[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Rules and Regulations]
[Page 5695-5697]
[DOCID:fr04fe10-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1116; Directorate Identifier 2009-CE-061-AD;
Amendment 39-16193; AD 2010-03-09]
RIN 2120-AA64

Airworthiness Directives; PIAGGIO AERO INDUSTRIES S.p.A Model
PIAGGIO P-180 Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Cracks have been detected on the upper flange (cap) of several
``0'' pressure bulkheads on the production line; none of the cracks
had spread across the thickness of material.
    Investigation revealed that all ``0'' pressure bulkheads
installed on aircraft from MSN 1106 up to 1189 could have the same
cracks.

    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective March 11, 2010.
    On March 11, 2010, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Sarjapur Nagarajan, Aerospace
Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on November 30, 2009
(74 FR 62516). That NPRM proposed to correct an unsafe condition for
the specified products. The MCAI states:

    Cracks have been detected on the upper flange (cap) of several
``0'' pressure bulkheads on the production line; none of the cracks
had spread across the thickness of material.
    Investigation revealed that all ``0'' pressure bulkheads
installed on aircraft from MSN 1106 up to 1189 could have the same
cracks.
    Although calculations confirm the low stress level in that area,
a reinforcement of the ``0'' pressure bulkhead is suggested to avoid
crack growth and the eventual failure of the bulkhead.
    For the reasons stated above, this new Airworthiness Directive
(AD) mandates a non-destructive inspection and a reinforcement--by
installation of doublers--of the ``0'' pressure bulkhead. This AD
also includes a reporting requirement of the inspection results.

    You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.
    Mr. Carlo Cardu of Piaggio Aero Industries states that he
understands owners/operators may comply with an AD before the specified
compliance time; however, he also states it would be best for the
owners/operators of the airplanes affected by this AD to do the
inspection and modification of the pressure bulkhead during a D
inspection, which is at 3,000 hours time-in-service (TIS).
    Mr. Cardu requests changing the compliance time for the inspection
and modification from ``when the airplane reaches a total of 3,600
hours TIS * * *'' to ``before the airplane reaches a total of 3,600
hours TIS * * *.''
    We agree with the intent of the commenter. To make it clear that
the owners/operators of the airplanes affected by this AD may comply
with the AD before their airplane reaches 3,600 hours TIS, we will
change the compliance time in the final rule AD action to allow the
inspection and modification to be done before or when the airplane
reaches a total of 3,600 hours TIS or within the next 30 days after the
effective date of the AD, whichever occurs later.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the changes described previously. We determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 63 products of U.S. registry.
We also estimate that it would take about 120

work-hours per product to comply with the basic requirements of this
AD. The design approval holder is providing warranty credit for parts
and up to 120 work-hours of labor.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $0.

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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD Docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2010-03-09 Piaggio Aero Industries S.p.A.: Amendment 39-16193;
Docket No. FAA-2009-1116; Directorate Identifier 2009-CE-061-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
11, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model PIAGGIO P-180 airplanes,
manufacturer's serial numbers 1106 through 1189, certificated in any
category.

Subject

    (d) Air Transport Association of America (ATA) Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Cracks have been detected on the upper flange (cap) of several
``0'' pressure bulkheads on the production line; none of the cracks
had spread across the thickness of material.
    Investigation revealed that all ``0'' pressure bulkheads
installed on aircraft from MSN 1106 up to 1189 could have the same
cracks.
    Although calculations confirm the low stress level in that area,
a reinforcement of the ``0'' pressure bulkhead is suggested to avoid
crack growth and the eventual failure of the bulkhead.
    For the reasons stated above, this new Airworthiness Directive
(AD) mandates a non-destructive inspection and a reinforcement--by
installation of doublers--of the ``0'' pressure bulkhead. This AD
also includes a reporting requirement of the inspection results.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) As of March 11, 2010 (the effective date of this AD), before
or when the airplane reaches a total of 3,600 hours time-in-service
or within the next days 30 after the effective date of the AD,
whichever occurs later, inspect the ``0'' pressure bulkhead for
cracks using a dye-penetrant inspection method. Do the inspection in
accordance with Part A of the Accomplishment Instructions in PIAGGIO
AERO INDUSTRIES S.p.A Service Bulletin (Mandatory) N.: SB-80-
0267Rev.0, dated May 19, 2009; or PIAGGIO AERO INDUSTRIES S.p.A.
Service Bulletin (Mandatory) N.: SB-80-0267Rev.1, dated June 16,
2009.
    (2) Before further flight after the inspection required in
paragraph (f)(1) of this AD (whether or not cracks were found),
install doublers on the ``0'' pressure bulkhead. Do the modification
in accordance with Part B and Part C of the Accomplishment
Instructions in PIAGGIO AERO INDUSTRIES S.p.A Service Bulletin
(Mandatory) N.: SB-80-0267Rev.0, dated May 19, 2009; or PIAGGIO AERO
INDUSTRIES S.p.A. Service Bulletin (Mandatory) N.: SB-80-0267Rev.1,
dated June 16, 2009.
    (3) Within 30 days after doing the inspection required in
paragraph (f)(1) of this AD, report all inspection results, negative
or positive, to Piaggio Aero Industries S.p.a., Via Cibrario, 4--
16154 Genoa, Italy; fax: +39 010 6481 881; e-mail:
<EMAIL_ADDRESS>
FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Sarjapur Nagarajan, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection

requirements and has assigned OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2009-0211, dated October 6, 2009; PIAGGIO AERO INDUSTRIES S.p.A.
Service Bulletin (Mandatory) N.: SB-80-0267Rev.0, dated May 19,
2009; and PIAGGIO AERO INDUSTRIES S.p.A. Service Bulletin
(Mandatory) N.: SB-80-0267Rev.1, dated June 16, 2009, for related
information.

Material Incorporated by Reference

    (i) You must use PIAGGIO AERO INDUSTRIES S.p.A. Service Bulletin
(Mandatory) N.: SB-80-0267Rev.0, dated May 19, 2009; and PIAGGIO
AERO INDUSTRIES S.p.A. Service Bulletin (Mandatory) N.: SB-80-
0267Rev.1, dated June 16, 2009, to do the actions required by this
AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Piaggio Aero Industries S.p.a., Via Cibrario, 4--16154 Genoa, Italy;
fax: +39 010 6481 881; e-mail<EMAIL_ADDRESS>    (3) You may review copies of the service information
incorporated by reference for this AD at the FAA, Central Region,
Office of the Regional Counsel, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
Central Region, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Kansas City, Missouri, on January 26, 2010.
John Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-2001 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Notices]
[Page 52957-52958]
[DOCID:fr30au10-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0445]

Supplemental Funding Under the Food and Drug Administration's
Food Emergency Response Laboratory Network Microbiological Cooperative
Agreement Program (U18) PAR-09-215; Request for Supplemental
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent to provide supplemental funding to the
existing cooperative agreement (U18), PAR-09-215, with the Food and
Drug Administration and a request for supplemental applications.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of supplemental grant funds for the support of Food
Emergency Response Laboratory Network (FERN) Microbiological
Laboratories. The goal of these FERN Microbiological Laboratories
supplements is a minor program expansion to enhance the lab
capabilities to handle human pathogenic bacteria in animal feed.

DATES: Important dates are as follows:
    1. The supplemental application due date is August 30, 2010.
    2. The anticipated start date is September 2010.
    3. The opening date is August 30, 2010.
    4. The expiration date is September 6, 2010.

FOR FURTHER INFORMATION CONTACT: Tim McGrath, Office of Regulatory
Affairs, Food and Drug Administration, 5600 Fishers Lane, rm. 12-41,
Rockville, MD 20857,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
or Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    For more information on the original funding opportunity
announcement (FOA) for the FERN Microbiological Laboratories, please
refer to the full FOA located at http://grants.nih.gov/grants/guide/pa-
files/PAR-09-215.html. The program is further described in the Catalog
of Federal Domestic Assistance under 93.103.

A. Background

    This Federal Register announcement issued by FDA under the FERN
Microbiological Cooperative Agreement Program Grant mechanism (U18) is
to solicit applications from existing FERN Microbiology Laboratories to
enhance current Cooperative Agreement Program (CAP) capabilities. The
FERN cooperative agreements are to enable the analyses of foods and
food products in the event that laboratory surge capacity is needed by
FERN and FDA for analyses related to microbiological contamination,
either through intentional or unintentional means. The supplemental
grant funds will enable analyses of human pathogenic bacteria found in
animal feed, for samples collected by Federal, State, or local
agencies. Numbers of samples and scheduling of samples will be done by
the FERN National Program Office (NPO) in coordination with State/local
lab authorities.
    These supplemental grant funds will also be utilized to enhance
animal feed analysis results through the usage of standardized methods,
equipment platforms (provided by the grant), analytical worksheets, and
electronic reporting. The supplemental funds will also provide training
and proficiency testing for each method/platform. Minimal quality
management systems will be initiated for each lab, based on existing
systems in place in each lab and consultations between the FERN NPO and
each lab management group.
    Each laboratory shall develop its own consensus decisionmaking,
size, and format. Federal agency representatives may be invited to be
nonmember liaisons or advisors to the laboratory and its meetings.
Supplemental funds may not be used for Federal employees to travel to
or participate in these meetings.

