[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Rules and Regulations]
[Pages 20522-20526]
[FR Doc No: 2012-8040]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0723; Directorate Identifier 2010-NM-080-AD;
Amendment 39-16978; AD 2012-05-06]
RIN 2120-AA64

Airworthiness Directives; Lockheed Martin Corporation/Lockheed
Martin Aeronautics Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company
Model L-1011-385-1, L-1011-385-1-14, and L-1011-385-1-15 airplanes.
That AD currently requires implementation of a Supplemental Inspection
Document (SID) program of structural inspections to detect fatigue
cracking, and repair if necessary, to ensure continued airworthiness of
these airplanes as they approach the manufacturer's original fatigue
design life goal. This new AD adds Model L-1011-385-3 airplanes to the
applicability, changes certain inspection thresholds, adds three new
structurally significant details (SSDs), and removes an SSD that has
been addressed by a different AD. This AD was prompted by an evaluation
by the manufacturer of usage and flight data that provided additional
information about certain SSDs where fatigue damage is likely to occur.
We are issuing this AD to prevent fatigue cracking that could
compromise the structural integrity of these airplanes.

DATES: This AD is effective May 10, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 10, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
November 2, 1995 (60 FR 51713, October 3, 1995).

ADDRESSES: For service information identified in this AD, contact
Lockheed Martin Corporation/Lockheed Martin Aeronautics Company,
Airworthiness Office, Dept. 6A0M, Zone 0252, Column P-58, 86 S. Cobb
Drive, Marietta, Georgia 30063; phone:<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.lockheedmartin.com/ams/tools/TechPubs.html. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Carl Gray, Aerospace Engineer,
Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office
(ACO), 1701 Columbia Avenue, College Park, Georgia 30337; phone: 404-
474-5554; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 95-20-04 R1, Amendment 39-9454 (60 FR 63414,
December 11, 1995). That AD applies to the specified products. The NPRM
published in the Federal Register on August 8, 2011 (76 FR 48049). That
NPRM proposed to continue to require implementation of a SID program of
structural inspections to detect fatigue cracking, and repair if
necessary. That NPRM also proposed to add Model L-1011-385-3 airplanes
to the applicability, change certain inspection thresholds and
intervals for Model L-1011-385-1, L-1011-385-1-14, and L-1011-385-1-15
airplanes, include three additional SSDs for Model L-1011-385-3
airplanes, and remove an SSD that has been addressed by a different AD
action.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
NPRM (76 FR 48049, August 8, 2011) and the FAA's response to each
comment.

Request To Withdraw NPRM (76 FR 48049, August 8, 2011)

    An anonymous commenter requested that we stop ``regulating job(s)
out of this country'' and leave companies alone to run their business
as they see fit.
    We infer the commenter is requesting that we withdraw the NPRM (76
FR 48049, August 8, 2011). We disagree. This AD addresses an identified
unsafe condition. If the structural inspections required by this AD are
not done, an airplane could develop fatigue cracking that could
compromise the structural integrity of the airplane. We have not
revised this AD in this regard.

Request To Clarify Reference

    Lockheed Martin requested that we clarify the section of the
document referenced in paragraph (g)(5) of the NPRM (76 FR 48049,
August 8, 2011) by replacing ``Appendix VI'' with ``Section VI.,
Appendix.'' The commenter noted that there is no Appendix VI in the
document and that there is a section VI titled Appendix.
    We agree, for the reason provided by the commenter. We have revised
paragraph (g)(5) of this AD accordingly.

Clarification of Repair Service Information

    We have added Note 1 following paragraph (n)(1) of this AD to
clarify that guidance on doing repairs in accordance with a ``L-1011-
385 Series Supplemental Inspection Document'' specified in paragraph
(n)(1) of this AD can be found in the applicable service bulletins
identified in certain SSDs of the ``L-1011-385 Series Supplemental
Inspection Document.''

Explanation of Changes Made to This AD

    We have revised certain headers throughout this AD. We have also
revised the wording in paragraph (g) of this AD. These changes have not
changed the intent of this AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the change described previously--and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 48049, August 8, 2011) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 48049, August 8, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 26 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
            Action                Labor cost      Parts cost        Cost per        airplanes     Cost for U.S.
                                                                    product         affected        operators
----------------------------------------------------------------------------------------------------------------
Incorporate SID into           550 work-hours               $0  $46,750........              26  $1,215,500.
 maintenance program            x $85 per hour
 [retained actions from AD 95-  = $46,750.
 20-04 R1, Amendment 39-9454
 (60 FR 63414, December 11,
 1995)].
Initial inspections [retained  245 work-hours               $0  $20,825........              26  $541,450.
 actions from AD 95-20-04 R1,   x $85 per hour
 Amendment 39-9454 (60 FR       = $20,825.
 63414, December 11, 1995)].
Repetitive inspections         52 work-hours x              $0  $4,420 per                   26  $114,920 per
 [retained actions from AD 95-  $85 per hour =                   inspection                       inspection
 20-04 R1, Amendment 39-9454    $4,420 per                       cycle.                           cycle.
 (60 FR 63414, December 11,     inspection
 1995)].                        cycle.
Incorporate SID into           1 work-hour x                $0  $85............               2  $170.
 maintenance program [new       85 = $85.
 action for Model L-1011-385-
 3 airplanes].
Initial inspections [new       48 work-hours x              $0  $4,080.........               2  $8,160.
 action for Model L-1011-385-   $85 per hour =
 3 airplanes].                  $4,080.
Repetitive inspections [new    44 work-hours x              $0  $3,740 per                    2  $7,480 per
 action for Model L-1011-385-   $85 per hour =                   inspection                       inspection
 3 airplanes].                  $3,740 per                       cycle.                           cycle.
                                inspection
                                cycle.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII,

Part A, Subpart III, Section 44701, ``General requirements.'' Under
that section, Congress charges the FAA with promoting safe flight of
civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
95-20-04 R1, Amendment 39-9454 (60 FR 63414, December 11, 1995), and
adding the following new AD:

2012-05-06 Lockheed Martin Corporation/Lockheed Martin Aeronautics
Company: Amendment 39-16978; Docket No. FAA-2011-0723; Directorate
Identifier 2010-NM-080-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective May 10, 2012.

(b) Affected ADs

    This AD supersedes AD 95-20-04 R1, Amendment 39-9454 (60 FR
63414, December 11, 1995).

