[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19657-19658]
[FR Doc No: 2015-08398]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER15-1461-000.
    Applicants: MidAmerican Energy Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
MidAmerican-Ameren Transmission Interconnection Agreement to be
effective 3/30/2015.
    Filed Date: 4/6/15.
    Accession Number: 20150406-5172.
    Comments Due: 5 p.m. ET 4/27/15.

    Docket Numbers: ER15-1462-000.
    Applicants: ISO New England Inc.
    Description: Identification of Potential New Capacity Zone
Boundaries of ISO New England, Inc.
    Filed Date: 4/6/15.
    Accession Number: 20150406-5205.
    Comments Due: 5 p.m. ET 4/27/15.

    Docket Numbers: ER15-1463-000.
    Applicants: Triton Energy, Inc.
    Description: Initial rate filing per 35.12 Triton Energy, Inc. MBR
Tariff to be effective 5/15/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5087.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1464-000.
    Applicants: PJM Interconnection, L.L.C., Rochelle Municipal
Utilities.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): PJM and
City of Rochelle submit revisions to PJM OATT and TOA re: integration
to be effective 8/1/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5105.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1465-000.
    Applicants: PJM Interconnection, L.L.C., Rochelle Municipal
Utilities.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): PJM and
City of Rochelle submit revisions to OATT and TOA re: integration to be
effective 8/1/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5112.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1466-000.
    Applicants: ISO New England Inc., New England Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): First
Revised Service Agreement Nos. TSA-NEP-83 and TSA-NEP-86 Under ISO-NE
OATT to be effective 6/7/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5130.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1467-000.

    Applicants: Emera Maine.
    Description: Compliance filing per 35: Emera Maine Filing of Blue
Sky East E and P Agreement to be effective 6/8/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5136.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1468-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2015-
04-07_Attachment E revisions to be effective 6/7/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5159.
    Comments Due: 5 p.m. ET 4/28/15.

    Docket Numbers: ER15-1469-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): White
Pine Solar LGIA Filing to be effective 3/24/2015.
    Filed Date: 4/7/15.
    Accession Number: 20150407-5209.
    Comments Due: 5 p.m. ET 4/28/15.

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

    Dated: April 7, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-08398 Filed 4-10-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Notices]
[Pages 76014-76015]
[FR Doc No: 2015-30735]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER15-1196-003.
    Applicants: Nevada Power Company, Sierra Pacific Power Company.
    Description: Supplement to July 13, 2015 Compliance Filing of
Nevada Power Company and Sierra Pacific Power Company.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5460.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER15-2641-001.
    Applicants: ISO New England Inc.
    Description: Compliance filing: Notice of Effective Date for CTS,
Compliance and Conforming Filing to be effective 12/15/2015.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5105.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-426-000.

    Applicants: Fairless Energy, LLC.
    Description: Compliance filing: Compliance Filing--Removal of
Affiliate Waiver to be effective 11/1/2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5285.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-427-000.
    Applicants: Entergy Louisiana, LLC.
    Description: Sec.  205(d) Rate Filing: EGSL-SRMPA 5th Extension of
Interim Agreement to be effective 12/1/2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5284.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-428-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Sec.  205(d) Rate Filing: Nov 30 2015 Membership
Filing to be effective 11/1/2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5273.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-429-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Designated Entity
Agreement, SA No. 4310 among PJM and Northeast to be effective 10/29/
2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5272.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-430-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Bylaws 9.7 Revisions to
Expand Regional Entity Trustees to be effective 1/29/2016.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5268.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-431-000.
    Applicants: Virginia Electric and Power Company.
    Description: Compliance filing: Compliance Filing--VEPCO Removal of
Affiliate Waiver to be effective 11/1/2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5307.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-432-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2015-11-30_RPU RTO Adder
Filing to be effective 2/1/2016.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5328.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-433-000.
    Applicants: Virginia Electric and Power Company.
    Description: Compliance filing: Compliance Filing--Removal of
Affiliate Waiver to be effective 11/1/2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5344.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-434-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 142
Dynamic Scheduling Agreement Amendment--Transfer to be effective 12/1/
2015.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5345.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-435-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Baseline eTariff Filing: Wabash Valley Power
Association--MISO Reactive Tariff to be effective 2/1/2016.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5351.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-436-000.
    Applicants: Old Dominion Electric Cooperative, Inc.
    Description: Request of Old Dominion Electric Cooperative for
Waiver of Notice Requirement.
    Filed Date: 11/30/15.
    Accession Number: 20151130-5362.
    Comments Due: 5 p.m. ET 12/21/15.

    Docket Numbers: ER16-437-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2015-12-01_SA 2874 ATC
Transmission Capacity Exchange Agreement to be effective 10/30/2015.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5112.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-438-000.
    Applicants: Marshall Wind Energy LLC.
    Description: Baseline eTariff Filing: Marshall Wind MBRA Filing to
be effective 1/30/2016.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5114.
    Comments Due: 5 p.m. ET 12/22/15.

    Docket Numbers: ER16-439-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2015-12-01_SA 2875 ATC
Operations and Maintenance Agreement to be effective 10/30/2015.
    Filed Date: 12/1/15.
    Accession Number: 20151201-5116.
    Comments Due: 5 p.m. ET 12/22/15.

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

    Dated: December 1, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30735 Filed 12-4-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 173 (Thursday, September 6, 2012)]
[Notices]
[Page 54945]
[FR Doc No: 2012-21540]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Change in Use of Aeronautical
Property at Louisville International Airport, Louisville, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comment.

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SUMMARY: The Federal Aviation Administration is requesting public
comment on request by the Louisville Regional Airport Authority to
change a portion of airport property from aeronautical to non-
aeronautical use at the Louisville International Airport, Louisville,
Kentucky. The request consists approximately of 1.27 acres of fee
simple release. This action is taken under the provisions of Section
125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st
Century (AIR 21).

DATES: Comments must be received on or before October 9, 2012.

ADDRESSES: Documents are available for review at the Louisville
Regional Airport Authority, 700 Administration Drive, Louisville, KY
40209 and the FAA Memphis Airports District Office, 2862 Business Park
Drive, Building G, Memphis, TN 38118. Written comments on the Sponsor's
request must be delivered or mailed to: Mr. Phillip J. Braden, Manager,
Memphis Airports District Office, 2862 Business Park Drive, Building G,
Memphis, TN 38118.
    In addition, a copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Charles T. Miller, Executive Director,
Louisville Regional Airport Authority, P.O. Box 9129, Louisville, KY
40209.

