[Federal Register: November 12, 2009 (Volume 74, Number 217)]
[Rules and Regulations]
[Page 58191-58195]
[DOCID:fr12no09-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0687; Directorate Identifier 2009-NM-033-AD;
Amendment 39-16080; AD 2009-23-08]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de
Aeron[aacute]utica S.A. (EMBRAER) Model ERJ 170 and ERJ 190 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for the products listed above. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    It has been found the occurrence of two events of aircraft being
dispatched with the cargo door opened without indication. In one of
the events the aircraft took off with the cargo door opened.
* * * * *
    The unsafe condition is a cargo door opening during flight, which
could result in reduced structural integrity and consequent rapid
decompression of the airplane. We are issuing this AD to require
actions to correct the unsafe condition on these products.

DATES: This AD becomes effective December 17, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 17,
2009.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2848; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 18, 2009 (74
FR 41642), and proposed to supersede AD 2007-06-53, Amendment 39-15035
(72 FR 21088, April 30, 2007). That NPRM proposed to correct an unsafe
condition for the specified products. The MCAI states:

    It has been found the occurrence of two events of aircraft being
dispatched with the cargo door opened without indication. In one of
the events the aircraft took off with the cargo door opened.

    The unsafe condition is a cargo door opening during flight, which
could result in reduced structural integrity and consequent rapid
decompression of the airplane. Required actions include repetitive
inspections of the forward and aft cargo doors to detect signs of
interference between the lock handle and the aft edge liner assembly
and

reworking the assembly; a one-time inspection for signs of damage of
the lateral roller fitting on the forward and aft cargo door frames at
the fuselage and replacement of the roller if necessary, and
modification of the cargo door, which ends the repetitive inspections.
After accomplishing the modification, the actions include incorporating
information into the maintenance program to include the operational
(OPC) and functional (FNC) checks of the forward and aft cargo doors
and accomplishing repetitive OPC and FNC checks. You may obtain further
information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Costs of Compliance

    We estimate that this AD will affect about 145 products of U.S.
registry.
    The actions that are required by AD 2007-06-53 and retained in this
AD take about 1 work-hour per product, at an average labor rate of $80
per work hour. Based on these figures, the estimated cost of the
currently required actions is $80 per product.
    We estimate that it would take about 7 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $80 per work-hour. Required parts will cost about $17,162 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these costs. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of the AD on U.S.
operators to be $2,569,690, or $17,722 per product.

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 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 this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 Amendment 39-15035 (72 FR
21088, April 30, 2007) and adding the following new AD:

2009-23-08 Empresa Brasileira de Aeron[aacute]utica S.A. (EMBRAER):
Amendment 39-16080. Docket No. FAA-2009-0687; Directorate Identifier
2009-NM-033-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
17, 2009.

Affected ADs

    (b) This AD supersedes AD 2007-06-53, Amendment 39-15035.

Applicability

    (c) This AD applies to EMBRAER Model ERJ 170-100 LR, -100 STD, -
100 SE, -100 SU, -200 LR, -200 STD, and -200 SU airplanes; and ERJ
190-100 STD, -100 LR, -100 IGW, -200 LR, -200 STD, and -200 IGW
airplanes; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 52: Doors.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It has been found the occurrence of two events of aircraft being
dispatched with the cargo door opened without indication. In one of
the events the aircraft took off with the cargo door opened.

    The unsafe condition is a cargo door opening during flight,
which could result in reduced structural integrity and consequent
rapid decompression of the airplane. Required actions include
repetitive inspections of the forward and aft cargo doors to detect
signs of interference between the lock handle and the aft edge liner
assembly and reworking the assembly; a one-time inspection for signs
of damage of the lateral roller fitting on the forward and aft

cargo door frames at the fuselage and replacement of the roller if
necessary, and modification of the cargo door, which ends the
repetitive inspections. After accomplishing the modification, the
actions include incorporating information into the maintenance
program to include the operational (OPC) and functional (FNC) checks
of the forward and aft cargo doors and accomplishing repetitive OPC
and FNC checks.

Compliance

    (f) Required as indicated, unless accomplished previously.

Restatement of Requirements of AD 2007-06-53, With New Service
Information

Preflight Verification of Correct Door Closure

    (g) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: As of 24 hours after May 7, 2007 (the
effective date of AD 2007-06-53), before each flight after closing
the cargo doors, verify that the forward and aft cargo doors are
closed flush with the fuselage skin, and that all 4 latched and
locked indicators at the bottom of each door are green. Persons
qualified to do this verification are mechanics and flightcrew
members. If it cannot be verified that both doors are closed flush
with the fuselage skin, and that all 4 latched and locked indicators
at the bottom of each door are green, repair before further flight.
Repeat the verification before every flight until accomplishment of
the actions required by paragraph (h) of this AD.