(c) Applicability

    All Lockheed Martin Corporation/Lockheed Martin Aeronautics
Company Model L-1011-385-1, L-1011-385-1-14, L-1011-385-1-15, and L-
1011-385-3 airplanes, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the manufacturer of
usage and flight data that provided additional information about
certain structurally significant details (SSDs) where fatigue damage
is likely to occur. We are issuing this AD to prevent fatigue
cracking that could compromise the structural integrity of these
airplanes.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Maintenance Program Revision

    This maintenance program revision is retained from AD 95-20-04
R1, Amendment 39-9454 (60 FR 63414, December 11, 1995): For Model L-
1011-385-1, L-1011-385-1-14, and L-1011-385-1-15 airplanes: Within
12 months after November 2, 1995 (the effective date of AD 95-20-04
R1, Amendment 39-9454 (60 FR 63414, December 11, 1995)), incorporate
a revision into the maintenance inspection program which provides
for inspection(s) of the structurally significant details (SSD)
defined in Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994. Doing the
revision required by paragraph (h) of this AD terminates the
requirement to revise the maintenance inspections program specified
in this paragraph. Doing the inspections required by paragraph (i)
of this AD terminates the corresponding inspection requirements of
this paragraph.
    (1) The initial inspection for each SSD must be performed at the
later of the times specified in paragraph (g)(1)(i) or (g)(1)(ii) of
this AD.
    (i) Within one repeat interval measured from November 2, 1996
(12 months after November 2, 1995).
    (ii) Prior to the threshold specified in Lockheed Document
Number LG92ER0060, ``L-1011-385 Series Supplemental Inspection
Document,'' revised January 1994, for that SSD.
    (2) A 10 percent deviation from the repetitive interval
specified in Lockheed Document Number LG92ER0060, ``L-1011-385
Series Supplemental Inspection Document,'' revised January 1994, for
that SSD is acceptable to allow for planning and scheduling time.
    (3) If Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994, specifies
that inspection of any SSD be performed at every ``C'' check, those
inspections must be performed at intervals not to exceed 5,000 hours
time-in-service or 2,500 flight cycles, whichever occurs earlier.
    (4) If Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994, specifies
either the initial inspection or the repetitive inspection intervals
for any SSD in terms of flight hours or flight cycles, the
inspection shall be performed prior to the earlier of the terms
(whichever occurs first on the airplane: either accumulated number
of flight hours, or accumulated number of flight cycles).
    (5) The non-destructive inspection techniques referenced in
Section VI., ``Appendix,'' of Lockheed Document Number LG92ER0060,
``L-1011-385 Series Supplemental Inspection Document,'' revised
January 1994, provide acceptable methods for accomplishing the
inspections required by paragraph (g) of this AD.

(h) New Requirements of This AD: Maintenance Program Revision

    For all airplanes: Within 12 months after the effective date of
this AD, incorporate a revision into the maintenance inspection
program which provides for inspection(s) of the SSDs defined in
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised April 2009. Doing this
revision terminates the requirement to revise the maintenance
inspection program as specified in paragraph (g) of this AD.

(i) New Requirement of This AD: Threshold and Intervals

    For all airplanes: Do all applicable inspections specified in
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised April 2009. Do the
initial inspection or next repetitive inspection at the applicable
time specified in paragraphs (i)(1) and (i)(2) of this AD, except as
provided by paragraphs (j), (k), and (l) of this AD. Repeat the
inspections thereafter in accordance with the intervals and actions
specified in Lockheed Document Number LG92ER0060, ``L-1011-385
Series Supplemental Inspection Document,'' revised April 2009,
except as provided by paragraphs (j), (k), and (l) of this AD. The
non-destructive inspection techniques referenced in Lockheed
Document Number LG92ER0060, ``L-1011-385 Series Supplemental
Inspection Document,'' revised April 2009, provide acceptable
methods for accomplishing the inspections required by this AD. Doing
the inspections required by this paragraph of this AD terminates the
corresponding inspection requirements of paragraph (g) of this AD.
    (1) For Model L-1011-385-3 airplanes; and for Model L-1011-385-
1, L-1011-385-1-14, and L-1011-385-1-15 airplanes on which the
initial inspection required by paragraph (g) of this AD has not been

accomplished before the effective date of this AD: Do the initial
inspection at the later of the times specified in paragraphs
(i)(1)(i) and (i)(1)(ii) of this AD.
    (i) Within one repeat interval measured from a date 12 months
after the effective date of this AD.
    (ii) Before the threshold specified for that SSD in Lockheed
Document Number LG92ER0060, ``L-1011-385 Series Supplemental
Inspection Document,'' revised April 2009.
    (2) For Model L-1011-385-1, L-1011-385-1-14, and L-1011-385-1-15
airplanes on which the initial inspection required by paragraph (g)
of this AD has been accomplished before the effective date of this
AD: Do the next repetitive inspection at the earlier of the times
specified in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD.
    (i) Within the next repetitive inspection interval specified in
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994, for that
SSD.
    (ii) Within one repeat interval measured from a date 12 months
after the effective date of this AD; or within the next repetitive
interval specified in Lockheed Document Number LG92ER0060, ``L-1011-
385 Series Supplemental Inspection Document,'' revised April 2009,
for that SSD; whichever occurs later.

(j) Exception to Intervals--10 Percent Deviation Allowed

    For all airplanes: A 10 percent deviation from the repetitive
interval specified in Lockheed Document Number LG92ER0060, ``L-1011-
385 Series Supplemental Inspection Document,'' revised April 2009,
for that SSD is acceptable to allow for planning and scheduling
time.

(k) Exception to Intervals Specifying ``C'' Check

    For all airplanes: Where Lockheed Document Number LG92ER0060,
``L-1011-385 Series Supplemental Inspection Document,'' revised
April 2009, specifies that inspection of any SSD be performed at
every ``C'' check, those inspections must be performed at intervals
not to exceed 5,000 flight hours or 2,500 flight cycles, whichever
occurs earlier.

(l) Exceptions to Threshold and Intervals

    For all airplanes: Where Lockheed Document Number LG92ER0060,
``L-1011-385 Series Supplemental Inspection Document,'' revised
April 2009, specifies either the initial inspection or the
repetitive inspection intervals for any SSD in terms of flight hours
or flight cycles, the inspection must be performed prior to the
earlier of the terms (whichever occurs first on the airplane: either
accumulated number of flight hours, or accumulated number of flight
cycles).

(m) Exception to Inspection Procedure

    For all airplanes: There should be no repair or modification
work done in the inspection area before the initial inspections
required by paragraph (i) of this AD; any changes in the inspection
area could affect the inspection procedure.

(n) New Requirements of This AD: Repair

    For all airplanes: If any cracking is found in any SSD during
any inspection required by this AD, prior to further flight, repair
in accordance with paragraph (n)(1), (n)(2), or (n)(3) of this AD:
    (1) In accordance with the Lockheed Document Number LG92ER0060,
``L-1011-385 Series Supplemental Inspection Document,'' revised
January 1994; or revised April 2009. After doing the revision
required by paragraph (h) of this AD, repair in accordance with
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised April 2009.

    Note 1 to paragraph (n)(1) of this AD: Guidance on doing repairs
in accordance with a ``L-1011-385 Series Supplemental Inspection
Document'' specified in paragraph (n)(1) of this AD can be found in
the applicable service bulletins identified in certain SSDs of the
``L-1011-385 Series Supplemental Inspection Document'' specified in
paragraph (n)(1) of this AD.

