[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Proposed Rules]
[Pages 68386-68389]
[FR Doc No: 2019-26942]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Chapter III

[Docket No. FMCSA-2019-0151]

National Association of the Deaf Petition for Rulemaking; Hearing
Requirement for Commercial Motor Vehicle Drivers

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

ACTION: Petition for rulemaking; request for public comments.

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

SUMMARY: FMCSA requests public comments on the National Association of
the Deaf's (NAD) petition for rulemaking to rescind the requirement for
interstate drivers of commercial motor vehicles (CMVs) to be able to
hear. NAD also requests that FMCSA amend the requirement that
interstate drivers be able to speak, and the rule prohibiting the use
of interpreters during the administration of the commercial driver's
license (CDL) skills test. NAD believes the origins of the hearing
requirement dates to a time of misguided stereotypes about the
abilities and inabilities of deaf and hard of hearing individuals and
the rules should now be changed.

DATES: Comments must be submitted by February 14, 2020.

ADDRESSES: You may submit comments identified by Docket Number FMCSA-
2019-0151 using any of the following methods:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between
9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section for instructions on submitting
comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. 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 or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Submitting Comments

    If you submit a comment, please include the docket number for this
document (Docket No. FMCSA-2019-0151), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2019-0151, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is customarily not made available to the general
public by the submitter. Under the Freedom of Information Act (5 U.S.C.
552), CBI is eligible for protection from public disclosure. If you
have CBI that is relevant or responsive to this document, it is
important that you clearly designate the submitted comments as CBI.
Accordingly, please mark each page of your submission as
``confidential'' or ``CBI.'' Submissions designated as CBI and meeting
the definition noted above will not be placed in the public docket of
this document. Submissions containing CBI should be sent to Brian
Dahlin, Chief, Regulatory Evaluation Division, Federal Motor Carrier
Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001. Any commentary that FMCSA receives that is not specifically
designated as CBI will be placed in the public docket for this
document.

B. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2019-0151 in the
keyword box, and click ``Search.'' Next, click the ``Open Docket
Folder'' button and choose the document to review. If you do not have
access to the internet, you may view the docket online by visiting the
Docket Management Facility in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001, between 9 a.m. and 5 p.m. ET, Monday through Friday, except
Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. 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.transportation.gov/privacy.

I. Background

A. The Hearing Standard and the Granting of Exemptions

    The current hearing standard under 49 CFR 391.41(b)(11) was adopted
in 1970, with a revision in 1971 to allow drivers to be qualified under
this standard while wearing a hearing aid, 35 FR 6458, 6463 (April 22,
1970) and 36 FR 12857 (July 3, 1971).\1\
---------------------------------------------------------------------------

    \1\ A hearing requirement has been included in the physical
qualifications for commercial drivers since 1940. Cf. 4 FR 2294,
2295 (June 7, 1939).
---------------------------------------------------------------------------

    On May 25, 2012, FMCSA published a notice requesting public comment
on the application from NAD for an exemption from the regulatory
requirement in 49 CFR 391.41(b)(11) on behalf of 45 deaf drivers (77 FR
31423). The Agency received 570 comments in response to that notice,
and 40 of the 45 applicants were granted exemptions (78 FR 7479). Since
that time, FMCSA has granted more than 450 hearing exemptions to
individuals who do not meet the hearing standard. In doing so, FMCSA
has published numerous Federal Register notices announcing receipt of
hearing exemption applications and requesting public comment, prior to
granting the individual exemptions. See, e.g., 84 FR 5544 (February 21
2019); 84 FR 21392 (May 14, 2019).

B. Speaking Requirement for Interstate Drivers

    Currently, Sec.  391.11(b)(2) requires that interstate CMV drivers
read and speak the English language sufficiently to converse with the
general public, to understand highway traffic signs and signals in the
English language, to respond to official inquiries, and to make entries
on reports and records.
    The requirement to speak was adopted on December 23, 1936 by the
Interstate Commerce Commission (ICC), the Federal agency responsible
for motor carrier safety prior to the establishment of the U.S.
Department of Transportation. (1 M.C.C. 1, at 18-19).
    On May 27, 1939, the ICC made certain changes and additions to the
Motor Carrier Safety Regulations, including elimination of the
exceptions granted by the original rules for those drivers unable to
read and speak English. As stated in that notice, ``The intent of the
Commission to require such ability of all drivers in this service has
been unmistakable since 1937, and the intervening period of more than
two years is regarded as sufficient to justify the removal of the
exception.'' (14

M.C.C. 669, at 675). The requirements have remained essentially
unchanged since the 1930s.

C. Prohibition Against Interpreters During the CDL Skills Test

    On May 9, 2011 (76 FR 26854), FMCSA published a final rule amending
the CDL knowledge and skills testing standards. The final rule included
prohibitions against the use of interpreters during the administration
of the CDL knowledge and skills tests. Section 383.133(b)(3) provides
that the CDL knowledge tests may be administered in written form,
verbally, or in automated format and can be administered in a foreign
language, provided that no interpreter is used in administering the
test. Section 383.133(c)(5) prohibits interpreters during the
administration of skills tests. Paragraph (c)(5) also states that
applicants must be able to understand and respond to verbal commands
and instructions in English by a skills test examiner. Neither the
applicant nor the examiner may communicate in a language other than
English during the skills test.

