[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Notices]
[Pages 28706-28710]
[FR Doc No: E9-14212]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0648]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; PDUFA Pilot Project
Proprietary Name Review

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 July
17, 2009.

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
the title ``PDUFA Pilot Project Proprietary Name Review.'' 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,<PHONE_NUMBER>.

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.

PDUFA Pilot Project Proprietary Name Review

    In the Federal Register of October 7, 2008 (73 FR 58604), FDA
announced the availability of a concept paper entitled ``PDUFA Pilot
Project Proprietary Name Review.'' The concept paper describes how
pharmaceutical firms may evaluate proposed proprietary names and submit
the data generated from those evaluations to FDA for review under a
pilot program to begin by the end of fiscal year (FY) 2009.
    On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (Pub. L. 110-85, 121 Stat.
823), which includes the reauthorization and expansion of the
Prescription Drug User Fee Act (PDUFA IV). As part of the
reauthorization of PDUFA IV, FDA committed to certain performance
goals, including the goal of using user fees to implement various
measures to reduce, among other things, medication errors related to
look-alike and sound-alike product proprietary names. FDA also agreed
to develop and implement a voluntary pilot program to enable
pharmaceutical firms participating in the pilot to evaluate proposed
proprietary names and to submit the data generated from those
evaluations to the FDA for review. The concept paper is intended to
help pharmaceutical firms choose appropriate proprietary names for
their drug and biological products before submitting marketing
applications to FDA and describes how pharmaceutical firms may use
``best practices'' to carry out their own proprietary name reviews and
provide FDA with the data that result from those reviews. The goals of
the concept paper and the voluntary pilot program are to minimize the
use of names that are misleading or that are likely to lead to
medication errors, to make FDA's marketing application review more
efficient, and to make regulatory decisions more transparent. The
concept paper explains how an applicant who chooses to participate in
the pilot program could assess a proposed proprietary name for safety
(i.e., potential for medication errors) and, at the applicant's option,
for promotional implications, before marketing application approval and
subsequent marketing of a drug or biological product in the United
States, and how to submit the results of the assessment for review
under the pilot program.
    The information described in the concept paper and the data
collected may not be submitted to FDA until OMB has approved the
information collection associated with the pilot program. After OMB
approval, FDA will accept requests to register for the pilot program.
FDA will announce OMB's approval and other details on participating in
the pilot program in the Federal Register. FDA expects that the pilot
program will begin by the end of FY 2009.
    The information collection that will result from the voluntary
pilot program, as described in the concept paper, consists of the
following:
    1. Applicants should contact FDA to register and indicate the
approximate date of their proprietary name submission, as described in
the concept paper and as will be described in more detail when FDA
announces OMB's approval and the specific information on participating
in the pilot program.
    2. Applicants should contact the appropriate FDA center 120 days
prior to the intended date of the proposed proprietary name submission
to discuss the specific details of the planned submission. Applicants
should communicate with the Director in the Division of Medication
Error Prevention and Analysis in the Office of Surveillance and
Epidemiology in the Center for Drug Evaluation and Research, or the
Branch Chief at the Advertising and Promotion Labeling Branch of the
Division of Case Management in the Office of Compliance and Biologics
Quality in the Center for Biologics Evaluation and Research, concerning
any questions about their proposed submissions. For prescription
products, applicants should inform the appropriate center at the 120-
day pre-submission discussion if they plan to use alternative or
additional methods to evaluate the safety of their proposed proprietary
name. For nonprescription products, sponsors should discuss with FDA
different protocols that could be used for their specific drug products
prior to the submission of the proprietary name.
    3. Applicants should submit two separate sets of product name-
related information to enable parallel reviews by FDA as follows: (a) A
comprehensive evaluation of the proposed proprietary name including the
information and data listed in Appendix B (``Proposed Template For A
Pilot Program Submission'') of the concept paper; and (b) the
proprietary name information that they would ordinarily submit under
FDA's current practice. (Note: The proprietary name information
ordinarily submitted under FDA's current practice is not included in
the estimates in table 1 of this document because this information
collection is already approved under OMB Control Numbers 0910-0001 and
0910-0338).
    4. After review of the proprietary name submissions, and if FDA
informs the applicant that the proposed first-choice proprietary name
is unacceptable, the applicant should confirm in writing that it would
like its originally submitted second-choice name reviewed, or the
applicant should submit an alternative second-choice name along with
the information described in the concept paper. At that time, FDA will
begin review of the second-choice name. If an applicant has submitted a
complete proprietary name analysis for the second-choice name, the
responsible center will use discretion to determine whether to review
the applicant's analysis in addition to conducting its own analysis
using the traditional approach. Although FDA would ideally review the
applicant's completed proprietary name analysis for the second-choice
name, factors such as staffing and timelines will be used in making
this determination.

