[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Proposed Rules]
[Pages 28277-28279]
[FR Doc No: 2017-12811]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 312, and 812

[Docket No. FDA-2017-D-1105]

Use of Electronic Records and Electronic Signatures in Clinical
Investigations Under Part 11--Questions and Answers; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Use of
Electronic Records and Electronic Signatures in Clinical Investigations
under our regulations--Questions and Answers.'' The draft guidance
provides guidance to sponsors, clinical investigators, institutional
review boards (IRBs), contract research organizations (CROs), and other
interested parties on the use of electronic records and electronic
signatures under our regulations in clinical investigations of medical
products. The draft guidance expands upon recommendations in the
guidance for industry entitled ``Part 11, Electronic Records;
Electronic Signatures--Scope and Application'' issued in August 2003
(referred to as the 2003 part 11 guidance) for recommendations that
pertain to FDA-regulated clinical investigations conducted under our
regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 21, 2017.

ADDRESSES: You may submit comments 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-1105 for ``Use of Electronic Records and Electronic
Signatures in Clinical Investigations Under 21 CFR Part 11--Questions
and Answers; 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.
    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; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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: Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Irfan
Khan, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3563, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Use of Electronic Records and Electronic Signatures in
Clinical Investigations under 21 CFR Part 11--Questions and Answers.''
The draft guidance provides guidance to sponsors, clinical
investigators, IRBs, CROs, and other interested parties on the use of
electronic records and electronic signatures under part 11 in clinical
investigations of medical products. The draft guidance thus expands
upon recommendations in the 2003 part 11 guidance for recommendations
that pertain to FDA-regulated clinical investigations conducted under
parts 312 and 812 and is limited to the scope and application of part
11 requirements to such clinical investigations.
    Since 2003, advances in electronic technology have expanded the
uses and capabilities of electronic systems in clinical investigations.
In addition, electronic systems and technologies are used and managed
in novel ways, services are shared or contracted between organizations
in new ways, and electronic data flow between parties is more efficient
and more prevalent. The standards and capabilities of electronic
systems have improved, and features--such as audit trails, automated
date-and-time stamps, appropriate validation, and the ability to
generate copies and retain records--are standard components of many
electronic systems.
    FDA's overall approach to the 2003 part 11 guidance was to provide
a narrow and practical interpretation of part 11 requirements. FDA
continues to support and promote such a narrow and practical
interpretation in the draft guidance, including our intent to exercise
enforcement discretion regarding specific part 11 provisions for
validation, audit trails, record retention, and record copying. FDA
reminds sponsors, however, that records must still be maintained or
submitted in accordance with the underlying predicate rules, and the
Agency can take regulatory action for noncompliance with such predicate
rules. In addition, FDA continues to encourage sponsors and other
regulated entities to use a risk-based approach, as introduced in the
2003 part 11 guidance and further described in the draft guidance, when
deciding to validate electronic systems, implement audit trails, or
archive required records for clinical investigations. The draft
guidance clarifies and expands upon recommendations for applying and
implementing part 11 requirements, as appropriate, in the current
environment of electronic systems used in clinical investigations.
    The draft guidance discusses the following: (1) Procedures that may
be followed to help ensure that electronic records and electronic
signatures meet FDA requirements and are considered to be trustworthy,
reliable, and generally equivalent to paper records and handwritten
signatures executed on paper, and (2) the use of a risk-based approach
when deciding to validate electronic systems, implement audit trails
for electronic records, and archive records that are pertinent to
clinical investigations conducted under parts 312 and 812.
    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 the use of
electronic records and electronic signatures for FDA-regulated clinical
investigations conducted under parts 312 and 812. 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
applicable statutes and regulations. This is not a significant
regulatory action subject to Executive Order 12866.

II. Paperwork Reduction Act

    This draft guidance refers to previously approved collections of
information that are found in regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). This draft guidance pertains to sponsors, clinical
investigators, IRBs, CROs, and other interested parties who use
electronic records, electronic signatures, and electronic systems in
FDA-regulated clinical investigations and who send certain information
to FDA or others or who keep certain records and make them available to
FDA inspectors. The collections of information in part 11 have been
approved under OMB control

