[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65734]
[FR Doc No: 2015-27253]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e) (1) (v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic 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>.
---------------------------------------------------------------------------

    \1\ Record of 10-6-15 telephone conversation with Richard
Jessee, Dominion Columbia Gas regarding 3rd party contractor
assistance.
    \2\ Notes from 10-13-15 conference call with Natural Resource
Group, LLC and National Fuel Gas Supply Corporation regarding
Northern Access 2016 Project.
    \3\ Summary of 9-8-15 telephone call with Cardno ENTRIX (FERC's
contractor), Rover Pipeline LLC (Rover), Fullbright & Jaworski LLP,
TRC (Rover's contractor), and Apex (Rover's contractor).

----------------------------------------------------------------------------------------------------------------
                 Docket No.                            File date                   Presenter or requester
----------------------------------------------------------------------------------------------------------------
                                                   Prohibited
----------------------------------------------------------------------------------------------------------------
1. CP15-115-000............................  10-7-15                       Anne M. Kudla.
2. EL15-18-000, EL15-18-001, EL15-67-000...  10-14-15                      Consolidated Edison Company of NY,
                                                                            Inc.
----------------------------------------------------------------------------------------------------------------
                                                     Exempt:
----------------------------------------------------------------------------------------------------------------
1. P-1494-000..............................  10-5-15                       Mayor Dewey F. Bartlett, Jr., City of
                                                                            Tulsa, OK.
2. CP15-504-000............................  10-13-15                      FERC Staff.\1\
3. CP15-115-000............................  10-14-15                      FERC Staff.\2\
4. CP15-93-000, CP15-94-000, CP15-96-000...  10-15-15                      FERC Staff.\3\
----------------------------------------------------------------------------------------------------------------

    Dated: October 21, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-27253 Filed 10-26-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Pages 62561-62562]
[FR Doc No: 2023-19635]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

------------------------------------------------------------------------
                                                    Docket Nos.
------------------------------------------------------------------------
Red Tailed Hawk Solar LLC...............  EG23-174-000
AEUG Union Solar LLC....................  EG23-175-000
Antelope Valley BESS, LLC...............  EG23-176-000
Rayburn Energy Station LLC..............  EG23-177-000
Trinity River Solar 1, LLC..............  EG23-178-000
Champion Solar 1, LLC...................  EG23-179-000

Crossvine Solar 1, LLC..................  EG23-180-000
Granite Hill Solar, LLC.................  EG23-181-000
Jones City Solar, LLC...................  EG23-182-000
Mayapple Solar, LLC.....................  EG23-183-000
Mountain Daisy Solar, LLC...............  EG23-184-000
Mowata Solar, LLC.......................  EG23-185-000
Earthrise Gibson City Interconnection,    EG23-186-000
 LLC.
Earthrise Lincoln Interconnection, LLC..  EG23-187-000
Earthrise Shelby County Interconnection,  EG23-188-000
 LLC.
Earthrise Tilton Interconnection, LLC...  EG23-189-000
Earthrise Crete Interconnection, LLC....  EG23-190-000
ETEM Remediation Two LLC................  EG23-191-000
Glover Creek Solar, LLC.................  EG23-192-000
PGR 2022 Lessee 9, LLC..................  EG23-193-000
Cascade Energy Storage, LLC.............  EG23-194-000
DeCordova BESS LLC......................  EG23-195-000
Crane 2 BESS, LLC.......................  EG23-196-000
SR DeSoto II, LLC.......................  EG23-197-000
SR DeSoto III, LLC......................  EG23-198-000
SR DeSoto III Lessee, LLC...............  EG23-199-000
SR Canadaville, LLC.....................  EG23-200-000
SR Canadaville Lessee, LLC..............  EG23-201-000
SR Lambert I, LLC.......................  EG23-202-000
SR Lambert II, LLC......................  EG23-203-000
TRS Fuel Cell, LLC......................  EG23-204-000
Algodon Solar Energy Holdings LLC.......  EG23-205-000
Algodon Solar Energy LLC................  EG23-206-000
Chisholm Trail Solar Energy Holdings LLC  EG23-207-000
Flat Ridge 4 Wind, LLC..................  EG23-208-000
Chisholm Trail Solar Energy LLC.........  EG23-209-000
Flat Ridge 4 Wind Holdings LLC..........  EG23-210-000
Flat Ridge 5 Wind Energy Holdings LLC...  EG23-211-000
Flat Ridge 5 Wind Energy LLC............  EG23-212-000
Lazbuddie Wind Energy LLC...............  EG23-213-000
Pixley Solar Energy Holdings LLC........  EG23-214-000
Pixley Solar Energy LLC.................  EG23-215-000
Lazbuddie Wind Energy Holdings LLC......  EG23-216-000
Last Mile Transmission LLC..............  EG23-217-000
Vikings Energy Farm LLC.................  EG23-218-000
Oak Ridge Solar, LLC....................  EG23-219-000]
------------------------------------------------------------------------

    Take notice that during the month of August 2023, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR 366.7(a)
(2022).

    Dated: September 6, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-19635 Filed 9-11-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Notices]
[Page 45773-45776]
[DOCID:fr06au08-75]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0451] (formerly Docket No. 2007N-0321)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental
Evaluation of the Impact of Distraction on Consumer Understanding of
Risk and Benefit Information in Direct-to-Consumer Prescription Drug
Broadcast Advertisements

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
September 5, 2008.

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 e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-NEW and title
``Experimental Evaluation of the Impact of Distraction on Consumer
Understanding of Risk and Benefit Information in Direct-to-Consumer
Prescription Drug Broadcast Advertisements.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-796-3792.

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.

Experimental Evaluation of the Impact of Distraction on Consumer
Understanding of Risk and Benefit Information in Direct-to-Consumer
Prescription Drug Broadcast Advertisements

