[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Proposed Rules]
[Pages 70073-70076]
[FR Doc No: 2019-27490]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 /
Proposed Rules

DEPARTMENT OF THE TREASURY

Office of the Comptroller of the Currency

12 CFR Part 43

[Docket No. OCC-2019-0012]

FEDERAL RESERVE SYSTEM

12 CFR Part 244

[Docket No. OP-1688]

FEDERAL DEPOSIT INSURANCE CORPORATION

12 CFR Part 373

RIN 3064-ZA07

FEDERAL HOUSING FINANCE AGENCY

12 CFR Part 1234

[Notice No. 2019-N-7]

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 246

[Release No. 34-87714]

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

24 CFR Part 267

[FR-6172-N-01]

Credit Risk Retention-Notice of Commencement of Review

AGENCY: Office of the Comptroller of the Currency, Treasury (OCC);
Board of Governors of the Federal Reserve System (Board); Federal
Deposit Insurance Corporation (FDIC); U.S. Securities and Exchange
Commission (Commission); Federal Housing Finance Agency (FHFA); and
Department of Housing and Urban Development (HUD).

ACTION: Notice of commencement of review.

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SUMMARY: The OCC, Board, FDIC, Commission, FHFA, and HUD (the agencies)
are providing notice of the commencement of the review of the
definition of qualified residential mortgage; the community-focused
residential mortgage exemption; and the exemption for qualifying three-
to-four unit residential mortgage loans, in each case as currently set
forth in the Credit Risk Retention Regulations (as defined below) as
adopted by the agencies.

DATES: Comments on the review must be received by February 3, 2020.

ADDRESSES: Interested parties are encouraged to submit written comments
jointly to all of the agencies and use the title ``QRM review'' to
facilitate the organization and distribution of comments among the
agencies.
    Office of the Comptroller of the Currency: Commenters are
encouraged to submit comments through the Federal eRulemaking Portal or
email, if possible. Please use the title ``Credit Risk Retention-Notice
of Commencement of Review'' to facilitate the organization and
distribution of the comments. You may submit comments by any of the
following methods:

 Federal eRulemaking Portal--Regulations.gov Classic or
Regulations.gov Beta

    Regulations.gov Classic: Go to https://www.regulations.gov/. Enter
``Docket ID OCC-2019-0012'' in the Search Box and click ``Search.''
Click on ``Comment Now'' to submit public comments. For help with
submitting effective comments please click on ``View Commenter's
Checklist.'' Click on the ``Help'' tab on the Regulations.gov home page
to get information on using Regulations.gov, including instructions for
submitting public comments.
    Regulations.gov Beta: Go to https://beta.regulations.gov/ or click
``Visit New Regulations.gov Site'' from the Regulations.gov classic
homepage. Enter ``Docket ID OCC-2019-0012'' in the Search Box and click
``Search.'' Public comments can be submitted via the ``Comment'' box
below the displayed document information or click on the document title
and click the ``Comment'' box on the top-left side of the screen. For
help with submitting effective comments please click on ``Commenter's
Checklist.'' For assistance with the Regulations.gov Beta site please
call<PHONE_NUMBER> (toll free) or<PHONE_NUMBER> Monday-Friday, 9
a.m.-5 p.m. ET or email to<EMAIL_ADDRESS>     Email<EMAIL_ADDRESS>     Mail: Chief Counsel's Office, Attention: Comment
Processing, Office of the Comptroller of the Currency, 400 7th Street
SW, Suite 3E-218, Washington, DC 20219.
     Hand Delivery/Courier: 400 7th Street SW, Suite 3E-218,
Washington, DC 20219.
     Fax:<PHONE_NUMBER>.
    Instructions: You must include ``OCC'' as the agency name and
``Docket ID OCC-2019-0012'' in your comment. In general, the OCC will
enter all comments received into the docket and publish the comments on
the Regulations.gov website without change, including any business or
personal information provided such as name and address information,
email addresses, or phone numbers. Comments received, including
attachments and other supporting materials, are part of the public
record and subject to public disclosure. Do not include any information
in your comment or supporting materials that you consider confidential
or inappropriate for public disclosure.
    You may review comments and other related materials that pertain to
this notice by any of the following methods:

 Viewing Comments Electronically--Regulations.gov Classic or
Regulations.gov Beta

    Regulations.gov Classic: Go to https://www.regulations.gov/. Enter
``Docket ID OCC-2019--0012'' in the Search box and click ``Search.''
Click on ``Open Docket Folder'' on the right side of the screen.
Comments and supporting materials can be viewed and filtered by
clicking on ``View all documents and comments in this docket'' and then
using the filtering tools on the left side of the screen. Click on the
``Help'' tab on the Regulations.gov home page to get information on
using Regulations.gov. The docket may be viewed after the close of the
comment period in the same manner as during the comment period.
    Regulations.gov Beta: Go to https://beta.regulations.gov/ or click
``Visit New Regulations.gov Site'' from the Regulations.gov classic
homepage. Enter ``Docket ID OCC-2019-0012'' in the Search Box and click
``Search.'' Click on the ``Comments'' tab. Comments can be viewed and
filtered by clicking on the

