Verner Liipfert Bernhard

McPherson and Hand, Chartered

901 15th Street, N.W., Suite 700

Washington, D.C.  20005

202-371-6030

	ShawPittman LLP

2300 N Street, N.W.

Washington, D.C.  20037

202-663-8060

November 30, 2001

Via electronic submission

Mr. Paul L. Gretch

Director, Office of International Aviation

U.S. Department of Transportation

400 Seventh Street, S.W., Room 6402

Washington, D.C.  20590

RE:	30-Day Notice of Delta Air Lines, Inc. ("Delta") and

Aerovias de Mexico, S.A. de C.V. ("Aeromexico")

(Intra-U.S. codesharing), Docket OST-97-3289

Dear Mr. Gretch:

Pursuant to Order 99-6-6, Delta and Aeromexico hereby notify the Department that, beginning on or about January 1, 2002, Delta will display Aeromexico's "AM" designator code on flights operated by Delta between Salt Lake City, on the one hand, and Kansas City and Missoula, on the other hand.

Respectfully submitted,

/s/							/s/

William C. Evans

Verner Liipfert Bernhard

McPherson and Hand, Chartered

901 15th Street, NW, Suite 700

Washington, D.C.  20005

202-371-6030

Robert E. Cohn

Alexander Van der Bellen

ShawPittman LLP

2300 N Street, NW

Washington, D.C.  20037

202-663-8060

Counsel for

Aerovias de Mexico, S.A. de C.V.

Counsel for

Delta Air Lines, Inc.

cc: Jonathan Echmalian

Footnote continued from previous page

Footnote continued on next page


Cymoxanil Notice of Filing:  IR-4 Pesticide Petitions 7E7282 and 7E7283

EPA Registration Division contact: Susan Stanton<PHONE_NUMBER>

EPA has received pesticide petitions (PP Nos. 7E7282 and 7E7283) from
the Interregional Research Project No. 4 (IR-4), 500 College Road East,
Suite 201 W., Princeton, New Jersey  98540, proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR Part 180.503 by establishing tolerances
for residues of the fungicide cymoxanil;
2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide, in or on the
raw agricultural commodities as follows:

PP 7E7282:  Leaf petioles, subgroup 4B at 6 parts per million (ppm)

PP 7E7283:  Leafy greens, subgroup 4A and Cilantro at 19 ppm; Bulb
vegetables group 3-07 at 1.1 ppm; and Caneberry subgroup 13-07A at 4.0
ppm.  The petition also proposes to remove existing tolerances of  4.0
ppm on Lettuce, head and Caneberry, which would be replaced by the
proposed subgroup tolerances on Leafy greens subgroup 4A and Caneberry
subgroup 13-07A.

EPA has determined that the petitions contain data or information
regarding the elements set forth in section 408 (d)(2) of the FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
petitions. Additional data may be needed before EPA rules on the
petitions.

A. Residue Chemistry

	1. Plant metabolism.

The plant metabolism of cymoxanil is adequately understood in three
diverse crops: potatoes, tomatoes, and lettuce. The results of these
plant metabolism studies indicate that cymoxanil degrades extensively to
primarily the amino acid glycine, with subsequent re-incorporation into
other naturally-occurring products, such as glucose.

	2. Analytical method.

An analytical enforcement method is available for determining these
plant residues by high performance level chromatography (HPLC) with
ultraviolet (UV) detection. The limit of quantitation allows monitoring
of crops with cymoxanil residues at or above the levels proposed in
these tolerances.  The LOQ is 0.05 ppm for cymoxanil.

	3. Magnitude of residues.

Leaf Lettuce

Magnitude of residue data were collected from field trials conducted in
California (region 10), Maryland (region 2) and Florida (region 3).
Residues of cymoxanil ranged from <0.05 to 14 ppm (no washing).

Celery

Magnitude of residue data were collected from field trials conducted in
California (region 10), Florida (region 3) and Michigan (region 5).
Data was also collected from field trials conducted in Canada (Ontario
and Quebec, region 5).  Residues of cymoxanil ranged from <0.05 to 2.5
ppm (no washing or trimming).

Spinach

Magnitude of residue data were collected from field trials conducted in
California (region 10), Colorado (region 9), New York (region 1), New
Jersey (region 2) and Texas (region 6).  Residues of cymoxanil ranged
from 1.3 to 13.5 ppm (unwashed).

Dry bulb onion

Magnitude of residue data were collected from field trials conducted in
New York (region 1), Texas (region 6), Colorado (region 9) and
Washington (region 11).  Residues of cymoxanil were <0.05 ppm.

Green onion

Magnitude of residue data were collected from field trials conducted in
California (region 10), New Jersey (region 2), Wisconsin (region 5),
Texas (region 6), Idaho (region 11) and Oregon (region 12).  Residues of
cymoxanil ranged from <0.05 to 0.43 ppm.

B. Toxicological Profile

	1. Acute toxicity.

A battery of acute toxicity tests on technical cymoxanil places it in
the following Toxicity Categories:

Oral LD50		Rat			285-960 mg/kg	Category II-III

Dermal LD50		Rabbit			>2000 mg/kg		Category III

Inhalation LC50	Rat			>5.06 mg/L		Category IV

Eye irritation		Rabbit			Mild-slight irritant	Category III-IV

Dermal irritation	Rabbit			Slight irritant		Category IV

Dermal sensitization	Guinea Pig		Not a sensitizer

An acute neurotoxicity study was not required with cymoxanil.  No acute
neurotoxicity has been observed in short-term or subchronic studies
(including repeated dose neurotoxicity studies).

