[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Proposed Rules]
[Pages 48767-48769]
[FR Doc No: 2015-19950]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-2890; Airspace Docket No. 15-ASO-8]

Proposed Establishment of Class E Airspace; Placida, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E Airspace at Placida,
FL, to accommodate new Area Navigation (RNAV) Global Positioning System
(GPS) Standard Instrument Approach Procedures (SIAPs) serving Coral
Creek Airport. Controlled airspace is necessary for the safety and
management of instrument flight rules (IFR) operations at the airport.

DATES: Comments must be received on or before September 28, 2015.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg Ground Floor, Rm. W12-140, Washington, DC 20590-0001; Telephone:
1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2015-2890; Airspace Docket No. 15-ASO-8, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.
    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this proposed incorporation by
reference material at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and Regulations Group,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This proposed rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This proposed regulation is within the scope of that
authority as it would establish Class E airspace at Coral Creek
Airport, Placida, FL.

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-2890; Airspace Docket No. 15-ASO-8) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2015-2890; Airspace Docket No. 15-ASO-8.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Y, Airspace
Designations and Reporting Points, dated August 6, 2014, and effective
September 15, 2014. FAA Order 7400.9Y is publicly available as listed
in the ADDRESSES section of this proposed rule. FAA Order 7400.9Y lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace extending
upward from 700 feet above the surface at Coral Creek Airport, Placida,
FL, providing the controlled airspace required to support the new RNAV
(GPS) standard instrument approach procedures for Coral Creek Airport.
Controlled airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the airport would be established for IFR
operations.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9Y, Airspace Designations and Reporting
Points, dated August 6, 2014, effective September 15, 2014, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth

* * * * *

ASO FL E5 Placida, FL [New]

Coral Creek Airport, FL
    (Lat. 26[deg]51'13'' N., long. 82[deg]15'09'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Coral Creek Airport.

    Issued in College Park, Georgia, on August 5, 2015.
Gerald E. Lynch
Acting Manager, Operations Support Group Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2015-19950 Filed 8-13-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Rules and Regulations]
[Page 12395]
[FR Doc No: 2022-04448]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0169; Airspace Docket No. 21-ASO-3]
RIN 2120-AA66

Amendment Class D and Class E Airspace; South Florida

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, delay of effective date.

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

SUMMARY: This action changes the effective date of a final rule
published in the Federal Register on September 8, 2021, amending
airspace for several airports in the south Florida area. The FAA is
delaying the effective date to coincide with the completion of ongoing
airspace projects in the area.

DATES: The effective date of the final rule published on September 8,
2021 (86 FR 50245), delayed on January 27, 2022 (87 FR 4154), is
further delayed until September 8, 2022. The Director of the Federal
Register approved this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order JO 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The FAA published a final rule in the Federal Register for Docket
No. FAA-2021-0169 (86 FR 50245, September 8, 2021), amending Class D
and Class E airspace for eight airports in the south Florida area. The
FAA then delayed the effective date for that final rule until May 19,
2022 (87 FR 4154). Due to delays in other rule making projects in the
area, the FAA is delaying the effective date to September 8, 2022. This
rulemaking is promulgated under the authority described in Subtitle
VII, Part A, Subpart I, Section 40103. Under that section, the FAA is
charged with prescribing regulations to assign the use of airspace
necessary to ensure the safety of aircraft and the efficient use of
airspace. FAA Order JO 7400.11, Airspace Designations and Reporting
Points, is published yearly and effective on September 15.

Good Cause for No Notice and Comment

    Section 553(b)(3)(B) of Title 5, United States Code, (the
Administrative Procedure Act) authorizes agencies to dispense with
notice and comment procedures for rules when the agency for ``good
cause'' finds that those procedures are ``impracticable, unnecessary,
or contrary to the public interest.'' Under this section, an agency,
upon finding good cause, may issue a final rule without seeking comment
prior to the rulemaking. The FAA finds that prior notice and public
comment to this final rule is unnecessary due to the brief length of
the extension of the effective date and the fact that there is no
substantive change to the rule.

Delay of Effective Date

    Accordingly, pursuant to the authority delegated to me, the
effective date of the final rule, Airspace Docket 21-ASO-3, as
published in the Federal Register on September 8, 2021 (86 FR 50245)
and delayed to May 19, 2022, on January 27, 2022 (87 FR 4154; FR Doc.
2021-19268), is hereby delayed until September 8, 2022.

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in College Park, Georgia, on February 24, 2022.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2022-04448 Filed 3-3-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12108-12109]
[FR Doc No: 2013-03972]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17a-5; SEC File No. 270-155, OMB Control No. 3235-0123.

    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'') is soliciting comments on the existing
collection of information provided for in Rule 17a-5 (17 CFR 240.17a-
5), under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
The Commission plans to submit this existing collection of information
to the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 17a-5 is the basic financial reporting rule for brokers and
dealers.\1\ The Rule requires the filing of Form X-17A-5, the Financial
and Operational Combined Uniform Single Report (``FOCUS Report''),
which was the result of years of study and comments by representatives
of the securities industry through advisory committees and through the
normal rule proposal methods. The FOCUS Report was designed to
eliminate the overlapping regulatory reports required by various self-
regulatory organizations and the Commission and to reduce reporting
burdens as much as possible. The Rule also requires the filing of an
annual audited report of financial statements.
---------------------------------------------------------------------------

    \1\ Rule 17a-5(c) requires a broker or dealer to furnish certain
of its financial information to customers and is subject to a
separate PRA filing (OMB Control Number 3235-0199).
---------------------------------------------------------------------------

