[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21792-21796]
[FR Doc No: 2011-9323]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0093]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of applications for exemption from the diabetes mellitus
standard; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 21 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before May 18, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0093 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time 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. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' The statute also allows the Agency to
renew exemptions at the end of the 2-year period. The 21 individuals
listed in this notice have recently requested such an exemption from
the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to
drivers of CMVs in interstate commerce. Accordingly, the Agency will
evaluate the qualifications of each applicant to determine whether
granting the exemption will achieve the required level of safety
mandated by the statutes.

Qualifications of Applicants

Jerry L. Arrington

    Mr. Arrington, age 61, has had ITDM since 1992. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Arrington understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Arrington meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Alabama.

Edward W. Carlson

    Mr. Carlson, 62, has had ITDM since 2007. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Carlson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Carlson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Thomas F. Cook

    Mr. Cook, 59, has had ITDM since 2011. His endocrinologist examined
him in 2011 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Cook understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Cook meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2011 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Iowa.

Dale C. Cromer

    Mr. Cromer, 49, has had ITDM since 2008. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Cromer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cromer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from California.

Jerry R. Earle

    Mr. Earle, 57, has had ITDM since 2009. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Earle understands diabetes
management and monitoring, has stable control of his diabetes using

insulin, and is able to drive a CMV safely. Mr. Earle meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
New Mexico.

Terry J. Johnson

    Mr. Johnson, 60, has had ITDM since 2009. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Johnson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Johnson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Minnesota.

Ida D. Kidd

    Ms. Kidd, 54, has had ITDM since 2010. Her endocrinologist examined
her in 2011 and certified that she has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. Her
endocrinologist certifies that Ms. Kidd understands diabetes management
and monitoring, has stable control of her diabetes using insulin, and
is able to drive a CMV safely. Ms. Kidd meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her
in 2010 and certified that she does not have diabetic retinopathy. She
holds a Class B CDL from New Jersey.

Ronald J. Klinke

    Mr. Klinke, 50, has had ITDM since 2010. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Klinke understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Klinke meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from
Wisconsin.

Raymond H. LaGrow

    Mr. LaGrow, 46, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. LaGrow understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. LaGrow meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

Doyle F. Love

    Mr. Love, 49, has had ITDM since 2010. His endocrinologist examined
him in 2011 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Love understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Love meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2011 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Georgia.

Todd L. McAuley

    Mr. McAuley, 49, has had ITDM since 2009. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. McAuley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McAuley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from North Carolina.

Stephen A. Miles

    Mr. Miles, 51, has had ITDM since 1975. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Miles understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Miles meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2010 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from Ohio.

David W. Neher

    Mr. Neher, 32, has had ITDM since 2007. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Neher understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Neher meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from New
Jersey.

Richard S. Polly

    Mr. Polly, 65, has had ITDM since 2007. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function

that occurred without warning in the past 12 months and no recurrent (2
or more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Polly understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Polly meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class C CDL from New
Jersey.

Edgar M. Ridlon

    Mr. Ridlon, 78, has had ITDM since 2009. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ridlon understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ridlon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Vermont.

Andrew M. Schutt

    Mr. Schutt, 28, has had ITDM since 2009. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Schutt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Schutt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Illinois.

Billy Joe Sisk

    Mr. Sisk, 43, has had ITDM for 15 years. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sisk understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sisk meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from North
Carolina.

Robert J. Talbert

    Mr. Talbert, 53, has had ITDM since 2005. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Talbert understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Talbert meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Illinois.

Gregory L. Whitt

    Mr. Whitt, 55, has had ITDM since 2003. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Whitt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Whitt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class D operator's
license from Alabama.

John W. Wortman

    Mr. Wortman, 50, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wortman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wortman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin .

Kemlyn K. Yowell

    Mr. Yowell, 46, has had ITDM since 1986. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Yowell understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Yowell meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class D operator's
license from Ohio.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\ The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section

4018 of the Transportation Equity Act for the 21st Century (49 U.S.C.
31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
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    Section 4129 requires: (1) Elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary. The FMCSA concluded that all of
the operating, monitoring and medical requirements set out in the
September 3, 2003 notice, except as modified, were in compliance with
section 4129(d). Therefore, all of the requirements set out in the
September 3, 2003 notice, except as modified by the notice in the
Federal Register on November 8, 2005 (70 FR 67777), remain in effect.