    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 903(b)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the act.
    FDA regulations require that advertisements that make claims about
a prescription drug include a ``fair balance'' of information about the
benefits and risks of advertised products, in terms of both content and
presentation. Ads can present information in ways that can optimize or
skew the relative balance of risks and benefits. Both healthcare
providers and consumers have expressed concerns to FDA about the
effectiveness of its regulation of manufacturers' Direct-to-Consumer
(DTC) prescription drug advertising, especially as it relates to
assuring balanced communication of risks compared with benefits.
    One characteristic of DTC television broadcast ads is the use of
compelling visuals. Many assert that the visuals present during the
product risk presentation are virtually always positive in tone and
often depict product benefits. A consistently raised question is if
advertising visuals of benefits interferes with consumers'
understanding and processing of the risk information in the ad's audio
or text.
    The manner in which required risk information is presented in DTC
ads has been recently addressed in the Food and Drug Administration
Amendments Act of 2007 (FDAAA). Section 901(3) states that the major
statement in DTC broadcast ads ``shall be presented in a clear,
conspicuous and neutral manner.'' Further, the Secretary of Health and
Human Services ``shall establish standards for determining whether the
major statement is presented in such a manner.'' FDAAA does not define
how the objective of ``clear, conspicuous, and neutral'' is to be
achieved.
    The purpose of the proposed study is, in part, to determine whether
the use of competing, compelling visual information about potential
drug benefits interferes with viewers' processing and comprehension of
risk information about drugs in DTC advertising or with their cognitive
representations of the drugs. Positive visual images could influence
the processing of risk-related information and the final representation
of the advertised drug in multiple ways. First, compelling visuals
could simply distract consumers from carefully considering and encoding
the risk information. To the extent that compelling visuals cause them
to attend to or to process risk information less, participants exposed
to risk information with simultaneous compelling positive visuals
should recall fewer risks (and perhaps fewer benefits) than do
participants exposed to the risk information without the positive
visuals. Second, compelling visuals may affect the way consumers think
about the brand, specifically their attitudes toward the advertised
brand. An attitude is simply an association between an object and a
degree of positivity or negativity. Thus, the impact of varying visual
displays during the presentation of audio risks may be manifested in
varying attitudes toward the brand. This is important because brand
attitudes may be an important determinant of future behavior toward the
brand. In contexts where product information is complex, initial
impressions based on more subtle processes may have as significant an
impact on behavioral tendencies as impressions based upon more
``cognitively-effortful'' factual information. Since visual cues are
typically easier to process than verbal information, initial attitudes
for this group are likely to be greatly influenced by these cues. Under
many circumstances, people rely much less on facts that they know, such
as the number of risks associated with, for example, ibuprofen, and
much more on general feelings they have, such as strong positivity
toward a brand, such as the Advil brand of ibuprofen. Compelling
visuals during the audio risk presentation of DTC broadcast
advertisements have the potential to lead a consumer to form a positive
opinion of a drug for no other reason than that it is presented in the
same context as positive images.
    Another purpose of the present study is to examine the role of
textual elements in the processing of risk information. Sponsors often
place superimposed text (``supers'') onto the screen to clarify spoken
information or to provide extra information that is not included in the
audio. For example, information that fulfills certain requirements
(such as adequate provision statements, for example ``See our ad in * *
*'') and limits claims of product use may appear. Providing verbatim
text repetition of the risks required to be in the audio portion in
broadcast ads may facilitate processing the risks, but only if viewers
pay attention to the text. Viewers' attention may be affected by both
the prominence of the textual information and the combined effects of
text prominence and different visual information. The proposed study
examines these associations.
    A final purpose of this study is to provide FDA with information on
defining the presentation of the major statement as ``clear,
conspicuous, and neutral'' as required by FDAAA. We have limited data
about how consumers perceive risk and benefit information in DTC
broadcast ads as a function of exposure to different content and
presentations. Therefore, we do not fully understand the influence of
visual and textual factors on the conveyance of a balanced or
``neutral'' picture of the product.
    This study will investigate the impact of visual distraction and
the interplay of different sensory modalities (oral, visual) used to
present risk and benefit information during a television prescription
drug advertisement. Data from this study will provide useful
information for FDA as it considers whether it is appropriate to
develop guidance to help improve how broadcast ads present a
prescription drug's risks and benefits. This study will also provide
preliminary data on how FDA might interpret the ``clear, conspicuous,
and neutral'' standard. The data should help us plan whether additional
research is needed to develop the standards called for in FDAAA.
    Overview: To investigate the overall and interactive role of visual
images and text presentations during the audio presentation of risk
information in television DTC ads, we will create a variety of ads for
a new (fictitious) brand of high blood pressure medication. The ads
will vary only in the type of information shown on screen during the
presentation of required risk information (the ``major statement''). We
will conduct pretesting to determine whether participants will view one
version of the test ad two times or if the test ad will be viewed in
the context of other ads (``clutter reel''). Respondents

will answer questions about the test ad, including information about
product risks and benefits, whether they intend to ask the doctor about
the product, basic comprehension of the risk and benefit information,
and their general attitudes toward the product. This experimental
design will allow for comparisons between conditions in a controlled
presentation where only the visual information varies.
    Design: The study includes two primary designs that, taken
together, investigate three different variables.
    A one-way, 5 condition design will examine the impact of degree of
consistency between visuals presented during orally presented (audio)
risk information. The visuals will be either very consistent, somewhat
consistent, neutral, somewhat inconsistent, or very inconsistent with
the audio risk information. The consistent conditions will visually
reinforce the product risks by presenting the words of the risks on the
screen as they are being spoken. The inconsistent conditions will
reinforce the product's benefits by presenting visuals that suggest
blood pressure being decreased from high to normal levels. The degree
or magnitude of consistency will be manipulated by including fewer
pieces of information, interspersed with images of the fictitious drug
logo. A control or ``neutral'' condition will consist of showing the
brand logo during the entire audio risk presentation.
    The second design will be a two-way factorial design combining each
level of one independent variable with each level of a second
independent variable. The first variable consists of three levels of
visual ``tone''--neutral, mildly positive, and highly positive. The
second variable consists of three levels of prominence of ``supers''--
level one, level two, and no SUPER (control).
    Because the control cell in each of the 2 designs will overlap
(neutral, no SUPERs), both designs together will amount to a total of
13 separate ``cells,'' and corresponding versions of advertisements for
the fictitious brand.
    In a separate sub-experiment, 5 selected cells taken from across
the two designs will assess implicit attitudes using the Attitude
Misattribution Procedure (AMP). The questions asked of the participants
in the AMP conditions will be reduced in number to account for the
additional time needed to administer the AMP.
    Eligible participants for the study (n= 2,400, following
pretesting) will be recruited from Synovate Inc.'s online Internet
panel. They will be 40 years of age or older to increase the likelihood
of including members of the population most likely to have high blood
pressure. At least 30% of the recruited sample within each of the
designs will have equal to or less than a high school education. The
composition of participants in each format condition will be balanced
with respect to gender (50% female, +/- 10%). Panel members who meet
age and education requirements will not be screened further for disease
condition.
    Dependent Measures: The primary dependent variables are recall and
comprehension of risk and benefit information. We will also investigate
behavioral intention and attitudes toward the fictitious brand. In a
separate sub-experiment using only five cells throughout both designs,
we will use the AMP, in addition to some explicit measures, to collect
implicit attitude measures that should not be affected by social
desirability biases.
    In the Federal Register of August 22, 2007 (72 FR 47051), FDA
published a 60-day notice requesting public comment on the information
collection provisions. Thirty commenters responded. In total, this
amounted to approximately 29 distinct comments that specifically
referenced the study. Of these, 12 were not PRA related. As a result of
the comments that were PRA-related, FDA made extensive modifications to
the study's methodology and design. As reflected in these
modifications, we agreed to: (1) Change from a mall-intercept to an
Internet administered procedure, (2) limit use of the AMP to a sub-
experiment consisting of only five of the experimental conditions, (3)
add questions addressing the advertised (fictitious) drug's benefits,
and (4) make certain changes to the wording of the questions. Changing
the administration procedure also allows us to double our sample size
and test more conditions. In response to comments received both by the
commenters and by our peer reviewers, we also decided to conduct
significantly more pretesting than originally planned to address the
suggestion that the test ad should be embedded in a clutter reel of
other ads and to test the validity of the stimulus manipulations (the
mocked up advertisements). We disagreed, primarily because of time and
complexity constraints, with suggestions to: (1) Add more independent
variables, (2) recruit a different set of participants, (3) change the
use of Chinese characters in the (now more limited) AMP-measured
conditions, (4) add certain additional dependent measures, (5) increase
or decrease the number of behavioral intention questions (both were
requested), (6) control for baseline attitudes (because this is not
needed in an experimental design and we are using a fictitious drug for
the stimulus materials), or (7) get industry approval and public
comment on the mocked up ads.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                     No. of        Annual Frequency     Total Annual        Hours per      Total
        21 CFR Section            Respondents        per Response        Responses           Response      Hours
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     1,600                  1              1,600                .03   48
 Screener, pretesting
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                       800                  1                800                .16  128
 Questionnaire, pretesting
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     4,800                  1              4,800                .03  144
 Screener, study
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     2,400                  1              2,400                .25  600
 Questionnaire, study
----------------------------------------------------------------------------------------------------------------
Total                                                                                930
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18091 Filed 8-5-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Pages 68454-68455]
[FR Doc No: 2014-27039]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1285]

Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 14 new drug applications (NDAs) from multiple holders of these
applications. The basis for the withdrawals is that the holders of the
applications have repeatedly failed to file required annual reports for
the applications.

