A P P E N D I X J J 1 APPENDIX J Federal Consistency Report A P P E N D I X J J 2 This Page Intentionally Left Blank. A P P E N D I X J J 3 Peconic Estuary Program Comprehensive Conservation and Management Plan Federal Consistency Report September 2000 Peconic Estuary Program CCMP A P P E N D I X J J 5 This Page Intentionally Left Blank. Peconic Estuary Program CCMP A P P E N D I X J J 6 FEDERAL CONSISTENCY REPORT FOR THE PECONIC ESTUARY PROGRAM Background The National Estuary Program ( NEP) was established by the Water Quality Act of 1987, which amended the Federal Clean Water Act. The purpose of the NEP is to identify, protect and restore estuaries of national significance. The Peconic Estuary was nominated for the NEP by the Governor of New York in 1991. In 1993, the Management Conference was convened to oversee development of a Comprehensive Conservation and Management Plan ( CCMP).

There is a Federal consistency review requirement for the NEP. This is distinct from the Federal consistency requirement of the Federal Coastal Zone Management Act, conducted as part of the State's coastal zone management program.

The Federal consistency review procedure being applied for the Peconic Estuary is explained below. The procedure was originally developed by the Long Island Sound Study and New York   New Jersey Harbor Estuary Program for their CCMPs. The State of New York has decided to apply this procedure to the Peconic Estuary.

Purpose of Review EPA guidance defines the goal of the Federal consistency review process as to ensure that Federal actions do not adversely affect CCMP goals, and that they support actions proposed in the CCMP where possible. In addition, under an agreement between the U. S. Environmental Protection Agency ( EPA) and the National Oceanic and Atmospheric Administration ( NOAA) ( see below), CCMPs are submitted for determination that they are consistent with the coastal zone management plans of the affected State or States. The major tasks in the Federal consistency review process are:

  Consistency of Federal actions with the CCMP:

1. Development of an inventory of Federal programs and projects to be reviewed for consistency with the CCMP, and a one time assessment of these programs/ projects for consistency with the CCMP.

2. Setting up and implementing a process to continually review individual Federal projects for consistency with the CCMP.

  Consistency of the CCMP with coastal zone management plans:

3. Determination whether the CCMP is consistent with affected State CZM plans.

4. Concurrence of the State with the determination. Peconic Estuary Program CCMP A P P E N D I X J J 7 Consistency of Federal Actions with the CCMP Activities that affect the quality of the Peconic Estuary are both supported and regulated, both directly and/ or indirectly, by Federal, State and local agencies. Because government sponsored activities have a wide variety of objectives, it is possible that some activities may be inconsistent with the goals of the CCMP for the Peconic Estuary.

The need for coordination among governmental programs and program goals that will affect the Management Conference ( and ultimately the CCMP) has been addressed in Section 320( b)( 7) of the Clean Water Act, as amended. " Purpose 7" states that:

" The purpose of a management conference shall be to review all Federal financial assistance programs and Federal development projects in accordance with the requirements of Executive Order 12372, as in effect on September 17, 1983, to determine whether such assistance program or project would be consistent with and further the purposes of the CCMP."

In 1992, EPA and NOAA entered into an agreement designed to avoid conflicts and duplication regarding the NEP and the Coastal Zone Management Program. One provision is that, after concurrence by the State Governor( s) and approval by the EPA Administrator, EPA and NOAA will encourage and/ or require, to the extent permitted by law, that the CCMPs be submitted for incorporation into the Coastal Zone Management Program, as appropriate.

Therefore, the consistency review requirement of the NEP can be met by integrating the process into the existing State Coastal Management Plan ( CMP) consistency review process in New York. PEP would be available to participate, as appropriate under existing appeal and mediation procedures, in assisting the State in the resolution of consistency determinations.

Note also that potential inconsistencies among coastal activities can be addressed through the Management Conference itself. Under Section 320( b)( 7) of the Clean Water Act, as amended, the Management Conference has such authority, as described above. However, the goal of the review process established under purpose 7 is to complement the State's existing review process rather than duplicate them, and PEP would be best served by using the existing process.

The appropriate ongoing review program in the State of New York has the staff and experience necessary to perform Federal consistency reviews, whereas the costs and start up time in addition to the lack of experienced personnel could make the undertaking of a separate Federal consistency review prohibitive to the PEP. Concerns have also been raised at the Management Conference regarding the review of non Federal programs for consistency with the CMP. These concerns would be addressed in the existing State review programs, which require the review of certain non Federal activities and programs1 and allow the review of activities outside the coastal zone if they affect the coastal zone2.

1 These concerns would be addressed in the existing State CMP, which requires the activities of State agencies to be consistent with the State's coastal policies or, in the case of the Villages of Greenport and Sag Harbor, the policies of their State approved Local Waterfront Revitalization Programs. 2 In New York State, this applies only to Federal activities. Peconic Estuary Program CCMP A P P E N D I X J J 8 Consistency of the CCMP with Coastal Management Programs Under Section 307( c) of the Coastal Zone Management Act ( CZMA) of 1972, as amended, and implementing regulations ( see 15 CFR 930) consistency with an approved State coastal zone management program is required: ( a) for direct Federal activities and development projects; ( b) for activities requiring Federal licenses or permits; and ( c) for activities receiving Federal financial assistance. In New York, the program and the review of Federal activities consistency with the State's CMP is administered by the New York State Department of State.

The 1988 EPA/ NOAA agreement states that:

" CCMPs developed under the NEP will voluntarily, as a matter of policy, be submitted for review under the Federal consistency provisions of Section 307 ( c) of the CZMA of 1972, as amended."

The State of New York, pursuant to the Federal and State consistency provision of their existing coastal management program, already has a review process in place. Based on a review of the CCMP and a consistency review submitted by EPA Region II, the State reviews the overall approval and adoption of the CCMP, and each proposal within it, for consistency with policies of their CMP, which is very specific with respect to use and development of coastal resources.

Area to be included for Federal Consistency Review The study area for the Peconic Estuary Program includes the waters of Peconic Bay to an imaginary line connecting the eastern end of Plum Island and Montauk Point. The land based area includes the surface water, storm water, and ground water contributing areas.

Federal Consistency Review for the PEP in New York The Federal consistency review requirement under Section 320( b)( 7) for the PEP will be delegated to the State of New York because of the previously mentioned advantages of using the existing process under the State's CMP, rather than establishing a new process under the PEP. Upon acceptance of the final CCMP for the Peconic Estuary Program by the Administrator of EPA, the CMP in New York will take all necessary actions to include the enforceable components of the CCMP in the CMP and its existing Federal consistency process.

To accomplish this incorporation, the New York Department of State ( NYDOS) must review the final CCMP and the consistency determination submitted by EPA to determine its consistency with New York's approved CMP. Having New York CMP program staff serve on the CCMP work groups and the Management Committee has helped to ensure that consistency. New York's Federally approved CMP must, if necessary, be amended and approved by NOAA. All steps must be in accordance with NOAA's established regulatory and statutory procedures, including public review and comment. Note that any Federal action that affects New York's coastal zone can be reviewed for consistency with the State's CMP. An " inconsistent" decision, however, must be based on enforceable coastal policies ( i. e., those that are based on existing State law and regulation). New York's review of the PEP CCMP indicates that all of the committed actions, and many recommended actions, in the CCMP applicable to New York, are based on existing State law and regulation. New York's review also did not indicate the need for New York to enact new legislation or regulatory authority to help Peconic Estuary Program CCMP A P P E N D I X J J 9 implement any recommended CCMP actions. Thus, most of the CCMP will be enforceable under New York's CMP.

The PEP Office should be notified of Federal activities that are subject to Federal consistency review with regard to the CCMP. To accomplish this, PEP will request to be added to the NYDOS project review notification list. The PEP Office may comment on the activities and, when the review is complete, shall be notified of the results. If the PEP office comments on any Federal actions, it must do so in timely manner so the State can adhere to the prescribed time frames established by regulation in the Federal Register by NOAA for review/ approval. As part of the consistency review determination under the CMP, New York will ensure that each action is consistent with the enforceable components of the CMP.

