[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19718-19721]
[FR Doc No: 2013-07528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0341]

Modifications To Labeling of Nicotine Replacement Therapy
Products for Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that we
have concluded that certain statements set forth in the FDA-approved
labels of over-the-counter nicotine replacement therapy products,
related to concomitant use with other nicotine-containing products and
duration of use, can be modified. In light of currently available
evidence, these statements are no longer believed to be necessary in
their current form to ensure the safe and effective use of over-the-
counter nicotine replacement therapy products for their approved
intended use as aids to smoking cessation. We encourage the submission
of supplemental new drug applications (labeling supplements) to modify
these statements as described in this notice.

ADDRESSES: Submit labeling supplements to the Center for Drug
Evaluation and Research, Food and Drug Administration, Central Document
Room (CDR), 5901-B Ammendale Rd., Beltsville, MD 20705-1266. Copies of
the recommended revisions to product labeling may be requested from the
Center for Drug Evaluation and Research's Division of Nonprescription
Clinical Evaluation, 10903 New Hampshire Ave., Bldg. 22, Stop 5411,
Silver Spring, MD 20993,<PHONE_NUMBER>. Copies of published studies that
can be used to support labeling supplements will be on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and can be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Doris J. Bates, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4417, Silver Spring, MD 20993, 301-796-
1040, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Smoking and Tobacco Dependence

    Tobacco use is the leading preventable cause of death and disease
in the United States. According to an estimate by the Centers for
Disease Control and Prevention, cigarette smoking causes 443,000 deaths
each year in the United States, including nearly 50,000 deaths per year
from involuntary exposure to tobacco smoke (Ref. 1). Smoking is known
to cause multiple cancers, heart disease, stroke, complications of
pregnancy, chronic obstructive pulmonary disease, and many other
diseases that, on average, shorten smokers' lifespans by 14 years (Ref.
2).
    Surveys show that approximately 70 percent of current smokers want
to stop smoking, and nearly half of all smokers make a quit attempt
each year (Ref. 3). Unfortunately, dependence on nicotine--the primary
addictive substance in tobacco--is a chronic disease that often
requires repeated intervention and multiple quit attempts to overcome.
As a result, only a small percentage of smokers successfully quit each
year (Ref. 3).

B. Over-the-Counter Nicotine Replacement Therapies

    Nicotine replacement therapy (NRT) products are designed to help
people stop smoking by supplying controlled amounts of nicotine to ease
the withdrawal symptoms associated with a quit attempt. NRT products do
not contain all of the carcinogens and other harmful constituents that
are found in cigarette smoke. There are currently three types of NRT
products approved by FDA for over-the-counter (OTC) use as smoking
cessation aids: Nicotine gum, transdermal nicotine patch, and nicotine
lozenge products.\1\ The nicotine gum and patch products were
originally approved through the new drug application (NDA) process
between 1984 and 1992. Both the gum and the patch were initially
available by prescription only; these products were switched from
prescription to OTC status between 1996 and 2002. The nicotine lozenge
and mini-lozenge were approved directly for OTC use in 2002 and 2009,
respectively.
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    \1\ A nicotine spray and a nicotine inhaler have also been
approved as smoking cessation aids. However, these NRT products are
available by prescription only and are therefore outside the scope
of this notice.
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    Currently, the FDA-approved labeling for OTC NRT products instructs
consumers that they should stop smoking when they begin using the
product and that they should not use

the product in combination with cigarettes or other nicotine-containing
products (including other NRT products). The labeling also recommends a
specific duration of use of up to 12 weeks, depending on the product,
and instructs consumers to stop using the NRT product at the end of
that period. Consumers are advised to consult a doctor if they feel
they need to continue using the NRT product for longer than the
recommended course of treatment.
    In recent years, a number of stakeholders in the public health and
health care provider communities have suggested that these labeling
statements act as barriers to the effective use of OTC NRT products for
smoking cessation. These stakeholders have argued that the statement
advising against concomitant use of the NRT products with cigarettes
may cause some smokers to abandon quit attempts if they experience a
lapse (e.g., if they have a cigarette while using an NRT product).
Stakeholders have also argued that use of more than one NRT product
(e.g., patch plus gum) is more effective for some smokers than use of a
single NRT product in achieving cessation, and that current labeling
discourages such use. With regard to duration of use, stakeholders have
argued that the use of OTC NRT products beyond the labeled treatment
period may increase the chances of quitting for certain smokers.\2\
These stakeholders have asserted that there are no safety concerns
associated with concomitant use of OTC NRT products with other
nicotine-containing products, or with the use of OTC NRT products for
longer than the labeled duration of use.
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    \2\ In this notice, the Agency takes no position on the
effectiveness of NRT products when used concomitantly with other
nicotine-containing products, or when used for longer than the
labeled duration of use.
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    Over the nearly 30 years since NRT products were first approved,
evidence has accumulated to suggest that the current labeling
provisions on concomitant use and duration of use may no longer be
necessary to ensure the safe use of OTC NRT products for smoking
cessation. Based on this evidence, FDA has concluded that the current
labeling statements for OTC NRT products concerning concomitant use and
duration of use can be modified as described in this document. We
invite the products' sponsors to submit supplemental NDAs (labeling
supplements) to modify these statements in the labeling of their drug
products. To facilitate the process, the Agency has identified
revisions to the labeling of OTC NRT products that can be included in
these labeling supplements. Those revisions are set forth in section
II.

