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Federal Register / Vol. 71, No.

101 / Thursday, May 25, 2006 / Proposed Rules 30097

consistent with the FAA’s safety and part 193 from information the FAA determine whether one substance is an
security responsibilities, including a receives from other sources. optical or geometric isomer of another.
statement as to the circumstances under In accordance with AC 00–58, all The term ‘‘positional isomer,’’ however,
which, and a summary of why, VRDP submissions must be clearly is subject to scientific interpretation.
withholding such information from identified as such by the regulated This Notice of Proposed Rulemaking
disclosure would not be consistent with entity making the submission. Any proposes the addition of a specific
the FAA’s safety and security other information received by the FAA definition for the term ‘‘positional
responsibilities, as described in 14 CFR from the regulated entity concerning the isomer’’ to allow for the systematic
193.9. content of a VDRP submission must be determination of which isomers of
The FAA finds that withholding clearly labeled as follows to be eligible Schedule I substances would be
VDRP information provided to the FAA for protection under this designation: considered to be ‘‘positional’’ and,
is consistent with the FAA’s safety ‘‘WARNING: The Information in this therefore subject to Schedule I control.
responsibilities. The VDRP specifically Document is Protected from Disclosure The addition of a definition for the
provides that appropriate corrective under 49 U.S.C. 40123 and 14 CFR part term ‘‘positional isomer’’ will assist
action must be taken by the regulated 193.’’ If the information is submitted legitimate research and industry in
entity for all instances of regulatory electronically, the warning notice must determining the control status of
noncompliance accepted under the be appropriately embedded in the materials that are ‘‘positional isomers’’
program. To be accepted by the FAA, electronic submission in a fashion that of Schedule I hallucinogens. While the
apparent violations disclosed under the assures the visibility of the warning to DEA will remain the authority for
program must be inadvertent, and, any viewer. ultimately determining the control
where applicable, must not indicate a Proposed Designation status of a given material, providing a
lack, or reasonable question of a lack, of specific definition for ‘‘positional
qualification of the regulated entity. Accordingly, the Federal Aviation
isomer’’ will ensure consistent criteria
Corrective action under the VDRP can Administration proposes to designate
are utilized in making these
be accomplished by the regulated entity the above-described information
determinations.
and verified by the FAA without submitted under a VDRP to be protected
under 49 U.S.C. 40123 and 14 CFR part This rule is relevant only to
disclosure of the protected information. specialized forensic or research
If the FAA determines that the steps 193.
chemists. Most of these individuals are
taken by the entity are not those Issued in Washington, DC, on May 17, existing DEA registrants who are
documented in the written report, the 2006. authorized by the DEA to handle
submission may be excluded from the John M. Allen, Schedule I hallucinogenic substances.
VDRP, and appropriate legal Acting Director, Flight Standards Service.
DATES: Written comments must be
enforcement action may be initiated. [FR Doc. E6–8078 Filed 5–24–06; 8:45 am] postmarked, and electronic comments
The FAA will release information BILLING CODE 4910–13–P must be sent, on or before July 24, 2006.
submitted under a VDRP as specified in
part 193 and this proposed order. To ADDRESSES: To ensure proper handling
explain the need for changes in FAA of comments, please reference ‘‘Docket
DEPARTMENT OF JUSTICE
policies, procedures, and regulations, No. DEA–260P’’ on all written and
the FAA may disclose de-identified (i.e., Drug Enforcement Administration electronic correspondence. Written
the identity of the source of the comments being sent via regular mail
information and the names of the 21 CFR Part 1300 should be sent to the Deputy
certificate holder, employees, and other Administrator, Drug Enforcement
[Docket No. DEA–260P] Administration, Washington, DC 20537,
persons, as well as any other
information that could be used to RIN 1117–AA94 Attention: DEA Federal Register
ascertain the identity of the submitter, Representative/ODL. Written comments
redacted) summary information that has Definition of ‘‘Positional Isomer’’ as It sent via express mail should be sent to
been extracted from submissions Pertains to the Control of Schedule I the DEA Headquarters, Attention: DEA
accepted under the VDRP. The FAA Controlled Substances Federal Register Representative/ODL,
may disclose de-identified, summarized 2401 Jefferson-Davis Highway,
AGENCY: Drug Enforcement
VDRP information that identifies a Alexandria, VA 22301. Comments may
Administration (DEA), U.S. Department
systemic problem in the aviation be directly sent to the DEA
of Justice.
system, when other persons need to be electronically by sending an electronic
ACTION: Notice of proposed rulemaking. message to
advised of the problem so that they can
take corrective action. The FAA may SUMMARY: The Controlled Substances dea.diversion.policy@usdoj.gov. An
disclose de-identified aggregate Act (CSA) and its implementing electronic copy of this document is also
statistical information concerning VDRP regulations specify which available at the http://
submissions. The FAA may disclose hallucinogenic substances are www.regulations.gov Web site. The DEA
independently obtained information considered Schedule I controlled will accept attachments to electronic
relating to any event disclosed in a substances. The CSA states that all salts, comments in Microsoft Word,
VDRP report. The FAA also may isomers and salts of isomers of these WordPerfect, Adobe PDF, or Excel file
disclose any information about a substances are also Schedule I formats only. The DEA will not accept
disclosure initially submitted under the controlled substances. In non-technical any file format other than those
VDRP that is not accepted, or accepted, terms, an isomer of a substance is a specifically listed here.
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but later excluded because of the different compound, but a compound FOR FURTHER INFORMATION CONTACT:
regulated entity’s failure to comply with which has the same number and kind of Christine A. Sannerud, Ph.D., Chief,
the criteria of the VDRP. atoms. The terms ‘‘optical isomer’’ and Drug and Chemical Evaluation Section,
(6) Summary of how the FAA will ‘‘geometric isomer’’ are specific Office of Diversion Control, Drug
distinguish information protected under scientific terms and it is easy to Enforcement Administration,