D. NAD Petition To Change the Rules

    NAD petitioned FMCSA to change its safety regulations so that deaf
and hard of hearing individuals would be allowed to operate CMVs in
interstate commerce. Although FMCSA has granted exemptions from Sec.
391.41(b)(11) concerning physical qualifications for deaf and hard of
hearing individuals as noted above, NAD believes the rule should be
changed to eliminate the regulatory barrier to these individuals
operating CMVs in interstate commerce. NAD also contends that both the
hearing requirement for physical qualification to operate a commercial
vehicle and the speaking requirement are violations of the
Rehabilitation Act of 1973.\2\ A copy of the petition is included in
the docket referenced at the beginning of this document.
---------------------------------------------------------------------------

    \2\ 29 U.S.C. 701, et seq.
---------------------------------------------------------------------------

    In granting the exemptions discussed above, the Agency did not
provide relief from the requirement that drivers be able to communicate
in English and the prohibition against interpreters during the CDL
knowledge and skills tests. However, the Agency has provided
clarifications on how these requirements should be applied in the
context of deaf or hard of hearing individuals.
    On December 29, 2017 (82 FR 61809), FMCSA published a notice
announcing its response to certain substantive comments submitted to
one of the notices regarding the granting of exemptions from the
hearing requirement for multiple drivers. The Agency explained that the
restriction under 49 CFR 383.133(c)(5) does not mean that a skills test
cannot be accomplished with a deaf or hard of hearing individual. The
2017 notice stated:

    Generally, FMCSA has addressed this issue in formal guidance,
which is found at Question 7 to 49 CFR 391.11(b)(2) (published on
October 1, 2014 at 79 FR 59139). The guidance is premised on the
position that the term ``speak,'' as used with the associated rule,
should not be construed so narrowly as to find a deaf driver who
does not use oral communication in violation of that regulation.
Similarly, the term ``verbal'' in 49 CFR 383.133 should not be
construed so narrowly when examiners are administering skills tests
to applicants with a hearing exemption, and should be applied to
permit communication in forms other than verbal. If the actual
skills tests are administered without the aid of an interpreter, the
State is in compliance with 49 CFR 383.133(c)(5). Additionally, as
noted above, there are no prohibitions against the use of an
interpreter prior to the skills test generally or in between the
three segments of the test. Use of a skills test examiner who is
capable of communicating via American Sign Language is also an
option.

II. Requests for Public Comments

    After the publication of the December 29, 2017, notice, several
motor carriers and CDL training providers shared with FMCSA their
concerns about safety when it comes to behind-the-wheel training of
deaf or hard of hearing individuals. Behind-the-wheel training requires
communication between the instructor and the student while the vehicle
is in motion under a variety of conditions. This includes operating on
public roads in traffic, and at highway speeds. Given that deaf and
hard of hearing individuals rely on sign language, written messages or
other visual indicators, training providers have expressed concerns
about safety when the students take their eyes off the road to focus on
communication with the instructor.
    Motor carriers also raised concerns about work-place safety with
such individuals. Safety concerns include identifying effective
alternatives to audible alerts and warnings for hazardous conditions,
such as trucks backing around loading docks and driven around
terminals.
    The FMCSA requests public comments on NAD's petition for
rulemaking, with a focus on five areas of concern:

Safety During CDL Training

    FMCSA's hearing requirement is applicable to individuals who
operate CMVs (as defined in 49 CFR 390.5) in interstate commerce,
regardless of whether they are required to have a CDL. There are also
some regulatory exemptions from the physical qualification
requirements. See, generally, 49 CFR 390.3(f) and 391.2. Therefore,
some individuals seeking CDL training have not been, and would not be,
subject to the hearing standard. This includes, for example,
individuals that drive or plan to drive for Federal, State or local
government agencies that do not impose the same physical qualification
requirements on their employees, etc. What actions have CDL training
providers, including governmental entities providing such training,
taken to address the needs of CDL applicants seeking employment
opportunities in transportation sectors that are exempt from FMCSA's
physical qualifications standards and to what extent would these
practices be helpful to training providers preparing drivers to operate
in sectors subject to FMCSA's physical qualifications standards? How do
CDL training providers ensure safe operations during behind-the-wheel
training of deaf and hard of hearing individuals on public roads?

CDL Skills Test Administration

    With the granting of hearing exemptions as discussed above, some
State Driver Licensing Agencies (SDLAs) have raised concerns about
challenges administering the CDL skills test to deaf and hard of
hearing individuals. The SDLAs expressed concern that the prohibition
against interpreters during the skills test precludes the
administration of the tests if the CDL examiner is not capable of
communicating with sign language.
    In addition, SDLAs have expressed concerns about safety of
operations when the CDL examiner must communicate with the applicant
while the vehicle is in operation on a public road.
    FMCSA requests information from the SDLAs concerning challenges
their examiners have experienced administering the CDL skills test
under such circumstances and what accommodations, if any, have been
made to complete the skills test while complying with the prohibition
against the use of interpreters. The Agency also requests comment on
steps taken to address or minimize the time applicants must take their
eyes off the road to receive instruction or feedback from the CDL
examiner.

