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5778 Federal Register / Vol. 73, No.

21 / Thursday, January 31, 2008 / Proposed Rules

Comments Invited (IFR) operations at Seamans Field. This proposes to amend 14 CFR part 71 as
Interested parties are invited to proposal would increase current Class E follows:
participate in this proposed rulemaking airspace from a 6.2-mile radius to an
8.2-mile radius of Seamans Field and PART 71—DESIGNATION OF CLASS A,
by submitting such written data, views CLASS B, CLASS C, CLASS D, AND
or arguments, as they may desire. including the airspace within 5.3 miles
each side of the Lake Henry VORTAC CLASS E AIRSPACE AREAS;
Comments that provide the factual basis AIRWAYS; ROUTES; AND REPORTING
supporting the views and suggestions 299° radial extending from the 8.2-mile
radius of Seamans Field to the POINTS
presented are particularly helpful in
developing reasoned regulatory VORTAC. Class E airspace designations 1. The authority citation for part 71
decisions on the proposal. Comments for airspace areas extending upward continues to read as follows:
are specifically invited on the overall from 700 feet or more above the surface
of the earth are published in Paragraph Authority: 49 U.S.C. 106(g); 40103, 40113,
regulatory, aeronautical, economic, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
environmental, and energy-related 6005 of FAA Order 7400.9R, signed 1963 Comp., p. 389.
aspects of the proposal. August 15, 2007, and effective
Communications should identify both September 15, 2007, which is § 71.1 [Amended]
docket numbers and be submitted in incorporated by reference in 14 CFR 2. The incorporation by reference in
triplicate to the address listed above. 71.1. The Class E airspace designation 14 CFR 71.1 of Federal Aviation
Persons wishing the FAA to listed in this document would be Administration Order 7400.9R, Airspace
acknowledge receipt of their comments published subsequently in the Order. Designations and Reporting Points,
on this notice must submit with those The FAA has determined that this signed August 15, 2007, and effective
comments a self-addressed, stamped proposed regulation only involves an September 15, 2007, is amended as
postcard on which the following established body of technical follows:
statement is made: ‘‘Comments to regulations for which frequent and Paragraph 6005 Class E Airspace Areas
Docket No. FAA–2007–29361/Airspace routine amendments are necessary to Extending Upward From 700 Feet or More
Docket No. 07–AEA–5.’’ The postcard keep them operationally current. It, Above the Surface of the Earth.
will be date/time stamped and returned therefore, (1) is not a ‘‘significant * * * * *
to the commenter. All communications regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant AEA PA E5 Factoryville, PA [Amended]
received before the specified closing
date for comments will be considered rule’’ under DOT Regulatory Policies Seamans Field, PA
and Procedures (44 FR 11034; February (Lat. 41°35′22″ N., long. 75°45′22″ W.)
before taking action on the proposed Lake Henry VORTAC
rule. The proposal contained in this 26, 1979); and (3) does not warrant
preparation of a Regulatory Evaluation (Lat. 41°28′33″ N., long. 75°28′57″ W.)
notice may be changed in light of the That airspace extending upward from 700