B. Research Objectives

    Selected FDA FERN Microbiological Cooperative Agreement
Laboratories (CAP labs) will participate in a special Cooperative
Agreement program to enhance their ability to handle human pathogenic
bacteria in animal feed. This additional program will be compatible
with other FERN Cooperative Agreement work that the selected
laboratories will be performing. This special program will involve
screening and detection studies for selected pathogens (Listeria,
Salmonella, Escherichia coli O157:H7 and generic E. coli). The isolates
will be tested using methods agreed upon in consultation with the
Center for Veterinary Medicine's (CVM) Office of Research, most of
which are already being used to isolate these organisms from human
foods. The selected labs will participate in FERN food defense/food
safety assignments. The participation in this cooperative agreement
will expand the ability of FERN to screen for potential foodborne
pathogens in these feed matrices. In addition, this project will
provide CVM with information needed to assess future testing needs.

C. Eligibility Information

    These supplemental grant funds are only available to existing grant
recipients from State, local, and tribal government FERN laboratories
and are authorized by section 312 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188)
(42 U.S.C. 247b-20). This program is described in the Catalog of
Federal Assistance under number 93.448. All projects developed with
these funds at State, local, and tribal levels must have national
implication or application that can enhance Federal food and feed
safety and security programs.

D. Requirements

    Laboratories will be selected based on the following criteria:
     If it's an existing FDA FERN Microbiological Cooperative
Agreement Laboratory;
     If it has routine microbiological capabilities as
demonstrated through established, ongoing State testing programs,
preferably those involving animal feed testing;
     If it participates in FERN Food Safety/Food Defense
surveillance assignments;
     If it participates in FERN proficiency testing; and
     If it has a geographically balanced distribution of the
selected laboratories.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing approximately $50,000 total costs (direct
costs only) in support of this supplemental program in fiscal year
2010. It is estimated that up to six microbiological laboratories will
be supplemented at the level requested, but not exceeding $50,000 total
costs (direct costs only) for a 1-year minor program expansion.

B. Length of Support

    The initial award will be for a 1-year performance period and any
additional funding related to this supplement will be dependant on
successful performance and fiscal appropriations.

III. Paper Application and Submission Information

    To submit an application in response to this supplemental notice,
applicants should download the PHS-398 form at http://grants.nih.gov/
grants/funding/phs398/phs398.html.
    Submit the paper application to:
    Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857,<PHONE_NUMBER>; and
    Jenny Gabb, Office of Regulatory Affairs (HFC-150), Food and Drug
Administration, 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-
827-8299.

    Dated: August 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21480 Filed 8-27-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Rules and Regulations]
[Pages 56294-56295]
[FR Doc No: 2011-23271]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 160

[Docket No. USCG-2011-0076]
RIN 1625-AB60

Inflatable Personal Flotation Devices

AGENCY: Coast Guard, DHS.

ACTION: Direct final rule; notice of withdrawal.

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SUMMARY: The Coast Guard is withdrawing its direct final rule published
on March 30, 2011. The direct final rule notified the public of the
Coast Guard's intent to harmonize structural and performance standards
for inflatable recreational personal flotation devices (PFDs) with
current voluntary industry consensus standards, and to slightly modify
regulatory text in

anticipation of a future rulemaking addressing the population for which
inflatable recreational PFDs are approved. The Coast Guard is
withdrawing that rule because we received an adverse comment. That rule
will not become effective as scheduled. Instead, the Coast Guard plans
to consider these issues in a notice of proposed rulemaking.

DATES: The direct final rule published March 30, 2011, (76 FR 17561),
is withdrawn effective September 13, 2011.

ADDRESSES: The docket for this rulemaking, USCG-2011-0076, is available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. You
may also find this docket on the Internet by going to http://www.regulations.gov, inserting USCG-2011-0076 in the ``Keyword'' box,
and then clicking ``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or e-mail Ms. Brandi Baldwin, Lifesaving and Fire Safety
Division (CG-5214), U.S. Coast Guard, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing material in
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On March 30, 2011, we published a direct final rule entitled
``Inflatable Personal Flotation Devices'' in the Federal Register (76
FR 17561). That rule would have revised 46 CFR part 160, subpart
160.076 to update the editions of the Underwriters Laboratories (UL)
Standards incorporated by reference and made necessary conforming
changes resulting from incorporating the updated standards. The
conforming changes included removing test methods, acceptance criteria,
and other standards currently contained in subpart 160.076 that are
made redundant by the newer editions of the UL Standards. That rule
also made minor regulatory text revisions to subpart 160.076 which had
a non-substantive effect.
    We published the rule as a direct final rule under 33 CFR 1.05-55
because we considered this rule to be noncontroversial and did not
expect any adverse comment regarding this rulemaking. In the direct
final rule we notified the public of our intent to make the rule
effective on September 26, 2011, unless an adverse comment or notice of
intent to submit an adverse comment was received on or before May 31,
2011.
    We received three submissions during this comment period, and have
determined that one of those submissions contains an adverse comment,
as explained below. As such the Coast Guard is withdrawing the direct
final rule and is instead planning to consider these issues in a notice
of proposed rulemaking.