number 0910-0303; the collections of information in part 312, including
Sec. Sec.  312.41, 312.57, 312.58, 312.62, and 312.120, have been
approved under OMB control number 0910-0014; and the collections of
information in Sec.  812.140 have been approved under OMB control
number 0910-0078. The use of electronic records, electronic signatures,
and electronic systems (as described in the draft guidance) would not
result in any new costs, including capital costs or operating and
maintenance costs because sponsors and others already have experience
using computer-based equipment and software necessary to be consistent
with the draft guidance.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: June 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-12811 Filed 6-20-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58637-58638]
[FR Doc No: 2017-26805]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1769]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 13, 2018.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1769, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 29, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Hughes County, Oklahoma and Incorporated Areas
          Project: 11-06-2177S Preliminary Date: April 29, 2016
------------------------------------------------------------------------
City of Holdenville....................  City Hall, 100 North Creek
                                          Street, Holdenville, OK 74848.
City of Wetumka........................  City Hall, 202 North Main
                                          Street, Wetumka, OK 74883.
Town of Allen..........................  Town Hall, 216 East Broadway
                                          Street, Allen, OK 74825.
Town of Atwood.........................  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
Town of Calvin.........................  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
Town of Dustin.........................  Town Hall, 117 North Broadway
                                          Avenue, Dustin, OK 74839.

Town of Horntown.......................  Horntown Fire Department, 3319
                                          Highway 75, Holdenville, OK
                                          74848.
Town of Lamar..........................  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
Town of Spaulding......................  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
Town of Stuart.........................  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
Unincorporated Areas of Hughes County..  Hughes County Emergency
                                          Management Director's Office,
                                          200 North Broadway Street,
                                          Holdenville, OK 74848.
------------------------------------------------------------------------
            McIntosh County, Oklahoma and Incorporated Areas
          Project: 11-06-2177S Preliminary Date: April 29, 2016
------------------------------------------------------------------------
City of Checotah.......................  City Hall, 414 West Gentry
                                          Avenue, Checotah, OK 74426.
City of Eufaula........................  City Hall, 64 Memorial Drive,
                                          Eufaula, OK 74432.
Unincorporated Areas of McIntosh County  McIntosh County Clerk's Office,
                                          110 North 1st Street, Eufaula,
                                          OK 74432.
------------------------------------------------------------------------
          Pottawatomie County, Oklahoma and Incorporated Areas
          Project: 11-06-2177S Preliminary Date: June 20, 2016
------------------------------------------------------------------------
City of McLoud.........................  City Hall, 107 North Main
                                          Street, McLoud, OK 74851.
City of Shawnee........................  City Hall Annex Building, 222
                                          North Broadway Street,
                                          Shawnee, OK 74801.
City of Tecumseh.......................  City Hall, 114 North Broadway
                                          Street, Tecumseh, OK 74873.
Town of Bethel Acres...................  Bethel Acres Town Hall, 18101
                                          Bethel Road, Shawnee, OK
                                          74801.
Town of Earlsboro......................  Town Hall, 110 South Lamar
                                          Avenue, Earlsboro, OK 74840.
Town of Johnson........................  Pottawatomie County Courthouse,
                                          325 North Broadway Street,
                                          Shawnee, OK 74801.
Absentee-Shawnee Tribe of Indians of     Absentee Shawnee Tribal
 Oklahoma.                                Complex, 2025 South Gordon
                                          Cooper Drive, Shawnee, OK
                                          74801.
Citizen Potawatomi Nation..............  Citizen Potawatomi Nation
                                          Transportation Building, 405
                                          Transportation Drive, Shawnee,
                                          OK 74801.
Kickapoo Tribe of Oklahoma.............  Kickapoo Tribe of Oklahoma
                                          Secondary Administration
                                          Building, 400 North Highway
                                          102, McLoud, OK 74851.
Sac and Fox Nation.....................  Sac and Fox Nation
                                          Administration Building,
                                          920883 South Highway 99,
                                          Building A, Stroud, OK 74079.
Unincorporated Areas of Pottawatomie     Pottawatomie County Courthouse,
 County.                                  325 North Broadway Street,
                                          Shawnee, OK 74801.
------------------------------------------------------------------------
               Burnet County, Texas and Incorporated Areas
 Project: 13-06-0041S Preliminary Date: February 15, 2017 and September
                                26, 2017
------------------------------------------------------------------------
City of Burnet.........................  City Hall, 1001 Buchanan Drive,
                                          Suite 4, Burnet, TX 78611.
City of Marble Falls...................  Development Services
                                          Department, 801 4th Street,
                                          Marble Falls, TX 78654.
City of Meadowlakes....................  City Hall, 177 Broadmoor
                                          Street, Suite A, Meadowlakes,
                                          TX 78654.
Unincorporated Areas of Burnet County..  Burnet County Annex, 133 East
                                          Jackson Street, Room 107,
                                          Burnet, TX 78611.
------------------------------------------------------------------------
             Williamson County, Texas and Incorporated Areas
  Project: 13-06-1181S Preliminary Date: January 30, 2017 and September
                                26, 2017
------------------------------------------------------------------------
City of Austin.........................  Watershed Engineering Division,
                                          505 Barton Springs Road, 12th
                                          Floor, Austin, TX 78704.
City of Cedar Park.....................  City Hall, 450 Cypress Creek
                                          Road, Building 1, Cedar Park,
                                          TX 78613.
City of Coupland.......................  Coupland Fire Station, 403 FM
                                          1466, Coupland, TX 78615.
City of Georgetown.....................  Georgetown Utility Systems, 300-
                                          1 Industrial Avenue,
                                          Georgetown, TX 78626.
City of Hutto..........................  Department of Public Works, 210
                                          U.S. 79 East, Suite 203,
                                          Hutto, TX 78634.
City of Leander........................  City Hall, 200 West Willis
                                          Street, Leander, TX 78641.
City of Round Rock.....................  Utilities and Environmental
                                          Services, 2008 Enterprise
                                          Drive, Round Rock, TX 78664.
City of Taylor.........................  City Hall, 400 Porter Street,
                                          Taylor, TX 76574.
Unincorporated Areas of Williamson       Williamson County Central
 County.                                  Maintenance Facility, 3151
                                          Southeast Inner Loop, Suite B,
                                          Georgetown, TX 78626.
------------------------------------------------------------------------

