[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33433]
[DOCID:fr13jy09-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR09-15-000]

Tesoro Refining and Marketing Company, Complainant v. Calnev Pipe
Line, L.L.C., Respondent; Notice of Complaint

July 2, 2009.
    Take notice that on June 30, 2009, Tesoro Refining and Marketing
Company (Tesoro) filed a formal complaint against Calnev Pipe Line,
L.L.C. (Calnev) pursuant to Rule 206 of the Rules of Practice and
Procedure of the Federal Energy Regulatory Commission, 18 CFR 385.206;
the Procedural Rules Applicable to Oil Pipeline Proceedings, 18 CFR
343.2, sections 1(5), 8, 9, 13, 15, and 16 of the Interstate Commerce
Act (ICA), 49 U.S.C. App. Sec. Sec.  1(5), 8, 9, 13, 15 and 16 (1984);
and section 1803 of the Energy Policy Act of 1992 (EPAct). Among other
things, Tesoro alleges that Calnev was over-recovering its cost of
service in 2007 and 2008 and, therefore, charged Tesoro excessive rates
that are unjust and unreasonable.
    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, 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. The Respondent's
answer and all interventions or protests must be filed on or before the
comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 on July 20, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16433 Filed 7-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 16, 2010 (Volume 75, Number 136)]
[Notices]
[Page 41484-41485]
[DOCID:fr16jy10-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0332; FRL-8834-2]

Methyl Parathion; Registration Review Proposed Decision; Notice
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
registration review decision for the pesticide methyl parathion and
opens a public comment period on the proposed decision. Registration
review is EPA's periodic review of pesticide registrations to ensure
that each pesticide continues to satisfy the statutory standard for
registration, that is, that the pesticide can perform its intended
function without unreasonable adverse effects on human health or the
environment. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before September 14, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0332, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0332. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: Kelly Ballard, Chemical Review Manager, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>    For general information on the registration review program,
contact: Kevin Costello, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5026; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the chemical review manager listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying

information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed registration review decision for the pesticide,
methyl parathion, case number 0153, and opens a 60-day public comment
period on the proposed decision. Methyl parathion is a restricted use
organophosphate insecticide and acaricide registered for use on
alfalfa, almonds, barley, canola/rapeseed, corn (field, pop, and
sweet), cotton, grass (forage), oats, onions, potatoes (sweet and
white), rice, rye, soybeans, sunflowers, walnuts, and wheat. There are
no residential uses.
    The registration review docket for a pesticide includes earlier
documents related to the registration review of the case. For example,
the review opened with the posting of a Summary Document, containing a
Preliminary Work Plan, for public comment. A Final Work Plan was posted
to the docket following public comment on the initial docket.
    As stated in the Methyl Parathion Preliminary Work Plan and Methyl
Parathion Final Work Plan for registration review, the Agency had
intended to revise the existing risk assessments for methyl parathion.
However, after the publication of the Methyl Parathion Final Work Plan,
pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended, the Agency announced receipt of
requests to voluntarily cancel all methyl parathion product
registrations from the registrants of methyl parathion. After a 30-day
comment period, the EPA granted the voluntary cancellation requests,
establishing effective cancellation dates (FRL-8033-8) for all of the
products registered for use in the United States containing the active
ingredient, methyl parathion.
    Following public comment, the Agency will issue a final
registration review decision for products containing methyl parathion.
    The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended, required EPA to establish by regulation procedures for
reviewing pesticide registrations, originally with a goal of reviewing
each pesticide's registration every 15 years to ensure that a pesticide
continues to meet the FIFRA standard for registration. The Agency's
final rule to implement this program was issued in August 2006 and
became effective in October 2006, and appears at 40 CFR part 155,
subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA)
was amended and extended in September 2007. FIFRA, as amended by PRIA
in 2007, requires EPA to complete registration review decisions by
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed registration
review decisions. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the proposed decision. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
docket for methyl parathion. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The final registration review decision will explain the
effect that any comments had on the decision and provide the Agency's
response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of this pesticide are
provided at: http://www.epa.gov/oppsrrd1/registration_review/methyl-
parathion/index.html.

B. What is the Agency's Authority for Taking this Action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Pesticides and pests, Methyl parathion.

    Dated: July 7, 2010.
Richard P. Keigwin,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-17403 Filed 7-15-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Page 11189]
[FR Doc No: 2015-04240]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR15-17-000]

Marathon Pipe Line LLC; Notice of Petition for Declaratory Order

    Take notice that on February 18, 2015, pursuant to Rule 207(a)(2)
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2014), Marathon Pipe Line
LLC filed a petition for a declaratory order approving priority service
and the overall rate structure and terms of service for an expansion of
its crude oil pipeline from Patoka, Illinois to Lima, Ohio, all as more
fully explained in the petition.
    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, 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 Petitioner.
    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 5 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on March 18, 2015.

    Dated: February 24, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-04240 Filed 2-27-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Proposed Rules]
[Pages 52707-52709]
[FR Doc No: 2022-18485]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1028; Airspace Docket No. 22-ASO-9]

Proposed Amendment and Revocation of Air Traffic Service (ATS)
Routes; Eastern United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify VHF Omnidirectional Range (VOR)
Federal airways V-5, V-20, V-155, V-241, and V-321; and to remove jet
routes J-37, J-55, J-79, J-121, J-174, J-191, and J-209. These changes
support the VOR Minimum Operation Network (MON) project in the eastern
United States.

DATES: Comments must be received on or before October 13, 2022.

