[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Page 63868]
[FR Doc No: 2013-25209]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2013-0802; Airspace Docket No. 13-AWP-7]
RIN 2120-AA66

Amendment of Restricted Area R-2515; Muroc Lake, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action changes the using agency name for Restricted Area
R-2515 Muroc Lake, CA, to read ``Commander, 412th Test Wing (412 TW)
Edwards AFB, CA'' due to Department of the Air Force organizational
realignments. There are no changes to the boundaries; designated
altitudes; time of designation; or activities conducted within the
restricted area.

DATES: Effective date 0901 UTC, December 12, 2013.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 73 by changing the using agency name for Restricted Area R-2515
Muroc Lake, CA, from ``Commander Air Force Flight Test Center, Edwards
AFB, CA'' to ``Commander, 412th Test Wing (412 TW), Edwards AFB, CA.''
As part of the Air Force Materiel Command's reorganization,
responsibility for the day-to-day operation of R-2515 was assigned to
the 412 TW at Edwards AFB, CA. This is an administrative change to
update the name of the using agency. It does not affect the boundaries,
designated altitudes, or activities conducted within the restricted
area; therefore, notice and public procedure under 5 U.S.C. 553(b) are
unnecessary.
    The FAA has determined that this action only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as amends the description of Restricted Area R-2515, Edwards AFB, CA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures,
paragraph 311d. This action is an administrative change to the
description of the affected restricted area to update the using agency
name. It does not alter the dimensions, altitudes, or times of
designation of the airspace; therefore, it is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exists that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73, as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

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

Sec.  73.25  [Amended]

0
2. Section 73.25 is amended as follows:
* * * * *

R-21515 Muroc Lake, CA [Amended]

    Under Using Agency, remove ``Commander, Air Force Flight Test
Center, Edwards AFB, CA'' and insert ``Commander, 412 Test Wing (412
TW), Edwards AFB, CA.''

    Issued in Washington, DC on October 21, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-25209 Filed 10-24-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Proposed Rules]
[Pages 27048-27050]
[FR Doc No: 2022-09468]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2022-0382; FRL-9767-01-R7]

Air Plan Approval; Missouri; Removal of Control of Emissions From
Bakery Ovens

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
approval of a State Implementation Plan (SIP) revision submitted by the
State of Missouri on January 15, 2019 and supplemented by letter on
July 11, 2019. Missouri requests that the EPA remove from its SIP a
rule related to control of emissions from bakery ovens in St. Louis
City and Jefferson, St. Charles, Franklin, and St. Louis Counties. The
EPA's proposed approval of this rule revision is in accordance with the
requirements of the Clean Air Act (CAA).

DATES: Comments must be received on or before June 6, 2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2022-0382 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: William Stone, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
7714; email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
III. What is the EPA's analysis of missouri's SIP revision request?
IV. Have the requirements for approval of a SIP revision been met?
V. What Action is the EPA taking?
VI. Incorporation by Reference
VII. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2022-
0382, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve the removal of 10 Code of State
Regulation (CSR) 10-5.440, Control of Emissions From Bakery Ovens, from
the Missouri SIP.
    Section 110(l) of the CAA prohibits the EPA from approving a SIP
revision that interferes with any applicable requirement concerning
attainment and reasonable further progress (RFP), or any other
applicable requirement of the CAA. The State supplemented its SIP
revision with a July 11, 2019 letter in order to address the
requirements of section 110(l) of the CAA.

III. What is the EPA's analysis of Missouri's SIP revision request?

    According to the January 15, 2019, letter from the Missouri
Department of Natural Resources (MoDNR), available in the docket for
this proposed action, Missouri rescinded 10 CSR 10-5.440, Control of
Emissions from Bakery Ovens because the only source subject to the rule
ceased operations in 2012. The state asserts in their submission to the
Agency that this rule is no longer necessary for controlling emissions
of volatile organic compounds (VOC's) because there are no existing
sources subject to the rule and new sources would be controlled by
other rules.

    In its supplemental submission dated July 11, 2019, MoDNR notes
that the purpose of 10 CSR 10-5.440, Control of Emissions From Bakery
Ovens, was to reduce VOC emissions from bakery ovens located in the St.
Louis nonattainment area, which at the time of promulgation (state
effective Date: December 30, 1996), included the City of St. Louis and
the counties of Franklin, Jefferson, St. Charles, and St. Louis
(hereinafter referred to in this document as the ``St. Louis
Area'').\1\ The rule applied to new or existing commercial bakeries
with potential VOC emissions greater than 100 tons per year (tpy).
---------------------------------------------------------------------------

    \1\ These counties were previously designated for nonattainment
for ozone for the 1979, 1997 and 2008 standards. They are currently
designated attainment for each of those standards.
---------------------------------------------------------------------------