If necessary, New York will amend its CMP to incorporate the enforceable components of the CCMP for the PEP. The review process shall consider all Federal financial assistance and development activities as well as all other Federal actions including the issuance of Federal permits which are listed in the State's CMP. State actions not requiring Federal consistency review are often subject to review under the existing State consistency review process, and a formal or informal agreement should be established between New York and the PEP whereby the PEP Office is notified of the projects that may affect achieving the CCMP goals, strategies and proposed actions for the PEP. The PEP will be best served by utilizing the State's existing CMP for its Federal consistency review requirements.

For the CCMP consistency review with the State CMP under Section 307( c) of the CZMA, EPA will send a formal consistency determination to the NYDOS at the same time that the final CCMP is submitted to the Governor of New York and the EPA Administrator. The NYDOS will determine the consistency of the PEP CCMP with the CMP and implement enforceable PEP actions that are consistent with the CMP.

Federal programs and activities subject to consistency review by New York State are identified in the State's CMP. In some areas, State programs are reviewed under State approved Waterfront Revitalization Plans. The inventory of Federal programs is provided in Table 1.

Criteria for Consistency The general criteria for determination of consistency are whether programs encourage or support the objectives listed in the CCMP.

More specific criteria are whether the programs encourage or support the proposed CCMP actions in the following ways. Programs or projects are inconsistent if they inhibit these activities or harm the resources that they seek to protect or restore.

  Complies with existing management plans or supports continued development of management plans for a wide variety of living resources and habitats;

  Encourages development of tools for such compliance, including GIS and community classification systems; Peconic Estuary Program CCMP A P P E N D I X J J 10   Encourages or provides for restoration of a variety of valuable habitats, including wetlands, streams, stream corridors, riparian and wetland buffer zones, artificial reefs, oyster reefs, shorelines, and large forested upland tracts;

  Reduces loss of wetlands;

  Protects shorelines;

  Promotes sustainable development;

  Reduces NPS pollution and protects water quality and quantity through watershed based planning, BMPs, and riparian corridor protection;

  Promotes improved land use planning to protect water quality and reduce sprawl;

  Encourages regional coordination;

  Encourages redevelopment and compact development;

  Encourages water conservation and integrated planning for water supply and wastewater;

  Promotes better coordination and planning for dredging, including dredge material disposal;

  Encourages development and use of pump out facilities;

  Improves public access to the estuary;

  Encourages wise use of chemicals by residents and businesses;

  Supports development and implementation of toxics water quality criteria;

  Helps to identify sources of contaminated sediments and identify control measures;

  Promotes regional information sharing and development of Geographic Information Systems;

  Supports private sector efforts to achieve all these objectives and activities;

  Supports public education activities, including newsletters, other outreach materials, ecotourism promotion, hands on activities for volunteers, and curricula development; and,

  Supports existing and expanded monitoring plans, including volunteer monitoring. Peconic Estuary Program CCMP A P P E N D I X J J 11 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan.

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 10.200 Grants for Agricultural Research, Special Research Grants USDA ES X     10.069 Conservation Reserve Program USDA FSA X     10.072 Wetlands Reserve Program USDA NRCS X     10.901 Resource Conservation and Development USDA NRCS X X   10.902 Soil and Water Conservation USDA NRCS X     10.903 Soil Survey USDA NRCS X     10.904 Watershed Protection and Flood Prevention USDA NRCS X     10.906 Watershed Surveys and Planning USDA NRCS X     10.912 Environmental Quality Incentives Program USDA NRCS X   X 10.913 Farmland Protection Program USDA NRCS X     10.914 Wildlife Habitat Incentive Program USDA NRCS X   X 10.768 Business and Industry Loans USDA RB CS X X   10.769 Rural Development Grants USDA RB CS X X   10.854 Rural Development Loans and Grants USDA RB CS X X   10 410 Very Low to Moderate Income Housing Loans USDA RHS X X   10 411 Rural Housing Site Loans and Self Help Housing Land Development Loans USDA RHS X X   10 433 Rural Housing Preservation Grants USDA RHS X     10 766 Community Facilities Loans and Grants USDA RHS X X   10.760 Water and Wastewater Disposal Systems for Rural Communities USDA RUS X X   10.762 Solid Waste Management Grants USDA RUS X X   10.770 Water and Waste Disposal Loans and Grants USDA RUS X X   11.300 Grants for Public Works and Economic Development DOC EDA X     11.302 Economic Development Support for Planning Organizations DOC EDA X     11.307 Economic Adjustment Assistance DOC EDA X X   Peconic Estuary Program CCMP A P P E N D I X J J 12 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan. ( continued)

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 11.405 Anadromous Fish Conservation Act Program NOAA X     11.407 Interjurisdictional Fisheries Act of 1986 NOAA X   X 11.417 Sea Grant Support NOAA X   X 11.419 Coastal Zone Management Administration Awards NOAA X   X 11.420 Coastal Zone Management Estuarine Research Reserves NOAA X     11.426 Financial Assistance for National Centers for Coastal Ocean Science NOAA X     11.427 Fisheries Development and Utilization Research and Development Grants and Cooperative Agreements Program NOAA X     11.429 Marine Sanctuary Program NOAA X     11.433 Marine Fisheries Initiative NOAA X     11.441 Regional Fishery Management Councils NOAA X     11.444 Aquaculture Program NOAA X X   11.463 Habitat Conservation NOAA X     11.473 Coastal Services Center NOAA X     11.474 Atlantic Coastal Fisheries Cooperative Management Act NOAA X     11.477 Fisheries Disaster Relief NOAA X     11.478 Center for Sponsored Coastal Research  Coastal Ocean Program NOAA X   X 12.100 Aquatic Plant Control ACOE X     12.101 Beach Erosion Control Projects ACOE X X   12.102 Emergency Rehabilitation of Flood Control Works or Federally Authorized Coastal Protection Works ACOE X     12.104 Flood Plain Management Services ACOE X     12.105 Protection of Essential Highways, Highway Bridge Approaches and Public Works ACOE X X   12.106 Flood Control Projects ACOE X X   12.107 Navigation Projects ACOE X X   Peconic Estuary Program CCMP A P P E N D I X J J 13 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan. ( continued)

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 12.109 Protection, Clearing and Straightening Channels ACOE X X   12.110 Planning Assistance to States ACOE X     12.111 Emergency Advance Measures for Flood Protection ACOE X X   12.300 Basic and Applied Scientific Research ONR X     12.301 Basic and Applied Scientific Research ONR X     12.600 Community Economic Adjustment DOD OEA X X   12.607 Community Economic Adjustment Planning Assistance DOD OEA X X   12.612 Community Base Reuse Plans DOD OEA X X   12.613 Growth Management Planning Assistance DOD OEA X X   14.218 Community Development Block Grants/ Entitlement Grants HUD CPD X X   14.2246 Community Development Block Grants/ Economic Development Initiative HUD CPD X X   15.605 Sport Fish Restoration FWS X     15.611 Wildlife Restoration FWS X     15.614 Coastal Wetlands Planning, Protection and Restoration Act FWS X     15.615 Cooperative Endangered Species Conservation Fund FWS X     15.616 Clean Vessel Act FWS X   X 15.618 Administrative Grants for Federal Aid in Sport Fish and Wildlife Restoration FWS X     15.623 North American Wetlands Conservation Fund FWS X     15.805 Assistance to State Water Resources Research Institutes USGS X     15.976 Migratory Bird Banding and Data Analysis USGS X     15.916 Outdoor Recreation  Acquisition, Development and Planning NPS X X   15.918 Disposal of Federal Surplus Real Property for Parks, Recreation, and Historic Monuments NPS X X   Peconic Estuary Program CCMP A P P E N D I X J J 14 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan. ( continued)