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:
(800) 647-5527 or<PHONE_NUMBER>. You must identify FAA Docket No. FAA-
2022-1028; Airspace Docket No. 22-ASO-9 at the beginning of your
comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at 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.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, 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 VOR Federal airway route structure in
the eastern United States to maintain the 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-2022-1028; Airspace Docket No. 22-ASO-9) 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 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-2022-1028; Airspace Docket No. 20-ASO-9.'' 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. 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 www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see 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 Eastern Service Center, Federal
Aviation Administration, Room 210, 1701 Columbia Ave., College Park, GA
30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this proposed rule. FAA Order
7400.11F lists Class A, B, C, D, and E airspace areas, air traffic
service routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to modify five
VOR Federal airways (V-5, V-20, V-155, V-241, and V-321); and to remove
seven jet routes (J-37, J-55, J-79, J-121, J-174, J-191, and J-209).
These changes support the planned decommissioning of one or more of the
following ground-based navigation aids under the VOR MON project in the
eastern United States: Columbus, GA (CSG), VHF Omnidirectional Range
and Tactical Air Navigational System (VORTAC); Electric City, SC (ELW),
VORTAC; Choo Choo, GA (GQO), VORTAC; Nottingham, MD (OTT), VORTAC;
Patuxent, MD (PXT), VORTAC; Sugarloaf Mountain, NC (SYG), VORTAC;
Tuskegee, AL (TGE), VHF Omnidirectional Range/Distance Measuring
Equipment (VOR/DME). The proposed changes are described below.
    V-5: V-5 extends from Pecan, GA, to Appleton, OH. The FAA proposes
to remove the segments from the intersection of the Athens, GA 340[deg]
and the Electric City, SC 274[deg] radials, to Choo Choo, GA. As
amended, V-5 would extend, in two parts, from Pecan, GA to Athens, GA;
and from New Hope, KY, to Appleton, OH.
    V-20: V-20 extends, in two parts, from McAllen, TX, to Palacios,
TX; and from Beaumont, TX, to Nottingham, MD. This action proposes to
remove the segments between Tuskegee, AL, and Sugarloaf Mountain, NC;
and remove the segments between the intersection of the Richmond, VA
039[deg] and the Brooke, VA 132[deg] radials, and Nottingham, MD. As
amended, V-20 would consist of three parts: From McAllen, TX, to
Palacios, TX; From Beaumont, TX, to Montgomery, AL; and From Barretts
Mountain, NC to Richmond, VA. In addition the wording ``The airspace
within R-4007A and R-4007B is excluded'' would be remove from the route
description because the amended route would no longer pass in the
vicinity of the restricted areas.
    V-155: V-155 extends from Columbus, GA to Brooke, VA. The FAA
proposes to remove the segments from Columbus, GA to the intersection
of the Columbus 068[deg] and the Colliers, SC, 243[deg] radials (the
charted SINCA Fix). The SINCA, GA, Fix would be redefined by replacing
the Columbus radial with the Dublin, GA, 309[deg](T)/314[deg](M)
radial. This supports the scheduled decommissioning of the Columbus, GA
(CSG), VORTAC. As amended, V-155 would extend from the intersection of
the Dublin, GA, 309[deg](T)/314[deg](M) and Colliers, SC 243[deg]
radials, to Brooke, VA.
    V-241: V-241 extends from Semmes, AL to the intersection of the
Columbus, GA 010[deg] and the LaGrange, GA 048[deg] radials (the
charted TIROE, GA, Fix). The FAA proposes to remove the segments from
Columbus, GA to the TIROE Fix. The intersection of the Eufaula, AL
008[deg](T)/006[deg](M) and the LaGrange, GA 160[deg](T)/159[deg](M)
would be used in place of the Columbus, GA VORTAC. As amended, V-241
would extend from Semmes, AL, to the intersection of the Eufaula, AL
008[deg](T)/006[deg](M) and the LaGrange, GA 160[deg](T)/159[deg](M)
radials.
    V-321: V-321 extends from Pecan, GA to Livingston, TN. The FAA
proposes to remove the Columbus, GA (CSG), VORTAC from the route and
replace it with the intersection of the Pecan, GA 327[deg](T)/
329[deg](M) and the LaGrange, GA 160[deg](T)/159[deg](M) radials.
Otherwise, V-321 would still extend from Pecan, GA, to Livingston, TN
as currently charted.
    J-37: J-37 consists of three parts: From Harvey, LA; to Montgomery,
AL; from Lynchburg, VA; to Coyle, NJ; and From Kennedy, NY; to Albany,
NY. The FAA proposes to remove the entire route. RNAV routes Q-22, Q-
127, and Q-479 are being published as a partial overlay and replacement
of J-37.
    J-55: J-55 consists of two parts: From the intersection of the Flat
Rock, VA, 212[deg] and Raleigh-Durham, NC, 224[deg] radials; to the
intersection of the Hopewell, VA 030[deg] and Nottingham, MD, 174[deg]
radials; and From Sea Isle, NJ; to Presque Isle, ME. This action
proposes to remove the entire routs. RNAV routes Q-167, Q-220, Q-439,
and Q-445 will be published to replace J-55, reflecting current traffic
flows in the area.

    J-79: J-79 extends from Charleston, SC to Bangor, ME. This action
proposes to remove the entire route. RNAV route Q-133 will be published
as a partial overlay and replacement of J-79.
    J-121: J-121 extends from Charleston, SC; to the intersection of
the Sea Isle, NJ 050[deg] and the Cedar Lake, NJ 091[deg] radials. This
action proposes to remove the entire route. RNAV route Q-109 will be
published as a partial overlay and replacement of J-121.
    J-174: J-174 extends from Charleston, SC, to the intersection of
the Marconi, MA 090[deg] and Nantucket, MA, 066[deg] radials. This
action proposes to remove the entire route. RNAV route Q-97 will be
published as a partial overlay and replacement of J-174.
    J-191: J-191 extends from Hopewell, VA to Wilmington, NC. This
action proposes to remove the entire route. RNAV routes Q-85 and Q-409
will be published to replace J-191, reflecting current traffic flows in
this area.
    J-209: J-209 extends from Raleigh-Durham, NC to the intersection of
the Coyle, NJ 036[deg] and the Robbinsville, NJ, 136[deg] radials. This
action proposes to remove the entire route. The route is no longer used
by air traffic control and no overlay is required. Other Performance
Based Navigation structure will be implemented reflecting current
traffic flows in this area.
    When new navigation aid radials are proposed in an NPRM, both True
North (T) and Magnetic North (M) values are stated in route
descriptions. Only True North is specified in any subsequent final
rules.
    Domestic VOR Federal airways are published in paragraph 6010(a),
and jet routes are published in paragraph 2004, respectively, of FAA
Order JO 7400.11F, dated August 10, 2021, and effective September 15,
2021, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airways and jet routes listed in this document would be
subsequently published in, or removed from FAA Order JO 7400.11.
    FAA Order JO 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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-5 [Amended]