FOR FURTHER INFORMATION CONTACT: Mr. Tommy L. Dupree, Team Lead/Civil
Engineer, Federal Aviation Administration, Memphis Airports District
Office, 2862 Business Park Drive, Building G, Memphis, TN 38118. The
application may be reviewed in person at this same location, by
appointment.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the request to release property at the Louisville
International Airport, Louisville, KY 42103. Under the provisions of
AIR 21 (49 U.S.C. 47107(h)(2)).
    On August 23, 2012, the FAA determined that the request to release
property at Louisville International Airport meets the procedural
requirements of the Federal Aviation Administration. The FAA may
approve the request, in whole or in part, no later than October 9,
2012.
    The following is a brief overview of the request:
    The Louisville Regional Airport Authority is proposing the release
of approximately 1.27 acres, which include small portions of 28 various
parcels located west of Louisville International Airport, bordered on
the south by Woodlawn Avenue, bordered on the west by Louisville
Avenue, bordered on the north by Dakota and Horn Avenue, and bordered
on the east by Crittenden Drive. This release is for the swapping of
like value property to the Commonwealth of Kentucky and the Louisville
Metropolitan Government for the relocation of future Crittenden Drive.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT.

    Issued in Memphis, TN on August 23, 2012.
Tommy L. Dupree,
Acting Manager, Memphis Airports District Office, Southern Region.
[FR Doc. 2012-21540 Filed 9-5-12; 8:45 am]
BILLING CODE 4910-13-P


DRAFT

Supporting Statement

for

Information Collection Request

Control of Evaporative Emissions from New and In-Use

Portable Gasoline Containers (Renewal)

EPA ICR 2213.04

March, 2013

Compliance and Innovative Strategies Division

Office of Transportation and Air Quality

Office of Air and Radiation

U.S. Environmental Protection Agency

  SEQ CHAPTER \h \r 1 	PART A OF THE SUPPORTING STATEMENT

1.	Identification of the Information Collection

(a)	Title and Number of Information Collection.

	"Control of Evaporative Emissions from New and In-Use Portable Gasoline
Containers (Renewal)", ICR 2213.04, OMB 2060-0597.

(b)	Short Characterization.

	Under regulations promulgated on February 26, 2007 (72 FR 8428; 40 CFR
Part 59, Subpart F), manufacturers of new portable gasoline containers
from 0.25 to 10.0 gallons in capacity are required to obtain
certificates of conformity with the Clean Air Act. The rule applies to
containers manufactured on or after January 1, 2009 (manufacturers and
importers were given until June 30, 2009 and wholesale distributors
until December 31, 2009 to dispose of stocks manufactured before January
1, 2009). Certificates are valid from the effective date until the end
of the production period, with a maximum of five years. This ICR covers
the burdens associated with the applications for certification and the
required annual reports of successful warranty claims, based on
experience during the first three years of the program. The applications
are processed by the Compliance Division (CD), Office of Transportation
and Air Quality, EPA. In essence, an application is in support of an
emission limitation of 0.3 grams per gallon per day for the mandated
five-year useful life of the container. Applicants submit test results
conducted in accordance with the regulations, maintenance instructions
and warranty information given to the purchasers, copies of the labels,
and other information listed in section 4(b).  Applications are
submitted in no fixed format, although EPA did work with industry
informally on application questions and provided non-confidential
versions of acceptable received applications (“FOIA applications”)
as examples to other potential applicants. Applications are submitted
electronically as a part of the EPA’s Verify certification information
system.

	The current authorization is based on an estimated ten respondents for
213.2 hours and $20,439 in costs, including $10,519 in capital and O&M
costs per year, the rest labor..

The burdens in this ICR are based on experience administering the
program from January 1, 2009, through December, 2012. During that
period, EPA has issued fifteen certificates to seven companies. All
certificates were issued for five years. Annual warranty reports were
due July 1, 2010.  The portable fuel container companies have not
experienced any emission related warranty claims, so no warranty reports
have been received to date.  The main changes from the prior ICR are the
following: updating the agency burden estimate,  labor costs, and the
number of respondents and responses, including allowance for carry-over
applications.  The current request estimates eight respondents for 179.4
hours and $23,170 in costs, including $12,552 for capital and O&M costs,
including the costs of conducting tests.

2.	Need for and Use of the Collection

(a)	Need/Authority for the Collection.

	Statutory authority for the portable gasoline container controls is
found in Sections 183(e) and 111 of the Clean Air Act, 42 U.S.C.
sections 7511b(e) and 7414. The EPA is required under Section 183(e) of
the Clean Air Act (Act) to regulate Volatile Organic Compound (VOC)
emissions from the use of consumer and commercial products.  Pursuant to
Section 183(e)(3), the EPA published a list of consumer and commercial
products and a schedule for their regulation on March 23, 1995 (60 FR
15264).  Consumer products were included in Group I of the list, and
standards were promulgated on September 11, 1998.  In the
Administrator's judgment, VOC emissions from the use of consumer
products contribute to ground-level ozone formation in ozone
non-attainment areas. Portable gasoline containers are a consumer
product which has been shown to be deficient in preventing VOCs in the
form of fuel vapors from being emitted into the air.  The certification
program for portable fuel containers was promulgated in 2007 (72 FR
8533; February 26, 2007).  The regulations appear in 40 CFR Part 59,
Subpart F (40 CFR §§ 59.600 - 59.699).

The information in the application is needed to insure that the emission
standard will be met during the useful life of the container and that
the certified containers comply with the labeling, warranty, and other
requirements of the regulations. The information is sufficient to allow
the manufacture to aggregate containers of like design into one emission
family.  This saves the manufacturer the expense of testing models of
similar but not identical design.  The information is also detailed
enough to allow subsequent recertification when a certificate has
expired (“carry over”).

	The record keeping requirements are likewise in support of a
demonstration that the emissions family certified will meet the emission
standard in the regulation. The records specified are to be provided to
EPA upon request.

