ENVIRONMENTAL PROTECTION AGENCY ANNUAL PUBLIC WATER SYSTEMS COMPLIANCE REPORT 1. Identification of the Information Collection 1( a) Title of the Information Collection Annual Public Water Systems Compliance Report, ICR Number 1812.03 1( b) Short Characterization/ Abstract Section 1414 ( c)( 3)( A) of the Safe Drinking Water Act requires that each state ( a term that includes states, commonwealths and territories) that has primary enforcement authority under the Act shall prepare, make readily available to the public, and submit to the Administrator of EPA, an annual report of violations of national primary drinking water regulations in the state.

These Annual State Public Water System Compliance Reports are to include violations of maximum contaminant levels, treatment requirements, variances and exemptions, and monitoring requirements determined to be significant by the Administrator after consultation with the states.

To minimize a state's burden in preparing its annual statutorily required report, EPA issued guidance that explains what Section 1414( c)( 3)( A) requires and provides model language and reporting templates. EPA also annually makes available to the states a computer query that generates for each state ( from information states are already separately required to submit to EPA's national database on a quarterly basis) the required violations information in a table consistent with the reporting template in EPA's guidance.  2 states ( including Puerto Rico, the Virgin Islands, American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands, Navajo Nation) currently have primary enforcement authority under the Safe Drinking Water Act. The Navajo Nation was approved for primacy on December 6, 2000. The State of Wyoming and the District of Columbia neither currently have primary enforcement authority nor are currently seeking primary authority, so the number of 56 states is unlikely to change during the next three years. The cost of this ICR to each state with primary enforcement authority will be approximately during each year of this ICR.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection As stated above, Section 1414 ( c)( 3)( A) of the Safe Drinking Water Act requires that each state that has primary enforcement authority under the Act shall prepare, make readily available to the public, and submit to the Administrator of EPA, an annual report of violations of national primary drinking water regulations in the state. The states' reports are to include violations of maximum contaminant levels, treatment requirements, variances and exemptions, and monitoring requirements determined to be significant by the Administrator after consultation with the states. Section 1414( c)( 3)( B) of the Safe Drinking Water Act requires EPA to prepare and make available to the public an annual report that summarizes and evaluates the reports submitted by the states pursuant to subparagraph ( A).

2( b) Practical Utility/ Users of the Data EPA summarizes the data submitted by the states and uses that information in preparing its annual report that provides a national overview of the compliance performance of public  3 water systems. In its annual national report, EPA must also use the violations data provided specified by the states to make recommendations concerning the resources necessary to improve compliance with the Safe Drinking Water Act. The information submitted by the states also helps EPA identify and resolve discrepancies between violations data in the states' reports and the violations data states submit quarterly to EPA's national database.

3. Nonduplication, Consultations, and Other Collection Criteria 3( a) Nonduplication The information to be obtained under this ICR has not been collected by EPA or any other federal agency. States are required to report public water system violations to EPA's national database on a quarterly basis, but states cannot satisfy their obligations under Section 1414( c)( 3)( A) simply by referring interested parties to EPA's Safe Drinking Water Information System/ Federal System ( SDWIS/ FED). EPA works with states to ensure they can efficiently extract from SDWIS/ FED the calendar year violations data they need to prepare a report in which the violations data are readily available to the public. Some states elect not to use the EPAprovided query to extract the essential reporting data from SDWIS/ FED, and use their own data systems instead.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on March 16, 2004. The only comment recieved during the public comment period concerned fluoridation of public water systems. The Federal Register on December 24, 1975 ( Volume 40 59566) addresses the comment. The commenter wanted to know why EPA required flouridation of the public water supply systems while most of Europe did  4 not.

" The flouride question has been complicated by the flouridation controversy. It was clearly the intent of Congress that Primary Drinking Water Regulation not be used as the vehicle for a national fluoridation program [ House Report p15]. At the same time Congress made it that there was no intent to prohibit or discourage fluoridation. As for changing the MCL's, either raising or lowering them, very little data were submitted to support the recommendations."

3( c) Consultations To obtain comments from actual respondents regarding the annual public water systems compliance report and the corresponding burden hour estimates, EPA staff consulted with the following individuals:

Name Telephone Telephone Darron Busch 605 773 3754 South Dakota Department of Environment and Natural Resources Mary Alvey 503 731 43810 Oregon Health Division Joanne Wagner 402 471 2541 Nebraska Department of Health As states have now completed seven of these annual reports, most now simply generate the necessary data from SDWIS/ FED, confirm the accuracy of the numbers, and update the previous year's report. As a result, the burden hours associated with preparing a report have not  5 changed. EPA's burden hour estimates reflect input from these consultations.

3( d) Effects of Less Frequent Collection Because Section 1414( c)( 3)( A) requires the states to prepare these reports annually and to make the reports readily available to the public, states do not have the option of collecting this information less frequently.

3( e) General Guidelines All of the collection activities described within this ICR fall within OMB's General Guidelines.

3( f) Confidentiality The required information consists of violations data and other information that are a matter of public record. None of the information collected as part of the states' annual public water systems compliance report comprises confidential business information.

3( g) Sensitive Questions No questions of a sensitive nature are asked or answered in the states' annual public water systems compliance report.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are states that have received primary enforcement authority under the Safe Drinking Water Act. The term " state", in this context can include states, commonwealths, territories, and Indian Tribes. Currently, primary enforcement authority has been approved for every state but Wyoming, and for the U. S. Virgin Islands, Puerto Rico, American Samoa, Guam, and the Northern Mariana Islands. Primary  6 enforcement authority has not been approved for the District of Columbia or for Indian Tribes.

EPA has primary enforcement authority in those jurisdictions and is likely to retain that during the three year duration of this ICR.

4( b) INFORMATION REQUESTED ( i) Data Items The reporting items as required by section 1414( c)( 3)( A) include:

° State name and reporting period ° Full report, including a description of the data in the Summary of Violations chart,

specific information on the violation categories for each rule identified on the chart, a list of the systems that had maximum contaminant level or treatment technique requirement violations, explanations of any aggregated number of violations, and a description of systems that were out of compliance during the year, a discussion of variance or exemption violations;

° Summary report, including a description of the data on violations, a list of the systems that had maximum contaminant level or treatment technique requirement violations, and a discussion of variance or exemption violations; and ° Reviewed and completed Summary of Violations chart.

In addition to these items, States are encouraged to provide optional information as outlined EPA guidance. EPA provided guidance to the States's to assist them in the development of their statutorily mandated reports.

ii. Respondent Activities States will need to conduct the following activities in order to complete and submit their  7 Annual State Public Water Systems Compliance Report.