Withdrawal

    The Coast Guard received three submissions in response to the
direct final rule: one supportive of the rulemaking generally, one
which raised questions about a revision to one of the standards
incorporated by reference, and one adverse comment related to the
deletion of the words ``approved for use by adults only'' from the
regulations.
    One commenter expressed support for the rule, citing the removal of
barriers to the development of innovative PFDs leading to an expected
improvement in the quality and variety of inflatable lifejackets
available to the public. The Coast Guard appreciates this support.
    One commenter expressed disagreement with a specific revision made
to UL Standard 1191, which increased the tolerance for the minimum
gross weight of inflation gas cylinders from 10% to 15%. Following
publication of the direct final rule, UL 1191 was revised to return
this value to 10%.
    Another commenter expressed concern about deleting the words
``approved for use by adults only''; the Coast Guard has determined
this comment to be an adverse comment. In the direct final rule, we
explained that a comment is considered adverse if the comment explains
why this rule or a part of this rule would be inappropriate, including
a challenge to its underlying premise or approach, or why it would be
ineffective or unacceptable without a change (76 FR 17563). This
commenter explains that deleting the words ``approved for use by adults
only'' would create a perception that inflatable PFDs for youth would
be available on the date this rule goes into effect, would facilitate
teens using existing inflatable PFDs, and would enable the marketing of
existing inflatable PFDs to youth. The commenter also expressed concern
that this rulemaking is premature in light of the work that still needs
to be done to evaluate sizing requirements for infant or child PFDs.
Because the Coast Guard considers these concerns to be adverse
comments, the Coast Guard is withdrawing the direct final rule. The
Coast Guard will seek comment on the commenter's concerns in the
forthcoming notice of proposed rulemaking.

    Dated: September 7, 2011.
J.G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2011-23271 Filed 9-12-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61013-61014]
[FR Doc No: 2022-21877]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER22-2924-000.
    Applicants: RWE Supply & Trading Americas, LLC.
    Description: Supplement to September 23, 2022, RWE Supply & Trading
Americas, LLC Application for Market-Based Rate Authorization.
    Filed Date: 9/30/22.
    Accession Number: 20220930-5454.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2986-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Balancing Accounts Update
2023 (TRBAA, RSBAA, ECRBAA) to be effective 1/1/2023.
    Filed Date: 9/30/22.
    Accession Number: 20220930-5401.
    Comment Date: 5 p.m. ET 10/21/22.

    Docket Numbers: ER22-2987-000.
    Applicants: Entergy Services, LLC, Midcontinent Independent System
Operator, Inc.
    Description: Schedule 41 Refund Report of Entergy Services, LLC, et
al.
    Filed Date: 9/26/22.
    Accession Number: 20220926-5228.
    Comment Date: 5 p.m. ET 10/17/22.

    Docket Numbers: ER23-1-000.
    Applicants: ITC Midwest LLC, Interstate Power and Light Company.
    Description: Sec.  205(d) Rate Filing: ITC Midwest LLC submits
tariff filing per 35.13(a)(2)(iii: Update to O&T Agreement Exhibits and
Appendices (2022) to be effective 12/2/2021.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5024.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-2-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original IISA, Service
Agreement No. 6615; Queue No. AF2-205 to be effective 9/2/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5130.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-3-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: Concurrence IPL Amended
Exhibits and Attachments (2022) to be effective 12/2/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5131.

    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-4-000.
    Applicants: New Market Solar ProjectCo 2, LLC.
    Description: Sec.  205(d) Rate Filing: SFA Amendment Filing to be
effective 10/4/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5225.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-5-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 311,
Sierra Estrella LGIA to be effective 12/3/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5237.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-6-000.
    Applicants: Top Hat Wind Energy Holdings LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 12/3/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5245.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-7-000.
    Applicants: Top Hat Wind Energy LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 12/3/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5246.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-8-000.
    Applicants: Microgrid Networks LLC.
    Description: Baseline eTariff Filing: Application for Market Based
Rate Authority to be effective 10/31/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5268.
    Comment Date: 5 p.m. ET 10/24/22.