    MoDNR stated that following rescission of this rule, any new source
is required to meet New Source Review (NSR) in attainment or
attainment/unclassifiable areas, and for nonattainment areas,
Nonattainment New Source Review (NANSR) in the St. Louis Area.
    EPA agrees that in the St. Louis nonattainment area for the 2015
ozone standard, which includes St. Louis City and the counties of
Franklin (partial; Boles Township), Jefferson, St. Charles, and St.
Louis, any new sources or major modifications of existing sources are
subject to NANSR permitting.\2\ Under NANSR, a new major source or
major modification of an existing source with a PTE of 100 tpy or more
of any NAAQS pollutant is required to obtain a NANSR permit when the
area is in nonattainment, which requires an analysis of Lowest
Achievable Emission Rate (LAER) in addition to an air quality analysis,
an additional impacts analysis and emission offsets. LAER is defined in
Sec.  51.165(a)(1)(xiii), in pertinent part, ``. . . for any source,
the more stringent rate of emissions based on the following: (A) The
most stringent emissions limitation which is contained in the
implementation plan of any State for such class or category of
stationary source, unless the owner or operator of the proposed
stationary source demonstrates that such limitations are not
achievable; or (B) The most stringent emissions limitation which is
achieved in practice by such class or category of stationary sources.
This limitation, when applied to a modification, means the lowest
achievable emissions rate for the new or modified emissions units
within or stationary source. In no event shall the application of the
term permit a proposed new or modified stationary source to emit any
pollutant in excess of the amount allowable under an applicable new
source standard of performance.'' \3\
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    \2\ https://www.federalregister.gov/documents/2021/06/14/2021-11454/revised-air-quality-designations-for-the-2015-ozone-national-ambient-air-quality-standards.
    \3\ https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-51/subpart-I.
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    Therefore, any new bakery oven that would have been subject to 10
CSR 10-5.440, in the St. Louis ozone Nonattainment Area, will be
subject to NANSR permitting which would result in a LAER limit at least
as stringent as the limit in this rule in addition to the requirement
to offset the emissions.
    In the rest of Franklin County (the portions that do not include
Boles Township), any new sources or major modifications of existing
sources are subject to NSR permitting. Under NSR, for attainment or
attainment/unclassifiable areas, a new major source or major
modification of an existing source with a potential to emit (PTE) of
250 tpy or more of any NAAQS pollutant is required to obtain a
Prevention of Significant Deterioration (PSD) permit. Sources with a
PTE greater than 100 tpy of VOC's, but less than 250 tpy, are required
to obtain a minor permit in accordance with Missouri's NSR permitting
program, which is approved into the SIP.\4\ In the Final Area
Designations for the 2015 Ozone National Ambient Air Quality Standards
(NAAQS) Technical Support Document (TSD) EPA observes that emissions
from sources outside Boles Township are relatively low, with levels
less than the more densely populated City of St. Louis and five other
counties in the area of analysis.\5\ As noted in the TSD, there are no
other large sources of VOC or NOx in Franklin County, outside of Boles
Township, which remains a nonattainment area and therefore subject to
NANSR permitting. Therefore, EPA believes that any newly permitted NSR
or minor NSR bakery ovens in Franklin County would have little to no
impact on the St. Louis Area ozone levels.
---------------------------------------------------------------------------

    \4\ EPA's latest approval of Missouri's NSR permitting program
rule was published in the Federal Register on October 11, 2016. 81
FR 70025.
    \5\ https://www.epa.gov/sites/default/files/2021-05/documents/st._louis_mo-il_tsd_remand_final.pdf.
---------------------------------------------------------------------------

    Therefore, EPA agrees with the State that approving this SIP
revision will not have an adverse impact on air quality because the
only source subject to the rule has permanently shutdown and new
sources would be subject to NANSR, NSR and minor NSR in the St. Louis
Area. As stated above, new bakery ovens with a PTE of 100 tpy or more
of VOC's would be very well controlled in all areas where 10 CSR 10-
5.440 previously applied.
    Further, the rescission of this rule from the SIP will have no
impact on any approved maintenance plan. On September 20, 2018, the EPA
redesignated the St. Louis, Missouri area to attainment of the 2008
ozone NAAQS. In the state's maintenance plan submittal for this
standard, this rule was not relied upon. The EPA agrees with this
analysis.
    For these reasons, EPA proposes to determine that the SIP revision
submission meets the substantive requirements of the CAA, including
section 110 and implementing regulations.
    EPA is proposing to approve this SIP revision.

IV. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from May 15, 2018 to
August 2, 2018 and received 11 comments from the EPA. Missouri received
11 comments from the EPA that related to Missouri's lack of an adequate
demonstration that the rule could be removed from the SIP in accordance
with section 110(l) of the CAA. Missouri's July 11, 2019 letter
addressed the EPA's comments. In addition, as explained above, the
revision meets the substantive SIP requirements of the CAA, including
section 110 and implementing regulations.