Comment and Related Issues

    In the Federal Register of December 23, 2008 (73 FR 78813), FDA
published a 60-day notice requesting comments on the information
collection. We received one comment, which raised the following issues:
    1. The comment stated that the focus of the Pilot Program should be
on safety evaluations for drug products that will be marketed in the
United States. The comment said that trademark clearance from both the
legal and regulatory perspectives is often conducted by sponsors to
support the geographic markets for the product and therefore often
extends beyond the United States. The comment said it is not uncommon
for pharmaceutical companies to develop trademarks that will be granted
registrations from trademark offices in connection with approvals from
health authorities in multiple countries with the goal of becoming
global trademarks. Except for product names in foreign markets that are
identical to the trademark under review, the comment recommended that
FDA limit its requests for search data to clearance activities relating
to trademarks that are in use or appear likely from public sources to
be in use in the near future in the United States. The comment said
that data from outside the United States can be voluminous and are not
necessary for the proper performance of FDA's functions or for
determining the

appropriateness of the name in the United States.
    The comment also expressed concern with ``FDA's proposed broad
request for trademark search-related information insofar as they apply
to all search queries.'' (The comment referenced bullet points on pages
14 and 36 of the concept paper). The comment said that FDA
underestimates the burden of collecting such information. At the early
stages of trademark clearance, the comment noted that a sponsor
generally begins with a list that could include hundreds of candidates,
and that this list is typically narrowed in successive waves of more
in-depth searches of candidates based on legal and regulatory concerns.
The comment said that because a sponsor cannot determine in advance
which of the candidates on the initial list will survive the clearance
process, sponsors would have to maintain the records of the early-
stage, en masse searches relating to possibly hundreds of names on the
list to comply with a request for all search queries. The comment said
that sponsors should not be expected to maintain search query
information for en masse search investigations on name candidates,
especially those which had been eliminated previously and well before
submission to FDA as proposed trademarks. It also asserted companies'
entitlement to maintain applicable legal privileges for information and
communications developed in the course of trademark availability
assessment.
    2. The comment also said that medication errors can be caused by
any number of system failures or other causes at any one or more stages
in the process of prescribing, dispensing, and administering
medications, and that medication errors are the result of multiple
causes. The comment said that there is no scientifically valid and
reliable method for measuring the extent to which pharmaceutical
proprietary names might contribute to the risk of such errors or
whether such methods could ever adequately take into account the
subjectivity and complexity of human perception. It also stated that
the agency's proprietary name review process must be guided by the
first amendment.
    3. The comment noted that the burden of the collection of
information should be minimized by using various automated collection
techniques and other forms of information technology, and referred to
the computerized databases listed in Attachment A of the concept paper.
The comment said that some of the databases listed have limited value
because they are substantially redundant with the collective content of
the remaining databases, are not amenable to automated searching, or
have more limited automated searching capabilities than others. The
comment also noted that some sponsors may not have the resources to
subscribe to many databases and will have to rely on the search
capabilities of vendors, and questioned whether vendors that offer
search services include all of the sources listed on Attachment A of
the concept paper.