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 15.919 Urban Park and Recreation Recovery Program NPS X     15.925 National Maritime Heritage Grants NPS X     20.005 Boating Safety Financial Assistance USCG X     20.006 State Access to the Oil Spill Liability Trust Fund USCG X     20.007 Bridge Alteration USCG X X   20.205 Highway Planning and Construction FHA X X   20.219 Recreational Trails Program FHA X X X 20.312 High Speed Ground Transportation  Next Generation High Speed Rail Program FRA X X   20.500 Federal Transit Capital Investment Grants FTA X X   20.505 Federal Transit Metropolitan Planning Grants FTA X X   20.507 Federal Transit Formula Grants FTA X X   20.509 Formula Grants for Other than Urbanized Areas FTA X X   20.514 Transit Planning and Research FTA X X   20.515 State Planning and Research FTA X X   20.801 Development and Promotion of Ports and Intermodal Transportation DOT MA X X   66.419 Water Pollution Control State and Interstate Program Support EPA X   X 66.433 State Underground Water Source Protection EPA X     66.454 Water Quality Management Planning EPA X   X 66.456 National Estuary Program EPA X   X 66.458 Capitalization Grants for State Revolving Funds EPA X   X 66.460 Nonpoint Source Implementation Grants EPA X   X 66.461 Wetlands Protection Development Grants EPA X     66.463 National Pollutant Discharge Elimination System Related State Program EPA X     Peconic Estuary Program CCMP A P P E N D I X J J 15 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan. ( continued)

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 66.500 Environmental Protection Consolidated Research EPA X v   66.600 Environmental Protection Consolidated Grants Program Support EPA X     66.605 Performance Partnership Grants EPA X   X 66.606 Surveys, Studies, Investigations and Special Purpose Grants EPA X   X 66.608 One Stop Reporting EPA X     66.609 Children's Health Protection EPA X     66.700 Consolidated Pesticide Enforcement Cooperative Agreements EPA X     66.701 Toxic Substances Compliance Monitoring Cooperative Agreements EPA X     66.604 Environmental Justice Grants to Small Community Groups EPA X     66.710 Environmental Justice Community/ University Partnership Grants Program EPA X     66.713 State and Tribal Environmental Justice EPA X     66.801 Hazardous Waste Management State Program Support EPA X     66.802 Superfund State Site Specific Cooperative Agreements EPA X     66.804 State and Tribal Underground Storage Tanks Program EPA X     66.805 Leaking Underground Storage Tank Trust Fund Program EPA X     66.806 Superfund Technical Assistance Grants for Citizen Groups at Priority Sites EPA X     66.807 Superfund Innovative Technology Evaluation Program EPA X     66.808 Solid Waste Management Assistance EPA X     66.809 Superfund State Core Program Cooperative Agreements EPA X     66.810 CEPP Technical Assistance Grants Program EPA X     Peconic Estuary Program CCMP A P P E N D I X J J 16 Table 1. Inventory of Federal Programs for Consistency with the Peconic Estuary Plan. ( continued)

Catalog of Federal Domestic Assistance* Program Title Agency** Potential to support PEP CCMP Potential to conflict with PEP CCMP Priority? 66.811 Brownfield Pilots Cooperative Agreements EPA X     66.708 Pollution Prevention Grants Program EPA X     83.536 Flood Mitigation Assistance FEMA X X   83.537 Community Disaster Loans FEMA X X   83.548 Hazard Mitigation Grant FEMA X X   83.551 Project Impact Building Disaster Resistant Communities FEMA X X   * 2000 Catalog of Federal Domestic Assistance, Executive Office of the President, Office of Management and Budget ** Agency Names:

ACOE   Army Corps of Engineers DOC   Department of Commerce DOC EDA   Department of Commerce  Economic Development Administration DOD OEA   Department of Defense  Office of Economic Adjustment DOT MA   Department of Transportation  Maritime Administration EPA   Environmental Protection Agency FEMA   Federal Emergency Management Agency FHA   Federal Highway Administration FRA   Federal Railroad Administration FTA   Federal Transit Administration FWS   Fish and Wildlife Service HUD CPD   Department of Housing and Urban Development   Community Planning and Development NOAA   National Oceanic and Atmospheric Administration NPS   National Park Service ONR   Office of Naval Research USCG   U. S. Coast Guard USDA   U. S. Department of Agriculture USDA ERS   USDA Economic Research Service USDA ES   USDA Cooperative State Research, Education and Extension Service USDA FSA   USDA Farm Services Agency USDA NRCS   USDA Natural Resources Conservation Service USDA RB CS   USDA Rural Business Cooperative Service USDA RHS   USDA Rural Housing Service USDA RUS   USDA Rural Utilities Service USGS   U. S. Geological Survey Peconic Estuary Program CCMP A P P E N D I X J J 17 This Page Intentionally Left Blank.


[Federal Register Volume 84, Number 55 (Thursday, March 21, 2019)]
[Rules and Regulations]
[Pages 10413-10415]
[FR Doc No: 2019-05366]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-1119]
RIN 1625-AA00

Safety Zone; Commandant's State of the Coast Guard Address, San
Pedro, California

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The U.S. Coast Guard is establishing a temporary safety zone
in the Port of Los Angeles around a portion of Reservation Point on U.
S. Coast Guard Base Los Angeles--Long Beach, in support of the U. S.
Coast Guard aviation and waterborne asset demonstration for the
Commandant's State of the Coast Guard Address. This action is necessary
to protect for the safety of life on these navigable waters in the area
of the Coast Guard asset demonstration. Entry of persons or vessels
into this temporary safety zone is prohibited unless specifically
authorized by the Captain of the Port (COTP), Los Angeles--Long Beach,
or her designated representative.

DATES: This rule is effective from 12:01 a.m. through 11:59 p.m. on
March 21, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-1119 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Waterways Management, U.S. Coast Guard Sector Los
Angeles--Long Beach; telephone<PHONE_NUMBER>, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
LLNR Light List Number
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. Publishing an NPRM would be impracticable
because there is not enough time for Notice and Comment procedures
before the event. The date for the State of the Coast Guard event was
not set until February 15, 2019, and the Coast Guard's normal Security
Zone and Safety Zone processes were interrupted by the extended
government shutdown in the beginning of 2019.
    We are issuing this rule, and under 5 U.S.C. 553(d) (3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register, as delaying the
effective date of this rule would be impracticable and potentially
threaten the Coast Guards ability to enforce safety measures in to
protect for the safety of life in these navigable waters in the area of
the Coast Guard asset demonstration.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port (COTP), Los Angeles--Long Beach has
determined that potential hazards associated with navigation safety
that arise because of the potentially hazardous conditions associated
with event safety due to the expected high-speed maneuvers from
waterborne vessels and aircraft Search and Rescue demonstration related
to this event along the main shipping channel of the nation's most
economically vital port complex. For these reasons, the Coast Guard
believes that a safety zone is necessary to ensure the safety of, and
reduce the risk to, the public, and the participants of the event in
the Port of Los Angeles.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone on March 21, 2019,
encompassing all navigable waters from the surface to the sea floor
within 500-foot radius in approximate position: 33[deg]43.241' N,
118[deg]15.942' W. All coordinates displayed are referenced by North
American Datum of 1983, World Geodetic System, 1984. This temporary
safety zone will only be enforced between 7:00 a.m. PST and 5:00 p.m.
PST March 21, 2019. During the enforcement period, vessels are
prohibited from entering into, transiting through, or remaining within
the designated area unless authorized by the Captain of the Port or her
designated representative. Sector Los Angeles--Long Beach may be
contacted on VHF-FM Channel 16 or<PHONE_NUMBER>. The general boating
public will be notified prior to the enforcement of the temporary
safety zone via Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 (``Regulatory Planning and Review'') and 13563
(``Improving Regulation and Regulatory Review'') direct agencies to
assess the costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits including potential economic, environmental,
public health and safety effects, distributive impacts, and equity.
E.O.13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Executive Order 13771 (``Reducing Regulation and
Controlling Regulatory Costs''), directs agencies to reduce regulation
and control regulatory costs and provides that ``for every one new
regulation issued, at least two prior regulations be identified for
elimination, and that the cost of planned regulations be prudently
managed and controlled through a budgeting process.''
    We expect the economic impact of this rule will not rise to the
level of necessitating a full Regulatory Evaluation. This regulatory
action determination is based on the size, location, and duration of
the safety zone. The size of the zone is the minimum necessary to
provide adequate protection for the waterways users, adjoining areas,
and the public. The zone will be in place during the scheduled
Commandant's State of the Coast Guard Address at U. S. Coast Guard base
Los Angeles--Long Beach, which will be conducted in the vicinity of
Reservation Point, San Pedro, CA. Moreover, the Coast Guard will issue
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
safety zone and the rule allows vessels to seek permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator. Under section 213(a) of the Small Business
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want
to assist small entities in understanding this rule. If the rule would
affect your small business, organization, or governmental jurisdiction
and you have questions concerning its provisions or options for
compliance, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under E.O. 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 01. An environmental analysis checklist supporting this
determination and Record of Environmental Consideration (REC) are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165. T11-1119 to read as follows:

Sec.  165. T11-966  Safety Zone; Commandant's State of the Coast Guard
Address, San Pedro, California.