DATES: November 17, 2014.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec.  314.81 (21 CFR 314.81).
    In the Federal Register of November 6, 2013 (78 FR 66748), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of 14 NDAs because the firms had failed
to submit the required annual reports for these applications. The
holders of these applications did not respond to the NOOH. Failure to
file a written notice of participation and request for hearing as
required by Sec.  314.200 (21 CFR 314.200) constitutes an election by
the applicant not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of the applications and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the 14 applications listed in
table 1 of this document.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
        Application No.                 Drug              Applicant
------------------------------------------------------------------------
NDA 004979....................  Multi-Vitamin        Smith Miller and
                                 Tablets.             Patch Inc., P.O.
                                                      Box 367, San
                                                      German, PR 00753.
NDA 008176....................  Methostan            Do.
                                 (methandriol)
                                 Tablets.
NDA 008326....................  Methischol           USV Pharmaceutical
                                 (inositol/vitamin    Corp., 500
                                 B12/racemethionine/  Virginia Dr., Fort
                                 choline chloride)    Washington, PA
                                 Injection.           19034-2779.
NDA 008362....................  Corticotropin        Vitarine
                                 Injection.           Pharmaceuticals
                                                      Inc., 227-15 North
                                                      Conduit Ave.,
                                                      Springfield
                                                      Gardens, NY 11413.
NDA 009346....................  ACTH                 Parke-Davis, 201
                                 (corticotropin)      Tabor Rd., Morris
                                 Injection.           Plains, NJ 07950.
NDA 009515....................  Hyrye (riboflavin    S.F. Durst and Co.,
                                 5'-phosphate         Inc., 5317-21
                                 sodium) Injection.   North Third St.,
                                                      Philadelphia, PA
                                                      19120.
NDA 010415....................  Flamotide            Philadelphia
                                 (riboflavin 5'-      Ampoule
                                 phosphate sodium)    Laboratories, 400
                                 Injection.           Green St.,
                                                      Philadelphia, PA
                                                      19123.
NDA 010565....................  Duracton             Nordic Biochemicals
                                 (corticotropin)      Inc., 45 Bay State
                                 Injection.           Rd., Boston, MA
                                                      02215.
NDA 010791....................  Rubivite             Bel Mar
                                 (cyanocobalamin)     Laboratories,
                                 Injection.           Inc., 6-10 Nassau
                                                      Ave., Inwood, NY
                                                      11696.
NDA 010831....................  Corticotropin        Organics/LaGrange,
                                 Injection.           Inc., 1935 Techny
                                                      Rd., suite 14,
                                                      Northbrook, IL
                                                      60062.
NDA 011015....................  RU-B-12-1000         Dow Pharmaceutical
                                 (cyanocobalamin)     Corp., 9550 North
                                 Injection.           Zionsville Rd.,
                                                      Indianapolis, IN
                                                      46268.
NDA 011578....................  Efacin (niacin)      Person and Covey,
                                 Tablet.              Inc., 616 Allen
                                                      Ave., Glendale, CA
                                                      91201.
NDA 017861....................  Acthar Gel           Armour
                                 Synthetic            Pharmaceutical
                                 (seractide           Co., P.O. Box 511,
                                 acetate) Injection.  Kankakee, IL
                                                      60901.
NDA 018087....................  Thyrel TRH           Ferring
                                 (protirelin)         Pharmaceuticals,
                                 Injection.           Inc., 400 Rella
                                                      Blvd., suite 300,
                                                      Suffern, NY 10901.
------------------------------------------------------------------------

    The Director, Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), and under authority delegated by the Commissioner, finds that
the holders of the applications listed in this document have repeatedly
failed to submit reports required by Sec.  314.81. In addition, under
Sec.  314.200, we find that the holders of the applications have waived
any contentions concerning the legal status of the drug products.
Therefore, under these findings, approval of the applications listed in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective November 17, 2014.

    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27039 Filed 11-14-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19692-19695]
[FR Doc No: 2021-07569]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petitions for Exemption From the Federal Motor Vehicle Theft
Prevention Standard; General Motors, LLC

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

ACTION: Grant of petitions for exemption.

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

SUMMARY: This document grants in full the General Motors, LLC's (GM)
petition for exemption from the Federal Motor Vehicle Theft Prevention
Standard (Theft Prevention Standard) for its Chevrolet Trax line
beginning in model year (MY) 2022. The petition is granted because the
agency has determined that the antitheft device to be placed on the
line as standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard.

DATES: The exemption granted by this notice is effective beginning with
the 2022 model year.

FOR FURTHER INFORMATION CONTACT: Carlita Ballard, Office of
International Policy, Fuel Economy, and Consumer Programs, NHTSA, West
Building, W43-439, NRM-310, 1200 New Jersey Avenue SE, Washington, DC
20590. Ms. Ballard's phone number is<PHONE_NUMBER>. Her fax number is
(202) 493-2990.

SUPPLEMENTARY INFORMATION: Under 49 U.S.C. Chapter 331, the Secretary
of Transportation (and the National Highway Traffic Safety
Administration (NHTSA) by delegation) is required to promulgate a theft
prevention standard to provide for the identification of certain motor
vehicles and their major replacement parts to impede motor vehicle
theft. NHTSA promulgated regulations at Part 541 (Theft Prevention
Standard) to require parts-marking for specified passenger motor
vehicles and light trucks. Pursuant to 49 U.S.C. 33106, manufacturers
that are subject to the parts-marking requirements may petition the
Secretary of Transportation

for an exemption for a line of passenger motor vehicles equipped as
standard equipment with an antitheft device that the Secretary decides
is likely to be as effective in reducing and deterring motor vehicle
theft as compliance with the parts-marking requirements. In accordance
with this statute, NHTSA promulgated 49 CFR part 543, which establishes
the process through which manufacturers may seek an exemption from the
Theft Prevention Standard.
    49 CFR 543.5 provides general submission requirements for petitions
and states that each manufacturer may petition NHTSA for an exemption
of one vehicle line per model year. Among other requirements,
manufacturers must identify whether the exemption is sought under
section 543.6 or section 543.7. Under section 543.6, a manufacturer may
request an exemption by providing specific information about the
antitheft device, its capabilities, and the reasons the petitioner
believes the device to be as effective at reducing and deterring theft
as compliance with the parts-marking requirements. Section 543.7
permits a manufacturer to request an exemption under a more streamlined
process if the vehicle line is equipped with an antitheft device (an
``immobilizer'') as standard equipment that complies with one of the
standards specified in that section.
    Section 543.8 establishes requirements for processing petitions for
exemption from the Theft Prevention Standard. As stated in section
543.8(a), NHTSA processes any complete exemption petition. If NHTSA
receives an incomplete petition, NHTSA will notify the petitioner of
the deficiencies. Once NHTSA receives a complete petition it will
process it and, in accordance with section 543.8(b), will grant the
petition if it determines that, based upon substantial evidence, the
standard equipment antitheft device is likely to be as effective in
reducing and deterring motor vehicle theft as compliance with the
parts-marking requirements of Part 541.
    Section 543.8(c) requires NHTSA to issue its decision either to
grant or to deny an exemption petition not later than 120 days after
the date on which a complete petition is filed. If NHTSA does not make
a decision within the 120-day period, the petition shall be deemed to
be approved and the manufacturer shall be exempt from the standard for
the line covered by the petition for the subsequent model year.\1\
Exemptions granted under Part 543 apply only to the vehicle line or
lines that are subject to the grant and that are equipped with the
antitheft device on which the line's exemption was based, and are
effective for the model year beginning after the model year in which
NHTSA issues the notice of exemption, unless the notice of exemption
specifies a later year.
---------------------------------------------------------------------------

    \1\ 49 U.S.C. 33106(d).
---------------------------------------------------------------------------

    Sections 543.8(f) and (g) apply to the manner in which NHTSA's
decisions on petitions are to be made known. Under section 543.8(f), if
the petition is sought under section 543.6, NHTSA publishes a notice of
its decision to grant or deny the exemption petition in the Federal
Register and notifies the petitioner in writing. Under section
543.8(g), if the petition is sought under section 543.7, NHTSA notifies
the petitioner in writing of the agency's decision to grant or deny the
exemption petition.
    This grant of petition for exemption considers GM's petition for
its Chevrolet Trax vehicle line beginning in MY 2022.