II. Proposed Revisions to the Labeling of OTC NRT Products

A. Concomitant Use of OTC NRT Products With Cigarettes or Other
Nicotine-Containing Products, Including Other NRT

    The ``Drug Facts'' section of the label for OTC NRT products
currently contains two statements relating to the use of these products
with other nicotine-containing products. The first statement is found
under the ``Do not use'' subheading of the ``Warnings'' section. It
instructs consumers not to use the OTC NRT product if they ``continue
to smoke, chew tobacco, use snuff, or use [a different NRT product] or
other nicotine containing products.'' This statement was included in
the labeling because at the time during which these products were
switched to OTC use, there was little reliable data on the safety of
the higher levels of nicotine that would result from using NRT products
in combination with other nicotine-containing products. The second
statement appears under the ``Directions'' section, and tells consumers
to ``stop smoking completely when you begin using the [NRT product].''
This statement was included in the label because in the clinical trials
that were conducted for the original NRT product approvals, individuals
who stopped smoking completely when they began using NRT were more
likely to quit.
    Since we first approved NRT products for OTC use, a number of
studies have been conducted that provide information on the safety of
using NRT products in combination with other nicotine-containing
products. Many of these studies focused on the effects of using NRT
products while smoking. For example, there have been studies on the use
of NRT products by smokers who were not immediately interested in
quitting (see Hatsukami et al., 2007), on the use of NRT products as an
aid to smoking reduction (see Wennike et al., 2003; Batra et al.,
2005), and on the use of NRT products before initiating a quit attempt
(Lindson and Aveyard, 2011). In addition, several studies have been
conducted on the use of higher-than-standard-dose NRT products
(T[oslash]nnesen et al., 1999) and on the concomitant use of more than
one type of NRT product (see Bohadana et al., 2000; Piper et al.,
2009).
    Upon reviewing the published reports of these and other studies, we
have determined that the concomitant use of OTC NRT products with
cigarettes or with other nicotine-containing products does not raise
significant safety concerns. The published literature contains few
reports of adverse events arising from the use of NRT products while
smoking or using another NRT product. The Agency also notes that few
adverse events have been reported in studies of concomitant use
conducted under the investigational new drug (IND) process, which
involves mandatory reporting of adverse events.
    Accordingly, we are announcing that the statements in the current
labeling of OTC NRT products relating to concomitant use of those
products with other nicotine-containing products can be modified. The
following specific changes to the current approved ``Drug Facts''
labeling are recommended:
     Warnings. The ``Do not use'' subheading and the statement
underneath it instructing consumers not to use the NRT product if they
``continue to smoke, chew tobacco, use snuff, or use [a different NRT
product] or other nicotine containing products'' should be deleted.
     Directions. The third bullet should be revised from ``stop
smoking completely when you begin using the [NRT product]'' to ``begin
using the [NRT product] on your quit day.''

B. Duration of Use of OTC NRT Products

    Currently, the labeling of OTC NRT products recommends a specific
duration of use of up to 12 weeks, depending on the product. For
example, the ``Drug Facts'' section of the label for nicotine gum and
lozenge products recommends that those products be used for 12 weeks;
the label for certain nicotine patch products recommends a duration of
use of 8 weeks, others 10 weeks. These labeled durations of use reflect
the treatment periods that were studied in the clinical trials that
supported the switch of these products to OTC status. Because NRT
products treat the acute withdrawal symptoms associated with a quit
attempt, and those symptoms typically diminish over time, most of the
clinical trials conducted to support approval were short--generally
between 6 and 12 weeks in length.
    In addition to recommending a specific duration of use, current OTC
NRT product labels direct consumers to stop using the product at the
end of the recommended treatment period and to talk to a doctor if they
feel they need to use the product longer. This statement was included
in the labeling because at the time of the first prescription-to-OTC
switch, there was insufficient data to