FDA Response

    To evaluate the proposed information collection, FDA believes it is
important to recall that the information collection not only supports
the agency's statutory mandates to ensure that drugs are safe and
effective and are not misbranded, but also that it is part of a
voluntary pilot program intended to make FDA's regulatory decisions
more transparent and to explore ways to make FDA's application review
more efficient. As indicated in the concept paper, FDA committed to
this program in conjunction with the reauthorization of PDUFA IV, after
extensive discussion with industry, to support the goals of reducing
medication errors related to look-alike and sound-alike proprietary
names, unclear label abbreviations, acronyms, dose designations, and
error-prone label and packaging designs.
    The pilot program is intended not only to minimize the use of names
that are misleading or that are likely to lead to medication errors,
but also to provide a basis for FDA to determine whether in the future,
it would be feasible and preferable for FDA to achieve these goals
through review of analyses of proprietary names conducted and submitted
by applicants, as many applicants have suggested, rather than
conducting its own analyses, as is the current practice. To this end,
the proposed information collection recommended in the pilot program is
largely modeled on the information that FDA itself currently generates
and analyzes in evaluating proposed proprietary names, in accordance
with its statutory authorities and the first amendment. FDA requests
that these elements be submitted by pilot program participants because
of its own direct experience supporting the utility of such
information, but as the pilot program concept paper makes clear,
applicants can still participate in the pilot program if they plan to
deviate from the proposed proprietary name safety evaluation methods
recommended in the concept paper and instead use alternative or
additional methods. Also, to the extent that the comment also suggests
that the information collection for the pilot program should also be
limited to information related to safety concerns, we note that
applicants can participate in the pilot program without submitting any
information to evaluate the promotional implications of their proposed
proprietary names.

With Regard to the Specific Elements of the Comment

    1. FDA does not seek to expand the burden of collecting trademark
search-related information, and is not requesting that sponsors submit
broad trademark search queries or other search-related screening
information about any preliminary or early-stage proprietary name
candidates which the sponsor eliminated from consideration and
therefore did not submit to FDA for review as part of the proprietary
name pilot program.
    FDA is interested in collecting all search queries that are
specific to the proposed proprietary name a sponsor submits to the
pilot program for review, including all existing, publicly available
drug names initially identified as a potential source of confusion with
respect to the proposed name. Specifically, FDA requests that a sponsor
submit all of the search queries that were generated only for the
specific proposed proprietary name submitted to FDA. For each query,
the results are dependent upon how each data source was searched.
    Thus, in order for FDA to evaluate the strength of the results,
information pertaining to each query, such as--the system parameters
that were used for each search; the precise databases that were
searched; any thresholds imposed on the output; the date the search was
conducted or the last update of the database searched; the pooled
results with source citation and full product characteristics of each
name identified as a possible source of confusion with the proposed
name--should be provided on the proposed name submitted to FDA for
evaluation. Providing FDA with all of the search queries relevant to
the proposed name and associated tests, including the Failure Mode and
Effects Analysis, will permit FDA to understand and evaluate the basis
for the sponsor's conclusions that existing drug names that are
identical or potentially similar to the proposed proprietary name would
not be likely to cause confusion and medication errors. By submitting
this information, the sponsor would be supporting the goals of the
concept paper and the voluntary pilot program.