V. What action is the EPA taking?

    The EPA is proposing to approve Missouri's request to rescind 10
CSR 10-5.440 from the SIP because the rule applied to a single source
that has permanently ceased operations and it therefore no longer
serves to reduce emissions in the St. Louis Area. Furthermore, any new
sources or major modifications of existing sources in the St. Louis
Area are subject to NSR permitting.\6\ We are processing this as a
proposed action because we are soliciting comments on this proposed
action. Final rulemaking will occur after consideration of any
comments.
---------------------------------------------------------------------------

    \6\ ``NSR Permitting'' includes PSD permitting in areas
designated attainment and unclassifiable, NANSR in areas designated
nonattainment and minor source permitting.
---------------------------------------------------------------------------

VI. Incorporation by Reference

    In this document, the EPA is proposing to amend regulatory text
that

includes incorporation by reference. As described in Sections II, III,
and V of this preamble and set forth below in the proposed amendments
to 40 CFR part 52, the EPA is proposing to remove provisions of the
EPA-Approved Missouri Regulations from the Missouri State
Implementation Plan, which is incorporated by reference in accordance
with the requirements of 1 CFR part 51.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Dated: April 27, 2022.
Meghan A. McCollister,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart AA--Missouri

Sec.  52.1320  [Amended]

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by removing
the entry ``10-5.440'' under the heading ``Chapter 5--Air Quality
Standards and Air Pollution Control Regulations for the St. Louis
Metropolitan Area''.

[FR Doc. 2022-09468 Filed 5-5-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72895-72897]
[FR Doc No: 2013-28989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Tissue Intended
for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by January
3, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0302.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food

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

Human Tissue Intended for Transplantation--21 CFR Part 1270 (OMB
Control Number 0910-0302)--Extension

    Under section 361 of the Public Health Services (PHS) Act (42
U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270)
to prevent the transmission of human immunodeficiency virus, hepatitis
B, and hepatitis C through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures be
prepared and followed for the following steps: (1) All significant
steps in the infectious disease testing process under Sec.  1270.21;
(2) all significant steps for obtaining, reviewing, and assessing the
relevant medical records of the donor as prescribed in Sec.  1270.21;
(3) designating and identifying quarantined tissue; and (4) prevention
of infectious disease contamination or cross-contamination by tissue
during processing. Section 1270.31(a) and (b) also requires recording
and justification of any deviation from the written procedures. Section
1270.33(a) requires records to be maintained concurrently with the
performance of each significant step required in the performance of
infectious disease screening and testing of human tissue donors.
Section 1270.33(f) requires records to be retained regarding the
determination of the suitability of the donors and of the records
required under Sec.  1270.21. Section 1270.33(h) requires all records
to be retained for at least 10 years beyond the date of transplantation
if known, distribution, disposition, or expiration of the tissue,
whichever is the latest. Section 1270.35(a) through (d) requires
specific records to be maintained to document the following: (1) The
results and interpretation of all required infectious disease tests;
(2) information on the identity and relevant medical records of the
donor; (3) the receipt and/or distribution of human tissue; and (4) the
destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, FDA estimates that there are approximately 281 tissue
establishments of which 185 are conventional tissue banks and 96 are
eye tissue banks. Based on information provided by industry, there are
an estimated total of 1,959,270 conventional tissue products and 82,741
eye tissue products distributed per year with an average of 25 percent
of the tissue discarded due to unsuitability for transplant. In
addition, there are an estimated 30,380 donors of conventional tissue
and 49,026 donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information provided by CBER's
database system, 90 percent of the conventional tissue banks are
members of AATB (185 x 90 percent = 166), and 85 percent of eye tissue
banks are members of EBAA (96 x 85 percent = 82). Therefore,
recordkeeping by these 248 establishments (166 + 82 = 248) is excluded
from the burden estimates as usual and customary business activities (5
CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the
remaining 33 establishments, which is 12 percent of all establishments
(281-248 = 33, or 33 / 281 = 12 percent).
    FDA assumes that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, their
information collection burden is for the general review and update of
written procedures estimated to take an annual average of 24 hours, and
for the recording and justifying of any deviations from the written
procedures under Sec.  1270.31(a) and (b), estimated to take an annual
average of 1 hour. The information collection burden for maintaining
records concurrently with the performance of each significant screening
and testing step and for retaining records for 10 years under Sec.
1270.33(a), (f), and (h) include documenting the results and
interpretation of all required infectious disease tests and results,
and the identity and relevant medical records of the donor required
under Sec.  1270.35(a) and (b). Therefore, the burden under these
provisions is calculated together in table 1 of this document. The
recordkeeping estimates for the number of total annual records and
hours per record are based on information provided by industry and FDA
experience.
    In the Federal Register of July 10, 2013 (78 FR 41403), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One letter of comment was received from a
trade organization. The comment requested that the notice be corrected
to reflect that an estimated total of 1,959,270 conventional tissue
products are distributed (not recovered) per year. The comment also
requested a revision in the number of donors of conventional tissues
based on the AATB Annual Survey 2007. FDA agrees with these comments
and made the recommended changes.
    FDA estimates the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
           21 CFR Part                Number of     records per    Total annual         per         Total hours
                                    recordkeepers   recordkeeper      records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) \2\              33           1                 33              24             792
1270.31(a) and 1270.31(b) \3\....              33           2                 66               1              66
1270.33(a), (f), and (h), and                  33       7,714.24         254,570               1         254,570
 1270.35(a) and (b)..............
1270.35(c).......................              33      14,850.96         490,082               1         490,082
1270.35(d).......................              33       1,856.36          61,260               1          61,260
                                  ------------------------------------------------------------------------------