    Docket Numbers: ER23-9-000.
    Applicants: Doc Brown LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
10/4/2022.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5274.
    Comment Date: 5 p.m. ET 10/24/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date.
    Protests may be considered, but intervention is necessary to become
a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 3, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-21877 Filed 10-6-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28372-28374]
[FR Doc No: 2019-12786]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86092; File No. SR-ICEEU-2019-008]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Publication of a Circular Regarding the Interpretation of References
to EU Legislation in the Clearing Rules Post-Brexit

June 12, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 31, 2019, ICE Clear Europe Limited (``ICE Clear Europe'' or the
``Clearing House'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes described in Items I, II,
and III below, which Items have been primarily prepared by ICE Clear
Europe. ICE Clear Europe filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(1) thereunder,\4\
so that the proposal was immediately effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe is proposing to publish a Circular, titled ICE
Clear Europe: Interpretation of References to EU Legislation in the
Clearing Rules Post-Brexit (the ``Circular''), to provide guidance as
to the interpretation of references to European Union (``EU'')
directives and regulations in the ICE Clear Europe Clearing Rules and
Procedures in the event that the United Kingdom (``UK'') ceases to be
an EU member state, in circumstances where no withdrawal agreement
stipulating that EU laws will continue to apply in the UK has been
agreed between the UK and the EU-27. The interpretation contained in
the Circular will only apply under such circumstances.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    The purpose of the proposed Circular is to provide guidance with
respect to the interpretation of certain provisions in the Rules and
Procedures in the event that the UK ceases to be an EU member state, in
circumstances where no withdrawal agreement has been agreed between the
UK and the EU-27 stipulating that EU laws will continue to apply in the
UK. In such circumstances, directly applicable EU directives and
regulations will be incorporated into UK law with modifications on
``exit day'' through the European Union (Withdrawal) Act 2018 (the
``EUWA''), which would result in there being two versions of a directly
applicable EU legislative act which may be applicable to the Rules: (1)
The version as enacted in the EU, directly applicable throughout the EU
(and, in certain cases, the EEA); and (2) the version incorporated into
UK law (referred to as ``on-shored'').
    There are various references to EU directives and regulations in
the Rules and Procedures; others may arise by implication by virtue of
definitions such as that of ``Applicable Laws'' or ``Governmental
Authority'' (Rule 101). ICE Clear Europe is proposing to publish the
Circular to provide guidance as to the proper interpretation of such
references in the event of the UK leaving the EU without withdrawal
agreement that provides for continued applicability of EU law in the
UK. The guidance is intended to be consistent with the views of legal
practitioners in the UK with respect to references to EU directives and
regulations in English law contracts generally, but applied to the
particular definitions and situations that arise under the Rules and
Procedures.
    The Circular sets out several principles that will be applied by
ICE Clear Europe when interpreting references to an EU regulation or
directive in its Rules:
    1. Where the reference concerns an obligation on, or otherwise
applies to, the Clearing House or a UK Clearing Member:
    [cir] Where the reference is to an EU regulation, it should be
interpreted as the regulation as it forms part of UK domestic law
through section 3 of the EUWA, and as amended by UK law from time to
time; and
    [cir] Where the reference is to an EU directive, it should be
interpreted as the UK domestic law corresponding to the directive or
provision thereof.
    2. Where the reference concerns an obligation on, or otherwise
applies to, an EU Clearing Member:
    [cir] Where the reference is to an EU regulation, it should be
interpreted as the regulation as it applies in the EU, and as amended
by EU law from time to time; and
    [cir] Where the reference is to an EU directive, it should be
interpreted as the EU directive, as amended by EU law from time to time
and as implemented in the relevant member state of the EU Clearing
Member.
    The Circular also addresses situations where both sets of laws
apply, for example for entities established in the UK with an EU branch
(or vice versa) or which continue to be regulated in both systems under
cross-border licenses, the UK temporary permissions regime or other
grandfathering arrangements. By way of example, it explains how Rule
requirements that Clearing Members maintain sufficient capital and
segregated accounts would require UK Clearing Members to comply with
the on-shored version of the applicable regulatory requirements, while
EU Clearing Members would be required to comply with the existing EU
regulations.
    The Circular further sets out certain exceptions to these general
principles relating to the following:
     A reference to an EU law relating to emission allowance
units issued under the EU Emissions Trading Scheme should be
interpreted to continue to refer to the EU law since the UK no longer
participates in the scheme;
     References to EU member state laws transposing or
implementing an EU directive will be read to include UK laws
corresponding to that EU directive;
     Certain references relating to the European Market
Infrastructure Regulation (Regulation (EU) No 648/2012) and related EU
authorities will be read to continue to refer to relevant EU law and
authorities, for example in the context of ICE Clear Europe's status as
a third country central counterparty thereunder; and
     References relating to EU data protection legislation are
excluded, since these are addressed separately in ICE Clear Europe
Circular C19/053 dated March 15, 2019.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed rule change is
consistent with the requirements of Section 17A of the Act \5\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\6\ In particular, Section 17A(b)(3)(F) of the Act \7\
requires, among other things, that the rules of a clearing agency be
designed to promote the prompt and accurate clearance and settlement of
securities transactions and, to the extent