Such goals include not only minimizing the use of names that are
misleading or that are likely to lead to medication errors in the
clinical setting (due to look-alike and sound-alike proprietary names),
but also include allowing FDA to evaluate whether to have applicants
perform their own name analysis and submit resulting data to FDA for
review.
    At the conclusion of the pilot program, FDA will be evaluating what
information would be most useful as the basis of those industry-
conducted proprietary name reviews. These evaluations will be largely
qualitative. The results of the pilot program and recommended additions
and changes to methods based on the reported results will be discussed
in a future public meeting. With regard to the comment addressing legal
privilege related to trademark evaluations, as noted previously,
applicants can participate in the voluntary pilot program even if they
deviate from the proposed proprietary name safety evaluation methods
recommended in the concept paper, and therefore may determine for
themselves how to submit useful information without compromising legal
privileges related to trademark.
    FDA also acknowledges that ``search data'' for trademark clearance
activities collected from outside the United States can be voluminous,
particularly if sponsors are seeking to register a single global
trademark for their drug in multiple countries. As already indicated
FDA is not seeking broad trademark clearance search data but is
interested in information specifically relevant to assessing the
potential for medication error related to the specific proprietary name
proposed for the United States. For this purpose, FDA agrees that the
most relevant information includes information identifying product
names in foreign markets that are identical to the name proposed for
the U.S. market, regardless of active ingredient or other product
characteristic.
    In addition, FDA agrees that it is important to collect information
regarding phonological or orthographic similarities between the
proposed name and foreign drug names that are in use or appear likely
from public sources to be in use in the near future in the United
States; such names should be considered in the same way as the names of
any other drug products also in use in the United States.
    FDA believes that in certain circumstances, however, it is in the
interest of public health for sponsors to provide the agency with other
data that they may possess that indicates close similarities in
spelling and pronunciation between the proprietary name proposed for
the U.S. and foreign drug names. For example, patients in the United
States may experience medication errors related to confusion of the
names of a drug marketed in the United States and one obtained from a
foreign country, either while the patient was abroad or through other
means, whether or not the foreign drug is intended for the U.S. market
by the manufacturer. This potential situation presents a particular
public health risk where a drug product is currently marketed in a
foreign country under a proprietary name which is identical or very
similar to the proposed proprietary drug name under FDA review, but the
drugs contain a different active ingredient. FDA therefore believes it
is useful and supportive of the agency's drug safety mandates to
encourage the submission of such data in the pilot program.
    2. Concerning the comment that there is no scientifically valid and
reliable method for measuring the extent to which pharmaceutical
proprietary names might contribute to the risk of medication errors,
FDA agrees that medication errors can be caused by any number of system
failures or other contributing factors at any one or more stages in the
medication use system, and that medication errors may be the result of
multiple causes, many of which are not easily controllable. However,
proprietary product names have been widely recognized as one important
contributing source of medication errors, and one that is amenable to
control. In the U.S. healthcare system, healthcare practitioners rely
on a product's name as the critical identifier of the appropriate
therapy in a market of thousands of products. Although review of
proprietary names will not eliminate all medication errors, it can help
reduce the risk of such errors by identifying and eliminating a
contributing factor prior to drug approval. The Institute of Medicine
(IOM) has repeatedly recognized that medication use errors may occur
due to sound-alike or look-alike names, unclear labels, or poorly
designed packaging and are pivotal causes of these system-wide problems
(To Err is Human--Building a Safer Health System (2000) and Preventing
Medication Errors (2006)). (See section II.A. of the concept paper for
a brief summary of pertinent IOM conclusions). In 2007 Congress
responded to these IOM findings, and as part of the reauthorization of
PDUFA IV, mandated FDA's collection and use of user fees for, among
other things, the review of drug applications and drug safety
activities, in support of which FDA committed to meet performance
goals, several of which highlighted the importance of considering
proprietary names as a potential source of medication errors. These
PDUFA IV goals, communicated to Congress, include FDA's commitment to
implement this pilot program as one measure to help reduce medication
errors related to look-alike and sound-alike proprietary names.
    FDA has acknowledged in three public meetings on proprietary drug
review (held in June 2003, December 2003, and June 2008) that there is
no gold standard for testing proprietary drug product names to assess
the risk of medication error. At the public technical meeting held in
June 2008, topics included subsequent review of developments in the
science and practice of proprietary name analysis since the 2003
meetings, the strength of evidence for the current approaches to name
review for prescription and nonprescription products, and in the
absence of a gold standard, the elements of best practices in testing.
At the June 2008 public meeting, all of the proposed evaluation methods
were judged by individual experts participating in the public meeting
to be complementary and were considered to offer value in the name
testing process. As discussed in section IV of the concept paper, in
the absence of a gold standard, FDA emphasizes that the best approach
has proved to be the use of a combination of tests to evaluate name
appropriateness. The concept paper contains FDA's current thinking on
the logistics and name testing and evaluation under the pilot program.
However, docket number FDA-2008-N-0281 remains open for comment during
the pendency of the pilot program and FDA invites comments on human
factors testing. In addition, after accruing 2 years of experience with
pilot program submissions, including reviewing applicants' name
analyses that use alternative methodologies, FDA is committed to
publish draft guidance on best test practices for proprietary name
review following public consultation with industry, academia, and
others from the general public. Thus, the pilot program, in which
participants are free to propose and provide results of alternate
methodologies for name assessment, is in part intended to help inform
potential future program modifications and changes in information
collected to help prevent medication error.
    3. Concerning the comment that some of the databases listed in the
concept paper have limited value because of redundancy with the
collective content

