[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47531-47533]
[FR Doc No: 2017-22049]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5868]

Requests for Reconsideration at the Division Level Under the
Generic Drug User Fee Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Requests
for Reconsideration at the Division Level Under GDUFA.'' This guidance
provides recommendations for industry on the procedures for resolving
scientific and/or regulatory issues or matters between FDA and
applicants of abbreviated new drug applications (ANDAs) that wish to
pursue a request for reconsideration within the review discipline at
the division level or original signatory authority. This guidance also
provides information for applicants to consider before pursuing a
request for reconsideration, procedures for submitting a request for
reconsideration, and the Agency's process for responding to those
requests.

DATES: Submit either electronic or written comments on the draft
guidance by December 11, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-

2017-D-5868 for ``Requests for Reconsideration at the Division Level
Under GDUFA; Draft Guidance for Industry; Availability.'' 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.
     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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    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: Lisa Bercu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Requests for Reconsideration at the Division Level Under
GDUFA.'' This guidance provides recommendations for industry on the
procedures for resolving scientific and/or regulatory issues or matters
between FDA and applicants of ANDAs that wish to pursue a request for
reconsideration within the review discipline at the division level or
original signatory authority. In accordance with ``GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022'' (GDUFA II Goals Letter or GDUFA II Commitment Letter;
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to certain review goals and procedures for
the review of requests for reconsideration received on or after October
1, 2017.\1\
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    \1\ The FDA Reauthorization Act of 2017 (Pub. L. 115-52)
included the reauthorization of generic user fees as Title III,
Generic Drug User Amendments of 2017 (GDUFA II).
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    As agreed to by FDA and industry in the GDUFA II Commitment Letter,
applicants may pursue a request for reconsideration within the review
discipline at the division level. In addition, if an applicant requests
a teleconference as part of its request to reclassify a major amendment
or standard review status, FDA will schedule and conduct the
teleconference and decide 90 percent of such reclassification requests
within 30 days of the date of FDA's receipt of the request for a
teleconference. As stated in the GDUFA II Commitment Letter, this goal
only applies when the applicant accepts the first scheduled
teleconference date offered by FDA. This guidance provides additional
details and recommendations concerning considerations for applicants
before pursuing a request for reconsideration and procedures for
submitting a request for reconsideration and the Agency's process for
responding to those requests.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requests for
Reconsideration at the Division Level Under GDUFA.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information, including each proposed extension of an
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Applications for FDA Approval To Market a New Drug
OMB Control Number 0910-0001--Revision
    The information collection request supports the Agency's draft
guidance entitled, ``Requests for Reconsideration at the Division Level
Under GDUFA.'' As discussed in section I of this notice, this guidance
provides information to respondents regarding procedures for

submitting requests for reconsideration, including details on the
content and format of the submission. Respondents to the collection of
information are applicants of ANDAs. Based on available data with
regard to similar information collections, FDA's Center for Drug
Evaluation and Research will receive approximately 150 requests for
reconsideration annually from 75 respondents. Because we estimate it
will take 5 hours to prepare a request for reconsideration, we estimate
it will take an average of 750 total hours annually for respondents to
prepare and submit requests for reconsideration. The burden of the
information collection, therefore, is estimated as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                      Guidance recommendation                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section IV: Procedures for Submitting and Responding to a Request                75                2              150                5              750
 for Reconsideration...............................................
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\1\ There are no capital or operating and maintenance costs associated with the collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22049 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 25, 2009 (Volume 74, Number 36)]
[Notices]
[Page 8519-8520]
[DOCID:fr25fe09-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12619-002; Project No. 13363-000; Project No. 13364-000;
Project No. 13366-000]

Cascade Creek, LLC; City and Borough of Wrangell, AK; Petersburg
Municipal Power and Light; City of Angoon, AK; Notice of Competing
Preliminary Permit Applications Accepted for Filing and Soliciting
Comment, Motions To Intervene, and Competing Applications

