[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26807-26811]
[FR Doc No: 2016-10396]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2406]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Market Claims in
Direct-to-Consumer Prescription Drug Print Ads

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by June 3,
2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--NEW and
title, ``Market Claims in Direct-to-Consumer Prescription Drug Print
Ads.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Market Claims in Direct-to-Consumer Prescription Drug Print Ads--OMB
Control Number 0910--NEW

    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 (the 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 marketing literature divides product attributes (``cues'') into
intrinsic and extrinsic. Intrinsic cues are physical characteristics of
the product (e.g., size, shape), whereas extrinsic cues are product-
related but not part of the product (e.g., price and brand name) (Refs.
1 and 2). Research has found that both intrinsic and extrinsic cues can
influence perceptions of product quality (Ref. 3). Consumers may rely
on product cues in the absence of explicit quality information. The
objective quality of prescription drugs is not easily obtained from
promotional claims in direct-to-consumer (DTC) ads; thus consumers may
rely upon extrinsic cues to inform their decisions. Market claims such
as ``#1 Prescribed'' and ``New'' may act as extrinsic cues about the
product's quality, independent of the product's intrinsic
characteristics. Prior research has found that market leadership claims
can affect consumer beliefs about product efficacy, as well as their
beliefs about doctors' judgments about product efficacy (Ref. 4). One
limitation of these prior studies is the lack of quantitative
information about product efficacy in the information provided to
respondents. Research indicates that providing consumers with efficacy
information generally improves understanding and facilitates
decisionmaking (Refs. 5 and 6). Efficacy information may moderate the
effect of the extrinsic cue by providing insight into characteristics
that would otherwise be unknown. Other research has shown that
consumers are able to use information about efficacy to inform
judgments about the product (Refs. 6 and 7).
    The Office of Prescription Drug Promotion (OPDP) plans to
investigate, through empirical research, the impact of market claims on
prescription drug product perceptions with and without quantitative
information about product efficacy. This will be investigated in DTC
print advertising for prescription drugs.

I. Design Overview and Procedure

    The design consists of two parts: A main study and a followup
study. We will conduct two sequential pretest waves prior to the main
study and one pretest prior to the followup study. The purpose of the
pretests are to (1) ensure the stimuli are understandable and viewable,
(2) identify and address any challenges to embedding the stimuli within
the online survey, and (3) ensure the study questions are appropriate
and meet the study's goals.
    Participants in the main study will be randomly assigned to view
one of nine versions of an ad, as depicted in table 1. The two
variables of interest are type of market claim (#1 Prescribed, New) and
type of efficacy information (High, Low, or None). Efficacy information
will be operationalized in the form of realistic quantitative
information (for example, ``46 percent of patients felt their nerve
pain reduced by at least half, compared to baseline'').

                                           Table 1--Main Study Design
----------------------------------------------------------------------------------------------------------------
                                                                              Type of market claim
                                                              --------------------------------------------------
                                                                #1 Prescribed         New         None (control)
----------------------------------------------------------------------------------------------------------------
Efficacy Level Information:                                    ...............  ...............  ...............
    High.....................................................               A                B                 C
    Low......................................................               D                E                F
    None (control)...........................................               G                H                I
----------------------------------------------------------------------------------------------------------------

    In the followup study, participants (n = 216) will complete a 15-
minute paired choice experiment. Participants will be asked to choose
between two hypothetical drugs based on print ads, one of which
includes a market claim from the Main Study (#1 Prescribed or New). The
ads also include different efficacy information (for example, ``46
percent of patients felt their nerve pain reduced by at least half,
compared to baseline'' versus ``51 percent of patients felt their nerve
pain reduced by at least half, compared to baseline''). Figure 1
depicts an example choice. Participants are asked to indicate which
drug they would prefer. They are given 48 such choice sets, which vary
in efficacy information and the presence of the market claim.

[GRAPHIC] [TIFF OMITTED] TN04MY16.000

II. Procedure

    Pretests: Each participant will be randomly assigned to view a
print ad for a fictitious prescription drug indicated to treat diabetic
neuropathy and will be asked to complete an online survey assessing
their benefit/risk perceptions, intentions, and attitudes toward the
drug. Based on the pretest findings, we will revise and remove poorly
performing survey items prior to full-scale testing.
    Main study: Each participant will be randomly assigned to view a
print ad for a fictitious prescription drug for diabetic neuropathy and
will be asked to complete an online survey assessing their benefit/risk
perceptions, intentions, and attitudes toward the drug.
    Followup study: Each participant will be asked to view a series of
pairs of print ads for a product that treats diabetic neuropathy. One
ad will contain a market claim. Both ads will contain quantitative
efficacy information that varies along a continuum of effectiveness in
a series of 48 trials. In each comparison, participants will be asked
to choose one of the two drugs.
    In the Federal Register of July 20, 2015 (80 FR 42823), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Six submissions were received; three from
biopharmaceutical companies (AbbVie, Eli Lilly, Merck), two that were
anonymous, and one from Danny Weiss, PharmD. The comments from the two
anonymous submitters and Dr. Weiss requested the United States ban DTC
advertising for pharmaceuticals. This is outside the scope of this
project. We summarize and respond to the other comments as follows.
    (Comment 1) From AbbVie: Respondents may view ``benefits'' and
``risks'' more generally versus ``side effects'' as a specific inquiry.
For example, ``side effects'' could be interpreted as adverse effects
or adverse events, and as such, elicit a much more specific response
than ``risks'' which could be seen more broadly. We suggest that ``side
effects'' be eliminated from question 4 to keep questions 3 and 4 as
both general in nature.
    (Response) We are interested in recall of both risks and side
effects, and so we inquire about both. Inquiring about risks only may
artificially reduce the quantity of recall. Moreover, we counterbalance
the presentation of questions 3 and 4 in efforts to account for any
influence of question ordering. It would be feasible to instead inquire
about risks and side effects in separate questions; however, in our
experience, we find that consumers tend to think about risks and side
effects together, which makes sense given the typical presentation of
risks and side effects in direct-to-consumer promotional materials.
    (Comment 2) From AbbVie: The answers to questions 7 through 12 may
be biased by attitudes toward advertising in general and may go well
beyond the pharmaceutical ad they are shown.
    (Response) By asking these questions, we hope to detect any
differences in perceived effectiveness and risk between those exposed
to different experimental conditions. For example, those exposed to an
ad with a #1 Prescribed market claim may perceive the product to be
more effective than those in the control condition. We acknowledge
participants may bring their own opinions about advertising to the
study. However, these opinions tend to be evenly distributed across
experimental conditions based on random assignment procedures. Thus,
any differences result from the experimental manipulations.
    (Comment 3) From AbbVie: We acknowledge we have not seen the test
ad; but, we wish to point out that questions 13 and 17 rely on the ad
presenting numeric efficacy and safety information that can be
interpreted by respondents.
    (Response) Prior research has shown that consumers can reach
numeric judgments about efficacy and risk despite no numeric
information being presented (Ref. 5). As described in our study design
(see table 1), we are not manipulating quantitative safety information
and not all test ads contain quantitative efficacy information. We have
worked with an expert reviewer in OPDP to produce efficacy claims that
are realistic for this drug product class.
    (Comment 4) From AbbVie: Question 18 relies on the ad presenting
information about the seriousness of one or more ``side effects'' that
the respondent could rank. We do not usually see print ads that present
details about the extent of the seriousness of one or more side
effects. In the absence of this presentation, how are respondents to
answer this question?
    (Response) We find that consumers are generally able to
differentiate between the seriousness of various risks and side
effects, and also that they can make judgments about the overall (gist)
seriousness of the risks and side effects. We ask this question with
the intention to detect whether or not exposure to market claims and
efficacy information impacts risk perceptions.
    (Comment 5) From AbbVie: The answers to questions 21 to 26 may
reflect a patient's perception of their doctor rather than the ad.
Therefore, the answers may not reflect what was communicated in the ad
but rather

