Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2012-49 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2012-49. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of NYSE. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-NYSE-2012-49, and should be submitted on or before February 12,
2013.

VII. Conclusion

    In summary, and for the reasons discussed in more detail above, the
Commission believes that the rules being adopted by NYSE, taken as
whole, should benefit investors by helping listed companies make
informed decisions regarding the amount and form of executive
compensation. NYSE's new rules will help to meet Congress's intent that
compensation committees that are responsible for setting compensation
policy for executives of listed companies consist only of independent
directors.
    NYSE's rules also, consistent with Rule 10C-1, require compensation
committees of listed companies to assess the independence of
compensation advisers, taking into consideration six specified factors.
This should help to assure that compensation committees of NYSE-listed
companies are better informed about potential conflicts when selecting
and receiving advice from advisers. Similarly, the provisions of NYSE's
standards that require compensation committees to be given the
authority to engage and oversee compensation advisers, and require the
listed company to provide for appropriate funding to compensate such
advisers, should help to support the compensation committee's role to
oversee executive compensation and help provide compensation committees
with the resources necessary to make better informed compensation
decisions.
    For the foregoing reasons, the Commission finds that the proposed
rule change, SR-NYSE-2012-49, as modified by Amendment Nos. 1 and 3, is
consistent with the Act and the rules and regulations thereunder
applicable to a national securities exchange, and, in particular, with
Section 6(b)(5) of the Act.\184\
---------------------------------------------------------------------------

    \184\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\185\ that the proposed rule change, SR-NYSE-2012-49, as modified
by Amendment Nos. 1 and 3, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \185\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\186\
---------------------------------------------------------------------------

    \186\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01106 Filed 1-18-13; 8:45 am]
BILLING CODE 8011-01-P


Overview
The modeling analysis determined the extent and significant contributors to predicted 1-hour sulfur dioxide (SO2) exceedances in the Muscatine area.  Model predictions regarding the culpability of facilities in the area to the predicted exceedances were used to develop SO2 emissions control measures for the affected facilities.  The control measures show modeled attainment of the 1-hour SO2 National Ambient Air Quality Standard (NAAQS).  This section summarizes the modeling analysis conducted for the attainment demonstration.
Model Selection and Options
Air Quality Model Selection:  The dispersion model used for this analysis was the American Meteorological Society/Environmental Protection Agency Regulatory Model (AERMOD).  The most current version of AERMOD available during each phase of the analysis was used.  Preliminary analyses were not reevaluated with the newest version of AERMOD. The final control strategy analysis utilized version 14134.
All analyses were conducted with EPA's regulatory default options.  The modeling analysis was conducted using the latest EPA guidance available for evaluating SO2 impacts.  This guidance includes the August 23, 2010 1-hour SO2 clarification memo; the applicable portions of the March 1, 2011 1-hour NO2 clarification memo; and the applicable portions of the December 2013 SO2 Technical Assistance Document (TAD).
Receptor Grid/Spacing/Terrain Elevations:  The receptor grid was centered on the Musser Park monitor, and extended out to the edges of the nonattainment area.  The grid utilized 50-meter receptor spacing along property boundaries and extending out to 0.5 kilometers from the Musser Park monitor, 100-meter spacing out to 1.5 kilometers, 250-meter spacing out to 3 kilometers, 500-meter spacing out to 5 kilometers, and 1000-meter spacing beyond 5 km.  The receptor grid encompassed the entire nonattainment area.
Those portions of the fence lines of the facilities being evaluated that fall outside of the nonattainment area were omitted from the analysis.  Finer grid spacing of 50 meters was used to resolve modeled impacts around other nearby individual facilities included in the analyses, but only within the confines of the nonattainment area.  Receptors were excluded from areas within the property boundaries of each facility in the analysis.
The most recent version of AERMAP (11103) was used to import terrain and source elevations from the National Elevation Dataset (NED).
Downwash: All building downwash analyses were conducted using the most recent version (04274) of EPA's Building Profile Input Program with Plume Rise Enhancements (BPIP-Prime).
Meteorological Data:    A detailed representivity analysis to support the use of Davenport meteorological data was previously approved by EPA for use in the PM2.5 Muscatine SIP analysis.  Modeling for the SO2 Muscatine SIP submittal was conducted using the surface station and upper air data from Davenport, and used consecutive years from 2008-2012.  This represents the most recent, readily available 5-year period at the time of the initial analysis per section <IP_ADDRESS> of 40 CFR Part 51 Appendix W.
The most current version of AERMET available during each phase of the analysis was used.  The data used in the preliminary analyses were not updated with the newest version of AERMET.  The final control strategy analysis utilized data processed with AERMET version 14134.
Modeled Sources
Source Inventory:  A modeling analysis was conducted in support of the Technical Support Document (TSD) developed by the Department in April, 2013 to evaluate proposed SO2 non-attainment boundaries in Muscatine County.  That analysis demonstrated that industrial sources along the Mississippi River have a role in causing or contributing to monitored exceedances at the Musser Park SO2 monitor.  Based on this analysis, all major sources of SO2 emissions within the nonattainment area were included in the SIP analysis.  These sources include Grain Processing Corporation (GPC), Muscatine Power and Water (MPW), and Monsanto.
The MidAmerican Energy  -  Louisa Generating Station (LGS) facility is located immediately south of the nonattainment area.  This source was shown to be insignificant at the Musser Park monitor during predicted exceedances, but it is possible that it could cause a significant concentration gradient in the vicinity of the southern portion of the nonattainment area.  For this reason, LGS was also included in the modeling analysis.  There are two other major sources of SO2 emissions in the vicinity of the Muscatine SO2 nonattainment area, Gerdau Ameristeel (Gerdau) and SSAB, but they were both screened out of the analysis due to their low SO2 emissions and distance from the nonattainment area.
The relative locations of the sources in the modeling inventory are shown in Figure 1. All emission units were modeled using their actual stack parameters and site layout.  There were no stacks above formula GEP height.  There are stacks greater than 65 meters at GPC, MPW and Louisa.  The tallest stack at Monsanto is 49 meters.  Each stack that is taller than 65 meters is adjacent to tall buildings making the formula height taller than the actual stack height (Table 1).  Therefore each of these stacks were modeled at their actual stack heights.
Figure 1. Facility Locations

Table 1. Tall Stack GEP Height Determination.
Facility
Emission Point
Actual Height
(meters)
GEP Formula Height
(meters)
GPC
EP001.0
66.75
82.95
MPW
EP70
67.06
81.32

EP80
68.58
81.32

EP90
91.44
131.34
LGS
EP1
185.93
194.66
Intermittent Sources:  Per EPA's March 1, 2011 clarification memo all emission units that operate intermittently were excluded from the analysis.  Emergency engines and fire pumps that operate intermittently were excluded.  Additionally, emission units that are limited to burning a specific fuel intermittently were modeled at emission rates that represent the fuel that is burned during normal operations.  The two auxiliary boilers (EP2 and EP3) at Louisa are limited to burning fuel oil for no more than 48 hours per year.  These two sources were modeled at emission rates associated with burning natural gas.
Background Value
Temporally varying background concentrations by hour and season from the Davenport SO2 monitor were used to account for contributions to the predicted impacts from background SO2 sources.  The background values account for emissions from natural sources, major and minor sources not included in the analysis, and unidentified sources.  The existing statewide SO2 monitoring network was evaluated for an appropriate background (Table 2).
Table 2. Comparison of Existing SO2 Monitoring Sites.
                               Monitor Location
                    2011-2013 Monitor Design Concentration
                                     (ppb)
                       2013 County-wide SO2 Emissions[A]
                                    (tons)
                           Proximity to SO2 Sources
                                 Cedar Rapids
                            23 (average of 2 sites)
                                     6,419
                               Adjacent / 1+ km
                                    Clinton
                                      38
                                     3,642
                                   Adjacent
                                   Davenport
                                      15
                                     4,771
                                     1+ km
                                  Des Moines
                                       1
                                      163
                                     5+ km
                                  Lake Sugema
                                       3
                                      ~0
                                   >10 km
                                   Muscatine
                                      217
                                    20,086
                                   Adjacent
                              Default (Tier 1)[B]
                                     10.5
                                      ---
                                      ---
[A]	Includes major and minor point sources.
[B]	Average of 2011-2013 design values for Cedar Rapids, Davenport, Des Moines, and Lake Sugema.