I. Specific Petition Content Requirements Under 49 CFR 543.6

    Pursuant to 49 CFR part 543, Exemption from Vehicle Theft
Prevention, GM petitioned for an exemption for its specified vehicle
line from the parts-marking requirements of the Theft Prevention
Standard, beginning in MY 2022. GM petitioned under 49 CFR 543.6,
Petition: Specific content requirements, which, as described above,
requires manufacturers to provide specific information about the
antitheft device installed as standard equipment on all vehicles in the
line for which an exemption is sought, the antitheft device's
capabilities, and the reasons the petitioner believes the device to be
as effective at reducing and deterring theft as compliance with the
parts-marking requirements.
    More specifically, section 543.6(a)(1) requires petitions to
include a statement that an antitheft device will be installed as
standard equipment on all vehicles in the line for which the exemption
is sought. Under section 543.6(a)(2), each petition must list each
component in the antitheft system, and include a diagram showing the
location of each of those components within the vehicle. As required by
section 543.6(a)(3), each petition must include an explanation of the
means and process by which the device is activated and functions,
including any aspect of the device designed to: (1) Facilitate or
encourage its activation by motorists; (2) attract attention to the
efforts of an unauthorized person to enter or move a vehicle by means
other than a key; (3) prevent defeating or circumventing the device by
an unauthorized person attempting to enter a vehicle by means other
than a key; (4) prevent the operation of a vehicle which an
unauthorized person has entered using means other than a key; and (5)
ensure the reliability and durability of the device.\2\
---------------------------------------------------------------------------

    \2\ 49 CFR 543.6(a)(3).
---------------------------------------------------------------------------

    In addition to providing information about the antitheft device and
its functionality, petitioners must also submit the reasons for their
belief that the antitheft device will be effective in reducing and
deterring motor vehicle theft, including any theft data and other data
that are available to the petitioner and form a basis for that
belief,\3\ and the reasons for the petitioner's belief that the agency
should determine that the antitheft device is likely to be as effective
as compliance with the parts-marking requirements of Part 541 in
reducing and deterring motor vehicle theft, including any statistical
data that are available to the petitioner and form the basis for the
petitioner's belief that a line of passenger motor vehicles equipped
with the antitheft device is likely to have a theft rate equal to or
less than that of passenger motor vehicles of the same, or a similar,
line which have parts marked in compliance with Part 541.\4\
---------------------------------------------------------------------------

    \3\ 49 CFR 543.6(a)(4).
    \4\ 49 CFR 543.6(a)(5).
---------------------------------------------------------------------------

    The following sections describe GM's petition information provided
pursuant to 49 CFR part 543, Exemption from Vehicle Theft Prevention.
To the extent that specific information in GM's petition is subject to
a properly filed confidentiality request, that information will not be
disclosed as part of this notice. See 49 CFR 512.20(a).
    In a petition dated August 14, 2020, GM requested an exemption from
the parts-marking requirements of the Theft Prevention Standard for its
Chevrolet Trax vehicle line beginning with MY 2022. Pursuant to section
543.6(a)(1), GM stated that the antitheft device described in its
petition, the PASS-Key III+, will be installed as standard equipment on
its Chevrolet Trax vehicles starting with MY 2022. PASS-Key III+ is a
transponder-based electronic engine immobilizer antitheft device.
    In accordance with section 543.6(a)(2), GM provided a detailed
description and diagram of the identity, design, and location of the
components of the antitheft device for its Chevrolet Trax vehicle line.
Key components of the antitheft device include a PASS-Key III+
controller module, engine control module (ECM), an electronically-coded
ignition key, a radio frequency (RF) receiver, an immobilizer exciter
module, three low frequency antennas, and a

passive antenna module and provided a diagram of the locations of the
components.
    GM stated that the PASS-Key III+ immobilizer device is designed to
be active at all times without direct intervention by the vehicle
operator. GM further stated that activation of the device occurs
immediately after the ignition has been turned off and the key has been
removed and deactivation of the antitheft device occurs automatically
when the engine is started.
    GM stated that the Chevrolet Trax vehicle line will be equipped
with one of two ignition versions. Specifically, the Chevrolet Trax
will be equipped with either a keyed or keyless ignition version of its
PASS-Key III+ immobilizer antitheft device. GM stated that the
``keyed'' ignition version utilizes a special ignition key and decoder
module and its electrical code must be sensed and properly decoded by
the controller module before the vehicle can be operated. GM further
stated that with the ``keyless'' ignition version, an electronic key
fob performs normal remote keyless entry functions and communicates
with the vehicle without direct owner intervention. Specifically,
during operation of the vehicle, when the owner presses the engine
start/stop switch, the vehicle transmits a randomly generated challenge
and vehicle identifier within the passenger compartment of the vehicle
via three low-frequency antennas, controlled by the passive antenna
module. The electronic key receives the data and if the vehicle
identifier matches that of the vehicle, the electronic key will
calculate the response to the vehicle using the challenge and secret
information shared between the key and the vehicle. The electronic key
then transmits the response via a radio frequency channel to a vehicle
mounted receiver, conveying the information to the PASS-Key III+
control module. The PASS-Key III+ control module compares the received
response with an internally calculated response. If the values match,
the device will allow the vehicle to enter functional modes and
transmit a fixed code pre-release password to the engine controller
over the serial data bus, and enable computation and communication of a
response to any valid challenge received from the engine controller. If
a valid key is not detected, the system will not transmit a fixed code
pre-release password to the engine controller and fuel will not be
delivered to the engine and the starter will not be enabled, so the
vehicle will be immobilized.
    GM provided information on the reliability and durability of its
proposed device as required by section 543.6(a)(3)(v). To ensure
reliability and durability of the device, GM followed its own standards
in assessing reliability and conducted tests to validate the integrity,
durability and reliability of the PASS-Key III+ device, including tests
for high temperature storage, low temperature storage, thermal shock,
humidity, frost, salt fog, flammability and others. GM further stated
that the design and assembly processes of the PASS-Key III+ subsystem
and components are validated for 10 years of vehicle life and 150,000
miles of performance.
    In support of its belief that its antitheft device will be as
effective as or more effective than the parts-marking requirement in
reducing and deterring vehicle theft, and in accordance with 49 CFR
543.6(a)(5), GM referenced data provided by the American Automobile
Manufacturers Association (AAMA) in support of the effectiveness of
GM's PASS-Key devices in reducing and deterring motor vehicle theft,
and stated that the PASS-Key III+ device has been designed to enhance
the functionality and theft protection provided by its first, second
and third generation PASS-Key, PASS-Key II, and PASS-Key III devices.
Specifically, GM stated that data which provide the basis for GM's
confidence that the PASS-Key III+ system will be effective in reducing
and deterring motor vehicle theft are contained in the response of the
American Automobile Manufacturers Association (AAMA) to Docket 97-042;
Notice I (NHTSA Request for Comments on its preliminary Report to
Congress on the effects of the Anti Car Theft Act of 1992 and the Motor
Vehicle Theft Law Enforcement Act of 1984). In the Report to Congress,
AAMA stated the more recent antitheft systems are more effective in
reducing auto theft.
    GM also stated that theft rate data have indicated a decline in
theft rates for vehicle lines equipped with comparable devices that
have received full exemptions from the parts-marking requirements. GM
stated that the theft rate data, as provided by the Federal Bureau of
Investigation's National Crime Information Center (NCIC) and compiled
by the agency, show that theft rates are lower for exempted GM models
equipped with the PASS-Key-like systems than the theft rates for
earlier models with similar appearance and construction that were
parts-marked. Based on the performance of the PASS-Key, PASS-Key II,
and PASS-Key III devices on other GM models, and the advanced
technology utilized in PASS-Key III+, GM believes that the PASS-Key
III+ device will be more effective in deterring theft than the parts-
marking requirements of 49 CFR part 541.