February 18, 2009.
    Cascade Creek, LLC (Cascade), City and Borough of Wrangell, Alaska
(Wrangell), Petersburg Municipal Power and Light (Petersburg) and the
City of Angoon, Alaska filed applications, pursuant to section 4(f) of
the Federal Power Act, proposing to study the feasibility of the Ruth
Lake Project, to be located on Ruth Lake and Delta Creek, in an
unorganized Borough near Petersburg, Alaska. There are no existing
facilities. The project would be located in the Tongass National
Forest. All of these applications were filed electronically and given
the filing date of February 3, 2009, at 8:30 a.m.
    The proposed Ruth Lake Projects:
    The proposed Ruth Lake Project by Cascade Creek, LLC for Project
No. 12619-002 filed on February 3, 2009 at 8:30 a.m. would consist of:
(1) A proposed 170-foot-high concrete arch dam at the exit of the
natural Ruth Lake; (2) an existing reservoir having a surface area of
130 acres and a storage capacity of 17,000 acre-feet and normal water
surface elevation of 1,527 feet mean sea level (msl); (3) a proposed
12,600-foot-long, 6 to 12-inch diameter combination bored tunnel and
steel penstock; (4) a proposed powerhouse containing three new
generating units having an installed capacity of 20 megawatts; (5) an
existing 20-mile-long, 138 kilovolt transmission line; and (6)
appurtenant facilities. The proposed Ruth Lake Project would have an
average annual generation of 70 gigawatt-hours. Cascade is also
exploring alternatives that would connect this project to their Cascade
Creek Project, which they have preliminary permit for FERC No. 12495.
    The proposed Ruth Lake Project by City and Borough of Wrangell,
Alaska for Project No. 13363-000 filed on February 3, 2009 at 8:30 a.m.
would consist of: (1) A proposed 170-foot-high concrete arch dam at the
exit of the natural Ruth Lake; (2) an existing reservoir having a
surface area of 130 acres and a storage capacity of 17,000 acre-feet
and normal water surface elevation of 1,527 feet mean sea level (msl);
(3) a proposed 12,600-foot-long, 6 to 12-foot diameter combination
bored tunnel and steel penstock; (4) a proposed powerhouse containing
three new generating units having an installed capacity of 20
megawatts; (5) an existing 20-mile-long, 138 kilovolt transmission
line; and (6) appurtenant facilities. The proposed Ruth Lake Project
would have an average annual generation of 70 gigawatt-hours.
    The proposed Ruth Lake Project by Petersburg Municipal Power and
Light for Project No. 13363-000 filed on February 3, 2009 at 8:30 a.m.
would consist of: (1) A proposed 200-foot-high concrete faced rockfill
dam at the exit of the natural Ruth Lake; (2) an existing reservoir
having a surface area of 190 acres and a storage capacity of 17,000
acre-feet and normal water surface elevation of 1,560 feet mean sea
level (msl); (3) a proposed 3,500-foot-long, 10-foot diameter tunnel
and a 7,800-foot-long, 6-foot-diameter steel penstock; (4) a proposed
powerhouse containing three new generating units having an installed
capacity of 20 megawatts; (5) would connect directly to their
distribution system; and (6) appurtenant facilities. The proposed Ruth
Lake Project would have an average annual generation of 70 gigawatt-
hours.
    The proposed Ruth Lake Project by City of Angoon, Alaska for
Project No. 13366-000 filed on February 3, 2009 at 8:30 a.m. would
consist of: (1) A proposed 170-foot-high concrete arched dam at the
exit of the natural Ruth Lake; (2) an existing reservoir having a
surface area of 130 acres and a storage capacity

of 17,000 acre-feet and normal water surface elevation of 1,527 feet
mean sea level (msl); (3) a proposed 3,600-foot-long, 6 to 12-inch
diameter combination bored tunnel and steel penstock; (4) a proposed
powerhouse containing three new generating units having an installed
capacity of 20 megawatts; (4) an existing 20-mile-long, 138 kilovolt
transmission line; and (5) appurtenant facilities. The proposed Ruth
Lake Project would have an average annual generation of 70 gigawatt-
hours.
    Applicants Contact: For Cascade Creek, LLC: Mr. Chris Spears,
Cascade Creek, LLC, 3633 Alderwood Avenue, Bellingham, WA 98225, (360)
738-9999. For City and Borough of Wrangell, Alaska: Mr. Warren Edgley,
City and Borough of Wrangell, Alaska, P.O. Box 531, Wrangell, AK 99929,
(907) 874-2381. For Petersburg Municipal Electric & Light: Mr. Joe
Nelson, Superintendent, Petersburg Municipal Electric & Light, P.O. Box
329, 11 South Nordic, Petersburg, AK 99833,<PHONE_NUMBER>. For the
City of Angoon, Alaska: Mayor, Albert Howard, City of Angoon, Alaska,
P.O. Box 189, Angoon, AK 99820,<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
12619-002, 13363-000, 13364, or P-13366) in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-3971 Filed 2-24-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Rules and Regulations]
[Page 49979]
[FR Doc No: 2022-17211]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0803; Airspace Docket No. 19-AAL-58]
RIN 2120-AA66

Amendment of United States Area Navigation Route (RNAV) T-222;
Bethel, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: This action corrects a final rule published by the FAA in the
Federal Register on June 30, 2022, that amends United States Area
Navigation (RNAV) route T-222 in the vicinity of Bethel, AK, in support
of a large and comprehensive T-route modernization project for the
state of Alaska. The final rule identified the CABOT, AK, and IKUFU,
AK, route points as waypoints (WPs), in error. This action makes
editorial corrections to all references of the CABOT, AK, and IKUFU,
AK, WPs to change them to be reflected as Fixes and match the FAA's
aeronautical database information.