reflect the patient-doctor relationship (e.g., patient perception of
their doctor).
    (Response) We are endeavoring to replicate the results of Mitra et
al. (Ref. 4), who found that market leadership claims affected consumer
beliefs about doctor's judgments.
    (Comment 6) From AbbVie: In the table headers for questions 27 and
28, please change ``claim'' to ``statement'' so that it matches the
text in the question.
    (Response) We will make this change.
    (Comment 7) From AbbVie: It is beneficial to rotate the order of
response choices in questions 27 and 28 as is done in prior questions.
Some of the features a-h are broad (b. pictures and images) while some
are specific (e. percentages). It would be better to compare the very
general features in a question and group the very specific features
into another question to compare like features.
    (Response) We will make this change.
    (Comment 8) From AbbVie: For questions 35 to 38, rather than rank
from Strongly Disagree to Strongly Agree, which are absolutes, it would
be better to rank by frequency from Never to Always; this moves the
response to how often patients perceive this and away from absolutes.
    (Response) We acknowledge that it is difficult to rank agree/
disagree on all drugs. However, a scale range of Always-Never is
unipolar; we can't assess whether respondents think the opposite, e.g.,
that New drugs tend to be more risky or that the #1 Prescribed drug is
more risky. Our intention is to use these items as a moderator when
examining the impact of the experimental manipulations (i.e., market
claims, efficacy claims) on benefit and risk perceptions, intentions to
take the product, and other outcomes. We believe the most relevant
scale for this analysis is the current Strongly Disagree to Strongly
Agree scale. Although it would be interesting to assess participant
responding using both scales, doing so may not add significant value
relative to the additional burden it would pose for participants.
    (Comment 9) From AbbVie: We suggest that all the features of
question 43a to h be stated in the affirmative/positive. For example,
question 43h should be worded as ``the drug has few side effects'' to
be consistent with features of question 43a to g that are positively
stated.
    (Response) The proposed item, ``the drug has few side effects,''
assesses a different outcome than our current question, ``the drug has
serious side effects.'' We have also added items assessing ``drug cost
and/or copay'' and ``doctor's recommendation.'' For consistency, we
will change the wording so that all features are neutral (for instance:
The drug's side effects, opinions of people I know, how often the drug
is prescribed).
    (Comment 10) From Lilly: Given the proposed FDA research questions,
Lilly believes the design is appropriate and the sample size will allow
for breakouts by each cell. In advertising A/B tests, in which this is
similar to, all aspects of the stimulus not being tested are held the
same in order to reduce bias and isolate the feature being tested. We
strongly recommend that this guideline is followed in this study.
    (Response) We intend to hold all features other than the
manipulations constant in the stimuli.
    (Comment 11) From Lilly: One research objective for the main study
suggests that the study will measure perceptions of the doctors'
acceptance of the drug by respondents. Since respondents will only be
seeing a print ad and not interacting with a doctor, we believe the
research setting will be too artificial to gain meaningful insights
into this topic. We recommend removing the section (questions 21 to
26).
    (Response) Please see response to Comment 5 from AbbVie.
    (Comment 12) From Lilly: The details of the followup study are less
clear than the main study. What are the techniques and what are the
dependent measures on which the respondent will be asked to decide?
    (Response) The followup study assesses the relative weighting of a
market claim and efficacy in decisionmaking. Participants are asked to
choose a drug out of two options that vary in (1) the presence of a
market claim and (2) efficacy. We will examine product preference as a
function of efficacy using logistic regression. The difference in
efficacy between the two drugs on each choice set will be a continuous
predictor variable and drug choice will be a binary outcome variable.
Critically, we will examine whether, and to what extent, the efficacy-
choice relationship varies as a function of an added market claim;
thus, market claim presence will be an interaction term. The experiment
uses a discrete choice approach common in psychology and economics
(Ref. 8).
    (Comment 13) From Lilly: We suggest FDA stratify the sample for
both studies across demographic variables to ensure it is
representative of the U.S. diabetic population.
    (Response) We are applying demographic quotas to achieve a
representative sample.
    (Comment 14) From Lilly: The questionnaire employs a number of
different Likert scales that differ on the number of scale values and
definition of values. Lilly suggests using a standard five-point scale
with a mid-point and definitions for each value for all scalar
questions.
    (Response) We have changed the Likert scales to be internally
consistent.
    (Comment 15) From Lilly: For questions 9 and 16, by asking the
respondents to perceive overall quality of the drug, the survey risks
introducing perceptions outside of experimental control into the study.
Overall quality is a very broad topic and might be dependent on the
graphics, wording, and personal biases that are outside of the market
claims and efficacy levels being tested. We suggest removing these
questions, or changing the question to ``overall efficacy.''
    (Response) By asking these questions, we hope to detect any
differences in perceived quality between those exposed to different
experimental conditions. For example, those exposed to an ad with a #1
Prescribed market claim may perceive the product to be of higher
quality than those in the control condition. By keeping all ad elements
beyond the experimental manipulations (market claims, efficacy claims)
constant, we can ensure that significant differences between conditions
are a result of the manipulations rather than any extraneous factors.
Random assignment to conditions should also distribute any random
variance equally across all cells.
    (Comment 16) From Lilly: We recommend removing questions 13 and 17
as they have the potential to be misinterpreted or simply difficult for
the respondent to answer if the stimulus is not communicating
prevalence of the drug's side effects or benefits using precise
numbers.
    (Response) Please see response to Comment 3 from AbbVie.
    (Comment 17) From Lilly: For questions 27 and 28, we recommend
slightly changing the wordings for the possible answer choices to
``Yes/No, claim is/is not mentioned as a benefit in the ad'' for
question 27, and ``Yes/No, claim is/is not mentioned as a side effect
or risk in the ad'' for question 28.
    (Response) We agree that more specific wording would be helpful and
have revised the answer choices to read ``Yes, statement is mentioned
in the ad'' and ``No, statement is not mentioned in the ad.''
    (Comment 18) From Lilly: Recommend removing question 31 as the
question is an inverse of question 30 to avoid confounding data.