III. Decision To Grant the Petition

    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.8(b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541, either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds GM has provided adequate reasons for its belief that the
antitheft device for the Chevrolet Trax vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard.
This conclusion is based on the information the manufacturer provided
about its antitheft device. NHTSA believes, based on the supporting
evidence submitted by the manufacturer, that the antitheft device
described for its vehicle line is likely to be as effective in reducing
and deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard.
    The agency concludes that GM's antitheft device will provide four
of the five types of performance features listed in section
543.6(a)(3): Promoting activation; preventing defeat or circumvention
of the device by unauthorized persons; preventing operation of the
vehicle by unauthorized entrants; and ensuring the reliability and
durability of the device.
    The agency notes that 49 CFR part 541, Appendix A-1, identifies
those lines that are exempted from the Theft Prevention Standard for a
given model year. 49 CFR 543.8(f) contains publication requirements
incident to the disposition of all Part 543 petitions. Advanced
listing, including the release of future product nameplates, the
beginning model year for which the petition is granted and a general
description of the antitheft device is necessary in order to notify law
enforcement agencies of new vehicle lines exempted from the parts-
marking requirements of the Theft Prevention Standard.
    If GM decides not to use the exemption for its requested vehicle
line, the manufacturer must formally notify the agency. If such a
decision is made, the line must be fully marked as required by 49 CFR
541.5 and 541.6

(marking of major component parts and replacement parts).
    NHTSA notes that if GM wishes in the future to modify the device on
which this exemption is based, the company may have to submit a
petition to modify the exemption. Section 543.8(d) states that a Part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, section 543.10(c)(2) provides for
the submission of petitions ``to modify an exemption to permit the use
of an antitheft device similar to but differing from the one specified
in the exemption.''
    The agency wishes to minimize the administrative burden that
section 543.10(c)(2) could place on exempted vehicle manufacturers and
itself. The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if GM
contemplates making any changes, the effects of which might be
characterized as de minimis, it should consult the agency before
preparing and submitting a petition to modify.
    For the foregoing reasons, the agency hereby grants in full GM's
petition for exemption for the Chevrolet Trax vehicle line from the
parts-marking requirements of 49 CFR part 541, beginning with its MY
2022 vehicles.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95 and 501.8.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2021-07569 Filed 4-13-21; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: July 31, 2007 (Volume 72, Number 146)]
[Notices]
[Page 41718]
[DOCID:fr31jy07-49]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR07-12-000]

Giant Pipeline Company and Giant Industries Arizona, Inc.; Notice
of Request for Temporary Waiver of Tariff Filing and Reporting
Requirements

July 19, 2007.
    Take notice that on July 2, 2007, Giant Pipeline Company (GPL) and
Giant Industries Arizona, Inc. (GIA) pursuant to Rule 207(a)(2) of the
Commission's Rules of Practice and Procedure, 18 CFR 385.204 (2007),
tendered for filing an application for temporary waiver of the
Interstate Commerce Act (ICA) Section 6 and Section 20 tariff filing
and reporting requirements applicable to interstate common carrier
pipelines.
    GPL and GIA state that as a result of leasing arrangements with
TEPPCO Crude Pipeline, L.P., their pipeline facilities will be used
exclusively for the transportation of crude oil to refineries owned by
direct or indirect wholly-owned subsidiaries of Western Refining, Inc.,
the parent company of GPL and GIA.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time July 31, 2007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-14730 Filed 7-30-07; 8:45 am]

BILLING CODE 6717-01-P


Sampling of soil water and ground water should continue until the patterns of transport and
decline have been established for the test pesticide and associated degradates.  No study will be
terminated before the questions for which the study was designed have been reasonably
answered.  The registrant may suspend sample analysis with EPA approval (but not continued
sample collection) if they believe these criteria have been met while awaiting formal response
from EPA as to whether the Agency agrees that the criteria for study termination have been met.

56
CHAPTER 5 - SITE CHARACTERIZATION AND MONITORING PLAN DESIGN
REPORTS
Reports summarizing the site characterization process and the development of monitoring plans
for each study site should be submitted to EPA for approval prior to the installation of the
monitoring system.  The Monitoring Plan Design Report should be prepared simultaneously with
the Site Characterization Report.  Although both reports should be submitted before the
implementation phase of the study can begin, they do not have to be submitted together.  Final
approval of monitoring plans will be provided after review.  Required elements of both of these
reports are described below.  All reports and supporting data should be submitted in an editable
electronic format and as many hard copies as required by Registration Division or Special
Review and Reregistration Division.
5.1 SITE CHARACTERIZATION REPORT
The Site Characterization Report should be completed after the site characterization process.
The required elements of this report have been described in detail in Chapter 3.  They will be
briefly summarized here and include:
·
A summary of regional conditions,
·
A site base map,
·
Description of surficial soil characteristics,
·
Description of field testing methods and results in the vadose zone (saturated and
unsaturated hydraulic conductivity, soil water content)
·
Description of historical water needs of crop and net recharge at the site,
·
Descriptions and results of test pit excavations,
·
Description of the design, implementation, and results of the exploratory boring
program,
·
Results of shallow saturated zone investigations,
·
Description of the irrigation, ground water and precipitation water quality,
·
Development of a conceptual model of the site, and
·
Any additional information that may impact the design, performance, or
conclusions of the study.

57
·
Summary of Regional Conditions
Regional hydrogeology and agriculture should be described to provide a framework for
interpreting the site-specific data collected during the site characterization process.  A description
and map depicting the site location with respect to geographic features, regional topography,
dominant soil types, major aquifers (including those used for drinking water), regional water
table depths and direction of ground-water flow, regional irrigation trends, and other regional
agricultural practices should be included.  Maps and figures to illustrate the regional conditions
are encouraged.
5.11  Site Base Map
An accurate base map of each study site displaying the information collected during the site
characterization process should be included in the Site Characterization Report.  The required
elements of a site base map are listed in Chapter 3, Section 1.
5.12  Surficial Soil Characteristics
The results of detailed soil investigations conducted by a qualified soil scientist should be
presented.  A map depicting the soil series present at each study site should accompany a
description of the characteristics of the soils present on each site.  A site-specific soil profile
describing the various soil horizons typical at each study site should be included.  Soil profile
descriptions should follow the conventions established by the U.S. Department of Agriculture.
5.13  Field Testing Methods and Results
The procedures used to determine the hydraulic conductivity, matric potential head and soil water
content of each test site should be reported.  A map indicating the locations of test sites should be
presented along with the results of the tests.
5.14  Historical Water Needs and Net Recharge
The data used to establish a baseline value for the average historical water needs of the crop and
net recharge at the site should be summarized.  If historical weather data is derived from readily
available sources, such as the nearest NOAA weather station, the average of the monthly
precipitation and evaporation data should be summarized in a concise table, and the data source
cited.  If these data were derived from a local source near the study site, the summary table
should be accompanied by a more detailed description of the data source, as well as the name of
a contact that is willing to discuss and verify the data.  If historical irrigation records are
available, these should be described in text and summary tables.  If such data are not available,
the method used to estimate irrigation requirements should be described in detail.  Copies of the
historical irrigation records or calculations used to estimate irrigation needs should be included
as an appendix to the Site Characterization Report.