``Sort By'' drop-down on the right side of the screen or the ``Refine
Results'' options on the left side of the screen. Supporting Materials
can be viewed by clicking on the ``Documents'' tab and filtered by
clicking on the ``Sort By'' drop-down on the right side of the screen
or the ``Refine Results'' options on the left side of the screen.'' For
assistance with the Regulations.gov Beta site please call (877)-378-
5457 (toll free) or<PHONE_NUMBER> Monday-Friday, 9 a.m.-5 p.m. ET or
email to<EMAIL_ADDRESS>    The docket may be viewed after the close of the comment period in
the same manner as during the comment period.
     Viewing Comments Personally: You may personally inspect
comments at the OCC, 400 7th Street SW, Washington, DC 20219. For
security reasons, the OCC requires that visitors make an appointment to
inspect comments. You may do so by calling<PHONE_NUMBER> or, for
persons who are deaf or hearing impaired, TTY,<PHONE_NUMBER>. Upon
arrival, visitors will be required to present valid government-issued
photo identification and submit to security screening in order to
inspect comments.
    Board of Governors of the Federal Reserve System:
    You may submit comments, identified by Docket No. OP-1688, by any
of the following methods:
     Agency website: http://www.federalreserve.gov. Follow the
instructions for submitting comments at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.
     Email<EMAIL_ADDRESS>Include the
docket number in the subject line of the message.
     Fax:<PHONE_NUMBER> or<PHONE_NUMBER>.
     Mail: Address to Ann E. Misback, Secretary, Board of
Governors of the Federal Reserve System, 20th Street and Constitution
Avenue NW, Washington, DC 20551.
    All public comments will be made available on the Board's website
at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm as
submitted, unless modified for technical reasons or to remove sensitive
personal identifying information at the commenter's request.
Accordingly, comments will not be edited to remove any identifying or
contact information. Public comments may also be viewed electronically
or in paper form in Room 146, 1709 New York Avenue NW, Washington, DC
20006, between 9:00 a.m. and 5:00 p.m. on weekdays.
    Federal Deposit Insurance Corporation: You may submit comments,
identified by RIN 3064-ZA07, by any of the following methods:
     Agency Website: http://www.FDIC.gov/regulations/laws/federal. Follow instructions for submitting comments on the agency
website.
     Email<EMAIL_ADDRESS>Include RIN 3064-ZA07 in the
subject line of the message.
     Mail: Robert E. Feldman, Executive Secretary, Attention:
Comments, Federal Deposit Insurance Corporation, 550 17th Street NW,
Washington, DC 20429.
     Hand Delivery/Courier: Guard station at the rear of the
550 17th Street building (located on F Street) on business days between
7:00 a.m. and 5:00 p.m.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
    Instructions: All comments will be posted without change to http://www.fdic.gov/regulations/laws/federal/, including any personal
information provided. Paper copies of public comments may be ordered
from the Public Information Center by telephone at<PHONE_NUMBER> or
(703) 562-2200.
    Securities and Exchange Commission: Comments may be submitted by
any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/proposed.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number S7-14-11 on the subject line.

Paper Comments

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

All submissions should refer to File Number S7-14-11. This file number
should be included on the subject line if email is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
internet website (http://www.sec.gov/rules/proposed.shtml). Comments
are also available for website viewing and printing in the Commission's
Public Reference Room, 100 F Street NE, Washington, DC 20549, on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
All comments received will be posted without change. Persons submitting
comments are cautioned that the Commission does not redact or edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    Federal Housing Finance Agency: You may submit your written
comments on the notice, identified by notice number 2019-N-7, by any of
the following methods:
     Agency Website: www.fhfa.gov/open-for-comment-or-input.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. If you submit your
comments to the Federal eRulemaking Portal, please also send it by
email to FHFA at<EMAIL_ADDRESS>to ensure timely receipt by the
agency. Please include ``QRM Review Input/Notice No. 2019-N-7'' in the
subject line of the message.
     U.S. Mail, United Parcel Service, Federal Express, or
Other Mail Service: The mailing address for comments is: Alfred M.
Pollard, General Counsel, Attention: QRM Review Input/Notice No. 2019-
N-7, Federal Housing Finance Agency, Constitution Center, (OGC) Eighth
Floor, 400 7th Street SW, Washington, DC 20219.
     Hand Delivery/Courier: The hand delivery address is:
Alfred M. Pollard, General Counsel, Attention: QRM Review Input/Notice
No. 2019-N-7, Federal Housing Finance Agency, Constitution Center,
(OGC) Eighth Floor, 400 7th Street SW, Washington, DC 20219. Deliver
the package at the Seventh Street entrance Guard Desk, First Floor, on
business days between 9:00 a.m. and 5:00 p.m.

All comments received by the deadline will be posted for public
inspection without change, including any personal information you
provide, such as your name, address, email address, and telephone
number, on the FHFA website at http://www.fhfa.gov. In addition, copies
of all comments received will be available for examination by the
public through the electronic comments docket for this Notice also
located on the FHFA website.
    Department of Housing and Urban Development: Interested persons are
invited to submit comments regarding this rule to the Regulations
Division, Office of General Counsel, Department of Housing and Urban
Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500.
Communications must refer to the docket number and title. There are two
methods for submitting public comments.
     Submission of Comments by Mail. Comments may be submitted
by mail to the Regulations Division, Office of General Counsel,
Department of Housing and Urban Development, 451 7th Street SW, Room
10276, Washington, DC 20410-0500.