The annual warranty reports are needed to assure that the containers
survive normal use and provide EPA important information on the success
of its certification program, weaknesses therein, or examples or
patterns of noncompliance.  Cans showing excessive warranty claims could
be candidates for in-use testing by EPA.  Although EPA does not have the
authority to recall portable fuel containers, the warranty information
along with possible in-use testing by EPA could be used as grounds to
withhold subsequent certification or to enter into enforcement action
under the Clean Air Act.

(b)	Practical Utility/Users of the Information.

	Agency personnel will use the information collected to:

Determine if a manufacture’s portable gasoline containers meet the
emission standard when new;

Allow the agency to issue a certificate of compliance to the
manufacturer so that they can market the approved containers;

Allow the agency to issue carry-over certificates waiving the testing
process required for a new design;

Allow the agency to issue certificates to the manufacturer for
containers that are substantially similar to the tested prototype and
waive the testing process required for a new design (“carry
across”);

Provide information to the agency to indicate that the portable gasoline
containers are meeting the standard in-use; and

Provide information to the agency that a portable gasoline container
design is not meeting the standard in-use and provide a basis on which
to reject a manufactures application for that design in subsequent model
years or take other appropriate action.

3.	Non-duplication, Consultations, and Other Collection Criteria

(a)	Non-duplication.

	The information collected includes product and manufacturing
specifications, testing documentation, and successful warranty claims.
Similar information is collected by the state of California and
approximately 13 other states that have adopted the California Portable
Fuel Container regulation.  However, the California regulation is
different in several key areas that make the information unsuitable for
information collection required for Federal rule.  These are all due to
the following differences in the standards and certification
requirements in the two rules:

The test fuel and the temperature cycles used in the Federal program are
more in keeping with nationwide ambient temperatures and fuels, while
those required in the California regulation are more suitable to
California fuels and ambient conditions.

The Federal rule requires the reporting of successful warranty claims
concerning fuel containers sold as certified under the rule.  While the
California regulation does require that the manufacturer issue
warranties, it does not require them to report on the outcomes of
successful claims against them.

These differences make the California data unsuitable for the Federal
rule on fuel containers.

	Public Notice Required Prior to ICR Submission to OMB

An announcement soliciting public comment on this ICR was published in
the Federal Register on March ______, 2013 (__ FR ____). A copy of the
draft ICR was placed in the docket. No comments were received.

(c)	Consultations

	For this renewal, EPA will consult the following individual:

Organization			Name					Phone Number

Scepter USA.			Phil Monckton<PHONE_NUMBER>

	For the prior ICR, we consulted the following individuals (Blitz has
subseqently gone out of business).\:

Blitz USA			Dan Weibel<PHONE_NUMBER>

No Spill, LLC			Tom Cray<PHONE_NUMBER>

Testing Services Group	Andy Meloney<PHONE_NUMBER>

Their responses were very helpful in developing this request. On the
whole they approve of the EPA program and express frustration at the
areas of the California program that differ from EPA, particularly the
fuel specifications. Information from TSG on contract costs for testing
and application preparation were particularly helpful.

(d)	Effects of Less Frequent Collection.

	Certificates of conformity are issued for the production period of the
models covered in the emissions family, not to exceed five years. All
certificates to date have been issued for five years.  However, when a
fuel container design is a “carried over” or a new version of a
container that is substantially similar to a current container (“carry
across”), the amount of new information required is substantially
reduced.  Warranty reports are required by regulation to be submitted
annually.

(e)	General Guidelines.

	This ICR adheres to the guidelines for Federal data requesters, as
provided at 5 CFR 1320.5(d)(2), with the exception that the regulation
requires that records concerning the application for certification be
maintained for 5 years (except for routine testing data for 1 year).
The five-year requirement is consistent with the maximum production
period and the consequent five-year duration of certificates. The
retention is necessary to allow the agency to adequately monitor
compliance. Information on successful warranty claims is required for
the preceding model by July 1 of the following year.  There is no
requirement to report unsuccessful claims against container warranties.
There is no requirement by EPA for the manufactures to retain that
information beyond the extent necessary to report it annually.

(f)	Confidentiality.

Any information submitted to EPA for which a claim of confidentiality is
made will be safeguarded according to EPA regulations at 40 CFR 2.201
Part 2, as stated explicitly in the regulations (40 CFR §59.695). The
section sets fort how to make confidentiality claims and how documents
raising confidentiality issues will be handled.

	Sensitive Questions.

	This collection does not involve matters of a sensitive nature.

4.	The Respondents and the Information Requested

(a)	Respondents/SIC and NAICS Codes.

	Respondents to this information collection are manufacturers of
portable fuel containers. They fall within standard industrial
classification (SIC) 3411 and within the North American Industrial
Classification System (NAICS) code of 332431 (metal can manufacturing)
or SIC 3089, NAICS 326199 (all other plastic product manufacturing).

(b)	Information Requested.

	(i)	Data items.

	The required data items are specifically enumerated in the regulations
(40 CFR §59.623):

(a) Describe the emission family's specifications and other basic
parameters of the emission controls. List each distinguishable
configuration in the emission family. Include descriptions and part
numbers for all detachable components such as spouts and caps.

(b) Describe and explain the method of emission control.

(c) Describe the products you selected for testing and the reasons for
selecting them.

(d) Describe the test equipment and procedures that you used, including
any special or alternate test procedures you used (see §59.650).

(e) List the specifications of the test fuel to show that it falls
within the required ranges specified in §59.650.

(f) Include the maintenance and use instructions and warranty
information you will give to the ultimate purchaser of each new portable
fuel container (see §59.613).

(g) Describe your emission control information label (see §59.615).

(h) State that your product was tested as described in the application
(including the test procedures, test parameters, and test fuels) to show
you meet the requirements of this subpart.

(i) Present emission data to show your products meet the applicable
emission standards. Where applicable, §§59.626 and 59.627 may allow
you to submit an application in certain cases without new emission data.

(j) Report all test results, including those from invalid tests or from
any other tests, whether or not they were conducted according to the
test procedures of §§59.650 through 59.653. We may ask you to send
other information to confirm that your tests were valid under the
requirements of this subpart.

(k) Unconditionally certify that all the products in the emission family
comply with the requirements of this subpart, other referenced parts of
the CFR, and the Clean Air Act.

(l) Include estimates of U.S.-directed production volumes.

(m) Include the information required by other sections of this subpart.

(n) Include other relevant information, including any additional
information requested by EPA.