58
5.15  Test Pit Excavation
Test pit investigation results should be reported.  All excavations should be located on a site
map, and sketches and descriptions of significant features in the test pit walls should be included
in the report.
5.16  Exploratory Boring Program
The design of an exploratory boring program is described in Chapter 3, Section 2.
Documentation of all exploratory borings is critical to the characterization of subsurface
conditions at each study site.  This documentation should include a reference to the boring
methods and subsurface sample collection methods used, copies of all drilling logs, reference to
the preservation and transportation procedures for soil samples, a summary of the methods used
to analyze soil sample properties, and the physical and chemical characteristics of all soil
samples.  Quality assurance procedures ensuring the integrity of soil samples and the data derived
from those samples should also be reported.
5.17  Saturated Zone Investigations
The procedures used to gather information on the hydraulic characteristics of the shallow
saturated zone should be reported.  Contour maps illustrating the potentiometric surface of the
shallow aquifer at each study site should be constructed, and estimates of the hydraulic gradient
at each site should be reported.  Any information on water-table fluctuations associated with each
study site should be reported, along with estimates of the magnitude and potential impacts of the
fluctuations on the study.  Hydraulic conductivity estimates obtained at each study site should be
reported, and the methods used to determine these estimates should be described.  The range of
hydraulic conductivity values obtained from different locations across the site, the results of
pump testing, if used, and the results of laboratory permeability tests should be compared to
obtain an estimate of the variability in hydraulic conductivity at the site.
5.18  Background Water Quality
Basic data should be collected to establish the background quality of ground water, irrigation
water and precipitation at the study site.  Analyses should include major ions, major nutrients,
temperature, electrical conductivity and pH.  Additionally, water should be analyzed for the test
compound (to ensure that there are no residues, and to check the analytical method) and the
tracer compound (typically bromide).
5.19  Conceptual Model
Information required for each study site is presented in Chapter 3, Section 4 and includes:
·
A topographic map of the site,
·
A detailed map of surface soils (1:100 to 1:1,000),
·
Graphs or tables of particle-size distribution vs. depth,

59
·
Graphs or tables of matric potential head vs. depth and soil water content,
·
Graphs or tables of hydraulic conductivity vs. soil water content,
·
Graphs or tables of organic matter content vs. depth for each core,
·
An estimate of the amount of water needed for the tracer to reach ground water in
two years
·
An estimate of travel time needed for the tracer and/or pesticide to reach ground
water.
·
Graphs or tables of infiltration rates and saturated and unsaturated hydraulic
conductivity measured across each study site, and
·
Contour maps of site hydraulic conductivity, soil water content, matric potential
head and hydraulic head.  The latter map should illustrate the direction of ground-
water flow and give estimates of the hydraulic gradient.
Geologic cross-sections should be constructed from soil core information collected during site
characterization.  At least two cross-sections should be prepared for each study site that depicts
significant stratigraphic and hydrogeologic features.  One cross-section should be oriented
parallel to the direction of ground-water flow; the other should be perpendicular to the flow
direction.  The following information should be included on each cross-section:
·
Orientation of the section across the site,
·
Description of all stratigraphic units,
·
Structural features,
·
Zones of high and low hydraulic conductivity,
·
Location of each borehole intersecting or projected into the section, with the total
depth of the borehole and the depth to the water table indicated,
·
Indication of the rate and direction of ground-water flow.
5.2 MONITORING PLAN DESIGN REPORT (PROTOCOL)
In contrast to the level of site-specific detail required in a Site Characterization Report, extensive
detail in the Monitoring Plan Design Report should only be provided for chemical-specific

60
information, or when elements of the proposed study design vary from the recommendations
provided in the remaining chapters of this Guidance Document.  Study directors are discouraged
from submitting "draft protocols."  If the design requirements spelled out in this guidance
document are met, then timely approval of the Monitoring Plan Design Report will allow the
experimental phase of the study to begin on schedule.  Most subsequent changes to the study
design can be addressed in a series of memoranda, rather than by submitting a series of draft
reports.
If the study director believes that some aspect of the Monitoring Plan Design cannot be
consistent with the guidelines in this document, a detailed description and justification should be
submitted.   This situation may be caused by the conditions of the study site or chemical
characteristics of the pesticide or degradates.
The Monitoring Plan Design Report should clearly detail how the pesticide application,
sampling, and analysis will provide the data necessary to evaluate the leaching potential of the
pesticide and its degradates under the site-specific study conditions.  The following chemical-
specific data should be provided:
·
Application rates,
·
Compounds to be analyzed, including degradates and tracer,
·
Analytical methods,
·
Application method,
·
Equipment calibration methods, and
·
Method used to confirm the application rate.
The above information should be provided in summary form, with reference to readily available
standard operating procedures.  Field personnel should document referenced procedures in
official field notebooks to comply with Good Laboratory Practice requirements.
The design of the proposed monitoring program for each study site should also be fully described
in the Monitoring Plan Design Report.  The following information, detailed in Chapter 4, should
be provided in the Monitoring Plan Design Report:
·
The number of monitoring wells and suction lysimeters that will be installed,
·
A diagram showing proposed well and lysimeter locations,
·
A description of the proposed soil water sampler design,

61
·
A schematic diagram of the proposed well construction details,
·
Intended method, rate, schedule, and duration of irrigation,
·
Proposed experimental start and finish dates, and
·
Soil, soil water, soil water content, matric potential and ground-water sampling
schedules.
The Monitoring Plan Design Report should also detail the field procedures that will be used to
instrument the site, conduct the sampling, and abandon the site at the conclusion of the study.
These required elements are described in Chapter 4.  These procedures should be described in
summary form, with reference to readily available standard operating procedures.

62
CHAPTER 6 - MONITORING PLAN IMPLEMENTATION
Once the Monitoring Plan Design has been approved, work on instrumentation can begin.  At
this stage all design decisions have been made.  What remains is to install monitoring devices,
apply the pesticide and tracer, to collect samples, and to send them off for analysis.  This chapter
describes factors to be considered in the field during instrumentation, application, sample
collection, and sample handling.
EPA anticipates that field-scale ground-water monitoring studies will be conducted over a
minimum of a 3-year period.  This period includes 1 year for site selection, site characterization,
the development of a monitoring plan, and the installation of the monitoring system, and at least
2 years for post-application monitoring.  Additional time will likely be required for the
preparation of the final study report.  The duration of these studies may vary depending on the
results obtained.  Termination of monitoring at study sites requires EPA approval.  Generally,
conditions appropriate for termination of the study include:
·
The tracer has peaked in concentration in all monitoring wells at the site, and has
shown a marked decline for at least three months and
·
Residues of the pesticide (parent and degradates of concern) have completely
degraded and dissipated in the entire profile (vadose and, if applicable, saturated
zone).  This is generally defined as no detections for three consecutive sampling
times over an interval of at least two months, or
·
Pesticide residues have clearly peaked (parent and degradates of concern) in
ground water beneath the treated field (for each of the well clusters) or
concentrations have leveled off for an extended period (usually about 4 to 8
months) while significant  pesticide residues and tracer substance no longer
remain in the vadose zone.
Sampling of soil water and ground water should continue until the patterns of transport and
decline have been established for the test pesticide and associated degradates.  No study will be
terminated before the questions for which the study was designed have been reasonably
answered.  The registrant may suspend sample analysis with EPA approval (but not continued
sample collection) if they believe these criteria have been met while awaiting formal response
from EPA as to whether the Agency agrees that the criteria for study termination have been met.
This chapter is divided into the following sections:
·
Application of Pesticide and Tracer
·
Irrigation

63
·
Soil Monitoring
·
Soil Water Monitoring
·
Ground-Water Monitoring
·
Sample Handling and Tracking
6.1 APPLICATION OF PESTICIDE AND TRACER
The field crew should document that the application of the test pesticide and tracer corresponds
to the rates and methods defined in the Monitoring Plan Design Report.  Background
concentrations of the tracer in the vadose and saturated zones need to be established ahead of
time and the application rate should be sufficient that breakthrough of the tracer into shallow
ground water can be clearly detected with the analytical method used.  Application methods,
calibration procedures, amount applied, and the date and time of each application should be
documented carefully in the field notebook and reported in the First Quarterly and Final Report.
The tracer identified in the Monitoring Plan Design Report should be applied the same day as the
test pesticide.
Field notes should record the climatic conditions on the day of application, including wind speed,
temperature and precipitation.  It is particularly important to document in detail soil water
content and temperature conditions on the day of application and for following days.  The field
crew should take detailed notes (supported by photographs when appropriate) on the amount,
type, and positioning of plant residues or organic amendments relative to the planting rows (if
applicable), surface roughness, row spacing, ridge height and depth and method of plowing, crop
stage and vigor, weed composition and cover, and other factors which may significantly
influence pesticide dissipation especially in the critical first few hours and days after application.
Application should not take place on a day when conditions could cause pesticide loss due to
spray drift or runoff, or if conditions are inconsistent with label directions.  All entries to the field
notebook throughout the study should be consistent with FIFRA Good Laboratory Practices
(GLP).
6.2  IRRIGATION
Detailed guidance on how to determine the amount of irrigation water needed throughout the
course of the study is provided in Chapter 4.  The cooperating farmer tending the study field
should be familiarized with the schedule and method of irrigation identified in Monitoring Plan
Design.  With the exception of the irrigation event during the first week after pesticide
application, times when irrigation is needed will not necessarily correspond to days field
personnel are scheduled to conduct sampling.  Soil water content determinations up to a one
meter depth should always be made prior to any irrigation event as well as for all sampling events
(normally several in the first month after application and once a month thereafter).  The Study