applicable, derivative agreements, contracts, and transactions, the
safeguarding of securities and funds in the custody or control of the
clearing agency or for which it is responsible, and the protection of
investors and the public interest. The proposed Circular would provide
guidance with respect to the interpretation of the Rules that would
apply to EU and UK Clearing Members and ICE Clear Europe upon the UK
departure from the EU if there is no withdrawal agreement that provides
for EU law to continue to apply in the UK. The interpretation would
thus facilitate continued clearing by EU and UK Clearing Members in
compliance with applicable law in relevant jurisdictions and promote
the prompt and accurate clearance and settlement of transactions by
such persons. As such, the interpretation is consistent with the
safeguarding of securities and funds in the custody or control of the
Clearing House or for which it is responsible, the protection of
investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 17 CFR 240.17Ad-22.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Moreover, the interpretation is consistent with Rule 17Ad-
22(e)(1),\8\ which requires that each covered clearing agency
establish, implement, maintain and enforce written policies and
procedures reasonably designed to provide for a well-founded, clear,
transparent, and enforceable legal basis for each aspect of its
activities in all relevant jurisdictions. As discussed herein, the
interpretation is designed to ensure that references to EU legislation
in the Rules and Procedures are properly interpreted should the UK
cease to be an EU member state with no withdrawal agreement stipulating
that EU laws will continue to apply in the UK. The guidance set out in
the Circular would facilitate continued clearing in light of the
requirements of UK and EU law in those circumstances and would minimize
the potential for disputes and legal uncertainty. ICE Clear Europe does
not expect that the interpretation will adversely impact its ability to
comply with the Act or any standards under Rule 17Ad-22.\9\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22(e)(1).
    \9\ 17 CFR 240.17Ad-22.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed guidance in the
Circular would have any impact, or impose any burden, on competition
not necessary or appropriate in furtherance of the purpose of the Act.
The guidance is will not change the substantive requirements of any
Rules or Procedures but will clarify the proper interpretation of
references to EU legislation in order to facilitate that the Clearing
House and EU and UK Clearing Members continue to adhere to applicable
laws and regulations. ICE Clear Europe does not believe the
interpretation will in itself materially affect the cost of, or access
to, clearing. As a result, ICE Clear Europe does not believe the
proposed the rule change imposes any burden on competition that is
inappropriate in furtherance of the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received with respect to the proposed
rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and paragraph (f) of Rule 19b-4 \11\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2019-008 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2019-008. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Section, 100 F Street NE, Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2019-008 and should be
submitted on or before July 9, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-12786 Filed 6-17-19; 8:45 am]
 BILLING CODE 8011-01-P


From: Beekman, Christopher<EMAIL_ADDRESS>Sent: Friday, August 29, 2014 1:37 PM
To: Cain, Alexis
Cc: Hodanbosi, Robert; Ward, Adam; Van Vlerah, Jennifer; Bergman, Andrew
Subject: Ohio EPA IPM request

Alexis:

During our call this past Wednesday, USEPA's willingness to assist in resolving Ohio EPA's outstanding IPM issues was expressed.

Firstly, I would very much like to have this call soon.  My availability next week is as follows:

Tuesday, September 2: 8:30 AM until 5:00 PM
Wednesday, September 3: 1:00 PM until 5:00 PM
Friday, September 5: 8:30 AM until 5:00 PM

Secondly, please find attached Ohio EPA's specific request.  If you need additional information prior to our call, please feel free to contact me.

