Meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to Consider and Review Scientific Issues Associated with
RNA Interference: Problem Formulation for Human Health and Ecological Risk Assessment

                               January 28, 2014

Docket Number: EPA-HQ-OPP-2013-0485				OPP Docket Tel:<PHONE_NUMBER>

                  Please note that all times are approximate
                      (See note at the end of the Agenda)

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Tuesday, January 28, 2014

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Opening Remarks  -  Steven Bradbury, Ph.D., Director, Office of Pesticide Programs (OPP), EPA

9:15 A.M.	Overview  -  Robert McNally, Director, Biopesticides and Pollution Prevention Division (BPPD), OPP, EPA

9:25 A.M.	Introduction to the Scientific Issues Associated with RNAi  - Based Pesticidal Products  -  Chris Wozniak, Ph.D., BPPD, OPP, EPA

9:45 A.M.	Human Health Considerations for RNAi-Based Pesticidal Products -  John Kough, Ph.D., BPPD, OPP, EPA

10:00 A.M. 	Environmental Considerations for Plant-Incorporated Protectant (PIP) Expressed dsRNA  -  Shannon Borges, BPPD, OPP, EPA

10:15 A.M. 	Environmental Considerations for Non-PIP RNAi End-Use Products  -  Russell Jones, Ph.D., BPPD, OPP, EPA

10:30 A.M. 	Break

10:40 A.M.	Public Comments

12:15 P.M.	Lunch

1:00 P.M.	Panel Discussion of Charge Questions 1-4

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Introduction

The intent of this meeting is to solicit scientific expertise for the problem formulation phase of risk assessment of pesticidal products based on RNA interference (RNAi). Problem formulation is the first step in the risk assessment process and guides the subsequent questions to pose about hazard and exposure (EPA, 1998b). The framework for the risk assessment of biopesticides is found in the RNAi issue paper in two sections. The current approach for mammalian safety assessment of PIPs and biochemical pesticides can be found at the start of section III. The framework for ecological safety assessment for PIPS and biochemical pesticides can be found in section IV A and B.

EPA has found that the current approach utilizing reduced data sets and tiered approaches for more involved studies works well for the risk assessment of products based on biological materials. EPA recognizes that biopesticides tend to be more specific in their activity and present a lower risk profile than some alternative pest control measures. Biopesticide products are likely to be developed utilizing RNAi phenomena as both dsRNA PIPs expressed in plants and typical sprays and other products based on isolated dsRNA molecules. EPA is asking the following questions to ascertain the issues unique to RNAi and how they could fit under the existing risk assessment framework.
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Human Health Considerations

Question 1. Please discuss the nature and extent of uncertainty in the specificity of long sequences of dsRNA targeted at pest species, if bioinformatic analysis shows no significant similarity to mammalian genes?
Question 2. Based on data indicating degradation of the majority of dsRNA in the digestive system, please discuss the strengths and limitations in concluding there will not be significant absorption of dsRNA with possible mammalian effects on oral exposure?
Question 3. To what extent does the specific structure of dsRNA, if it is super coiled or in a hairpin structure, make it more likely to survive degradation in the gut and lead to possible mammalian effects with oral exposure?
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Environmental Considerations: Questions directed toward dsRNA expressed as part of a PIP and applied to the plant as a biochemical

Question 4. EPA needs a clear understanding of the environmental fate of dsRNAs in terrestrial and aquatic environments. In sections IV.A.1. and IV.B.3, respectively, EPA has presented potential scenarios for dsRNA movement within the environment that may result from their pesticidal uses as PIPs or as exogenously applied dsRNAs. Environmental fate of dsRNAs is not well understood; however, EPA has frameworks in place for PIPs and Biochemicals to obtain data related to degradation and movement of pesticides in the environment. These data can be used to refine environmental exposure estimates to dsRNAs.

    While nontarget exposure to dsRNA PIPs may result primarily from consumption of PIP crop plant tissue, EPA must also assess the exposure of nontarget organisms to dsRNA that may enter the environment through plant exudates and plant tissue breakdown. In section IV.A.2.a, EPA presented the current approach for testing to assess environmental fate for PIPs, which focuses on degradation within soil.
         i) To what extent will data on degradation in soil inform EPA on nontarget exposure to dsRNA PIPs?
         ii) What additional information, if any, would EPA need to assess environmental fate of dsRNA PIPs?
    In section IV.B.4, EPA proposed environmental fate data needs for exogenously applied dsRNAs. To what extent is the proposed testing sufficiently robust to inform nontarget organism exposure for these dsRNAs?

    For both dsRNA PIPs that may be free in the environment and exogenously applied dsRNAs, knowledge of the initial residue burden, and the dissipation rate of residues, is essential for developing environmental exposure estimates, particularly if models of environmental fate are used to arrive at these estimates. What analytical methods are available to accurately and precisely measure dsRNAs in diverse plant, soil, and water matrices?

2:50 P.M.	Break

3:00 P.M.	Panel Discussion of Charge Questions 5-6

Question 5. The primary route of exposure for nontarget organisms to dsRNA PIPs is assumed to be ingestion, either of dsRNAs contained in plant tissue or free in the environment. However, some evidence also indicates the potential for exposure by direct contact in nematodes and some arthropods.  For dsRNAs that are applied to plants and/or the environment, the primary routes of exposure are expected to be both ingestion and direct contact.

    In section III.C. and IV.A.1.c. of the issue paper, EPA discusses potential barriers to uptake of dsRNA in the gut of mammals and arthropods; however, little information exists for other taxa.

         i) In addition to the conditions of the gut environment and enzymes influencing digestion, what other factors may play a role in uptake within the gut and potentially limit exposure to dsRNA?
         ii) Please comment on how these barriers can be generalized across all nontarget taxa that are considered in EPA's risk assessments (e.g., birds, plants, fish, etc.) for both dsRNA PIPs and exogenously applied dsRNA.
    The degree of exposure by direct contact is likely to differ between nontarget risk assessments for dsRNA PIPs and nontarget risk assessments for exogenously applied dsRNAs.

         i) Please comment on the importance of the contact route of exposure for nontarget risk assessments for each of these types of dsRNAs

         ii) What barriers are likely to exist for this route of exposure for both terrestrial and aquatic organisms, and how can these be generalized across nontarget taxa?

Question 6. In the issue paper, EPA discussed possible effects other than silencing of the target gene in the target organism that may occur as a result of exposure to dsRNA. These unintended effects of dsRNA include off-target effects, silencing the target gene in nontarget organisms, degradation of non-targeted mRNA by transitive RNA, and effects resulting from immune stimulation and saturation of the RNAi machinery. EPA has little information to estimate the range of unintended effects that may occur and their probability of occurrence as a result of exposure to dsRNA in the environment.