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30098 Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Proposed Rules

Washington, DC 20537 at (202) 307– compound, mixture, or preparation, Schedule I hallucinogens are any and all
7183. which contains any quantity of the substances which:
following hallucinogenic substances, or (1) Are not already controlled in a
SUPPLEMENTARY INFORMATION:
which contains any of its salts, isomers, different Schedule I category, or are
Background and salts of isomers whenever the listed in another Schedule, or are
In many instances, the control of a existence of such salts, isomers and salts specifically exempted from control by
substance under the CSA often includes of isomers is possible within the law; and
specific chemical designation (for (2) Have the same molecular formula
the specific substance listed under the
purposes of this paragraph only, the and core structure as a Schedule I
CSA, as well as the substance’s salts,
term ‘‘isomer’’ includes the optical, hallucinogen; and
isomers and/or salts of isomers. In most (3) Have the same functional group(s)
instances, the term isomer includes only positional and geometric isomers).’’
and/or substituent(s) as those found in
optical isomers. In other instances, Why Proposed Definition Is Needed the respective Schedule I hallucinogen,
however, the term isomer includes The CSA (21 U.S.C. 802(14) and 21 attached at any position(s) on the core
positional and/or geometric isomers. U.S.C. 812(c)(I)(c)) and its implementing structure, but in such manner that no
In non-technical terms, isomers are regulations (21 CFR 1308.11(d)) specify new chemical functionalities are created
different compounds that have the same which hallucinogenic substances are and no existing chemical functionalities
molecular formula (the same number considered Schedule I controlled are destroyed relative to the respective
and types of atoms). The terms ‘‘optical substances. The CSA further states that Schedule I hallucinogen; except that
isomer’’ and ‘‘geometric isomer’’ are all salts, isomers and salts of isomers of (4) Rearrangements of alkyl moieties
specifically defined and well these substances are also Schedule I within or between functional group(s) or
understood scientific terms, and it is controlled substances. substituent(s), or divisions or
easy to determine whether one Under the definition of ‘‘isomer’’ combinations of alkyl moieties, that do
substance is an optical or geometric found in 21 CFR 1300.01(b)(21), ‘‘The not create new chemical functionalities
isomer of another. The term ‘‘positional term ‘‘isomer’’ means the optical isomer, or destroy existing chemical
isomer,’’ however, is not universally except as used in §§ 1308.11(d) and functionalities, would be within the
defined and, therefore, is subject to 1308.12(b)(4) of this chapter. As used in definition of positional isomer (and
scientific interpretation. In order to § 1308.11(d) of this chapter, the term therefore be controlled).
ensure that consistent criteria are ‘‘isomer’’ means the optical, positional, As clarification, note that the ‘‘core
utilized in determining whether one or geometric isomer. As used in structure’’ is the parent molecule that is
substance is considered a ‘‘positional § 1308.12(b)(4) of this chapter, the term the common basis for the class; for
isomer’’ of another, the DEA is ‘‘isomer’’ means the optical or geometric example, tryptamine, phenethylamine,
proposing that a specific definition for isomer.’’ or ergoline. The following are examples
‘‘positional isomer’’ be added to 21 CFR Therefore, according to this definition of rearrangements resulting in creation