All major sources in Muscatine County were explicitly included in the modeling analysis except for Gerdau and SSAB.  Both of these sources are approximately 8-9 km away from the non-attainment boundary.  These two sources combined accounted for 254 of the 20,086 tons of SO2 emitted in Muscatine County in 2013.  The next closest major sources not included in the modeling analysis are Linwood and Lafarge, which are located in Scott County, approximately 20 km away from the non-attainment area.  These two distant sources accounted for 1,539 of the 4,771 tons of SO2 emitted in Scott County in 2013.  In addition, the most recently available emissions data from all minor sources in Muscatine County totaled approximately 2 tons/yr.  The ideal background would represent the contribution from these major and minor sources as well as any unknown or natural sources, while at the same time not include the contribution from the sources being explicitly modeled.
The Muscatine monitors are impacted heavily by sources that are being explicitly included in the modeling analysis.  As such those monitors were eliminated as an option to represent the background concentrations in the area.  Of the remaining monitor locations, two are situated adjacent to industrialized areas (Cedar Rapids and Clinton), and could overestimate the concentrations caused by distant major sources.  The Des Moines and Lake Sugema monitors are impacted by less SO2 emissions than need to be represented by the background for the nonattainment area.  Therefore, the Davenport monitor was evaluated to determine if it would be a representative site.
The Davenport monitor is the nearest location other than those in Muscatine.  The Davenport monitor is near a moderately industrialized area, but is not situated adjacent to those sources of emissions.  It is approximately 1 km from the nearest industry and 11 km from Linwood and Lafarge.  It is in a county with a moderate amount of SO2 emissions.  For these reasons it could account for the sources screened out of the control strategy, major sources in Scott County that may impact the Muscatine area (such as Lafarge and Linwood), minor sources in Muscatine County (approximately 2 tons), and more distant sources that could impact the Muscatine area (as measured at Lake Sugema).  In addition, using this monitor is consistent with the meteorological data used for the analysis.
To account for seasonal and diurnal variations in the background levels, the background concentration was based on the average diurnal and seasonal concentration pattern observed at the Davenport monitor during the years 2011-2013.  As referenced in Appendix A of the Guidance for 1-hour SO2 Nonattainment Area SIP Submissions, "an appropriate methodology for calculating temporally varying background monitored concentrations by hour and season" is outlined in the SO2 NAAQS Designations Modeling TAD and in the March 2011 EPA guidance for 1-hour NO2 Modeling.
For the years 2011 through 2013, the 99th percentile monitor concentration was calculated for each season and hour of day and averages of these values across the three years (Figure 2).
Figure 2: Davenport Monitor Concentrations by Season and Hour of Day

Only one hour in the winter approaches the overall 99[th] percentile design value for the Davenport monitor and the default (Tier 1) background value of 10.5 ppb is higher than all but one of the seasonal/diurnal concentrations.  This shows that the use of the default (Tier 1) value for all hours and seasons would have been very conservative.  The method of using temporally varying background monitor concentrations by hour and season from the Davenport monitor is still conservative as it is calculated from the 99[th] percentile versus an unbiased estimate from average values, which would yield a much lower background value.
Modeling Analysis Methodology and Results
The modeling analysis was conducted in multiple iterations as part of two distinct phases.  The first phase of the analysis was a screening analysis to determine the sources that needed to be included in the analysis.  The second phase of the analysis was used to develop the control strategy and included all significant sources identified for inclusion in the analysis from Phase 1.
Phase 1  -  Preliminary Analysis:  This phase was accomplished by modeling actual emissions from each facility and then determining what percentage of predicted NAAQS exceedances each facility significantly contributed to.  This information was further subdivided by classifying the significant contributions as either primary or secondary contributors.  If the facility's significant contribution to the predicted NAAQS exceedance was greater than or equal to half of the total concentration (minus background) it was considered the primary contributor.  If the facility's contribution was less than half of the total concentration, but still more than the Significant Impact Level (SIL) it was considered a secondary contributor.
Each iteration of this phase implemented new information received from the facilities during the course of the analysis.  The last of the iterations of Phase 1 represented the best picture of predicted concentrations caused by actual emissions from each facility.  The results of this analysis are summarized in Figure 3 below.

Figure 3. Culpability Analysis Results

GPC was identified as the primary contributor to all predicted NAAQS exceedances within the nonattainment area.  MPW, Louisa, and Monsanto also all had significant contributions at multiple predicted exceedances.  Both SSAB and Gerdau were evaluated at their allowable emission rates, and were insignificant at each predicted NAAQS exceedance.  As such, these two sources were not included in the second phase of the analysis.
Phase 2  -  Control Strategy Development:  Sources identified in Phase 1 were modeled at their maximum permitted allowable emission rates.  Using the process summarized below, more restrictive maximum permitted emission rates were developed where necessary to ensure modeled attainment.
GPC was provided with a model input file that included its emission units as well as the exceedance receptors to which it contributed.  GPC reviewed the input data for accuracy and then mitigated all modeled exceedances caused by their facility alone.  Since GPC was the primary contributor at every predicted exceedance, subsequent iterations of this phase were completed after GPC's initial control strategy was submitted.
The remaining facilities were then added to the analysis with their maximum permitted allowable emission rates and the cumulative impacts were determined across the entire nonattainment area.  Any remaining predicted exceedances were then discussed with the affected facilities and additional control measures were developed.
Monsanto proposed to decrease the emission rate for Boiler 8 at their facility to mitigate a small number of exceedances just north of their property.
MPW proposed multiple operational scenarios for their three main boilers (Units 7, 8, and 9).  The model results varied depending on which combination of boilers was running.  The modeling results for each scenario (with background included) are summarized in Table 3.
Table 3.  Comparison of Cumulative SO2 Modeling Results to NAAQS for MPW Operating Scenarios
                                 MPW Scenario
                            Cumulative Model Result
                                  (ug/m[3])
                               1-hour SO2 NAAQS
                                  (ug/m[3])
                                      All
                                    181.35
                                      196
                                    U9 Off
                                    181.91

                                    U8 Off
                                    182.05

                                    U7 Off
                                    181.99

                                    U7 Only
                                    180.94

                                    U8 Only
                                    181.80

                                    U9 Only
                                    180.41

These results indicate that all currently proposed operational scenarios at MPW combined with all mitigation strategies at each facility will result in attainment of the 1-hour SO2 NAAQS.