    Please comment on the unintended effects that EPA might reasonably anticipate in nontarget organisms exposed to dsRNAs, the likelihood of such unintended effects, and the biological significance of these effects in nontarget organisms, should they occur.

    To the extent that additional information would reduce uncertainty in addressing these issues, please describe specifically the nature of additional information that EPA may need and the degree to which this information would reduce uncertainty in the ecological risk assessment.

4:50 P.M.	Break

5:00 P.M.	Panel Discussion of Charge Question 7

Question 7. In sections IV.A.2.a. and IV.B.4. of the issue paper, EPA presents the current framework of testing for determining nontarget effects resulting from exposure to PIPs and biochemicals, respectively. In section IV.A.2.c, EPA also raised potential issues related to nontarget testing with dsRNAs that may arise given their unique mode of action, which included 1) the potential influence of latent effects on results of nontarget testing, 2) the appropriate life stage for testing, and 3) the possibility for chronic effects.

    Please comment on how each of EPA's current PIP and biochemical frameworks for nontarget effects testing will inform risk assessment for dsRNA PIPs and exogenously applied dsRNAs. In providing a response, please address the potential for unintended effects as described in Question 7, as well as the three issues outlined as concerns for nontarget testing listed above.

    What additional nontarget effects testing, if any, should EPA consider to gain a full understanding of the potential for dsRNAs to cause effects to nontarget organisms?

    What other approaches, such as bioinformatics analysis, may be used to address concerns for effects on nontarget species and reduce the set of data requirements?

    In providing answers to the above subquestions, please be specific in discussing the extent to which additional information would reduce the nature and magnitude of these specific areas of uncertainty.

6:00 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the Designated Federal Official for this meeting, Dr. Sharlene Matten, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>


[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Proposed Rules]
[Pages 70861-70863]
[FR Doc No: 2010-29228]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1114; Directorate Identifier 2010-NM-206-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Model F.28 Mark
0100, 1000, 2000, 3000, and 4000 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

    Prompted by an accident * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88, and the Joint Aviation Authorities
(JAA) published Interim Policy INT/POL/25/12. The design review
conducted by Fokker on the F28 in response to these regulations
revealed that, in case of a lightning strike, an ignition source can
develop in the wing tank vapour space during fuel transfer from bag
tank CWT [center wing tank], if the electrical power for refuelling
is not switched off after refuelling.
    Service experience has revealed situations where the power
switch of the Fuelling Control Panel (FCP) appeared to be ``ON''
with the access panel closed. The cam on the access panel that
should operate the power switch, if forgotten by flight crew or
maintenance staff, can pivot away during closing of the panel, which
may result in the switch staying in the ``ON'' position.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.
* * * * *
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by January 3, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE
Nieuw-Vennep, the Netherlands; telephone +31 (0)252-627-350; fax +31
(0)252-627-211; e-mail<EMAIL_ADDRESS>
Internet http://www.myfokkerfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1114;
Directorate Identifier 2010-NM-206-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0139, dated July 1, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Prompted by an accident * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88, and the Joint Aviation Authorities
(JAA) published Interim Policy INT/POL/25/12. The design review
conducted by Fokker on the F28 in response to these regulations
revealed that, in case of a lightning strike, an ignition source can
develop in the wing tank vapour space during fuel transfer from bag
tank CWT [center wing tank], if the electrical power for refuelling
is not switched off after refuelling.
    Service experience has revealed situations where the power
switch of the Fuelling Control Panel (FCP) appeared to be ``ON''
with the access panel closed. The cam on the access panel that
should operate the power switch, if forgotten by flight crew or
maintenance staff, can pivot away during closing of the panel, which
may result in the switch staying in the ``ON'' position.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.
    For the reasons described above, this [EASA] AD requires an
inspection of the cam and, depending on findings, replacement with
an improved part. Subsequently, this AD requires repetitive
functional checks of the cam and, depending on findings, the
necessary corrective actions.

The corrective action is adjusting the FCP cam until it operates
correctly. You may obtain further information by examining the MCAI in
the AD docket.

Relevant Service Information

    Fokker Services B.V. has issued Fokker Service Bulletins SBF28-28-
052, dated April 20, 2010; and SBF100-28-063, dated April 15, 2010. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 6 products of U.S. registry. We also estimate that
it would take about 3 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $426 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $4,086, or $681 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2010-1114; Directorate
Identifier 2010-NM-206-AD.

Comments Due Date

    (a) We must receive comments by January 3, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Services B.V. Model F28 Mark 1000,
2000, 3000, and 4000 airplanes, all serial numbers, equipped with a
center wing tank (CWT); and Model F28 Mark 0100 airplanes, serial
numbers 11244 through 11441; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

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

    Prompted by an accident * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88, and the Joint Aviation Authorities
(JAA) published Interim Policy INT/POL/25/12. The design review
conducted by Fokker on the F28 in response to these regulations
revealed that, in case of a lightning strike, an ignition source can
develop in the wing tank vapour space during fuel transfer from bag
tank CWT [center wing tank], if the electrical power for refuelling
is not switched off after refuelling.
    Service experience has revealed situations where the power
switch of the Fuelling Control Panel (FCP) appeared to be ``ON''
with the access panel closed. The cam on the access panel that
should operate the power switch, if forgotten by flight crew or
maintenance staff, can pivot away during closing of the panel, which
may result in the switch staying in the ``ON'' position.
    This condition, if not corrected, could result in a wing fuel
tank explosion and consequent loss of the aeroplane.

Compliance

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

Actions

Initial Inspection and Corrective Actions

    (g) Within 6 months after the effective date of this AD, inspect
the FCP cam to determine the part number (P/N), in accordance with
Part 1 of the Accomplishment Instructions of Fokker Service Bulletin
SBF28-28-052, dated April 20, 2010 (for Model F28 Mark 1000, 2000,
3000, and 4000 airplanes); or SBF100-28-063, dated April 15, 2010
(for Model F28 Mark 0100 airplanes).
    (1) If the correct part number is installed (P/N D48127-009 for
Model F28 Mark 0100 airplanes and P/N A42509-089 for Model F28 Mark
1000, 2000, 3000, and 4000 airplanes), before further flight, do an
inspection to verify that the cam operates correctly, in accordance
with Part 1 of the Accomplishment Instructions of Fokker Service
Bulletin SBF28-28-052, dated April 20, 2010 (for Model F28 Mark
1000, 2000, 3000, and 4000 airplanes); or SBF100-28-

063, dated April 15, 2010 (for Model F28 Mark 0100 airplanes).
    (2) If a part number other than P/N D48127-009 for Model F28
Mark 0100 airplanes and P/N A42509-089 for Model F28 Mark 1000,
2000, 3000, and 4000 airplanes is installed, within 24 months after
the effective date of this AD, replace the cam with a cam having a
correct part number, and do an inspection to verify that the cam
operates correctly, in accordance with Part 2 of the Accomplishment
Instructions of Fokker Service Bulletin SBF28-28-052, dated April
20, 2010 (for Model F28 Mark 1000, 2000, 3000, and 4000 airplanes);
or SBF100-28-063, dated April 15, 2010 (for Model F28 Mark 0100
airplanes).
    (3) If, during any inspection required by paragraphs (g)(1) and
(g)(2) of this AD, the cam does not operate correctly, before
further flight, adjust the cam until it operates correctly, in
accordance with Part 2 of the Accomplishment Instructions of Fokker
Service Bulletin SBF28-28-052, dated April 20, 2010 (for Model F28
Mark 1000, 2000, 3000, and 4000 airplanes); or SBF100-28-063, dated
April 15, 2010 (for Model F28 Mark 0100 airplanes).