DATES: Effective date 0901 UTC, September 8, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register (87 FR
38915; June 30, 2022), amending T-222 in support of a large and
comprehensive T-route modernization project for the state of Alaska.
Subsequent to publication, the FAA determined that the CABOT, AK, and
IKUFU, AK, route points were inadvertently identified as WPs, in error.
This rule corrects those errors by changing all references of the
CABOT, AK, and IKUFU, AK, WPs to the CABOT, AK, and IKUFU, AK, Fixes,
respectively. These are editorial changes only to match the FAA's
aeronautical database information and does not alter the alignment of
the affected T-222 route.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F, dated August 10, 2021, and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV T-route listed in this document will be published subsequently
in FAA Order JO 7400.11.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, all
references to the CABOT, AK, and IKUFU, AK, WPs reflected in Docket No.
FAA-2021-0803, as published in the Federal Register of June 30, 2022
(87 FR 38915), FR Doc. 2022-13879, are corrected as follows:
    1. In FR Doc. 2022-13879, appearing on page 38915, in the second
column, at lines 54-56, correct ``adding five additional WPs (CABOT,
WOGAX, IKUFU, JILSI, and CYCAS) in the'' to read ``adding three
additional WPs (WOGAX, JILSI, and CYCAS) and two Fixes (CABOT and
IKUFU) in the''.
    2. In FR Doc. 2022-13879, appearing on page 38916, in the third
column, at line 17, correct ``CABOT, AK WP (lat. 61[deg]12'01.32'' N,
long. 160[deg]45'20.93'' W)'' to read ``CABOT, AK FIX (lat.
61[deg]12'01.32'' N, long. 160[deg]45'20.93'' W)''.
    3. In FR Doc. 2022-13879, appearing on page 38916, in the third
column, at line 19, correct ``IKUFU, AK WP (lat. 61[deg]40'34.53'' N,
long. 159[deg]52'35.43'' W)'' to read ``IKUFU, AK FIX (lat.
61[deg]40'34.53'' N, long. 159[deg]52'35.43'' W)''.

    Issued in Washington, DC, on August 3, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-17211 Filed 8-12-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82942-82944]
[FR Doc No: 2023-26045]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0058; FMCSA-2018-0136; FMCSA-2018-0138; FMCSA-
2018-0139; FMCSA-2019-0109; FMCSA-2019-0110]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for 16
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions are applicable on December 26, 2023. The
exemptions expire on December 26, 2025. Comments must be received on or
before December 27, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2017-0058, Docket No. FMCSA-2018-
0136, Docket No. FMCSA-2018-0138, Docket No. FMCSA-2018-0139, Docket
No. FMCSA-2019-0109, or Docket No. FMCSA-2019-0110 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2017-0058, FMCSA-2018-0136, FMCSA-2018-
0138, FMCSA-2018-0139, FMCSA-2019-0109, or FMCSA-2019-0110) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click on the
``Comment'' button. Follow the online instructions for submitting
comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001, 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'' portion of the SUPPLEMENTARY INFORMATION
section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are 8:30 a.m. to 5 p.m. ET Monday
through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2017-0058, Docket No. FMCSA-2018-0136, Docket
No. FMCSA-2018-0138, Docket No. FMCSA-2018-0139, Docket No. FMCSA-2019-
0109, or Docket No. FMCSA-2019-0110) 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 phone 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 www.regulations.gov/, insert
the docket number (FMCSA-2017-0058, FMCSA-2018-0136, FMCSA-2018-0138,
    FMCSA-2018-0139, FMCSA-2019-0109, or FMCSA-2019-0110) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, click the ``Comment''
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. FMCSA will consider all comments and
material received during the comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2017-0058, FMCSA-2018-0136, FMCSA-2018-0138, FMCSA-2018-
0139, FMCSA-2019-0109, or FMCSA-2019-0110) in the keyword box and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click ``Browse Comments.'' If you do not
have access to the internet, you may view the docket online by visiting
Dockets Operations 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. To be sure
someone is there to help you, please call<PHONE_NUMBER> or (202) 366-
9826 before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. 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 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes also allow the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5-1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971),
respectively).
    The 16 individuals listed in this notice have requested renewal of
their exemptions from the hearing standard in Sec.  391.41(b)(11), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 16
applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The 16 drivers in this notice
remain in good standing with the Agency. In addition, for commercial
driver's license (CDL) holders, the Commercial Driver's License
Information System and the Motor Carrier Management Information System
are searched for crash and violation data. For non-CDL holders, the
Agency reviews the driving records from the State Driver's Licensing
Agency. These factors provide an adequate basis for predicting each
driver's ability to continue to safely operate a CMV in interstate
commerce. Therefore, FMCSA concludes that extending the exemption for
each of these drivers for a period of 2 years is likely to achieve a
level of safety equal to that existing without the exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of December
and are discussed below. As of December 26, 2023, and in accordance
with 49 U.S.C. 31136(e) and 31315(b), the following 16 individuals have
satisfied the renewal conditions for obtaining an exemption from the
hearing requirement in the FMCSRs for interstate CMV drivers:

Denis Ayers (MD)
Joseph Bence (OH)
Daryl Broker (MN)
Justin Brooks (WA)
Christa Butner (NC)

William Darnell (AZ)
Travis Davisson (IA)
Steven Gandee (PA)
Derek Hawkins (NH)
James Johnson (MN)
Keith Kenyon (WI)
John Martikainen (CT)
Willis Ryan (GA)
John Silvers (NY)
Jeremy Williams (CA)
Joseph Williams (MD)

    The drivers were included in docket numbers FMCSA-2017-0058, FMCSA-
2018-0136, FMCSA-2018-0138, FMCSA-2018-0139, FMCSA-2019-0109, or FMCSA-
2019-0110. Their exemptions are applicable as of December 26, 2023 and
will expire on December 26, 2025.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) each driver must report any crashes or accidents as defined in
Sec.  390.5T; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR parts 383 and 391 to FMCSA; and (3)
each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for 2 years
unless rescinded earlier by FMCSA. The exemption will be rescinded if:
(1) the person fails to comply with the terms and conditions of the
exemption; (2) the exemption has resulted in a lower level of safety
than was maintained before it was granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 16 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in Sec.  391.41 (b)(11). In accordance with 49 U.S.C.
31136(e) and 31315(b), each exemption will be valid for 2 years unless
revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-26045 Filed 11-24-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Rules and Regulations]
[Pages 45479-45481]
[FR Doc No: 2017-20829]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2017-0517; FRL-9968-66-Region 7]

Approval of Iowa Air Quality Implementation Plans; Elements of
the Infrastructure SIP Requirements for the 2012 Annual Fine
Particulate Matter (PM2.5) National Ambient Air Quality Standard
(NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve elements of a State Implementation Plan (SIP)
submission, for the 2012 Annual Fine Particulate Matter
(PM2.5) National Ambient Air Quality Standard (NAAQS).
Infrastructure SIPs address the applicable requirements of Clean Air
Act (CAA) section 110, which requires that each state adopt and submit
a SIP for the implementation, maintenance, and enforcement of each new
or revised NAAQS promulgated by the EPA. These SIPs are commonly
referred to as ``infrastructure'' SIPs. The infrastructure requirements
are designed to ensure that the structural components of each state's
air quality management program are adequate to meet the state's
responsibilities under the CAA.

DATES: This direct final rule is effective November 28, 2017, without
further notice, unless EPA receives adverse comment by October 30,
2017. If EPA receives adverse comment, we will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2017-0517, to https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Air Planning and
Development Branch, U.S. Environmental Protection Agency, Region 7,
11201 Renner Boulevard, Lenexa, KS 66219 at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    EPA is approving elements of the 2012 PM2.5 NAAQS
infrastructure SIP submission from the State of Iowa, dated December
15, 2015, and received on December 22, 2015. Specifically, EPA is
approving the following elements of section 110(a)(2): (A), (B), (C),
(D)(i)(II)--prevent significant deterioration of air quality (prong 3),
(D)(ii) (E) through (H), and (J) through (M).
    A Technical Support Document (TSD) is included as part of the
docket to discuss the details of this action, including analysis of how
the SIP meets the applicable 110 requirements for infrastructure SIPs.

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

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The state held a 30-day
comment period, and a public hearing on November 16, 2015. No oral or
written comments were received. This submission also satisfied the
completeness criteria of 40 CFR part 51, appendix V. In addition, as
explained above and in more detail in the technical support document
which is part of this docket, the revision meets the substantive SIP
requirements of the CAA, including section 110 and implementing
regulations.