    (a) Location. The following area is a safety zone: All navigable
waters from the surface to the sea floor within 500-foot radius in
approximate position: 33[deg]43.241' N, 118[deg]15.942' W. All
coordinates displayed are referenced by North American Datum of 1983,
World Geodetic System, 1984.
    (b) Definitions. For the purposes of this section:
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Los Angeles--Long
Beach (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, hail Coast Guard Sector Los
Angeles--Long Beach on VHF-FM Channel 16 or call at<PHONE_NUMBER>.
Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement period. This section is effective from 12:01 a.m.
through 11:59 p.m. on March 21, 2019. No vessel or person would be
permitted to operate in the safety zone without obtaining permission
from the COTP or her designated representative. This temporary safety
zone will only be enforced between 7:00 a.m. PST and 5:00 p.m. PST
March 21, 2019. The general boating public will be notified prior to
the enforcement of the temporary moving safety zone via Broadcast
Notice to Mariners.

M.L. Rochester,
Captain, U.S. Coast Guard, Captain of the Port, Los Angeles Long Beach.
[FR Doc. 2019-05366 Filed 3-20-19; 8:45 am]
 BILLING CODE 9110-04-P


Lydia Wegman/RTP/USEPA/US

11/16/2007 09:43 AM

To

<EMAIL_ADDRESS> cc

Tricia Crabtree/RTP/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject

Fw: Lydia: Could EPA forward Lanphear et al 2005 to OMB pls?

Heidi,

Here is the Lanphear paper you requested.  In response to you messge this morning, I'm checking to see if Deirdre is available to talk with you this morning or if she'd rather I talk with you.  I'll let you know as soon as I hear from her.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 11/16/2007 09:41 AM -----

Deirdre Murphy/RTP/USEPA/US

11/16/2007 07:49 AM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Karen Martin/RTP/USEPA/US@EPA

Subject

Fw: Lydia: Could EPA forward Lanphear et al 2005 to OMB pls?

Hi Lydia,

Here's the paper per your request for OMB.

Deirdre

----- Forwarded by Deirdre Murphy/RTP/USEPA/US on 11/16/2007 07:39 AM -----

Lydia Wegman/RTP/USEPA/US

11/15/2007 10:56 PM

To

"Deirdre Murphy"<EMAIL_ADDRESS> cc

Subject

Fw: Lydia: Could EPA forward Lanphear et al 2005 to OMB pls?

Can you please send this to me to send to Heidi?  Thanks a lot.

 ----- Original Message -----

  From: "King, Heidi R."<EMAIL_ADDRESS>   Sent: 11/15/2007 10:18 PM

  To: Lydia Wegman

  Cc: "Beck, Nancy"<EMAIL_ADDRESS>"Johansson, Robert" <EMAIL_ADDRESS>   Subject: Lydia: Could EPA forward Lanphear et al 2005 to OMB pls?

Lydia,

Would it be possible for someone on your staff to share a copy of the Lanphear et al pooled analysis (2005) with us?

Thanks,

heidi

(202) 395-4551


[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60772-60773]
[FR Doc No: 2016-21108]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Release Certain Properties From All Terms,
Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement
Between the City of Vero Beach and the Federal Aviation Administration
for the Vero Beach Regional Airport, Vero Beach, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for Public Comment.

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

SUMMARY: The FAA hereby provides notice of intent to release certain
airport properties 8.73 acres at the Vero Beach Regional Airport,
Florida from the conditions, reservations, and restrictions as
contained in a Quitclaim Deed agreement between the FAA and the Vero
Beach Regional Airport, dated October 3, 1947. The City of Vero Beach
dedicated an 8.73 acre tract along 27th Avenue, Aviation Boulevard and
Airport Drive to become a Public Right-of-Way. This release will be
retroactive for the improvements along the airport entrance roadway by
the City of Vero Beach. The Fair Market Value (FMV) of this parcel has
been determined to be $228,510.16.
    Documents reflecting the Sponsor's request are available, by
appointment only, for inspection at the Vero Beach Regional Airport and
the FAA Airports District Office.

DATES: Comments are due on or before October 3, 2016.

ADDRESSES: Documents are available for review at the Vero Beach
Regional Airport, P.O. Box 1389, 3400 Cherokee Drive, Vero Beach, FL
32961 and the FAA Airports District Office, 5950 Hazeltine National
Drive, Suite 400, Orlando, FL 32822. Written comments on the Sponsor's
request must be delivered or mailed to: Stephen Wilson, Program
Manager, Orlando Airports District Office, 5950 Hazeltine National
Drive, Suite 400, Orlando, FL 32822-5024.
    In addition, a copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Eric Menger, Airport

Director, Vero Beach Regional Airport, P.O. Box 1389, 3400 Cherokee
Drive, Vero Beach, FL 32961-1389.

FOR FURTHER INFORMATION CONTACT: Stephen Wilson, Program Manager,
Orlando Airports District Office, 5950 Hazeltine National Drive, Suite
400, Orlando, FL 32822-5024.

SUPPLEMENTARY INFORMATION: Section 125 of The Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century (AIR-21) requires the
FAA to provide an opportunity for public notice and comment prior to
the ``waiver'' or ``modification'' of a sponsor's Federal obligation to
use certain airport land for non-aeronautical purposes.

    Issued in Orlando, FL, on August 23, 2016.
Bart Vernace, P.E.,
Manager, Orlando Airports District Office, Southern Region.
[FR Doc. 2016-21108 Filed 9-1-16; 8:45 am]
 BILLING CODE 4910-13-P


Appendix II.C.9.

Co-Occurrence of Organophosphorus Pesticides

on PDP Samples, 1994-2004

This appendix is available on EPA’s website at

  HYPERLINK
"http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op"
http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op

A CD containing the data in this appendix may also be obtained by

contacting the Office of Pesticide Programs Public Docket

Docket #  EPA-HQ-OPP-2006-0618

One Potomac Yard

12777 S. Crystal Drive Room S-4400

Arlington, Virginia, 22202

703-305-5805

Monday through Friday, 8:30 am – 4:00 pm


[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31019-31022]
[FR Doc No: 2012-12591]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1029]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
25, 2012.

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 ``General Licensing Provisions; Section 351(k) Biosimilar
Applications''. Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

General Licensing Provisions; Section 351(k) Biosimilar Applications--
(OMB Control Number 0910--New)

    On March 23, 2010, the President signed into law the Patient
Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-
148). The Affordable Care Act contains a subtitle called the Biologics
Price Competition and Innovation Act of 2009 (BPCI Act) which amends
the Public Health Service Act (PHS Act) and establishes an abbreviated
licensure pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference product.
(See sections 7001 through 7003 of the Affordable Care Act.)
    Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI
Act,

