[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Notices]
[Pages 10588-10589]
[FR Doc No: 2017-02812]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0051]

Manlifts; Extension of the Office of Management and Budget's
(OMB) Approval of Information Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Standard on
Manlifts.

DATES: Comments must be submitted (postmarked, sent, or received) by
April 17, 2017.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2010-0051, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-3653, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 10:00 a.m. to 3:00 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2010-0051) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information
is in the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act

also requires that OSHA obtain such information with minimum burden
upon employers, especially those operating small businesses, and to
reduce to the maximum extent feasible unnecessary duplication of
efforts in obtaining information (29 U.S.C. 657).
    Paragraph 1910.68(e) of the Standard specifies two paperwork
requirements. The following sections describe who uses the information
collected under each requirement, as well as how they use it. The
purpose of the requirements is to reduce workers' risk of death or
serious injury by ensuring that manlifts are in safe operating
condition.
    Periodic Inspections and Records. This provision requires that each
manlift be inspected at least once every 30 days and it also requires
that limit switches shall be checked weekly. The manlift inspection is
to cover at least the following items: Steps; step fastenings; rails;
rail supports and fastenings; rollers and slides; belt and belt
tension; handholds and fastenings; floor landings; guardrails;
lubrication; limit switches; warning signs and lights; illumination;
drive pulley; bottom (boot) pulley and clearance; pulley supports;
motor; driving mechanism; brake; electrical switches; vibration and
misalignment; and any ``skip'' on the up or down run when mounting a
step (indicating worn gears). A certification record of the inspection
must be prepared upon completion of the inspection. The record must
contain the date of the inspection, the signature of the person who
performed the inspection, and the serial number or other identifier of
the inspected manlift.
    Disclosure of Inspection Certification Records. Employers are to
maintain the certification record and make it available to OSHA
compliance officers. This record provides assurance to employers,
workers, and compliance officers that manlifts were inspected as
required by the Standard. The inspections are made to keep equipment in
safe operating condition thereby preventing manlift failure while
carrying workers to elevated worksites. These records also provide the
most efficient means for the compliance officers to determine that an
employer is complying with the Standard.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The Agency requests an adjustment decrease of 1 (one) burden hour
associated with this Information Collection Request (from 37,801 hours
to 37,800 hours). This is a result of the Agency no longer taking a
burden or cost for disclosure of records during an OSHA inspection.
    Type of Review: Extension of a currently approved collection.
    Title: Manlifts (29 CFR 1910.68).
    OMB Control Number: 1218-0226.
    Affected Public: Business or other for-profits.
    Number of Respondents: 18,372.
    Frequency of Responses: 36,042.
    Average Time per Response: Varies from 2 minutes (.03 hour) for an
employer to disclose the inspection certification record to 1.05 hour
to inspect a manlift.
    Estimated Total Burden Hours: 37,800.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2010-0051). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the Web site, and for assistance in using the Internet
to locate docket submissions.

V. Authority and Signature

    Dorothy Dougherty, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on January 27, 2017.
Dorothy Dougherty,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-02812 Filed 2-13-17; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Proposed Rules]
[Pages 34609-34611]
[FR Doc No: 2013-13570]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1174; Airspace Docket No. 12-AAL-12]

Proposed Modification of Class D and E Airspace; Kenai, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class D and E airspace at
Kenai, AK, to accommodate aircraft departing and arriving under
Instrument Flight Rules (IFR) at Kenai Municipal Airport. A minor
adjustment also would be made to the geographic coordinates of the
airport. This action, initiated by the biennial review of the Kenai
airspace area, would enhance the safety and management of aircraft
operations at the airport.

DATES: Comments must be received on or before July 25, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2012-
1174; Airspace Docket No. 12-AAL-12, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire.

Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2012-1174 and Airspace Docket No. 12-AAL-12) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2012-1174 and Airspace Docket No. 12-AAL-12''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address 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 Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class D airspace, Class E
surface airspace and Class E airspace designated as an extension to
Class D surface area, at Kenai Municipal Airport, Kenai, AK. Also, the
geographic coordinates of the airport would be updated to coincide with
the FAA's aeronautical database. After biennial review of the airspace,
the FAAs Aeronautical Products Office found modification of the
airspace necessary for the safety and management of aircraft departing
and arriving under IFR operations at the airport. The Class D airspace
and Class E surface area airspace excluded below 1,100 feet MSL beyond
4 miles from the airport would be decreased, and the segment of the
Class E airspace designated as an extension extending to 10.2 miles
northeast of the airport would be adjusted to coincide with the
dimensions of the cutout.
    Class D airspace and Class E airspace designations are published in
paragraph 5000, 6002 and 6004, respectively, of FAA Order 7400.9W,
dated August 8, 2012, and effective September 15, 2012, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designations listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for 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 controlled airspace at Kenai Municipal Airport,
Kenai, AK.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

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

    Authority: 49 U.S.C. 106(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 the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AAL AK D Kenai, AK [Amended]

Kenai Municipal Airport, AK
    (Lat. 60[deg]34'24'' N., long. 151[deg]14'41'' W.)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 5.2-mile radius of Kenai Municipal Airport,
excluding the airspace below 1,100 feet MSL beyond 4 miles from the
airport extending from the 310[deg] bearing clockwise to the
346[deg] bearing of the airport. This Class D airspace area is
effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter
be continuously published in the Airport/Facility Directory.

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AAL AK E2 Kenai, AK [Amended]

Kenai Municipal Airport, AK
    (Lat. 60[deg]34'24'' N., long. 151[deg]14'41'' W.)

    That airspace extending upward from the surface to and including
2600 feet MSL within a 5.2-mile radius of Kenai Municipal Airport,
excluding the airspace below 1,100 feet MSL beyond 4 miles from the
airport extending from the 310[deg] bearing clockwise to the
346[deg] bearing of the airport; and that airspace extending upward
from the surface beginning at lat. 60[deg]39'25'' N., long.
151[deg]17'17'' W.; to lat. 60[deg]45'01'' N., long. 151[deg]10'27''
W.; to lat. 60[deg]41'12'' N., long. 150[deg]57'33'' W.; to lat.
60[deg]35'34'' N., long. 151[deg] 04'25'' W., thence
counterclockwise along the 5.2-mile radius of the airport to the
point of beginning. This Class E airspace area is effective during
the specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.