    The FOCUS Report consists of: (1) Part I, which is a monthly report
that must be filed by brokers or dealers that clear transactions or
carry customer securities; (2) one of three alternative quarterly
reports: Part II, which must be

filed by brokers or dealers that clear transactions or carry customer
securities; Part IIA, which must be filed by brokers or dealers that do
not clear transactions or carry customer securities; and Part IIB,
which must be filed by specialized broker-dealers registered with the
Commission as OTC derivatives dealers; \2\ (3) supplemental schedules,
which must be filed annually; and (4) a facing page, which must be
filed with the annual audited report of financial statements. Under the
Rule, a broker or dealer that computes certain of its capital charges
in accordance with Appendix E to Exchange Act Rule 15c3-1 must file
additional monthly, quarterly, and annual reports with the Commission.
---------------------------------------------------------------------------

    \2\ Part IIB of Form X-17A-5 must be filed by OTC derivatives
dealers under Exchange Act Rule 17a-12 and is subject to a separate
PRA filing (OMB Control Number 3235-0498).
---------------------------------------------------------------------------

    The variation in the size and complexity of brokers and dealers
subject to Rule 17a-5 and the differences in the FOCUS Report forms
that must be filed under the Rule make it difficult to calculate the
cost of compliance. However, we estimate that, on average, each report
will require approximately 12 hours. At year-end 2011, the Commission
estimates that there were approximately 4,802 brokers or dealers, and
that of those firms there were approximately 513 brokers or dealers
that clear transactions or carry customer securities. The Commission
therefore estimates that approximately 513 firms filed monthly reports,
approximately 4,134 firms filed quarterly reports, and approximately 63
firms filed annual reports. In addition, approximately 4,650 firms
filed annual audited reports. As a result, there were approximately
27,405 total annual responses ((513 x 12) + (4,134 x 4) + 63 + 4,650 =
27,405). This results in an estimated annual burden of 328,860 hours
(27,405 annual responses x 12 hours = 328,860).
    In addition, we estimate that approximately 9 brokers or dealers
will elect to use Appendix E to Rule 15c3-1 to compute certain of their
capital charges (as of September 2012, six brokers or dealers have
elected to use Appendix E). We estimate that the average amount of time
necessary to prepare and file the additional monthly reports that must
be filed by these firms is about 4 hours per month, or approximately 48
hours per year; the average amount of time necessary to prepare and
file the additional quarterly reports is about 8 hours per quarter, or
approximately 32 hours per year; and the average amount of time
necessary to prepare and file the additional supplemental reports with
the annual audit required is approximately 40 hours per year.
Consequently, we estimate that the total additional annual burden for
these 9 brokers or dealers is approximately 1,080 hours ((48 + 32 + 40)
x 9 = 1,080).
    The Commission therefore estimates that the total annual burden
under Rule 17a-5 is approximately 330,000 hours (328,860 + 1,080 =
329,940, rounded to 330,000).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia 22312 or
send an email to<EMAIL_ADDRESS>
    Dated: February 15, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-03972 Filed 2-20-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]
[Page 28629]
[DOCID:fr21my10-100]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1909-DR; Docket ID FEMA-2010-0002]

Tennessee; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Tennessee (FEMA-1909-DR), dated May 4, 2010, and
related determinations.

DATES: Effective Date: May 7, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Tennessee is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 4, 2010.

    Robertson, Smith, and Wilson Counties for Individual Assistance.
    Robertson, Smith, and Wilson Counties for debris removal and
emergency protective measures (Categories A and B), including direct
Federal assistance, under the Public Assistance program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-12202 Filed 5-20-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Notices]
[Page 50033-50036]
[DOCID:fr25au08-60]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0466]

Over the Counter Cough and Cold Medications for Pediatric Use;
Notice of Public Hearing

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to obtain input regarding over-the-counter (OTC) cough and cold
drugs marketed for pediatric use. Many of these nonprescription cough
and cold drug products are marketed under the OTC Drug Review, which
established a monograph describing the conditions under which certain
OTC ingredients are considered to be generally recognized as safe and
effective. Recently, safety and efficacy concerns have been raised
regarding the pediatric dosing and use of certain active ingredients in
OTC cough and cold drug products. FDA is developing a proposed rule to
revise the pediatric labeling contained in the Final Monograph for
Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products
for Over-the-Counter Human Use. At this public hearing, FDA is
interested in obtaining public comment about certain scientific,
regulatory, and product use issues as it proceeds with the rulemaking
and reviews new drug applications (NDAs) for these ingredients.
    Dates and Times: The public hearing will be held on October 2,
2008, from 8 a.m. to 5 p.m.
    Location: The public hearing will be held at the Sheraton
Washington North Hotel, 4095 Powder Mill Rd., Beltsville, MD 20705.