(o) Name an agent for service located in the United States. Service on
this agent constitutes service on you or any of your officers or
employees for any action by EPA or otherwise by the United States
related to the requirements of this subpart.

	An additional reporting requirement is listed in 40 CFR §59.628(e):

(e) Send us an annual warranty report summarizing successful warranty
claims by emission family under §59.612, including the reason for the
claim. You must submit the report by July 1 for the preceding calendar
year.

There is also a one-to-one correspondence between the recordkeeping
requirements and the requirements listed in the regulations (40 CFR
§59.628):

(a) Organize and maintain the following records:

(1) A copy of all applications and any other information you send us.

(2) Any of the information we specify in §59.623 that you were not
required to include in your application.

(3) A detailed history of each emission-data unit. For each
emission-data unit, include all of the following:

(i) The emission-data unit's construction, including its origin and
buildup, steps you took to ensure that it represents production
containers, any components you built specially for it, and all the
components you include in your application for certification.

(ii) All your emission tests, including documentation on routine and
standard tests, as specified in §§59.650 through 59.653, and the date
and purpose of each test.

(iii) All tests to diagnose emission-control performance, giving the
date and time of each and the reasons for the test.

(iv) Any other relevant events or information.

(4) Production figures for each emission family divided by assembly
plant.

(5) If you identify your portable fuel containers by lot number or other
identification numbers, keep a record of these numbers for all the
containers you produce under each certificate of conformity.

(b) Keep data from routine emission tests (such as test cell
temperatures and relative humidity readings) for one year after we issue
the associated certificate of conformity. Keep all other information
specified in paragraph (a) of this section for five years after we issue
your certificate.

(c) Store these records in any format and on any media, as long as you
can promptly send us organized, written records in English if we ask for
them. You must keep these records readily available. We may review them
at any time.

(d) Send us copies of any maintenance instructions or explanations if we
ask for them.

	By implication, the annual report of successful warranty claims
includes a requirement to keep records of such claims on a yearly basis
until July 1 of the following year.

	(ii)	Respondent Activities.

	The applications are in no set format but generally follow the
enumerated application requirements specified in §59.623 (see 4(b)(i)
above).  The respondent will have to document fuel container
specifications in detail, such as physical size, shapes, materials,
quality of component fit, and production methods, in submitting its
application(s) for certification. The respondent will also perform tests
and keep records on them.  The respondent must collect and keep
information on successful warranty claims for annual reporting.  The
respondent must also retain records on the units produced, apply serial
numbers to individual containers, and track the serial numbers to their
certificates of conformity.  Many of these activities are performed in
the production of any modern consumer product, but clearly some of the
information is uniquely required by the fuel container regulation.

5.	The Information Collected--Agency Activities, Collection Methodology,
and Information Management.

(a)	Agency Activities.

	 During the renewal period the most significant portion of EPA’s
activity for the fuel container regulation will be spent reviewing new
applications and renewal applications.  Other activities include
processing exceptions and answering questions concerning details of the
testing and certification requirements, including researching the
answers and communicating by email and telephone. Running change
submissions must also be reviewed for possible impacts and
manufacturers’ evaluations thereof. A part of this process involves
determining if “carry over” or “carry across” of data from a
previous model year or addition of a new container model to an existing
emissions family is appropriate or instead that new testing will be
required. EPA has the right to select a number of containers for testing
to confirm that the cans are indeed meeting the emissions standards, but
no confirmatory testing burden is anticipated in this estimate. EPA will
also be reviewing the annual submissions of successful warranty claims
and processing exemption requests.

(b)	Collection Methodology and Management.

	Applicants submit their applications for certification in the document
module of EPA’s Verify information system. All Verify users go through
an initial registration process that includes submission of basic
information and assignment of a manufacturer code.  It is anticipated
that warranty reports will also be submitted through the Verify document
module, with no set format.

(c)	Small Entity Flexibility.

	There are several provisions for small entity flexibility in the
regulations. Hardship deadline extensions for compliance with the
standard are available where, due to circumstances neither foreseeable
nor preventable, compliance would jeopardize the solvency of the
company. Exemptions are for up to one year and are renewable. There are
also exemptions for containers intended only for export, used for the
sole purpose of testing, or for national security. As with other
certification programs, small as well as larger manufacturers have
recourse to carry over and carry across. They may also request to use
alternative testing methods or emissions data already collected using
other procedures. The portable fuel container program currently collects
no certification fees.

(d)	Collection Schedule.

	The portable fuel container regulation applies to all fuel containers
as defined in the regulations manufactured on or after January 1, 2009.
Information collections are on a production period basis, five years in
all cases so far.  Warranty reports are on a calendar year basis, with
reports due July 1 for the previous calendar year.

6.	Estimating the Burden and Cost of the Collection

	These estimates represent the average annual burden that will be
incurred by the affected industry during the three-year period beginning
on September 30, 2013, with a margin for error.

(a)	Estimating Respondent Burden.

	The previous ICR, 2213.03, estimated 213.2 hours and $9,920 in labor
hours and labor costs and $10,519 in startup capital and O&M costs, for
a  total of $20,439 per year for  ten estimated respondents, assuming a
total of two applications per year.

	This ICR estimates 179.4 labor hours from eight manufacturers. This
figure primarily reflects the following adjustments: we conservatively
ask authorization to cover five applications per year, half of which are
counted as carry-over applications (a conservative figure, as the actual
figure is quite likely to be higher), and because warranty violations
have not been reported so far, the labor associated with annual warranty
reports is decreased. In addition, the number of manufacturers covered
is reduced to 8.

	This ICR does not include the costs of developing products that comply
with the Clean Air Act, only the burdens of making the showing to EPA
that they do. TSG, which does nearly all of the contract work, states
that it charges under $2,000 for application preparation and submission
and under $5,000 for testing work. Because the facility does a wide
variety of testing, including for these clients, it is difficult to
allocate these contracted costs among labor, capital, and O&M.

	This ICR uses $7,500 per application cost for new applications,
allocated approximately one third to labor and two thirds to the
contractor’s remaining O&M costs, following the Regulatory Impact
Analysis and the prior ICR.  Carry-over applications only require labor
costs, with no testing (O&M) costs. .

Estimating Respondent Costs.