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Rules and Regulations]
[Page 16205]
[FR Doc No: 2019-07829]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-6238]

Listing of Color Additives Exempt From Certification; Synthetic
Iron Oxide; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is confirming the
effective date of December 4, 2018, for the final rule that appeared in
the Federal Register of November 1, 2018, and that amended the color
additive regulations to provide for the expanded safe use of synthetic
iron oxides as color additives to include use in dietary supplement
tablets and capsules.

DATES: Effective date of final rule published in the Federal Register
of November 1, 2018 (83 FR 54869) confirmed: December 4, 2018.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 1, 2018
(83 FR 54869), we amended the color additive regulations in Sec.
73.200, ``Synthetic iron oxide'' (21 CFR 73.200), to provide for the
expanded safe use of synthetic iron oxides as color additives in
dietary supplement tablets and capsules, including coatings and
printing inks, such that the total amount of elemental iron per day for
labeled dosages does not exceed 5 milligrams.
    We gave interested persons until December 3, 2018, to file
objections or requests for a hearing. We received no objections or
requests for a hearing on the final rule. Therefore, we find that the
effective date of the final rule that published in the Federal Register
of November 1, 2018, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and
under authority delegated to the Commissioner of Food and Drugs, we are
giving notice that no objections or requests for a hearing were filed
in response to the November 1, 2018, final rule. Accordingly, the
amendments issued in the final rule became effective December 4, 2018.

    Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07829 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 167 (Wednesday, August 30, 2023)]
[Notices]
[Pages 59913-59914]
[FR Doc No: 2023-18726]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-11362-01-R6]

Clean Air Act Operating Permit Program; Petition for Objection to
State Operating Permit for XTO Energy Inc., Wildcat Compressor Station,
Lea County, New Mexico

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final Order on Petition for objection to Clean Air
Act title V operating permit.

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

SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order dated August 7, 2023, granting in part and denying in part a
Petition from the WildEarth Guardians dated March 1, 2023. The Petition
requested that the EPA object to the Clean Air Act (CAA) title V
operating permit issued by the New Mexico Environment Department (NMED)
to XTO Energy Inc., Wildcat Compressor Station, located in Lea County,
New Mexico.

ADDRESSES: The EPA requests that you contact the individual listed in
the FOR FURTHER INFORMATION CONTACT section to view copies of the final
Order, the Petition, and other supporting information. Please call or
email the contact listed below if you need alternative access to the
final Order and Petition, which are available electronically at:
https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Elizabeth Layton, EPA Region 6 Office,
Air Permits Section,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: The CAA affords the EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities under title V of the CAA. Section
505(b)(2) of the CAA authorizes any person to petition the EPA
Administrator to object to a title V operating permit within 60 days
after the expiration of the EPA's 45-day review period if the EPA has
not objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or unless the grounds for the issue arose
after this period.
    The Petitioner claims that the Proposed Permit fails to ensure the
facility operates in compliance with the New Mexico State
Implementation Plan (SIP) by lacking a reasoned explanation, basis, or
analysis demonstrating how the Proposed Permit will ensure the
facility's operation will not cause or contribute to an exceedance in
the National Ambient Air Quality Standard (NAAQS) for ozone, fails to
include emission limitations and standards necessary to assure
compliance with applicable requirements, and fails to include
sufficient periodic monitoring

and is unenforceable as a practical matter.
    On August 7, 2023, the EPA Administrator issued an Order granting
in part and denying in part the Petition. The Order explains the basis
for the EPA's decision.
    Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner
may request judicial review of those portions of an order that deny
issues in a petition. Any petition for review shall file in the United
States Court of Appeals for the appropriate circuit no later than
October 30, 2023.

    Dated: August 24, 2023.
David Garcia,
Director, Air and Radiation Division, Region 6.
[FR Doc. 2023-18726 Filed 8-29-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66051-66052]
[FR Doc No: 2016-23191]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2016-0023; OMB No. 1660-0125]

Agency Information Collection Activities: Proposed Collection;
Comment Request; FEMA Preparedness Grants: Homeland Security Grant
Program (HSGP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the Homeland Security Grant
Program (HSGP).

DATES: Comments must be submitted on or before November 25, 2016.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2016-0023. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Belkin, Branch Chief, FEMA, Grant
Programs Directorate,<PHONE_NUMBER>. You may contact the Records
Management Division for copies of the proposed collection of
information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FEMA's Homeland Security Grant Program
(HSGP) supports State and local efforts to prevent terrorism and other
catastrophic events and to prepare the Nation for the threats and
hazards that pose the greatest risk to the security of the United
States. The HSGP provides funding to implement investments that build,
sustain, and deliver the 31 core capabilities essential to achieving
the National Preparedness Goal (the Goal) of a secure and resilient
Nation. The building, sustainment, and delivery of these core
capabilities are not exclusive to any single level of government,
organization, or community, but rather, require the combined effort of
the whole community. The HSGP supports core capabilities across the
five mission areas of Prevention, Protection, Mitigation, Response, and
Recovery based on allowable costs. HSGP is comprised of three grant
programs: State Homeland Security Program (SHSP), Urban Area Security
Initiative (UASI), and Operation Stonegarden (OPSG). Together, these
grant programs fund a range of activities, including planning,
organization, equipment purchase, training, exercises, and management
and administration across all core capabilities and mission areas. The
authorizing authority of the HSGP is Section 2002 of the Homeland
Security Act of 2002, as amended (Pub. L. 107-296), (6 U.S.C. 603).

Collection of Information

    Title: FEMA Preparedness Grants: Homeland Security Grant Program
(HSGP).
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0125.
    FEMA Forms: FEMA Form 089-1, HSGP Investment Justification (SHSP
and UASI); FEMA Form 089-16, OPSG Operations Order Report; FEMA Form
089-20, OPSG Inventory of Operation Orders; FEMA Form 089-0-27,
Operation Stonegarden Daily Activity Report (DAR).
    Abstract: The HSGP is an important tool among a comprehensive set
of measures to help strengthen the Nation against risks associated with
potential terrorist attacks. DHS/FEMA uses the information to evaluate
applicants' familiarity with the national preparedness architecture and
identify how elements of this architecture have been incorporated into
regional/State/local planning, operations, and investments.
    The HSGP is a primary funding mechanism for building and sustaining
national preparedness capabilities. The HSGP is comprised of three
separate grant programs: The SHSP, the UASI,

and OPSG. Together, these grants fund a range of preparedness
activities, including planning, organization, equipment purchase,
training, exercises, and management and administration costs. The OPSG
will begin to utilize the Office of Management and Budget's web-based
portal MAX.GOV, at https://www.MAX.GOV/, for operational management of
the grant program. The HSGP now requires applicants to submit the
SAFECOM Compliance Letter, which has been added to this collection. The
compliance letter certifies that the applicant will comply with SAFECOM
Guidance when implementing interoperable communications projects. The
letter will be attached in the Non-Disaster Grants Management System as
part of the HSGP application.
    Affected Public: State, Local or Tribal Government.
    Number of Respondents: 664.
    Number of Responses: 53,920.
    Estimated Total Annual Burden Hours: 269,579 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $16,587,196. There are no annual costs to respondents'
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$2,022,270.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: September 21, 2016.
Richard W. Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-23191 Filed 9-23-16; 8:45 am]
 BILLING CODE 9111-19-P


[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76970-76971]
[FR Doc No: 2010-31016]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-40-000]

