[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Proposed Rules]
[Page 71957-71959]
[DOCID:fr26no08-30]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0186; Directorate Identifier 2007-NM-226-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-10-10, DC-
10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40,
DC-10-40F, MD-10-10F, and MD-10-30F Airplanes

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

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: The FAA is revising an earlier NPRM for an airworthiness
directive (AD) that applies to certain McDonnell Douglas Model DC-10-
10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-
10-40, and DC-10-40F airplanes. The original NPRM would have revised an
existing AD that currently requires installing or replacing with
improved parts, as applicable, the bonding straps between the metallic
frame of the fillet and the wing leading edge ribs, on both the left
and right sides of the airplane. The original NPRM proposed to revise
the applicability to clarify the identity of the affected airplanes.
The original NPRM resulted from fuel system reviews conducted by the
manufacturer. This new action proposes to revise the applicability to
add and remove certain airplanes, and to add a requirement to
reposition or replace two bonding straps for certain airplanes. This
new action also proposes to supersede, rather than revise, the existing
AD. We are proposing this supplemental NPRM to reduce the potential of
ignition sources inside fuel tanks in the event of a severe lightning
strike, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

DATES: We must receive comments on this supplemental NPRM by December
22, 2008.

ADDRESSES: You may send comments 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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Data and Service Management,
Dept. C1-L5A (D800-0024); telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
e-mail<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.

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 this proposed AD, 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.

FOR FURTHER INFORMATION CONTACT: Samuel Lee, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0186;
Directorate Identifier 2007-NM-226-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of 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 proposed AD.

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for an AD
(the ``original NPRM'') to revise AD 2006-16-03, amendment 39-14703 (71
FR 43962, August 3, 2006). The original NPRM applied to certain
McDonnell Douglas Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-
30F (KC-10A and KDC-10), DC-10-40, and DC-10-40F airplanes, and MD-10-
10F and MD-10-30F airplanes. The affected airplanes are identified by
the manufacturer's fuselage numbers referenced in the applicable
McDonnell Douglas DC-10 service bulletin (Service Bulletin 53-109,
Revision 4, dated October 7, 1992; or Service Bulletin 53-111, Revision
3, dated August 24, 1992).
    The original NPRM was published in the Federal Register on November
13, 2007 (72 FR 63836). The original NPRM proposed to revise AD 2006-
16-03 to clarify the identity of the affected airplanes in the
applicability.

Actions Since Original NPRM Was Issued

    Since we issued the original NPRM, Boeing has revised the service
bulletins. Service Bulletin DC10-53-111, Revision 5, dated March 19,
2008, and DC10-53-109, Revision 6, dated July 10, 2008, correct
effectivity errors (to add and remove certain airplanes incorrectly
excluded or included from previous versions). In addition, Service
Bulletin DC10-53-109, Revision 5, now includes an action to reposition
two bonding straps by using new bonding straps that are less
susceptible to cracking. Revision 6 of Service Bulletin DC10-53-109
provides a faster and easier method, which involves replacing the
straps with longer straps instead of relocating them.
    The revised service bulletins have been approved by the FAA as
alternative methods of compliance (AMOCs) with the requirements of AD
2006-16-03. Paragraph (i)(3) has been revised in this supplemental NPRM
to include information about these AMOCs.

FAA's Determination and Proposed Requirements of the Supplemental NPRM

    The changes discussed above expand the scope of the original NPRM;
therefore, we have determined that it is necessary to reopen the
comment period for revising AD 2006-16-03 to provide additional
opportunity for public comment on this supplemental NPRM. Also, because
of the expanded scope, we must supersede, rather than revise, the AD
2006-16-03.

Costs of Compliance

    There are about 457 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this supplemental NPRM.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
              Work hours                 Average labor             Parts                Cost per airplane         registered           Fleet cost
                                         rate per hour                                                            airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-17..................................             $80   Up to $4,169.............  Up to $5,529.............             281   Up to $1,553,649.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed
regulation:
    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); 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 supplemental NPRM and placed it in the AD docket. See
the ADDRESSES section for a location to examine the regulatory
evaluation.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14703 (71 FR 43962, August 3, 2006) and adding
the following new airworthiness directive (AD):

McDonnell Douglas: Docket No. FAA-2007-0186; Directorate Identifier
2007-NM-226-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by December
22, 2008.

Affected ADs

    (b) This AD supersedes AD 2006-16-03.

Applicability

    (c) This AD applies to McDonnell Douglas Model DC-10-10, DC-10-
10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40,
and DC-10-40F airplanes, and MD-10-10F and MD-10-30F airplanes that
have been converted from Model DC-10 series airplanes; certificated
in any category; with manufacturer's fuselage numbers as identified
in the applicable service bulletin listed in Table 1 of this AD.