address the Agency's concern that consumers could potentially become
dependent on NRT products.
    In the years since NRT products became available for OTC use, a
number of studies have examined the use of NRT products over periods
longer than 12 weeks. We have reviewed the published literature on this
longer-term use of NRT products and have not identified any safety
risks associated with such use. A well-known and highly regarded study
on the effects of long-term use of NRT products is the Lung Health
Study, in which almost 6,000 smokers were given access to free nicotine
gum for up to 5 years (see Murray et al., 1996). In this study, over
1,000 subjects were still using the gum after 1 year. The adverse
effects of long-term nicotine gum use reported by these subjects were
described as minor and transient, and there was no correlation between
long-term gum use and cardiovascular events. A followup study found
that long-term ad lib use of nicotine gum neither increased nor
decreased the Lung Health Study subjects' likelihood of developing
cancer (see Murray et al., 2009). Other informative studies on the
effects of long-term use of NRT products include a 52-week study of NRT
product use in which nearly half of the subjects used two or more OTC
NRT products in combination (see Joseph et al., 2011), and a trial
involving the use of nicotine patches for 6 to 12 months by nonsmokers
with mild cognitive impairment (see Newhouse et al., 2012). Both of
these studies had high rates of completion and reported few adverse
events from long-term use of NRT products.
    We also note that although any nicotine-containing product has the
potential to be addicting, based on the available evidence, currently
marketed OTC NRT products do not appear to have significant potential
for abuse or dependence. A 2010 review of historical reports made to
the Agency's Adverse Event Reporting System and to the Substance Abuse
and Mental Health Services Administration's Drug Abuse Warning Network
between 1984 and 2009 suggested that NRT products have a low potential
for abuse. Several published studies have also found that the abuse
liability and dependence potential of NRT products is low, especially
compared to cigarettes (see West et al., 2000; Houtsmuller et al.,
2002).
    Accordingly, we are announcing that the statement in the labeling
of OTC NRT products directing consumers to stop using the NRT product
at the end of the recommended treatment period can be modified. The
following specific change to the current approved ``Drug Facts''
labeling is recommended:
     Directions. The last bullet should be revised from ``it is
important to complete treatment. Stop using the [NRT product] at the
end of [x] weeks. If you still feel the need to use [the NRT product],
talk to your doctor'' to ``it is important to complete treatment. If
you feel you need to use [the NRT product] for a longer period to keep
from smoking, talk to your health care provider.''

C. Summary of Proposed Labeling Revisions

    In light of currently available evidence on the concomitant use of
OTC NRT products with cigarettes or other nicotine-containing products,
and on the use of OTC NRT products beyond the labeled period of
treatment, the following changes to the ``Drug Facts'' labeling of OTC
NRT products are recommended:

------------------------------------------------------------------------
      Current drug facts  labeling        Proposed drug facts  labeling
------------------------------------------------------------------------
                                Warnings
------------------------------------------------------------------------
Do not use:
     if you continue to smoke,   None. The ``Do not use''
     chew tobacco, use snuff, or use [a   statement would be deleted.
     different NRT product] or other
     nicotine containing products.
------------------------------------------------------------------------
                               Directions
------------------------------------------------------------------------
 stop smoking completely when     begin using the [NRT
 you begin using the [NRT product].       product] on your quit day.
 it is important to complete      it is important to
 treatment. Stop using the [NRT           complete treatment. If you
 product] at the end of [ x ] weeks. If   feel you need to use [the NRT
 you still feel the need to use [the      product] for a longer period
 NRT product], talk to your doctor.       to keep from smoking, talk to
                                          your health care provider.
------------------------------------------------------------------------

    We have determined that these labeling revisions may be addressed
through a changes being effected (CBE) supplement under 21 CFR
314.70(c)(6).
    We are also recommending conforming changes to other FDA-approved
labeling for OTC NRT products, such as product user guides and
leaflets. Copies of the recommended changes to these other labeling
items may be obtained from the Center for Drug Evaluation and
Research's Division of Nonprescription Clinical Evaluation (see
ADDRESSES).

