was
prompted by reports of failure of certain fasteners on the MLG support
rib lower flange. We are issuing this AD to detect and correct
discrepancies of the fasteners at the outboard MLG support rib lower
flange, which could result in an airplane not meeting its maximum loads
expected in service. This condition could result in structural failure.

DATES: This AD becomes effective February 24, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 6,
2015 (80 FR 3155, January 22, 2015).
    We must receive comments on this AD by March 26, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0087; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued
Airworthiness Directive 2014-0270R1, dated December 15, 2014 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition on certain Airbus Model
A319-115, A319-133, A320-214, A320-232, and A320-233 airplanes. The
MCAI states:

    During production of wings, a number of taperlok fasteners were
found failed after installation. The fasteners in question are
located at the bottom skin of the Main Landing Gear (MLG)
reinforcing plate, wing skin and Gear Support Rib 5 lower flange.
    This condition, if not detected and corrected could reduce the
design margin of the structure [and could result in structural
failure].
    Based on the results of the preliminary investigation, this
affects only certain A319 and A320 aeroplane Models delivered since
January 2014. A321 aeroplanes are not affected, as the wing assembly
is done using parallel fasteners. A318 aeroplanes are not affected,
since none have been delivered since January 2014.
    Prompted by these findings, EASA issued Emergency AD 2014-0270-E
[dated December 11, 2014] to require repetitive inspections of the
bottom skin taperlok fasteners at the MLG Rib 5 footprint location
and, depending on findings, accomplishment of applicable corrective
action(s).
    Since that [EASA] AD was issued, operator comments have
indicated the need for clarification, as well as correction.
    For the reason described above, this [EASA] AD is revised to add
Notes for information and to correct paragraphs (1) and (2) of the
[EASA] AD.
    This [EASA] AD is still considered to be an interim action and
further AD action may follow.

    Required actions include repetitive detailed visual inspections to
detect discrepancies (broken or missing fastener tails or nuts) of the
outboard MLG support rib lower flange location fasteners, and,
depending on findings, accomplishment of applicable corrective
action(s). Corrective actions include fastener replacement. You may
examine the MCAI on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-0087.

Related Rulemaking

    On January 7, 2015, the FAA issued AD 2014-26-53, Amendment 39-
18068 (80 FR 3155, January 22, 2015), for certain Airbus Model A319-
115, A319-133, A320-214, A320-232, and A320-233 airplanes. That AD
requires

repetitive detailed visual inspections to detect discrepancies of the
wing lower skin surface and inboard MLG support rib lower flange
location fasteners and, depending on findings, accomplishment of
applicable corrective action(s).
    The preamble to AD 2014-26-53, Amendment 39-18068 (80 FR 3155,
January 22, 2015), explains that EASA AD 2014-0270R1, dated December
15, 2014, specifies to do repetitive detailed visual inspections of the
outboard MLG support rib lower flange fasteners and nuts. However,
those inspections were not required by AD 2014-26-53 because the
specified compliance time for those actions was four months, and the
FAA was considering further rulemaking to require those inspections. We
now have determined that further rulemaking is indeed necessary, and
this AD follows from that determination.
    This new AD applies to the same airplane models as AD 2014-26-53,
Amendment 39-18068 (80 FR 3155, January 22, 2015), but requires
repetitive detailed visual inspections of the outboard MLG support rib
lower flange fasteners for discrepancies (broken or missing fastener
tails or nuts) and fastener replacement if applicable.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Differences Between This AD and the MCAI or Service Information

    In addition to specifying detailed visual inspections of the
outboard MLG support rib lower flange fasteners for discrepancies, EASA
Airworthiness Directive 2014-0270 R1, dated December 15, 2014,
specifies to do repetitive detailed visual inspections of the external
surface of the left and right lower skin to detect missing or migrating
fasteners, and detailed inspections of the inboard MLG support rib
lower flange to detect any missing or broken nuts or fastener tails;
and corrective actions, if necessary. However, these inspections are
not required by this AD. Those actions are required by AD 2014-26-53,
Amendment 39-18068 (80 FR 3155, January 22, 2015).

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
failure of more than two fasteners at the outboard MLG support rib
lower flange could result in an airplane not meeting its maximum loads
expected in-service. This condition could result in failure of the
structure. Therefore, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and that good
cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2015-0087; Directorate
Identifier 2014-NM-234-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 80 airplanes of U.S. registry.
    We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD on U.S. operators to be $6,800, or $85 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 3 work-hours and require parts costing $400 per fastener,
for a cost of $655 per fastener replacement. We have no way of
determining the number of aircraft that might need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-03-02 Airbus: Amendment 39-18098. Docket No. FAA-2015-0087;
Directorate Identifier 2014-NM-234-AD.

(a) Effective Date

    This AD becomes effective February 24, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A319-115, A319-133, A320-214,
A320-232, and A320-233 airplanes, certificated in any category,
manufacturer serial numbers (MSN) 5817, 5826, 5837, 5848, 5855,
5864, 5875, 5886, 5896, and 5910, and MSNs 5918 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by reports of failure of certain fasteners
on the main landing gear (MLG) support rib lower flange. We are
issuing this AD to detect and correct discrepancies of the fasteners
at the outboard MLG support rib lower flange, which could result in
an airplane not meeting its maximum loads expected in service. This
condition could result in structural failure.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    Within 4 months after the effective date of this AD, or within 4
months after the date of issuance of the original certificate of
airworthiness or the original export certificate of airworthiness,
or before further flight for any airplane that is not in operation
for more than 4 months, whichever occurs latest: Do a detailed
visual inspection of the left and right outboard MLG support rib
lower flange to detect any discrepancy (broken or missing fastener
tails or nuts), in accordance with Airbus Alert Operators
Transmission (AOT) A57N006-14, Revision 00, dated December 4, 2014.
Repeat the inspection thereafter at intervals not to exceed 4
months.

(h) Corrective Actions for the Inspections Required by Paragraph (g) of
This AD

    If, during any inspection required by paragraph (g) of this AD,
any discrepancy is found on the left or right outboard MLG support
rib lower flange: Before further flight, replace all affected
fasteners on the affected side(s), in accordance with Airbus AOT-
A57N006-14, Revision 00, dated December 4, 2014. Replacement of
fasteners on an airplane does not constitute terminating action for
the repetitive inspections required by paragraph (g) of this AD.