[FR Doc. 2017-26805 Filed 12-12-17; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34666-34667]
[FR Doc No: 2018-15574]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2018-0029]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 37 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on June 29, 2018. The exemptions
expire on June 29, 2020.

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

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    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 http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On May 29, 2018, FMCSA published a notice announcing receipt of
applications from 37 individuals requesting an exemption from diabetes
requirement in 49 CFR 391.41(b)(3) and requested comments from the
public (83 FR 24576). The public comment period ended on June 28, 2018,
and one comments was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received one comment in this proceeding. Vicky Johnson from
the Minnesota Department of Public Safety stated that Minnesota has no
objections to granting diabetes exemptions to Jon E. Behle, Gavin C.
Gore, Stephen R. Henderscheidt, and Jose C. Rosario.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the May 29, 2018, Federal
Register notice (83 FR 24576) and will not be repeated in this notice.
    These 37 applicants have had ITDM over a range of 1 to 22 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must submit a quarterly monitoring checklist completed by
the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) each driver must report within
two business days of occurrence, all episodes of severe hypoglycemia,
significant complications, or inability to manage diabetes; also, any
involvement in an accident or any other adverse event in a CMV or
personal vehicle, whether or not it is related to an episode of
hypoglycemia; (3) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the Medical Examiner at
the time of the annual medical examination; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keeping a copy in his/
her driver's qualification file if he/she is self-employed. The driver
must also have a copy of the exemption when driving, for presentation
to a duly authorized Federal, State, or local enforcement official.

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 37 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Clayton W. Baenziger (CO)
John E. Behle (MN)
Myles S. Bolton (AK)
Francisco Chavez, Jr. (CA)
David C. Clarke (NE)
Steven R. Condon (NE)
Gilbert L. Fleming, Jr. (MD)
Gavin C. Gore (MN)
Johnny Gregg, Jr. (NC)
Thomas W. Guzier (IL)
Willard R. Hammond, Jr. (NY)
Greg C. Hardcastle (OR)
Joseph E. Heck (IA)
Stephen R. Henderschiedt (MN)
Larry D. Johnston (IA)
Leodon L. Killinger, Jr. (ME)
Joshua M. Lenhart (AK)
Michelle L. Logsdon (WV)
Tiernan E. McKinney (OH)
Kevin R. McClerren (IL)
Bryant L. Murray (UT)
Manuel C. Pineda (TX)
Kenneth M. Putt (VA)
John D. Randall (MO)
John F. Reilly (IL)
Tyree E. Rhodes (LA)
Jose C. Rosario (MN)
Matthew L. Shelley (VA)
Brian R. Smallcanyon (UT)
Kenneth J. Sortman (OH)
Gregory R. Suckow (SD)
Jack W. Terrio (LA)
Curtis D. Van Koevering (MI)
Trent J. Vandyken (MN)
Gregory A. Westfall (OH)
Kevin L. Willis Sloan (MO)
Debra A. Wiss (WA)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (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 prior to being 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.