Inspection for Interference and Damage

    (h) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: Within 10 days after May 7, 2007, do the
actions specified in paragraphs (h)(1), (h)(2), and (h)(3) of this
AD, in accordance with the Accomplishment Instructions of Embraer
Alert Service Bulletin 170-52-A036 (for Model ERJ 170 airplanes) or
190-52-A018 (for Model ERJ 190 airplanes), both dated March 12,
2007; or Revision 01, both dated March 23, 2007; as applicable. As
of the effective date of this AD, use Revision 01 of Embraer Alert
Service Bulletin 170-52-A036 or 190-52-A018.
    (1) Remove the roller fitting cover plate on the forward and aft
cargo door frames.
    (2) Perform a detailed inspection of the forward and aft cargo
doors to detect signs of interference between the lock handle and
the aft edge liner assembly. Then rework the aft edge liner assembly
at the applicable time specified in paragraph (h)(2)(i) or
(h)(2)(ii) of this AD.
    (i) If any sign of interference is detected: Rework the assembly
before further flight.
    (ii) If no sign of interference is detected: Rework the assembly
within 150 flight cycles after the inspection.
    (3) Perform a detailed inspection for signs of damage of the
lateral roller fitting on the forward and aft cargo door frames at
the fuselage. If any damage is found, replace the lateral roller
fitting before further flight with a new roller fitting having the
same part number, in accordance with Embraer Alert Service Bulletin
170-52-A036 or 190-52-A018, as applicable.
    (4) Actions done before May 7, 2007, in accordance with Embraer
Alert Service Bulletin 170-52-A036 or 190-52-A018, both dated March
12, 2007, are acceptable for compliance with the corresponding
requirements of this AD.

    Note 1: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

    Note 2: Embraer Alert Service Bulletins 170-52-A036 and 190-52-
A018 refer to Embraer Service Bulletins 170-50-0006 and 190-50-0006,
respectively, as additional sources of guidance for the rework and
roller fitting cover plate removal. Embraer Alert Service Bulletins
170-50-0006 and 190-50-0006 are currently at Revision 01, dated
March 13, 2007.

Repetitive Inspections for Damage

    (i) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: Repeat the inspection specified in paragraph
(h)(3) of this AD at intervals not to exceed 150 flight cycles until
the terminating action specified in paragraph (k)(3) of this AD has
been accomplished.

Parts Installation

    (j) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: As of May 7, 2007, no person may install a
roller fitting cover plate on the forward and aft cargo door frames
on any airplane.

New Requirements of This AD

Actions and Compliance

    (k) Unless already done, do the following actions.
    (1) For Model ERJ 190-200 LR, -200 STD, and -200 IGW airplanes:
As of 24 hours after the effective date of this AD, before each
flight after closing the cargo doors, verify that the forward and
aft cargo doors are closed flush with the fuselage skin, and that
all 4 latched and locked indicators at the bottom of each door are
green. Persons qualified to do this verification are mechanics and
flightcrew members. If it cannot be verified that both doors are
closed flush with the fuselage skin, and that all 4 latched and
locked indicators at the bottom of each door are green, repair
before further flight. Repeat the verification before every flight
until accomplishment of the actions required by paragraph (k)(2) of
this AD.
    (2) For Model ERJ 190-200 LR, -200 STD, and -200 IGW airplanes:
Within 10 days after the effective date of this AD, do the actions
specified in paragraphs (k)(2)(i), (k)(2)(ii), and (k)(2)(iii) of
this AD, in accordance with the Accomplishment Instructions of
Embraer Alert Service Bulletin 190-52-A018, Revision 01, dated March
23, 2007. Repeat the inspection specified in paragraph (k)(2)(iii)
of this AD at intervals not to exceed 150 flight cycles until the
terminating action specified in paragraph (k)(3) of this AD has been
accomplished.
    (i) Remove the roller fitting cover plate on the forward and aft
cargo door frames.
    (ii) Perform a detailed inspection of the forward and aft cargo
doors to detect signs of interference between the lock handle and
the aft edge liner assembly. Then rework the aft edge liner assembly
at the applicable time specified in paragraph (k)(2)(ii)(A) or
(k)(2)(ii)(B) of this AD.
    (A) If any sign of interference is detected: Rework the assembly
before further flight.
    (B) If no sign of interference is detected: Rework the assembly
within 150 flight cycles after the inspection.
    (iii) Perform a detailed inspection for signs of damage of the
lateral roller fitting on the forward and aft cargo door frames at
the fuselage. If any damage is found, replace the lateral roller
fitting before further flight with a new roller fitting having the
same part number, in accordance with Embraer Alert Service Bulletin
190-52-A018, Revision 01, dated March 23, 2007.
    (3) For all airplanes: Within 5,000 flight cycles after the
effective date of this AD, do the actions specified in paragraphs
(k)(3)(i) and (k)(3)(ii) of this AD on the forward and aft cargo
doors. Accomplishing the actions in this paragraph terminates the
repetitive inspections required by paragraphs (i) and (k)(2) of this
AD.
    (i) Relocate the cargo door closed indication sensor in
accordance with the Accomplishment Instructions of Embraer Service
Bulletin 170-52-0041, Revision 01, dated June 13, 2008; or 190-52-
0023, Revision 02, dated March 11, 2008; as applicable.
    (ii) Modify the cargo door lock handle mechanism and replace the
forward and aft cargo door roller fittings having part number (P/N)
170-92569-401 and 170-85452-401 with new fittings having P/N 170-
92569-403 and 170-85452-403, as applicable. Do the modification in
accordance with the Accomplishment Instructions of Embraer Service
Bulletins 170-52-0044, dated January 18, 2008; or 190-52-0027, dated
March 20, 2008; as applicable.
    (4) Actions done before the effective date of this AD in
accordance with Embraer Service Bulletin 170-52-0041, dated
September 6, 2007; or 190-52-0023, dated September 6, 2007, or
Revision 01, dated December 6, 2007; as applicable; are acceptable
for compliance with the corresponding requirements of this AD.
    (5) Within 12 months after the effective date of this AD or 12
months after accomplishing the modification required by paragraph
(k)(3) of this AD, whichever occurs later: Incorporate information
into the maintenance program to include the operational (OPC) and
functional (FNC) checks of the forward and aft cargo doors; in
accordance with a method approved by the

Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or the Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (or its delegated agent). Within 6,000
flight hours after doing the actions required by paragraph (k)(3) of
this AD, do the OPC and FNC checks and repeat the checks thereafter
at intervals not to exceed 6,000 flight hours.