	2. Genotoxicty.

Cymoxanil was tested in a battery of assays to evaluate genotoxicity and
chromosome aberrations with the following results.  Based on the
weight-of-evidence, cymoxanil is not considered to be genotoxic or
clastogenic.

Bacterial gene mutation           			Salmonella typhimurium    	Negative

Mammalian gene mutation in vitro  		CHO/HGPRT           		Negative

Mammalian chromosome aberrations in vitro		CHO
Positive

Mammalian chromosome aberrations in vivo 		Mouse micronucleus
Negative

Unscheduled DNA synthesis in vitro     		Primary rat hepatocytes
Positive

Unscheduled DNA synthesis in vivo     		Primary rat hepatocytes
Negative

                             				and Spermatocytes

	3. Reproductive and developmental toxicity.

In a 2-generation cymoxanil rat reproduction study, the NOAEL for both
parents and offspring was approximately 7 mg/kg/day, based on decreased
body weight, weight gain and food consumption in adults and decreased
offspring neonatal viability or weight at 32 mg/kg/day or greater.
There were no reproductive or fertility effects at any dietary level.

In developmental studies, EPA has selected a maternal NOAEL of 25
mg/kg/day in rats and a developmental NOAEL of 10 mg/kg/day.  In
rabbits, EPA has selected a maternal NOAEL of 32 mg/kg/day and a
developmental NOAEL of 4 mg/kg/day.  In both species the developmental
effects included delayed ossifications or skeletal variations.

In a developmental neurotoxicity study, the maternal and offspring
NOAELs were both 50 mg/kg/day based on body weight effects at 100
mg/kg/day.

	4. Subchronic toxicity.

Subchronic (90-day) feeding studies were conducted with rats, mice, and
dogs.  In addition, the following subchronic feeding studies were
conducted: A 90-day in rats to evaluate neurotoxicity and 28-day feeding
studies in rats and mice to evaluate immunotoxicity.   A 28-day dermal
study was also conducted in rats.

In a subchronic toxicity/neurotoxicity study in rats with cymoxanil, the
NOAEL was 47.6 mg/kg/day in males and 59.9 mg/kg/day in females  based
on the following changes at higher concentrations: decreased body
weights in both sexes,  decreased food efficiency in females, and
minimal to mild testicular and epididymal changes in males.  In a
concurrent 90-day rat neurotoxicity study, there was no evidence of
neurotoxicity at any level.  The neurotoxicity NOAEL was 3000 ppm (224
mg/kg/day), the highest dose tested.

The subchronic NOAEL for male mice administered cymoxanil was 8.25
mg/kg/day based on body weight and weight gain effects at 82.4 mg/kg/day
and above.  The NOAEL for females was 121 mg/kg/day based on increases
in spleen and liver weights at 433 mg/kg/day and above.

In a subchronic study in dogs, the LOEL was 3 mg/kg/day based on
decreased body weight and food consumption in females.  Although, a NOEL
was not established in the dog subchronic study, 3 mg/kg/day was found
to be a NOAEL in a subsequent chronic study in dogs.

Subchronic 28-day studies were conducted in rats and mice to evaluate
the immunotoxicity potential of cymoxanil.   Cymoxanil was not
immunotoxic up to and including the highest dose tested which was 1,600
ppm in rats (108 and 117 mg/kg/day in males and females, respectively),
1,200 ppm (218 mg/kg/day) in male mice, and 2,400 ppm (552 mg/kg/day) in
female mice.

In a 28-day dermal study in rats there were no effects at any dose
tested. The 28-day dermal NOAEL was 1,000 mg/kg/day, the highest dose
tested.

	5. Chronic toxicity.

Chronic studies with cymoxanil were conducted on rats, mice, and dogs to
determine oncogenic potential and/or chronic toxicity of the compound.
Effects generally similar to those observed in the 90-day studies were
seen in the chronic studies.

Cymoxanil was not oncogenic in lifetime feeding studies in rats and
mice.  The chronic NOAEL for cymoxanil in rats was 4.1 mg/kg/day in
males and 5.4 mg/kg/day in females based on body weight and nutritional
changes and non-neoplastic lesions in several organs (lungs, liver,
tested, eye, sciatic nerve) at higher dietary concentrations.   In mice,
the chronic NOAELs for cymoxanil were 4.2 and 5.8 mg/kg/day for males
and females, respectively, based on changes in organ weights,
gastrointestinal effects in females and liver, testes, and epididymal
effects in males at the LOAEL.  There was no evidence of
carcinogenicity.

The chronic NOAEL for dogs was 3.0 mg/kg/day in males based on  body
weight gain and hematology changes at 5.7 mg/kg/day, and 3.1 mg/kg/day
in females, the highest dose tested.

	6. Animal metabolism.

When administered by gavage to rats, cymoxanil was readily absorbed and
eliminated. Absorption reached maximum concentrations in whole blood
within 4 hours post-dosing.  A rapid and almost complete elimination was
observed in the urine and feces. The majority of radioactivity was
recovered within 96 hours, mainly in urine but also in feces.
Radioactivity in the tissues and carcass was less than 1%.  In the urine
and feces, the majority of the radioactivity was free and/or conjugated
glycine. 2-Cyano-2-methoxyimino-acetic acid was also found in low levels
in the urine and trace levels in the feces. Intact cymoxanil was less
than 1% in feces and not detected in the urine. The metabolite profile
in urine and feces was similar between sexes, among dose groups, and
between dosing regimens (single vs. multiple).

	7. Metabolite toxicology.

There are no metabolites of toxicological significance to mammals.