1300.01(b)(21). as it specifically applies to and/or destruction of chemical
Existing CSA and CFR References to hallucinogens, the term ‘‘isomer’’ functionalities. These rearrangements
‘‘Positional Isomers’’ includes all optical, positional, or result in compounds which are not
geometric isomers. As such, all salts, positional isomers: ethoxy to alpha-
The CSA and its implementing isomers (including optical, positional, hydroxyethyl, hydroxy and methyl to
regulations (21 CFR 1308.11(d)) specify or geometric isomers) and salts of methoxy, or the repositioning of a
which hallucinogenic substances are isomers (including optical, positional, phenolic or alcoholic hydroxy group to
considered Schedule I controlled or geometric isomers) of the create a hydroxyamine. Examples of
substances. Under the CSA and its hallucinogenic substances listed in 21 rearrangements resulting in compounds
implementing regulations, there are U.S.C. 812(c)(I)(c) and 21 CFR which would be positional isomers
only three references to the term 1308.11(d) are considered Schedule I include, but are not limited to: tert-butyl
‘‘positional isomer’’: controlled substances. to sec-butyl, methoxy and ethyl to
(1) Pursuant to 21 U.S.C. 802(14), ‘‘the Because the determination as to isopropoxy, N,N-diethyl to N-methyl-N-
term ‘isomer’ means the optical isomer, whether a substance is considered a propyl, or alpha-methylamino to N-
except as used in Schedule I(c) and ‘‘positional isomer’’ can be subject to methylamino.
Schedule II(a)(4). As used in Schedule scientific interpretation, the DEA
I(c), the term ‘‘isomer’’ means any Impact of Rule Limited to Specialized
believes it is necessary to specifically
optical, positional, or geometric isomer. Forensic or Research Chemists
define the term ‘‘positional isomer’’.
As used in Schedule II(a)(4), the term This definition will only pertain to The addition of a definition for the
‘‘isomer’’ means any optical or those substances that are ‘‘positional term ‘‘positional isomer’’ as it applies to
geometric isomer.’’ isomers’’ of Schedule I controlled 21 CFR 1308.11(d) will assist legitimate
(2) Under 21 CFR 1300.01(b)(21), substances pursuant to 21 U.S.C. research and industry in determining
‘‘The term ‘‘isomer’’ means the optical 812(c)(I)(c) and 21 CFR 1308.11(d). the control status of substances that are
isomer, except as used in §§ 1308.11(d) The DEA is not proposing the isomers of Schedule I hallucinogens.
and 1308.12(b)(4) of this chapter. As addition of definitions for either optical While the DEA will remain the
used in § 1308.11(d) of this chapter, the or geometric isomers. The DEA believes authority on ultimately determining the
term ‘‘isomer’’ means the optical, that these terms are highly specific and control status of a given substance,
positional, or geometric isomer. As used are not subject to differing scientific providing a specific definition for
in § 1308.12(b)(4) of this chapter, the interpretation. ‘‘positional isomer’’ will greatly reduce
term ‘‘isomer’’ means the optical or
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any potential confusion or


geometric isomer.’’ Proposed Criteria That Will Apply to inconsistencies in making these
(3) 21 CFR 1308.11(d) states, Positional Isomers determinations.
‘‘Hallucinogenic substances. Unless Pursuant to 21 U.S.C. 802(14), 21 This definition will enable
specifically excepted or unless listed in U.S.C. 812(c)(I)(c) and 21 CFR researchers and industry to determine
another schedule, any material, 1308.11(d) positional isomers of definitively whether a substance is a