comments received. A report as the anticipated impact is so minimal.
Since this is a routine matter that will feet above the surface within an 8.2-mile
summarizing each substantive public radius of Seamans Field and including the
contact with FAA personnel concerned only affect air traffic procedures and air airspace within 5.3 miles each side of the
with this rulemaking will be filed in the navigation, it is certified that this rule, Lake Henry VORTAC 299° radial extending
docket. when promulgated, will not have a from the 8.2-mile radius of Seamans Field to
significant economic impact on a the VORTAC.
Availability of NPRMs substantial number of small entities * * * * *
An electronic copy of this document under the criteria of the Regulatory
Issued in College Park, Georgia, on
may be downloaded through the Flexibility Act. December 17, 2007.
Internet at http://www.regulations.gov. The FAA’s authority to issue rules
Mark D. Ward,
Recently published rulemaking regarding aviation safety is found in the
Manager, System Support Group, Eastern
documents can also be accessed through Title 49 of the United States Code. Service Center.
the FAA’s web page at http:// Subtitle I, Section 106 describes the
[FR Doc. 08–350 Filed 1–30–08; 8:45 am]
www.faa.gov or the Federal Register’s authority of the FAA administrator.
BILLING CODE 4910–13–M
web page at http://www.gpoaccess.gov/ Subtitle VII, Aviation Programs,
fr/index.html. Persons interested in describes in more detail the scope of the
being placed on a mailing list for future agency’s authority.
NPRMs should contact the FAA’s Office This rulemaking is promulgated DEPARTMENT OF JUSTICE
of Rulemaking, (202) 267–9677, to under the authority described in Drug Enforcement Administration
request a copy of Advisory Circular No. Subtitle VII, Part, A, Subpart I, Section
11–2A, Notice of Proposed Rulemaking 40103. Under that section, the FAA is 21 CFR Part 1308
Distribution System, which describes charged with prescribing regulations to
the application procedure. assign the use of airspace necessary to [Docket No. DEA–283P]
ensure the safety of aircraft and the
The Proposal efficient use of airspace. This regulation Schedules of Controlled Substances:
The FAA is considering an is within the scope of that authority as Placement of Indiplon Into Schedule IV
amendment to Title 14, Code of Federal it amends Class E Airspace at AGENCY: Drug Enforcement
Regulations (14 CFR) part 71 to amend Factoryville, PA. Administration, Department of Justice.
Class E airspace at Factoryville, PA. A ACTION: Notice of proposed rulemaking.
List of Subjects in 14 CFR Part 71
new Runway 4 Standard Instrument
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Approach Procedure (SIAP) has been Airspace, Incorporation by reference, SUMMARY: This proposed rule is issued
developed for Seamans Field. As a Navigation (air). by the Deputy Administrator of the Drug
result, controlled airspace extending Enforcement Administration (DEA) to
The Proposed Amendment
upward from 700 feet Above Ground place the substance indiplon (N-methyl-
Level (AGL) is needed to contain the In consideration of the foregoing, the N-[3-[3-(2-thienylcarbonyl)-
SIAP and for Instrument Flight Rules Federal Aviation Administration pyrazolo[1,5-a]pyrimidin-7-