	8. Endocrine disruption.

Chronic, lifespan, and multi-generational bioassays in mammals and acute
and subchronic studies on aquatic organisms and wildlife did not reveal
endocrine effects. Any endocrine-related effects would have been
detected in this definitive array of required tests. The probability of
any such effect due to agricultural uses of cymoxanil is negligible.

C. Aggregate Exposure

Cymoxanil has tolerances established in the United States on cucurbits,
head lettuce, hops, peppers, potatoes, tomatoes, grapes, and
caneberries.  This tolerance petition proposes the following new uses in
the United States: bulb vegetables, leafy greens and cilantro leaves,
leaf petiole crop groups. There are no residential uses.

	1. Dietary exposure.

The chronic dietary RfD of 0.04 mg/kg/day is based on a NOAEL of 4.1
mg/kg/day from the two-year rat feeding study and an uncertainty factor
of 100.  EPA selected an acute dietary RfD of 0.04 mg/kg for females
13-50 based on a NOAEL of 4.0 mg/kg/day in a rabbit developmental study.

	i. Food.

Chronic Dietary Exposure Assessment

Chronic dietary cymoxanil exposure risk resulting from the proposed use
of cymoxanil on bulb vegetables, leafy greens including cilantro leaves,
and leaf petiole vegetables, as well as on cucurbits, fruiting
vegetables, potatoes, grapes, hops, and caneberries was estimated using
the Dietary Exposure Evaluation Model with the Food Commodity Intake
Database (DEEM-FCIDTM, Exponent, Inc., Version 2.16). The analysis
employed overall-mean field-trial values and employed crop treated
percentages based on 5-year annual averages for currently labeled crops
and projections of the 5-year annual averages for proposed crops.  For
the general U.S. population and all subpopulations <1% of the chronic
RfD was used.  This chronic dietary risk estimate for cymoxanil shows
that an adequate margin of safety exists for all population subgroups
and that no effects would result from dietary exposure to cymoxanil.

Acute Dietary Exposure

The Tier 3 acute dietary exposure analysis resulting from the proposed
use of cymoxanil on bulb vegetables, leafy greens including cilantro
leaves, and leaf petiole vegetables as well as on cucurbits, fruiting
vegetables, head lettuce, potatoes, grapes, hops, and caneberries was
conducted with the acute module of the DEEM-FCIDTM software.  The acute
dietary analysis used field trial residue data in a probabilistic
assessment, which also employed processing factors and 5-year maximum
annual percent crop treated values.

The acute exposure analysis demonstrates that an adequate margin of
safety exists for the only population group of interest, adult females.
(An aRfD was not established for other populations since an effect
attributable to a single exposure was not observed in the oral toxicity
studies.) The results of the acute dietary exposure analysis for
cymoxanil indicate that the predicted exposure to the only relevant
population group, females 13-49 years, is 0.001776 mg/kg/day, 4% of the
aRfD at the 99.9th percentile.  Cymoxanil clearly meets the Food Quality
Protection Act (FQPA) standard of reasonable certainty of no harm.

	ii. Drinking Food.

Surface water exposure was estimated using the EXPRESS v.<IP_ADDRESS>
(PRZM-EXAMS) model.  Ground water exposure was estimated using SCI-GROW
v 2.3.  These are screening level models used for determining upper
bound concentrations of pesticides in surface water and ground water.
Results indicate that a reasonable certainty exists that cymoxanil
residues in drinking water will not contribute significantly to the
acute and chronic human risk.

The predicted chronic concentration for cymoxanil under worst-case
conditions was 0.00102 parts per billion (ppb) in ground water and 0.04
ppb in surface water.  When the higher surface water concentration was
included in the dietary risk assessment, there was little change from
the food-only chronic risk assessment; for the general U.S. population
and all population subgroups <1% of the cRfD was used, indicating a
significant margin of safety.

The predicted acute concentration for cymoxanil under worst-case
conditions was 0.00102 parts per billion (ppb) in ground water and 3.5
ppb in surface water.  When the higher surface water concentration was
included in the dietary risk assessment, there was little change from
the food-only acute risk assessment; the predicted exposure at the
99.9th percentile for the only relevant population, females (13-49
years), was 0.001933 mg/kg/day, 5% of the aRfD.  Since the % aRfD for
the only relevant population group is well below 100%, the acute dietary
safety of cymoxanil, including the contribution of drinking water,
clearly meets the standard of reasonable certainty of no harm.

	2. Non-dietary exposure.

Cymoxanil products are not labeled for residential non-food uses,
thereby eliminating the potential for residential exposure.
Non-occupational, non-dietary exposure for cymoxanil has not been
estimated because the proposed products are limited to commercial crop
production. Therefore, the potential for non-occupational exposure is
insignificant.

D. Cumulative Effects

 EPA's consideration of a common mechanism of toxicity is not necessary
at this time because there is no indication that toxic effects of
cymoxanil should be cumulative with those of any other chemical
compounds or with each other. Cymoxanil is a unique cyanoacetamide and
is chemically unrelated to any other commercial plant disease control
agent. Its biochemical mode of action on fungi appears to be unique; it
is theorized to act through inhibition of multiple cellular processes,
but a definitive mechanism has not been completely elucidated.
Similarly, the mechanism of action underlying observed toxicological
effects in mammals is not fully characterized and there is no reliable
information to suggest that cymoxanil has a mechanism of toxicity in
common with any other compound.

Given the distinct chemical and toxicological profile of cymoxanil, its
low acute toxicity, absence of genotoxic, oncogenic, developmental, or
reproductive effects, and low exposure potential, the expression of
cumulative human health effects with any other natural or synthetic
pesticide is not anticipated.