Workplace Safety

    FMCSA has statutory direction to ensure that operation of a CMV
does not have a deleterious effect on the health of CMV operators. To
consider the impact of a change in the hearing requirement on driver
health, the Agency requests comments from motor carriers about their
concerns about ensuring the safety of deaf and hard of hearing
individuals at facilities where trucks are loaded and unloaded, and
terminals at which trucks may be operated with workers walking around.
Under such scenarios, deaf or hard of hearing individuals would not be
able to hear audible alarms or signals of workplace hazards. The Agency
requests information about safety precautions that are being taken to
accommodate such individuals and the experiences of these employers
with workplace incidents and injuries.

Safety Impacts if FMCSA Grants NAD's Petition

    In consideration of the areas highlighted above, the Agency request
comments on whether the Agency should grant NAD's petition for
rulemaking, in whole or in part, and initiate a notice-and-comment
rulemaking proceeding. The Agency seeks information on whether a
regulatory change would significantly increase the number of
individuals seeking training and employment as interstate CMV drivers.
Also, would CDL training providers and motor carriers face additional
challenges if the population of deaf and hard of hearing individuals
seeking entry into the industry increased significantly?

Granting of Hearing Exemptions

    As noted above, the Agency has granted more than 450 hearing
exemptions since 2012. The exemptions cover a range of circumstances
necessitating relief from the hearing standard, from individuals with
CDLs in need of an exemption to allow them to operate in interstate
commerce, to individuals seeking a CDL to begin a career in the
interstate motor carrier industry. The exemptions also cover
individuals interested in operating CMVs for which a CDL is not
required. If FMCSA denies the NAD petition for rulemaking, should the
Agency continue granting exemptions, or consider limiting the
exemptions to certain categories such as individuals intending to
operate CMVs for which a CDL is not required, or individuals who
already hold a CDL?

    Issued under authority delegated in 49 CFR 1.87 on: December 10,
2019.
 Jim Mullen,
 Acting Administrator.
[FR Doc. 2019-26942 Filed 12-13-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51434-51436]
[FR Doc No: 2016-18494]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC16-158-000.
    Applicants: Boulder Solar Power, LLC.
    Description: Application for authorization under Section 203 of the
Federal Power Act and request for expedited action, confidential
treatment, and waivers re Boulder Solar Power, LLC.
    Filed Date: 7/27/16.
    Accession Number: 20160727-0001.
    Comments Due: 5 p.m. ET 8/17/16.

    Docket Numbers: EC16-159-000.
    Applicants: FPL Energy Marcus Hook, L.P., FPL Energy MH50 L.P.,
NatGas Holdings 2, L.L.C.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act and Requests for Confidential Treatment and
Waivers of FPL Energy Marcus Hook, L.P., et al.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5154.
    Comments Due: 5 p.m. ET 8/19/16.

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

    Docket Numbers: ER10-2331-057; ER10-2319-048; ER10-2317-048; ER13-
1351-030; ER10-2330-055.
    Applicants: J.P. Morgan Ventures Energy Corporation, BE Alabama
LLC, BE CA LLC, Florida Power Development LLC, Utility Contract
Funding, L.L.C.
    Description: Notice of Non-Material Change in Status of the J.P.
Morgan Sellers, et al.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5048.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER10-2721-006.
    Applicants: El Paso Electric Company.
    Description: Second Supplement to December 31, 2015 Updated Market
Power Analysis of El Paso Electric Company.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5088.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-1023-002.
    Applicants: Eversource Energy Service Company (as ag,ISO New
England Inc.
    Description: Compliance filing: Compliance Filing to Conform
Attachment F to be effective 6/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5134.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-1518-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2016-07-25 Compliance EIM
Enhancements Year One--Phase 2 to be effective 10/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5125.

    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2307-000.
    Applicants: Vista Energy Marketing, L.P.
    Description: Baseline eTariff Filing: Final Version of Vista MBR
Filing to be effective 10/1/2016.
    Filed Date: 7/28/16.
    Accession Number: 20160728-5131.
    Comments Due: 5 p.m. ET 8/18/16.