(i) Other FAA Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Special Flight Permits

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Airworthiness Directive 2014-0270R1, dated December 15, 2014,
for related information. You may examine the MCAI on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2015-0087.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
February 6, 2015 (80 FR 3155, January 22, 2015).
    (i) Airbus Alert Operators Transmission A57N006-14, Revision 00,
dated December 4, 2014.
    (ii) Reserved.
    (4) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (5) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on January 30, 2015.
Jeffrey E.Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-02407 Filed 2-6-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Rules and Regulations]
[Pages 22369-22370]
[FR Doc No: 2019-10331]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0356]

Safety Zones; Annual Fireworks Displays Within the Sector
Columbia River Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce safety zone regulations at 29
locations in the Sector Columbia River Captain of the Port zone during
the dates and times noted under SUPPLEMENTARY INFORMATION. This action
is necessary to prevent injury and to protect life and property of the
maritime public from the hazards associated with annual fireworks
displays. These regulations prohibit persons and vessels from entry
into, transit through, mooring, or anchoring within the regulated area
unless authorized by the Captain of the Port, Sector Columbia River or
their designated representative.

DATES: The regulations in 33 CFR 165.1315 will be enforced for the 29
safety zones identified in the SUPPLEMENTARY INFORMATION section below
for the dates and times specified in this document.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LCDR Dixon Whitley, Waterways
Management Division, Marine Safety Unit Portland, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce safety zones
regulations found in 33 CFR 165.1315 for the following 29 events listed
below. These safety zones will be activated 1 hour prior to and
conclude 1 hour following the duration of the event as listed in the
following Table:

 Table--Dates and Durations in 2019 for Events Listed in 33 CFR 165.1315 and the Location of These Events Within
                               the Sector Columbia River Captain of the Port Zone
----------------------------------------------------------------------------------------------------------------
                                                      Date and duration
     Event name (typically)        Event location         of event            Latitude            Longitude
----------------------------------------------------------------------------------------------------------------
Splash Aberdeen Waterfront       Aberdeen, WA......  July 4, 2019 10     46[deg]58'40'' N    123[deg]47'45'' W
 Festival.                                            p.m. to 10:30 p.m.
Astoria Warrenton 4th of July    Astoria, OR.......  July 4, 2019 10     46[deg]11'34'' N    123[deg]49'28'' W
 Fireworks.                                           p.m. to 10:30 p.m.
Bandon 4th of July.............  Bandon, OR........  July 4, 2019 10     43[deg]07'29'' N    124[deg]25'05'' W
                                                      p.m. to 10:30 p.m.
Brookings, OR July 4th           Brookings, OR.....  July 4, 2019 9:30   42[deg]02'39'' N    124[deg]16'14'' W
 Fireworks.                                           p.m. to 10 p.m.
Port of Cascade Locks 4th of     Cascade Locks, OR.  July 4, 2019 10     45[deg]40'15'' N    121[deg]53'43'' W
 July Fireworks.                                      p.m. to 10:30 p.m.
Bald Eagle Days................  Cathlamet, WA.....  July 20, 2019 10    46[deg]12'14'' N    123[deg]23'17'' W
                                                      p.m. to 10:30 p.m.
Clatskanie Heritage Days         Clatskanie, OR....  July 4, 2019 10     46[deg]6'17'' N     123[deg]12'02'' W
 Fireworks.                                           p.m. to 10:30 p.m.
City of Coos Bay July 4th        Coos Bay, OR......  July 4, 2019 10     43[deg]22'06'' N    124[deg]12'24'' W
 Celebration/Fireworks Over the                       p.m. to 10:30 p.m.
 Bay.

Florence Independence Day        Florence, OR......  July 4, 2019 10     43[deg]58'09'' N    124[deg]05'50'' W
 Celebration.                                         p.m. to 10:30 p.m.
Garibaldi Days Fireworks.......  Garibaldi, OR.....  July 27, 2019 10    45[deg]33'13'' N    123[deg]54'56'' W
                                                      p.m. to 10:30 p.m.
July 4th Party at the Port of    Gold Beach, OR....  July 4, 2019 10     42[deg]25'30'' N    124[deg]25'03'' W
 Gold Beach.                                          p.m. to 10:30 p.m.
Huntington 4th of July.........  Huntington, OR....  July 4, 2019 10     44[deg]18'02'' N    117[deg]13'33'' W
                                                      p.m. to 10:30 p.m.
Ilwaco July 4th Committee        Ilwaco, WA........  July 6, 2019 10     46[deg]18'17'' N    124[deg]02'00'' W
 Fireworks/Independence Day at                        p.m. to 10:30 p.m.
 the Port.
Lincoln City 4th of July.......  Lincoln City, OR..  July 4, 2019 10     44[deg]55'28'' N    124[deg]01'31'' W
                                                      p.m. to 10:30 p.m.
Waverly Country Club 4th of      Milwaukie, OR.....  July 4, 2019 10     45[deg]27'03'' N    122[deg]39'18'' W
 July Fireworks.                                      p.m. to 10:30 p.m.
Cedco Inc./The Mill Casino       North Bend, OR....  July 3, 2019 10     43[deg]23'42'' N    124[deg]12'55'' W
 Independence Day.                                    p.m. to 10:30 p.m.
Port Orford 4th of July........  Port Orford, OR...  July 4, 2019 10     42[deg]44'31'' N    124[deg]29'30'' W
                                                      p.m. to 10:30 p.m.
Oaks Park Association 4th of     Portland, OR......  July 4, 2019 10     45[deg]28'22'' N    122[deg]39'59'' W
 July.                                                p.m. to 10:30 p.m.
Portland Rose Festival           Portland, OR......  May 24, 2019 9:45   45[deg]30'58'' N    122[deg]40'12'' W
 Fireworks.                                           p.m. to 10:30 p.m.
Waterfront Blues Festival        Portland, OR......  July 4, 2019 10     45[deg]30'42'' N    122[deg]40'14'' W
 Fireworks.                                           p.m. to 10:30 p.m.
City of Rainier/Rainier Days...  Rainier, OR.......  July 13, 2019 10    46[deg]05'46'' N    122[deg]56'18'' W
                                                      p.m. to 10:30 p.m.
City of St. Helens 4th of July   St. Helens, OR....  July 4, 2019 10     45[deg]51'54'' N    122[deg]47'26'' W
 Fireworks.                                           p.m. to 10:30 p.m.
The Dalles Area Fourth of July.  The Dalles, OR....  July 4, 2019 10     45[deg]36'18'' N    121[deg]10'23'' W
                                                      p.m. to 10:30 p.m.
Toledo Summer Festival.........  Toledo, OR........  July 20, 2019 10    44[deg]37'08'' N    123[deg]56'24'' W
                                                      p.m. to 10:30 p.m.
Waldport 4th of July...........  Waldport, OR......  July 3, 2019 10     44[deg]25'31'' N    124[deg]04'44'' W
                                                      p.m. to 10:30 p.m.
Washougal 4th of July..........  Washougal, WA.....  July 4, 2019 10     45[deg]34'32'' N    122[deg]22'53'' W
                                                      p.m. to 10:30 p.m.
Westport 4th of July...........  Westport, WA......  July 4, 2019 10     46[deg]54'17'' N    124[deg]05'59'' W
                                                      p.m. to 11 p.m.
Winchester Bay 4th of July       Winchester Bay, OR  July 4, 2019 10     43[deg]40'56'' N    124[deg]11'13'' W
 Fireworks.                                           p.m. to 10:30 p.m.
Yachats 4th of July............  Yachats, OR.......  July 4, 2019 10     44[deg]18'38'' N    124[deg]06'27'' W
                                                      p.m. to 10:30 p.m.
----------------------------------------------------------------------------------------------------------------
All coordinates are listed in reference Datum NAD 1983.