° Review the instructions and other necessary materials;

° Gather inventory and violations data from SDWIS/ FED and from their own data bases;

° Review and analyze inventory and violations data from SDWIS/ FED and from their own data bases;

° Prepare summary of violations of variances and exemptions; and ° Prepare report and submit to EPA in hard copy or hard copy and electronic version, make report readily available to the public, prepare and distribute a summary of the report.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities During the lifetime of this ICR, EPA Headquarters activities associated with the Annual State Public Water Systems Compliance Report consist of the following:

° Modify guidance documents as necessary and distribute to states and EPA Regional Offices;

° Prepare and distribute tools for states and EPA Regional Offices to use to gather data from SDWIS/ FED ( annual activity);

° Answer questions from states and EPA Regional Offices ( annual activity);  8 ° Provide support for Indian Land reporting ( annual activity); and ° Review Annual State Public Water System Compliance Reports, and data from SDWIS/ FED, prepare the Annual National Public Water Systems Compliance Report that summarized and evaluates the annual state reports, and distribute the national report.

EPA Regional Offices will need to complete the following activities to prepare Annual State Public Water Systems Compliance Reports for states that do not have primary enforcement authority, to gather public water system compliance data for Indian lands, and to assist the states as they prepare their reports:

° Assist EPA Headquarters in the development and distribution of any necessary guidance materials;

° Assist EPA Headquarters in the development and distribution of tools for gathering data from SDWIS/ FED ( annual activity);

° Provide general guidance to all states in the Region for completing the Annual state Public Water Systems Compliance Report;

° Gather information from SDWIS/ FED for each Indian land in the Region;

° Prepare a summary of variances and exemptions violations in each Indian land in the Region;

° Gather and submit to EPA Headquarters inventory and violations information from SDWIS/ FED for each Indian land in the Region, information about enforcement and compliance assistance activities related to the Safe Drinking Water Act on Indian lands in the Region, and information about financial assistance related to  9 implementation of the Safe Drinking Water Act on Indian lands in the Region;

° Prepare Annual State Public water Systems Compliance Report for each State in the Region that does not have primary enforcement authority and submit it to EPA Headquarters in hard copy or hard copy and electronic version, make report readily available to the public, prepare and distribute a summary of the report.

5( b) Collection Methodology and Management EPA asks States with primary enforcement authority to submit their Annual State Public Water System Reports to in electronic ( WordPerfect compatible) and hard copy format. Section 1414( c)( 3)( A) requires that both the Annual State Public Water Systems Compliance Reports and the State prepared summaries be accessible to the public. In its guidance, EPA recommends that States and EPA Regions use one or more of the following mechanisms for making the reports and summaries readily available:

° Publish an official notice in newspapers regarding the availability of the report or summary;

° Conduct a press conference, issue a press release, or incorporate a notice into standard press conferences to announce report availability;

° Prepare notices for distribution in public libraries and other public buildings;

° Provide copies of the report for review at public offices and locations, libraries,

web sites, state/ local departments of health, etc; and ° Include notices of availability in local, state and EPA web sites.

Additionally, EPA's national report, which will summarize the data collected from the states, will be posted on the Internet.  10 5( c) Small Entity Flexibility None of the states, commonwealths, or territories affected by this ICR are small entities as defined by the Regulatory Flexibility Act.

5( d) Collection Schedule Each Annual State Public Water Systems Compliance Report covers violations that occurred in a calendar year. States with primary enforcement authority have six months after the end of each calendar year to prepare their Reports, which are due to EPA on the first of July.

6. Estimating the Burden and Cost of the Collection 6( a) Estimating Respondent Burden Table 1 presents the burden hours and costs per respondent as well as for all respondents during each year covered by this ICR. Preparing an Annual State Public Water Systems Compliance Report involves reviewing and describing information on public water systems violations. EPA encourages states to rely on SDWIS/ FED data for this purpose, as the states are already obligated to provide data to SDWIS/ FED on a quarterly basis. EPA further facilitates this process by providing a set of computer queries to the states every year that extracts from SDWIS/ FED the violations data each state needs to prepare its annual report. Some states prefer to extract data from their own databases. Each state must also prepare a narrative describing any violations of variances or exemptions. The burden for each state of preparing an Annual State Public Water System Compliance Report is estimated to be 208 hours.

6( b) Estimating Respondent Costs Based on responses from the states contacted, EPA estimates an average hourly labor rate ( hourly rate plus overhead) of $ 95.35 for managerial staff, $ 64.60 for technical staff, and $ 40.09  11 for clerical staff. Table 2 presents a summary of the estimated average annual cost to respondents. No capital or operations and maintenance costs are incurred by respondents under this ICR. This ICR does not require continuous monitoring.

6( c) Estimating Agency Burden and Cost Table 1 presents the estimated Agency burden hours and costs associated with the information collection activities under this ICR. Other direct costs ( copying, printing, telephone,

and mailing expenses) are also included.

Based on the GSA pay schedule, EPA estimates an average hourly labor rate ( hourly rate plus the standard government overhead factor of 1.6) of $ 54 for managerial staff, $ 40 for technical staff, and $ 21 for clerical staff.

6( d) Estimating the Respondent Universe and Total Burden and Costs Responding to this ICR by preparing an Annual State Public Water Systems Report is a statutory requirement for the 56 states with primary enforcement authority and for all 10 EPA Regions. EPA's burden estimate assumes all 56 states and 10 EPA Regions will prepare reports.

6( e) Bottom Line Burden Hours And Cost Tables See attached tables.

6( f) Reasons for Change in Burden The increase in burden from the most recently approved ICR is due to the fact that the Navajo Nation was approved for primacy on December 6, 2000. Federal approval to implement the drinking water program is call primary enforcement authority or " primacy."

6( g) Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average hours per response. Burden means the total  12 time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West,

Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at  13 http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington,

DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OECA

2004 0003 and OMB control number ( 2020 0020) in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. Table 1. Annual Respondent Burden and Cost Annual Public Water Systems Compliance Report, EPA ICR Number 1812.03 OMB Control Number 2020 0020 Information Collection Activity Hours and Costs Per Respondent Total Hours and Costs Mgr. $ 95.32/ Hour Tech. $ 64/ 60/ Hour Cler. $ 40.09/ Hour Labor Hours/ Year Labor Cost/ Year ($) Capital/ Startup Cost ($)* O & M Cost ($)* Number of Respondent s Total, Hours/ Year Total, Cost/ Year ($)**

Review instructions and other necessary materials 4 4 258.40 0 0 56 224 14,470.40 Gather inventory and violations data from SDWIS/ FED and State databases 4 4 258.40 0 0 56 224 14,470.40 Review and analyze data 24 24 1550.40 0 0 56 1,344 86,822.40 Prepare summary of violations of variences and exemptions 4 4 258.40 0 0 56 224 14,470.40 Prepare report and submit to EPA 4 28 8 40 2510.80 0 0 56 2,240 $ 140,604.80 Make report available to public 4 4 160.00 0 0 56 224 8,980.16 Total 4 64 12 80 4996.40 0 0 56 4480 279,818.56 * Same as the Capital/ Startup and Operation & Maintenance Costs addressed in Section 6( b).