    From Pecan, GA; Vienna, GA; Dublin, GA; to Athens, GA. From New
Hope, KY; Louisville, KY; Cincinnati, OH; to Appleton, OH.
* * * * *

V-20 [Amended]

    From McAllen, TX, INT McAllen 038[deg] and Corpus Christi, TX,
178[deg] radials; 10 miles 8 miles wide, 37 miles 7 miles wide (3
miles E and 4 miles W of centerline), Corpus Christi; INT Corpus
Christi 054[deg] and Palacios, TX, 226[deg] radials; to Palacios.
From Beaumont, TX; Lake Charles, LA; Lafayette, LA; Reserve, LA; INT
Reserve 084[deg] and Gulfport, MS, 247[deg] radials; Gulfport;
Semmes, AL; INT Semmes 048[deg] and Monroeville, AL, 231[deg]
radials; Monroeville; to Montgomery, AL; From Barretts Mountain, NC;
South Boston, VA; to Richmond, VA. The airspace on the main airway
above 14,000 feet MSL from McAllen to 49 miles northeast and the
airspace within Mexico is excluded.
* * * * *

V-155 [Amended]

    From INT Dublin, GA 309[deg](T)/314[deg](M) and Colliers, SC,
243[deg] radials; Colliers; Chesterfield, SC; Sandhills, NC;
Raleigh-Durham, NC; Lawrenceville, VA; INT Lawrenceville 034[deg]
and Flat Rock, VA, 171[deg] radials; Flat Rock; to Brooke, VA. The
airspace within R-6602A is excluded.
* * * * *

V-241 [Amended]

    From Semmes, AL, via Crestview, FL; INT Crestview 076[deg] and
Wiregrass, AL, 232[deg] radials; Wiregrass; Eufaula, AL; to INT
Eufaula, AL 008[deg](T)/006[deg] (M) and LaGrange, GA, 160[deg](T)/
159[deg](M) radials.
* * * * *

V-321 [Amended]

    From Pecan, GA, via INT Pecan 327[deg](T)/329[deg](M) and
LaGrange, GA, 160[deg](T)/159[deg](M) radials; LaGrange; INT
LaGrange 342[deg] and Gadsden, AL, 124[deg] radials; Gadsden; INT
Gadsden 333[deg] and Rocket, AL, 149[deg] radials; Rocket,
Shelbyville, TN; to Livingston, TN.
* * * * *

Paragraph 2004 Jet Routes.

* * * * *

J-37 [Removed]

* * * * *

J-55 [Removed]

* * * * *

J-79 [Removed]

* * * * *

J-121 [Removed]

* * * * *

J-174 [Removed]

* * * * *

J-191 [Removed]

* * * * *

J-209 [Removed]

* * * * *

    Issued in Washington, DC, on August 23, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-18485 Filed 8-26-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Notices]
[Pages 5545-5548]
[FR Doc No: 2022-01967]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94069; File No. SR-GEMX-2022-03]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Reduce GEMX's
Options Regulatory Fee

January 26, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 20, 2022, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend GEMX's Pricing Schedule at Options
7, Section 5 to reduce the GEMX Options Regulatory Fee or ``ORF''.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on February 1,
2022.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/gemx/rules at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    GEMX previously filed to waive its ORF from October 1, 2021 through
January 31, 2022.\3\ The Waiver Filing provided that GEMX would
continue monitoring the amount of revenue collected from the ORF to
determine if regulatory revenues would exceed regulatory costs when it
recommenced assessing ORF on February 1, 2022. If so, the Exchange
committed to adjust its ORF.\4\ At this time, after a review of its
regulatory revenues and regulatory costs, the Exchange proposes to
reduce the ORF from $0.0018 (the amount of the ORF prior to the waiver)
to $0.0014 per contract side as of February 1, 2022, to ensure that
revenue collected from the ORF, in combination with other regulatory
fees and fines, does not exceed the Exchange's total regulatory costs.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 92698 (August 18,
2021), 86 FR 47355 (August 24, 2021) (SR-GEMX-2021-08) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Amend
GEMX's Options Regulatory Fee) (``Waiver Filing'').
    \4\ Id. at 47357.
---------------------------------------------------------------------------

    The options industry continues to experience high options trading
volumes and volatility. At this time, GEMX believes that the options
volume it experienced in the second half of 2021 is likely to persist
into 2022. The anticipated options volume would impact GEMX's ORF
collection which, in turn, has caused GEMX to propose reducing the ORF
to ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, would not exceed the Exchange's total
regulatory costs.
Collection of ORF
    Upon recommencement of the ORF on February 1, 2022,\5\ GEMX will
assess its ORF for each customer option transaction that is either: (1)
Executed by a Member on GEMX; or (2) cleared by an GEMX Member at The
Options Clearing Corporation (``OCC'') in the customer range,\6\ even
if the transaction was executed by a non-Member of GEMX, regardless of
the exchange on which the transaction occurs.\7\ If the OCC clearing
member is a GEMX Member, ORF is assessed and collected on all cleared
customer contracts (after adjustment for CMTA \8\); and (2) if the OCC
clearing member is not a GEMX Member, ORF is collected only on the
cleared customer contracts executed at GEMX, taking into account any
CMTA instructions which may result in collecting the ORF from a non-
Member.\9\
---------------------------------------------------------------------------

    \5\ Prior to the Waiver Filing, the Exchange similarly collected
ORF as described herein.
    \6\ Participants must record the appropriate account origin code
on all orders at the time of entry of the order. The Exchange
represents that it has surveillances in place to verify that members
mark orders with the correct account origin code.
    \7\ The Exchange uses reports from OCC when assessing and
collecting the ORF.
    \8\ CMTA or Clearing Member Trade Assignment is a form of
``give-up'' whereby the position will be assigned to a specific
clearing firm at OCC.
    \9\ By way of example, if Broker A, a GEMX Member, routes a
customer order to CBOE and the transaction executes on CBOE and
clears in Broker A's OCC Clearing account, ORF will be collected by
GEMX from Broker A's clearing account at OCC via direct debit. While
this transaction was executed on a market other than GEMX, it was
cleared by a GEMX Member in the member's OCC clearing account in the
customer range, therefore there is a regulatory nexus between GEMX
and the transaction. If Broker A was not a GEMX Member, then no ORF
should be assessed and collected because there is no nexus; the
transaction did not execute on GEMX nor was it cleared by a GEMX
Member.
---------------------------------------------------------------------------