sets forth the requirements for an application for a proposed
biosimilar product and an application or a supplement for a proposed
interchangeable product. Section 351(k) defines biosimilarity to mean
``that the biological product is highly similar to the reference
product notwithstanding minor differences in clinically inactive
components'' and that ``there are no clinically meaningful differences
between the biological product and the reference product in terms of
the safety, purity, and potency of the product''. (See section
351(i)(2) of the PHS Act.) A 351(k) application must contain, among
other things, information demonstrating that the biological product is
biosimilar to a reference product based upon data derived from
analytical studies, animal studies, and clinical studies, unless FDA
determines, in its discretion, that certain studies are unnecessary in
a 351(k) application. (See section 351(k)(2) of the PHS Act.) To
demonstrate interchangeability, an applicant must provide sufficient
information to demonstrate biosimilarity and that the biosimilar
biological product can be expected to produce the same clinical result
as the reference product in any given patient and, if the biosimilar
biological product is administered more than once to an individual, the
risk in terms of safety or diminished efficacy of alternating or
switching between the use of the biosimilar biological product and the
reference product is not greater than the risk of using the reference
product without such alternation or switch. (See section 351(k)(4) of
the PHS Act.) Interchangeable products may be substituted for the
reference product without the intervention of the prescribing health
care provider. (See section 351(i)(3) of the PHS Act.) This Federal
Register information collection document begins the process of
requesting public comment and obtaining OMB approval for the
information collection regarding the burden on the submission of a
351(k) application not otherwise covered by existing OMB approvals.
    In estimating the information collection burden for 351(k)
applications, FDA has reviewed the collection of information regarding
the general licensing provisions for biologics license applications
under section 351(a) of the PHS Act to OMB (approved under OMB control
number 0910-0338). For the information collection burden for 351(a)
applications, FDA described Sec.  601.2(a) (21 CFR 601.2(a)) as
requiring a manufacturer of a biological product to submit an
application on forms prescribed for such purpose with accompanying data
and information including certain labeling information to FDA for
approval to market a product in interstate commerce. FDA also added in
the burden estimate the container and package labeling requirements
provided under Sec. Sec.  610.60 through 610.65 (21 CFR 610.60 through
610.65). The estimated hours per response for Sec.  601.2, and
Sec. Sec.  610.60 through 610.65, were 860 hours.
    In addition, in submitting a 351(a) application, an applicant
completes the Form FDA 356h ``Application to Market a New Drug,
Biologic, or an Antibiotic Drug for Human Use.'' The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. The checklist helps to ensure that the application
is complete and contains all the necessary information, so that delays
due to lack of information may be eliminated. The form provides key
information to FDA for efficient handling and distribution to the
appropriate staff for review. The estimated burden hours for biological
product submissions using FDA Form 356h are included under the
applicable requirements approved under OMB control number 0910-0338.
    FDA intends for an applicant to submit a 351(k) application
following Form FDA 356h, modifying the information submitted to support
the information required under section 351(k) of the BPCI Act. To
submit an application seeking licensure of a proposed biosimilar
product under section 351(k)(2)(A)(i) and (k)(2)(A)(iii), FDA believes
that the estimated burden hours would be approximately the same as
noted under OMB control number 0910-0338 for a 351(a) application--860
hours. The burden estimates for seeking licensure of a proposed
biosimilar product that meets the standards for interchangeability
under section 351(k)(2)(B) and (k)(4) would also be 860 hours. Until we
gain more experience with biosimilar applications, FDA believes this
estimate is appropriate for 351(k) applications because to determine
biosimilarity or interchangeability of a proposed 351(k) product, the
application and the information submitted is expected to be comparably
complex and technically demanding as a proposed 351(a) application. FDA
may determine, in its discretion, that an element required under a
351(k) application to be unnecessary to support licensure of a
biosimilar or interchangeable product. In those cases, the number of
hours per response may be less than the hours estimated.
    A summary of the collection of information requirements in the
submission of a 351(k) application as described under the BPCI Act
follows:
    Section 351(k)(2)(A)(i) requires manufactures of 351(k) products to
submit an application for FDA review and licensure before marketing a
biosimilar product. An application submitted under this section shall
include information demonstrating that:
     The biological product is biosimilar to a reference
product based upon data derived from analytical studies, animal studies
(including toxicity) and a clinical study or studies (including
immunogenicity and pharmacokinetics or pharmacodynamics). The Secretary
of Health and Human Services (the Secretary) may determine that any of
these elements is unnecessary.
     The biological product and reference product utilize the
same mechanism or mechanisms of action for the condition or conditions
of use prescribed, recommended, or suggested in the proposed labeling,
but only to the extent the mechanism or mechanisms of action are known
for the reference product.
     The condition or conditions of use prescribed,
recommended, or suggested in the labeling proposed for the biological
product have been previously approved for the reference product.
     The route of administration, the dosage form, and the
strength of the biological product are the same as those of the
reference product.
     The facility in which the biological product is
manufactured, processed, packed, or held meets standards designed to
assure that the biological product continues to be safe, pure, and
potent.
    Section 351(k)(2)(A)(iii) requires the application to include
publicly-available information regarding the Secretary's previous
determination that the reference product is safe, pure, and potent. The
application may include any additional information in support of the
application, including publicly-available information with respect to
the reference product or another biological product.
    Under section 351(k)(2)(B) and (k)(4), a manufacturer may include
information demonstrating that the biological product meets the
standards for interchangeability either in the application described in
this document to show biosimilarity, or in a supplement to such an
application. The information submitted to meet the standard for
interchangeability must show that: (1) The biological product is
biosimilar to the reference product and can be expected to produce the
same

clinical result as the reference product in any given patient and (2)
for a biological product that is administered more than once to an
individual, the risk in terms of safety or diminished efficacy of
alternating or switching between use of the biological product and the
reference product is not greater than the risk of using the reference
product without such alternation or switch.
    In addition to the collection of information regarding the
submission of a 351(k) application for a proposed biosimilar or
interchangeable biological product, section 351(l) of the BPCI Act
establishes procedures for identifying and resolving patent disputes
involving applications submitted under section 351(k) of the PHS Act.
The burden estimates for the patent provisions under section
351(l)(6)(C) of the BPCI Act are included in table 1 of this document
and are based on the estimated number of 351(k) biosimilar respondents.
Based on similar reporting requirements, FDA estimates this
notification will take 2 hours. A summary of the collection of
information requirements under 351(l)(6)(C) follows:
    Not later than 30 days after a complaint from the reference product
sponsor is served to a 351(k) applicant in an action for patent
infringement described under 351(l)(6), section 351(l)(6)(C) requires
that the 351(k) applicant provide the Secretary with notice and a copy
of such complaint. The Secretary shall publish in the Federal Register
notice any complaint received under 351(l)(6)(C)(i).
    FDA has not received any 351(k) applications to date. Under table 1
of this document, the estimated number of respondents submitting 351(k)
applications is based on the estimated annual number of manufacturers
that would submit the required information to FDA and the estimated
annual number of 351(k) submissions FDA would receive. In making this
estimate, FDA has taken into account, among other things, the
expiration dates of patents that relate to potential reference
products, and general market interest in biological products that could
be candidates for 351(k) applications.
    On November 2 and 3, 2010, FDA held a public hearing and
established a public docket to obtain input on specific issues and
challenges associated with the implementation of the BPCI Act. (See
Docket No. FDA-2010-N-0477.) Based in part on this input, FDA announced
the availability of three draft guidances describing FDA's current
interpretation of certain statutory requirements added by the BPCI Act
as well as quality and analytical issues, demonstrating biosimilarity,
and implementation policy issues. These draft guidances are:
``Biosimilars: Questions and Answers Regarding Implementation of the
Biologics Price Competition and Innovation Act of 2009,'' ``Quality
Considerations in Demonstrating Biosimilarity to a Reference Protein
Product,'' and ``Scientific Considerations in Demonstrating
Biosimilarity to a Reference Product.'' The Federal Register documents
for these guidances reference this Federal Register information
collection document regarding the burden on the submission of a 351(k)
application not otherwise covered by existing OMB approvals. In
addition, we note that the draft guidance on ``Scientific
Considerations in Demonstrating Biosimilarity to a Reference Product''
recommends that labeling for a product subject to approval under
section 351(k) include statements that indicate that: (1) The product
is approved as biosimilar to a reference product for stated
indication(s) and (2) the product (has or has not) been determined to
be interchangeable with the reference product. FDA has determined,
under 5 CFR 1320.3(c)(2)), that these labeling recommendations are not
``collections of information'' for the purposes of the PRA because the
statements will comprise solely information that FDA will supply to the
applicant for the purpose of disclosing it to the public, i.e., FDA's
determination upon review of the application submitted under section
351(k), that the product is biosimilar and/or interchangeable to its
reference product.
    In the Federal Register of February 15, 2012 (77 FR 8880), FDA
published a 60-day notice requesting comments on the information
collection for the requirements for an application for a proposed
biosimilar product and an application or a supplement for a proposed
interchangeable product. In the Federal Register of February 23, 2012
(77 FR 10752), FDA published a correction to the 60-day notice
providing the correct docket number to submit comments. FDA received no
comments that pertained to the information collection analysis.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     351(k) Application for          Number of     responses per   Total annual     burden per      Total hours
 Biosimilars (42 U.S.C. 262(k))     respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
351(k)(2)(A)(i) and                            2               1               2             860            1720
 (k)(2)(A)(iii).................
351(k)(2)(B) and (k)(4).........               1               1               1             860             860
351(l)(6)(C)....................               2               1               2               2               4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12591 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Proposed Rules]
[Pages 74061-74063]
[FR Doc No: 2015-29912]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-4452; Airspace Docket No. 15-AWA-7]
RIN 2120-AA66

Proposed Amendment of Class C Airspace; Capital Region
International Airport, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class C airspace at Capital
Region International Airport, formerly Lansing Capital City Airport,
Lansing, MI, by removing a cutout from the surface area that was put in
place to accommodate operations around Davis Airport, now permanently
closed. Also, this proposal would update the airport's name and
geographic coordinates to reflect the current information in the FAA's
aeronautical database. The FAA is proposing this action to enable more
efficient operations at Capital Region International Airport.