----------------------------------------------------------------------------------------------------------------
   McDonnell Douglas DC-10 Service
             Bulletin --                Revision--               Dated--                For airplanes with--
----------------------------------------------------------------------------------------------------------------
DC10-53-109.........................               6  July 10, 2008...............  Extended wing-to-fuselage
                                                                                fillets.
DC10-53-111.........................               5  March 19, 2008..............  Conventional wing-to-
                                                                                fuselage fillets.
----------------------------------------------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to reduce the potential of
ignition sources inside fuel tanks in the event of a severe
lightning strike, which, in combination with flammable fuel vapors,
could result in fuel tank explosions and consequent loss of the
airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2006-16-03

Installation or Replacement

    (f) For airplanes with manufacturer's fuselage numbers
identified in the applicable service bulletin listed in Table 2 of
this AD: Within 7,500 flight hours or 60 months after September 7,
2006 (the effective date of AD 2006-16-03), whichever occurs
earlier: Install or replace with improved parts, as applicable, the
bonding straps between the metallic frame of the fillet and the wing
leading edge ribs, on both the left and right sides of the airplane,
in accordance with the Accomplishment Instructions of the applicable
service bulletin identified in Table 1 or Table 2 of this AD.

                                                   Table 2--Fuselage Numbers Affected by AD 2006-16-03
--------------------------------------------------------------------------------------------------------------------------------------------------------
    McDonnell Douglas DC-10 Service
              Bulletin--                 Revision--                  Dated--                                     For airplanes with--
--------------------------------------------------------------------------------------------------------------------------------------------------------
53-109................................            4  October 7, 1992.......................  Extended wing-to-fuselage fillets.
53-111................................            3  August 24, 1992.......................  Conventional wing-to-fuselage fillets.
--------------------------------------------------------------------------------------------------------------------------------------------------------

New Requirements of This AD

Installation or Replacement

    (g) For airplanes with fuselage numbers not identified in Table
2 of this AD: Within 7,500 flight hours or 60 months, whichever
occurs first after the effective date of this AD, install or replace
with improved parts, as applicable, the bonding straps between the
metallic frame of the fillet and the wing leading edge ribs, on both
the left and right sides of the airplane, and reposition two bonding
straps. Do the actions in accordance with the Accomplishment
Instructions of the applicable service bulletin identified in Table
1 of this AD.

Strap Repositioning for Certain Airplanes

    (h) For Configuration 3 airplanes, as identified in McDonnell
Douglas DC-10 Service Bulletin DC10-53-109, Revision 6, dated July
10, 2008: Within 7,500 flight hours or 60 months, whichever occurs
first after the effective date of this AD, reposition two bonding
straps, in accordance with the Accomplishment Instructions of the
service bulletin.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, ATTN: Samuel Lee, Aerospace Engineer, Samuel Lee,
Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California 90712-4137; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
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.
    (3) AMOCs approved previously in accordance with AD 2006-16-03
are approved as AMOCs for the corresponding provisions of this AD.
McDonnell Douglas DC-10 Service Bulletins DC10-53-109 and DC10-53-
111, both Revision 5, both dated March 19, 2008, and Service
Bulletin DC10-53-109, Revision 6, dated July 10, 2008, have been
approved by the FAA as an AMOC with the requirements of AD 2006-16-
03.

    Issued in Renton, Washington, on November 16, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E8-28129 Filed 11-25-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Page 69644]
[FR Doc No: 2012-28120]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3352-EM; Docket ID FEMA-2011-0001]

The District of Columbia; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for The District of Columbia (FEMA-3352-EM), dated October
28, 2012, and related determinations.

DATES: Effective Date: October 28, 2012.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 28, 2012, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the District of Columbia resulting from Hurricane Sandy beginning
on October 28, 2012, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the District of Columbia.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

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

    Emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program for the
District of Columbia.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-28120 Filed 11-19-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 17071-17072]
[FR Doc No: 2023-05684]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97145; File No. SR-NYSEARCA-2023-06]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Amend Rule 7.44-E Relating to the Retail Liquidity Program

March 15, 2023.
    On January 10, 2023, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``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 amend the Exchange's Retail Liquidity Program
(the ``Program'').\3\ The proposed rule

change was published for comment in the Federal Register on January 30,
2023.\4\ The Commission has received no comments on the proposed rule
change.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The Program was established on a pilot basis in 2013 and was
approved by the Commission to operate on a permanent basis in 2019.
See Securities Exchange Act Release No. 87350 (October 18, 2019), 84
FR 57106 (October 24, 2019) (SR-NYSEArca-2019-63). In connection
with the Commission's approval of the Program on a pilot basis, the
Commission granted the Exchange's request for exemptive relief from
Rule 612 of Regulation NMS, 17 CFR 242.612, which, among other
things, prohibits a national securities exchange from accepting or
ranking orders priced greater than $1.00 per share in an increment
smaller than $0.01. See Securities Exchange Act Release No. 71176
(December 23, 2013), 78 FR 79524 (December 30, 2013) (SR-NYSEArca-
2013-107).
    \4\ See Securities Exchange Act Release No. 96741 (Jan. 24,
2023), 88 FR 5948.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is March 16, 2023. The Commission is extending this 45-day time period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to section 19(b)(2) of the Act,\6\ designates
April 28, 2023 as the date by which the Commission shall either approve
or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEARCA-2023-06).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-05684 Filed 3-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17823-17824]
[FR Doc No: 2019-08425]