    In the case where a Member both executes a transaction and clears
the transaction, the ORF will be assessed to and collected from that
Member. In the case where a Member executes a transaction and a
different Member clears the transaction, the ORF will be assessed to
and collected from the Member who clears the transaction and not the
Member who executes the transaction. In the case where a non-Member
executes a transaction at an away market and a Member clears the
transaction, the ORF will be assessed to and collected from the Member
who clears the transaction. In the case where a Member executes a
transaction on GEMX and a non-Member clears the transaction, the ORF
will be assessed to the Member that executed the transaction on GEMX
and collected from the non-Member who cleared the transaction. In the
case where a Member

executes a transaction at an away market and a non-Member clears the
transaction, the ORF will not be assessed to the Member who executed
the transaction or collected from the non-Member who cleared the
transaction because the Exchange does not have access to the data to
make absolutely certain that ORF should apply. Further, the data does
not allow the Exchange to identify the Member executing the trade at an
away market.
ORF Revenue and Monitoring of ORF
    The Exchange monitors the amount of revenue collected from the ORF
to ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. In determining whether an expense is
considered a regulatory cost, the Exchange reviews all costs and makes
determinations if there is a nexus between the expense and a regulatory
function. The Exchange notes that fines collected by the Exchange in
connection with a disciplinary matter offset ORF.
    Revenue generated from ORF, when combined with all of the
Exchange's other regulatory fees and fines, is designed to recover a
material portion of the regulatory costs to the Exchange of the
supervision and regulation of member customer options business
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities. Regulatory costs include
direct regulatory expenses and certain indirect expenses in support of
the regulatory function. The direct expenses include in-house and
third-party service provider costs to support the day-to-day regulatory
work such as surveillances, investigations and examinations. The
indirect expenses include support from such areas as Office of the
General Counsel, technology, and internal audit. Indirect expenses were
approximately 38% of the total regulatory costs for 2021. Thus, direct
expenses were approximately 62% of total regulatory costs for 2021.\10\
---------------------------------------------------------------------------

    \10\ The Exchange will set a 2022 Regulatory Budget in the first
quarter of 2022.
---------------------------------------------------------------------------

    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of its Members,
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities.
Proposal
    Based on the Exchange's most recent review, the Exchange is
proposing to reduce the amount of ORF that will be collected by the
Exchange from $0.0018 per contract side to $0.0014 per contract side.
The Exchange issued an Options Trader Alert on December 31, 2021
indicating the proposed rate change for February 1, 2022.\11\
---------------------------------------------------------------------------

    \11\ See Options Trader Alert 2021-63.
---------------------------------------------------------------------------

    The proposed reduction is based on a sustained high level of
options volume in 2021. The below table displays average daily volume
for 2021.\12\
---------------------------------------------------------------------------

    \12\ The OCC data from December 2021 numbers reflect only 13
trading days as this information is through December 17, 2021.
Volume data in the table represents numbers of contracts; each
contract has two sides.
[GRAPHIC] [TIFF OMITTED] TN01FE22.001

    To date, fourth quarter options average daily volume in 2021 has
been higher than options average daily volume in any of the prior three
quarters of 2021. With respect to customer options volume across the
industry, total customer options contract average daily volume, to
date, in 2021 is 36,565,398 as compared to total customer options
contract average daily volume in 2020 which was 27,002,511.\13\
---------------------------------------------------------------------------

    \13\ See data from OCC at: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Volume-by-Account-Type.
---------------------------------------------------------------------------

    There can be no assurance that the Exchange's costs for 2022 will
not differ materially from these expectations and prior practice, nor
can the Exchange predict with certainty whether options volume will
remain at the current level going forward. The Exchange notes however,
that when combined with regulatory fees and fines, the revenue that may
be generated utilizing an ORF rate of $0.0018 per contract side may
result in revenue which exceeds the Exchange's estimated regulatory
costs for 2022 if options volume persists. In 2021, options volume
remained high, due in large part to the extreme volatility in the
marketplace as a result of the COVID-19 pandemic. The Exchange
therefore proposes to reduce its ORF to $0.0014 per contract side to
ensure that revenue does not exceed the Exchange's estimated regulatory
costs in 2022. Particularly, the Exchange believes that reducing the
ORF when combined with all of the Exchange's other regulatory fees and
fines, would allow the Exchange to continue covering a material portion
of its regulatory costs, while lessening the potential for generating
excess revenue that may otherwise occur using the rate of $0.0018 per
contract side.\14\
---------------------------------------------------------------------------

    \14\ The Exchange notes that its regulatory responsibilities
with respect to Member compliance with options sales practice rules
have largely been allocated to FINRA under a 17d-2 agreement. The
ORF is not designed to cover the cost of that options sales practice
regulation.
---------------------------------------------------------------------------

    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed regulatory costs. If the
Exchange determines regulatory revenues exceed regulatory costs, the
Exchange will adjust the ORF by submitting a fee change filing to the
Commission and

notifying \15\ its Members via an Options Trader Alert.\16\
---------------------------------------------------------------------------