DATES: Comments must be received on or before January 26, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2015-
4452 and Airspace Docket No. 15-AWA-7 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays. The Docket Office (telephone 1-800-
647-5527), is on the ground floor of the building at the above address.
    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC, 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use

of the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify terminal airspace as required to preserve
the safe and efficient flow of air traffic in the Lansing, MI, area.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-4452 and Airspace Docket No. 15-AWA-7) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2015-4452 and Airspace Docket No. 15-AWA-7.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, Operations
Support Group, Federal Aviation Administration, 2601 Meacham Blvd.,
Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, airspace
Designations and Reporting Points, dated August 6, 2015, and effective
September 15, 2015. FAA Order 7400.9Z is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.9Z lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to modify the Capital Region International
Airport Class C airspace area by removing the cutout from the Class C
surface area that excluded the airspace within a 1-mile radius of the
former Davis Airport and the airspace 1 mile either side of the
090[deg] bearing from the former Davis Airport. The exclusion from the
Class C surface area was in place solely to accommodate operations at
Davis Airport, which was located about 3.5 NM east of the Capital
Region International Airport. Davis Airport was permanently closed in
2000, and removed from the FAA's aeronautical database in 2006. Since
the original purpose of the exclusion no longer exists, the FAA is
proposing to remove the words ``. . . excluding that airspace within a
1-mile radius of the Davis Airport and excluding that airspace 1 mile
either side of the 090[deg] bearing from Davis Airport to the 5-mile
radius from Capital City Airport . . .'' from the Class C airspace
description. This would restore the Class C surface area to a standard
configuration of a 5-NM radius around Capital Region International
Airport and enhance the management of aircraft operations at the
airport.
    Also, this action would update the airport name and geographic
coordinates to reflect the current information in the FAA's
aeronautical database. This change would replace ``Capital City
Airport'' with ``Capital Region International Airport'' and replace
``lat. 42[deg]46'43'' N., long. 84[deg]35'15'' W.'' with ``lat.
42[deg]46'43'' N., long. 84[deg]35'10'' W.''
    Class C airspace areas are published in paragraph 4000 of FAA Order
7400.9Z, dated August 6, 2015 and effective September 15, 2015, which
is incorporated by reference in 14 CFR 71.1. The Class C airspace area
modification proposed in this document would be published subsequently
in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9Z,

Airspace Designations and Reporting Points, dated August 6, 2015, and
effective September 15, 2015, is amended as follows:

Paragraph 4000--Subpart C-Class C Airspace

* * * * *

AGL MI C Lansing, MI [Amended]

Capital Region International Airport, MI
    (Lat. 42[deg]46'43'' N., long. 84[deg]35'10'' W.)

    That airspace extending upward from the surface to and including
4,900 feet MSL within a 5-mile radius of Capital Region
International Airport; and that airspace extending upward from 2,100
feet MSL to and including 4,900 feet MSL within a 10-mile radius of
Capital Region International Airport.

    Issued in Washington, DC, on November 16, 2015.
Gary A. Norek,
Manager, Airspace Policy Group.
[FR Doc. 2015-29912 Filed 11-25-15; 8:45 am]
 BILLING CODE 4910-13-P


Subpart F   Reporting Defects and Recalling Engines § 1068.501 How do I report engine defects? ( a) General provisions. As an engine manufacturer, you must investigate in certain circumstances whether emission related components are defective and send us reports as specified by this section. ( 1) The term emission related component includes those components listed in Appendix I of this part. For the purposes of this section, complete engines shall also be considered an emissions related component. It also includes factory settings of emissionrelated parameters and specifications listed in Appendix II of this part. ( 2) For the purposes of this section, defects do not include damage to emission related components ( or maladjustment of parameters) caused by owners improperly maintaining or abusing their engine. ( 3) You must track the information specified in paragraph ( b)( 1) of this section. You are not required to collect additional information other than that specified in paragraph ( b)( 1) of this section before reaching the threshold for an investigation specified in paragraph ( e) of this section. ( 4) You may ask us to allow you to use alternate methods for tracking, investigating, reporting, and correcting emission related defects. In your request, explain and demonstrate why you believe your alternate system will be at least as effective in tracking, identifying, investigating, evaluating, reporting, and correcting potential and actual emissions related defects as the requirements in this section. ( 5) If we determine that emissionrelated defects result in a substantial number of properly maintained and used engines not conforming to the regulations of this chapter during their VerDate 0ct< 31> 2002 19: 22 Nov 07, 2002 Jkt 200001 PO 00000 Frm 00203 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 08NOR2. SGM 08NOR2 68444 Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Rules and Regulations useful life, we may order you to conduct a recall of your engines ( see § 1068.505). ( 6) Send the defect reports and status reports required by this section to the Designated Officer. ( b) Investigation of possible defects. If the number of engines that possibly have a defect, as defined by paragraph ( b)( 1) of this section, exceed the thresholds specified in paragraph ( e) of this section, you must conduct an investigation to determine if an emission related component is actually defective. ( 1) You must track warranty claims, parts shipments, and the other information specified in paragraph ( b)( 1)( iii) of this section. You must classify an engine as possibly having a defective component if any of the following is true: ( i) A warranty claim is submitted for the component, whether this is under your emission related warranty or any other warranty. ( ii) You ship a replacement component other than for normally scheduled maintenance during the useful life of the engine. ( iii) You receive any other information indicating the component may be defective, such as information from dealers or hot line complaints. ( 2) Your investigation must be prompt, thorough, consider all relevant information, follow scientific and engineering principles, and be designed to obtain all the information specified in paragraph ( d) of this section. ( 3) Your investigation only needs to consider defects that occur within the useful life period, or within five years after the end of the model year, whichever is longer. ( 4) You must continue your investigation until you are able to obtain all the information specified for a defect report in paragraph ( d) of this section. Send us an updated defect report anytime you have significant additional information. ( 5) If a component believed to be defective is used in additional engine families or model years, you must investigate whether the component or part is defective when used in these additional engine families or model years, and include these results as part of your defect report. ( 6) If your initial investigation concludes that the number of engines with a defect is fewer than the thresholds specified in paragraph ( f) of this section, but other information becomes available that may show that the number of engines with a defect exceeds these thresholds, then you must resume your investigation. If you resume an investigation, you must include the information from the earlier investigation to determine whether to send a defect report. ( c) Reporting defects. You must send us a defect report in either of the following cases: ( 1) Your investigation shows that the number of engines with a defect exceeds the thresholds specified in paragraph ( f) of this section. Send the defect report within 15 days after the date you identify this number of defective engines. ( 2) You know a defective emissionrelated component exists in a number of engines that exceeds the thresholds specified in paragraph ( f) of this section, regardless of how you obtain this information. Send the defect report within 15 days after you learn that the number of defects exceeds one of these thresholds. ( d) Contents of a defect report. Include the following information in a defect report: ( 1) Your corporate name and a person to contact regarding this defect. ( 2) A description of the defect, including a summary of any engineering analyses and associated data, if available. ( 3) A description of the engines that may have the defect, including engine families, models, and range of production dates. Note that you must address all model years for the engines, not just the model year for which you triggered the reporting requirement. ( 4) An estimate of the number and percentage of each class or category of affected engines that have or may have the defect, and an explanation of how you determined this number. ( 5) An estimate of the defect's impact on emissions, with an explanation of how you calculated this estimate and a summary of any emission data demonstrating the impact of the defect, if available. ( 6) A description of your plan for addressing the defect or an explanation of your reasons for not believing the defects must be remedied. ( e) Thresholds for conducting a defect investigation. Unless the standardsetting part specifies otherwise, you must begin a defect investigation based on the following threshold values: ( 1) For engine with rated power under 560 kW: ( i) When the component is a catalytic converter ( or other aftertreatment device), if the number of engines in an engine family that may have the defect exceeds 2 percent of the total number of engines in the engine family or 2,000 engines, whichever is less. ( ii) When the emission related component is anything but a catalytic converter ( or other aftertreatment device), if the number of engines in an engine family that may have the defect exceeds 4 percent of the total number of engines in the engine family or 4,000 engines, whichever is less. ( 2) For engine with rated power greater than or equal to 560 kW, if the number of engines in an engine family that may have the defect exceeds 1 percent of the total number of engines in the engine family or 5 engines, whichever is greater. ( f) Thresholds for filing a defect report. You must send a defect report based on the following threshold values: ( 1) For engine with rated power under 560 kW: ( i) When the component is a catalytic converter ( or other aftertreatment device), if the number of engines in an engine family that has the defect exceeds 0.125 percent of the total number of engines in the engine family or 125 engines, whichever is less. ( ii) When the emission related component is anything but a catalytic converter ( or other aftertreatment device), if the number of engines in an engine family that has the defect exceeds 0.250 percent of the total number of engines in the engine family or 250 engines, whichever is less. ( 2) For engine with rated power greater than or equal to 560 kW, if the number of engines in an engine family that has the defect exceeds 0.5 percent of the total number of engines in the engine family or 2 engines, whichever is greater. ( g) How to count defects. In most cases, you may track defects separately for each model year and engine family. For families with annual U. S. directed production volumes under 5,000 engines, you may apply the percentage thresholds in paragraphs ( e) and ( f) of this section on the basis of multiple model years, for engines using the same emission related components. To determine whether you exceed the investigation threshold in paragraph ( e) of this section, count defects that you correct before they reach the ultimate purchaser. Do not count these corrected defects to determine whether you exceed the reporting threshold in paragraph ( f) of this section. ( h) Status reports. You must send us a mid year or end of year status report if you concluded an investigation during the previous six months without filing a defect report or if you have an unresolved investigation at the end of the six month period. Include the information specified in paragraph ( c) of this section, or explain why the information is not relevant. Send these VerDate 0ct< 31> 2002 17: 09 Nov 07, 2002 Jkt 200001 PO 00000 Frm 00204 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 08NOR2. SGM 08NOR2 68445 Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Rules and Regulations status reports no later than June 30 and December 31 of each year. ( i) Future production. If you identify a design or manufacturing defect that prevents engines from meeting the requirements of this part, you must correct the defect as soon as possible for any future production for engines in every family affected by the defect. This applies without regard to whether you are required to conduct a defect investigation or submit a defect report under this section.