    Note 3: Guidance on the OPC and FNC checks specified in
paragraph (k)(5) of this AD can be found in the document specified
in Table 1 of this AD, as applicable:

                      Table 1--OPC and FNC Guidance
------------------------------------------------------------------------
           Manual--                    Task--               Date--
------------------------------------------------------------------------
Embraer 170 Aircraft            52-31-00-710-801-A/   July 15, 2008.
 Maintenance Manual.             500.
                                52-31-20-720-801-A/   July 15, 2008.
                                 500.
                                52-32-00-710-801-A/   July 15, 2008.
                                 500.
                                52-32-20-720-801-A/   July 15, 2008.
                                 500.
Embraer 190 Aircraft            52-31-00-710-801-A/   July 15, 2008.
 Maintenance Manual.             500.
                                52-31-20-720-801-A/   July 15, 2008.
                                 500.
                                52-32-00-710-801-A/   July 15, 2008.
                                 500.
                                52-32-20-720-801-A/   July 15, 2008.
                                 500.
------------------------------------------------------------------------

    Note 4: For the purposes of this AD, a functional check (FNC)
is: ``A quantitative check to determine if one or more functions of
an item perform within specified limits.''

    Note 5:  For the purposes of this AD, an operational check (OPC)
is: ``A task to determine if an item is fulfilling its intended
purpose. Since it is a failure finding task, it does not require
quantitative tolerances.''

FAA AD Differences

    Note 6:  This AD differs from the MCAI and/or service
information as follows: Where the MCAI includes a compliance time of
``after accomplishment of the modification'' for revising the
maintenance program for Model ERJ-170 airplanes, we have determined
that a compliance time of ``within 12 months after the effective
date of the AD or within 12 months after accomplishment of the
modification, whichever occurs later'' is appropriate. This
compliance time is equivalent to the compliance time required for
Model ERJ-190 airplanes. The manufacturer and ANAC agree with this
compliance time.

Other FAA AD Provisions

    (l) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, FAA, has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
Send information to ATTN: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone
(425) 227-2848; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD. AMOCs approved previously in
accordance with AD 2007-06-53, are approved as AMOCs for the
corresponding provisions of paragraph (i) of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
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 and has assigned
OMB Control Number 2120-0056.

Related Information

    (m) Refer to Brazilian Airworthiness Directives 2007-03-01R1,
dated June 9, 2008, and 2007-03-02R2, dated November 21, 2008; and
the service information contained in Table 2 of this AD; for related
information.

                      Table 2--Service Information
------------------------------------------------------------------------
         Service bulletin            Revision             Date
------------------------------------------------------------------------
Embraer Alert Service Bulletin 170-        01  March 23, 2007.
 52-A036.
Embraer Alert Service Bulletin 190-        01  March 23, 2007.
 52-A018.
Embraer Service Bulletin                   01  June 13, 2008.
 170[dash]52[dash]0041.
Embraer Service Bulletin                  \1\  January 18, 2008.
 170[dash]52[dash]0044.
Embraer Service Bulletin                   02  March 11, 2008.
 190[dash]52[dash]0023.
Embraer Service Bulletin                  \1\  March 20, 2008.
 190[dash]52[dash]0027.
------------------------------------------------------------------------
\1\ Original.

Material Incorporated by Reference

    (n) You must use the applicable service information contained in
Table 3 of this AD to do the actions required by this AD, unless the
AD specifies otherwise.

               Table 3--Material Incorporated by Reference
------------------------------------------------------------------------
         Service bulletin            Revision             Date
------------------------------------------------------------------------
Embraer Alert Service Bulletin 170-        01  March 23, 2007.
 52-A036.
Embraer Alert Service Bulletin 190-        01  March 23, 2007.
 52-A018.
Embraer Service Bulletin 170-52-           01  June 13, 2008.
 0041.
Embraer Service Bulletin 170-52-          \1\  January 18, 2008.
 0044.
Embraer Service Bulletin 190-52-           02  March 11, 2008.
 0023.

Embraer Service Bulletin 190-52-          \1\  March 20, 2008.
 0027.
------------------------------------------------------------------------
\1\ Original.

     (1) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--
Putim--12227-901 S[atilde]o Jose dos Campos--SP--Brasil; telephone:
+55 12 3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com.
    (2) 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> or<PHONE_NUMBER>.
    (3) 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 NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on October 26, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-26622 Filed 11-10-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 36 (Wednesday, February 23, 2011)]
[Notices]
[Page 10087]
[FR Doc No: 2011-4022]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

CSX Transportation, Inc.

Waiver Petition Docket Number FRA-2011-0002

    The CSX Transportation, Inc. (CSXT) seeks a waiver of compliance
from certain provisions of Title 49 CFR parts 231 and 232, concerning
the operation of RoadRailer[supreg] and RailRunner[supreg] equipment on
their railroad. Specifically, CSXT seeks relief from certain provisions
of the Railroad Safety Appliance Standards in 49 CFR part 231, that
stipulates the number, location, and dimensions for handholds, ladders,
sill steps, uncoupling levers, and handbrakes. CSXT also seeks relief
from 49 CFR 231.1, which sets the standard height for drawbars. CSXT
states that this relief is necessary to allow them to operate and
commingle the RoadRailer[supreg] and RailRunner[supreg] equipment on
dedicated trains operating on their railroad.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2011-0002) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, 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 (Volume 65, Number 70;
Page 19477) or at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on February 16, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2011-4022 Filed 2-22-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Rules and Regulations]
[Pages 34626-34627]
[FR Doc No: 2021-13895]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0210; Airspace Docket No. 21-ANM-3]
RIN 2120-AA66

Amendment of Class E Airspace; Dillon, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the Class E airspace extending upward
from 1,200 feet above the surface at Dillon Airport, Dillon, MT. The
airspace is designed to support instrument flight rules (IFR)
operations at the airport.