    Total........................                                                                        806,770
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28989 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Notices]
[Page 36164-36165]
[DOCID:fr25jn08-148]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-RSPA-2004-19856]

Pipeline Safety: Notice to Hazardous Liquid Pipeline Operators of
Request for Voluntary Advance Notification of Intent To Transport
Biofuels

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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SUMMARY: PHMSA is requesting that any hazardous liquid pipeline
operator intending to transport ethanol, ethanol-gasoline blends, or
other biofuels by pipeline voluntarily provide us with advance notice
of their intent to transport these fuels to facilitate cooperation in
achieving safety. We request that any operator intending to field test
transportation of biofuels by pipeline notify PHMSA of such testing in
advance so that PHMSA can work with the operator to address any safety
concerns that arise. PHMSA will be interested in discussing the steps
the operator will take to ensure safety during the test and informing
the local emergency response officials about the product being
transported.

FOR FURTHER INFORMATION CONTACT: Alan Mayberry,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 10, 2007, PHMSA published a Federal Register document
regarding the transportation of ethanol and biofuels by pipeline (72 FR
45002). PHMSA advised pipeline operators that the transportation of
batches of ethanol or other biofuels in an existing petroleum products
pipeline, and the transportation of blends of biofuels and petroleum
products, are subject to the pipeline safety regulations and standards.
The document described the potential technical issues associated with
transporting biofuels by pipeline including internal corrosion and
stress corrosion cracking, and the performance of seals, gaskets and
internal coatings. As with the transportation of any hazardous liquid
by pipeline, operators intending to transport these new fuels are
expected to conduct risk analysis, monitoring, and controls as needed
to move biofuels safely as well as conduct spill response planning for
the new product. PHMSA seeks to work with pipeline operators that plan
to transport these new fuels in existing regulated hazardous liquid
pipelines (or in new pipelines that might be constructed for the
purpose of transporting ethanol or biofuels). Accordingly, we are
requesting that operators provide us with advance notice of their
intent to transport these fuels to facilitate cooperation in achieving
safety.

II. Advisory Bulletin (ADB-08-05)

    To: Owners and Operators of Hazardous Liquid Pipeline Systems.
    Subject: Notice to Operators of Request for Voluntary Advance
Notification of Intent to Transport Biofuels.
    Advisory: On August 10, 2007, PHMSA published a Federal Register
document on the applicability of the pipeline safety regulations to the
transportation of ethanol and biofuels by pipeline (72 FR 45002). In
the document, PHMSA noted the technical issues associated with
transporting biofuels by pipeline including internal corrosion and
stress corrosion cracking, and the performance of seals, gaskets and
internal coatings. As with the transportation of any hazardous liquid
by pipeline, operators intending to transport these new fuels are
expected to conduct risk analysis, monitoring, and controls as needed
to move biofuels safely as well as conduct spill response planning for
the new product. PHMSA seeks to work with pipeline operators that plan
to transport these new fuels in existing regulated hazardous liquid
pipelines or in new pipelines that might be constructed for the purpose
of transporting ethanol or biofuels. Accordingly, we are requesting
that operators provide us with advance notice of their intent to
transport these fuels to facilitate cooperation in achieving safety.
    Notice of Field Testing: PHMSA seeks to encourage field testing by
pipeline operators to accelerate the development of knowledge about the
safe and reliable transportation of ethanol and biofuels by pipeline.
We are requesting that any operator intending to field test
transportation of biofuels by pipeline provide advance notification to
PHMSA of such testing so that PHMSA can work with the operator to
address any safety concerns that arise. To the extent proprietary
concerns permit, PHMSA also seeks to share in the evaluation of the
results to supplement the information we are receiving from our
collaborative research efforts and help facilitate standards
development. Although such field testing would be limited in scope and
duration, PHMSA will be interested in discussing the steps the operator
will take to ensure safety during the test and inform local emergency
response officials about the product being transported.
    Commencement of Commercial Operations: Under 49 CFR part 195, an
operator is obligated to modify its operating procedures, integrity
management programs, and emergency response plans, among other things,
prior to commencing commercial transportation of a new hazardous
liquid. Under part 194, operators must also update their spill response
plans to account for the new product being transported. PHMSA will
apply its proven risk-based regulatory approach to the operation of
pipelines transporting these fuels. PHMSA requests that any operator
intending to commence regular commercial transportation of ethanol or
other biofuels provide advance notification to PHMSA as soon as
possible, but preferably 60 days in advance, to provide time for
review. PHMSA is interested in learning about: The work to be performed
to prepare the pipeline for ethanol or biofuel service; the anticipated
blend concentration and batch frequency; the additional employee
training to be conducted; the additional emergency response planning
and liaison with local emergency response officials, including spill
response plans; and the plans for ongoing monitoring of the integrity
of the pipe. We would also like to know what modifications operators
will make to their written operating and maintenance procedures,
including their integrity management program and spill response plans
prior to commencement of operations. On being notified by an operator
about the new biofuel operations and associated program modifications,
PHMSA will