§ 1068.505 How does the recall program work? ( a) If we make a determination that a substantial number of properly maintained and used engines do not conform to the regulations of this chapter during their useful life, you must submit a plan to remedy the nonconformity of your engines. We will notify you of our determination in writing. Our notice will identify the class or category of engines affected and describe how we reached our conclusion. If this happens, you must meet the requirements and follow the instructions in this subpart. You must remedy at your expense noncompliant engines that have been properly maintained and used. You may not transfer this expense to a dealer or equipment manufacturer through a franchise or other agreement. ( b) You may ask for a hearing if you disagree with our determination ( see subpart G of this part). ( c) Unless we withdraw the determination of noncompliance, you must respond to it by sending a remedial plan to the Designated Officer by the later of these two deadlines: ( 1) Within 60 days after we notify you. ( 2) Within 60 days after a hearing. ( d) Once you have sold an engine to the ultimate purchaser, we may inspect or test the engine only if he or she permits it, or if state or local inspection programs separately provide for it. ( e) You may ask us to allow you to conduct your recall differently than specified in this subpart, consistent with section 207( c) of the Act.

§ 1068.510 How do I prepare and apply my remedial plan? ( a) In your remedial plan, describe all of the following: ( 1) The class or category of engines to be recalled, including the number of engines involved and the model year or other information needed to identify the engines. ( 2) The modifications, alterations, repairs, corrections, adjustments, or other changes you will make to correct the affected engines. ( 3) A brief description of the studies, tests, and data that support the effectiveness of the remedy you propose to use. ( 4) The instructions you will send to those who will repair the engines under the remedial plan. ( 5) How you will determine the owners' names and addresses. ( 6) How you will notify owners; include copies of any notification letters. ( 7) The proper maintenance or use you will specify, if any, as a condition to be eligible for repair under the remedial plan. Describe how owners should show they meet your conditions. ( 8) The steps owners must take for you to do the repair. You may set a date or a range of dates, specify the amount of time you need, and designate certain facilities to do the repairs. ( 9) Which company ( or group) you will assign to do or manage the repairs. ( 10) If your employees or authorized warranty agents will not be doing the work, state who will and say they can do it. ( 11) How you will ensure an adequate and timely supply of parts. ( 12) The effect of proposed changes on fuel consumption, driveability, and safety of the engines you will recall; include a brief summary of the information supporting these conclusions. ( 13) How you intend to label the engines you repair and where you will place the label on the engine ( see § 1068.515). ( b) We may require you to add information to your remedial plan. ( c) We may require you to test the proposed repair to show it will remedy the noncompliance. ( d) Use all reasonable means to locate owners. We may require you to use government or commercial registration lists to get owners' names and addresses, so your notice will be effective. ( e) The maintenance or use that you specify as a condition for eligibility under the remedial plan may include only things you can show would cause noncompliance. Do not require use of a component or service identified by brand, trade, or corporate name, unless we approved this approach with your original certificate of conformity. Also, do not place conditions on who maintained the engine. ( f) We may require you to adjust your repair plan if we determine owners would be without their engines or equipment for an unreasonably long time. ( g) We will tell you in writing within 15 days of receiving your remedial plan whether we have approved or disapproved it. We will explain our reasons for any disapproval. ( h) Begin notifying owners within 15 days after we approve your remedial plan. If we hold a hearing, but do not change our position about the noncompliance, you must begin notifying owners within 60 days after we complete the hearing, unless we specify otherwise.

§ 1068.515 How do I mark or label repaired engines? ( a) Attach a label to each engine you repair under the remedial plan. At your discretion, you may label or mark engines you inspect but do not repair. ( b) Make the label from a durable material suitable for its planned location. Make sure no one can remove the label without destroying or defacing it. ( c) On the label, designate the specific recall campaign and state where you repaired or inspected the engine. ( d) We may waive or modify the labeling requirements if we determine they are overly burdensome.

§ 1068.520 How do I notify affected owners? ( a) Notify owners by first class mail, unless we say otherwise. We may require you to use certified mail. Include the following in your notice: ( 1) State: `` The U. S. Environmental Protection Agency has determined that your engine may be emitting pollutants in excess of the Federal emission standards, as defined in Title 40 of the Code of Federal Regulations. These emission standards were established to protect the public health or welfare from air pollution''. ( 2) State that you ( or someone you designate) will repair these engines at your expense. ( 3) If we approved maintenance and use conditions in your remedial plan, state that you will make these repairs only if owners show their engines meet the conditions for proper maintenance and use. Describe these conditions and how owners should prove their engines are eligible for repair. ( 4) Describe the components your repair will affect and say generally how you will repair the engines. ( 5) State that the engine, if not repaired, may fail an emission inspection test if state or local law requires one. ( 6) Describe any adverse effects on its performance or driveability that would be caused by not repairing the engine. ( 7) Describe any adverse effects on the functions of other engine components that would be caused by not repairing the engine.