    The special requirements listed in 33 CFR 165.1315(b) apply to the
activation and enforcement of these safety zones, along with special
requirements for fireworks barges. Before any vessel operator may enter
the designated zone, they must obtain permission from the Captain of
the Port or their Designated Representative. The Coast Guard may be
assisted by other Federal, State, or local law enforcement agencies in
enforcing this regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via the Local Notice to Mariners and marine information broadcasts.

    Dated: May 13, 2019.
J.C. Smith,
Captain, U.S. Coast Guard, Captain of the Port Columbia River.
[FR Doc. 2019-10331 Filed 5-16-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 1, 2007 (Volume 72, Number 211)]
[Notices]
[Page 61945]
[DOCID:fr01no07-98]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Prepare an Environmental Impact Statement
(EIS) for a Replacement Airport Near Hailey, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent to prepare an Environmental Impact Statement
and request for scoping comments.

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SUMMARY: The FAA is issuing this Notice of Intent to the public an EIS
under the provisions of the National Environmental Policy Act (NEPA) of
1969, as amended, will be prepared to consider the siting and
construction of a replacement airport for the Friedman Memorial Airport
(SUN), Hailey, Idaho. The Bureau of Land Management (BLM) is involved
in the project as alternative sites may occur on BLM land. The BLM has
not entered into a cooperating or co-lead agreement at this time.
    The Friedman Memorial Airport Authority, the sponsor of the
project, has proposed to construct and operate a replacement airport
for the Friedman Memorial Airport within Blaine County, Idaho.
    Friedman Memorial Airport is located in Hailey, Idaho and serves
the Wood River region of South Central Idaho. The airport currently
does not and cannot comply with FAA airfield design standards on the
limited land owned by the airport. Further, the airport is close to
numerous residences. Mountainous terrain on the east, west, and north
sides of SUN precludes instrument approach procedures which would make
SUN accessible in poor weather.
    All alternatives at the existing airport site are extremely costly
and extend into residential areas. Further, they provide no benefit to
reliability and safe operation in either good or adverse weather.
Considering the limitations of the existing airport, elected and
appointed officials in Blaine County, Idaho have decided to evaluate
the environmental impacts of building and operating an airport meeting
FAA design standards and supporting an instrument approach. Several
alternatives, as well as the no-action alternative will be evaluated.
    The EIS will determine all environmental impacts, such as and not
limited to, noise impacts, impacts on air and water quality, wetlands,
fish, wildlife, and plants, farmlands, floodplains, historic/tribal
resources, hazardous wastes, socioeconomics, and economic factors.

FOR FURTHER INFORMATION CONTACT: Ms. Cayla Morgan, Federal Aviation
Administration, Seattle Airports District Office, 1601 Lind Avenue,
SW., Suite 250, Renton, Washington, 98057-3356,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The purpose of this notice is to inform
federal, state, and local government agencies, and the public of the
intent to prepare an EIS and to conduct a public and agency scoping
process. Information, data, opinions, and comments obtained throughout
the scoping process will be considered in preparing the draft EIS.
    The scoping process for this EIS will include a comment period for
interested agencies and parties to submit oral and/or written comments
representing the concerns and issues they believe should be addressed.
Please submit any written comments to Cayla Morgan no later than
January 15, 2008.
    Public Scoping Meetings: To ensure that the full range of issues
related to the proposed action is addressed and that all significant
issues are identified, comments and suggestions are invited from all
interested parties. Public and agency scoping meetings will be
conducted to identify any significant issues associated with the
proposed action.
    An agency scoping meeting for all Federal, State, and local
regulatory agencies which have jurisdiction by law or have special
expertise with respect to any potential environmental impacts
associated with the proposed action will be held on December 4, 2007.
This meeting will take place at 1 p.m. at the Community Campus, Fox
Acres Road, Hailey, Idaho. A notification letter will be sent in
advance of the meeting.
    Two public scoping meetings for the general public will be held.
The first meeting will be held from 6 p.m. to 8 p.m. on December 3,
2007. The second meeting will be held from 10 a.m. to 12 p.m. December
4, 2007. The meetings will be conducted at the Community Campus, Fox
Acres Road, Hailey, Idaho. Each meeting will include an overview of the
project, an informal open house period, and a question and answer
session. To notify the general public of the scoping process, a legal
notice will be placed in newspapers having general circulation in the
study area. The newspaper notice will notify the public that scoping
meetings will be held to gain their input concerning the proposed
action, alternatives to be considered, and impacts to be evaluated.
    The FAA is aware that there are Native American tribes with a
historical interest in the area. The FAA will interact on a government-
to-government basis, in accordance with all executive orders, laws,
regulations, and other memoranda. The tribes will also be invited to
participate in accordance with NEPA and Section 106 of the National
Historic Preservation Act.
    Further information about the EIS and the proposed action will be
posted when available at the following Web site: http://www.airportsites.net/SUN-EIS
.