DATES: Effective 0901 UTC, October 7, 2021. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov//air_traffic/publications/. For further information, you
can contact the Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. 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.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the Class E airspace at Dillon Airport, Dillon, MT, to
ensure the safety and management of IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 18484; April 9, 2021) for Docket No. FAA-2021-0210 to
modify the Class E airspace at Dillon Airport, Dillon, MT. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. One comment, in
favor of the airspace modification, was received.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71 modifies the Class E airspace,
extending upward from 1,200 feet above the surface, at Dillon Airport,
Dillon, MT. This airspace is designed to contain IFR aircraft
transitioning to/from the terminal and en route environments. This
action increases the airspace's radius from ``25 miles'' to ``50
miles'' around the airport. The 50-mile radius will properly contain
IFR aircraft transitioning to/from the airport.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant the preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

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

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM MT E5 Dillon, MT [Amended]

Dillon Airport, MT
    (Lat. 45[deg]15'19'' N, long. 112[deg]33'09'' W)

    That airspace extending upward from 700 feet above the surface
within a 5.2-mile radius of the airport, and within 3 miles each
side of the 205[deg] bearing from the airport, extending from the
5.2-mile radius to 9.9 miles southwest of the airport, and that
airspace within 8 miles west and 4 miles east of the 005[deg]
bearing from the airport, extending from the 5.2-mile radius to 16
miles north of the airport; and that airspace extending upward from
1,200 feet above the surface within a 50-mile radius of Dillon
Airport.

    Issued in Des Moines, Washington, on June 24, 2021.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2021-13895 Filed 6-29-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Proposed Rules]
[Page 69638-69639]
[DOCID:fr10de07-31]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29058; Airspace Docket 07-ASO-21]

Proposed Amendment of Class D Airspace; Jacksonville Whitehouse
NOLF, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This notice proposes to amend the Class D airspace at
Jacksonville Whitehouse Naval Out Lying Field (NOLF), FL. As a result
of an evaluation, it has been determined the Class D airspace should be
reduced at Jacksonville NOLF.

DATES: Comments must be received on or before January 24, 2008.

ADDRESSES: Send comments on this proposal to the Docket Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
1200 New Jersey Ave., SE., West Building, Ground Floor, Room W12-140,
Washington, DC 20590; telephone: 1-800-647-5527. You must identify the
docket number FAA-2007-29058/Airspace Docket No. 07-ASO-21, at the
beginning of your comments. You may also submit comments on the
Internet at http://www.regulations.gov. You may review the public

docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office (see ADDRESSES section for
address and phone number) between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views or arguments, as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2007-29058/
Airspace Docket No. 07-ASO-21.'' The postcard will be date/time stamped
and returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://.

www.faa.gov or the Federal Register's Web page at http://www.gpoaccess.gov/fr/index.html.
 Persons interested in being placed on

a mailing list for future NPRM's should contact the FAA's Office of
Rulemaking,<PHONE_NUMBER>, to request a copy of Advisory Circular No.
11-2A, Notice of Proposed Rulemaking Distribution System, which
describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class D airspace at Jacksonville
Whitehouse NOLF, FL. The current Class D airspace supports the Airport
Surveillance Radar (ASR) Standard Instrument Approach Procedure (SIAP)
at Jacksonville Whitehouse NOLF. This proposed action would reduce the
Class D airspace area and contain the SIAP. Class D airspace
designations are published in Paragraph 5000 of FAA Order 7400.9R,
dated August 15, 2007, and effective September 15, 2007, which is
incorporated by reference in 14 CFR 71.1. The Class D airspace
designations listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it has been determined the Class D airspace should be reduced at
Jacksonville NOLF.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400-9R, Airspace Designations and
Reporting Points, dated August 15, 2007, and

effective September 15, 2007, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Jacksonville Whitehouse NOLF, FL [Revised]

Jacksonville Whitehouse NOLF, FL
    (Lat. 30[deg]21'01'' N, long. 81[deg]52'59'' W)
Herlong Airport
    (Lat. 30[deg]16'40'' N, long. 81[deg]48'21'' W)

    That airspace extending upward from the surface, to and
including 2,600 feet MSL, within a 4.3-mile radius of Whitehouse
NOLF; excluding that airspace within the Jacksonville Cecil Field
Class D airspace area and that airspace within a 1.8-mile radius of
Herlong Airport. This Class D airspace area is effective during the
specific days and times established in advance by a Notice to
Airmen. The effective days and times will thereafter be continuously
published in the Airport/Facility Directory.
* * * * *

    Issued in College Park, Georgia, on November 9, 2007.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center.
[FR Doc. 07-5983 Filed 12-7-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55158-55160]
[FR Doc No: 2019-22370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]

Notice to Public of Website Location of Center for Devices and
Radiological Health Fiscal Year 2020 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the website location where the Agency will post two lists of
guidance documents that the Center for Devices and Radiological Health
(CDRH or the Center) intends to publish in fiscal year (FY) 2020. In
addition, FDA has established a docket where interested persons may
comment on the priority of topics for guidance, provide comments and/or
propose draft language for those topics, suggest topics for new or
different guidance documents, comment on the applicability of guidance
documents that have issued previously, and provide any other comments
that could benefit the CDRH guidance program and its engagement with
stakeholders. This feedback is critical to the CDRH guidance program to
ensure that we meet stakeholder needs.

