[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21684-21685]
[FR Doc No: 2023-07527]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0941]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Drug User Fee Program; Controlled
Correspondence Related to Generic Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on controlled correspondence related to
generic drug development.

DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.

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 June 12, 2023. 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 No.
FDA-2018-D-1592 for ``Controlled Correspondence Related to Generic Drug
Development.'' 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 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use

of automated collection techniques, when appropriate, and other forms
of information technology.

Generic Drug User Fee Program; Controlled Correspondence

OMB Control Number 0910-0727--REVISION

    This information collection supports implementation of FDA's
Generic Drug User Fee program. The Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112-144, Title III) were enacted to speed the delivery
of safe and effective generic drugs to the public and reduce costs to
industry. GDUFA authorizes FDA to assess user fees to fund critical and
measurable enhancements to the performance of FDA's generic drugs
program, bringing greater predictability and timeliness to the review
of generic drug applications. GDUFA is currently authorized through
September 30, 2027. For more information regarding GDUFA and ongoing
implementation, we invite you to visit our website at https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.
    For operational efficiency, we are revising the information
collection to include recommendations found in Agency guidance
currently approved in OMB control no. 0910-0797. As discussed in the
current GDUFA Commitment Letter, found on our website and included in
the information collection, FDA has agreed to specific program
enhancements and performance goals. Accordingly, we issued the guidance
document entitled ``Controlled Correspondence Related to Generic Drug
Development'' (December 2022), to communicate instruction regarding the
process by which generic drug manufacturers and related industry or
their representatives can request information related to generic drug
development. The guidance document also identifies necessary content
elements to facilitate FDA's prompt consideration of the request, as
well as prescribed timeframes. The guidance document is available from
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development and was issued consistent with our Good Guidance Practice
regulations found in 21 CFR 10.115, which provide for public comment at
any time.
    We are also revising the information collection to include Covered
Product Authorization Requests (CPAs), provided for under the Creating
and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES
Act). The CREATES Act provides a pathway for eligible product
developers to obtain access to the product samples they need to fulfill
testing and other regulatory requirements to support their
applications. To make use of this pathway, an eligible product
developer seeking to develop a product subject to a Risk Evaluation and
Mitigation Strategies with elements to assure safe use must obtain from
the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)).
The draft procedural guidance document entitled ``How to Obtain Covered
Product Authorization'' (September 2022) explains that CPAs are
submitted as controlled correspondence to the CDER NextGen
Collaboration Portal and that general questions may be submitted by
email to [email protected]. The draft guidance is available from
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization.
    We estimate the burden of the information collection as follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Information collection activity     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
GDUFA Controlled Correspondence              390            12.5           4,875               5          24,375
 submitted consistent with GFI
 Section IV.....................
CPA Requests submitted                        10            12.5             125               5             625
 consistent with Draft GFI
 Section IV.....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           5,000  ..............          25,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our burden estimate reflects an increase of 125 responses and 625
hours annually corresponding with the inclusion of CPAs to the
information collection. We have otherwise retained the currently
approved burden estimate associated with controlled correspondence for
generic drug development

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07527 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 31, 2008 (Volume 73, Number 251)]
[Proposed Rules]
[Page 80349-80360]
[DOCID:fr31de08-21]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 240

[Docket No. FRA-2008-0091]
RIN 2130-AB95

Qualification and Certification of Locomotive Engineers;
Miscellaneous Revisions

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: FRA proposes revisions to its regulation governing the
qualification and certification of locomotive engineers by prohibiting
a railroad from reclassifying a person's locomotive engineer
certificate to that of a more restrictive class during the period in
which the certificate is otherwise valid while permitting the railroad
to place restrictions on the locomotive engineer if appropriate. FRA
also proposes to clarify that revocation of an engineer's certificate
may only occur for the reasons specified in the regulation.
Additionally, FRA proposes provisions that would require each railroad
to identify the actions it will take in the event that a person fails a
skills performance test or the railroad finds deficiencies with an
engineer's performance during an operational monitoring observation or
unannounced compliance test. These proposals will address unanticipated
consequences arising from reclassifications and clarify the grounds
upon which a railroad may revoke a locomotive engineer's certification.

DATES: Written Comments: Written comments on the proposed rule must be
received by March 2, 2009. Comments received after that date will be
considered to the extent possible without incurring additional expense
or delay. FRA anticipates being able to determine these matters without
a public, oral hearing. However, if prior to January 30, 2009, FRA
receives a specific request for a public, oral hearing accompanied by a
showing that the party is unable to adequately present his or her
position by written statement, a hearing will be scheduled and FRA will
publish a supplemental notice in the Federal Register to inform
interested parties of the date, time, and location of any such hearing.

ADDRESSES: You may submit comments identified by the docket number FRA-
2008-0091 by any one of the following methods:
     Fax: 1-202-493-2251;
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590;
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey
Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays; or
     Electronically through the Federal eRulemaking Portal,
http://www.regulations.gov. Follow the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name, docket
name and docket number or Regulatory Identification Number (RIN) for
this rulemaking. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: John L. Conklin, Program Manager,
Locomotive Engineer Certification, U.S. Department of Transportation,
Federal Railroad Administration, Mail Stop 25, West Building 3rd Floor
West, Room W38-208, 1200 New Jersey Avenue, SE., Washington, DC 20590
(telephone:<PHONE_NUMBER>); or John Seguin, Trial Attorney, U.S.
Department of Transportation, Federal Railroad Administration, Office
of Chief Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room
W31-217, 1200 New Jersey Avenue, SE., Washington, DC 20590 (telephone:
202-493-6045).

SUPPLEMENTARY INFORMATION:

1. Background

    Pursuant to the Rail Safety Improvement Act of 1988, Public Law No.
100-342, Sec.  4, 102 Stat. 624, 625-27 (June 22, 1988) (recodified at
49 U.S.C. 20135), Congress conferred on the Secretary of DOT the
authority to establish a locomotive engineer qualification licensing or
certification program. The Secretary of Transportation delegated this
authority to the Federal Railroad Administrator. 49 CFR 1.49(m). In
1991, FRA implemented this statutory provision by issuing a final rule.
56 FR 28228, 28254 (June 19, 1991) (codified at 49 CFR part 240).
    FRA does not test or certify engineers itself. Rather, the
regulation requires each railroad to adopt training and certification
programs that meet minimum requirements. See, e.g., 49 CFR 240.1 and
240.101. These requirements include, inter alia, a determination ``that
the person has demonstrated . . . the skills to safely operate
locomotives or locomotives and trains, including the proper application
of the railroad's rules and practices for the safe operation of
locomotives or trains, in the most demanding class or type of service
that the person will be permitted to perform.'' 49 CFR 240.211(a). If a
candidate passes the certification program, a railroad may issue a
certificate to that person for any of the following classes of service:
train service engineer, locomotive servicing engineer, or student
engineer. 49 CFR 240.107(b). Train service engineers may operate
locomotives singly or in multiples and may move them with or without
cars coupled to them. Locomotive servicing engineers may operate
locomotives singly or in multiples but may not move them with cars
coupled to them. Student engineers may operate only under direct and
immediate supervision of an instructor engineer. 49 CFR 240.107(c). A
railroad may impose additional conditions or operational restrictions
on the service an engineer may perform provided those conditions or
restrictions are not inconsistent with part 240. 49 CFR 240.107(d).
    A certified engineer must undergo periodic retesting and shall have
his or her certification revoked if he or she demonstrates a failure to
comply with those railroad rules and practices deemed essential for the
safe operation of trains specified in Sec.  240.117(e). Section
240.117(e) provides that a certification may only be revoked for six
specific types of operating rules and operating practices violations:
(1) Failure to control a locomotive or train in accordance with a
signal indication that requires a complete stop before passing it; (2)
Failure to adhere to limitations concerning train speed when the speed
exceeds the maximum authorized limit by at least 10 miles per hour or a
violation of restricted speed