    Docket Numbers: ER16-2308-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to Original WMPA
SA No. 3915, Queue Nos. Y2-042/Z2-104 to be effective 6/19/2015.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5039.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2309-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 3216 WAPA & City of
Pierre, SD Interconnection Agreement to be effective 7/5/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5047.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2310-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to Original ISA
No. 4242, Queue No. Z1-092 to be effective 7/23/2015.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5051.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2311-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Section 205(d) Rate Filing: Dyanmic Transfer Agreement
to be effective 8/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5052.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2312-000.
    Applicants: Alabama Power Company.
    Description: Section 205(d) Rate Filing: Attachment S (APCo) 2016
Updated Depreciation Rates Filing to be effective 1/1/2017.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5057.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2313-000.
    Applicants: Alabama Power Company.
    Description: Section 205(d) Rate Filing: Attachment S (SEGCo) 2016
Updated Depreciation Rates Filing to be effective 1/1/2017.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5062.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2314-000.
    Applicants: Southern Electric Generating Company.
    Description: Section 205(d) Rate Filing: SEGCO 2016 Updated
Depreciation Rates Filing to be effective 1/1/2017.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5065.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2315-000.
    Applicants: Georgia Power Company.
    Description: Section 205(d) Rate Filing: FP&L Scherer Unit 4 TSA
Amendment Filing (SEGCo 2016 Updated Depreciation Rates) to be
effective 1/1/2017.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5074.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2316-000.
    Applicants: Georgia Power Company.
    Description: Section 205(d) Rate Filing: JEA Scherer Unit 4 TSA
Amendment Filing (SEGCo 2016 Updated Depreciation Rates) to be
effective 1/1/2017.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5075.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2317-000.
    Applicants: Southern California Edison Company.
    Description: Section 205(d) Rate Filing: DSA Calleguas Municipal
Water District Santa Rosa Project to be effective 7/2/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5087.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2318-000.
    Applicants: BIF III Holtwood LLC.
    Description: Section 205(d) Rate Filing: Order No. 816 Tariff
Update for Hydroelectric Generator to be effective 8/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5095.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2319-000.
    Applicants: Sabine Cogen, LP.
    Description: Compliance filing: Reactive Revenue Rate Schedule of
Sabine Cogen, LP to be effective 10/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5099.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2320-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Section 205(d) Rate Filing: Transmission Owner Rate
Case 2017 (TO18) to be effective 10/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5100.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2321-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Section 205(d) Rate Filing: Aug 2016 Membership Filing
to be effective 7/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5127.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2322-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 1518R11 Arkansas Electric
Cooperative Corp NITSA NOA to be effective 7/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5128.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2323-000.
    Applicants: Appalachian Power Company.
    Description: Section 205(d) Rate Filing: OATT--Revise Attachments K
& L, TCC and TNC Rate Update to be effective 12/31/9998.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5139.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2324-000.
    Applicants: ITC Midwest LLC.
    Description: Section 205(d) Rate Filing: Filing of Amendments to
Facilities Agreements to be effective 8/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5140.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2325-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 2969R1 Associated Electric
Cooperative, Inc. NITSA NOA to be effective 7/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5141.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ER16-2326-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Revisions to the PJM/MMU
Service Level Agreement to be effective 8/1/2016.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5146.
    Comments Due: 5 p.m. ET 8/19/16.

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

    Docket Numbers: ES16-47-000.
    Applicants: AEP Utilities, Inc.
    Description: Application Under Section 204 of the Federal Power Act
for

Authorization to Issue Securities of AEP Utilities, Inc.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5090.
    Comments Due: 5 p.m. ET 8/19/16.

    Docket Numbers: ES16-48-000.
    Applicants: New Hampshire Transmission, LLC.
    Description: Application for Authorization of Issuance of Long-Term
Debt Securities under FPA Section 204 of New Hampshire Transmission,
LLC.
    Filed Date: 7/29/16.
    Accession Number: 20160729-5149.
    Comments Due: 5 p.m. ET 8/19/16.

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

    Dated: July 29, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-18494 Filed 8-3-16; 8:45 am]
 BILLING CODE 6717-01-P


Page 1 of 5 Ha Ha UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 14, 2006 MEMORANDUM Subject: Transmittal of materials for review by the Human Studies Review Board.

To: Paul Lewis, Ph. D. Designated Federal Officer Human Studies Review Board Office of Science Advisor ( 8105R)

From: Jack E. Housenger Associate Director Office of Pesticide Programs, Health Effects Division ( 7509C)

Betty Shackleford Associate Director Office of Pesticide Programs, Antimicrobials Division ( 7510C)

The Agency's Human Studies Review Board ( HSRB) is scheduled to meet May 2 4, 2006, to address scientific and ethical issues surrounding human toxicity studies involving two pesticide active ingredients, carbofuran and methyl isothiocyanate ( MITC), and chromium, a constituent of wood preservative products. ( Wood preservatives are regulated as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act.) By this memo the Office of Pesticide Programs ( OPP) is transmitting to the HSRB the documents discussed below.

On March 21, 2006, the Agency sent to the HSRB materials containing background information regarding EPA review policies and approaches and the newlyeffective amended rules for protecting human subjects of research. These materials may also be useful in preparing for this HSRB meeting. Page 2 of 5 DOCUMENTS PROVIDED TO THE HUMAN STUDIES REVIEW BOARD ( HSRB) FOR THE MAY 2 4, 2006 MEETING Introduction The Pesticide Registration Improvement Act ( PRIA) requires that EPA complete its decision making process on certain types of applications to register a pesticide product within specified amounts of time after receiving the application for registration. In addition, PRIA established deadlines for EPA to complete " reregistration" of pesticide active ingredients that are contained in pesticide products initially registered before 1984. Reregistration involves the systematic reexamination of older pesticides, applying contemporary scientific and regulatory standards. When a pesticide active ingredient is approved for use on food, EPA combines reregistration with the tolerance reassessment process mandated by the Food Quality Protection Act of 1996 ( FQPA).