    (Response) We have removed question 31 (skepticism).
    (Comment 19) From Lilly: The instructions for the questions 35
through 38 section seem to have an omitted word. We recommend revising
to ``how much do you agree or disagree with the following statements?''
    (Response) Thank you for pointing this out. We will correct this.
    (Comment 20) From Lilly: We agree with placement of demographic
questions (questions 39-44) at the end but recommend reevaluating them
and consider removing them so as to avoid lack of response due to
respondent fatigue.
    (Response) The comment about respondent fatigue is well taken.
However, we are adhering to good questionnaire design in putting our
most important dependent measures first and are willing to accept the
potential tradeoff in missing demographic data.
    (Comment 21) From Lilly: We suggest providing a more complete list
of choices for question 43 and placing this question earlier in the
study.
    (Response) We appreciate this suggestion and have added questions
about cost.
    (Comment 22) From Merck: Merck supports the importance of
communicating information that can be understood by consumers so that
they can make better decisions about prescription drugs. We believe
that FDA should focus their efforts and research first on improving the
health literacy of approved patient labeling and then on DTC print
advertising. In addition, FDA should consider exploring the inclusion
of benefit information in patient labeling, which may help improve
consumer understanding and comprehension of patient labeling.
    (Response) We share the goal of improving communications about
prescription drugs. There are efforts underway within FDA examining
ways to improve patient labeling (Ref. 9). Although this comment is
outside the scope of this project, we will share this information
internally.
    (Comment 23) From Merck: Merck believes the current study design
limits the practical utility of the information collected. The study
proposes presenting efficacy information in the form of simple
quantitative information. Prior OPDP research acknowledged the
limitations of studying simple quantitative information. For many
prescription drugs, clinical trial outcomes are often more complicated
than simple frequencies, which limit the applicability of this
research. Numeracy challenges are common in people with inadequate
health literacy. Numeracy challenges are not well represented in online
research, and hence the proposed methodology may not detect a lack of
comprehension.
    (Response) We are pleased Merck has read FDA's prior research in
the area of communicating quantitative information. As this is the
first study examining the impact of quantitative efficacy information
on the perception of market share claims, we felt it was better to
start with relatively straightforward, though not simplistic,
quantitative efficacy information. We have worked with an expert
reviewer in OPDP to product efficacy claims that are realistic for this
drug product class. The efficacy claim communicates both the level of
expected benefit and the likelihood of experiencing that benefit. We
encourage additional research on this topic utilizing increasingly
complex quantitative information.
    We have included a measure of numeracy in our questionnaire. We
acknowledge that online panels may underrepresent individuals with
extremely low health literacy. Thus, any differences we find as a
function of numeracy in our sample may be magnified in the general
population.
    (Comment 24) From Merck: Merck recommends a mixed-method approach
to reach limited-literacy respondents. The phone or Web approach allows
for a broad, diverse geographic sample. Respondents with low health
literacy are not typically represented in these databases, and may need
to be recruited in less traditional places, such as literacy centers,
senior centers, and health clinics. Additionally, if a desktop computer
is required, this may inadvertently eliminate respondents from low
socioeconomic status, who are less likely to have a desktop computer
and more likely to have internet only on their mobile device.
    (Response) We acknowledge that internet administration is not
perfect and have chosen this method to maximize our budget. We will
permit the survey to be taken on a variety of devices. We are excluding
phones because the stimuli cannot be fully viewed on a very small
screen.
    (Comment 25) From Merck: For the followup study, we recommend
reducing the number of trials for respondents across health literacy
levels, as respondent fatigue can occur, resulting in reduced focus and
unreliably responses. Refining the methodology to present fewer choices
to each respondent, and assuring the clarity of the information
presented, would help to enhance comprehension.
    (Response) We agree that minimizing respondent burden is a
priority. We estimate that the 48 trials and instructions would require
less than 8 minutes, on average. Pretest data may reveal that the
experiment can be shortened without loss to validity, in which case we
will reduce the number of trials.
    (Comment 26) From Merck: Questions 6, 32, and 50 include
percentages. According to Health Literacy Missouri, natural frequencies
(1 out of 10) may be more useful than percentages. Research suggests
that less literate readers may interpret numbers as more risky when in
frequency form (1 out of 10) versus percentage form (10 percent).
    (Response) We have worked with an expert reviewer in OPDP to
product efficacy claims that are realistic for this drug product class.
    (Comment 27) From Merck: We suggest adding the following screener
question to increase the odds of recruiting limited-literacy
respondents: ``How confident are you in filling out medical forms by
yourself?''
    (Response) We acknowledge that internet panels underrepresent
individuals with very low literacy. Thus, it is important to
acknowledge that our findings may not apply to very low literacy
individuals. It would be prohibitively expensive for us to screen for
literacy up front in order to establish quotas. We will measure health
literacy and included it in analyses.
    The first two pretests and main study are expected to last no more
than 30 minutes. The third pretest and followup study are expected to
last no more than 15 minutes. This will be a one-time (rather than
annual) collection of information. FDA estimates the burden of this
collection of information as follows:

                                                              Table 2--Estimated Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per       Total             Average burden per response           Total hours
                                                 respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample Outgo (Pretests and Main Survey)......          16,384  ..............  ..............  .........................................  ..............
Screener Completes...........................           1,638               1           1,638  0.03 (2 minutes).........................            49.1
Eligible.....................................           1,556  ..............  ..............  .........................................  ..............
Completes, Pretest 1.........................             252               1             252  0.5 (30 minutes).........................             126
Completes, Pretest 2.........................             252               1             252  0.5 (30 minutes).........................             126
Completes, Main Study........................             495               1             495  0.5 (30 minutes).........................           247.5
Completes, Pretest 3.........................             108               1             108  0.25 (15 minutes)........................              27
Completes, Followup Study....................             216               1             216  0.25 (15 minutes)........................              54
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           629.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Lee, M. and Y-C. Lou, ``Consumer Reliance on Intrinsic and
Extrinsic Cues in Product Evaluations: A Conjoint Approach,''
Journal of Applied Business Research, 12(1):21-29, 2011.
2. Teas, R.K. and S. Agarwal, ``The Effects of Extrinsic Product
Cues on Consumers' Perceptions of Quality, Sacrifice, and Value,''
Journal of the Academy of Marketing Science, 28(2):278-290, 2000.
3. Rao, A.R. and K.B. Monroe, ``The Effect of Price, Brand Name, and
Store Name on Buyers' Perceptions of Product Quality: An Integrative
Review,'' Journal of Marketing Research, 26(3):351-357, 1989.
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ``How Do Consumers
Interpret Market Leadership Claims in Direct-to-Consumer Advertising
of Prescription Drugs?'' Advances in Consumer Research, 33:381-387,
2006.
5. O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al., ``Presenting
Efficacy Information in Direct-to-Consumer Prescription Drug
Advertisements,'' Patient Education and Counseling, 95(2):271-280,
2014.
6. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts
Box to Communicate Drug Benefits and Harms: Two Randomized Trials,''
Annals of Internal Medicine, 150(8):516-527, 2009.
7. Sullivan, H.W., A.C. O'Donoghue, and K.J. Aikin, ``Presenting
Quantitative Information About Placebo Rates to Patients,'' JAMA
Internal Medicine, 173(2):2006-2007, 2013.
8. Train, K.E., Discrete Choice Methods With Simulation, Cambridge
University Press, 2009.
9. Boudewyns, V., A.C. O'Donoghue, B. Kelly, et al., ``Influence of
Patient Medication Information Format on Comprehension and
Application of Medication Information: A Randomized, Controlled
Experiment,'' Patient Education and Counseling, 98(12):1592-1599,
2015.

    Dated: April 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10396 Filed 5-3-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Proposed Rules]
[Pages 88550-88552]
[FR Doc No: 2023-28237]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-2362; Airspace Docket No. 23-AEA-25]
RIN 2120-AA66

Amendment of Class D and Class E Airspace and Revocation of Class
E Airspace; Clarksburg, WV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class D and Class E airspace
and revoke Class E airspace at Clarksburg, WV. The FAA is proposing
this action as the result of a biennial airspace review. This action
will bring the airspace into compliance with FAA orders to support
instrument flight rule (IFR) operations.

DATES: Comments must be received on or before February 5, 2024.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-2362 and
Airspace Docket No. 23-AEA-25 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instruction 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, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to Docket Operations in Room W12-140 of the
West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    FAA Order JO 7400.11H, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class D airspace and Class E airspace extending
upward from 700 feet above the surface and revoke the Class E airspace
designated as an extension to Class D airspace at North Central West
Virginia Airport, Clarksburg, WV, to support IFR operations at this
airport.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.

    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it received on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or dely. The FAA may change this proposal in light of
the comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT post these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov as described in the system
of records notice (DOT/ALL-14FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the Federal Aviation Administration, Air
Traffic Organization, Central Service Center, Operations Support Group,
10101 Hillwood Parkway, Fort Worth, TX 76177.

Incorporation by Reference

    Class D and E airspace is published in paragraphs 5000, 6004, and
6005 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document proposes to amend the current version of that
order, FAA Order JO 7400.11H, dated August 11, 2023, and effective
September 15, 2023. These updates would be published subsequently in
the next update to FAA Order JO 7400.11. That order is publicly
available as listed in the ADDRESSES section of this document.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Proposal

    The FAA is proposing to amend 14 CFR part 71 by:
    Modifying the Class D airspace extending upward from the surface to
3,700 feet MSL to within a 7.1-mile (increased from 4.1-mile) radius of
the North Central West Virginia Airport, Clarksburg, WV, excluding that
airspace within a 1-mile radius of Wade F. Maley Field, Shinnston, WV;
and updating the outdated terms ``Notice to Airmen'' and ``Airport
Facility Directory'' to ``Notice to Air Missions'' and ``Chart
Supplement'';
    Revoking the Class E airspace designated as an extension to Class D
airspace at North Central West Virginia Airport as it is no longer
required;
    And modifying the Class E airspace extending upward from 700 feet
above the surface to within a 9.6-mile (increased from a 8.9-mile)
radius of North Central West Virginia Airport.
    This FAA is proposing this action as the result of a biennial
airspace review conducted in accordance with FAA orders, to bring the
airspace into compliance with current FAA orders, and to support IFR
operations at this airport.

Regulatory Notices and Analyses

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

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA WV D Clarksburg, WV [Amended]

North Central West Virginia Airport, WV
    (Lat. 39[deg]17'52'' N, long. 80[deg]13'39'' W)
Wade F. Maley Field, WV
    (Lat. 39[deg]24'22'' N, long. 80[deg]16'37'' W)

    That airspace extending upward from the surface up to and
including 3,700 feet within a 7.1-mile radius of North Central West
Virginia Airport excluding that airspace within a 1-mile radius of
Wade F. Maley Field. This Class D airspace area is effective during
specific dates and times established in advance by a Notice to Air
Missions. The effective dates and times will thereafter be
continuously published in the Chart Supplement.
* * * * *

Paragraph 6004 Class E Airspace Areas Designates as an Extension to
a Class D or Class E Surface Area.

* * * * *

AEA WV E4 Clarksburg, WV [Remove]

* * * * *

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

* * * * *

AEA WV E5 Clarksburg, WV [Amended]

North Central West Virginia Airport, WV
    (Lat. 39[deg]17'52'' N, long. 80[deg]13'39'' W)

    That airspace extending upward from 700 feet above the surface
within an 9.6-mile radius of North Central West Virginia Airport.
* * * * *

    Issued in Fort Worth, Texas, on December 19, 2023.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-28237 Filed 12-21-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71166-71168]
[FR Doc No: 2016-24965]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0213]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions of four
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any

loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to continue to operate CMVs in interstate commerce.

