[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61700-61703]
[FR Doc No: 2016-21350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2523]

Request for Comment on the Status of Vinpocetine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is requesting
comments related to the regulatory status of vinpocetine. Specifically,
we request comments on our tentative conclusion that vinpocetine is not
a dietary ingredient and is excluded from the definition of dietary
supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This
action is being taken as part of an administrative proceeding to
determine the regulatory status of vinpocetine. All comments submitted
by the comment deadline (see DATES) will be accepted as part of the
official record for this proceeding.

DATES: Submit either electronic or written comments on the notice by
November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that

identifies you in the body of your comments, that information will be
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-2523 for ``Request for Comment on the Status of
Vinpocetine.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cara Welch, Center for Food Safety and
Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    We are initiating an administrative proceeding under 21 CFR
10.25(b) to determine the regulatory status of vinpocetine (chemical
name: Ethyl apovincaminate). Specifically, we are trying to determine:
(1) Whether vinpocetine is a dietary ingredient within the meaning of
the FD&C Act and (2) whether it is excluded from being a dietary
supplement under the FD&C Act.

A. Statutory Background

    Under section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)),
the term ``dietary supplement'' is defined in part as a product (other
than tobacco) intended to supplement the diet that bears or contains
one or more of the following dietary ingredients: (A) A vitamin; (B) a
mineral; (C) an herb or other botanical; (D) an amino acid; (E) a
dietary substance for use by man to supplement the diet by increasing
the total dietary intake; or (F) a concentrate, metabolite,
constituent, extract, or combination of any ingredient described in
clause (A), (B), (C), (D), or (E).
    Additionally, under section 201(ff)(3)(B)(ii) of the FD&C Act, a
dietary supplement cannot include ``an article authorized for
investigation as a new drug . . . for which substantial clinical
investigations have been instituted and for which the existence of such
investigations has been made public'' unless the article was marketed
as a dietary supplement or as a food before such authorization.
    Recently, questions have been raised as to whether vinpocetine is a
dietary ingredient and is excluded from the definition of dietary
supplement under sections 201(ff)(1) and (3) of the FD&C Act,
respectively.

B. Factual Background

    According to records on file in FDA's Center for Drug Evaluation
and Research, vinpocetine was authorized for investigation as a new
drug in 1981.\1\ A trade press article from 1985 reported that four
single-center phase 3 clinical trials \2\ of vinpocetine had been
completed and that two major multicenter studies were ongoing (Ref. 1).
A 1986 article in a major newspaper reported that Ayerst had recently
completed a study of vinpocetine for the treatment of multiple-infarct
dementia at eight institutions in the United States (Ref. 2). An
article published in a medical journal in 1986 reported on the results
of a double-blind study of vinpocetine in elderly patients with central
nervous system degenerative disorders (Ref. 3). A trade press article
published in 1988 reported that vinpocetine was in phase 3 clinical
trials for Alzheimer's disease (Ref. 4). These articles document that
substantial clinical investigations of vinpocetine were instituted and
that the existence of these substantial clinical investigations was
made public.
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    \1\ An article becomes ``authorized for investigation as a new
drug'' after the sponsor has submitted an investigational new drug
application (IND) to FDA and the IND has gone into effect. Unless
FDA notifies the sponsor that the clinical investigation described
in the IND has been placed on clinical hold, the IND goes into
effect 30 days after being submitted to FDA (21 CFR 312.40(b)).
Although FDA will not disclose the existence of an IND that has not
previously been publicly disclosed or acknowledged (see 21 CFR
312.130), the existence of the 1981 IND for vinpocetine was publicly
disclosed in the press no later than 1986 (Ref. 2).
    \2\ Generally speaking, under our regulations pertaining to
investigational new drugs, there are three phases of a clinical
investigation of a new drug; phase 3 trials are the last in the
sequence and are ``expanded controlled and uncontrolled trials''
that are ``performed after preliminary evidence suggesting
effectiveness of the drug has been obtained, and are intended to
gather the additional information about effectiveness and safety
that is needed to evaluate the overall benefit-risk relationship of
the drug and to provide an adequate basis for physician labeling''
(21 CFR 312.21(c)).
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    On July 8, 1997, a new dietary ingredient notification \3\ for
vinpocetine was submitted to FDA (see FDA's Table of New Dietary
Ingredient Notifications