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

* * * * *

AAL AK E4 Kenai, AK [Amended]

Kenai Municipal Airport, AK
    (Lat. 60[deg]34'24'' N., long. 151[deg]14'41'' W.)

    That airspace extending upward from the surface beginning at
lat. 60[deg]39'25'' N., long. 151[deg]17'17'' W.; to lat.
60[deg]45'01'' N., long. 151[deg]10'27'' W.; to lat. 60[deg]41'12''
N., long. 150[deg]57'33'' W.; to lat. 60[deg]35'34'' N., long.
151[deg] 04'25'' W., thence counterclockwise along the 5.2-mile
radius of the airport to the point of beginning.

    Issued in Seattle, Washington, on May 24, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-13570 Filed 6-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3736-3739]
[FR Doc No: 2020-00917]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87982; File No. SR-NASDAQ-2020-001]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Modify the Delisting
Process for Securities With a Bid Price Below $0.10 and for Securities
That Have Had One or More Reverse Stock Splits With a Cumulative Ratio
of 250 or More to One Over the Prior Two Year Period

January 15, 2020.
    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 2, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the delisting process for
securities with a bid price below $0.10 and for securities that have
had one or more reverse stock splits with a cumulative ratio of 250
shares or more to one over the prior two year period.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, 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
    Nasdaq proposes to modify the delisting process for securities with
a bid price below $0.10 for ten consecutive trading days and for
securities that have had one or more reverse stock splits with a
cumulative ratio of 250 shares or more to one over the prior two year
period (meaning that an investor would hold one share for every 250
shares or more owned at the start of the period).
    Currently, Nasdaq rules require that primary equity securities,
preferred stocks and secondary classes of common stock maintain a
minimum $1.00 bid price for continued listing.\3\ Under Listing Rule
5810(c)(3)(A), a security is considered deficient with this requirement
if its bid price closes below $1.00 for a period of 30 consecutive
business days. A company with a bid price deficiency has 180 calendar
days from notification of the deficiency to regain compliance. A
company generally can regain compliance with the bid price requirement
by maintaining a $1.00 closing bid price for a minimum of ten
consecutive business days during the compliance period.\4\ Under
Listing Rule 5810(c)(3)(A)(ii), a company that lists a security on the
Nasdaq Capital Market, or transfers its listing to that market, may be
eligible for a second 180 calendar day period to regain compliance,
provided that on the last day of the first compliance period the
company meets the market value of publicly held shares requirement for
continued listing as well as all other applicable standards for initial
listing on the Capital Market and notifies Nasdaq of its intent to cure
the bid deficiency.
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    \3\ See Listing Rules 5450(a)(1), 5460(a)(3), 5550(a)(2) and
5555(a)(1).
    \4\ Under Listing Rule 5810(c)(3)(G), Nasdaq Staff could extend
this ten-day period to a maximum of 20 days.
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    This process is designed to allow adequate time for a company
facing temporary business issues, a temporary decrease in the market
value of its securities, or temporary market conditions to come back
into compliance with a bid price deficiency. Nasdaq has observed
certain situations where, in Nasdaq's view, a company may be facing
more serious issues and a compliance period of up to 360 days \5\
therefore may not be appropriate. Specifically, these situations
involve: (i) Securities with very low security prices (below $0.10);
and (ii) securities where the company has completed one or more reverse
stock splits over the prior two year period that, when considered
cumulatively, result in a ratio of 250 shares or more to one (meaning
that an investor would receive one share for every 250 shares or more
owned at the start of the period), and then fails to satisfy the bid
price requirement.
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    \5\ As noted above, under Listing Rule 5810(c)(3)(A) all
companies are eligible for an initial compliance period of 180
calendar days from the notification of non-compliance with the bid
price requirement and a company that lists its security on the
Nasdaq Capital Market, or transfers its listing to that market, may
be eligible for a second 180 calendar day period to regain
compliance, for a total compliance period of up to 360 calendar
days.
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    In these situations, Nasdaq has observed that the challenges facing
the company generally are not temporary and may be so severe that the
company is not likely to regain compliance within the prescribed
compliance period. Moreover, the bid price issues can be a leading
indicator of other listing compliance concerns. As a result, these
companies often become subject to delisting for other reasons during
the compliance periods. Finally, these companies frequently need to
raise additional capital to fund their business operations and often do
so by engaging in extremely dilutive transactions. Accordingly, in
order to enhance investor protection, Nasdaq proposes to modify the
listing rules so that these companies are subject to shortened
compliance periods, which could lead to earlier delisting, and enhanced
review procedures.
    With respect to securities with very low prices, Nasdaq proposes to
modify the Listing Rules to provide that a company in a bid price
compliance period (i.e., the company's security has already traded
below $1.00 for thirty consecutive days) will immediately receive a
Staff Delisting Determination if the security trades below $0.10 for a
period of ten consecutive trading days, ending any otherwise applicable
compliance period. Such a company could request review of the Delisting
Determination by a Hearings Panel, and the Panel could grant the
company additional time to complete a reverse stock split or otherwise
regain compliance.\6\ Nasdaq believes that placing such companies
immediately under the scrutiny of a Hearings Panel will serve to better
protect investors.
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    \6\ Under Listing Rule 5815(c)(1)(A), a Hearings Panel can grant
an exception to the continued listing standards for a period not to
exceed 180 days from the date of the Staff Delisting Determination.
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    Nasdaq also proposes to change the Listing Rules to require the
issuance of a Staff Delisting Determination if a company falls out of
compliance with the $1.00 minimum bid price (i.e., it has had a closing
bid price below $1.00 for 30 consecutive business days) after
completing one or more reverse stock splits resulting in a cumulative
ratio 250 shares or more to one over the two year period before such
non-compliance.\7\ In these cases, Nasdaq believes it is inappropriate
for a security to remain listed while relying on very large reverse
stock splits to maintain compliance with the $1.00 minimum bid price.
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    \7\ For example, a company could effect a reverse stock split in
a ratio of 25 shares to one followed within the two-year period by a
second reverse stock split in a ratio of 10 shares to one, resulting
in a cumulative ratio of 250 shares to one. Alternatively, a company
could effect three reverse stock splits in the two year period, with
ratios of 10 shares to one, five shares to one, and five shares to
one, respectively, resulting in a cumulative ratio of 250 shares to
one.
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    A company that is not eligible for a compliance period under these
proposed rule changes would receive a Staff Delisting Determination,
which it