    \15\ The Exchange will provide Members with such notice at least
30 calendar days prior to the effective date of the change.
    \16\ The Exchange notes that in connection with this proposal,
it provided the Commission confidential details regarding the
Exchange's projected regulatory revenue, including projected revenue
from ORF, along with a projected regulatory expenses.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\17\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act,\18\ which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members, and other persons using its facilities.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \19\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(4).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed fee change is reasonable because
customer transactions will be subject to a lower ORF fee than the rate
that would otherwise be in effect on February 1, 2022. Moreover, the
proposed reduction is necessary for the Exchange to avoid collecting
revenue, in combination with other regulatory fees and fines, that
would be in excess of its anticipated regulatory costs which is
consistent with the Exchange's practices.
    The Exchange designed the ORF to generate revenues that would be
less than the amount of the Exchange's regulatory costs to ensure that
it, in combination with its other regulatory fees and fines, does not
exceed regulatory costs, which is consistent with the view of the
Commission that regulatory fees be used for regulatory purposes and not
to support the Exchange's business operations. As discussed above,
however, after review of its regulatory costs and regulatory revenues,
which includes revenues from ORF and other regulatory fees and fines,
the Exchange determined that absent a reduction in ORF, it may collect
revenue which would exceed its regulatory costs. Indeed, the Exchange
notes that when taking into account the potential that recent options
volume persists, it estimates the ORF may generate revenues that would
cover more than the approximated Exchange's projected regulatory costs.
As such, the Exchange believes it's reasonable and appropriate to
reduce the ORF amount from $0.0018 to $0.0014 per contract side.
    The Exchange also believes the proposed fee change is equitable and
not unfairly discriminatory in that it is charged to all Members on all
their transactions that clear in the customer range at OCC.\20\ The
Exchange believes the ORF ensures fairness by assessing higher fees to
those Members that require more Exchange regulatory services based on
the amount of customer options business they conduct. Regulating
customer trading activity is much more labor intensive and requires
greater expenditure of human and technical resources than regulating
non-customer trading activity, which tends to be more automated and
less labor-intensive. For example, there are costs associated with main
office and branch office examinations (e.g., staff expenses), as well
as investigations into customer complaints and the terminations of
registered persons. As a result, the costs associated with
administering the customer component of the Exchange's overall
regulatory program are materially higher than the costs associated with
administering the non-customer component (e.g., Member proprietary
transactions) of its regulatory program. Moreover, the Exchange notes
that it has broad regulatory responsibilities with respect to
activities of its Members, irrespective of where their transactions
take place. Many of the Exchange's surveillance programs for customer
trading activity may require the Exchange to look at activity across
all markets, such as reviews related to position limit violations and
manipulation. Indeed, the Exchange cannot effectively review for such
conduct without looking at and evaluating activity regardless of where
it transpires. In addition to its own surveillance programs, the
Exchange also works with other SROs and exchanges on intermarket
surveillance related issues. Through its participation in the
Intermarket Surveillance Group (``ISG'') \21\ the Exchange shares
information and coordinates inquiries and investigations with other
exchanges designed to address potential intermarket manipulation and
trading abuses. Accordingly, there is a strong nexus between the ORF
and the Exchange's regulatory activities with respect to customer
trading activity of its Members.
---------------------------------------------------------------------------

    \20\ If the OCC clearing member is a GEMX member, ORF is
assessed and collected on all cleared customer contracts (after
adjustment for CMTA); and (2) if the OCC clearing member is not a
GEMX member, ORF is collected only on the cleared customer contracts
executed at GEMX, taking into account any CMTA instructions which
may result in collecting the ORF from a non-member.
    \21\ ISG is an industry organization formed in 1983 to
coordinate intermarket surveillance among the SROs by cooperatively
sharing regulatory information pursuant to a written agreement
between the parties. The goal of the ISG's information sharing is to
coordinate regulatory efforts to address potential intermarket
trading abuses and manipulations.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. This proposal does not create
an unnecessary or inappropriate intra-market burden on competition
because the ORF applies to all customer activity, thereby raising
regulatory revenue to offset regulatory expenses. It also supplements
the regulatory revenue derived from non-customer activity. The Exchange
notes, however, the proposed change is not designed to address any
competitive issues. Indeed, this proposal does not create an
unnecessary or inappropriate inter-market burden on competition because
it is a regulatory fee that supports regulation in furtherance of the
purposes of the Act. The Exchange is obligated to ensure that the
amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \22\ and paragraph (f) of Rule 19b-4 \23\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of

investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission will institute
proceedings to determine whether the proposed rule change should be
approved or disapproved.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-GEMX-2022-03 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File No. SR-GEMX-2022-03. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. SR-GEMX-2022-03, and should be submitted on or
before February 22, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01967 Filed 1-31-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Proposed Rules]
[Pages 25758-25763]
[FR Doc No: 2014-10304]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0504]

Administrative Destruction of Certain Drugs Refused Admission to
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
a regulation to implement its authority to destroy a drug valued at
$2,500 or less (or such higher amount as the Secretary of the Treasury
may set by regulation) that has been refused admission into the United
States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), by
providing to the owner or consignee notice and an opportunity to appear
and introduce testimony to the Agency prior to the destruction. The
proposed regulation is authorized by amendments made to the FD&C Act by
the Food and Drug

Administration Safety and Innovation Act (FDASIA). Once finalized, this
proposed regulation will allow FDA to better protect the public health
by providing an administrative process for the destruction of certain
refused drugs, thus increasing the integrity of the drug supply chain.

DATES: Submit either electronic or written comments on the proposed
rule by July 7, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0504, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0504 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), 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: Ann M. Metayer, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4338, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

    The proposed rule would provide the owner or consignee of a drug
that has been refused admission into the United States, and that is
valued at $2,500 or less (or such higher amount as the Secretary of the
Treasury may set by regulation) with (1) written notice that FDA
intends to destroy the drug and (2) an opportunity to present testimony
to the Agency before the drug is destroyed. In 2012, Congress amended
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) to provide FDA with
the authority to destroy these refused drugs without providing the
owner or consignee with the opportunity to export the drug. Congress
directed FDA to issue regulations that provide the drug's owner or
consignee with notice and an opportunity to present testimony to the
Agency prior to the drug's destruction. (Section 708 of FDASIA (Pub. L.
112-144).) This provision, as well as section 701 of the FD&C Act (21
U.S.C. 371), provide the legal authority for this proposed rule.

Summary of the Major Provisions of the Proposed Regulatory Action

    This proposed rule would provide the owner or consignee of a drug
that has been refused admission into the United States under section
801(a) of the FD&C Act, and that is valued at $2,500 or less (or such
higher amount as the Secretary of the Treasury may set by regulation)
with (1) written notice that FDA intends to destroy the drug and (2)
notice and an opportunity to present testimony to the Agency before the
drug is destroyed.
    FDA proposes to amend part 1 (21 CFR part 1) by expanding the scope
of Sec.  1.94 (21 CFR 1.94). Currently this regulation provides the
owner or consignee of an FDA-regulated product offered for import into
the United States with notice and opportunity to present testimony to
the Agency prior to refusal of admission of the product. The proposed
rule would expand the scope of Sec.  1.94 to provide an owner or
consignee with notice and opportunity to present testimony to the
Agency prior to the destruction of certain refused drugs.