Regards,
Chris Beekman
Ohio EPA, Division of Air Pollution Control
614-644-3597
--------------------------------------------------------------------------------

Alexis Cain
US Environmental Protection Agency, Region 5
77 W. Jackson Blvd (AT-18J)
Chicago, IL 60604
(312) 886-7018
fax<PHONE_NUMBER>
<EMAIL_ADDRESS>
Pursuant to our hub call on Wednesday, 8/27/2014, I am providing a description of Ohio EPA's assessment of the available IPM result.  I am working with the IPM output RPE files, and aggregating the data specifically for Ohio.  This is simple enough.  I am able to accurately account for emissions and generation in the state for our existing units based on fuel type for coal, co-fired biomass, biomass, wind, natural gas combustion turbines, NGCC, hydro, nuclear, and the remainder.  I am also able to account for new wind generation in Ohio.   Thus, the only source of discrepancies is the distribution of new combined cycle natural gas units, which, in the RPE files, are treated as region/RTO specific units. Although on a macro scale this approach has logic, but states need to meet specific targets and must know if there are or are not to be new fossil-fuel fired EGUs within our borders or contributing significant amounts of generation to our state.

In the parsed data that is available, one can easily determine how these new units are distributed to each state in terms of generation and emissions.  When one has to rely on only the RPE outputs, this distribution cannot be replicated or estimated based on the information that is available. We are requesting that USEPA either help us locate this information, provide the information directly, or provide us with the information and methodology necessary to make these determinations.

I will use the Base Case, 2025 results for Ohio as an example of our main issue.

The parsed results indicate that existing NGCC units in Ohio generated 11,752,832 MWh, with 5,064,609 tons of CO2 in the 2025 base case.  These are matched 100% by the existing NGCC units in the RPE file.

However, the parsed file indicates three new NGCC units, as follows (Ohio data only):

                                    Region
                                   Total MWh
                                   Total CO2
                                   PJM_ATSI
                                  13,514,595
                                   5,087,058
                                   PJM_EMAC
                                   1,251.86
                                      471
                                    S_C_KY
                                   12,620.61
                                     4,750

This additional generation and the associated emissions would be incorporated into the projected situation in Ohio for that year and scenario.

Examination of the RPE file for that same year and scenario shows these three new NGCC units as follows:

                                    UNIT ID
                                    Region
                                   Total MWh
                                   Total CO2
                                     46318
                                   PJM_ATSI
                                  17,075,381
                                   6,427,382
                                     45874
                                   PJM_EMAC
                                  23,306,598
                                   8,772,888
                                     46595
                                    S_C_KY
                                   1,194,349
                                    825,980

As can be seen, the units are identifiable and accessible via the RPE file, but the generation and emissions appear to be distributed by some unknown proportion to other states/regions in addition to Ohio, which is clearly and plainly demonstrated in the parsed results, above, but not in the RPE files.

We have the parsed file to compare in this case, but do not in most other instances. As we try to analyze and develop comments for various scenarios, it is critical that we are able to accurately distribute and translate the generation and emissions from these new NGCC units to Ohio, using only the available RPE results for most cases.  This issue arises in all other cases that we have analyzed, and appears to be specific to new natural gas units (at least for Ohio).

I would appreciate if we could focus an upcoming informal call on getting this discrepancy resolved for the following cases, based on RPE data alone:

State Plan, Option 1, 2025 and 2030
Base Case, 2025 and 2030
Regional Plan, 2025 and 2030
State Plan, Alternative RE, 2025 and 2030
State Plan, Blocks 1 and 2 only, 2025 and 2030

I have all of the data parsed out from the RPE files, by fuel type, for all ten of the scenario/year combinations listed above, and would like to be able to get all of our emissions and generation for new natural gas combined units accurately parsed and get total emissions to resolve with those listed in the state emission reports for each scenario and year above.

Thank you for your willingness to assist Ohio EPA in this matter,

Regards,
Christopher Beekman
Ohio EPA, Division of Air Pollution Control
614-644-3597
<EMAIL_ADDRESS>


[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27312-27313]
[FR Doc No: 2014-10952]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0288]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH
GL51); Guidance for Industry on Statistical Evaluation of Stability
Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of guidance for industry (GFI 219) entitled
``Guidance for Industry on Statistical Evaluation of Stability Data,
VICH GL51.'' This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide recommendations on how to use
stability data generated in accordance with the principles detailed in
the VICH guidance entitled ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products, GL3(R)'' to propose a retest period
or shelf life in a registration application.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based, harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify, and then reduce, differences in
technical requirements for drug development among regulatory agencies
in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, FDA, the U.S. Department of Agriculture, the Animal Health
Institute, the Japanese Veterinary Pharmaceutical Association, the
Japanese Association of Veterinary Biologics, and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the governments of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Guidance on Statistical Evaluation of Stability Data