    Issued on: July 13, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-15574 Filed 7-19-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: June 18, 2009 (Volume 74, Number 116)]
[Notices]
[Page 28931]
[DOCID:fr18jn09-23]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13351-000]

Marseilles Land and Water Company; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene and Protests

June 11, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major license.
    b. Project No.: P-13351-000.
    c. Date filed: December 30, 2008.
    d. Applicant: Marseilles Land and Water Company.
    e. Name of Project: Marseilles Lock and Dam Project.
    f. Location: On the Illinois River, in the town of Marseilles, La
Salle County, Illinois. This project would not occupy any Federal
lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Lee W. Mueller, Architect and Vice President,
Marseilles Land & Water Company, 4132 S. Rainbow Blvd., 247,
Las Vegas, NV 89103,<PHONE_NUMBER>.
    i. FERC Contact: Steve Kartalia<EMAIL_ADDRESS>(202)
502-6131.
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedures require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov/docs-filing/
ferconline.asp) under the ``efiling'' link. For a simpler method of
submitting text only comments, click on ``Quick Comment.''
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. Project Description: The Marseilles Lock and Dam Project would
utilize the head created by the existing 24-foot-high Army Corps of
Engineers (Corps) Marseilles Lock and Dam and two existing Corps
headgate structures and would consist of: (1) The existing north and
south headraces in which a portion of the south headrace would be
filled in and joined to the existing north headrace which would be
deepened to accommodate the flow from both headraces leading to; (2) a
new intake structure and forebay leading to; (3) a new powerhouse
containing four generating units with a total installed capacity of
10.26 megawatts (MW); (4) a new tailrace discharging water back to the
Illinois River; (5) a new 400-foot-long underground transmission line;
and (6) appurtenant facilities.
    The project would operate in a run-of-river mode.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Competing development applications, notices of intent to file
such an application, and applications for preliminary permits will not
be accepted in response to this notice.
    Anyone may submit a protest or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210, 385.211, and 385.214. In determining the appropriate action to
take, the Commission will consider all protests filed, but only those
who file a motion to intervene in accordance with the Commission's
Rules may become a party to the proceeding. Any protests or motions to
intervene must be received on or before the specified deadline date for
the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-14291 Filed 6-17-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Pages 27442-27443]
[FR Doc No: 2016-10754]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0495; EPA-HQ-OAR-2013-0603; FRL-9946-09-OAR]

Reconsideration of Standards of Performance for Greenhouse Gas
Emissions From New, Modified, and Reconstructed Stationary Sources:
Electric Utility Generating Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action denying petitions for reconsideration.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) received six
petitions for reconsideration of the final Standards of Performance for
Greenhouse Gas Emissions from New, Modified, and Reconstructed
Stationary Sources: Electric Utility Generating Units, published in the
Federal Register on October 23, 2015. The agency is providing notice
that it is denying five of these petitions, and deferring action on the
issue of treatment of biomass raised in the petitions of both the
Biogenic CO2 Coalition and the State of Wisconsin. The basis
for the EPA's action is set out fully in a separate memorandum
available in the rulemaking docket.

DATES: Effective May 6, 2016.

FOR FURTHER INFORMATION CONTACT: Dr. Nick Hutson, Energy Strategies
Group, Sector Policies and Programs Division (D243-01), U.S. EPA,
Research Triangle

Park, NC 27711; telephone number:<PHONE_NUMBER>; facsimile number:
(919) 541-5450; email address<EMAIL_ADDRESS>or Mr. Christian
Fellner, Energy Strategies Group, Sector Policies and Programs Division
(D243-01), U.S. EPA, Research Triangle Park, NC 27711; telephone
number:<PHONE_NUMBER>; facsimile number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Where can I get a copy of this document and other related
information?

    A copy of this Federal Register notice, the petitions for
reconsideration, and the separate memorandum describing the full basis
for this action is available in the rulemaking dockets (Docket ID No.
EPA-HQ-OAR-2013-0495 and Docket ID No. EPA-HQ-OAR-2013-0603). In
addition, following signature, an electronic copy of this final action
and the memorandum will be available on the World Wide Web (WWW) at the
following address: https://www.epa.gov/cleanpowerplan.