Both MITC and carbofuran are undergoing reevaluation in the reregistration process. EPA is considering the human health risks of chromium both in its reregistration program and as part of its review of an application for registration pending under FIFRA and PRIA.

Types of Documents Provided to the Human Studies Review Board ( HSRB) for the May 2  4, 2006 Meeting For each of the human studies under consideration, the Agency has provided the Board members with the complete study report and any supplements available to the Agency. Each of these studies is assigned a unique identifier, the Master Record Identifier or MRID, which OPP uses to manage documents in its archive. When a company submits multiple documents pertaining to a single study, each document is assigned a unique MRID as it is received and catalogued. Thus a study with several supplements, such as the MITC study to be discussed at this meeting, may be associated with several MRIDs.

For each study the Agency has provided a review of the ethical conduct of the study. Each ethics review identifies any deficiencies noted in the conduct of the specific study compared to both current ethical standards and the ethical standards prevailing at the time the research was performed. EPA has intentionally deferred making a final determination of whether an individual study satisfies the ethical standards for acceptability in 40 CFR sections 26.1704   26.1706, pending the advice of the Board.

For most studies, the Agency develops documents, called Data Evaluation Records ( DERs), containing a scientific review of the study; the Board has been provided with one or more DERs for carbofuran and MITC. DERs contain summaries of the study design, methods and results, describe potential deficiencies, and provide conclusions about the usefulness of the study in risk assessment. Page 3 of 5 In addition to the DERs, OPP has prepared a " Weight of Evidence" ( WOE) memorandum for carbofuran and MITC discussing the differences and similarities between the human and animal responses to each chemical and characterizing the usefulness of the human toxicity studies for human health risk assessment. The WOE memos express the Agency's current scientific conclusions on which the Agency is soliciting the Board's comments. To maintain the historical record of review, EPA may, in some cases, include a DER for a study that expresses scientific conclusions differing from those in the WOE document.

For chromium, EPA has provided a set of documents which contain similar information to DERs and WOEs, but which have a slightly different format and presentation, due to the procedural history of the EPA's review of this chemical. As noted above, chromium is a constituent in wood preservative products. EPA has concern about the potential for chromium to elicit an allergic response in sensitized individuals who come in contact with residues remaining in products made from wood that has been treated with chromium containing wood preservatives. To assess the risk of potential dermal exposure, EPA reviewed, among other information, a study involving intentional exposure of sensitized subjects to different levels of chromium, ( Nethercott 1994). This assessment was one of the first assessments of this kind performed by OPP, and it raised significant scientific issues. Accordingly, EPA prepared a background document for its independent, peer review advisory committee, the FIFRA Scientific Advisory Panel ( SAP). The SAP is a federally chartered advisory committee of scientific experts who provide advice to EPA on scientific issues arising in connection with the regulation of pesticides. We are providing a copy of the materials given to the SAP for its review, as well as a copy of the SAP's final report. After receiving the SAP's recommendations, EPA sought review and comment from other Agency scientists through the steering committee of EPA's internal Science Policy Council ( SPC) to ensure consistency across programs in the approach to regulating substances that are skin sensitizers. Using the advice of the SAP and the steering committee of the SPC, OPP developed a memorandum describing how OPP intended to use the results of the Nethercott study to derive a sensitization Reference Dose. This memorandum, developed in the Antimicrobials Division Toxicity Endpoint Selection Committee ( ADTC), is analogous to the WOE documents generated by HED. Page 4 of 5 Table of contents 1. Transmittal memo 2. Charge to HSRB 3. Chromium   Nethercott J., et al., " A study of chromium induced allergic contact dermatitis with 54 volunteers; implications for environmental risk assessment," Occup. Environ. Med. 1994; 51: 371 380. 4. Chromium   Ethics review by John Carley, USEPA; April 11, 2006. 5. Chromium   FIFRA Scientific Advisory Panel Background Document [ for the] May 4 6, 2004 Meeting, by McMahon, T., et al., USEPA. 6. Chromium   " Transmittal of Minutes of the FIFRA Scientific Advisory Panel Meeting Held May 4 6, 2004: A Consultation On Dermal Sensitization Issues For Exposures To Pesticides" July 1, 2004. 7. Chromium   ADTC MEMORANDUM: " Hexavalent Chromium  Finalization of Issues related to Quantitation of Dermal Risk from exposure to treated wood containing hexavalent chromium," McMahon, T., August 31, 2004.