Repetitive Inspections

    (h) Within 1,200 flight hours after verifying that the cam
operates correctly, as required by paragraphs (g)(1) and (g)(2) of
this AD, as applicable: Do an inspection to verify that the cam
operates correctly and, before further flight, do all applicable
corrective actions, in accordance with Part 2 of the Accomplishment
Instructions of Fokker Service Bulletin SBF28-28-052, dated April
20, 2010 (for Model F28 Mark 1000, 2000, 3000, and 4000 airplanes);
or SBF100-28-063, dated April 15, 2010 (for Model F28 Mark 0100
airplanes). Thereafter, repeat the inspection of the cam at
intervals not to exceed 1,200 flight hours.

Parts Installation

    (i) As of the effective date of this AD, no person may install
an FCP access door, cam, or fueling panel on any airplane, unless
the requirements of this AD have been accomplished on the cam.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: Although paragraph (6) of the MCAI provides an option to
incorporate the repetitive functional inspection into the
maintenance program and then use the maintenance program as a method
of complying with the repetitive inspection requirement, this AD
does not include that provision.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.,
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

Related Information

    (k) Refer to MCAI EASA Airworthiness Directive 2010-0139, dated
July 1, 2010; Fokker Service Bulletin SBF28-28-052, dated April 20,
2010; and Fokker Service Bulletin SBF100-28-063, dated April 15,
2010; for related information.

    Issued in Renton, Washington, on November 10, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-29228 Filed 11-18-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]
[Page 46020]
[DOCID:fr07au08-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-M-0208]

Medical Devices Regulated by the Center for Biologics Evaluation
and Research; Availability of Summaries of Safety and Effectiveness
Data for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved by the
Center for Biologics Evaluation and Research (CBER). This list is
intended to inform the public of the availability through the Internet
and FDA's Division of Dockets Management of summaries of safety and
effectiveness data of approved PMAs.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please include the appropriate docket number as listed in
table 1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness data.

FOR FURTHER INFORMATION CONTACT: Tiffany Brown, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register, providing instead to post this information on the
Internet at http://www.fda.gov. In addition, the regulations provide
that FDA publish a quarterly list of available safety and effectiveness
summaries of PMA approvals and denials that were announced during the
quarter. FDA believes that this procedure expedites public notification
of these actions because announcements can be placed on the Internet
more quickly than they can be published in the Federal Register, and
FDA believes that the Internet is accessible to more people than the
Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting administrative reconsideration of an FDA action
under Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval
of a PMA begins on the day the notice is placed on the Internet.
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a
PMA may be sought only by the applicant; in these cases, the 30-day
period will begin when the applicant is notified by FDA in writing of
its decision.
    The following is a list of PMAs approved by CBER for which
summaries of safety and effectiveness data were placed on the Internet
from April 1, 2008, through June 30, 2008. There were no denial actions
during this period. The list provides the manufacturer's name, the
product's generic name or the trade name, and the approval date.

Table 1. List of Summaries of Safety and Effectiveness Data for Approved
        PMAs Made Available April 1, 2008, through June 30, 2008
------------------------------------------------------------------------
  PMA No./Docket
       No.           Applicant      Trade Name         Approval Date
------------------------------------------------------------------------
BP050051/0/FDA-    Ortho-        VITROS                  March 27, 2008
 2008-M-0208        Clinical      Immunodiagnosti
                    Diagnostics   cs Products
                    , Inc.        Anti-HIV 1+2
                                  Calibrator, and
                                  VITROS
                                  Immunodiagnosti
                                  cs Products
                                  Anti-HIV 1+2
                                  Reagent Pack
------------------------------------------------------------------------

II.Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cber/products.htm.

    Dated: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18125 Filed 8-6-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Rules and Regulations]
[Page 43172-43176]
[DOCID:fr03au07-12]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2006-0362-200702; FRL-8449-5]

 Approval and Promulgation of Implementation Plans and
Designation of Areas for Air Quality Planning Purposes; Kentucky:
Redesignation of Boyd County, Kentucky Portion of the Huntington-
Ashland 8-Hour Ozone Nonattainment Area to Attainment for Ozone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking final action to approve a request, submitted on
September 29, 2006, from the Commonwealth of Kentucky (Kentucky),
through the Kentucky Division for Air Quality (KDAQ), to redesignate
the Kentucky portion of the bi-state Huntington-Ashland 8-hour ozone
nonattainment area to attainment for the 8-hour ozone National Ambient
Air Quality Standard (NAAQS). The Kentucky portion of the bi-state
Huntington-Ashland 8-hour ozone nonattainment area (hereafter referred
to as ``Boyd County'') is comprised of one county in Kentucky (Boyd
County) and two counties in West Virginia (Cabell and Wayne Counties).
EPA's approval of Kentucky's redesignation request is based upon the
determination that Kentucky has demonstrated that Boyd County has met
the criteria for redesignation to attainment specified in the Clean Air
Act (CAA), including the determination that the entire (including both
the Kentucky and West Virginia counties) bi-state Huntington-Ashland 8-
hour ozone nonattainment area has attained the 8-hour ozone standard.
Additionally, EPA is approving a revision to the Kentucky State
Implementation Plan (SIP) including the 8-hour ozone maintenance plan
for Boyd County that contains the new 2018 motor vehicle emission
budgets (MVEBs) for nitrogen oxides (NOX) and volatile
organic compounds (VOCs). Through this action, EPA is also finding the
2018 MVEBs adequate for the purposes of transportation conformity. On
May 17, 2006, the State of West Virginia submitted a redesignation
request and maintenance plan through a separate action. The final
rulemaking approving the West Virginia submittal was published in the
Federal Register on September 15, 2006. MVEBs for Cabell and Wayne
Counties in West Virginia were approved through EPA's September 15,
2006, action.