(i) Estimating Labor Costs

Rates for managers, mechanical engineer technicians, and administrative
staff are from the May 2011 National Industry-Specific Occupational
Employment and Wage Estimates
http://www.bls.gov/oes/current/naics4_326100.htm , accessed January 8,
2013). With a overhead multiplier of 1.6, these are $85.44, $42.37, and
$26.26, respectively. Applying these figures to the application,
warranty, and record keeping labor totals above, the total labor cost is
$9,116.

(ii) Estimating Capital and Operations and Maintenance Costs

The prior ICR included a one-time startup cost estimate of $519 per year
 for ten new manufacturer applicants. The current ICR assumes one new
manufacturer with the startup cost allocated proportionately. We assume
the same $5,000 in O&M costs, for testing, for 2.5 new applications per
year, for a total O&M cost of $12,500 per year for the industry.

 (c)	Estimating Agency Burden and Cost.

	  The program is now in place and the considerable startup efforts are
in the past. One hour per application by a GS 13, Step 10, EPA employee
is estimated for review of the portable fuel container certifications.
There are no secretarial or database management costs, as these too
small to differentiate from the very much larger Verify baseline as part
of the motor vehicle certification IC.  The EPA employee cost is $86.96
per certification review. The EPA labor estimate is  based on Office of
Personnel Management SALARY TABLE 2009-DET (  HYPERLINK
"http://www.opm.gov/oca/09tables/pdf/salhr.pdf"
http://www.opm.gov/oca/09tables/pdf/salhr.pdf  ). For five applications
per year the estimated annual Agency burden is $434.80.  We anticipate
nominal effort in eliciting and reviewing  warranty action reports,
which to date have included only notice of no warranty actions,
estimated at an average of one hour  for each of a maximum of 8 report
per year for a total of $695.68. The current estimate includes no new
hardship and national security exemption determinations. The agency
total is therefore ten hours and $1,130.48.

	Estimating the Respondent Universe and Total Burden and Costs

The following assumptions were used to estimate the respondent universe
and total burden and costs for industry to comply with the various
requirements of the rule.

The estimated ten manufactures of fuel containers for the domestic
market from the prior ICR is reduced to eight. So far seven
manufacturers have applied for certificates, one has gone out of the
business, and four are currently active, with one new entry expected.

. We conservatively anticipate 25 applications in the next five years,
or five applications a year.

 We conservatively expect half the applications over the next five years
to be carry-over applications requiring no testing. As many as 90
per-cent of applications could be carry-over, which would reduce the
testing O&M costs from those presented in this estimate.

Manufactures will continue to contract for testing services and most
certificate application preparation.

(e)	Bottom Line Burden Hours and Cost Tables.

	(i)	Respondent Tally

RESPONDENTS	8

BURDEN HOURS	179.4

LABOR COST	$9,116

OPERATING COST	     $12,500

CAPITALIZED COST	$ 52

TOTAL COST	$23,170

	(ii)	Agency Tally

EMPLOYEES	1

STARTUP	$0

LABOR HOURS	13

LABOR COST	$ 1,130

(f)     Reasons for Change in Burden.

	The program is now mature and startup costs have largely already been
incurred, except for one new expected entrant. Similarly, at least half
of the certification applications are expected to be carry-overs. No
warranty violation report have been received, so warranty report
applications are expected to be less time consuming. The number of
manufacturers is reduced from ten to eight. These reductions are
partially offset by an increase from two to five in the number of
applications per year covered by this authorization, to provide a margin
of error for fluctuations in the small number of manufacturers and
certifications in this industry.

(g)    Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 12.64 hours respondent.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations are listed in 40 CFR part
9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, 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.
EPA-HQ-OAR-2013-0018, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Air and Radiation Docket and Information Center
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Air and Radiation
Docket and Information Center is<PHONE_NUMBER>.  An electronic version
of the public docket is available at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  .  Use this site 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. EPA-HQ-OAR-2010-0328 and OMB Control Number
2060-0597 in any correspondence.

 “Certification Procedure for Portable Fuel Containers and Spill-Proof
Spouts”, California Air Resources Board July 22, 2005

	 PAGE   12

	-   PAGE  12  -

						-   PAGE  11  -


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Proposed Rules]
[Pages 27339-27340]
[FR Doc No: 2020-09823]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0377; Airspace Docket No. 20-AGL-20]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Winner, SD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class E airspace extending
upward from 700 feet above the surface at Winner Regional Airport,
Winner, SD. The FAA is proposing this action as the result of an
airspace review caused by the decommissioning of the Winner VHF
omnidirectional range (VOR) navigation aid, which provided navigation
information for the instrument procedures this airport, as part of the
VOR Minimum Operational Network (MON) Program. The name and geographic
coordinates of the airport would also be updated to coincide with the
FAA's aeronautical database.

DATES: Comments must be received on or before June 22, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0377/Airspace Docket No. 20-AGL-20, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class E airspace extending upward from 700 feet
above the surface at Winner Regional Airport, Winner, SD, to support
instrument flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2020-0377/
Airspace Docket No. 20-AGL-20.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the

ADDRESSES section for the address and phone number) between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except federal holidays. An
informal docket may also be examined during normal business hours at
the Federal Aviation Administration, Air Traffic Organization, Central
Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort
Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace extending
upward from 700 feet above the surface by removing the Winner VOR and
all associated extensions associated with the Winner Regional Airport,
Winner, SD, from the airspace legal description; removing the city
associated with the airport to comply with changes to FAA Order
7400.2M, Procedures for Handling Airspace Matters; and updating the
name and geographic coordinates of the Winner Regional Airport
(previously Bob Wiley Field) to coincide with the FAA's aeronautical
database.
    This action is the result of an airspace review caused by the
decommissioning of the Winner VOR, which provided navigation
information for the instrument procedures this airport, as part of the
VOR MON Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL SD E5 Winner, SD [Amended]

Winner Regional Airport, SD
    (Lat. 43[deg]23'22'' N, long. 99[deg]50'28'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Winner Regional Airport.

    Issued in Fort Worth, Texas, on May 4, 2020.
Steven T. Phillips,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-09823 Filed 5-7-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Page 29170]
[FR Doc No: 2022-10227]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4474-DR; Docket ID FEMA-2022-0001]

Vermont; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Vermont (FEMA-4474-DR), dated January 17, 2020, and
related determinations.