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Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Proposed Rules 5779

yl]phenyl]acetamide), including its If you want to submit personal should state, with particularity, the
salts, and all products containing identifying information (such as your issues concerning which the person
indiplon into schedule IV of the name, address, etc.) as part of your desires to be heard. All correspondence
Controlled Substances Act (CSA). This comment, but do not want it to be regarding this matter should be
proposed action is based on a posted online or made available in the submitted to the DEA using the address
recommendation from the Assistant public docket, you must include the information provided above.
Secretary for Health of the Department phrase ‘‘PERSONAL IDENTIFYING Background
of Health and Human Services (DHHS) INFORMATION’’ in the first paragraph
and an evaluation of the relevant data of your comment. You must also place Indiplon acts as an agonist at
by DEA. This scheduling of indiplon in all the personal identifying information benzodiazepine sites of the GABAA
schedule IV will not be finalized until you do not want posted online or made receptor-channel complex. It has
a New Drug Application (NDA) for an available in the public docket in the first comparable sedative/hypnotic action to
indiplon product is approved by the paragraph of your comment and identify that of the benzodiazepines, diazepam
Food and Drug Administration (FDA). If what information you want redacted. and triazolam, and non-benzodiazepines
finalized, this action will impose the If you want to submit confidential that bind to the GABAA complex, such
regulatory controls and criminal business information as part of your as zolpidem, zaleplon and zopiclone, all
sanctions applicable to schedule IV non- comment, but do not want it to be of which are controlled as depressants
narcotics on those who handle indiplon posted online or made available in the in schedule IV of the CSA. Indiplon has
and products containing indiplon. public docket, you must include the a similar pharmacological profile as
phrase ‘‘CONFIDENTIAL BUSINESS these substances in addition to a short
DATES:Written comments must be plasma half-life and short duration of
postmarked, and electronic comments INFORMATION’’ in the first paragraph
of your comment. You must also action. In a human abuse-liability study
must be sent, on or before March 3, in individuals with known histories of
2008. prominently identify confidential
business information to be redacted sedative abuse, oral administration of
ADDRESSES: To ensure proper handling within the comment. If a comment has indiplon (30 mg, 50 mg and 80 mg)
of comments, please reference ‘‘Docket so much confidential business produced dose-dependent increases in
No. DEA–283’’ on all written and information that it cannot be effectively drug-liking and decreases in
electronic correspondence. Written redacted, all or part of that comment psychomotor and cognitive functioning
comments being sent via regular mail may not be posted online or made comparable to those produced by the
should be sent to the Deputy available in the public docket. schedule IV benzodiazepine, triazolam.
Administrator, Drug Enforcement Personal identifying information and Indiplon is likely to be diverted and
Administration, Washington, DC 20537, confidential business information abused in the same manner as other
Attention: DEA Federal Register identified and located as set forth above schedule IV depressants.
Representative/ODL. Written comments will be redacted and the comment, in The FDA has received two NDAs for
sent via express mail should be sent to redacted form, will be posted online and indiplon products, Somposure and
the Deputy Administrator, Drug placed in the Drug Enforcement Somposure MR. These products are
Enforcement Administration, Attention: Administration’s public docket file. If currently under review for the treatment
DEA Federal Register Representative/ you wish to inspect the agency’s public of insomnia, as characterized by
ODL, 8701 Morrissette Drive, docket file in person by appointment, difficulty in sleep onset or sleep
Springfield, VA 22152. Comments may please see the FOR FURTHER INFORMATION maintenance. Indiplon is a new
be directly sent to DEA electronically by paragraph. chemical entity and has not been
sending an electronic message to marketed in the United States or in
FOR FURTHER INFORMATION CONTACT:
dea.diversion.policy@usdoj.gov. other countries.
Christine A. Sannerud, PhD, Chief, Drug
Comments may also be sent On January 23, 2006, the Assistant
and Chemical Evaluation Section, Drug
electronically through http:// Secretary for Health of the DHHS sent
Enforcement Administration,
www.regulations.gov using the the Administrator of the DEA a
Washington, DC 20537, (202) 307–7183.
electronic comment form provided on scientific and medical evaluation and a
SUPPLEMENTARY INFORMATION: letter recommending that indiplon be
that site. However, persons wishing to
request a hearing should note that such Note Regarding This Proposed placed into schedule IV of the CSA.
requests must be written and manually Scheduling Action Enclosed with the January 23, 2006,
signed; requests for a hearing will not be letter was a document prepared by the
In accordance with the provisions of FDA entitled, ‘‘Basis for the
accepted via electronic means. DEA will the Controlled Substances Act (21
accept electronic comments containing Recommendation for Control of
U.S.C. 811(a)), this action is a formal Indiplon in Schedule IV of the
MS Word, WordPerfect, Adobe PDF, or rulemaking ‘‘on the record after
Excel file formats only. DEA will not Controlled Substances Act (CSA).’’ The
opportunity for a hearing.’’ Such document contained a review of the
accept any file format other than those proceedings are conducted pursuant to
specifically listed here. factors which the CSA requires the
the provisions of the Administrative Secretary to consider (21 U.S.C. 811(b)).
Posting of Public Comments: Please Procedure Act (5 U.S.C. 556 and 557). The factors considered by the
note that all comments received are Interested persons are invited to submit Assistant Secretary of Health and DEA
considered part of the public record and their comments, objections or requests with respect to Indiplon were:
made available for public inspection for a hearing with regard to this (1) Its actual or relative potential for
online at http://www.regulations.gov proposal. Persons wishing to request a abuse;
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and in the Drug Enforcement hearing should note that such requests (2) Scientific evidence of its
Administration’s public docket. Such must be written and manually signed; pharmacological effects;
information includes personal requests for a hearing will not be (3) The state of current scientific
identifying information (such as your accepted via electronic means. Requests knowledge regarding the drug;
name, address, etc.) voluntarily for a hearing should be made in (4) Its history and current pattern of
submitted by the commenter. accordance with 21 CFR 1308.44 and abuse;

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5780 Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Proposed Rules