(available on the Web at http://www.fda.gov/food/dietarysupplements/newdietaryingredientsnotificationprocess/ucm109764.htm#new_din)). Four
additional new dietary ingredient notifications for vinpocetine were
later submitted to FDA.\4\
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    \3\ As defined in section 413(d) of the FD&C Act (21 U.S.C.
350b(d)), the term ``new dietary ingredient'' means a dietary
ingredient that was not marketed in the United States before October
15, 1994. Section 413(a) of the FD&C Act (21 U.S.C. 350b(a))
requires manufacturers and distributors who wish to market dietary
supplements that contain ``new dietary ingredients'' to submit a
notification containing safety information to FDA before they begin
marketing, unless the new dietary ingredient and all other dietary
ingredients in the dietary supplement have been present in the food
supply, without chemical alteration, as articles used for food.
    \4\ We acknowledged receipt of each of those new dietary
ingredient notifications without objection.
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C. Vinpocetine and Section 201(ff)(1) of the FD&C Act

    We first consider whether vinpocetine is a dietary ingredient under
section 201(ff)(1) of the FD&C Act--specifically, whether it is a
vitamin, mineral, herb or other botanical, amino acid, dietary
substance for use by man to supplement the diet by increasing the total
dietary intake, or a concentrate, metabolite, constituent, extract, or
combination of dietary ingredients from the preceding categories. We
are not aware of any argument that vinpocetine is a vitamin, a mineral,
or an amino acid. Thus, vinpocetine does not appear to qualify as a
dietary ingredient under section 201(ff)(1)(A), (B), or (D) of the FD&C
Act.
    Vinpocetine is not an herb or other botanical, nor is it a
constituent of any botanical. Rather, vinpocetine is a synthetic
compound, derived from vincamine, an alkaloid found in the Vinca minor
plant, or tabersonine, an alkaloid found in Voacanga seeds (Ref. 5).
Vinpocetine can be formed synthetically from vincamine, including via a
``one-pot'' synthesis, through transesterification and/or dehydration
of vincamine in ethanol using Lewis acids and catalyzed by ferric
chloride (Refs. 5 and 6). The process to prepare vinpocetine from
tabersonine involves first converting to vincamine via hydrogenation,
oxidation, reduction and, finally, isolation of vincamine (Ref. 7). The
previously discussed method of producing vinpocetine from vincamine can
then be used. As a synthetic compound, vinpocetine is not an herb or
other botanical. Thus, vinpocetine does not appear to qualify as a
dietary ingredient under section 201(ff)(1)(C) of the FD&C Act.
    Vinpocetine is not a dietary substance for use by man to supplement
the diet by increasing the total dietary intake. Extensive database and
literature searches did not identify any food use of vinpocetine. Thus,
vinpocetine does not appear to qualify as a dietary ingredient under
section 201(ff)(1)(E) of the FD&C Act.
    Finally, vinpocetine is not a concentrate, metabolite, constituent,
extract, or combination of any ingredient described in section
201(ff)(1)(A), (B), (C), (D), or (E) of the FD&C Act. We are not aware
of any factual basis to conclude that vinpocetine is a concentrate,
metabolite, constituent, extract, or combination of a vitamin, mineral,
amino acid, or dietary substance. As described earlier, vinpocetine is
not found in V. minor, Voacanga, or any other botanical, but rather is
a synthetic derivative of vincamine or tabersonine. Therefore,
vinpocetine cannot be a concentrate, constituent, or extract of a
botanical. After extensive literature and database searches, we have
been unable to find any evidence that vinpocetine is a concentrate,
metabolite, constituent, extract, or combination of another dietary
ingredient or dietary ingredients. Therefore, vinpocetine does not
appear to qualify as a dietary ingredient under section 201(ff)(1)(F)
of the FD&C Act.
    We therefore tentatively conclude that vinpocetine is not a dietary
ingredient under section 201(ff)(1) of the FD&C Act because it does not
fit any of the dietary ingredient categories.