E. Safety Determination

	1. U.S. population.

Based on the completeness and reliability of the toxicity data and the
conservative exposure assessments, there is reasonable certainty that no
harm will result from the aggregate exposure of residues of cymoxanil.
No additional safety factors are warranted.

	2. Infants and children.

Based on the completeness and reliability of the toxicity data base, the
lack of toxicological endpoints of special concern, the lack of any
indication that children are more sensitive than adults to cymoxanil,
and the conservative exposure assessment, there is a reasonable
certainty that no harm will result to infants and children from the
aggregate exposure of residues of cymoxanil, including all anticipated
dietary exposure and all other non-occupational exposures. Accordingly,
there is no need to apply an additional safety factor for infants and
children.

F. International Tolerances

 To date, no international tolerances exist for cymoxanil.


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31605-31606]
[FR Doc No: 2022-11082]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release of Land Affecting Federal Grant Assurance
Obligations at Pinal Airpark, Marana, Pinal County, Arizona

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of request to release airport obligations.

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

SUMMARY: The Federal Aviation Administration (FAA) is considering a
proposal and invites public comment to change a portion of the airport
from aeronautical to non-aeronautical use at the Pinal Airpark (MZJ),
Marana, Pinal County, Arizona. The proposal consists of approximately
477.53 acres more or less of airport land, located on airport property,
east and north of Pinal Airpark Rd.

DATES: Comments must be received on or before June 23, 2022.

ADDRESSES: Comments on the request may be mailed or delivered to the
FAA at the following address: Mr. Mike N. Williams, Manager, Phoenix
Airports District Office, Federal Aviation Administration, 3800 N
Central Ave., Suite 1025, 10th Floor, Phoenix, Arizona 85012. In
addition, one copy of the comment submitted to the FAA must be mailed
or delivered to Mr. Jim Petty, Airport Economic Development Director,
Pinal Airpark, 31 N Pinal St., Building A, Florence, AZ 85132.

SUPPLEMENTARY INFORMATION: The land was originally acquired by Pinal
County through Reorganization Plan One of 1947, and the Surplus
Property Act of 1944, by the War Assets Administrator, on June 17,
1948. The land will be released from aeronautical obligations for a
future non-aeronautical use. Such use of the land represents a
compatible land use that will not interfere with the airport or its
operation, thereby protecting the interests of civil aviation. The
airport will be compensated for the fair market value of the use of the
land.

    In accordance with the Wendell H. Ford Aviation Investment and
Reform Act for the 21st Century (AIR 21), Public Law 106-181 (Apr. 5,
2000; 114 Stat. 75), this notice must be published in the Federal
Register 30 days before the DOT Secretary may waive any condition
imposed on a federally obligated airport by surplus property conveyance
deeds or grant agreements.

    Issued in El Segundo, California, on May 18, 2022.
Brian Q. Armstrong,
Manager, Safety and Standards Branch, Airports Division, Western-
Pacific Region.
[FR Doc. 2022-11082 Filed 5-23-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88398-88401]
[FR Doc No: 2023-28093]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4201]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Examination of Implied Claims in Direct-to-Consumer
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Examination of Implied
Claims in Direct-to-Consumer Prescription Drug Promotion.''

DATES: Either electronic or written comments on the collection of
information must be submitted by February 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 20, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-4201 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Examination of Implied Claims in
Direct-to-Consumer Prescription Drug Promotion.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected]. The draft survey instrument is available upon
request from [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Examination of Implied Claims in Direct-to-Consumer Prescription Drug
Promotion

OMB Control Number 0910-NEW

I. Background
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotion is truthful, balanced, and accurately communicated, so
that patients and healthcare providers can make informed decisions
about treatment options. OPDP's research program provides scientific
evidence to help ensure that our policies related to prescription drug
promotion will have the greatest benefit to public health. Toward that
end, we have consistently conducted research to evaluate the aspects of
prescription drug promotion that are most central to our mission,
focusing in particular on three main topic areas: advertising features,
including content and format; target populations; and research quality.
Through the evaluation of advertising features, we assess how elements
such as graphics, format, and the characteristics of the disease and
product impact the communication and understanding of prescription drug
risks and benefits. Focusing on target populations allows us to
evaluate how understanding of prescription drug risks and benefits may
vary as a function of audience. Our focus on research quality aims at
maximizing the quality of our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform the first topic area, advertising
features.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved through the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our homepage at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
    Direct-to-consumer (DTC) prescription drug promotion may include
truthful and non-misleading claims about the product. A particular
claim may be direct (explicit) or indirect (implied or implicit). Some
prior