    Issued on: April 7, 2011.
Larry W. Minor,
Associate Administrator, Office of Policy.
[FR Doc. 2011-9323 Filed 4-15-11; 8:45 am]
BILLING CODE P


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61064-61065]
[FR Doc No: 2019-24509]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0823]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Format and Content
Requirements for Over-the-Counter Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by
December 12, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the

OMB control number 0910-0340. Also include the FDA docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Format and Content Requirements for Over-the-Counter Drug Product
Labeling--21 CFR Part 201

OMB Control Number 0910-0340--Extension

    This information collection supports FDA regulations at Sec.
201.66 (21 CFR 201.66), which establish standardized content and format
requirements for the labeling of all marketed over-the-counter (OTC)
drug products. The regulations set forth the content and format
requirements for the Drug Facts portion of labels on OTC drug products.
These regulations require OTC drug product labeling to include uniform
headings and subheadings, presented in a standardized order, with
minimum standards for type size and other graphical features.
    Currently marketed OTC drug products are already required to comply
with these labeling requirements and will incur no further burden to
comply with Drug Facts labeling requirements in Sec.  201.66. Labeling
modifications already required to be in Drug Facts format are ``usual
and customary'' as part of routine redesign practice, thus they do not
create additional burden within the meaning of the PRA.
    Therefore, burden for this information collection is that which is
necessary to comply with the labeling requirements in Sec.  201.66,
applicable to new OTC drug products and OTC sunscreen drug products
introduced to the marketplace under new drug applications, abbreviated
new drug applications, or an OTC drug monograph. New OTC drug products
must comply with the labeling requirements in Sec.  201.66 as they are
introduced to the marketplace.
    Based on our electronic drug registration and listing database, we
estimate that approximately 10,463 new OTC drug product stock keeping
units (SKUs) are introduced to the marketplace each year. We estimate
that these SKUs are marketed by 1,416 manufacturers. We estimate that
the preparation of labeling for new OTC drug products requires 12 hours
to prepare, complete, and review prior to submitting the new labeling
to us. Based on this estimate, the annual reporting burden for this
type of labeling is 94,296 hours.
    All currently marketed sunscreen products are required to comply
with the Drug Facts labeling requirements in Sec.  201.66, so they will
incur no further burden under the information collection provisions in
the regulation. However, a new OTC sunscreen drug product, like any new
OTC drug product, will be subject to a one-time burden to comply with
Drug Facts labeling requirements in Sec.  201.66. We estimate, based on
our electronic drug registration and listing database, that 5,253 new
SKUs of OTC sunscreen drug products will be marketed each year. We
estimate that these 5,253 SKUs will be marketed by 294 manufacturers.
We estimate that 12 hours will be spent on each label. This is
reflected in table 1, row 1.
    When determining the burden for Sec.  201.66, it is also important
to consider exemptions or deferrals of the regulation allowed products
under Sec.  201.66(e). We receive very few requests for exemptions or
deferrals. We also estimate that a request for deferral or exemption
requires 24 hours to complete. This is reflected in table 1, row 2.
    In the Federal Register of June 19, 2019 (84 FR 28555), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received from a trade
organization representing nurse practitioners. The comment advocated
revising FDA regulations to provide for provider-neutral language in
Agency regulations but acknowledged its use in current Agency guidance.
We appreciate this comment, but we decline to adopt the suggestion at
this time.
    We estimate the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
         21 CFR section             respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
----------------------------------------------------------------------------------------------------------------
Sec.   201.66(c) and (d) for new             855            9.19           7,858              12          94,296
 OTC drug products..............
Sec.   201.66(e)................               1               1               1              24              24
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          94,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 82,797 hours and a corresponding increase of 6,898
disclosures. This increase corresponds with data obtained from our
database.

    Dated: October 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24509 Filed 11-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Rules and Regulations]
[Pages 1302-1303]
[FR Doc No: 2018-00288]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0266; FRL-9972-90-Region 1]

Air Plan Approval; NH; Approval of Recordkeeping and Reporting
Requirements and Single Source Order; Withdrawal of Direct Final Rule

AGENCY: Environmental Protection Agency.

ACTION: Withdrawal of direct final rule.