    (2) In accordance with Lockheed L-1011 Structural Repair Manual,
Revision 80, dated December 15, 2009.
    (3) In accordance with a method approved by the Manager, Atlanta
Aircraft Certification Office (ACO), FAA.

(o) New Requirements of This AD: Reporting

    For all airplanes: At the later of the times specified in
paragraphs (o)(1) and (o)(2) of this AD, submit a report of the
results (positive or negative) of the inspection(s) to Lockheed in
accordance with Section V., Data Reporting System (DRS), of the
applicable Lockheed Document specified in paragraph (o)(1) of this
AD. Under the provisions of the Paperwork Reduction Act (44 U.S.C.
3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements contained in this
AD and has assigned OMB Control Number 2120-0056.
    (1) Within 30 days after returning the airplane to service,
subsequent to accomplishment of the inspection(s) specified in
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994; or
Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised April 2009.
    (2) Within 30 days after the effective date of this AD.

(p) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(q) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in the
Related Information section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(r) Related Information

    For more information about this AD, contact Carl Gray, Aerospace
Engineer, Airframe Branch, ACE-117A, FAA, Atlanta ACO, 1701 Columbia
Avenue, College Park, Georgia 30337; phone:<PHONE_NUMBER>; fax: 404-
474-5606; email<EMAIL_ADDRESS>
(s) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51 on the date
specified.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 10, 2012.
    (i) Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised April 2009.
    (ii) Lockheed L-1011 Structural Repair Manual, Revision 80,
dated December 15, 2009, which contains the following errors:
    (A) Page 13/14 of Section 51-10-06, pages 1 through 10 of the
Table of Contents for Chapter 54, and page 809/810 of Section 55-35-
00 show a page date of ``Date 15XX;'' these pages should be dated
December 15, 2009.
    (B) The List of Effective Pages for Chapter 51 identifies
incorrect dates for pages 3 and 4 of the Table of Contents for
Chapter 51; the correct date of those pages is March 15, 1999.
    (C) Page 7 of the List of Effective Pages for Chapter 53 does
not list a configuration number for page 20 of Section 53-21-00;
that page should be identified as configuration 2.
    (D) The List of Effective Pages for Chapter 53 identifies
incorrect dates for pages 3 and 5 of Section 53-14-00 (Configuration
2); the correct dates are September 15, 1995, for page 3, and March
15, 1994, for page 5.
    (E) The List of Effective Pages for Chapter 53 identifies an
incorrect date for page 4 of Section 53-15-00; the correct date for
that page is September 15, 1981.

    (F) The List of Effective Pages for Chapter 54 identifies an
incorrect date for page 1 of Section 54-23-00; the correct date for
that page is May 15, 1986.
    (G) The List of Effective Pages for Chapter 54 identifies an
incorrect date for page 4 of Section 54-32-00; the correct date for
that page is March 15, 1992.
    (H) The List of Effective Pages for Chapter 57 identifies an
incorrect date for page 13 of Section 57-00-00; the correct date for
that page is April 15, 2005.
    (I) The List of Effective Pages for Chapter 57 identifies an
incorrect date for pages 16 and 18 of Section 57-12-00; the correct
date for those pages is March 15, 1983.
    (J) The List of Effective Pages for Chapter 57 identifies an
incorrect date for pages 801, 802, and 805/806 of Section 57-13-00;
the correct date for those pages is December 15, 2009.
    (K) The List of Effective Pages for Chapter 57 identifies an
incorrect date for pages 810 through 819 of Section 57-51-00; the
correct date for those pages is December 15, 2009.
    (L) The List of Effective Pages for Chapter 57 identifies an
incorrect date for page 4 of Section 57-52-00; the correct date for
that page is December 15, 2009.
    (M) Page 25, dated March 15, 1983, and page 26, dated May 15,
1986, of Section 57-12-00 were inadvertently omitted from the List
of Effective Pages for Chapter 57.
    (4) The following service information was approved for IBR
November 2, 1995 (60 FR 51713, October 3, 1995).
    (i) Lockheed Document Number LG92ER0060, ``L-1011-385 Series
Supplemental Inspection Document,'' revised January 1994.
    (5) For service information identified in this AD, contact
Lockheed Martin Corporation/Lockheed Martin Aeronautics Company,
L1011 Technical Support Center, Dept. 6A4M, Zone 0579, 86 South Cobb
Drive, Marietta, Georgia 30063-0579; telephone<PHONE_NUMBER>; fax
770-494-5445; email<EMAIL_ADDRESS>Internet http://www.lockheedmartin.com/ams/tools/TechPubs.html.
    (6) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (7) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, WA, on March 1, 2012.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-8040 Filed 4-4-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Notices]
[Page 11599]
[DOCID:fr08mr06-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-459-000, ER01-688-002]

IPP Energy LLC; Notice of Issuance of Order

March 2, 2006.
    IPP Energy LLC (IPP) filed an application for market-based rate
authority, with an accompanying rate schedule. The proposed market-
based rate schedule provides for the sale of energy, capacity and
ancillary at market-based rates. IPP also requested waiver of various
Commission regulations. In particular, IPP requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by IPP.
    On March 1, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the request
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approval of issuances of securities or assumptions of liability by IPP
should file a motion to intervene or protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is March 31, 2006.
    Absent a request to be heard in opposition by the deadline above,
IPP is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
IPP, compatible with the public interest, and is reasonably necessary
or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of IPP's issuances of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3274 Filed 3-7-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Page 8258]
[FR Doc No: 2018-03819]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI18-2-000]

Merchant Hydro Developers LLC; Notice of Declaration of Intention
and Soliciting Comments, Protests, and Motions To Intervene