8. Carbofuran    Arnold, J. D. ( 1976) Evaluation of the Safe Exposure Levels to Carbamate, Administered Orally to Healthy Adult Normal Male Volunteers. ( Unpublished study received Oct 24, 1979 under 279 2712; prepared by Quincy Research Center, submitted by FMC Corp., Philadelphia, Pa.; CDL: 241303 B) Accession no. 241303. MRID 00092826. 9. Carbofuran   Arnold, J. D. ( 1977) Carbamate ( Carbofuran) Human Dermal Study. Final rept. ( Unpublished study received Oct 24, 1979 under 279 2712; prepared by Quincy Research Center, submitted by FMC Corp., Philadelphia, Pa.; CDL: 241303 C), Accession no. 241303. MRID 00092827. 10. Carbofuran   Arnold, J. D. ( 1978) Comparison of Cholinesterase Inhibition and Effects of Furadan 4F and FMC 35001 4 EC ( ACT 152.03). Rev. final rept. ( Unpublished study received Oct 24, 1979 under 279 2712; prepared by Quincy Research Center, submitted by FMC Corp., Philadelphia, Pa.; CDL: 241305 A) Accession no. 241305, MRID no. 00092829. 11. Carbofuran   Ethics review of human oral study by John Carly, USEPA; April 14, 2006 12. Carbofuran   Ethics review of human dermal study by John Carly, USEPA; April 14, 2006 13. Carbofuran   Ethics review of human dermal comparison study by John Carly, USEPA; April 14, 2006 14. Carbofuran   Data Evaluation Record   human oral study with carbofuran. Memo from Amal Mahfouz to Jay Ellenberger dated June 26, 1981. Carbofuran; EPA Reg.# 279 2875 ( Furadan 75 WP) and EPA Reg. # 279 2876 ( Furadan 4 F); also FMC 35001 4 EC ( unregistered Carbofuran analog). 15. Carbofuran   Data Evaluation Record   acute human dermal study ( 1977) with carbofuran. Memo from Amal Mahfouz to Jay Ellenberger dated June 26, 1981. Page 5 of 5 Carbofuran; EPA Reg.# 279 2875 ( Furadan 75 WP) and EPA Reg. # 279 2876 ( Furadan 4 F); also FMC 35001 4 EC ( unregistered Carbofuran analog). 16. Carbofuran   Data Evaluation Record   acute human dermal study ( 1978) with carbofuran. Memo from Amal Mahfouz to Jay Ellenberger dated June 26, 1981. Carbofuran; EPA Reg.# 279 2875 ( Furadan 75 WP) and EPA Reg. # 279 2876 ( Furadan 4 F); also FMC 35001 4 EC ( unregistered Carbofuran analog). 17. Carbofuran   Discussion of Outside Peer Review Comments on the Carbofuran RfD, Memo from William Burnam to Tina Levine dated September 11, 1997. 18. Carbofuran   Human Studies Review Board: CARBOFURAN Weight of Evidence Presentation of Human and Animal Toxicity Studies 19. MITC   Russell, M. J. and Rush, T. I. ( 1996) Methyl Isothiocyanate: Determination of human olfactory detection threshold and human no observable effect level for eye irritation. Sensory Testing Laboratory, University of California at Davis. Report No. RR 96 049B. September 10, 1996 MRID 44400401. 20. MITC   Supplementary material for Russell et al. ( 1996). MRIDs 46546601, 46558201, and 46584901. 21. MITC   Ethics review by John Carley, April 13, 2006 22. MITC   Data Evaluation Record, Special Study: Human Eye Irritation and Odor Threshold. MRIDs 44400401, 46546601, 46558201, and 46584901. 23. MITC   Human Studies Review Board: Weight of Evidence Discussion for Methyl isothiocyanate ( MITC), April 13, 2006


[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30961-30962]
[FR Doc No: 2022-10701]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process as a means
to

develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on February 18, 2022 (87 FR 9366). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Arsenic trioxide.
Acetaminophen.
Asenapine.
Bupivacaine.
Cedazuridine; Decitabine.
Chlorhexidine gluconate.
Cocaine hydrochloride.
Exenatide synthetic (multiple referenced listed drugs).
Flunisolide.
Halobetasol propionate.
Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate.
Ibuprofen.
Lorezepam.
Naloxone hydrochloride.
Oliceridine.
Palbociclib.
Pralsetinib.
Risdiplam.
Secretin synthetic human.
Solifenacin succinate.
Tegaserod maleate.
Torsemide.
Triheptanoin.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Acarbose.
Doxorubicin hydrochloride.
Linaclotide.
Metoprolol succinate.
Midostaurin.
Oseltamivir phosphate.
Selinexor.
Solifenacin succinate.
Theophylline.
Tiopronin.
Torsemide.
Trametinib dimethyl sulfoxide.
Uridine triacetate.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that these draft guidances contain no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

V. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10701 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Notices]
[Page 52393]
[FR Doc No: 2012-21265]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257Notice No. 69]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Announcement of Railroad Safety Advisory Committee (RSAC)
meeting.

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

SUMMARY: FRA announces the forty-seventh meeting of the RSAC, a Federal
Advisory Committee that develops railroad safety regulations through a
consensus process. The RSAC meeting topics will include opening remarks
from the FRA Administrator, and status reports will be provided by the
Critical Incident, Fatigue Management, and Risk Reduction Working
Groups. Status reports will also be provided by the Engineering and
System Safety Task Forces, and a presentation on headwear will be
provided. This agenda is subject to change, including the possible
addition of further proposed tasks under the Rail Safety Improvement
Act of 2008.

DATES: The RSAC meeting is scheduled to commence at 9:30 a.m. on
Thursday, September 27, 2012, and will adjourn by 4:30 p.m.

ADDRESSES: The RSAC meeting will be held at the National Housing
Center, 1201 15th Street NW., Washington, DC 20005. The meeting is open
to the public on a first-come, first-served basis and is accessible to
individuals with disabilities. Sign and oral interpretation can be made
available if requested 10 calendar days before the meeting.