East Cheyenne Gas Storage, LLC; Notice of Amendment

December 3, 2010.
    Take notice that on November 19, 2010, East Cheyenne Gas Storage,
LLC (East Cheyenne), 10901 W. Toller Drive, Suite 200, Littleton,
Colorado 80127, filed in the captioned docket an application under
section 7 of the Natural Gas Act (NGA), as amended, and part 157 of the
Commission's

regulations for an order amending the certificate of public convenience
and necessity issued in Docket No. CP10-34-000 to authorize East
Cheyenne to make certain changes to its certificated Project, which
relate primarily to the design and number of wells to be employed in
the initial Project development, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to James
F. Bowe, Jr., Dewey & LeBoeuf LLP, 1101 New York Avenue, NW.,
Washington, DC 20005-4213, at<PHONE_NUMBER>.
    East Cheyenne also seeks reaffirmation of its previously granted
authorization to charge market-based rates for its storage and hub
services, as well as the various waivers granted in the order issuing
certificates. East Cheyenne also requests that the Commission rescind
the pre-granted abandonment authorization issued to East Cheyenne
because East Cheyenne no longer plans to construct the temporary West
Peetz Compressor Station. East Cheyenne refers to this project as the
``Well Plan Amendment.''
    East Cheyenne states that it does not propose any change in
capacity, pressures, injection rates or withdrawal rates authorized by
the Commission in the original certificate order in this Application.
East Cheyenne represents that the Well Plan Amendment will have minimal
impact on the natural environment and on adjacent landowners.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: December 27, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-31016 Filed 12-9-10; 8:45 am]
BILLING CODE 6717-01-P


 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania  19103-2029

June 16, 2007

Ms. Joyce E. Epps, Director

Pennsylvania Department of Environmental Protection

Bureau of Air Quality

Rachel Carson State Office Building

P.O. Box 2063

Harrisburg, PA  17105-2063

Dear Ms. Epps:

On June 14, 2007, the U.S. Environmental Protection Agency (EPA)
received revisions to the Pennsylvania State Implementation Plan (SIP)
from the Pennsylvania Department of Environmental Protection (PADEP).
These revisions requested the redesignation of the Clearfield/Indiana
(Clearfield and Indiana Counties) 8-hour ozone nonattainment area to
attainment, and approval of the area’s maintenance plan and 2002 base
year inventory.  EPA has determined that the submittal is
administratively and technically complete, and is reviewing it to
prepare a Notice of Proposed Rulemaking (NPR).

If members of your staff have any questions, they may direct them to
LaKeshia N. Robertson, Air Quality Planning Branch, at<PHONE_NUMBER>.
She is the principal contact for this rulemaking.

		Sincerely,

						\s\

   		Judith M. Katz, Director

                          		   		Air Protection Division  (3AP00)

cc:   Dean E. Van Orden, PADEP

 Arleen Shulman, PADEP

	Customer Service Hotline: 1-800-438-2474


[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Page 489]
[FR Doc No: 2015-33262]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Orthopaedic and
Rehabilitation Devices Panel of the Medical Devices Advisory Committee.
This meeting was announced in the Federal Register of November 23,
2015. The amendment is being made to reflect a change in the Agenda
portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Sara Anderson, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1643,
10903 New Hampshire Ave., Silver Spring, MD 20993,
<EMAIL_ADDRESS>301-796-7047, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 23,
2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and
Rehabilitation Devices Panel of the Medical Devices Advisory Committee
would be held on February 19, 2016. On page 72972, in the first column,
the Agenda portion of the document is changed to read as follows:
    The Committee will discuss, make recommendations, and vote on
information regarding the premarket application (PMA) for the DIAM
Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA.
The DIAM Spinal Stabilization System is indicated for skeletally mature
patients that have moderate low back pain (with or without radicular
pain) with current episode lasting less than 1 year in duration
secondary to lumbar degenerative disc disease (DDD) at a single
symptomatic level from L2-L5. DDD is confirmed radiologically with one
or more of the following factors: (1) Patients must have greater than 2
mm of decreased disc height compared to the adjacent level; (2)
scarring/thickening of the ligamentum flavum, annulus fibrosis, or
facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device
is implanted via a minimally invasive posterior approach.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33262 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Proposed Rules]
[Pages 1543-1547]
[FR Doc No: 2023-00330]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R09-OAR-2022-0953; FRL-10502-01-R9]

Designation of Areas for Air Quality Planning Purposes;
California; Coachella Valley Ozone Nonattainment Area; Reclassification
to Extreme

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Under the Clean Air Act (CAA or ``Act''), the Environmental
Protection Agency (EPA) is proposing to approve a request from the
State of California to reclassify the Coachella Valley ozone
nonattainment area from ``Severe-15'' to ``Extreme'' for the 2008 ozone
national ambient air quality standards (NAAQS). This action does not
reclassify any areas of Indian country within the boundaries of the
Coachella Valley 2008 ozone nonattainment area. Upon final
reclassification of the Coachella Valley ozone nonattainment area as an
Extreme nonattainment area for the 2008 ozone NAAQS, the applicable
attainment dates would be as expeditiously as practicable but no later
than July 20, 2032. The EPA is proposing to establish a deadline of no
later than 18 months from the effective date of reclassification for
submittal of revisions to the Coachella Valley portion of the
California SIP to meet additional requirements for Extreme ozone
nonattainment areas. Lastly, the EPA is proposing to extend our
previous limited approval of the motor vehicle emissions budgets to new
budgets to be developed as part of a SIP submission meeting the Extreme
area requirements for the Coachella Valley.

DATES: Written comments must arrive on or before February 10, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0953 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. 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, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For 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. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Khoi Nguyen, Air Planning Office (AIR-
2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415)
947-4120, or by email at [email protected].

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

Table of Contents

I. Reclassification as Extreme Nonattainment and Extreme Area SIP
Requirements
    A. Reclassification as Extreme and Applicable Attainment Date
    B. Clean Air Act Requirements for Extreme Ozone Nonattainment
Area Plans
II. Motor Vehicle Emissions Budgets
III. Summary of Proposed Action and Request for Public Comment
IV. Statutory and Executive Order Reviews

I. Reclassification as Extreme Nonattainment and Extreme Area SIP
Requirements

A. Reclassification as Extreme and Applicable Attainment Date

    Effective July 20, 2012, the EPA designated and classified the
Riverside County (Coachella Valley), California, nonattainment area
(``Coachella Valley'') as ``Severe-15'' nonattainment for the 2008
ozone NAAQS.\1\ Air quality in the Coachella Valley is jointly overseen
by the South Coast Air Quality Management District (``District'') and
the California Air Resources Board (CARB). The Coachella Valley is
located within a portion of Riverside County, and its geographic
borders also include Indian country under the jurisdiction of six
federally recognized tribes.\2\ Our classification of the Coachella
Valley as a Severe-15 ozone nonattainment area established a
requirement that the area attain the 2008 ozone NAAQS as expeditiously
as practicable, but no later than 15 years from the date of designation
as nonattainment, i.e., July 20, 2027.\3\
---------------------------------------------------------------------------

    \1\ 77 FR 30088 (May 21, 2012). The 2008 ozone NAAQS is 0.075
parts per million (ppm), daily maximum 8-hour average. The 2008
ozone NAAQS is met at an ambient air quality monitoring site when
the 3-year average of the annual fourth-highest daily maximum 8-hour
average ozone concentration is less than or equal to 0.075 ppm. See
40 CFR 50.15.
    \2\ For a precise definition of the boundaries of the Coachella
Valley 2008 ozone nonattainment area, see 40 CFR 81.305.
    \3\ Throughout this document, we use ``Severe'' to refer to
Severe areas that have 15 years to attain the ozone standards.''
---------------------------------------------------------------------------