could appeal to a Hearings Panel, and the Panel could grant the company
an exception to remain listed if it believes the company will be able
to achieve and maintain compliance with the bid price requirement.
However, Nasdaq also proposes to modify the Listing Rules so that
following such a Panel exception the company would be subject to the
procedures applicable to a company with recurring deficiencies as
described in Rule 5815(d)(4)(B). As a result, if within one year of the
date the company regains compliance the company again fails to maintain
compliance with the price requirement, the company would not be
eligible for a compliance period and instead the Listing Qualifications
Department will issue a Staff Delisting Determination, which can be
appealed to the Hearings Panel.
    Nasdaq believes that it would be unfair to modify the rules
impacting companies with securities that are already in a compliance
period, and therefore proposes to implement these new rules for
companies that first receive notification of non-compliance with the
bid price requirement after the date of the Commission's approval of
these changes. A company that has already received notification of non-
compliance would be permitted to regain compliance under the existing
rule, in the manner that the notification of non-compliance would have
described.\8\
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    \8\ Nasdaq notes that under Listing Rule 5810(c)(3)(A)(ii), a
company is not eligible for the second compliance period ``if it
does not appear to Nasdaq that it is possible for the Company to
cure the deficiency.'' As is currently the case, Nasdaq may rely
upon this language to deny the second compliance period to a company
with a very low stock price or that has engaged in significant prior
reverse stock splits, even though the company is not yet subject to
the new rule.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Section
6(b)(5) and 6(b)(7) of the Act,\10\ in particular. The proposed rule
change furthers the objectives of Section 6(b)(5) in that it is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest, by enhancing Nasdaq's listing requirements and
limiting the time that a security can remain listed with a price below
$0.10 or following one or more reverse stock splits with a cumulative
ratio of 250 to one or more over the prior two year period. In that
regard, Nasdaq has observed that the challenges facing such companies
generally are not temporary and may be so severe that the company is
not likely to regain compliance within the prescribed compliance
period. Moreover, the price concerns with these companies can be a
leading indicator of other listing compliance concerns, and these
companies often become subject to delisting for other reasons during
the compliance periods. Finally, these companies often have a need to
raise additional capital to fund their business operations at extremely
low prices in dilutive transactions. While listed, these securities are
exempt from the ``Penny Stock Rules,'' \11\ which provide enhanced
investor protections to prevent fraud and safeguard against potential
market manipulation. In particular, the Penny Stock Rules generally
require that broker-dealers provide a disclosure document to their
customers describing the risk of investing in Penny Stocks and approve
customer accounts for transactions in Penny Stocks. Nasdaq believes
that an exemption from these Penny Stock requirements may not be
appropriate for abnormally low priced stocks and stocks that are
trading below $1 after completing one or more reverse stock splits with
a cumulative ratio of 250 to one or more over the prior two year period
because these securities may have similar characteristics to Penny
Stocks. Nasdaq therefore believes it is appropriate to subject these
securities to heightened scrutiny given the availability of the
exemption to securities listed on Nasdaq.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5) and (7).
    \11\ See Exchange Act Rules 3a51-1, 17 CFR 240.3a51-1, and 15g-1
to 15g-100, 17 CFR 240.5g-1 et seq.
---------------------------------------------------------------------------

    The proposed rule change furthers the objectives of Section 6(b)(7)
of the Act in that it continues to provide a fair procedure for
companies subject to these enhanced listing requirements. These
companies can seek review of a Staff Delisting Determination from a
Hearings Panel, which can afford the company additional time to regain
compliance, and can appeal the Hearings Panel decision to the Nasdaq
Listing and Hearing Review Council.\12\ As a result, Nasdaq believes
that the proposed rule appropriately balances the need for appropriate
listing standards with the statutory requirement to protect investors
and the public interest.
---------------------------------------------------------------------------

    \12\ See Listing Rules 5815 and 5820, respectively.
---------------------------------------------------------------------------

    Finally, Nasdaq believes that the ten consecutive trading day
period that a company must trade below $0.10 before the proposed rule
would require issuance of a Staff Delisting Determination appropriately
balances Nasdaq's obligation and desire to protect investors under
Section 6(b)(5) with the need for a fair and equitable procedure under
Section 6(b)(7). The ten consecutive trading day period is long enough
that a temporary decline below $0.10 will not trigger the proposed
heightened requirements. Moreover, the ten-day period is designed to
parallel the timeframe, already a part of Nasdaq's rules, that a
company must trade above $1.00 to demonstrate compliance with the bid
price requirement.