** Includes Labor Cost, Capital/ Startup and O& M Cost. Table 2. Annual Agency Burden and Cost Annual Public Water Systems Compliance Report, EPA ICR Number 1812.03 OMB Control Number 2020 0020 Information Collection Activity Agency Hours and Costs Total Hours and Costs Mgr. $ 54.00/ Hour Tech. $ 40.00/ Hour Cler. $ 21.00/ Hour Agency Hours/ Year Labor Cost/ Year ($) Capital/ Startup Cost ($) O& M Cost ($)* Number of Respondent s Total Hours/ Year Total Cost/ Year ($)

Modify guidance as necessary and distribute to states and EPA Regions 1 24 25 1014 1 25 1014 Prepare and distribute tools for gathering data from SDWIS/ FED 1 16 17 694 12 204 8,328 Answer questions from states and EPA Regional Offices 40 40 1600 12 480 19,200 Provide support for Indian Land reporting 120 120 4800 9 1080 43,200 Review state reports and data from SDWIS/ FED 40 40 1600 12 480 19,200 Prepare and distribute annual report where EPA directly implements drinking water 4 80 12 96 3668 2 192 7,336 Prepare and distribute national summary report 4 120 16 140 5352 1 140 5352 Total 10 440 28 478 18,728 49 2601 103,630 * O& M costs include photocopying, postage, and telephone.


[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Rules and Regulations]
[Pages 21545-21547]
[FR Doc No: 2013-08255]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0886; FRL-9778-4]

Revisions to the California State Implementation Plan, Antelope
Valley Air Quality Management District and Monterey Bay Unified and
Santa Barbara County Air Pollution Control Districts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action to approve revisions to the
Antelope Valley Air Quality Management District (AVAQMD) and Monterey
Bay Unified Air Pollution Control District (MBUAPCD) and Santa Barbara
County Air Pollution Control District (SBCAPCD) portions of the
California State Implementation Plan (SIP). Under authority of the
Clean Air Act as amended in 1990 (CAA or the Act), we are approving
local rules that address emission statements for AVAQMD, rule
rescissions that addresses public records for MBUAPCD, and define terms
for SBCAPCD.

DATES: This rule is effective on June 10, 2013 without further notice,
unless EPA receives adverse comments by May 13, 2013. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0886, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed at www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps), and some may not be publicly
available in either location (e.g., CBI). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Cynthia Allen, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action.
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving and the rules we are
rescinding with the dates that they were adopted by the local air
agencies and submitted by the California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
           Local  agency                Rule No.              Rule title              Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
AVAQMD.............................             107  Certification of                   05/15/12        09/21/12
                                                      Submissions and Emission
                                                      Statements.
MBUAPCD............................             900  Inspection of Public               04/20/05        07/15/05
                                                      Records--Disclosure Policy
                                                      (rescinded).
MBUAPCD............................             901  Public Records--Definitions        04/20/05        07/15/05
                                                      (rescinded).
MBUAPCD............................             902  Districts Request for              04/20/05        07/15/05
                                                      Information (rescinded).
MBUAPCD............................             903  Inspection of Public               04/20/05        07/15/05
                                                      Records--Disclosure
                                                      Procedure (rescinded).
MBUAPCD............................             904  Trade Secrets--Procedure           04/20/05        07/15/05
                                                      When Inspection is
                                                      Requested (rescinded).
SBCAPCD............................             102  Definitions................        06/21/12        09/21/12
----------------------------------------------------------------------------------------------------------------

    On August 18, 2005, EPA determined that the submittal for MBUAPCD
Rules 900, 901, 902, 903, and 904 met the completeness criteria in 40
CFR Part 51 Appendix V, which must be met before formal EPA review.
    On October 11, 2012, EPA determined that the submittal for AVAQMD
Rule 107 and SBCAPCD Rule 102 met the completeness criteria in 40 CFR
Part 51 Appendix V, which must be met before formal review.

B. Are there other versions of these rules?

    There is no previous version of AVAQMD Rule 107 in the SIP. We
approved an earlier version of MBUAPCD Rules 900, 901, 902, 903, and
904 into the SIP on July 13, 1987 (52 FR 26148) and SBCAPCD Rule 102
into the SIP on May 4, 2012 (77 FR 26448).

C. What is the purpose of the submitted rule revisions?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, oxides of nitrogen,
particulate matter, and other air pollutants which harm human health
and the environment. These rules were developed as part of the local
agency's program to control these pollutants.
    Antelope Valley AQMD Rule 107, Certification of Submissions and
Emission Statements, requires the owner or operator of a stationary
sources emitting VOC or NOX to provide AVAQMD with an annual
statement of actual emissions. The emission statement must contain the
information described in the California Air Resources Board (CARB)
Emission Inventory Guidelines. The statement must also contain a
certification signed and dated by a responsible official of the
company, which attests that the information contained in the submitted
documents are accurate to the best knowledge of the individual
certifying the submission. The APCO may waive the emission statement
requirement for sources which emit less than 25 tpy if AVAQMD provides
CARB with an emission inventory of sources emitting greater than 10 tpy
of VOC or NOX using emission factors acceptable to CARB and
EPA.
    Monterey Bay Unified APCD Rule 900, Inspection of Public Records--
Disclosure, Rule 901, Public records--Definitions, Rule 902, Districts
Request for Information, Rule 903, Inspection of Public Records--
Disclosure Procedure and Rule 904, Trade Secrets--Procedure When
Inspection is Requested, are being repealed. These rules are being
repealed because the District has updated their Public Records Request
Procedures pursuant to changes made to the California Public Records
Act.
    Santa Barbara County APCD Rule 102, Definitions, is being amended
by adding new definitions to terms common to the proposed amended rules
and to improve rule clarity. The District added and modified several
solvent-related and surface-coating definitions that are used in
various parts of the rulebook. The definition of reactive organic
compound was updated to include most of the exempt compounds listed in
40 CFR 50.100(s) and an exempt compound definition was added.
    EPA's technical support documents (TSD) have more information about
these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    These rules describe administrative provisions and definitions that
support emission controls found in other local agency requirements. In
combination with the other requirements, these rules must be
enforceable (see section 110(a) of the Act) and must not relax existing
requirements (see sections 110(l) and 193). EPA policy that we used to
evaluate enforceability requirements consistently includes the Bluebook
(``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988) and the Little Bluebook (``Guidance
Document for Correcting Common VOC & Other Rule Deficiencies,'' EPA
Region 9, August 21, 2001).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability and SIP relaxations. The TSDs have
more information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by May 13, 2013, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on June 10, 2013. This will incorporate these
rules into the federally enforceable SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and

     does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 10, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: January 25, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(159)(iii)(H),
(c)(423)(i)(D), and (c)(423)(i)(E) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (159) * * *
    (iii) * * *
    (H) Previously approved on July 13, 1987 in (c)(159)(iii)(A) of
this section and now deleted without replacement Rules 900, 901, 902,
903, and 904.
* * * * *
    (423) * * *
    (i) * * *
    (D) Antelope Valley Air Quality Management District.
    (1) Rule 107, ``Certification of Submission and Emission
Statements,'' adopted on May 15, 2012.
    (E) Santa Barbara County Air Pollution Control District.
    (1) Rule 102, ``Definitions'' amended on June 21, 2012.