research has shown that implied claims are misremembered as explicit
claims (Ref. 1). Other research has shown that claims can result in a
misleading impression of the product through implication, rather than
literal interpretation (Ref. 2). Understanding how consumers who self-
report having been diagnosed with a target condition interpret implied
claims in DTC prescription drug promotion--and how their perceptions
differ from those of consumers who have not been diagnosed with the
target condition--will provide valuable insight into the relevance and
impact of various product attributes and promotional claims on
treatment decisions.
    The current project will test the impact of several implied claims
in DTC prescription drug advertising on consumer perceptions. The
project has two phases: experimental and conjoint analysis. In the
experimental phase, participants will view one version of a DTC
television ad containing both explicit and one of four implicit product
claims of interest or a control ad containing only explicit claims, and
be asked their impressions of the product's risks, benefits, and other
attributes. In the conjoint analysis phase, we will conduct a best-
worst scaling (BWS) experiment to elicit the relative importance of
various characteristics of immunotherapies indicated to treat patients
with advanced melanoma, including several implied claims. For this
study, we will use an object case design, which does not require us to
manipulate different levels of the characteristics included in the
design. Participants will be shown a series of choice tasks that are
each made up of different subsets of an experiment-wide list of
characteristics. Each participant will complete several tasks, and will
be asked to first select which one they would care about the most if
they were considering an immunotherapy, followed by the characteristic
they would care about the least.
    We are proposing to include 13 characteristics in our BWS
experiment. Each task will include only four of those characteristics,
the combination of which will be drawn from a balanced incomplete block
design (BIBD; see Ref. 3). A BIBD ensures that (1) each task contains
the same number of characteristics; (2) each characteristic occurs the
same number of times across tasks; and (3) each pair of characteristics
is shown to participants the same number of times over the entire
experiment. These three properties are desirable for meeting estimation
assumptions (e.g., balance and orthogonality). An additional (and
unique) favorable property of including 13 characteristics in the
experiment is that BIBDs exist that yield 13 tasks with 4
characteristics per task. Thirteen is a manageable number of tasks for
a single participant to complete, and as a result, the full
experimental design will be replicated by each participant.
    We estimate that participation in the study will take approximately
20 minutes. Adult voluntary participants aged 18 years or older will be
recruited by email through an internet panel, and participant
eligibility will be determined with a screener at the beginning of the
online survey. We will exclude individuals who work in healthcare
settings, employees of the Department of Health and Human Services, or
individuals who work in the marketing, advertising, or pharmaceutical
industries. Half the sample will consist of individuals who self-
identify as cancer survivors, excluding survivors of certain
nonmelanoma skin cancers.
    The target sample size for the experimental phase is 1,030 adults
and the target sample size for the conjoint analysis phase is 800
adults. Prior to conducting the main study for both the experimental
phase and conjoint analysis phase, we will conduct at least one wave of
pretests for each study phase: one before the experimental phase and
one before the conjoint analysis phase. If the first pretest wave
reveals that changes to the measurement instruments, stimuli, or
procedures are required, a second pretest wave (for either the
experimental phase, conjoint phase, or both) will be conducted with
revised materials. The target sample size for each wave of pretests is
120 adults, split evenly between the experimental and conjoint analysis
phases.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                    Activity                        Number of     responses per   Total annual       Average burden per response \2\        Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experimental phase Pretest 1 Screener \3\......             132               1             132  0.08 (5 minutes).......................              11
Experimental Phase Pretest 1...................              66               1              66  0.33 (20 minutes)......................              22
Conjoint Analysis Phase Pretest 1 Screener \3\.             132               1             132  0.08 (5 minutes).......................              11
Conjoint Analysis Phase Pretest 1..............              66               1              66  0.33 (20 minutes)......................              22
Experimental Phase Pretest 2 Screener 3 4......             132               1             132  0.08 (5 minutes).......................              11
Experimental Phase Pretest 2 \4\...............              66               1              66  0.33 (20 minutes)......................              22
Conjoint Analysis Phase Pretest 2 Screener 3 4.             132               1             132  0.08 (5 minutes).......................              11
Conjoint Analysis Phase Pretest 2 \4\..........              66               1              66  0.33 (20 minutes)......................              22
Experimental Phase Screener \3\................           2,266               1           2,266  0.08 (5 minutes).......................             181
Experimental Phase Main Study..................           1,133               1           1,133  0.33 (20 minutes)......................             374
Conjoint Analysis Phase Screener \3\...........           1,760               1           1,760  0.08 (5 minutes).......................             141
Conjoint Analysis Phase Main Study.............             880               1             880  0.33 (20 minutes)......................             290
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............           6,831  .......................................           1,118
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\3\ Number of screener respondents assumes a 50 percent eligibility rate with targeted recruitment.
\4\ Pretest 2 will be conducted only if changes to study materials for the respective study phase are made in response to the findings of Pretest 1 for
  that phase.

    As with most online and mail surveys, it is always possible that
some participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage for

samples in the pretest and main study of the experimental phase and
conjoint analysis phase.

II. References

    The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Harris, R.J., M.L. Trusty, J.I. Bechtold, et al. ``Memory for
Implied Versus Directly Stated Advertising Claims,'' Psychology &
Marketing, vol. 6, issue 2, pp. 87-96, 1989, https://doi.org/10.1002/mar.4220060202.
2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et al. ``Deception By
Implication: An Experimental Investigation,'' Journal of Consumer
Research, vol. 14, issue 4, pp. 483-494, 1988, https://doi.org/10.1086/209130.
3. Louviere, J.J., T.N. Flynn, and A.A.J. Marley, Best-Worst
Scaling: Theory, Methods, and Applications. Cambridge: Cambridge
University Press, 2015.

    Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28093 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P


North Carolina Recommendation for Randolph County The purpose of this paper is to discuss the rationale for recommending the area north of Highway 64 and the Asheboro municipal boundary, rather than the entire county, as nonattainment for the 8 hour ozone standard.