Costs and Benefits

    The primary public health benefit from adoption of the proposed
rule would be the value of the illnesses and deaths avoided because FDA
destroyed a drug valued at $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation) that posed a public
health risk. This benefit accrues whenever the Agency's other
enforcement tools would not have prevented a drug that does not comply
with the requirements of the FD&C Act (violative drug) from entering
the U.S. market. The estimated primary costs of the proposed rule, if
finalized, include the additional costs to destroy a violative drug.
The Agency estimates the quantifiable net annual social benefit of the
proposed rule to range between $228,000 and $618,000.

I. Background and Legal Authority

    On July 9, 2012, President Obama signed FDASIA into law. Title VII
of FDASIA provides FDA with important new authorities to help the
Agency better protect the integrity of the drug supply chain. One of
those new authorities is in section 708, which amends section 801(a) of
the FD&C Act, to provide FDA with the authority to use an
administrative procedure to destroy a drug valued at $2,500 or less (or
such higher amount as the Secretary of the Treasury may set by
regulation) that was not brought into compliance as described in
section 801(b) of the FD&C Act and was refused admission into the
United States. Section 708 of FDASIA authorizes FDA to use this new
administrative procedure without offering the owner or consignee the
opportunity to export the drug. Section 708 further provides that FDA
will store and, as applicable, dispose of the drug that the Agency
intends to destroy. The drug's owner or consignee is liable for FDA's
storage and disposal costs pursuant to section 801(c) of the FD&C Act.
    FDA is issuing this proposed rule to implement section 708 of
FDASIA. That provision directs FDA to issue regulations that provide
the owner or consignee of a drug valued at $2,500 or less (or such
higher amount as the Secretary of the Treasury may set by regulation)
that has been refused admission with notice and an opportunity to
introduce testimony to the Agency prior to the destruction of the drug.
The provision further states that this process may be combined with the
notice and opportunity to appear before FDA and introduce testimony on
the admissibility of the drug under section 801(a) of the FD&C Act, as
long as appropriate notice is provided to the owner or consignee. FDA
is also issuing this proposed rule under section 701(b) of the FD&C
Act, which authorizes regulations for the efficient enforcement of
section 801 of the FD&C Act.
    A drug that is imported or offered for import is subject to refusal
of admission under section 801(a) of the FD&C Act if, among other
reasons, it is or appears to be adulterated, misbranded, or unapproved
in violation of section 505 of the FD&C Act (21 U.S.C. 355). Under
current regulation Sec.  1.94, FDA issues a notice of the Agency's
intention to refuse a drug to the owner or consignee, as defined in
Sec.  1.83, stating the reasons for the intended refusal. If the
article is

sent by international mail, FDA generally considers the addressee of
the parcel to be the owner or consignee. If this notice is to an
individual who is importing a drug for personal use, it is issued
consistent with the requirements of section 801(g) of the FD&C Act. The
owner or consignee is given an opportunity to appear before the Agency
and introduce testimony orally or in writing on why the drug should not
be refused admission into the United States. The owner or consignee can
also submit an application for authorization to recondition the drug to
bring it into compliance with the FD&C Act or to render it other than a
food, drug, device, or cosmetic. If, after providing the owner or
consignee with notice and opportunity to present testimony, FDA
determines that the drug should be refused admission, a notice of such
refusal is issued to the owner or consignee.
    The majority of refused drug products subject to FDA's new
destruction authority come into the United States via an International
Mail Facility (IMF) or an express courier hub. Parcels that come into
the United States via an IMF are routed by the United States Postal
Service (USPS) to Customs and Border Protection (CBP). CBP interdicts
certain drug shipments and turns them over to FDA for examination and a
determination of admission under the FD&C Act. Some of these parcels
may include one or more drugs that are unapproved, adulterated and/or
misbranded, including counterfeit drugs and drugs that purport to be
dietary supplements. USPS estimated that the average daily number of
parcels that came into the United States via international mail from
November 1, 2011, to October 31, 2012, was nearly 1.2 million (Ref. 1).
It is estimated that the number of such parcels which contain drugs
that enter the United States each year through the IMFs is between 20
million and 100 million.
    Operation Safeguard is a multiagency initiative to target illicit
imports of prescription drugs. In total, from fiscal years 2010 through
2012, FDA examined nearly 45,000 shipments and CBP seized more than
14,000 illicit shipments of prescription drugs during Operation
Safeguard, with international mail shipments constituting the majority
of the shipments that were seized (Ref. 1). Despite these efforts, the
high volume of inbound international mail shipments has strained
limited Federal resources at the IMFs making it extremely difficult to
interdict all incoming shipments of violative drugs.
    Violative drugs pose a serious public health threat to consumers in
the United States because they might not contain the active ingredient
that patients need for the treatment of their disease; they might have
too much or too little of an active ingredient; they might contain the
wrong active ingredient; and/or they might contain toxic ingredients.
For certain classes of drugs (e.g. antibiotics), these quality problems
can also increase the likelihood of drug resistance (Ref. 2). By taking
these drugs, consumers may be harmed directly by exposure to unsafe
drugs or they may be harmed because they are prevented from getting the
appropriate dose or strength of medications they need. Adverse events
due to these violative drugs are underreported. Patients taking
ineffective drugs may die or suffer the adverse effects of the
underlying disease, making it difficult to detect or attribute these
consequences to the violative drug (Ref. 3).
    FDA has issued several warnings about counterfeit and unapproved
drugs, including warnings issued in 2012 and 2013 about counterfeit
versions of the cancer medicines AVASTIN and ALTUZAN (bevacizumab)
approved for marketing outside of the United States, that were
purchased by medical practices in the United States. Certain
counterfeit versions of these drugs did not contain the active
pharmaceutical ingredient, (bevacizumab), which may have resulted in
patients not receiving needed therapy (Ref. 4). In July 2013, a British
citizen was sentenced to 18 months in prison for distributing
adulterated cancer drugs and selling a counterfeit version of ALTUZAN
that was obtained from Turkey to physicians in the United States (Ref.
5). As of December 2013, FDA has issued over 1500 letters to medical
practices in the United States to educate them about risky buying
practices and to warn them about counterfeit and unapproved drugs in
U.S. distribution. FDA publishes warnings about counterfeit medications
on its Web site at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm.
    Many violative drugs are purchased by U.S. consumers over the
Internet. In July 2013, the Government Accountability Office (GAO)
issued a report on rogue Internet pharmacies. In its report, GAO
defined a rogue Internet pharmacy as a fraudulent enterprise that
operates in violation of Federal and/or State law, offers cheap drugs
for sale without a prescription that meets Federal and State
requirements, or operates without a pharmacy license in the United
States. These rogue pharmacies may also operate in violation of laws
relating to fraud, money laundering and/or intellectual property
rights. Rogue Internet pharmacies operate Web sites that may look
professional and legitimate, but in reality are often marketplaces for
unapproved, adulterated and/or misbranded drugs (Ref. 6). According to
the GAO report, LegitScript, an online pharmacy verification service
that assesses the legitimacy of Internet pharmacies, determined that
there were over 34,000 active rogue Internet pharmacies as of April
2013 (Ref. 7).
    FDA has received a number of reports of adverse events resulting
from the purchase of violative drugs over the internet. For example,
FDA received reports from several consumers who ordered the FDA-
approved drugs AMBIEN, XANAX, LEXAPRO, or ATIVAN over the Internet but
instead received products containing haloperidol (the active
pharmaceutical ingredient in the FDA-approved antipsychotic drug
HALDOL). These consumers required emergency medical treatment for
symptoms such as difficulty in breathing, muscle spasms, and muscle
stiffness--all drug reactions associated with this powerful
antipsychotic (Ref. 8). In May 2012, FDA warned consumers about a
counterfeit version of ADDERALL (a drug used to treat attention deficit
hyperactivity disorders and narcolepsy) containing the wrong active
pharmaceutical ingredients, that was being purchased on the Internet
(Ref. 9).
    Some drugs that are represented and sold as dietary supplements can
also present a significant public health risk. For example, some
purported dietary supplements actually contain hidden or deceptively
labeled active pharmaceutical ingredients, some at levels much higher
than those found in drug products that are the subject of approved
applications. Such products, especially when taken without physician
supervision, can cause harm and have been associated with serious
adverse events. Some purported dietary supplements, although they may
not contain harmful ingredients, present a significant indirect public
health risk because they are promoted to prevent or treat serious
diseases but have not been proven safe and effective for that purpose.
Instead of seeing a doctor for diagnosis and treatment, na[iuml]ve
consumers may rely on such unproven remedies and may even substitute
them for doctor-prescribed medications that have been approved by FDA
based on proof of safety and effectiveness.
    Approximately 60 percent of the Class I drug recalls for fiscal
years 2007 through 2013 involved drugs purported