DATES: The exemptions were effective on September 16, 2016. The
exemptions will expire on September 16, 2018. Comments must be received
on or before November 14, 2016.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0213 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to 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.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for two years if it finds ``such exemption would likely achieve a level
of safety that is equivalent to or greater than the level that would be
achieved absent such exemption.'' The statute also allows the Agency to
renew exemptions at the end of the two-year period.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
    The four individuals listed in this notice have requested renewal
of their exemptions from the Epilepsy and Seizure Disorders prohibition
in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable two-
year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application. In accordance with 49 U.S.C. 31136(e) and 31315, each of
the four applicants has satisfied the conditions for obtaining an
exemption from the Epilepsy and Seizure Disorder requirements and were
published in the Federal Register (80 FR 16495). In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License information System (CDLIS) and the Motor Carrier Management
Information System (MCMIS) are searched for crash and violation data.
For non-CDL holders, the Agency reviews the driving records from the
State Driver's Licensing Agency (SDLA). These factors provide an
adequate basis for predicting each driver's ability to continue to
safely operate a CMV in interstate commerce.
    The four drivers in this notice remain in good standing with the
Agency, have maintained their medical monitoring and have not exhibited
any medical issues that would compromise their ability to safely
operate a CMV during the previous two-year exemption period. FMCSA has
concluded that renewing the exemptions for each of these applicants is
likely to achieve a level of safety equal to that existing without the
exemption. Therefore, FMCSA has decided to renew each exemption for a
two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each
driver has received a renewed exemption.
    As of September 16, 2016, the following four individuals have
satisfied the renewal conditions for obtaining an exemption from the
Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from
driving CMVs in interstate commerce (80 FR 16495): Lee Anderson (MA);
Gary Combs (KY); Roland Mezger (PA); and Robert Thomas Jr. (NC).
    These drivers were included in FMCSA-2014-0213. The exemptions were
effective on September 16, 2016, and will expire on September 16, 2018.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the two-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver

has remained seizure-free; (3) each driver must undergo an annual
medical examination by a certified Medical Examiner, as defined by 49
CFR 390.5; and (4) each driver must provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy of his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the four exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the Epilepsy
and Seizure Disorders requirement in 49 CFR 391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two
years unless revoked earlier by FMCSA.

    Issued on: October 7, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-24965 Filed 10-13-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Proposed Rules]
[Page 18166-18167]
[DOCID:fr21ap09-20]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0188; Airspace Docket No. 09-AGL-5]

Proposed Amendment of Class E Airspace; Port Clinton, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Port
Clinton, OH. Additional controlled airspace is necessary to accommodate
new Standard Instrument Approach Procedures (SIAPs) at Carl R. Keller
Field Airport, Port Clinton, OH. The FAA is taking this action to
enhance the safety and management of Instrument Flight Rules (IFR)
aircraft operations at Carl R. Keller Field Airport.

DATES: 0901 UTC. Comments must be received on or before June 5, 2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2009-0188/Airspace Docket No. 09-
AGL-5, at the beginning of your comments. You may also submit comments
on the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone: (817)
321-7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2009-0188/
Airspace Docket No. 09-AGL-5.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration (FAA),
Office of Air Traffic Airspace Management, ATA-400, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRMs
should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by adding additional Class E airspace for SIAPs
operations at Carl R. Keller Field Airport, Port Clinton, OH. The area
would be depicted on appropriate aeronautical charts.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9S, dated October 3, 2008, and effective October 31, 2008, which
is

incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 describes the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it would add
additional controlled airspace at Carl R. Keller Field Airport, Port
Clinton, OH.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, dated October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL OH E5 Port Clinton, OH [Amended]

Port Clinton, Carl R. Keller Field Airport, OH
    (Lat. 41[deg]30'59'' N., long. 82[deg]52'07'' W.)
Magruder Memorial Hospital, OH
Point in Space Coordinates
    (Lat. 41[deg]29'43'' N., long. 82[deg]55'50'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Carl R. Keller Field Airport and within 4
miles each side of the 083[deg] bearing from the airport extending
from the 7-mile radius to 9.4 miles east of the airport and within a
6-mile radius of the Point in Space serving Magruder Memorial
Hospital.
* * * * *

    Issued in Fort Worth, TX, on April 6, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-9054 Filed 4-20-09; 8:45 am]

BILLING CODE 4901-13-P


[Federal Register Volume 86, Number 93 (Monday, May 17, 2021)]
[Proposed Rules]
[Pages 26687-26688]
[FR Doc No: 2021-10123]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0298; FRL-10023-53-Region 7]

Air Plan Approval; Nebraska; Revisions to Title 129 of the
Nebraska Administrative Code; General Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State Implementation Plan (SIP) submitted by
the State of Nebraska on July 16, 2020. This proposed action will amend
the SIP to revise title 129 of the Nebraska Administrative Code by
removing a portion of the SIP that addresses general conformity.
General Conformity ensures that the actions taken by federal agencies
do not interfere with a state's plan to attain and maintain national
standards for air quality. Since states are no longer required to
include general conformity requirements in SIPs, these proposed
revisions remove unnecessary language and do not substantively change
any existing statutory or regulatory requirement. The proposed
revisions do not impact the stringency of the SIP or air quality nor do
they impact the State's ability to attain or maintain the National
Ambient Air Quality Standards. The EPA's proposed approval of this rule
revision is in accordance with the requirements of the Clean Air Act
(CAA).

DATES: Comments must be received on or before June 16, 2021.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2021-0298 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: Allie Donohue, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
7986; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

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

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2021-
0298, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The 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://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to amend Nebraska's SIP to include revisions
to title 129 of the Nebraska Administrative Code. The EPA is proposing
to approve revisions to the Nebraska SIP submitted by the State of
Nebraska on July 16, 2020. Specifically, the EPA is proposing to amend
the Nebraska SIP by removing a portion of the SIP as follows: Title
129, Chapter 40. General Conformity. EPA is proposing approval of these
revisions as they remove unnecessary language and do not substantively
change any existing statutory or regulatory requirement.
    The EPA approved this rule into the Nebraska SIP in 1972. In August
2005, Congress passed the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU) which
eliminated the requirement for states to adopt and submit General
Conformity SIPs. Section 6011 of SAFETEA-LU revised the conformity
requirements in section 176(c)of the CAA. Specifically, section 6011(f)
revised section 176(c)(4)(A) of the CAA by deleting the requirement for
the states to adopt and submit General Conformity SIPs.
    In 2010, EPA revised the General Conformity regulations to make the
adoption and submittal of the General Conformity SIP optional for state
and eligible federally-recognized tribal governments. See 75 FR 17253
(April 5, 2010). Since there is no longer a requirement for SIPs to
include general conformity requirements, EPA finds that the proposed
revisions will not impact the stringency of the SIP or air quality.
    States are no longer required to have their own general conformity
rules. If a state does not have a conformity SIP, then federal agencies
will conduct an evaluation under the requirements of 40 CFR 93.150-
93.165. The SIP revision being proposed for approval by this action
removes unnecessary language from the SIP and does not have an adverse
effect on air quality in Nebraska.