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SUMMARY: Due to the receipt of adverse comments, the Environmental
Protection Agency (EPA) is withdrawing the November 14, 2017 direct
final rule approving State Implementation Plan (SIP) revisions
submitted by the State of New Hampshire. New Hampshire's SIP revisions
modified existing recordkeeping and reporting requirements for sources
of air pollution, and modified an existing order for Sturm Ruger &
Company. This action is being taken in accordance with the Clean Air
Act.

DATES: The direct final rule published at 82 FR 52664 on November 14,
2017 is withdrawn effective January 11, 2018.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Air Quality Planning
Unit, U.S. Environmental Protection Agency, New England Regional
Office, 5 Post Office Square, Suite 100 (Mail code OEP05-2), Boston, MA
02109--3912, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In the direct final rule, EPA stated that if
adverse comments were submitted by December 14, 2017, the rule would be
withdrawn and not take effect. EPA received adverse comments prior to
the close of the comment period and,

therefore, is withdrawing the direct final rule. EPA will address the
comments in a subsequent final action based upon the proposed rule also
published on November 14, 2017 (82 FR 52683). EPA will not institute a
second comment period on this action.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Regional haze, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 22, 2017.
Kenneth Moraff,
Acting Regional Administrator, EPA New England.

0
Accordingly, the amendments to 40 CFR 52.1520 published on November 14,
2017 (82 FR 52664) are withdrawn effective January 11, 2018.

[FR Doc. 2018-00288 Filed 1-10-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]
[Page 32838-32839]
[DOCID:fr09jn10-128]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2010-0065]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes one collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before August 9, 2010.

ADDRESSES: Direct all written comments to the U.S. Department of
Transportation Dockets, 1200 New Jersey Ave., SE., W46-474, Washington,
DC 20590. Docket No. NHTSA-2010-0065.

FOR FURTHER INFORMATION CONTACT: Angela Eichelberger, Ph.D., Office of
Behavioral Safety Research (NTI-132), 1200 New Jersey Avenue, SE.,
Washington, DC 20590. Dr. Eichelberger's telephone number is (202) 366-
5586 and her e-mail is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document.
    Under OMB's regulations (at 5 CFR 1320.8(d)), an agency must ask
for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: National Child Restraint Use Special Study (NCRUSS).
    Type of Request: Reinstatement with change of a previously approved
collection.
    OMB Control Number: 2127-0577.
    Form Number: This collection of information uses no standard forms.
    Requested Expiration Date of Approval: 3 years from the date of OMB
approval (estimated March 30, 2014).
    Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) proposes to collect observational
data on correct and incorrect use of child restraint systems in
passenger vehicles, as well as interview information from drivers about
their knowledge and perceptions of child restraint systems. The primary
population for observation will be restrained and unrestrained child
passengers riding in any seating position in passenger vehicles.
Participation in the study will be voluntary. Interviews with drivers
who agree to participate will be used to obtain the following data:
demographic information on occupants, the driver's knowledge about the
specific CRS in the vehicle, and the driver's general knowledge and
experience with different types of restraint systems. While the
interview is being conducted, a trained observer will collect
information about the CRS in the vehicle, including the type of
restraint that is used, the type of installation (seat belt or LATCH),
how the CRS is installed, harness use, and seat belt fit. The observer
will not remove the child or CRS from the vehicle. At the conclusion of
the survey, respondents will receive information on child passenger
safety and specific information regarding the locations of inspection
stations and seat check events that are available in the area.
    Description of the Need for the Information and Proposed Use of the
Information: The National Highway Traffic Safety Administration (NHTSA)
was established by the Highway Safety Act of 1966 (23 U.S.C. 101) to
carry out a Congressional mandate to reduce the mounting number of
deaths, injuries and economic losses resulting from motor vehicle
crashes on our Nation's highways. In support of this mission, NHTSA
proposes to conduct information collections to assess the levels of
child restraint system use and misuse for children riding in passenger
vehicles, and to examine whether the levels of use and/or misuse are
related to any specific characteristics of the drivers, their
passengers and/or their vehicles. Previous studies have shown that
there is a gap between recommended child restraint use and observed
use. Actions have been taken by NHTSA to close the gap. In March 1999,
NHTSA published a final rule establishing a uniform child restraint
attachment system known as LATCH, Lower Anchors and Tethers for
Children (Federal Motor Vehicles Safety Standard 213, Child Restraint
Systems and FMVSS 225, Child Restraint Anchorage Systems), in order to
provide another, easier method of attaching a child restraint to the
vehicle. This new collection of data is necessary in order to evaluate
the effectiveness of FMVSS 225 and FMVSS 213, as well as to obtain an
up to date snapshot of child restraint use and misuse across the United
States. This information will be used in assessing what additional
actions NHTSA should take to improve child passenger safety. In
addition, NTHSA will publish the findings of this research study to
provide information to States, localities, and other interested
organizations in support of their efforts to reduce and prevent
injuries among child occupants.
    Description of the Likely Respondents (Including Estimated Number,
and Proposed Frequency of Response to the Collection of Information):
NHTSA anticipates conducting approximately 5,000 observations of
children in passenger vehicles and interviews with