DATES: This change occurred on April 28, 2022.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Robert V.
Fogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of James R. McPherson as
Federal Coordinating Officer for this disaster.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-10227 Filed 5-11-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Page 11780]
[FR Doc No: 2022-04387]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-61, OMB Control No. 3235-0073]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form S-3

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form S-3 (17 CFR 239.13) is a short form registration statement
used by domestic issuers to register a public offering of their
securities under the Securities Act of 1933 (15 U.S.C. 77a et seq.).
Form S-3 takes approximately 466.4566 hours per response and is filed
by approximately 1,651 issuers annually. We estimate that 25% of the
466.4566 hours per response (116.6141 hours) is prepared by the issuer
for a total annual reporting burden of 192,530 hours (116.6141 hours
per response x 1,651 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by May 2, 2022.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: February 25, 2022.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-04387 Filed 3-1-22; 8:45 am]
BILLING CODE 8011-01-P


Information Collection Request for UCMR 2
November 2009
14
4(b)(i)(b) State Reporting and Recordkeeping
As was the case for UCMR 1, UCMR 2 is a direct implementation rule, and therefore
States will not be required to report to EPA. Implementation activities for each State will be
identified and determined through PAs with EPA. If participating in a PA, States will at a
minimum be reviewing and revising Initial State Monitoring Plans, notifying systems of their
UCMR responsibilities, and providing EPA with a list of the systems notified. Note, however,
that these particular State activities are likely to have been completed prior to this ICR renewal
period. Because States have no specified reporting cycle, it is assumed that States have 1.0
response per year from 2007-2011, encompassing all communication and coordination activities
with EPA and systems.
4(b)(ii) Respondent Activities
Respondents include both PWSs and States. System activities and State activities are
discussed below in sections 4(b)(ii)(a) and 4(b)(ii)(b), respectively (Part A of this ICR
document).
4(b)(ii)(a) Public Water System Activities
To comply with the requirements in this regulation, systems are expected to conduct the
following activities:
•
read regulations and/or letter from State or EPA which outline requirements;
•
monitor or provide monitoring assistance (e.g., sample collection and shipping);
•
report and maintain records; and
•
report to the public.
Each of these activities is discussed in more detail below.
Read Regulations/State Letter: All PWSs that are participating in UCMR monitoring are
assumed to have read the UCMR regulations and/or a State-issued guidance letter during the
2007-2009 ICR period. Small systems can rely on summarized information from the State or
EPA for information pertaining to the regulation, rather than reading the regulation.
Monitoring or Monitoring Assistance: Monitoring activities that are considered in the
system cost and burden estimates include receiving sampling kits from the laboratory, reading
sampling instructions, and collecting and shipping the sample. Assessment Monitoring is
scheduled to occur during January 2008 through December 2010 for 10 chemical contaminants.
The Screening Survey is scheduled for January 2008 through December 2010 for 15 other
chemical contaminants. For cost estimation and scheduling purposes, EPA assumes that
approximately one-third of systems will monitor during each of the three monitoring years (2008
- 2010); thus, two-thirds of all systems required to conduct UCMR 2 monitoring were assumed
to monitor during the first UCMR 2 ICR period of 2007-2009, and one-third of systems required
to conduct UCMR 2 monitoring are assumed to monitor during the second UCMR 2 ICR period
of 2010-2012.  Appendix B provides a comprehensive cost estimate for implementation of the
rule, including labor and non-labor costs for the entire five-year UCMR cycle of 2007 - 2011.
Note that the complete five-year UCMR 2 cycle of 2007-2011 overlaps with the applicable ICR

Information Collection Request for UCMR 2
November 2009
15
period only during 2010 and 2011 (and, PWSs will only be involved in active monitoring during
2010 (i.e., one-third of this ICR period)).
For both Assessment Monitoring and the Screening Survey, surface water (and GWUDI)
sampling points will be monitored four times during the applicable year of monitoring, and
ground water sampling points will be monitored twice during the applicable year of monitoring.
Monitoring will be conducted at EPTDSs. Large ground water systems with multiple EPTDSs
will only be required to sample at representative sampling locations for each ground water
source, as long as those sites have been approved by EPA or the State. In addition, Screening
Survey systems that are required to monitor for DBPs will be required to sample for nitrosamines
at one distribution system sampling point per treatment plant (i.e., at the distribution system
maximum residence time (DSMRT)), as well as their EPTDS sampling locations.
Reporting and Recordkeeping: As noted in section 4(b)(i)(a), Part A of this ICR
document, the rule modifies and clarifies several of the requirements related to reporting of
contact information, reporting of sampling location data, electronic reporting by laboratories, and
data elements associated with monitoring data. Activities related to these reporting requirements
include:
Reporting Prior to Monitoring - All PWSs are assumed to have implemented the
following “reporting prior to monitoring” during the 2007-2009 ICR period.
Contact information: As under UCMR 1, large systems were required to report
contact information to EPA. This information includes the name, affiliation,
mailing address, phone number, facsimile number, and e-mail address for the
PWS Technical Contact and PWS Official (i.e., the official spokesperson for a
PWS’s UCMR activities). UCMR 2 clarifies that the information must be
submitted to EPA’s electronic data reporting system within a specified time frame
after rule promulgation. Small systems must provide this information by mail, in
response to a specific written request that they will receive from EPA.
Sampling location information: Prior to sampling, large PWSs were required to
provide inventory information related to each applicable sampling location. For
each sampling location or each approved representative sampling location, large
PWSs must submit: PWS identification (PWSID) code; PWS facility
identification code; sampling point identification code; sampling point type code;
sampling location water type. In addition, large systems that are required to
conduct Screening Survey monitoring must report the disinfectant(s) used to
maintain a residual in the distribution system for each distribution system
sampling location.
Representative EPTDS proposal: Some systems that use ground water as a source
and have multiple EPTDSs may monitor at representative entry point(s), rather
than at each EPTDS. To qualify, these ground water systems must have either the
same treatment or no treatment at all of their well sources; and they must have an
EPTDS for each well within a well field (resulting in multiple EPTDSs from the
same source, such as an aquifer). Systems meeting these criteria were allowed to