FOR FURTHER INFORMATION CONTACT: Mr. Larry Woolverton, RSAC
Administrative Officer/Coordinator, FRA, 1200 New Jersey Avenue SE.,
Mailstop 25, Washington, DC 20590,<PHONE_NUMBER>; or Mr. Robert Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington,
DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the Railroad Safety Advisory Committee (RSAC). The RSAC was
established to provide advice and recommendations to FRA on railroad
safety matters. The RSAC is composed of 54 voting representatives from
32 member organizations, representing various rail industry
perspectives. In addition, there are non-voting advisory
representatives from the agencies with railroad safety regulatory
responsibility in Canada and Mexico, the National Transportation Safety
Board, and the Federal Transit Administration. The diversity of the
Committee ensures the requisite range of views and expertise necessary
to discharge its responsibilities. See the RSAC Web site for details on
prior RSAC activities and pending tasks: http://rsac.fra.dot.gov/.
Please refer to the notice published in the Federal Register on March
11, 1996 (61 FR 9740), for additional information about the RSAC.

    Issued in Washington, DC, on August 23, 2012.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2012-21265 Filed 8-28-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Rules and Regulations]
[Pages 10464-10466]
[FR Doc No: 2023-03456]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0841; FRL-10489-02-R5]

Air Plan Approval; Illinois; Alton Township 2010 SO2 Attainment
Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
State Implementation Plan (SIP) revision which Illinois submitted to
EPA on December 31, 2018, for attaining the 1-hour sulfur dioxide
(SO2) primary national ambient air quality standard (NAAQS)
for the Alton Township nonattainment area in Madison County. This plan
(herein called a ``nonattainment plan'') includes Illinois' attainment
demonstration and other elements required under the Clean Air Act
(CAA), including the requirement for meeting reasonable further
progress (RFP) toward attainment of the NAAQS, reasonably available
control measures and reasonably available control technology (RACM/
RACT), base-year and projection-year emission inventories, enforceable
emission limitations and control measures, nonattainment new source
review (NNSR), and contingency measures. EPA is approving Illinois'
submission as a SIP revision for attaining the 2010 1-hour primary
SO2 NAAQS in the Alton township nonattainment area, finding
that Illinois has adequately demonstrated that the plan provisions
provide for attainment of the NAAQS in the nonattainment area and that
the plan meets the other applicable requirements under the CAA. EPA
proposed to approve this action on December 30, 2022, and received no
comments.

DATES: This final rule is effective on March 23, 2023.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2018-0841. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Andrew Lee,
Physical Scientist, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Andrew Lee, Physical Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background Information

    Following the promulgation in 2010 of a 1-hour primary
SO2 NAAQS, on June 30, 2016, EPA designated the Alton
Township area within the State of Illinois as nonattainment for this
NAAQS, in conjunction with designating multiple areas in other states
as nonattainment as part of the Agency's Round 2 designations. On
December 31, 2018, Illinois submitted a nonattainment plan for the
Alton Township area to attain the 1-hour SO2 primary NAAQS.
EPA published a notice of proposed rulemaking (NPRM) approving
Illinois' attainment plan on December 30, 2022 (87 FR 80509).
    The dispersion modeling results submitted by Illinois, and
supplemented by EPA, show design values that are less than the standard
of 75 parts per billion (ppb), specifically 74.9 ppb for the Alton
Township area. EPA proposed that these areas demonstrate attainment of
the 2010 SO2 standard and meet the applicable requirements
of CAA sections 110, 172, 191, and 192, including emission inventories,
RACT/RACM, RFP, and contingency measures, and that Illinois has
previously addressed requirements regarding NNSR. An explanation of the
CAA requirements, a detailed analysis of the nonattainment plan for the
Alton Township area, and EPA's reasons for proposing approval were
provided in the NPRM and will not be restated here.

II. Public Comments

    The public comment period for this proposed rule ended on January
30, 2023. EPA received no comments on its NPRM.

III. Final Action

    EPA is approving Illinois' attainment plan as submitted to EPA on
December 31, 2018, as a revision to Illinois' SIP, for attaining the
2010 SO2 NAAQS for the Alton Township area. As part of this
action, EPA is incorporating Illinois' Permit to Construct Number
#18020009, applicable to Alton Steel, by reference into the SIP. The
permit requires that Alton Steel operates a new ladle metallurgy
facility (LMF) stack to replace the four downward facing vents on the
individual compartments on the LMF stack. The attainment plan includes
Illinois' attainment demonstrations for the Alton nonattainment area
using dispersion modeling, and supplemented by EPA's modeling, to
demonstrate that the emission limits required by the Illinois SIP, and
submitted for EPA approval, provide for modeled concentrations meeting
the SO2 NAAQS.
    The attainment plan also satisfies requirements for emission
inventories, RACT/RACM, RFP, and contingency measures. Illinois has
previously addressed NNSR requirements for this area. For these
reasons, EPA has determined that Illinois' SO2 attainment
plan meets the applicable requirements of CAA sections 110, 172, 191,
and 192.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Illinois
construction permit for Alton Steel, Inc., issued March 5, 2018, as
described in section III. Of this preamble and set forth in the
amendments to 40 CFR part 52 set forth below. EPA has made, and will
continue to make, these documents generally available through
www.regulations.gov, and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 24, 2023. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2) of the CAA.)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: February 14, 2023.
Debra Shore,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, 40 CFR part 52 is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