the drivers of these vehicles. Data collection is expected to take
place over a 3-5 month period in the spring and summer of 2011. To
minimize the survey start-up cost and to provide a trained cadre of
data collectors, field data collection will be conducted through the
infrastructure of the National Automotive Sampling System (NASS)
Crashworthiness Data System (CDS). The NASS CDS consists of 24 Primary
Sampling Units (PSUs) that are a probability sample selected from a
sample frame of 1,195 PSUs across the United States. The NASS PSUs are
used to obtain a nationally representative probability sample of police
reported crashes in the U.S. Within each PSU, drivers will be
approached at specific types of locations where children are likely to
be riding in a passenger vehicle. Data collection sites may include gas
stations, fast food restaurants, shopping centers, hospitals/clinics,
and/or day care centers.
    Estimate of the Total Annual Reporting and Record Keeping Burden
Resulting from the Collection of Information: Each of the 5,000
interview/observation sessions will last 15 minutes including the
initial screening. Therefore, the estimated annual burden is 1,250
hours. The respondents would not incur any reporting cost from the
information collection. The respondents also would not incur any record
keeping burden or record keeping cost from the information collection.
Additionally, respondents would receive information on child passenger
safety and a list of inspection stations where they may choose to have
their child restraint system inspected. Consequently, the respondent is
potentially receiving benefit in return for his/her participation.

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2010-13857 Filed 6-8-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: January 20, 2010 (Volume 75, Number 12)]
[Rules and Regulations]
[Page 3153-3154]
[DOCID:fr20ja10-7]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 120 and 135

[Docket No. FAA-2008-0937; Amendment No. 120-0A, 135-117A]
RIN 2120-AJ37

Drug and Alcohol Testing Program; Correction

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; correction.

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

SUMMARY: The Federal Aviation Administration (FAA) is correcting its
drug and alcohol testing regulations published on May 14, 2009. The FAA
inadvertently excluded necessary wording within the text of two
separate definitions; added wording to the sections describing refusals
to submit to drug or alcohol tests; directed readers to an incorrect
subpart for a referenced definition; omitted a cross reference to a
list of applicable regulations; and added wording when describing an
operator. This rule corrects those inadvertent errors and includes
other minor editorial corrections. These corrections will not impose
any additional requirements on operators affected by these regulations.

DATES: Effective January 20, 2010.

FOR FURTHER INFORMATION CONTACT: Rafael Ramos, Office of Aerospace
Medicine, Drug Abatement Division, AAM-800, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On May 14, 2009, we published a final rule (74 FR 22649) that
amended the regulations governing FAA-required drug and alcohol testing
requirements. The final rule was necessary to gather all of the
existing drug and alcohol requirements into one part because the
regulations governing FAA-required drug and alcohol testing
requirements were scattered throughout Chapter I of Title 14, Code of
Federal Regulations. In that final rule in Sec.  120.7 we omitted the
words ``and alcohol'' from the definitions for ``DOT agency'' and
``Employer.'' In Sec. Sec.  120.13 and 120.15, we inadvertently
included the word ``authorization.'' In Sec. Sec.  120.17 and 120.33,
we used the term ``subpart'' instead of ``part'' when directing readers
to the definition of prohibited drugs. In Sec. Sec.  120.103 and
120.211, we omitted the reference to Sec.  135.1 from the list of
applicable regulations. In Sec.  120.117, we included the word
``sightseeing'' when describing an operator as defined in Sec.  91.147
and omitted mailing instructions for Sec.  91.147 operators. In Sec.
120.119, we made reference to appendix H of 49 CFR part 40 as subpart
H. In Sec.  120.225, we omitted mailing instructions for Sec.  91.147
operators. In the instruction for a change to 14 CFR part 135, we
incorrectly listed a cross-reference to Sec.  120.39 as Sec.  135.39.
This document corrects these errors.