64
Director should keep in close communication with the cooperating farmer to ensure that monthly
irrigation targets are being met, and that records of the dates and amounts of irrigation are being
kept.
6.3  SOIL MONITORING
Soil sampling is important for verification of field application rate.  For at least the month after
application (normally including samples taken 0, 1, 3, 7, 14, and 30 days post-treatment) samples
should not be composited before analysis in order to establish spatial variability of the
application.  Analysis of soil samples for pesticide and tracer residues should be continued until
at least three consecutive (normally monthly) samples show no residues above the minimum
detection (not quantitation) limit.
For soil monitoring, permanent equipment will not be installed in the field.  Therefore, the first
step in the field procedure is decontamination of sampling equipment, followed by sample
collection and handling.  Careful attention to avoid cross contamination of samples is important,
especially in the early sampling intervals when pesticide residues on the field are highest.  The
field crew should carefully document procedures in the field notebook, noting any problems or
deviations from the Monitoring Plan Design.
6.31  Decontamination of Sampling Equipment
Decontamination minimizes the likelihood that pesticide or tracer residues will be introduced
into deeper soil horizons during sampling.  A decontamination area should be designated in a
location downgradient of the study plot.  Soil-sampling equipment should be cleaned prior to
sample collection at each sampling interval.  Field-blank water samples should be taken with
each sampling round to test the effectiveness of the soil-equipment decontamination methods.
All rinsate used in the decontamination process should be disposed of away from the study site.
Additionally, rinsate should not be disposed of in “ecologically sensitive” areas, such as wetlands
or down other wells.
Field personnel can take additional precautions beyond equipment decontamination to prevent
sample cross-contamination.  For example, each person collecting samples should wear a clean
pair of gloves during collection of each soil core.  Decontaminated sampling equipment should
never come in contact with the ground until the actual sample collection.  Decontaminated
sampling equipment should be placed in a clean plastic bag between uses to avoid accidental
contact with contaminated soil or water.
6.32  Soil Sample Collection and Handling
The primary concern at the time of soil sampling is that representative samples be collected,
being careful not to cross-contaminate samples from different depths or cores.  Surface plant
residue should be included with shallow soil samples to account for pesticide residues clinging to
this material.  When collecting successive samples for a deeper core, the top portion of each core
should be carefully scraped to remove soil from the previous depth increment.  The locations of
sampling cores should be carefully measured and recorded in the field notebook, to avoid re-

65
sampling in a location previously disturbed by coring.  After sampling, core holes should be
refilled with pesticide-residue free soil according to State and local regulations.
6.4  PORE-WATER MONITORING
The primary purpose of soil water monitoring is to track the movement of dissolved pesticide and
tracer toward the water table.  Detection of tracer in the soil column indicates that downward
movement is occurring; detection of tracer in the ground water indicates that recharge has
occurred.  Monitoring pesticide residues gives an indication of the relative rate of transport of the
pesticide.
6.41  Instrumentation
The proper installation of soil water content monitoring devices is described in manufacturer's
materials and in USEPA (1986b), ASTM (1994), Nielsen and Johnson (1990), Everett, Wilson,
and Hoylman (1984), and Morrison (1983).  All lysimeters should be cleaned and leak tested
before installation in the field to ensure that they will be able to hold sufficient vacuum to draw a
soil-water sample.  Testing of lysimeters prior to installation is of special practical importance,
since any lysimeter that does not function properly during the study will require that a
replacement be installed.  Recommended methods for pre-installation cleaning and leak testing of
pore-water samplers are described in US EPA (1986b).  In some instances, the manufacturer of
the sampling device may recommend other cleaning procedures that are appropriate for the
specific device.
The maximum suction that can be applied to a lysimeter before contact with soil-water is broken
is the bubbling pressure (or air entry pressure).  If a suction greater than the bubbling pressure is
applied to a lysimeter, only air will be drawn into the collection cup.  If the bubbling pressure for
a lysimeter is not provided by the manufacturer, this value should be determined before
lysimeters are installed in the field.  This can be done by saturating the collection cup with water,
immersing the cup in water, and applying pressure to the lysimeter.  The bubbling pressure is the
pressure at which air escapes from the ceramic cup into the surrounding water.
Pressure-vacuum lysimeters offer some advantages over suction lysimeters.  For example, the
maximum operating depth of pressure-vacuum lysimeters is 15 meters, as opposed to 6 meters
for suction lysimeters.   Also, pressure-vacuum lysimeters collected samples through tubing
which is part of the sample equipment, thus tubing is not reused eliminating this as a potential
source of contamination.  Good hydraulic contact between the porous segment of the sampler and
the unsaturated media is needed to minimize leakage along the annulus of the borehole.  This
may be accomplished by packing silica flour around and beneath the porous segment of suction
samplers.  The use of other materials, such as sand or soil backfill will not provide as strong a
hydraulic connection and may necessitate equipment replacement.  Bentonite powder should be
used to form a tight seal in the annular space immediately above the porous component of the
sampler to prevent contamination from the surface.  The supervising scientist should record
problems encountered during installation or deviations from procedures and describe them in the
First Quarterly Report and in the Final Report.

66
6.42  Decontamination
Sample collection tubing in a pressure-vacuum lysimeter is a dedicated part of the sampling
device, and need not be decontaminated.  Other types of lysimeters, for example suction
lysimeters, have sampling tubing that is attached at the time of sampling and should be
decontaminated if it is used for multiple lysimeters.  In all cases, sampling tubing should not be
allowed to come in contact with the ground and should be handled with clean gloves during
sample collection.  Any rinsate should be disposed of away from the study area. Additionally,
rinsate should not be disposed of in “ecologically sensitive” areas, such as wetlands or down
other wells.
6.43  Sample Collection
The following procedures pertain to the collection of samples from pressure-vacuum lysimeters.
Methods for the collection of pore-water samples are generally provided by the equipment
manufacturer and are summarized in ASTM (1994), Nielsen and Johnson (1990), and USEPA
(1986a).
Pore-water samples should be collected from suction lysimeters by maintaining a constant level
of suction on the porous cup of the lysimeter for at least 24 hours.  The suction induces the flow
of water from the surrounding unsaturated media into the sampler.  To collect a sample, pressure
is applied to the second line and water is forced from the porous cup through the discharge tubing
into the collection bottle.
The appropriate amount of suction for each lysimeter depends upon the type of soil and the
ambient soil moisture at the time of sampling.  The suction placed on the lysimeter should be
greater than the suction naturally occurring in the soil in order to induce flow into the collection
container and to prevent backflow from the porous sampling cup to the soil matrix.  The pressure
applied to the lysimeter to force sample water from the collection cup to the surface should not
exceed the bubbling pressure of the lysimeter, or the collected sample will be forced from the
ceramic cup back into the surrounding soil.
The following should be included in the field notes for each lysimeter sampled:
·
Amount of suction applied,
·
Date and time that suction was applied,
·
Remaining suction at time of sampling,
·
Date and time of sampling,
·
Pressure applied for sampling and

67
·
Volume of sample collected
If the volume of available pore water or ground water is not sufficient for both pesticide and
tracer analyses, pesticide analyses should be given first priority.  If sample volume allows,
duplicate and field-spike samples should be collected. A trip blank sample should be included to
ensure cross-contamination of samples does not occur during shipment to the laboratory.
Any problems or variations in procedures in the Monitoring Plan Design Report should be
described in the Quarterly Reports and in the Final Report.  Reasonable effort should be made to
follow the prescribed sampling program.  Adjustments may have to be made during periods of


[Federal Register: April 20, 2009 (Volume 74, Number 74)]
[Rules and Regulations]
[Page 17900-17901]
[DOCID:fr20ap09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1084; Airspace Docket No. 08-ASO-17]

Establishment of Class E Airspace; Dallas, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; confirmation of effective date, technical
amendment.