    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI18-2-000.
    c. Date Filed: February 6, 2018.
    d. Applicant: Merchant Hydro Developers LLC.
    e. Name of Project: Old Forge Bore Hole Reclamation Pump Storage
Project.
    f. Location: The proposed Old Forge Bore Hole Reclamation Pump
Storage Project would be located near the Borough of Duryea, in Luzerne
and Lackawanna counties, Pennsylvania.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b) (2012).
    h. Applicant and Agent Contact: Merchant Hydro Developers LLC, c/o
Adam R. Rousselle, Sr., 5710 Oak Crest Drive, Doylestown, PA 45150,
telephone:<PHONE_NUMBER>; email: [email protected];
    i. FERC Contact: Any questions on this notice should be addressed
to Jennifer Polardino,<PHONE_NUMBER>, or email:
[email protected].
    j. Deadline for filing comments, protests, and motions to intervene
is: 30 days from the issuance date of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
comments, protests, and motions to intervene using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number DI18-2-000.
    k. Description of Project: The proposed closed-loop Old Forge Bore
Hole Reclamation Pump Storage Project would consist of: (1) A new upper
reservoir with a surface area of 300 acres and a storage capacity of
4,500 acre-feet at a surface elevation of approximately 1,356 feet
above mean sea level (msl) created through construction of a new
roller-compacted concrete or rock-fill dam; (2) a new lower reservoir
with a surface area of 300 acres and a storage capacity of 5,014 acre-
feet at a surface elevation of 550 feet msl; (3) four new 5,640-foot-
long, 16-foot-diameter penstocks connecting the upper and lower
reservoirs; (4) a new 250-foot-long, 150-foot-wide, 50-foot-high
powerhouse containing two or three turbine-generator units with a total
rated capacity of 450 megawatts; (5) a new transmission line connecting
the powerhouse to the 230/69-kilovolt Stanton substation owned by PPL
Electric Utilities; and (6) appurtenant facilities. Merchant Hydro
Developers LLC states that it will use only groundwater from an
underground abandoned mine to initially charge and seasonally refill
the upper reservoirs. The applicant proposes to transport groundwater
to its upper reservoirs using underground pumping equipment and
intakes. The applicant also states the project effectuates an
interconnection line without crossing the Susquehanna River or any
other body of water.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the project would affect the interests of
interstate or foreign commerce. The Commission also determines whether
or not the project: (1) Would be located on a navigable waterway; (2)
would occupy public lands or reservations of the United States; (3)
would utilize surplus water or water power from a government dam; or
(4) would be located on a non-navigable stream over which Congress has
Commerce Clause jurisdiction and would be constructed or enlarged after
1935.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number excluding the last three digits in the docket
number field to access the document. You may also register online at
http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above and in the Commission's Public Reference Room located at 888
First Street NE, Room 2A, Washington, DC 20426, or by calling (202)
502-8371.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must
bear in all capital letters the title COMMENTS, PROTESTS, and MOTIONS
TO INTERVENE, as applicable, and the Docket Number of the particular
application to which the filing refers. A copy of any Motion to
Intervene must also be served upon each representative of the Applicant
specified in the particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: February 20, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-03819 Filed 2-23-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: February 15, 2007 (Volume 72, Number 31)]
[Notices]
[Page 7485-7486]
[DOCID:fr15fe07-113]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

    Upon written request, copies available from: Securities and
Exchange Commission, Office of Filings and Information Services,
Washington, DC 20549.

    Extension: Rule 30e-1, SEC File No. 270-21 OMB Control No. 3235-
0025

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for extension of the previously approved collection
of information discussed below.
    The collection of information is entitled: ``Rule 30e-1 under the
Investment Company Act of 1940, Reports to Stockholders of Management
Companies.'' Section 30(e) (15 U.S.C. 80a-29(e)) of the Investment
Company Act of 1940 (``Investment Company Act'') (15 U.S.C. 80a-1 et
seq.) requires a registered investment company (``fund'') to transmit
to its shareholders, at least semi-annually, reports containing
information and financial statements as the Commission may prescribe.
Among other requirements, Rule 30e-1 (17 CFR 270.30e-1) under the
Investment Company Act directs funds to include in the shareholder
reports the information that is required by the fund's registration
statement. Failure to require the collection of this information would
seriously impede the amount of current information available to
shareholders and the public about funds and would prevent the
Commission from implementing the regulatory program required by
statute. The estimated annual number of respondents providing
shareholder reports under Rule 30e-1 is 4,040. The proposed frequency
of response is semi-annual. The estimate of the total annual reporting
burden of the collection of information is approximately 145.8 hours
per shareholder report and the total estimated annual burden for the
industry is 1,178,064 hours (145.8 hours per report x 2 reports x 4,040
funds). Providing the information required by Rule 30e-1 is mandatory.
Responses will not be kept confidential. Estimates of the burden hours
are made solely for the purposes of the Paperwork Reduction Act, and
are not derived from a comprehensive or even a representative survey or
study of the costs of SEC rules and forms.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or e-mail to:

<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312, or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: February 5, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-2614 Filed 2-14-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Pages 49532-49533]
[FR Doc No: 2011-20234]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0112]

Federal Motor Vehicle Safety Standards; Electronic Stability
Control; Technical Report on the Effectiveness of Electronic Stability
Control Systems for Cars and LTVs

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for comments on technical report.

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SUMMARY: This notice announces NHTSA's publication of a Technical
Report on its existing Safety Standard 126, Electronic Stability
Control Systems. The report's title is: Crash Prevention Effectiveness
in Light-Vehicle Electronic Stability Control: An Update of the 2007
NHTSA Evaluation.

DATES: Comments must be received no later than December 8, 2011

ADDRESSES: Report: The technical report is available on the Internet
for viewing in PDF format at http://www-nrd.nhtsa.dot.gov/Pubs/811486.pdf. You may obtain a copy of the report free of charge by
sending a self-addressed mailing label to Robert Sivinski (NVS-431),
National Highway Traffic Safety Administration, Room W53-438, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    Comments: You may submit comments [identified by Docket Number
NHTSA-2011-0112] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern Time,
Monday through Friday, except Federal holidays.
    You may call Docket Management at<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments, see
the Procedural Matters section of this document. Note that all comments
received will be posted without change to http://www.regulations.gov,
including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Bob Sivinski, Statistician, Evaluation
Division, NVS-431, National Center for Statistics and Analysis,
National Highway Traffic Safety Administration, Room W53-438, 1200 New
Jersey Avenue, SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>. E-
mail<EMAIL_ADDRESS>    For information about NHTSA's evaluations of the effectiveness of
existing regulations and programs: You may see a list of published
evaluation reports at http://www-nrd.nhtsa.dot.gov/cats/listpublications.aspx?Id=226&ShowBy=Category and if you click on any
report you will be able to view it in PDF format.

SUPPLEMENTARY INFORMATION: Statistical analyses based on data for
calendar years 1997 to 2009 from the Fatality Analysis Reporting System
(FARS) and the General Estimates System (GES) of the National
Automotive Sampling System (NASS) estimate the long-term effectiveness
of electronic stability control (ESC) for passenger cars and LTVs
(light trucks and vans). Safety Standard 126 establishes standards for
electronic stability control systems manufactured for use in light
vehicles. This report is an update of a previous NHTSA analysis of ESC
effectiveness (72 FR 41582) published in 2007.
    The principal findings are that ESC was associated with a six
percent decrease in the likelihood that a vehicle would be involved in
any police reported crash and an 18 percent reduction in the
probability that a vehicle would be involved in a fatal crash. For
passenger cars, the reductions are 5 percent and 23 percent,
respectively; for LTVs, 7 percent and 20 percent. Each of these
reductions is statistically significant except for the 5 percent
overall effect in cars.
    Procedural Matters:

How can I influence NHTSA's thinking on this subject?

    NHTSA welcomes public review of the technical report. NHTSA will
submit to the Docket a response to the comments and, if appropriate,
will supplement or revise the report.

How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the Docket
number of this document (NHTSA-2010-0116) in your comments.