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. While Nasdaq does not believe
there will be any impact on competition from the proposed change, any
impact on competition that does arise will be necessary to better
protect investors, in furtherance of a central purpose of the Act.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

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_ADDRESS>Please include
File Number SR-NASDAQ-2020-001 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 Number SR-NASDAQ-2020-001. 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 Number SR-NASDAQ-2020-001, and should be submitted
on or before February 12, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-00917 Filed 1-21-20; 8:45 am]
 BILLING CODE 8011-01-P


As submitted on November 28, 2007, the 2007 South Coast AQMP
included a set of PM2.5 budgets for RFP years 2009 and 2012,
the attainment year 2014, and analysis years 2023 and 2030. See CARB
Resolution 07-05, which revised the budgets in the 2007 South Coast
AQMP as adopted by the District, and which was included in the November
28, 2007 submittal. We refer herein to these budgets as the
``original'' budgets. On April 30, 2008, CARB submitted a SIP revision
that replaces the original set of PM2.5 budgets with two new
sets of budgets (herein, ``replacement'' budgets). One set of the
replacement budgets is referred to as ``SIP-based'' budgets, and the
other set is referred to as ``baseline'' budgets. In its April 30, 2008
submittal, CARB requests that EPA give primary consideration to the
``SIP-based'' budgets and only find the ``baseline'' budgets to be
adequate if EPA cannot find the ``SIP-based'' budgets adequate in their
entirety.
    The replacement budgets submitted on April 30, 2008 differ from the
original budgets in that they reflect the EPA-approved EMFAC2007 motor
vehicle emissions factor model (See 73 FR 3464, January 18, 2008)
rather than District's CEPA emission factor model, which had been used
for the original budgets. The ``SIP-based'' budgets reflect emissions
reductions from rules adopted by October 2006 and also from control
measures CARB expects to adopt in regulatory form in the future. The
``baseline'' budgets differ from the ``SIP-based'' budgets by excluding
emission reductions from control measures in the 2007 State Strategy
that had not been adopted in regulatory form by October 2006.\28\
Moreover, the ``baseline'' budgets are only established for RFP years
2009 and 2012 whereas the ``SIP-based'' budgets are established for the
RFP years, the attainment year, and analysis years 2023 and 2030. The
two sets of PM2.5 budgets (i.e., the replacement budgets)
are shown in Tables 10 and 11, below.
---------------------------------------------------------------------------

    \28\ With respect to the ``SIP-based'' budget for RFP year 2009,
however, CARB did exclude the emissions reductions from measures not
adopted by October 2006. Thus, the ``SIP-based'' PM2.5
budget for 2009 is the same as the ``baseline'' PM2.5
budget for that year.

    Table 10--``SIP-Based'' PM[ihel2].[ihel5] Motor Vehicle Emissions
                                 Budgets
                      [Annual average tons per day]
------------------------------------------------------------------------
   Budget year            VOC                NOX              PM2.5
------------------------------------------------------------------------
           2009                196                413                38
           2012                139                276                37
           2014                122                201                33
           2023                 89                131                37
           2030                 75                121                39
------------------------------------------------------------------------

 Table 11--``Baseline'' [ihel2].[ihel5] Motor Vehicle Emissions Budgets
                      [Annual average tons per day]
------------------------------------------------------------------------
   Budget year            VOC                NOX              PM2.5
------------------------------------------------------------------------
           2009                196                413                38
           2012                163                337                38
------------------------------------------------------------------------

    On August 12, 2009, CARB submitted a SIP revision that updates
certain portions of the 2007 State Strategy to account for emission
reductions from regulations adopted in 2007 and 2008, some of which
relate to on-road sources, such as modifications to the reformulated
gasoline program, smog check improvements, and cleaner in-use heavy
duty trucks. CARB's August 12, 2009 SIP revision did not revise the
budgets but documents the extent to which control measures for which
credit had been taken in the ``SIP-based'' budgets, but not in the
``baseline'' budgets, have now been adopted in regulatory form.
    EPA generally first reviews budgets submitted with an attainment,
RFP, or maintenance plan for adequacy, prior to taking action on the
plan itself, and did so with respect to the PM2.5 budgets in
the 2007 South Coast AQMP. The availability of the original budgets was
announced for public comment on EPA's adequacy Web page on February