     Electronic Submission of Comments. Interested persons may
submit comments electronically through the Federal eRulemaking Portal
at www.regulations.gov. HUD strongly encourages persons providing
comments to submit comments electronically. Electronic submission of
comments allows the submitter maximum time to prepare and submit
comments, ensures timely receipt by HUD, and enables HUD to make them
immediately available to the public. Comments submitted electronically
through the www.regulations.gov website can be viewed by other
submitters and interested members of the public. Submitters should
follow the instructions provided on that site to submit comments
electronically.
     Note: To receive consideration as public comments,
comments must be submitted through one of the two methods specified
above. Again, all submissions must refer to the docket number and title
of the rule.
     No Facsimile Comments. Facsimile (FAX) comments are not
acceptable.
     Public Inspection of Public Comments. All properly
submitted comments and communications submitted to HUD will be
available for public inspection and copying between 8 a.m. and 5 p.m.
weekdays at the above address. Due to security measures at the HUD
Headquarters building, an appointment to review the public comments
must be scheduled in advance by calling the Regulations Division at
202-708-3055 (this is not a toll-free number). Individuals with speech
or hearing impairments may access this number via TTY by calling the
Federal Relay Service at<PHONE_NUMBER>. Copies of all comments submitted
are available for inspection and downloading at www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    OCC: Daniel Borman, Senior Attorney,<PHONE_NUMBER> or, for persons
who are deaf or hearing impaired, TTY,<PHONE_NUMBER>, Chief Counsel's
Office; Ajay Palvia,<PHONE_NUMBER>, Senior Financial Economist, Office
of the Comptroller of the Currency, 400 7th Street SW, Washington, DC
20219.
    Board: Flora H. Ahn, Special Counsel,<PHONE_NUMBER>, David W.
Alexander, Counsel, (202) 452-287, or Matthew D. Suntag, Senior
Counsel,<PHONE_NUMBER>, Legal Division; Donald N. Gabbai, Lead
Financial Institutions Policy Analyst, Division of Supervision and
Regulation,<PHONE_NUMBER>; Karen Pence, Assistant Director, Division
of Research & Statistics,<PHONE_NUMBER>; Nikita Pastor, Senior
Counsel, Division of Consumer & Community Affairs<PHONE_NUMBER>; Board
of Governors of the Federal Reserve System, 20th and C Streets NW,
Washington, DC 20551.
    FDIC: Rae-Ann Miller, Associate Director,<PHONE_NUMBER>; Kathleen
M. Russo, Counsel,<PHONE_NUMBER><EMAIL_ADDRESS>or Phillip E.
Sloan, Counsel,<PHONE_NUMBER><EMAIL_ADDRESS>Federal Deposit
Insurance Corporation, 550 17th Street NW, Washington, DC 20429.
    Commission: Arthur Sandel, Special Counsel; Kayla Roberts, Special
Counsel; Katherine Hsu, Chief,<PHONE_NUMBER>, in the Office of
Structured Finance, Division of Corporation Finance; or Chandler Lutz,
Economist,<PHONE_NUMBER>, in the Office of Risk Analysis, Division of
Economic and Risk Analysis, U.S. Securities and Exchange Commission,
100 F Street NE, Washington, DC 20549.
    FHFA: Ron Sugarman, Principal Policy Analyst, Office of Policy
Analysis and Research,<PHONE_NUMBER><EMAIL_ADDRESS>or Peggy
K. Balsawer, Associate General Counsel, Office of General Counsel,
(202) 649-3060<EMAIL_ADDRESS>Federal Housing Finance
Agency, Constitution Center, 400 7th Street SW, Washington, DC 20219.
The telephone number for the Telecommunications Device for the Deaf is
(800) 877-8339.
    HUD: Keith Becker, Deputy Assistant Secretary for Risk Management &
Regulatory Affairs, U.S. Department of Housing & Urban Development, 451
7th Street SW, Washington, DC 20410; telephone number<PHONE_NUMBER>
(this is not a toll-free number). Persons with hearing or speech
impairments may access this number through TTY by calling the toll-free
Federal Relay at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The credit risk retention regulations,
codified at 12 CFR part 43; 12 CFR part 244; 12 CFR part 373; 17 CFR
part 246; 12 CFR part 1234; and 24 CFR part 267 (the Credit Risk
Retention Regulations), require the OCC, Board, FDIC and Commission, in
consultation with the FHFA and HUD, to commence a review of the
following provisions of the Credit Risk Retention Regulations no later
than December 24, 2019: (1) The definition of qualified residential
mortgage (QRM) in section _.13 of the Credit Risk Retention
Regulations; (2) the community-focused residential mortgage exemption
in section _.19(f) of the Credit Risk Retention Regulations; and (3)
the exemption for qualifying three-to-four unit residential mortgage
loans in section _.19(g) of the Credit Risk Retention Regulations.
Notice of the commencement of this review is hereby given.
    In the Supplementary Information to the Credit Risk Retention
Regulations the agencies noted that they were committing in the final
rule to review the QRM definition at regular intervals to consider,
among other things, changes in the mortgage and securitization market
conditions and practices, and that this review might include, for
example, the structures of securitizations, the relationship between,
and roles undertaken by, the various transaction parties, implications
for investor protection and financial stability arising from the
relationship between government-sponsored enterprise (GSE) markets and
private label markets, and trends in mortgage products in various
markets and structures, as well as how the QRM definition is affecting
residential mortgage underwriting and securitization of residential
mortgage loans under evolving market conditions.\1\ The Supplementary
Information also stated that the agencies would want the opportunity to
consider the results of future reviews of, and any changes made to, the
qualified mortgage definition by the Consumer Financial Protection
Bureau, any additional regulatory changes affecting securitization that
are adopted by the agencies, as well as any changes to the structure
and framework of the GSEs and those markets.\2\ The simultaneous review
of the community-focused lending exemption and the exemption for
qualifying three-to-four unit residential mortgage loans will similarly
allow the agencies to evaluate the advantages and disadvantages of
these exemptions as their respective markets evolve over time.
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    \1\ See 79 FR 77601, 77689 (December 24, 2014).
    \2\ See 79 FR 77601, 77689 (December 24, 2014).
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    The agencies welcome public comments relating to the review of
these provisions of the Credit Risk Retention Regulations, including
the matters listed above that might be considered as part of the
review.

Joseph M. Otting,
Comptroller of the Currency.

    By Order of the Board of Governors of the Federal Reserve
System.
Ann E. Misback,
Secretary of the Board.
Federal Deposit Insurance Corporation.

    Dated at Washington, DC, on December 10, 2019.
Robert E. Feldman,
Executive Secretary.
    Dated: December 10, 2019.

    By the Securities and Exchange Commission.
Vanessa A. Countryman,
Secretary.
    Dated: November 21, 2019.
Mark A. Calabria,
Director, Federal Housing Finance Agency.
    Dated: November 21, 2019.