    Your primary comments must not be more than 15 pages long (49 CFR
553.21). However, you may attach additional documents to your primary
comments. There is no limit on the length of the attachments.
    Anyone is able to search the electronic form of all comments
received into any of our dockets 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) or you may visit http://www.regulations.gov.
    Please send two paper copies of your comments to Docket Management,
fax them, or use the Federal eRulemaking Portal. The mailing address is
U.S. Department of Transportation, Docket Management Facility, M-30,
West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590. The fax number is 1-202-493-2251. To use the
Federal eRulemaking Portal, go to http://www.regulations.gov and follow
the online instructions for submitting comments.
    We also request, but do not require you to send a copy to Bob
Sivinski, Statistician, Evaluation Division, NVS-431, National Highway
Traffic Safety Administration, Room W53-440, 1200 New Jersey Avenue,
SE., Washington, DC 20590 (or e-mail them to robert.sivinski@dot.gov).
He can check if your comments have been received at the Docket and he
can expedite their review by NHTSA.

How can I be sure that my comments were received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, send three copies of your complete submission,
including the information you claim to be confidential business
information, to the Chief Counsel, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Include a cover letter supplying the information specified in our
confidential business information regulation (49 CFR part 512).
    In addition, send two copies from which you have deleted the
claimed confidential business information to U.S. Department of
Transportation, Docket Management Facility, M-30, West Building, Ground
Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
or submit them via the Federal eRulemaking Portal.

Will the agency consider late comments?

    In our response, we will consider all comments that Docket
Management receives before the close of business on the comment closing
date indicated above under DATES. To the extent possible, we will also
consider comments that Docket Management receives after that date.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the Docket for new material.

How can I read the comments submitted by other people?

    You may read the materials placed in the docket for this document
(e.g., the comments submitted in response to this document by other
interested persons) at any time by going to http://www.regulations.gov.
Follow the online instructions for accessing the dockets. You may also
read the materials at the Docket Management Facility by going to the
street address given above under ADDRESSES. The Docket Management
Facility is open between 9 a.m. and 5 p.m. Eastern Time, Monday through
Friday, except Federal holidays.

    Authority:  49 U.S.C. 30111, 30168; delegation of authority at
49 CFR 1.50 and 501.8.

James F. Simons,
Director, Office of Regulatory Analysis and Evaluation.
[FR Doc. 2011-20234 Filed 8-9-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Proposed Rules]
[Pages 5767-5770]
[FR Doc No: 2013-01596]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Parts 234, 235, and 236

[Docket No. FRA-2011-0061, Notice No. 2]
RIN 2130-AC32

Positive Train Control Systems (RRR)

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

ACTION: Clarification of NPRM and extension of comment period.

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SUMMARY: In response to a petition for rulemaking, FRA proposed, in a
notice of proposed rulemaking (NPRM) dated December 11, 2012,
amendments to regulations implementing a requirement of the Rail Safety
Improvement Act of 2008 that certain passenger and freight railroads
install positive train control (PTC) systems. The present document
clarifies FRA's responses to several elements of the Association of
American Railroads' (AAR) petition for rulemaking and which elements of
the petition for rulemaking FRA is considering, and asks specific
questions concerning those elements. This document does not alter FRA's
proposal as issued December 11, 2012, but it does extend the comment
period in this proceeding to March 11, 2013.

DATES: Written comments must be received by March 11, 2013. Comments
received after that date will be considered to the extent possible
without incurring additional expenses or delays.

ADDRESSES: Comments: Comments related to Docket No. FRA-2011-0061 may
be submitted by any of the following methods:
     Web Site: Comments should be filed at the Federal
eRulemaking Portal, http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: Room W12-140 on the Ground level of the
West Building, 1200 New Jersey Avenue SE., Washington, DC between 9
a.m. and 5 p.m. Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the agency 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. Please see the Privacy Act heading in the SUPPLEMENTARY
INFORMATION section of this document for Privacy Act information
related to any submitted comments or materials.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
Room W12-140 on the Ground level of the West Building, 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: Ronald Hynes, Director, Office of
Safety Assurance and Compliance, Federal Railroad Administration, Mail
Stop 25, West Building 3rd Floor West, Room W35-302, 1200 New Jersey
Avenue SE., Washington, DC 20590 (telephone:<PHONE_NUMBER>); or Matthew
T. Prince, Trial Attorney, Office of Chief Counsel, RCC-10, Mail Stop
10, West Building 7th Floor, Room W75-208, 1200 New Jersey Avenue SE.,
Washington, DC 20590 (telephone:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Table of Contents for Supplementary Information

I. Purpose and Background
II. Questions Concerning Proposals in the Petition Not Adopted in
the December 11, 2012 NPRM
    A. De Minimis Exception
    B. Yard Movement Exceptions
    C. Provision on En Route Failures

I. Purpose and Background

    FRA is issuing this document to clarify and seek additional
information related to its proposed rule published at 77 FR 73589 on
December 11, 2012, which was intended to provide additional regulatory
guidance and flexibility related to the implementation of PTC systems
by railroads as mandated by the Rail Safety Improvement Act of 2008,
Sec. 104, Div.A, Public Law 110-432, 122 Stat. 4854 (Oct. 16, 2008)
(codified at 49 U.S.C. 20157) (hereinafter ``RSIA''). This document
also extends the comment period in this proceeding to March 11, 2013,
in order to provide interested parties sufficient time in which to
develop responses.
    RSIA was signed into law on October 16, 2008, mandating PTC system
implementation by December 31, 2015. To effectuate this goal, RSIA
required the railroads to submit for FRA approval a PTC Implementation
Plan (PTCIP) within 18 months (i.e., by April 16, 2010). On July 27,
2009, FRA published an NPRM regarding the mandatory implementation and
operation of PTC systems in accordance with RSIA. During the comment
period for that proceeding, CSX Transportation, Inc. (CSX) suggested
that FRA create a de minimis exception to the requirement that lines
carrying materials poisonous by inhalation (PIH materials) traffic be
equipped with PTC systems.
    The final rule, published on January 15, 2010, included a de
minimis exception, because FRA believed that the exception had
significant merit and that it fell within the scope of the issues set
forth in the proposed rule. However, because none of the parties had
had an

opportunity to comment on this specific exception as provided in the
final rule, FRA sought further comments on the extent of the de minimis
exception. The further comments responsive to this issue were largely
favorable, although the AAR sought some additional expansion and
clarification. In publishing its second PTC final rule on September 27,
2010, based on the comments submitted, FRA decided not to further amend
the de minimis exception.
    In a petition for rulemaking dated April 22, 2011 (Petition), AAR
requested that FRA initiate a rulemaking to propose expanding the de
minimis exception and otherwise amend the rules concerning the
``limited operations'' exception, en route failures of trains operating
with PTC systems, and the discontinuance of signal systems once PTC
systems are installed. AAR also requested that FRA develop a new
exception for allowing unequipped trains to operate on PTC lines during
certain yard operations, create a new ``limited operations'' exception
for freight movements, modify the default procedures for handling the
en route failure of PTC systems, and allow automatic approval of the
discontinuance of signal systems where PTC systems are implemented. In
response to the Petition, FRA's December 11, 2012 NPRM proposed to make
many of the amendments requested in the Petition and requested
additional comment on the others.