12, 2008 and the availability of the replacement (then available in
draft form) was announced for public comment on March 27, 2008. EPA
received comments from the public in response to both postings.
    On May 6, 2008, we found the ``SIP-based'' PM2.5 budgets
for the 2007 South Coast AQMP, as revised on April 30, 2008, to be
inadequate for transportation conformity purposes. See the letter and
enclosures dated May 6, 2008 from Deborah Jordan, Director, Air
Division, EPA Region IX to James Goldstene, Executive Officer, CARB (a
copy of which has been placed in the docket for this rulemaking).
However, in our May 2008 adequacy determination, we found the
``baseline'' PM2.5 budgets for RFP years 2009 and 2012 to be
adequate. Generally, we found the ``SIP-based'' budgets to be
inadequate because they reflected control measures not yet adopted in
regulatory form and thus not adequately quantified or supported by the
plan. In contrast, we found the ``baseline'' PM2.5 budgets
to be consistent with the plan's RFP demonstration and to be based on
adopted mobile source regulations that have already been implemented.
Our notice of adequacy/inadequacy of the budgets was published on May
15, 2008 at 73 FR 28110 (corrected on June 18, 2008 at 73 FR 34837),
and was effective on May 30, 2008.
    The criteria by which we determine whether a SIP's budgets are
adequate and approvable for conformity purposes are outlined in 40 CFR
93.118(e)(4) and (5). The following paragraphs provide our review of
the ``SIP-based'' and ``baseline'' PM2.5 budgets for the
2007 South Coast AQMP against our adequacy criteria and provide the
basis for our proposed action relative to the budgets. Since the
criteria for evaluation purposes are the same for adequacy or
inadequacy as for approval or disapproval of budgets, we incorporate by
reference our earlier determination of adequacy/inadequacy, and focus
in the following paragraphs on those considerations that have changed
since the time of our May 2008 adequacy/inadequacy determination.
    Under 40 CFR 93.118(e)(4)(i), we review a submitted plan to
determine whether the plan was endorsed by the Governor (or designee)
and was subject to a public hearing. As documented in our May 2008
adequacy/inadequacy determination, the 2007 South Coast AQMP and 2007
State Strategy, and April 2008 replacement budgets, were all submitted
under cover of letters signed by CARB's Executive Officer, the
Governor's designee. Likewise, CARB's August 12, 2009 SIP revision was
submitted under cover of a letter sent by CARB's Executive Officer and
includes documentation of a public hearing held on April 23-24, 2009.
Therefore, we propose that the submitted plan and related ``SIP-based''
and ``baseline'' budgets meet the criterion under 40 CFR
93.118(e)(4)(i).
    Under 40 CFR 93.118(e)(4)(ii), we review a submitted plan to
determine whether the plan was developed through consultation with
Federal, State and local agencies and whether full implementation plan
documentation was provided to EPA and EPA's stated concerns, if any,
were addressed. As documented in our May 2008 adequacy/inadequacy
determination, the 2007 South Coast AQMP and 2007 State Strategy, and
April 2008 replacement budgets, were all developed through consultation
with Federal, State and local agencies and included documentation of
adequate responses to EPA's concerns. Moreover, CARB's August 12, 2009
SIP revision was developed to meet EPA's requests for additional
information to aid in our review of the 2007 South Coast AQMP and 2007
State Strategy. We propose that the submitted plan, and related ``SIP-
based'' and ``baseline'' budgets, were developed through sufficient
consultation with Federal, State and local agencies and thereby meet
the criterion under 40 CFR 93.118(e)(4)(ii).
    Under 40 CFR 93.118(e)(4)(iii), we review a submitted plan to
determine whether the budgets are clearly identified and precisely
quantified. Both the ``SIP-based'' and ``baseline'' budgets are clearly
identified. As noted in our May 2008 adequacy/inadequacy determination,
the budgets are shown in attachments 1 (``SIP-based'' budgets) and 2
(``baseline'' budgets) to CARB Resolution 08-27, which was included in
the SIP revision submitted by CARB on April 30, 2008. The ``SIP-based''
budgets are not precisely quantified because the new emission
reductions do not result from adequately specified control measures. In
contrast, the ``baseline'' budgets reflect control measures that are
already implemented and do not include new emission reductions
attributed to general commitments; therefore, these budgets are
precisely quantified. We propose that the ``SIP-based'' budgets do not
meet the criterion under 40 CFR 93.118(e)(4)(iii) but the ``baseline''
budgets do.
    Under 40 CFR 93.118(e)(4)(iv), we review a submitted plan to
determine whether the budgets, when considered together with all other
emissions sources, are consistent with applicable requirements for
reasonable further progress, attainment, or maintenance (whichever is
relevant to a given SIP submission). Based on our proposed disapproval
of the RFP and attainment demonstrations (See sections IV.D and IV.E of
this document), EPA proposes that all of the ``SIP-based'' and the
``baseline'' budgets, when considered together with all other emission
sources, are not consistent with the requirement to demonstrate
attainment or RFP of the PM2.5 NAAQS by 2014.
    Because we are proposing to disapprove the RFP demonstrations for
years 2009 and 2012, we do encourage CARB to submit revised budgets to
lock in the benefit of the new regulations and thereby avoid the chance
that increases in vehicle activity will increase the overall challenge
of attaining the NAAQS. For the reasons stated above, we propose that
the ``baseline'' and ``SIP-based'' budgets do not meet the criterion
under 40 CFR 93.118(e)(4)(iv).
    Under 40 CFR 93.118(e)(4)(v), we review a plan to determine whether
the budgets are consistent with and clearly related to the emissions
inventory and the control measures in the submitted control strategy
plan or maintenance plan. The plan, as supplemented by the SIP revision
dated August 12, 2009, does not show a clear relationship between the
``SIP-based'' budgets and the emissions inventory and control measures.
The ``SIP-based'' budgets incorporate new emission reductions from the
State's strategy that result, in part, from specified control measures
that have not been adopted in regulatory form (or have been adequately
supported as a voluntary measure). As noted above, more control
measures have been adopted by CARB in regulatory form than was the case
when the ``SIP-based'' budgets were adopted and submitted by CARB to
EPA, but a portion of the emission reductions included in the ``SIP-
based'' budgets remains unsupported by regulations or as a voluntary
measure. In contrast, as discussed further in our May 2008 adequacy/
inadequacy determination, the plan does show a clear relationship
between the ``baseline'' budgets, control measures, and the total
emissions inventory. Thus, we propose that the submitted plan's ``SIP-
based'' budgets do not meet this criterion for adequacy and approval
and the ``baseline'' budgets do.
    Under 40 CFR 93.118(e)(4)(vi), we review a submitted plan to
determine whether revisions to previously submitted plans explain and
document any changes to previously submitted budgets and control
measures; impacts on point and area source emissions; any changes to
established safety margins; and reasons for the changes (including

the basis for any changes related to emissions factors or estimates of
vehicle miles traveled and changes in control measures). As noted in
our May 2008 adequacy/inadequacy determination, the SIP revision
submitted on April 30, 2008 explains and documents all changes to
previously submitted budgets. Thus, we propose that the submitted plan
meets this criterion for adequacy and approval with respect to both the
``SIP-based'' and ``baseline'' budgets.
    Under 40 CFR 93.118(e)(5), we review the State's compilation of
public comments and response to comments that are required to be
submitted with any SIP revision. As noted in our May 2008 adequacy/
inadequacy determination, District compiled public comments submitted
during the June 1, 2007 public hearing and during the public comment
periods and we reviewed this compilation and found that District's and
CARB's responses were acceptable. No issues that might have affected
our adequacy findings remain unanswered. Thus, we propose that the plan
meets this criterion for adequacy and approval with respect to both the
``SIP-based'' and ``baseline'' budgets.
    For the reasons described in the May 6, 2008 letter from Deborah
Jordan to James Goldstene, we found that the ``SIP-based'' budgets for
the 2007 South Coast AQMP, as submitted on April 30, 2008, do not meet
certain adequacy requirements under 40 CFR 93.118(e)(4) and (5) and
concluded that they were inadequate for transportation conformity
purposes. Now that we have completed a thorough review of the entire
South Coast PM2.5 SIP, which is described above in this
proposal, we have concluded that the ``SIP-based'' budgets are not
precisely quantified because the new emission reductions do not result
from adequately specified control measures, and that the plan as a
whole will not ensure RFP and attainment of the PM2.5 NAAQS
and does not show a clear relationship between the ``SIP-based''
budgets and the emissions inventory and control measures. Thus, we
propose to disapprove both the ``baseline'' and the ``SIP-based''
PM2.5 budgets (shown in Table 11 above) for transportation
conformity purposes. SCAG and the U.S. Department of Transportation are
not currently using the ``SIP-based'' budgets in transportation
conformity determinations due to the inadequacy finding made in 2008.
If the proposed disapproval of the budgets is finalized, then neither
the ``baseline'' nor ``SIP-based'' budgets could be used in
transportation conformity determinations after the effective date of
the disapproval.
    In summary, for the reasons discussed above, we are now proposing
disapproval of the PM2.5 budgets that we previously had
determined to be inadequate. Because we are proposing to disapprove the
RFP demonstration, we are proposing to disapprove the PM2.5
budgets we previously found adequate as well.