    On November 15, 2022, CARB submitted a request to the EPA seeking a
voluntary reclassification of the Coachella Valley from Severe-15 to
Extreme for the 2008 ozone NAAQS.\4\ We are proposing to approve CARB's
reclassification request under the ``voluntary reclassification''
provisions of section 181(b)(3) of the Act, which mandates that the EPA
approve such a request. Upon final reclassification, the applicable
attainment dates will be as expeditiously as practicable, but no later
than 20 years from the area's date of designation as nonattainment,
i.e., July 20, 2032.
---------------------------------------------------------------------------

    \4\ Letter dated November 15, 2022, from Steven S. Cliff,
Executive Officer, CARB, to Martha Guzman, Regional Administrator,
EPA Region IX (submitted electronically November 15, 2022).
---------------------------------------------------------------------------

    Because the State of California does not have jurisdiction over
Indian country geographically located within the borders of the state,
CARB's request to reclassify the Coachella Valley does not apply to
Indian country under the jurisdiction of the tribes identified in 40
CFR 81.305. In these areas of Indian country, the EPA implements
federal CAA programs, including reclassifications, consistent with our
discretionary authority under sections 301(a) and 301(d)(4) of the CAA.
When the EPA designated the Coachella Valley as nonattainment for the
2008 ozone NAAQS, we included the jurisdictional lands of the six
federally recognized tribes located within the boundaries of the
nonattainment area: the Agua Caliente Band of Cahuilla Indians; the
Augustine Band of Cahuilla Mission Indians; the Cabazon Band of
Cahuilla Indians; \5\ the Santa Rosa Band of Cahuilla Indians; the
Torres Martinez Desert Cahuilla Indians; and the Twenty-Nine Palms Band
of Mission Indians.
---------------------------------------------------------------------------

    \5\ The designation table at 40 CFR 81.305 lists the Cabazon
Band of Cahuilla Indians as the ``Cabazon Band of Mission Indians,''
which was the federally recognized name of the tribe at the time of
the designation.
---------------------------------------------------------------------------

    This action does not reclassify any areas of Indian country within
the Coachella Valley. Under the EPA's Consultation Policy, the EPA
consults on a government-to-government basis with federally recognized
tribal governments when the EPA's actions and decisions may affect
tribal interests.\6\ The EPA is currently undergoing this consultation
process and any proposed reclassification of tribal lands will be
addressed in a future rulemaking action.
---------------------------------------------------------------------------

    \6\ The EPA's Consultation Policy is available at https://www.epa.gov/tribal/epa-policy-consultation-and-coordination-indian-tribes.

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

B. Clean Air Act Requirements for Extreme Ozone Nonattainment Area
Plans

1. Extreme Area Plan Requirements
    Under CAA section 182(e), an attainment plan for an Extreme
nonattainment area must include the elements required for a Severe area
as well as additional plan elements for an Extreme area.\7\ Where
applicable, the plan elements should reflect the reduction of the major
source threshold under 182(e) from 25 tons per year (tpy) for a Severe
area to 10 tpy for an Extreme area. The requirements for an Extreme
area plan include, but are not limited to: (1) base year emissions
inventory (CAA sections 172(c)(3) and 182(a)(1)); (2) emissions
statement rule (CAA section 182(a)(3)(B)); (3) New Source Review (NSR)
program (CAA sections 172(c)(5), 173, 182(a)(2)(C), 182(d) and
182(d)(2)); (4) additional reasonably available control technology
(RACT) rules to address sources subject to the lower Extreme area major
source threshold (CAA section 182(b)(2)); (5) reasonably available
control measures (RACM) demonstration (CAA section 172(c)(1)); (6)
attainment demonstration (CAA sections 172(c)(1) and 182(c)(2)(A)); (7)
reasonable further progress (RFP) demonstration (CAA sections
172(c)(2), 182(b)(1), 182(c)(2)(B)); \8\ (8) contingency measures (CAA
sections 172(c)(9) and 182(c)(9)); (9) enhanced vehicle inspection and
maintenance program (CAA section 182(c)(3)); (10) clean fuels fleet
program (CAA sections 182(c)(4)(A) and 246); (11) enhanced ambient air
monitoring (CAA section 182(c)(1)); (12) transportation control
strategies and measures to offset emissions increases from vehicle
miles traveled (CAA section 182(d)(1)(A)); (13) CAA section 185 fee
program (CAA sections 182(d)(3) and 185); and (14) use of clean fuels
or advanced control technology for boilers (CAA section 182(e)(3)).
---------------------------------------------------------------------------

    \7\ CAA section 182(e) specifically excludes certain Severe area
requirements from the Extreme area requirements, e.g., CAA section
182(c)(6), (7), and (8).
    \8\ CAA section 182(e) does not allow the state to use the
provision at CAA section 182(c)(2)(B)(ii) that allows RFP reductions
of less than three percent per year based on additional
demonstrations.
---------------------------------------------------------------------------

    For the Coachella Valley, the District and State will need to
submit a plan that includes all elements required under CAA section
182(e), and that demonstrates attainment of the 2008 ozone NAAQS as
expeditiously as practicable but no later than July 20, 2032. The plan
should identify adopted measures sufficient to make the required RFP
and attainment demonstrations for the area.\9\
---------------------------------------------------------------------------

    \9\ CAA section 182(e)(5) allows the EPA to approve an Extreme
area attainment demonstration based on anticipated development of
new control techniques or improvement of existing control
technologies. This option requires a state to demonstrate that
provisions based on these new techniques or improvements are not
necessary to meet emission reductions required within the first 10
years after an area's designation as Extreme, and to submit, at
least three years before implementation of the proposed provisions
relying on new technology, contingency measures to be implemented in
case the anticipated technologies do not achieve the planned
reductions. Based on the shorter timeline to attainment (roughly
nine years from reclassification), use of CAA section 182(e)(5) is
not appropriate in this instance.
---------------------------------------------------------------------------

    For areas initially designated Extreme, the CAA and the EPA's ozone
SIP Requirements Rules (SRR) for the 2008 ozone NAAQS \10\ generally
provides, depending on the element, up to four years from the date of
designation to submit the required SIP elements to the EPA. For the
2008 ozone NAAQS, the statutory deadline for SIP submissions for areas
initially designated as Extreme was July 20, 2016. Under our general
CAA section 301(a) authority, the EPA proposes to establish a deadline
of 18 months from the effective date of the final reclassification for
the State to submit SIP revisions addressing the Extreme area
requirements for the Coachella Valley. This timeframe is consistent
with how the EPA has handled establishing SIP submission deadlines
under CAA section 182(i) for ozone areas reclassified by operation of
law under CAA section 181(b)(2),\11\ and generally aligns with the
timeframe established in our prior reclassification of the Coachella
Valley to Extreme for the 1997 ozone NAAQS.\12\ We recognize that the
District and CARB will require adequate time to develop and implement
new measures and strategies, revise local rules, complete necessary
analysis and demonstrations, and to provide adequate opportunities for
public involvement.\13\ The State must ensure that all required
planning elements for an Extreme nonattainment area are satisfied, that
public processes are completed, and that the resulting plan is
sufficient to demonstrate attainment of the 2008 ozone NAAQS in the
Coachella Valley as expeditiously as practicable but no later than July
20, 2032.
---------------------------------------------------------------------------