    Issued in Renton, Washington, October 22, 2007.
Donna P. Taylor,
Manager, Airports Division, Northwest Mountain Region.
[FR Doc. 07-5424 Filed 10-31-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Notices]
[Page 5742]
[FR Doc No: 2020-02017]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Pub. L. 94-409, that the Securities
and Exchange Commission Fixed Income Market Structure Advisory
Committee (``FIMSAC'') will hold a public meeting on Monday, February
10, 2020 at 9:30 a.m.

PLACE: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE, Washington, DC.

STATUS: The meeting will begin at 9:30 a.m. and will be open to the
public. Seating will be on a first-come, first-served basis. Doors will
open at 9:00 a.m. Visitors will be subject to security checks. The
meeting will be webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED: On January 13, 2020, the Commission published
notice of the Committee meeting (Release No. 34-87956), indicating that
the meeting is open to the public and inviting the public to submit
written comments to the Committee. This Sunshine Act notice is being
issued because a majority of the Commission may attend the meeting.
    The agenda for the meeting will include panel discussions and
potential recommendations from the Municipal Securities Transparency,
Credit Ratings, and Technology and Electronic Trading subcommittees.

CONTACT PERSON FOR MORE INFORMATION: For further information, please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: January 29, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-02017 Filed 1-29-20; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Page 59711]
[FR Doc No: 2016-20740]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78644; File No. SR-NYSEArca-2016-87]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Withdrawal of a Proposed Rule Change, as Modified by Amendment No. 1,
To List and Trade Shares of the First Trust Horizon Managed Volatility
Domestic ETF and the First Trust Horizon Managed Volatility Developed
International ETF Under NYSE Arca Equities Rule 8.600

August 23, 2016.
    On June 16, 2016, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the First Trust Horizon Managed Volatility Domestic ETF and
the First Trust Horizon Managed Volatility Developed International ETF.
The proposed rule change was published for comment in the Federal
Register on July 6, 2016.\3\ On July 18, 2016, the Exchange submitted
Amendment No. 1 to the proposed rule change.\4\ On August 16, 2016,
pursuant to Section 19(b)(2) of the Act,\5\ the Commission designated a
longer period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to disapprove the proposed rule change.\6\ The
Commission received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78191 (June 29,
2016), 81 FR 44056.
    \4\ Amendment No. 1 replaced and superseded the original filing
in its entirety. Amendment No. 1 is available at https://www.sec.gov/comments/sr-nysearca-2016-87/nysearca201687-1.pdf.
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 78587, 81 FR 56728
(August 22, 2016).
---------------------------------------------------------------------------

    On August 18, 2016, the Exchange withdrew the proposed rule change,
as modified by Amendment No. 1 (SR-NYSEArca-2016-87).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-20740 Filed 8-29-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70666-70667]
[FR Doc No: 2023-22463]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2030]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Allegations of
Regulatory Misconduct Voluntarily Submitted to the Center for Devices
and Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by November 13, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0769. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Allegations of Regulatory Misconduct Voluntarily Submitted to the
Center for Devices and Radiological Health

OMB Control Number 0910-0769--Extension

    This information collection supports the voluntary submission of
allegations of regulatory misconduct to FDA's Center for Devices and
Radiological Health (CDRH). An allegation of regulatory misconduct is a
claim that a medical device manufacturer or individuals marketing
medical devices or electronic products regulated by CDRH may be doing
so in a manner that violates the law. Reporting these allegations can
help make FDA aware of regulatory concerns it may not learn of
otherwise. This information can help FDA identify the potential risks
to patients and determine whether further investigation is warranted,
as well as any steps needed to address or correct a potential
violation. Anyone may file a complaint reporting an allegation of
regulatory misconduct. FDA encourages people submitting allegations to
include supporting information and contact information in case
additional information is needed for FDA to understand the allegation
and act on the report; however, you can choose to submit a report
anonymously. FDA will not share your identity or contact information
with anyone outside FDA unless required to do so by law, regulation, or
court order.
    Allegations of regulatory misconduct may include failure to
register and list a medical device, marketing uncleared or unapproved
products, failure to follow quality system requirements, or misleading
promotion.
    You can submit an allegation through the Allegations of Regulatory
Misconduct Form (https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form), by email, or by regular mail.

    FDA published a 60-day notice for public comment in the Federal
Register of June 12, 2023 (88 FR 38061) and received comments. While
one comment appeared to question the purpose of the information
collection, another comment supported FDA activities regarding the
reporting of information covered by the collection. No comment
suggested that we revise our burden estimate.
    We also received suggestions on how our submission form might be
improved. In response to this comment, we are revising the submission
form using asterisks to more clearly indicate which fields are required
for submission versus non-required fields. The form also has been
updated to allow submission of the company's website.
    Similarly, one comment noted that current procedures do not allow
for complete anonymity when submitting allegations of regulatory
misconduct to FDA. The comment suggests changing the submission process
to allow submission of attachments to the form, rather than via
separate email. While we have not made changes regarding the submission
process at this time, we appreciate these suggestions and continue to
consider enhancements and updates to our systems as our limited
resources permit. We recognize that confidentiality is an important
concern. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552),
the public has broad access to government documents. However, FOIA
provides certain exemptions from mandatory public disclosure of
government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest
possible disclosure of records to the public, consistent with the
rights of individuals to privacy, the property rights of persons in
trade and confidential commercial or financial information.
    Finally, one comment expressed concern regarding verification by
FDA of the accuracy and validity of the information (allegations)
submitted. Allegations of regulatory misconduct related to medical
devices are reviewed by CDRH. CDRH prioritizes the review of
allegations based on the level of potential risks, within the context
of an overall benefit-risk profile, to patients, and takes responsive
action accordingly. We note, however, that subsequent questions or
inquiry intended to clarify information submitted is not considered a
collection of information under the PRA (see 5 CFR 1320.3(h)(9))
subject to OMB review and approval. To learn more about CDRH's process
for handling allegations, please visit: https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                    Activity                         Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of voluntary allegations             2,500                1            2,500   0.25 (15 minutes).................             625
 to CDRH.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We recently consolidated the intake of allegations across CDRH
Offices. This has improved our estimate and we have adjusted the number
of responses accordingly. The number of responses is based on the
voluntary allegations received by CDRH in 2022. The adjusted estimated
burden for the information collection reflects an increase of 900
responses and a corresponding increase of 225 hours.

    Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22463 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 19, 2008 (Volume 73, Number 161)]
[Notices]
[Page 48378]
[DOCID:fr19au08-45]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 659-000]

Crisp County Power Commission; Notice of Authorization for
Continued Project Operation

August 12, 2008.
    On August 3, 2006, the Crisp County Power Commission, licensee for
the Lake Blackshear, filed an application for a new or subsequent
license pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Lake Blackshear Hydroelectric Project is
located on the Flint River in Worth, Lee, Sumter, Dooly, and Crisp
Counties, near Cordele, Georgia.
    The license for Project No. 659 was issued for a period ending
August 9, 2008. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 659 is issued to
the Crisp County Power Commission, for a period effective August 10,
2008 through August 9, 2009, or until the issuance of a new license for
the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place
on or before August 9, 2009, notice is hereby given that, pursuant to
18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise. If the project is
not subject to section 15 of the FPA, notice is hereby given that the
Crisp County Power Commission, is authorized to continue operation of
the Lake Blackshear Hydroelectric Project until such time as the
Commission acts on its application for a subsequent license.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-19123 Filed 8-18-08; 8:45 am]

BILLING CODE 6717-01-P


                    DRAFT SUPPORTING STATEMENT  -  PART A                    RECORDKEEPINGAND REPORTING RELATED TO E15                                                                    Docket EPA-HQ-OAR-2015-0202

      A.	JUSTIFICATION

1.	Identification of the Information Collection

      a.	Title:  Recordkeeping and Reporting Related to E15,        EPA ICR No. 2408.03. OMB 2060-0675

      b. 	Short characterization:

	In two recent actions under the Clean Air Act (CAA), EPA granted partial waivers that allow gasoline containing greater than 10 volume percent (vol%) ethanol up to 15 vol% ethanol (E15) to be introduced into commerce for use in model year (MY) 2001 and newer light-duty motor vehicles, subject to certain conditions.   EPA has issued final rule establishing several measures to mitigate misfueling of other vehicles, engines and equipment with E15 and the potential emissions consequences of misfueling.  The rule prohibits the use of gasoline containing more than 10 vol% ethanol in vehicles, engines and equipment that are not covered by the partial waiver decisions.  The final rule also requires all E15 gasoline fuel dispensers to have a specific label when a retail stations or wholesale-purchaser consumer chooses to sell E15.  In addition, the rule requires that product transfer documents (PTDs) specifying ethanol content and Reid Vapor Pressure (RVP) accompany the transfer of gasoline blended with ethanol, and a survey of retail stations to ensure compliance with these requirements.  The rule also modifies the Reformulated Gasoline (RFG) program by updating the Complex Model to allow fuel manufacturers to certify batches of gasoline containing up to 15 vol% ethanol.  This ICR supporting statement will addresses recordkeeping and reporting related to E15.  	 	       EPA finalized four measures to help mitigate misfueling. The recordkeeping and reporting measures in this ICR are related to the four measures, which are:

	1.  A regulatory prohibition on misfueling.  With adoption of the misfueling prohibition, gasoline and ethanol producers, distributors, retailers and consumers have a legal obligation not to make, distribute, sell or use gasoline containing more than 10 vol% ethanol for (or in) vehicles, engines and equipment not covered by the partial waiver decisions.    	2.  A pump labeling requirement.  To provide consumers with information at the pump to avoid misfueling, the regulation requires an E15 pump label that reflects many commenters' suggestions and our consultation with consumer labeling experts at the Federal Trade Commission (FTC).  Before EPA issued its partial waiver decisions, FTC had proposed labels for gasoline-ethanol blends containing more than 10 vol% ethanol to address issues within its jurisdiction.  Commenters on our proposed E15 label urged us to work with FTC to develop a coordinated labeling program to avoid multiple, potentially conflicting labels.  Commenters also recommended that we seek advice from labeling experts.  In developing the final labeling requirements, we consulted with FTC consumer labeling experts and other staff about effective label design and potential coordination with FTC labels.  Since EPA is dictating the content and appearance of the label, there is no "information collection" except in the narrow circumstance where an individual seeks an alternative label, which must be submitted to EPA for approval.  We expect very few (if any) requests for alternative labels.  However, as described below, we have provided an estimate for this item.

	EPA's final E15 label incorporates public and FTC staff suggestions for more simply and effectively communicating the information consumers need to avoid misfueling with E15.  The label also adopted FTC's color scheme for alternative fuel labels and other aspects of the design of FTC's gasoline-ethanol blend labels, such as size, shape, and font, so that the two agencies' labels could work together as a coordinated labeling scheme for gasoline-ethanol blends containing more than 10 vol% ethanol.  We believe that the final E15 label provides consumers with the key information they need about the appropriate use of E15.

	The required label in the regulation appears as follows:

	3.  A product transfer document (PTD) requirement.  The final rule included PTD requirements that have been revised and refined in response to public comments to better accomplish their purpose.  The fine rule required that PTDs provide pertinent information, and provided a good deal of flexibility in how that information is conveyed to help ensure that fuel producers, distributors and retailers have the information they need to properly blend, track and label E15. PTDs are commonly used in the course of business and, once programmed, are generally produced via a quick, automated process.

	4.  A survey requirement.  For surveys of whether E15 is being properly blended and labeled, the final rule provided options that allow the businesses involved to match the geographic scope of an ongoing survey to their business plans and to share the cost of surveys among themselves as they see fit.  The final rule required that surveys collect RVP information for fuel samples labeled as E15 to help ensure implementation of the waiver condition that E15 be limited to 9.0 psi RVP in the summertime.  In the aggregate, these measures will provide strong incentives for fuel providers to properly blend and label E15 and for consumers to avoid misfueling.  As discussed below, we believe that most parties will choose to use the existing survey association (i.e. we expect one respondent and certainly fewer than nine respondents).  However, we have provided an option for doing an individual survey and have priced that option, as described below.

    2.  Need For, and Use of, the Collection

      a. Authority for the Collection        	Sections 114 and 208 of the Clean Air Act (CAA), 42 U.S.C. §§ 7414 and 7542, authorize EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the CAA.   	 	b. 	Practical Utility/Uses of the Data

	The recordkeeping and reporting requirements of this regulation will allow EPA to monitor compliance with the E15 labeling rule.