work closely with the operator and provide technical review and
feedback.
    Submittal: Notifications may be submitted in writing to:
Information Resources Manager, Office of Pipeline Safety, Pipeline and
Hazardous Materials Safety Administration, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>.
PHMSA requests the name, title, telephone number, and e-mail address of
the person responsible for compliance with the integrity management
requirements and a physical description of facilities involved
including pipe design, manufacture, vintage, diameter, relevant
operating history, and presence of any breakout tanks along with
project timelines. The public may view summaries of all notifications
that have been submitted by operators, and the status of PHMSA review
of each notification, via this Web site. PHMSA expects to receive fewer
than ten notifications per year.
    Review: PHMSA will review all notifications received from
operators. Review may include site inspections by PHMSA or state
pipeline safety agencies, particularly in states with certified
hazardous liquid programs. If PHMSA finds that an operator's plans and
operating procedures need additional attention or modification, we will
provide feedback to the operator.

    Authority: 49 U.S.C. chapter 601; 49 CFR 1.53.

    Issued in Washington, DC, on June 18, 2008.
William H. Gute,
Deputy Associate Administrator for Pipeline Safety.
 [FR Doc. E8-14137 Filed 6-24-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Rules and Regulations]
[Pages 63714-63716]
[FR Doc No: 2012-24949]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0801; Directorate Identifier 2012-NM-106-AD;
Amendment 39-17212; AD 2012-20-06]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-200 and -200C series airplanes. This AD
was prompted by a report of elevator vibration and bearing swage
failures. This AD requires, for certain airplanes, repetitive
inspections for any discrepancies (such as a gap or a loose spacer) of
the aft attach lugs for the elevator tab control mechanism, and
replacement if necessary; and, for other airplanes, contacting the FAA
for inspection or repair instructions and doing the work specified in
those instructions. We are issuing this AD to detect and correct
discrepancies in the aft attach lugs for the elevator tab control
mechanism, which could result in elevator and tab vibration. Consequent
structural failure of the elevator or horizontal stabilizer could
result in loss of structural integrity and loss of airplane control.

DATES: This AD is effective November 21, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of November 21,
2012.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate; 1601 Lind
Avenue SW., Renton, WA. 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 Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kelly McGuckin, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on August 1, 2012 (77 FR
45513). That NPRM proposed to require, for certain airplanes,
repetitive inspections for any discrepancies (such as a gap or a loose
spacer) of the aft attach lugs for the elevator tab control mechanism,
and replacement if necessary; and, for other airplanes, contacting the
FAA for inspection or repair instructions and doing the work specified
in those instructions.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. Boeing supports the
NPRM (77 FR 45513, August 1, 2012).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 45513, August 1, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 45513, August 1, 2012).

Costs of Compliance

    We estimate that this AD affects 200 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection for Group 2 airplanes.  7 work-hours x $85               $0  $595 per inspection  $119,000 per
                                    per hour = $595                      cycle.               inspection cycle.
                                    per inspection
                                    cycle.
----------------------------------------------------------------------------------------------------------------

    For Group 1 airplanes, we do not have definitive data that would
enable us to provide cost estimates for the action specified in this
AD.
    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of a mechanism....................  7 work-hours x $85 per hour =            $29,289         $29,884
                                                 $595.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2012-20-06 The Boeing Company: Amendment 39-17212; Docket No. FAA-
2012-0801; Directorate Identifier 2012-NM-106-AD.

(a) Effective Date

    This AD is effective November 21, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-200 and -200C
series airplanes, certificated in any category; as identified in
Boeing Alert Service Bulletin 737-27A1302, dated April 24, 2012.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 27, Flight Controls.

(e) Unsafe Condition

    This AD was prompted by a report of elevator vibration and
bearing swage failures. We are issuing this AD to detect and correct
discrepancies in the aft attach lugs for the elevator tab control
mechanism, which could result in elevator and tab vibration.
Consequent structural failure of the elevator or horizontal
stabilizer could result in loss of structural integrity and loss of
airplane control.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Actions for Group 1 Airplanes

    For Group 1 airplanes as identified in Boeing Alert Service
Bulletin 737-27A1302, dated April 24, 2012: Within 1,500 flight
cycles or 2,000 flight hours after the effective date of this AD,
whichever occurs first, inspect the left and right elevator tab
control mechanisms, and repair or replace as applicable, in
accordance with a method approved by the Manager, Seattle Aircraft
Certification Office (ACO), FAA. For a repair method to be approved,
the repair must meet the certification basis of the airplane, and
the approval must specifically refer to this AD.