  The 8 hour ozone problem for Randolph County is marginal with a design value of 0.088 ppm from 2000 2002 and 0.085 ppm from 2001 2003.   Based on the 2000 census, the population in the recommended area is about 91,134 and the total population in Randolph County is 130,454. Also, North Carolina believes that this boundary captures the area from which the roughly 7.5% commuters to Guilford County drive each day to work.   The population density in the remaining portion of Randolph County is very low, with 2 large tracts with 0 50 people per square mile and one large tract with 50 100 people per square mile.   Regarding the meteorology, the winds are climatologically from the southwest. On the days when the monitor exceeds the 8 hour standard, it appears to be measuring the urban plume or pollution from the Greensboro/ Winston Salem/ High Point and Charlotte areas. Therefore, as the pollution in the Greensboro/ Winston Salem/ High Point and Charlotte areas are reduced, the monitor should observe lower ozone levels.   The majority of the NOx emissions are from mobile and nonroad sources. Of the total 25.04 tons per day from NOx, 17.96 tons per day are from mobile and 6.44 tons per day are from nonroad. Point sources contribute only 0.05 tons per day of NOx. Federal and State control programs, such as low sulfur gasoline being required statewide, will address these NOx emissions from mobile and nonroad sources. The I/ M program will be implemented in Randolph County by January 2004.   In conclusion, based on the information presented above, North Carolina continues to believe this is an appropriate boundary for this region. North Carolina expects this area to attain by 2007 with a projected design value of 0.073 ppm.


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80354-80355]
[FR Doc No: 2015-32402]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP14-554-000; CP15-16-000; CP15-17-000]

Florida Southeast Connection, LLC; Transcontinental Gas Pipe Line
Company, LLC; Sabal Trail Transmission, LLC; Notice of Availability of
the Final Environmental Impact Statement for the Proposed Southeast
Market Pipelines Project

    The staff of the Federal Energy Regulatory Commission (FERC or

Commission) has prepared a final environmental impact statement (EIS)
for the Hillabee Expansion, Sabal Trail, and Florida Southeast
Connection (FSC) Projects as proposed by Transcontinental Gas Pipe Line
Company, LLC (Transco), Sabal Trail Transmission, LLC (Sabal Trail),
and Florida Southeast Connection, LLC (FSC), respectively, in the
above-referenced dockets. These are separate, but connected, natural
gas transmission pipeline projects collectively referred to as the
Southeast Market Pipelines (SMP) Project. The applicants request
authorization to construct and operate a total of about 686.0 miles of
natural gas transmission pipeline and associated facilities, six new
natural gas-fired compressor stations, and modify existing compressor
stations in Alabama, Georgia, and Florida. The SMP Project would
provide about 1.1 billion cubic feet per day of natural gas to meet
growing demands by the electric generation, distribution, and end use
markets in Florida and the southeast United States.
    The final EIS assesses the potential environmental effects of the
construction and operation of the SMP Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the SMP Project would have some
adverse environmental impacts; however, these impacts would be reduced
to less-than-significant levels with the implementation of the
applicants' proposed mitigation and the additional measures recommended
in the final EIS.
    The U.S. Army Corps of Engineers (USACE) participated as a
cooperating agency in the preparation of the final EIS. The USACE has
jurisdiction by law or special expertise with respect to resources
potentially affected by the proposals and participate in the NEPA
analysis. The USACE may adopt and use the EIS as it has jurisdictional
authority pursuant to section 404 of the Clean Water Act, which governs
the discharge of dredged or fill material into waters of the United
States; section 10 of the Rivers and Harbors Act, which regulates any
work or structures that potentially affect the navigable capacity of
navigable waters of the United States; and section 14 of the Rivers and
Harbors Act which regulates the temporary occupation of water-related
structures constructed by the United States. Although the cooperating
agency provides input to the conclusions and recommendations presented
in the final EIS, the agency will present its own conclusions and
recommendations in its Record of Decision for the project.
    The final EIS of the SMP Project addresses the potential
environmental effects of the construction and operation of the
following project facilities:
    The Hillabee Expansion Project would include:
     Approximately 43.5 miles of new 42- and 48-inch-diameter
natural gas pipeline loop \1\ in Alabama;
---------------------------------------------------------------------------

    \1\ A loop is a segment of pipe that is installed adjacent to an
existing pipeline and connected to it at both ends. A loop generally
allows more gas to move through the system.
---------------------------------------------------------------------------

     one new compressor station in Choctaw County, Alabama and
modifications to three existing compressor stations in Dallas, Chilton,
and Coosa Counties, Alabama; and
     installation of pig \2\ launchers/receivers and mainline
valves (MLVs).
---------------------------------------------------------------------------

    \2\ A pig is an internal tool that can be used to clean and dry
a pipeline and/or to inspect it for damage or corrosion.
---------------------------------------------------------------------------

    The Sabal Trail Project would include:
     approximately 516.2 miles of new natural gas pipeline in
Alabama, Georgia, and Florida, including:
    [cir] 481.6 miles of 36-inch-diameter mainline pipeline in Alabama,
Georgia, and Florida;
    [cir] the 21.5-mile-long, 24-inch-diameter Citrus County Line in
Florida; and
    [cir] the 13.1-mile-long, 36-inch-diameter Hunters Creek Line in
Florida;
     five new compressor stations in Tallapoosa County,
Alabama; Dougherty County, Georgia; and Suwannee, Marion, and Osceola
Counties, Florida;
     subsequent modifications to two of the new compressor
stations in Dougherty County, Georgia and Suwannee County, Florida; and
     installation of pig launchers/receivers, MLVs, and meter
and regulating stations.
    The FSC Project would include:
     approximately 126.3 miles of new 30- and 36-inch-diameter
natural gas pipeline in Florida; and
     installation of pig launchers/receivers, MLVs, and meter
and regulating stations.
    The FERC staff mailed copies of the final EIS to federal, state,
and local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding. Paper copy versions of the final EIS were mailed to
those specifically requesting them; all others received a CD version.
In addition, the final EIS is available for public viewing on the
FERC's Web site (www.ferc.gov) using the eLibrary link. A limited
number of copies are available for distribution and public inspection
at: Federal Energy Regulatory Commission, Public Reference Room, 888
First Street NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Additional information about the SMP Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP14-
554, CP15-16, and CP15-17). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>; for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 18, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-32402 Filed 12-23-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Rules and Regulations]
[Pages 64441-64443]
[FR Doc No: 2018-26621]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0805; Product Identifier 2018-NM-103-AD; Amendment
39-19527; AD 2018-25-16]
RIN 2120-AA64