I. Mid Course Review

    Any State that submits to EPA an approvable attainment plan for a
PM2.5 nonattainment area justifying an attainment date of
nine or ten years from the date of designation also must submit to EPA
a mid-course review six years from the date of designation, or by April
2011. 40 CFR 51.1011. The mid-course review for an area must include:
(1) A review of emissions reductions and progress made in implementing
control measures to reduce emissions of direct PM2.5 and
PM2.5 attainment plan precursors contributing to
PM2.5 concentrations in the area; (2) an analysis of changes
in ambient air quality data for the area; (3) a revised air quality
modeling analysis to demonstrate attainment; (4) any new or revised
control measures adopted by the State, as necessary to ensure
attainment by the attainment date in the approved SIP of the
nonattainment area. We anticipate receiving this midcourse review from
the District and CARB by April 2011.

V. EPA's Proposed Actions

A. EPA's Proposed Approvals and Disapprovals

    For the reasons discussed above, EPA is proposing to approve in
part and disapprove in part California's attainment SIP for the South
Coast nonattainment area for the 1997 PM2.5 NAAQS. This SIP
submittal consists of the portions of the District's South Coast 2007
AQMP and the South Coast nonattainment area-specific portions of CARB's
revised 2007 State Strategy addressing CAA and EPA regulations for
attainment of the 1997 PM2.5 NAAQS for the South Coast
nonattainment area.
    EPA is proposing to approve under CAA section 110(k)(3) the
following elements of the South Coast PM2.5 attainment SIP:
    1. The SIP's base year and baseline emissions inventories as
meeting the requirements of CAA section 172(c)(3) and 40 CFR Sec.
51.1008;
    2. the District's commitments for the adoption and implementation
schedule for specific control measures listed in Table 7-3 in the South
Coast 2007 AQMP to the extent that these commitments have not yet been
fulfilled, and to achieve specific aggregate emission reductions of 32
tpd of NOX, 10 tpd of VOC, 4 tpd of direct PM2.5,
and 3 tpd of SOX by 2014 as listed in Table 4-10 of the
South Coast 2007 AQMP and the CARB Staff Report for the South Coast
2007 AQMP, page 17, as SIP-strengthening;
    3. CARB's commitments to propose certain defined measures, as
listed on page 23 of the 2009 State Strategy Status Report; and to
achieve aggregate emission reductions of 152 tpd of NOX, 9
tpd of direct PM2.5, 46 tpd of VOC, and 20 tpd of
SOX in the South Coast nonattainment area by 2014 as
provided, as SIP-strengthening; and
    4. the air quality modeling in the South Coast 2007 AQMP as meeting
the requirements of the CAA and EPA guidance.
    EPA is proposing to disapprove under CAA section 110(k)(3) the
following elements of the South Coast PM2.5 attainment SIP:
    1. The attainment demonstration for failing to meet the
requirements of CAA section 172(c)(1) and 40 CFR 51.1007 due to
insufficient adopted and EPA-approved rules needed to support the
determination that the South Coast nonattainment area will attain by
the State's proposed attainment date. As a result, we are also
proposing to disapprove the RACM/RACT demonstration, the State's
request for an attainment date extension to April 5, 2015, and the RFP
demonstration, because they are dependent on the approval of an
attainment demonstration under the PM2.5 implementation rule
(See 40 CFR 51.1009, 51.1010, and 51.1004);
    2. The motor vehicle emissions budgets for the RFP milestone years
of 2009 and 2012, and for the attainment year, because they are derived
from RFP and attainment demonstrations which we are proposing to
disapprove;
    3. The contingency measures for failing to meet the requirements of
CAA section 172(c)(9) and 40 CFR 51.1012; and
    4. The assignment of 10 tpd of NOX to the federal
government.

B. CAA Consequences of a Final Disapproval

    EPA is committed to working with the District, CARB and SCAG to
resolve the identified problems that make the current South Coast 2007
AQMP for the South Coast nonattainment area for the 1997
PM2.5 NAAQS not fully approvable under the CAA. We firmly
believe that such solutions are available and that expeditious
attainment of the 1997

PM2.5 standards in the South Coast is achievable.
    However, should we finalize the disapprovals as proposed here, a
conformity freeze would take effect once the action becomes effective
(usually 30 days after publication of the final action in the Federal
Register). A conformity freeze means that only projects in the first
four years of the most recent conforming Regional Transportation Plan
(RTP) and Transportation Improvement Program (TIP) can proceed. During
a freeze, no new RTPs, TIPs or RTP/TIP amendments can be found to
conform. See 40 CFR 93.120.
    In addition to the effect on conformity, should we finalize the
disapprovals proposed here, the offset sanction in CAA section
179(b)(2) would apply in the South Coast PM2.5 nonattainment
area 18 months after the effective date of a final disapproval. The
highway funding sanctions in CAA section 179(b)(1) would apply in the
area six months after the offset sanction is imposed. Neither sanction
will be imposed if California submits and we approve prior to the
implementation of the sanctions, SIP revisions that correct the
problems identified in EPA's final action on the South Coast 2007 AQMP
and applicable portions of the revised 2007 State Strategy that are the
basis for any disapprovals.
    In addition to the sanctions, CAA section 110(c)(1) provides that
EPA must promulgate a federal implementation plan addressing the
deficient elements in the PM2.5 attainment SIP for the South
Coast, two years after the effective date of any disapproval should we
not be able to approve a revised SIP revision before that date.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely proposes to partially approve and
partially disapprove state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.