0
2. In Sec.  52.720:
0
a. Amend the table in paragraph (d) by adding an entry for ``Alton
Steel'' before the entry for ``Alumax Incorporated, Morris, IL''.
0
b. Amend the table in paragraph (e) under the heading ``Attainment and
Maintenance Plans'' by adding an entry for ``Sulfur dioxide (2010)
nonattainment plan'' after the entry ``Sulfur dioxide (2010)
nonattainment plans''.
    The additions read as follows:

Sec.  52.720  Identification of plan.

* * * * *
    (d) * * *

                               EPA-Approved Illinois Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                  Order/permit        State
         Name of source                No.       effective date  EPA approval date            Comments
----------------------------------------------------------------------------------------------------------------
Alton Steel....................        18020009        3/5/2018  2/21/2023,
                                                                  [INSERT Federal
                                                                  Register
                                                                  CITATION].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                       EPA-Approved Illinois Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                    Applicable
                                  geographic or         State        EPA approval
     Name of SIP provision        nonattainment    submittal date        date                  Comments
                                       area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Attainment and Maintenance Plans
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sulfur dioxide (2010)           Alton Township...      12/31/2018  2/21/2023,        ...........................
 nonattainment plan.                                                [INSERT Federal
                                                                    Register
                                                                    CITATION].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-03456 Filed 2-17-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 9, 2006 (Volume 71, Number 111)]
[Notices]
[Page 33446-33448]
[DOCID:fr09jn06-33]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0309; FRL-8059-4]

Pesticide Product; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any previously registered products pursuant to the provisions of
section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended.

DATES: Comments must be received on or before August 8, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0309, by one of the following methods:
     http://www.regulations.gov/: Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502P), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity Branch
(PIRIB) (7502P), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. S-4400, One Potomac Yard 2777 S. Crystal Dr.,
Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2006-0309. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Docket
Facility is<PHONE_NUMBER>. Such deliveries are only accepted during
the Docket's normal hours of operation, and

special arrangements should be made for deliveries of boxed
information.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0309. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm/.

     Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, i.e., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov/ or in hard copy at the Public

Information and Records Integrity Branch (PIRIB) (7502P), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. S-4400
One Potomac Yard 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Docket Facility
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Regulatory Action Leader,
Biopesticides and Pollution Prevention Division (7511P), listed in the
table in this unit:

----------------------------------------------------------------------------------------------------------------
                                       Telephone number/e-mail
       Regulatory Action Leader                address              Mailing address            File symbol
----------------------------------------------------------------------------------------------------------------
Rebecca Edelstein<PHONE_NUMBER>           Biopesticides and        81179-R
                                       Edelstein.Rebecca@epa.   Pollution Prevention
                                        ov..                     Division (7511P),
                                                                 Office of Pesticides,
                                                                 Environmental
                                                                 Protection Agency,
                                                                 1200 Pennsylvania
                                                                 Ave., NW., Washington,
                                                                 DC 20460-0001
----------------------------------------------------------------------------------------------------------------
Gail Tomimatsu<PHONE_NUMBER>;          Do.                      82706-R
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing active ingredients not included in any previously registered
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice
of receipt of these applications does not imply a decision by the
Agency on the applications.

Products Containing Active Ingredients not Included in any Previously
Registered Products

    File Symbol: 81179-R. Applicant: BioProdex, Inc., Gainesville
Technology Enterprise Center (GTEC) Box 5, Suite 205, 2153 SE Hawthorne
Rd., Gainesville, FL 32641. Product Name: Solvinix.Type of product:
microbial pesticide (herbicide) Active ingredient: Tobacco Mild Green
Mosaic Tobamovirus at 20%.Proposed classification/Use: For
postemergence application to kill tropical soda apple in rangelands,
grass pastures, sod-production fields, Conservation Reserve Program
areas, other natural areas (wildlife management areas, Florida
Greenways and Trail lands, campgrounds and trails, and woodlands),
around cattle feedlots, pens, and stockyards, rights-of-way, roadsides,
ditch-banks, and citrus and sugarcane in Florida and other southeastern
states. (R. Edelstein.)
    File Symbol: 82706-R. Applicant: Bio-Oz Biotechnologies Ltd.,
Kibbutz Yad Mordechai DN Hof Ashkelon 79145, Israel. Product
Name:AgroGuard Z. Type of product: microbial pesticide (viruscide)
Active ingredient: Avirulent Strain of Zucchini Yellow Mosaic Virus.
Proposed classification/Use: For protection of young cucurbit plants:
cucumbers, cantaloupes, watermelons, muskmelons, winter and summer
squash, pumpkins, zucchini and other cucurbits against virulent
Zucchini Yellow Mosaic Virus infection. (G. Tomimatsu.)

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: June 1, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 06-5265 Filed 6-8-06; 8:45 am]

BILLING CODE 6560-50-S