[FR Doc. 2013-08255 Filed 4-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69271-69272]
[FR Doc No: 2015-28363]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0114]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 of Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated September 29, 2015, the Graham-White Company (Graham-
White) has petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR 231.27. FRA assigned the
petition Docket Number FRA-2015-0114.
    Graham-White manufactures electric locomotive parking brakes. The
Graham White design provides transmission of torque from the hand wheel
into the input shaft of the brake through a key that engages the hand
wheel hub and the input shaft. Title 49 CFR 231.27(a)(2) requires the
hand brake wheel be affixed to the input shaft using a square taper fit
not less than seven-eighths of an inch square. A Graham-White technical
analysis report demonstrates that the company's design provides the
same degree of safety or a greater degree of safety than that specified
in 49 CFR 231.27. Graham-White is requesting relief from the hand brake
shaft square taper fit regulation, as stipulated in 49 CFR 231 Plate A,
to allow the key and shaft design currently in service on Graham-White
electric parking hand brakes.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.

    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by December 24, 2015 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL--14 FDMS), which can be reviewed at www.dot.gov/privacy. See also http://www.regulations.gov/#!privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC, on November 3, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-28363 Filed 11-6-15; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41610-41612]
[FR Doc No: 2014-16648]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72584; File No. SR-BX-2014-036]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Fees and Rebates for Various Options

July 10, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 1, 2014, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend BX Options Rules, Chapter XV,
Section 2 entitled ``BX Options Market--Fees and Rebates'' to amend
fees and rebates for various options.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    BX proposes to amend certain rebates and fees in Chapter XV,
Section 2(1), Fees for Execution of Contracts on the BX Options Market.
Specifically, the Exchange proposes to: (i) Increase the BX Options Fee
to Remove Liquidity for BX Options Market Makers as well as Non-
Customers in Penny Pilot \3\ Options and Non-Penny Pilot Options; and
(ii) increase the BX Options Customer Rebate to Remove Liquidity in
certain Penny Pilot Options from $0.32 to $0.35 per contract, as
explained further below.
---------------------------------------------------------------------------

    \3\ The Penny Pilot on BX Options was established in June 2012,
and was expanded and extended through December 31, 2014. See
Securities Exchange Act Release Nos. 67256 (June 26, 2012), 77 FR
39277 (July 2, 2012) (SR-BX-2012-030) (order approving BX Options
rules and establishing Penny Pilot); 67342 (July 3, 2012), 77 FR
40666 (July 10, 2012) (SR-BX-2012-046) (notice of filing and
immediate effectiveness expanding and extending Penny Pilot); 68518
(December 21, 2012), 77 FR 77152 (December 31, 2012) (SR-BX-2012-
076) (notice of filing and immediate effectiveness expanding and
extending Penny Pilot); 69784 (June 18, 2013), 78 FR 37873 (June 24,
2013) (SR-BX-2013-039); 71107 (December 12, 2013), 78 FR 77528
(December 23, 2013) (SR-BX-2013-061) (notice of filing and immediate
effectiveness expanding and extending Penny Pilot); and 72246 (May
23, 2014), 79 FR 31160 (May 30, 2014) SR-BX-2014-027) (notice of
filing and immediate effectiveness expanding and extending Penny
Pilot).
---------------------------------------------------------------------------

    First, the BX Options Fee to Remove Liquidity for BX Options Market
Makers and Non-Customers will increase from $0.45 per contract to $0.46
per contract in all Penny Pilot Options. Penny Pilot Options include
two categories of options that are part of the Penny Pilot: (i) Certain
options that are specified on the Exchange's pricing schedule \4\ and
(ii) all other Penny Pilot Options. Accordingly, this proposal raises
the BX Options Fee to Remove Liquidity for BX Options Market Makers and
Non-Customers for all Penny Pilot Options; the fee is currently the
same ($0.45 per contract) and will continue to be the same $0.46 per
contract) for all Penny Pilot Options. The Exchange is similarly
proposing to increase the Fee for Removing Liquidity for BX Options
Market Makers and Non-Customers in Non-Penny Pilot Options from $0.88
to $0.89 per contract. Non-Customers

include a Professional, Firm, Broker-Dealer and Non-BX Options Market
Maker. These modest increases are intended to defray the cost of the
proposed increased rebate, which is described below.
---------------------------------------------------------------------------

    \4\ These include options on Bank of America Corporation
(``BAC''), iShares Russell 2000 Index (``IWM''), PowerShares QQQ
(``QQQ''), SPDR S&P 500 (``SPY''), and iPath S&P 500 VIX St Futures
ETN (``VXX'') (together, ``Specified Penny Pilot Options'').
---------------------------------------------------------------------------

    Second, the Exchange proposes to increase the BX Options Customer
Rebate to Remove Liquidity in Penny Pilot Options from $0.32 per
contract to $0.35 per contract. This change does not apply to Penny
Pilot Options overlying the following stocks: BAC, IWM, QQQ and SPY,
because there is no rebate in those particular options.
    The Exchange believes that the proposed amended BX Options fees are
competitive and should encourage BX members to transact business on the
Exchange.
2. Statutory Basis
    BX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\5\ in general, and with Section
6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which BX operates or controls, and is not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers,
as explained further below.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposed increase in the Fee to Remove Liquidity for BX Options
Market Makers and Non-Customers from $0.45 per contract to $0.46 per
contract in all Penny Pilot Options is reasonable, because it is a very
modest increase. In addition, it is similar to the fees charged by The
NASDAQ Stock Market LLC's NASDAQ Options Market (``NOM'') (which is
$0.48 per contract for xxx [sic]) and NASDAQ OMX PHLX (which charges
$0.48 per contract). Similarly, the increase in the Fee for Removing
Liquidity for BX Options Market Makers and Non-Customers in Non-Penny
Pilot Options from $0.88 to $0.89 per contract is also reasonable,
because it is a very modest increase, and would result in the same fee
as NOM currently charges. These proposed increases are equitable and
not unfairly discriminatory, because they apply to all BX Options
Market Makers and Non-Customers in Penny Pilot Options equally.\7\
---------------------------------------------------------------------------