    By the Department of Housing and Urban Development.
John L. Garvin,
General Deputy Assistant Secretary for Housing.
[FR Doc. 2019-27490 Filed 12-19-19; 8:45 am]
BILLING CODE 4810-33-P; 6210-01-P; 3064-01-P; 8070-01-P; 8011-01-P;
4210-67-P


[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Notices]
[Page 64262-64264]
[DOCID:fr01no06-62]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0874; FRL-8101-5]

Chlorflurenol Risk Assessment; Notice of Availability, and Risk
Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's risk
assessment(s), and related documents for the herbicidal pesticide
chlorflurenol, and opens a public comment period on these documents.
The public is encouraged to suggest risk management ideas or proposals
to address the risks identified. EPA is developing a Reregistration
Eligibility Decision (RED) for chlorflurenol through a modified, 4-
Phase public participation process that the Agency uses to involve the
public in developing pesticide reregistration and tolerance
reassessment decisions. This is Phase 3 of the 4-Phase process. Through
these programs, EPA is ensuring that all pesticides meet current health
and safety standards.

DATES: Comments must be received on or before January 2, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0874, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
    Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006 0874. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although

listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either in the
electronic docket at http://www.regulations.gov, or, if only available

in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.
The hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tracy L. Perry, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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

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

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and ecological
risk assessments and related documents for chlorflurenol and soliciting
public comment on risk management ideas or proposals. EPA developed the
risk assessments and risk characterization for chlorflurenol through a
modified version of its public process for making pesticide
reregistration eligibility and tolerance reassessment decisions.
Through these programs, EPA is ensuring that pesticides meet current
standards under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
    Chlorflurenol is a nonfood use herbicide, plant growth retardant,
and plant growth regulator used in agricultural, commercial, and
residential settings. As an herbicide or plant growth retardant, it is
used for the postemergent control of annual grasses, broadleaf weeds,
trees, shrubs and vines for nonagricultural rights-of-way (e.g.,
utility lines), lawns, ornamental turf (including golf courses and
parks), and high density forestry management areas. As a plant growth
regulator, chlorflurenol is used in the production of pineapple
planting material (sliplets); this use is considered to be nonfood as
no finite residues are expected. Chlorflurenol is registered in
emulsifiable concentrate and granular formulations.
    EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for chlorflurenol. Such comments and input could address,
for example, the availability of additional data to further refine the
risk assessments, such as worker, residential, and drinking water
exposure data and ecological effects data, or could address the
Agency's risk assessment methodologies and assumptions as applied to
this specific pesticide.
    Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for chlorflurenol. Risks of concern
associated with the use of chlorflurenol are: dermal occupational risks
from applying liquid sprays with rights-of-way equipment at 3 to 5 lbs
active ingredient/acre (a.i./A); post-application dermal risks for
adults at 3 lbs a.i./A; post-application dermal risks to toddlers from
high contact activity on lawns at 1 to 3 lbs a.i./A; and risks to
infants from chronic exposure to drinking water using modeled ground
water estimated concentrations. Risk could not be precluded for
terrestrial and aquatic organisms and plants due to a lack of data;
limited data suggest potential chronic risk to mammals. In targeting
these risks of concern, the Agency solicits information on effective
and practical risk reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to chlorflurenol, compared to
the general population.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation

Process, published in the Federal Register on May 14, 2004 (69 FR
26819)(FRL-7357-9), explains that in conducting these programs, the
Agency is tailoring its public participation process to be commensurate
with the level of risk, extent of use, complexity of the issues, and
degree of public concern associated with each pesticide. For
chlorflurenol, a modified, 4-Phase process with one comment period and
ample opportunity for public consultation seems appropriate in view of
its limited use. However, if as a result of comments received during
this comment period EPA finds that additional issues warranting further
discussion are raised, the Agency may lengthen the process and include
a second comment period, as needed.
    All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments
will become part of the Agency Docket for chlorflurenol. Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory
action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: October 24, 2006.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-18398 Filed 10-31-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59038-59039]
[FR Doc No: 2013-23293]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0530]

Mobile Medical Applications; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Mobile Medical Applications.''
The FDA is issuing this guidance to inform manufacturers, distributors,
and other entities about how the FDA intends to apply its regulatory
authorities to select software applications intended for use on mobile
platforms (mobile applications or ``mobile apps''). At this time, the
FDA intends to apply regulatory requirements to only a small subset of
mobile apps referred to in this guidance as mobile medical applications
(mobile medical apps).

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Mobile Medical Applications'' to the Division of
Small Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-
0002; or to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For devices regulated by CDRH: Bakul
Patel, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

I. Background

    Given the rapid expansion and broad applicability of mobile apps,
the FDA is issuing this guidance document to clarify the subset of
mobile apps to which the FDA intends to apply its authority. Many
mobile apps are not medical devices (meaning such mobile apps do not
meet the definition of a device under section 201(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate
them. Some mobile apps may meet the definition of a medical device but
because they pose a lower risk to the public, FDA intends to exercise
enforcement discretion over these devices (meaning it will not enforce
requirements under the FD&C Act). The majority of mobile apps on the
market at this time fit into these two categories.
    Consistent with the FDA's existing oversight approach that
considers functionality rather than platform, the FDA intends to apply
its regulatory oversight to only those mobile apps that are medical
devices and whose functionality could pose a risk to a patient's safety
if the mobile app were to not function as intended. This subset of
mobile apps the FDA refers to as mobile medical apps.
    FDA is issuing this guidance to provide clarity and predictability
for manufacturers of mobile medical apps. Should FDA determine at a
later date that the policy in this guidance should be changed in light
of new information, the agency would follow a public process, including
the opportunity for public input, consistent with FDA's good guidance
practices (GGP) regulation in 21 CFR 10.115.
    In the Federal Register of July 21, 2011 (76 FR 43689), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by October 19, 2011. FDA reviewed the
comments and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on mobile medical applications. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Mobile Medical Applications'' from CDRH, you may either send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1741 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved information collections
found in FDA 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). The collections of information in 21
CFR part 801 are approved under OMB control number 0910-0485; the
collection of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; the collections of information in 21 CFR part
806 are approved under OMB control number 0910-0359; the collections of
information in 21 CFR part 807 Subpart B are approved under OMB control
number 0910-0387; the collections of information in 21 CFR part 807
Subpart E are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814 Subparts B and E are
approved under OMB control number 0910-0231; and the collections of
information in 21 CFR part 820 are approved under OMB control number
0910-0073.