DATES: Submit either electronic or written comments by December 16,
2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 16, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-2012-N-1021 for ``Notice to Public of website Location of CDRH
Fiscal Year 2020 Proposed Guidance 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of
2012, Title II, Food and Drug Administration Safety and Innovation Act
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. Among these commitments included:
     Annually posting a list of priority medical device
guidance documents that the Agency intends to publish within 12 months
of the date this list is published each fiscal year (the ``A-list''),
and
     Annually posting a list of device guidance documents that
the Agency intends to publish, as the Agency's guidance-development
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA
Reauthorization Act of 2017, (Pub. L. 115-52) maintained these
commitments.
    In addition, to ensure that final guidance documents continue to
provide stakeholders with the Agency's current thinking, CDRH annually
conducts a staged review of previously issued final guidances in
collaboration with stakeholders. CDRH intends to annually provide lists
of previously issued final guidances that are subject to review through
FY 2025 so that by 2025, FDA and stakeholders will have assessed the
applicability of all guidances older than 10 years. For instance, in
the annual notice for FY 2021, CDRH expects to provide a list of the
final guidance documents that issued in 2011, 2001, 1991, and 1981; the
annual notice for FY 2022 is expected to provide a list of the final
guidance documents that issued in 2012, 2002, 1992, and 1982, and so
on.
    FDA welcomes comments on any or all of the guidance documents on
the lists as explained in 21 CFR 10.115(f)(5). FDA has established
Docket No. FDA-2012-N-1021 where comments on the FY 2020 lists, draft
language for guidance documents on those topics, suggestions for new or
different guidances, and relative priority of guidance documents may be
submitted and shared with the public (see ADDRESSES). FDA believes this
docket is a valuable tool for receiving information from interested
persons. FDA anticipates that feedback from interested persons will
allow CDRH to better prioritize and more efficiently draft guidances to
meet the needs of the Agency and our stakeholders.
    In addition to posting the lists of prioritized device guidance
documents, CDRH has identified as a priority, and has devoted resources
to, finalization of draft guidance documents. To assure the timely
completion or reissuance of draft guidances, in FY 2015 CDRH committed
to performance goals for current and future draft guidance documents.
For draft guidance documents issued after October 1, 2014, CDRH
committed to finalize, withdraw, reopen the comment period, or issue
new draft guidance on the topic for 80 percent of the documents within
3 years of the close of the comment period and for the remaining 20
percent, within 5 years. As part of MDUFA IV commitments, FDA
reaffirmed this commitment, as resources permit.
    Fulfillment of these commitments will be reflected through the
issuance of updated guidance on existing topics, withdrawal of
guidances that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.

II. CDRH Guidance Development Initiatives

A. Metrics for FY 2019 A-List and B-List Publication

    Stakeholder feedback on guidance priorities is important to ensure
that the CDRH guidance program meets the needs of stakeholders. The
feedback received on the FY 2019 list was mostly in agreement, and CDRH
continued to work toward issuing the guidances on this list. Some
guidances requested for inclusion in the FY2019 list by stakeholders
have been included as part of the FY 2020 list. In FY 2019, CDRH
published 21 of 28 guidances on the FY 2019 list (17 from the A-list, 4
from the B-list).

A. Finalization of Draft Guidance Documents

    Of the 23 draft guidances issued in FY 2015, CDRH finalized 87
percent within 3 years of the comment period close. Five years from the
comment period close has not yet elapsed for the remaining guidances
issued in FY 2015. In addition, in FY 2019, one draft guidance issued
prior to October 1, 2013, remains, and CDRH has been continuing to work
towards taking an action on this remaining draft guidance.
    Looking forward, in FY 2020, CDRH will strive to finalize,
withdraw, or reopen the comment period for 50 percent of existing draft
guidances issued prior to October 1, 2014.

B. Applicability of Previously Issued Final Guidance

    At the website where CDRH has posted the ``A-list'' and ``B-list''
for FY 2020, CDRH has also posted a list of final guidance documents
that issued in 2010, 2000, 1990, and 1980 for our annual review of
previously issued final guidances.\1\ CDRH is interested in external
feedback on whether any of these final guidances should be revised or
withdrawn. In addition, for guidances that are recommended for
revision, information explaining the need for revision, such as the
impact and risk to public health associated with not revising the
guidance, would also be helpful as the Center considers potential
action with respect to these guidances. CDRH will consider the comments
received from this retrospective review

when determining priorities for updating guidance documents and will
revise these as resources permit.
---------------------------------------------------------------------------

    \1\ The retrospective list of final guidances does not include
special controls documents.
---------------------------------------------------------------------------

    Consistent with the Good Guidance Practices regulation at 21 CFR
10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or
withdraw an already existing guidance document. We request that the
suggestion clearly explain why the guidance document should be revised
or withdrawn and, if applicable, how it should be revised. While we are
requesting feedback on the list of previously issued final guidances
located in the annual agenda website, feedback on any guidance is
appreciated and will be considered.
    In FY 2019, CDRH received comments regarding guidances issued in
2009, 1999, and 1989, and has withdrawn three guidance documents in
response to comments received and because these guidance documents were
determined to no longer represent the Agency's current thinking. The
revision of several guidance documents is also being considered as
resources permit.