Airworthiness Directives; Airbus Defense and Space S.A. (Formerly
Known as Construcciones Aeronauticas, S.A.) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Defense and Space S.A. Model CN-235, CN-235-200 and CN-235-300
airplanes. This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. This AD requires
revising the maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective January 22, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 22,
2019.

ADDRESSES: For service information identified in this final rule,
contact Airbus Defense and Space, Services/Engineering Support, Avenida
de Arag[oacute]n 404, 28022 Madrid, Spain; telephone +34 91 585 55 84;
fax +34 91 585 31 27; email<EMAIL_ADDRESS>You may
view this service information at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0805.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0805; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus Defense and
Space S.A. Model CN-235, CN-235-200 and CN-235-300 airplanes. The NPRM
published in the Federal Register on October 9, 2018 (83 FR 50539). The
NPRM was prompted by a determination that new or more restrictive
airworthiness limitations are necessary. The NPRM proposed to require
revising the maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations.
    We are issuing this AD to address fatigue cracking, damage, and
corrosion in principal structural elements; such fatigue cracking,
damage, and corrosion could result in reduced structural integrity of
the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0134, dated June 25, 2018 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Airbus Defense and Space S.A. Model CN-
235, CN-235-200, and CN-235-300 airplanes. The MCAI states:

    The airworthiness limitations and/or certification maintenance
instructions for the EADS-CASA CN-235 aeroplanes, which are approved
by EASA, are currently defined and published in the Airbus D&S CN-
235 ALL [Airworthiness Limitations List] DT-86-3001 document. These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition [i.e., fatigue cracking, damage, and corrosion in
principal structural elements, which could result in reduced
structural integrity of the airplane].
    For the reason described above, this [EASA] AD requires
accomplishment of the actions specified in the ALL.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0805.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We received no comments on the NPRM or on the
determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this final rule as proposed,
except for minor editorial changes. We have determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Airbus Defence and Space has issued Technical Document DT-86-3001,
CN-235 Airworthiness Limitations List, Issue R, dated March 20, 2018.
This service information describes airworthiness limitations for
airplane systems, structural inspections, safe life structural items,
and safe life system items.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 9 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we

have determined that a per-operator estimate is more accurate than a
per-airplane estimate. Therefore, we estimate the total cost per
operator to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-25-16 Airbus Defense and Space S.A. (Formerly Known as
Construcciones Aeronauticas, S.A.): Amendment 39-19527; Docket No.
FAA-2018-0805; Product Identifier 2018-NM-103-AD.

(a) Effective Date

    This AD is effective January 22, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Defense and Space S.A. (formerly known
as Construcciones Aeronauticas, S.A.) Model CN-235, CN-235-200, and
CN-235-300 airplanes, all manufacturer serial numbers, certificated
in any category, with an original certificate of airworthiness or
original export certificate of airworthiness issued on or before
March 20, 2018. This AD does not apply to Model CN-235-300 airplanes
in a Maritime Patrol (SM01) configuration.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. We are issuing
this AD to address fatigue cracking, damage, and corrosion in
principal structural elements; such fatigue cracking, damage, and
corrosion could result in reduced structural integrity of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
information specified in Airbus Defence and Space Technical Document
DT-86-3001, CN-235 Airworthiness Limitations List, Issue R, dated
March 20, 2018. The initial compliance times for doing the tasks are
at the applicable times specified in Airbus Defence and Space
Technical Document DT-86-3001, CN-235 Airworthiness Limitations
List, Issue R, dated March 20, 2018, or within 90 days after the
effective date of this AD, whichever occurs later.

(h) No Alternative Actions or Intervals

    After accomplishment of the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections) or intervals,
may be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus Defense and Space S.A.'s EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0134, dated June 25, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0805.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this

paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Defence and Space Technical Document DT-86-3001, CN-
235 Airworthiness Limitations List, Issue R, dated March 20, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Airbus Defense and Space, Services/Engineering Support, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone: +34 91 585 55 84;
fax: +34 91 585 31 27; email<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on November 29, 2018.
James Cashdollar,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-26621 Filed 12-14-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Rules and Regulations]
[Pages 58342-58344]
[FR Doc No: 2015-24464]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-2775; Directorate Identifier 2015-CE-021-AD;
Amendment 39-18277; AD 2015-19-15]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for PILATUS
AIRCRAFT LTD. Models PC-12, PC-12/45, and PC-12/47E airplanes. This AD
results from mandatory continuing airworthiness information (MCAI)
issued by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as a malfunction of the universal joint. We are
issuing this AD to require actions to address the unsafe condition on
these products.