V. Comments

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

    Dated: September 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23293 Filed 9-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Rules and Regulations]
[Pages 69373-69374]
[FR Doc No: 2014-27618]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 211

[Release No. SAB 115]

Staff Accounting Bulletin No. 115

AGENCY: Securities and Exchange Commission.

ACTION: Publication of Staff Accounting Bulletin.

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

SUMMARY: This staff accounting bulletin rescinds portions of the
interpretive guidance included in the Staff Accounting Bulletin Series
in order to make the relevant interpretive guidance consistent with
authoritative accounting guidance and Securities and Exchange
Commission rules and regulations. Specifically, the staff is updating
the Series in order to bring existing guidance into conformity with a
recent consensus of the Financial Accounting Standards Board Emerging
Issues Task Force, Accounting Standards Update No. 2014-17--Business
Combinations (Topic 805): Pushdown Accounting (a consensus of the FASB
Emerging Issues Task Force).

DATES: Effective Date: November 21, 2014.

FOR FURTHER INFORMATION CONTACT: Christopher D. Semesky, Professional
Accounting Fellow, Office of the Chief Accountant, at<PHONE_NUMBER>,
or Todd E. Hardiman, Associate Chief Accountant, Division of
Corporation Finance, at<PHONE_NUMBER>, Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The statements in staff accounting bulletins
are not rules or interpretations of the Commission, nor are they
published as bearing the Commission's official approval. They represent
interpretations and practices followed by the Division of Corporation
Finance and the Office of the Chief Accountant in administering the
disclosure requirements of the Federal securities laws.

    Dated: November 18, 2014.
Brent J. Fields,
Secretary.

PART 211--[AMENDED]

    Accordingly, Part 211 of Title 17 of the Code of Federal
Regulations is amended by adding Staff Accounting Bulletin No. 115 to
the table found in Subpart B.

Staff Accounting Bulletin No. 115

    This staff accounting bulletin rescinds portions of the
interpretive guidance included in the Staff Accounting Bulletin Series
in order to make the relevant interpretive guidance consistent with
current authoritative accounting and auditing guidance and Securities
and Exchange Commission (``Commission'') rules and regulations.
Specifically, the staff is updating the Series in order to bring
existing guidance into conformity with a recent consensus of the
Financial Accounting Standards Board Emerging Issues Task Force,
Accounting Standards Update No. 2014-17--Business Combinations (Topic
805): Pushdown Accounting (a consensus of the FASB Emerging Issues Task
Force) (ASU No. 2014-17).
    The following describes the changes made to the Staff Accounting
Bulletin Series that are presented at the end of this release:

1. Topic 5: Miscellaneous Accounting

    a. Topic 5.J is removed. This topic provided guidance on the
application of the ``push down'' basis of accounting in the separate
financial statements of entities acquired in purchase transactions.
Under this guidance, when a purchase transaction results in an entity
becoming substantially wholly owned,\1\ a new basis of accounting
should be established in the acquired entity's financial statements to
reflect the acquirer's basis in the purchased assets and liabilities.
Further, this guidance indicates circumstances when an acquired
entity's financial statements should reflect the acquirer's debt,
related interest expense, and allocable debt issuance costs, when the
acquirer borrows funds to acquire substantially all of the common stock
of the acquired entity. ASU No. 2014-17 establishes new guidance on the
recognition of a new accounting basis. That guidance provides an option
to apply ``push down'' accounting in the separate financial statements
of an acquired entity upon the occurrence of an event in which an
acquirer obtains control of the acquired entity. In addition, any
acquisition-related debt incurred by the acquirer would be recognized
in the acquired entity's separate financial statements only if the
acquired entity is required to recognize a liability for the debt in
accordance with other applicable U.S. generally accepted accounting
principles.
---------------------------------------------------------------------------

    \1\ As defined in Rule 1-02(aa) of Regulation S-X.
---------------------------------------------------------------------------

    Accordingly, the staff hereby amends the Staff Accounting Bulletin
Series as follows:

    Note: The text of SAB 115 will not appear in the Code of Federal
Regulations.

* * * * *

TOPIC 5: MISCELLANEOUS ACCOUNTING

* * * * *

J. Removed by SAB 115

* * * * *

[FR Doc. 2014-27618 Filed 11-20-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 23, 2007 (Volume 72, Number 77)]
[Notices]
[Page 20150]
[DOCID:fr23ap07-84]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 10b-10, SEC File No. 270-389, OMB Control No. 3235-
0444.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget a
request for extension of the previously approved collection[s] of
information discussed below.