D. Vinpocetine and Section 201(ff)(3) of the FD&C Act

    As noted above, the statutory definition of ``dietary supplement''
excludes an article authorized for investigation as a new drug for
which substantial clinical investigations have been instituted and made
public, unless the article was marketed as a dietary supplement or as a
food before such authorization (see section 201(ff)(3)(B)(ii) of the
FD&C Act).
    Based on FDA's IND records and articles published between 1985 and
1988 that mention or report on phase 3 clinical trials for vinpocetine
(Refs. 1 to 4), it appears that: (1) Vinpocetine was authorized for
investigation as a new drug in 1981, long before the first new dietary
ingredient notification for vinpocetine was filed in 1997 and,
therefore, also long before vinpocetine was marketed as a dietary
supplement; (2) substantial clinical investigations of vinpocetine have
been instituted, and (3) the existence of such investigations has been
made public.
    We therefore tentatively conclude that vinpocetine is excluded from
the dietary supplement definition under section 201(ff)(3)(B) of the
FD&C Act.

E. Tentative Conclusion

    Based on the evidence available to us to date, we tentatively
conclude that vinpocetine is not a dietary ingredient as defined in
section 201(ff)(1) of the FD&C Act. We further tentatively conclude
that vinpocetine is excluded from the dietary supplement definition
under section 201(ff)(3)(B) of the FD&C Act and therefore may not be
marketed as or in a dietary supplement. We are interested in receiving
information that would inform our final decision on the regulatory
status of vinpocetine, such as information about any food uses of
vinpocetine and information on the date vinpocetine was first marketed
as a food or as a dietary supplement.
    To afford all interested parties an adequate opportunity to
participate in this matter, we request comments and other supporting
information related to this matter. Interested persons may submit to
the Division of Dockets Management (see ADDRESSES) written or
electronic comments regarding this document.

II. References

    The following references are on display in FDA's Division of
Dockets Management (see ADDRESSES) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. The Pink Sheet, ``Ayerst Planning on First Quarter 1986 NDA
Submission for Alredase (Tolrestat) in Diabetic Neuropathy; Firm is
Shooting for Early 1987 Market Launch,'' June 17, 1985. Retrieved
from: https://pink.pharmamedtechbi.com/PS008480/AYERST-PLANNING-ON-FIRST-QUARTER-1986-NDA-SUBMISSION-FOR-ALREDASE-TOLRESTAT-IN-DIABETIC-NEUROPATHY-F.
2. Maugh II, T. H., ``Firm Hopes to Market New `Memory' Drug,'' The
Los Angeles Times, April 15, 1986. Retrieved from: http://articles.latimes.com/1986-04-15/news/mn-4847_1_vinpocetine.
3. Manconi, E., F. Binaghi, and F. Pitzus, ``A Double-Blind Clinical
Trial of Vinpocetine in the Treatment of Cerebral Insufficiency of
Vascular and Degenerative Origin,'' Current Therapeutic Research,
Vol. 40, No. 4, 1986.
    4. The Pink Sheet, ``American Home Products' `Third Generation'
TPA Entering Clinicals,'' March 21, 1988. Retrieved from: https://pink.pharmamedtechbi.com/PS013359/AMERICAN-HOME-PRODUCTS-THIRD-GENERATION-TPA-ENTERING-CLINICALS.
5. National Toxicology Program, U.S. Dept. of Health and Human
Services, ``Chemical Information Review Document for Vinpocetine
[CAS No. 42971-09-5].'' Retrieved from: http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/vinpocetine091613_508.pdf.
6. Y. Kuge, H. Nakazawa, T. Kometani, et al., ``A Facile One-Pot
Synthesis of Vinpocetine,'' Synthetic Communications:

An Internal Journal for Rapid Communication of Synthetic Organic
Chemistry, vol. 24, no. 6, 1994.
7. U.S. Patent and Trademark Office, ``Process of Preparation of
Vincamine from Tabersonine.'' Retrieved from: http://www.google.com/patents/US3892755.

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21350 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Notices]
[Page 14777]
[FR Doc No: 2014-05721]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-22 ]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before April 7, 2014.

ADDRESSES: You may send comments identified by docket number FAA-2013-
1095 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Forseth, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
phone<PHONE_NUMBER>, email<EMAIL_ADDRESS>or Sandra Long, ARM-
201, Office of Rulemaking, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591, phone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 11, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-1095.
    Petitioner: Embraer.
    Section of 14 CFR Affected: Sec.  25.981(a)(3).
    Description of Relief Sought: The petitioner requests relief from
fuel tank systems lightning protection requirement for three
independent layers of protection on its Embraer Model EMB-550
airplanes.