3.  Non-duplication, Consultation, and other Collection Criteria

	a. 	Non-duplication

	Efforts have been made to eliminate duplication in this information collection. The information is not considered general in nature and is not found in other databases, directories or sources. The data submitted to EPA is specific to a company's business practices.

      b. 	Public Notice

	EPA is seeking comment from industry on the cost estimates in section 6(d) of this ICR. We have docketed a copy of this supporting statement on the estimates in EPA-HQ-OAR-2015-0202.  	 	       c. 	Consultations

	We have drawn upon our experience with similar fuels regulations and actual number of respondent who submitted reports in the last collection approved by OMB to develop the estimates in this supporting statement as discussed in section 6(d)  -  Estimating the Respondent Universe  -  below. 	 	d. 	Effects of Less Frequent Data Collection

	Less frequent collection of data would make it impossible to carry out the provisions of the Clean Air Act.

	e. 	General Guidelines

This information collection activity complies with 5 CFR 1320.6, except that respondents would be required to keep certain records for longer than three years. Section 40 CFR Part 80.1454(l) requires record retention for five years from the date the records were created.

	f. 	Confidentiality

	We inform respondents that they may assert claims of business confidentiality (CBI) for information they submit. Information that is received without a claim of confidentiality may be made available to the public without further notice to the submitter under 40 CFR § 2.203.

      g. 	Sensitive Information 	 	This information collection does not require submission of any sensitive information. No personal or private information such as social security numbers, health care, credit card numbers, education or financial information will be collected in this collection.

4.	The Respondents and the Information Requested

	a.	Respondents/with NAICS and SIC Codes

 The respondents are related to the following major group Standard Industrialization Classification (SIC) codes:    2869 - Denatured Alcohol Manufacturing     2911 - Petroleum Refineries    4212 - Gasoline Distributors    5171 - Gasoline Bulk Stations and Terminals    5172 - Gasoline Merchant Wholesalers (except bulk stations, terminals)    5541 - Retailers/Wholesale Purchaser-consumers    	The respondents are related to the following major group NAICS codes:    324110 - Petroleum Refineries    325193 - Denatured Alcohol Manufacturing    424710 - Gasoline Bulk Stations and Terminals    424720 - Gasoline Merchant Wholesalers (except bulk stations, terminals)            	Using the terminology associated with E15, we have assumed the following classes of party, with the number of each in parenthesis:                 * Gasoline refiners (150) and gasoline/ethanol importers (50), for a total of 200 parties          * Gasoline/ethanol blenders (terminals) (1,000)          * Gasoline/ethanol blenders (carriers) 800       	       In addition, retailers and wholesale purchaser consumers may apply for alternative labels.  We only expect a small number of parties to apply for an alternative labels. Using the terminology associated with E15, we have assumed the following classes of party, with the number of each expected to apply in parenthesis:                         * Other retailer ( 1)                * Wholesale purchaser-consumer (1)                    The numbers of parties we have estimated are based upon information we have in our databases for other fuels programs requiring these parties to register (e.g., reformulated gasoline, renewable fuels standard) under 40 CFR Part 80.  We believe our registration databases for existing programs are sufficient to characterize the universe of potential respondents under the E15 labeling rule.                  Retailers and wholesale purchaser-consumers are only required to retain PTDs, and already do so under existing fuels programs for a period of five (5) years.   In addition, since such parties normally retain copies of PTDs as customary business practice (CBP), we do not estimate any ICR burden for those parties.               	  	b.	Information Requested 		 	A)	Reporting:  The E15 final rule contains information collection provisions that permit a party to apply for approval of an alternative or additional E15 label.  We anticipate that this provision may be utilized by some refiners for their branded retailers, as well as by some individual retailers and wholesale purchaser-consumers.  However, we anticipate very few respondents (applicants) based upon our experience with prior regulations that included provisions for alternative labeling under 40 CFR Part 80 (e.g. oxygenated gasoline labels).  It is also quite possible that no party will request an alternative label.   However, we have provided an estimate for this item because it is possible we will receive applications for alternative labeling under this program.

	A party may elect to satisfy the survey requirements of this rule individually rather than through using a nationwide, consortium survey option (i.e., they may elect "Survey Option 1."   In such circumstances, the individual information collection requirements associated with "Survey Option 1" will apply.  Parties that may be subject to survey information collection requirements include gasoline refiners, gasoline and ethanol importers, gasoline and ethanol blenders (including terminals and carriers), and ethanol producers.  We anticipate that few, if any, parties will elect to satisfy the survey by choosing "Survey Option 1."  When we have offered this option in the past under other 40 CFR Part 80 fuels programs (e.g. RFG), no party has elected to do so.  Therefore it is quite possible that no party will choose "Survey Option 1."  However, we have provided an estimate for this option because the opportunity to choose "Survey Option 1" exists under this program.

	Under the terms of the E15 partial waiver, which is separate from the final rule but closely related to it, fuel and fuel additive manufacturers must submit a written plan to EPA for approval.  The plan must include provisions designed to prevent misfueling.  The plan must be submitted by all fuel and fuel additive manufacturers, regardless of whether a party elects "Survey Option 1" (individual) or "Survey Option 2" (nationwide).  Parties that may be subject to this information collection item may include gasoline refiners, gasoline and ethanol importers, gasoline and ethanol blenders (including terminals and carriers), and ethanol producers.  These estimates are included in this draft supporting statement.

	The final rule contained provisions related to product transfer documents (PTDs).  Parties upstream of the retail station or wholesale purchaser-consumer were required to develop and program new codes and statements for PTDs.  This was a one burden requirement and eliminated from the cost estimates in this collection.  These codes will reflect the ethanol content, as well as the Reid Vapor pressure (RVP).  Parties subject to this one time burden include gasoline refiners, gasoline importers, and gasoline and ethanol blenders (including terminals and carriers).

	In addition to the one time burden of establishing/programming codes and statements for PTDs, parties will be required to apply the new codes and statements to PTDs as part of the normal course of business. The application of codes and statements is typically an automated process.  Typically, refiners and wholesale purchaser-consumers who are not acting as blenders merely accept PTDs given to them by upstream parties.  The following parties may have the burden of applying codes and statements:  gasoline refiners, gasoline importers, gasoline and ethanol blenders (including terminals and carriers).