ADDRESSES: Submit written registration and written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
registration to http://www.regulations.gov.
    Submit electronic comments to http://www.regulations.gov. All
comments should be identified with the docket number found in brackets
in the heading of this document.
    Transcripts of the hearing will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the hearing.
    For Registration to Attend and/or Participate in the Hearing:
Seating at the hearing is limited. People interested in attending
should submit written or electronic registration to the Division of
Docket Management (see ADDRESSES) by close of business on September 15,
2008. Registration is free and will be on a first-come, first-served
basis. Written or electronic comments will be accepted until December
2, 2008.
    If you wish to make an oral presentation at the hearing, you must
state your intention on your registration submission (see ADDRESSES).
To speak, submit your name, title, business affiliation, address,
telephone and fax numbers, and e-mail address. FDA has included
questions for comment in section II of this document. You should also
identify by number each question you wish to address in your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and to request time for
a joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin.
    If you need special accommodations because of a disability, please
inform Faith Dugan, (see For Information on the Hearing Contact).
    For Information on the Hearing Contact: Faith Dugan, Food and Drug
Administration, 5600 Fishers Lane, rm. 14-101, Rockville, MD 20857,
301-796-3446, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 1, 2007, FDA received a citizen petition submitted by a
number of pediatric health care practitioners that raised concerns
about the safety and efficacy of OTC cough and cold products in
children less than 6 years old. The petition requested that FDA, among
other actions, amend the OTC drug monograph for Cold, Cough, Allergy,
Bronchodilator, and Antiasthmatic Drug Products (CCABADP) in 21 CFR
part 341 to revise the labeling for OTC antitussive, expectorant, nasal
decongestant, antihistamine, and combination cough and cold products.
The petition requested that revised labeling state that these products
should not be used in children under 6 years of age for the treatment
of cough and cold because the products have not been found to be safe
or effective. In addition, the petition requested that the agency
notify manufacturers of products whose labeling either uses such terms
as ``infant'' or ``baby,'' or displays images of children under the age
of 6, that such marketing is not supported by scientific evidence and
that manufacturers will be subject to enforcement action at any time.
The petition and additional information can be found at the following
Web site: http://www.fda.gov/ohrms/dockets/dockets/07p0074/07p0074.htm.
    Many of today's OTC cough and cold medicines are marketed under
monographs established through the OTC Drug Review and published in the
Code of Federal Regulations. FDA initiated the OTC Drug Review in 1972,
after amendments to the Federal Food, Drug, and Cosmetic Act in 1962
required that drugs be shown to be effective as well as safe. Using
expert advisory panels to review data, the OTC Drug Review examined
drug ingredients marketed OTC in the United States to verify which of
these ingredients can be generally recognized among qualified experts
as safe and effective for their intended uses (GRAS/E). After review by
the panel, FDA published advance notices of proposed rulemaking for
active ingredients in various therapeutic categories to establish
monographs describing the conditions under which the products could be
considered GRAS/E and marketed under the monograph without an approved
new drug application. Based on the recommendations in the panel reports
and additional public comments and data, FDA published a proposed rule,
also known as a tentative final monograph (TFM), which set forth the
FDA's views on the conditions of use for the monograph. Finally, based
on additional comments and information submitted in response to the
TFM, FDA published final monographs. The final monographs, codified in
the Code of Federal Regulations, specify the active ingredients that
are GRAS/E for each indication, and for each such active ingredient,
the permitted dosages, claims, and warnings. Products that comply with
all specified monograph conditions may be marketed without prior FDA
approval.
    Through the OTC Drug Review, FDA has established numerous
monographs for classes of OTC drug ingredients. Each completed OTC drug
monograph considers a particular therapeutic class of drugs (e.g.,
antacids, topical antifungal drugs, nighttime sleep aids) and describes
the active ingredients that have been determined to be GRAS/E through
the OTC Drug Review process,

with specifications for the amount of drug per dose, labeling, and
other general requirements. As long as a manufacturer uses ingredients
(or combinations of ingredients) that are included in the monograph,
and follows the monograph specifications in manufacturing and
marketing, these ``OTC Monograph'' products may be sold over the
counter without FDA pre-clearance. Drugs that are not covered under the
OTC Drug Review may be marketed OTC under the terms of an approved NDA.
    In the Federal Register of September 9, 1976 (41 FR 38312), FDA
published an advance notice of proposed rulemaking (ANPRM) to establish
a monograph under Sec.  330.10(a)(6) (21 CFR 330.10(a)(6)), for OTC
cold, cough, allergy, bronchodilator, and antiasthmatic drug products.
At the same time, FDA published the recommendations of the Advisory
Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and
Antiasthmatic Drug Products (the Panel), which was the advisory review
panel that evaluated these products.
    The final CCABADP monograph includes GRAS/E active ingredients in
five separate categories: Antihistamines (13 active ingredients),
decongestants (13 active ingredients), antitussives (10 active
ingredients), bronchodilator (7 active ingredients), and expectorants
(1 active ingredient).\1\
---------------------------------------------------------------------------

    \1\ The FDA issued the tentative final monograph for single
ingredient OTC cold, cough, allergy, bronchodilator, and
antiasthmatic drug products in segments, over a 3-year period. The
first segment, on anticholinergic drug product and expectorant drug
products, was published in the Federal Register of July 9, 1982 (47
FR 30002). The second segment, on bronchodilator drug products, was
published in the Federal Register of October 26, 1982 (47 FR 47520).
The third segment, on antitussive drug products, was published in
the Federal Register of October 19, 1983 (48 FR 48576). The fourth
and fifth segments, on nasal decongestant drug products and
antihistamine drug products, were published in the Federal Register
of January 15, 1985 (50 FR 2200 and 50 FR 2220). The agency's
tentative final monograph for OTC cough-cold combination drug
products was published in the Federal Register of August 12, 1988
(53 FR 30522). Final monographs for these OTC drug products also
were published in segments between 1985 and 1994: Anticholinergic
(50 FR 46582, November 8, 1985); bronchodilator (51 FR 35326,
October 2, 1986); antitussive (52 FR 30042, August 12, 1987);
expectorant (54 FR 8494, February 28, 1989); antihistamine (57 FR
58356, December 9, 1992); nasal decongestant (59 FR 43386, August
23, 1994); and combination products (67 FR 78158, December 23,
2002).
---------------------------------------------------------------------------