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Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Proposed Rules 30099

‘‘positional isomer’’ of a Schedule I methoxy and ethyl to isopropoxy, N,N- action. Therefore, this action has not
hallucinogen. As such, they will be able diethyl to N-methyl-N-propyl, or alpha- been reviewed by the Office of
to know the control status of a particular methylamino to N-methylamino. Management and Budget.
substance when considering new
Scientific/Technical Nature of Proposed Executive Order 12988
research.
This rule is relevant only to Definition
This regulation meets the applicable
specialized forensic or research The DEA understands that the standards set forth in §§ 3(a) and 3(b)(2)
chemists. Most of these individuals are proposed definition is highly technical of Executive Order 12988 Civil Justice
existing DEA registrants who are and laden with scientific terms. Reform.
authorized by the DEA to handle However, the DEA believes that such a
Schedule I hallucinogenic substances. highly technical definition is necessary Executive Order 13132
to ensure that consistent criteria are
Specific Changes and Proposed This rulemaking does not preempt or
utilized in determining whether one
Definition modify any provision of state law; nor
substance is a ‘‘positional isomer’’ of
As currently defined in 21 CFR does it impose enforcement
another.
1300.01(b)(21), the term ‘‘isomer’’ responsibilities on any state; nor does it
means the optical isomer, except as Request for Comments diminish the power of any state to
used in § 1308.11(d) and § 1308.12(b)(4) The proposed definition of enforce its own laws. Accordingly, this
of this chapter. As used in § 1308.11(d) ‘‘positional isomer’’ will be used in the rulemaking does not have federalism
of this chapter, the term ‘‘isomer’’ determination of the control status of implications warranting the application
means any optical, positional, or substances as Schedule I controlled of Executive Order 13132.
geometric isomer. As used in substances pursuant to 21 CFR Unfunded Mandates Reform Act of
§ 1308.12(b)(4) of this chapter, the term 1308.11(d). This definition is highly 1995
‘‘isomer’’ means any optical or technical in nature and the DEA has
geometric isomer. sought to provide specific criteria for This rule will not result in the
Title 21 CFR 1300.01(b)(21) is determination as to whether a substance expenditure by state, local, and tribal
proposed to be revised to include a is a ‘‘positional isomer’’ of Schedule I governments, in the aggregate, or by the
specific definition for the term hallucinogens. The DEA welcomes private sector, of $117,000,000 or more
‘‘positional isomer’’. The proposed input from all interested parties in any one year, and will not
modification will specify that, as used regarding the proposed definition of significantly or uniquely affect small
in § 1308.11(d), the term ‘‘positional ‘‘positional isomer.’’ Prior to publication governments. Therefore, no actions were
isomer’’ means any substance of a Final Rule, the DEA will consider deemed necessary under the provisions
possessing the same molecular formula all comments received. Comments must of the Unfunded Mandates Reform Act
and core structure and has the same be submitted on or before July 24, 2006. of 1995.
functional group(s) and/or substituent(s) Small Business Regulatory Enforcement
Regulatory Certifications
as those found in the respective Fairness Act of 1996
Schedule I hallucinogen, attached at any Regulatory Flexibility Act
position(s) on the core structure, but in The Deputy Administrator hereby This rule is not a major rule as
such manner that no new chemical certifies that this rulemaking has been defined by section 804 of the Small
functionalities are created and no drafted in accordance with the Business Regulatory Enforcement
existing chemical functionalities are Regulatory Flexibility Act (5 U.S.C. Fairness Act of 1996. This rule will not
destroyed relative to the respective 605(b)), has reviewed this regulation, result in an annual effect on the
Schedule I hallucinogen. and by approving it certifies that this economy of $114,000,000 or more; a
Rearrangements of alkyl moieties within regulation will not have a significant major increase in costs or prices; or
or between functional group(s) or economic impact on a substantial significant adverse effects on
substituent(s), or divisions or number of small entities. The inclusion competition, employment, investment,
combinations of alkyl moieties, that do of the definition of positional isomer set productivity, innovation, or on the
not create new chemical functionalities forth herein is unlikely to subject any ability of United States-based
or destroy existing chemical new substances to CSA control. Also, companies to compete with foreign-
functionalities, would be within the this rule does not require the obtaining based companies in domestic and
definition of positional isomer. For of new DEA registrations. Most persons export markets.
purposes of this definition, the ‘‘core affected by this rule are already DEA
structure’’ is the parent molecule that is List of Subjects in 21 CFR Part 1300
registrants (or would have to become
the common basis for the class. Some registrants even absent this rule in order Controlled substances, Definitions,
examples would include tryptamine, to handle Schedule I hallucinogens.) Drug traffic control.
phenethylamine, or ergoline. Examples Further, this rule does not impose any
of non-permissible rearrangements For the reasons set out above, 21 CFR
additional regulatory burden on the part 1300 is proposed to be amended as
resulting in creation and/or destruction regulated community. The proposed
of chemical functionalities (and follows:
change simply will ensure that
therefore would not be considered consistent criteria are utilized in making PART 1300—DEFINITIONS [AMENDED]
positional isomers) include, but are not scheduling determinations.
limited to: ethoxy to alpha- 1. The authority citation for part 1300
hydroxyethyl, hydroxy and methyl to Executive Order 12866
continues to read as follows:
methoxy, or the repositioning of a The Deputy Administrator further
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Authority: 21 U.S.C. 802, 871(b), 951,