		B)	Recordkeeping: Parties must retain PTDs and other records related to compliance, such as QA results, for five (5) years.  Retention of PTDs is already a customary business practice (CBP) for the industry.  In addition, parties are already required to retain these records for five (5) years under existing 40 CFR Part 80 fuels programs.  Therefore, this final rule imposes no changed or additional recordkeeping burden.    5.  The Information Collected, Agency Activities, Collection Methodology, and Information Management

      a.	Agency Activities

      We are not establishing any periodic compliance reporting provisions under this regulation.  The frequency of reporting is determined by the activities of the respondents themselves.  The estimates in this ICR for use of PTDs, or application to EPA for an alternative label, are based upon our expectations and experience with similar programs.  EPA may request production of records, particularly in situations where a violation is suspected or observed.

      b. 	Collection and Methodology and Management

	Normally, we will not collect records or reports from regulated parties, but we may, particularly in connection with enforcement actions.  A party may claim that information it submits to EPA is confidential business information (CBI).  Information claimed as CBI will be stored in appropriately controlled areas and will be treated in accordance with 40 CFR Part 2 and EPA policies and procedures for handling of CBI.

      c.	Small Entity Flexibility

	The final rule and its information collection requirements will not have any substantial impact on small entities.

      d.	Collection Schedule              Reporting is occasional.  The frequency of reporting is determined by the respondent.

6.	Estimating the Burden and Cost of Collection

      a.	Estimating the Respondent Universe

	We drew upon experience implementing similar regulations among the same and similar entities to develop estimates of the burden associated with this collection.

	         b.	 Estimating Respondent Costs         (i) Estimating Labor Costs              Four labor categories were identified as having involvement: managerial, legal, professional/technical (prof/tech) and clerical.  According to the Bureau of Labor Statistics, May 2013 National Industry-Specific Occupational Employment and Wage Estimates, mean wages were:              Wages       Managerial 	$63.74 per hour       Legal		$82.50 per hour       Prof/Tech	$56.24 per hour       Clerical	$17.62 per hour              Doubling for company overhead and for convenience, rounding to the nearest dollar, gives the following rates that will be used for this ICR:              Total Employer Cost       Managerial	$128       Legal		$165       Prof/Tech	$113       Clerical	$ 35              The labor mix for each task is assumed to be about 0.05 hour managerial, 0.05 hour legal, 0.7 hour professional/technical, and 0.2 hour technical.  This gives an average labor cost of about $101 per hour, which will be used in this ICR.  Our estimates are summarized in the following table:   DETAILED ICR ESTIMATES

                                  Collection                                                                            Type of                                      No. of                                     No. of                                   Total No. of                                    Time Per                                    Cost Per                                   Total Hours                                   Total Cost   Assumes:                                    Activity                                                                              Party                                     Parties                                    Responses                                    Responses                                    Response                                      Hour                                                                                per Party                                                                              Hours                                                                                Labels - 80.1501(b)(5) Other

The number of responses for other retailer, WP-C are actual numbers of responses received. Submission of Alt. or Retailer                                                                               1                                                                               1                                                                               1                                                                              24                                                                             101                                                                              24                                      2424

  Additional Labels for

  EPA Approval

  REPORTING WP-C                                                                               1                                                                               1                                                                               1                                                                              24                                                                             101                                                 24           2424

The response from the Survey Association, if chosen will serve as 1 report for industry.

  80.1502(a)

Survey Association (Nationwide)                                                                               1                                                                               1                                                                               1                                                                             200                                                                             101                                                                             200        20,200

  Survey Option 1

  REPORTING

  Survey Option 2  -  REPORTING - Individually

  80.1503 - Use of PTDs                   HOURS: indicating RVP and G Refiner                                                                             150                                                                          22,000                                                                         3300000                                                                       0.0002778                                                                             101                                                                       916.66667               92583.33      1 second/ and EtOH content G Importer                                                                              50                                                                          22,000                                                                         1100000                                                                       0.0002778                                                                             101                                                                       305.55556                30861.11   Report  to log PTD's (Upstream of terminal)                   REPORTING

                                                                                PTDs for downstream G/E blender                                                                           1,000                                                                          22,000                                                                        22000000                                                                       0.0002778                                                                             101                                                                       6111.1111                                                                       617222.22     indicating RVP and (terminal)                   EtOH content G/E blender                                                                             800                                                                          22,000                                                                        17600000                                                                       0.0002778                                                                             101                                                                       4888.8889                                                                       493777.78

(carrier)                  Waiver Plan

Assumes 5% or less will submit reports in this collection   REPORTING

Waiver - Submission  G Refiner                                                                              20                                                                               1                                                                              20                                                                               8                                                                             101                                                                             160                                                                          16160

of Waiver Plan G/E Importer                                                                               5                                                                               1                                                                               5                                                                               8                                                                             101                                                                      40                               4040

by Fuel and  G/E Blender                                                                              60                                                                               1                                                                              60                                                                               8                                                                             101                                                                             480                                                                           48480

Fuel Additive (terminal)

Manufacturers G/E Blender                                                                               5                                                                               1                                                                               5                                                                               8                                                                             101                                                 40                                                                            4040

(carrier)

E Producer                                                                              10                                                                               1                                                                              10                                                                               8                                                                             101                                                                              80                                                                            8080

REPORTING TOTALS

                                                                           2103

                                                                       44000103

                                                                    13270.22227                                                                  $ 1,340,292.44

See NOTES below regarding retention of QA records.