III. 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 submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice of this SIP revision from September 28,
2019 to November 6, 2019 and held a public hearing on November 7, 2019.
In a letter to the state dated November 7, 2019, the EPA stated that
the agency ``has no comment on the proposed repeal of this
regulation.'' The SIP revision meets the substantive requirements of
the CAA, including section 110 and implementing regulations.

IV. What action is the EPA taking?

    The EPA is proposing to amend the Nebraska SIP by approving the
state's request to remove Title 129 section 40. General Conformity. The
removal of this portion of the SIP will remove unnecessary language and
does not substantively change any existing statutory or regulatory
requirement. The EPA has determined that these changes will not impact
the stringency of the SIP or adversely impact air quality.
    The EPA is processing this as a proposed action because we are
soliciting comments on this proposed action. Final rulemaking will
occur after consideration of any comments.

V. Incorporation by Reference

    In this document, the EPA is proposing to amend regulatory text
that includes incorporation by reference. As described in the proposed
amendments to 40 CFR part 52 set forth below, the EPA is proposing to
remove provisions of the EPA-Approved Nebraska Regulations from the
Nebraska State Implementation Plan, which is incorporated by reference
in accordance with the requirements of 1 CFR part 51.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the 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 the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; 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).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations.

    Dated: May 7, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
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 CC--Nebraska

0
2. In Sec.  52.1420, the table in paragraph (c) is amended by removing
the entry ``129-40'' under the heading ``Title 129--Nebraska Air
Quality Regulations''.

[FR Doc. 2021-10123 Filed 5-14-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79886-79888]
[FR Doc No: 2015-32175]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0789; FRL-9940-13]

Chlorinated Paraffins; Request for Available Information on PMN
Risk Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is requesting new available data on certain chlorinated
paraffins in different industries and for different uses, to inform the
risk assessments for chlorinated paraffins submitted as Toxic
Substances Control Act (TSCA) Premanufacture Notices (PMNs). The risk
assessments have been placed in a public docket. Any comments on the
assessments or data to inform the assessments will be placed in the
docket subject to Confidential Business Information considerations.

DATES: Available data and/or comments must be received on or before
February 22, 2016.

ADDRESSES: Submit your data and/or comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2015-0789, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers, processors, or users of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.

B. What is the agency's authority for taking this action?

    This action is issued under the authority in Section 5 of the Toxic
Substances Control Act (TSCA), 15 U.S.C. 2604.

C. What action is the agency taking?

    EPA is requesting new available data on the chlorinated paraffins,
referenced in Unit II., in different industries and for different uses,
to inform the risk assessments for chlorinated paraffins submitted as
Toxic Substances Control Act (TSCA) Premanufacture Notices (PMNs). The
risk assessments have been placed in a public docket. Any comments on
the assessments or data to inform the assessments will be placed in the
docket subject to Confidential Business Information considerations.

C. Why is EPA taking this action?

    As a result of its TSCA new chemicals review, EPA preliminarily
determined that the above mentioned chlorinated paraffin PMN substances
may present an unreasonable risk to the environment for two independent
reasons: (1) The PMN substances are expected to be persistent,
bioaccumulative and toxic (PBT) chemicals; and (2) releases of the PMN
substances may exceed concentrations of concern (COCs) to aquatic and
sediment-dwelling