III. Conclusions

    We have determined that the current OTC NRT products can be used
safely and effectively for their approved intended use as aids to
smoking cessation with the labeling modifications identified in section
II. We encourage the submission of labeling supplements for these drug
products. These supplements should modify the labeling statements
concerning concomitant use and duration of use as described in section
II. The requirement for data to support these labeling changes may be
met by citing the published literature we relied on in preparing this
notice. A list of the published literature and reprints of the reports
will be available for public inspection in the Division of Dockets
Management (see ADDRESSES). It is unnecessary to submit copies and
reprints of the reports from the listed published literature. We invite
applicants to submit any other pertinent studies and literature of
which they are aware.

IV. Published Literature Supporting Proposed Labeling Revisions

    The published literature we have relied on in making the
determinations contained in this notice is listed in this section of
the document. Copies of the published literature will be on display in
the Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. Batra, A., et al., ``Smoking Reduction Treatment With 4-Mg
Nicotine Gum: A Double-Blind, Randomized, Placebo-Controlled
Study,'' Clinical

Pharmacology and Therapeutics, 78(6):689-96, 2005.
2. Benowitz, N.L., et al., ``Suppression of Nicotine Intake During
Ad Libitum Cigarette Smoking by High-Dose Transdermal Nicotine,''
Journal of Pharmacology and Experimental Therapeutics, 287(3):958-
62, 1998.
3. Blondal, T., et al., ``Nicotine Nasal Spray With Nicotine Patch
for Smoking Cessation: Randomised Trial With Six Year Follow Up,''
BMJ, 318(7179):285-8, 1999.
4. Bohadana, A., et al., ``Nicotine Inhaler and Nicotine Patch as a
Combination Therapy for Smoking Cessation,'' Archives of Internal
Medicine, 160(20):3128-34, 2000.
5. Bolliger, C.T., et al, ``Smoking Reduction With Oral Nicotine
Inhalers: Double Blind, Randomised Clinical Trial of Efficacy And
Safety,'' BMJ, 321(7257):329-33, 2000.
6. Bullen, C., et al., ``Precessation Nicotine Replacement Therapy:
Pragmatic Randomized Trial,'' Addiction, 105(8):1474-83, 2010.
7. Dale, L.C., et al., ``High-Dose Nicotine Patch Therapy.
Percentage of Replacement and Smoking Cessation,'' JAMA,
274(17):1353-58, 1995.
8. Etter, J.F., et al., ``Nicotine Replacement to Reduce Cigarette
Consumption in Smokers Who Are Unwilling to Quit: A Randomized
Trial,'' Journal of Clinical Psychopharmacology, 22(5):487-95, 2002.
9. Etter, J.F., et al., ``Postintervention Effect of Nicotine
Replacement Therapy on Smoking Reduction in Smokers Who Are
Unwilling to Quit: A Randomized Trial,'' Journal of Clinical
Psychopharmacology, 24(2):174-79, 2004.
10. Etter, J.F., et al., ``Nicotine Gum Treatment Before Smoking
Cessation--A Randomized Trial,'' Archives of Internal Medicine,
169(11):1028-34, 2009.
11. Hajek, P., et al., ``Dependence Potential of Nicotine
Replacement Treatments: Effects of Product Type, Patient
Characteristics, and Cost to User,'' Preventive Medicine, 44(3):230-
34, 2007.
12. Hall, S.M., et al., ``Extended Treatment of Older Cigarette
Smokers,'' Addiction, 104(6):1043-52, 2009.
13. Hatsukami, D., et al., ``Effects of High Dose Transdermal
Nicotine Replacement in Cigarette Smokers,'' Pharmacology,
Biochemistry, and Behavior, 86(1):132-39, 2007.
14. Horst, W.D., et al., ``Extended Use of Nicotine Replacement
Therapy to Maintain Smoking Cessation in Persons With
Schizophrenia,'' Neuropsychiatric Disease and Treatment, 1(4):349-
55, 2005.
15. Houtsmuller, E.J., et al., ``Flavor Improvement Does Not
Increase Abuse Liability of Nicotine Chewing Gum,'' Pharmacology,
Biochemistry, and Behavior, 72(3):559-68, 2002.
16. Hughes, J.R., et al., ``A Randomized, Controlled Trial of NRT-
Aided Gradual Vs. Abrupt Cessation in Smokers Actively Trying to
Quit,'' Drug and Alcohol Dependence, 111(1-2):105-13, 2010.