of the remaining databases, and because they are not amenable to
automated searching or have more limited automated searching
capabilities than others, FDA understands that there may be some
overlap across some of the databases and/or some limitation to
automated search capabilities. However, as discussed in section IV.A.3.
of the concept paper, the majority of names with similarity to the
proposed proprietary name can be identified through database searches,
and a variety of publicly available databases and resources containing
product names can be used to identify similar names. FDA itself uses
databases, the Internet, and other printed and electronic drug product
resources to search for orthographic and phonological name
similarities. The concept paper recommends that applicants search a
variety of sources and, at a minimum, search the publicly available
databases listed in Appendix A of the concept paper ``Computerized
Resources'' because these databases are ones that FDA itself uses and
considers the information in these references useful screening tools if
properly searched. If a name appears in more than one database, it is
acceptable to list the name once and list the sources along with the
identified name. In addition, in most cases, the computerized resources
listed in Appendix A are publicly available, including the Phonetic
Orthographic Computer Analysis (POCA) software (see FDA's notice of
availability in the Federal Register of February 17, 2009 (74 FR 7450).
As part of the pilot program, FDA encourages sponsors to identify any
new databases or those databases which are more amenable to automated
searching.
    FDA estimates the burden of this collection of information in table
1 of this document. The ``Hours Per Response'' is for all of the
submissions and notifications to FDA described previously under
paragraphs 1 to 4 in this document, and is based on information
provided by industry as well as FDA's familiarity with the time
required for this information collection as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                 Number of       Number of Responses       Total Annual
                                                Respondents         per Respondent          Responses       Hours Per  Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Project Proprietary Name Review                       20                      1                   20                  480                    9,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14212 Filed 6-16-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Rules and Regulations]
[Page 69769]
[FR Doc No: 2012-28303]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 33

[Docket No. OST 2010-0298]
RIN 2105-AD83

Prioritization and Allocation Authority Exercised by the
Secretary of Transportation Under the Defense Production Act

AGENCY: Office of the Secretary of Transportation (OST), DOT.

ACTION: Confirmation of effective date.

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SUMMARY: On October 1, 2012, the Department published a final rule
requesting comment at 77 FR 59793 to clarify the priorities and
allocation authorities exercised by the Secretary of Transportation
(Secretary) under title I of the Defense Production Act of 1950 and to
establish the administrative procedures by which the Secretary will
exercise this authority. In the final rule, the Department requested
comment on certain revised definitions found in 49 CFR 33.20. No
comments were received by the comment closing date of October 31, 2012.
As a result, this document confirms that the October 1 final rule will
not be changed and its effective date is November 30, 2012.

DATES: Effective Date: This document confirms that the Department's
final rule at 77 FR 59793 is effective on November 30, 2012.

FOR FURTHER INFORMATION CONTACT: Donna L. O'Berry, Office of the
General Counsel, Department of Transportation, 1200 New Jersey Avenue
SE., Room W96-320, Washington, DC 20590; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: As the Department received no comments on
its final rule published on October 1, 2012, we are making no changes
to the rule and its effective date is November 30, 2012.

    Issued in Washington, DC, on November 14, 2012.
Ronald Jackson,
Assistant General Counsel for Operations.
[FR Doc. 2012-28303 Filed 11-20-12; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77870-77871]
[DOCID:fr19de08-196]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Burlington Junction Railway

[Waiver Petition Docket Number FRA-2008-0133]

    The Burlington Junction Railway (BJRY) located in Burlington, Iowa,
has petitioned FRA to grant a waiver of compliance from 49 CFR part
223, Railroad Locomotive Safety Glazing Standards, for one locomotive,
specifically locomotive number BJRY 8711. BJRY 8711 is used primarily
in switch service for an industrial park next to the city of Rochelle,
Illinois, which has a population of approximately 8,000 people. They
operate over three (3) miles of track and the surrounding area is
composed of warehousing and underdeveloped rural agriculture fields.
There are also three (3) grade crossings within the industrial park and
BJRY operates at a speed not exceeding ten (10) miles per hour. The
cost of replacing the existing glazing with FRA Type I or Type II
safety glazing would impose an extreme financial burden.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number 2008-
0133) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on December 15, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-30159 Filed 12-18-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Proposed Rules]
[Pages 50344-50346]
[FR Doc No: 2019-20715]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0729; Airspace Docket No. 19-AGL-12]
RIN 2120-AA66

Proposed Amendment of Air Traffic Service (ATS) Routes V-82, V-
217, and T-383 in the Vicinity of Baudette, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend two VHF Omnidirectional Range
(VOR) Federal airways, V-82 and V-217, and one area navigation (RNAV)
route, T-383. The FAA is proposing this action due to the planned
decommissioning of the VOR portion of the Baudette VOR/Distance
Measuring Equipment (VOR/DME) navigation aid (NAVAID). The Baudette VOR
is being decommissioned in support of the FAA's VOR Minimum Operational
Network (MON) program.