    Dosing for each active ingredient was largely based on the advisory
panel recommendations, made in consultation with the Special Panel on
Pediatric Dosage. The following statements appear in the ANPRM:
    The dosage that will produce optimum therapeutic effects in a
particular patient, adult or child, is dependent upon factors such
as the drug itself, individual patient variables such as special
sensitivity or tolerance to the specific agent, age, weight and
metabolic, pathological, or psychological conditions. Children's
dosage calculated by any method that does not take all of these
variables into account, therefore, can only be considered general
guides.
    Definitive pediatric drug dosage should be derived from data
obtained in clinical trials with children using protocols similar to
those used in adult patients. The Panel recognizes the extreme
difficulties attendant upon such trials but also recognizes the
immediate need to make recommendations for pediatric dosage pending
availability of such definitive data.
    Traditionally, pediatric dosage calculations for infants and
children have been based on body surface area, weight, or age of the
child as a proportion of the ``usual adult dose.'' Dosage calculated
on the basis of the age of the child, although convenient, may be
the least reliable method because of the large variation in the
weight of patients at a specific age. However, for OTC products that
have a relatively wide margin of safety, the Panel has concluded
that dosage recommendations based on age are the most reasonable
since they would be most easily understood by the consumer * * *.
    Unless indicated contrarily, the Panel recommends the following
guidelines for determining safe and effective pediatric dosages for
the individual [CCABADP] ingredients discussed in this document: For
infants under 2 years of age, the pediatric dosage should be
established by a physician. For children 2 to under 6 years of age,
the pediatric dosage is 1/4 the adult dosage; for children 6 to
under 12 years of age, the dosage is 1/2 the adult dosage * * *.
    The differences between children under 2 years of age, and other
age groups with respect to the anatomy and physiology disorders of
their respiratory system, their responses to diseases affecting the
respiratory system, and their responses to drugs make general
labeling restrictions for this age group essential. For example,
infants because of the smaller diameter of their respiratory airways
are particularly prone to the complications of respiratory distress
during an acute respiratory tract infection such as may occur in the
``common cold.'' Therefore, parents of children under 2 years of age
should be advised to consult a physician for diagnosis and
individualized therapeutic recommendations, even for symptoms and
conditions that are considered appropriate for self-medication in
older children and adults. Because of these considerations, the
Panel recommends that the general labeling of [CCABADP] products for
use in children under 2 years of age requires the advice and
supervision of a physician * * *.
41 FR 38312; 38333 (September 9, 1976).
    We estimate that there are approximately 10,000 products being
marketed for cold, cough, or combined indications under the OTC Drug
Review. (See 67 FR 78158 at 78166.) Depending on the dosage form and
strength of these products, many of them are labeled for pediatric use,
including some that are labeled for use in both adults and children.
There are approximately 38 active ingredients in the final CCABADP
monograph. Some combination cough and cold products contain as many as
four of these active ingredients in a single dosage form, meaning that
patients may be exposed to four different active ingredients when using
a single product. From 2002 to 2006, there were approximately 36
billion units of combination cough and cold products sold each year in
the United States. For liquid formulations used for the youngest
children, there were approximately 190 million units sold each year in
the combined cough and cold categories during this period.\2\
---------------------------------------------------------------------------

    \2\ Transcript of joint meeting of the Nonprescription Drug
Advisory Committee and the Pediatric Advisory Committee, October 18,
2007, p. 10.
---------------------------------------------------------------------------

    During the past decade, there have been several important new
developments in the evaluation of safety and efficacy of drugs for
pediatric use. First, the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Public Law 105-115) (Nov. 21, 1997) was enacted,
and included a provision to create voluntary incentives to develop
medications for use in the pediatric population. This program was
reauthorized and expanded first in the Best Pharmaceuticals for
Children Act of 2002 (Public Law 107-109) (January 4, 2002), and then
again in Title V of the FDA Amendments Act of 2007 (FDAAA) (Public Law
110-85) (September 27, 2007). The Pediatric Research Equity Act (PREA)
of 2003 required that drugs be studied in pediatric patients in certain
circumstances. The PREA requirements were reauthorized and expanded by
Title IV of FDAAA in 2007. Collectively, these laws recognize that
differences in metabolism between adults and children, as well as
differences between pediatric age groups, may require individualized
dosing. They also recognize that there are often differences in effects
of drugs and in adverse events observed in pediatric patients when
compared to adult patients. Although these laws do not apply to
products marketed under an OTC monograph, data from studies performed
under these provisions suggest that children are not small adults, but
rather may have a response to medication, both beneficial and adverse,
that is different from adults.
    Given the evolution in our thinking about the use of drugs in
children, the passage of more than 30 years since the