17. Joseph, A.M., et al., ``Chronic Disease Management for Tobacco
Dependence,'' Archives of Internal Medicine, 171(21):1894-1900,
2011.
18. Lerman, C., et al., ``Genetic Variation in Nicotine Metabolism
Predicts the Efficacy of Extended-Duration Transdermal Nicotine
Therapy,'' Clinical Pharmacology and Therapeutics, 87(5):553-57,
2010.
19. Lindson, N. and Aveyard, P., ``An Updated Meta-Analysis of
Nicotine Preloading for Smoking Cessation: Investigating Mediators
of the Effect,'' Psychopharmacology, 214(3):579-92, 2011.
20. Murray, R.P., et al., ``Safety of Nicotine Polacrilex Gum Used
by 3,094 Participants in the Lung Health Study. Lung Health Study
Research Group,'' CHEST, 109(2):438-45, 1996.
21. Murray, R.P., et al., ``Does Nicotine Replacement Therapy Cause
Cancer? Evidence From the Lung Health Study,'' Nicotine & Tobacco
Research, 11(9):1076-82, 2009.
22. Newhouse, P., et al., ``Nicotine Treatment of Mild Cognitive
Impairment: A 6-Month Double-Blind Pilot Clinical Trial,''
Neurology, 78(2):91-101, 2012.
23. Piper, M.E., et al., ``A Randomized Placebo-Controlled Clinical
Trial of 5 Smoking Cessation Pharmacotherapies,'' Archives of
General Psychiatry, 66(11):1253-62, 2009.
24. Rennard, S.I., et al., ``Efficacy of the Nicotine Inhaler in
Smoking Reduction: A Double-Blind, Randomized Trial,'' Nicotine &
Tobacco Research, 8(4):555-64, 2006.
25. Rose, J.E., et al., ``Mecamylamine Combined With Nicotine Skin
Patch Facilitates Smoking Cessation Beyond Nicotine Patch Treatment
Alone,'' Clinical Pharmacology and Therapeutics, 56(1):86-99, 1994.
26. Rose, J.E., et al., ``Nicotine-mecamylamine Treatment for
Smoking Cessation: The Role of Precessation Therapy,'' Experimental
and Clinical Psychopharmacology, 6(3):331-43, 1998.
27. Rose, J.E., et al., ``Precessation Treatment With Nicotine Skin
Patch Facilitates Smoking Cessation,'' Nicotine & Tobacco Research,
8(1):89-101, 2006.
28. Rose, J.E., et al., ``Precessation Treatment With Nicotine Patch
Significantly Increases Abstinence Rates Relative to Conventional
Treatment,'' Nicotine & Tobacco Research, 11(9):1067-75, 2009.
29. Schuurmans, M.M., et al., ``Effect of Pretreatment With Nicotine
Patch on Withdrawal Symptoms and Abstinence Rates in Smokers
Subsequently Quitting With the Nicotine Patch: A Randomized
Controlled Trial,'' Addiction, 99(5):634-40, 2004.
30. T[oslash]nnesen, P., et al., ``Higher Dosage Nicotine Patches
Increase One-Year Smoking Cessation Rates: Results From the European
CEASE Trial,'' European Respiratory Journal, 13(2):238-46, 1999.
31. Wang, D., et al., '' `Cut Down to Quit' With Nicotine
Replacement Therapies in Smoking Cessation: A Systematic Review of
Effectiveness and Economic Analysis,'' Health Technology Assessment,
12(2):iii-iv, ix-xi, 1-135, 2008.
32. Wennike, P., et al., ``Smoking Reduction Promotes Smoking
Cessation: Results From a Double Blind, Randomized, Placebo-
Controlled Trial of Nicotine Gum With 2-Year Follow-Up,'' Addiction,
98(10):1395-402, 2003.
33. West, R., et al, ``A Comparison of the Abuse Liability and
Dependence Potential of Nicotine Patch, Gum, Spray and Inhaler,''
Psychopharmacology, 149(3):198-202, 2000.
34. Zevin, S., et al, ``Dose-Related Cardiovascular and Endocrine
Effects of Transdermal Nicotine,'' Clinical Pharmacology and
Therapeutics, 64(1):87-95, 1998.

V. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. Centers for Disease Control and Prevention, ``Annual Smoking-
Attributable Mortality, Years of Potential Life Lost, and
Productivity Losses--United States, 2000-2004,'' Morbidity and
Mortality Weekly Report, 57(45):1226-1228; November 14, 2008.
2. Centers for Disease Control and Prevention, ``Annual Smoking-
Attributable Mortality, Years of Potential Life Lost, and
Productivity Losses--United States, 1995-1999,'' Morbidity and
Mortality Weekly Report, 51(14):300-303; April 12, 2002.
3. Centers for Disease Control and Prevention, ``Quitting Smoking
Among Adults--United States, 2001-2010,'' [serial online], Morbidity
and Mortality Weekly Report, 60(44):1513-1519; November 11, 2011.