DATES: Effective Date: This rule will be effective September 4, 2007.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2006-0362. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed in the

index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or in hard

copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. EPA

requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Heidi LeSane, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. Ms. LeSane can be reached via
telephone number at<PHONE_NUMBER> or electronic mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is the Background for the Actions?
II. What Actions are EPA Taking?
III. Why Are We Taking These Actions?
IV. What Are the Effects of These Actions?
V. Final Action
VI. Statutory and Executive Order Reviews

I. What is the Background for the Actions?

    On September 29, 2006, Kentucky, through the KDAQ, submitted a
request to redesignate Boyd County to attainment for the 8-hour ozone
standard, and for EPA approval of the Kentucky SIP revision containing
a maintenance plan for Boyd County. In an action published on May 11,
2007 (72 FR 26759), EPA proposed to approve the redesignation of Boyd
County to attainment. EPA also proposed approval of Kentucky's plan for
maintaining the 8-hour NAAQS as a SIP revision, and proposed to approve
the 2018 state \1\ MVEBs for Boyd County that were contained in the
maintenance plan. EPA received no comments on the May 11, 2007,
proposal. Today's rule is EPA's final action following the May 11,
2007, proposed rule.
---------------------------------------------------------------------------

    \1\ The term ``state'' with regard to MVEBs refers to the
portion of the area, in a multi-state area, for which the MVEBs
apply. In this case, the term ``state'' indicates that the MVEBs
cover Boyd County, and also indicates to transportation conformity
implementers in this area that there are separate MVEBs for the West
Virginia portion of this area. EPA's Companion Guidance for the July
1, 2004, Final Transportation Conformity Rule: Conformity
Implementation in Multi-Jurisdictional Nonattainment and Maintenance
Areas for Existing and New Air Quality Standards explains more about
the possible geographical extent of an MVEB, how these geographical
areas are defined, and how transportation conformity is implemented
in these different geographical areas. For the purposes of today's
final action, the term ``state MVEBs'' refers to the Boyd County
MVEBs being approved as part of the Boyd County maintenance plan.
---------------------------------------------------------------------------

    Today, EPA is also providing information on the status of the
Agency's transportation conformity adequacy determination for the new
state MVEBs for the year 2018 that are contained in the maintenance
plan for Boyd County. The maintenance plan establishes the following
state MVEBs for Boyd County.

                         Boyd County 2018 MVEBs
                             [Tons per day]
------------------------------------------------------------------------
                                                               2018
------------------------------------------------------------------------
VOCs....................................................            1.18
NOX.....................................................            1.30
------------------------------------------------------------------------

    EPA's adequacy public comment period on these budgets (as contained
in Kentucky's submittal) began on June 21, 2006, and closed on July 23,
2006. No comments were received during EPA's adequacy public comment
period. Through this Federal Register notice, EPA is finding the 2018
state MVEBs, as contained in Kentucky's submittal, adequate. These
MVEBs meet the adequacy criteria contained in the Transportation
Conformity Rule. The new state MVEBs must be used for future
transportation conformity determinations.
    Various aspects of EPA's Phase 1 8-hour ozone implementation rule
were challenged in court and on December 22, 2006, the U.S. Court of
Appeals for the District of Columbia Circuit (DC Circuit Court) vacated
EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard (69 FR
23951, April 30, 2004). South Coast Air Quality Management Dist. v.
EPA, 472 F.3d 882 (DC Cir. 2006). On June 8, 2007, in response to
several petitions for rehearing, the DC Circuit Court clarified that
the Phase 1 Rule was vacated only with regard to those parts of the
Rule that had been successfully challenged. Therefore, the Phase 1 Rule
provisions related to classifications for areas currently classified
under subpart 2 of title I, part D of the CAA as 8-hour nonattainment
areas, the 8-hour attainment dates and the timing for emissions
reductions needed for attainment of the 8-hour ozone NAAQS, remain
effective. The June 8th decision left intact the Court's rejection of
EPA's reasons for implementing the 8-hour standard in certain
nonattainment areas under subpart 1 in lieu of subpart 2. By limiting
the vacatur, the Court let stand EPA's revocation of the 1-hour
standard and those anti-backsliding provisions of the Phase 1 Rule that
had not been successfully challenged. The June 8th decision affirmed
the December 22, 2006, decision that EPA had improperly failed to
retain measures required for 1-hour nonattainment areas under the anti-
backsliding provisions of the regulations: (1) Nonattainment area New
Source Review (NSR) requirements based on an area's 1-hour
nonattainment classification; (2) Section 185 penalty fees for 1-hour
severe or extreme nonattainment areas; and (3) measures to be
implemented pursuant to section 172(c)(9) or 182(c)(9) of the CAA, on
the contingency of an area not making reasonable further progress
toward attainment of the 1-hour NAAQS, or for failure to attain that
NAAQS. The June 8th decision clarified that the Court's reference to
conformity requirements for anti-backsliding purposes was limited to
requiring the continued use of 1-hour MVEBs until 8-hour budgets were
available for 8-hour conformity determinations, which is already
required under EPA's conformity regulations. The Court thus clarified
that 1-hour conformity determinations are not required for anti-
backsliding purposes.
    For the reasons set forth in the proposal action for Boyd County,
EPA does not believe that the Court's rulings alter any requirements
relevant to this redesignation action so as to preclude redesignation,
and do not prevent EPA from finalizing this redesignation. EPA believes
that the Court's December 22, 2006, and June 8, 2007, decisions impose
no impediment to moving forward with redesignation of Boyd County to
attainment. Even in light of the Court's decisions, redesignation is
appropriate under the relevant redesignation provisions of the CAA and
longstanding policies regarding redesignation requests.
    With respect to the requirement for transportation conformity under
the 1-hour standard, the Court in its June 8th decision clarified that
for those areas with 1-hour MVEBs in their 1-hour maintenance plans (in
this instance, Boyd County), anti-backsliding requires only that those
1-hour budgets must be used for 8-hour conformity determinations until
replaced by 8-hour budgets. To meet this requirement, conformity
determinations in such areas must continue to comply with the
applicable requirements of EPA's conformity regulations at 40 CFR part
93.