organisms, even without taking into consideration the expected
persistence and bioaccumulative properties of the PMN substances. EPA's
assessments of the PMN substances have been placed in the docket.
    1. The PMN substances are expected to be PBT chemicals based on the
following lines of evidence:
    (a) The available data on medium-chain chlorinated paraffins
(MCCPs), sediment core studies, environmental fate studies, and
associated calculations, indicate transformation half-lives of months
to years, depending on the environmental media. Even though there are
limited data on the long-chain chlorinated paraffins (LCCPs),
biodegradation data indicate increasing stability with increasing chain
length. LCCPs are also expected to have transformation half-lives
comparable to, or greater than, MCCPs. Therefore, the PMN substances
are expected to be very persistent.
    (b) The available data on MCCPs and LCCPs indicate that these
substances have bioconcentration factors (BCFs) and bioaccumulation
factors (BAFs) that exceed 1,000 or 5,000 liters per kilogram wet
weight of tissue (L/kg ww). Therefore, the PMN substances are expected
to be very bioaccumulative.
    (c) The available data on MCCPs and LCCPs indicate acute and
chronic toxicity to aquatic organisms with effect levels below 10
milligrams per liter (mg/L) or 0.1 mg/L, depending on the species and
MCCP or LCCP congener evaluated. Therefore, the PMN substances are
expected to be toxic to aquatic organisms.
    (d) EPA is concerned about PBT chemicals because even small
releases may persist in environmental media, build up in the
environment and concentrate/accumulate in organisms over time. These
properties increase the potential for continual exposure, and thus
risk.
    (e) EPA expects there to be releases of the PMN substances to the
environment resulting from distribution in commerce and during
processing and all of the substances' intended uses.
    2. Releases of the PMN substances may exceed concentrations of
concern to aquatic and sediment-dwelling organisms, even without taking
into consideration the expected persistence and bioaccumulation of the
PMN substances, based on the following evidence:
    (a) Using estimated environmental concentrations, the PMN
substances may present unreasonable acute and chronic risks to aquatic
organisms because releases result in exceedances of COCs for aquatic
organisms. Also, using the available measured concentrations of MCCPs
in the environment as supporting information, the PMN substances are
expected to partition to sediment and may partition to soil through
land application of biosolids; and may be released to the environment
resulting in levels at or above concentrations that are likely to
exceed the COC. These concentrations may present acute and chronic
risks to aquatic organisms.
    (b) EPA expects releases of the PMN substances to water during
processing and all of the substances' intended uses to result in
surface water concentrations that may present an unreasonable risk of
adverse effects to aquatic and sediment-dwelling organisms. As
described in EPA's risk assessment documents entitled ``Standard Review
Risk Assessment on Medium-Chain Chlorinated Paraffins (PMN P-12-0282,
P-12-0283) and Long-Chain Chlorinated Paraffins (PMN P-12-0284)'',
``Standard Review Risk Assessment on Medium-Chain Chlorinated Paraffins
(PMN P-12-0453) and Long-Chain Chlorinated Paraffins (PMN P-12-0433)'',
and '' Standard Review Risk Assessment: Medium Chain Chlorinated
Paraffins (PMNs P-14-0683/P-14-0684)'', EPA reviewed a variety of
sources to inform its assessment on the PMN substances, including:
Information provided in the PMNs, information on the environmental fate
of MCCPs and LCCPs in different environmental compartments, the
properties that control transport, and assessments performed by Canada
and the European Union.
    Given EPA's preliminary risk determinations, under section 5(e) of
TSCA, EPA has informed the PMN submitters that it does not believe that
manufacture of these PMN substances should commence (Qualice, LLC,) or
continue (Dover Chemical and INOVYN Americas, Inc.) absent the
development of sufficient information to permit a reasoned evaluation
of the environmental effects of the substances, as described in a
testing strategy shared with the PMN submitters. This testing strategy
and the risk assessments for these three groups of PMNs are available
in the public docket (EPA-HQ-OPPT-2015-0789).
    While EPA used information provided by the submitters of the PMNs,
EPA realizes that its assessment of some uses may be improved by more
specific information on the chlorinated paraffins identified above.
With this notice, EPA is requesting new, available information on
chlorinated paraffins in different industries and for different uses to
reduce the uncertainties in the risk assessments for the three groups
of PMNs, submitted under TSCA by three companies. Such information may
include whether there are uses for the PMN chlorinated paraffin
substances that do not present the potential for direct or indirect
release to water. In developing the risk assessments for these PMN
substances, EPA used the information provided by the submitters of the
PMNs and standard PMN models and scenarios. Processors and users of the
PMN substances may have specific available data on such issues as
treatment methods, environmental releases and other waste management
practices, particularly for non-water based applications. EPA has
received some information from the Independent Lubricant Manufacturers
Association and would like to augment this information with specific
data from other user sectors, particularly those sectors that formulate
and use chlorinated paraffins as plasticizers and flame retardants in
adhesives, sealants and coatings.

II. What chemicals are subjects of this notice?

    This notice covers seven medium- and long-chain chlorinated
paraffins (MCCPs and LCCPs). EPA is reviewing five PMNs as a result of
settlements resolving violations of the TSCA premanufacture notice
obligations for production and import of various chlorinated paraffins.
As part of consent decrees between the Department of Justice (DOJ) and
EPA and Dover Chemical (February 7, 2012) and separately between DOJ
and EPA and INEOS Chlor Americas (now INOVYN Americas, Inc) (August 21,
2012) these companies were required to submit premanufacture notices
under TSCA section 5 for all chlorinated paraffins domestically
produced or imported. Also as part of the settlement, the companies
were required to cease domestic manufacture and import of the closely-
related short-chain chlorinated paraffins, which have persistent,
bioaccumulative and toxic (PBT) characteristics.
    On March 30, 2012, EPA received three PMNs: P-12-282 for the new
chemical substance identified as Alkanes C14-16, chloro (no Chemical
Abstract Service Registry Number (CASRN) assigned yet), P-12-283 for
Tetradecane, chloro derivs. (no CASRN assigned yet), and Octadecane,
chloro derivs. (no CASRN assigned yet). On October 28, 2015, the
submitter, Dover Chemical Corporation, removed all prior assertions of
CBI claims covering any or

all of the information associated with these PMNs.
    On June 27, 2012, EPA received PMN P-12-0433 for the new chemical
substance identified as Alkanes, C18-20, chloro (CASRN 106232-85-3). On
July 9, 2012, EPA received PMN P-12-0453 for the new chemical substance
identified as Alkanes, C14-17, chloro (CASRN 85535-85-9). On August 13,
2012, EPA received PMN P-12-0453 for the new chemical substance
identified as Alkanes, C22-30, chloro (CASRN 288260-42-4). The
submitter, INEOS Chlor Americas (now INOVYN Americas Inc.), claimed
only production volume as CBI in these three PMN submissions.
    On July 10, 2014, EPA received PMN P-14-0683 for the new chemical
substance identified as Tetradecane, chloro derivs. (CASRN 198840-65-2)
and P-14-0684 for the new chemical substance identified as Alkanes,
C14-C16, chloro (CASRN 1372804-76-6). The submitter, Qualice, LLC, made
no CBI claims in their PMN submissions.
    As with all PMN submissions, EPA has followed the processes,
procedures and statutory provisions of TSCA section 5 for the
chlorinated paraffin PMNs, including EPA's Policy Statement on PBT New
Chemical Substances in the Federal Register of November 4, 1999 (64 FR
60194) (FRL-6097-7).

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 15, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2015-32175 Filed 12-22-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 18, 2006 (Volume 71, Number 96)]
[Notices]
[Page 28859-28860]
[DOCID:fr18my06-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-167-000]

Questar Overthrust Pipeline Company; Notice of Application

May 11, 2006.
    Take notice that on May 1, 2006, Questar Overthrust Pipeline
Company (Overthrust), 180 East 100 South, Salt Lake City, Utah 84111,
filed an application under section 7 of the Natural Gas Act seeking
authority to expand its interstate natural-gas transmission system by
constructing and operating 27.1 miles of 36-inch diameter pipeline and
related facilities in Uinta and Lincoln Counties, Wyoming to transport
up to 550,000 Dth/day, all as more fully set forth in the application
which is on file with the Commission and open for public inspection.
These filings are available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at

http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Lenard G. Wright, Manager, Federal Regulatory Affairs, Questar Pipeline
Company, 180 East 100 South, P.O. Box 45360, Salt Lake City, Utah
84145-0360 at<PHONE_NUMBER>, or by fax at<PHONE_NUMBER>.
    On December 15, 2005, the Commission staff granted Overthrust's
request to utilize the National Environmental Policy Act (NEPA) Pre-
Filing Process and assigned Docket No. PF06-9-000 to staff activities
involving the Overthrust's expansion project. Now, as of the filing of
Overthrust's application on May 1, 2006, the NEPA Pre-Filing Process
for this project has ended. From this time forward, Overthust's
proceeding will be conducted in Docket No. CP06-167-000, as noted in
the caption of this Notice.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: June 1, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7553 Filed 5-17-06; 8:45 am]

BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Pesticide Petition Number 2E7991

	EPA has received a pesticide petition, 2E7991, from Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ  08540 requesting, 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 by establishing a tolerance for residues of 1-Naphthaleneacetic acid (NAA) and its conjugates  in or on the raw agricultural commodities rambutan at 3 parts per million (ppm); avocado, mamey sapote and mango at 0.05 ppm; and fruit, pome, group 11-10 at 0.15 ppm. Upon approval of the aforementioned tolerances, this petition additionally requests to remove the tolerance for fruit, pome, group 11 at 0.15 ppm, as it will be superseded by the tolerance on fruit, pome, group 11-10 at 0.15 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. HED has now determined that the terminal residues of concern in plants are the parent compounds, NAA and its conjugates, based on the nature of residues identified from apple and olive studies [MRID 43948501 and 44190501].1

	2. Analytical method. The nature of the residues of NAA is adequately understood and an acceptable analytical method is available for enforcement purposes.2

	3. Magnitude of residues. . Avocados  -  All total NAA residues from five avocado field trials were <0.050 ppm at a 10 (+/-1) PHI after each application.  All total NAA residues were also <0.050 ppm in the decline trial.  Rambutan  -  The results from two rambutan trials show that the maximum total residue of NAA in rambutan fruit was 0.636 ppm after one application of NAA (90 ppm solution applied to runoff) and a 2 day PHI.2

B. Toxicological Profile

	1. Acute toxicity.  NAA and all its conjugates show low acute toxicity.3

	2. Genotoxicty. NAA and all its conjugates are not mutagenic.3

	3. Reproductive and developmental toxicity. There was no evidence of developmental toxicity at highest doses tested of 250 mg/kg/day in the rat or 150 mg/kg/day of NAA in the rabbit administered by gavage during the critical gestation period of pregnancy.  Reproductive effects of NAA sodium salt occurred at 210 mg/kg/day and were limited to reduced litter survival and pup weight throughout lactation in both generations of offspring in a two generation reproduction study. Parental effects (reduced body weight gain and reduced food consumption) occurred at the same dose level.4

	4. Subchronic toxicity The most common short term effect from high exposures to NAA and all its conjugates is reduced body weight gain, seen at dose levels of 200 mg/kg/day and higher. 3

	5. Chronic toxicity. Repeated exposure in the oral toxicity studies primarily resulted in decreased body weight and body weight gain accompanied by decreased food consumption.  Other chronic effects included vomiting, stomach lesions and slight sinusoidal histiocytosis in the livers of males (dogs) .Studies in the rat and mouse have shown no evidence of carcinogenicity .4

	6. Animal metabolism. The metabolism studies of the acid and its acetamide and the ethyl ester in animals provide supporting evidence that the toxicity of these various forms of NAA would be expected to be similar since all are metabolized to the acid form and eliminated from the body within 36 to 48 hours after exposure as glycine and glucuronic acid conjugates.4

	7. Metabolite toxicology. EPA has not identified any metabolites of toxicological concern.3

	8. Endocrine disruption. As the appropriate screening and/or testing protocols  under the Agency's EDSP have now been developed and vetted, the naphthalene acetates may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

C. Aggregate Exposure

	1. Dietary exposure. The acute and chronic aggregate risk assessments for naphthalene acetates include exposure from food and drinking water only.  Both acute and chronic aggregate risks are not of concern.3

	i. Food. Based on analyses of estimated dietary risks for the general U.S. population and various population subgroups, the acute and chronic dietary exposure estimates for naphthalene acetates are significantly below EPA's level of concern for all supported commodities and not a risk of concern.3

	ii. Drinking water. Based on screening level computer models that provide high-end estimates of pesticide concentrations for surface and ground water sources, all EDWCs are low and do not pose risks of concern.3

	2. Non-dietary exposure. Residential  -  Estimated dermal and inhalation MOEs for the most highly exposed scenario of residential exposure to the naphthalene acetates are well above the target MOE of 100 and do not pose risks of concern.  Occupational Handler  -  The Agency believes all naphthalene acetate handler risks are not of concern and all handlers will only be required to wear baseline PPE.  Post-Application Exposure  -  The MOEs for the two post-application exposure scenarios are well above the target MOE of 100 on the day of application and, therefore, not of risk concern.3

D. Cumulative Effects

	Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for the naphthalene acetates.  They do not appear to produce a toxic metabolite produced by other substances.  Therefore, for the purpose of risk assessments, EPA has not assumed that the naphthalene acetates have a common mechanism of toxicity with other substances.3

E. Safety Determination  Acute and chronic risk estimates for all commodities are less than 100% of the aPAD (0.5 mg/kg/day) and cPAD (0.15 mg/kg/day).2  The % aPAD and % cPAD utilized by the proposed tolerances are for small use minor crops and are not expected to add to the existing percentages.

	1. U.S. population. 2% of the aPAD and 1% of the cPAD.3

	2. Infants and children. Infants  -  8% of the aPAD and 6% of the cPAD.   Children  -  10% of the aPAD and 8% of the cPAD.3

F. International Tolerances

	No maximum residue limits (MRLs) for NAA, its salts, ester, and acetamide have been established in the Codex Alimentarius, the food code established by the UN's World Health Organization and the Food and Agriculture Organization;  therefore, issues of compatibility between Codex MRLs and U.S. tolerances do not exist.  Moreover, no Canadian or Mexican MRLs have been established for naphthalene acetates.3

FOOTNOTES: 1.  1-Naphthaleneacetic Acid (NAA), its Salts, Ester, and Acetamide.  Residue Chemistry Considerations for Reregistration Eligibility Decision. Case No. 0379. 2.  Enclosed Petition Proposing Tolerances for NAA Use in Avocado, Mango, Mamey Sapote and Rambutan 3.  Amended Reregistration Eligibility Decision.  October 2007. 4.  1-Naphthaleneacetic Acid  -  Toxicology Disciplinary Chapter for the Reassessment Eligibility Decision (RED) (or Registration Support) Document (Revised).  March 8, 2004