    In the Federal Register of April 4, 2012 (77 FR 20406), FDA
published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry on Statistical Evaluation of Stability
Data, VICH GL51.'' Interested persons were given until June 4, 2012, to
comment on the draft guidance. FDA received several comments on the
draft, and those comments, as well as those received by other VICH
member regulatory agencies, were considered as the guidance was
finalized. No substantive changes were made in finalizing this guidance
document. The guidance announced in this document finalizes the draft
guidance dated January 10, 2012. The final guidance is a product of the
Quality Expert Working Group of the VICH.
    This VICH guidance document provides recommendations on how to use
stability data generated in accordance with the principles detailed in
the VICH guidance entitled, ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products, GL3(R)'' to propose a retest period
or shelf life in a registration application. This guidance describes
when and how extrapolation can be considered when proposing a retest
period for a drug substance or a shelf life for a veterinary medicinal
product that extends beyond the period covered by available data from
the stability study under the long-term storage condition.
    This guidance addresses the evaluation of stability data that
should be submitted in registration applications for new molecular
entities and associated veterinary medicinal products. The guidance
provides recommendations on establishing retest periods and shelf lives
for drug

substances and veterinary medicinal products intended for storage at or
below ``room temperature''. It covers stability studies using single-
or multi-factor designs and full or reduced designs.

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised
to conform to FDA's good guidance practices regulation (21 CFR 10.115).
For example, the document has been designated ``guidance'' rather than
``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    This guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB control number 0910-0032.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10952 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Notices]
[Page 15785]
[FR Doc No: 2017-06295]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of ARAC.

DATES: The meeting will be held on April 20, 2017, starting at 1:00
p.m. Eastern Standard Time. Arrange oral presentations by April 13,
2017.

ADDRESSES: The meeting will take place at the Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
Conference Room 5 A-B-C. In addition, a phone bridge has been
established for those wishing to participate by telephone.

FOR FURTHER INFORMATION CONTACT: Nikeita Johnson, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a
meeting of the ARAC taking place on April 20, 2017, at the Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591. The purpose of this meeting is to consider one or more new ARAC
tasks.
    Improvement of regulations is a continuous focus for the
Department. Accordingly, the Department regularly makes a conscientious
effort to review its rules in accordance with the Department's 1979
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
Executive Order 12866, Executive Order 13563, and section 610 of the
Regulatory Flexibility Act. Through two new Executive Orders, President
Trump directed agencies to further scrutinize its regulations. On
January 30, 2017, President Trump signed Executive Order 13771 titled
``Reducing Regulation and Controlling Regulatory Costs (EO).'' Under
Section 2a of that Executive Order, unless prohibited by law, whenever
an executive department or agency publicly proposes for notice and
comment or otherwise promulgates a new regulation, it shall identify at
least two existing regulations to be repealed.
    In addition, on February 24, 2017, President Trump signed Executive
Order 13777 titled ``Enforcing the Regulatory Reform Agenda.'' Under
this Executive Order, each agency is required to establish a Regulatory
Reform Task Force (RRTF) to evaluate existing regulations, and make
recommendations for their repeal, replacement, or modification. As part
of this process, the Department is directed to seek input/assistance
from entities significantly affected by its regulations. Accordingly,
the agenda for this ARAC meeting will be to task ARAC to consider (1)
recommendations on existing regulations that are good candidates for
repeal, replacement, or modification and (2) recommendations on
regulatory action identified in FAA's Regulatory Agenda.
    The ARAC will also consider the new task Flight Test Harmonization
Working Group- Transport Airplane Performance and Handling
Characteristics, Phase 3 that was on the agenda for the March 16, 2017,
ARAC meeting. At that meeting, all discussions on new tasks were
postponed to later ARAC meetings.
    Attendance is open to the interested public but limited to the
space available. Please confirm your attendance, either in person or by
telephone, with the person listed in the FOR FURTHER INFORMATION
CONTACT section no later than April 13, 2017. Please provide the
following information: full legal name, country of citizenship, and
name of your industry association, or applicable affiliation. If you
are attending as a public citizen, please indicate so.
    For persons participating by telephone, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by email or phone
for the teleconference call-in number and passcode. Callers are
responsible for paying long-distance charges.
    The public must arrange by April 13, 2017, to present oral
statements at the meeting. The public may present written statements to
the Aviation Rulemaking Advisory Committee by providing 25 copies to
the Designated Federal Officer, or by bringing the copies to the
meeting.
    If you are in need of assistance or require a reasonable
accommodation for this meeting, please contact the person listed under
the heading FOR FURTHER INFORMATION CONTACT. Sign and oral
interpretation, as well as a listening device, can be made available if
requested 10 calendar days before the meeting.

    Issued in Washington, DC, on March 24, 2017.
Lirio Liu,
Designated Federal Officer, Aviation Rulemaking Advisory Committee.
[FR Doc. 2017-06295 Filed 3-29-17; 8:45 am]
 BILLING CODE 4910-13-P