A. Executive Order 12866, Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,
because this proposed SIP disapproval under section 110 and subchapter
I, part D of the Clean Air Act will not in-and-of itself create any new
information collection burdens but simply disapproves certain State
requirements for inclusion into the SIP. Burden is defined at 5 CFR
1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. For purposes of assessing the impacts of today's rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
impact on a substantial number of small entities. This rule does not
impose any requirements or create impacts on small entities. This
proposed SIP disapproval under section 110 and subchapter I, part D of
the Clean Air Act will not in-and-of itself create any new requirements
but simply disapproves certain State requirements for inclusion into
the SIP. Accordingly, it affords no opportunity for EPA to fashion for
small entities less burdensome compliance or reporting requirements or
timetables or exemptions from all or part of the rule. The fact that
the Clean Air Act prescribes that various consequences (e.g., higher
offset requirements) may or will flow from this disapproval does not
mean that EPA either can or must conduct a regulatory flexibility
analysis for this action. Therefore, this action will not have a
significant economic impact on a substantial number of small entities.
    We continue to be interested in the potential impacts of this
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector.'' EPA has determined that the proposed disapproval action does
not include a Federal mandate that may result in estimated costs of
$100 million or more to either State, local, or tribal governments in
the aggregate, or to the private sector. This action proposes to
disapprove pre-existing requirements under State or local law, and
imposes no new requirements. Accordingly, no additional costs to State,
local, or tribal governments, or to the private sector, result from
this action.

E. Executive Order 13132, Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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.''
    This action does not have federalism implications. It will not 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, as
specified in Executive Order 13132, because it merely disapproves
certain State requirements for inclusion into the SIP and does not
alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, Executive
Order 13132 does not apply to this action.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
EPA is proposing

to disapprove would not apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law. Thus, Executive Order 13175
does not apply to this action.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it is not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997). This proposed SIP disapproval under section 110
and subchapter I, part D of the Clean Air Act will not in-and-of itself
create any new regulations but simply disapproves certain State
requirements for inclusion into the SIP.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001) because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    The EPA believes that this action is not subject to requirements of
Section 12(d) of NTTAA because application of those requirements would
be inconsistent with the Clean Air Act.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this proposed action. In reviewing SIP submissions, EPA's
role is to approve or disapprove state choices, based on the criteria
of the Clean Air Act. Accordingly, this action merely proposes to
disapprove certain State requirements for inclusion into the SIP under
section 110 and subchapter I, part D of the Clean Air Act and will not
in-and-of itself create any new requirements. Accordingly, it does not
provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: November 8, 2010.
Jared Blumenfeld,
Regional Administrator, EPA Region IX.
[FR Doc. 2010-29235 Filed 11-19-10; 8:45 am]
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[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Notices]
[Page 63918]
[FR Doc No: 2014-25477]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9918-47-Region 2]

Proposed CERCLA Section 122(h) Cost Recovery Settlement for the
Hooker Chemical/Ruco Polymer Superfund Site, Located in Hicksville,
Town of Oyster Bay, Nassau County, New York

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for public comment.

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SUMMARY: In accordance with Section 122(i) of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980, as
amended (``CERCLA''), notice is hereby given by the U.S. Environmental
Protection Agency (``EPA''), Region II, of a proposed cost recovery
settlement agreement pursuant to Section 122(h) of CERCLA, with
Occidental Chemical Corporation (``Settling Party'') for the Hooker
Chemical/Ruco Polymer Superfund Site (the ``Site''), located in
Hicksville, Town of Oyster Bay, Nassau County, New York. The Settling
Party agrees to pay EPA $722,250 in reimbursement of past response
costs related to EPA oversight of response actions performed by the
Settling Party at the Site.
    The settlement includes a covenant by EPA not to sue or to take
administrative action against the Settling party pursuant to Section
107(a) of CERCLA, with regard to the past response costs and future
response costs as defined in the settlement agreement. For thirty (30)
days following the date of publication of this notice, EPA will receive
written comments relating to the settlement. EPA will consider all
comments received and may modify or withdraw its consent to the
settlement if comments received disclose facts or considerations that
indicate that the proposed settlement is inappropriate, improper or
inadequate. EPA's response to any comments received will be available
for public inspection at EPA Region II, 290 Broadway, New York, New
York 10007-1866.

DATES: Comments must be submitted on or before November 26, 2014.

ADDRESSES: The proposed settlement is available for public inspection
at EPA Region II offices at 290 Broadway, New York, New York 10007-
1866. Comments should reference the Hooker Chemical/Ruco Polymer
Superfund Site, located in Hicksville, Town of Oyster Bay, Nassau
County, New York, Index No. CERCLA-02-2014-2017. To request a copy of
the proposed settlement agreement, please contact the EPA employee
identified below.

FOR FURTHER INFORMATION CONTACT: Argie Cirillo, Assistant Regional
Counsel, New York/Caribbean Superfund Branch, Office of Regional
Counsel, U.S. Environmental Protection Agency, 290 Broadway--17th
Floor, New York, New York 10007-1866. Telephone:<PHONE_NUMBER>.