    \7\ Customers do not pay a Fee for Removing Liquidity in any
options.
---------------------------------------------------------------------------

    The proposal to increase the Customer Rebate to Remove Liquidity in
Penny Pilot Options from $0.32 per contract to $0.35 per contract is
intended to attract additional customer business to BX Options. This,
in turn, should bring more liquidity to the BX Options marketplace,
which should benefit all market participants. The Exchange believes
that the increase in the rebate is reasonable, because it is modest.
The rebate has been $0.32 since it was first established in 2012.\8\
The Exchange pays the Rebate to Add Liquidity to a Customer only when
the Customer is contra to a Non-Customer or BX Options Market Maker.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 67339 (July 3,
2012), 77 FR 40688 (July 10, 2012) (SR-BX-2012-043) (notice of
filing and immediate effectiveness of proposed rule change to adopt
transaction and routing fees).
---------------------------------------------------------------------------

    The Exchange believes the proposed Customer Rebate to Remove
Liquidity in Penny Pilot Options is equitable and not unfairly
discriminatory, because it is available to all Customers. In addition,
the Exchange believes the proposal is equitable and not unfairly
discriminatory, because the Exchange desires to incentivize
participants to transact Customer orders on the Exchange and obtain
this rebate. The Exchange believes that this rebate will incentivize
members to bring order flow and increase the liquidity on the Exchange
to the benefit of all market participants. Further, the Exchange also
believes that it continues to be reasonable, equitable and not unfairly
discriminatory to only offer the Rebate to Remove Liquidity to
Customers and not to other market participants as an incentive to
attract Customer order flow to the Exchange. As the Exchange stated
when adopting this rebate,\9\ it is an important Exchange function to
provide an opportunity to all market participants to trade against
Customer orders.
---------------------------------------------------------------------------

    \9\ Id.
---------------------------------------------------------------------------

    Customer order flow benefits all market participants by improving
liquidity, the quality of order interaction and executions at the
Exchange.

B. Self-Regulatory Organization's Statement on Burden on Competition

    BX does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act. To the contrary, BX has designed its fees and
rebates to compete effectively for the execution and routing of options
contracts. The Exchange operates in a highly competitive market
comprised of twelve U.S. options exchanges in which sophisticated and
knowledgeable market participants can and do send order flow to
competing exchanges if they deem fee levels at a particular exchange to
be excessive. The Exchange believes that the proposed fee and rebate
program discussed herein is competitive. The Exchange believes that
this competitive marketplace materially impacts the fees and rebates
present on the Exchange today and substantially influences the proposal
set forth above.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     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-BX-2014-036 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2014-036. 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, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. 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-BX-2014-036, and should be
submitted on or before August 6, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-16648 Filed 7-15-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5549-5550]
[FR Doc No: 2019-02967]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2001-9800]

Qualifications of Drivers; Exemption Applications; Diabetes;
Withdrawal of Notices of Final Disposition

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of withdrawal of 2003 and 2005 final disposition notices
for the diabetes exemption program.

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

SUMMARY: FMCSA withdraws its September 3, 2003, notice concerning
exemptions for certain individuals with insulin-treated diabetes
mellitus (ITDM) and its November 8, 2005, revision. This action is in
response to the Qualifications of Drivers; Diabetes Standard final
rule, published on September 19, 2018, which revised the physical
qualifications standard for ITDM individuals who wish to operate
commercial motor vehicles (CMVs) in interstate commerce. The revised
standard allows certified medical examiners, in consultation with the
treating clinician, to evaluate and determine whether to grant an ITDM
individual a medical examiner's certificate (MEC) to drive a CMV in
interstate commerce. FMCSA has determined, therefore, that an exemption
program for ITDM individuals is no longer necessary.

DATES: This notice is applicable February 21, 2019.

FOR FURTHER INFORMATION CONTACT: Ms. Christine Hydock, Chief, Medical
Programs Division, Federal Motor Carrier Safety Administration, 1200
New Jersey Avenue SE, Washington, DC 20590-0001, by telephone at (202)
366-4001, or by email at<EMAIL_ADDRESS>If you have questions on
viewing material in the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Background

    Since 1970, 49 CFR 391.41(b)(3) prohibited ITDM individuals from
operating CMVs. On September 3, 2003, FMCSA announced that the Agency
would begin authorizing exemptions from 49 CFR 391.41(b)(3) for certain
ITDM individuals (68 FR 52441). Section 31315(b)(2) of 49 U.S.C. allows
the Agency to grant exemptions for a 2-year period and to renew them at
the end of the period.\1\ The 2003 notice of final disposition outlined
the requirements for ITDM individuals to apply for an exemption, and
the considerations FMCSA would apply in determining whether to grant
such applications in accordance with the statute and the provisions of
49 CFR part 381, subpart C. It addressed the requirements to renew
exemptions and the considerations that would be used by the Agency to
determine whether to renew an exemption once issued. It also set out
the circumstances that would require revocation of an exemption.
---------------------------------------------------------------------------

    \1\ At the time, the statute limited exemptions to 2 years. The
statute was subsequently amended to allow exemptions for up to 5
years, but, as a practical matter, diabetes exemptions have been
limited to 2 years.
---------------------------------------------------------------------------

    In response to the enactment of section 4129(a) through (c) of the
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA-LU) (Pub. L. 109-59, 119 Stat. 1144, 1742,
Aug. 10, 2005), the Agency revised certain considerations for such
exemptions on November 8, 2005 (70 FR 67777).
    On September 19, 2018, the Agency published a final rule revising
the physical qualification standard for operators of CMVs with ITDM (83
FR 47486). As of September 19, 2018, there were 4,719 ITDM drivers who
held Federal diabetes exemptions. While the exemption program provides
a pathway to medical certification for ITDM individuals who otherwise
meet the physical qualifications standards of 49 CFR 391.41(b), the
amended diabetes standard provides a less burdensome approach that
emphasizes individualized assessment and utilizes the treating
clinician of the ITDM individual to assist the certified medical
examiner in making the certification determination. Detailed
explanations of the process for complying with the new physical
qualification requirements are included in the preamble to the final
rule published on September 19, 2018.

II. Transition From Exemption Program to the New Standard

    The withdrawal of the 2003 and 2005 program notices is applicable
February 21, 2019. Individuals could begin the process of obtaining
MECs following the new streamlined process on November 19, 2018.