List of Subjects

14 CFR Part 120

    Air carriers, Airmen, Alcohol testing, Aviation safety, Charter
flights, Commercial air tour operators, Drug testing, Operators,
Safety, Safety-sensitive, Transportation.

14 CFR Part 135

    Air taxis, Aircraft, Airmen, Alcohol abuse, Aviation safety, Drug
abuse, Drug testing.

0
Accordingly, Title 14 of the Code of Federal Regulations (CFR) parts
120 and 135 are amended as follows:

PART 120--DRUG AND ALCOHOL TESTING PROGRAM

0
1. The authority citation for part 120 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40101-40103, 40113, 40120, 41706,
41721, 44106, 44701, 44702, 44703, 44709, 44710, 44711, 45101-45105,
46105, 46306.

0
2. Revise paragraphs (g) and (i) of Sec.  120.7 to read as follows:

Sec.  120.7  Definitions.

* * * * *
    (g) DOT agency means an agency (or ``operating administration'') of
the United States Department of Transportation administering
regulations requiring drug and alcohol testing (14 CFR parts 61, 65,
121, and 135; 46 CFR part 16; 49 CFR parts 199, 219, and 382) in
accordance with 49 CFR part 40.
* * * * *
    (i) Employer is a part 119 certificate holder with authority to
operate under parts 121 and/or 135 of this chapter, an operator as
defined in Sec.  91.147 of this chapter, or an air traffic control
facility not operated by the FAA or by or under contract to the U.S.
Military. An employer may use a contract employee who is not included
under that employer's FAA-mandated drug and alcohol testing program to
perform a safety-sensitive function only if that contract employee is
included under the contractor's FAA-mandated drug and alcohol testing
program and is performing a safety-sensitive function on behalf of that
contractor (i.e., within the scope of employment with the contractor.)
* * * * *

0
3. Revise paragraphs (b)(1) and (2) of Sec.  120.13 to read as follows:

Sec.  120.13  Refusal to submit to a drug or alcohol test by a Part 63
certificate holder.

* * * * *
    (b) * * *
    (1) Denial of an application for any certificate or rating issued
under part 63 of this chapter for a period of up to 1 year after the
date of such refusal; and
    (2) Suspension or revocation of any certificate or rating issued
under part 63 of this chapter.

0
4. Revise paragraphs (b)(1) and (2) of Sec.  120.15 to read as follows:

Sec.  120.15  Refusal to submit to a drug or alcohol test by a Part 65
certificate holder.

* * * * *
    (b) * * *
    (1) Denial of an application for any certificate or rating issued
under part 65 of this chapter for a period of up to 1 year after the
date of such refusal; and
    (2) Suspension or revocation of any certificate or rating issued
under part 65 of this chapter.

0
5. Revise paragraph (b) of Sec.  120.17 to read as follows:

Sec.  120.17  Use of Prohibited drugs.

* * * * *
    (b) No employer may knowingly use any individual to perform, nor
may any individual perform for an employer, either directly or by
contract, any air traffic control function while that individual has a
prohibited drug, as defined in this part, in his or her system.
* * * * *

0
6. Revise paragraph (b) of Sec.  120.33 to read as follows:

Sec.  120.33  Use of prohibited drugs.

* * * * *
    (b) No certificate holder or operator may knowingly use any
individual to perform, nor may any individual perform for a certificate
holder or an operator, either directly or by contract, any function
listed in subpart E of this part while that individual has a prohibited
drug, as defined in this part, in his or her system.
* * * * *
0
7. Add paragraph (d)(2)(v) of Sec.  120.103 to read as follows:

Sec.  120.103  General.

* * * * *

    (d) * * *
    (2) * * *
    (v) Sec.  135.1--Applicability
* * * * *

0
8. Revise paragraphs (a)(2) and (e)(2) of Sec.  120.117 to read as
follows:

Sec.  120.117  Implementing a drug testing program.