II. What Actions are EPA Taking?

    EPA is taking final action to approve Kentucky's redesignation
request and to change the legal designation of Boyd County from
nonattainment to attainment for the 8-hour ozone NAAQS. The entire bi-
state Huntington-Ashland 8-hour ozone nonattainment area is comprised
of one county in Kentucky (Boyd County) and two West Virginia Counties
(Cabell and Wayne Counties). This final action addresses

only Boyd County. EPA has already taken action on the redesignation
request and maintenance plan for the West Virginia portion of this area
in a separate action. EPA is also approving Kentucky's 8-hour ozone
maintenance plan for Boyd County (such approval being one of the CAA
criteria for redesignation to attainment status). The maintenance plan
is designed to help keep Boyd County in attainment for the 8-hour ozone
NAAQS through 2018. These approval actions are based on EPA's
determination that Kentucky has demonstrated that Boyd County has met
the criteria for redesignation to attainment specified in the CAA,
including a demonstration that the entire bi-state Huntington-Ashland
Area has attained the 8-hour ozone standard. EPA's analyses of
Kentucky's 8-hour ozone redesignation request and maintenance plan are
described in detail in the proposed rule published May 11, 2007 (72 FR
26759).
    Consistent with the CAA, the maintenance plan that EPA is approving
today also includes 2018 state MVEBs for NOX and VOCs for
Boyd County. In this action, EPA is approving these 2018 MVEBs. For
regional emission analysis years that involve years prior to 2018, the
applicable budgets, for the purpose of conducting transportation
conformity analyses, are the 1-hour ozone maintenance plan state MVEBs.
For regional emission analysis years that involve the year 2018 and
beyond, the applicable budgets, for the purpose of conducting
transportation conformity analyses, are the new 2018 MVEBs. EPA is
finding adequate and approving the Boyd County MVEBs for NOX
and VOCs in this action. MVEBs for Cabell and Wayne Counties in West
Virginia were found adequate and approved through a separate action.

III. Why Are We Taking These Actions?

    EPA has determined that the entire bi-state Huntington-Ashland Area
has attained the 8-hour ozone standard and has also determined that
Kentucky has demonstrated that all other criteria for the redesignation
of Boyd County from nonattainment to attainment of the 8-hour ozone
NAAQS have been met. See, section 107(d)(3)(E) of the CAA. EPA is also
taking final action to approve the maintenance plan for Boyd County as
meeting the requirements of sections 175A and 107(d) of the CAA.
Furthermore, EPA is finding adequate and approving the new 2018 state
MVEBs contained in Kentucky's maintenance plan because these MVEBs are
consistent with maintenance for the entire bi-state Huntington-Ashland
Area. In the May 11, 2007, proposal to redesignate Boyd County, EPA
described the applicable criteria for redesignation to attainment and
its analysis of how those criteria have been met. The rationale for
EPA's findings and actions is set forth in the proposed rulemaking and
summarized in this rulemaking.

IV. What Are the Effects of These Actions?

    Approval of the redesignation request changes the official
designation of Boyd County, Kentucky for the 8-hour ozone NAAQS, found
at 40 CFR Part 81. The approval also incorporates into the Kentucky SIP
a plan for maintaining the 8-hour ozone NAAQS in Boyd County through
2018. The maintenance plan includes contingency measures to remedy
future violations of the 8-hour ozone NAAQS, and establishes state
MVEBs for the year 2018 for Boyd County. In a separate action, EPA has
already approved 8-hour ozone MVEBs for the West Virginia portions
(Cabell and Wayne Counties) of this area.

V. Final Action

    After evaluating Kentucky's redesignation request, EPA is taking
final action to approve the redesignation and change the legal
designation of Boyd County, Kentucky from nonattainment to attainment
for the 8-hour ozone NAAQS. Through this action, EPA is also approving
into the Kentucky SIP the 8-hour ozone maintenance plan for Boyd
County, which includes the new state 2018 MVEBs of 1.18 tpd for VOCs,
and 1.30 tpd for NOX. Within 24 months from the publication
date for this final rule, the Kentucky transportation partners will
need to demonstrate conformity to these new MVEBs pursuant to 40 CFR
93.104(e) as effectively amended by section 172(c)(2)(E) of the CAA as
added by the Safe, Accountable, Flexible, Efficient Transportation
Equity Act--A Legacy for Users (SAFETEA-LU), which was signed into law
on August 10, 2005. EPA has taken action on the West Virginia SIP
through a separate rulemaking, and the transportation partners are
currently using the West Virginia 8-hour ozone MVEBs.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely affects the status of a
geographical area, does not impose any new requirements on sources or
allow a state to avoid adopting or implementing other requirements, and
does not alter the relationship or the distribution of power and
responsibilities established in the CAA. This rule also is not subject
to Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because
it is not economically significant and because the Agency does not have
reason to believe that the rule concerns an environmental health risk
or safety risk that may disproportionately affect children.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the
Commonwealth to use voluntary consensus standards (VCS), EPA has no
authority to disapprove a SIP submission for failure to use VCS. It
would thus be inconsistent with applicable law for EPA, when it reviews

a SIP submission, to use VCS in place of a SIP submission that
otherwise satisfies the provisions of the CAA. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 2, 2007. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2) of the CAA.)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: July 25, 2007.
J.I. Palmer, Jr.,
Regional Administrator, Region 4.
    40 CFR part 52 and 81 are amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart S--Kentucky

0
2. Section 52.920 is amended by adding a new entry at the end of the
table for ``Huntington-Ashland 8-hour Ozone Maintenance Plan'' to read
as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable         State submittal
    Name of nonregulatory SIP          geographic or       date/effective     EPA approval date     Explanation
            provision               nonattainment area          date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Huntington-Ashland 8-hour Ozone    Boyd County.........            09/29/06  08/03/07 [Insert
 Maintenance Plan.                                                            first page of
                                                                              publication].
----------------------------------------------------------------------------------------------------------------

PART 81--[AMENDED]

0
3. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
4. In Sec.  81.318, the table entitled ``Kentucky-Ozone (8-Hour
Standard)'' is amended by revising the entry for ``Huntington-Ashland,
WV-KY:'', ``Boyd County'' to read as follows:

Sec.  81.318  Kentucky.

* * * * *

                                        Kentucky-Ozone (8-Hour Standard)
----------------------------------------------------------------------------------------------------------------
                                                   Designation \a\                    Category/classification
          Designated area           ----------------------------------------------------------------------------
                                        Date \1\                 Type                Date \1\          Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Huntington-Ashland, WV-KY:
    Boyd County....................        09/04/07  Attainment.................

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
[FR Doc. E7-14982 Filed 8-2-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33266-33267]
[FR Doc No: 2021-13375]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-14-000]

Commission Information Collection Activities (FERC-516g); Comment
Request; Revision and Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-516G (Electric Rates Schedules and Tariff
Filings), as it would be revised in this information collection
request. The Commission will submit this request to the Office of
Management and Budget (OMB) for review.

DATES: Comments on the collection of information are due July 26, 2021.