A. Existing Diabetes Exemption Holders

    Diabetes exemptions under the program are issued for 2 years, but
exemption holders must be medically certified by a certified medical
examiner and issued an MEC annually. Any MEC that was obtained under an
exemption and was in effect when the final rule became effective on
November 19, 2018, will remain in effect until the MEC expires or is
replaced by an MEC issued under the new standard. Prior to its
expiration, a new MEC must be issued under the new standard to operate
a CMV. FMCSA will direct certified medical examiners to cease issuing
MECs under the exemption program on or after the date of this
withdrawal notice.
    Beginning November 19, 2018, exemption holders could begin the
process of obtaining certification under the new standard. This
requires being evaluated by a treating clinician who must complete an
Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, which is
available on the Agency's website, and then obtaining a medical
certification examination by a certified medical examiner. Existing
diabetes exemption holders should have adequate time to comply with the
provisions of the final rule before their current MECs expire.
Obtaining certification under the new standard should be much less
burdensome in terms of both time and resources than the lengthy process
of applying for and maintaining an exemption.

B. State Driver Licensing Agencies and Variances

    When an ITDM individual obtains an MEC under the new standard, it
will not be necessary for the certified medical examiner to indicate on
the MEC that certification is made consistent with the terms of an
exemption (unless other exemptions are involved) because a diabetes
exemption is no longer required to operate a CMV. Therefore, in the
case of an ITDM individual holding a commercial driver's license or a
commercial learner's permit, it will not be necessary for a State
Driver Licensing Agency to receive and post the information about such
a medical variance on the individual's Commercial Driver's License
Information System (CDLIS) record (see 49 CFR 383.73(o)).

    Issued on: February 13, 2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-02967 Filed 2-20-19; 8:45 am]
BILLING CODE 4910-EX-P


September 30, 2010

MEMORANDUM

SUBJECT:	CH4 Data from 2010 and 2011 Heavy-Duty Vehicle Certification
Tests

FROM:	Antonio Fernandez, Engineer

Assessment and Standards Division

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum contains the results of 9 tests of various
manufacturers’ heavy-duty certified models in 2010 and 2011.  They
were all tested over the FTP city and highway fuel economy cycles.  Two
of the tests represent gasoline fueled vehicles while the remaining
seven represent diesel vehicles.  The emission levels reflect the
composite result with the city cycle accounting for 55% and the highway
accounting for 45% of the result.

Eight of the tests resulted in levels at or below half of the proposed
cap standard of 0.05 g/mile.

Only one of the vehicles, a diesel, exceeded the proposed cap of 0.05
g/mile.  Since methane is not currently a regulated emission in
heavy-duty, there has been little effort at controlling methane.  We
believe that with some concentrated effort by the manufacturer at
controlling the methane emissions, this diesel vehicle should be able to
meet the proposed methane cap.


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5691-5692]
[DOCID:fr07fe07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-153-000]

Texas Gas Transmission, LLC; Notice of Cash-Out Revenue
Adjustment

February 1, 2007.
    Take notice that on January 29, 2007, Texas Gas Transmission, LLC
(Texas Gas) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, the following tariff sheets, to become effective
March 1, 2007:

Ninth Revised Sheet No. 20
Eighth Revised Sheet No. 21
Ninth Revised Sheet No. 22
Sixth Revised Sheet No. 23
Eighth Revised Sheet No. 25
Ninth Revised Sheet No. 26
Ninth Revised Sheet No. 29
Ninth Revised Sheet No. 30

    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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: 5 p.m. Eastern Time February 9, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-2021 Filed 2-6-07; 8:45 am]

BILLING CODE 6717-01-P


TABLE 1 CALCULATIONS FOR THE AVAILABILITY OF BOILERMAKERS FOR CAIR  PHASE I & II ANALYSE Case No. 1 2 3 4 Description CAIR NPR Proposal CAIR Phase I Policy Case ( Using EPA NPR Assumptions and All Available Boilermaker Sources) CAIR Phase I Policy Case ( Using EIA Electricity Demand and Natural Gas Prices, UARG Boilermaker Duty Rates, and All Available Boilermaker Sources) CAIR Phase II Policy Case ( Using EIA Electricity Demand and Natural Gas Prices, UARG Boilermaker Duty Rates, and All Available Boilermaker Sources)

Expected date for final CAIR Rule 6/ 30/ 2005 3/ 15/ 2005 3/ 15/ 2005 3/ 15/ 2005 Expected date for SIPs to be available 12/ 31/ 2006 9/ 15/ 2006 9/ 15/ 2006 9/ 15/ 2006 Compliance deadline, Phase I 1/ 1/ 2010 1/ 1/ 2010 1/ 1/ 2010 1/ 1/ 2010 Compliance deadline, Phase II 1/ 1/ 2015 1/ 1/ 2015 1/ 1/ 2015 1/ 1/ 2015 Availability of Union Boilermakers Time available for procuring and installing controls, years 3 3.25 3.25 5 Duration of boilermaker activities during the construction schedule, month 18 21.5 21.5 36 Projected membership of International Brotherhood of Boilermakers 28,000 26,000 26,000 26,000 Projected percentage of boilermakers available for controls retrofits 35% 35% 35% 35%

Annual hours per boilermaker, hrs 2,000 2,000 2,000 2,000 Projected number of boilermakers available for controls retrofit 9,800 9,100 9,100 9,100 Boilermaker Requirements for Scrubbers:

Scrubbers to be installed for CAIR, GW 48.75 37 45.4 23.1 Scrubbers to be installed for base case, GW 2.65 2.6 3.7 4.4 Total scrubber capacity to be installed, GW 51.4 39.6 49.1 27.5 Required boilermaker years/ MW of scrubbers 0.152 0.152 0.269 0.271 Boilermaker years required, yrs 7,813 6,019 13,208 7,453 Boilermaker Requirements for SCRs:

SCRs to be installed for CAIR, GW 23.9 18.2 20.6 21.1 SCRs to be installed for base case, GW 4.3 5.7 4.6 5.5 Total SCR capacity to be installed, GW 28.2 23.9 25.2 26.6 Required boilermaker years/ MW of SCR 0.175 0.175 0.343 0.344 Boilermaker years required, yrs 4,935 4,183 8,644 9,150 Boilermaker Requirements for Wet ESPs:

Total Wet ESPs to be installed, GW 41.66 48.75 27.76 Required boilermaker years/ MW of Wet ESP 0.050 0.050 0.050 Boilermaker years required, yrs 2,083 2,438 1,388 Boilermaker Requirements for SNCRs:

SNCRs to be installed for CAIR, GW 0 0 0.2 0 SNCRs to be installed for base case, GW 0 0.1 0 1.8 Total SNCR capacity to be installed, GW 0 0.1 0.2 1.8 Required boilermaker years/ MW of SNCR 0.01 0.01 0.01 0.01 Boilermaker years required, yrs 0 1 2 17 Total boilermaker years required, yrs 12,748 12,286 24,291 18,007 Total boilermaker years available from union sources 14,700 16,304 16,304 27,300 Add'l boilermaker years due to fewer new capacity additions ( see Tables 2 and 3) 4617 4617  7674 Add'l boilermaker years due to Canadian sources ( see Tables 2 and 3) 1792 1792 3000 Add'l boilermaker years due to non union sources ( see Tables 2 and 3) 1,229 2,429 1,801 Total boilermaker years available, yrs 23,941 25,142 24,427 Existing contingency in available boilermaker years, % 95% 4% 36%