VerDate 0ct< 31> 2002 17: 09 Nov 07, 2002 Jkt 200001 PO 00000 Frm 00205 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 08NOR2. SGM 08NOR2 68446 Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Rules and Regulations ( 8) Specify the date you will start the repairs, the amount of time you will need to do them, and where you will do them. Include any other information owners may need to know. ( 9) Include a self addressed card that owners can mail back if they have sold the engine ( or equipment in which the engine is installed); include a space for owners to write the name and address of a buyer. ( 10) State that owners should call you at a phone number you give to report any difficulty in obtaining repairs. ( 11) State: `` To ensure your full protection under the emission warranty on your engine by federal law, and your right to participate in future recalls, we recommend you have your engine serviced as soon as possible. We may consider your not servicing it to be improper maintenance''. ( b) We may require you to add information to your notice or to send more notices. ( c) You may not in any communication with owners or dealers say or imply that your noncompliance does not exist or that it will not degrade air quality.

§ 1068.525 What records must I send to EPA?

( a) Send us a copy of all communications related to the remedial plan you sent to dealers and others doing the repairs. Mail or e mail us the information at the same time you send it to others. ( b) From the time you begin to notify owners, send us a report within 25 days of the end of each calendar quarter. Send reports for six consecutive quarters or until all the engines are inspected, whichever comes first. In these reports, identify the following: ( 1) The range of dates you needed to notify owners. ( 2) The total number of notices sent. ( 3) The number of engines you estimate fall under the remedial plan ( explain how you determined this number). ( 4) The cumulative number of engines you inspected under the remedial plan. ( 5) The cumulative number of these engines you found needed the specified repair. ( 6) The cumulative number of these engines you have repaired. ( 7) The cumulative number of engines you determined to be unavailable due to exportation, theft, retirement, or other reasons ( specify). ( 8) The cumulative number of engines you disqualified for not being properly maintained or used. ( c) If your estimated number of engines falling under the remedial plan changes, change the estimate in your next report and add an explanation for the change. ( d) We may ask for more information. ( e) We may waive reporting requirements or adjust the reporting schedule. ( f) If anyone asks to see the information in your reports, we will follow the provisions of § 1068.10 for handling confidential information.

§ 1068.530 What records must I keep? We may review your records at any time, so it is important that you keep required information readily available. Keep records associated with your recall campaign for three years after you complete your remedial plan. Organize and maintain your records as described in this section. ( a) Keep a paper copy of the written reports described in § 1068.525. ( b) Keep a record of the names and addresses of owners you notified. For each engine, state whether you did any of the following: ( 1) Inspected the engine. ( 2) Disqualified the engine for not being properly maintained or used. ( 3) Completed the prescribed repairs. ( c) You may keep the records in paragraph ( b) of this section in any form we can inspect, including computer databases.

§ 1068.535 How can I do a voluntary recall for emission related problems? If we have made a determination that a substantial number of properly maintained and used engines do not conform to the regulations of this chapter during their useful life, you may not use a voluntary recall or other alternate means to meet your obligation to remedy the noncompliance. Thus, this section only applies where you learn that your engine family does not meet the requirements of this chapter and we have not made such a determination. ( a) To do a voluntary recall under this section, first send the Designated Officer a plan, following the guidelines in § 1068.510. Within 15 days, we will send you our comments on your plan. ( b) Once we approve your plan, start notifying owners and carrying out the specified repairs. ( c) From the time you start the recall campaign, send us a report within 25 days of the end of each calendar quarter, following the guidelines in § 1068.525( b). Send reports for six consecutive quarters or until all the engines are inspected, whichever comes first. ( d) Keep your reports and the supporting information as described in § 1068.530. § 1068.540 What terms do I need to know for this subpart? The following terms apply to this subpart: Days means calendar days. Owner means someone who owns an engine affected by a remedial plan or someone who owns a piece of equipment that has one of these engines.

Subpart G   Hearings § 1068.601 What are the procedures for hearings? If we agree to hold a hearing related to our decision to order a recall under § 1068.505, we will hold the hearing according to the provisions of 40 CFR 85.1807. For any other issues, you may request an informal hearing, as described in 40 CFR 86.1853   01.

Appendix I to Part 1068   Emission Related Components This appendix specifies emission related components that we refer to for describing such things as emission related defects or requirements related to rebuilding engines. I. Emission related components include any engine parts related to the following systems: 1. Air induction system. 2. Fuel system. 3. Ignition system. 4. Exhaust gas recirculation systems. II. The following parts are also considered emission related components: 1. Aftertreatment devices. 2. Crankcase ventilation valves. 3. Sensors. 4. Electronic control units. III. Emission related components also include any other part whose only purpose is to reduce emissions or whose failure will increase emissions without significantly degrading engine performance. IV. We also consider the emission control information label to be an emissionrelated component.

Appendix II to Part 1068   Emission Related Parameters and Specifications This appendix specifies emission related parameters and specifications that we refer to for describing such things as emission related defects or requirements related to rebuilding engines. I. Basic Engine Parameters   Reciprocating Engines. 1. Compression ratio. 2. Type of air aspiration ( natural, Rootsblown supercharged, turbocharged). 3. Valves ( intake and exhaust). a. Head diameter dimension. b. Valve lifter or actuator type and valve lash dimension. 4. Camshaft timing. a. Valve opening   intake exhaust ( degrees from top dead center or bottom dead center). b. Valve closing   intake exhaust ( degrees from top dead center or bottom dead center).

VerDate 0ct< 31> 2002 17: 09 Nov 07, 2002 Jkt 200001 PO 00000 Frm 00206 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 08NOR2. SGM 08NOR2 68447 Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Rules and Regulations c. Valve overlap ( degrees). 5. Ports   two stroke engines ( intake and/ or exhaust). a. Flow area. b. Opening timing ( degrees from top dead center or bottom dead center). c. Closing timing ( degrees from top dead center or bottom dead center). II. Intake Air System. 1. Roots blower/ supercharger/ turbocharger calibration. 2. Charge air cooling. a. Type ( air to air; air to liquid). b. Type of liquid cooling ( engine coolant, dedicated cooling system). c. Performance. 3. Temperature control system calibration. 4. Maximum allowable inlet air restriction. III. Fuel System. 1. General. a. Engine idle speed. b. Engine idle mixture. 2. Carburetion. a. Air fuel flow calibration. b. Idle mixture. c. Transient enrichment system calibration. d. Starting enrichment system calibration. e. Altitude compensation system calibration. f. Hot idle compensation system calibration. 3. Fuel injection for spark ignition engines. a. Control parameters and calibrations. b. Idle mixture. c. Fuel shutoff system calibration. d. Starting enrichment system calibration. e. Transient enrichment system calibration. f. Air fuel flow calibration. g. Altitude compensation system calibration. h. Operating pressure( s). i. Injector timing calibration. 4. Fuel injection for compression ignition engines. a. Control parameters and calibrations. b. Transient enrichment system calibration. c. Air fuel flow calibration. d. Altitude compensation system calibration. e. Operating pressure( s). f. Injector timing calibration. IV. Ignition System for Spark ignition Engines. 1. Control parameters and calibration. 2. Initial timing setting. 3. Dwell setting. 4. Altitude compensation system calibration. 5. Spark plug voltage. V. Engine Cooling System   thermostat calibration. VI. Exhaust System   maximum allowable back pressure. VII. System for Controlling Exhaust Emissions. 1. Air injection system. a. Control parameters and calibrations. b. Pump flow rate. 2. EGR system. a. Control parameters and calibrations. b. EGR valve flow calibration. 3. Catalytic converter system. a. Active surface area. b. Volume of catalyst. c. Conversion efficiency. 4. Backpressure. VIII. System for Controlling Crankcase Emissions. 1. Control parameters and calibrations. 2. Valve calibrations. IX. Auxiliary Emission Control Devices ( AECD). 1. Control parameters and calibrations. 2. Component calibration( s). X. System for Controlling Evaporative Emissions. 1. Control parameters and calibrations. 2. Fuel tank. a. Volume. b. Pressure and vacuum relief settings. XI. Warning Systems Related to Emission Controls. 1. Control parameters and calibrations. 2. Component calibrations.

[ FR Doc. 02   23801 Filed 11   7   02; 8: 45 am]

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