III. What action is EPA taking?

    EPA is approving elements of the December 15, 2015, infrastructure
SIP submission from the State of Iowa, which addresses the requirements
of CAA sections 110(a)(1) and (2) as applicable to the 2012
PM2.5 NAAQS. As stated above, EPA is approving the following
elements of section 110(a)(2): (A), (B), (C), (D), (D)(i)(II)--prevent
significant deterioration of air quality (prong 3), (D)(ii), (E)
through (H), and (J) through (M). Details of the submission are
addressed in a TSD as part of the docket to discuss this approval
action.
    EPA is not taking action on section 110(a)(2)(I). Section
110(a)(2)(I) requires that in the case of a plan or plan revision for
areas designated as nonattainment areas, states must meet applicable
requirements of part D of the CAA, relating to SIP requirements for
designated nonattainment areas. EPA does not expect infrastructure SIP
submissions to address element (I). The specific SIP submissions for
designated nonattainment areas, as required under CAA title I, part D,
are subject to different submission schedules than those for section
110 infrastructure elements. EPA will take action on part D attainment
plan SIP submissions through a separate rulemaking governed by the
requirements for nonattainment areas, as described in part D.
    EPA is not taking action on section 110(a)(2)(D)(i)(I) prongs 1 and
2, and section 110(a)(2)(D)(i)(II) prong 4.
    We are publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and anticipate
no adverse comment. However, in the ``Proposed Rules'' section of this
issue of the Federal Register, we are publishing a separate document
that will serve as the proposed rule to approve the SIP revision if
adverse comments are received on this direct final rule. We will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document. If EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that
this direct final rule will not take effect. We will address all public
comments in any subsequent final rule based on the proposed rule.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, 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).
    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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 28, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

 List of Subjects in 40 CFR Part 52

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

    Dated: September 20, 2017.
Cathy Stepp,
Acting Regional Administrator, Region 7.

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

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart Q Iowa

0
2. Amend Sec.  52.820(e) by adding an entry for ``(49) Sections
110(a)(1) and (2) Infrastructure Requirements 2012 annual
PM2.5 NAAQS'' in numerical order at the end of the table to
read as follows:

Sec.  52.820  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Iowa Nonregulatory SIP Provisions
----------------------------------------------------------------------------------------------------------------
  Name of non-regulatory SIP     Applicable geographic        State        EPA approval
           provision             or nonattainment area   submittal date        date             Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(49) Sections 110(a)(1) and     Statewide..............        12/15/15  09/29/17 and      This action addresses
 (2) Infrastructure                                                       [Insert Federal   the following CAA
 Requirements 2012 annual                                                 Register          elements:
 PM2.5 NAAQS.                                                             citation].        110(a)(2)(A), (B),
                                                                                (C), (D)(i)(II)
                                                                                prong 3, (D)(ii),
                                                                                (E), (F), (G), (H),
                                                                                (J), (K), (L), and
                                                                                (M). 110(a)(2)(I) is
                                                                                not applicable. [EPA-
                                                                                R07-OAR-2017-0517;
                                                                                FRL-XXXX-Region 7.]
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-20829 Filed 9-28-17; 8:45 am]
BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as a concerned consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.

On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of important issues and questions that are relevant to me as a consumer of products that are proposed for regulation under the Proposed Rule.

The Proposed Rule asks a number of questions that I might want to respond to. I want the opportunity to provide my thoughts and comments on many of these issues, but as a working mother, the time I have to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but that takes time, and the Proposed Rules address questions that require additional research.

Understanding that the FDA took many years to develop the Proposed Rule, it is not at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback, and I am respectfully asking for that consideration.

I feel very strongly about e-cigarettes as an alternative to traditional, combustible cigarettes. I firmly believe that they saved my husband’s life, and have given our son the opportunity to grow up with a father. I wish to provide you with my family’s personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account.

I understand that the FDA has the authority under 21 CFR 10.40 to extend this time frame, and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

Thank you in advance for your consideration of my request.  I am happy to discuss this issue with you, or any member of your team.

Sincerely,

Fabiola Elias-Ramsey


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Page 78992]
[FR Doc No: 2013-31001]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3354-EM; Docket ID FEMA-2013-0001]

New Jersey; Amendment No. 5 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
State of New Jersey (FEMA-3354-EM), dated October 28, 2012, and related
determinations.

DATES: Effective December 13, 2013.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, William L.
Vogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this emergency.
    This action terminates the appointment of Gracia B. Szczech as
Federal Coordinating Officer for this emergency.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-31001 Filed 12-26-13; 8:45 am]
BILLING CODE 9111-23-P