ADDRESSES: Send written comments on FERC-516G to OMB through
www.reginfo.gov/public/do/PRAMain, Attention: Federal Energy Regulatory
Commission Desk Officer. Please identify the OMB control number (1902-
0295) in the subject line. Your comments should be sent within 30 days
of publication of this notice in the Federal Register.
    Please submit copies of your comments (identified by Docket No.
IC21-14-000) to the Commission as noted below. Electronic filing
through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery.
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: OMB submissions must be formatted and filed in
accordance with submission guidelines at www.reginfo.gov/public/do/PRAMain; Using the search function under the ``Currently Under Review
field,'' select Federal Energy Regulatory Commission; click ``submit''
and select ``comment'' to the right of the subject collection.
    FERC submissions must be formatted and filed in accordance with
submission guidelines at: http://www.ferc.gov. For user assistance,
contact FERC Online Support by email at<EMAIL_ADDRESS>or
by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Electric Rates Schedules and Tariff Filings.
    OMB Control No.: 1902-0295.
    Type of Request: Three-year revision and renewal of FERC-516G.
    Type of Respondents: Independent System Operators (ISOs) and
Regional Transmission Organizations (RTOs).
    Abstract: In accordance with 18 CFR 35.28(g)(10), each RTO and ISO
must post information regarding uplift on a publicly accessible portion
of its website. In this context, ``uplift'' refers to payments that a
regional grid operator makes to a resource whose commitment and
dispatch result in a shortfall between the costs in the resource's
offer and the revenue earned through market clearing prices. At
minimum, the information must include:
     Uplift, paid in dollars, and categorized by transmission
zone, day, and uplift category, to be posted within 20 calendar days of
the end of each month;
     The resource name and the total amount of uplift paid in
dollars

aggregated across the month to each resource that received uplift
payments within the calendar month, to be posted within 90 calendar
days of the end of each month; and
     Each operator-initiated commitment, listing the size of
the commitment, transmission zone, commitment reason,\1\ and commitment
start time, to be posted within 30 calendar days of the end of each
month.
---------------------------------------------------------------------------

    \1\ Commitment reasons may include, but are not limited to,
system-wide capacity, constraint management, and voltage support.
---------------------------------------------------------------------------

    As originally cleared by OMB, FERC-516G also included a one-time
requirement that ITOs and RTOs revise their tariffs in accordance with
18 CFR 35.28(g)(10)(iii). The relevant tariffs have been revised, and
FERC is now requesting removal of that information collection activity.
    Estimate of Annual Burden: The estimated burden and cost \2\ for
the requirements contained in 18 CFR 35.28(g)(10) are as follows:
---------------------------------------------------------------------------

    \2\ The hourly cost estimate is based on data from the Bureau of
Labor Statistics for three occupational categories for 2020 involved
in the reporting and recordkeeping requirements. These figures
include salary (https://www.bls.gov/oes/current/oes_nat.htm) and
benefits and are:
     Manager (Occupation Code 11-0000): $97.15/hour.
     Electrical Engineer (Occupation Code 17-2071): $70.19/
hour.
     File Clerk (Occupation Code 43-4071): 34.70/hour.
    The estimated hourly cost for the reporting requirement ($67.38)
is an average of the costs listed above.

                                               FERC-516G Annual Burden Estimates in Docket No. IC21-14-000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Total number                                                         Cost per
                                          Number of     Annual number   of responses    Average burden hours &     Total annual burden      respondent
           Type of response              respondents    of responses     (Column B x       cost per response      hours & cost (Column D    (Column F /
                                                       per respondent     Column C)                                    x Column E)           Column B)
A.                                                 B.              C.              D.  E.......................  F......................              G.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing and Posting of 3 reports on               6              12              72  3 hrs.; $202.14.........  216 hrs.; $14,554.08...       $2,425.68
 company website each month.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments are invited on: (1) Whether the collection of information
is necessary for the proper performance of the functions of the
Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: June 15, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-13375 Filed 6-23-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 21, 2010 (Volume 75, Number 13)]
[Rules and Regulations]
[Page 3372-3375]
[DOCID:fr21ja10-5]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-1072]
RIN 1625-AA00

Safety Zone: Congress Street Bridge, Pequonnock River,
Bridgeport, CT

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
waters surrounding the Congress Street Bridge over the Pequonnock River
in Bridgeport, Connecticut. This zone is necessary to protect vessels
transiting in the area from hazards imposed by construction barges and
equipment that are being utilized for partial demolition of the
Congress Street Bridge. Entry into this zone is prohibited unless
authorized by the Captain of the Port Long Island Sound, New Haven,
Connecticut.

DATES: This rule is effective from 11:59 p.m. on January 31, 2010,
through 11:59 p.m. on April 16, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-1072 and are available online
by going

to http://www.regulations.gov, inserting USCG-2009-1072 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail, Chief Petty Officer Christie Dixon,
Prevention Department, USCG Sector Long Island Sound at<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final 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 because immediate action is necessary to
protect the public from the dangers inherent in the bridge demolition
project. Also, establishing a safety zone on the Pequonnock River at
this time of year should not hinder any appreciable recreational
traffic and commercial traffic does not transit the portion of the
river that will be impacted by the closure. The need for immediate
action to protect the public makes a comment period impractical as a
delay in the bridge demolition is contrary to public interest.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. In addition to the reasons stated
above, any delay encountered in the temporary rule's effective date
would be contrary to the public interest given the immediate need to
minimize danger to mariners prior to, during, and after demolition.

Background and Purpose

    The Congress Street Bridge, owned by the City of Bridgeport, was
closed in January 1999 due to deterioration of the structural and
mechanical/electrical components. It is approximately 419 feet from
abutment face to abutment face and consists of a center movable span
and two fixed spans on each approach. The center movable span is a
double leaf rolling bascule span. The bascule span was opened to allow
marine traffic to pass and the leaves locked into the open position.
    From January 1, 2010 through May 15, 2010 the City of Bridgeport's
Engineering Department will be removing both bascule spans and the
associated operating machinery of the Bridge. The existing fender
system will remain in place and power will be re-routed on the bridge
to allow the existing navigation lights to continue to function during
and after construction. Mariners are advised to transit the area with
extreme caution during this time.
    The Coast Guard is establishing a safety zone in all waters of the
Pequonnock River within 100-yards to either side of the Congress Street
Bridge from February 1, 2010 through April 16, 2010 during the removal
of the bascule spans. This portion of the Pequonnock River will be
closed to all marine traffic due to construction hazards posed to
recreational vessels attempting to transit the waterway. This safety
zone is necessary to protect the safety of the boating community who
wish to utilize the Pequonnock River during demolition. With the
exception of the Bridgeport Fire Rescue Boats, entry into this zone is
prohibited unless authorized by the Captain of the Port, Long Island
Sound.