    \10\ The EPA promulgated the SRR for the 2008 ozone NAAQS at 40
CFR part 52, subpart AA.
    \11\ See 87 FR 60926 (October 7, 2022) (providing 18 months from
effective date of final reclassification of areas to Severe). See
also discussion in proposal at 87 FR 21825, 21838.
    \12\ 85 FR 2311 (January 15, 2020) (establishing deadline
roughly 19 months after reclassification effective upon
publication).
    \13\ See id. at 2312.
---------------------------------------------------------------------------

    RACT controls for an area reclassified to a higher nonattainment
classification should be implemented no later than the ozone season of
the attainment year for the new classification, i.e., the ozone season
immediately preceding the maximum attainment date.\14\ For the
Coachella Valley, which has a year-round ozone season and which would
have a July 20, 2032 attainment date for an Extreme classification,
RACT controls would need to be implemented by January 1, 2031.
---------------------------------------------------------------------------

    \14\ See 40 CFR 51.1312(a)(3)(ii).
---------------------------------------------------------------------------

2. NSR and Title V Program Revisions
    Reclassification to Extreme ozone nonattainment triggers several
changes under the CAA's NSR and title V permitting programs. Under CAA
sections 182(e) and 182(f), sources in Extreme nonattainment areas are
defined as ``major sources'' of volatile organic compounds (VOC) or
nitrogen oxides (NOX) under the NSR and title V permitting
programs if they emit at least 10 tpy of these pollutants, compared to
25 tpy in a Severe nonattainment area. Additionally, under CAA section
182(e)(1), emissions from new major sources of VOC or NOX
and major modifications in an Extreme nonattainment area must be offset
at a rate of at least 1.5 to 1 (or at least 1.2 to 1 if the plan
requires all existing major sources in the nonattainment area to use
best available control technology). Further, under CAA section
182(e)(2), any change at a major stationary source that results in an
increase in emissions from any discrete operation, unit, or other
pollutant emitting activity at the source is generally considered a
modification, subject to additional provisions for emissions increases
that are offset through internal reductions and for equipment that is
installed to comply with CAA requirements.
    Accordingly, in addition to the required plan revisions discussed
in section I.B.1 of this action, we are proposing to require the State
to submit revised rules for the Coachella Valley that reflect the
Extreme area definitions for new major sources and major modifications,
and that increase the offset ratios for these sources and modifications
consistent with CAA section 182(e)(1) and (2), by no later than 18
months from the effective date of the EPA's final reclassification of
the area to Extreme. We are also proposing to require the State to
submit any changes to the title V operating permits program for the
Coachella Valley necessary to reflect the change in the major source
threshold from 25 (tpy) for

Severe areas to 10 tpy for Extreme areas by no later than 18 months
from the effective date of final reclassification. The rationale for
the EPA's deadline of 18 months from the effective date of the final
action for this reclassification is discussed in Section I.B.1.
    State lands in the Coachella Valley are already classified as
Extreme for the 1997 ozone NAAQS,\15\ and we recognize that certain
Extreme area requirements may already be met through existing rules. In
lieu of submitting new revised regulations to address these
requirements, the State may provide a written statement certifying that
it has determined that existing regulations are adequate to meet the
applicable nonattainment area planning requirements of CAA section 182.
---------------------------------------------------------------------------

    \15\ 84 FR 32841 (July 10, 2019).
---------------------------------------------------------------------------

II. Motor Vehicle Emissions Budgets

    Under our transportation conformity rule, as a general matter, once
motor vehicle emission budgets (``budgets'') are approved, they can
only be superseded by revised budgets that the EPA approves as a SIP
revision. In other words, approved budgets generally cannot be
superseded through an EPA adequacy finding of revised budgets, but
rather only through EPA approval of the revised budgets, unless the
initial approval of the budgets specifies that the EPA is limiting the
duration of the approval to last only until subsequently submitted
budgets are found adequate.\16\
---------------------------------------------------------------------------

    \16\ 40 CFR 93.118(e)(1).
---------------------------------------------------------------------------

    In our previous action on the Severe area plan, we limited the
duration of the approval of the budgets to last only until the
effective date of the EPA's adequacy finding for any subsequently
submitted budgets.\17\ We limited our approval in response to a request
by CARB, in light of the EPA's then-recent approval of EMFAC2017 as an
updated version of the model (EMFAC2014) used for the budgets in the
2016 Coachella Valley Ozone SIP.\18\ CARB stated that without the
ability to replace the budgets using the budget adequacy process, the
benefits of using the updated data might not be realized for a year or
more after the updated SIP revision (with the EMFAC2017-derived
budgets) was submitted, due to the length of the SIP approval process.
We found CARB's explanation appropriate and accordingly limited the
duration of the budgets.
---------------------------------------------------------------------------

    \17\ 85 FR 57714 (September 16, 2020).
    \18\ EMFAC is short for EMission FACtor. On December 15, 2015,
the EPA approved EMFAC2014 for use by State and local governments to
meet CAA requirements. 80 FR 77337. On August 15, 2019, the EPA
approved and announced the availability of EMFAC2017 for use by
State and local governments to meet CAA requirements. See 84 FR
41717.
---------------------------------------------------------------------------

    As part of the recent reclassification request, the State also
requested that the EPA revise our previous limited approval of the
budgets for the Coachella Valley to allow the existing SIP-approved
budgets for the Severe area plan to be replaced with new budgets for
the Extreme area plan. Similar to the previous request, CARB indicated
that the new budgets being developed for the SIP will be based on
EMFAC2017, whereas the budgets for the SIP-approved Severe area plan
were developed using EMFAC2014. We find that CARB's explanation for
limiting the duration of the approval of the budgets is still
appropriate and provides us with a reasonable basis on which to
continue to limit the duration of the approval of the budgets to the
new Extreme area plan. We also note that on November 15, 2022, the EPA
approved and announced the availability of EMFAC2021 for use by State
and local governments to meet CAA requirements.\19\ Therefore, we
propose to continue to limit the duration of our approval of the
budgets in the 2016 Coachella Valley Ozone SIP until we find revised
budgets developed for the Extreme area plan to be adequate.
---------------------------------------------------------------------------

    \19\ 87 FR 68483 (November 15, 2022). As indicated in this
action, the CAA requires that SIP inventories and control measures
be based on the most current information and applicable models that
are available when a SIP revision is developed and thus there is no
grace period for use of EMFAC2021 in SIP revisions. However, the EPA
also recognizes the time and level of effort that air quality
planning agencies may have already undertaken in SIP development
using EMFAC2017. Agencies should consult with EPA Region IX if they
have questions about how the EPA's approval of EMFAC2021 affects SIP
revisions under development in specific nonattainment or maintenance
areas.
---------------------------------------------------------------------------

III. Summary of Proposed Action and Request for Public Comment

    Pursuant to CAA section 181(b)(3), we are proposing to grant CARB's
request to reclassify the Coachella Valley ozone nonattainment area
from Severe-15 to Extreme for the 2008 ozone NAAQS. Upon
reclassification, the new attainment dates for the Coachella Valley
ozone nonattainment area would be as expeditiously as practicable, but
no later than July 20, 2032, for the 2008 ozone NAAQS. This action
would not reclassify any areas of Indian country within the Coachella
Valley. The EPA is proposing to establish a deadline of no later than
18 months from the effective date of the final reclassification action
for the State to submit revisions to the Coachella Valley portion of
the California SIP to meet the additional requirements applicable to
Extreme ozone nonattainment areas.
    Lastly, the EPA is proposing to continue to limit the duration of
our approval of the budgets in the 2016 Coachella Valley Ozone SIP
until we find revised budgets developed for the Extreme area plan to be
adequate.
    We will accept comments from the public on these proposals for the
next 30 days. The deadline and instructions for submission of comments
are provided in the DATES and ADDRESSES sections at the beginning of
this preamble.