III. Website Location of Guidance Lists

    This notice announces the website location of the document that
provides the A and B lists of guidance documents, which CDRH is
intending to publish during FY 2020. To access these two lists, visit
FDA's website at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development. We note that the topics on this and past
guidance priority lists may be removed or modified based on current
priorities, as well as comments received regarding these lists.
Furthermore, FDA and CDRH priorities are subject to change at any time
(e.g., newly identified safety issues). The Agency is not required to
publish every guidance on either list if the resources needed would be
to the detriment of meeting quantitative review timelines and statutory
obligations. In addition, the Agency is not precluded from issuing
guidance documents that are not on either list.

    Dated: October 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22370 Filed 10-11-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54891-54893]
[FR Doc No: 2016-19576]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78545; File No. SR-NYSEArca-2016-111]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Equities Schedule of Fees and Charges for Exchange Services
Related to Tier 1 and Cross Asset Tier 2 Fees and Credits for Orders
Executed on the Exchange, and Eliminate the Routable Retail Order Tier

August 11, 2016.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on July 29, 2016, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Equities Schedule of
Fees and Charges for Exchange Services (the ``Fee Schedule'') related
to Tier 1 and Cross Asset Tier 2 fees and credits for orders executed
on the Exchange, and eliminate the Routable Retail Order Tier. The
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule related to Tier 1
and Cross Asset Tier 2 fees and credits for orders executed on the
Exchange.\4\ The Exchange also proposes to eliminate the Routable
Retail Order Tier. The Exchange proposes to implement the fee change
effective August 1, 2016.
---------------------------------------------------------------------------

    \4\ The Tier 2 [sic] fees and credits are available for round
lots and odd lots with a per share price $1.00 or above.
---------------------------------------------------------------------------

Tier 1
    Currently, ETP Holders and Market Makers qualify for Tier 1 fees
and credits by providing liquidity an average daily share volume per
month of 0.70% or more of the United States consolidated average daily
volume (``US CADV'').\5\ In Tape C Securities, ETP Holders and Market
Makers currently receive a credit of $0.0033 per share for orders that
provide liquidity to the Book and pay a fee of $0.0029 per share for
orders that take liquidity from the Book. The Exchange proposes to
amend the fees and credits applicable to ETP Holders and Market Makers
for orders executed in Tape C Securities. As proposed, ETP Holders and
Market Makers would receive a credit of $0.0032 per share for orders
that provide liquidity to the Book in Tape C Securities and would pay a
fee of $0.0030 per share for orders that take liquidity from the Book
in Tape C Securities. The Exchange is not proposing any other pricing
change in Tier 1.
---------------------------------------------------------------------------

    \5\ US CADV would mean the United States Consolidated Average
Daily Volume for transactions reported to the Consolidated Tape,
excluding odd lots through January 31, 2014 (except for purposes of
Lead Market Maker pricing), and excludes volume on days when the
market closes early and on the date of the annual reconstitution of
the Russell Investments Indexes. Transactions that are not reported
to the Consolidated Tape are not included in US CADV. See Fee
Schedule, footnote 3.
---------------------------------------------------------------------------

Cross Asset Tier 2
    Additionally, Cross Asset Tier 2 fees and credits currently apply
to ETP Holders and Market Makers that either (1) provide liquidity an
average daily volume share per month of 0.30% or more of the US CADV
and are affiliated with an OTP Holder or OTP Firm that provides an ADV
of electronic posted executions for the account of a market maker in
Penny Pilot issues on NYSE Arca Options (excluding mini options) of at
least 0.75% of total Customer equity and ETF option ADV as reported by
The Options Clearing Corporation (``OCC''), or (2) provide liquidity an
average daily volume share per month of 0.40% or more of the US CADV
and are affiliated with an OTP Holder or OTP Firm that provides an ADV
of electronic posted executions for the account of a market maker in
Penny Pilot issues on NYSE Arca Options (excluding mini options) of at
least 0.65% of total Customer equity and ETF option ADV as reported by
OCC. Such ETP Holders and Market Makers receive a credit of $0.0033 per
share for orders that provide liquidity to the Book in Tape C
Securities and pay a fee of $0.0029 per share for orders that take
liquidity from the Book in Tape C Securities. The Exchange proposes to
amend the fees and credits applicable to ETP Holders and Market Makers
for orders executed in Tape C Securities. As proposed, ETP Holders and
Market Makers would receive a credit of $0.0032 per share for orders
that provide liquidity to the Book in Tape C Securities and pay a fee
of $0.0030 per share for orders that take liquidity from the Book in
Tape C Securities.
Elimination of Obsolete Pricing
    The Fee Schedule currently includes a pricing tier, Routable Retail
Order Tier, that has not encouraged ETP Holders and Market Makers to
increase their activity to qualify for this pricing tier as
significantly as the Exchange had anticipated it would. As a result,
the Exchange proposes to remove this pricing tier from the Fee
Schedule.
    The proposed changes are not otherwise intended to address any
other problem, and the Exchange is not aware of any significant problem
that the affected market participants would have

in complying with the proposed changes.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\6\ in general, and furthers the
objectives of sections 6(b)(4) and 6(b)(5) of the Act,\7\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its members, issuers and
other persons using its facilities and does not unfairly discriminate
between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

Tier 1
    The Exchange believes that the proposed change to increase the fee
from $0.0029 per share to $0.0030 per share and to lower the credit
from $0.0033 per share to $0.0032 per share for Tier 1 customers in
Tape C Securities is reasonable as it is comparable to fees charged and
credits paid by at least one other exchange, specifically, Bats BZX
Exchange, which charges a fee of $0.0030 per share for orders that
remove liquidity in Tape C Securities on that market,\8\ and provides a
credit that ranges between $0.0020 per share and $0.0032 per share,
depending on the amount of volume transacted.\9\ The Exchange believes
that the proposed fee change is equitable and not unfairly
discriminatory because the proposed fees and credits would apply
uniformly to all similarly situated ETP Holders and Market Makers and
would apply to all Tier 1 orders that add or take liquidity from the
Book in Tape C Securities. The Exchange believes that recalibrating the
fees and credits will continue to attract order flow to the Exchange,
thereby contributing to price discovery on the Exchange and benefiting
investors generally.
---------------------------------------------------------------------------