phenolic or alcoholic hydroxy group to certifies that this rulemaking has been 958(f).
create a hydroxyamine. Examples of drafted in accordance with the
permissible rearrangements (that are principles in Executive Order 12866 2. § 1300.01 is proposed to be
within the definition of positional section 1(b). The DEA has determined amended by revising paragraph (b)(21)
isomers) include: tert-butyl to sec-butyl, that this is not a significant regulatory to read as follows:

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30100 Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Proposed Rules

§ 1300.01 Definitions relating to controlled DEPARTMENT OF TRANSPORTATION Statement in the Federal Register
substances. published on April 11, 2000 (Volume
* * * * * Federal Highway Administration 65, Number 70, Pages 19477–78) or you
may visit http://dms.dot.gov.
(b) * * *
23 CFR Parts 630, 635 and 636 FOR FURTHER INFORMATION CONTACT: Mr.
(21)(i) The term isomer means the Gerald Yakowenko, Office of Program
[FHWA Docket No. FHWA–2005–22477]
optical isomer, except as used in Administration, (202) 366–1562, or Mr.
§ 1308.11(d) and § 1308.12(b)(4) of this RIN 2125–AF12 Michael Harkins, Office of the Chief
chapter. As used in § 1308.11(d) of this Counsel, (202) 366–4928, Federal
chapter, the term ‘‘isomer’’ means any Design-Build Contracting
Highway Administration, 400 Seventh
optical, positional, or geometric isomer. AGENCY: Federal Highway Street, SW., Washington, DC 20590.
As used in § 1308.12(b)(4) of this Administration (FHWA), DOT. Office hours are from 7:45 a.m. to 4:15
chapter, the term ‘‘isomer’’ means any ACTION: Notice of proposed rulemaking p.m., e.t., Monday through Friday,
optical or geometric isomer. (NPRM); request for comments. except Federal holidays.
(ii) As used in § 1308.11(d) of this SUPPLEMENTARY INFORMATION:
SUMMARY: The FHWA proposes to revise
chapter, the term ‘‘positional isomer’’ Electronic Access
its regulations for design-build
means any substance possessing the You may submit or retrieve comments
contracting as mandated by section 1503
same molecular formula and core of the ‘‘Safe, Accountable, Flexible, online through the Document
structure and having the same Efficient Transportation Equity Act: A Management System (DMS) at: http://
functional group(s) and/or substituent(s) Legacy for Users’’ (SAFETEA–LU). The dmses.dot.gov/submit. The DMS is
as those found in the respective primary revision would involve a available 24 hours each day, 365 days
Schedule I hallucinogen, attached at any statutory requirement that FHWA not each year. Electronic submission and
position(s) on the core structure, but in preclude State transportation retrieval help and guidelines are
such manner that no new chemical departments or local transportation available under the help section of the
functionalities are created and no agencies from issuing request-for- Web site. An electronic copy of this
existing chemical functionalities are proposal documents, awarding document may also be downloaded by
destroyed relative to the respective contracts, and issuing notices-to- using the internet to reach the Office of
Schedule I hallucinogen. proceed for preliminary design work the Federal Register’s home page at:
Rearrangements of alkyl moieties within prior to the conclusion of the National http://www.archives.gov or the
or between functional group(s) or Environmental Policy Act (NEPA) Government Printing Office’s Web page
substituent(s), or divisions or process. The FHWA also proposes to at: http://www.access.gpo.gov/nara.
combinations of alkyl moieties, that do revise certain provisions in 23 CFR part Background