    Dated: October 14, 2014.
Walter Mugdan,
Director, Emergency and Remedial Response Division, U.S. Environmental
Protection Agency, Region 2.
[FR Doc. 2014-25477 Filed 10-24-14; 8:45 am]
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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85630-85632]
[FR Doc No: 2023-26997]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2014 and FDA-2022-E-2016]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Fotivda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Fotivda and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 5, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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 Nos.
FDA-2022-E-2014 and FDA-2022-E-2016 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; FOTIVDA.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Fotivda
(tivozanib hydrochloride), which is indicated for treatment of adult
patients with relapsed or refractory advanced renal cell carcinoma
following two or more prior systemic therapies. Subsequent to this
approval, the USPTO received patent term restoration applications for
Fotivda (U.S. Patent Nos. 6,821,987; 7,166,722) from AVEO
Pharmaceuticals, Inc. (agent of Kyowa Kirin Co., Ltd.) and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated September 13, 2022, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of Fotivda represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Fotivda is 5,035 days. Of this time, 4,690 days occurred during the
testing phase of the regulatory review period, while 345 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
May 30, 2007. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 30,
2007.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 31,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for the approved product, Fotivda (NDA 212904), was
initially submitted on March 31, 2020.
    3. The date the application was approved: March 10, 2021. FDA has
verified the applicant's claim that NDA 212904 was approved on March
10, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several

statutory limitations in its calculations of the actual period for
patent extension. In its application for patent extension, this
applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26997 Filed 12-7-23; 8:45 am]
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[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18562-18563]
[FR Doc No: 2014-07335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0337]

Standards for the Interoperable Exchange of Information for
Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic
Format; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Standards for the Interoperable Exchange of
Information for Tracing of Human, Finished, Prescription Drugs, in
Paper or Electronic Format.'' This public workshop will provide a forum
for discussing the development of these standards in the Drug Supply
Chain Security Act of 2013. In particular, participants will be asked
to provide information, current practices, research, and ideas on the
interoperable exchange of transaction information, transaction history,
and transaction statements, in paper or electronic format, for each
transfer of drug product in which a change of ownership occurs. This
public workshop will also provide a forum to discuss the feasibility of
establishing standardized documentation to be used by members of the
pharmaceutical distribution supply chain to convey this information to
the subsequent purchaser of a drug product and to facilitate the
exchange of lot level data. As FDA continues to work on developing
standards for interoperable exchange, the Agency is seeking public
input to ensure that we consider information regarding all drug supply
chain stakeholders.

DATES: The public workshop will be held on May 8 and 9, 2014, from 9
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room
(rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting

participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Connie T. Jung, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:
301-847-8722, email<EMAIL_ADDRESS>    Comments: In order to permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is June 9, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding the topics of the
workshop to http://www.regulations.gov or written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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.
    Registration: To register for the workshop either: (1) Email your
registration information to<EMAIL_ADDRESS>or (2) mail
your registration information to Connie T. Jung (see Contact Person).
Registration information should include:
     ``Registration'' in the subject line, and
     Registrant name, company or organization, address, phone
number, and email address in the body of your email or mailing.
    Registration requests should be received by April 24, 2014.
Registration is free. Seats are limited. FDA may limit the numbers of
participants from each organization based on space limitations.
Registrants will receive confirmation upon acceptance for participation
in the workshop. Onsite registration on the day of the meeting will be
based on space availability on the day of the event starting at 8 a.m.
If registration reaches maximum capacity, FDA will post a notice
closing meeting registration for the workshop on FDA's Web site at:
http://www.fda.gov/Drugs/NewsEvents/ucm388993.htm.
    If you need special accommodations due to a disability, please
contact Connie Jung (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the public workshop.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system over the
next 10 years to identify and trace certain prescription drugs as they
are distributed within the United States. Section 202 of the DSCSA,
which adds section 582(a)(2)(A) to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), requires the Secretary to establish initial
standards for the interoperable exchange of transaction information,
transaction history, and transaction statements, in paper or electronic
format, in consultation with other appropriate Federal officials,
manufacturers, repackagers, wholesale drug distributors, dispensers,
and other pharmaceutical distribution supply chain stakeholders. The
system that will be established under the DSCSA will enhance FDA's
ability to help protect U.S. consumers from exposure to drugs that may
be counterfeit, stolen, contaminated, or otherwise harmful by improving
detection and removal of potentially dangerous drugs from the drug
supply chain.
    FDA has used a multilayered approach to improve the security of the
drug supply chain to protect U.S. patients from unsafe, ineffective,
and poor quality drugs. In addition to considering the standards
developed under section 505D of the FD&C Act (21 U.S.C. 355e), the
DSCSA directs FDA to establish initial standards for trading partners
to utilize to achieve the interoperable exchange of transaction
information, transaction history, and transaction statements. On
February 20, 2014, FDA issued a Federal Register notice (79 FR 9745)
that established a public docket (Docket No. FDA-2014-N-0200) for this
topic. FDA is seeking additional stakeholder input based on the
information received in that docket.

II. Purpose of the Workshop

    This public workshop is intended to provide an opportunity for
interested persons to share information, current practices, research,
and ideas on the feasibility of establishing standardized documentation
to be used by members of the pharmaceutical distribution supply chain
to convey the transaction information, transaction history, and
transaction statement to the subsequent purchaser of a drug product and
to facilitate the exchange of lot level data. In addition, FDA is
interested in learning about practices, processes, and systems that
supply chain stakeholders currently use to exchange information, such
as product information, information related to the sale or change of
ownership of prescription drugs, or communications about drugs in
distribution. Discussions at this public workshop may also include
current practices and suggestions for the exchange of information
between supply chain stakeholders to provide, receive, and terminate
notifications. Discussions may also include how trading partners should
respond to requests for verification of suspect drug product, and
respond to requests for information from FDA or other appropriate
Federal or State officials in the event of a recall or for the purpose
of investigating a suspect or illegitimate drug product. Participants
will not be asked to develop consensus opinions during the discussion,
but rather to provide their individual perspectives. By May 2, 2014,
FDA will post the following information on our Web site under Standards
Development for Interoperable Exchange of Tracing Information at http://www.fda.gov/Drugs/NewsEvents/ucm388993.htm:
     Workshop agenda;
     Workshop discussion topics.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07335 Filed 4-1-14; 8:45 am]
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