    Dated: March 26, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07528 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Rules and Regulations]
[Pages 43846-43848]
[FR Doc No: 2017-19935]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2017-0208; FRL-9967-93-Region 7]

Approval of Implementation Plans; State of Iowa; Elements of the
Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National
Ambient Air Quality Standard (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve elements of a State Implementation Plan (SIP)
submission, and an amended SIP submission from the State of Iowa for
the 2010 Nitrogen Dioxide (NO2) National Ambient Air Quality
Standard (NAAQS).
    Infrastructure SIPs address the applicable requirements of Clean
Air Act (CAA) section 110, which requires that each state adopt and
submit a SIP for the implementation, maintenance, and enforcement of
each new or revised NAAQS promulgated by the EPA. These SIPs are
commonly referred to as ``infrastructure'' SIPs. The infrastructure
requirements are designed to ensure that the structural components of
each state's air quality management program are adequate to meet the
state's responsibilities under the CAA.

DATES: This direct final rule will be effective November 20, 2017,
without further notice, unless EPA receives adverse comment by October
20, 2017. If EPA receives adverse comment, we will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2017-0208, to https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Air Planning and
Development Branch, U.S. Environmental Protection Agency, Region 7,
11201 Renner Boulevard, Lenexa, KS 66219 at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    EPA is approving elements of the 2010 NO2 NAAQS
infrastructure SIP submission from the State of Iowa received on July
29, 2013, and an amended SIP submission received on March 9, 2017.
Specifically, EPA is approving the following elements of section
110(a)(2): (A), (B), (C), (D)(i)(I)--significant contribution to
nonattainment (prong 1), interfering with maintenance of the NAAQS
(prong 2) and (D)(i)(II)--prevent of significant deterioration of air
quality (prong 3), and (D)(ii), (E) through (H), and (J) through (M).
EPA is not acting on the elements of section 110(a)(2)(D)(i)(II)--
protection of visibility (prong 4), and 110(a)(2)(I).
    A Technical Support Document (TSD) is included as part of this
docket to discuss the details of this action, including analysis of how
the SIP meets the applicable 110 requirements for infrastructure SIPs.

II. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The state initiated
public comment from April 6, 2013, to May 8, 2013. One comment was
received and adequately addressed in the final SIP submission. The
amended submission was placed on public comment January 12, 2017, to
February 15, 2017. No comments were received. These submissions also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, as explained above and in more detail in the technical
support document which is part of this docket, the revisions meets the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations.

III. What action is EPA taking?

    EPA is approving elements of the July 23, 2013, (received July 29,
2013) infrastructure SIP submission from the State of Iowa, which
addresses the requirements of CAA sections 110(a)(1) and (2) as
applicable to the 2010 NO2 NAAQS. As stated above, EPA is
approving the following elements of section 110(a)(2): (A), (B), (C),
(D)(i)(I)--significant contribution to nonattainment (prong 1),
interfering with maintenance of the NAAQS (prong 2) and (D)(i)(II)--
prevent significant deterioration of air quality (prong 3), and
(D)(ii), (E) through (H), and (J) through (M). The March 1, 2017, SIP
amendment, revised 110(a)(2)(D)(i)(I). Details of the submission are
addressed in the TSD, included as part of the docket, to discuss this
approval action.
    EPA is not taking action on section 110(a)(2)(I). Section
110(a)(2)(I) requires that in the case of a plan or plan revision for
areas designated as nonattainment areas, states must meet applicable
requirements of part D of the CAA, relating to SIP requirements for
designated nonattainment areas. EPA does not expect infrastructure SIP
submissions to address element (I). The specific SIP submissions for
designated nonattainment areas, as required under CAA title I, part D,
are subject to different submission schedules than those for section
110 infrastructure elements. EPA will take action on part D attainment
plan SIP submissions through a separate rulemaking governed by the
requirements for nonattainment areas, as described in part D.
    EPA is not taking action on section 110(a)(2)(D)(i)(II), prong 4.
    We are publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and anticipate
no adverse comment. However, in the ``Proposed Rules'' section of this
Federal Register, we are publishing a separate document that will serve
as the proposed rule to approve the SIP

revision if adverse comments are received on this direct final rule. We
will not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document. If EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that
this direct final rule will not take effect. We will address all public
comments in any subsequent final rule based on the proposed rule.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 20, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

 List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Reporting and
recordkeeping requirements.