 Rule 10b-10, Confirmation of Transactions

    Rule 10b-10 (17 CFR 240.10b-10) of the Securities Exchange Act of
1934 (17 U.S.C. 78a et seq.) requires broker-dealers to convey basic
trade information to customers regarding their securities transactions.
This information includes: the date and time of the transaction, the
identity and number of shares bought or sold, and the trading capacity
of the broker-dealer. Depending on the trading capacity of the broker-
dealer, Rule 10b-10 requires the disclosure of commissions as well as
mark-up and mark-down information. For transactions in debt securities,
Rule 10b-10 requires the disclosure of redemption and yield
information. Rule 10b-10 potentially applies to all of the
approximately 6,014 firms registered with the Commission that effect
transactions on behalf of customers.
    The confirmations required by Rule 10b-10 are generally processed
through automated systems. It takes approximately 1 minute to generate
and send a confirmation. It is estimated that broker-dealers spend 77.4
million hours per year complying with Rule 10b-10.
    The Commission staff estimates the costs of producing and sending a
paper confirmation, including postage to be approximately 91 cents. The
Commission staff also estimates that the cost of producing a sending a
wholly electronic confirmation is approximately 52 cents. The amount of
confirmations sent and the cost of sending each confirmation varies
from firm to firm. Smaller firms generally send fewer confirmations
than larger firms because they effect fewer transactions.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    General comments regarding the estimated burden hours should be
directed to the following persons: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief Information

Officer, Securities and Exchange Commission, c/o Shirley Martinson,
6432 General Green Way, Alexandria VA 22312 or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of

this notice.

    Dated: April 16, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-7688 Filed 4-20-07; 8:45 am]

BILLING CODE 8010-01-P


From:
Kaplan, Mary<EMAIL_ADDRESS>Sent:
Friday, January 22, 2021 6:46 PM
To:
Raymond, Gabrielle<EMAIL_ADDRESS><EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>'Knight, Jeffrey A.'<EMAIL_ADDRESS><EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Subject:
RE: Coke - EPA responses to Model Shell File Review and Other Emissions Files

Good evening,

Please find the attached update to the model shell file.  We've provided responses to outstanding items in the EPA-01-05-21 tab as well as provided several updates to previous entries as noted below:

 Tab 3-CCCCC: Updated comments regarding flares in Column B noted in green.
 Tab 3-CCCCC: Change from battery bleeder flare to Excess COG flare in Row 56 and 87.
 Tab 3-CCCCC: Updates to stack parameters and coordinates for some Excess COG flares.

If there are any questions concerning these updates, please let us know.  We are happy to discuss.

Kind regards,

Mary Kaplan
Scientist IV, Air Quality and Engineering Studies
Environment
D 1.978.905.2260
<EMAIL_ADDRESS>
AECOM
250 Apollo Drive, Chelmsford, Massachusetts 01824
T 1.978.905.2100  F 1.978.905.2101 Cisco 1232260
www.aecom.com

<< CokeOven_RTR_ModFile_COETFResp_122420_EPAResp_010521_COETFResp012221.xlsx >>

From: Raymond, Gabrielle<EMAIL_ADDRESS>Sent: Tuesday, January 5, 2021 5:11 PM
To<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>'Knight, Jeffrey A.'<EMAIL_ADDRESS>Kaplan, Mary<EMAIL_ADDRESS><EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Subject: [EXTERNAL] Coke - EPA responses to Model Shell File Review and Other Emissions Files

Hello,

Thank you all very much for your review and comments on the coke modeling shell file and other emissions files.

Attached are the EPA's responses to the coke modeling shell file, Method 303 file, Flare file, and Byproduct file:
CokeOven_NonCategory_RTR_ModFile_COETFResponses_122420_EPAResponses_010521.xlsx
CokeOvens-Method303_for Industry review_COETF Comments rev122220_EPAresponse-010521.xlsx
Coke_Flare_Emissions_for Industry review_COETF Comments rev122220_EPAResponse-010521.xlsx
Coke_Byproduct_Chemical Plant_Emissions COETF Comments rev122120_EPAresponse010521.xlsx

Please review and provide any comments by 1/19/2021.

EPA is still reviewing the other emissions files (fugitive pushing and boiler-new method) and will send those when ready, likely before end of week.

EPA has also reviewed the memo from Mostardi Platt and the ArcelorMittal Burns Harbor ICR pushing test data again for semi-volatile compounds, dioxins/furans, and volatile organics and agrees that the AM BH SW846 Method 0031 emissions should be retained except for methylene chloride and toluene. The SW846 Method 0010 and Method 23 results also will be retained.

Let us know if there are any questions.

Thank you for all your help,
Gabrielle

Gabrielle Raymond
she/her/hers
RTI International
3040 Cornwallis Road
P.O. Box 12194
Research Triangle Park, NC 27709
Phone:<PHONE_NUMBER>


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5787-5788]
[FR Doc No: 2018-02666]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2379]

Determination of Regulatory Review Period for Purposes of Patent
Extension; IDELVION

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for IDELVION and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 8, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2016-E-2379 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; IDELVION.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count

toward the actual amount of extension that the Director of USPTO may
award (for example, half the testing phase must be subtracted as well
as any time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product IDELVION
(Coagulation Factor IX (recombinant), albumin fusion protein). IDELVION
is indicated for the following: (1) On-demand control and prevention of
bleeding episodes, (2) perioperative management of bleeding, and (3)
routine prophylaxis to prevent or reduce the frequency of bleeding
episodes. Subsequent to this approval, the USPTO received a patent term
restoration application for IDELVION (U.S. Patent No. 7,939,632) from
CSL Behring GmbH, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 26, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of IDELVION represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
IDELVION is 1,479 days. Of this time, 1,023 days occurred during the
testing phase of the regulatory review period, while 456 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February
17, 2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on February
17, 2012.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 5, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
IDELVION (BLA 125582/0) was initially submitted on December 5, 2014.
    3. The date the application was approved: March 4, 2016. FDA has
verified the applicant's claim that BLA 125582/0 was approved on March
4, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 531 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02666 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Proposed Rules]
[Pages 10589-10591]
[FR Doc No: 2013-03249]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0064; FRL-9777-7]

Revision of Air Quality Implementation Plan; California;
Sacramento Metropolitan Air Quality Management District; Stationary
Source Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to fully approve two permitting rules
submitted by California as a revision to the Sacramento Metropolitan
Air Quality Management District (SMAQMD or District) portion of the
California State Implementation Plan (SIP). These rules were adopted by
the SMAQMD to regulate the construction and modification of stationary
sources of air pollution within Sacramento County. EPA is proposing to
approve this SIP revision based on the Agency's conclusion that the
rules are consistent with applicable Clean Air Act (CAA) requirements,
policies and guidance. Final approval of these rules would make the
rules federally enforceable and correct program deficiencies identified
in a previous EPA rulemaking on July 20, 2011.