Discussion of Rule

    This regulation establishes a temporary safety zone on the waters
of the Pequonnock River, at mile 0.4 within 100-yards to either side of
the Congress Street Bridge. This action is intended to prohibit vessel
traffic in a portion of the Pequonnock River in the City of Bridgeport,
Connecticut to provide for the safety of the boating community due to
the hazards posed by significant construction equipment and barges
located in the waterway for the partial demolition of the bridge. The
safety zone is being established from 11:59 p.m. on January 31, 2010,
to 11:59 p.m. on April 16, 2010. Marine traffic may continue to transit
the area during the January 1 to January 31 and April 17 to May 15
portions of the project. While the channel is open and the safety zone
is not in place, mariners are still advised to transit the area with
extreme caution. In the event of an emergency, a ten (10) foot wide
passage will be maintained for the duration of the project exclusively
for the passage of Bridgeport Fire Rescue boats. With the exception of
these Fire Rescue boats, entry into this zone is prohibited unless
authorized by the Captain of the Port, Long Island Sound.
    Any violation of the safety zone described herein is punishable by,
among other things, civil and criminal penalties, in rem liability
against the offending vessel, and the initiation of suspension or
revocation proceedings against Coast Guard-issued merchant mariner
credentials.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. We expect the economic impact of this
proposed rule to be so minimal that a full Regulatory Evaluation is
unnecessary.
    This regulation may have some impact on the public, but the
potential impact will be minimal for the following reasons: We do not
anticipate that there will be any appreciable recreational traffic
during the time the project will be taking place and commercial traffic
does not transit the portion of the Pequonnock River that will be
impacted by the closure. Vessels may transit in all areas of the
Pequonnock River other than the area delineated for the safety zone.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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. This rule may affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit or anchor in those portions of the Pequonnock River in the city
of Bridgeport, Connecticut covered by the safety zone. For the reasons
outlined in the Regulatory Evaluation section above, this rule will not
have a significant impact on a substantial number of small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. 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, Chief Petty Officer Christie
Dixon, Prevention Department, USCG Sector Long Island Sound at 203-468-
4459<EMAIL_ADDRESS>The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 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.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this temporary final 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 (NEPA) (42 U.S.C. 4321-
4370f), and have concluded this action is one of a category of actions
which do not individually or cumulatively have a significant effect on
the human environment. This rule involves creation of a regulation that
establishes a safety zone and therefore is categorically excluded,
under figure 2-1, paragraph (34)(g), of the Instruction. An
environmental analysis checklist and a categorical exclusion
determination will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
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: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;

Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T01-1072 to read as follows:

Sec.  165.T01-1072  Safety Zone: Congress Street Bridge, Pequonnock
River, Bridgeport, Connecticut.

    (a) Location. The following area is a safety zone: All navigable
waters of the Pequonnock River in Bridgeport, Connecticut, from surface
to bottom, within 100 yards to either side of the Congress Street
Bridge.
    (b) Definitions. The following definitions apply to this section:
Designated on-scene patrol personnel, means any commissioned, warrant,
and petty officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port,
Long Island Sound.
    (c) Regulations. (1) The general regulations contained in 33 CFR
165.23 apply.
    (2) In accordance with the general regulations in Sec.  165.23 of
this part, entry into or movement within this zone is prohibited unless
authorized by the Captain of the Port (COTP), Long Island Sound.
    (3) All persons and vessels must comply with the Coast Guard
Captain of the Port or designated on-scene patrol personnel.
    (4) Upon being hailed by siren, radio, flashing light or other
means from a U.S. Coast Guard vessel or other vessel with on-scene
patrol personnel aboard, the operator of the vessel shall proceed as
directed.
    (5) Persons and vessels may request permission to enter the zone on
VHF-16 or via phone at<PHONE_NUMBER>.
    (d) Effective dates. The safety zone is being established from
11:59 p.m. on January 31, 2010, to 11:59 p.m. on April 16, 2010. Marine
traffic may continue to transit the area during the January 1 to
January 31 and April 17 to May 15 portions of the project. While the
channel is open and the safety zone is not in place, mariners are still
advised to transit the area with extreme caution.

    Dated: December 29, 2009.
D.A. Ronan,
Captain, U.S. Coast Guard, Captain of the Port Long Island Sound.
[FR Doc. 2010-1003 Filed 1-20-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16384-16385]
[FR Doc No: 2017-06609]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-1318-000]

Redbed Plains Wind Farm LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Redbed Plains Wind Farm LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888

First Street NE., Washington, DC 20426, in accordance with Rules 211
and 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.211 and 385.214). Anyone filing a motion to intervene or protest
must serve a copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 18, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 29, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06609 Filed 4-3-17; 8:45 am]
 BILLING CODE 6717-01-P


1 SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION ( a) TITLE OF THE INFORMATION COLLECTION Contractor Cumulative Claim and Reconciliation, EPA Form 1900 10. Information Collection Request ( ICR) 0246.08, OMB Control No. 2030 0016. The current ICR expires February 28, 2003.

( b) SHORT CHARACTERIZATION The Federal Acquisition Regulation ( FAR) 4.804 5 states that the office administering a contract is responsible for initiating administrative close out following physical completion of the contract. Funds status review is a mandatory part of contract closeout. It includes settlement of interim or disallowed costs and settlement of indirect cost rates.

Under a cost reimbursement type contract, when the contract is completed, the contractor submits EPA Form 1900 10 which summarizes all cost incurred in performance of the contract and sets forth the final indirect rates. This form is reviewed by the contracting office to determine the final costs reimbursable to the contractor. A copy of the form is attached to this request.

2. NEED FOR AND USE OF THE COLLECTION ( a) NEED/ AUTHORITY FOR THE COLLECTION FAR 52.216 7 states that the Government will pay only the costs determined to be allowable by the contracting officer in accordance with FAR 31.2. Furthermore, FAR 52.216 7 states that indirect cost rates shall be established for each fiscal year at the close of a contractor's fiscal year. EPA Form 1900 10 summarizes this information for the entire contract period and provides a basis for cost review by contracting, finance, and audit personnel. As stated previously, FAR 4.804 5 mandates that the office administering the contract shall ensure that the costs and indirect cost rates are settled.

( b) USES/ USERS OF THE DATA Information collected on the 1900 10 will be used by the contracting, financial, and audit personnel to determine the final amount of costs reimbursable to the contractor. EPA personnel and auditors from the Defense Contract Audit Agency ( DCAA), if requested, will review the information in order to determine the final contract costs prior to final payment under the contract. 2 3. THE RESPONDENTS AND THE INFORMATION REQUESTED ( a) RESPONDENTS/ NORTH AMERICAN INDUSTRY CLASSIFICATION ( NAICS) CODES All contractors who have completed an EPA cost reimbursement type contract will be required to submit EPA Form 1900 10. These contractors represent a wide range of industries which include, but are not limited to: 541511, custom computer programming, 5416 Management and Consulting Services, 6215 Medical Laboratories, and 541380, Testing Laboratories.