    \8\ See Fee Codes and Associated Fees, Bats BZX Exchange Fee
Schedule, at https://batstrading.com/support/fee_schedule/bzx/.
    \9\ See Add Volume Tiers, Bats BZX Exchange Fee Schedule, at
https://batstrading.com/support/fee_schedule/bzx/.
---------------------------------------------------------------------------

Cross Asset Tier 2
    The Exchange believes that the proposed change to increase the fee
from $0.0029 per share to $0.0030 per share and to lower the credit
from $0.0033 per share to $0.0032 per share for Cross Asset Tier 2
customers in Tape C Securities is reasonable as it is comparable to
fees charged and credits paid by at least one other exchange,
specifically, Bats BZX Exchange, which charges a fee of $0.0030 per
share for orders that remove liquidity from that exchange in Tape C
Securities,\10\ and provides a lower cross-asset tier rebate of $0.0029
[sic] per share in Tape C Securities.\11\ The Exchange believes that
the proposed fee change is equitable and not unfairly discriminatory
because the proposed fees and credits would apply uniformly to all
similarly situated ETP Holders and Market Makers and would apply to all
Cross Asset Tier 2 orders that add or take liquidity from the Book in
Tape C Securities. The Exchange believes that recalibrating the fees
and credits will continue to attract order flow to the Exchange,
thereby contributing to price discovery on the Exchange and benefiting
investors generally.
---------------------------------------------------------------------------

    \10\ See Fee Codes and Associated Fees, Bats BZX Exchange Fee
Schedule, at https://batstrading.com/support/fee_schedule/bzx/.
    \11\ See Add Volume Tiers, Bats BZX Exchange Fee Schedule, at
https://batstrading.com/support/fee_schedule/bzx/.
---------------------------------------------------------------------------

Elimination of Obsolete Pricing
    The Exchange believes that it is reasonable to eliminate the
obsolete pricing tier from the Fee Schedule because ETP Holders and
Market Makers have not increased their activity to qualify for the
Routable Retail Order Tier as significantly as the Exchange anticipated
they would. The Exchange believes that it is equitable and not unfairly
discriminatory to eliminate the Routable Retail Order Tier because, as
proposed, the pricing tier would be eliminated entirely--ETP Holders
and Market Makers would no longer be able to qualify for this pricing
tier. This aspect of the proposed change would therefore result in a
more streamlined Fee Schedule.
    The Exchange believes that it is subject to significant competitive
forces, as described below in the Exchange's statement regarding the
burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with section 6(b)(8) of the Act,\12\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposal to amend the level of fees and
credits applicable to Tier 1 customers in Tape C Securities and to
Cross Asset Tier 2 customers in Tape C Securities would not place a
burden on competition as the proposed changes are comparable to fees
and credits for Tape C Securities provided by at least one other
exchange.\13\ The Exchange believes that the proposed fee changes could
promote competition between the Exchange and other execution venues,
including those that currently offer comparable transaction pricing, by
encouraging additional orders to be sent to the Exchange for execution.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(8).
    \13\ See supra, notes 8-11.
---------------------------------------------------------------------------

    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of ETP Holders or competing order execution venues to maintain
their competitive standing in the financial markets.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
section 19(b)(3)(A) \14\ of the Act and subparagraph (f)(2) of Rule
19b-4 \15\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of

investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings under section 19(b)(2)(B) \16\ of the Act to determine
whether the proposed rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2016-111 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2016-111. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2016-111 and should
be submitted on or before September 7, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-19576 Filed 8-16-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 44 (Wednesday, March 8, 2017)]
[Notices]
[Pages 13042-13043]
[FR Doc No: 2017-04528]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0382; FMCSA-2011-0383; FMCSA-2013-0194; FMCSA-
2014-0012; FMCSA-2014-0013]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions of 47
individuals from its prohibition in the Federal Motor Carrier Safety
Regulations (FMCSRs) against persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions enable these individuals with ITDM
to continue to operate CMVs in interstate commerce.

DATES: Each group of renewed exemptions was effective on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8 a.m. to 5:30 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or 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., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On November 25, 2016, FMCSA published a notice announcing its
decision to renew exemptions for 47 individuals from the insulin-
treated diabetes mellitus prohibition in 49 CFR 391.41(b)(3) to operate
a CMV in interstate commerce and requested comments from the public (81
FR 85317). The public comment period ended on December 27, 2016, and no
comments were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to or greater
than the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this preceding.