DATES: Any comments must arrive by March 18, 2013.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0064, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. Email<EMAIL_ADDRESS>

    3. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or email. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send email directly to EPA, your email address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: EPA has established a docket for this action under EPA-R09-
OAR-2013-0064. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents are listed at http://www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps, multi-volume reports), and
some may not be publicly available in either location (e.g., CBI). To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Proposed Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Proposed action and request for public comment.
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal, including the
dates they were adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
          Local agency              Rule No.       Rule title             Amended/Adopted            Submitted
----------------------------------------------------------------------------------------------------------------
SMAQMD..........................          214  Federal New Source  Amended 8/23/12..............         9/26/12
                                                Review.
SMAQMD..........................          217  Public Notice       Adopted 8/23/12..............         9/26/12
                                                Requirements for
                                                Permits.
----------------------------------------------------------------------------------------------------------------

    CARB's SIP submittal includes evidence of public notice and
adoption of these regulations. We find that the submittals for SMAQMD
Rules 214 and 217 meet the completeness criteria in 40 CFR part 51,
appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    EPA approved a previous version of Rule 214 into the SIP on July
20, 2011 (76 FR 43183). There are no previous versions of Rule 217 in
the SIP.

C. What is the purpose of the submitted rules?

    Section 110(a)(2) of the CAA requires that each SIP include, among
other things, a preconstruction permit program to provide for
regulation of the construction and modification of stationary sources
within the areas covered by the plan as necessary to assure that the
National Ambient Air Quality Standards (NAAQS) are achieved, including
a permit program as required in parts C and D of title I of the CAA.
For areas designated as nonattainment for one or more NAAQS, the SIP
must include preconstruction permit requirements for new or modified
major stationary sources of such nonattainment pollutant(s), commonly
referred to as ``Nonattainment New Source Review'' or ``NSR.'' CAA
172(c)(5).
    Sacramento County is currently designated and classified as severe
nonattainment for the 1997 and 2008 8-hour ozone NAAQS and moderate
nonattainment for the 24-hour PM10 NAAQS. The area is also
designated nonattainment for the 2006 24-hour PM2.5 NAAQS.
See 40 CFR 81.305. Therefore, California is required under part D of
title I of the Act to adopt and implement a SIP-approved NSR program
for the Sacramento area that applies, at minimum, to new or modified
major stationary sources of the following pollutants: volatile organic
compounds (VOCs), nitrogen oxides (NOX), particulate matter
of 10 microns of less (PM10), particular matter of 2.5
microns or less (PM2.5) and sulfur oxides
(SOX).\1\
---------------------------------------------------------------------------

    \1\ VOCs and NOX are subject to NSR as precursors to
ozone, and NOX and SOX are subject to NSR as
precursors to PM2.5 in Sacramento County. See 40 CFR
51.165(a)(1)(xxxvii)(C).
---------------------------------------------------------------------------

    Rule 214 (Federal New Source Review) implements the NSR
requirements under part D of title I of the CAA for new or modified
major stationary sources of these nonattainment pollutants within
Sacramento County. Rule 217 (Public Notice Requirements for Permits)
contains the public notice and other procedural requirements for
issuance of permits to all minor sources and to new or modified major
sources of nonattainment pollutants in the County.\2\ The SMAQMD
amended Rule 214 and adopted Rule 217 to correct program deficiencies
identified by EPA on July 20, 2011 (76 FR 43183).
---------------------------------------------------------------------------

    \2\ New or modified major stationary sources of air pollutants
for which Sacramento County is designated attainment or
unclassifiable are subject to separate permitting procedures and
requirements under Rule 203 (Prevention of Significant
Deterioration), which EPA fully approved into the California SIP on
July 20, 2011. See 76 FR 43183.
---------------------------------------------------------------------------

II. EPA's Evaluation and Proposed Action

A. How is EPA evaluating the rules?

    EPA has reviewed the submitted permitting rules for compliance with
the CAA's general requirements for SIPs in CAA section 110(a)(2), EPA's
regulations for stationary source permit programs in 40 CFR part 51,
subpart I (``Review of New Sources and Modifications''), and the CAA

requirements for SIP revisions in CAA section 110(l).\3\ As explained
below, EPA is proposing to fully approve the submitted rules.
---------------------------------------------------------------------------

    \3\ Section 110(l) of the CAA requires SIP revisions to be
subject to reasonable notice and public hearing prior to adoption
and submittal by states to EPA and prohibits EPA from approving any
SIP revision that would interfere with any applicable requirement
concerning attainment and reasonable further progress or any other
applicable requirement of the Act.
---------------------------------------------------------------------------

B. Do the rules meet the evaluation criteria?

    With respect to procedures, CAA sections 110(a) and 110(l) require
that revisions to a SIP be adopted by the State after reasonable notice
and public hearing. EPA has promulgated specific procedural
requirements for SIP revisions in 40 CFR part 51, subpart F. These
requirements include publication of notices, by prominent advertisement
in the relevant geographic area, of a public hearing on the proposed
revisions, a public comment period of at least 30 days, and an
opportunity for a public hearing.
    Based on our review of the public process documentation included in
the SMAQMD's September 26, 2012 rule submittals, we find that the State
has provided sufficient evidence of public notice and opportunity for
comment and public hearings prior to adoption and submittal of these
rules to EPA.
    With respect to substantive requirements, EPA has reviewed the
submitted rules in accordance with the CAA and regulatory requirements
that apply to NSR permit programs under part D of title I of the Act
and the general public notice requirements for stationary source
permits in 40 CFR section 51.161. Based on our evaluation of these
rules, we are proposing to fully approve Rule 214 as satisfying the CAA
and regulatory requirements for NSR permit programs in part D of title
I of the Act and EPA's NSR implementing regulations in 40 CFR section
51.165 for new or modified major stationary sources proposing to locate
in Sacramento County. Additionally, we are proposing to fully approve
Rule 217 as satisfying the general public notice requirements in 40 CFR
51.161 for both minor source permits and major source NSR permits
issued in Sacramento County. Final approval of Rule 214 and Rule 217
would correct all deficiencies in SMAQMD's permit programs identified
in our July 20, 2011 final rule. See 76 FR 43183. The Technical Support
Document (TSD) for this action contains a more detailed discussion of
our evaluation.