    Dated: September 8, 2017.
Cathy Stepp,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amending 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart Q--Iowa

0
2. Section 52.820(e) is amended by adding new entry (47) in numerical
order at the end of the table to read as follows:

Sec.  52.820  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Iowa Nonregulatory SIP Provisions
----------------------------------------------------------------------------------------------------------------
                                                              State
   Name of nonregulatory SIP     Applicable  geographic     submittal      EPA approval         Explanation
           revision             or  nonattainment  area       date             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(47) Sections 110(a)(1) and     Statewide..............   7/23/13, 3/1/  9/20/2017,        This action addresses
 (2) Infrastructure                                                  17   [Insert Federal   the following CAA
 Requirements 2010 Nitrogen                                               Register          elements:
 Dioxide NAAQS.                                                           citation].        110(a)(2)(A), (B),
                                                                                (C), (D)(i)(I)
                                                                                prongs 1 and 2,
                                                                                D(i)(II) prong 3
                                                                                only, and D(ii),
                                                                                (E), (F), (G), (H),
                                                                                (J), (K), (L), and
                                                                                (M). 110(a)(2)(I) is
                                                                                not applicable. [EPA-
                                                                                R07-OAR-2017-0208;
                                                                                FRL-9967-93-Region
                                                                                7].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-19935 Filed 9-19-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Proposed Rules]
[Pages 43099-43101]
[FR Doc No: 2010-17999]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0732; Directorate Identifier 2010-NE-04-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CT7-9C
and -9C3 Turboprop Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for GE CT7-9C and -9C3 turboprop engines with certain serial number (S/
N) gas generator turbine (GGT) shafts, part number (P/N) 6068T44P02,
installed. This proposed AD would require inspecting the GGT shaft for
nonconforming land balance-cuts, and if found, removing the shaft from
service. This proposed AD results from reports of a manufacturing
quality problem. We are proposing this AD to detect nonconforming GGT
shaft land balance-cuts, which could result in the shaft failing before
its published life limit, and which could result in an uncontained
engine failure and damage to the airplane.

DATES: We must receive any comments on this proposed AD by September
21, 2010.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact General Electric Company, GE-Aviation, Room 285, 1 Newmann
Way, Cincinnati, Ohio 45215; e-mail<EMAIL_ADDRESS>telephone (513)
552-3272; fax<PHONE_NUMBER>, for a copy of the service information
identified in this proposed AD.

FOR FURTHER INFORMATION CONTACT: Barbara Caufield, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2010-0732; Directorate
Identifier 2010-NE-04-AD'' in the subject line of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the proposed AD. We will consider
all comments received by the closing date and may amend the proposed AD
in light of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets,

including, if provided, the name of the individual who sent the comment
(or signed the comment on behalf of an association, business, labor
union, etc.). You may review the DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    We have received reports of 21 nonconforming land balance-cuts on
GGT shafts, P/N 6068T44P02. The nonconforming land balance-cuts can
negatively affect the low-cycle fatigue life capability of the shaft.
This condition, if not corrected, could result in the shaft failing
before its published life limit, and which could result in an
uncontained engine failure and damage to the airplane.

Relevant Service Information

    We have reviewed and approved the technical contents of GE CT7-TP
Alert Service Bulletin (ASB) 72-A0501, Revision 01, dated March 3,
2010, that lists the affected shafts by P/N and S/N, and describes
procedures for inspecting the GGT shaft for nonconforming land balance-
cuts.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would require
inspecting certain S/N GGT shafts, P/N 6068T44P02, for nonconforming
land balance-cuts, and if found, replacing the shaft. The proposed AD
would require you to use the service information described previously
to perform these actions.

Costs of Compliance

    We estimate that this proposed AD would affect five engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 1 work-hour per engine to perform the inspection, 1.5 work-
hours to replace the shaft, and that the average labor rate is $85 per
work-hour. Required parts would cost about $28,633 per engine. Based on
these figures, we estimate the total cost of the proposed AD to U.S.
operators to be $144,227.

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 have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed 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); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive:

General Electric Company (GE): Docket No. FAA-2010-0732; Directorate
Identifier 2010-NE-04-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by September
21, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to GE CT7-9C and -9C3 turboprop engines with
gas generator turbine (GGT) shafts, part number (P/N) 6068T44P02,
that have a serial number (S/N) listed in Table 1 of this AD,
installed. These engines are installed on, but not limited to, EADS
CASA (formerly Construcciones Aeronauticas, S.A.) CN-235 series
airplanes.