recommendations from the advisory review panels were made, and the
concerns about pediatric cough and cold products that have been
presented to FDA, including those raised by the March 1, 2007, citizen
petition, the agency has taken a new look at the assumptions that were
used to create the pediatric conditions for cough and cold medicines
contained in the CCABADP monograph. As part of this review, FDA
convened a joint meeting of the Nonprescription Drugs Advisory
Committee and the Pediatric Advisory Committee on October 18 and 19,
2007, to discuss the safety and efficacy of these OTC cough and cold
products marketed for pediatric use. The discussion at the Advisory
Committee meeting addressed a variety of issues including the
extrapolation of efficacy data from adults to children of any age for
cough and cold products; the safety profile of these products in
children; the basis for dosing recommendations in the CCABADP monograph
and the use of pharmacokinetic data to determine appropriate dosing in
children; the basis of dosing recommendations for various age intervals
of less than 2 years, 2 to 5 years of age, and 6 to 11 years of age;
the use of the products in children less than 2 years of age; the
potential for misuse, unintentional overdose, and excessive dosing; the
ability of parents or caregivers to correctly dose and administer cough
and cold products to their children; and the labeling changes
recommended by the petitioner and the effects they would have on the
use of these products in children and the recommendations of health
care providers. The 22 person Advisory Committee was nearly unanimous
in agreeing that new studies were necessary because extrapolation of
efficacy data for the common cold indication from adults to children
was not acceptable for children less than 2 years old or for children 2
years to less than 12 years. The vote was 22 to 0 and 21 to 1,
respectively, for the two age groups. The committee understood that
changing the OTC drug monographs required rulemaking that would take
several years to complete. The Advisory Committee also voted 13 to 9 to
recommend that pediatric cough and cold drugs should not be used for
children under 6 years of age while rulemaking proceeded, and voted 15
to 7 to recommend that the products should continue, for the time
being, to be sold for use in children ages 6 to under 12 while new
studies are conducted.
    On January 17, 2008, FDA issued a Public Health Advisory (PHA)
available at: http://www.fda.gov/cder/drug/advisory/cough_cold_
2008.htm. The PHA recommended that these drugs not be used to treat
infants and children under 2 years of age because serious and
potentially life-threatening side effects can occur. The PHA also
indicated that FDA had not yet completed its review of the safety of
these medicines in children 2 through 11, and the agency committed to
completing the review as quickly as possible. Pending completion of
this review, the PHA recommended a number of precautions for parents
and caregivers using OTC cough and cold medicines in children 2 years
of age and older, including carefully following the directions in the
Drug Facts label; using appropriate measuring spoons or instruments
made for measuring medicines; choosing products with safety caps;
avoiding concurrent use of different OTC cough and cold medications to
avoid unintentional overdose; not using these products to sedate
children; and consulting a physician, pharmacist, or other health care
professional with any questions about using these products in children.
    In the PHA, we also announced strong support for the voluntary
action taken by many pharmaceutical manufacturers to withdraw cough and
cold medicines that were being sold for use in children under 2 years
of age.
    Since we issued the Public Health Advisory, we have continued our
review of available data concerning the use of cough and cold
medications in children, including information from the Advisory
Committee meeting about the efficacy of the products, information from
FDA's drug Adverse Event Reporting (AERS) database, and a published
report in the medical literature from the Centers for Disease Control
and Prevention (CDC) about children who ingested cough and cold
medicines and had side effects that were serious enough to require an
emergency room visit.\3\ While many of the observed adverse events were
due to overdoses associated with accidental ingestions or dosing
errors, allergic and non-allergic adverse events occurred with the
labeled dose in children. FDA reviewed the CDC study and underlying
data, particularly looking at the type of events that occurred with the
labeled dose of OTC cough and cold medications, and noted that children
under 4 years of age are more likely to experience non-allergic adverse
events than older children.
---------------------------------------------------------------------------

    \3\ Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse Events
From Cough and Cold Medications in Children. Pediatrics
2008;121;783-787; originally published online Jan 28, 2008.
---------------------------------------------------------------------------

    Cough and cold products are commonly used in children. A recent
report suggested that 1 in 10 children uses one or more cough and cold
products during a given week with exposure being highest among 2 to 5
year olds, and high in children under 2.\4\ Based on the number of
cases of serious adverse events reported to FDA and the number of
serious adverse events in the CDC emergency room study, we believe that
serious adverse events are relatively rare given the extensive use of
the drug products.
---------------------------------------------------------------------------

    \4\ Boston University's Slone Epidemiology Center presention at
the 2008 Pediatric Academic Societies' & Asian Society for Pediatric
Research Joint Meeting in Honolulu, Hawaii. Vernacchio L, Kelly JP,
Kaufman DW, Mitchell AA. Cough and Cold Medication Use by US
Children, 1999-2006: Results From the Slone Survey, Pediatrics 2008;
122:e323-e329.
---------------------------------------------------------------------------

     Despite the fact that serious adverse events are relatively rare
in children using cough and cold drugs, we have determined that the
collection of additional data using modern standards is warranted to
support the current dosing or to establish new dosing regimens for
children, given the concerns that have been raised about the safety and
efficacy of these products, particularly in younger age groups. Lack of
safety and efficacy data for specific pediatric age groups also
inhibits the conduct of a meaningful risk benefit analysis under 21 CFR
330.10(a)(4)(iii).
    We recognize that many scientific issues must be addressed and
resolved to support the development and review of data that, in the
long term, will provide increased confidence in the safe and effective
pediatric use of these OTC cough and cold products, either under the
monograph or approved NDAs. FDA has decided to hold a Part 15 hearing
to hear from the public, including parents, health care practitioners,
manufacturers of cough and cold products, retailers, and other
interested persons, about these issues. FDA will consider this public
input in developing a proposed rule to amend the CCABADP monograph to
reflect the new data and any appropriate changes to the conditions
necessary to ensure that these medications can be considered GRAS/E.