II. Questions Concerning Proposals in the Petition Not Adopted in the
December 11, 2012 NPRM

    To fully develop the record, FRA seeks additional information from
all parties on the issues raised in the Petition. FRA also continues to
seek comment on all of the proposals in the NPRM, even those not
addressed in this document. This document further serves to clarify the
input FRA requests on specific items in the Petition and other matters.
FRA views all elements of the Petition as within the scope of this
rulemaking and seeks comment on each of the elements contained in the
Petition. The Petition can be found in the public docket related to
this proceeding, FRA-2011-0061, which can be accessed by following the
directions contained in the ADDRESSES section of this document. Nothing
in the NPRM has foreclosed FRA's further consideration of any issues or
approaches related to this rulemaking that may be submitted in public
comments.
    As a general note, when commenters are addressing specific
provisions of the NPRM, and when suggesting specific changes, FRA seeks
information, to the extent feasible and practicable, on the number of
additional miles and/or locomotives that would or would not require PTC
component installation (e.g., wayside components, onboard components).
For example, if a commenter suggests a change to a de minimis exception
alternative by recommending the use of a speed restriction instead of
track class criteria, FRA is interested in the number of track miles
that would no longer require PTC installation. FRA also seeks any
information on the potential costs associated with any increased
accident risk from not installing PTC. This type of information would
help FRA evaluate the benefits and costs for each potential change to
the PTC rule as well as the NPRM as a whole. Pursuant to Executive
Order 13563 and to the extent permitted by law, FRA seeks information
sufficient to make a reasoned determination that benefits justify costs
and therefore requests comment on the magnitude of specific proposed
rule changes.

A. De Minimis Exception

    FRA seeks comment on several aspects of the categorical de minimis
exception. The Petition proposed modifying the categorical exception to
apply only to 100 loaded PIH cars, and not to residue cars. AAR notes
that the Transportation Security Administration does not deem it
necessary to regulate residue cars for security purposes since
consequences of the release of a residue quantity of PIH materials
would be significantly less than the consequences of an incident
involving a loaded PIH car. In the NPRM, FRA proposes limiting the
categorical de minimis exception to lines with fewer than 200 cars
containing PIH materials (including both loaded and residue cars) per
year. For the reasons stated in the NPRM, FRA did not propose a
wholesale elimination of the applicability of the yearly cap on number
of cars to residue cars. Nonetheless, FRA seeks comments on that
decision and whether the car cap should apply only to loaded PIH cars
and at what level.
    FRA also seeks comment on the proposal to modify the de minimis
exception to include a two-trains-per-day limitation on trains carrying
PIH materials. Specifically, FRA seeks comment on the constraints
proposed on the two-train limitation in the NPRM (e.g., annual carload
limit, inclusion of residue cars) and whether different, or any,
constraints on a train-per-day limitation would be appropriate. FRA
seeks comment on the relationship between daily train limitations and
safety and the relationship between a daily train limitation and the
annual car limitation particularly with respect to different PIH
materials. For example, if the transit time for a tank car carrying
anhydrous hydrogen chloride is too long, there is a risk that the car
will become over-pressurized and that locations where such tank cars
are held need to have the capability to vent the cars. FRA also seeks
comment on the types of track segments that might not qualify for the
categorical de minimis exception solely due to the trains-per-day
limitation as well as operational changes that might be necessary to
comply with the daily train limitation on track segments that would
otherwise qualify for the de minimis exception (i.e., track segments
carrying less than 200 PIH material cars per year, but more than two
trains daily carrying PIH materials).
    The categorical de minimis exception also includes two criteria
meant to establish that a line qualifies as a ``low density track
segment,'' as discussed in 49 CFR 236.1005(b)(iii): (1) That the line
segment is Class 1 or Class 2 track; and (2) that the line density is
less than 15 million gross tons (MGT) per year. With respect to the
track class criterion, FRA seeks comment on the impact of the track
class criterion on track maintenance standards; specifically, on
whether the track class criterion creates a disincentive to setting
higher maintenance standards for excluded track segments. FRA also
seeks comment on whether the categorical de minimis exception should be
extended to include Class 3 track segments. Alternatively, FRA seeks
comment on the concept of eliminating the track class criteria and
using a speed restriction on trains carrying PIH materials, and, if so,
what that speed limit should be. FRA notes that in 2009, the Pipeline
and Hazardous Materials Safety Administration (PHMSA) of DOT issued
enhanced tank car design standards for new construction of railroad
tank cars designed to transport PIH materials. The new design standards
are intended to enhance the accident survivability of tank cars
transporting PIH materials. 74 FR 1770 (January 13, 2009). Commenters
should address the impact on the speed limit issue of the replacement
of the historical tank car fleet with newer, more robust tank cars
meeting the enhanced standards of PHMSA's rule. Commenters should
address both the probability and severity of a potential accident when
accounting for the costs of a potential change in track class