    (a) * * *

------------------------------------------------------------------------
             If you are ...                        You must ...
------------------------------------------------------------------------

                              * * * * * * *
(2) An operator as defined in Sec.       Register with the FAA by
 91.147 of this chapter.                  contacting the Flight
                                          Standards District Office
                                          nearest to your principal
                                          place of business.

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

* * * * *
    (e) * * *
    (2) Send this information in the form and manner prescribed by the
Administrator, in duplicate to the appropriate address below:
    (i) For Sec.  91.147 operators: The Flight Standards District
Office nearest to your principal place of business.
    (ii) For all others: The Federal Aviation Administration, Office of
Aerospace Medicine, Drug Abatement Division (AAM-800), 800 Independence
Avenue, SW., Washington, DC 20591.
* * * * *

0
9. Revise paragraph (b) of Sec.  120.119 to read as follows:

Sec.  120.119  Annual reports.

* * * * *
    (b) As an employer, you must use the Management Information System
(MIS) form and instructions as required by 49 CFR part 40 (at 49 CFR
40.26 and appendix H to 49 CFR part 40). You may also use the
electronic version of the MIS form provided by DOT. The Administrator
may designate means (e.g., electronic program transmitted via the
Internet) other than hard-copy, for MIS form submission. For
information on where to submit MIS forms and for the electronic version
of the form, see: http://www.faa.gov/about/office_org/headquarters_
offices/avs/offices/aam/drug_alcohol.
* * * * *

0
10. Add paragraph (b)(5) to Sec.  120.211 to read as follows:

Sec.  120.211  Applicable Federal regulations.

* * * * *
    (b) * * *
    (5) Sec.  135.1--Applicability

0
11. Revise paragraph (e)(2) of Sec.  120.225 to read as follows:

Sec.  120.225  How to implement an alcohol testing program.

* * * * *
    (e) * * *
    (2) Send this information in the form and manner prescribed by the
Administrator, in duplicate to the appropriate address below:
    (i) For Sec.  91.147 operators: The Flight Standards District
Office nearest to your principal place of business.
    (ii) For all others: The Federal Aviation Administration, Office of
Aerospace Medicine, Drug Abatement Division (AAM-800), 800 Independence
Avenue, SW., Washington, DC 20591.
* * * * *

PART 135--OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT

0
12. The authority citation for part 135 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 41706, 40113, 44701-44702, 44705,
44709, 44711-44713, 44715-44717, 44722, 45101-45105.

0
13. Revise paragraph (a)(5) of Sec.  135.1 to read as follows:

Sec.  135.1  Applicability.

    (a) * * *
    (5) Nonstop Commercial Air Tour flights conducted for compensation
or hire in accordance with Sec.  119.1(e)(2) of this chapter that begin
and end at the same airport and are conducted within a 25-statute-mile
radius of that airport; provided further that these operations must
comply only with the drug and alcohol testing requirements in
Sec. Sec.  120.31, 120.33, 120.35, 120.37, and 120.39 of this chapter;
and with the provisions of part 136, subpart A, and Sec.  91.147 of
this chapter by September 11, 2007.
* * * * *

Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. 2010-908 Filed 1-19-10; 8:45 am]
BILLING CODE 4910-13-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on June 1, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17676

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 UNITED AIR LINES, INC. (UNITED), filed  4/29/04, for:

XX Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between (1) the terminal point Denver, Colorado, and the terminal point
Ixtapa/Zihuatanejo, Mexico; and (2) the terminal point Denver, Colorado,
and the terminal point San Jose del Cabo, Mexico.  United proposes to
serve the markets on a seasonal basis.

Applicant reps: Jeffrey Manley (United)<PHONE_NUMBER>  DOT Analyst:
Linda Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions and remarks, see below)

The above action was effective when taken:  _June 1, 2004,  through
_June 1, 2006  .

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 Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	XX   United’s certificates of public convenience and necessity

	XX   Standard Exemption Conditions (attached)

Conditions/Remarks:  The U.S.-Mexico exemption authority granted to
United is subject to the dormancy notice requirements set forth in
condition 7 of Appendix A of Order 88-10-2.  Consistent with our policy,
the dormancy notice period will begin on December 1, 2004, the
carrier’s proposed start-up date for the subject services.

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

				Appendix A

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.

										5/2004