II. Scope of Hearing

    FDA is interested in obtaining public comment on the following
issues relating to the use of pediatric cough and cold medicines:
    1. What types of studies, if any, should be conducted to assess
effectiveness and/or safety, and

determine appropriate dosing of cough and cold ingredients in the
pediatric population? How should these studies be designed and powered?
    2. Should cough and cold products for the pediatric population
continue to be available OTC, or should they be made available only by
prescription?
    3. If the pediatric indications and dosing for cough and cold
products were no longer available OTC, would the public use the adult
formulations of the OTC monograph products for children, and thus
create a greater risk of misuse or overdose?
    4. Do the answers to the previous questions depend on the age of
the pediatric patients? If so, how should age be considered in making
regulatory decisions for these products?
    5. At the time the monograph was established, FDA routinely
extrapolated safety and efficacy data from adults to children age 12
and over. Current PREA standards permit extrapolation of pediatric
efficacy -- but not safety-- based upon sufficient adult data. Does it
remain appropriate to recommend in the cough and cold monograph that
children 12 and over should receive the same dose of medication as
adults, without requiring any additional studies in children in this
age group? What additional safety and/or efficacy studies should be
required in this age group?
    6. What is the most appropriate method for determining pediatric
doses that could be used as an alternative to the quarter- and half-
dose assumptions used in the monograph? Should products be dosed by
age, by weight, or both?
    7. There are monographs for topical and intranasal ingredients to
treat the common cold. Should these monographs be considered in a
similar fashion to the oral cough and cold products? Are the answers to
the previous questions different for any subcategories of cough and
cold medicines (e.g., topical or intranasal products)?
    8. The CCABADP monograph allows for the combination of ingredients
to treat colds and/or coughs. Should combination products be permitted
for all pediatric age groups? Should data be provided to support each
unique combination?
    9. Can measurement errors in dosing be reduced using more
standardized measuring devices or alternative dosage forms and, if so,
what is the best way to effect this change?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner is announcing that the public hearing will be held
in accordance with part 15 (21 CFR part 15). The hearing will be
conducted by a presiding officer, accompanied by FDA senior management
from the Office of the Commissioner and the Center for Drug Evaluation
and Research.
    Under Sec.  15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10), subpart C)). Under Sec.  10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b). To the extent that the conditions for the hearing, as
described in this document, conflict with any provisions set out in
part 15, this document acts as a waiver of those provisions as
specified in 21 CFR 15.30(h).

IV. Comments

    Regardless of attendance at the public hearing, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by (see DATES). Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857. Interested persons may submit to the Division of
Dockets Management (see ADDRESSES) written or electronic notices of
participation and comments for consideration.

    Dated: August 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19657 Filed 8-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]
[Page 42072-42074]
[DOCID:fr01au07-53]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0936; FRL-8138-1]

Notice of Filing of Pesticide Petitions for Residues of Pesticide
Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or modification of regulations
for residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before August 31, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest, 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
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the assigned docket ID number
and the pesticide petition number of interest. 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 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
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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. Publicly available docket materials are available
electronically 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 Bldg.), 2777 S. Crystal Dr., 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
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The person listed at the end of the
pesticide petition summary of interest.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

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. Docket ID Numbers

    When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.

------------------------------------------------------------------------
                 PP Number                        Docket ID Number
------------------------------------------------------------------------
PP 7E7218                                   EPA-HQ-OPP-2007-0495
------------------------------------------------------------------------
PP 6F7024                                   EPA-HQ-OPP-2007-0539
------------------------------------------------------------------------
PP 6F7119                                   EPA-HQ-OPP-2007-0475
------------------------------------------------------------------------
PP 7F7222                                   EPA-HQ-OPP-2007-0504
------------------------------------------------------------------------

III. What Action is the Agency Taking?

    EPA is printing notice of the filing of pesticide petitions
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this notice contain data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the pesticide
petitions. Additional data may be needed before EPA rules on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
included in this notice, prepared by the petitioner, is included in a
docket EPA has created for each rulemaking. The docket for each of the
petitions is available on-line at http://www.regulations.gov.