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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: ER18-2344-003.
    Applicants: Headwaters Wind Farm LLC.
    Description: Compliance filing: Headwaters Wind Farm LLC, Docket
No. ER18-2344-003 to be effective 10/29/2018.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5025.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER18-2397-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2019-04-22_Compliance filing to
Order 844 to be effective 7/1/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5112.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-875-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2019-04-22_Deficiency Response to
Cyber Security Coordination to be effective 3/30/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5142.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1343-000; ER19-1342-000.
    Applicants: NMRD Data Center III, LLC, NMRD Data Center II, LLC.
    Description: Supplement to March 18, 2019 NMRD Data Center III,
LLC, et al. tariff filings.
    Filed Date: 4/19/19.
    Accession Number: 20190419-5127.
    Comments Due: 5 p.m. ET 5/3/19.

    Docket Numbers: ER19-1629-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3357 Monument Road Wind GIA
Cancellation to be effective 3/21/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5005.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1630-000.
    Applicants: Entergy Louisiana, LLC.
    Description: Tariff Cancellation: Entergy Louisiana, LLC to be
effective 1/1/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5020.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1631-000.
    Applicants: Entergy Mississippi, LLC.
    Description: Tariff Cancellation: Entergy Mississippi, LLC to be
effective 1/1/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5024.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1632-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ICSA,
SA No. 3399, Queue Position V3-045 to be effective 3/7/2017.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5057.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1633-000.
    Applicants: Rumford Power LLC.
    Description: Compliance filing: Notice of Succession, Revised MBR
Tariff, & New eTariff Baseline to be effective 4/23/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5101.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1634-000.
    Applicants: Bridgeport Energy LLC.
    Description: Compliance filing: Revised MBR Tariff & New eTariff
Baseline to be effective 4/23/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5111.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1635-000.
    Applicants: Glaciers Edge Wind Project, LLC.
    Description: Baseline eTariff Filing: Glaciers Edge Initial Market-
Based Rate Application Filing to be effective 6/22/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5113.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1636-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-04-22_Termination of SA
6510 MISO-Cleco SSR Agreement for Teche Unit No. 3 to be effective 4/
30/2019.

    Filed Date: 4/22/19.
    Accession Number: 20190422-5123.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1637-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Attachment AE
to Allow DVERs to Utilize Control Status 3 to be effective 12/31/9998.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5128.
    Comments Due: 5 p.m. ET 5/13/19.

    Docket Numbers: ER19-1638-000.
    Applicants: Tiverton Power LLC.
    Description: Compliance filing: Revised MBR Tariff & New eTariff
Baseline to be effective 4/23/2019.
    Filed Date: 4/22/19.
    Accession Number: 20190422-5133.
    Comments Due: 5 p.m. ET 5/13/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: April 22, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-08425 Filed 4-25-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1670-1671]
[FR Doc No: 2016-00468]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76854; File No. SR-FINRA-2015-48]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of Longer Period for Commission
Action on a Proposed Rule Change To Establish Rules To Adopt FINRA Rule
6191(b) and Amend FINRA Rule 7440 To Implement the Data Collection
Requirements of the Plan To Implement a Tick Size Pilot Program

January 7, 2016.
    On November 13, 2015, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') 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 adopt FINRA Rule 6191(b) and amend FINRA Rule
7440 to implement the data collection requirements of the Plan to
Implement a Tick Size Pilot Program.\3\ The proposed rule change was
published for comment in the Federal Register on November 25, 2015.\4\
The Commission has received two comment letters on the proposal.\5\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015).
    \4\ See Securities Exchange Act Release No. 76484 (November 19,
2015), 80 FR 73858.
    \5\ See Letters from Mary Lou Von Kaenel, Managing Director,
Financial Information Forum, dated December 16, 2015 and Manisha
Kimmel, Chief Regulatory Officer, Wealth Management, Thomson
Reuters, dated December 16, 2015 to Robert W. Errett, Deputy
Secretary, Commission.
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    Section 19(b)(2) of the Act \6\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day for this filing is January 9, 2016.
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    \6\ 15 U.S.C. 78s(b)(2).
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    The Commission is extending this 45-day time period. The Commission
finds that it is appropriate to designate a longer period within which
to take action on the proposed rule change so that it has sufficient
time to consider the proposal.

    Accordingly, pursuant to Section 19(b)(2) of the Act,\7\ the
Commission designates February 23, 2016, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File No.
SR-FINRA-2015-48).
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    \7\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(31).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00468 Filed 1-12-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42877-42878]
[FR Doc No: 2017-18828]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[OST Docket No. DOT-OST-2011-0170]

Notice of Submission of Proposed Information Collection to OMB
Agency Request for Renewal of a Previously Approved Collection:
Disclosure of Code-Sharing Arrangements and Long-Term Wet Leases

AGENCY: Office of the Secretary, Department of Transportation.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 this
notice announces the Department of Transportation's (Department)
intention to reinstate an Office of Management and Budget (OMB) control
number as related to the Disclosure of Code-Sharing Arrangements and
Long-Term Wet Leases. The growth in the use of code-sharing, wet-
leasing, and similar marketing tools, particularly in international air
transportation, led the Department on March 15, 1999, to adopt specific
regulations requiring the disclosure of code-sharing arrangements and
long-term wet leases by air carriers (U.S. and foreign) and ticket
agents via oral, written, and internet communications. In a recent
final rule published in the Federal Register on November 3, 2016,
titled ``Enhancing Airline Passenger Protections'', the Department,
among other things, amended the code-share disclosure regulation to
require that carriers and ticket agents must disclose any code-share
arrangements on their Web sites, including mobile Web sites and
applications; clarify the format in which that information must be
displayed; and specify that verbal code-share disclosures should be
made the first time a flight involving a code-share arrangement is
offered to consumers or the first time a consumer inquiries about such
a flight whether by telephone or in person conversations.