( b) INFORMATION REQUESTED ( i) DATA ITEMS Data requested has not changed since the last OMB review. This information includes major cost elements such as direct labor, direct material and supplies, equipment, travel, subcontract costs, consultant fees, indirect costs and fixed fees. Indirect costs are broken down showing base year and rate for each cost center for each year of contract performance.

( ii) RESPONDENT ACTIVITIES In order to complete the EPA Form 1900 10, respondents must total all cost incurred under the contract, including costs for direct labor, all equipment, materials and supplies, travel, subcontracts, consulting fees, indirect costs, and fees. During contract performance, this information is included on the contractor's monthly invoice for reimbursement. To calculate total contract costs, the contractor adds the cost from each invoice submitted under the contract. If costs were claimed on an invoice that were disallowed, the contractor would subtract the disallowed amount from the total.

Negotiated indirect cost rates are applied to the base costs in order to determine the indirect costs for each cost center. This information is also contained in the contractor's invoices, and in correspondence concerning allowable costs and negotiated agreements on indirect rates. None of the information collected under this ICR must be created or researched. Rather, the data is complied from various existing sources and summarized for this information collection. After the data is compiled, it must be reviewed for accuracy against existing records. It is customary business practice for a contractor to maintain the type of financial performance information required to complete EPA Form 1900 10.

4. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT ( a) AGENCY ACTIVITIES 3 Once EPA Form 1900 10 is reviewed by the Agency, the data is reconciled with Agency records, and audited. If the information collected is correct, final contract payment is made.

( b) COLLECTION METHODOLOGY AND MANAGEMENT Information submitted is checked against Agency records such as invoices, correspondence, and negotiated agreements. Respondents have the option of reporting in their own computerized format provided all the required data is present. Completed forms, after review, become part of the contract files and will not be disclosed outside the Government.

( c) SMALL ENTITY FLEXIBILITY Data requested is required by the Federal Acquisition Regulation. It is not possible to develop separate or simplified requirements for small businesses or other small entities because the information required is necessary to complete the closing out of a contract, an alternate collection of information for small businesses is not appropriate.

( d) COLLECTION SCHEDULE Data is collected once at contract completion. Generally, this is after a five year period of performance.

5. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA ( a) NONDUPLICATION Information collected is contract specific. Cumulative contract cost information, as requested, is not available from any other source.

( b) Consultations The following vendors were contacted to discuss collection activities:

FIRM PERSON CONTACTED PHONE Bayaud Industries Ms. Lanelle Munger ( 817) 649 5419 MCA Research Corporation Ms. Terri Williams ( 301) 896 0500 ext. 113 Techlaw Ms. Patricia Brown ( 703) 818 3210 All of these firms have recently completed a contract with EPA. Each firm indicated the financial information requested is kept routinely for company records and for audit purposes. None of the firms contacted felt the information collection was burdensome and each recognized the 4 contract.

( c) EFFECTS OF LESS FREQUENT COLLECTION The information is collected only once at contract closeout. This information is required by the Federal Acquisition Regulation to be collected at that time.

( d) GENERAL GUIDELINES This information collection meets all OMB guidelines with the exception of two: ( 1) small entities have to follow the same collection procedures as other respondents and ( 2) confidential business information ( CBI) is requested. Item one is addressed in paragraph 4( c). CBI is protected from release to the public by 40 CFR Part 2.

( e) Information collected under this request, particularly cost and pricing data, is treated as Confidential Business Information ( CBI). This information is protected from public release in accordance with the Agency's confidentially regulation, 40 C. F. R. Part 2.201 et seq.

( f) Public Notice Required Prior to ICR Submission to OMB: The Federal Register document required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on July 26, 2002, 64 FR 43177. No comments were received.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION ( a) ESTIMATING RESPONDENT BURDEN ( i) Labor Costs The annual cost to respondents is estimated at $ 4,349.67 based on the following calculations. Contractors may claim the cost of completing this form under the appropriate contract.

ACTIVITY TIME TO COMPLETE RATE COST 1. Gather information 15 minutes $ 35.21 $ 8.80 2. Compile data 10 minutes $ 35.21 $ 5.87 3. Review data 10 minutes $ 35.21 $ 5.87 4. Type form 5 minutes $ 16.03 $ 1.34 Total 40 minutes $ 21.88 A contractor employee, comparable in position to a Government employee at the GS 12 grade level, would be required to gather, compile, and review the data. The wage rate was calculated by taking the GS 12 median hourly rate ($ 30.35) and multiplying it by a factor of 1.16 to account for 5 benefits. A typist, equivalent to a Federal GS 05, would complete the actual form. The wage rate for a typist was calculated by taking the GS 05 median hourly rate ($ 13.82) and multiplying it by a factor of 1.16 to account for benefits. EPA processed approximately 247 contract closeouts in the previous year using EPA Form 1900 10. As indicated above, each form takes 40 minutes, or .67 hours to complete. The 247 yearly actions, multiplied by .67 hours equates to an annual hourly burden of 165 hours. The amount of time required to complete each of the tasks involved in completing the form is based on consultations with contractors and Agency experience. Most firms keep all financial data required for completion of this form in a computer database.

( ii) Capital/ Start up Costs Because it will not be necessary for respondents to acquire any capital goods to provide the requested information, EPA included no capital or start up costs in the burden estimate.

( iii) Operating and Maintenance Costs Operating and Maintenance Costs, which include such items as file storage, photocopying, and postage, are minimal for this effort, and are estimated at $ 10.00 per action for a total annual burden of $ 2,470.00.

( b) ESTIMATING AGENCY BURDEN & COST Once the Agency receives the information, it is reviewed by the employee conducting contract close out. Annual Agency burden is estimated at $ 4,349.67 calculated as follows:

ACTIVITY TIME REQUIRED RATE COST 1. Review data against 30 minutes $ 35.21 $ 17.61 Agency records Generally, the individual closing out the contract is a GS 12 grade level. The hourly rate for a GS 12 is calculated as described in paragraph ( a) above. Also, as described above, 247 cases per year were used to calculate Agency burden.

( c) REASONS FOR CHANGE IN BURDEN In the last OMB clearance, respondent burden hours were estimated at 42.9 hours per year. The current estimate is 165 hours per year for an overall increase of 122.1 hours. A comparison of the last OMB approval and the present request is shown below.

Prior Approval Present Request 6 65 contracts ( closed out) 247 contracts ( closed out) 42.9 hours per year 165 hours per year 40 minutes per response 40 minutes per response The increase in the number of information collected is due to a large quantity of contracts that were closed out during the previous year. The time required to prepare each information collection has not changed since the last clearance.

7. BURDEN STATEMENT The annual public reporting and recordkeeping burden for this collection of information is estimated to average 40 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OEI 2002 0014, which is available for public viewing at the Office of Environmental Information ( OEI) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the OEI Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OEI 2002 0014 and OMB Control Number 2030 0016 in any correspondence.