not create new chemical functionalities 636 to facilitate the use of public-private
partnerships. Section 1503 of the SAFETEA–LU
or destroy existing chemical (Pub. L. 109–59; August 10, 2005, 119
functionalities, are allowed i.e., result in DATES: Comments must be received on
Stat. 1144) revises the definition of a
compounds which are positional or before July 24, 2006.
design-build ‘‘qualified project’’ in 23
isomers. For purposes of this definition, ADDRESSES: Mail or hand deliver U.S.C. 112(b)(3). Formerly, ‘‘qualified
the ‘‘core structure’’ is the parent comments to the U.S. Department of projects’’ included design-build projects
molecule that is the common basis for Transportation, Dockets Management approved by FHWA with total costs
the class; for example, tryptamine, Facility, Room PL–401, 400 Seventh estimated to exceed $50,000,000 or
phenethylamine, or ergoline. Examples Street, SW., Washington, DC 20590– intelligent transportation system
of rearrangements resulting in creation 0001, or submit electronically at http:// projects exceeding $5,000,000. This
and/or destruction of chemical dmses.dot.gov/submit or fax comments statutory definition limited Federal-aid
functionalities (and therefore resulting to (202) 493–2251. participation to design-build projects
in compounds which are not positional Alternatively, comments may be that met this monetary threshold. The
isomers) include, but are not limited to: submitted via the eRulemaking Portal at revision required by Section 1503
http://www.regulations.gov. All removes the monetary threshold and
ethoxy to alpha-hydroxyethyl, hydroxy
comments should include the docket defines a qualified project as ‘‘* * * a
and methyl to methoxy, or the
number that appears in the heading of project under this chapter (including
repositioning of a phenolic or alcoholic this document. All comments received
hydroxy group to create a intermodal projects) for which the
will be available for examination and Secretary has approved the use of
hydroxyamine. Examples of copying at the above address from 9 design-build contracting under criteria
rearrangements resulting in compounds a.m. to 5 p.m., e.t., Monday through specified in regulations issued by the
which would be positional isomers Friday, except Federal holidays. Those Secretary.’’ These regulations are found
include: tert-butyl to sec-butyl, methoxy desiring notification of receipt of in 23 CFR part 636. Thus, it is no longer
and ethyl to isopropoxy, N,N-diethyl to comments must include a self- necessary for the FHWA to approve
N-methyl-N-propyl, or alpha- addressed, stamped postcard or you design-build projects exceeding certain
methylamino to N-methylamino. may print the acknowledgment page dollar thresholds under Special
* * * * * that appears after submitting comments Experimental Project No. 14 (SEP–14).1
electronically. Anyone is able to search When appropriate, the FHWA will
Dated: May 17, 2006.
the electronic form on all documents continue to make SEP–14 available for
Michele M. Leonhart, received into any of our dockets by the
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Deputy Administrator. name of the individual submitting the 1 Information concerning Special Experimental

[FR Doc. E6–7979 Filed 5–24–06; 8:45 am] comment (or signing the comment, if Project No. 14 (SEP–14), ‘‘Innovative Contracting
Practices,’’ is available on FHWA’s home page:
BILLING CODE 4410–09–P submitted on behalf of an association, http://www.fhwa.dot.gov. Additional information
business, labor union, etc.). You may may be obtained from the FHWA Division
review DOT’s complete Privacy Act Administrator in each State.

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