DATES: This AD is effective November 3, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of November 3,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
2775; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact PILATUS
AIRCRAFT LTD, Customer Support Manager, CH-6371 STANS, Switzerland;
phone: +41 (0)41 619 33 33; fax: +41 (0)41 619 73 11; email:
<EMAIL_ADDRESS>Internet: http://www.pilatus-
aircraft.com. You may view this referenced service information at the
FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2015-2775.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to adding an AD that would apply to PILATUS AIRCRAFT LTD. Model
PC-12, PC-12/45, and PC-12/47E airplanes. The NPRM was published in the
Federal Register on July 14, 2015 (80 FR 40949). The NPRM proposed to
correct an unsafe condition for the specified products and was based on
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country. The MCAI states:

    A case of malfunctioning was reported of a universal joint
installed between the control tube assembly and the control column
on a PC-12/47E aeroplane.
    Investigation determined that the malfunction was caused by an
incorrectly manufactured universal joint. Universal joints from the
same manufacturing batch were provided to operators between 01 March
2014 and 28 February 2015, and are thus potentially affected.
    This condition, if not corrected, could lead to other cases of
malfunctioning of a universal joint, possibly resulting in reduced
control of the aeroplane.
    To address this potential unsafe condition, Pilatus Aircraft
Ltd. issued Service Bulletin (SB) No. 27-022 to provide instructions
for replacement of the universal joints in the flight controls.

    For the reason described above, this AD requires removal from
service of the potentially incorrectly manufactured universal joints.
The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-2775-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 40949, July 14,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 40949, July 14, 2015) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already

proposed in the NPRM (80 FR 40949, July 14, 2015).

Related Service Information Under 1 CFR Part 51

    We reviewed PILATUS AIRCRAFT LTD. PILATUS PC-12 Service Bulletin
No: 27-022, dated March 17, 2015. The service information describes
procedures for replacement of the universal joint on the aileron
control system. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section
of the AD.

Costs of Compliance

    We estimate that this AD will affect 55 products of U.S. registry.
We also estimate that it would take about 3 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts would cost about $1,000 per
product.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $69,025 or $1,255 per product.
    According to the manufacturer, all of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
2775; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2015-19-15 Pilatus Aircraft Ltd.: Amendment 39-18277; Docket No.
FAA-2015-2775; Directorate Identifier 2015-CE-021-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective November 3,
2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45,
and PC-12/47E airplanes, manufacturer serial numbers 244, 307, 409,
646, 1447 through 1450, 1461, 1462, 1466 through 1514, 1516 through
1520, and 1523, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD results from mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a malfunction of
the universal joint. We are issuing this AD to replace defective
aileron control system universal joints.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (f)(2) of this AD, to include all subparagraphs.
    (1) For airplanes equipped with aileron control system universal
joints part number (P/N) 9<IP_ADDRESS> or P/N 5<IP_ADDRESS>,
purchased between March 1, 2014, and February 28, 2015; or universal
joints installed in service through an aileron control system
inspection kit P/N 5<IP_ADDRESS>4, purchased between March 1, 2014,
and February 28, 2015, do one of the following actions as
applicable:
    (i) For airplanes with less than 200 flight cycles since first
flight of the airplane or less than 200 flight cycles since
installation of an affected universal joint or inspection kit,
whichever applies: Within 10 flight cycles after November 3, 2015
(the effective date of this AD) or 3 months after November 3, 2015
(the effective date of this AD), whichever occurs first, replace
with a new universal joint P/N 5<IP_ADDRESS> purchased after March
1, 2015, and marked with a placard ``RT iO'' following the
Accomplishment Instructions in PILATUS PC-12 Service Bulletin No:
27-022, dated March 17, 2015.
    (ii) For airplanes with 200 flight cycles or more since first
flight of the airplane or 200 flight cycles or more since
installation of an affected universal joint or inspection kit,
whichever applies: Within 12 months after November 3, 2015 (the
effective date of this AD), replace with a new universal joint P/N
5<IP_ADDRESS> purchased after March 1, 2015, and marked with a
placard ``RT iO'' following the Accomplishment Instructions in
PILATUS PC-12 Service Bulletin No: 27-022, dated March 17, 2015.
    (iii) For all airplanes where total flight cycles are not
tracked: The conversion formula is one flight cycle equals one
flight hour.
    (2) For all airplanes: After November 3, 2015 (the effective
date of this AD), do not install the following parts on any airplane
after the modification of the airplane as required in paragraphs
(f)(1)(i) and (f)(1)(ii) of this AD or any airplane that does not
have an affected part installed:
    (i) A universal joint P/N 9<IP_ADDRESS> or P/N 5<IP_ADDRESS>
(except for a P/N

5<IP_ADDRESS> marked with a placard ``RT iO'').
    (ii) Inspection kit P/N 5<IP_ADDRESS>4 purchased between March 1,
2014, and February 28, 2015.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2015-0111, dated June 16, 2015, for related information. The MCAI
can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-2775-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) PILATUS PC-12 Service Bulletin No: 27-022, dated March 17,
2015.
    (ii) Reserved.
    (3) For PILATUS AIRCRAFT LTD. service information identified in
this AD, contact: PILATUS AIRCRAFT LTD, Customer Support Manager,
CH-6371 STANS, Switzerland; phone: +41 (0)41 619 33 33; fax: +41
(0)41 619 73 11; email<EMAIL_ADDRESS>Internet:
http://www.pilatus-aircraft.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-2775.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on September 18, 2015.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-24464 Filed 9-28-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Notices]
[Page 35427]
[DOCID:fr23jn08-85]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on June 26, 2008 at
10 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(5),
(7), 9(ii) and (10), permit consideration of the scheduled matters at
the Closed Meeting.
    Commissioner Atkins, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for June 26,
2008 will be:

    Formal orders of investigation;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    Adjudicatory matters; and
    Other matters related to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 18, 2008
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-14160 Filed 6-20-08; 8:45 am]

BILLING CODE 8010-01-P