II. Judicial Review

    Section 307(b)(1) of the Clean Air Act (CAA) specifies which
Federal Courts of Appeal have venue over petitions for review of final
EPA actions. This section provides, in part, that ``a petition for
review of action of the Administrator in promulgating . . . any
standard of performance or requirement under section [111] of [the
CAA],'' or any other ``nationally applicable'' final action, ``may be
filed only in the United States Court of Appeals for the District of
Columbia.''
    The EPA has determined that its action denying the petitions for
reconsideration is nationally applicable for purposes of CAA section
307(b)(1) because the action directly affects the Standards of
Performance for Greenhouse Gas Emissions from New, Modified, and
Reconstructed Stationary Sources: Electric Utility Generating Units,
which are nationally applicable section 111 standards. Thus, any
petitions for review of the EPA's decision to deny petitioners'
requests for reconsideration must be filed in the United States Court
of Appeals for the District of Columbia by July 5, 2016.

III. Background and Summary of the Action

    On October 23, 2015, pursuant to section 111(b) of the CAA, the EPA
published the final rule titled ``Standards of Performance for
Greenhouse Gas Emissions from New, Modified, and Reconstructed
Stationary Sources: Electric Utility Generating Units.'' (``section
111(b) greenhouse gas (GHG) new source performance standards (NSPS)'')
80 FR 64510.\1\ Following publication of the final rule, the
Administrator received petitions for reconsideration of certain
provisions of the final rule pursuant to CAA section 307(d)(7)(B).
---------------------------------------------------------------------------

    \1\ The rule is also often referred to as the ``Carbon Pollution
Standards.''
---------------------------------------------------------------------------

    CAA section 307(d)(7)(B) requires the EPA to convene a proceeding
for reconsideration of a rule if a party raising an objection to the
rule ``can demonstrate to the Administrator that it was impracticable
to raise such objection within [the public comment period] or if the
grounds for such objection arose after the period for public comment
(but within the time specified for judicial review) and if such
objection is of central relevance to the outcome of the rule.'' The
requirement to convene a proceeding to reconsider a rule is, thus,
based on the petitioner demonstrating to the EPA both: (1) That it was
impracticable to raise the objection during the comment period, or that
the grounds for such objection arose after the comment period but
within the time specified for judicial review (i.e., within 60 days
after publication of the final rulemaking notice in the Federal
Register, see CAA section 307(b)(1)); and (2) that the objection is of
central relevance to the outcome of the rule.
    The EPA received six petitions for reconsideration of the CAA
section 111(b) greenhouse gas (GHG) new source performance standard
(NSPS) from the following entities: the Utility Air Regulatory Group
(UARG); American Electric Power (AEP); Ameren Corp. (Ameren); the
Energy and Environmental Legal Institute (EELI); State of Wisconsin;
and the Biogenic CO2 Coalition. The EPA is denying all but
the last of these petitions as not satisfying one or both of the
statutory conditions for compelled reconsideration. The EPA is
deferring action on the petition of the Biogenic CO2
Coalition pending our further on-going consideration of the underlying
issue of whether and how to account for biomass when co-firing with
fossil fuels.\2\
---------------------------------------------------------------------------

    \2\ The State of Wisconsin, in its petition, also raises the
issue of whether and how to account for biomass fuels for purposes
of determining compliance with applicable standards when biomass is
co-fired with fossil fuels. The EPA is likewise not acting at this
time on this portion of the State's petition.
---------------------------------------------------------------------------

    We discuss each of the five petitions we are denying and the basis
for those denials in a separate, docketed memorandum titled ``Basis for
Denial of Petitions to Reconsider the CAA section 111(b) Standards of
Performance for Greenhouse Gas Emissions from New, Modified, and
Reconstructed Fossil Fuel-Fired Electric Utility Generating Units.''
For reasons set out in the memorandum, the petitions for review of
UARG, AEP, Ameren, EELI, and the State of Wisconsin (with the exception
of the issue regarding treatment of biomass) are denied.\3\
---------------------------------------------------------------------------

    \3\ The Administrator is also sending an individual letter to
each of the petitioners announcing her decision on their petition.

    Dated: April 29, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016-10754 Filed 5-5-16; 8:45 am]
 BILLING CODE 6560-50-P