(5) The scope, duration, and administrative, civil and criminal proceedings are conducted pursuant to
significance of abuse; sanctions applicable to the manufacture, the provisions of 5 U.S.C. 556 and 557
(6) What, if any, risk there is to the distribution, dispensing, importing and and, as such, are exempt from review by
public health; exporting of a schedule IV controlled the Office of Management and Budget
(7) Its psychic or physiological substance, including the following: pursuant to Executive Order 12866,
dependence liability; and Registration. Any person who section 3(d)(1).
(8) Whether the substance is an manufactures, distributes, dispenses,
immediate precursor of a substance imports, exports, engages in research or Regulatory Flexibility Act
already controlled under this conducts instructional activities with
subchapter (21 U.S.C. 811(c)). The Deputy Administrator, in
indiplon, or who desires to accordance with the Regulatory
Based on the recommendation of the manufacture, distribute, dispense,
Assistant Secretary for Health, received Flexibility Act (5 U.S.C. 601–612), has
import, export, engage in instructional
in accordance with section 201(b) of the reviewed this proposed rule and by
activities or conduct research with
Act (21 U.S.C. 811(b)), and the approving it certifies that it will not
indiplon, would need to register with
independent review of the available have a significant economic impact on
the DEA to conduct such activities in
data by the DEA, the Deputy a substantial number of small entities.
accordance with part 1301 of Title 21 of
Administrator of the DEA, pursuant to the Code of Federal Regulations. Indiplon products will be prescription
section 201(a) and 201(b) of the Act (21 Security. Indiplon would be subject to drugs used for the treatment of
U.S.C. 811(a) and 811(b)), finds that: schedule III-V security requirements insomnia. Handlers of indiplon often
(1) Based on information now and must be manufactured, distributed handle other controlled substances
available, indiplon has a low potential and stored in accordance with 21 CFR which are already subject to the
for abuse relative to the drugs or other 1301.71, 1301.72(b), (c), and (d), regulatory requirements of the CSA.
substances in schedule III; 1301.73, 1301.74, 1301.75(b) and (c),
(2) Once approved for marketing, Executive Order 12988
1301.76, and 1301.77.
indiplon will have a currently accepted Labeling and Packaging. All labels This regulation meets the applicable
medical use in treatment in the United and labeling for commercial containers standards set forth in section 3(a) and
States; and of indiplon which are distributed on or 3(b)(2) of Executive Order 12988 Civil
(3) Abuse of indiplon may lead to after finalization of this rule would need Justice Reform.
limited physical dependence or to comply with requirements of 21 CFR
psychological dependence relative to 1302.03–1302.07. Executive Order 13132
the drugs or other substances in Inventory. Every registrant required to
schedule III. This rulemaking does not preempt or
keep records and who possesses any modify any provision of state law; nor
Based on these findings, the Deputy
quantity of indiplon would be required does it impose enforcement
Administrator of the DEA concludes
to keep an inventory of all stocks of responsibilities on any state; nor does it
that indiplon, including its salts, and all
indiplon on hand pursuant to 21 CFR diminish the power of any state to
products containing indiplon, warrant
1304.03, 1304.04 and 1304.11. Every enforce its own laws. Accordingly, this
control in schedule IV of the CSA, if and
registrant who desires registration in
when a NDA for indiplon is approved. rulemaking does not have federalism
schedule IV for indiplon would be
Interested persons are invited to implications warranting the application
required to conduct an inventory of all
submit their comments, objections or of Executive Order 13132.
stocks of the substance on hand at the
requests for a hearing with regard to this
time of registration. Unfunded Mandates Reform Act of 1995
proposal. Requests for a hearing should
Records. All registrants would be
state, with particularity, the issues This rule will not result in the
required to keep records pursuant to 21
concerning which the person desires to expenditure by state, local and tribal
CFR 1304.03, 1304.04, 1304.05, 1304.21,
be heard. All correspondence regarding governments, in the aggregate, or by the
1304.22, and 1304.23.
this matter should be submitted to the private sector, of $120,000,000 or more
Prescriptions. All prescriptions for
Drug Enforcement Administration using (adjusted for inflation) in any one year,
indiplon or prescriptions for products
the address information provided above. and will not significantly or uniquely
containing indiplon would be required
Persons wishing to request a hearing affect small governments. Therefore, no
to be issued pursuant to 21 CFR
should note that such requests must be actions were deemed necessary under
1306.03–1306.06, 1306.21–1306.27.
written and manually signed; requests provisions of the Unfunded Mandates
Importation and Exportation. All
for a hearing will not be accepted via Reform Act of 1995.
importation and exportation of indiplon
electronic means. In the event that
would need to be in compliance with 21
comments, objections, or requests for a Congressional Review Act
CFR Part 1312.
hearing raise one or more issues which Criminal Liability. Any activity with
the Deputy Administrator finds warrant This rule is not a major rule as
indiplon not authorized by, or in defined by section 804 of the Small
a hearing, the Deputy Administrator violation of, the Controlled Substances
shall order a public hearing by notice in Business Regulatory Enforcement
Act or the Controlled Substances Import Fairness Act of 1996 (Congressional
the Federal Register, summarizing the and Export Act occurring on or after
issues to be heard and setting the time Review Act). This rule will not result in
finalization of this proposed rule would an annual effect on the economy of
for the hearing. be unlawful. $100,000,000 or more; a major increase
Requirements for Handling Indiplon Regulatory Certifications in costs or prices; or, significant adverse
sroberts on PROD1PC70 with PROPOSALS