DATES: Written comments should be submitted by November 13, 2017.

ADDRESSES: You may submit comments (identified by DOT Docket Number
OST-2011-0170) through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Hand Delivery: U.S. Department of Transportation, West
Building Ground Floor, 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except on Federal Holidays. The telephone number is<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-
140, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Daeleen Chesley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Office of the Assistant General Counsel for
Aviation Enforcement and Proceedings (C-70), U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2105-0537.
    Title: Disclosure of Code-Sharing Arrangements and Long-Term Wet
Leases.
    Abstract: Code-sharing is the name given to a common airline
industry marketing practice where, by mutual agreement between
cooperating carriers, at least one of the airline designator codes used
on a flight is different from that of the airline operating the
aircraft. In one version of code-sharing, two or more airlines each use
their own designator codes on the same aircraft operation. Although
only one airline operates the flight, each airline in a code-sharing
arrangement may hold out, market, and sell the flight as its own in
published schedules. Code-sharing also refers to other arrangements,
such as when a code on a passenger's ticket is not that of the operator
of the flight, but where the operator does not hold out the service in
its own name. Such code-sharing arrangements are common between
commuter air carriers and their larger affiliates. In a wet lease
situation, a leasing arrangement is made whereby the lessor provides
both an aircraft and crew to a lessee dedicated to a certain route
under either an agreement that lasts more than 60 days or under a
series of such lease agreements that amount to a continuing arrangement
lasting more than 60 days.
    Although code-sharing and wet-lease arrangements can offer
significant consumer benefits, they can also be misleading unless
consumers know the identity of the airline operating the flight. The
growth in the use of code-sharing and wet-leasing, particularly in
international air transportation, led the Department to adopt specific
regulations requiring the disclosure of code-sharing arrangements and
long-term wet leases on March 15, 1999 (14 CFR part 257). More
specifically, the rule requires carriers to provide information about
their code-share relationships in written or electronic schedule
information provided by carriers to the public (e.g., the Official
Airline Guide/OAG). The rule also requires carriers and ticket agents
to disclose code-share information in written notice at the time of a
ticket purchase. Further, the regulation requires those entities to
tell prospective consumers in all oral communications that the
transporting airline is not the airline whose designator code will
appear on travel documents and to identify the transporting airline by
its corporate name and any other name under which that service is held
out to the public.
    In 2010, to further enhance these consumer protections, Congress
enacted by Public Law 111-216, sec. 210 (August 1, 2010), which was
codified as 49 U.S.C. 41712(c). Among other things, the statute
requires ticket agents and air carriers (U.S. and foreign) to disclose
in oral communication or in written or electronic communications
(including on the internet), prior to the purchase of a ticket, the
name of the air carrier providing the air transportation and, if the
flight has more than one segment, the name of each air carrier
providing the air transportation for each flight segment. The statute
also requires ticket agents and air carriers (U.S. and foreign) that
sell tickets on an Internet Web site to disclose the required
information on the first display of their Web site following a
consumer's search of a requested itinerary in a format that is easily
visible.
    In a recent final rule, Enhancing Airline Passenger Protections III
(81 FR 76800, November 3, 2016), the Department clarified its code-
share disclosure regulation to ensure that carriers and ticket agents
disclose code-share arrangements in schedules, advertisements, and
communications with consumers. The rule amended the Department's code-
share disclosure regulation to codify the statutory requirement that
carriers and ticket agents must in a format that is easily visible to a
viewer disclose any code-share arrangements on the first display of the
Web site following itinerary search results; clarify that the
requirement for code-share disclosures in flight itinerary search
results and flight schedule displays includes information provided by
airlines via mobile Web sites and applications; clarify the format in
which that information must be displayed; and specify that verbal code-
share disclosures should be made the first time a flight involving a
code-share arrangement is offered to consumers or inquired about by
consumers during telephone or in person conversations.
    As most of these provisions are implementing the statutory
requirement