[FR Doc. 2014-05721 Filed 3-14-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10804-10805]
[FR Doc No: 2021-02066]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0003; Airspace Docket No. 19-ACE-11]
RIN 2120-AA66

Amendment of VOR Federal Airways V-12, V-74, and V-516 in the
Vicinity of Anthony, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-12, V-74, and V-516, in the vicinity of Anthony, KS. The
modifications are necessary due to the planned decommissioning of the
VOR portion of the Anthony, KS, VOR/Tactical Air Navigation (VORTAC)
navigation aid (NAVAID), which provides navigation guidance for
portions of the affected VOR Federal airways. The Anthony VOR is being
decommissioned as part of the FAA's VOR Minimum Operational Network
(MON) program.

DATES: Effective date 0901 UTC, April 22, 2021. 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 7400.11E, 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 Rules and Regulations 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 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, 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 route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2020-0003 in the Federal Register (85 FR 3290; January 21, 2020),
amending VOR Federal airways V-12, V-74, and V-516 in the vicinity of
Anthony, KS, due to the planned decommissioning of the VOR portion of
the Anthony, KS, VORTAC. Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal. No comments were received.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11E dated July 21, 2020, and effective September 15, 2020, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document will be subsequently published in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

The Rule

    The FAA is amending 14 CFR part 71 by modifying VOR Federal airways
V-12, V-74, and V-516. The planned decommissioning of the VOR portion
of the Anthony, KS, VORTAC NAVAID has made this action necessary. The
VOR Federal airway changes are outlined below.
    V-12: V-12 extends between the Gaviota, CA, VORTAC and the

Shelbyville, IN, VOR/Distance Measuring Equipment (VOR/DME); and
between the Allegheny, PA, VOR/DME and the Pottstown, PA, VORTAC. The
airway segment between the Mitbee, OK, VORTAC and the Wichita, KS,
VORTAC is removed. Additionally, the Amarillo, TX, VOR listed in the
airway description is corrected to reflect the Panhandle, TX, VORTAC.
The unaffected portions of the existing airway remain as charted.
    V-74: V-74 extends between the Garden City, KS, VORTAC and the
Magnolia, MS, VORTAC. The airway segment between the Dodge City, KS,
VORTAC and the Pioneer, OK, VORTAC is removed. The unaffected portions
of the existing airway remain as charted.
    V-516: V-516 extends between the Liberal, KS, VORTAC and the
Oswego, KS, VOR/DME. The airway segment between the Liberal, KS, VORTAC
and the Pioneer, OK, VORTAC is removed. The unaffected portion of the
existing airway remains as charted.
    All radials listed in the VOR Federal airway descriptions below are
unchanged and stated in True degrees.

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.
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 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 of modifying VOR Federal
airways V-12, V-74, and V-516, due to the planned decommissioning of
the VOR portion of the Anthony, KS, VORTAC NAVAID, qualifies for
categorical exclusion under the National Environmental Policy Act and
its implementing regulations at 40 CFR part 1500, and in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points). As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. The FAA has determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

List 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 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-12 [Amended]

    From Gaviota, CA; San Marcus, CA; Palmdale, CA; 38 miles, 6
miles wide, Hector, CA; 12 miles, 38 miles, 85 MSL, 14 miles, 75
MSL, Needles, CA; 45 miles, 34 miles, 95 MSL, Drake, AZ; Winslow,
AZ; 30 miles, 85 MSL, Zuni, NM; Albuquerque, NM; Otto, NM; Anton
Chico, NM; Tucumcari, NM; Panhandle, TX; to Mitbee, OK. From
Wichita, KS; Emporia, KS; INT Emporia 063[deg] and Napoleon, MO,
243[deg] radials; Napoleon; INT Napoleon 095[deg] and Columbia, MO,
292[deg] radials; Columbia; Foristell, MO; Troy, IL; Bible Grove,
IL; to Shelbyville, IN. From Allegheny, PA; Johnstown, PA;
Harrisburg, PA; INT Harrisburg 092[deg] and Pottstown, PA, 278[deg]
radials; to Pottstown.
* * * * *

V-74 [Amended]