that causes a reportable accident or incident under 49 CFR part 225;
(3) Failure to adhere to certain federally required procedures for the
safe use of train or engine brakes; (4) Occupying a main track or a
segment of main track without proper authority or permission; (5)
Failure to comply with prohibitions against tampering with locomotive
mounted safety devices or knowingly operating a train with an
unauthorized disabled safety device; or (6) Incidents of noncompliance
with the regulations regarding the use or possession of alcohol and
drugs. 49 CFR 240.117(e); see also 49 CFR 219.101 and 240.119(c).
    Due to the potentially severe consequences to the individual
resulting from the denial of certification, the denial of
recertification, or the revocation of a certificate (e.g., making it
more difficult to be certified by another U.S. railroad under Sec.
240.225 or being temporarily banned from operating a locomotive or
train for any railroad operating in the U.S.), FRA regulations require
each railroad to make a deliberative decision and provide for
considerable FRA oversight. For example, if a railroad determines that
a locomotive engineer may have violated an operating rule specified in
Sec.  240.117(e), the railroad is required to suspend the engineer's
certificate pending a revocation determination. 49 CFR 240.307(b)(1).
Prior to or upon suspending an engineer's certificate, a railroad shall
provide notice of the reason for the suspension and an opportunity for
a hearing before a presiding officer other than the investigating
officer. 49 CFR 240.307(b)(2). Although a person may waive the
opportunity for a hearing, the waiver must be in writing and meet
certain safeguards to ensure the waiver is made voluntarily and with
knowledge and understanding of the person's rights. 49 CFR 240.307(f).
    If adversely affected by a railroad's decision regarding
revocation, an engineer may petition FRA's Locomotive Engineer Review
Board (LERB) to review the decision. 49 CFR 240.401. Following the
LERB's decision, the adversely affected party (either the engineer or
the railroad) has the right to request an administrative proceeding
provided for by FRA. 49 CFR 240.407. The FRA administrative proceeding
is a de novo hearing to find the relevant facts and determine the
correct application of federal regulations and railroad rules and
practices to those facts. Any party aggrieved by the presiding
officer's decision may file an appeal with the Administrator. 49 CFR
240.411. In the case of a prospective engineer who is denied
certification or a certified engineer who is denied recertification
when the currently held certificate lapses, the railroad must notify
the person ``of information known to the railroad that forms the basis
for denying the person certification [or recertification] and provide
the person a reasonable opportunity to explain or rebut that adverse
information in writing prior to denying certification.'' 49 CFR
240.219(a). The person may then seek review of an adverse certification
decision through a similar dispute resolution process that FRA affords
to an engineer who has had his or her certificate revoked. 49 CFR
240.401-240.411.
    With respect to deficiencies in an engineer's performance that do
not rise to the level of revocation, each railroad retains a measure of
discretion to fashion, within the context of collective bargaining
agreements, appropriate responses, including disciplinary sanctions, to
those types of deficiencies. See, e.g., 49 CFR 240.5(d). However, in
exercising that discretion, at least one Class I railroad has handled
engineer performance deficiencies in a manner not contemplated by FRA
when it implemented the engineer certification regulation and not used
by the industry generally. The practices of this railroad included
reclassifying the certificates of some of its train service engineers
to student engineer certificates when it discovered deficiencies in the
engineers' performance not specifically identified in Sec.  240.117(e).
The railroad did not provide a hearing regarding the reclassification
decision. The reason for the reclassifications appears to be related to
a deficiency in performance skills, but not a failure to pass a skills
performance test required for recertification. In some instances,
subsequent skills performance tests were provided and the newly
reclassified student engineers that failed those tests were denied
certification and their employment was terminated by the railroad.
    The consequences of that Class I railroad's policy--inter alia,
engineers being required to exchange their train service certificates
for student engineer certificates based on deficiencies not specified
in Sec.  240.117(e) without receiving a hearing pursuant to Sec.
240.307 and the potential for disparate treatment of similarly situated
engineers--were simply not anticipated by FRA when it originally issued
the regulations contained in part 240. However, because the regulation
is silent with respect to reclassifications, FRA has interpreted the
plain language of the existing regulation to permit reclassifications
despite these unanticipated consequences. Consequently, FRA believes
that modification of the existing regulation is necessary to address
this issue.
    In an effort to eliminate the unanticipated consequences created by
unilateral reclassification of an engineer's certificate and to clarify
the regulations regarding revocations, FRA proposes to make three
specific changes to part 240. First, FRA proposes to prohibit the
practice of reclassifying any type of engineer's certification to a
more restrictive class of certificate or to a student engineer
certificate during the period in which the certification is otherwise
valid. Second, FRA proposes to clarify part 240 to ensure that all
parties understand that revocation of an engineer's certificate may
only occur for the reasons specified in the regulation. Third, FRA
proposes to require each railroad to identify the potential actions it
may take in the event that a person fails a skills performance test or
that the railroad finds deficiencies with an engineer's performance
during an operational monitoring observation or unannounced compliance
test or otherwise becomes aware of such deficiencies. These proposals
are not only consistent with the overall original intent of part 240,
but are also consistent with current industry practice concerning
reclassification and revocation.

2. Additional Issues

    In addition to the proposed changes discussed above, FRA is
considering making some minor revisions to update part 240 and make it
consistent with other FRA regulations and guidance. Those proposed
revisions are detailed below. FRA seeks comments from interested
parties on these proposed modifications.

A. Deletion of Implementation and Phase-In Dates

    FRA proposes to eliminate the implementation and phase-in dates
listed throughout part 240 and any section or section heading that
references those dates. The dates have long passed and are no longer
relevant.

B. Deletion of Prior Incident Provisions

    FRA proposes to delete Sec. Sec.  240.117(i) and (j). The dates
listed in those sections concerning prior incidents have long passed
and those sections are no longer needed.

C. Consistency With Other Regulations

    FRA proposes to revise the language in part 240 containing
references to various provisions in 49 CFR part 232

(see, e.g., Sec. Sec.  240.117(e)(3) and 240.309(e)(3)) in order to
make them consistent with the language in part 232. When FRA previously
made substantive modifications to part 240, the provisions of part 232
were still being drafted. As a result, the terms used in some sections
of part 240 to describe the provisions of part 232 (i.e., initial
terminal, intermediate terminal, or transfer train and yard test)
differ from the actual terms used in part 232 (i.e., Class I, Class IA,
Class II, Class III, or transfer train brake test).
    FRA also proposes to revise the term ``annually monitored'' in
Sec.  240.129(c)(2) to read ``monitored each calendar year.'' That
revision would make the provision consistent with the language used in
Sec.  240.303(b).

D. Consistency With FRA Guidance

    FRA proposes to amend Sec. Sec.  240.129(e) and 240.303(d) in order
to make them consistent with guidance provided by FRA in Memorandum OP-
04-13 (February 3, 2004) which can be found on FRA's Web site at http:/
/www.fra.dot.gov/downloads/safety/advisories/op0413.pdf. Although
Sec. Sec.  240.129(e) and 240.303(d) could be read to require railroads
to give engineers three different tests per calendar year, Memorandum
OP-04-13 makes clear that railroads are required to only give one test
per calendar year under those sections. Accordingly, Sec. Sec.
240.129(e) and 240.303(d) would be amended to make them consistent with
Memorandum OP-04-13.

E. Civil Penalty Schedule

    FRA proposes to amend the penalty schedule for Sec.  240.203 listed
in the Schedule of Civil Penalties in Appendix A to part 240. Although
the text of Sec.  240.203 only lists two subsections ((a) and (b)), the
current penalty schedule for Sec.  240.203 lists three subsections
((a), (b), and (c)). FRA proposes to delete the reference to Sec. Sec.
240.203(a)(1)-(3) in the penalty schedule and revise Sec. Sec.  240.203
(b) and (c) in the penalty schedule to reference paragraphs (a) and
(b). These proposed changes will make the regulatory text and the
penalty schedule consistent.
    FRA also proposes to amend the penalty schedule for Sec.  240.205
listed in the Schedule of Civil Penalties in Appendix A to part 240.
Although the text of Sec.  240.205 only lists subsections (a) and (b),
the current penalty schedule for Sec.  240.205 lists subsections (a)
and (d). FRA proposes to amend the reference to subsection (d) in the
current penalty schedule for Sec.  240.205 to read (b).