16 TABLE 2 ADDITIONAL BOILERMAKER LABOR SOURCES PHASE I IMPACT Effect of New Generation Capacity Addition Compliance deadline, Phase I 1/ 1/ 2010 New Coal Fired Plants to be Added During CAIR Construction: Total construction period during which boilermakers are used, months 21.5 New coal fired power plant capacity to be built in 2007 2010, GW( 1) 0 New or repowered combined cycle plants to be built in 2007 2010, GW 15.5 Capacity of new coal fired power plants to be built during CAIR period, GW 0.0 No. of new coal fired power plants built, with average 500 MW size 0 Boilermaker hours required per 500 MW coal plant, hrs( 2) 500,000 Capacity of combined cycle plants to be built during CAIR period, GW 9.2 No. of new combined cycle plants built, with average 250 MW size 37 Boilermaker hours required per 250 MW combined cycle plant, hrs( 2) 48,000 Total boilermaker hours required between 2007 2010 1,774,467 Boilermaker years required between 2007 2010( 3) 887 SIP Call Experience with New Combined Cycle Power Plants: Capacity of new combined cycle plants built during NOx SIP Call, GW/ yr( 2) 32 Capacity of new combined cycle plants built during equivalent CAIR period, GW 57 No. of new combined cycle plants built, with average 250 MW size 229 Boilermaker hours required per 250 MW combined cycle plant, hrs( 2) 48,000 Total boilermaker hours used during SIP Call 11,008,000 Boilermaker years used during SIP Call 5,504 No. of additional boilermaker years available for CAIR 4,617 Effect of Canadian Labor Availability No. of Canadian boilermakers available during 2003( 4) 1,300 No. of Canadian boilermakers assumed to be available during CAIR( 4) 1,000 No. of boilermaker years available for CAIR due to Canadian labor 1,792 Effect of Non Union Labor Availability % of projects assumed to be built by non union boilermakers( 5) 10 Increase in the available boilermaker years for CAIR( 6) Note 6 NOTES 1. New coal fired generation capacity addition is projected to be negligible during 2007 2010, by both EPA and EIA ( see " Annual Energy Outlook 2005 ( Early Release), Tables A9 and 9, December 2004), http:// www. eia. doe. gov/ oiaf/ aeo/ index. html. Combined cycle capacity is based on EPA's IPM projections ( see IPM Run CAIR 2004_ EIA). 2. Boilermaker estimates provided by UARG. See comments to the NPR proposal, VII. C 1784 and 1786. 3. Based on an average boilermaker annual hours of 2,000 ( see " Boilermaker Labor Analysis and Installation Timing", CAIR Docke 4. Phone conversations with International Brotherhood of Boilermakers ( see " Boilermaker Labor Analysis and Installation Timing", 5. Assumption by EPA, based on the number of projects in traditionally non union states ( see " Boilermaker Labor Analysis and Ins 6. This increase will be 10% of the boilermaker years required for each case ( see Table 1) 7. This case reflects acceleration of the Phase I compliance deadline by one year for both NOx and SO2. 8. This case reflects acceleration of the Phase I compliance deadline by one year for only NOx.

17 TABLE 3 ADDITIONAL BOILERMAKER LABOR SOURCES PHASE II IMPACT( 1)

Effect of New Generation Capacity Addition Compliance deadline, Phase I 1/ 1/ 2015 New Coal Fired Plants to be Added During CAIR Construction: Total construction period during which boilermakers are used, months 36 New coal fired power plant capacity to be built in 2010 2015, GW( 2) 54 New or repowered combined cycle plants to be built in 2010 2015, GW( 2) 12.0 Capacity of new coal fired power plants to be built during CAIR period, GW 32.4 No. of new coal fired power plants built, with average 500 MW size 65 Boilermaker hours required per 500 MW coal plant, hrs 500,000 Capacity of combined cycle plants to be built during CAIR period, GW 7.2 No. of new combined cycle plants built, with average 250 MW size 29 Boilermaker hours required per 250 MW combined cycle plant, hrs 48,000 Total boilermaker hours required between 2007 2010 33,779,866 Boilermaker years required between 2007 2010( 3) 16,890 SIP Call Experience with New Combined Cycle Power Plants: Capacity of new combined cycle plants built during NOx SIP Call, GW/ yr 32 Capacity of new combined cycle plants built during equivalent CAIR period, GW 96 No. of new combined cycle plants built, with average 250 MW size 384 Boilermaker hours required per 250 MW combined cycle plant, hrs 48,000 Total boilermaker hours used during SIP Call 18,432,000 Boilermaker years used during SIP Call 9,216 No. of additional boilermaker years available for CAIR  7,674 Effect of Canadian Labor Availability No. of Canadian boilermakers available during 2003 1300 No. of Canadian boilermakers assumed to be available during CAIR 1000 No. of boilermaker years available for CAIR due to Canadian labor 3000 Effect of Non Union Labor Availability % of projects assumed to be built by non union boilermakers 10 Increase in the available boilermaker years for CAIR see Note 3 NOTES 1. See Table 2 for general notes. 2. The new coal and gas fired capacity addition is based on EPA's IPM projections ( see IPM Run CAIR 2004_ EIA). 3. This increase will be 10% of the boilermaker years required for each applicable case ( see Table 1)

18 18


[Federal Register: April 10, 2007 (Volume 72, Number 68)]
[Notices]
[Page 17887]
[DOCID:fr10ap07-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-387-000]

Kern River Gas Transmission Company; Notice of Report of Gas
Compressor Fuel and Lost and Unaccounted-For Gas Factors for 2006

April 4, 2007.
    Take notice that on March 30, 2007, Kern River Gas Transmission
Company tendered a report supporting its gas compressor fuel and lost
and unaccounted-for gas factors for 2006.
    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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: 5 p.m. Eastern Time April 11, 2007.