If this rule is finalized as proposed, effects on competition, employment,


indiplon and all products containing Executive Order 12866 investment, productivity, innovation, or
indiplon would be subject to the In accordance with the provisions of on the ability of United States-based
Controlled Substances Act and the the CSA (21 U.S.C. 811(a)), this action companies to compete with foreign
Controlled Substances Import and is a formal rulemaking ‘‘on the record based companies in domestic and
Export Act regulatory controls and after opportunity for a hearing.’’ Such export markets.

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Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Proposed Rules 5781

List of Subjects in 21 CFR Part 1308 organic compounds (VOCs) from the you submit. If EPA cannot read your
Administrative practice and Kraft Foods Global, Inc.—Richmond comment due to technical difficulties
procedure, Drug traffic control, Bakery located in Henrico County, and cannot contact you for clarification,
Narcotics, Prescription drugs. Virginia. The submittal is for the EPA may not be able to consider your
purpose of meeting the requirements for comment. Electronic files should avoid
Under the authority vested in the reasonably available control technology the use of special characters, any form
Attorney General by § 201(a) of the CSA (RACT) in order to implement the of encryption, and be free of any defects
(21 U.S.C. 811(a)), and delegated to the maintenance plan for the Richmond 8- or viruses.
Administrator of DEA by Department of hour ozone maintenance area. EPA is Docket: All documents in the
Justice regulations (28 CFR 0.100), and proposing to approve the revision to the electronic docket are listed in the
redelegated to the Deputy Administrator Virginia SIP in accordance with the www.regulations.gov index. Although
pursuant to 28 CFR 0.104, the Deputy requirements of the Clean Air Act listed in the index, some information is
Administrator hereby proposes that 21 (CAA). not publicly available, i.e., CBI or other
CFR part 1308 be amended as follows: information whose disclosure is
DATES: Written comments must be
PART 1308—SCHEDULES OF received on or before March 3, 2008. restricted by statute. Certain other
CONTROLLED SUBSTANCES material, such as copyrighted material,
ADDRESSES: Submit your comments,
is not placed on the Internet and will be
identified by Docket ID Number EPA–
1. The authority citation for 21 CFR publicly available only in hard copy
R03–OAR–2007–1139, by one of the
part 1308 continues to read as follows: form. Publicly available docket
following methods:
Authority: 21 U.S.C. 811, 812, 871(b) materials are available either
A. www.regulations.gov. Follow the
unless otherwise noted. electronically in www.regulations.gov or
on-line instructions for submitting
in hard copy during normal business
2. Section 1308.14 is amended by comments.
B. E-mail: hours at the Air Protection Division,
redesignating paragraphs (c)(25) through U.S. Environmental Protection Agency,
(c)(51) as (c)(26) through (c)(52) and fernandez.cristina@epa.gov.
C. Mail: EPA–R03–OAR–2007–1139, Region III, 1650 Arch Street,
adding a new paragraph (c)(25) to read Philadelphia, Pennsylvania 19103.
as follows: Cristina Fernandez, Chief, Air Quality
Planning Branch, Mailcode 3AP21, U.S. Copies of the State submittal are
§ 1308.14 Schedule IV. Environmental Protection Agency, available at the Virginia Department of
* * * * * Region III, 1650 Arch Street, Environmental Quality, 629 East Main
(c) * * * Philadelphia, Pennsylvania 19103. Street, Richmond, Virginia 23219.