F. Inaccurate References

    FRA proposes to amend the reference to Sec.  240.15 in Sec.
240.307(j) to read Sec.  240.215. Section 240.15 does not exist.
    FRA proposes to amend the reference to 49 CFR 218.5(f) in Sec.
240.7 (subsection (1) of the definition of ``locomotive engineer'') to
read 49 CFR 218.5. There is no subsection (f) in Sec.  218.5.
    FRA proposes to amend the reference to paragraph (c) in Sec.
240.203(a) to read paragraph (b). There is no paragraph (c) in Sec.
240.203.

G. Appendix D

    FRA proposes to delete the last paragraph of Appendix D to part 240
which begins ``Although the number of state agencies * * *.'' The
paragraph is no longer relevant because all states now participate in
the National Driver Register program.

III. Section-by-Section Analysis

Section 240.107 Criteria for designation of classes of service

    FRA proposes to amend this section by adding a new paragraph (e)
that would prohibit a railroad from reclassifying the certification of
any type of certified engineer to a more restrictive class of
certificate or to a student engineer certificate during the period in
which the certification is otherwise valid. Although reclassification
has been referred to by different names by various parties (e.g.,
demotion, diminution in the quality of a license, etc.), the practice
that FRA is proposing to prohibit is the taking of any type of
engineering certificate, during the period in which the certificate is
valid, and replacing it with a more restrictive class of certificate or
a student engineer certificate based on deficiencies found during
operational and skills tests that do not require revocation of an
engineer's certification under Sec. Sec.  240.117(e) or 240.119(c).
    Although FRA has previously interpreted the plain language of the
regulation to permit reclassification, the unanticipated consequences
of that practice necessitate its prohibition. As explained earlier in
this preamble, the effect of the reclassification policy used by one
Class I railroad has been to require some engineers to exchange their
train service or locomotive servicing certificates for student engineer
certificates without an opportunity for review of the reclassification
decision. An engineer who is reclassified to a student could find it
more difficult to be certified by another U.S. railroad than an
engineer who has not been reclassified. Further, there is significant
room for abuse in a system that allows reclassification based on the
somewhat subjective scoring of a skills performance test. Thus, FRA
proposes to prohibit railroads from requiring an engineer to exchange
his or her train service or locomotive servicing certification for a
more restrictive class of certificate or a student engineer certificate
during the period in which the recertification is otherwise valid.
    FRA has considered other options, including permitting
reclassification while providing affected engineers with the option of
challenging the reclassification through a hearing. However, allowing
reclassifications, even with a hearing, could result in the disparate
treatment of engineers. If, for example, two train service engineers
commit the same operating deficiency, a railroad may decide to
reprimand one of the engineers but reclassify the certificate of the
other engineer to a student engineer certificate. Assuming the
reclassification is upheld during the hearing process, one engineer
could return to work as a train service engineer while the other could
only return to work as a student engineer. This proposal attempts to
eliminate the potential for disparate treatment that could result from
the practice of reclassifying engineers' certificates.
    The elimination of disparate treatment of locomotive engineers
accords with the original design and intent of part 240. As FRA noted
in the 1989 NPRM:

    [T]here is at least anecdotal evidence to support the
proposition that similar events receive significantly disparate
treatment. Such differences exist both within and between railroads.
Those differences include decisions on whether a particular person
will or will not be brought before the discipline system for a given
course of conduct to a wide range of punishments imposed for the
same types of failure to adhere to company rules under similar
circumstances.

54 FR 50890, 50899-50900 (December 11, 1989). Accordingly, part 240
requires railroads to take specific actions for clearly articulated
types of non-compliance in an effort to prevent disparate treatment.
For example, Sec. Sec.  240.117 and 240.119 establish specific
revocation periods for instances of non-compliance with operating rules
and practices, as well as drug and alcohol regulations. The proposals
in this NPRM further FRA's objective to prevent the disparate treatment
of engineers by prohibiting the reclassification of an engineer
certificate and providing that revocation of an engineer's certificate
may only occur for the reasons specified in the regulation.
    While the proposal would prohibit the practice of reclassification,
it would

not prevent the railroads from continuing to pursue other measures to
ensure the safe operation of locomotives. For example, this proposal
would not prevent a railroad from placing restrictions on a certificate
pursuant to Sec.  240.107(d). As FRA stated in the 1993 interim final
rule:

    A second set of interpretive questions has been generated by the
desire of some railroads to certify a person as a train service
engineer but then impose significant limits or constraints on the
operational authority of that person. This section [240.107] permits
railroads to take such action and can be employed by them to address
issues such as utilizing persons who have sufficient skills to
perform in terminal or yard service but lack the knowledge or skill
to operate trains beyond terminal areas. Railroads that elect to
follow this approach will of course need to structure their
implementation program submissions to reflect any differences in the
training or testing of these engineers that would flow from their
more limited operating responsibilities.

58 FR 18982, 18995 (April 9, 1993). It should be noted, however, that
while Sec.  240.107(d) permits a railroad to place restrictions on a
certificate, restrictions are applied and reviewed in accordance with
internal railroad rules, procedures and processes developed in
coordination with its employees. Part 240 does not govern the issuance
or review of restrictions; that is a matter handled under a railroad's
internal discipline system or collective bargaining agreement.
    This proposal would also not prevent a railroad from suspending/
revoking a certificate pursuant to Sec.  240.307 for violation of one
of the provisions contained in Sec.  240.117(e), or prohibiting a
person from operating a locomotive as a train service or locomotive
servicing engineer pursuant to Sec.  240.211(c). Further, this proposal
would not prevent a railroad from offering an engineer the opportunity
to work for the railroad in any other capacity as long as the
engineer's current certificate was not reclassified. For example,
collective bargaining agreements often contain a provision by which the
parties agree to permit flowback from an engineer job to a conductor
job if a locomotive engineer should somehow become ineligible to
operate locomotives or trains. As FRA has previously clarified, part
240 is not intended to create or prohibit flowback. See Sec.  240.5(e)
and 64 FR 60966, 60975 (November 8, 1999).
    This proposal would not convert part 240's locomotive engineer
certification system into a licensing system. Although some parties
have referred to the practice of reclassification as a ``diminution in
the quality of a license,'' a certificate is not a license and the
proposal would not convert a locomotive engineer certificate issued in
accordance with part 240 into a license. Indeed, in adopting a
certification system (i.e., FRA sets eligibility criteria but leaves it
to the railroads to evaluate candidates by those standards) rather than
a traditional licensing system (i.e., a government agency sets
eligibility criteria and evaluates candidates), FRA noted that part 240
``afford railroads considerable discretion'' in the daily
administration of their certification program but ``FRA bears
responsibility for the manner in which the railroads exercise that
discretion, since the performance of the railroads'' under part 240
will determine whether their safety purposes are fulfilled. 56 FR
28228, 28229-28230 (June 19, 1991). This proposal continues that
relationship. FRA seeks comments from interested parties on this
proposal.
    Additionally, FRA seeks comments regarding the railroads'
assessment of engineer performance during the period in which an
engineer's certificate is otherwise valid. Are the current processes
set up by the railroads to assess an engineer's performance during the
period of certification appropriate? Are railroads accurately assessing
the skills and knowledge of engineers? Do engineers have a chance to
seek meaningful review of the railroads' assessments during the period
in which an engineer's certificate is otherwise valid? FRA seeks
comments from interested parties on these topics.