Information Collection Request for UCMR 2
November 2009
16
submit a proposal to EPA or the State. The proposal must demonstrate that any
EPTDS selected as representative of the ground water supplied from multiple
wells be associated with an individual well that draws from the same aquifer as
the multiple wells (i.e., those being represented).
Reporting Monitoring Results
Small systems: Under UCMR 1, small systems were held to the same data review
and approval requirements as those for large systems. However, because EPA
pays for and organizes the small system testing program, this review and approval
step for small systems proved unnecessary and impractical. Under UCMR 2,
small systems are only required to record system and sample location information
on the sampling forms and bottles that are sent to them by the UCMR Sampling
Coordinator. The schedule for submitting this information is specified in the
instructions sent to the system.
Large systems: UCMR 2 specifies that laboratories must post the analytical
results and associated data elements to EPA’s electronic data reporting system
within 120 days of sample collection. The rule also clarifies that large systems
must ensure that their laboratory meets this requirement, and that systems review,
approve, and submit the data to the State and EPA via the electronic reporting
system within 60 days from when the laboratory posts the data. If the PWS has
not approved and submitted the data after 60 days from the laboratory’s posting,
the data will be considered approved and final for EPA review.
Recordkeeping
Section 141.33 requires systems to maintain records of chemical monitoring data
for 10 years. No changes are being made to those recordkeeping requirements.
Reporting to the Public: SDWA section 1445(a)(2)(E) requires notification of the results
of the UCMR program to be made available to those served by the system. CWSs are required to
notify their users of the detection of any contaminants (including unregulated contaminants) in
their Consumer Confidence Reports (CCRs), pursuant to §141.153(d)(3)(iv), published in the
Federal Register (63 FR 44512). Monitoring and reporting violations for all systems (CWSs and
NTNCWSs) will be reportable under the Public Notification Rule (64 FR 25964 (May 13,
1999)).
4(b)(ii)(b) State Activities
For UCMR 1, EPA estimated State burdens and costs using the 1993 State Resource
Model (documented in the “Resource Analysis Computer Program for State Drinking Water
Agencies”). That model was designed by EPA, in coordination with ASDWA and required
specific input for a list of activities and variables related to State operation of the UCMR
drinking water program (e.g., number of systems affected, estimates of violation rates, etc.).
Since that time, EPA and ASDWA have worked together to update and improve the previous
version of the resource model. EPA used the updated resource model (the “2001 ASDWA
Drinking Water Program Resource Needs Self Assessment”, as documented in: “Public Health

Information Collection Request for UCMR 2
November 2009
17
Protection Threatened by Inadequate Resources for State Drinking Water Programs - An
Analysis of State Drinking Water Program Resources, Needs, and Barriers”; ASDWA, April
2003) to estimate resources that States may need for the oversight and implementation of UCMR
2. Assumptions that were applied in using this resource assessment tool are described in section
6(b), Part A of this ICR document. EPA assumes that State participation will closely reflect that
which occurred during UCMR 1. Therefore, model estimates were adjusted to account for actual
levels of prior State participation.
Since UCMR is a “direct implementation” rule, specifics of each State’s role will be
delineated in PAs between the States and EPA. However, in response to the regulation, EPA
anticipates that State activities will generally include EPA coordination activities/PAs, data
management and support, program implementation, and training/overhead. Though some States
may choose to conduct sampling for their systems, this activity is not part of the PA agreement
and is optional for States. Burden for sampling is currently attributed to systems only. If States
choose to conduct monitoring for systems, burden would be similar to that estimated for systems.
State Coordination with EPA/PAs: State activities that involve coordination with EPA
include coordination and drafting of a PA, review of and response to EPA’s proposed State
Monitoring Plan, review of PWS proposals for representative EPTDSs, and general ongoing
coordination.
Review of State Monitoring Plans was one of the first UCMR activities to take place at
the State level. Each State received a proposed initial State Monitoring Plan from EPA which
listed all systems that would be required to conduct Assessment Monitoring and the Screening
Surveys.  For systems that are part of the sample, EPA generated a list to provide similar
replacement systems for States to select from, for those systems that may not have been correctly
specified in the initial plan. If a State identified systems on the original proposed State
Monitoring Plan that it determined were not appropriate for the representative sample (e.g., if
systems were inactive, or had switched to purchased water), the State could propose an
alternative plan by selecting other systems from EPA’s alternate list to replace the ineligible
systems. The State Monitoring Plans also specified the year and months during which systems
would monitor. States were given the option to modify these schedules. Since these UCMR 2
activities were completed by States in 2007, they are not applicable to the current ICR period of
2010-2012.
EPA predicts that some systems that use ground water as a source of water will submit a
proposal for monitoring at representative entry point(s), rather than monitor at every EPTDS.
State involvement in the review of these proposals was determined in the PA process.
EPA recognizes the necessity for States to maintain ongoing communications with EPA
regarding the requirements of UCMR. An example of this would be instances when States need
clarification and guidance regarding a specific requirement of the regulation. These ongoing
communication activities are included in estimated burdens across the entire UCMR 2
implementation period of 2007-2011.
Data Management and Support: Though there are no data management and support
activities included in UCMR, EPA recognizes that many States may update their databases to

Information Collection Request for UCMR 2
November 2009
18
accommodate the revised UCMR data elements. Activities likely include data entry/downloading
of data, and general recordkeeping.
Program Implementation: Program implementation activities for each State may include
notification and guidance letter to systems, data review, ongoing system support, and
enforcement.
Following review and finalization of State Monitoring Plans, participating States
prepared a notification letter that described system monitoring schedules and requirements under
the regulation. The participating States notified each applicable system and sent the list of these
notified systems to EPA. It is also likely that States will receive telephone calls from water
systems asking for clarification and guidance pertaining to the requirements of UCMR. States
may choose to review monitoring results, in part to determine whether a system has met its
monitoring and reporting requirements.
State Staff Training and Overhead: Technical staff are assumed to participate in rule-
specific training designed to assist them in understanding the regulation, their roles and
responsibilities, and to allow the State to better provide technical assistance to the systems. In
addition, general overhead costs, such as clerical and managerial needs, are allocated to the
UCMR staff requirements in the standard State Resource Model, which allocates support staff
needs as a percentage of professional staff needs. See section 6(b), Part A of this ICR document,
for further discussion of model assumptions.