enacted in 2010, carriers and ticket agents should already be complying
with most of the requirements.\1\ The aspect of the provision which is
new is the specification of when during a telephone or in-person
booking process a carrier or ticket agent must disclose the code-share
information, which may result in additional compliance costs for some
carriers and ticket agents. Those additional costs would be borne by
those carriers and ticket agents that currently do not present code-
share information at the first mention of a flight during a reservation
call or in-person booking. As such, these carriers and ticket agents
may have slightly longer reservation calls and longer in-person
bookings. However, the disclosure at a point during the information
gathering and decision-making process was already required so the
additional time, if any, would be minimal.
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    \1\ The regulated entities that have a Web site should already
have the required information programmed in their systems and that
information should already appear on their Web sites. Thus, the
incremental costs to add the information to mobile Web sites and
applications should be small. To the extent there are any costs,
they could be minimized if any necessary changes were incorporated
at the same time as another upgrade.
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    In addition to costs for additional agent time during some calls
and in-person bookings, some respondents may have a slight increase in
their training costs, as they modify their trainings to note that code-
share information must be shared when the flight is first presented to
the consumer.\2\ These additional training costs are likely to be
incurred only by those respondents which do not already present code-
share information at the first mention of a flight.
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    \2\ The costs are minimal if this change is incorporated into
agent curricula during the same time as other updates and/or sent in
an update bulletin via the carrier's/travel agent's intranet system.
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    A Federal agency generally cannot conduct or sponsor a collection
of information, and the public is generally not required to respond to
an information collection, unless it is approved by the OMB under the
PRA and displays a currently valid OMB Control Number. In addition,
notwithstanding any other provisions of law, no person shall generally
be subject to penalty for failing to comply with a collection of
information if the collection of information does not display a valid
OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.
    This notice addresses the information collection requirements set
forth in the Department's regulation requiring disclosure of code-share
and wet-leases, 14 CFR 257. The reinstated OMB control number will be
applicable to all the provisions set forth in this notice. The title, a
description of the respondents, and an estimate of the annual
recordkeeping and periodic reporting burden are set forth below:
    Title: Disclosure of Code-Sharing Arrangements and Long Term Wet
Leases in Flight Itineraries and Schedules, Oral Communications with
Prospective Consumers, Ticket Confirmations, and Advertisements.
    Respondents: All U.S. air carriers, foreign air carriers, Global
Distribution Systems (GDSs, formerly known as computer reservations
systems), and travel agents doing business in the United States.
    Number of Respondents: 5,031 (estimated 48 marketing carriers and
4,983 travel agents/GDSs).
    Frequency:
    For transactions involving oral communications: 15 seconds per call
(to reveal the code-share information) and an average of 1.5 calls per
trip (a total of 22.5 seconds per respondent) for the approximately 25%
to 39% (using 2016 Bureau of Transportation Statistic's ((BTS)) data)
of itineraries that involve personal contact/phone call and a code-
share itinerary.\3\
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    \3\ Per BTS data, there were 932 million enplanements in 2016
(34% of these flights involve a one-way ticket and 66% involve
round-trip travel). It is estimated that 20% of these travelers make
a call to an airline or travel agent to book a ticket or obtain
information about a flight and each traveler will only need to
obtain the information once per travel itinerary. Of those travel
itineraries, 25% to 39% involve a code-share flight in which an
agent must reveal that information.
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    For transactions involving written and internet disclosure: The
burden should be minimal to non-existent as many airlines are already
required to submit certain code-share related information to BTS \4\
and/or already have code-share information available on their Web
sites.\5\ In addition, the marketing airlines currently provide
information about their code-share flights to the GDSs who, in turn,
provide that information to travel agents. As the code-share
information is integrated into the data provided by the airlines to
GDSs and travel agents, the code-share information is automatically
displayed on the internet/computer, as well as on a printed version of
an itinerary/ticket.
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    \4\ Large U.S. carriers must provide BTS with information for
the ``Airline Passenger and Destination Survey.'' The reported
information must include the name of the marketing carrier, as well
as the operating carrier of the flight (which may be a regional or
foreign carrier).
    \5\ For example, many ``reporting'' carriers (e.g., United
Airlines) disclose on their Web sites on-time performance
information for their domestic code-share flights.
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    Total Annual Burden: Annual reporting burden for this data
collection is estimated at 195,138 to 304,415- hours for all travel
agents and airline ticket agents who have personal contact with a
consumer. Most of this data collection is accomplished through
travelers using highly automated computerized systems to make their air
travel reservation(s) and the data is already available on the
regulated entities Web sites and/or is programmed into their database/
reservation systems.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility, and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on August 28, 2017.
Blane A. Workie,
Assistant General Counsel for Aviation Enforcement and Proceedings.
[FR Doc. 2017-18828 Filed 9-11-17; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29933-29934]
[DOCID:fr24my06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-759-000]

Selkirk Cogen Partners, L.P.; Notice of Issuance of Order

May 17, 2006.
    Selkirk Cogen Partners, L.P. (Selkirk Cogen) filed an application
for market-based rate authority, with an accompanying tariff. The
proposed market-based rate tariff provides for the sale of energy,
capacity and ancillary services at market-based rates. Selkirk Cogen
also requested waiver of various Commission regulations. In particular,
Selkirk Cogen requested that the Commission grant blanket approval
under 18 CFR part 34 of all future issuances of securities and
assumptions of liability by Selkirk Cogen.
    On May 12, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the request
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approval of issuances of securities or assumptions of liability by
Selkirk Cogen should file a motion to intervene or protest with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is June 12, 2006.
    Absent a request to be heard in opposition by the deadline above,
Selkirk Cogen is authorized to issue securities and assume obligations
or liabilities as a guarantor, indorser, surety, or otherwise in
respect of any security of another person; provided that such issuance
or assumption is for some lawful object within the corporate purposes
of Selkirk Cogen, compatible with the public interest, and is

reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of Selkirk Cogen's issuances of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7896 Filed 5-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]
[Page 16668]
[DOCID:fr28mr08-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-561-000]