Section 240.127 Criteria for Examining Skill Performance

    FRA proposes to amend this section to require each railroad to
indicate the action it will take, beyond those required by Sec.
240.211(c), in the event that a person fails a skills performance test.
Pursuant to Sec.  240.101 and Sec.  240.103, each railroad must submit
its written certification program, including its procedures for skill
performance testing under Sec.  240.127 and monitoring operational
performance under Sec.  240.129, for FRA approval. That review process,
in connection with this proposal, would permit FRA an opportunity to
ensure that each railroad is handling skills test failures in
accordance with the intent and spirit of the regulation. The proposal
will also compel each railroad to carefully consider the process by
which it will handle skill test failures and demonstrate to FRA that it
is dealing with its engineers in an objective manner.
    Although FRA considered other options, such as prescribing the
specific actions a railroad must take, FRA believes it should be left
up to each railroad to decide the appropriate action to take in light
of various factors, including collective bargaining agreements. Indeed,
FRA previously proposed prescribing the number of tests and interval
between retests and other consequences of test failure in the 1989 NPRM
(54 FR 50890, 50933-50935 (December 11, 1989)), but did not implement
those proposals based, in part, on commenters' concerns that the
proposals would disrupt contractual agreements (56 FR 28228, 28236-
28237 (June 19, 1991)). Further, FRA has found that the vast majority
of railroads have adequate policies to deal with skills test failures
or deficiencies and have handled them appropriately for many years.
    To avoid restricting the options available to the railroads and
employee representatives to develop processes for handling skill test
failures, FRA designed this proposal to be as flexible as possible.
There are a variety of actions and approaches that a railroad can take
in response to a skills test failure and FRA does not want to stifle a
railroad's ability to adopt an approach that is best for its
organization. Some of the actions railroads may want to consider
include: Provide remedial training for engineers who fail skills tests
or have deficiencies in their performance; automatically download event
recorder data upon a test failure or deficient performance in order to
preserve evidence of the failure/deficiency; require two supervisors to
ride along on a retest; and retest an engineer on an actual train if
the engineer failed a test on a simulator. Each railroad should also
consider implementing a formal procedure whereby an engineer is given
the opportunity to explain, in writing, the factors that he or she
believes caused their skills test failure or performance deficiencies.
This explanation may allow a railroad to determine what areas of
training to focus on or perhaps discover that the reason for the
failure/deficiency was due to something other than a lack of skills.
Indeed, it is disconcerting for FRA to be informed that a certified
engineer, who may have been safely operating locomotives for years, no
longer has the skills necessary to operate safely; thus FRA also
suggests that each railroad consider whether a medical examination
might reveal a reason for a diminishment in skills proficiency.
    FRA believes there are numerous other approaches that could and
should be considered and evaluated by railroads and their employees.
FRA realizes that a railroad's list of actions

it will take in response to a skills test failure or deficient
performance could be expansive given the various circumstances that
could contribute to a test failure or deficient performance.
    Although a railroad will be required to update its certification
program under this proposal, FRA does not consider the update to be a
material modification pursuant to Sec.  240.103(e). Of course, FRA may
find issues during a review or audit of the updated certification
program and will address those issues with the railroad at that time.
FRA seeks comments from interested parties on this proposal.
    Additionally, FRA is aware of concerns raised by engineers that
they have no way of knowing why and how they failed a skills test or
monitoring ride. In particular, some engineers are concerned that they
do not know how the scoring systems used by railroads to grade skills
and operational monitoring rides function. FRA is seeking comments on
whether FRA should require the railroads to explain the scoring system
they use to determine whether a person passes or fails a skills test or
operational monitoring ride. Requiring a railroad to explain its
scoring system will likely have the benefit of ensuring that the
scoring criteria are transparent and that pass/fail determinations are
arrived at consistently throughout the railroad.

Section 240.129 Criteria for Monitoring Operational Performance of
Certified Engineers

    FRA proposes to amend this section to require railroads to indicate
the action they will take in the event they find deficiencies with an
engineer's performance during an operational monitoring observation or
unannounced compliance test. As explained in Sec.  240.127 above, FRA
believes it is up to each railroad to decide the appropriate action to
take in light of various factors, including collective bargaining
agreements. Further, FRA has found that the vast majority of railroads
have adequate policies to deal with deficiencies with an engineer's
performance and have handled them appropriately for many years.
    For a discussion of the benefits of this proposal and actions
railroads may want to consider taking in the event they find
deficiencies with an engineer's performance, see section 240.127 above.
    Although a railroad will be required to update its certification
program under this proposal, FRA does not consider the update to be a
material modification pursuant to Sec.  240.103(e). FRA seeks comments
from interested parties on this proposal.
    Additionally, for the reasons explained above, FRA is seeking
comments on whether FRA should require the railroads to explain the
scoring system they use to determine whether a person passes or fails a
skills test or operational monitoring ride.

Section 240.307 Revocation of Certification

    FRA proposes to amend this section to clarify and ensure that
railroads understand that they may revoke an engineer's certificate
only for that conduct specifically identified in Sec.  240.117(e) or
Sec.  240.119(c). FRA has been informed by at least one Class I
railroad that it believes Sec.  240.307 could be read to allow
revocation for deficiencies other than those specified in Sec.
240.117(e) or Sec.  240.119(c). FRA proposes to make clear that such an
interpretation is incorrect and contravenes the intent and purpose of
part 240 when it was issued. As FRA stated in the 1993 interim final
rule:

    Revocation of certification can occur when the locomotive
engineer in question is found to have violated one of the five
cardinal safety rules or the rules controlling alcohol and drug use.
* * * * *
    When considering revocation, FRA[] * * * contemplated that
decisions to revoke certification would only be based on
noncompliance with an operational safety directive or a violation of
FRA's rules controlling alcohol and drug use by railroad workers.
* * * * *
    As noted above, FRA contemplated that decisions to revoke
certification would be based on noncompliance with the operational
safety directives contained in Sec.  240.117 and Sec.  240.119.

58 FR 18982, 18989, 18999-19000 (April 9, 1993). To eliminate any
ambiguity, FRA is proposing to clarify the regulation to ensure that it
is applied in accordance with FRA's intent. FRA seeks comments from
interested parties on this proposal.

IV. Regulatory Impact and Notices

1. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This proposed rule has been evaluated in accordance with existing
policies and procedures, and determined to be non-significant under
both Executive Order 12866 and DOT policies and procedures. See 44 FR
11034 (February 26, 1979). FRA has prepared and placed in Docket No.
FRA-2008-0091 a Regulatory Analysis addressing the economic impact of
this proposed rule. Document inspection and copying facilities are
available at the DOT Central Docket Management Facility located in Room
W12-140 on the Ground level of the West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590. Docket material is also available
for inspection electronically through the Federal eRulemaking Portal at
http://www.regulations.gov. Photocopies may also be obtained by
submitting a written request to the FRA Docket Clerk at the Office of
Chief Counsel, RCC-10, Mail Stop 10, Federal Railroad Administration,
1200 New Jersey Avenue, SE., Washington, DC 20590; please refer to
Docket No. FRA-2008-0091.
    In this proposed rule, FRA is clarifying and/or amending certain
sections of its existing regulation pertaining to the qualification and
certification of locomotive engineers. Costs that may be incurred due
to the proposed rule are presented below. The revision or amendments to
a railroad's certification program will not need to be submitted to
FRA, but must be available to present to FRA inspectors. The table
below presents the estimated 20-year monetary costs associated with the
proposed rule, at discount rates of 3 percent and 7 percent.

------------------------------------------------------------------------
                      Total 20-year costs                          ($)
------------------------------------------------------------------------
Revisions to engineer certification programs..................   345,168
  Total Cost..................................................   345,168
  Total 20-Year Costs (Discounted at 3%)......................   335,115
  Total 20-Year Costs (Discounted at 7%)......................   322,587
------------------------------------------------------------------------

    This analysis determines that over a 20-year period the discounted
costs would be approximately $322,587.
    The benefits that would accrue cannot be expressed in monetary
terms; however, FRA is confident that such benefits would meet or
exceed the costs associated with implementation of the proposed rule.
The main benefit of this proposed rule is that railroads will no longer
be able to use this regulation in a manner not contemplated by FRA. FRA
also anticipates benefits flowing from a more precise and complete
regulation. Benefits resulting from this proposed rule are process
improvements that assist FRA in working with a railroad to resolve
problems associated with the engineer certifications. The proposed rule
works with railroad carriers' needs and operating environments to
produce a regulatory scheme that is economically efficient while
providing FRA oversight. Savings, that have not been quantified, would
accrue from the consolidated provisions of the rule and the
clarification of the railroads' certification programs.