IV. Conclusion

    Based upon its evaluation of the 47 renewal exemption applications
and that no comments were received, FMCSA confirms its' decision to
exempt the following drivers from the rule prohibiting drivers with
ITDM from driving CMVs in interstate commerce in 49 CFR 391.41(b)(3):
    As of April 1, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 24 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (79 FR 6987; 79 FR
18388):

Dana A. Albert (NY)
John R. Benshoff (OH)
George A. Blanda (NY)
Terrence K. Cannon (IL)
Trisha J. Davis (ME)
Paul D. Ferris (NY)
Larry Gaskill (RI)
Thomas H. Gaskins (NC)
Gary A. Grant (WA)
Brian C. Halcomb (IL)
Gerald Lee (CA)
Timothy R. Lewis (OR)
Gregory J. Littlefield (MN)
Glen H. Miller (MI)
Ryan M. Ottis (ND)
Steven M. Parsons (WV)
William L. Reece (ND)
Jay R. Rude (AZ)
Denise D. Ruffin (MS)
Ryan E. Stretch (MO)
William F. Sullivan, IV (NY)
John R. Thompson (WI)
Everette L. Twyman (MO)
John F. Whitesides (NC)

    The drivers were included in Docket No. FMCSA-2013-0194. Their
exemptions are effective as of April 1, 2016, and will expire on April
1, 2018.
    As of April 6, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the

following 10 individuals, have satisfied the renewal conditions for
obtaining an exemption from the rule prohibiting drivers with ITDM from
driving CMVs in interstate commerce (77 FR 10612; 77 FR 20874):

Rick J. Birdsall (NE)
Steven L. Drake (CA)
Benjamin J. Duea (MN)
Steven E. Greer (MN)
Jonathan E. Hunsaker (OR)
William D. Larsen (SD)
Lee A. Richardson (NC)
William W. Simmons (FL)
Ronald O. Snyder (OH)
Douglas J. Wood (NY)

    The drivers were included in Docket No. FMCSA-2011-0382. Their
exemptions are effective as of April 6, 2016, and will expire on April
6, 2018.
    As of April 15, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, Maximo E. Gaytan (CO) has satisfied the renewal conditions for
obtaining an exemption from the rule prohibiting drivers with ITDM from
driving CMVs in interstate commerce (79 FR 14579; 79 FR 28590):
    This driver was included in Docket No. FMCSA-2014-0013. The
exemption is effective as of April 15, 2016, and will expire on April
15, 2018.
    As of April 27, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 10 individuals, have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (77 FR 13686; 77 FR
25227):

Alvin Acevedo (NJ)
Bobby D. Bennett (GA)
Mark S. Clemence (KS)
Elwood F. Gorom (WA)
Mike W. Holland (IL)
Dan M. McAllister (WI)
Paul F. Rivers (MN)
Marcus V. Romo (ID)
Wayne L. Snyder (OH)
Justin K. Zimmerschied (KS)

    The drivers were included in Docket No. FMCSA-2011-0383. Their
exemptions are effective as of April 27, 2016, and will expire on April
27, 2018.
    As of April 30, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 2 individuals, have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (79 FR 10612; 79 FR
14579; 79 FR 28590; 79 FR 27685):

Charles L. Bryant (PA)
Christopher P. Martin (NH)

    The drivers were included in Docket Nos. FMCSA-2014-0012; FMCSA-
2014-0013. Their exemptions are effective as of April 30, 2016, and
will expire on April 30, 2018.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136 and
31315.

    Issued on: February 28, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-04528 Filed 3-7-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66849-66850]
[FR Doc No: 2015-27706]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1856]

Human Cells, Tissues, and Cellular and Tissue-Based Products From
Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the draft document entitled ``Human Cells, Tissues,
and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory
Considerations; Draft Guidance for Industry'' published in the Federal
Register of December 24, 2014. FDA is reopening the comment period to
allow interested persons additional time to submit comments and any new
information.

DATES: Submit either electronic or written comments on the draft
guidance by April 29, 2016.

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-2014-D-1856 for ``Human Cells, Tissues, and Cellular and Tissue-
Based Products from Adipose Tissue: Regulatory Considerations; Draft
Guidance for Industry.'' 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: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 24, 2014 (79 FR 77414), FDA
announced the availability of a draft document entitled ``Human Cells,
Tissues, and Cellular and Tissue-Based Products from Adipose Tissue:
Regulatory Considerations; Draft Guidance for Industry'' dated December
2014. The draft guidance document provides sponsors, clinicians, and
other establishments that manufacture and use adipose tissue, with
recommendations for complying with the regulatory framework for human
cells, tissues, and cellular and tissue-based products (HCT/Ps). For
purposes of applying the HCT/P regulatory framework, FDA considers
connective tissue, including adipose tissue, to be a structural tissue.
Interested persons were originally given until February 23, 2015, to
comment on the draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is announcing
four other related documents. In a separate document, FDA is announcing
a public hearing entitled ``Draft Guidances Relating to the Regulation
of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public
Hearing; Request for Comments'' (part 15 hearing) to be held on April
13, 2016, to provide stakeholders with the opportunity to discuss FDA's
policy on regulation of HCT/Ps related to the four draft guidances on
the following topics: Homologous use, same surgical procedure
exception, minimal manipulation, and adipose tissue.
    In a separate document, FDA is announcing the availability of a
draft document entitled ``Homologous Use of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA
Staff.''
    In separate documents, FDA is also reopening the comment periods to

FDA's public dockets on the previously issued draft guidance documents
on the following topics related to HCT/Ps: Minimal manipulation (Docket
No. FDA-2014-D-1696) and same surgical procedure exception (Docket No.
FDA-2014-D-1584).

II. Reopening of Comment Period

    Following publication of December 24, 2014, notice of availability,
FDA received several requests to allow interested persons additional
time to comment. In conjunction with the part 15 hearing and
announcement of availability of the homologous use draft guidance, FDA
is reopening the comment period to allow potential respondents to
thoroughly evaluate and address pertinent issues. The adipose tissue
draft guidance and other related guidances (homologous use, minimal
manipulation, same surgical procedure exception) all deal with the
interpretation of the regulations under 21 CFR part 1271 that will be
addressed as part of the part 15 hearing.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27706 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P