IV. Statutory and Executive Order Reviews

    Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011), this proposed action is not a
``significant regulatory action'' and therefore is not subject to
Executive Order 12866. With respect to lands under state jurisdiction,
voluntary reclassifications under CAA section 181(b)(3) of the CAA are
based solely upon requests by the state, and the EPA is required under
the CAA to grant them. These actions do not, in and of themselves,
impose any new requirements on any sectors of the economy. In addition,
because the statutory requirements are clearly defined with respect to
the differently classified areas, and because those requirements are
automatically triggered by reclassification, reclassification does not
impose a materially adverse impact under Executive Order 12866. With
respect to Indian country, reclassifications do not establish deadlines
for air quality plans or plan revisions. For these reasons, this
proposed action is also not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001).
    In addition, I certify that this proposed action will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), and that
this proposed action 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), because the EPA
is required to grant requests by states for voluntary reclassifications
and such reclassifications in and of themselves do not impose any
federal intergovernmental mandate, and because tribes are not subject
to implementation plan submittal deadlines that apply to states as a
result of reclassifications.

    This proposed action also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the federal government and Indian
tribes, or on the distribution of power and responsibilities between
the federal government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000).
    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. The State did not evaluate
environmental justice considerations as part of its reclassification
request. There is no information in the record inconsistent with the
stated goals of Executive Order 12898 of achieving environmental
justice for people of color, low-income populations, and indigenous
peoples.
    This proposed action also does not have federalism implications
because it does not have substantial direct effects on the states, on
the relationship between the national government and the states, nor on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This proposed action does not alter the relationship
or the distribution of power and responsibilities established in the
CAA.
    This proposed action also is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because the EPA interprets
Executive Order 13045 as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of the Executive Order has the potential to influence the
regulation.
    Reclassification actions do not involve technical standards and
thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This proposed action does not impose an information collection burden
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone.

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

    Dated: January 5, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2023-00330 Filed 1-10-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64552]
[FR Doc No: 2016-22539]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78840; File No. SR-NYSEArca-2016-100]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade Shares of the Direxion Daily Municipal Bond
Taxable Bear 1X Fund Under NYSE Arca Equities Rule 5.2(j)(3)

September 14, 2016.
    On July 13, 2016, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the Direxion Daily Municipal Bond Taxable Bear 1X Fund. The
proposed rule change was published for comment in the Federal Register
on August 3, 2016.\3\ The Commission received no comment letters on the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78433 (July 28,
2016), 81 FR 51241.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is September 17, 2016. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates November 1, 2016, as the date by which the
Commission shall either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-NYSEArca-2016-100).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Robert W. Errett,
Deputy Secretary.
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

[FR Doc. 2016-22539 Filed 9-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24208-24211]
[FR Doc No: 2013-09622]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Protection of Human Subjects: Informed Consent;
Institutional Review Boards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the regulations that provide protection for
human subjects of clinical investigations conducted in support of
applications or submissions to FDA for FDA-regulated products. The
regulations provide protection of the rights, safety, and welfare of
human subjects involved in research activities within FDA's
jurisdiction.

DATES: Submit either electronic or written comments on the collection
of information by June 24, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information of an
existing collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Protection of Human Subjects; Informed Consent; Institutional Review
Boards--21 CFR Parts 50 and 56 (OMB Control Number 0910--NEW)

    Part 50 (21 CFR part 50) applies to all clinical investigations
regulated by FDA under sections 505(i) and 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g),
respectively), as well as clinical investigations that support
applications for research or marketing permits for products regulated
by FDA, including foods and dietary supplements that bear a nutrient
content claim or a health claim, infant formulas, food and color
additives, drugs for human use, medical devices for human use,
biological products for human use, and electronic products. Compliance
with part 50 is intended to protect the rights and safety of subjects
involved in investigations filed with the FDA under sections 403, 406,
409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of
the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360,
360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and
354-360F of the Public Health Service Act.
    With few exceptions, no investigator may involve a human being as a
subject in FDA-regulated research unless the investigator has obtained
the legally effective informed consent of the subject or the subject's
legally authorized representative (see 21 CFR 50.20). In seeking
informed consent, each subject must be provided with certain elements
of informed consent. Those elements are listed in Sec.  50.25. Informed
consent shall be documented in writing as described in Sec.  50.27.
    An institutional review board (IRB) may approve emergency research
without requiring the informed consent of all research subjects
provided the IRB finds and documents that certain criteria are met as
required in Sec.  50.24. We estimate that about five times per year an
IRB is requested to review emergency research under Sec.  50.24. We
estimate, of the five yearly requests for IRB review under Sec.  50.24,
a particular IRB will take about an hour during each of three separate
fully convened IRB meetings to review the request under Sec.  50.24
(one meeting occurring after community consultation). The total annual
reporting burden for IRB review of emergency research under Sec.  50.24
is estimated at 15 hours (see table 1).
    The information requested in the regulations for exception from the
general requirements for informed consent for medical devices (21 CFR
812.47), and the information requested in the regulations for exception
from the general requirements of informed consent in Sec.  50.23,
paragraphs (a) through (c), and (e), is currently approved under OMB
control number 0910-0586. The information requested in the
investigational new drug (IND) regulations concerning exception from
informed consent for emergency research under Sec.  50.24 is currently
approved under OMB control number 0910-0014. In addition, the
information requested in the regulations for IND safety reporting
requirements for human drug and biological products and safety
reporting requirements for bioavailability and bioequivalence studies
in humans (21 CFR 320.31(d) and 312.32(c)(1)(ii) and (iv)) is currently
approved under OMB control number 0910-0672.
    Some clinical investigations involving children, although otherwise
not approvable, may present an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children
(see Sec.  50.54). Certain clinical investigations involving children
may proceed if the IRB finds and documents that the clinical
investigation presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children and when the Commissioner
of Food and Drugs, after consultation with a panel of experts in
pertinent disciplines and following opportunity for public review and
comment, makes a determination that certain conditions are met (see
Sec.  50.54(b)).
    The information requested for clinical investigations in children
of FDA-regulated products is covered by the collections of information
in the IND regulations (part 312 (21 CFR part 312), the investigational
device exemption (IDE) regulations (part 812 (21 CFR part 812), the IRB
regulations (21 CFR 56.115), the food additive petition and nutrient
content claim petition regulations (21 CFR 101.69 and 101.70), and the
infant formula regulations (parts 106 and 107 (21 CFR parts 106 and
107)), all of which are approved by OMB. Specifically, the information
collected under the IND regulations is currently approved under OMB
control number 0910-0014. The information collected under the IDE
regulations is currently approved under OMB control number 0910-0078.
The information collected under the IRB regulations is currently
approved under OMB control number 0910-0130. The information collected
in food additive and nutrient content claim petitions is currently
approved under OMB control number 0910-0381 (general requirements) and
0910-0016 (Form FDA 3503). The information collected under the infant
formula regulations is currently approved under OMB control number
0910-0256 (general requirements) and 0910-0188 (infant formula
recalls).
    Part 56 (21 CFR part 56) contains the general standards for the
composition, operation, and responsibility of an IRB that reviews
clinical investigations regulated by FDA under sections 505(i) and
520(g) of the FD&C Act, as well as clinical investigations that support
applications for research or marketing permits for products regulated
by FDA, including foods and dietary supplements that bear a nutrient
content claim or a health claim, infant formulas,