DATES: Comments must be received on or before November 12, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0729; Airspace Docket No. 19-AGL-12 at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. FAA Order 7400.11D, Airspace Designations and
Reporting Points, and subsequent amendments can be viewed online at
http://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:<PHONE_NUMBER>. 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: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the National Airspace System as necessary
to preserve the safe and efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2019-0729; Airspace Docket No. 19-AGL-12) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2019-0729; Airspace Docket No. 19-AGL-12.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood Blvd.,
Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend 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.

Background

    The FAA is planning to decommission the VOR portion of the
Baudette, MN (BDE), VOR/DME in May 2020. The Baudette VOR was one of
the candidate VORs identified for discontinuance by the FAA's VOR MON
program and listed in the Final policy statement notice, ``Provision of
Navigation Services for the Next Generation Air Transportation System
(NextGen) Transition to Performance-Based Navigation (PBN) (Plan for
Establishing a VOR Minimum Operational Network),'' published in the

Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-
1082. Although the VOR portion of the Baudette, MN, VOR/DME NAVAID is
planned for decommissioning, the DME portion is being retained with the
``BDE'' identifier. The ATS routes effected by the Baudette VOR
decommissioning are VOR Federal airways V-82 and V-217.
    With the planned decommissioning of the Baudette VOR, the remaining
ground-based NAVAID coverage in the area is insufficient to enable the
continuity of V-82 and V217 within the affected area. As such, proposed
modifications to V-82 and V-217 would result in the V-82 airway segment
between the Baudette VOR/DME and the intersection of the Baudette VOR/
DME 194[deg] radial and the Park Rapids, MN, VOR/DME 003[deg] radial
(BLUOX fix) and the V-217 airway segment between the Hibbing, MN, VOR/
DME and the Winnipeg, MB, Canada, VOR/Tactical Air Navigation (VORTAC)
being removed.
    To overcome the removal of the V-82 and V-217 airway segments, the
FAA plans to retain the current fixes located along those airway
segments to assist pilots and air traffic controllers already familiar
with them, for navigation purposes. Additionally, the Baudette, MN, DME
facility is planned to be retained and charted in its current location
as a DME facility with the ``BDE'' identifier. Further, the FAA
proposes to extend RNAV route T-383 between the BLUOX fix and the
Baudette, MN, DME facility to overlay the V-82 routing being removed.
Instrument flight rules (IFR) traffic could use the extended T-383
route segment, file point-to-point using the fixes that will remain in
place, or receive air traffic control (ATC) radar vectors to continue
operating through the affected area. Visual flight rules (VFR) pilots
who elect to navigate via the airways through the affected area could
also take advantage of the air traffic services previously listed.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to remove VOR Federal airways V-82 and V-
217 airway segments and extend RNAV route T-383 to overlay the V-82
routing being removed. The planned decommissioning of the VOR portion
of the Baudette, MN, VOR/DME has made this action necessary. The
proposed air traffic service (ATS) route actions are described below.
    V-82: V-82 currently extends between the Baudette, MN, VOR/DME and
the intersection of the Baudette VOR/DME 194[deg] and Park Rapids, MN,
VOR/DME 003[deg] radials (BLUOX fix), and between the Gopher, MN,
VORTAC and the Dells, WI, VORTAC. The FAA proposes to remove the airway
segment between the Baudette VOR/DME and the intersection of the
Baudette VOR/DME 194[deg] and Park Rapids, MN, VOR/DME 003[deg]
radials. The unaffected portions of the existing airway would remain as
charted.
    V-217: V-217 currently extends between the intersection of the
Madison, WI, VOR/DME 138[deg] and Badger, WI, VOR/DME 193[deg] radials
and the Winnipeg, MB, Canada, VORTAC. The airspace within Canada is
excluded and the portion of the airway that lies within the Beaver
Military Operations Area (MOA) is excluded when the Beaver MOA is
active. The FAA proposes to remove the airway segment between the
Hibbing, MN, VOR/DME and the Winnipeg, MB, Canada, VORTAC, as well as
the exclusion language addressing the airspace within Canada and the
Beaver MOA. The unaffected portions of the existing airway would remain
as charted.
    T-383: T-383 currently extends between the Gopher, MN, VORTAC and
the BLUOX, MN, fix. The FAA proposes to extend the route between the
BLUOX fix and the Baudette, MN, DME. The unaffected portions of the
existing airway would remain as charted.
    The NAVAID radials listed in the V-217 airway description below are
unchanged and stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a) and low
altitude RNAV T-routes are published in paragraph 6011 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 ATS routes listed in
this document would be subsequently published in the Order.
    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 proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