New Tolerances

    1. PP 7E7218. (EPA-HQ-OPP-2007-0495). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton,
NJ 08540-6635, proposes to establish a tolerance for residues of the
insecticide methoxyfenozide in or on food commodities avocado, black-
sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star
apple at 0.6 parts per million (ppm); guava, feijoa, jaboticaba, wax
jambu, starfruit, passion fruit, and acerola at 0.4 ppm; green onion,
fresh chive leaves, fresh Chinese chive leaves, Elegans Hosta,
Fritillaria leaves, kurrat, Lady's leek, leek, wild leek, Beltsville
bunching onion, fresh onion, macrostem onion, tree onion tops, Welsh
onion tops, and fresh shallot leaves at 5.0 ppm. Adequate enforcement
methods are available for determination of methoxyfenozide residues in
plant commodities based on the Rohm and Haas Company Technical Report
No. 34-98-87, ``Tolerance Enforcement Method for Parent RH-2485 in Pome
Fruit''. The available Analytical Enforcement Methodology was
previously reviewed in the Federal Register of September 20, 2002 (67
FR 59193). Contact: Susan Stanton, telephone number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>    2. PP 6F7024. (EPA-HQ-OPP-2007-0539). Bayer CropScience, P.O. Box
12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, proposes
to establish a tolerance for residues of the fungicide trifloxystrobin
in or on food commodities grass, forage at 10.0 ppm and grass, hay at
14.0 ppm. A practical analytical methodology for detecting and
measuring levels of trifloxystrobin in or on raw agricultural
commodities has been submitted. The limit of detection (LOD) for each
analyte of this method is 0.08 ng injected, and the limit of
quantitation (LOQ) is 0.02 ppm. The method is based on crop specific
cleanup procedures and determination by gas chromatography with
nitrogen-phosphorus detection. Contact: Janet Whitehurst, telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>    3. PP 6F7119. (EPA-HQ-OPP-2007-0475). Bayer CropScience, P.O. Box
12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, proposes
to establish a tolerance for residues of the insecticide spirotetramat,
cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl
ethyl carbonate and its metabolite cis-3-(2,5-dimethylphenyl)-4-
hydroxy-8-methoxy- 1-azaspiro[4.5]dec-3-en-2-one], calculated as
spirotetramat equivalents, in or on food commodities vegetable,
tuberous and corm, subgroup 1C at 1.0 ppm; potato, granules/flakes at
2.5 ppm; onions, dry bulb, subgroup 3A at 0.3 ppm; vegetables, leafy,
except Brassica, group 4 at 5.0 ppm; Brassica, head and stem, subgroup
5A at 3.0 ppm; Brassica, leafy greens, subgroup 5B at 16.0 ppm;
vegetables, fruiting, group 8 at 1.0 ppm; tomato, dried pomace at 2.5
ppm; vegetable, cucurbit, group 9 at 0.2 ppm; fruit, citrus, group 10
at 0.5 ppm; citrus, oil at 4.0 ppm; fruit, pome, group 11 at 0.5 ppm;
fruit, stone, group 12 at 2.0 ppm; nut, tree, group 14 at 0.5 ppm;
almond, hulls at 9.0 ppm; grape at 1.0 ppm; grape, raisin at 2.5 ppm;
hop at 10.0 ppm; strawberry at 0.5 ppm; cattle, goat, hog, sheep and
horse, meat at 0.01 ppm; cattle, goat, hog, sheep and horse, fat at
0.01 ppm; cattle, goat, hog, sheep and horse, liver at 0.01 ppm;
cattle, goat, hog, sheep and horse, meat byproducts, except liver at
0.02 ppm. The residues of spirotetramat and its metabolites were
quantified by high pressure liquid chromatography/triple stage
quadrupole mass spectrometry (LC-MS/MS) using the stable isotopically
labeled analytes as internal standards. The individual analyte residues
were converted to spirotetramat molar equivalents and summed to give
total spirotetramat residues. The limit of quantification (LOQ) for
each analyte was 0.01 ppm for all commodities, except citrus (0.05 ppm)
and hops (0.1 ppm). Contact: Rita Kumar, telephone number: (703) 308-
8291; e-mail address<EMAIL_ADDRESS>    4. PP 7F7222. Dow AgroSciences, 9330 Zionsville Road, Indianapolis,
IN, 46268, proposes to establish a tolerance for residues of the
herbicide isoxaben in or on food commodities grape/grape, juice/grape,
raisin at 0.01 ppm; nut, tree, group 14 and pistachio at 0.03 ppm;
almond, hulls at 0.35 ppm; and to request a waiver for the requirement
of a tolerance for isoxaben in or on the raw agricultural commodity
cattle, meat byproducts; meat and milk. There is a practical method
(liquid chromatography with positive ion atmospheric pressure chemical
ionization tandem mass spectrometry (LC-MS/MS)) for detection of
isoxaben residues. The limit of detection (LOD) and limit of
quantitation (LOQ) are 0.003 [micro]g/g and 0.01 [micro]g/g,
respectively and are suitable for detecting and measuring levels of
isoxaben in or on food and allows monitoring of food with residues at
or above the level set for these tolerances. The method has an
independent laboratory validation. Contact: Kathryn Montague, telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed

additives, Food additives, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 16, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E7-14678 Filed 7-31-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43597-43598]
[FR Doc No: 2017-19806]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81597; File No. SR-MRX-2017-17]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Remove Language
From Chapter 19 of the Rulebook

September 13, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 31, 2017, Nasdaq MRX, LLC (``MRX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to remove language from Chapter 19 related to
a systems issue that has been resolved with the completed migration of
the Exchange to Nasdaq INET.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to remove language from
Chapter 19 related to a systems issue that has been resolved with the
completed migration of the Exchange to Nasdaq INET. On June 6, 2017,
the Exchange filed a proposed rule change to amend Chapter 19 to notify
members of a systems issue related to allocations made pursuant to
Supplementary Material .02(a)-(b) to Rule 1901 (``Flash auction'').\3\
As explained in that proposed rule change, due to a systems issue,
Flash auction allocations pursuant to Supplementary Material .02(a)-(b)
to Rule 1901 were not being provided as described in that rule, and
instead Primary Market Maker quotes were being given a Flash auction
allocation pursuant to Supplementary Material .01(b)-(c) to Rule 713
after Priority Customer Orders on the book, and ahead of Responses,
Professional Orders, and other market maker quotes. This systems issue
has been resolved with the Exchange's migration to Nasdaq INET, which
was completed on Monday, August 21, 2017. As all symbols are now
trading on INET, contracts executed in a Flash auction will be
allocated correctly pursuant to Supplementary Material .02 to Rule
1901. The Exchange therefore proposes to remove the language described
above from its rulebook.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 80965 (June 19,
2017), 82 FR 28716 (June 23, 2017) (SR-MRX-2017-07).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\4\ In
particular, the proposal is consistent with Section 6(b)(5) of the
Act,\5\ because is designed to promote just and equitable principles of
trade, remove impediments to and perfect the mechanisms of a free and
open market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that the
proposed rule change is consistent with the protection of investors and
the public interest because the systems issue described in Chapter 19
has been resolved. Due to a systems issue, allocations in the Flash
auction were not being done in the manner described in Supplementary
Material .02(a)-(b) to Rule 1901. As a temporary measure, the Exchange
therefore added language to that effect to Chapter 19. With the
migration of the Exchange's trading system to Nasdaq INET, this systems
issue has been eliminated, and the Exchange therefore believes that it
is appropriate to remove this language from Chapter 19.
---------------------------------------------------------------------------