food and color additives, drugs for human use, medical devices for
human use, biological products for human use, and electronic products.
Compliance with part 56 is intended to protect the rights and welfare
of human subjects involved in such investigations.
    The information collected under the IRB regulations, ``Protection
of Human Subjects--Recordkeeping and Reporting Requirements for
Institutional Review Boards (part 56)'', including the information
collection activities in the provisions in Sec.  56.108(a)(1) and (b),
is currently approved under OMB control number 0910-0130. The
information collected under the regulations for the registration of
IRBs in Sec.  56.106 is currently approved under OMB control number
0910-0279. The information collected for IRB review and approval for
the IDE regulations (part 812) is currently approved under OMB control
number 0910-0078. The information collected for premarket approval of
medical devices (part 814 (21 CFR part 814)) is currently approved
under OMB control number 0910-0231. The information collected under the
regulations for IRB requirements for humanitarian use devices (part
814, subpart H) is currently approved under OMB control number 0910-
0332. The information collected under the regulations for IRB review
and approval of INDs (part 312) is currently approved under OMB control
number 0910-0014.
    This new collection of information is limited to certain provisions
in part 50, subpart B (informed consent of human subjects), and part 56
(IRBs), not currently approved under the OMB control numbers referenced
elsewhere in this document. Those new proposed collections of
information in part 50 are Sec. Sec.  50.24 (emergency research), 50.25
(elements of informed consent), and 50.27 (documentation of informed
consent).
    In part 56, those new proposed collections of information are in
Sec.  56.109(e) (IRB written notification to approve or disapprove
research); Sec.  56.109(f) (continuing review of research); Sec.
56.113 (suspension or termination of IRB approval of research); Sec.
56.120(a) (IRB response to lesser administrative actions for
noncompliance); and Sec.  56.123 (reinstatement of an IRB or
institution).
    In Sec.  56.109(f), the amount of time an IRB spends on the
continuing review of a particular study will vary depending on the
nature and complexity of the research, the amount and type of new
information presented to the IRB, and whether the investigator is
seeking approval of substantive changes to the research protocol or
informed consent document. For many studies, continuing review can be
fairly straightforward, and the IRB should be able to complete its
deliberations and approve the research within a brief period of time.
    When an IRB or institution violates the regulations, FDA issues to
the IRB or institution a noncompliance letter (see Sec.  56.120(a)).
The IRB or institution must respond to the noncompliance letter
describing the corrective actions that will be taken by the IRB or
institution. FDA estimates about five IRBs or institutions will be
issued a noncompliance letter annually. We estimate that the IRB's or
institution's response will take about 10 hours to prepare, with an
estimated total annual burden of 50 hours.
    To date, no IRB or institution has been disqualified by FDA under
Sec.  56.121. Therefore, no IRB or institution has been reinstated
under Sec.  56.123. For this reason, we estimate the annual reporting
burden for one respondent only. We estimate a 5-hour burden per
response, with an estimated total annual burden of 5 hours.
    Those regulatory provisions in parts 50 and 56 not currently
approved under certain OMB control numbers are shown in table 1.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
56.109(e) IRB Written                      6,000              40         240,000               1         240,000
 Notification to Approve or
 Disapprove Research; 56.109(f)
 Continuing Review; 50.25
 Elements of Informed Consent;
 and 50.27 Documentation of
 Informed Consent...............
50.24 Exception from Informed                  5               3              15               1              15
 Consent for Emergency Research.
56.113 Suspension or Termination           6,000               1           6,000             0.5           3,000
 of IRB Approval of Research....                                                    (30 minutes)
56.120(a) IRB Response to Lesser               5               1               5              10              50
 Administrative Actions for
 Noncompliance..................
56.123 Reinstatement of an IRB                 1               1               1               5               5
 or Institution.................
                                                                                ---------------
    Total.......................  ..............  ..............  ..............  ..............         243,070
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09622 Filed 4-23-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Page 42734]
[FR Doc No: 2010-17911]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

July 12, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP10-401-000. RP10-577-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Response to Data Request of Columbia Gas Transmission,
LLC.
    Filed Date: 07/07/2010.
    Accession Number: 20100707-5064.
    Comment Date: 5 p.m. e.t. on Monday, July 19, 2010.

    Docket Numbers: RP10-952-000.
    Applicants: CenterPoint Energy Gas Transmission Company.
    Description: CenterPoint Energy Gas Transmission Company submits
Second Revised Sheet 579 of its FERC Gas Tariff, Sixth Revised Volume
1, to be effective 8/6/10.
    Filed Date: 07/07/2010.
    Accession Number: 20100708-0204.
    Comment Date: 5 p.m. e.t. on Monday, July 19, 2010.

    Docket Numbers: RP10-953-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. 2010 Report of Overrun and
Penalty Revenue Distribution.
    Filed Date: 07/08/2010.
    Accession Number: 20100708-5061.
    Comment Date: 5 p.m. e.t. on Tuesday, July 20, 2010.

    Docket Numbers: RP10-954-000.
    Applicants: Gas Transmission Northwest Corporation.
    Description: Gas Transmission Northwest Corporation submits tariff
filing per 154.204: Master Service Agreement 7-9-10 to be effective 8/
9/2010.
    Filed Date: 07/09/2010.
    Accession Number: 20100709-5029.
    Comment Date: 5 p.m. e.t. on Wednesday, July 21, 2010.

    Docket Numbers: RP10-955-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. submits tariff filing per
154.204: DTI--Administrative Changes Volume No. 1A to be effective 8/8/
2010.
    Filed Date: 07/09/2010.
    Accession Number: 20100709-5065.
    Comment Date: 5 p.m. e.t. on Wednesday, July 21, 2010.

    Docket Numbers: RP10-956-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits the Fourth Revised
Sheet 2 et al. to FERC Gas Tariff, Third Revised Volume 1, to be
effective 8/9/10.
    Filed Date: 07/09/2010.
    Accession Number: 20100709-0210.
    Comment Date: 5 p.m. e.t. on Wednesday, July 21, 2010.

    Docket Numbers: RP10-958-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Texas Eastern Transmission, LP submits tariff filing
per 154.204: AMDDO Modification to be effective 8/12/2010.
    Filed Date: 07/12/2010.
    Accession Number: 20100712-5026.
    Comment Date: 5 p.m. e.t. on Monday, July 26, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. e.t. on the specified comment date. It is
not necessary to separately intervene again in a subdocket related to a
compliance filing if you have previously intervened in the same docket.
Protests will be considered by the Commission in determining the
appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Anyone filing a motion to intervene or
protest must serve a copy of that document on the Applicant. In
reference to filings initiating a new proceeding, interventions or
protests submitted on or before the comment deadline need not be served
on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-17911 Filed 7-21-10; 8:45 am]
BILLING CODE 6717-01-P