2. Regulatory Flexibility Act and Executive Order 13272

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) and
Executive Order 13272 (67 FR 53461, August 16, 2002) require agency
review of proposed and final rules to assess their impact on small
entities. Pursuant to the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), FRA has prepared and placed in the docket a Certification
Statement that assesses the small entity impact of this proposed rule,
and certifies that this proposed rule is not expected to have a
significant economic impact on a substantial number of small entities.
    Document inspection and copying facilities are available at the DOT
Central Docket Management Facility located in Room W12-140 on the
Ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590. Docket material is also available for inspection
electronically through the Federal eRulemaking Portal at http://
www.regulations.gov. Photocopies may also be obtained by submitting a
written request to the FRA Docket Clerk at the Office of Chief Counsel,
RCC-10, Mail Stop 10, Federal Railroad Administration, 1200 New Jersey
Avenue, SE., Washington, DC 20590; please refer to Docket No. FRA-2008-
0091.
    The U.S. Small Business Administration (SBA) stipulates in its
``Size Standards'' that the largest a railroad business firm that is
``for-profit'' may be, and still be classified as a ``small entity,''
is 1,500 employees for ``Line-Haul Operating Railroads,'' and 500
employees for ``Switching and Terminal Establishments.'' ``Small
entity'' is defined in the Act as a small business that is not
independently owned and operated, and is not dominant in its field of
operation. SBA's ``Size Standards'' may be altered by Federal agencies
after consultation with SBA and in conjunction with public comment.
Pursuant to that authority, FRA has published a final policy that
formally establishes ``small entities'' as railroads which meet the
line haulage revenue requirements of a Class III railroad. The revenue
requirements are currently $20 million or less in annual operating
revenue. The $20 million limit (which is adjusted by applying the
railroad revenue deflator adjustment) is based on the Surface
Transportation Board's threshold for a Class III railroad carrier. FRA
uses the same revenue dollar limit to determine whether a railroad or
shipper or contractor is a small entity.
    There are approximately 718 railroads that would be affected by
this regulation. Of this number, approximately 678, or 94 percent, are
small entities. Consequently, this regulation affects a substantial
number of small entities. However FRA does not anticipate that this
regulation would impose a significant economic impact on a substantial
number of small entities.
    The factual basis for the certification that this proposed rule, if
promulgated, will not have a significant economic impact on a
substantial number of small entities, is that the only net cost
incurred by small railroads due to this proposed regulation would be
$376 (not discounted), which small railroads would incur during the
first year of implementation of the regulation. This is far less than
one percent of the annual average revenue for all small railroads
((approximately $47,000 in 2006 (not discounted)) per small railroad.
Accordingly, FRA does not consider this impact to be significant. Nor
does FRA anticipate that this regulation would result in long-term or
short-term insolvency for any small railroad.
    FRA invites comments from all interested parties on this
Certification. FRA particularly encourages small entities that could
potentially be impacted by the proposed amendments to participate in
the public comment process by submitting comments on this assessment or
this rulemaking to the official U.S. Department of Transportation (DOT)
docket. A draft of the proposed rule has not been submitted to the
Small Business Administration (SBA) for formal review. However, FRA
will consider any comments submitted by the SBA in developing the final
rule.

3. Paperwork Reduction Act

    The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
The sections that contain the new information collection requirements
are duly designated, and the estimated time to fulfill each requirement
is as follows:

----------------------------------------------------------------------------------------------------------------
                                                            Total annual       Average time per    Total annual
       CFR section/subject         Respondent universe       responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
240.9--Waivers--Petitions for      718 railroads......  3 petitions........  1 hour.............               3
 Waiver.
240.101/103--Certification         718 railroads......  50 amend. prog.....  1 hour.............              50
 Program: Written Program for      20 railroads.......  20 new prog........  40 hours...........             800
 Certifying Qualifications of      20 railroads.......  20 reviews.........  1 hour.............              20
 Locomotive Engineers--Amendments. 718 railroads......  30 mod. prog.......  45 minutes.........              23
--Certification Programs for New
 Railroads.
--New Railroads Final Review and
 Submission of Certification
 Program.
--Material Modifications to
 Approved Prog.
240.105--Selection Criteria For    718 railroads......  50 examinations....  1 hour.............              50
 Designated Supervisors of         10 railroads.......  10 reports.........  1 hour.............              10
 Locomotive Engineers (DSLEs)--
 Examinations of DSLEs.
--Written Report by Railroad
 Chief Operating Officer of
 Testing of DSLE.
240.109--Candidate's Review and    17,667 candidates..  25 responses.......  1 hour.............              25
 Written Comments on Prior Safety
 Conduct Data.

240.111--Request for State         17,667 candidates..  17,667 requests....  15 minutes.........           4,417
 Driving Data and National Driver  718 railroads......  177 notifications +  15 minutes.........              89
 Register Data--Driver's License   718 railroads......   177 requests.       15 minutes.........               5
 Data Requests.                    53,000 candidates..  20 comments........  15 minutes.........               1
                                   718 railroads......  4 letters..........  10 minutes.........              33
                                                        200 calls..........
--National Driver Register Data:
 Notification by Railroad to
 Employees of Matches and
 Employee Requests to State
 Agency for Relevant Data.
--Written Responses from
 Candidate on Driver's License
 Data.
--Notice to Railroad of Absence
 of License.
--Individual Duty to Furnish Data
 on Prior Conduct as Motor
 Vehicle Operator--Ph. Calls.
240.113--Individual Duty to        17,667 candidates..  353 requests + 353   15 min.; 30 min....             265
 Furnish Data on Prior Safety                            responses.
 Conduct as an Employee of A
 Different Railroad--Requests to
 Former Employing Railroad of
 Service Record and Railroad
 Responses.
240.119--Employee Self-Referral    53,000 locomotive    50 self-referrals..  5 minutes..........               4
 to EAP Counselor for Substance     engineers.
 Abuse Disorder.
240.121--Criteria--Hearing/Vision  20 new railroads...  20 copies..........  15 min.............               5
 Acuity Subsequent Years--Copies   718 railroads......  20 reports.........  1 hours............              20
 of Part 240 Appendix F to RR      718 railroads......  10 notifications...  15 minutes.........               3
 Medical Examiner.
--Medical Examiners Consultation
 with DSLE to Issue Conditional
 Certification Report.
--Notification--Hearing/Vision
 Change by Certified Engineer to
 Railroad.
New..............................  718 railroads......  718 amended          5 hours............           3,590
                                                         programs.
New
240.201/221/223/301--List of       718 railroads......  718 railroads......  60 minutes.........             718
 DSLEs.                            718 railroads......  718 updates........  60 minutes.........             718
--List of Design. Qual.
 Locomotive Engineers.
240.201/217/223/301--Locomotive    53,000 candidates..  17,667 cert........  5 minutes..........           1,472
 Engineers Certificate.
240.205--Data to EAP Counselor     718 railroads......  177 records........  5 minutes..........              15
 and Furnishing of Records by
 Employee.
240.207--Medical Certificate on    53,000 candidates..  17,667 cert........  70 minutes.........          20,612
 Hearing/Vision Acuity--Tests and  718 railroads......  10 determination...  2 hours............              20
 Certificate Issuance.
--Written Determination by
 Medical Examiner Waiving
 Necessity of Wearing Hearing/
 Vision Corrective Device.
240.219--Denial of Certification-- 17,667 candidates..  30 letters + 30      1 hour.............              60
 Notification to Employee of       718 railroads......   responses.          1 hour.............              30
 Adverse Information and Employee                       30 notifications...
 Response.
--Notification of Adverse
 Decision.