                    Table 1--Affected GGT Shaft S/Ns
------------------------------------------------------------------------

------------------------------------------------------------------------
                           Affected Shaft S/Ns
------------------------------------------------------------------------
GATHHCPC           GATHHJR7           GATHHJR9          GATHHKG6
GATHHM9R           GATHHWM3           GATHJ4ED          GATHJ9FL
GATHJ19J           GATHJE8P           GATHJWWR          GATHK0KM
GATHK2N1           GATHK3M3           GATHK90K          GATHK96D
GATHKF9R           GATHKH36           GATHKMP7          GATHKRKN
NCE715DA           .................  ................  ................
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from reports of a manufacturing quality
problem. We are issuing this AD to detect nonconforming GGT shaft
land balance-cuts, which could result in the shaft failing before
its published life limit, and which could result in an uncontained
engine failure and damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at the first shop visit after the effective date of
this AD, or within 5,000 cycles-since-new, whichever occurs first,
unless the actions have already been done.

Inspection for Nonconforming Land Balance-Cuts

    (f) For CT7-9C and -9C3 engines with a GGT shaft, P/N
6068T44P02, that has a S/N listed in Table 1 of this AD, installed,
inspect the shaft for nonconforming land balance-cuts. Use the
Accomplishment Instructions 3.A.(1) through 3.A.(4) of GE CT7-TP
Alert Service Bulletin 72-A0501, Revision 01, dated March 3, 2010,
to perform the inspection.
    (g) If you find any nonconforming land balance-cuts, remove the
shaft from service.

Alternative Methods of Compliance

    (h) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (i) Contact Barbara Caufield, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781) 238-
7199, for more information about this AD.
    (j) GE CT7-TP Alert Service Bulletin 72-A0501, Revision 01,
dated March 3, 2010, pertains to the subject of this AD. Contact
General Electric Company, GE-Aviation, Room 285, 1 Newmann Way,
Cincinnati, Ohio 45215; e-mail<EMAIL_ADDRESS>telephone (513) 552-
3272; fax<PHONE_NUMBER>, for a copy of this service information.

    Issued in Burlington, Massachusetts, on July 15, 2010.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2010-17999 Filed 7-22-10; 8:45 am]
BILLING CODE 4910-13-P


  From: "William J. Mills"<EMAIL_ADDRESS> To: Keith Barnett/RTP/USEPA/US@EPA  Cc: <EMAIL_ADDRESS><EMAIL_ADDRESS>Kyle Hilst<EMAIL_ADDRESS>Uyen Nguyen<EMAIL_ADDRESS>Ben Grigg<EMAIL_ADDRESS> Date: 07/27/2009 10:52 PM  Subject: FW: questions regarding proposed PC NESHAP

Keith, thanks for the emails last week . as you requested/suggested , here are the extracts from the OAR Background document for the PC NESHAP and the referenced HWC MACT technical document  with our questioned equations outlined.  Mills Consulting Inc. questions are not about whether Vt=Vb+Vw  is a vailid approach but rather what equations  are used to calculate Vt and Vb.    If EPA could shed some light on the technical basis, including literature references for the highlighted equations it would be useful to all parties.   please let me know if there are any questions.  regards, bill mills   William J. Mills III Ph.D., M.Sc., CIH, C. Chem. President  Mills Consulting Inc. Oak Park, IL phone :<PHONE_NUMBER> <EMAIL_ADDRESS>www.mills-consulting.com


[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8910-8911]
[FR Doc No: 2022-03355]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No.-2021-0016]

Petition for Exemption; Summary of Petition Received; United
States Fish and Wildlife Service

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

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before March 8, 2022.

ADDRESSES: Send comments identified by docket number FAA-2021-0593
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for

accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jimeca Callaham,<PHONE_NUMBER>,
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

Timothy R. Adams,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2021-0593.
    Petitioner: United States Fish and Wildlife Service.
    Section(s) of 14 CFR Affected: Sec. Sec.  91.119(b) and (c).
    Description of Relief Sought: The United States Fish and Wildlife
Service (FWS) seeks relief from 14 CFR 91.119(b) and (c) in order to
conduct biological, enforcement, and disaster-response flights at low
altitudes. FWS is requesting an exemption that would be valid for 5
years in order to continue uninterrupted operations for the benefit of
the public health.

[FR Doc. 2022-03355 Filed 2-15-22; 8:45 am]
BILLING CODE 4910-13-P