Benton County Wind Farm LLC; Notice of Issuance of Order

March 24, 2008.
    Benton County Wind Farm LLC (Benton County) filed an application
for market-based rate authority, with an accompanying market-based rate
tariff. The proposed market-based rate schedule provides for the sale
of energy, capacity and ancillary services at market-based rates.
Benton County also requested waivers of various Commission regulations.
In particular, Benton County requested that the Commission grant
blanket approval under 18 CFR Part 34 of all future issuances of
securities and assumptions of liability by Benton County.
    On March 18, 2008, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the request
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Benton County, should file a protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2007). The
Commission encourages the electronic submission of protests using the
FERC Online link at http://www.ferc.gov.
    Notice is hereby given that the deadline for filing protests is
April 17, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Benton County is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Benton County, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Benton County's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at: http://www.ferc.gov, using the eLibrary link. Enter the
docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a) (1) (iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-6416 Filed 3-27-08; 8:45 am]

BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ OA/ OSDBU 2. OMB control number b.   None A 2090 0025 3. Type of information collection ( check one) a.   New collection b.

Revision of a currently approved collection c. X Extension of a currently approved collection d.   Reinstatement, without change, of a previously approved collection for which approval has expired e.   Reinstatement, with change, of a previously approved collection for which approval has expired f.   Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b.   Emergency  Approval requested by: / / c.   Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities?   Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b.   Other Specify: / /___

7. Title Minority Business Enterprise/ Woman Business Enterprise ( MBE/ WBE) Utilization under Federal Grants Cooperative Agreements and Interagency Agreements ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR Number 2212.02, EPA Form Number 5700 52A 9. Keywords MBE, WBE, Minority, Women, Utilization 10. Abstract EPA Form 5700 52A is used to collect data concerning the utilization of minority and women owned businesses as contractors under procurements funded by EPA financial assistance agreements pursuant to Executive Orders 11625, 12138, and 12138 and 12432, and Public Laws 101 507 and 102 389.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. X Business or other for profit e. X Federal Government c. X Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a.   Voluntary b.   Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 3600 b. Total annual responses 10,800 1. Percentage of these responses collected electronically 0 % c. Total hours requested 10,800 d. Current OMB inventory ________________ 3,600 e. Difference ____________________________ 7,200 f. Explanation of difference 1. Program Change 0 2. Adjustment __________________ 7,200 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 0 e. Difference $ 0 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. X Program evaluation f. __ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b.   Third party disclosure c. X Reporting 1.   On occasion 2.   Weekly 3.   Monthly 4. X Quarterly 5.   Semi annually 6. X Annually 7.   Biennially 8.   Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

  Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Kimberly Patrick Phone: ( 202) 564 5386 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4345-4348]
[FR Doc No: 2017-00694]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]

Nonproprietary Naming of Biological Products; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Nonproprietary
Naming of Biological Products.'' The guidance describes our current
thinking on the need for biological products previously and newly
licensed under the Public Health Service Act (PHS Act) to bear
nonproprietary names that include FDA-designated suffixes. Accordingly,
we intend to designate nonproprietary names for originator biological
products, related biological products, or biosimilar products which
will include a core name and a distinguishing suffix that is devoid of
meaning and composed of four lowercase letters. This guidance finalizes
the draft guidance issued on August 28, 2015.
    FDA is also 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 either electronic or written comments on Agency guidances
at any time. Submit written comments on the collection of information
by February 13, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--New and
title ``Nonproprietary Naming of Biological Products.'' Also include
the FDA docket number found in brackets in the heading of this
document.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1543 for ``Nonproprietary Naming of Biological Products.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential

with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Sandra Benton,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
Regarding the information collection: FDA PRA Staff, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Nonproprietary Naming of Biological Products.'' The guidance
describes our current thinking on the need for biological products
licensed under section 351(a) and (k) of the PHS Act (42 U.S.C. 262(a)
and (k)) to bear a nonproprietary name that includes an FDA-designated
suffix. Under this naming convention, the nonproprietary name
designated for each originator biological product, related biological
product, and biosimilar product will be a proper name that is a
combination of the core name and a distinguishing suffix that is devoid
of meaning and composed of four lowercase letters. The suffix format
described in this guidance is applicable to originator biological
products, related biological products, and biosimilar products
previously licensed and newly licensed under section 351(a) or 351(k)
of the PHS Act. FDA is continuing to consider the appropriate suffix
format for interchangeable biological products.
    This naming convention will facilitate pharmacovigilance for
originator biological products, related biological products, and
biosimilar products containing related drug substances when other means
to track a specific dispensed product are not readily accessible or
available. Distinguishable nonproprietary names will also facilitate
accurate identification of these biological products by health care
practitioners and patients. Further, distinguishing suffixes should
help minimize inadvertent substitution of any such products that have
not been determined to be interchangeable. Application of the naming
convention to biological products licensed under the PHS Act should (1)
encourage routine use of designated suffixes in ordering, prescribing,
dispensing, recordkeeping, and pharmacovigilance practices and (2)
avoid inaccurate perceptions of the safety and effectiveness of
biological products based on their licensure pathway, as described in
detail in the guidance.
    The guidance provides information to industry, the health care
community, other regulatory agencies, and the public on FDA's rationale
for this naming convention. The guidance is also intended to assist
applicants and application holders in proposing the suffix to be
incorporated into an originator biological product, related biological
product, or biosimilar product's nonproprietary name.
    In the Federal Register of August 28, 2015 (80 FR 52296), FDA
announced the availability of the draft guidance of the same title. FDA
received numerous comments on the draft guidance, and those comments
were considered as the guidance was finalized. In the notice announcing
the draft guidance, FDA asked about the benefits and challenges of
designating (1) a suffix that is devoid of meaning versus meaningful
(e.g., derived from the name of the license holder) and (2) a suffix
that is unique to each biological product versus shared by each
biological product manufactured by that license holder. FDA determined
that the suffix format that best achieves the goals described in the
guidance is a suffix that is devoid of meaning and not shared by each
biological product manufactured by that license holder.
    FDA intends to apply a naming convention to interchangeable
products that will feature a core name and a suffix included in the
proper name; however, FDA is continuing to consider the appropriate
format of the suffix for these products.
    This guidance also will apply to those biological products that are
approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
on or before March 23, 2020, when such products are deemed to be
licensed under section 351 of the PHS Act on March 23, 2020 (section
7002(e)(2) through (e)(4) of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)). FDA intends to provide additional
guidance regarding administrative issues associated with the transition
(including the process for implementing the naming convention described
in this guidance).
    For the purposes of the guidance, unless otherwise specified,
references to biological products include biological products licensed
under the PHS Act, such as therapeutic protein products, vaccines,
allergenic products, and blood derivatives, and do not include certain
biological products that also meet the definition of a device in
section 201(h) of the FD&C Act (21 U.S.C. 321(h)), such as in vitro
reagents (e.g., antibody to hepatitis B surface antigen, blood grouping
reagents, hepatitis C virus encoded antigen) and blood donor screening
tests (e.g., HIV and hepatitis C). Also, for the purposes of the

guidance, unless otherwise specified, references to biological products
do not include products for which a proper name is provided in the
regulations (e.g., 21 CFR part 640) or to certain categories of
biological products for which there are well-established, robust
identification and tracking systems to ensure safe dispensing practices
and optimal pharmacovigilance (e.g., ISBT 128 for cord blood products
and blood components).
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on nonproprietary naming of biological
products. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
    In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.

II. Paperwork Reduction Act of 1995, Nonproprietary Naming of
Biological Products, OMB Control Number 0910--New

    The guidance describes FDA's current thinking on the need for
biological products licensed under the PHS Act to bear a nonproprietary
name that includes an FDA-designated suffix. There is a need to clearly
identify biological products to facilitate pharmacovigilance and safe
use. Accordingly, for originator biological products, related
biological products, or biosimilar products licensed under the PHS Act,
FDA intends to designate a nonproprietary name that includes a core
name and a distinguishing suffix. This naming convention is applicable
to biological products previously licensed and newly licensed under
section 351(a) or 351(k) of the PHS Act.
    The final guidance proposes a new collection of information by
requesting that applicants and application holders propose a suffix
composed of four lowercase letters for use as the suffix included in
the proper name. The proper name is designated by FDA in the license
for biological products licensed under the PHS Act. The suffix will be
incorporated in the nonproprietary name of the product. The guidance
recommends that applicants and application holders submit up to 10
proposed suffixes, in the order of the applicant's preference. FDA also
recommends including supporting analyses demonstrating that the
proposed suffixes meet the factors described in the final guidance for
FDA's consideration.
    As indicated in table 1, we estimate that we will receive a total
of approximately 40 requests annually for the proposed proper name for
biological products submitted under section 351(a) of the PHS Act and
six requests annually for the proposed proper name for biological
products submitted under section 351(k) of the PHS Act. The average
burden per response (hours) is based on the Agency's experience with
similar information collection requirements for applicants to create
and submit suffix proposals to FDA.
    As noted, in the Federal Register of August 28, 2015, FDA published
a 60-day notice requesting public comment on the proposed collection of
information. Most comments supported FDA's proposal to designate a
suffix. Many comments suggested that a meaningful, distinguishable
suffix may help to improve pharmacovigilance, enhance safety, and
facilitate identification between biological products. Some comments
supported use of a random suffix to avoid creating an unfair advantage
for specific manufacturers. Several comments stated that the current
practices of FDA and non-FDA entities for identifying products is
sufficient for the purpose of pharmacovigilance, and designation of a
suffix is not needed. One comment stated that FDA's estimate of 6 hours
to submit proposed suffixes is based only on the time needed to prepare
the submission itself after the multiple suffixes have been selected.
The comment further stated that because FDA suggests that each
respondent submit three suggested suffixes for Agency consideration,
the time needed to do an analysis of each suffix would exceed 720 hours
per suffix (based on their own company experience) or 2,160 hours total
for the three suffixes. The commenter subsequently submitted additional
information to clarify how the estimates were calculated.
    Response: FDA's estimate of the annual reporting burden results
from information that would be submitted to FDA by applicants in order
to facilitate FDA's designation of a suffix as part of the proper name
of a biological product. We estimated that sponsors would spend 2 hours
completing the submission for each of the three suffixes, resulting in
6 hours as the average burden. This estimate for submission of the
requested information is based on the average number of responses per
respondent and the average burden per response over a 3-year period.
FDA understands that there is a certain amount of research and other
costs that an applicant might encounter in analyzing any proposed name
for a biological product. FDA also recognizes that the burden may be
higher for some applicants and lower for other applicants based on a
variety of factors specific to the applicant.
    The comment suggests that it will take 720 hours to complete an
analysis and submission for each suffix. We have considered the
information provided in support of this estimate and believe the
estimate is likely too high. Our original estimate of 6 hours was based
on the Agency's familiarity with the time it would take to make similar
submissions to FDA. However, as identified by the comment, FDA's
original estimate failed to adequately account for the time spent on
creating proposed suffixes. We have reconsidered our original estimate
as a result of the comment, and we have revised our estimate to account
for the burden to create and submit up to 10 proposed suffixes to FDA
for designation. As indicated in table 1, we estimate an average burden
of approximately 420 hours to account for creating and submitting
multiple proposed suffixes.
    FDA estimates the information collection burden as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Information for the Proposed                  20               2              40             420          16,800
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(a) of the PHS
 Act............................