to be dietary supplements. (Class I drug recalls involve public health
threats for which there is a reasonable probability that the use of or
exposure to a drug will cause serious adverse health consequences or
death.) Many of the drugs being unlawfully marketed as dietary
supplements are imported into the United States via IMFs and express
courier hubs.
    Currently, drugs that have been refused admission into the United
States under section 801(a) of the FD&C Act are destroyed unless they
are exported within 90 days. Certain illegal drugs may also be
destroyed if they are seized and condemned under FDA's seizure
authority, section 304 of the FD&C Act (21 U.S.C. 334), or if they are
seized and forfeited under CBP's seizure and forfeiture authority, such
as 19 U.S.C. 1595a(c). Drugs that are imported via an IMF which are
refused are sent back to the USPS for export. There is currently little
deterrence to prevent sellers from sending violative drugs or resending
previously refused drugs into the United States via the IMFs. Drugs
refused admission into the United States might be subsequently offered
for re-importation by unscrupulous sellers who choose to circumvent the
import regulatory systems. In fact, some of the parcels returned by
USPS have been resubmitted for entry into the United States by the
sender, with the sticker indicating prior refusal by FDA still attached
and visible. Under this proposed rule, FDA will be better able to
prevent such re-importation by having an administrative mechanism for
destroying a drug valued at $2,500 or less (or such higher amount as
the Secretary of the Treasury may set by regulation) that has been
refused admission.

II. Proposed Changes to Current Regulations

A. Proposed Revisions to Part 1

    FDA proposes to amend part 1 to create an implementing regulation
for the administrative destruction of refused drugs. The proposed
amendment to part 1 consists of amendments to Sec.  1.94.

B. Principal Features of the Proposed Rule

    Section 708 of FDASIA authorizes the Agency to destroy certain
drugs that have already been refused admission under section 801(a) of
the FD&C Act after the owner or consignee receives notice and an
opportunity to present testimony before the Agency prior to
destruction. The proposed rule allows FDA to provide two separate
notices and hearings--one for refusal of admission and one for
destruction of a refused drug product--or to combine both notices and
hearings into one notice and proceeding. Whether the determinations
occur separately or in one combined proceeding, the determination of
refusal and the determination regarding destruction of a drug will be
made separately by the Agency as the findings are separate and
distinct. As with refusal of admission, FDA plans to specify
operational details of its process for destruction by guidance,
operating guidelines, or similar means. For example, the proposed rule
says the notice will specify a time period for introducing testimony
regarding destruction, which may be adjusted upon timely request giving
reasonable grounds, and FDA could explain the time period it would
typically provide. The operational details could also include the
format of the notice and which FDA officials are authorized to make the
decision as to whether to destroy a particular drug.
    As noted, a drug is subject to refusal of admission if, among other
reasons, it is or appears to be adulterated, misbranded, or unapproved
in violation of section 505 of the FD&C Act. FDA intends to exercise
its new authority under section 708 of FDASIA to take the further step
of destroying a drug only in situations where, after providing the
owner or consignee with the opportunity to introduce testimony, the
Agency has made a determination that the drug is adulterated,
misbranded, or unapproved in violation of section 505.

III. Effective Date

    FDA intends that the effective date of the new requirements will be
30 days after publication of a final rule in the Federal Register.
Section 708 of FDASIA states that FDA's new authority under section
801(a) of the FD&C Act shall not take effect until FDA issues a final
regulation, and section 708 of FDASIA requires FDA to ``publish the
final regulation not less than 30 days before the regulation's
effective date.''