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

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

    In accordance with Section 6(b)(8) of the Act,\6\ the Exchange does
not believe that the proposed rule change will impose any burden on
intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule change eliminates outdated text reflecting a systems issue related
to Flash auction allocations, and is not designed to have any
competitive impact.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section

19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \9\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \10\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay. The
Exchange states that waiver of the operative delay is consistent with
the protection of investors and the public interest as it will allow
the Exchange to immediately remove outdated language from Chapter 19
and thereby avoid member confusion about how Flash auction allocations
are performed on the Exchange. The Commission believes the waiver of
the operative delay is consistent with the protection of investors and
the public interest. Accordingly, the Commission hereby waives the
operative delay and designates the proposed rule change operative upon
filing.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2017-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2017-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MRX-2017-17, and should be
submitted on or before October 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-19806 Filed 9-15-17; 8:45 am]
 BILLING CODE 8011-01-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

                                   	    Issued by the Department of
Transportation on June 29, 2004

		       NOTICE OF ACTION TAKEN -- DOCKET OST-2002-13408

________________________________________________________________________
______

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    American Airlines, Inc.    filed  6/10/04  to:

XX  Amend exemption under 49 U.S.C. 40109 so as to:

Permit American to operate its already authorized U.S.-Kenya service
(see Notice of Action Taken dated October 29, 2002, in this Docket)
pursuant to a code-share arrangement with Delta Air Transport N.V. d/b/a
SN Brussels Airlines.

Applicant rep.:   Carl B. Nelson<PHONE_NUMBER>     DOT analyst:
Sylvia Moore<PHONE_NUMBER>

DISPOSITION

XX  Granted  (subject to conditions, see below)

The above action was effective when taken:  June 29, 2004,  through
October 29, 2004, (coextensive with American’s existing authority in
this Docket)

Action taken by:   Paul L. Gretch, Director

	                 Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and  Belgium, and the overall state of
aviation relations between the United States and Kenya.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
Certificates of Public Convenience and Necessity

	   XX  Standard Exemption Conditions (attached)

	   XX  Statement of Authorization approving American SN Brussels
code-share operations

           dated April 11, 2003, and conditions therein

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our

action was consistent with Department policy; (2) grant of the authority
was consistent with the public interest; and (3) grant of the authority
would not constitute a major regulatory action under the Energy

2

Policy and Conservation Act of 1975.  To the extent not granted, we
denied all requests in the referenced Docket.  We may amend, modify, or
revoke the authority granted in this Notice at any time without hearing
at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004

 Initially, American proposes to operate to Mombasa, Kenya via Brussels,
Belgium.  American also operates its U.S.-Kenya service and
U.S.-Tanzania service pursuant to a code-share arrangement with Swiss
International Air Lines Ltd.  (See Notice of Action Taken dated October
29, 2002, in this Docket.)


[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79401-79402]
[FR Doc No: 2015-31981]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0067]

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 52 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on November 3, 2015. The
exemptions expire on November 3, 2017.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

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., 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 www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On October 1, 2015, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 52 individuals and requested
comments from the public (80 FR 59237). The public comment period
closed on November 2, 2015, and no comments were received.
    FMCSA has evaluated the eligibility of the 52 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).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 52 applicants have had ITDM over a range of 1 to 40 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 (2 or
more) severe hypoglycemic episodes in the past 5 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).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the October 1, 2015, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement 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.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    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 will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 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) that each individual 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) that each
individual provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy in his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the certification when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official.

VI. Conclusion

    Based upon its evaluation of the 52 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Melvin S. Adams (MD)
Kevin R. Arnett (MO)
David A. Ash (KS)
Louis Barrios (NV)
Robert W. Brown (TN)
Gallaspy C. Chapman (CO)
Frederick R. Conner (PA)
Charles A. Culler (OH)
Allan E. Dover (ID)
Warren L. Duncan (ME)
Larry D. Everett (CA)
James Ferrone (PA)
Kenneth C. Fosdick (OH)
Mark J. Greig (OR)
Todd E. Gross (WI)
Ricky V. Hoffman (KS)
Bernis Hursey (MD)
Gary A. Jackson (PA)
Wayne O. Jennings (KS)
Rocky N. Kennedy, Jr. (WV)
Larian A. Koger (NC)
Donald L. Kuhn (PA)
Richard C. Lakas (MO)
Amondo D. Lark (FL)
Walter L. Loyd, Jr. (IL)
Daniel T. Morse (MA)
Deborah C. Neece (NC)
Paul Neville (NJ)
Thomas M. Nicolaus (IA)
James D. Rast, III (SC)
Kevin B. Reese (FL)
Andrew R.W. Rictor (OR)
Jason K. Riley (WV)
Bryan N. Ripley (MN)
David C. Ripley (WA)
Scottie L. Russell (NY)
Jerome A. Shapiro (AL)
Joseph D. Shehan (NC)
Amanda K. Shelman (IA)
Michael Shuler (DC)
Joseph A. Sitarchyk (PA)
Max F. Smith (IA)
Vann H. Smith (AL)
Donald Snead (GA)
Arron L. Snook (WA)
John L. Stauffer (IA)
David L. Stephenson (SD)
Timothy R. Stirn (MD)
Connie E. Wideman (FL)
Gary W. Wood (AR)
Richard O. Yethman (MA)
Willard Zylstra (CA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years 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 before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: December 9, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-31981 Filed 12-18-15; 8:45 am]
BILLING CODE 4910-EX-P