Philis Posey,
Acting Secretary.
[FR Doc. E7-6689 Filed 4-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26057-26058]
[FR Doc No: 2015-10539]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1006]

Providing Regulatory Submissions in Electronic Format--Certain
Human Pharmaceutical Product Applications and Related Submissions Using
the Electronic Common Technical Document Specifications; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the Electronic Common
Technical Document Specifications.'' The guidance is being issued in
accordance with the Food and Drug Administration Safety and Innovation
Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to require that certain submissions under the FD&C Act
and Public Health Service Act (PHS Act) be submitted in electronic
format, beginning no earlier than 24 months after issuance of final
guidance on that topic. The guidance outlines Electronic Common
Technical Document (eCTD) specification requirements for submissions to
new drug applications (NDAs), abbreviated new drug applications
(ANDAs), certain biologics license applications (BLAs), and certain
investigational new drug applications (INDs).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the documents
to the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the documents.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDASIA (Pub. L. 112-144), signed by the President on July 9, 2012,
amended the FD&C Act to add section 745A (21 U.S.C. 379k-1), entitled
``Electronic Format for Submissions.'' Section 745A(a)(1) of the FD&C
Act requires that submissions under section 505(b), (i), or (j) of the
FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions under sections
351(a) or (k) of the PHS Act (42 U.S.C. 262(a) or (k)) be submitted to
FDA in electronic format no earlier than 24 months after FDA issues
final guidance on that topic.
    In accordance with section 745A(a)(1) of the FD&C Act, FDA is
issuing this guidance, announcing its determination that submission
types identified in this guidance must be submitted electronically
(except for submissions that are exempted) in the format specified in
this guidance.
    This guidance (and the technical specification documents it
incorporates by reference) describes how submissions under section
745A(a) of the FD&C Act must be organized and submitted in electronic
format using eCTD specifications listed in the FDA Data Standards
Catalog (http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). For more information concerning how
the FDA interprets section 745A(a), see the guidance for industry
``Providing Regulatory Submissions in Electronic Format--Submissions
Under Section745A(a) of the Federal Food, Drug, and Cosmetic Act''
(available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm). The
eCTD is an International Conference on Harmonization (ICH) format based
on specifications developed by ICH and its member parties. FDA's CDER
and CBER have been receiving submissions in the eCTD format since 2003,
and eCTD has been the recommended format for electronic submissions to
CDER and CBER since January 1, 2008. The majority of new electronic
submissions are now received in eCTD format.
    This guidance finalizes and replaces the previous 2013 draft
guidance on eCTD specifications. This supersedes the guidance for
industry entitled ``Providing Regulatory Submissions in Electronic
Format--Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications'' that was issued in June
2008. This guidance is applicable to all submissions within the scope
of section 745A(a) of the FD&C Act, i.e., NDAs, ANDAs, certain BLAs,
and certain INDs and all subsequent submissions, including amendments,
supplements, and reports, to these submission types. This guidance is
not applicable to submissions for blood and blood components, including
Source Plasma.
    In the Federal Register of July 25, 2014 (79 FR 43494), FDA
announced the availability of the revised draft guidance entitled
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
Electronic Common Technical Document Specifications.'' The comment
period on the revised draft guidance ended on September 23, 2014. We
reviewed all comments received on the draft guidance and revised
several sections of the guidance. The updates include:
    Section I: Clarified that in addition to this guidance and existing
technical specifications, more detailed technical instructions will be
issued in the form of a technical conformance guide.
    Section III.A: (1) Clarified which INDs and BLAs are addressed in
this guidance. Specifically, a footnote was added to clarify the
meaning of ``certain'' in the context of BLAs and INDs and states that
the guidance is not applicable to INDs for devices that are regulated
by CBER as biological products under Section 351 of the PHS Act and to
INDs that are noncommercial. Further, the guidance is not applicable to
those devices that are regulated by CBER as biological products under
Section 351 of the PHS Act. Examples are provided in this regard. (2)
Clarified that FDA considers master files to be submissions to an NDA,
ANDA, BLA, or IND, and therefore to fall within the scope of
requirements set forth in section 745A(a). These include new drug
master files (DMFs) (21 CFR 314.420), new biological product files
(BPFs) (21 CFR

601.51), and any amendments to or annual reports on previously
submitted DMFs or BPFs. This guidance also applies to submissions for
drug/device combination products filed pursuant to section 505 of the
FD&C Act or subsection (a) or (k) of section 351 of the PHS Act.
    Section Technical Specification Documents Incorporated by
Reference: Provides a list of documents incorporated by reference into
this guidance and provides a complete listing of technical supportive
files on the FDA eCTD Web page at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm.
    We also received a comment concerning the implementation timeline
for the Portable Document Format (PDF) technical specification. As
discussed in the guidance for industry ``Providing Regulatory
Submissions in Electronic Format--Submissions Under Section 745A(a) of
the Federal Food, Drug, and Cosmetic Act,'' certain technical
specifications are required no earlier than 2 years after the final
guidance is published.
    This guidance implements the electronic submission requirements of
section 745A(a) of the FD&C Act by specifying the format for electronic
submissions. All submissions submitted 24 months after the publication
of this guidance must use the appropriate FDA-supported eCTD
specifications for NDA, ANDA, and certain BLA submissions. Certain IND
submissions must use the FDA-supported eCTD specifications for
electronic submissions submitted 36 months after publication of this
guidance.
    In section 745A(a) of the FD&C Act, Congress granted explicit
authorization to FDA to implement the statutory electronic submission
requirements by specifying the format for such submissions in guidance.
Because this guidance provides such requirements under section 745A(a)
of the FD&C Act, indicated by the use of the words must or required, it
is not subject to the usual restrictions in FDA's good guidance
practice regulations, such as the requirement that guidances not
establish legally enforceable responsibilities. See 21 CFR 10.115(d).

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The guidance pertains to sponsors and applicants making
regulatory submissions to FDA in electronic format for NDAs, ANDAs,
BLAs, INDs, master files, and advertising and promotional labeling. The
information collection discussed in the guidance is contained in our
IND regulations (21 CFR part 312) and approved under OMB control number
0910-0014, our NDA regulations (including ANDAs) (21 CFR part 314) and
approved under OMB control number 0910-0001, and our BLA regulations
(21 CFR part 601) and approved under OMB control number 0910-0338.
    Sponsors and applicants have been submitting NDAs, ANDAs, BLAs,
INDs, and master files electronically since 2003, and the majority of
these submissions are already received in electronic format. Under
section 745A(a) of the FD&C Act, sponsors and applicants are required
to file most of these submissions electronically. These requirements
will be phased in over 2- and 3-year periods after the issuance of this
guidance.
    For some sponsors and applicants, there may be new costs, including
capital costs or operating and maintenance costs, which would result
from the requirements under FDASIA and this guidance, because some
sponsors and applicants may have to upgrade eCTD specifications and/or
change their method of submitting information to FDA. FDA estimates
that, for some sponsors and applicants, the costs may be as follows:
     eCTD Publishing Software: $25,000 to $150,000
     Publishing Operations Support: $50,000 to $1 million
     Training: $5,000 to $50,000

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10539 Filed 5-5-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 21, 2009 (Volume 74, Number 97)]
[Notices]
[Page 23854]
[DOCID:fr21my09-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1099-000]

Empire Generating Company; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

May 13, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Empire Generating Company's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is June 2, 2009.
    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-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-11790 Filed 5-20-09; 8:45 am]

BILLING CODE 6717-01-P