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

SUMMARY: This action confirms the effective date of the direct final
rule that establishes controlled airspace at Dallas, GA, published in
the Federal Register on October 22, 2008, (73 FR 62876). This action
also changes the airport name from Paulding County Airport to Paulding
County Regional Airport.

DATES: Effective Date: 0901 UTC, April 20, 2009. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

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

SUPPLEMENTARY INFORMATION:

Correction to Final Rule

    After publication, it was observed that the airport name was
incomplete. Therefore, in the Federal Register Docket No. FAA-2008-
1084; Airspace Docket No. 08-ASO-17, published October 22, 2008, (73 FR
62876) make

the following change: On page 62876, in the third column, under
``Summary'', and on page 62877, in the second column, under ``History
and The Rule'', and on page 62878, in the first column, under ``ASO GA
E Dallas, GA [New]'', correct the airport name to read ``Paulding
County Regional Airport''.

Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on October 22, 2008, (73 FR 62876),
establishing Class E airspace to support Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedures
(SIAPS) developed for Paulding County Regional Airport. The FAA uses
the direct final rulemaking procedure for a non-controversial rule
where the FAA believes that there will be no adverse public comment.
This direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment or a written
notice of intent to submit such an adverse comment were received within
the comment period, the regulation would become effective on January
15, 2009. No adverse comments were received, and thus this notice
confirms that effective date.
* * * * *

    Issued in College Park, GA, on April 2, 2009.
Myron A. Jenkins,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E9-8846 Filed 4-17-09; 8:45 am]

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[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Rules and Regulations]
[Pages 26605-26606]
[FR Doc No: 2020-09486]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-1044; Airspace Docket No. 19-ASW-19]
RIN 2120-AA66

Amendment of Class E Airspace; McAlester, Henryetta, and Poteau,
OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E surface area airspace at
McAlester Regional Airport, McAlester, OK, and the Class E airspace
extending upward from 700 feet above the surface at Henryetta Municipal
Airport, Henryetta, OK; McAlester Regional Airport; and Robert S. Kerr
Airport, Poteau, OK. These actions are the result of airspace reviews
caused by the decommissioning of the McAlester VHF omnidirectional
range (VOR) navigation aid, which provided navigation information for
the instrument procedures at these airports. The geographic coordinates
of the McAlester Regional Airport are also being updated to coincide
with the FAA's aeronautical database. Airspace redesign is necessary
for the safety and management of instrument flight rules (IFR)
operations at these airports.

DATES: Effective 0901 UTC, July 16, 2020. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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 amends the Class E surface area airspace at McAlester Regional
Airport, McAlester, OK, and the Class E airspace extending upward from
700 feet above the surface at Henryetta Municipal Airport, Henryetta,
OK; McAlester Regional Airport; and Robert S. Kerr Airport, Poteau, OK,
to support IFR operations at these airports.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 5350; January 30, 2020) for Docket No. FAA-2019-1044 to
amend the Class E surface area airspace at McAlester Regional Airport,
McAlester, OK, and the Class E airspace extending upward from 700 feet
above the surface at Henryetta Municipal Airport, Henryetta, OK;
McAlester Regional Airport; and Robert S. Kerr Airport, Poteau, OK.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and
effective September 15, 2019, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists

Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71:
    Amends the Class E surface area airspace at McAlester Regional
Airport, McAlester, OK, by adding an extension within 1 mile each side
of the 020[deg] bearing from the airport extending from the 4-mile
radius to 4.1 miles north of the airport; and updates the geographic
coordinates of the airport to coincide with the FAA's aeronautical
database;
    Amends the Class E airspace area extending upward from 700 feet
above the surface to within a 6.3-mile radius (decreased from a 7.1-
mile radius) at Henryetta Municipal Airport, Henryetta, OK; and removes
the Henryetta Medical Center Heliport and associated airspace from the
Henryetta, OK, airspace legal description as the instrument procedures
at the heliport have been cancelled and the airspace is no longer
required;
    Amends the Class E airspace area extending upward from 700 feet
above the surface at McAlester Regional Airport, McAlester, OK, by
removing the McAlester VORTAC and associated extensions from the
airspace legal description; removes the Wampa LOM and associated
extension from the airspace legal description as it is no longer
required; removes the McAlester Regional Health Center Heliport and
associated airspace contained within the McAlester, OK, airspace legal
description as the instrument procedures at the heliport have been
cancelled and the airspace is no longer required; removes the
exclusionary language from the airspace legal description as it is no
longer required; adds an extension 2 miles each side of the 020[deg]
bearing from the airport extending from the 6.5-mile radius to 10.4
miles north of the airport; and adds an extension 2 miles each side of
the 200[deg] bearing from the airport extending from the 6.5-mile
radius to 10.5 miles south of the airport; and updates the geographic
coordinates of the airport to coincide with the FAA's aeronautical
database;
    And amends the Class E airspace area extending upward from 700 feet
above the surface at Robert S. Kerr Airport, Poteau, OK, by removing
the Rich Mountain VORTAC and associated extension from the airspace
legal description as it is no longer required; removes the Eastern
Oklahoma Medical Center Heliport and associated airspace contained
within the Poteau, OK, airspace legal description as the instrument
procedures at the heliport have been cancelled and the airspace is no
longer required; and removes the city associated with Robert S. Kerr
Airport in the header of the airspace legal description to comply with
changes to FAA Order 7400.2M, Procedures for Handling Airspace Matters.
    These actions are the result of airspace reviews caused by the
decommissioning of the McAlester VOR, which provided navigation
information for the instrument procedures at these airports.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

ASW OK E2 McAlester, OK [Amended]

McAlester Regional Airport, OK
    (Lat. 34[deg]52'57'' N, long. 95[deg]47'01'' W)

    Within a 4-mile radius of McAlester Regional Airport, and within
1 mile each side of the 020[deg] degree bearing from the airport
extending from the 4-mile radius to 4.1 miles north of the airport.

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

* * * * *

ASW OK E5 Henryetta, OK [Amended]

Henryetta Municipal Airport, OK
    (Lat. 35[deg]24'25'' N, long. 96[deg]00'57'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Henryetta Municipal Airport.
* * * * *

ASW OK E5 McAlester, OK [Amended]

McAlester Regional Airport, OK
    (Lat. 34[deg]52'57'' N, long. 95[deg]47'01'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of McAlester Regional Airport, and within 2
miles each side of the 020[deg] bearing from the airport extending
from the 6.5-mile radius to 10.4 miles north of the airport, and
within 2 miles each side of the 200[deg] bearing from the airport
extending from the 6.5-mile radius to 10.5 miles south of the
airport.
* * * * *

ASW OK E5 Poteau, OK [Amending]

Robert S. Kerr Airport, OK
    (Lat. 35[deg]01'18'' N, long. 94[deg]37'17'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Robert S. Kerr Airport.

    Issued in Fort Worth, Texas, on April 27, 2020.
Steven Phillips,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-09486 Filed 5-4-20; 8:45 am]
BILLING CODE 4910-13-P