C. Proposed action and request for public comment

    For the reasons given above and described more fully in the TSD for
this rulemaking, EPA is proposing to fully approve Rule 214 and Rule
217 into the California SIP pursuant to CAA section 110(k)(3). We will
accept comments from the public on this proposal for the next 30 days.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely proposes to approve State law as
meeting Federal requirements and does not impose additional
requirements beyond those imposed by State law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

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

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

    Dated: January 29, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013-03249 Filed 2-13-13; 8:45 am]
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[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51223-51224]
[FR Doc No: 2014-20367]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0017]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA confirms its decision to exempt 72 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions allow these individuals to operate CMVs in interstate
commerce.

DATES: The new exemptions were granted on July 25, 2014. All exemptions
expire two years from the effective date.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER>, U.S. Department of Transportation,
FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

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 dockets 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., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

Background

    FMCSA has published notices of receipt of Federal diabetes
exemption applications and its intent to grant the exemptions. The
Agency also requested comments from the public. The comment period
closed 30 days after the publication date and the exemptions were
issued the day after the comment period closed.
    FMCSA evaluated the eligibility of the drivers 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 determining criteria for and the conditions and requirements of
the exemptions, to which all exempted drivers are subject, were
discussed in detail when the docket was originally published (79 FR
35844). As always, any adverse comments that come in after the
exemption is granted will be evaluated, and if they indicate that the
driver is not achieving a level of safety equivalent to or greater than
the level of safety that would be obtained by complying with the
regulation, the exemption will be revoked. When

granted, the exemptions will enable these individuals with ITDM to
operate in interstate commerce.

Exemptions Granted

    The following 72 individuals were included in Docket No. FMCSA-
2014-0017 (79 FR 35844), published on June 24, 2014:
Todd Y. Albright (MT)
Weslyn E. Allen (IL)
John H. Ascheman (MN)
Robert M. Borunda (CA)
Alan F. Brown Jr. (IN)
Forrest L. Burghard (PA)
Theodore W. Burnette (CA)
Kevin M. Butler (CA)
John Canal (NY)
Anthony C. Cole (WY)
Kevin G. Comstock (MN)
Jacob S. Crawford (GA)
Christopher Dave (MI)
Anthony J. Davis (IN)
Justin J. Day (SD)
Charles G. Denegal (WA)
Wayne H. Dirks (WA)
Charles G. Elliot (IN)
Joseph S. Farrow (MN)
James R. Fiecke (ND)
Rebecca A. Frye (IN)
Eric C. Gambill (OH)
Mark P. Gerrits (WI)
Michael Gilon (NH)
Chance A. Gooch (GA)
Robert L. Harris (IN)
William G. Harvey (OR)
Darrel S. Haynes (PA)
Joseph D. Helget (OR)
Charles D. Henderson (NY)
Russell J. Hicks (MN)
Stephen L. Hill (NY)
Marvin S. Howard (OH)
Larry A. Hrdlicka (IA)
Michael L. Jackson (NC)
Eric A. Knox (KY)
Erik M. Lindquist (WA)
Thomas K. Linkel (IN)
Christine I. Llewellyn (IL)
Larry D. Lynds (ME)
Ryan A. Malandrone (WI)
Thomas J. Manning (MN)
Joseph R. Martinez (AZ)
Steve A. Meharry (WA)
Robert A. Miller Jr. (WV)
Ben G. Moore (IL)
Chad M. Morris (NY)
Paul C. Mortenson (WI)
William D. Murray (AL)
Jacob D. Nafziger (OH)
Edward T. Nauer (VA)
Keith W. Nichols (TX)
Mark A. Novak (WI)
Colin R. Parmelee (IN)
Michelle L. Perkins (WA)
Robert S. Schreiber (PA)
Matthew P. Sczpanski (OH)
Jason F. Snyder (ME)
Anthony S. Sobreiro (NJ)
Carl A. Spivey (AL)
Colby E. Starner (PA)
Daniel E. Stephens (NY)
Robert A. Stewart (IA)
Bartholomew Taliaferro (PA)
Johnathan D. Truitt (IL)
Brett T. Tyler (OK)
Rylan P. Wheeler (IL)
Gordon J. White (MO)
Kelly L. Whitley (NC)
Jerry R. Williams (GA)
Charles L. Wojton (PA)
Steven L. Zimmer (OH)
    The public comment period for this docket closed on July 24, 2014
and the exemptions were issued and effective on July 25, 2014. The
exemptions will expire two years from the effective date on July 25,
2016.
    FMCSA received two comments in this proceeding. The comments are
considered and discussed below.
    An anonymous commenter stated that he or she is in favor of
granting the exemptions to the aforementioned drivers.
    Another anonymous commenter stated that a person ``with diabetes
that monitors their sugar levels, takes their medications as directed,
watches their food intake and regularly makes doctor visits is
healthier than most people.''
    Two drivers published in the Docket No. FMCSA-2014-0017 (79 FR
35844), Gary L. Burkett (IL) and Frank E. Shamer (MD), are no longer
using insulin and therefore do not need an exemption.

    Issued On: August 20, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-20367 Filed 8-26-14; 8:45 am]
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