240.229--Requirements for Joint    321 railroads......  184 calls..........  5 minutes..........              15
 Operations Territory--
 Notification by Engineer of Non-
 Qualification to Operate Train
 on Track Segment.
240.309--Railroad Oversight        15 railroads.......  6 annotations......  15 minutes.........               2
 Responsibilities--Instances of
 Identified Poor Safety Conduct.
TESTING REQUIREMENTS 240.209/213-- 53,000 candidates..  17,667 tests.......  2 hours............          35,334
 Written Test.
240.211/213--Performance Test....  53,000 candidates..  17,667 tests.......  2 hours............          35,334
240.303--Annual Op. Monit. Obs.    53,000 candidates..  53,000 tests.......  2 hours............         106,000
 Test--Annual Operating Rules      53,000 candidates..  53,000 tests.......  1 hour.............          53,000
 Compliance Test.
RECORDKEEPING REQUIREMENTS         718 railroads......  17,667 records.....  30 minutes.........           8,834
 240.215--Recordkeeping--Cert.
 Loc. Eng.
240.305--Engineer's Non-           53,000 candidates..  100 notific........  5 minutes..........               8
 Qualification Notice.             1,060 candidates...  2 letters..........  30 minutes.........               1
--Engineer's Notice to RR--Loss
 of Qualification.
240.307--Notice to Engineer of     718 railroads......  900 notific.         1 hour.............             900
 Disqualification.                                       letters.
240.309--Railroad Oversight        51 railroads.......  51 reviews.........  40 hours...........           2,040
 Responsibilities.                 51 railroads.......  12 reports.........  1 hour.............              12
--Performance of Annual Reviews/
 Analysis.
--Railroad Report of Findings....
----------------------------------------------------------------------------------------------------------------

    All estimates include the time for reviewing instructions;
searching existing data sources; gathering or maintaining the needed
data; and reviewing the information. Pursuant to 44 U.S.C.
3506(c)(2)(B), FRA solicits comments concerning: Whether these
information collection requirements are necessary for the proper
performance of the functions of FRA, including whether the information
has practical utility; the accuracy of FRA's estimates of the burden of
the information collection requirements; the quality, utility, and
clarity of the information to be collected; and whether the burden of
collection of information on those who are to respond, including
through the use of automated collection techniques or other forms of
information technology, may be minimized. For information or a copy of
the paperwork package submitted to OMB, contact Mr. Robert Brogan, FRA
Information Clearance Officer, at<PHONE_NUMBER>, or Ms. Nakia Jackson at
202-493-6073.
    Organizations and individuals desiring to submit comments on the
collection of information requirements should direct them to Mr. Robert
Brogan or Ms. Nakia Jackson, Federal Railroad Administration, 1200 New
Jersey Avenue, SE., 3rd Floor, Washington, DC 20590. Comments may also
be submitted via e-mail to Mr. Brogan or Ms. Jackson at the following
address<EMAIL_ADDRESS><EMAIL_ADDRESS>    OMB is required to make a decision concerning the collection of
information requirements contained in this proposed rule between 30 and
60 days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication.
    The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal. FRA is
not authorized to impose a penalty on persons for violating information
collection requirements which do not display a current OMB control
number, if required. FRA intends to obtain current OMB control numbers
for any new information collection requirements resulting from this
rulemaking action prior to the effective date of the final rule. The
OMB control number, when assigned, will be announced by separate notice
in the Federal Register.

4. Federalism Implications

    Executive Order 13132, ``Federalism'' (64 FR 43255, Aug. 10, 1999),
requires FRA 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'' are 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.'' Under Executive Order 13132, the agency
may not issue a regulation with federalism implications that imposes
substantial direct compliance costs and that is not required by
statute, unless the Federal government provides the funds necessary to
pay the direct compliance costs incurred by State and local
governments, the agency consults with State and local governments, or
the agency consults with State and local government officials early in
the process of developing the regulation. Where a regulation has
federalism implications and preempts State law, the agency seeks to
consult with State and local officials in the process of developing the
regulation.
    This NPRM has been analyzed in accordance with the principles and

criteria contained in Executive Order 13132. This proposed rule would
not have a substantial effect on the States or their political
subdivisions; it would not impose any compliance costs; and it would
not affect the relationships between the Federal government and the
States or their political subdivisions, or the distribution of power
and responsibilities among the various levels of government.
Consequently, FRA concludes that this NPRM has no federalism
implications.

5. International Trade Impact Assessment

    The Trade Agreement Act of 1979 prohibits Federal agencies from
engaging in any standards or related activities that create unnecessary
obstacles to the foreign commerce of the United States. Legitimate
domestic objectives, such as safety, are not considered unnecessary
obstacles. The statute also requires consideration of international
standards and where appropriate, that they be the basis for U.S.
standards.
    This proposed rulemaking is purely domestic in nature and is not
expected to affect trade opportunities for U.S. firms doing business
overseas or for foreign firms doing business in the United States.

6. Environmental Impact.

    FRA has evaluated this proposed rule in accordance with its
``Procedures for Considering Environmental Impacts'' (FRA's Procedures)
(64 FR 28545, May 26, 1999) as required by the National Environmental
Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes,
Executive Orders, and related regulatory requirements. FRA has
determined that this proposed rule is not a major FRA action (requiring
the preparation of an environmental impact statement or environmental
assessment) because it is categorically excluded from detailed
environmental review pursuant to section 4(c)(20) of FRA's Procedures.
See 64 FR 28547 (May 26, 1999). Section 4(c)(20) reads as follows:

    (c) Actions categorically excluded. Certain classes of FRA
actions have been determined to be categorically excluded from the
requirements of these Procedures as they do not individually or
cumulatively have a significant effect on the human environment.
* * * * *
    The following classes of FRA actions are categorically excluded:
* * * * *
    (20) Promulgation of railroad safety rules and policy statements
that do not result in significantly increased emissions or air or
water pollutants or noise or increased traffic congestion in any
mode of transportation.

    In accordance with section 4(c) and (e) of FRA's Procedures, the
agency has further concluded that no extraordinary circumstances exist
with respect to this regulation that might trigger the need for a more
detailed environmental review. As a result, FRA finds that this
proposed rule is not a major Federal action significantly affecting the
quality of the human environment.

7. Unfunded Mandates Reform Act of 1995

    Pursuant to section 201 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency ``shall, unless
otherwise prohibited by law, assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
(other than to the extent that such regulations incorporate
requirements specifically set forth in law).'' Section 202 of the Act
(2 U.S.C. 1532) further requires that ``before promulgating any general
notice of proposed rulemaking that is likely to result in the
promulgation of any rule that includes any Federal mandate that may
result in expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) [currently $141,000,000] in any 1 year, and
before promulgating any final rule for which a general notice of
proposed rulemaking was published, the agency shall prepare a written
statement'' detailing the effect on State, local, and tribal
governments and the private sector. The proposed rule would not result
in the expenditure, in the aggregate, of $141,000,000 or more in any
one year, and thus preparation of such a statement is not required.

8. Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' 66
FR 28355 (May 22, 2001). Under the Executive Order, a ``significant
energy action'' is defined as any action by an agency (normally
published in the Federal Register) that promulgates or is expected to
lead to the promulgation of a final rule or regulation, including
notices of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking: (1)(i) That is a significant regulatory action
under Executive Order 12866 or any successor order, and (ii) is likely
to have a significant adverse effect on the supply, distribution, or
use of energy; or (2) that is designated by the Administrator of the
Office of Information and Regulatory Affairs as a significant energy
action. FRA has evaluated this NPRM in accordance with Executive Order
13211. FRA has determined that this NPRM is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy. Consequently, FRA has determined that this NPRM is not a
``significant energy action'' within the meaning of Executive Order
13211.

9. Privacy Act

    FRA wishes to inform all potential commenters that anyone is able
to search the electronic form of all comments received into any agency
docket by the name of the individual submitting the comment (or signing
the comment, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477-78) or
you may visit http://www.regulations.gov/search/footer/
privacyanduse.jsp.

List of Subjects in 49 CFR Part 240

    Administrative practice and procedure, Penalties, Railroad
employees, Railroad operating procedures, Railroad safety, Reporting
and recordkeeping requirements.

The Proposed Rule

    For the reasons discussed in the preamble, FRA proposes to amend
Part 240 of chapter II, subtitle B of title 49 of the Code of Federal
Regulations as follows:

PART 240--[AMENDED]

    1. The authority citation for part 240 continues to read as
follows:

    Authority: 49 U.S.C. 20103, 20107, 20135, 21301, 21304, 21311;
28 U.S.C. 2461, note; and 49 CFR 1.49.

    2. Section 240.7 is amended by revising paragraph (1) of the
definition of ``Locomotive engineer'' to read as follows:

Sec.  240.7  Definitions.