(h) Inspection for Group 2 Airplanes

    For Group 2 airplanes as identified in Boeing Alert Service
Bulletin 737-27A1302, dated April 24, 2012: Within 1,500 flight
cycles or 2,000 flight hours after the effective date of this AD,
whichever occurs first, do a detailed inspection for any
discrepancies of the inboard and outboard aft attach lugs of the
left and right elevator tab control mechanisms, in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-27A1302, dated April 24, 2012. Repeat the detailed inspection
thereafter at intervals not to exceed 1,500 flight cycles or 2,000
flight hours, whichever occurs first.

(i) Corrective Actions for Paragraph (h) of This AD

    If any discrepancy is found during any inspection required by
paragraph (h) of this AD, before further flight, replace the
discrepant elevator tab control mechanism with a non-discrepant
mechanism by doing the actions specified in paragraphs (i)(1) and
(i)(2) of this AD.
    (1) Do a detailed inspection for discrepancies of the
replacement elevator tab control mechanism; and, if no discrepancy
is found, before further flight, install the replacement elevator
tab control mechanism; in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-27A1302, dated
April 24, 2012. If any discrepancy is found in that mechanism, then
that mechanism may not be installed.
    (2) Repeat the inspection on the installed replacement elevator
tab control mechanism in accordance with the requirements of
paragraph (h) of this AD.

(j) Inspection Report

    Submit a report of the findings (both positive and negative) of
the initial inspection required by paragraph (h) of this AD to
Boeing Commercial Airlines Group, Attention: Manager, Airline
Support, email<EMAIL_ADDRESS>at the applicable time
specified in paragraph (j)(1) or (j)(2) of this AD. The report must
include the inspection results, a description of any discrepancies
found, the airplane serial number, and the number of landings and
flight hours on the airplane.
    (1) If the inspection was done after the effective date of this
AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was accomplished prior to the effective
date of this AD: Submit the report within 30 days after the
effective date of this AD.

(k) Parts Installation Limitations

    As of the effective date of this AD, no person may install an
elevator tab control mechanism assembly, part number 65-79425-2, -3,
-4, -5, or -6, on any airplane, unless the assembly has been
inspected in

accordance with paragraph (i) of this AD both before and after
installation.

(l) Paperwork Reduction Act Burden Statement

    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.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in the
Related Information section of this AD. Information may be emailed
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(n) Related Information

    For more information about this AD, contact Kelly McGuckin,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-27A1302, dated April 24,
2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate; 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 28, 2012.
Ali Bahrami,
Manager, Transport Airplanes Directorate, Aircraft Certification
Service.
[FR Doc. 2012-24949 Filed 10-16-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Rules and Regulations]
[Pages 16924-16926]
[FR Doc No: 2017-06879]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2014-0428; FRL-9960-95-Region 4]

Air Plan Approval; NC; Infrastructure Requirements for the 2012
PM2.5 National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve portions of the State Implementation Plan (SIP)
submission, submitted by the State of North Carolina, through the
Department of Environmental Quality (DEQ), on December 4, 2015, for
inclusion into the North Carolina SIP, to demonstrate that the State
meets the infrastructure requirements of the Clean Air Act (CAA or Act)
for the 2012 annual fine particulate matter (PM2.5) national
ambient air quality standard (NAAQS). The CAA requires that each state
adopt and submit a SIP for the implementation, maintenance and
enforcement of each NAAQS promulgated by EPA, which is commonly
referred to as an ``infrastructure SIP submission.'' DEQ certified that
the North Carolina SIP contains provisions that ensure the 2012 Annual
PM2.5 NAAQS is implemented, enforced, and maintained in
North Carolina. EPA has determined that portions of North Carolina's
SIP satisfies certain required infrastructure elements for the 2012
Annual PM2.5 NAAQS.

DATES: This rule will be effective May 8, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2014-0428. All documents in the docket
are listed on the 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 www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation 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 a.m. to 4:30 p.m.,
excluding federal holidays.

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

SUPPLEMENTARY INFORMATION:

I. Background and Overview

    On December 14, 2012, EPA promulgated a revised primary annual
PM2.5 NAAQS. The standard was strengthened from 15.0
micrograms per cubic meter ([mu]g/m\3\) to 12.0 [mu]g/m\3\. See 78 FR
3086 (January 15, 2013). Pursuant to section 110(a)(1) of the CAA,
states are required to submit SIPs meeting the applicable requirements
of section 110(a)(2) within three years after promulgation of a new or
revised NAAQS or within such shorter period as EPA may prescribe.
Section 110(a)(2) requires states to address basic SIP elements such as
requirements for monitoring, basic program requirements and legal
authority that are designed to assure attainment and maintenance of the
NAAQS. States were required to submit such SIPs for the 2012 Annual
PM2.5 NAAQS to EPA no later than December 14, 2015.
    In a proposed rulemaking published on July 21, 2016 (81 FR 47314),
EPA proposed to approve portions of North Carolina's December 4, 2015,
SIP submission for the 2012 Annual PM2.5 NAAQS with the
exception of the interstate transport requirements of section
110(a)(2)(D)(i)(I) and (II) (prongs 1 through 4) and preconstruction
prevention of significant deterioration (PSD) permitting requirements
for major sources of section 110(a)(2)(C) and (J). On September 14,
2016 (81 FR 63107), EPA finalized approval in part and disapproval in
part of North Carolina's December 4, 2015, infrastructure SIP
submission regarding the PSD permitting requirements for major sources
of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2012 Annual
PM2.5 NAAQS. Additionally, on June 3, 2016, EPA finalized a
rule related to the prong 4 element of North Carolina's December 4,
2015, SIP submission for the 2012 Annual PM2.5 NAAQS. See 81
FR 35634. Therefore, EPA is not taking final action pertaining to
sections 110(a)(2)(C), prongs 3 and 4 of D(i) and (J) for North
Carolina for the 2012 Annual PM2.5 NAAQS in this action.
With respect to the interstate transport requirements of section
110(a)(2)(D)(i)(I) (prongs 1 and 2), EPA will consider these
requirements in relation to North Carolina's 2012 Annual
PM2.5 NAAQS infrastructure submission in a separate
rulemaking. The details of North Carolina's submission and the
rationale for EPA's actions for this final rule are explained in the
July 21, 2016, proposed rulemaking. Comments on the proposed rulemaking
were due on or before August 22, 2016. EPA received no comments,
adverse or otherwise.

II. Final Action

    EPA is taking final action to approve North Carolina's
infrastructure

submission submitted on December 4, 2015, for the 2012 Annual
PM2.5 NAAQS for the infrastructure SIP requirements, with
the exception of the interstate transport requirements of section
110(a)(2)(D)(i)(I) and (II) (prongs 1 through 4) and preconstruction
PSD permitting requirements for major sources of section 110(a)(2)(C)
and (J). EPA is taking final action to approve all other elements of
North Carolina's infrastructure SIP submission for the 2012 Annual
PM2.5 NAAQS because the submission is consistent with
section 110 of the CAA. EPA notes that the Agency is not approving any
specific rule, but rather approving that North Carolina's already
approved SIP meets certain CAA requirements.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.
    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 action 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 June 6, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements, Volatile organic compounds.

    Dated: March 15, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart II--North Carolina

0
2. Section 52.1770(e) is amended by adding a new entry ``110(a)(1) and
(2) Infrastructure Requirements for the 2012 Annual PM2.5
NAAQS'' at the end of the table to read as follows:

Sec.  52.1770   Identification of plan.

* * * * *
    (e) * * *

                              EPA-Approved North Carolina Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                         State
             Provision                 effective     EPA  approval     Federal Register         Explanation
                                         date            date               notice
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2) Infrastructure         12/4/2015        4/7/2017  [Insert citation of    With the exception of
 Requirements for the 2012 Annual                                    publication].          section
 PM2.5 NAAQS.                                                                               110(a)(2)(D)(i)(I)
                                                                                and (II) (prongs 1
                                                                                through 4) and the
                                                                                PSD requirements of
                                                                                section 110(a)(2)(C)
                                                                                and (J).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-06879 Filed 4-6-17; 8:45 am]
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[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19714-19715]
[FR Doc No: 2013-07577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0051]

User Fees and Refunds for Premarket Approval Applications and
Device Biologics License Applications; Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``User Fees and Refunds for
Premarket Approval Applications (PMAs) and Device Biologics License
Applications (BLAs).'' The purpose of this guidance document is to
identify the types of PMAs and BLAs subject to device user fees,
including supplements and other submissions, as well as those that do
not have an associated user fee. The guidance also identifies industry
and FDA actions on these submissions that may result in a refund of the
fee. The draft of this document was issued on March 16, 2009.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``User Fees and Refunds for Premarket Approval
Applications and Device Biologics License Applications'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002 or Office of Communication, Outreach and
Development (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist that
office in processing your request, or fax your request to<PHONE_NUMBER>.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medical Device User Fee Amendments of 2012 (MDUFA III), amended
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize
FDA to collect user fees for the review of certain premarket
submissions received on or after October 1, 2012, including PMAs and
device BLAs. The additional funds obtained from user fees will enable
FDA, with the cooperation of industry, to improve the medical device
review process to meet certain performance goals and implement
improvements for the medical device review process.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on user fees and refunds for PMAs and device
BLAs. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all Center for Devices and
Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``User Fees and Refunds for Premarket Approval
Applications and Device Biologics License Applications,'' you may
either send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1681 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.