criteria or use of a speed restriction. With respect to the tonnage
limitation, FRA seeks comment on whether 15 MGT is the appropriate
threshold, taking into account both derailment rates and the severity
of derailments by traffic density, for the categorical de minimis
exemption. FRA also seeks comment on AAR's suggestion that the 15 MGT
limit be eliminated from the categorical de minimis exception and
potential alternative standards for the categorical de minimis
exception.
    The categorical de minimis exception also contains a 1-percent
grade restriction. The Petition suggests that the exception be
restricted to grades that are not ``heavy grade'' as defined in 49 CFR
part 232. Section 232.407 of title 49 CFR defines ``heavy grade'' as an
average grade of at least 2 percent over two continuous miles in the
case of a train operating with no more than 4,000 trailing tons, and as
an average grade of at least 1 percent over three continuous miles in
the case of a train operating with more than 4,000 trailing tons. After
noting the difficulty of applying these criteria to track segments
independent of specific train movements, FRA proposed in the NPRM a
grade restriction of 1 percent for three continuous miles. FRA
indicated that a railroad may seek relief under the general de minimis
exception for train operations with 4,000 trailing tons or less over
track with an average grade of two percent or less over a distance of
two miles. FRA seeks information on operational impacts associated with
grade limitations proposed in the NPRM and the Petition, and seeks
information on both the probability of a potential accident and the
severity of a potential accident associated with both grade
limitations. FRA also seeks specific information regarding the track
miles that would be excluded from the exception should either grade
limitation be adopted.
    In the existing regulations, the categorical de minimis exception
also requires that PIH materials be transported in trains that are
temporally separated from other trains, as the term is discussed in 49
CFR part 211, appendix A. In the Petition, AAR suggested that FRA
replace this requirement with a requirement that trains carrying PIH
materials be operated with an absolute block ahead of and behind the
train. FRA indicated in the NPRM that it is considering this block-
separation proposal, though it would not be accurate to refer to it as
``temporal separation.'' FRA requests comment on whether the block-
separation proposal would be an adequate alternative to temporal
separation in providing adequate protection for the remaining PIH
materials trains on a PTC-excluded track segment. FRA also seeks
comment on any other techniques (implementation of technology, methods
of operation, etc.) that could be used in place of temporal separation
to establish separation between trains and ensure the safety of trains
carrying PIH materials on PTC-excluded track segments.
    Under the proposal and the existing rule, track segments that do
not meet the specific requirements of the categorical de minimis
exception are still potentially excludable under the general de minimis
exception, so long as it can be demonstrated that the track segment has
only ``negligible risk'' of events occurring that PTC systems are
designed to prevent. FRA seeks comment generally on methods for
determining negligible risk and whether there should be an established
rule for what constitutes negligible risk. In the NPRM, FRA noted the
difficulty the agency encountered when seeking to quantify risk in the
development of the residual risk qualifying test with respect to the
initial PTC final rule issued on January 15, 2010, and that it could be
difficult to quantify risk in this circumstance as well. To establish a
quantified risk assessment as AAR requested in the Petition, such a
calculation would presumably be necessary, and FRA requests discussion
of how to quantify the risk of any particular track segment and what
might be an appropriate threshold using that quantification.
Additionally, FRA requests that commenters specifically address what
elements (e.g., traffic type, train speed, geography, grade, or
proximity to populated areas, or other relevant factors), should be
considered when calculating negligible risk, as well as the potential
utility of the hazardous material routing analysis to determining the
characteristics of a track segment with negligible risk. See 49 CFR
172.820.
    FRA notes that AAR's Petition also sought a new ``limited
operations'' exception in instances where there are limited freight
operations on a line segment (fewer than 2 trains carrying PIH per day
and less than 15 MGT of traffic annually), and where additional
restrictions are imposed (i.e., 40-mph speed restriction, exclusions of
any track segments with heavy grades, special notification requirements
prior to entering work zones, and temporal separation or an alternative
achieving at least as much risk reduction). As noted in the NPRM, FRA
was not willing to propose such an exception since FRA was provided
limited flexibility in the statute to modify the definition of ``main
line'' for freight operations, and the exception is already covered by
the general de minimis exception. FRA seeks comment from all interested
parties regarding these issues and any additional information related
to AAR's limited operations suggestion contained in its Petition.

B. Yard Movement Exceptions

    While yard tracks fall outside the statutory PTC mandate, movements
associated with yard operations frequently require some movement along
main track adjacent to or within a yard. As FRA recognized in the NPRM,
PTC system implementation and operation for such movements poses
significant burdens. As a result, FRA proposes an exception from PTC
equipage requirements for locomotives performing movements associated
with yard operations as long as appropriate safeguards are implemented
to ensure that the risk of PTC-preventable accidents and release of PIH
materials is negligible. In particular, FRA proposes a new de minimis
exception for movements associated with yard operations and seeks
comments on how to tailor such operations to provide adequate safety
mitigation. Consistent with the 20-mile distance limitation for
transfer train movements in 49 CFR part 232 and the limitation for
Class II and Class III railroads operating PTC-unequipped locomotives,
FRA proposes that movements under the new yard movements de minimis
exception be limited to 10 miles from entry onto PTC-equipped main line
track. This limitation allowed for 20-mile round-trip train movements
while limiting the track segment exposed to unequipped movements to
only 20 miles. In the NPRM, FRA requests comment on the proposed 10-
mile limitation and seeks information as to whether 10 miles is the
appropriate limit. Specifically, FRA is seeking discussion of the
impact of the 10-mile limit on current switching operations. FRA also
estimates that 500 locomotives would not have to be equipped with PTC
onboard apparatuses if a 10-mile limit were established. FRA requests
comment on this estimate as well as estimates of the number of
locomotives affected if instead FRA were to adopt a 20-mile limit from
entry on to PTC-equipped main line track. FRA also requests comments
regarding other operational benefits or hazards that might result from
extending the limit to 20 miles. FRA further recognizes that there may
be unusual switching operations that pose only a negligible risk of a
PTC-

preventable accident or PIH material release but nonetheless would not
qualify for the de minimis exception as defined here. FRA requests
examples of such operations, if any exist, and seeks comment on the
practicability of the waiver process as an acceptable method of
handling such operations.
    In the Petition, AAR suggested a concept that it refers to as
``absolute protection'' to address the issue of yard movements. The
AAR's proposal would require that the dispatcher withhold movement
authority between two points of control by signal indication or
mandatory directive; that the movement of non-PTC equipped locomotives
and non-initialized locomotives would be limited to 30 mph; and that
the distance the locomotives would be permitted to travel from a yard
or terminal would be limited to 20 miles. FRA solicited comment on
AAR's proposal in the NPRM and continues to seek comments on whether
the AAR's proposal regarding dispatcher control of train movements
provides a sufficiently low risk of an accident and PIH release to
support approval of such an operating restriction.

C. Provision on En Route Failures

    In the NPRM, FRA seeks comment on the issue of en route failures
and suggestions for other alternative default provisions, in addition
to the existing authority for railroads to provide alternative methods
of resolving en route failures in their PTC Safety Plans. Although the
NPRM notes that FRA rejected AAR's request in the Petition to amend the
existing rule with regard to en route failures, that statement was
intended to mean that based on the information currently available to
FRA, it was not willing to propose a specific change to the existing
rule in the NPRM. FRA remains open to consideration of viable
suggestions and ideas for handling en route failures in a manner
different than that contained in the existing rule and encourages all
interested parties to provide such comments on this issue. As discussed
below, FRA seeks specific comment on the potential frequency of en
route failures, any potential safety measures or operational
restrictions that could be utilized in the event of an en route
failure, as well as any information or data regarding the severity of
the effects on the rail network that might arise due to compliance with
the existing en route failure requirements. FRA also seeks comment on
the degree of flexibility proposed 49 CFR 236.1029 allows FRA to
address en route failures.
    As stated in the NPRM, FRA recognizes that there may be issues with
PTC system reliability during the early periods of use, and seeks to
balance the statutory mandate for increased safety with the realities
of implementing new and previously undeveloped systems, the failures of
which pose significant risks to overall network capacity. Accordingly,
FRA further seeks comment on the appropriate balance of the safety risk
and risk to network capacity both during the initial rollout of PTC
systems and once PTC systems are fully developed with system failures
mostly resolved. As part of that discussion, FRA requests information
on the experiences to date with PTC system failures and system
reliability. FRA also requests information on the actual consequences
experienced and the potential consequences of maintaining the current
en route failure provisions, including potential modal diversion due to
diminished capacity. FRA also seeks comment on replacing the existing
``en route failure'' provisions with limitations that pose less risk of
diminishing network capacity. One method of mitigating potential
reductions in network capacity could be a process to phase in the more
stringent ``en route failure'' requirements as PTC systems mature and
become more reliable. FRA seeks comment on this potential method
generally and on the specifics of potential timeframes and phase-in
procedures for the ``en route failure'' requirements.