0
1. The authority citation for 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 6010(a) Domestic VOR Federal Airways.

* * * * *

V-82 [Amended]

From Gopher, MN; Farmington, MN; Rochester, MN; Nodine, MN; to
Dells, WI.
* * * * *

V-217 [Amended]

From INT Madison, WI, 138[deg] and Badger, WI, 193[deg] radials;
Badger; Green Bay, WI; Rhinelander, WI; Duluth, MN; to Hibbing, MN.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-383 Gopher, MN (GEP) to Baudette, MN (BDE) [Amended]
--------------------------------------------------------------------------------------------------------------------------------------------------------

Gopher, MN (GEP)                       VORTAC                                 (Lat.45[deg]08'44.47'' N, long. 093[deg]22'23.45'' W)
BRNRD, MN                              WP                                     (Lat. 46[deg]20'53.81'' N, long. 094[deg]01'33.54'' W)
BLUOX, MN                              FIX                                    (Lat. 47[deg]34'33.13'' N, long. 095[deg]01'29.11'' W)
Baudette, MN (BDE)                     DME                                    (Lat. 48[deg]43'22.07'' N, long. 094[deg]36'26.24'' W)

    Issued in Washington, DC, on September 18, 2019.
Scott M. Rosenbloom,
Acting Manager, Airspace Policy Group.
[FR Doc. 2019-20715 Filed 9-24-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Page 78202]
[FR Doc No: 2022-27668]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0098]

Brightline Trains Florida's Request for Approval To Field Test
Positive Train Control

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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

SUMMARY: This document provides the public with notice that on December
9, 2022, Brightline Trains Florida (BTF) submitted a document entitled,
``Brightline OX Line Segment Test Request 120922,'' dated December 9,
2022, to FRA. BTF asks FRA to approve its request so that BTF may field
test its trains that have been equipped with positive train control
(PTC) technology.

DATES: FRA will consider comments received by February 21, 2023. FRA
may consider comments received after that date to the extent
practicable and without delaying implementation of valuable or
necessary modifications to a PTC system.

ADDRESSES: All comments should identify the agency name and Docket
Number FRA-2022-0098 and may be submitted on https://www.regulations.gov. Follow the online instructions for submitting
comments. All comments received will be posted without change to
https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 49 CFR 236.1035, a railroad must
obtain FRA's approval before field testing an uncertified PTC system,
or a product of an uncertified PTC system, or any regression testing of
a certified PTC system on the general rail system. See 49 CFR
236.1035(a). BTF is requesting FRA's approval to field test the
Interoperable Electronic Train Management System on territory BTF owns
between Cocoa Junction and the Orlando International Airport, which
BTF's test request refers to as the Orlando Extension (OX) Line
Segment. As discussed below, please see BTF's test request for the
required information, including a complete description of BTF's Concept
of Operations and its specific test procedures, including the measures
that will be taken to ensure safety during testing.
    BTF's test request is available for review online at https://www.regulations.gov (Docket No. FRA-2022-0098). Interested parties are
invited to comment on the test request by submitting written comments
or data. During its review of the test request, FRA will consider any
comments or data submitted. However, FRA may elect not to respond to
any particular comment, and under 49 CFR 236.1035, FRA maintains the
authority to approve, approve with conditions, or deny the test request
at its sole discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2022-27668 Filed 12-20-22; 8:45 am]
BILLING CODE 4910-06-P