V. Comments

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

    Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07577 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 15, 2008 (Volume 73, Number 73)]
[Rules and Regulations]
[Page 20163-20164]
[DOCID:fr15ap08-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29055; Airspace Docket 07-ASO-19]

Amendment of Class D and E Airspace; Jacksonville Cecil Field, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class D airspace and establishes Class
E airspace at Jacksonville Cecil Field, FL. An evaluation determined
the Class D airspace should be modified and a required Class E surface
airspace extension be established. This rule increases the safety and
efficiency of the National Airspace System enhancing operations with
adjacent Jacksonville Whitehouse Naval Out Lying Field (NOLF),
Jacksonville Naval Air Station (NAS) and the Jacksonville Herlong
Airport. This action additionally supports the Standard Instrument
Approach Procedures at Cecil Field by the establishment of a Class E4
airspace extension to the Class D.

DATES: Effective 0901 UTC, June 05, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Daryl Daniels, System Support, Eastern
Service Center, Federal Aviation Administration, P.O. Box 20636,
Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 10, 2007, the FAA published in the Federal Register a
NPRM to amend the Class D and E airspace at Jacksonville Cecil Field,
FL (72 FR 69640). Airspace evaluation identified the ability to reduce
the size of the current Class D airspace while continuing to provide
adequate support for the Standard Instrument Approach Procedures (SlAP)
and by the establishment a Class E surface area at Jacksonville Cecil
Field. The airspace was also adjusted to allow neighboring Herlong
Airport adequate airspace for its operations and a demarcation line was
established between Jacksonville Cecil's and Jacksonville Whitehouse
NOLF's Class D Airspace. This action will establish permanent
geographic dimensions for the Class D airspace which will be
independent of the surrounding airports Class D/Tower operation.
    Interested parties were invited to participate in this proposed
rulemaking by submitting such written data, views or arguments, as they
may have desired on the proposal to the FAA. Minor adjustments were
made to the description to enhance charting. No comments objecting to
the proposal were received.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class D airspace and establishes Class E4 airspace at
Jacksonville Cecil Field, FL by reducing the Class D airspace area to a
4.3-mile radius of Cecil Field excluding: (1) That airspace within a 1
.8-mile radius of Herlong Airport, (2) that airspace north of the
demarcation line between Jacksonville Cecil Field's and Jacksonville
Whitehouse's Class D airspace, and (3) that airspace designated as the
Jacksonville NAS Class D airspace. Additionally, this action provides
controlled airspace extending upwards for the surface of the Earth to
support the VHF Omnidirectional Range (VOR) Runway (RWY) 9 Standard
Instrument Approach Procedure (SlAP) at Cecil Field.
    Class D and E4 airspace designations for airspace areas extending
upwards from the surface of the Earth are published in Paragraph 5000
and 6004 of FAA Order 7400.9R, dated August 15, 2007, and effective
September 15, 2007, which is incorporated by reference in 14 CFR 71.1.
The Class D and E4 airspace designations listed in this document will
be published subsequently in the Order.

Agency Findings

    The regulations adopted herein will 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 various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    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.
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, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    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 modifies the Class D and establishes Class E4 airspace at
Jacksonville Cecil Field.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

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

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

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; ED. 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 Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, dated August 15, 2007, and effective September 15, 2007, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Jacksonville Cecil Field, FL [Revised]

Cecil Field, FL
    (Lat. 30[deg]13'07'' N., long. 81[deg]52'36'' W.)
Jacksonville NAS, FL

    (Lat. 30[deg]14'09'' N., long. 81[deg]40'50'' W.)
Whitehouse NOLF, FL
    (Lat. 30[deg]21'01'' N., long. 81[deg]52'59'' W.)
Herlong Airport
    (Lat. 30[deg]16'40'' N., long. 81[deg]48'21'' W.)

    That airspace extending upward from the surface of the Earth, to
and including 2,600 feet MSL, within a 4.3-mile radius of Cecil
Field; excluding that airspace within the Jacksonville NAS Class D
airspace area, excluding that airspace north of a line from lat.
30[deg]17'00'' N., long. 81[deg]50'24'' W. to lat. 30[deg]17'00''
N., long. 81[deg]54'47'' W., which abuts the Jacksonville Whitehouse
NOLF Class D airspace, and excluding that airspace within a 1.8-mile
radius of Herlong Airport. This Class D airspace area is effective
during the specific days and times established in advance by a
Notice to Airmen. The effective days and times will thereafter be
continuously published in the Airport/Facility Directory.
* * * * *

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D Surface Area.

* * * * *

ASO FL E4 Jacksonville Cecil Field, FL [New]

Cecil Field, FL
    (Lat. 30[deg]13'07'' N., long. 81[deg]52'36'' W.)
Cecil VOR
    (Lat. 30[deg]12'47'' N., long. 81[deg]53'27'' W.)

    That airspace extending upward from the surface of the Earth
within 2.4 miles each side of the Cecil VOR 286 radial extending
from the 4.3-mile radius to 7 miles west of the VOR. This Class E
airspace area is effective during the specific days and times
established in advance by a Notice to Airmen. The effective days and
times will thereafter be continuously published in the Airport/
Facility Directory.
* * * * *

    Issued in College Park, Georgia, on March 27, 2008.
Mark D. Ward,
Manager, System Support Group, Eastern Service Center.
[FR Doc. E8-7669 Filed 4-14-08; 8:45 am]

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