* * * * *
    Locomotive engineer * * *
    (1) A person who moves a locomotive or group of locomotives within
the confines of a locomotive repair or servicing area as provided for
in 49 CFR 218.5 and 218.29(a)(1); or
* * * * *
    3. Section 240.101 is amended by revising paragraphs (a), (b) and
(c) introductory text to read as follows:

Sec.  240.101  Certification program required.

    (a) Each railroad subject to this part shall have in effect a
written program

for certifying the qualifications of locomotive engineers.
    (b) Each railroad shall have such a program in effect prior to
commencing operations.
    (c) Each railroad shall have a certification program approved in
accordance with Sec.  240.103 that includes:
* * * * *
    4. Section 240.107 is amended by adding a new paragraph (e) to read
as follows:

Sec.  240.107  Criteria for designation of classes of service.

* * * * *
    (e) A railroad shall not reclassify the certification of any type
of certified engineer to a more restrictive class of certificate or a
student engineer certificate during the period in which the
certification is otherwise valid.
    5. Section 240.109 is amended by revising paragraph (e) as follows:

Sec.  240.109  General criteria for eligibility based on prior safety
conduct.

* * * * *
    (e) When evaluating a person's motor vehicle driving record or a
person's railroad employment record, a railroad shall not consider
information concerning motor vehicle driving incidents or prior
railroad safety conduct that occurred at a time other than that
specifically provided for in Sec.  240.115, Sec.  240.117 or Sec.
240.119 of this subpart.
* * * * *
    6. Section 240.111 is amended by revising paragraph (a)
introductory text to read as follows:

Sec.  240.111  Individual's duty to furnish data on prior safety
conduct as motor vehicle operator.

    (a) Except for persons covered by Sec.  240.109(h), each person
seeking certification or recertification under this part shall, within
366 days preceding the date of the railroad's decision on certification
or recertification:
* * * * *
    7. Section 240.113 is amended by revising paragraph (a)
introductory text to read as follows:

Sec.  240.113  Individual's duty to furnish data on prior safety
conduct as an employee of a different railroad.

    (a) Except for persons covered by Sec.  240.109(h), each person
seeking certification under this part shall, within 366 days preceding
the date of the railroad's decision on certification or
recertification:
* * * * *
    8. Section 240.117 is amended by revising paragraph (e)(3) and by
removing paragraphs (g)(4), (i), and (j) to read as follows:

Sec.  240.117  Criteria for consideration of operating rules compliance
data.

* * * * *
    (e) * * *
    (3) Failure to adhere to procedures for the safe use of train or
engine brakes when the procedures are required for compliance with the
Class I, Class IA, Class II, Class III, or transfer train brake test
provisions of 49 CFR part 232 or when the procedures are required for
compliance with the class 1, class 1A, class II, or running brake test
provisions of 49 CFR part 238;
* * * * *
    9. Section 240.127 is amended by adding a new paragraph (e) to read
as follows:

Sec.  240.127  Criteria for examining skill performance.

* * * * *
    (e) Each railroad's program shall indicate the action the railroad
will take in the event that a person fails an initial examination or a
reexamination of his or her performance skills in accordance with the
procedures required under Sec.  240.211.
    10. Section 240.129 is amended by revising paragraphs (c)(2) and
(e) and adding a new paragraph (f) to read as follows:

Sec.  240.129  Criteria for monitoring operational performance of
certified engineers.

* * * * *
    (c) * * *
    (2) Be designed so that each engineer shall be monitored each
calendar year by a Designated Supervisor of Locomotive Engineers, who
does not need to be qualified on the physical characteristics of the
territory over which the operational performance monitoring will be
conducted;
* * * * *
    (e) The testing and examination procedures selected by the railroad
for the conduct of a monitoring program shall be:
    (1) Designed so that each locomotive engineer shall be given at
least one unannounced test each calendar year;
    (2) Designed to test:
    (i) Engineer compliance with provisions of the railroad's operating
rules that require response to signals that display less than a
``clear'' aspect, if the railroad operates with a signal system that
must comply with part 236 of this chapter;
    (ii) Engineer compliance with provisions of the railroad's
operating rules, timetable or other mandatory directives that require
affirmative response by the locomotive engineer to less favorable
conditions than that which existed prior to initiation of the test; or
    (iii) Engineer compliance with provisions of the railroad's
operating rules, timetable or other mandatory directives violation of
which by engineers were cited by the railroad as the cause of train
accidents or train incidents in accident reports filed in compliance
with part 225 of this chapter in the preceding calendar year;
    (3) Designed so that the administration of these tests is
effectively distributed throughout whatever portion of a 24-hour day
that the railroad conducts its operations; and
    (4) Designed so that individual tests are administered without
prior notice to the engineer being tested.
    (f) Each railroad's program shall indicate the action the railroad
will take in the event that it finds deficiencies with a locomotive
engineer's performance during an operational monitoring observation or
unannounced compliance test administered in accordance with the
procedures required under Sec.  240.303.
    11. Section 240.201 is revised to read as follows:

Sec.  240.201  Implementation.

    (a) Each railroad shall designate in writing any person(s) it deems
qualified as a designated supervisor of locomotive engineers. Each
person so designated shall have demonstrated to the railroad through
training, testing or prior experience that he or she has the knowledge,
skills, and ability to be a designated supervisor of locomotive
engineers.
    (b) Each railroad shall designate in writing all persons that it
will deem to be qualified as certified locomotive engineers for the
purpose of initial compliance with paragraph (d) of this section,
except as provided for in paragraph (h) of this section.
    (1) Each person so designated shall have demonstrated to the
railroad through training, testing or prior experience that he or she
has the knowledge and skills to be a certified locomotive engineer.
    (2) Each railroad shall issue a certificate that complies with
Sec.  240.223 to each person that it designates as qualified under the
provisions of paragraph (b) of this section.
    (c) No railroad shall permit or require a person, designated as
qualified for certification under the provisions of paragraph (b) of
this section, to perform service as a certified locomotive or train
service engineer for more than a 36-

month period unless that person has been determined to be qualified in
accordance with procedures that comply with subpart C of this part.
    (d) No railroad shall permit or require any person to operate a
locomotive in any class of locomotive or train service unless that
person has been certified as a qualified locomotive engineer and issued
a certificate that complies with Sec.  240.223.
    (e) No Class I railroad (including the National Railroad Passenger
Corporation) or railroad providing commuter service shall designate any
person it deems qualified as a designated supervisor of locomotive
engineers or initially certify or recertify a person as a locomotive
engineer in either locomotive or train service unless that person has
been tested, evaluated, and determined to be qualified in accordance
with procedures that comply with subpart C of this part.
    (f) No Class II railroad shall designate any person it deems
qualified as a designated supervisor of locomotive engineers or
initially certify or recertify a person as a locomotive engineer in any
class of locomotive or train service unless that person has been
tested, evaluated and determined to be qualified in accordance with
procedures that comply with subpart C of this part.
    (g) No Class III railroad (including a switching and terminal or
other railroad not otherwise classified) shall designate any person it
deems qualified as a designated supervisor of locomotive engineers or
initially certify or recertify a person as a locomotive engineer in any
class of locomotive or train service unless that person has been
tested, evaluated and determined to be qualified in accordance with
procedures that comply with subpart C of this part.
    (h) Each person designated as a locomotive engineer shall be issued
a certificate that complies with Sec.  240.223 prior to being required
or permitted to operate a locomotive.
    12. Section 240.203 is amended by revising paragraph (a)
introductory text to read as follows:

Sec.  240.203  Determinations required as a prerequisite to
certification.

    (a) Except as provided in paragraph (b) of this section, each
railroad, prior to initially certifying or recertifying any person as
an engineer for any class of service, shall, in accordance with its
FRA-approved program determine in writing that:
* * * * *
    13. Section 240.205 is amended by revising paragraph (a) to read as
follows:

Sec.  240.205  Procedures for determining eligibility based on prior
safety conduct.

    (a) Each railroad, prior to initially certifying or recertifying
any person as an engineer for any class of service, shall determine
that the person meets the eligibility requirements of Sec.  240.115
involving prior conduct as a motor vehicle operator, Sec.  240.117
involving prior conduct as a railroad worker, and Sec.  240.119
involving substance abuse disorders and alcohol/drug rules compliance.
* * * * *
    14. Section 240.207 is amended by revising paragraph (a) to read as
follows:

Sec.  240.207  Procedures for making the determination on vision and
hearing acuity.