IV. Analysis of Impacts (Summary of the Initial Regulatory Impact
Analysis)

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule, if finalized,
would not be an economically significant regulatory action as defined
by Executive Order 12866.
    If a rule has a significant economic impact on a substantial number
of small businesses, the Regulatory Flexibility Act requires Agencies
to analyze regulatory alternatives that would minimize any significant
impact of a rule on small entities. As further explained in this
section, FDA has determined that this proposed rule, if finalized,
would not have a significant economic impact on a substantial number of
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
state, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule, if finalized, to result in any 1-year expenditure that
would meet or exceed this amount.
    The primary public health benefit from adoption of the proposed
rule would be the value of the illnesses or deaths avoided because the
Agency destroyed a refused drug valued at $2,500 or less (or such
higher amount as the Secretary of the Treasury may set by regulation)
that posed a public health risk. Additionally, the proposed rule may
benefit firms through increases in sales, brand value, and investment
in research and development if the destroyed drug is a counterfeit or
an otherwise falsified version of an approved drug. The threat of
destruction may also have a deterrent effect resulting in a reduction
in the amount of violative drugs shipped into the United States in the
future. These benefits accrue whenever the Agency's other enforcement
tools would not have prevented a violative drug from entering the U.S.
market. The current procedure whereby a drug refused admission might be
exported does not ensure that the drug would not be imported into the
United States in the future.
    The estimated primary costs to FDA include the additional costs
associated with destroying a refused drug. Our

estimates of the primary costs assume that all refused drugs valued at
$2,500 or less (or such higher amount as the Secretary of the Treasury
may set by regulation) would be destroyed (estimated 12,100
destructions performed each year), that FDA would contract with another
Government agency or private firm to destroy the drug, and the notice
and hearing process for destruction would likely be combined with the
notice and hearing process for refusals. Based on an assumed 12,100
administrative destructions performed each year, the Agency estimates
the quantifiable net annual social benefit of the proposed rule, if
finalized, to be between $228,000 and $618,000. The present discounted
value of the quantifiable net social benefit over 20 years would be in
the range of $3,386,000 to $9,169,000 at a 3 percent discount rate and
in the range of $2,411,000 to $6,529,000 at a 7 percent discount rate.
    FDA has examined the economic implications of the proposed rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. In the proposed rule, small entities will bear costs to the
extent that they are responsible for the violative product. The number
of expected destructions per year along with the very small value per
event implies that this burden would not be significant, so we find
that this proposed rule, if finalized, would not have a significant
economic impact on a substantial number of small entities. This
analysis, together with other relevant sections of this document,
serves as the Initial Regulatory Flexibility Analysis, as required
under the Regulatory Flexibility Act.
    The full discussion of economic impacts is available in docket FDA-
2014-N-0504 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm# (Ref. 10).

V. Paperwork Reduction Act of 1995

    FDA concludes that the requirements contained in this proposed rule
are not subject to review by the Office of Management and Budget
because they do not constitute a ``collection of information'' under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

1. Government Accountability Office. ``Internet Pharmacies: Federal
Agencies and States Face Challenges Combating Rogue Sites,
Particularly Those Abroad,'' (GAO-13-560), p. 29, 2013. http://www.gao.gov/products/GAO-13-560.
2. U.S. Food and Drug Administration. ``Remarks as Delivered of
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs,
Partnership for Safe Medicines Interchange,'' 2010. http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/UCM235240.pdf.
3. Institute of Medicine. ``Countering the Problem of Falsified and
Substandard Drugs.'' Washington, DC: The National Academies Press,
p. 57, 2013. http://books.nap.edu/openbook.php?record_id=18272.
4. U.S. Food and Drug Administration. ``Health Care Provider Alert:
Another Counterfeit Cancer Medicine Found in the United States,''
2013. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/ucm338283.htm.
5. Department of Justice, United States Attorney's Office for the
Eastern District of Missouri. ``English Citizen Sentenced for
Distributing Adulterated and Counterfeit Cancer Drugs,'' 2013.
http://www.justice.gov/usao/moe/news/2013/july/taylor_richard.html.
6. Government Accountability Office. ``Internet Pharmacies: Federal
Agencies and States Face Challenges Combating Rogue Sites,
Particularly Those Abroad,'' (GAO-13-560), What GAO Found, 2013.
http://www.gao.gov/products/GAO-13-560.
7. Id., p. 14.
8. U.S. Food and Drug Administration. ``The Possible Dangers of
Buying Drugs Over the Internet,'' 2011. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm.
9. U.S. Food and Drug Administration. ``FDA Warns Consumers about
Counterfeit Version of Teva's Adderall,'' 2011. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm305932.htm.
10. U.S. Food and Drug Administration. ``Preliminary Regulatory
Impact Analysis, Initial Regulatory Flexibility Analysis, and
Unfunded Mandates Reform Act Analysis for Administrative Destruction
of Certain Drugs Refused Admission to the United States,'' 2014.
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food Labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Revise Sec.  1.94 to read as follows:

Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of
admission, or that the article is a drug that may be subject to
destruction under section 801(a) of the Federal Food, Drug, and
Cosmetic Act, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility or destruction of the article, and may be introduced
orally or in writing.
    (b) If such owner or consignee submits or indicates his or her
intention to submit an application for authorization to relabel or
perform other action to bring the article into compliance with the
Federal Food, Drug, and Cosmetic Act or to render it other than a food,
drug, device, or cosmetic, such testimony shall include evidence in
support of such application. If such application is not submitted at or
prior to the hearing on refusal of admission, the district director
shall specify a time limit, reasonable in the light of the
circumstances, for filing such application.
    (c) If the article is a drug that may be subject to destruction
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the
district director may give the owner or consignee a single written
notice that provides the notice on refusal of admission and the notice
on destruction of an article described in paragraph (a) of this
section. The district director may also combine the hearing on refusal
of admission with the hearing on destruction of the article described
in paragraph (a) of this section into a single proceeding.

    Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10304 Filed 5-5-14; 8:45 am]
BILLING CODE 4160-01-P