    Issued in Washington, DC, on January 22, 2013.
Joseph C. Szabo,
Administrator.
[FR Doc. 2013-01596 Filed 1-25-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66543-66545]
[FR Doc No: 2015-27581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3579]

Using Technologies and Innovative Methods To Conduct Food and
Drug Administration-Regulated Clinical Investigations of
Investigational Drugs; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a public docket to solicit input from a broad
group of stakeholders on the scope and direction of the use of
technologies and innovative methods in the conduct of clinical
investigations. Specifically, FDA seeks information to understand
individual and industry experiences with the use of such technologies
to more efficiently conduct clinical research. FDA also seeks
stakeholder perspectives on possible barriers to implementing these
technologies and methods to conduct clinical investigations.

DATES: Submit electronic or written comments by December 28, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-3579 for ``Using Technologies and Innovative Methods to
Conduct FDA-Regulated Clinical Investigations of Investigational
Drugs.'' Please identify the specific question or issue that the
comment addresses. Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole Silva, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3341, Silver Spring, MD 20993-0002, 301-
796-3419; Aaliyah K. Eaves, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Clinical investigations that ensure the protection of the rights,
safety, and welfare of trial participants and that yield reliable data
are critical to FDA's mission to ensure that medical products are safe
and effective. The clinical trial enterprise continues to evolve and
become more complex, and the scientific and infrastructure challenges
of conducting clinical investigations affect the cost and timeliness of
medical product development. Challenges in recruiting and retaining
sufficient numbers of trial participants to conduct an adequately
powered investigation in a reasonable amount of time may contribute to
the cost and complexity. Creative uses of technology in conducting
clinical investigations have emerged over the previous decade and
include advances that have the potential to improve recruitment,
participation, and retention of trial participants. New technology and
communication infrastructure allow for collection of data and
communication wherever the trial participant is located, including at
his or her health care provider's location, creating opportunities to
overcome geographical and logistical barriers that otherwise might
prevent a potential trial participant from participating in a clinical
investigation, as well as facilitating the integration of research with
clinical care. In addition to potential convenience for the trial
participant, these tools and technologies may present sponsors with the
opportunity to capture data more frequently and efficiently than would
be feasible if data collection were only conducted when the trial
participant visited the study site. This may enhance the sponsor's
ability to understand the safety and effectiveness of drugs, biologics,
and medical devices; increase additional meaningful data gathering;
minimize missing data; and maximize trial participation and retention.
    Some of these technologies and methods may be used regardless of
the trial participant's location and may include, for example, mobile
health technology, telemedicine, and remote sensors. Use of these
technologies and methods allows for more flexibility for the sponsor
and clinical investigator in the oversight of clinical investigation
conduct, data collection, and monitoring of trial participants and
clinical sites. Other elements that may be incorporated into clinical
investigations to improve trial participant recruitment include online/
Web-based eligibility screening, informed consent, and communication
between investigators and participants.

II. Purpose of the Docket

    FDA is soliciting public input from a broad group of stakeholders
regarding technologies and innovative methods for using technology to
more efficiently conduct clinical research. FDA is interested in
identifying new opportunities to study medical products, as well as
receiving comments on barriers, challenges, and relevant considerations
that may affect a medical product clinical investigation that uses
these technologies and methods.

III. Issues for Comment

    In addition to the general information requests in section II of
this document, FDA is interested in obtaining information and public
comment on the following specific issues:
    1. What technologies, communication infrastructure, or innovative
methods are being used to conduct clinical investigations? FDA is aware
of several groups conducting and interested in conducting clinical
investigations using mobile technology and remote methods for data
collection. FDA requests feedback on experiences with implementing such
methods or models (for example, lessons learned), as well as
information supporting the use of any suggested technologies, methods,
or models, including any characteristics that would make the technology
more or less desirable for use in clinical trials.
    2. What are ways FDA could encourage adoption of these technologies
and innovative methods in the conduct of clinical investigations?
    3. Identify any clinical, cultural, business, regulatory, or other
barriers perceived by stakeholders that serve as a disincentive to the
use of technology to facilitate the conduct of clinical investigations.
    a. What challenges do stakeholders anticipate in adoption of these
technologies or methods? Are there challenges in complying with
regulatory requirements surrounding the conduct of clinical
investigations that use such technologies or methods?
    b. What are the perceived barriers or challenges to obtaining and
documenting informed consent or obtaining institutional review board
review, approval, and oversight for clinical investigations utilizing
these technologies or methods?
    4. FDA is interested in obtaining information on potential trial
participant acceptance, privacy, and human subject protection issues
that may occur as a result of the use of technologies and innovative
methods for the conduct of clinical investigations. In particular, FDA
is

interested in assessing potential trial participants' interest,
tolerance, concerns, and willingness to participate in clinical
investigations that involve nontraditional settings or utilize new
technologies. FDA is also interested in identifying the factors that
affect trial participant awareness, acceptance, enrollment, and
retention for these investigations.
    a. Are there specific patient groups or therapeutic areas that
could particularly benefit from these types of technologies or methods?
    b. What new opportunities for the conduct of clinical
investigations are created through the use of continuous or
intermittent remote monitoring and data collection?
    c. What are some of the anticipated risks to trial participants
that may occur as a result of the use of these technologies or off-site
methods in clinical investigations?
    d. What are some of the anticipated benefits to trial participants
that may occur as a result of the use of these technologies or off-site
methods in clinical investigations?
    e. Are there perceived challenges to participation in clinical
investigations utilizing these types of technologies or methods because
of concerns regarding inadvertent disclosure of trial participants'
information or breach of privacy? Are there concerns relating to the
integrity of data collection or encryption or the secure transmission
of information?
    f. Are there unique considerations for ensuring integrity of the
source data, for example, authenticity and reliability?
    g. How should validation of participant-operated mobile devices be
addressed?
    h. What are the challenges presented when data are collected using
the Bring Your Own Device (BYOD) model? BYOD in clinical investigations
refers to the practice of trial participants using their own devices,
such as smartphones or tablets, for data collection. For example,
participants in a clinical investigation may use their own computer
devices to access and respond to study-related questionnaires. What are
the perceived barriers to pooling data collected from different devices
provided by individual trial participants, as well as pooling data from
the BYOD model with data collected at the investigational site or on
paper forms? How should situations such as mid-study user device
switches be handled?
    i. What are the challenges or special considerations with
recruiting and/or retaining potential trial participants with low
levels of computer literacy or individuals who may have limited or no
access to mobile technologies, computer devices, or the Internet? How
can these challenges or special considerations best be addressed?

    Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27581 Filed 10-28-15; 8:45 am]
 BILLING CODE 4164-01-P