    (a) Each railroad, prior to initially certifying or recertifying
any person as an engineer for any class of service, shall determine
that the person meets the standards for visual acuity and hearing
acuity prescribed in Sec.  240.121.
* * * * *
    15. Section 240.209 is amended by revising paragraph (a) to read as
follows:

Sec.  240.209  Procedures for making the determination on knowledge.

    (a) Each railroad, prior to initially certifying or recertifying
any person as an engineer for any class of train or locomotive service,
shall determine that the person has, in accordance with the
requirements of Sec.  240.125 of this part, demonstrated sufficient
knowledge of the railroad's rules and practices for the safe operation
of trains.
* * * * *
    16. Section 240.211 is amended by revising paragraph (a) to read as
follows:

Sec.  240.211  Procedures for making the determination on performance
skills.

    (a) Each railroad, prior to initially certifying or recertifying
any person as an engineer for any class of train or locomotive service,
shall determine that the person has demonstrated, in accordance with
the requirements of Sec.  240.127 of this part, the skills to safely
operate locomotives or locomotives and trains, including the proper
application of the railroad's rules and practices for the safe
operation of locomotives or trains, in the most demanding class or type
of service that the person will be permitted to perform.
* * * * *
    17. Section 240.213 is amended by revising paragraph (a) to read as
follows:

Sec.  240.213  Procedures for making the determination on completion of
training program.

    (a) Each railroad, prior to the initial issuance of a certificate
to any person as a train or locomotive service engineer, shall
determine that the person has, in accordance with the requirements of
Sec.  240.123 of this part, the knowledge and skills to safely operate
a locomotive or train in the most demanding class or type of service
that the person will be permitted to perform.
* * * * *
    18. Section 240.215 is amended by revising paragraph (a) to read as
follows:

Sec.  240.215  Retaining information supporting determinations.

    (a) A railroad that issues, denies, or revokes a certificate after
making the determinations required under Sec.  240.203 shall maintain a
record for each certified engineer or applicant for certification that
contains the information the railroad relied on in making the
determinations.
* * * * *
    19. Section 240.217 is amended by revising paragraph (a)
introductory text to read as follows:

Sec.  240.217  Time limitations for making determinations.

    (a) A railroad shall not certify or recertify a person as a
qualified locomotive engineer in any class of train or engine service,
if the railroad is making:
* * * * *
    20. Section 240.221 is amended by revising paragraphs (a) and (b)
to read as follows:

Sec.  240.221  Identification of qualified persons.

    (a) A railroad shall maintain a written record identifying each
person designated by it as a supervisor of locomotive engineers.
    (b) A railroad shall maintain a written record identifying each
person designated as a certified locomotive engineer. That listing of
certified engineers shall indicate the class of service the railroad
determines each person is qualified to perform and date of the
railroad's certification decision.
* * * * *
    21. Section 240.225 is amended by revising paragraph (a)
introductory text to read as follows:

Sec.  240.225  Reliance on qualification determinations made by other
railroads.

    (a) A railroad that is considering certification of a person as a
qualified engineer may rely on determinations made by another railroad
concerning that person's qualifications. The railroad's certification
program shall address how the railroad will administer the training of
previously uncertified engineers with extensive

operating experience or previously certified engineers who have had
their certification expire. If a railroad's certification program fails
to specify how to train a previously certified engineer hired from
another railroad, then the railroad shall require the newly hired
engineer to take the hiring railroad's entire training program. A
railroad relying on another's certification shall determine that:
* * * * *
    22. Section 240.303 is amended by revising paragraphs (a) and (d)
to read as follows:

Sec.  240.303  Operational monitoring requirements.

    (a) Each railroad to which this part applies shall, prior to FRA
approval of its program in accordance with Sec.  240.201, have a
program to monitor the conduct of its certified locomotive engineers by
performing both operational monitoring observations and by conducting
unannounced operating rules compliance tests.
* * * * *
    (d) The unannounced test program shall:
    (1) Test engineer compliance with:
    (i) One or more provisions of the railroad's operating rules that
require response to signals that display less than a ``clear'' aspect,
if the railroad operates with a signal system that must comply with
part 236 of this chapter;
    (ii) One or more provisions of the railroad's operating rules,
timetable or other mandatory directives that require affirmative
response by the locomotive engineer to less favorable conditions than
that which existed prior to initiation of the test; or
    (iii) Provisions of the railroad's operating rules, timetable or
other mandatory directives the violations of which engineers were cited
by the railroad as the cause of train accidents or train incidents in
accident reports filed in compliance with part 225 of this chapter for
the preceding year;
    (2) Be conducted so that the administration of these tests is
effectively distributed throughout whatever portion of a 24-hour day
that the railroad conducts its operations;
    (3) Be conducted so that individual tests are administered without
prior notice to the locomotive engineer being tested; and
    (4) Be conducted so that the results of the test are recorded on
the certificate and entered on the record established under Sec.
240.215 within 30 days of the day the test is administered.
    23. Section 240.305 is amended by removing the introductory text
and revising paragraph (a)(3) to read as follows

Sec.  240.305  Prohibited conduct.

    (a) * * *
    (3) Operate a locomotive or train without adhering to procedures
for the safe use of train or engine brakes when the procedures are
required for compliance with the Class I, Class IA, Class II, Class
III, or transfer train brake test provisions of 49 CFR part 232 or when
the procedures are required for compliance with the class 1, class 1A,
class II, or running brake test provisions of 49 CFR part 238;
* * * * *
    24. Section 240.307 is amended by revising paragraphs (a) and (j)
introductory text to read as follows:

Sec.  240.307  Revocation of certification.

    (a) Except as provided for in Sec.  240.119(e), a railroad that
certifies or recertifies a person as a qualified locomotive engineer
and, during the period that certification is valid, acquires
information regarding violations of Sec.  240.117(e) or Sec.
240.119(c) of this chapter, which convinces the railroad that the
person no longer meets the qualification requirements of this part,
shall revoke the person's certificate as a qualified locomotive
engineer.
* * * * *
    (j) The railroad shall place the relevant information in the
records maintained in compliance with Sec.  240.309 for Class I
(including the National Railroad Passenger Corporation) and Class II
railroads, and Sec.  240.215 for Class III railroads if sufficient
evidence meeting the criteria provided in paragraph (i) of this
section, becomes available either:
* * * * *
    25. Section 240.309 is amended by revising paragraphs (a) and
(e)(3) to read as follows:

Sec.  240.309  Railroad oversight responsibilities.

    (a) No later than March 31 of each year, each Class I railroad
(including the National Railroad Passenger Corporation and a railroad
providing commuter service) and Class II railroad shall conduct a
formal annual review and analysis concerning the administration of its
program for responding to detected instances of poor safety conduct by
certified locomotive engineers during the prior calendar year.
* * * * *
    (e) * * *
    (3) Incidents involving noncompliance with the procedures for the
safe use of train or engine brakes when the procedures are required for
compliance with the Class I, Class IA, Class II, Class III, or transfer
train brake test provisions of 49 CFR part 232 or when the procedures
are required for compliance with the class 1, class 1A, class II, or
running brake test provisions of 49 CFR part 238;
* * * * *

Appendix A to Part 240 [Amended]

    26. Appendix A to part 240--Schedule of Civil Penalties is amended
by removing the entries for sections 240.203(a) through (a)(3);
redesignating the entries for sections 240.203(b) through 240.203(b)(4)
as 240.203(a) through (a)(4); redesignating the entries for sections
240.203(c) through (c)(3) as 240.203(b) through (b)(3); and
redesignating the entry for section 240.205(d) as 240.205(b) as
follows:

Appendix D to Part 240 [Amended]

    27. Appendix D is amended by removing the last paragraph.

    Issued in Washington, DC, on December 23, 2008.
Clifford C. Eby,
Acting Administrator.
 [FR Doc. E8-31062 Filed 12-30-08; 8:45 am]

BILLING CODE 4910-06-P