Information Collection Request for UCMR 2
November 2009
19
5 INFORMATION COLLECTED–AGENCY ACTIVITIES,
COLLECTION METHODOLOGY, AND INFORMATION
MANAGEMENT
5(a) Agency Activities
EPA Headquarters and Regional offices will be responsible for oversight of State PWS
programs, and processing and analysis of the UCMR data. EPA implementation activities are
categorized, as follows, into three major categories: regulatory support activities; program
oversight and data analysis; and small system testing program, which are described below, in
5(a)(i)-(iii).
5(a)(i) Regulatory Support Activities
Regulatory support activities include: laboratory approval and quality assurance/quality
control; and technical support to PWSs, such as guidance documents.
Laboratory Approval and Quality Assurance/Quality Control (QA/QC) Activities: EPA
incurs various costs related to laboratory approvals and laboratory quality assurance and control,
including the following activities:
•
Laboratory approvals/Proficiency Testing (PT) program - EPA assessed whether
laboratories met the required equipment, laboratory performance, and data reporting
criteria. EPA registered and evaluated laboratories based on the applications. Selected
laboratories then participated in the UCMR 2 PT program. Laboratory assessments were
conducted during 2006 and 2007, and are thus not applicable to this ICR period of 2010-
2012.
•
QC audits of contract laboratories - EPA will be conducting QC audits at each of the
approved laboratories during each year of UCMR 2 monitoring (January 2008 through
December 2010). Only those QC audits for 2010 coincide with this ICR period.
•
Analytical standards provision and coordination - Specialized analytical standards are
distributed to participating laboratories by EPA during each year of UCMR 2 monitoring
(January 2008 through December 2010). This ICR includes EPA’s coordination and
distribution of these standards in 2010 only.
Technical Support/Guidance Document Development: Technical support and guidance
documents include: developing and distributing guidance for laboratory calculations of
MRL/LCMRL; and background information (e.g., fact sheets) about the health effects of the
UCMR 2 contaminants. This was completed by 2007, and thus does not apply to this ICR period.

Information Collection Request for UCMR 2
November 2009
20
5(a)(ii) National and Regional Oversight/Data Analysis
EPA’s UCMR program activities include data analysis, management oversight, and
implementation assistance to States. These are key management and oversight activities that
must be conducted by EPA Headquarters or its Regional offices. Exhibit 3, below, illustrates the
time line for UCMR implementation activities. EPA developed its PAs with States and the State
Monitoring Plans prior to the beginning of PWS monitoring activities. EPA is conducting its
ongoing evaluation of the data during 2007-2011 (i.e., the five-year UCMR 2 cycle).
Exhibit 3: Time Line of UCMR Activities
2006 and 2007
2008
2009
2010
2011
Final EPA data
analysis
Assessment Monitoring:
List 1 Contaminants
All systems serving more than 10,000;
800 systems serving 10,000 or fewer people

Screening Survey:
List 2 Contaminants
All systems serving more than 100,000 people;
800 systems serving 100,000 or fewer people

EPA Lab approval
program
Representative
Sample of PWSs
Selected by EPA
EPA/State PAs
and State
Monitoring Plans
Developed
Inform
PWSs/Establish
Monitoring Plans
Next RegDet
1
scheduled for CCL
2 contaminants
<s>1</s>
RegDet = Regulatory Determination
5(a)(iii) Costs for Small System Testing Program
Implementation of small system testing program is the largest portion of Agency costs for
the UCMR program. Prior to monitoring, EPA activities for logistical support of the small
system testing program includes coordination of small system testing and provision of testing
supplies.
The single largest cost to EPA for implementation of UCMR is for small system sample
analyses. During the ICR period of 2010-2012, EPA will pay for the analytical and shipping
costs for just one-third of small systems selected for Assessment Monitoring and Screening
Survey monitoring (two-thirds of monitoring was completed during 2008 and 2009, covered

Information Collection Request for UCMR 2
November 2009
21
under the previous UCMR 2 ICR period of 2007-2009). EPA is conducting some QC activities
that apply only to small systems. Specifically, EPA is sending “duplicates” of 10 percent of
small system samples to separate laboratories for analysis. The quality control duplicates are
intended to provide standard, real time, QC checks among the different contract laboratories.
5(b) Information Collection Methodology and Management
UCMR 2 specifies that laboratories must report the analytical results and associated data
elements to EPA’s electronic data reporting system. UCMR 2 clarifies that large systems must
ensure that their laboratory posts the data in EPA’s electronic data reporting system, and must
review, approve, and submit the data to the State and EPA via the EPA electronic reporting
system. After 60 days from the laboratory’s posting, if the PWS has not approved and submitted
the data, the data will be considered approved and final for EPA review. Electronic reporting will


[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61006-61008]
[FR Doc No: 2017-27710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2582]

Determination of Regulatory Review Period for Purposes of Patent
Extension; STRIVERDI RESPIMAT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STRIVERDI RESPIMAT and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 26, 2018.

See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date. Furthermore, any
interested person may petition FDA for a determination regarding
whether the applicant for extension acted with due diligence during the
regulatory review period by June 25, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-2582 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; STRIVERDI RESPIMAT.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product STRIVERDI
RESPIMAT (olodaterol hydrochloride). STRIVERDI RESPIMAT is indicated
for the long-term, once-daily maintenance bronchodilator treatment of
airflow obstruction in patients with chronic obstructive pulmonary
disease, including chronic bronchitis and/or emphysema. Subsequent to
this approval, the USPTO received a patent term restoration application
for STRIVERDI RESPIMAT (U.S. Patent No. 7,727,984) from Boehringer
Ingelheim Pharma GmbH & Co. KG, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 15, 2015, FDA advised the USPTO
that this human drug product

had undergone a regulatory review period and that the approval of
STRIVERDI RESPIMAT represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
STRIVERDI RESPIMAT is 2,712 days. Of this time, 1,903 days occurred
during the testing phase of the regulatory review period, while 809
days occurred during the approval phase. These periods of time were
derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
February 28, 2007. FDA has verified the Boehringer Ingelheim Pharma
GmbH & Co. KG claim that February 28, 2007, is the date the
investigational new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 14,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for STRIVERDI RESPIMAT (NDA 203108) was initially
submitted on May 14, 2012.
    3. The date the application was approved: July 31, 2014. FDA has
verified the applicant's claim that NDA 203108 was approved on July 31,
2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,166 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27710 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P