RECORDKEEPING TOTALS                                                                                0                                                                                0                                                                                0                                                                               0

GRAND                       TOTALS                                                                                2103                                                                          44000103                                                                            37350.22                                                                   $1,340,292.44                                                     NOTES ON THE ESTIMATES:                     REPORTING                     Under survey option1, there is assumed to be only one possible respondent (the survey association) which would seek   Approval of labs.  See 80.1502(b)(3)(iii)(B).  Since there is only one non-Fed respondent, no burden is included.     RECORDKEEPING                     Parties already retain PTDs as CBP and under existing fuels programs, so "new" 80.1507(a)(1)(i) represents no added burden.     Similarly, parties already retain records of QA assurance, so "new" 80.1507(a)(1)(ii) represents no added burden.                                  c.  	Estimating the Agency Burden and Cost

	The annual Agency burden consist of 0.10 of a GS-13 step 1 professional employee (estimated at $181,646 including overhead), or $18,165. The burden estimates reviewing twenty (20) survey plans for twenty (20) respondents (whom we estimate will choose "Survey Option 2." This also includes the effort of the employee reviewing one survey plan for a survey consortium under "Survey Option 1."  This assumes a total of 24 weeks of burden, including 21 weeks to complete review survey plans (one week each) and three (3) weeks to review and approval alternative labels for a total of sixty (60) respondents.     	       d.	Estimating the Respondent Universe

	We were able to estimate the number of regulated entities drawing upon experience regulating the same or similar entities. EPA expects that only 1 alternative or additional label from retailers and WP-C party members during this collection.  EPA expects only 1 report from "Option 1" survey association. These amounts were drawn from actual submission to the Agency during last collection period.  Survey Option 2" (nationwide).  Parties included gasoline refiners, gasoline and ethanol importers, gasoline and ethanol blenders (including terminals and carriers), and ethanol producers.  Less than 10% in each party were included as respondents in the collection which derived from the actual numbers in the Agency's DCFUEL data base. For those parties, they have reporting the burden of logging PTD's, the actual application of a PTD code is an automated process that would take one second or less. There is no added recordkeeping burden in this collection due to information under existing fuel programs are already kept.             e.	Bottom Line Burden Hours and Costs

	From the tables, we estimate the following totals:

The annual burden is estimated as: 2,103 respondents; 44,000,103 responses; and 13,270 hours. The annual ICR cost is estimated at $1,340,292.

Total Respondents		         2,103

Total Responses		44,000,103

Total Hours			       13,270

Total Cost			$1,340,292

      f.	Reason for Change in Burden

	Not applicable, as this is a new information collection.

      g.	Burden Statement

	The annual public reporting and recordkeeping burden for this collection of information is estimated to be 8.5 hours per response. (Note:  Most responses under this ICR will consist of the simple application of codes/statements to PTDs, a process that takes less than 1 second.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.  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.  The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, an  d any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID number EPA-HQ-OAR-2015-0202, which is available for online viewing at www.regulations.gov, or in person viewing at the Air Docket in the EPA Docket Center in Washington, DC (EPA/DC).  The docket is located in the EPA West Building, 1301 Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30 p.m., Eastern Standard Time, Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.   	  	You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number EPA-HQ-OAR-2015-0202.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OAR-2015-0202 and OMB Control Number 2060-0675 in any correspondence.


[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Notices]
[Pages 37899-37900]
[FR Doc No: 2012-15358]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0259; FRL-9518-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for the Surface Coating of
Large Household and Commercial Appliances (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before July 25, 2012.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2011-0259, to: (1) EPA online, using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2011 (76 FR 26900), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2011-0259, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted either electronically or in paper, will be
made available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NESHAP for the Surface Coating of Large Household and
Commercial Appliances (Renewal).
    ICR Numbers: EPA ICR Number 1954.05, OMB Control Number 2060-0457.
    ICR Status: This ICR is scheduled to expire on July 31, 2012. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the Provisions specified at 40 CFR part 63, subpart
NNNN. Owners or operators of the affected facilities must submit
initial notification, performance tests, and periodic reports and
results.
    Owners or operators are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports, at a minimum, are required
semiannually.
    All reports are sent to the delegated state or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA regional office. This information is being
collected to assure compliance with 40 CFR part 63, subpart NNNN, as
authorized in section 112 and 114(a) of the Clean Air Act. The required
information consists of emissions data and other information that have
been determined to be private.
    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. The OMB Control Numbers for the EPA
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 98
hours per response. ``Burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of surface
coating of large household and commercial appliances facilities.
    Estimated Number of Respondents: 102.
    Frequency of Response: Initially, occasionally, and semiannually.
    Estimated Total Annual Hour Burden: 32,634.
    Estimated Total Annual Cost: $3,721,318, which includes $3,126,918
in labor costs, $64,000 in capital/startup costs, and $530,400 in
operation and maintenance (O&M) costs.
    Changes in the Estimates: There is an adjustment increase in the
total estimated burden hours and cost for both the respondents and the
Agency as currently identified in the OMB Inventory of Approved
Burdens. This change is due to both an increase in the average number
of respondents subject to the standard and an increase in labor rates.
This ICR uses updated labor rates for each of the three labor
categories.
    There is also an increase in the O&M costs to the respondents. The
costs were updated to reflect comments received during consultation.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-15358 Filed 6-22-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Page 15017]
[FR Doc No: 2015-06426]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0456]

Pediatric Stakeholder Meeting; Request for Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration is correcting a document
entitled ``Pediatric Stakeholder Meeting; Request for Comments'' that
appeared in the Federal Register of February 26, 2015 (80 FR 10493).
The document announced a public meeting seeking input from patient
groups, consumer groups, regulated industry, academia and other
interested parties to obtain any recommendations or information
relevant to the report to Congress that FDA is required to submit
concerning pediatrics, as outlined in the Food and Drug Administration
Safety and Innovation Act (FDASIA). The document was published with the
incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Planning, Legislation, and Analysis, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993,
301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 26,
2015, in FR Doc. 2015-03974, on page 10493, the following correction is
made:
    On page 10493, in the first column, the Docket No. heading,
``[Docket No. FDA-20115-N-0456]'' is corrected to read ``[Docket No.
FDA-2015-N-0456]''.

    Dated: March 17, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-06426 Filed 3-19-15; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Mitch Zeller:

I am writing as an individual consumer to request an extension of the comment period for the FDA's Proposed Rule Deeming Tobacco Products to be subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.  I am requesting an extension to the 75-day comment period to 105 days for a total of 180 days.

The proposed rule raises a significant amount of questions and issues that concerns me greatly.  Although I have spent quite of bit of time researching the issues to the proposal, I will need more time to fully review the proposal so that I can express an educated opinion on the matter.  I understand that the FDA took many years to even come up with the Proposed Rule, so  I do not think it is at all unreasonable to allow the public a mere six months to provide feedback.

I am very passionate about how this new piece of technology has saved my life.  I would like to explain my story along with science- and evidence-based responses to your questions so that you can take my comment into account.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past.  Please, extend the comment period, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

Thank you for considering my request.  I will be happy to discuss this issue with you further.

Sincerely, J.A.