(25) indiplon (N-methyl-N-[3-[3-(2- D. Hand Delivery: At the previously- FOR FURTHER INFORMATION CONTACT:
thienylcarbonyl)-pyrazolo[1,5- listed EPA Region III address. Such Irene Shandruk, (215) 814–2166, or by
a]pyrimidin-7-yl]phenyl]-acetamide)— deliveries are only accepted during the e-mail at shandruk.irene@epa.gov.
2726 Docket’s normal hours of operation, and SUPPLEMENTARY INFORMATION: On
* * * * * special arrangements should be made October 29, 2007, the Commonwealth of
for deliveries of boxed information. Virginia submitted a revision to its State
Dated: January 22, 2008. Instructions: Direct your comments to Implementation Plan (SIP) for the
Michele M. Leonhart, Docket ID No. EPA–R03–OAR–2007– control of emissions of VOCs from the
Deputy Administrator. 10139. EPA’s policy is that all Kraft Foods Global, Inc.—Richmond
[FR Doc. E8–1692 Filed 1–30–08; 8:45 am] comments received will be included in Bakery located in Henrico County,
BILLING CODE 4410–09–P the public docket without change, and Virginia. The submittal is for the
may be made available online at purpose of meeting the requirements for
www.regulations.gov, including any Reasonably Available Control
ENVIRONMENTAL PROTECTION personal information provided, unless Technology (RACT) in order to
AGENCY the comment includes information implement the maintenance plan for the
claimed to be Confidential Business Richmond 8-hour ozone maintenance
40 CFR Part 52 Information (CBI) or other information area.
whose disclosure is restricted by statute.
[EPA–R03–OAR–2007–1139; FRL–8523–4] Do not submit information that you I. Background
consider to be CBI or otherwise RACT is the lowest emission limit
Approval and Promulgation of Air
protected through www.regulations.gov that a particular source is capable of
Quality Implementation Plans; Virginia;
or e-mail. The www.regulations.gov Web meeting by the application of control
Control of Volatile Organic Compound
site is an ‘‘anonymous access’’ system, technology that is reasonably available
(VOCs) Emissions From the Kraft
which means EPA will not know your with the consideration of technological
Foods Global, Inc.—Richmond Bakery
identity or contact information unless and economic feasibility. When the
located in Henrico County, VA
you provide it in the body of your Richmond area was originally
AGENCY: Environmental Protection comment. If you send an e-mail designated as an ozone nonattainment
Agency (EPA). comment directly to EPA without going area under the 1-hour standard, it was
ACTION: Proposed rule. through www.regulations.gov, your classified as moderate and thereby had
e-mail address will be automatically to meet the non-CTG RACT
SUMMARY: EPA is proposing to approve captured and included as part of the requirements of section 182 of the CAA.
a State Implementation Plan (SIP) comment that is placed in the public As part of the 1-hour ozone attainment
sroberts on PROD1PC70 with PROPOSALS

revision submitted by the docket and made available on the plan, one of the sources located in the
Commonwealth of Virginia on October Internet. If you submit an electronic area identified as being subject to non-
29, 2007. This revision pertains to a comment, EPA recommends that you CTG RACT was Nabisco Brands (now
federally enforceable state operating include your name and other contact Kraft Foods). Cookies, crackers, and
permit containing terms and conditions information in the body of your pretzels are produced at this plant. The
for the control of emissions of volatile comment and with any disk or CD–ROM sources of VOC emissions at this plant

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