    From Garden City, KS; to Dodge City, KS. From Pioneer, OK;
Tulsa, OK; Fort Smith, AR; 6 miles, 7 miles wide (4 miles north and
3 miles south of centerline) Little Rock, AR; Pine Bluff, AR;
Greenville, MS; to Magnolia, MS.
* * * * *

V-516 [Amended]

    From Pioneer, OK; to Oswego, KS.
* * * * *

    Issued in Washington, DC, on January 27, 2021.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-02066 Filed 2-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4892-4893]
[FR Doc No: 2011-1720]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 13740-000, 13749-000, 13775-000, 13781-000]

Lock+ Hydro Friends Fund XXXIX, FFP Missouri 3, LLC, Allegheny 3
Hydro, LLC, Three Rivers Hydro, LLC; Notice Announcing Preliminary
Permit Drawing

January 20, 2011.
    On May 18, 2010, at 8:30 a.m., the Commission received four
preliminary permit applications for proposed projects to be located at
the C. W. Bill Young Lock and Dam located on the Allegheny River in
Allegheny County, Pennsylvania.\1\ The applications were filed by Lock+
Hydro Friends Fund XXXIX, for Project No. 13740-000, FFP Missouri 3,
LLC, for Project No. 13749-000, Allegheny 3 Hydro, LLC, for Project No.
13775-000, and Three Rivers Hydro, LLC, for Project No. 13781-000.
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    \1\ The Commission is open each day from 8:30 a.m. to 5 p.m.,
except Saturdays, Sundays, and holidays. 18 CFR 375.101(c) (2010).
The applications were filed between 5 p.m. on Monday May 17, 2010,
and 8:30 a.m. on Tuesday May 18, 2010. Under the Commission's Rules
of Practice and Procedure, any document received after regular
business hours is considered filed at 8:30 a.m. on the next regular
business day. 18 CFR 385.2001(a)(2) (2010).
---------------------------------------------------------------------------

    Where all permit applicants are municipalities or all permit
applicants are non-municipalities, and no applicant's plans are better
adapted than the others' to develop, conserve, and utilize in the
public interest the water resources of a region, the Commission issues
a permit to the applicant who filed first in time.\2\ In this case,
because four applications from entities not claiming municipal
preference are deemed filed at the same time, the Commission will
conduct a random tie breaker to determine priority. In the event that
the Commission concludes

that no applicant's plans are better adapted than the others, priority
will be determined accordingly.
---------------------------------------------------------------------------

    \2\ 18 CFR 4.37 (2010). See, e.g., BPUS Generation Development,
LLC, 126 FERC ] 61,132 (2009).
---------------------------------------------------------------------------

    On January 27, 2011, at 10 a.m. (eastern time), the Secretary of
the Commission, or her designee, will, by random drawing, determine the
filing priority for the four applicants identified in this notice. The
drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St., NE., Washington, DC
20426. The results of the drawing will be recorded by the Secretary or
her designee. A subsequent notice will be issued by the Secretary
announcing the results of the drawing.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-1720 Filed 1-26-11; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:A 75 day comment period is insufficient time for the e-cigarette industry and the wider e-cigarette community to comment on the proposed deeming regulations. As an e-cigarette user and ex-smoker who does most of my shopping with small businesses and is extremely concerned about the effects this regulation would have on them, I would respectfully request that the period for comment be extended to 180 days.  I worry that the product registration requirements will be burdensome enough to push small vendors out of business and hand the e-cigarette industry over to big tobacco, as they may be the only ones with the funding and preparation to accommodate this type of regulation.


[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Page 56926]
[FR Doc No: 2021-22229]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER02-2001-000]

Southern California Edison Company; Notice of Filing

    Take notice that on September 15, 2021, Southern California Edison
Company (SCE) requested that the Federal Energy Regulatory Commission
(Commission) review and confirm SCE's Electric Quarterly Report
submission practices for transaction information received from the
California Independent System Operator Corporation (CAISO). In
particular, given recent changes to the CAISO market settlement
timeline, SCE requests that the Commission approve SCE's longstanding
practices of (1) providing CAISO transaction data for a given quarter
by the filing deadline for the following quarter; and (2) providing
CAISO transaction data only once using final settlement data, as
opposed to filing both initial and final settlement data.
    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 comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on November 5, 2021.

    Dated: October 6, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-22229 Filed 10-12-21; 8:45 am]
BILLING CODE 6717-01-P