Information for the Proposed                   3               2               6             420           2,520
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(k) of the PHS
 Act............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          19,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This guidance also refers to previously approved collections of
information found in FDA regulations. The collection of information
related to the submission of a BLA under section 351(k) of the PHS Act
(biosimilar products and interchangeable products) has been approved
under OMB control number 0910-0719. The guidance also refers to a
previously approved collection of information found in FDA regulations
that is expected to change as a result of the guidance and the
retrospective application of the naming convention. The collections of
information in 21 CFR part 601 related to the submission of a biologics
license application (BLA) and changes to an approved application have
been approved under OMB control number 0910-0338. As a result of the
guidance, the estimated number of additional responses for the annual
burden for changes to an approved application under Sec.  601.12 would
be increased by approximately 25 responses.
    FDA is issuing this final guidance subject to OMB approval of the
collections of information. Before implementing the information
collection provisions of the guidance, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the collections of information, including OMB control
number(s) for newly approved collections.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00694 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18508-18509]
[DOCID:fr12ap10-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0163]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Metabolism Study to Determine the Quantity and Identify the Nature of
Residues (VICH GL46); Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (205) entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Metabolism Study to Determine the Quantity and Identify the Nature of
Residues (MRK),'' VICH GL46. This draft guidance has been developed for
veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This draft VICH guidance document is intended to
provide recommendations for internationally harmonized test procedures
to study the quantity and nature of residues of veterinary drugs in
food-producing animals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft
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.
    Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(205) entitled ``Draft Guidance for Industry on Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Metabolism Study to Determine the Quantity and
Identify the Nature of Residues (MRK),'' VICH GL46. 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, the U.S. 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 government 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. Draft Guidance on Study to Determine the Quantity and Identify the
Nature of Residues

    The VICH Steering Committee held a meeting on November 5, 2009, and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Studies to Evaluate the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing Animals: Metabolism Study to
Determine the Quantity and Identify the Nature of Residues (MRK),''
VICH GL46 should be made available for public comment. This draft VICH
guidance document is one of a series developed to facilitate the mutual
acceptance of residue chemistry data for veterinary drugs used in food-
producing animals. This guidance was prepared after consideration of
the current requirements for evaluating veterinary drug residues in the
European Union, Japan, United States, Australia, New Zealand, and
Canada.
    Although this guidance recommends a framework for metabolism
testing, it is important that the design of the studies remains
flexible. It is recommended that studies be tailored to sufficiently
characterize the components of the residue of toxicological concern.
    The human food safety evaluation of veterinary drugs assures that
food derived from treated animals is safe for human consumption. As
part of the data collection process, studies are conducted to permit an
assessment of the quantity and nature of residues in food derived from
animals treated with a veterinary drug. These metabolism studies
provide data on the following topics: (1) The depletion of residues of
toxicological concern from edible tissues of treated animals at varying
times after drug administration; (2) the individual components, or
residues, that comprise the residue of toxicological concern in edible
tissues; (3) the residue(s) that may serve as marker for analytical
methods intended for compliance purposes (i.e., monitoring of
appropriate drug use); and (4) the identification of a target tissue or
tissues, as applicable to national or regional programs.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft 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.
    The draft guidance, when finalized, will represent 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 applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft 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 sections 1-4 of this guidance have been
approved under OMB Control No. 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VI. Electronic Access

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

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8228 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S